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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2023
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission
file number: 001-39717
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
20-2903526 |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
Identification
Number) |
680
East Colorado Boulevard, Suite 180
Pasadena,
California 91101
(Address
of principal executive offices, including Zip Code)
(631)
830-7092
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
LIXT |
|
The
Nasdaq Stock Market LLC |
Warrants
to Purchase Common Stock, par value $0.0001 per share |
|
LIXTW |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Yes
☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”,
“smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
|
Emerging
growth company ☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
☐ No ☒
As
of November 6, 2023, the Company had 2,249,290 shares of common stock, $0.0001 par value, issued and outstanding.
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
ITEM
1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED BALANCE SHEETS
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
| |
| |
| | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 5,105,611 | | |
$ | 5,353,392 | |
Advances on research and development contract services | |
| 78,015 | | |
| 147,017 | |
Prepaid insurance | |
| 23,230 | | |
| 49,224 | |
Other prepaid expenses and current assets | |
| 27,840 | | |
| 10,380 | |
Total current assets | |
| 5,234,696 | | |
| 5,560,013 | |
Total assets | |
$ | 5,234,696 | | |
$ | 5,560,013 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accrued expenses, including $43,895 and $46,982 to related parties at September 30, 2023 and December 31, 2022, respectively | |
$ | 221,171 | | |
$ | 229,764 | |
Research and development contract liabilities | |
| 90,565 | | |
| 165,022 | |
Total current liabilities | |
| 311,736 | | |
| 394,786 | |
| |
| | | |
| | |
Commitments and contingencies | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Preferred Stock, $0.0001 par value; authorized – 10,000,000 shares; issued and outstanding – 350,000 shares of Series A Convertible Preferred Stock, $10.00 per share stated value, liquidation preference based on assumed conversion into common shares – 72,917 shares | |
| 3,500,000 | | |
| 3,500,000 | |
Common stock, $0.0001 par value; authorized – 100,000,000 shares; issued and outstanding – 2,249,290 shares and 1,664,706 shares at September 30, 2023 and December 31, 2022, respectively | |
| 225 | | |
| 166 | |
Additional paid-in capital | |
| 48,872,208 | | |
| 45,059,760 | |
Accumulated deficit | |
| (47,449,473 | ) | |
| (43,394,699 | ) |
Total stockholders’ equity | |
| 4,922,960 | | |
| 5,165,227 | |
Total liabilities and stockholders’ equity | |
$ | 5,234,696 | | |
$ | 5,560,013 | |
See
accompanying notes to condensed consolidated financial statements.
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative costs: | |
| | | |
| | | |
| | | |
| | |
Compensation to related parties, including stock-based compensation expense of $112,106 and $396,883 for the three months ended September 30, 2023 and 2022, respectively, and $669,146 and $1,160,649 for the nine months ended September 30, 2023 and 2022, respectively | |
| 356,001 | | |
| 643,957 | | |
| 1,398,042 | | |
| 1,963,409 | |
Patent and licensing legal and filing fees and costs | |
| 178,012 | | |
| 271,163 | | |
| 835,362 | | |
| 944,789 | |
Other costs and expenses | |
| 357,681 | | |
| 290,993 | | |
| 1,081,893 | | |
| 875,016 | |
Research and development costs | |
| 132,487 | | |
| 272,388 | | |
| 749,029 | | |
| 895,649 | |
Total costs and expenses | |
| 1,024,181 | | |
| 1,478,501 | | |
| 4,064,326 | | |
| 4,678,863 | |
Loss from operations | |
| (1,024,181 | ) | |
| (1,478,501 | ) | |
| (4,064,326 | ) | |
| (4,678,863 | ) |
Interest income | |
| 5,809 | | |
| 3,911 | | |
| 13,538 | | |
| 4,211 | |
Interest expense | |
| (279 | ) | |
| (2,119 | ) | |
| (6,088 | ) | |
| (5,240 | ) |
Foreign currency gain (loss) | |
| (109 | ) | |
| (1,300 | ) | |
| 2,102 | | |
| (1,339 | ) |
Net loss | |
$ | (1,018,760 | ) | |
$ | (1,478,009 | ) | |
$ | (4,054,774 | ) | |
$ | (4,681,231 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share – basic and diluted | |
$ | (0.49 | ) | |
$ | (0.89 | ) | |
$ | (2.25 | ) | |
$ | (3.01 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding – basic and diluted | |
| 2,074,938 | | |
| 1,664,659 | | |
| 1,803,466 | | |
| 1,554,183 | |
See
accompanying notes to condensed consolidated financial statements.
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
Three
Months and Nine Months Ended September 30, 2023 and 2022
| |
Shares | | |
Amount | | |
Shares | | |
Par Value | | |
Capital | | |
Deficit | | |
Equity | |
| |
Convertible Series A Preferred Stock | | |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Par Value | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Three months ended September 30, 2023: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2023 | |
| 350,000 | | |
$ | 3,500,000 | | |
| 1,665,956 | | |
$ | 166 | | |
$ | 45,623,081 | | |
$ | (46,430,713 | ) | |
$ | 2,692,534 | |
Proceeds from sale of securities in registered direct offering, net of offering costs | |
| — | | |
| — | | |
| 180,000 | | |
| 18 | | |
| 3,137,021 | | |
| — | | |
| 3,137,039 | |
Exercise of pre-funded common stock warrants | |
| — | | |
| — | | |
| 403,334 | | |
| 41 | | |
| — | | |
| — | | |
| 41 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| 112,106 | | |
| — | | |
| 112,106 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,018,760 | ) | |
| (1,018,760 | ) |
Balance, September 30, 2023 | |
| 350,000 | | |
$ | 3,500,000 | | |
| 2,249,290 | | |
$ | 225 | | |
$ | 48,872,208 | | |
$ | (47,449,473 | ) | |
$ | 4,922,960 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Nine months ended September 30, 2023: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, December 31, 2022 | |
| 350,000 | | |
$ | 3,500,000 | | |
| 1,664,706 | | |
$ | 166 | | |
$ | 45,059,760 | | |
$ | (43,394,699 | ) | |
$ | 5,165,227 | |
Proceeds from sale of securities in registered direct offering, net of offering costs | |
| — | | |
| — | | |
| 180,000 | | |
| 18 | | |
| 3,137,021 | | |
| — | | |
| 3,137,039 | |
Exercise of pre-funded common stock warrants | |
| — | | |
| — | | |
| 403,334 | | |
| 41 | | |
| — | | |
| — | | |
| 41 | |
Exercise of common stock options | |
| — | | |
| — | | |
| 1,250 | | |
| — | | |
| 6,281 | | |
| — | | |
| 6,281 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| 669,146 | | |
| — | | |
| 669,146 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4,054,774 | ) | |
| (4,054,774 | ) |
Balance, September 30, 2023 | |
| 350,000 | | |
$ | 3,500,000 | | |
| 2,249,290 | | |
$ | 225 | | |
$ | 48,872,208 | | |
$ | (47,449,473 | ) | |
$ | 4,922,960 | |
(Continued)
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
(Continued)
Three
Months and Nine Months Ended September 30, 2023 and 2022
| |
Convertible Series A Preferred Stock | | |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Par Value | | |
Capital | | |
Deficit | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Three months ended September 30, 2022: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, June 30, 2022 | |
| 350,000 | | |
$ | 3,500,000 | | |
| 1,664,593 | | |
$ | 166 | | |
$ | 44,277,486 | | |
$ | (40,285,386 | ) | |
$ | 7,492,266 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| 396,883 | | |
| — | | |
| 396,883 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,478,009 | ) | |
| (1,478,009 | ) |
Balance, September 30, 2022 | |
| 350,000 | | |
$ | 3,500,000 | | |
| 1,664,593 | | |
$ | 166 | | |
$ | 44,674,369 | | |
$ | (41,763,395 | ) | |
$ | 6,411,140 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Nine months ended September 30, 2022: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance, December 31, 2021 | |
| 350,000 | | |
$ | 3,500,000 | | |
| 1,374,593 | | |
$ | 137 | | |
$ | 38,372,365 | | |
$ | (37,082,164 | ) | |
$ | 4,790,338 | |
Balance | |
| 350,000 | | |
$ | 3,500,000 | | |
| 1,374,593 | | |
$ | 137 | | |
$ | 38,372,365 | | |
$ | (37,082,164 | ) | |
$ | 4,790,338 | |
Proceeds from sale of securities in registered direct offering, net of offering costs | |
| — | | |
| — | | |
| 290,000 | | |
| 29 | | |
| 5,141,355 | | |
| — | | |
| 5,141,384 | |
Stock-based compensation expense | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,160,649 | | |
| — | | |
| 1,160,649 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (4,681,231 | ) | |
| (4,681,231 | ) |
Balance, September 30, 2022 | |
| 350,000 | | |
$ | 3,500,000 | | |
| 1,664,593 | | |
$ | 166 | | |
$ | 44,674,369 | | |
$ | (41,763,395 | ) | |
$ | 6,411,140 | |
Balance | |
| 350,000 | | |
$ | 3,500,000 | | |
| 1,664,593 | | |
$ | 166 | | |
$ | 44,674,369 | | |
$ | (41,763,395 | ) | |
$ | 6,411,140 | |
See
accompanying notes to condensed consolidated financial statements.
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (4,054,774 | ) | |
$ | (4,681,231 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation expense included in - | |
| | | |
| | |
General and administrative costs | |
| 669,146 | | |
| 1,160,649 | |
Research and development costs | |
| — | | |
| — | |
Changes in operating assets and liabilities: | |
| | | |
| | |
(Increase) decrease in - | |
| | | |
| | |
Advances on research and development contract services | |
| 69,002 | | |
| 3,224 | |
Prepaid insurance | |
| 25,994 | | |
| 22,375 | |
Other prepaid expenses and current assets | |
| (17,460 | ) | |
| (13,708 | ) |
Increase (decrease) in - | |
| | | |
| | |
Accounts payable and accrued expenses | |
| (8,593 | ) | |
| 81,433 | |
Research and development contract liabilities | |
| (74,457 | ) | |
| 23,969 | |
Net cash used in operating activities | |
| (3,391,142 | ) | |
| (3,403,289 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from sale of securities in registered direct offering, net of offering costs | |
| 3,137,039 | | |
| 5,141,384 | |
Exercise of pre-funded common stock warrants | |
| 41 | | |
| — | |
Exercise of common stock options | |
| 6,281 | | |
| — | |
Net cash provided by financing activities | |
| 3,143,361 | | |
| 5,141,384 | |
| |
| | | |
| | |
Cash: | |
| | | |
| | |
Net increase (decrease) | |
| (247,781 | ) | |
| 1,738,095 | |
Balance at beginning of period | |
| 5,353,392 | | |
| 4,823,745 | |
Balance at end of period | |
$ | 5,105,611 | | |
$ | 6,561,840 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Cash paid for - | |
| | | |
| | |
Interest | |
$ | 6,088 | | |
$ | 5,240 | |
Income taxes | |
$ | — | | |
$ | — | |
See
accompanying notes to condensed consolidated financial statements.
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Three
Months and Nine Months Ended September 30, 2023 and 2022
1.
Organization and Basis of Presentation
The
condensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation), including its wholly-owned
Delaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”), at September 30, 2023, and for the three months
and nine months ended September 30, 2023 and 2022, are unaudited. In the opinion of management of the Company, all adjustments, including
normal recurring accruals, have been made that are necessary to present fairly the financial position of the Company as of September
30, 2023, and the results of its operations for the three months and nine months ended September 30, 2023 and 2022, and its cash flows
for the nine months ended September 30, 2023 and 2022. Operating results for the interim periods presented are not necessarily indicative
of the results to be expected for a full fiscal year. The consolidated balance sheet at December 31, 2022 has been derived from the Company’s
audited consolidated financial statements at such date.
The
condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities
and Exchange Commission (“SEC”). Accordingly, certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations.
These condensed consolidated financial statements should be read in conjunction with the financial statements and other information included
in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC.
President
and Chief Executive Officer
Effective
September 26, 2023, Bas van der Baan was appointed as the Company’s President and Chief Executive Officer, at which time he replaced
Dr. John S. Kovach as the Company’s President and Chief Executive Officer. Dr. Kovach passed away on October 5, 2023.
Reverse
Stock Split
On
June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. No fractional shares were issued
in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest whole
share.
All
share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for
all periods presented.
Nasdaq
Listing
The
Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”,
respectively.
In
order to achieve compliance with the $1.00 minimum closing bid price requirement of the Nasdaq Capital Market, the Company held a special
meeting of stockholders on May 26, 2023 to seek approval for an amendment to the Company’s Certificate of Incorporation to effect
a reverse stock split of its issued and outstanding shares of common stock. As a result of the approval of this amendment, the Company
effected a 1-for-10 reverse stock split of its issued and outstanding common stock effective on Friday, June 2, 2023. Commencing with
the opening of trading on the Nasdaq Capital Market on Monday, June 5, 2023, the Company’s common stock began trading on a post-split
basis under the same symbol LIXT. The Company subsequently received confirmation from Nasdaq that it had regained compliance with the
minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2) and currently meets all other applicable criteria
for continued listing.
However,
there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum bid price requirement over time,
or that it will be successful in maintaining compliance with any of the other Nasdaq continued listing requirements.
2.
Business
The
Company is a drug research company that uses biomarker technology to identify enzyme targets associated with serious common diseases
and then designs novel compounds to attack those targets. The Company’s corporate office is located in Pasadena, California.
The
Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic
agents and/or x-ray and immune checkpoint blockers. The Company believes that inhibitors of protein phosphatases have broad therapeutic
potential not only for cancer but also for other debilitating and life-threatening diseases. The Company is directing its efforts on
clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer
activity at doses that produce little or no toxicity.
The
Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company
has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation
for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its
operating requirements.
Going
Concern
As
reflected in the accompanying financial statements, for the nine months ended September 30, 2023, the Company recorded a net loss of
$4,054,774 and
used cash in operations of $3,391,142.
At September 30, 2023, the Company had cash of $5,105,611
available to fund its operations. Because the
Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and
resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s
business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company
is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance
that the Company will be able to achieve and maintain positive earnings and operating cash flows. At September 30, 2023, the Company’s
remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated
approximately $6,262,000 (see
Note 9), which are currently scheduled to be incurred through approximately December 31, 2027.
The
Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates
the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue
and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through
the recurring sale of its equity securities.
Based
on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern
within one year after the date that the accompanying interim condensed consolidated financial statements are being issued. The Company’s
interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The
Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research
and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future
cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the
availability of operating capital to fund such activities.
Based
on current operating plans, the Company estimates that its existing cash resources at September 30, 2023 will provide sufficient working
capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound
LB-100 through at least September 30, 2024. However, existing cash resources will not be sufficient to complete the development of and
obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional
capital. The Company estimates that it will need to raise additional capital to fund its operations by mid-2024 to be able
to proactively manage its current business plan during the remainder of 2024 and during 2025. In addition, the Company’s operating
plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional
funds may be needed sooner than planned.
As
market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the
Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.
If
cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back
or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development
efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights
to and/or control of LB-100, or to discontinue operations entirely.
3.
Summary of Significant Accounting Policies
Principles
of Consolidation
The
accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally
accepted accounting principles (“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc. and its
wholly-owned subsidiary, Lixte Biotechnology, Inc. Intercompany balances and transactions have been eliminated in consolidation.
Foreign
Currency Translation
The
consolidated financial statements are presented in the United States dollar, which is the functional and reporting currency of the Company.
The
Company periodically incurs a cost or expense denominated in a foreign currency. Such cost or expense is converted into United States
dollars for financial statement purposes based on the foreign currency conversion rate in effect on the transaction date. The Company
purchases the requisite foreign currency to pay such cost or expense on an as-needed basis. Any gain or loss resulting from the purchase
of the foreign currency is included as foreign currency gain (loss) in the consolidated statement of operations. As of September 30,
2023 and December 31, 2022, the Company did not hold any currencies other than the United States dollar in its bank account.
Segment
Information
The
Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated
with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported
in a manner consistent with the internal reporting provided to the Company’s Chief Operating Decision Maker, which is the Company’s
President and Chief Executive Officer.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.
Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under
different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed
to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management
regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes
in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates
are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions
used in the calculation of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services,
and the realization of deferred tax assets.
Cash
Cash
is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC
(“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash
balances with financial institutions in the United States with high credit ratings and in accounts insured by the Federal Deposit Insurance
Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically
has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. Morgan
Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has not
experienced any losses to date resulting from this policy.
Research
and Development
Research
and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation,
design, development and management of clinical trials with respect to the Company’s clinical compound and product candidate. Research
and development costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to
operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States
and in the European Union in accordance with the laws and regulations of such jurisdictions.
Research
and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of
milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing
schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are
charged to operations as incurred.
Obligations
incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research
and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified
in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions
are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded
as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the
Company’s consolidated statement of operations.
Payments
made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated
balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those
contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development
contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs
in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research
and development contracts on a quarterly basis.
Prepaid
Insurance
Prepaid
insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in
excess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined by
amortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurred
are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated
balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each
reporting period.
Patent
and Licensing Legal and Filing Fees and Costs
Due
to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s
research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development
and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing
fees and costs were $178,012 and $271,163 for the three months ended September 30, 2023 and 2022, respectively, and $835,362 and $944,789
for the nine months ended September 30, 2023 and 2022, respectively. Patent and licensing legal and filing fees and costs are included
in general and administrative costs in the Company’s consolidated statements of operations.
Concentration
of Risk
The
Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred
for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred
that represented 10% or more of general and administrative costs or research and development costs for the three months and nine months
ended September 30, 2023 and 2022 are described as follows.
General
and administrative costs for the three months ended September 30, 2023 and 2022 included charges from legal firms and other vendors for
general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 20.0% and 22.5% of
total general and administrative costs, respectively. General and administrative costs for the three months ended September 30, 2023
and 2022 also included charges for the fair value of stock options granted to directors and corporate officers representing 12.6% and
32.9%, respectively, of total general and administrative costs. General and administrative costs for the three months ended September
30, 2023 also included charges from two vendors representing 11.9% and 10.6%, respectively, of total general and administrative costs.
Research
and development costs for the three months ended September 30, 2023 included charges from four vendors and consultants representing 38.9%,
24.9%, 15.9% and 14.9%, respectively, of total research and development costs. Research and development costs for the three months ended
September 30, 2022 include charges from four vendors and consultants representing 32.0%, 23.2%, 16.9% and 11.0%, respectively, of total
research and development costs.
General
and administrative costs for the nine months ended September 30, 2023 and 2022 include charges from legal firms and other vendors for
general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 25.2% and 25.0% of
total general and administrative costs, respectively. General and administrative costs for the nine months ended September 30, 2023 and
2022 also included charges for the fair value of stock options granted to directors and corporate officers representing 20.2% and 30.7%,
respectively, of total general and administrative costs.
Research
and development costs for the nine months ended September 30, 2023 include charges from three vendors and consultants representing 35.9%,
21.0% and 12.4%, respectively, of total research and development costs. Research and development costs for the nine months ended September
30, 2022 include charges from three vendors and consultants representing 31.0%, 16.7% and 10.0%, respectively, of total research and
development costs.
Income
Taxes
The
Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly,
the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and
the tax basis of assets and liabilities.
The
Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In
the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded
amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Should the
Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred
tax assets would be charged to operations in the period such determination was made.
The
Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating
losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which
the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of September 30, 2023 or
December 31, 2022 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2023.
The
Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement,
presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The
tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as
of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of
the position are recognized. The Company had not recorded any liability for uncertain tax positions as of September 30, 2023 or December
31, 2022. Subsequent to September 30, 2023, any interest and penalties related to uncertain tax positions will be recognized as a component
of income tax expense.
Stock-Based
Compensation
The
Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members,
contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each
grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over
the vesting period.
The
Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants
by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the
cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period
of the awards. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash
for the services.
The
fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is
affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock
option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock.
Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between
the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical
volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of
the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant.
The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on
the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero.
The
Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development
costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to
satisfy stock option exercises.
Warrants
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the
warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480,
Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The
assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a
liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815,
including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially
require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for
equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued
and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of
the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the
time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are
required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at
each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on
the statements of operations. The Company has determined that the warrants issued in the July 20, 2023 equity financing (see Note 5)
meet the requirements for equity classification.
Earnings
(Loss) Per Share
The
Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as
the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted
EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares,
warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, if
later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share)
are excluded from the calculation of diluted EPS.
Loss
per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods.
Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options
outstanding were anti-dilutive.
At
September 30, 2023 and 2022, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire
shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings Per Share
| |
2023 | | |
2022 | |
| |
September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Series A Convertible Preferred Stock | |
| 72,917 | | |
| 72,917 | |
Common stock warrants | |
| 808,365 | | |
| 340,031 | |
Common stock options, including options issued in the form of warrants | |
| 674,896 | | |
| 332,500 | |
Total | |
| 1,556,178 | | |
| 745,448 | |
Fair
Value of Financial Instruments
The
authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed
in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair
value measurements, is also required.
Level
1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to
access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities
and exchange-based derivatives.
Level
2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable
through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities,
non-exchange-based derivatives, mutual funds, and fair-value hedges.
Level
3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop
its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives
and commingled investment funds and are measured using present value pricing models.
The
Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the
lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company
performs an analysis of the assets and liabilities at each reporting period end.
The
carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative of their
respective fair values due to the short-term nature of those instruments.
Recent
Accounting Pronouncements
In
May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-04,
Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation
(Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04
provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified
written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument
for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the
modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition
model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt
origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 was
effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An
entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective
date. The Company adopted ASU 2021-04 effective January 1, 2022. The adoption of ASU 2021-04 did not have any impact on the Company’s
consolidated financial statement presentation or related disclosures.
In
July 2023, the FASB issued ASU 2023-03, Presentation of Financial Statements (Topic 205), Income Statement — Reporting
Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation —
Stock Compensation (Topic 718) Presentation of Financial Statements (“ASU 2023-03”). ASU 2023-03 amends the FASB
Accounting Standards Codification to include Amendments to SEC Paragraphs pursuant to SEC Staff Accounting Bulletin No. 120, SEC
Staff Announcement at the March 24, 2022 EITF Meeting, and SEC Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280
— General Revision of Regulation S-X: Income or Loss Applicable to Common Stock. As ASU 2023-03 did not provide any new
guidance, there was no transition or effective date associated with its adoption. Accordingly, the Company adopted ASU 2023-03
immediately upon its issuance. The adoption of ASU 2023-03 did not have any impact on the Company’s consolidated financial
statement presentation or related disclosures.
Management
does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material
impact on the Company’s financial statement presentation or disclosures.
4.
Research and Development Costs
A
summary of research and development costs for the three months and nine months ended September 30, 2023 and 2022, including costs associated
with clinical trials involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical
regions where such costs have been incurred.
Schedule
of Research and Development Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
United States | |
$ | 68,315 | | |
$ | 161,744 | | |
$ | 291,846 | | |
$ | 316,565 | |
Spain | |
| 9,496 | | |
| 1,246 | | |
| 283,035 | | |
| 348,850 | |
China | |
| 3,108 | | |
| 63,330 | | |
| 17,198 | | |
| 81,050 | |
Netherlands | |
| 51,568 | | |
| 46,068 | | |
| 156,950 | | |
| 149,184 | |
Total | |
$ | 132,487 | | |
$ | 272,388 | | |
$ | 749,029 | | |
$ | 895,649 | |
Research and development
expense | |
$ | 132,487 | | |
$ | 272,388 | | |
$ | 749,029 | | |
$ | 895,649 | |
5.
Stockholders’ Equity
Preferred
Stock
The
Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.0001 per share. On March 17, 2015, the Company
filed a Certificate of Designations, Preferences, Rights and Limitations of its Series A Convertible Preferred Stock with the Delaware
Secretary of State to amend the Company’s certificate of incorporation. The Company has designated a total of 350,000 shares as
Series A Convertible Preferred Stock, which are non-voting and are not subject to increase without the written consent of a majority
of the holders of the Series A Convertible Preferred Stock or as otherwise set forth in the Preferences, Rights and Limitations. The
holders of each tranche of 175,000 shares of the Series A Convertible Preferred Stock are entitled to receive a per share dividend equal
to 1% of the annual net revenue of the Company divided by 175,000, until converted or redeemed. As of September 30, 2023 and December
31, 2022, the Company had 9,650,000 shares of undesignated preferred stock which may be issued with such rights and powers as the Board
of Directors may designate.
Each
share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 0.20833 shares of common stock (subject
to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion
rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000. The Series A Convertible
Preferred Stock has a liquidation preference based on its assumed conversion into shares of common stock. The Series A Convertible Preferred
Stock does not have any cash liquidation preference rights or any registration rights. If fully converted, the 350,000 outstanding shares
of Series A Convertible Preferred Stock would convert into 72,917 shares of common stock at September 30, 2023 and December 31, 2022.
Based
on the attributes of the Series A Convertible Preferred Stock as previously described, the Company has accounted for the Series A Convertible
Preferred Stock as a permanent component of stockholders’ equity.
Common
Stock
The
Company is authorized to issue a total of 100,000,000 shares of common stock, par value $0.0001 per share. As of September 30, 2023 and
December 31, 2022, the Company had 2,249,290 shares and 1,664,706 shares, respectively, of common stock issued and outstanding.
On
June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. No fractional shares were issued
in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest whole
share. All share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock
split for all periods presented.
Effective
March 10, 2023, the Company issued 1,250 shares of common stock upon the exercise of a stock option in the form of a warrant held by
a consultant to the Company for 1,250 shares exercisable at $5.025 per share for total cash proceeds of $6,281.
April
12, 2022 Sale of Common Stock
Effective
April 12, 2022, the Company completed the sale of 290,000 shares of common stock at a price of $20.00 per share in a registered direct
offering, generating gross proceeds of $5,800,000. The total cash costs of this offering were $658,616, resulting in net proceeds of
$5,141,384. Pursuant to the placement agents’ agreement, the Company granted warrants to the placement agents to purchase 29,000
shares of common stock at an exercise price of $20.00 per share exercisable through April 14, 2027.
July
20, 2023 Sale of Common Stock and Warrants
Effective
July 20, 2023, the Company sold 180,000 shares of common stock at a price of $6.00 per share and pre-funded warrants to purchase 403,334
shares of common stock at a price of $5.9999 per pre-funded warrant to an institutional investor in a registered direct offering. The
pre-funded warrants had an exercise price of $0.0001 per share, were immediately exercisable upon issuance, and were valid and exercisable
until all pre-funded warrants were exercised in full. As of August 7, 2023, all pre-funded warrants had been exercised in full. The pre-funded
warrants were determined to be common stock equivalents.
In
a concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 shares of common stock.
Each common warrant had an initial exercise price of $6.00 per share, was immediately exercisable upon issuance, and expires five years
thereafter on July 20, 2028. The common warrants and the shares of common stock issuable upon exercise of the common warrants were not
registered under the Securities Act of 1933, as amended (the “Securities Act”) and were offered pursuant to the exemption
provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The shares of common stock issuable upon
exercise of the warrants were subsequently registered for resale on a registration statement on Form S-3 declared effective by the SEC
on August 21, 2023.
The
registered direct offering and the concurrent private placement generated gross proceeds of $3,499,964. The total cash costs of the registered
direct offering and the private placement were $362,925, resulting in net proceeds of $3,137,039. Pursuant to the placement agent agreement,
the Company granted the placement agent warrants to purchase 35,000 shares of common stock at an exercise price of $6.60 per share and
expiring on July 20, 2028.
During
the period from July 24, 2023 through August 7, 2023, the 403,334 pre-funded warrants, exercisable at $0.0001 per common share, were
exercised for total cash proceeds of $41, resulting in the issuance of 403,334 shares of common stock.
The
exercise prices of the warrants issued to the institutional investor (exercisable at $6.00
per share) and to the placement agent (exercisable at $6.60
per share) are subject to customary adjustments for stock splits, stock dividends, stock combinations, reclassifications,
reorganizations or similar events affecting the Company’s common stock. In addition, the warrants issued to the institutional
investor contain a “fundamental transaction” provision whereby in the event of a fundamental transaction (a sale or
transfer of assets or ownership of the Company as defined in the warrant agreement) within the Company’s control, the holder
of the unexercised common stock warrants will be entitled to receive cash consideration equal to a Black-Scholes valuation, as
defined in the warrant agreement. If such fundamental transaction is not within the Company’s control, the warrant holder
would only be entitled to receive the same form of consideration (and in the same proportion) as the holders of the Company’s
common stock, hence these warrants are classified as a component of permanent equity. The Company will account for any such cash
payment for a warrant redemption as a distribution from stockholders’ equity, as and when such cash payment is
made.
Common
Stock Warrants
A
summary of common stock warrant activity during the nine months ended September 30, 2023, excluding the 403,334 pre-funded warrants,
exercisable at $0.0001 per common share, to purchase 403,334 shares of common stock described above, is presented below.
Schedule of Warrants Outstanding
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (in Years) | |
| |
| | |
| | |
| |
Warrants outstanding at December 31, 2022 | |
| 190,031 | | |
$ | 50.161 | | |
| | |
Issued | |
| 618,334 | | |
| 6.034 | | |
| | |
Exercised | |
| — | | |
| — | | |
| | |
Expired | |
| — | | |
| — | | |
| | |
Warrants outstanding at September 30, 2023 | |
| 808,365 | | |
$ | 16.407 | | |
| 4.24 | |
| |
| | | |
| | | |
| | |
Warrants exercisable at December 31, 2022 | |
| 190,031 | | |
$ | 50.161 | | |
| | |
Warrants exercisable at September 30, 2023 | |
| 808,365 | | |
$ | 16.407 | | |
| 4.24 | |
At
September 30, 2023, the outstanding warrants are exercisable at the following prices per common share:
Schedule of Warrants Outstanding and Exercisable
Exercise Prices | | |
Warrants Outstanding (Shares) | |
| | |
| |
$ | 6.000 | | |
| 583,334 | |
$ | 6.600 | | |
| 35,000 | |
$ | 20.000 | | |
| 29,000 | |
$ | 37.000 | | |
| 11,331 | |
$ | 57.000 | | |
| 149,700 | |
| | | |
| 808,365 | |
The
warrants exercisable at $57.00 per share at September 30, 2023 consist of 1,497,000 publicly-traded warrants pre-split 1-for-10 that
were issued as part of the Company’s November 2020 public offering of units and are exercisable for a period of five years thereafter.
As a result of the 1-for-10 reverse split of the Company’s common stock effective June 2, 2023, each such publicly-traded warrant
currently represents the right to purchase 1/10th of a share of common stock at the original exercise price of $5.70 per share. Accordingly,
upon exercise, 10 warrants, each exercisable at $5.70, will be required to acquire one share of post-split common stock, which is equivalent
to a purchase price of $57.00.
Based
on a fair market value of $2.45 per share on September 30, 2023, there was no intrinsic value attributed to exercisable but unexercised
common stock warrants at September 30, 2023.
Information
with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 7.
6.
Related Party Transactions
Related
party transactions include transactions with the Company’s officers, directors and affiliates.
Employment
Agreements with Officers
During
July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting
of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, payable monthly, as described below. These employment
agreements were automatically renewable for additional one-year periods unless terminated by either party upon 60 days written notice
prior to the end of the applicable one-year period, or by death, or by termination for cause. These employment agreements were automatically
renewed for additional one-year periods in July and August 2021, 2022 and 2023.
The
Company entered into an employment agreement with Dr. Kovach dated July 15, 2020, effective October 1, 2020, to provide for Dr. Kovach
to continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer, with an annual salary of $250,000.
During the three months ended September 30, 2023 and 2022, the Company paid $62,500 and $62,500, respectively, to Dr. Kovach under this
employment agreement, and during the nine months ended September 30, 2023 and 2022, the Company paid $187,500 and $187,500, respectively,
to Dr. Kovach under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated
statements of operations for such periods. The employment agreement with Dr. Kovach terminated upon his death on October 5, 2023.
The
Company entered into an employment agreement with Dr. James S. Miser, M.D., effective August 1, 2020 to act as the Company’s Chief
Medical Officer, with an annual salary of $150,000. Effective May 1, 2021, Dr. Miser’s annual salary was increased to $175,000.
Dr. Miser is required to devote at least 50% of his business time to the Company’s activities. During the three months ended September
30, 2023 and 2022, the Company paid $43,750 and $43,750, respectively, to Dr. Miser under this employment agreement, and during the nine
months ended September 30, 2023 and 2022, the Company paid $131,250 and $131,250, respectively, to Dr. Miser under this employment agreement,
which costs are included in general and administrative costs in the Company’s consolidated statements of operations for such periods.
The
Company entered into an employment agreement with Eric J. Forman effective July 15, 2020, as amended on August 12, 2020, to act as the
Company’s Chief Administrative Officer, with an annual salary of $120,000. Mr. Forman is the son-in-law of Gil Schwartzberg (deceased),
a former member of the Company’s Board of Directors who died on October 30, 2022 and was a significant stockholder of and consultant
to the Company, and is the son of Dr. Stephen Forman, a member of the Company’s Board of Directors. Julie Forman, the wife of Mr.
Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, at which firm the Company’s
cash is on deposit and with which the Company maintains a continuing banking relationship. Effective May 1, 2021, Mr. Forman’s
annual salary was increased to $175,000. Additionally, effective November 6, 2022, Mr. Forman was promoted to Vice President and Chief
Operating Officer with an annual salary of $200,000. Effective October 1, 2022, Mr. Forman has been provided a monthly office rent allowance,
pursuant to which Mr. Forman was paid $7,323 and $11,436, respectively, for the three months and nine months ended September 30, 2023.
During the three months ended September 30, 2023 and 2022, the Company paid $50,000 and $43,750, respectively, to Mr. Forman under this
employment agreement, and during the nine months ended September 30, 2023 and 2022, the Company paid $150,000 and $131,250, respectively,
to Mr. Forman under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated
statements of operations for such periods.
The
Company entered into an employment agreement with Robert N. Weingarten effective August 12, 2020 to act as the Company’s Vice President
and Chief Financial Officer, with an annual salary of $120,000. Effective May 1, 2021, Mr. Weingarten’s annual salary was increased
to $175,000. During the three months ended September 30, 2023 and 2022, the Company paid $43,750 and $43,750, respectively, to Mr. Weingarten
under this employment agreement, and during the nine months ended September 30, 2023 and 2022, the Company paid $131,250 and $131,250,
respectively, to Mr. Weingarten under this employment agreement, which costs are included in general and administrative costs in the
Company’s consolidated statements of operations for such periods.
The
Company entered into an employment agreement with Bastiaan van der Baan effective September 26, 2023, to act as the Company’s President
and Chief Executive Officer and as Vice Chairman of the Board of Directors with an annual salary of $150,000. The term of the employment
agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject
to early termination as described in the employment agreement. Under the employment agreement, Mr. van der Baan’s annual salary
may be increased from time to time at the sole discretion of the Board of Directors. In addition, Mr. van der Baan will be eligible to
receive an annual bonus as determined in the sole discretion of the Board of Directors. During the three months and nine months ended
September 30, 2023, the Company paid $1,667 to Mr. van der Baan under this employment agreement, which costs are included in general
and administrative costs in the Company’s consolidated statements of operations for such periods. Mr. Van der Baan was appointed
as Chairman of the Board of Directors upon the death of Dr. Kovach on October 5, 2023.
Appointment
of Dr. René Bernards to the Board of Directors
Effective
as of June 15, 2022, Dr. René Bernards was appointed to the Company’s Board of Directors as an independent director. Dr.
Bernards is a leader in the field of molecular carcinogenesis and is employed by the Netherlands Cancer Institute in Amsterdam. As a
new director, in lieu of a grant of stock options, Dr. Bernards received a one-time cash board fee of $100,000, which was paid upon his
appointment to the Board of Directors, and an annual cash board fee of $40,000, payable quarterly.
Previously,
on October 8, 2021, the Company had entered into a Development Collaboration Agreement (subsequently amended and extended) with the Netherlands
Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent
cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used
to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations (see Note
9).
Compensatory
Arrangements for Members of the Board of Directors
Effective
April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation program for the independent members of the
Board of Directors and committee members. Effective May 25, 2022, the Board of Directors approved an amendment to the program. Officers
who also serve on the Board of Directors are not compensated separately for their service on the Board of Directors.
Cash
compensation for independent directors, payable quarterly, is as follows:
Base
director compensation - $20,000 per year
Chairman
of audit committee – additional $10,000 per year
Chairman
of any other committees – additional $5,000 per year
Member
of audit committee – additional $5,000 per year
Member
of any other committees – additional $2,500 per year
Equity
compensation for independent directors is as follows:
Appointment
of new independent directors – The Company grants options to purchase 25,000 shares of common stock, exercisable for a period of
five years, at the closing market price on the date of grant, vesting 50% on the grant date and the remaining 50% vesting 12.5% on the
last day of each calendar quarter beginning in the quarter immediately subsequent to the date of the grant until fully vested, subject
to continued service. At the discretion of the Board of Directors, for a nominee to the Board of Directors who is restricted by their
respective institution or employer from receiving equity-based compensation, in lieu of the grant of such stock options, the Company
may elect to pay a one-time cash fee of $100,000 to such director, payable upfront.
Annual
grant of options to independent directors – Effective on the last business day of the month of June, the Company grants options
to purchase 10,000 shares of common stock, exercisable for a period of five years, at the closing market price on the date of grant,
vesting 12.5% on the last day of each calendar quarter beginning in the quarter immediately subsequent to the date of grant until fully
vested, subject to continued service. If any director has served for less than 12 full calendar months on the grant date, the amount
of such stock option grant shall be prorated based on the length of service of such director. At the discretion of the Board of Directors,
for a nominee to the Board of Directors who is restricted by their respective institution or employer from receiving equity-based compensation,
in lieu of the grant of such stock options, the Company may elect to pay an annual cash fee of $40,000 to such director, payable quarterly.
Total
cash compensation paid to independent directors was $42,228 and $53,324, respectively, for the three months ended September 30, 2023
and 2022. Total cash compensation paid to independent directors was $127,229 and $221,510, respectively, for the nine months ended September
30, 2023 and 2022.
Stock-based
compensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 7.
A
summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors
for their services on the Board of Directors, for the three months and nine months ended September 30, 2023 and 2022, is presented below.
Summary of Related Party Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Related party costs: | |
| | | |
| | | |
| | | |
| | |
Cash-based | |
$ | 243,895 | | |
$ | 247,074 | | |
$ | 728,896 | | |
$ | 802,760 | |
Stock-based | |
| 112,106 | | |
| 396,883 | | |
| 669,146 | | |
| 1,160,649 | |
Total | |
$ | 356,001 | | |
$ | 643,957 | | |
$ | 1,398,042 | | |
$ | 1,963,409 | |
Related
party costs | |
$ | 356,001 | | |
$ | 643,957 | | |
$ | 1,398,042 | | |
$ | 1,963,409 | |
7.
Stock-Based Compensation
The
Company periodically issues common stock and stock options as incentive compensation to directors and as compensation for the services
of employees, contractors and consultants of the Company.
On
July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which was subsequently
approved by the stockholders of the Company. The 2020 Plan provides for the granting of equity-based awards, consisting of stock options,
restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and
consultants of the Company and its affiliates, initially for a total of 233,333 shares of the Company’s common stock, under terms
and conditions as determined by the Company’s Board of Directors. On October 7, 2022, the stockholders of the Company approved
an amendment to the 2020 Plan to increase the number of common shares issuable thereunder by 180,000 shares, to a total of 413,333 shares.
The Company has scheduled a meeting of stockholders for November 27, 2023 to consider and vote on, among other matters, a proposal to
increase the number of common shares issuable under the 2020 Plan by 336,667 shares, to a total of 750,000 shares.
As
of September 30, 2023, there was a deficiency of 136,980 shares with respect to stock options issuable under the 2020 Plan. However,
subject to approval of the proposal to increase the number of common shares issuable under the 2020 Plan at the meeting of stockholders
scheduled for November 27, 2023, there will be unexpired stock options for 550,313 shares issued and outstanding under the 2020 Plan
and 199,687 shares available for issuance under the 2020 Plan.
The
fair value of a stock option award is calculated on the grant date using the Black-Scholes option-pricing model. The risk-free interest
rate is based on the U.S. Treasury yield curve in effect as of the grant date. The expected dividend yield assumption is based on the
Company’s expectation of dividend payouts and is assumed to be zero. The estimated volatility is based on the historical volatility
of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock
option being granted. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as
the mid-point between the vesting period and the contractual term (the “simplified method”). The fair market value of the
common stock is determined by reference to the quoted market price of the common stock on the grant date.
For
stock options requiring an assessment of value during the nine months ended September 30, 2023, the fair value of each stock option award
was estimated using the Black-Scholes option-pricing model with the following assumptions:
Schedule of Fair Value of Each Option Award Estimated Assumption
Risk-free interest rate | |
| 4.843 | % |
Expected dividend yield | |
| 0 | % |
Expected volatility | |
| 138.05 | % |
Expected life | |
| 4.0 years | |
For
stock options requiring an assessment of value during the nine months ended September 30, 2022, the fair value of each stock option award
was estimated using the Black-Scholes option-pricing model with the following assumptions:
Risk-free interest rate | |
| 3.03 | % |
Expected dividend yield | |
| 0 | % |
Expected volatility | |
| 198.79 | % |
Expected life | |
| 3.6 years | |
On
July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman
was granted stock options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis.
The options are exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market
price of the Company’s common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively,
with the final 25% vesting on August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant
to the Black-Scholes option-pricing model, was determined to be $400,855 ($68.718 per share), of which $100,214 was attributable to the
portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested
portion of the fair value of the stock options was charged to operations ratably from August 12, 2020 through August 12, 2023. The Company
recorded charges to general and administrative costs in the consolidated statement of operations of $11,806 and $25,259 for the three
months ended September 30, 2023 and 2022, respectively, and $61,501 and $74,954 for the nine months ended September 30, 2023 and 2022,
respectively, with respect to these stock options.
On
August 1, 2020, in connection with an employment agreement entered into with Dr. James S. Miser, M.D., Dr. Miser was granted stock options
to purchase 8,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable
for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s
common stock on the effective date of the employment agreement. The options vested 25% on August 1, 2020, 2021 and 2022, respectively,
with the final 25% vesting on August 1, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant
to the Black-Scholes option-pricing model, was determined to be $572,650 ($68.718 per share), of which $143,163 was attributable to the
portion of the stock options fully vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested
portion of the fair value of the stock options was charged to operations ratably from August 1, 2020 through August 1, 2023. The Company
recorded charges to general and administrative costs in the consolidated statement of operations of $12,551 and $36,085 for the three
months ended September 30, 2023 and 2022, respectively, and $83,544 and $107,078 for the nine months ended September 30, 2023 and 2022,
respectively, with respect to these stock options.
On
August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted stock
options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are
exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s
common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively, with the final 25% vesting on
August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $400,855 ($68.718 per share), of which $100,214 was attributable to the portion of the stock options fully
vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the
stock options was charged to operations ratably from August 12, 2020 through August 12, 2023. The Company recorded charges to general
and administrative costs in the consolidated statement of operations of $11,806 and $25,259 for the three months ended September 30,
2023 and 2022, respectively, and $61,501 and $74,954 for the nine months ended September 30, 2023 and 2022, respectively, with respect
to these stock options.
On
April 9, 2021, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by a former director’s resignation.
In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation
package for members of the Board of Directors, Mr. Schwartzberg was granted stock options to purchase 25,000 shares of the Company’s
common stock, exercisable for a period of five years at an exercise price of $32.00 per share (the closing market price on the grant
date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully
vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $753,611 ($30.144 per share), of which $376,800 was attributable to the portion of the stock options fully
vested on April 9, 2021 and was therefore charged to operations on that date. Although the remaining unvested portion of the fair value
of the stock options was being charged to operations ratably from April 9, 2021 through June 30, 2023, the vesting of these stock options
terminated on October 30, 2022 as a result of the death of Mr. Schwartzberg on that date. The Company recorded charges to general and
administrative costs in the consolidated statement of operations of $42,692 and $126,684 for the three months and nine months ended September
30, 2022, respectively, with respect to these stock options.
On
May 11, 2021, the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board
of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors,
Ms. Brown was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years
at an exercise price of $28.00 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder
vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value
of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $658,363 ($26.335 per
share), of which $329,188 was attributable to the portion of the stock options fully vested on May 11, 2021 and was therefore charged
to operations on that date. The remaining unvested portion of the fair value of the stock options was charged to operations ratably from
May 11, 2021 through June 30, 2023. The Company recorded charges to general and administrative costs in the consolidated statement of
operations of $0 and $38,827 for the three months ended September 30, 2023 and 2022, respectively, and $76,388 and $115,215 for the nine
months ended September 30, 2023 and 2022, respectively, with respect to these stock options.
On
June 30, 2021, the
Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of
Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000
shares (a total of 50,000
shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $30.30 per share (the
closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,
subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $1,421,095
($28.423
per share), which was charged to operations ratably from July 1, 2021 through June 30, 2023. The Company recorded charges to general
and administrative costs in the consolidated statement of operations of $0
and $179,100
for the three months ended September 30, 2023 and 2022, respectively, and $211,412
and $531,455
for the nine months ended September 30, 2023 and 2022, respectively, with respect to these stock options.
On
June 17, 2022, the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to the
Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors,
Mr. Baan was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years
at an exercise price of $7.40 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder
vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value
of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($6.341 per share),
of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 and was therefore charged to operations
on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from June
17, 2022 through June 30, 2024. The Company recorded charges to general and administrative costs in the consolidated statement of operations
of $9,801 and $9,801 for the three months ended September 30, 2023 and 2022, respectively, and $29,084 and $90,449 for the nine months
ended September 30, 2023 and 2022, respectively, with respect to these stock options.
On
June 30, 2022, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the
Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 shares (a total
of 50,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $7.40 per share
(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,
subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,
was determined to be $316,700 ($6.334 per share), which is being charged to operations ratably from July 1, 2022 through June 30, 2024.
The Company recorded charges to general and administrative costs in the consolidated statement of operations of $23,916 and $39,860 for
the three months ended September 30, 2023 and 2022, respectively, and $70,965 and $39,860 for the nine months ended September 30, 2023
and 2022, respectively, with respect to these stock options.
On
November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 20,000 shares
(a total of 80,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $20.00
per share, vesting 25% on issuance and 25% on each anniversary date thereafter until fully vested, subject to continued service. The
total fair value of the 80,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be
$262,560 ($3.282 per share), which is being charged to operations ratably from November 6, 2022 through November 6, 2025. The Company
recorded a total charge to general and administrative costs in the consolidated statement of operations of $16,528 and $49,053 for the
three months and nine months ended September 30, 2023, respectively, with respect to these stock options.
On
November 6, 2022, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 10,000 shares of the Company’s
common stock, which was fully vested upon issuance and is exercisable for a period of five years at $5.025 per share (the closing market
price on the issue date). The fair value of the warrant, as calculated pursuant to the Black-Scholes option-pricing model, was determined
to be $43,264 ($4.326 per share) and was charged to general and administrative costs in the consolidated statement of operations on that
date.
On
June 30, 2023, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the
Board of Directors, granted to each of the four non-officer directors of the Company stock options to purchase 10,000 shares (a total
of 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $5.88 per share
(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,
subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,
was determined to be $192,593 ($4.8131 per share), which is being charged to operations ratably from July 1, 2023 through June 30, 2025.
The Company recorded a total charge to general and administrative costs in the consolidated statement of operations of $24,232 for the
three months and nine months ended September 30, 2023 with respect to these stock options.
On
September 26, 2023, in connection with the employment agreement entered into with Bastiaan van der Baan, Mr. van der Baan was granted
stock options to purchase 250,000 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options
are exercisable for a period of five years at an exercise price of $1.95 per share, which was equal to the closing market price of the
Company’s common stock on the grant date. The options vest in equal increments quarterly over a three-year period commencing on
the last day of each calendar quarter commencing October 1, 2023, subject to continued service. The fair value of these stock options,
as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $403,066 ($1.612 per share), which is being charged
to operations ratably from September 26, 2023 through September 30, 2026. The Company recorded a charge to general and administrative
costs in the consolidated statement of operations of $1,466 for the three months and nine months ended September 30, 2023 with respect
to these stock options.
Dr.
Philip Palmedo, a director of the Company since 2006, did not stand for re-election to the Company’s Board of Directors at the
Company’s annual meeting of stockholders held on October 7, 2022. Gil Schwartzberg, a director of the Company, died on October
30, 2022. Dr. John S. Kovach, the Chairman of the Board of Directors and the Company’s President and Chief Executive Officer, and
Chief Scientific Officer, died on October 5, 2023. Accordingly, the unvested stock options for each of such persons ceased vesting effective
as of the respective dates that their service to the Company terminated. Furthermore, the expiration date of all vested stock options
owned by each of such persons are contractually scheduled to expire one year from the respective dates that their service to the Company
terminated.
A
summary of stock-based compensation costs for the three months and nine months ended September 30, 2023 and 2022 is as follows:
Summmary of Stock-based Compensation Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Related parties | |
$ | 112,106 | | |
$ | 396,883 | | |
$ | 669,146 | | |
$ | 1,160,649 | |
Non-related parties | |
| — | | |
| — | | |
| — | | |
| — | |
Total stock-based compensation costs | |
$ | 112,106 | | |
$ | 396,883 | | |
$ | 669,146 | | |
$ | 1,160,649 | |
A
summary of stock option activity, including options issued in the form of warrants, during the nine months ended September 30, 2023 is
as follows:
Summary of Stock Option Activity Including Options Form of Warrants
| |
Number of
Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (in Years) | |
| |
| | |
| | |
| |
Stock options outstanding at December 31, 2022 | |
| 389,479 | | |
$ | 29.1826 | | |
| | |
Granted | |
| 290,000 | | |
| 2.4920 | | |
| | |
Exercised | |
| (1,250 | ) | |
| 5.0250 | | |
| | |
Expired | |
| (3,333 | ) | |
| 16.800 | | |
| | |
Stock options outstanding at September 30, 2023 | |
| 674,896 | | |
$ | 17.8197 | | |
| 4.96 | |
| |
| | | |
| | | |
| | |
Stock options exercisable at December 31, 2022 | |
| 281,979 | | |
$ | 32.8335 | | |
| | |
Stock options exercisable at September 30, 2023 | |
| 313,959 | | |
$ | 31.8997 | | |
| 1.93 | |
Total
deferred compensation expense for the outstanding value of unvested stock options was approximately $808,000 at September 30, 2023, which
will be recognized subsequent to September 30, 2023 over a weighted-average period of approximately 28 months.
The
exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at September 30,
2023 are as follows:
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants
Exercise Prices | | |
Options Outstanding (Shares) | | |
Options Exercisable (Shares) | |
| | |
| | |
| |
$ | 1.950 | | |
| 250,000 | | |
| — | |
$ | 5.025 | | |
| 8,750 | | |
| 8,750 | |
$ | 5.880 | | |
| 40,000 | | |
| 5,000 | |
$ | 7.400 | | |
| 57,500 | | |
| 41,563 | |
$ | 20.000 | | |
| 80,000 | | |
| 20,000 | |
$ | 20.600 | | |
| 20,000 | | |
| 20,000 | |
$ | 28.000 | | |
| 25,000 | | |
| 25,000 | |
$ | 30.000 | | |
| 66,667 | | |
| 66,667 | |
$ | 30.300 | | |
| 42,500 | | |
| 42,500 | |
$ | 32.000 | | |
| 20,313 | | |
| 20,313 | |
$ | 32.100 | | |
| 15,000 | | |
| 15,000 | |
$ | 60.000 | | |
| 16,667 | | |
| 16,667 | |
$ | 66.000 | | |
| 4,167 | | |
| 4,167 | |
$ | 71.400 | | |
| 20,000 | | |
| 20,000 | |
$ | 120.000 | | |
| 8,332 | | |
| 8,332 | |
| | | |
| 674,896 | | |
| 313,959 | |
Based
on a fair market value of $2.45 per share on September 30, 2023, there was no intrinsic value attributed to exercisable but unexercised
common stock options at September 30, 2023.
Outstanding
stock options to acquire 360,938 shares of the Company’s common stock had not vested at September 30, 2023.
The
Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock.
8.
Income Taxes
During
the three months and nine months ended September 30, 2023 and 2022, the Company did not record any provision for income taxes, as the
Company incurred losses during those periods. Deferred tax assets and liabilities reflect the net tax effect of temporary differences
between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
The Company has recorded a full valuation allowance against its deferred tax assets for all periods presented as the Company currently
believes it is more likely than not that the deferred tax assets will not be realized.
9.
Commitments and Contingencies
Legal
Claims
The
Company may be subject to legal claims and actions from time to time as part of its business activities. As of September 30, 2023 and
December 31, 2022, the Company was not subject to any pending or threatened legal claims or actions.
Principal
Commitments
Clinical
Trial Agreements
At
September 30, 2023, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring
agreements not yet incurred, as described below, aggregated $6,262,000, which, based on current estimates, are currently scheduled to
be incurred through approximately December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is
subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation
of such funds to the Company’s current or future clinical trial programs. The Company expects that the full amount of these expenditures
will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration
are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can
frequently involve a series of changes and modifications over time as clinical data are obtained and analyzed, and are frequently modified,
suspended or terminated before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein
should be considered as estimates only based on current clinical assumptions and conditions, and are typically subject to significant
modifications and revisions over time.
The
following is a summary of the contractual clinical trials discussed below as of September 30, 2023:
Schedule
of Contractual Clinical Trials
Description of Clinical
Trial | |
Type of Clinical
Trial | |
Institution | |
Estimated Start
Date | |
Estimated
End Date | |
Number of Patients in
Trial | |
Study
Objective | |
Clinical
Update | |
NCT
No. |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with carboplatin, etoposide and atezolizumab in small cell lung cancer | |
Phase 1b | |
City of Hope and Sarah Cannon | |
March 2021 | |
March 2026 | |
14 to 36 | |
Determine RP2D | |
Three patients entered | |
NCT04560972 |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with doxorubicin in sarcoma | |
Phase 1b | |
GEIS | |
June 2023 | |
June 2024 | |
9 to 18 | |
Determine MTD and RP2D | |
One patient entered | |
NCT05809830 |
| |
| |
| |
| |
| |
| |
| |
| |
|
Doxorubicin with or without LB-100 in sarcoma | |
Randomized Phase 2 | |
GEIS | |
July 2024 | |
June 2026 | |
150 | |
Determine efficacy: PFS | |
Clinical trial not yet begun (subject to completion of Phase 1b GEIS clinical trial) | |
NCT05809830 |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with dostarlimab in ovarian clear cell carcinoma | |
Phase 1b/2 | |
MD Anderson | |
March 2024 | |
December 2025 | |
21 | |
Determine the survival of patients with ovarian clear cell carcinoma | |
No patients entered at September 30, 2023 | |
NCT06065462 |
Moffitt.
Effective August 20, 2018, the Company entered into a five-year Clinical Trial Research Agreement with the Moffitt Cancer Center
and Research Institute Hospital Inc., Tampa, Florida (“Moffitt”). Pursuant to the Clinical Trial Research Agreement, Moffitt
agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s lead
anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome
(MDS).
In
November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application
to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and intermediate-1
risk MDS who have failed or are intolerant of standard treatment. Patients with MDS, although usually older, are generally well except
for severe anemia requiring frequent blood transfusions. This Phase 1b/2 clinical trial utilized LB-100 as a single agent in the treatment
of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line
therapy.
During
the three months ended June 30, 2023, the Phase 1b/2 clinical trial at Moffitt evaluating LB-100 in patients with MDS was closed by the
principal investigator. In this clinical trial, single agent LB-100 was used on a new schedule of days 1, 3, and 5 every 3 weeks. The
Company is not employing this schedule in its other clinical trials. Although the Maximally Tolerated Dose (“MTD”) was not
achieved, there was no dose-limiting toxicity on this schedule at doses that were greater than the MTD in the Phase 1 clinical trial
of LB-100 on the Monday, Tuesday, Wednesday schedule.
During
the three months ended September 30, 2023 and 2022, the Company incurred costs of $0 and $9,218, respectively, pursuant to this agreement,
which have been included in research and development costs in the Company’s consolidated statements of operations. During the nine
months ended September 30, 2023 and 2022, the Company incurred costs of $0 and $18,623, respectively, pursuant to this agreement, which
have been included in research and development costs in the Company’s consolidated statements of operations. As of September 30,
2023, total costs of $131,074 have been incurred pursuant to this agreement.
The
Company has decided not to pursue further studies in MDS, as other opportunities have become available (see “Patent and License
Agreements - Moffitt” below).
GEIS.
Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the
Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas or “GEIS”), Madrid, Spain, to carry out a
study entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue
sarcoma”. The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined
with doxorubicin in soft tissue sarcomas. Doxorubicin is the global standard for initial treatment of advanced soft tissue sarcomas (“ASTS”).
Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little therapeutic gain from adding cytotoxic
compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 consistently enhances the anti-tumor
activity of doxorubicin without apparent increases in toxicity.
GEIS
has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative
studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as
well as to provide funding for the clinical trial. The goal is to enter approximately 150 to 170 patients in this clinical trial over
a period of two years. As advanced sarcoma is a very aggressive disease, the design of the study assumes a median progression free survival
(“PFS”, no evidence of disease progression or death from any cause) of 4.5 months in the doxorubicin arm and an alternative
median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression
or death by adding LB-100. There is a planned interim analysis of the primary endpoint when approximately 50% of the 102 events required
for final analysis is reached.
The
Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July
2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol,
it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These
standards were adopted subsequent to the production of the Company’s existing LB-100 inventory.
In
order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out
the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included
the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the
steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under
GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility,
provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal
application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory
authorities for review and approval before being used in a clinical trial.
As
of September 30, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially
for subsequent multiple trials within the European Union, had cost approximately $1,144,000. Although the production of new inventory
has been completed, nominal trailing costs subsequent to September 30, 2023 may be incurred.
On
October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos
y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead
clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas
(ASTS). Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report
prepared by December 31, 2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at
Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial.
The Phase 1b section of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on
both response and toxicity from this portion of the clinical trial, and subject to clinical results, anticipates that it will be able
to proceed to a related Phase 2 study.
The
interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has
the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study
would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit
of doxorubicin alone.
The
Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement.
During the three months ended September 30, 2023 and 2022, the Company did not incur any costs pursuant to this agreement. During the
nine months ended September 30, 2023 and 2022, the Company incurred costs of $268,829 and $0, respectively, pursuant to this agreement.
Such costs, when incurred, are included in research and development costs in the Company’s consolidated statements of operations.
Through September 30, 2023, the Company has paid GEIS an aggregate of $684,652 for work done under this agreement through the fourth
milestone.
The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,423,000
as of September 30, 2023, which is expected to be incurred through December 31, 2027. As the work is being conducted in Europe and is
paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations
are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate.
City
of Hope. Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the City of Hope National Medical
Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”),
to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor, combined with an
FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”). LB-100
will be given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved but marginally effective regimen, to previously
untreated ED-SCLC patients. The dose of LB-100 will be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended
Phase 2 dose (“RP2D”). Patient entry will be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm
the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration
of overall response, progression-free-survival and overall survival.
The
clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. However, as
patient accrual was slower than expected, the Company has been seeking to add additional sites to increase the rate of patient accrual.
Effective March 6, 2023, the Sarah Cannon Research Institute (“SCRI”), Nashville, Tennessee, joined the City of Hope’s
ongoing Phase 1b clinical trial. The Company is continuing its efforts to add additional sites. The addition of SCRI is expected to expedite
and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability
and efficacy of adding LB-100 to the current standard treatment regimen. With the addition of SCRI, the Company currently expects that
this clinical trial will be completed by March 31, 2026.
In
early July 2023, the Company was notified that one of three centers accruing patients to its Phase 1b clinical trial in small cell lung
cancer had a shortage of carboplatin and as a result the clinical trial was placed on a temporary enrollment hold. This matter was resolved
and the temporary enrollment hold was lifted in late July 2023.
During
the three months ended September 30, 2023 and 2022, the Company did not incur any costs pursuant to this agreement. During the nine months
ended September 30, 2023 and 2022, the Company incurred costs of $69,001 and $0, respectively, pursuant to this agreement, which are
included in research and development costs in the Company’s consolidated statements of operations. As of September 30, 2023, total
costs of $447,512 have been incurred pursuant to this agreement.
The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $2,433,000
as of September 30, 2023, which is expected to be incurred through March 31, 2026. If a significant number of patients fail during the
dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of approximately
$800,000.
The
Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees
as the most likely number. Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee
basis. If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment
of a very aggressive disease.
Theradex.
On June 22, 2023, the Company finalized a work order agreement with Theradex Systems, Inc. (“Theradex”), an international
contract research organization (“CRO”), to conduct a Phase I/II randomized trial of LB-100 plus doxorubicin vs. doxorubicin
alone in first line of advanced soft tissue sarcomas. The study is expected to be completed by June 30, 2026.
Costs
under this work order agreement are estimated to be approximately $153,000, with such payments expected to be allocated approximately
72% to Theradex for services and approximately 28% for payments for pass-through software costs. During the three months and nine months
ended September 30, 2023, the Company incurred costs of $$3,750 and 10,000, respectively, pursuant to this work order. As of September
30, 2023, total costs of $10,000 have been incurred pursuant to this work order agreement.
The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $144,000 as of September 30, 2023, which is expected to be incurred through June 30, 2026.
National
Cancer Institute Pharmacologic Clinical Trial. In May 2019, the National Cancer Institute (“NCI”) initiated a glioblastoma
(“GBM”) pharmacologic clinical trial. This study was being conducted and funded by the NCI under a Cooperative Research and
Development Agreement, with the Company responsible for providing the LB-100 clinical compound.
Primary
malignant brain tumors (gliomas) are very challenging to treat. Radiation combined with the chemotherapeutic drug temozolomide has been
the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with some further benefit gained
by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients. In animal
models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation,
temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment
in the clinic. Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human
cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain has not been determined. Many
drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.
The
NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas. Patients having surgery to remove
one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100
present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its
molecular target. As a result of the innovative design of the NCI study, it was believed that data from a few patients would be sufficient
to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment
regimen for GBMs. Five patients were entered into this study and analysis of the blood and tissue has been conducted. If there is clinical
evidence in at least two of the patients of penetration of LB 100 into tumor tissue, the study will be deemed as successful. Results
of this study are currently being reviewed by the NCI and a report is pending.
MD
Anderson Cancer Center Trial. On September 20, 2023, the Company announced a Phase 1b/2 collaborative clinical trial to assess whether
adding LB-100 to the programmed death receptor-1 (“PD-1”)-blocking monoclonal antibody of GSK plc (“GSK”), dostarlimab,
may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (“OCCC”). The clinical trial
is sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and will be conducted at MD Anderson, and
will also be open at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. The Company will provide LB-100 and
GSK will provide dostarlimab and financial support for the clinical trial.
Clinical
Trial Monitoring Agreements
Moffitt.
On September 12, 2018, the Company finalized a work order agreement with Theradex (“CRO”), to monitor the Phase 1b/2
clinical trial being managed and conducted by Moffitt. The clinical trial began in April 2019 and the first patient was entered into
the clinical trial in July 2019.
The
costs of the Phase 1b/2 clinical trial being paid to or through Theradex have been recorded and charged to operations based on periodic
documentation provided by the CRO. During the three months ended September 30, 2023 and 2022, the Company incurred costs of $566 and
$11,953, respectively, pursuant to this work order. During the nine months ended September 30, 2023 and 2022, the Company incurred costs
of $20,850 and $19,792, respectively, pursuant to this work order. As of September 30, 2023, total costs of $148,138 have been incurred
pursuant to this work order agreement.
As
a result of the closure of the Company’s Clinical Trial Research Agreement with Moffitt during the three months ended June 30,
2023 (see “Clinical Trial Agreements – Moffitt” above), this work order agreement with Theradex to monitor the Clinical
Trial Research Agreement with Moffitt was similarly suspended, although nominal oversight trailing costs subsequent to September 30,
2023 are expected to be incurred relating to the closure of the Moffitt study.
City
of Hope. On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated
clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party. Costs under this
work order agreement are estimated to be approximately $335,000. During the three months ended September 30, 2023 and 2022, the Company
incurred costs of $4,500 and $7,731, respectively, pursuant to this work order. During the nine months ended September 30, 2023 and 2022,
the Company incurred costs of $15,740 and $23,466, respectively, pursuant to this work order. As of September 30, 2023, total costs of
$74,181 have been incurred pursuant to this work order agreement.
The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $262,000 as of September 30, 2023, which is expected to be incurred through March 31, 2026.
Patent
and License Agreements
Moffitt.
Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt. Pursuant to the License Agreement,
Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating
to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results,
clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents
or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under
the Licensed Patents. The Company was obligated to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient
was entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt. The clinical trial began at a single site in April
2019 and the first patient was entered into the clinical trial in July 2019. The Company was also obligated to pay Moffitt an annual
license maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the
Company commences payment of minimum royalty payments. The Company had also agreed to pay non-refundable milestone payments to Moffitt,
which could not be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones
aggregating $1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term
is defined in the License Agreement.
On
October 4, 2023, the Company received a counter-signed termination letter dated September 29, 2023 with respect to the Exclusive License
Agreement dated August 20, 2018 between the Company and Moffitt, effective September 30, 2023. The Company and Moffitt agreed that no
termination fee shall be due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement.
During
the three months and nine months ended September 30, 2023, the Company recorded credits to operations of $21,507 and $9,109, respectively,
representing the reversal of obligations previously recorded with respect to the Exclusive License Agreement. During the three months
and nine months ended September 30, 2022, the Company recorded charges to operations of $6,301 and $18,699, respectively, in connection
with its obligations under the Exclusive License Agreement.
Employment
Agreements with Officers
During
July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting
of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, which provided for aggregate annual cash compensation
of $640,000, payable monthly (see Note 6). These employment agreements were automatically renewable for additional one-year periods unless
terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination
for cause. These employment agreements were automatically renewed for additional one-year periods in July and August 2021, 2022 and 2023.
On
April 9, 2021, the Board of Directors increased the annual cash compensation of Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten
under the employment agreements, such that the aggregate annual compensation for all officers increased to $775,000, effective May 1,
2021.
Effective
November 6, 2022, Mr. Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $200,000. In addition,
Mr. Forman is being provided an office allowance of approximately $1,500 per month through December 31, 2023.
On
September 26, 2023, the Company entered into an employment agreement with Bastiaan van der Baan to act as the Company’s President
and Chief Executive Officer and as Vice Chairman of the Board of Directors with an annual salary of $150,000. The term of the employment
agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject
to early termination as described in the employment agreement. Under the employment agreement, Mr. van der Baan’s annual may be
increased from time to time at the sole discretion of the Board of Directors. In addition, Mr. van der Baan will be eligible to receive
an annual bonus as determined in the sole discretion of the Board of Directors. Mr. Van der Baan was appointed as Chairman of the Board
of Directors upon the death of Dr. Kovach on October 5, 2023.
The
aggregate annual cash compensation for all officers increased to $950,000, effective September 26, 2023, which has continued through
September 30, 2023. As a result of Dr. Kovach’s death on October 5, 2023, aggregate annual compensation of all officers will decrease
to $700,000 from that date forward.
Other
Significant Agreements and Contracts
NDA
Consulting Corp. On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. for consultation and advice
in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel
D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year
and provided for a quarterly cash fee of $4,000. The agreement has been automatically renewed for additional one-year terms on its anniversary
date since 2014. Consulting and advisory fees charged to operations pursuant to this agreement were $4,000 and $4,000 for the three months
ended September 30, 2023 and 2022, respectively, and $12,000 and $12,000 for the nine months ended September 30, 2023 and 2022, which
were included in research and development costs in the consolidated statements of operations.
BioPharmaWorks.
Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged
BioPharmaWorks to perform certain services for the Company. Those services included, among other things, assisting the Company to commercialize
its products and strengthen its patent portfolio; identifying large pharmaceutical companies with a potential interest in the Company’s
product pipeline; assisting in preparing technical presentations concerning the Company’s products; consultation in drug discovery
and development; and identifying providers and overseeing tasks relating to clinical development of new compounds.
BioPharmaWorks
was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience.
The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated
by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the
Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in
lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation (see Note 7). The Company recorded
charges to operations pursuant to this Collaboration Agreement of $30,000 and $30,000 for the three months ended September 30, 2023 and
2022, respectively, and $90,000 and $90,000 for the nine months ended September 30, 2023 and 2022, respectively, which were included
in research and development costs in the consolidated statements of operations.
Netherlands
Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer
Institute, Amsterdam (“NKI”) (see Note 6), one of the world’s leading comprehensive cancer centers, and Oncode Institute,
Utrecht, a major independent cancer research center, for a term of three years. The Development Collaboration Agreement was subsequently
modified by Amendment No. 1 thereto. The Development Collaboration Agreement is intended to identify the most promising drugs to be combined
with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular
mechanisms underlying the identified combinations. The Company agreed to fund the study, at an approximate cost of 391,000 Euros and
provide a sufficient supply of LB-100 to conduct the study.
On
October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with NKI, which provides for additional
research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and adds
250,000 Euros (approximately $263,000 at October 3, 2023) to the operating budget being funded by the Company.
During
the three months ended September 30, 2023 and 2022, the Company incurred charges in the amount of $51,568 and $46,068, respectively,
with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated statements
of operations. During the nine months ended September 30, 2023 and 2022, the Company incurred charges in the amount of $156,949 and $149,184,
respectively, with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated
statements of operations. As of September 30, 2023, total costs of $416,356 have been incurred pursuant to this agreement. The Company’s
aggregate commitment pursuant to this agreement, as amended, less amounts previously paid to date, totaled approximately $316,000 as
of September 30, 2023, which is expected to be incurred through October 8, 2026. As the work is being conducted in Europe and is paid
for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.
MRI
Global. The Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials
in the United States. On June 10, 2022, the contract was amended to reflect a new total contract price of $273,980 for services to be
rendered through April 30, 2023. Effective April 17, 2023, the contract was further amended to reflect a new total contract price of
$326,274 for services to be rendered through April 30, 2024. During the three months ended September 30, 2023 and 2022, the Company incurred
costs of $19,845 and $5,549, respectively, pursuant to this contract. During the nine months ended September 30, 2023 and 2022, the Company
incurred costs of $27,028 and $25,902, respectively, pursuant to this work order. As of September 30, 2023, total costs of $241,841 have
been incurred pursuant to this contract.
The
Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $84,000 as
of September 30, 2023.
External
Risks
Covid-19
Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout
the world as businesses and governments implemented broad actions to mitigate this public health crisis. The extent to which the coronavirus
pandemic may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and
cannot be predicted.
Inflation
Risk. The Company does not believe that inflation has had a material effect on its operations to date, other than its impact on the
general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary and interest
rate pressures in the future, which would have the effect of increasing the Company’s operating costs (including, specifically,
clinical trial costs), and which would put additional stress on the Company’s working capital resources.
Supply
Chain Issues. The Company does not currently expect that supply chain issues will have a significant impact on its business activities,
including its ongoing clinical trials.
Potential
Recession. There are various indications that the United States economy may be entering a recessionary period. Although unclear at
this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn,
affect the Company.
The
Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance
become available.
10.
Subsequent Events
The
Company performed an evaluation of subsequent events through the date of filing of these condensed consolidated financial statements
with the SEC. Other than those matters described elsewhere in the footnotes, there were no material subsequent events which affected,
or could affect, the amounts or disclosures in the condensed consolidated financial statements.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q of Lixte Biotechnology Holdings, Inc. (the “Company”) contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These might
include statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations,
and assumptions and predictions about future clinical trials and their timing and costs, product demand, supply, manufacturing costs,
marketing and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as “intend”,
“anticipate”, “believe”, “estimate”, “potential(ly)”, “continue”, “forecast”,
“predict”, “plan”, “may”, “will”, “could”, “would”, “should”,
“expect” or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations
reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company
cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action
that the Company may presently be planning. These forward-looking statements are inherently subject to known and unknown risks and uncertainties.
Actual results or experience may differ materially from those expected, anticipated or implied in the forward-looking statements. Factors
that could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, available
cash, research and development results, competition from other similar businesses, and market and general economic factors. This discussion
should be read in conjunction with the condensed consolidated financial statements and notes thereto included in Item 1 of this Quarterly
Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, including the section
entitled “Item 1A. Risk Factors”. The Company does not intend to update or revise any forward-looking statements to reflect
new information, future events or otherwise.
Overview
The
Company is a drug research company that uses biomarker technology to identify enzyme targets associated with serious common diseases
and then designs novel compounds to attack those targets. The Company’s corporate office is located in Pasadena, California.
The
Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic
agents and/or x-ray and immune checkpoint blockers. The Company believes that inhibitors of protein phosphatases have broad therapeutic
potential not only for cancer but also for other debilitating and life-threatening diseases. The Company is directing its efforts on
clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer
activity at doses that produce little or no toxicity.
The
Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company
has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation
for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its
operating requirements.
Reverse
Stock Split
On
June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. No fractional shares were issued
in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest whole
share.
All
share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for
all periods presented.
Recent
Developments
President
and Chief Executive Officer
Effective
September 26, 2023, Bas van der Baan was appointed as the Company’s President and Chief Executive Officer, at which time he replaced
Dr. John S. Kovach as the Company’s President and Chief Executive Officer. Dr. Kovach passed away on October 5, 2023.
News
Release
On
September 20, 2023, the Company announced a Phase 1b/2 collaborative clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s
programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab, may enhance the effectiveness of immunotherapy in the treatment
of ovarian clear cell carcinoma (OCCC). The clinical trial is sponsored by The University of Texas - MD Anderson Cancer Center and will
be conducted at MD Anderson, and will also be open at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. LIXTE
will provide LB-100 and GSK will provide dostarlimab and financial support for the clinical trial.
The
clinical trial is based on the observation of longer survival of patients with OCCC treated with immunotherapy whose cancer cells have
an acquired gene mutation resulting in a reduction in PP2A. This finding was reported by the lead clinical investigators of this new
clinical trial: Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, and Emily Hinchcliff, MD, MPH, Assistant Professor
of Obstetrics and Gynecology at Northwestern University Feinberg School of Medicine. The observation by Drs. Jazaeri and Hinchcliff is
that a genetically acquired reduction in PP2A enhances sensitivity to immunotherapy and raises the possibility that reducing PP2A pharmacologically
with LB-100 will enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody dostarlimab in patients with OCCC lacking the
genetic reduction in PP2A.
Going
Concern
As reflected in the accompanying financial statements, for the nine months ended September 30, 2023, the Company recorded a net loss of
$4,054,774 and used cash in operations of $3,391,142. At
September 30, 2023, the Company had cash of $5,105,611 available to fund its operations. Because the Company is currently engaged in
various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product
or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate
any sustainable operating revenues in the next several years and may never do so. Even if the Company is able to generate revenues through
licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve
and maintain positive earnings and operating cash flows. At September 30, 2023, the Company’s remaining contractual commitments
pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $6,262,000,
which are currently scheduled to be incurred through approximately December 31, 2027.
The
Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates
the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue
and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through
the recurring sale of its equity securities.
Based
on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern
within one year after the date that the accompanying interim condensed consolidated financial statements are being issued. The Company’s
interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The
Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research
and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future
cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the
availability of operating capital to fund such activities.
Based
on current operating plans, the Company estimates that its existing cash resources at September 30, 2023 will provide sufficient working
capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound
LB-100 through at least September 30, 2024. However, existing cash resources will not be sufficient to complete the development of and
obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional
capital. The Company estimates that it will need to raise additional capital to fund its operations by mid-2024 to be able
to proactively manage its current business plan during the remainder of 2024 and during 2025. In addition, the Company’s operating
plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional
funds may be needed sooner than planned.
As
market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the
Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.
If
cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back
or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development
efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights
to and/or control of LB-100, or to discontinue operations entirely.
Recent
Accounting Pronouncements
Information
with respect to recent accounting pronouncements is provided at Note 3 to the condensed consolidated financial statements for the three
months and nine months ended September 30, 2023 and 2022 included elsewhere in this document.
Concentration
of Risk
Information
with respect to concentration of risk is provided at Note 3 to the condensed consolidated financial statements for the three months and
nine months ended September 30, 2023 and 2022 included elsewhere in this document.
Critical
Accounting Policies and Estimates
The
preparation of the Company’s consolidated financial statements in conformity with generally accepted accounting principles in the
United States (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Some of those judgments
can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions
or conditions. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable
in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates
the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances,
historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly.
Actual results could differ from those estimates. Significant estimates include those related to assumptions used in the calculation
of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services, and the realization
of deferred tax assets.
The
following critical accounting policies affect the more significant judgements and estimates used in the preparation of the Company’s
consolidated financial statements.
Cash
Cash
is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC
(“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash
balances with financial institutions in the United States with high credit ratings and in accounts insured by the Federal Deposit Insurance
Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically
has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. Morgan
Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has not
experienced any losses to date resulting from this policy.
Segment
Information
The
Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated
with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported
in a manner consistent with the internal reporting provided to the Company’s Chief Operating Decision Maker, which is the Company’s
President and Chief Executive Officer.
Research
and Development
Research
and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation,
design, development and management of clinical trials with respect to the Company’s clinical compound and product candidate. Research
and development costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to
operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States
and in the European Union in accordance with the laws and regulations of such jurisdictions.
Research
and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of
milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing
schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are
charged to operations as incurred.
Obligations
incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research
and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified
in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions
are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded
as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the
Company’s consolidated statement of operations.
Payments
made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated
balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those
contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development
contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs
in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research
and development contracts on a quarterly basis.
Patent
and Licensing Legal and Filing Fees and Costs
Due
to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s
research efforts and related patent applications, all patent and licensing legal and filing fees and costs are charged to operations
as incurred. Patent and licensing legal and filing fees and costs are included in general and administrative costs in the Company’s
consolidated statements of operations.
During
the three months ended September 30, 2023 and 2022, patent and licensing legal and filing fees and costs related to the development and
protection of its intellectual property were $178,012 and $271,163, respectively, a decrease of $93,151, or 34.4% in 2023, as compared
to 2022. During the nine months ended September 30, 2023 and 2022, patent and licensing legal and filing fees and costs related to the
development and protection of its intellectual property were $835,362 and $944,789, respectively, a decrease of $109,427, or 11.6% in
2023, as compared to 2022.
In
late 2021, the Company engaged a new patent law firm that is highly regarded for its expertise in biotechnology. This firm conducted
a comprehensive analysis of the Company’s extensive patent portfolio in order to implement a program to maximize intellectual property
protection, both domestically and internationally. As a result, several patents were filed in 2022, reflecting potential new uses of
the Company’s lead clinical compound LB-100 in cancer therapy. The Company expects that patent and licensing legal and filing fees
and costs will remain relatively stable for the remainder of 2023 as compared to 2022, as the Company continues to focus on efforts to
expand clinical programs to analyze various potential uses for LB-100 and to develop and expand its patent portfolio related to the clinical
development of LB-100.
A
descriptive summary of the patent portfolio for the Company’s most important clinical programs involving the development of LB-100,
as well as a detailed listing of each domestic and international patent that has been issued, is presented at “ITEM 1. BUSINESS
– Intellectual Property” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
Stock-Based
Compensation
The
Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members,
contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each
grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over
the vesting period.
The
Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants
by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the
cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period
of the awards.
The
fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is
affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock
option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock.
Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between
the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical
volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of
the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant.
The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on
the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero.
The
Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development
costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to
satisfy stock option exercises.
Warrants
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the
warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480,
Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The
assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a
liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815,
including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially
require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for
equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued
and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of
the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the
time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are
required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at
each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on
the statements of operations. The Company has determined that the warrants issued in the July 20, 2023 equity financing meet the
requirements for equity classification.
Summary
of Business Activities and Plans
Company
Overview
The
Company is a drug research company that uses biomarker technology to identify enzyme targets associated with serious common diseases
and then designs novel compounds to attack those targets. The Company’s product pipeline is primarily focused on inhibitors of
protein phosphatases, used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers, and encompasses
two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic
potential not only for cancer but also for other debilitating and life-threatening diseases.
The
Company is focusing its development activities on its LB-100 series of drugs. The Company believes that the mechanism by which compounds
of the LB-100 series affect cancer cell growth is different from cancer agents currently approved for clinical use. Lead compounds from
each series have activity against a broad spectrum of common and rarer human cancers in cell culture systems. In addition, compounds
from both series have anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma, all cancers
of neural tissue. Lead compounds of the LB-100 series also have activity against melanoma, breast cancer and sarcoma in animal models
and enhance the effectiveness of commonly used anti-cancer drugs in these animal models. The enhancement of anti-cancer activity of these
anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity in animals. It is therefore hoped that, when
combined with standard anti-cancer regimens against many tumor types, the Company’s compounds will improve therapeutic benefit
without enhancing toxicity in humans. The Company is not currently planning to allocate resources to further develop its LB-200 series
of drugs,
Product
Candidates
The
LB-100 series consists of novel structures which have the potential to be first in their class and may be useful in the treatment of
not only several types of cancer but also vascular and metabolic diseases. The LB-200 series contains compounds which have the potential
to be the most effective in its class and may be useful for the treatment of chronic hereditary diseases, such as Gaucher’s disease,
in addition to cancer and neurodegenerative diseases.
The
Company has demonstrated that lead compounds of both the LB-100 series and the LB-200 are active against a broad spectrum of human cancers
in cell culture and against several types of human cancers in animal models. The research on these compounds was initiated in 2006 under
a Cooperative Research and Development Agreement, or CRADA, with the National Institute of Neurologic Disorders and Stroke, or NINDS,
of the National Institutes of Health, or NIH, dated March 22, 2006 that was subsequently extended through a series of amendments until
it terminated on April 1, 2013. As discussed below, the Company’s primary focus is on the clinical development of LB-100.
The
LB-200 series consists of histone deacetylase inhibitors (HDACi). Many pharmaceutical companies are also developing drugs of this type,
and at least two companies have HDACi approved for clinical use, in both cases for the treatment of a type of lymphoma. Despite this
significant competition, the Company has demonstrated that its HDACi have broad activity against many cancer types, have neuroprotective
activity, and have anti-fungal activity. In addition, these compounds have low toxicity. LB-200 has not yet advanced to the clinical
stage and would require additional capital to fund further development. Accordingly, because of the Company’s focus on the clinical
development of LB-100 and analogs for cancer therapy as described below in more detail, the Company has decided not to actively pursue
the pre-clinical development of the LB-200 series of compounds. At this time, the Company intends to only maintain composition and synthesis
patents on the LB-200 series of compounds in the United States.
Collaborations
with leading academic research centers in the United States, Europe and Asia have established the breadth of activity of LB-100 in pre-clinical
models of several major cancers. There is considerable scientific interest in LB-100 because it exerts its activity by a novel mechanism
and is the first of its type to be evaluated so broadly in multiple animal models of cancer and now in human beings. LB-100 is one of
a series of serine/threonine phosphatase (s/t ptase) inhibitors designed by the Company. The s/t ptases are ubiquitous enzymes that regulate
many cell signaling networks important to cell growth, division and death. The s/t ptases have long been appreciated as potentially important
targets for anti-cancer drugs. However, because of the multi- functionality of these enzymes, it had been widely held that pharmacologic
inhibitors of s/t ptases would be too toxic to allow their development as anti-cancer treatments, but the Company has shown that this
is not the case. LB-100 was well tolerated at doses associated with objective regression (significant tumor shrinkage) and/or the arresting
of tumor progression in patients with progressive cancers.
Pre-clinical
studies showed that LB-100 itself inhibits a spectrum of human cancers and that combined with standard cytotoxic drugs and/or radiation,
LB-100 potentiates their effectiveness against hematologic and solid tumor cancers without enhancing toxicity. Given at very low doses
in animal models of cancer, LB-100 markedly increased the effectiveness of a PD-1 blocker, one of the widely used new immunotherapy drugs.
This finding raises the possibility that LB-100 may further expand the value of the expanding field of cancer immunotherapy.
The
Company completed a Phase 1 clinical trial of LB-100 to evaluate its safety that showed it is associated with antitumor activity in humans
at doses that are readily tolerable. Responses included objective regression (tumor shrinkage) lasting for 11 months of a pancreatic
cancer and cessation of growth (stabilization of disease) for 4 months or more of 9 other progressive solid tumors out of 20 patients
who had measurable disease. As Phase 1 clinical trials are fundamentally designed to determine safety of a new compound in humans, the
Company was encouraged by these results. The next step is to demonstrate in Phase 2 clinical trials the efficacy of LB-100 in one or
more specific tumor types, against which the compound has well documented activity in pre-clinical models.
As
a compound moves through the FDA-approval process, it becomes an increasingly valuable property, but at a cost of additional investment
at each stage. As the potential effectiveness of LB-100 has been documented at the clinical trial level, the Company has allocated resources
to expand the breadth and depth of its patent portfolio. The Company’s approach has been to operate with a minimum of overhead,
moving compounds forward as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain
milestones are reached. The Company’s longer-term objective is to secure one or more strategic partnerships or licensing agreements
with pharmaceutical companies with major programs in cancer.
External
Risks
Covid-19
Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout
the world as businesses and governments implemented broad actions to mitigate this public health crisis. The extent to which the coronavirus
pandemic may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and
cannot be predicted.
Inflation
Risk. The Company does not believe that inflation has had a material effect on its operations to date, other than its impact on the
general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary and interest
rate pressures in the future, which would have the effect of increasing the Company’s operating costs (including, specifically,
clinical trial costs), and which would put additional stress on the Company’s working capital resources.
Supply
Chain Issues. The Company does not currently expect that supply chain issues will have a significant impact on its business activities,
including its ongoing clinical trials.
Potential
Recession. There are various indications that the United States economy may be entering a recessionary period. Although unclear at
this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn,
affect the Company.
The
Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance
become available.
Results
of Operations
At
September 30, 2023, the Company had not yet commenced any revenue-generating operations, does not have any positive cash flows from operations,
and is dependent on its ability to raise equity capital to fund its operating requirements.
The
Company’s condensed consolidated statements of operations as discussed herein are presented below.
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
General and administrative costs: | |
| | | |
| | | |
| | | |
| | |
Compensation to related parties | |
| 356,001 | | |
| 643,957 | | |
| 1,398,042 | | |
| 1,963,409 | |
Patent and licensing legal and filing fees and costs | |
| 178,012 | | |
| 271,163 | | |
| 835,362 | | |
| 944,789 | |
Other costs and expenses | |
| 357,681 | | |
| 290,993 | | |
| 1,081,893 | | |
| 875,016 | |
Research and development costs | |
| 132,487 | | |
| 272,388 | | |
| 749,029 | | |
| 895,649 | |
Total costs and expenses | |
| 1,024,181 | | |
| 1,478,501 | | |
| 4,064,326 | | |
| 4,678,863 | |
Loss from operations | |
| (1,024,181 | ) | |
| (1,478,501 | ) | |
| (4,064,326 | ) | |
| (4,678,863 | ) |
Interest income | |
| 5,809 | | |
| 3,911 | | |
| 13,538 | | |
| 4,211 | |
Interest expense | |
| (279 | ) | |
| (2,119 | ) | |
| (6,088 | ) | |
| (5,240 | ) |
Foreign currency gain (loss) | |
| (109 | ) | |
| (1,300 | ) | |
| 2,102 | | |
| (1,339 | ) |
Net loss | |
$ | (1,018,760 | ) | |
$ | (1,478,009 | ) | |
$ | (4,054,774 | ) | |
$ | (4,681,231 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share – basic and diluted | |
$ | (0.49 | ) | |
$ | (0.89 | ) | |
$ | (2.25 | ) | |
$ | (3.01 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding – basic and diluted | |
| 2,074,938 | | |
| 1,664,659 | | |
| 1,803,466 | | |
| 1,554,183 | |
Three
Months Ended September 30, 2023 and 2022
Revenues.
The Company did not have any revenues for the three months ended September 30, 2023 and 2022.
General
and Administrative Costs. For the three months ended September 30, 2023, general and administrative costs were $891,694, which consisted
of the fair value of vested stock options issued to directors and officers of $112,106, patent and licensing legal and filing fees and
costs of $178,012, other consulting and professional fees of $199,884, insurance expense of $107,910, officer salaries and related costs
of $216,880, cash-based director and board committee fees of $42,228, shareholder reporting costs of $3,887, listing fees of $15,500,
filing fees of $4,439, taxes and licenses of $3,946, investor relations of $14,172, rent of $7,323 and other operating costs of $6,914,
offset by a credit to licensing fees of $21,507 relating to the termination of the Moffitt agreement.
For
the three months ended September 30, 2022, general and administrative costs were $1,206,113, which consisted of the fair value of vested
stock options issued to directors and officers of $396,883, patent and licensing legal and filing fees and costs of $271,163, other consulting
and professional fees of $108,630, insurance expense of $114,983, officer salaries and related costs of $207,091, cash-based director
and board committee fees of $53,324, licensing fees of $6,301, shareholder reporting costs of $20,487, listing fees of $14,875, filing
fees of $3,048, taxes and licenses of $4,094, investor relations of $2,397, and other operating costs of $2,837.
General
and administrative costs decreased by $314,419, or 26.1%, in 2023 as compared to 2022, primarily as a result of a decrease in the fair
value of vested stock options issued to directors and officers of $284,777, a decrease in patent and licensing legal and filing fees
and costs of $93,151, a decrease in licensing fees of $27,808 a decrease in shareholder reporting of $16,600, offset by increases in
investor relations of $11,775 and an increase in consulting and professional fees of $91,254.
Research
and Development Costs. For the three months ended September 30, 2023, research and development costs were $132,487, which consisted
of clinical and related oversight costs of $8,816, regulatory service costs of $10,919, and pre-clinical research focused on development
of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $124,752, offset by a credit of $12,000
relating to the termination of the Moffitt agreement.
For
the three months ended September 30, 2022, research and development costs were $272,388, which consisted of contractor costs incurred
in connection with the synthesis work done to develop a new supply of LB-100 for the Spanish clinical trial of $1,246, clinical and related
oversight costs of $28,902, regulatory service costs of $5,330, and pre-clinical research focused on development of additional novel
anti-cancer compounds to add to the Company’s clinical pipeline of $236,910.
Included
in pre-clinical research costs for the three months ended September 30, 2023 and 2022 were $51,568 and $46,068, respectively, of costs
paid to the Netherlands Cancer Institute, which employs Dr. René Bernards, a director of the Company since June 15, 2022. On October
8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the
world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, as amended
by Amendment No. 1. The Development Collaboration Agreement is intended to identify the most promising drugs to be combined with LB-100,
and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying
the identified combinations.
On
October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute,
which provides for additional research activities, extends the termination date of the Development Collaboration Agreement by two years
to October 8, 2026, and adds 250,000 Euros (approximately $263,000 at October 3, 2023) to the operating budget being funded by the Company
(see “Principal Commitments – Other Significant Agreements and Contracts – Netherlands Cancer Institute” below).
Research
and development costs decreased by $139,901, or 51.4%, in 2023 as compared to 2022, primarily as a result of a decrease in
pre-clinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of
$112,158 and a credit of $12,000 relating to the termination of the Moffitt agreement.
Interest
Income. For the three months ended September 30, 2023, the Company had interest income of $5,809, as compared to interest income
of $3,911 for the three months ended September 30, 2022, related to the investment of funds generated by the Company’s financing
activities.
Interest
Expense. For the three months ended September 30, 2023, the Company had interest expense of $279, as compared to interest expense
of $2,119 for the three months ended September 30, 2022, related to the financing of the premium for the Company’s directors and
officers liability insurance policy.
Foreign
Currency Loss. For the three months ended September 30, 2023, the Company had a foreign currency loss of $109, as compared to a foreign
currency loss of $1,300 for the three months ended September 30, 2022, from foreign currency transactions.
Net
Loss. For the three months ended September 30, 2023, the Company incurred a net loss of $1,018,760, as compared to a net loss of
$1,478,009 for the three months ended September 30, 2022.
Nine
Months Ended September 30, 2023 and 2022
Revenues.
The Company did not have any revenues for the nine months ended September 30, 2023 and 2022.
General
and Administrative Costs. For the nine months ended September 30, 2023, general and administrative costs were $3,315,297, which consisted
of the fair value of vested stock options issued to directors and officers of $669,146, patent and licensing legal and filing fees and
costs of $835,362, other consulting and professional fees of $529,830, insurance expense of $316,214, officer salaries and related costs
of $649,483, cash-based director and board committee fees of $127,229, shareholder reporting costs of $64,783, listing fees of $46,500,
filing fees of $14,634, taxes and licenses of $11,483, investor relations of $36,516, rent of $11,436 and other operating costs of $11,790,
offset by a credit to licensing fees of $9,109 relating to the termination of the Moffitt agreement.
For
the nine months ended September 30, 2022, general and administrative costs were $3,783,214, which consisted of the fair value of vested
stock options issued to directors and officers of $1,160,649, patent and licensing legal and filing fees and costs of $944,789, other
consulting and professional fees of $344,085, insurance expense of $349,254, officer salaries and related costs of $627,579, cash-based
director and board committee fees of $221,510, licensing fees of $18,699, shareholder reporting costs of $26,811, listing fees of $44,625,
filing fees of $11,460, taxes and licenses of $12,231, investor relations of $7,246, and other operating costs of $14,276.
General
and administrative costs decreased by $467,917, or 12.4%, in 2023 as compared to 2022, primarily as a result of a decrease in the fair
value of vested stock options issued to directors and officers of $491,503, a decrease in patent and licensing legal and filing fees
and costs of $109,427, a decrease in licensing fees of $27,808 a decrease in cash-based director and board committee fees of $94,281,
offset by an increase in shareholder reporting of $37,972, an increase in investor relations of $29,270, an increase in rent of $11,436
and an increase in consulting and professional fees of $185,745.
Research
and Development Costs. For the nine months ended September 30, 2023, research and development costs were $749,029, which consisted
of clinical and related oversight costs of $390,708, regulatory service costs of $18,738, and pre-clinical research focused on development
of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $339,583.
For
the nine months ended September 30, 2022, research and development costs were $895,649, which consisted of contractor costs incurred
in connection with the synthesis work done to develop a new supply of LB-100 for the Spanish clinical trial of $352,734, clinical and
related oversight costs of $61,880, regulatory service costs of $5,690, and pre-clinical research focused on development of additional
novel anti-cancer compounds to add to the Company’s clinical pipeline of $475,345.
Included
in pre-clinical research costs for the nine months ended September 30, 2023 and 2022 were $156,950 and $149,184, respectively, of costs
paid to the Netherlands Cancer Institute, which employs Dr. René Bernards, a director of the Company since June 15, 2022. On October
8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the
world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify
the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well
as to identify the specific molecular mechanisms underlying the identified combinations.
On
October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute,
which provides for additional research activities, extends the termination date of the Development Collaboration Agreement by two years
to October 8, 2026, and adds 250,000 Euros (approximately $263,000 at October 3, 2023) to the operating budget being funded by the Company
(see “Principal Commitments – Other Significant Agreements and Contracts – Netherlands Cancer Institute” below).
Research
and development costs decreased by $146,620, or 16.4%, in 2023 as compared to 2022, primarily as a result of a decrease in contractor
costs incurred in connection with the synthesis work done to develop a new supply of LB-100 for the Spanish clinical trial of $352,734
and a decrease in pre-clinical research focused on development of additional novel anti-cancer compounds to add to the Company’s
clinical pipeline of $135,762, offset by an increase in clinical and related oversight costs of $328,828.
Interest
Income. For the nine months ended September 30, 2023, the Company had interest income of $13,538, as compared to interest income
of $4,211 for the nine months ended September 30, 2022, related to the investment of funds generated by the Company’s financing
activities.
Interest
Expense. For the nine months ended September 30, 2023, the Company had interest expense of $6,088, as compared to interest expense
of $5,240 for the nine months ended September 30, 2022, related to the financing of the premium for the Company’s directors and
officers liability insurance policy.
Foreign
Currency Gain (Loss). For the nine months ended September 30, 2023, the Company had a foreign currency gain of $2,102, as compared
to a foreign currency loss of $1,339 for the nine months ended September 30, 2022, from foreign currency transactions.
Net
Loss. For the nine months ended September 30, 2023, the Company incurred a net loss of $4,054,774, as compared to a net loss of $4,681,231
for the nine months ended September 30, 2022.
Liquidity
and Capital Resources – September 30, 2023
The
Company’s consolidated statements of cash flows as discussed herein are as follows:
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Net cash used in operating activities | |
$ | (3,391,142 | ) | |
$ | (3,403,289 | ) |
Net cash provided by (used in) investing activities | |
| — | | |
| — | |
Net cash provided by financing activities | |
| 3,143,361 | | |
| 5,141,384 | |
Net increase (decrease) in cash | |
$ | (247,781 | ) | |
$ | 1,738,095 | |
At
September 30, 2023, the Company had working capital of $4,922,960, as compared to working capital of $5,165,227 at December 31, 2022,
reflecting a decrease in working capital of $242,267 for the nine months ended September 30, 2023. The decrease in working capital during
the nine months ended September 30, 2023 was primarily the result of the funding of the Company’s ongoing research and development
activities and other ongoing operating expenses, including maintaining and developing its patent portfolio, offset by proceeds from the
sale of securities on July 20, 2023. At September 30, 2023, the Company had cash of $5,105,611 available to fund its operations.
The
Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research
and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future
cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the
availability of operating capital to fund such activities.
Based
on current operating plans, the Company estimates that its existing cash resources at September 30, 2023 will provide sufficient working
capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound
LB-100 through at least September 30, 2024. However, existing cash resources will not be sufficient to complete the development of and
obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional
capital. The Company estimates that it will need to raise additional capital to fund its operations by mid-2024 to be able
to proactively manage its current business plan during the remainder of 2024 and during 2025. In addition, the Company’s operating
plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional
funds may be needed sooner than planned.
At
September 30, 2023, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring
agreements not yet incurred aggregated $6,262,000, which are currently scheduled to be incurred through approximately December 31, 2027.
At
September 30, 2023, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet
arrangements.
Operating
Activities. For the nine months ended September 30, 2023, operating activities utilized cash of $3,391,142, as compared to utilizing
cash of $3,403,289 for the nine months ended September 30, 2022, to fund the Company’s ongoing research and development activities
and to fund its other ongoing operating expenses, including maintaining and developing its patent portfolio.
Investing
Activities. For the nine months ended September 30, 2023 and 2022, the Company had no investing activities.
Financing
Activities. For the nine months ended September 30, 2023, financing activities consisted primarily of the gross proceeds from the
sale of securities in the Company’s registered direct offering of $3,499,964, reduced by offering costs of $362,925, and $6,281
from the exercise of common stock options. For the nine months September 30, 2022, financing activities consisted of the gross proceeds
from the sale of securities in the Company’s registered direct offering of $5,800,000, reduced by offering costs of $658,616.
Principal
Commitments
Clinical
Trial Agreements
At
September 30, 2023, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring
agreements not yet incurred, as described below, aggregated $6,262,000, which, based on current estimates, are currently scheduled to
be incurred through approximately December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is
subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation
of such funds to the Company’s current or future clinical trial programs. The Company expects that the full amount of these expenditures
will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration
are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can
frequently involve a series of changes and modifications over time as clinical data are obtained and analyzed, and are frequently modified,
suspended or terminated before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein
should be considered as estimates only based on current clinical assumptions and conditions, and are typically subject to significant
modifications and revisions over time.
The
following is a summary of the contractual clinical trials discussed below as of September 30, 2023:
Description of Clinical
Trial | |
Type
of Clinical
Trial | |
Institution | |
Estimated Start
Date | |
Estimated
End Date | |
Number
of Patients in
Trial | | |
Study
Objective | |
Clinical
Update | |
NCT
No. |
| |
| |
| |
| |
| |
| | |
| |
| |
|
LB-100 combined with carboplatin, etoposide and atezolizumab in small cell lung cancer | |
Phase 1b | |
City of Hope and Sarah Cannon | |
March 2021 | |
March 2026 | |
| 14 to 36 | | |
Determine RP2D | |
Three patients entered | |
NCT04560972 |
| |
| |
| |
| |
| |
| | | |
| |
| |
|
LB-100 combined with doxorubicin in sarcoma | |
Phase 1b | |
GEIS | |
June 2023 | |
June 2024 | |
| 9 to 18 | | |
Determine MTD and RP2D | |
One patient entered | |
NCT05809830 |
| |
| |
| |
| |
| |
| | | |
| |
| |
|
Doxorubicin with or without LB-100 in sarcoma | |
Randomized Phase 2 | |
GEIS | |
July 2024 | |
June 2026 | |
| 150 | | |
Determine efficacy: PFS | |
Clinical trial not yet begun (subject to completion of Phase 1b GEIS clinical trial) | |
NCT05809830 |
| |
| |
| |
| |
| |
| | | |
| |
| |
|
LB-100 combined with dostarlimab in ovarian clear cell carcinoma | |
Phase 1b/2 | |
MD Anderson | |
March 2024 | |
December 2025 | |
| 21 | | |
Determine the survival of patients with ovarian clear cell carcinoma | |
No patients entered at September 30, 2023 | |
NCT06065462 |
Moffitt.
Effective August 20, 2018, the Company entered into a five-year Clinical Trial Research Agreement with the Moffitt Cancer Center
and Research Institute Hospital Inc., Tampa, Florida (“Moffitt”). Pursuant to the Clinical Trial Research Agreement, Moffitt
agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s lead
anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome
(MDS).
In
November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application
to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and intermediate-1
risk MDS who have failed or are intolerant of standard treatment. Patients with MDS, although usually older, are generally well except
for severe anemia requiring frequent blood transfusions. This Phase 1b/2 clinical trial utilized LB-100 as a single agent in the treatment
of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line
therapy.
During
the three months ended June 30, 2023, the Phase 1b/2 clinical trial at Moffitt evaluating LB-100 in patients with MDS was closed by the
principal investigator. In this clinical trial, single agent LB-100 was used on a new schedule of days 1, 3, and 5 every 3 weeks. The
Company is not employing this schedule in its other clinical trials. Although the Maximally Tolerated Dose (“MTD”) was not
achieved, there was no dose-limiting toxicity on this schedule at doses that were greater than the MTD in the Phase 1 clinical trial
of LB-100 on the Monday, Tuesday, Wednesday schedule.
During
the three months ended September 30, 2023 and 2022, the Company incurred costs of $0 and $9,218, respectively, pursuant to this agreement,
which have been included in research and development costs in the Company’s consolidated statements of operations. During the nine
months ended September 30, 2023 and 2022, the Company incurred costs of $0 and $18,623, respectively, pursuant to this agreement, which
have been included in research and development costs in the Company’s consolidated statements of operations. As of September 30,
2023, total costs of $131,074 have been incurred pursuant to this agreement.
The
Company has decided not to pursue further studies in MDS, as other opportunities have become available (see “Patent and License
Agreements - Moffitt” below).
GEIS.
Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the
Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas or “GEIS”), Madrid, Spain, to carry out a
study entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue
sarcoma”. The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined
with doxorubicin in soft tissue sarcomas. Doxorubicin is the global standard for initial treatment of advanced soft tissue sarcomas (“ASTS”).
Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little therapeutic gain from adding cytotoxic
compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 consistently enhances the anti-tumor
activity of doxorubicin without apparent increases in toxicity.
GEIS
has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative
studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as
well as to provide funding for the clinical trial. The goal is to enter approximately 150 to 170 patients in this clinical trial over
a period of two years. As advanced sarcoma is a very aggressive disease, the design of the study assumes a median progression free survival
(“PFS”, no evidence of disease progression or death from any cause) of 4.5 months in the doxorubicin arm and an alternative
median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression
or death by adding LB-100. There is a planned interim analysis of the primary endpoint when approximately 50% of the 102 events required
for final analysis is reached.
The
Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July
2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol,
it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These
standards were adopted subsequent to the production of the Company’s existing LB-100 inventory.
In
order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out
the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included
the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the
steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under
GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility,
provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal
application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory
authorities for review and approval before being used in a clinical trial.
As
of September 30, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially
for subsequent multiple trials within the European Union, had cost approximately $1,144,000. Although the production of new inventory
has been completed, nominal trailing costs subsequent to September 30, 2023 may be incurred.
On
October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos
y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead
clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas
(ASTS). Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report
prepared by December 31, 2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at
Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial.
The Phase 1b section of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on
both response and toxicity from this portion of the clinical trial, and subject to clinical results, anticipates that it will be able
to proceed to a related Phase 2 study.
The
interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has
the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study
would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit
of doxorubicin alone.
The
Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement.
During the three months ended September 30, 2023 and 2022, the Company did not incur any costs pursuant to this agreement. During the
nine months ended September 30, 2023 and 2022, the Company incurred costs of $268,829 and $0, respectively, pursuant to this agreement.
Such costs, when incurred, are included in research and development costs in the Company’s consolidated statements of operations.
Through September 30, 2023, the Company has paid GEIS an aggregate of $684,652 for work done under this agreement through the fourth
milestone.
The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,423,000
as of September 30, 2023, which is expected to be incurred through December 31, 2027. As the work is being conducted in Europe and is
paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations
are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate.
City
of Hope. Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the City of Hope National Medical
Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”),
to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor, combined with an
FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”). LB-100
will be given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved but marginally effective regimen, to previously
untreated ED-SCLC patients. The dose of LB-100 will be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended
Phase 2 dose (“RP2D”). Patient entry will be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm
the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration
of overall response, progression-free-survival and overall survival.
The
clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. However, as
patient accrual was slower than expected, the Company has been seeking to add additional sites to increase the rate of patient accrual.
Effective March 6, 2023, the Sarah Cannon Research Institute (“SCRI”), Nashville, Tennessee, joined the City of Hope’s
ongoing Phase 1b clinical trial. The Company is continuing its efforts to add additional sites. The addition of SCRI is expected to expedite
and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability
and efficacy of adding LB-100 to the current standard treatment regimen. With the addition of SCRI, the Company currently expects that
this clinical trial will be completed by March 31, 2026.
In
early July 2023, the Company was notified that one of three centers accruing patients to its Phase 1b clinical trial in small cell lung
cancer had a shortage of carboplatin and as a result the clinical trial was placed on a temporary enrollment hold. This matter was resolved
and the temporary enrollment hold was lifted in late July 2023.
During
the three months ended September 30, 2023 and 2022, the Company did not incur any costs pursuant to this agreement. During the nine months
ended September 30, 2023 and 2022, the Company incurred costs of $69,001 and $0, respectively, pursuant to this agreement, which are
included in research and development costs in the Company’s consolidated statements of operations. As of September 30, 2023, total
costs of $447,512 have been incurred pursuant to this agreement.
The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $2,433,000
as of September 30, 2023, which is expected to be incurred through March 31, 2026. If a significant number of patients fail during the
dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of approximately
$800,000.
The
Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees
as the most likely number. Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee
basis. If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment
of a very aggressive disease.
Theradex.
On June 22, 2023, the Company finalized a work order agreement with Theradex Systems, Inc. (“Theradex”), an international
contract research organization (“CRO”), to conduct a Phase I/II randomized trial of LB-100 plus doxorubicin vs. doxorubicin
alone in first line of advanced soft tissue sarcomas. The study is expected to be completed by June 30, 2026.
Costs
under this work order agreement are estimated to be approximately $153,000, with such payments expected to be allocated approximately
72% to Theradex for services and approximately 28% for payments for pass-through software costs. During the three months and nine months
ended September 30, 2023, the Company incurred costs of $$3,750 and 10,000, respectively, pursuant to this work order. As of September
30, 2023, total costs of $10,000 have been incurred pursuant to this work order agreement.
The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $144,000 as of September 30, 2023, which is expected to be incurred through June 30, 2026.
National
Cancer Institute Pharmacologic Clinical Trial. In May 2019, the National Cancer Institute (“NCI”) initiated a glioblastoma
(“GBM”) pharmacologic clinical trial. This study was being conducted and funded by the NCI under a Cooperative Research and
Development Agreement, with the Company responsible for providing the LB-100 clinical compound.
Primary
malignant brain tumors (gliomas) are very challenging to treat. Radiation combined with the chemotherapeutic drug temozolomide has been
the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with some further benefit gained
by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients. In animal
models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation,
temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment
in the clinic. Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human
cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain has not been determined. Many
drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.
The
NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas. Patients having surgery to remove
one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100
present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its
molecular target. As a result of the innovative design of the NCI study, it was believed that data from a few patients would be sufficient
to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment
regimen for GBMs. Five patients were entered into this study and analysis of the blood and tissue has been conducted. If there is clinical
evidence in at least two of the patients of penetration of LB 100 into tumor tissue, the study will be deemed as successful. Results
of this study are currently being reviewed by the NCI and a report is pending.
MD
Anderson Cancer Center Trial. On September 20, 2023, the Company announced a Phase 1b/2 collaborative clinical trial to assess whether
adding LB-100 to the programmed death receptor-1 (“PD-1”)-blocking monoclonal antibody of GSK plc (“GSK”), dostarlimab,
may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (“OCCC”). The clinical trial
is sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and will be conducted at MD Anderson, and
will also be open at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. The Company will provide LB-100 and
GSK will provide dostarlimab and financial support for the clinical trial.
Clinical
Trial Monitoring Agreements
Moffitt.
On September 12, 2018, the Company finalized a work order agreement with Theradex (“CRO”), to monitor the Phase 1b/2
clinical trial being managed and conducted by Moffitt. The clinical trial began in April 2019 and the first patient was entered into
the clinical trial in July 2019.
The
costs of the Phase 1b/2 clinical trial being paid to or through Theradex have been recorded and charged to operations based on periodic
documentation provided by the CRO. During the three months ended September 30, 2023 and 2022, the Company incurred costs of $566 and
$11,953, respectively, pursuant to this work order. During the nine months ended September 30, 2023 and 2022, the Company incurred costs
of $20,850 and $19,792, respectively, pursuant to this work order. As of September 30, 2023, total costs of $148,138 have been incurred
pursuant to this work order agreement.
As
a result of the closure of the Company’s Clinical Trial Research Agreement with Moffitt during the three months ended June 30,
2023 (see “Clinical Trial Agreements – Moffitt” above), this work order agreement with Theradex to monitor the Clinical
Trial Research Agreement with Moffitt was similarly suspended, although nominal oversight trailing costs subsequent to September 30,
2023 are expected to be incurred relating to the closure of the Moffitt study.
City
of Hope. On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated
clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party. Costs under this
work order agreement are estimated to be approximately $335,000. During the three months ended September 30, 2023 and 2022, the Company
incurred costs of $4,500 and $7,731, respectively, pursuant to this work order. During the nine months ended September 30, 2023 and 2022,
the Company incurred costs of $15,740 and $23,466, respectively, pursuant to this work order. As of September 30, 2023, total costs of
$74,181 have been incurred pursuant to this work order agreement.
The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $262,000 as of September 30, 2023, which is expected to be incurred through March 31, 2026.
Patent
and License Agreements
Moffitt.
Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt. Pursuant to the License Agreement,
Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating
to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results,
clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents
or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under
the Licensed Patents. The Company was obligated to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient
was entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt. The clinical trial began at a single site in April
2019 and the first patient was entered into the clinical trial in July 2019. The Company was also obligated to pay Moffitt an annual
license maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the
Company commences payment of minimum royalty payments. The Company had also agreed to pay non-refundable milestone payments to Moffitt,
which could not be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones
aggregating $1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term
is defined in the License Agreement.
On
October 4, 2023, the Company received a counter-signed termination letter dated September 29, 2023 with respect to the Exclusive License
Agreement dated August 20, 2018 between the Company and Moffitt, effective September 30, 2023. The Company and Moffitt agreed that no
termination fee shall be due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement.
During
the three months and nine months ended September 30, 2023, the Company recorded credits to operations of $21,507 and $9,109, respectively,
representing the reversal of obligations previously recorded with respect to the Exclusive License Agreement. During the three months
and nine months ended September 30, 2022, the Company recorded charges to operations of $6,301 and $18,699, respectively, in connection
with its obligations under the Exclusive License Agreement.
Employment
Agreements with Officers
During
July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting
of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, which provided for aggregate annual cash compensation
of $640,000, payable monthly. These employment agreements were automatically renewable for additional one-year periods unless terminated
by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination for cause.
These employment agreements were automatically renewed for additional one-year periods in July and August 2021, 2022 and 2023.
On
April 9, 2021, the Board of Directors increased the annual cash compensation of Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten
under the employment agreements, such that the aggregate annual compensation for all officers increased to $775,000, effective May 1,
2021.
Effective
November 6, 2022, Mr. Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $200,000. In addition,
Mr. Forman is being provided an office allowance of approximately $1,500 per month through December 31, 2023.
On
September 26, 2023, the Company entered into an employment agreement with Bastiaan van der Baan to act as the Company’s President
and Chief Executive Officer and as Vice Chairman of the Board of Directors with an annual salary of $150,000. The term of the employment
agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject
to early termination as described in the employment agreement. Under the employment agreement, Mr. van der Baan’s annual may be
increased from time to time at the sole discretion of the Board of Directors. In addition, Mr. van der Baan will be eligible to receive
an annual bonus as determined in the sole discretion of the Board of Directors. Mr. Van der Baan was appointed as Chairman of the Board
of Directors upon the death of Dr. Kovach on October 5, 2023.
The
aggregate annual cash compensation for all officers increased to $950,000, effective September 26, 2023, which has continued through
September 30, 2023. As a result of Dr. Kovach’s death on October 5, 2023, aggregate annual compensation of all officers will decrease
to $700,000 from that date forward.
Other
Significant Agreements and Contracts
NDA
Consulting Corp. On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. for consultation and advice
in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel
D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year
and provided for a quarterly cash fee of $4,000. The agreement has been automatically renewed for additional one-year terms on its anniversary
date since 2014. Consulting and advisory fees charged to operations pursuant to this agreement were $4,000 and $4,000 for the three months
ended September 30, 2023 and 2022, respectively, and $12,000 and $12,000 for the nine months ended September 30, 2023 and 2022, which
were included in research and development costs in the consolidated statements of operations.
BioPharmaWorks.
Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged
BioPharmaWorks to perform certain services for the Company. Those services included, among other things, assisting the Company to commercialize
its products and strengthen its patent portfolio; identifying large pharmaceutical companies with a potential interest in the Company’s
product pipeline; assisting in preparing technical presentations concerning the Company’s products; consultation in drug discovery
and development; and identifying providers and overseeing tasks relating to clinical development of new compounds.
BioPharmaWorks
was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience.
The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated
by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the
Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in
lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation. The Company recorded charges to
operations pursuant to this Collaboration Agreement of $30,000 and $30,000 for the three months ended September 30, 2023 and 2022, respectively,
and $90,000 and $90,000 for the nine months ended September 30, 2023 and 2022, respectively, which were included in research and development
costs in the consolidated statements of operations.
Netherlands
Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer
Institute, Amsterdam (“NKI”), one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht,
a major independent cancer research center, for a term of three years. The Development Collaboration Agreement was subsequently modified
by Amendment No. 1 thereto. The Development Collaboration Agreement is intended to identify the most promising drugs to be combined with
LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms
underlying the identified combinations. The Company agreed to fund the study, at an approximate cost of 391,000 Euros and provide a sufficient
supply of LB-100 to conduct the study.
On
October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with NKI, which provides for additional
research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and adds
250,000 Euros (approximately $263,000 at October 3, 2023) to the operating budget being funded by the Company.
During
the three months ended September 30, 2023 and 2022, the Company incurred charges in the amount of $51,568 and $46,068, respectively,
with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated statements
of operations. During the nine months ended September 30, 2023 and 2022, the Company incurred charges in the amount of $156,949 and $149,184,
respectively, with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated
statements of operations. As of September 30, 2023, total costs of $416,356 have been incurred pursuant to this agreement. The Company’s
aggregate commitment pursuant to this agreement, as amended, less amounts previously paid to date, totaled approximately $316,000 as
of September 30, 2023, which is expected to be incurred through October 8, 2026. As the work is being conducted in Europe and is paid
for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.
MRI
Global. The Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials
in the United States. On June 10, 2022, the contract was amended to reflect a new total contract price of $273,980 for services to be
rendered through April 30, 2023. Effective April 17, 2023, the contract was further amended to reflect a new total contract price of
$326,274 for services to be rendered through April 30, 2024. During the three months ended September 30, 2023 and 2022, the Company incurred
costs of $19,845 and $5,549, respectively, pursuant to this contract. During the nine months ended September 30, 2023 and 2022, the Company
incurred costs of $27,028 and $25,902, respectively, pursuant to this work order. As of September 30, 2023, total costs of $241,841 have
been incurred pursuant to this contract.
The
Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $84,000 as
of September 30, 2023.
Trends,
Events and Uncertainties
Research
and development of new pharmaceutical compounds is, by its nature, unpredictable. Although the Company undertakes research and development
efforts with commercially reasonable diligence, there can be no assurance that the Company’s cash position will be sufficient to
enable it to develop pharmaceutical compounds to the extent needed to create future revenues sufficient to sustain operations.
There
can be no assurances that the Company’s pharmaceutical compounds will obtain the regulatory approvals and market acceptance to
achieve sustainable revenues sufficient to support operations. Even if the Company is able to generate revenues, there can be no assurances
that it will be able to achieve operating profitability or positive operating cash flows. There can be no assurances that the Company
will be able to secure additional financing, to the extent required, on acceptable terms or at all. If cash resources are insufficient
to satisfy the Company’s ongoing cash requirements, the Company would be required to reduce or discontinue its research and development
programs, or attempt to obtain funds, if available (although there can be no assurances), through strategic alliances that may require
the Company to relinquish rights to certain of its pharmaceutical compounds, or to curtail or discontinue its operations entirely.
Other
than as discussed above, the Company is not currently aware of any trends, events or uncertainties that are likely to have a material
effect on its financial condition in the near term, although it is possible that new trends or events may develop in the future that
could have a material effect on the Company’s financial condition.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
The
Company’s management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined
in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), that is designed
to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is
recorded, processed, summarized, and reported, within the time periods specified in the rules and forms. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the
reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its
principal executive officer and principal financial officer, or persons performing similar functions, as appropriate, to allow timely
decisions regarding required disclosure.
In
accordance with Exchange Act Rules 13a-15 and 15d-15, an evaluation was completed under the supervision and with the participation of
the Company’s management, including its Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design
and operation of the Company’s disclosure controls and procedures as of September 30, 2023, the end of the most recent fiscal period
covered by this report. Based on that evaluation, the Company’s management has concluded that the Company’s disclosure controls
and procedures were effective in providing reasonable assurance that information required to be disclosed in the Company’s reports
filed or submitted under the Exchange Act was recorded, processed, summarized, and reported within the time periods specified in the
rules and forms of the Securities and Exchange Commission.
Limitations
on Effectiveness of Disclosure Controls and Procedures
In
designing and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well
designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls
can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. In addition,
the design of disclosure controls and procedures must reflect that there are resource constraints and that management is required to
apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Changes
in Internal Control Over Financial Reporting
The
Company’s management, including its Chief Executive Officer and Chief Financial Officer, has determined that no change in the Company’s
internal control over financial reporting (as that term is defined in Rules 13(a)-15(f) and 15(d)-15(f) of the Securities Exchange Act
of 1934) occurred during the period ended September 30, 2023 that has materially affected, or is reasonably likely to materially affect,
the Company’s internal control over financial reporting.
PART
II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
The
Company is not currently subject to any pending or threatened legal actions or claims.
ITEM
1A. RISK FACTORS
The
Company’s business, financial condition, results of operations and cash flows may be impacted by a number of factors, many of which
are beyond the Company’s control, including those set forth in the Company’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2022, as filed with the Securities and Exchange Commission on March 29, 2023 (the “2022 Form 10-K”).
The
Risk Factors set forth in the 2022 Form 10-K should be read carefully in connection with evaluating the Company’s business and
in connection with the forward-looking statements contained in this Quarterly Report on Form 10-Q. Any of the risks described in the
2022 Form 10-K could materially adversely affect the Company’s business, financial condition or future results and the actual outcome
of matters as to which forward-looking statements are made. These are not the only risks that the Company faces. Additional risks and
uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adversely affect
the Company’s business, financial condition and/or operating results.
As
of the date of this filing, except as disclosed in this document, there have been no material changes to the Risk Factors previously
disclosed in the Company’s 2022 Form 10-K.
Nasdaq
Listing
The
Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”,
respectively.
In
order to achieve compliance with the $1.00 minimum closing bid price requirement of the Nasdaq Capital Market, the Company held a special
meeting of stockholders on May 26, 2023 to seek approval for an amendment to the Company’s Certificate of Incorporation to effect
a reverse stock split of its issued and outstanding shares of common stock. As a result of the approval of this amendment, the Company
effected a 1-for-10 reverse stock split of its issued and outstanding common stock effective on Friday, June 2, 2023. Commencing with
the opening of trading on the Nasdaq Capital Market on Monday, June 5, 2023, the Company’s common stock began trading on a post-split
basis under the same symbol LIXT. The Company subsequently received confirmation from Nasdaq that it had regained compliance with the
minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2) and currently meets all other applicable criteria
for continued listing.
However,
there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum bid price requirement over time,
or that it will be successful in maintaining compliance with any of the other Nasdaq continued listing requirements.
External
Risks
Covid-19
Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout
the world as businesses and governments implemented broad actions to mitigate this public health crisis. The extent to which the coronavirus
pandemic may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and
cannot be predicted.
Inflation
Risk. The Company does not believe that inflation has had a material effect on its operations to date, other than its impact on the
general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary and interest
rate pressures in the future, which would have the effect of increasing the Company’s operating costs (including, specifically,
clinical trial costs), and which would put additional stress on the Company’s working capital resources.
Supply
Chain Issues. The Company does not currently expect that supply chain issues will have a significant impact on its business activities,
including its ongoing clinical trials.
Potential
Recession. There are various indications that the United States economy may be entering a recessionary period. Although unclear at
this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn,
affect the Company.
The
Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance
become available.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Not
applicable.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
Not
applicable.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
During
the three months ended September 30, 2023, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company
adopted or terminated a “Rule 10b5-1 trading arrangement” as such term is defined in Item 408(a) of Regulation S-K.
ITEM
6. EXHIBITS
The
following documents are filed as part of this report:
Exhibit
Number |
|
Description
of Document |
|
|
|
4.1 |
|
Form of Common Stock Purchase Warrant, filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 20, 2023 |
|
|
|
4.2 |
|
Form of Pre-Funded Common Stock Purchase Warrant, filed as Exhibit 4.2 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 20, 2023 |
|
|
|
4.3 |
|
Form of Placement Agent Warrant, filed as Exhibit 4.3 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 20, 2023 |
|
|
|
10.1 |
|
Amendment to Contract between Lixte Biotechnology Holdings, Inc. and MRI Global effective April 17, 2023, filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as filed with the Securities and Exchange Commission on May 10, 2023 |
|
|
|
10.2 |
|
Securities Purchase Agreement, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 20, 2023 |
|
|
|
10.3* |
|
Amendment No. 1 to Development Collaboration Agreement by and between Lixte Biotechnology Holdings, Inc and the Netherlands Cancer Institute, Amsterdam, and the Oncode Institute, Utrecht, entered into on October 8, 2021 |
|
|
|
10.4 |
|
Amendment No. 2 to Development Collaboration Agreement by and between Lixte Biotechnology Holdings, Inc and the Netherlands Cancer Institute, Amsterdam, and the Oncode Institute, Utrecht, entered into on October 13, 2023, filed as Exhibit 10.2 to the Company Current Report on Form 8-K, as filed with the Securities and Exchange Commission on October 17, 2023 (certain portions of this Exhibit have been omitted) |
|
|
|
10.5* |
|
Termination letter between H. Lee Moffitt Cancer Center and Research Institute, Inc. and the Company dated October 4, 2023 and effective as of September 30, 2023 |
|
|
|
10.6 |
|
Employment Agreement between the Company and Bastiaan van der Baan effective as of September 26, 2023, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on September 27, 2023 |
|
|
|
31.1*
|
|
Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
31.2* |
|
Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1*
|
|
Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.2* |
|
Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
101.INS
|
|
Inline
XBRL Instance Document (does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) |
|
|
|
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
101.LAB |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
101.PRE |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
104 |
|
Cover
Page Interactive Data File (formatted as Inline XBRL document and included in Exhibit 101.INS) |
*
Filed herewith.
SIGNATURES
In
accordance with the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned thereunto duly authorized.
|
LIXTE
BIOTECHNOLOGY HOLDINGS, INC. |
|
(Registrant) |
|
|
|
Date:
November 9, 2023 |
By:
|
/s/
BASTIAAN VAN DER BAAN |
|
|
Bastiaan
van der Baan |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
Date:
November 9, 2023 |
By:
|
/s/
ROBERT N. WEINGARTEN |
|
|
Robert
N. Weingarten |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
Exhibit
10.3
Exhibit 10.5
Exhibit
31.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
UNDER
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Bastiaan van der Baan, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Lixte Biotechnology Holdings, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
I
am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant
and have: |
|
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
I
have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of registrant’s Board of Directors (or persons performing the equivalent functions): |
|
(a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
November 9, 2023 |
By:
|
/s/
BASTIAAN VAN DER BAAN |
|
|
Bastiaan
van der Baan |
|
|
(Principal
Executive Officer) |
Exhibit
31.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER
UNDER
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Robert N. Weingarten, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Lixte Biotechnology Holdings, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
I
am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant
and have: |
|
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
I
have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of registrant’s Board of Directors (or persons performing the equivalent functions): |
|
(a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
November 9, 2023 |
By:
|
/s/
ROBERT N. WEINGARTEN |
|
|
Robert
N. Weingarten |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
Exhibit
32.1
CERTIFICATIONS
OF CHIEF EXECUTIVE OFFICER
UNDER
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I,
Bastiaan van der Baan, the Chief Executive Officer of Lixte Biotechnology Holdings, Inc. (the “Company”), certify, pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that:
(i)
The Quarterly Report on Form 10-Q of the Company for the quarterly period ended September 30, 2023 (the “Report”) fully complies
with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(ii)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
A
signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company
and furnished to the Securities and Exchange Commission or its staff upon request.
Date:
November 9, 2023 |
By:
|
/s/
BASTIAAN VAN DER BAAN |
|
|
Bastiaan
van der Baan |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
Exhibit
32.2
CERTIFICATIONS
OF CHIEF FINANCIAL OFFICER
UNDER
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I,
Robert N. Weingarten, the Chief Financial Officer of Lixte Biotechnology Holdings, Inc. (the “Company”), certify, pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that:
(i)
The Quarterly Report on Form 10-Q of the Company for the quarterly period ended September 30, 2023 (the “Report”) fully complies
with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(ii)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
A
signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company
and furnished to the Securities and Exchange Commission or its staff upon request.
Date:
November 9, 2023 |
By:
|
/s/
ROBERT N. WEINGARTEN |
|
|
Robert
N. Weingarten |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 06, 2023 |
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-39717
|
|
Entity Registrant Name |
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
|
|
Entity Central Index Key |
0001335105
|
|
Entity Tax Identification Number |
20-2903526
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
680
East Colorado Boulevard
|
|
Entity Address, Address Line Two |
Suite 180
|
|
Entity Address, City or Town |
Pasadena
|
|
Entity Address, State or Province |
CA
|
|
Entity Address, Postal Zip Code |
91101
|
|
City Area Code |
(631)
|
|
Local Phone Number |
830-7092
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
2,249,290
|
Common Stock, par value $0.0001 per share |
|
|
Title of 12(b) Security |
Common
Stock, par value $0.0001 per share
|
|
Trading Symbol |
LIXT
|
|
Security Exchange Name |
NASDAQ
|
|
Warrants to Purchase Common Stock, par value $0.0001 per share |
|
|
Title of 12(b) Security |
Warrants
to Purchase Common Stock, par value $0.0001 per share
|
|
Trading Symbol |
LIXTW
|
|
Security Exchange Name |
NASDAQ
|
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v3.23.3
Condensed Consolidated Balance Sheets - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash |
$ 5,105,611
|
$ 5,353,392
|
Advances on research and development contract services |
78,015
|
147,017
|
Prepaid insurance |
23,230
|
49,224
|
Other prepaid expenses and current assets |
27,840
|
10,380
|
Total current assets |
5,234,696
|
5,560,013
|
Total assets |
5,234,696
|
5,560,013
|
Current liabilities: |
|
|
Accounts payable and accrued expenses, including $43,895 and $46,982 to related parties at September 30, 2023 and December 31, 2022, respectively |
221,171
|
229,764
|
Research and development contract liabilities |
90,565
|
165,022
|
Total current liabilities |
311,736
|
394,786
|
Commitments and contingencies |
|
|
Stockholders’ equity: |
|
|
Preferred Stock, $0.0001 par value; authorized – 10,000,000 shares; issued and outstanding – 350,000 shares of Series A Convertible Preferred Stock, $10.00 per share stated value, liquidation preference based on assumed conversion into common shares – 72,917 shares |
3,500,000
|
3,500,000
|
Common stock, $0.0001 par value; authorized – 100,000,000 shares; issued and outstanding – 2,249,290 shares and 1,664,706 shares at September 30, 2023 and December 31, 2022, respectively |
225
|
166
|
Additional paid-in capital |
48,872,208
|
45,059,760
|
Accumulated deficit |
(47,449,473)
|
(43,394,699)
|
Total stockholders’ equity |
4,922,960
|
5,165,227
|
Total liabilities and stockholders’ equity |
$ 5,234,696
|
$ 5,560,013
|
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v3.23.3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
10,000,000
|
10,000,000
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
2,249,290
|
1,664,706
|
Common stock, shares outstanding |
2,249,290
|
1,664,706
|
Series A Convertible Preferred Stock [Member] |
|
|
Preferred stock, shares issued |
350,000
|
350,000
|
Preferred stock, shares outstanding |
350,000
|
350,000
|
Preferred stock liquidation preference per share |
$ 10.00
|
$ 10.00
|
Preferred stock, issuable upon conversion |
72,917
|
72,917
|
Related Party [Member] |
|
|
Related parties accounts payable and accrued expenses |
$ 43,895
|
$ 46,982
|
X |
- DefinitionCarrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer).
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v3.23.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
|
|
|
|
General and administrative costs: |
|
|
|
|
Compensation to related parties, including stock-based compensation expense of $112,106 and $396,883 for the three months ended September 30, 2023 and 2022, respectively, and $669,146 and $1,160,649 for the nine months ended September 30, 2023 and 2022, respectively |
356,001
|
643,957
|
1,398,042
|
1,963,409
|
Patent and licensing legal and filing fees and costs |
178,012
|
271,163
|
835,362
|
944,789
|
Other costs and expenses |
357,681
|
290,993
|
1,081,893
|
875,016
|
Research and development costs |
132,487
|
272,388
|
749,029
|
895,649
|
Total costs and expenses |
1,024,181
|
1,478,501
|
4,064,326
|
4,678,863
|
Loss from operations |
(1,024,181)
|
(1,478,501)
|
(4,064,326)
|
(4,678,863)
|
Interest income |
5,809
|
3,911
|
13,538
|
4,211
|
Interest expense |
(279)
|
(2,119)
|
(6,088)
|
(5,240)
|
Foreign currency gain (loss) |
(109)
|
(1,300)
|
2,102
|
(1,339)
|
Net loss |
$ (1,018,760)
|
$ (1,478,009)
|
$ (4,054,774)
|
$ (4,681,231)
|
Net loss per common share basic |
$ (0.49)
|
$ (0.89)
|
$ (2.25)
|
$ (3.01)
|
Net loss per common share diluted |
$ (0.49)
|
$ (0.89)
|
$ (2.25)
|
$ (3.01)
|
Weighted average common shares outstanding basic |
2,074,938
|
1,664,659
|
1,803,466
|
1,554,183
|
Weighted average common shares outstanding diluted |
2,074,938
|
1,664,659
|
1,803,466
|
1,554,183
|
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v3.23.3
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v3.23.3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)
|
Preferred Stock [Member]
Series A Convertible Preferred Stock [Member]
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2021 |
$ 3,500,000
|
$ 137
|
$ 38,372,365
|
$ (37,082,164)
|
$ 4,790,338
|
Balance, shares at Dec. 31, 2021 |
350,000
|
1,374,593
|
|
|
|
Proceeds from sale of securities in registered direct offering, net of offering costs |
|
$ 29
|
5,141,355
|
|
5,141,384
|
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares |
|
290,000
|
|
|
|
Stock-based compensation expense |
|
|
1,160,649
|
|
1,160,649
|
Net loss |
|
|
|
(4,681,231)
|
(4,681,231)
|
Balance at Sep. 30, 2022 |
$ 3,500,000
|
$ 166
|
44,674,369
|
(41,763,395)
|
6,411,140
|
Balance, shares at Sep. 30, 2022 |
350,000
|
1,664,593
|
|
|
|
Balance at Jun. 30, 2022 |
$ 3,500,000
|
$ 166
|
44,277,486
|
(40,285,386)
|
7,492,266
|
Balance, shares at Jun. 30, 2022 |
350,000
|
1,664,593
|
|
|
|
Stock-based compensation expense |
|
|
396,883
|
|
396,883
|
Net loss |
|
|
|
(1,478,009)
|
(1,478,009)
|
Balance at Sep. 30, 2022 |
$ 3,500,000
|
$ 166
|
44,674,369
|
(41,763,395)
|
6,411,140
|
Balance, shares at Sep. 30, 2022 |
350,000
|
1,664,593
|
|
|
|
Balance at Dec. 31, 2022 |
$ 3,500,000
|
$ 166
|
45,059,760
|
(43,394,699)
|
5,165,227
|
Balance, shares at Dec. 31, 2022 |
350,000
|
1,664,706
|
|
|
|
Proceeds from sale of securities in registered direct offering, net of offering costs |
|
$ 18
|
3,137,021
|
|
3,137,039
|
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares |
|
180,000
|
|
|
|
Exercise of pre-funded common stock warrants |
|
$ 41
|
|
|
41
|
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares |
|
403,334
|
|
|
|
Stock-based compensation expense |
|
|
669,146
|
|
669,146
|
Net loss |
|
|
|
(4,054,774)
|
(4,054,774)
|
Exercise of common stock options |
|
|
6,281
|
|
$ 6,281
|
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares |
|
1,250
|
|
|
1,250
|
Balance at Sep. 30, 2023 |
$ 3,500,000
|
$ 225
|
48,872,208
|
(47,449,473)
|
$ 4,922,960
|
Balance, shares at Sep. 30, 2023 |
350,000
|
2,249,290
|
|
|
|
Balance at Jun. 30, 2023 |
$ 3,500,000
|
$ 166
|
45,623,081
|
(46,430,713)
|
2,692,534
|
Balance, shares at Jun. 30, 2023 |
350,000
|
1,665,956
|
|
|
|
Proceeds from sale of securities in registered direct offering, net of offering costs |
|
$ 18
|
3,137,021
|
|
3,137,039
|
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares |
|
180,000
|
|
|
|
Exercise of pre-funded common stock warrants |
|
$ 41
|
|
|
41
|
Proceeds from sale of common stock in direct equity offering, net of offering costs, shares |
|
403,334
|
|
|
|
Stock-based compensation expense |
|
|
112,106
|
|
112,106
|
Net loss |
|
|
|
(1,018,760)
|
(1,018,760)
|
Balance at Sep. 30, 2023 |
$ 3,500,000
|
$ 225
|
$ 48,872,208
|
$ (47,449,473)
|
$ 4,922,960
|
Balance, shares at Sep. 30, 2023 |
350,000
|
2,249,290
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.23.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (4,054,774)
|
$ (4,681,231)
|
Stock-based compensation expense included in - |
|
|
General and administrative costs |
669,146
|
1,160,649
|
Research and development costs |
|
|
Increase (decrease) in - |
|
|
Advances on research and development contract services |
69,002
|
3,224
|
Prepaid insurance |
25,994
|
22,375
|
Other prepaid expenses and current assets |
(17,460)
|
(13,708)
|
Accounts payable and accrued expenses |
(8,593)
|
81,433
|
Research and development contract liabilities |
(74,457)
|
23,969
|
Net cash used in operating activities |
(3,391,142)
|
(3,403,289)
|
Cash flows from financing activities: |
|
|
Proceeds from sale of securities in registered direct offering, net of offering costs |
3,137,039
|
5,141,384
|
Exercise of pre-funded common stock warrants |
41
|
|
Exercise of common stock options |
6,281
|
|
Net cash provided by financing activities |
3,143,361
|
5,141,384
|
Cash: |
|
|
Net increase (decrease) |
(247,781)
|
1,738,095
|
Balance at beginning of period |
5,353,392
|
4,823,745
|
Balance at end of period |
5,105,611
|
6,561,840
|
Supplemental disclosures of cash flow information: |
|
|
Interest |
6,088
|
5,240
|
Income taxes |
|
|
X |
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v3.23.3
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
Net Income (Loss) Attributable to Parent |
$ (1,018,760)
|
$ (1,478,009)
|
$ (4,054,774)
|
$ (4,681,231)
|
X |
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v3.23.3
Organization and Basis of Presentation
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Basis of Presentation |
1.
Organization and Basis of Presentation
The
condensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation), including its wholly-owned
Delaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”), at September 30, 2023, and for the three months
and nine months ended September 30, 2023 and 2022, are unaudited. In the opinion of management of the Company, all adjustments, including
normal recurring accruals, have been made that are necessary to present fairly the financial position of the Company as of September
30, 2023, and the results of its operations for the three months and nine months ended September 30, 2023 and 2022, and its cash flows
for the nine months ended September 30, 2023 and 2022. Operating results for the interim periods presented are not necessarily indicative
of the results to be expected for a full fiscal year. The consolidated balance sheet at December 31, 2022 has been derived from the Company’s
audited consolidated financial statements at such date.
The
condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities
and Exchange Commission (“SEC”). Accordingly, certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations.
These condensed consolidated financial statements should be read in conjunction with the financial statements and other information included
in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC.
President
and Chief Executive Officer
Effective
September 26, 2023, Bas van der Baan was appointed as the Company’s President and Chief Executive Officer, at which time he replaced
Dr. John S. Kovach as the Company’s President and Chief Executive Officer. Dr. Kovach passed away on October 5, 2023.
Reverse
Stock Split
On
June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. No fractional shares were issued
in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest whole
share.
All
share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock split for
all periods presented.
Nasdaq
Listing
The
Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”,
respectively.
In
order to achieve compliance with the $1.00 minimum closing bid price requirement of the Nasdaq Capital Market, the Company held a special
meeting of stockholders on May 26, 2023 to seek approval for an amendment to the Company’s Certificate of Incorporation to effect
a reverse stock split of its issued and outstanding shares of common stock. As a result of the approval of this amendment, the Company
effected a 1-for-10 reverse stock split of its issued and outstanding common stock effective on Friday, June 2, 2023. Commencing with
the opening of trading on the Nasdaq Capital Market on Monday, June 5, 2023, the Company’s common stock began trading on a post-split
basis under the same symbol LIXT. The Company subsequently received confirmation from Nasdaq that it had regained compliance with the
minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2) and currently meets all other applicable criteria
for continued listing.
However,
there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum bid price requirement over time,
or that it will be successful in maintaining compliance with any of the other Nasdaq continued listing requirements.
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- DefinitionThe entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure.
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v3.23.3
Business
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Business |
2.
Business
The
Company is a drug research company that uses biomarker technology to identify enzyme targets associated with serious common diseases
and then designs novel compounds to attack those targets. The Company’s corporate office is located in Pasadena, California.
The
Company’s product pipeline is primarily focused on inhibitors of protein phosphatases, used alone and in combination with cytotoxic
agents and/or x-ray and immune checkpoint blockers. The Company believes that inhibitors of protein phosphatases have broad therapeutic
potential not only for cancer but also for other debilitating and life-threatening diseases. The Company is directing its efforts on
clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer
activity at doses that produce little or no toxicity.
The
Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company
has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation
for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its
operating requirements.
Going
Concern
As
reflected in the accompanying financial statements, for the nine months ended September 30, 2023, the Company recorded a net loss of
$4,054,774 and
used cash in operations of $3,391,142.
At September 30, 2023, the Company had cash of $5,105,611
available to fund its operations. Because the
Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and
resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s
business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company
is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance
that the Company will be able to achieve and maintain positive earnings and operating cash flows. At September 30, 2023, the Company’s
remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated
approximately $6,262,000 (see
Note 9), which are currently scheduled to be incurred through approximately December 31, 2027.
The
Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates
the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue
and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through
the recurring sale of its equity securities.
Based
on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern
within one year after the date that the accompanying interim condensed consolidated financial statements are being issued. The Company’s
interim condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The
Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research
and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future
cash requirements depends on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the
availability of operating capital to fund such activities.
Based
on current operating plans, the Company estimates that its existing cash resources at September 30, 2023 will provide sufficient working
capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound
LB-100 through at least September 30, 2024. However, existing cash resources will not be sufficient to complete the development of and
obtain regulatory approval for the Company’s product candidate, which will require that the Company raise significant additional
capital. The Company estimates that it will need to raise additional capital to fund its operations by mid-2024 to be able
to proactively manage its current business plan during the remainder of 2024 and during 2025. In addition, the Company’s operating
plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional
funds may be needed sooner than planned.
As
market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the
Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.
If
cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back
or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development
efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights
to and/or control of LB-100, or to discontinue operations entirely.
|
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- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.23.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
3.
Summary of Significant Accounting Policies
Principles
of Consolidation
The
accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally
accepted accounting principles (“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc. and its
wholly-owned subsidiary, Lixte Biotechnology, Inc. Intercompany balances and transactions have been eliminated in consolidation.
Foreign
Currency Translation
The
consolidated financial statements are presented in the United States dollar, which is the functional and reporting currency of the Company.
The
Company periodically incurs a cost or expense denominated in a foreign currency. Such cost or expense is converted into United States
dollars for financial statement purposes based on the foreign currency conversion rate in effect on the transaction date. The Company
purchases the requisite foreign currency to pay such cost or expense on an as-needed basis. Any gain or loss resulting from the purchase
of the foreign currency is included as foreign currency gain (loss) in the consolidated statement of operations. As of September 30,
2023 and December 31, 2022, the Company did not hold any currencies other than the United States dollar in its bank account.
Segment
Information
The
Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated
with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported
in a manner consistent with the internal reporting provided to the Company’s Chief Operating Decision Maker, which is the Company’s
President and Chief Executive Officer.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.
Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under
different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed
to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management
regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes
in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates
are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions
used in the calculation of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services,
and the realization of deferred tax assets.
Cash
Cash
is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC
(“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash
balances with financial institutions in the United States with high credit ratings and in accounts insured by the Federal Deposit Insurance
Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically
has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. Morgan
Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has not
experienced any losses to date resulting from this policy.
Research
and Development
Research
and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation,
design, development and management of clinical trials with respect to the Company’s clinical compound and product candidate. Research
and development costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to
operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States
and in the European Union in accordance with the laws and regulations of such jurisdictions.
Research
and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of
milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing
schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are
charged to operations as incurred.
Obligations
incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research
and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified
in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions
are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded
as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the
Company’s consolidated statement of operations.
Payments
made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated
balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those
contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development
contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs
in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research
and development contracts on a quarterly basis.
Prepaid
Insurance
Prepaid
insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in
excess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined by
amortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurred
are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated
balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each
reporting period.
Patent
and Licensing Legal and Filing Fees and Costs
Due
to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s
research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development
and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing
fees and costs were $178,012 and $271,163 for the three months ended September 30, 2023 and 2022, respectively, and $835,362 and $944,789
for the nine months ended September 30, 2023 and 2022, respectively. Patent and licensing legal and filing fees and costs are included
in general and administrative costs in the Company’s consolidated statements of operations.
Concentration
of Risk
The
Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred
for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred
that represented 10% or more of general and administrative costs or research and development costs for the three months and nine months
ended September 30, 2023 and 2022 are described as follows.
General
and administrative costs for the three months ended September 30, 2023 and 2022 included charges from legal firms and other vendors for
general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 20.0% and 22.5% of
total general and administrative costs, respectively. General and administrative costs for the three months ended September 30, 2023
and 2022 also included charges for the fair value of stock options granted to directors and corporate officers representing 12.6% and
32.9%, respectively, of total general and administrative costs. General and administrative costs for the three months ended September
30, 2023 also included charges from two vendors representing 11.9% and 10.6%, respectively, of total general and administrative costs.
Research
and development costs for the three months ended September 30, 2023 included charges from four vendors and consultants representing 38.9%,
24.9%, 15.9% and 14.9%, respectively, of total research and development costs. Research and development costs for the three months ended
September 30, 2022 include charges from four vendors and consultants representing 32.0%, 23.2%, 16.9% and 11.0%, respectively, of total
research and development costs.
General
and administrative costs for the nine months ended September 30, 2023 and 2022 include charges from legal firms and other vendors for
general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 25.2% and 25.0% of
total general and administrative costs, respectively. General and administrative costs for the nine months ended September 30, 2023 and
2022 also included charges for the fair value of stock options granted to directors and corporate officers representing 20.2% and 30.7%,
respectively, of total general and administrative costs.
Research
and development costs for the nine months ended September 30, 2023 include charges from three vendors and consultants representing 35.9%,
21.0% and 12.4%, respectively, of total research and development costs. Research and development costs for the nine months ended September
30, 2022 include charges from three vendors and consultants representing 31.0%, 16.7% and 10.0%, respectively, of total research and
development costs.
Income
Taxes
The
Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly,
the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and
the tax basis of assets and liabilities.
The
Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In
the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded
amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Should the
Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred
tax assets would be charged to operations in the period such determination was made.
The
Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating
losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which
the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of September 30, 2023 or
December 31, 2022 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2023.
The
Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement,
presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The
tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as
of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of
the position are recognized. The Company had not recorded any liability for uncertain tax positions as of September 30, 2023 or December
31, 2022. Subsequent to September 30, 2023, any interest and penalties related to uncertain tax positions will be recognized as a component
of income tax expense.
Stock-Based
Compensation
The
Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members,
contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each
grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over
the vesting period.
The
Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants
by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the
cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period
of the awards. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash
for the services.
The
fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is
affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock
option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock.
Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between
the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical
volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of
the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant.
The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on
the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero.
The
Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development
costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to
satisfy stock option exercises.
Warrants
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the
warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480,
Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The
assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a
liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815,
including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially
require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for
equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued
and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of
the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the
time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are
required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at
each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on
the statements of operations. The Company has determined that the warrants issued in the July 20, 2023 equity financing (see Note 5)
meet the requirements for equity classification.
Earnings
(Loss) Per Share
The
Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as
the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted
EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares,
warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, if
later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share)
are excluded from the calculation of diluted EPS.
Loss
per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods.
Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options
outstanding were anti-dilutive.
At
September 30, 2023 and 2022, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire
shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings Per Share
| |
2023 | | |
2022 | |
| |
September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Series A Convertible Preferred Stock | |
| 72,917 | | |
| 72,917 | |
Common stock warrants | |
| 808,365 | | |
| 340,031 | |
Common stock options, including options issued in the form of warrants | |
| 674,896 | | |
| 332,500 | |
Total | |
| 1,556,178 | | |
| 745,448 | |
Fair
Value of Financial Instruments
The
authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed
in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair
value measurements, is also required.
Level
1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to
access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities
and exchange-based derivatives.
Level
2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable
through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities,
non-exchange-based derivatives, mutual funds, and fair-value hedges.
Level
3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop
its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives
and commingled investment funds and are measured using present value pricing models.
The
Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the
lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company
performs an analysis of the assets and liabilities at each reporting period end.
The
carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative of their
respective fair values due to the short-term nature of those instruments.
Recent
Accounting Pronouncements
In
May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-04,
Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation
(Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04
provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified
written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument
for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the
modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition
model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt
origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 was
effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An
entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective
date. The Company adopted ASU 2021-04 effective January 1, 2022. The adoption of ASU 2021-04 did not have any impact on the Company’s
consolidated financial statement presentation or related disclosures.
In
July 2023, the FASB issued ASU 2023-03, Presentation of Financial Statements (Topic 205), Income Statement — Reporting
Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation —
Stock Compensation (Topic 718) Presentation of Financial Statements (“ASU 2023-03”). ASU 2023-03 amends the FASB
Accounting Standards Codification to include Amendments to SEC Paragraphs pursuant to SEC Staff Accounting Bulletin No. 120, SEC
Staff Announcement at the March 24, 2022 EITF Meeting, and SEC Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280
— General Revision of Regulation S-X: Income or Loss Applicable to Common Stock. As ASU 2023-03 did not provide any new
guidance, there was no transition or effective date associated with its adoption. Accordingly, the Company adopted ASU 2023-03
immediately upon its issuance. The adoption of ASU 2023-03 did not have any impact on the Company’s consolidated financial
statement presentation or related disclosures.
Management
does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material
impact on the Company’s financial statement presentation or disclosures.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.3
Research and Development Costs
|
9 Months Ended |
Sep. 30, 2023 |
Research and Development [Abstract] |
|
Research and Development Costs |
4.
Research and Development Costs
A
summary of research and development costs for the three months and nine months ended September 30, 2023 and 2022, including costs associated
with clinical trials involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical
regions where such costs have been incurred.
Schedule
of Research and Development Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
United States | |
$ | 68,315 | | |
$ | 161,744 | | |
$ | 291,846 | | |
$ | 316,565 | |
Spain | |
| 9,496 | | |
| 1,246 | | |
| 283,035 | | |
| 348,850 | |
China | |
| 3,108 | | |
| 63,330 | | |
| 17,198 | | |
| 81,050 | |
Netherlands | |
| 51,568 | | |
| 46,068 | | |
| 156,950 | | |
| 149,184 | |
Total | |
$ | 132,487 | | |
$ | 272,388 | | |
$ | 749,029 | | |
$ | 895,649 | |
Research and development
expense | |
$ | 132,487 | | |
$ | 272,388 | | |
$ | 749,029 | | |
$ | 895,649 | |
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- DefinitionThe entire disclosure for research, development, and computer software activities, including contracts and arrangements to be performed for others and with federal government. Includes costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility and in-process research and development acquired in a business combination consummated during the period.
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v3.23.3
Stockholders’ Equity
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
5.
Stockholders’ Equity
Preferred
Stock
The
Company is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.0001 per share. On March 17, 2015, the Company
filed a Certificate of Designations, Preferences, Rights and Limitations of its Series A Convertible Preferred Stock with the Delaware
Secretary of State to amend the Company’s certificate of incorporation. The Company has designated a total of 350,000 shares as
Series A Convertible Preferred Stock, which are non-voting and are not subject to increase without the written consent of a majority
of the holders of the Series A Convertible Preferred Stock or as otherwise set forth in the Preferences, Rights and Limitations. The
holders of each tranche of 175,000 shares of the Series A Convertible Preferred Stock are entitled to receive a per share dividend equal
to 1% of the annual net revenue of the Company divided by 175,000, until converted or redeemed. As of September 30, 2023 and December
31, 2022, the Company had 9,650,000 shares of undesignated preferred stock which may be issued with such rights and powers as the Board
of Directors may designate.
Each
share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 0.20833 shares of common stock (subject
to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion
rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000. The Series A Convertible
Preferred Stock has a liquidation preference based on its assumed conversion into shares of common stock. The Series A Convertible Preferred
Stock does not have any cash liquidation preference rights or any registration rights. If fully converted, the 350,000 outstanding shares
of Series A Convertible Preferred Stock would convert into 72,917 shares of common stock at September 30, 2023 and December 31, 2022.
Based
on the attributes of the Series A Convertible Preferred Stock as previously described, the Company has accounted for the Series A Convertible
Preferred Stock as a permanent component of stockholders’ equity.
Common
Stock
The
Company is authorized to issue a total of 100,000,000 shares of common stock, par value $0.0001 per share. As of September 30, 2023 and
December 31, 2022, the Company had 2,249,290 shares and 1,664,706 shares, respectively, of common stock issued and outstanding.
On
June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock. No fractional shares were issued
in connection with the reverse split, with any fractional shares resulting from the reverse split being rounded up to the nearest whole
share. All share and per share amounts and information presented herein have been retroactively adjusted to reflect the reverse stock
split for all periods presented.
Effective
March 10, 2023, the Company issued 1,250 shares of common stock upon the exercise of a stock option in the form of a warrant held by
a consultant to the Company for 1,250 shares exercisable at $5.025 per share for total cash proceeds of $6,281.
April
12, 2022 Sale of Common Stock
Effective
April 12, 2022, the Company completed the sale of 290,000 shares of common stock at a price of $20.00 per share in a registered direct
offering, generating gross proceeds of $5,800,000. The total cash costs of this offering were $658,616, resulting in net proceeds of
$5,141,384. Pursuant to the placement agents’ agreement, the Company granted warrants to the placement agents to purchase 29,000
shares of common stock at an exercise price of $20.00 per share exercisable through April 14, 2027.
July
20, 2023 Sale of Common Stock and Warrants
Effective
July 20, 2023, the Company sold 180,000 shares of common stock at a price of $6.00 per share and pre-funded warrants to purchase 403,334
shares of common stock at a price of $5.9999 per pre-funded warrant to an institutional investor in a registered direct offering. The
pre-funded warrants had an exercise price of $0.0001 per share, were immediately exercisable upon issuance, and were valid and exercisable
until all pre-funded warrants were exercised in full. As of August 7, 2023, all pre-funded warrants had been exercised in full. The pre-funded
warrants were determined to be common stock equivalents.
In
a concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 shares of common stock.
Each common warrant had an initial exercise price of $6.00 per share, was immediately exercisable upon issuance, and expires five years
thereafter on July 20, 2028. The common warrants and the shares of common stock issuable upon exercise of the common warrants were not
registered under the Securities Act of 1933, as amended (the “Securities Act”) and were offered pursuant to the exemption
provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The shares of common stock issuable upon
exercise of the warrants were subsequently registered for resale on a registration statement on Form S-3 declared effective by the SEC
on August 21, 2023.
The
registered direct offering and the concurrent private placement generated gross proceeds of $3,499,964. The total cash costs of the registered
direct offering and the private placement were $362,925, resulting in net proceeds of $3,137,039. Pursuant to the placement agent agreement,
the Company granted the placement agent warrants to purchase 35,000 shares of common stock at an exercise price of $6.60 per share and
expiring on July 20, 2028.
During
the period from July 24, 2023 through August 7, 2023, the 403,334 pre-funded warrants, exercisable at $0.0001 per common share, were
exercised for total cash proceeds of $41, resulting in the issuance of 403,334 shares of common stock.
The
exercise prices of the warrants issued to the institutional investor (exercisable at $6.00
per share) and to the placement agent (exercisable at $6.60
per share) are subject to customary adjustments for stock splits, stock dividends, stock combinations, reclassifications,
reorganizations or similar events affecting the Company’s common stock. In addition, the warrants issued to the institutional
investor contain a “fundamental transaction” provision whereby in the event of a fundamental transaction (a sale or
transfer of assets or ownership of the Company as defined in the warrant agreement) within the Company’s control, the holder
of the unexercised common stock warrants will be entitled to receive cash consideration equal to a Black-Scholes valuation, as
defined in the warrant agreement. If such fundamental transaction is not within the Company’s control, the warrant holder
would only be entitled to receive the same form of consideration (and in the same proportion) as the holders of the Company’s
common stock, hence these warrants are classified as a component of permanent equity. The Company will account for any such cash
payment for a warrant redemption as a distribution from stockholders’ equity, as and when such cash payment is
made.
Common
Stock Warrants
A
summary of common stock warrant activity during the nine months ended September 30, 2023, excluding the 403,334 pre-funded warrants,
exercisable at $0.0001 per common share, to purchase 403,334 shares of common stock described above, is presented below.
Schedule of Warrants Outstanding
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (in Years) | |
| |
| | |
| | |
| |
Warrants outstanding at December 31, 2022 | |
| 190,031 | | |
$ | 50.161 | | |
| | |
Issued | |
| 618,334 | | |
| 6.034 | | |
| | |
Exercised | |
| — | | |
| — | | |
| | |
Expired | |
| — | | |
| — | | |
| | |
Warrants outstanding at September 30, 2023 | |
| 808,365 | | |
$ | 16.407 | | |
| 4.24 | |
| |
| | | |
| | | |
| | |
Warrants exercisable at December 31, 2022 | |
| 190,031 | | |
$ | 50.161 | | |
| | |
Warrants exercisable at September 30, 2023 | |
| 808,365 | | |
$ | 16.407 | | |
| 4.24 | |
At
September 30, 2023, the outstanding warrants are exercisable at the following prices per common share:
Schedule of Warrants Outstanding and Exercisable
Exercise Prices | | |
Warrants Outstanding (Shares) | |
| | |
| |
$ | 6.000 | | |
| 583,334 | |
$ | 6.600 | | |
| 35,000 | |
$ | 20.000 | | |
| 29,000 | |
$ | 37.000 | | |
| 11,331 | |
$ | 57.000 | | |
| 149,700 | |
| | | |
| 808,365 | |
The
warrants exercisable at $57.00 per share at September 30, 2023 consist of 1,497,000 publicly-traded warrants pre-split 1-for-10 that
were issued as part of the Company’s November 2020 public offering of units and are exercisable for a period of five years thereafter.
As a result of the 1-for-10 reverse split of the Company’s common stock effective June 2, 2023, each such publicly-traded warrant
currently represents the right to purchase 1/10th of a share of common stock at the original exercise price of $5.70 per share. Accordingly,
upon exercise, 10 warrants, each exercisable at $5.70, will be required to acquire one share of post-split common stock, which is equivalent
to a purchase price of $57.00.
Based
on a fair market value of $2.45 per share on September 30, 2023, there was no intrinsic value attributed to exercisable but unexercised
common stock warrants at September 30, 2023.
Information
with respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 7.
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v3.23.3
Related Party Transactions
|
9 Months Ended |
Sep. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
6.
Related Party Transactions
Related
party transactions include transactions with the Company’s officers, directors and affiliates.
Employment
Agreements with Officers
During
July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting
of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, payable monthly, as described below. These employment
agreements were automatically renewable for additional one-year periods unless terminated by either party upon 60 days written notice
prior to the end of the applicable one-year period, or by death, or by termination for cause. These employment agreements were automatically
renewed for additional one-year periods in July and August 2021, 2022 and 2023.
The
Company entered into an employment agreement with Dr. Kovach dated July 15, 2020, effective October 1, 2020, to provide for Dr. Kovach
to continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer, with an annual salary of $250,000.
During the three months ended September 30, 2023 and 2022, the Company paid $62,500 and $62,500, respectively, to Dr. Kovach under this
employment agreement, and during the nine months ended September 30, 2023 and 2022, the Company paid $187,500 and $187,500, respectively,
to Dr. Kovach under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated
statements of operations for such periods. The employment agreement with Dr. Kovach terminated upon his death on October 5, 2023.
The
Company entered into an employment agreement with Dr. James S. Miser, M.D., effective August 1, 2020 to act as the Company’s Chief
Medical Officer, with an annual salary of $150,000. Effective May 1, 2021, Dr. Miser’s annual salary was increased to $175,000.
Dr. Miser is required to devote at least 50% of his business time to the Company’s activities. During the three months ended September
30, 2023 and 2022, the Company paid $43,750 and $43,750, respectively, to Dr. Miser under this employment agreement, and during the nine
months ended September 30, 2023 and 2022, the Company paid $131,250 and $131,250, respectively, to Dr. Miser under this employment agreement,
which costs are included in general and administrative costs in the Company’s consolidated statements of operations for such periods.
The
Company entered into an employment agreement with Eric J. Forman effective July 15, 2020, as amended on August 12, 2020, to act as the
Company’s Chief Administrative Officer, with an annual salary of $120,000. Mr. Forman is the son-in-law of Gil Schwartzberg (deceased),
a former member of the Company’s Board of Directors who died on October 30, 2022 and was a significant stockholder of and consultant
to the Company, and is the son of Dr. Stephen Forman, a member of the Company’s Board of Directors. Julie Forman, the wife of Mr.
Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, at which firm the Company’s
cash is on deposit and with which the Company maintains a continuing banking relationship. Effective May 1, 2021, Mr. Forman’s
annual salary was increased to $175,000. Additionally, effective November 6, 2022, Mr. Forman was promoted to Vice President and Chief
Operating Officer with an annual salary of $200,000. Effective October 1, 2022, Mr. Forman has been provided a monthly office rent allowance,
pursuant to which Mr. Forman was paid $7,323 and $11,436, respectively, for the three months and nine months ended September 30, 2023.
During the three months ended September 30, 2023 and 2022, the Company paid $50,000 and $43,750, respectively, to Mr. Forman under this
employment agreement, and during the nine months ended September 30, 2023 and 2022, the Company paid $150,000 and $131,250, respectively,
to Mr. Forman under this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated
statements of operations for such periods.
The
Company entered into an employment agreement with Robert N. Weingarten effective August 12, 2020 to act as the Company’s Vice President
and Chief Financial Officer, with an annual salary of $120,000. Effective May 1, 2021, Mr. Weingarten’s annual salary was increased
to $175,000. During the three months ended September 30, 2023 and 2022, the Company paid $43,750 and $43,750, respectively, to Mr. Weingarten
under this employment agreement, and during the nine months ended September 30, 2023 and 2022, the Company paid $131,250 and $131,250,
respectively, to Mr. Weingarten under this employment agreement, which costs are included in general and administrative costs in the
Company’s consolidated statements of operations for such periods.
The
Company entered into an employment agreement with Bastiaan van der Baan effective September 26, 2023, to act as the Company’s President
and Chief Executive Officer and as Vice Chairman of the Board of Directors with an annual salary of $150,000. The term of the employment
agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject
to early termination as described in the employment agreement. Under the employment agreement, Mr. van der Baan’s annual salary
may be increased from time to time at the sole discretion of the Board of Directors. In addition, Mr. van der Baan will be eligible to
receive an annual bonus as determined in the sole discretion of the Board of Directors. During the three months and nine months ended
September 30, 2023, the Company paid $1,667 to Mr. van der Baan under this employment agreement, which costs are included in general
and administrative costs in the Company’s consolidated statements of operations for such periods. Mr. Van der Baan was appointed
as Chairman of the Board of Directors upon the death of Dr. Kovach on October 5, 2023.
Appointment
of Dr. René Bernards to the Board of Directors
Effective
as of June 15, 2022, Dr. René Bernards was appointed to the Company’s Board of Directors as an independent director. Dr.
Bernards is a leader in the field of molecular carcinogenesis and is employed by the Netherlands Cancer Institute in Amsterdam. As a
new director, in lieu of a grant of stock options, Dr. Bernards received a one-time cash board fee of $100,000, which was paid upon his
appointment to the Board of Directors, and an annual cash board fee of $40,000, payable quarterly.
Previously,
on October 8, 2021, the Company had entered into a Development Collaboration Agreement (subsequently amended and extended) with the Netherlands
Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent
cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used
to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations (see Note
9).
Compensatory
Arrangements for Members of the Board of Directors
Effective
April 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation program for the independent members of the
Board of Directors and committee members. Effective May 25, 2022, the Board of Directors approved an amendment to the program. Officers
who also serve on the Board of Directors are not compensated separately for their service on the Board of Directors.
Cash
compensation for independent directors, payable quarterly, is as follows:
Base
director compensation - $20,000 per year
Chairman
of audit committee – additional $10,000 per year
Chairman
of any other committees – additional $5,000 per year
Member
of audit committee – additional $5,000 per year
Member
of any other committees – additional $2,500 per year
Equity
compensation for independent directors is as follows:
Appointment
of new independent directors – The Company grants options to purchase 25,000 shares of common stock, exercisable for a period of
five years, at the closing market price on the date of grant, vesting 50% on the grant date and the remaining 50% vesting 12.5% on the
last day of each calendar quarter beginning in the quarter immediately subsequent to the date of the grant until fully vested, subject
to continued service. At the discretion of the Board of Directors, for a nominee to the Board of Directors who is restricted by their
respective institution or employer from receiving equity-based compensation, in lieu of the grant of such stock options, the Company
may elect to pay a one-time cash fee of $100,000 to such director, payable upfront.
Annual
grant of options to independent directors – Effective on the last business day of the month of June, the Company grants options
to purchase 10,000 shares of common stock, exercisable for a period of five years, at the closing market price on the date of grant,
vesting 12.5% on the last day of each calendar quarter beginning in the quarter immediately subsequent to the date of grant until fully
vested, subject to continued service. If any director has served for less than 12 full calendar months on the grant date, the amount
of such stock option grant shall be prorated based on the length of service of such director. At the discretion of the Board of Directors,
for a nominee to the Board of Directors who is restricted by their respective institution or employer from receiving equity-based compensation,
in lieu of the grant of such stock options, the Company may elect to pay an annual cash fee of $40,000 to such director, payable quarterly.
Total
cash compensation paid to independent directors was $42,228 and $53,324, respectively, for the three months ended September 30, 2023
and 2022. Total cash compensation paid to independent directors was $127,229 and $221,510, respectively, for the nine months ended September
30, 2023 and 2022.
Stock-based
compensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 7.
A
summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors
for their services on the Board of Directors, for the three months and nine months ended September 30, 2023 and 2022, is presented below.
Summary of Related Party Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Related party costs: | |
| | | |
| | | |
| | | |
| | |
Cash-based | |
$ | 243,895 | | |
$ | 247,074 | | |
$ | 728,896 | | |
$ | 802,760 | |
Stock-based | |
| 112,106 | | |
| 396,883 | | |
| 669,146 | | |
| 1,160,649 | |
Total | |
$ | 356,001 | | |
$ | 643,957 | | |
$ | 1,398,042 | | |
$ | 1,963,409 | |
Related
party costs | |
$ | 356,001 | | |
$ | 643,957 | | |
$ | 1,398,042 | | |
$ | 1,963,409 | |
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.3
Stock-Based Compensation
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-Based Compensation |
7.
Stock-Based Compensation
The
Company periodically issues common stock and stock options as incentive compensation to directors and as compensation for the services
of employees, contractors and consultants of the Company.
On
July 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which was subsequently
approved by the stockholders of the Company. The 2020 Plan provides for the granting of equity-based awards, consisting of stock options,
restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors and
consultants of the Company and its affiliates, initially for a total of 233,333 shares of the Company’s common stock, under terms
and conditions as determined by the Company’s Board of Directors. On October 7, 2022, the stockholders of the Company approved
an amendment to the 2020 Plan to increase the number of common shares issuable thereunder by 180,000 shares, to a total of 413,333 shares.
The Company has scheduled a meeting of stockholders for November 27, 2023 to consider and vote on, among other matters, a proposal to
increase the number of common shares issuable under the 2020 Plan by 336,667 shares, to a total of 750,000 shares.
As
of September 30, 2023, there was a deficiency of 136,980 shares with respect to stock options issuable under the 2020 Plan. However,
subject to approval of the proposal to increase the number of common shares issuable under the 2020 Plan at the meeting of stockholders
scheduled for November 27, 2023, there will be unexpired stock options for 550,313 shares issued and outstanding under the 2020 Plan
and 199,687 shares available for issuance under the 2020 Plan.
The
fair value of a stock option award is calculated on the grant date using the Black-Scholes option-pricing model. The risk-free interest
rate is based on the U.S. Treasury yield curve in effect as of the grant date. The expected dividend yield assumption is based on the
Company’s expectation of dividend payouts and is assumed to be zero. The estimated volatility is based on the historical volatility
of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stock
option being granted. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as
the mid-point between the vesting period and the contractual term (the “simplified method”). The fair market value of the
common stock is determined by reference to the quoted market price of the common stock on the grant date.
For
stock options requiring an assessment of value during the nine months ended September 30, 2023, the fair value of each stock option award
was estimated using the Black-Scholes option-pricing model with the following assumptions:
Schedule of Fair Value of Each Option Award Estimated Assumption
Risk-free interest rate | |
| 4.843 | % |
Expected dividend yield | |
| 0 | % |
Expected volatility | |
| 138.05 | % |
Expected life | |
| 4.0 years | |
For
stock options requiring an assessment of value during the nine months ended September 30, 2022, the fair value of each stock option award
was estimated using the Black-Scholes option-pricing model with the following assumptions:
Risk-free interest rate | |
| 3.03 | % |
Expected dividend yield | |
| 0 | % |
Expected volatility | |
| 198.79 | % |
Expected life | |
| 3.6 years | |
On
July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman
was granted stock options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis.
The options are exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market
price of the Company’s common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively,
with the final 25% vesting on August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant
to the Black-Scholes option-pricing model, was determined to be $400,855 ($68.718 per share), of which $100,214 was attributable to the
portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested
portion of the fair value of the stock options was charged to operations ratably from August 12, 2020 through August 12, 2023. The Company
recorded charges to general and administrative costs in the consolidated statement of operations of $11,806 and $25,259 for the three
months ended September 30, 2023 and 2022, respectively, and $61,501 and $74,954 for the nine months ended September 30, 2023 and 2022,
respectively, with respect to these stock options.
On
August 1, 2020, in connection with an employment agreement entered into with Dr. James S. Miser, M.D., Dr. Miser was granted stock options
to purchase 8,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable
for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s
common stock on the effective date of the employment agreement. The options vested 25% on August 1, 2020, 2021 and 2022, respectively,
with the final 25% vesting on August 1, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant
to the Black-Scholes option-pricing model, was determined to be $572,650 ($68.718 per share), of which $143,163 was attributable to the
portion of the stock options fully vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested
portion of the fair value of the stock options was charged to operations ratably from August 1, 2020 through August 1, 2023. The Company
recorded charges to general and administrative costs in the consolidated statement of operations of $12,551 and $36,085 for the three
months ended September 30, 2023 and 2022, respectively, and $83,544 and $107,078 for the nine months ended September 30, 2023 and 2022,
respectively, with respect to these stock options.
On
August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted stock
options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are
exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s
common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively, with the final 25% vesting on
August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $400,855 ($68.718 per share), of which $100,214 was attributable to the portion of the stock options fully
vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the
stock options was charged to operations ratably from August 12, 2020 through August 12, 2023. The Company recorded charges to general
and administrative costs in the consolidated statement of operations of $11,806 and $25,259 for the three months ended September 30,
2023 and 2022, respectively, and $61,501 and $74,954 for the nine months ended September 30, 2023 and 2022, respectively, with respect
to these stock options.
On
April 9, 2021, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by a former director’s resignation.
In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation
package for members of the Board of Directors, Mr. Schwartzberg was granted stock options to purchase 25,000 shares of the Company’s
common stock, exercisable for a period of five years at an exercise price of $32.00 per share (the closing market price on the grant
date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully
vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $753,611 ($30.144 per share), of which $376,800 was attributable to the portion of the stock options fully
vested on April 9, 2021 and was therefore charged to operations on that date. Although the remaining unvested portion of the fair value
of the stock options was being charged to operations ratably from April 9, 2021 through June 30, 2023, the vesting of these stock options
terminated on October 30, 2022 as a result of the death of Mr. Schwartzberg on that date. The Company recorded charges to general and
administrative costs in the consolidated statement of operations of $42,692 and $126,684 for the three months and nine months ended September
30, 2022, respectively, with respect to these stock options.
On
May 11, 2021, the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board
of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors,
Ms. Brown was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years
at an exercise price of $28.00 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder
vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value
of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $658,363 ($26.335 per
share), of which $329,188 was attributable to the portion of the stock options fully vested on May 11, 2021 and was therefore charged
to operations on that date. The remaining unvested portion of the fair value of the stock options was charged to operations ratably from
May 11, 2021 through June 30, 2023. The Company recorded charges to general and administrative costs in the consolidated statement of
operations of $0 and $38,827 for the three months ended September 30, 2023 and 2022, respectively, and $76,388 and $115,215 for the nine
months ended September 30, 2023 and 2022, respectively, with respect to these stock options.
On
June 30, 2021, the
Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of
Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000
shares (a total of 50,000
shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $30.30 per share (the
closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,
subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $1,421,095
($28.423
per share), which was charged to operations ratably from July 1, 2021 through June 30, 2023. The Company recorded charges to general
and administrative costs in the consolidated statement of operations of $0
and $179,100
for the three months ended September 30, 2023 and 2022, respectively, and $211,412
and $531,455
for the nine months ended September 30, 2023 and 2022, respectively, with respect to these stock options.
On
June 17, 2022, the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to the
Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors,
Mr. Baan was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years
at an exercise price of $7.40 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder
vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value
of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($6.341 per share),
of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 and was therefore charged to operations
on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from June
17, 2022 through June 30, 2024. The Company recorded charges to general and administrative costs in the consolidated statement of operations
of $9,801 and $9,801 for the three months ended September 30, 2023 and 2022, respectively, and $29,084 and $90,449 for the nine months
ended September 30, 2023 and 2022, respectively, with respect to these stock options.
On
June 30, 2022, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the
Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 shares (a total
of 50,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $7.40 per share
(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,
subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,
was determined to be $316,700 ($6.334 per share), which is being charged to operations ratably from July 1, 2022 through June 30, 2024.
The Company recorded charges to general and administrative costs in the consolidated statement of operations of $23,916 and $39,860 for
the three months ended September 30, 2023 and 2022, respectively, and $70,965 and $39,860 for the nine months ended September 30, 2023
and 2022, respectively, with respect to these stock options.
On
November 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 20,000 shares
(a total of 80,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $20.00
per share, vesting 25% on issuance and 25% on each anniversary date thereafter until fully vested, subject to continued service. The
total fair value of the 80,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be
$262,560 ($3.282 per share), which is being charged to operations ratably from November 6, 2022 through November 6, 2025. The Company
recorded a total charge to general and administrative costs in the consolidated statement of operations of $16,528 and $49,053 for the
three months and nine months ended September 30, 2023, respectively, with respect to these stock options.
On
November 6, 2022, the Company issued a stock option, in the form of a warrant, to BioPharmaWorks to purchase 10,000 shares of the Company’s
common stock, which was fully vested upon issuance and is exercisable for a period of five years at $5.025 per share (the closing market
price on the issue date). The fair value of the warrant, as calculated pursuant to the Black-Scholes option-pricing model, was determined
to be $43,264 ($4.326 per share) and was charged to general and administrative costs in the consolidated statement of operations on that
date.
On
June 30, 2023, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the
Board of Directors, granted to each of the four non-officer directors of the Company stock options to purchase 10,000 shares (a total
of 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $5.88 per share
(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,
subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,
was determined to be $192,593 ($4.8131 per share), which is being charged to operations ratably from July 1, 2023 through June 30, 2025.
The Company recorded a total charge to general and administrative costs in the consolidated statement of operations of $24,232 for the
three months and nine months ended September 30, 2023 with respect to these stock options.
On
September 26, 2023, in connection with the employment agreement entered into with Bastiaan van der Baan, Mr. van der Baan was granted
stock options to purchase 250,000 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options
are exercisable for a period of five years at an exercise price of $1.95 per share, which was equal to the closing market price of the
Company’s common stock on the grant date. The options vest in equal increments quarterly over a three-year period commencing on
the last day of each calendar quarter commencing October 1, 2023, subject to continued service. The fair value of these stock options,
as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $403,066 ($1.612 per share), which is being charged
to operations ratably from September 26, 2023 through September 30, 2026. The Company recorded a charge to general and administrative
costs in the consolidated statement of operations of $1,466 for the three months and nine months ended September 30, 2023 with respect
to these stock options.
Dr.
Philip Palmedo, a director of the Company since 2006, did not stand for re-election to the Company’s Board of Directors at the
Company’s annual meeting of stockholders held on October 7, 2022. Gil Schwartzberg, a director of the Company, died on October
30, 2022. Dr. John S. Kovach, the Chairman of the Board of Directors and the Company’s President and Chief Executive Officer, and
Chief Scientific Officer, died on October 5, 2023. Accordingly, the unvested stock options for each of such persons ceased vesting effective
as of the respective dates that their service to the Company terminated. Furthermore, the expiration date of all vested stock options
owned by each of such persons are contractually scheduled to expire one year from the respective dates that their service to the Company
terminated.
A
summary of stock-based compensation costs for the three months and nine months ended September 30, 2023 and 2022 is as follows:
Summmary of Stock-based Compensation Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Related parties | |
$ | 112,106 | | |
$ | 396,883 | | |
$ | 669,146 | | |
$ | 1,160,649 | |
Non-related parties | |
| — | | |
| — | | |
| — | | |
| — | |
Total stock-based compensation costs | |
$ | 112,106 | | |
$ | 396,883 | | |
$ | 669,146 | | |
$ | 1,160,649 | |
A
summary of stock option activity, including options issued in the form of warrants, during the nine months ended September 30, 2023 is
as follows:
Summary of Stock Option Activity Including Options Form of Warrants
| |
Number of
Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (in Years) | |
| |
| | |
| | |
| |
Stock options outstanding at December 31, 2022 | |
| 389,479 | | |
$ | 29.1826 | | |
| | |
Granted | |
| 290,000 | | |
| 2.4920 | | |
| | |
Exercised | |
| (1,250 | ) | |
| 5.0250 | | |
| | |
Expired | |
| (3,333 | ) | |
| 16.800 | | |
| | |
Stock options outstanding at September 30, 2023 | |
| 674,896 | | |
$ | 17.8197 | | |
| 4.96 | |
| |
| | | |
| | | |
| | |
Stock options exercisable at December 31, 2022 | |
| 281,979 | | |
$ | 32.8335 | | |
| | |
Stock options exercisable at September 30, 2023 | |
| 313,959 | | |
$ | 31.8997 | | |
| 1.93 | |
Total
deferred compensation expense for the outstanding value of unvested stock options was approximately $808,000 at September 30, 2023, which
will be recognized subsequent to September 30, 2023 over a weighted-average period of approximately 28 months.
The
exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at September 30,
2023 are as follows:
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants
Exercise Prices | | |
Options Outstanding (Shares) | | |
Options Exercisable (Shares) | |
| | |
| | |
| |
$ | 1.950 | | |
| 250,000 | | |
| — | |
$ | 5.025 | | |
| 8,750 | | |
| 8,750 | |
$ | 5.880 | | |
| 40,000 | | |
| 5,000 | |
$ | 7.400 | | |
| 57,500 | | |
| 41,563 | |
$ | 20.000 | | |
| 80,000 | | |
| 20,000 | |
$ | 20.600 | | |
| 20,000 | | |
| 20,000 | |
$ | 28.000 | | |
| 25,000 | | |
| 25,000 | |
$ | 30.000 | | |
| 66,667 | | |
| 66,667 | |
$ | 30.300 | | |
| 42,500 | | |
| 42,500 | |
$ | 32.000 | | |
| 20,313 | | |
| 20,313 | |
$ | 32.100 | | |
| 15,000 | | |
| 15,000 | |
$ | 60.000 | | |
| 16,667 | | |
| 16,667 | |
$ | 66.000 | | |
| 4,167 | | |
| 4,167 | |
$ | 71.400 | | |
| 20,000 | | |
| 20,000 | |
$ | 120.000 | | |
| 8,332 | | |
| 8,332 | |
| | | |
| 674,896 | | |
| 313,959 | |
Based
on a fair market value of $2.45 per share on September 30, 2023, there was no intrinsic value attributed to exercisable but unexercised
common stock options at September 30, 2023.
Outstanding
stock options to acquire 360,938 shares of the Company’s common stock had not vested at September 30, 2023.
The
Company expects to satisfy such stock obligations through the issuance of authorized but unissued shares of common stock.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Income Taxes
|
9 Months Ended |
Sep. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
8.
Income Taxes
During
the three months and nine months ended September 30, 2023 and 2022, the Company did not record any provision for income taxes, as the
Company incurred losses during those periods. Deferred tax assets and liabilities reflect the net tax effect of temporary differences
between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
The Company has recorded a full valuation allowance against its deferred tax assets for all periods presented as the Company currently
believes it is more likely than not that the deferred tax assets will not be realized.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
9.
Commitments and Contingencies
Legal
Claims
The
Company may be subject to legal claims and actions from time to time as part of its business activities. As of September 30, 2023 and
December 31, 2022, the Company was not subject to any pending or threatened legal claims or actions.
Principal
Commitments
Clinical
Trial Agreements
At
September 30, 2023, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring
agreements not yet incurred, as described below, aggregated $6,262,000, which, based on current estimates, are currently scheduled to
be incurred through approximately December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is
subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation
of such funds to the Company’s current or future clinical trial programs. The Company expects that the full amount of these expenditures
will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration
are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can
frequently involve a series of changes and modifications over time as clinical data are obtained and analyzed, and are frequently modified,
suspended or terminated before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein
should be considered as estimates only based on current clinical assumptions and conditions, and are typically subject to significant
modifications and revisions over time.
The
following is a summary of the contractual clinical trials discussed below as of September 30, 2023:
Schedule
of Contractual Clinical Trials
Description of Clinical
Trial | |
Type of Clinical
Trial | |
Institution | |
Estimated Start
Date | |
Estimated
End Date | |
Number of Patients in
Trial | |
Study
Objective | |
Clinical
Update | |
NCT
No. |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with carboplatin, etoposide and atezolizumab in small cell lung cancer | |
Phase 1b | |
City of Hope and Sarah Cannon | |
March 2021 | |
March 2026 | |
14 to 36 | |
Determine RP2D | |
Three patients entered | |
NCT04560972 |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with doxorubicin in sarcoma | |
Phase 1b | |
GEIS | |
June 2023 | |
June 2024 | |
9 to 18 | |
Determine MTD and RP2D | |
One patient entered | |
NCT05809830 |
| |
| |
| |
| |
| |
| |
| |
| |
|
Doxorubicin with or without LB-100 in sarcoma | |
Randomized Phase 2 | |
GEIS | |
July 2024 | |
June 2026 | |
150 | |
Determine efficacy: PFS | |
Clinical trial not yet begun (subject to completion of Phase 1b GEIS clinical trial) | |
NCT05809830 |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with dostarlimab in ovarian clear cell carcinoma | |
Phase 1b/2 | |
MD Anderson | |
March 2024 | |
December 2025 | |
21 | |
Determine the survival of patients with ovarian clear cell carcinoma | |
No patients entered at September 30, 2023 | |
NCT06065462 |
Moffitt.
Effective August 20, 2018, the Company entered into a five-year Clinical Trial Research Agreement with the Moffitt Cancer Center
and Research Institute Hospital Inc., Tampa, Florida (“Moffitt”). Pursuant to the Clinical Trial Research Agreement, Moffitt
agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s lead
anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome
(MDS).
In
November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application
to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and intermediate-1
risk MDS who have failed or are intolerant of standard treatment. Patients with MDS, although usually older, are generally well except
for severe anemia requiring frequent blood transfusions. This Phase 1b/2 clinical trial utilized LB-100 as a single agent in the treatment
of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line
therapy.
During
the three months ended June 30, 2023, the Phase 1b/2 clinical trial at Moffitt evaluating LB-100 in patients with MDS was closed by the
principal investigator. In this clinical trial, single agent LB-100 was used on a new schedule of days 1, 3, and 5 every 3 weeks. The
Company is not employing this schedule in its other clinical trials. Although the Maximally Tolerated Dose (“MTD”) was not
achieved, there was no dose-limiting toxicity on this schedule at doses that were greater than the MTD in the Phase 1 clinical trial
of LB-100 on the Monday, Tuesday, Wednesday schedule.
During
the three months ended September 30, 2023 and 2022, the Company incurred costs of $0 and $9,218, respectively, pursuant to this agreement,
which have been included in research and development costs in the Company’s consolidated statements of operations. During the nine
months ended September 30, 2023 and 2022, the Company incurred costs of $0 and $18,623, respectively, pursuant to this agreement, which
have been included in research and development costs in the Company’s consolidated statements of operations. As of September 30,
2023, total costs of $131,074 have been incurred pursuant to this agreement.
The
Company has decided not to pursue further studies in MDS, as other opportunities have become available (see “Patent and License
Agreements - Moffitt” below).
GEIS.
Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with the
Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas or “GEIS”), Madrid, Spain, to carry out a
study entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue
sarcoma”. The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combined
with doxorubicin in soft tissue sarcomas. Doxorubicin is the global standard for initial treatment of advanced soft tissue sarcomas (“ASTS”).
Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little therapeutic gain from adding cytotoxic
compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 consistently enhances the anti-tumor
activity of doxorubicin without apparent increases in toxicity.
GEIS
has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative
studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as
well as to provide funding for the clinical trial. The goal is to enter approximately 150 to 170 patients in this clinical trial over
a period of two years. As advanced sarcoma is a very aggressive disease, the design of the study assumes a median progression free survival
(“PFS”, no evidence of disease progression or death from any cause) of 4.5 months in the doxorubicin arm and an alternative
median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate a statistically significant decrease in relative risk of progression
or death by adding LB-100. There is a planned interim analysis of the primary endpoint when approximately 50% of the 102 events required
for final analysis is reached.
The
Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July
2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol,
it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These
standards were adopted subsequent to the production of the Company’s existing LB-100 inventory.
In
order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out
the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included
the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the
steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under
GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility,
provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal
application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory
authorities for review and approval before being used in a clinical trial.
As
of September 30, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially
for subsequent multiple trials within the European Union, had cost approximately $1,144,000. Although the production of new inventory
has been completed, nominal trailing costs subsequent to September 30, 2023 may be incurred.
On
October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos
y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead
clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas
(ASTS). Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report
prepared by December 31, 2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at
Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial.
The Phase 1b section of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on
both response and toxicity from this portion of the clinical trial, and subject to clinical results, anticipates that it will be able
to proceed to a related Phase 2 study.
The
interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has
the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study
would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit
of doxorubicin alone.
The
Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement.
During the three months ended September 30, 2023 and 2022, the Company did not incur any costs pursuant to this agreement. During the
nine months ended September 30, 2023 and 2022, the Company incurred costs of $268,829 and $0, respectively, pursuant to this agreement.
Such costs, when incurred, are included in research and development costs in the Company’s consolidated statements of operations.
Through September 30, 2023, the Company has paid GEIS an aggregate of $684,652 for work done under this agreement through the fourth
milestone.
The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,423,000
as of September 30, 2023, which is expected to be incurred through December 31, 2027. As the work is being conducted in Europe and is
paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations
are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate.
City
of Hope. Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the City of Hope National Medical
Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”),
to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor, combined with an
FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”). LB-100
will be given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved but marginally effective regimen, to previously
untreated ED-SCLC patients. The dose of LB-100 will be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended
Phase 2 dose (“RP2D”). Patient entry will be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm
the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration
of overall response, progression-free-survival and overall survival.
The
clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. However, as
patient accrual was slower than expected, the Company has been seeking to add additional sites to increase the rate of patient accrual.
Effective March 6, 2023, the Sarah Cannon Research Institute (“SCRI”), Nashville, Tennessee, joined the City of Hope’s
ongoing Phase 1b clinical trial. The Company is continuing its efforts to add additional sites. The addition of SCRI is expected to expedite
and expand the accrual of patients to this clinical trial, thus reducing the time required to demonstrate the feasibility, tolerability
and efficacy of adding LB-100 to the current standard treatment regimen. With the addition of SCRI, the Company currently expects that
this clinical trial will be completed by March 31, 2026.
In
early July 2023, the Company was notified that one of three centers accruing patients to its Phase 1b clinical trial in small cell lung
cancer had a shortage of carboplatin and as a result the clinical trial was placed on a temporary enrollment hold. This matter was resolved
and the temporary enrollment hold was lifted in late July 2023.
During
the three months ended September 30, 2023 and 2022, the Company did not incur any costs pursuant to this agreement. During the nine months
ended September 30, 2023 and 2022, the Company incurred costs of $69,001 and $0, respectively, pursuant to this agreement, which are
included in research and development costs in the Company’s consolidated statements of operations. As of September 30, 2023, total
costs of $447,512 have been incurred pursuant to this agreement.
The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $2,433,000
as of September 30, 2023, which is expected to be incurred through March 31, 2026. If a significant number of patients fail during the
dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of approximately
$800,000.
The
Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees
as the most likely number. Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee
basis. If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment
of a very aggressive disease.
Theradex.
On June 22, 2023, the Company finalized a work order agreement with Theradex Systems, Inc. (“Theradex”), an international
contract research organization (“CRO”), to conduct a Phase I/II randomized trial of LB-100 plus doxorubicin vs. doxorubicin
alone in first line of advanced soft tissue sarcomas. The study is expected to be completed by June 30, 2026.
Costs
under this work order agreement are estimated to be approximately $153,000, with such payments expected to be allocated approximately
72% to Theradex for services and approximately 28% for payments for pass-through software costs. During the three months and nine months
ended September 30, 2023, the Company incurred costs of $$3,750 and 10,000, respectively, pursuant to this work order. As of September
30, 2023, total costs of $10,000 have been incurred pursuant to this work order agreement.
The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $144,000 as of September 30, 2023, which is expected to be incurred through June 30, 2026.
National
Cancer Institute Pharmacologic Clinical Trial. In May 2019, the National Cancer Institute (“NCI”) initiated a glioblastoma
(“GBM”) pharmacologic clinical trial. This study was being conducted and funded by the NCI under a Cooperative Research and
Development Agreement, with the Company responsible for providing the LB-100 clinical compound.
Primary
malignant brain tumors (gliomas) are very challenging to treat. Radiation combined with the chemotherapeutic drug temozolomide has been
the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with some further benefit gained
by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients. In animal
models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation,
temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment
in the clinic. Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human
cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain has not been determined. Many
drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.
The
NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas. Patients having surgery to remove
one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100
present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its
molecular target. As a result of the innovative design of the NCI study, it was believed that data from a few patients would be sufficient
to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment
regimen for GBMs. Five patients were entered into this study and analysis of the blood and tissue has been conducted. If there is clinical
evidence in at least two of the patients of penetration of LB 100 into tumor tissue, the study will be deemed as successful. Results
of this study are currently being reviewed by the NCI and a report is pending.
MD
Anderson Cancer Center Trial. On September 20, 2023, the Company announced a Phase 1b/2 collaborative clinical trial to assess whether
adding LB-100 to the programmed death receptor-1 (“PD-1”)-blocking monoclonal antibody of GSK plc (“GSK”), dostarlimab,
may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (“OCCC”). The clinical trial
is sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and will be conducted at MD Anderson, and
will also be open at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. The Company will provide LB-100 and
GSK will provide dostarlimab and financial support for the clinical trial.
Clinical
Trial Monitoring Agreements
Moffitt.
On September 12, 2018, the Company finalized a work order agreement with Theradex (“CRO”), to monitor the Phase 1b/2
clinical trial being managed and conducted by Moffitt. The clinical trial began in April 2019 and the first patient was entered into
the clinical trial in July 2019.
The
costs of the Phase 1b/2 clinical trial being paid to or through Theradex have been recorded and charged to operations based on periodic
documentation provided by the CRO. During the three months ended September 30, 2023 and 2022, the Company incurred costs of $566 and
$11,953, respectively, pursuant to this work order. During the nine months ended September 30, 2023 and 2022, the Company incurred costs
of $20,850 and $19,792, respectively, pursuant to this work order. As of September 30, 2023, total costs of $148,138 have been incurred
pursuant to this work order agreement.
As
a result of the closure of the Company’s Clinical Trial Research Agreement with Moffitt during the three months ended June 30,
2023 (see “Clinical Trial Agreements – Moffitt” above), this work order agreement with Theradex to monitor the Clinical
Trial Research Agreement with Moffitt was similarly suspended, although nominal oversight trailing costs subsequent to September 30,
2023 are expected to be incurred relating to the closure of the Moffitt study.
City
of Hope. On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated
clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party. Costs under this
work order agreement are estimated to be approximately $335,000. During the three months ended September 30, 2023 and 2022, the Company
incurred costs of $4,500 and $7,731, respectively, pursuant to this work order. During the nine months ended September 30, 2023 and 2022,
the Company incurred costs of $15,740 and $23,466, respectively, pursuant to this work order. As of September 30, 2023, total costs of
$74,181 have been incurred pursuant to this work order agreement.
The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $262,000 as of September 30, 2023, which is expected to be incurred through March 31, 2026.
Patent
and License Agreements
Moffitt.
Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt. Pursuant to the License Agreement,
Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating
to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results,
clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents
or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under
the Licensed Patents. The Company was obligated to pay Moffitt a non-refundable license issue fee of $25,000 after the first patient
was entered into a Phase 1b/2 clinical trial to be managed and conducted by Moffitt. The clinical trial began at a single site in April
2019 and the first patient was entered into the clinical trial in July 2019. The Company was also obligated to pay Moffitt an annual
license maintenance fee of $25,000 commencing on the first anniversary of the Effective Date and every anniversary thereafter until the
Company commences payment of minimum royalty payments. The Company had also agreed to pay non-refundable milestone payments to Moffitt,
which could not be credited against earned royalties payable by the Company, based on reaching various clinical and commercial milestones
aggregating $1,897,000, subject to reduction by 40% under certain circumstances relating to the status of Valid Claims, as such term
is defined in the License Agreement.
On
October 4, 2023, the Company received a counter-signed termination letter dated September 29, 2023 with respect to the Exclusive License
Agreement dated August 20, 2018 between the Company and Moffitt, effective September 30, 2023. The Company and Moffitt agreed that no
termination fee shall be due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement.
During
the three months and nine months ended September 30, 2023, the Company recorded credits to operations of $21,507 and $9,109, respectively,
representing the reversal of obligations previously recorded with respect to the Exclusive License Agreement. During the three months
and nine months ended September 30, 2022, the Company recorded charges to operations of $6,301 and $18,699, respectively, in connection
with its obligations under the Exclusive License Agreement.
Employment
Agreements with Officers
During
July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting
of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, which provided for aggregate annual cash compensation
of $640,000, payable monthly (see Note 6). These employment agreements were automatically renewable for additional one-year periods unless
terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination
for cause. These employment agreements were automatically renewed for additional one-year periods in July and August 2021, 2022 and 2023.
On
April 9, 2021, the Board of Directors increased the annual cash compensation of Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten
under the employment agreements, such that the aggregate annual compensation for all officers increased to $775,000, effective May 1,
2021.
Effective
November 6, 2022, Mr. Forman was promoted to Vice President and Chief Operating Officer, with an annual salary of $200,000. In addition,
Mr. Forman is being provided an office allowance of approximately $1,500 per month through December 31, 2023.
On
September 26, 2023, the Company entered into an employment agreement with Bastiaan van der Baan to act as the Company’s President
and Chief Executive Officer and as Vice Chairman of the Board of Directors with an annual salary of $150,000. The term of the employment
agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject
to early termination as described in the employment agreement. Under the employment agreement, Mr. van der Baan’s annual may be
increased from time to time at the sole discretion of the Board of Directors. In addition, Mr. van der Baan will be eligible to receive
an annual bonus as determined in the sole discretion of the Board of Directors. Mr. Van der Baan was appointed as Chairman of the Board
of Directors upon the death of Dr. Kovach on October 5, 2023.
The
aggregate annual cash compensation for all officers increased to $950,000, effective September 26, 2023, which has continued through
September 30, 2023. As a result of Dr. Kovach’s death on October 5, 2023, aggregate annual compensation of all officers will decrease
to $700,000 from that date forward.
Other
Significant Agreements and Contracts
NDA
Consulting Corp. On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. for consultation and advice
in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel
D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year
and provided for a quarterly cash fee of $4,000. The agreement has been automatically renewed for additional one-year terms on its anniversary
date since 2014. Consulting and advisory fees charged to operations pursuant to this agreement were $4,000 and $4,000 for the three months
ended September 30, 2023 and 2022, respectively, and $12,000 and $12,000 for the nine months ended September 30, 2023 and 2022, which
were included in research and development costs in the consolidated statements of operations.
BioPharmaWorks.
Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged
BioPharmaWorks to perform certain services for the Company. Those services included, among other things, assisting the Company to commercialize
its products and strengthen its patent portfolio; identifying large pharmaceutical companies with a potential interest in the Company’s
product pipeline; assisting in preparing technical presentations concerning the Company’s products; consultation in drug discovery
and development; and identifying providers and overseeing tasks relating to clinical development of new compounds.
BioPharmaWorks
was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience.
The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated
by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the
Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in
lieu of the monthly payment and agreed to issue to BioPharmaWorks certain equity-based compensation (see Note 7). The Company recorded
charges to operations pursuant to this Collaboration Agreement of $30,000 and $30,000 for the three months ended September 30, 2023 and
2022, respectively, and $90,000 and $90,000 for the nine months ended September 30, 2023 and 2022, respectively, which were included
in research and development costs in the consolidated statements of operations.
Netherlands
Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer
Institute, Amsterdam (“NKI”) (see Note 6), one of the world’s leading comprehensive cancer centers, and Oncode Institute,
Utrecht, a major independent cancer research center, for a term of three years. The Development Collaboration Agreement was subsequently
modified by Amendment No. 1 thereto. The Development Collaboration Agreement is intended to identify the most promising drugs to be combined
with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular
mechanisms underlying the identified combinations. The Company agreed to fund the study, at an approximate cost of 391,000 Euros and
provide a sufficient supply of LB-100 to conduct the study.
On
October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with NKI, which provides for additional
research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and adds
250,000 Euros (approximately $263,000 at October 3, 2023) to the operating budget being funded by the Company.
During
the three months ended September 30, 2023 and 2022, the Company incurred charges in the amount of $51,568 and $46,068, respectively,
with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated statements
of operations. During the nine months ended September 30, 2023 and 2022, the Company incurred charges in the amount of $156,949 and $149,184,
respectively, with respect to this agreement, which amounts are included in research and development costs in the Company’s consolidated
statements of operations. As of September 30, 2023, total costs of $416,356 have been incurred pursuant to this agreement. The Company’s
aggregate commitment pursuant to this agreement, as amended, less amounts previously paid to date, totaled approximately $316,000 as
of September 30, 2023, which is expected to be incurred through October 8, 2026. As the work is being conducted in Europe and is paid
for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro.
MRI
Global. The Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinical trials
in the United States. On June 10, 2022, the contract was amended to reflect a new total contract price of $273,980 for services to be
rendered through April 30, 2023. Effective April 17, 2023, the contract was further amended to reflect a new total contract price of
$326,274 for services to be rendered through April 30, 2024. During the three months ended September 30, 2023 and 2022, the Company incurred
costs of $19,845 and $5,549, respectively, pursuant to this contract. During the nine months ended September 30, 2023 and 2022, the Company
incurred costs of $27,028 and $25,902, respectively, pursuant to this work order. As of September 30, 2023, total costs of $241,841 have
been incurred pursuant to this contract.
The
Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $84,000 as
of September 30, 2023.
External
Risks
Covid-19
Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout
the world as businesses and governments implemented broad actions to mitigate this public health crisis. The extent to which the coronavirus
pandemic may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and
cannot be predicted.
Inflation
Risk. The Company does not believe that inflation has had a material effect on its operations to date, other than its impact on the
general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary and interest
rate pressures in the future, which would have the effect of increasing the Company’s operating costs (including, specifically,
clinical trial costs), and which would put additional stress on the Company’s working capital resources.
Supply
Chain Issues. The Company does not currently expect that supply chain issues will have a significant impact on its business activities,
including its ongoing clinical trials.
Potential
Recession. There are various indications that the United States economy may be entering a recessionary period. Although unclear at
this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn,
affect the Company.
The
Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance
become available.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
10.
Subsequent Events
The
Company performed an evaluation of subsequent events through the date of filing of these condensed consolidated financial statements
with the SEC. Other than those matters described elsewhere in the footnotes, there were no material subsequent events which affected,
or could affect, the amounts or disclosures in the condensed consolidated financial statements.
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Principles of Consolidation |
Principles
of Consolidation
The
accompanying condensed consolidated financial statements of the Company have been prepared in accordance with United States generally
accepted accounting principles (“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc. and its
wholly-owned subsidiary, Lixte Biotechnology, Inc. Intercompany balances and transactions have been eliminated in consolidation.
|
Foreign Currency Translation |
Foreign
Currency Translation
The
consolidated financial statements are presented in the United States dollar, which is the functional and reporting currency of the Company.
The
Company periodically incurs a cost or expense denominated in a foreign currency. Such cost or expense is converted into United States
dollars for financial statement purposes based on the foreign currency conversion rate in effect on the transaction date. The Company
purchases the requisite foreign currency to pay such cost or expense on an as-needed basis. Any gain or loss resulting from the purchase
of the foreign currency is included as foreign currency gain (loss) in the consolidated statement of operations. As of September 30,
2023 and December 31, 2022, the Company did not hold any currencies other than the United States dollar in its bank account.
|
Segment Information |
Segment
Information
The
Company operates and reports in one segment, which focuses on the utilization of biomarker technology to identify enzyme targets associated
with serious common diseases and then designing novel compounds to attack those targets. The Company’s operating segment is reported
in a manner consistent with the internal reporting provided to the Company’s Chief Operating Decision Maker, which is the Company’s
President and Chief Executive Officer.
|
Use of Estimates |
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.
Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under
different assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believed
to be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management
regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes
in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates
are adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptions
used in the calculation of accruals for clinical trial costs and other potential liabilities, valuing equity instruments issued for services,
and the realization of deferred tax assets.
|
Cash |
Cash
Cash
is held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC
(“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cash
balances with financial institutions in the United States with high credit ratings and in accounts insured by the Federal Deposit Insurance
Corporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodically
has cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. Morgan
Stanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has not
experienced any losses to date resulting from this policy.
|
Research and Development |
Research
and Development
Research
and development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation,
design, development and management of clinical trials with respect to the Company’s clinical compound and product candidate. Research
and development costs also include the costs to manufacture the compounds used in research and clinical trials, which are charged to
operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United States
and in the European Union in accordance with the laws and regulations of such jurisdictions.
Research
and development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement of
milestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensing
schedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable are
charged to operations as incurred.
Obligations
incurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to research
and development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specified
in the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisions
are accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recorded
as liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in the
Company’s consolidated statement of operations.
Payments
made pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidated
balance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as those
contract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and development
contract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs
in the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and research
and development contracts on a quarterly basis.
|
Prepaid Insurance |
Prepaid
Insurance
Prepaid
insurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage in
excess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined by
amortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurred
are generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidated
balance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for each
reporting period.
|
Patent and Licensing Legal and Filing Fees and Costs |
Patent
and Licensing Legal and Filing Fees and Costs
Due
to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s
research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development
and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing
fees and costs were $178,012 and $271,163 for the three months ended September 30, 2023 and 2022, respectively, and $835,362 and $944,789
for the nine months ended September 30, 2023 and 2022, respectively. Patent and licensing legal and filing fees and costs are included
in general and administrative costs in the Company’s consolidated statements of operations.
|
Concentration of Risk |
Concentration
of Risk
The
Company periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurred
for these services can be for a specific time period (typically one year) or for a specific project or task. Costs and expenses incurred
that represented 10% or more of general and administrative costs or research and development costs for the three months and nine months
ended September 30, 2023 and 2022 are described as follows.
General
and administrative costs for the three months ended September 30, 2023 and 2022 included charges from legal firms and other vendors for
general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 20.0% and 22.5% of
total general and administrative costs, respectively. General and administrative costs for the three months ended September 30, 2023
and 2022 also included charges for the fair value of stock options granted to directors and corporate officers representing 12.6% and
32.9%, respectively, of total general and administrative costs. General and administrative costs for the three months ended September
30, 2023 also included charges from two vendors representing 11.9% and 10.6%, respectively, of total general and administrative costs.
Research
and development costs for the three months ended September 30, 2023 included charges from four vendors and consultants representing 38.9%,
24.9%, 15.9% and 14.9%, respectively, of total research and development costs. Research and development costs for the three months ended
September 30, 2022 include charges from four vendors and consultants representing 32.0%, 23.2%, 16.9% and 11.0%, respectively, of total
research and development costs.
General
and administrative costs for the nine months ended September 30, 2023 and 2022 include charges from legal firms and other vendors for
general licensing and patent prosecution costs relating to the Company’s intellectual properties representing 25.2% and 25.0% of
total general and administrative costs, respectively. General and administrative costs for the nine months ended September 30, 2023 and
2022 also included charges for the fair value of stock options granted to directors and corporate officers representing 20.2% and 30.7%,
respectively, of total general and administrative costs.
Research
and development costs for the nine months ended September 30, 2023 include charges from three vendors and consultants representing 35.9%,
21.0% and 12.4%, respectively, of total research and development costs. Research and development costs for the nine months ended September
30, 2022 include charges from three vendors and consultants representing 31.0%, 16.7% and 10.0%, respectively, of total research and
development costs.
|
Income Taxes |
Income
Taxes
The
Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly,
the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and
the tax basis of assets and liabilities.
The
Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. In
the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of its recorded
amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Should the
Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred
tax assets would be charged to operations in the period such determination was made.
The
Company is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operating
losses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in which
the Company currently operates or has operated in the past. The Company had no unrecognized tax benefits as of September 30, 2023 or
December 31, 2022 and does not anticipate any material amount of unrecognized tax benefits through December 31, 2023.
The
Company accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement,
presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. The
tax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority as
of the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits of
the position are recognized. The Company had not recorded any liability for uncertain tax positions as of September 30, 2023 or December
31, 2022. Subsequent to September 30, 2023, any interest and penalties related to uncertain tax positions will be recognized as a component
of income tax expense.
|
Stock-Based Compensation |
Stock-Based
Compensation
The
Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members,
contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each
grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over
the vesting period.
The
Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants
by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the
cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period
of the awards. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash
for the services.
The
fair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and is
affected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stock
option as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock.
Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point between
the vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historical
volatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of
the stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant.
The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock on
the grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero.
The
Company recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and development
costs, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock to
satisfy stock option exercises.
|
Warrants |
Warrants
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the
warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480,
Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The
assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a
liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815,
including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially
require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for
equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued
and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of
the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the
time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are
required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at
each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on
the statements of operations. The Company has determined that the warrants issued in the July 20, 2023 equity financing (see Note 5)
meet the requirements for equity classification.
|
Earnings (Loss) Per Share |
Earnings
(Loss) Per Share
The
Company’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as
the income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. Diluted
EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares,
warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, if
later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share)
are excluded from the calculation of diluted EPS.
Loss
per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods.
Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock options
outstanding were anti-dilutive.
At
September 30, 2023 and 2022, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire
shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings Per Share
| |
2023 | | |
2022 | |
| |
September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Series A Convertible Preferred Stock | |
| 72,917 | | |
| 72,917 | |
Common stock warrants | |
| 808,365 | | |
| 340,031 | |
Common stock options, including options issued in the form of warrants | |
| 674,896 | | |
| 332,500 | |
Total | |
| 1,556,178 | | |
| 745,448 | |
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
The
authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed
in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair
value measurements, is also required.
Level
1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to
access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities
and exchange-based derivatives.
Level
2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable
through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities,
non-exchange-based derivatives, mutual funds, and fair-value hedges.
Level
3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop
its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives
and commingled investment funds and are measured using present value pricing models.
The
Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the
lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company
performs an analysis of the assets and liabilities at each reporting period end.
The
carrying value of financial instruments (consisting of accounts payable and accrued expenses) is considered to be representative of their
respective fair values due to the short-term nature of those instruments.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
In
May 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2021-04,
Earnings Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation
(Topic 718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04
provides guidance as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified
written call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument
for a new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the
modified or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition
model that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt
origination, debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 was
effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An
entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective
date. The Company adopted ASU 2021-04 effective January 1, 2022. The adoption of ASU 2021-04 did not have any impact on the Company’s
consolidated financial statement presentation or related disclosures.
In
July 2023, the FASB issued ASU 2023-03, Presentation of Financial Statements (Topic 205), Income Statement — Reporting
Comprehensive Income (Topic 220), Distinguishing Liabilities from Equity (Topic 480), Equity (Topic 505), and Compensation —
Stock Compensation (Topic 718) Presentation of Financial Statements (“ASU 2023-03”). ASU 2023-03 amends the FASB
Accounting Standards Codification to include Amendments to SEC Paragraphs pursuant to SEC Staff Accounting Bulletin No. 120, SEC
Staff Announcement at the March 24, 2022 EITF Meeting, and SEC Staff Accounting Bulletin Topic 6.B, Accounting Series Release 280
— General Revision of Regulation S-X: Income or Loss Applicable to Common Stock. As ASU 2023-03 did not provide any new
guidance, there was no transition or effective date associated with its adoption. Accordingly, the Company adopted ASU 2023-03
immediately upon its issuance. The adoption of ASU 2023-03 did not have any impact on the Company’s consolidated financial
statement presentation or related disclosures.
Management
does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material
impact on the Company’s financial statement presentation or disclosures.
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v3.23.3
Summary of Significant Accounting Policies (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share |
At
September 30, 2023 and 2022, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire
shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.
Schedule
of Anti-dilutive Securities Excluded from Computation of Earnings Per Share
| |
2023 | | |
2022 | |
| |
September 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Series A Convertible Preferred Stock | |
| 72,917 | | |
| 72,917 | |
Common stock warrants | |
| 808,365 | | |
| 340,031 | |
Common stock options, including options issued in the form of warrants | |
| 674,896 | | |
| 332,500 | |
Total | |
| 1,556,178 | | |
| 745,448 | |
|
X |
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v3.23.3
Research and Development Costs (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Research and Development [Abstract] |
|
Schedule of Research and Development Costs |
A
summary of research and development costs for the three months and nine months ended September 30, 2023 and 2022, including costs associated
with clinical trials involving the Company’s lead clinical compound LB-100, are summarized below based on the respective geographical
regions where such costs have been incurred.
Schedule
of Research and Development Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
United States | |
$ | 68,315 | | |
$ | 161,744 | | |
$ | 291,846 | | |
$ | 316,565 | |
Spain | |
| 9,496 | | |
| 1,246 | | |
| 283,035 | | |
| 348,850 | |
China | |
| 3,108 | | |
| 63,330 | | |
| 17,198 | | |
| 81,050 | |
Netherlands | |
| 51,568 | | |
| 46,068 | | |
| 156,950 | | |
| 149,184 | |
Total | |
$ | 132,487 | | |
$ | 272,388 | | |
$ | 749,029 | | |
$ | 895,649 | |
Research and development
expense | |
$ | 132,487 | | |
$ | 272,388 | | |
$ | 749,029 | | |
$ | 895,649 | |
|
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v3.23.3
Stockholders’ Equity (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Schedule of Warrants Outstanding |
A
summary of common stock warrant activity during the nine months ended September 30, 2023, excluding the 403,334 pre-funded warrants,
exercisable at $0.0001 per common share, to purchase 403,334 shares of common stock described above, is presented below.
Schedule of Warrants Outstanding
| |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (in Years) | |
| |
| | |
| | |
| |
Warrants outstanding at December 31, 2022 | |
| 190,031 | | |
$ | 50.161 | | |
| | |
Issued | |
| 618,334 | | |
| 6.034 | | |
| | |
Exercised | |
| — | | |
| — | | |
| | |
Expired | |
| — | | |
| — | | |
| | |
Warrants outstanding at September 30, 2023 | |
| 808,365 | | |
$ | 16.407 | | |
| 4.24 | |
| |
| | | |
| | | |
| | |
Warrants exercisable at December 31, 2022 | |
| 190,031 | | |
$ | 50.161 | | |
| | |
Warrants exercisable at September 30, 2023 | |
| 808,365 | | |
$ | 16.407 | | |
| 4.24 | |
|
Schedule of Warrants Outstanding and Exercisable |
At
September 30, 2023, the outstanding warrants are exercisable at the following prices per common share:
Schedule of Warrants Outstanding and Exercisable
Exercise Prices | | |
Warrants Outstanding (Shares) | |
| | |
| |
$ | 6.000 | | |
| 583,334 | |
$ | 6.600 | | |
| 35,000 | |
$ | 20.000 | | |
| 29,000 | |
$ | 37.000 | | |
| 11,331 | |
$ | 57.000 | | |
| 149,700 | |
| | | |
| 808,365 | |
|
X |
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v3.23.3
Related Party Transactions (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Related Party Transactions [Abstract] |
|
Summary of Related Party Costs |
A
summary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directors
for their services on the Board of Directors, for the three months and nine months ended September 30, 2023 and 2022, is presented below.
Summary of Related Party Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Related party costs: | |
| | | |
| | | |
| | | |
| | |
Cash-based | |
$ | 243,895 | | |
$ | 247,074 | | |
$ | 728,896 | | |
$ | 802,760 | |
Stock-based | |
| 112,106 | | |
| 396,883 | | |
| 669,146 | | |
| 1,160,649 | |
Total | |
$ | 356,001 | | |
$ | 643,957 | | |
$ | 1,398,042 | | |
$ | 1,963,409 | |
Related
party costs | |
$ | 356,001 | | |
$ | 643,957 | | |
$ | 1,398,042 | | |
$ | 1,963,409 | |
|
X |
- DefinitionTabular disclosure of related party transactions. Examples of related party transactions include, but are not limited to, transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners and (d) affiliates.
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v3.23.3
Stock-Based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Fair Value of Each Option Award Estimated Assumption |
For
stock options requiring an assessment of value during the nine months ended September 30, 2023, the fair value of each stock option award
was estimated using the Black-Scholes option-pricing model with the following assumptions:
Schedule of Fair Value of Each Option Award Estimated Assumption
Risk-free interest rate | |
| 4.843 | % |
Expected dividend yield | |
| 0 | % |
Expected volatility | |
| 138.05 | % |
Expected life | |
| 4.0 years | |
For
stock options requiring an assessment of value during the nine months ended September 30, 2022, the fair value of each stock option award
was estimated using the Black-Scholes option-pricing model with the following assumptions:
Risk-free interest rate | |
| 3.03 | % |
Expected dividend yield | |
| 0 | % |
Expected volatility | |
| 198.79 | % |
Expected life | |
| 3.6 years | |
|
Summmary of Stock-based Compensation Costs |
A
summary of stock-based compensation costs for the three months and nine months ended September 30, 2023 and 2022 is as follows:
Summmary of Stock-based Compensation Costs
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Related parties | |
$ | 112,106 | | |
$ | 396,883 | | |
$ | 669,146 | | |
$ | 1,160,649 | |
Non-related parties | |
| — | | |
| — | | |
| — | | |
| — | |
Total stock-based compensation costs | |
$ | 112,106 | | |
$ | 396,883 | | |
$ | 669,146 | | |
$ | 1,160,649 | |
|
Summary of Stock Option Activity Including Options Form of Warrants |
A
summary of stock option activity, including options issued in the form of warrants, during the nine months ended September 30, 2023 is
as follows:
Summary of Stock Option Activity Including Options Form of Warrants
| |
Number of
Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (in Years) | |
| |
| | |
| | |
| |
Stock options outstanding at December 31, 2022 | |
| 389,479 | | |
$ | 29.1826 | | |
| | |
Granted | |
| 290,000 | | |
| 2.4920 | | |
| | |
Exercised | |
| (1,250 | ) | |
| 5.0250 | | |
| | |
Expired | |
| (3,333 | ) | |
| 16.800 | | |
| | |
Stock options outstanding at September 30, 2023 | |
| 674,896 | | |
$ | 17.8197 | | |
| 4.96 | |
| |
| | | |
| | | |
| | |
Stock options exercisable at December 31, 2022 | |
| 281,979 | | |
$ | 32.8335 | | |
| | |
Stock options exercisable at September 30, 2023 | |
| 313,959 | | |
$ | 31.8997 | | |
| 1.93 | |
|
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants |
The
exercise prices of common stock options outstanding and exercisable, including options issued in the form of warrants, at September 30,
2023 are as follows:
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants
Exercise Prices | | |
Options Outstanding (Shares) | | |
Options Exercisable (Shares) | |
| | |
| | |
| |
$ | 1.950 | | |
| 250,000 | | |
| — | |
$ | 5.025 | | |
| 8,750 | | |
| 8,750 | |
$ | 5.880 | | |
| 40,000 | | |
| 5,000 | |
$ | 7.400 | | |
| 57,500 | | |
| 41,563 | |
$ | 20.000 | | |
| 80,000 | | |
| 20,000 | |
$ | 20.600 | | |
| 20,000 | | |
| 20,000 | |
$ | 28.000 | | |
| 25,000 | | |
| 25,000 | |
$ | 30.000 | | |
| 66,667 | | |
| 66,667 | |
$ | 30.300 | | |
| 42,500 | | |
| 42,500 | |
$ | 32.000 | | |
| 20,313 | | |
| 20,313 | |
$ | 32.100 | | |
| 15,000 | | |
| 15,000 | |
$ | 60.000 | | |
| 16,667 | | |
| 16,667 | |
$ | 66.000 | | |
| 4,167 | | |
| 4,167 | |
$ | 71.400 | | |
| 20,000 | | |
| 20,000 | |
$ | 120.000 | | |
| 8,332 | | |
| 8,332 | |
| | | |
| 674,896 | | |
| 313,959 | |
|
X |
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v3.23.3
Commitments and Contingencies (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of Contractual Clinical Trials |
The
following is a summary of the contractual clinical trials discussed below as of September 30, 2023:
Schedule
of Contractual Clinical Trials
Description of Clinical
Trial | |
Type of Clinical
Trial | |
Institution | |
Estimated Start
Date | |
Estimated
End Date | |
Number of Patients in
Trial | |
Study
Objective | |
Clinical
Update | |
NCT
No. |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with carboplatin, etoposide and atezolizumab in small cell lung cancer | |
Phase 1b | |
City of Hope and Sarah Cannon | |
March 2021 | |
March 2026 | |
14 to 36 | |
Determine RP2D | |
Three patients entered | |
NCT04560972 |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with doxorubicin in sarcoma | |
Phase 1b | |
GEIS | |
June 2023 | |
June 2024 | |
9 to 18 | |
Determine MTD and RP2D | |
One patient entered | |
NCT05809830 |
| |
| |
| |
| |
| |
| |
| |
| |
|
Doxorubicin with or without LB-100 in sarcoma | |
Randomized Phase 2 | |
GEIS | |
July 2024 | |
June 2026 | |
150 | |
Determine efficacy: PFS | |
Clinical trial not yet begun (subject to completion of Phase 1b GEIS clinical trial) | |
NCT05809830 |
| |
| |
| |
| |
| |
| |
| |
| |
|
LB-100 combined with dostarlimab in ovarian clear cell carcinoma | |
Phase 1b/2 | |
MD Anderson | |
March 2024 | |
December 2025 | |
21 | |
Determine the survival of patients with ovarian clear cell carcinoma | |
No patients entered at September 30, 2023 | |
NCT06065462 |
|
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v3.23.3
Business (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
|
|
Net Income (Loss) Attributable to Parent |
$ 1,018,760
|
$ 1,478,009
|
$ 4,054,774
|
$ 4,681,231
|
|
Net Cash Provided by (Used in) Operating Activities |
|
|
3,391,142
|
$ 3,403,289
|
|
Cash and Cash Equivalents, at Carrying Value |
5,105,611
|
|
5,105,611
|
|
$ 5,353,392
|
Contractual Obligation |
$ 6,262,000
|
|
$ 6,262,000
|
|
|
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Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
1,556,178
|
745,448
|
Series A Convertible Preferred Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
72,917
|
72,917
|
Common Stock Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
808,365
|
340,031
|
Common Stock Options [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
674,896
|
332,500
|
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v3.23.3
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Product Information [Line Items] |
|
|
|
|
Cash FDIC insurance |
$ 250,000
|
|
$ 250,000
|
|
Cash SIPC insurance |
500,000
|
|
500,000
|
|
Legal Fees |
$ 178,012
|
$ 271,163
|
$ 835,362
|
$ 944,789
|
Cost of Sales [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
10.00%
|
10.00%
|
10.00%
|
10.00%
|
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
20.00%
|
22.50%
|
25.20%
|
25.00%
|
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | Vendor One [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
11.90%
|
|
|
|
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | Vendor Two [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
10.60%
|
|
|
|
General and Administrative Expense [Member] | Revenue Benchmark [Member] | Product Concentration Risk [Member] | Stock Options Granted to Directors and Corporate Officers [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
12.60%
|
32.90%
|
20.20%
|
30.70%
|
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor And Consultant One [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
38.90%
|
32.00%
|
35.90%
|
31.00%
|
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor And Consultant Two [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
24.90%
|
23.20%
|
21.00%
|
16.70%
|
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor And Consultant Three [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
15.90%
|
16.90%
|
12.40%
|
10.00%
|
Research and Development Expense [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Vendor and Consultant Four [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration of risk, percentage |
14.90%
|
11.00%
|
|
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Schedule of Research and Development Costs (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Research and development expense |
$ 132,487
|
$ 272,388
|
$ 749,029
|
$ 895,649
|
UNITED STATES |
|
|
|
|
Research and development expense |
68,315
|
161,744
|
291,846
|
316,565
|
SPAIN |
|
|
|
|
Research and development expense |
9,496
|
1,246
|
283,035
|
348,850
|
CHINA |
|
|
|
|
Research and development expense |
3,108
|
63,330
|
17,198
|
81,050
|
NETHERLANDS |
|
|
|
|
Research and development expense |
$ 51,568
|
$ 46,068
|
$ 156,950
|
$ 149,184
|
X |
- DefinitionThe aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use.
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Schedule of Warrants Outstanding (Details) - Common Stock Warrants [Member] - $ / shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
Number of Shares, Warrants Outstanding, Beginning Balance |
190,031
|
|
Weighted Average Exercise Price, Warrants Outstanding, Beginning |
$ 50.161
|
|
Number of Shares, Issued |
618,334
|
|
Weighted Average Exercise Price, Issued |
$ 6.034
|
|
Number of Shares, Exercised |
|
|
Weighted Average Exercise Price, Exercised |
|
|
Number of Shares, Expired |
|
|
Weighted Average Exercise Price, Expired |
|
|
Number of Shares, Warrants Outstanding, Ending Balance |
808,365
|
|
Weighted Average Exercise Price, Warrants Outstanding, Ending |
$ 16.407
|
|
Weighted Average Remaining Contractual Life (in Years), Outstanding |
4 years 2 months 26 days
|
|
Number of Shares, Warrants exercisable, Ending Balance |
808,365
|
190,031
|
Weighted Average Exercise Price, Warrants exercisable, Beginning Balance |
$ 16.407
|
$ 50.161
|
Weighted Average Remaining Contractual Life (in Years), Exercisable |
4 years 2 months 26 days
|
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Schedule of Warrants Outstanding and Exercisable (Details)
|
Sep. 30, 2023
$ / shares
shares
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Warrants Outstanding Shares |
808,365
|
Exercise Price One [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 6.000
|
Warrants Outstanding Shares |
583,334
|
Exercise Price Two [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 6.600
|
Warrants Outstanding Shares |
35,000
|
Exercise Price Three [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 20.000
|
Warrants Outstanding Shares |
29,000
|
Exercise Price Four [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 37.000
|
Warrants Outstanding Shares |
11,331
|
Exercise Price Five [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 57.000
|
Warrants Outstanding Shares |
149,700
|
X |
- DefinitionExercise price per share or per unit of warrants or rights outstanding.
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v3.23.3
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
|
|
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
96 Months Ended |
|
Aug. 07, 2023 |
Jul. 20, 2023 |
Jun. 02, 2023 |
Mar. 10, 2023 |
Apr. 12, 2022 |
Sep. 30, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Mar. 17, 2023 |
Mar. 17, 2015 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
|
|
10,000,000
|
10,000,000
|
|
10,000,000
|
|
|
Preferred stock, par value |
|
|
|
|
|
$ 0.0001
|
$ 0.0001
|
|
$ 0.0001
|
|
|
Common stock, shares authorized |
|
|
|
|
|
100,000,000
|
100,000,000
|
|
100,000,000
|
|
|
Common stock, par or stated value per share |
|
|
|
|
|
$ 0.0001
|
$ 0.0001
|
|
$ 0.0001
|
|
|
Common stock, shares issued |
|
|
|
|
|
2,249,290
|
2,249,290
|
|
1,664,706
|
|
|
Common stock, shares outstanding |
|
|
|
|
|
2,249,290
|
2,249,290
|
|
1,664,706
|
|
|
Proceeds from issuance initial public offering |
|
|
|
|
|
|
$ 3,137,039
|
$ 5,141,384
|
|
|
|
Exercise of common stock options |
|
|
|
|
|
|
$ 6,281
|
|
|
|
|
Warrants outstanding |
|
|
|
|
|
808,365
|
808,365
|
|
|
|
|
Investor [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, par or stated value per share |
$ 6.00
|
|
|
|
|
|
|
|
|
|
|
Placement Agents [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
$ 6.60
|
|
|
$ 20.00
|
|
|
|
|
|
|
Warrants to purchase shares |
|
35,000
|
|
|
29,000
|
|
|
|
|
|
|
Warrant expires date |
|
Jul. 20, 2028
|
|
|
|
|
|
|
|
|
|
Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, par or stated value per share |
6.60
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
$ 6.00
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance initial public offering |
|
$ 3,499,964
|
|
|
|
|
|
|
|
|
|
Costs of public offering |
|
362,925
|
|
|
|
|
|
|
|
|
|
Net proceeds from issuance of stock |
|
$ 3,137,039
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
|
583,334
|
|
|
|
|
|
|
|
|
|
Warrant expires term |
|
5 years
|
|
|
|
|
|
|
|
|
|
Warrant expires date |
|
Jul. 20, 2028
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common stock, par or stated value per share |
$ 0.0001
|
$ 5.9999
|
|
|
|
$ 0.0001
|
$ 0.0001
|
|
|
|
|
Reverse stock split |
|
|
1-for-10
|
|
|
|
|
|
|
|
|
Issuance of common stock |
403,334
|
|
|
1,250
|
|
180,000
|
180,000
|
290,000
|
|
|
|
Exercise price |
|
$ 0.0001
|
$ 5.70
|
|
|
|
|
|
|
|
|
Number of common stock shares issued during period |
|
180,000
|
|
|
290,000
|
|
|
|
|
|
|
Sale of stock price per share |
|
$ 6.00
|
|
|
$ 20.00
|
|
|
|
|
|
|
Proceeds from issuance initial public offering |
|
|
|
|
$ 5,800,000
|
|
|
|
|
|
|
Costs of public offering |
|
|
|
|
658,616
|
|
|
|
|
|
|
Net proceeds from issuance of stock |
|
|
|
|
$ 5,141,384
|
|
|
|
|
|
|
Warrants to purchase shares |
403,334
|
403,334
|
|
|
|
403,334
|
403,334
|
|
|
|
|
Exercise of common stock options |
$ 41
|
|
|
|
|
|
|
|
|
|
|
Fair market value of stock |
|
|
|
|
|
$ 57.00
|
$ 57.00
|
|
|
|
|
Warrants outstanding |
|
|
|
|
|
1,497,000
|
1,497,000
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock |
|
|
|
1,250
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
$ 5.025
|
|
|
|
|
|
|
|
Proceeds from warrant exercises |
|
|
|
$ 6,281
|
|
|
|
|
|
|
|
Warrants to purchase shares |
|
|
|
|
|
403,334
|
403,334
|
|
|
|
|
Fair market value of stock |
|
|
|
|
|
$ 5.70
|
$ 5.70
|
|
|
|
|
Warrants and rights outstanding |
|
|
$ 57.00
|
|
|
|
|
|
|
|
|
Common Stock Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Fair market value of stock |
|
|
|
|
|
$ 2.45
|
$ 2.45
|
|
|
|
|
Series A Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
|
|
|
|
|
|
|
350,000
|
Principal cash obligations and commitments |
|
|
|
|
|
|
|
|
|
|
175,000
|
Preferred stock dividend, percentage |
|
|
|
|
|
|
|
|
|
1.00%
|
|
Annual net revenue |
|
|
|
|
|
|
|
|
|
|
175,000
|
Preferred stock convertible into common stock |
|
|
|
|
|
|
72,917
|
|
72,917
|
|
|
Gross proceeds from sale of transaction |
|
|
|
|
|
|
$ 21,875,000
|
|
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
|
350,000
|
350,000
|
|
350,000
|
|
|
Series A Convertible Preferred Stock [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, conversion description |
|
|
|
|
|
|
Each
share of Series A Convertible Preferred Stock may be converted, at the option of the holder, into 0.20833 shares of common stock (subject
to customary anti-dilution provisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion
rate in the event of a merger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000.
|
|
|
|
|
Preferred stock convertible into common stock |
|
|
|
|
|
|
0.20833
|
|
|
|
|
Undesignated Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
|
|
9,650,000
|
9,650,000
|
|
9,650,000
|
|
|
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v3.23.3
Summary of Related Party Costs (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
Related party costs |
$ 356,001
|
$ 643,957
|
$ 1,398,042
|
$ 1,963,409
|
Related Party [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Related party costs |
243,895
|
247,074
|
728,896
|
802,760
|
Stock Based [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Related party costs |
$ 112,106
|
$ 396,883
|
$ 669,146
|
$ 1,160,649
|
X |
- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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v3.23.3
Related Party Transactions (Details Narrative) - USD ($)
|
|
|
|
|
|
|
|
3 Months Ended |
9 Months Ended |
|
Sep. 26, 2023 |
Nov. 06, 2022 |
May 01, 2021 |
Apr. 09, 2021 |
Oct. 01, 2020 |
Aug. 12, 2020 |
Aug. 01, 2020 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Jun. 15, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Cash board fee payable |
|
|
|
|
|
|
|
|
|
|
|
$ 100,000
|
Cash board fee payable quarterly |
|
|
|
|
|
|
|
|
|
|
|
$ 40,000
|
Share-based payment award, award vesting period |
|
|
|
|
|
|
|
|
|
12.50%
|
|
|
Annual cash fee |
|
|
|
|
|
|
|
$ 356,001
|
$ 643,957
|
$ 1,398,042
|
$ 1,963,409
|
|
Stock based compensation |
|
|
|
|
|
|
|
112,106
|
396,883
|
669,146
|
1,160,649
|
|
Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Annual cash fee |
|
|
|
|
|
|
|
243,895
|
247,074
|
728,896
|
802,760
|
|
Independent Director [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
42,228
|
53,324
|
$ 127,229
|
221,510
|
|
New Independent Director [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Options, grants in period, gross |
|
|
|
|
|
|
|
|
|
25,000
|
|
|
Share-based payment award, award vesting period |
|
|
|
|
|
|
|
|
|
50.00%
|
|
|
New Independent Director [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Annual cash fee |
|
|
|
|
|
|
|
|
|
$ 100,000
|
|
|
Annual Grant of Options [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Options, grants in period, gross |
|
|
|
|
|
|
|
|
|
10,000
|
|
|
Share-based payment award, award vesting period |
|
|
|
|
|
|
|
|
|
12.50%
|
|
|
Annual Grant of Options [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Annual cash fee |
|
|
|
|
|
|
|
|
|
$ 40,000
|
|
|
Forman [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
|
Paid office rent |
|
1,500
|
|
|
|
|
|
7,323
|
|
11,436
|
|
|
Director [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
|
|
$ 20,000
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
23,916
|
39,860
|
70,965
|
39,860
|
|
Chairman of Audit Committee [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
|
|
10,000
|
|
|
|
|
|
|
|
|
Chairman of Other Committees [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
|
|
5,000
|
|
|
|
|
|
|
|
|
Member of Audit Committee [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
|
|
5,000
|
|
|
|
|
|
|
|
|
Member of Other Committees [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
|
|
$ 2,500
|
|
|
|
|
|
|
|
|
Employment Agreement [Member] | Dr. Kovach [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Annual salary |
|
|
|
|
$ 250,000
|
|
|
|
|
|
|
|
Compensation |
|
|
|
|
|
|
|
62,500
|
62,500
|
187,500
|
187,500
|
|
Employment Agreement [Member] | Dr. James S. Miser, M.D [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Annual salary |
|
|
|
|
|
|
$ 150,000
|
|
|
|
|
|
Compensation |
|
|
|
|
|
|
|
43,750
|
43,750
|
131,250
|
131,250
|
|
Increase in annual salary |
|
|
$ 175,000
|
|
|
|
|
|
|
|
|
|
Employment Agreement [Member] | Eric J. Forman [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Annual salary |
$ 150,000
|
|
|
|
|
$ 120,000
|
|
|
|
|
|
|
Compensation |
|
|
|
|
|
|
|
50,000
|
43,750
|
150,000
|
131,250
|
|
Increase in annual salary |
|
|
175,000
|
|
|
|
|
|
|
|
|
|
Employment Agreement [Member] | Chief Operating Officer [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
|
Employment Agreement [Member] | Robert N. Weingarten [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Annual salary |
|
|
|
|
|
$ 120,000
|
|
|
|
|
|
|
Compensation |
|
|
|
|
|
|
|
43,750
|
$ 43,750
|
131,250
|
$ 131,250
|
|
Increase in annual salary |
|
|
$ 175,000
|
|
|
|
|
|
|
|
|
|
Employment Agreement [Member] | Mr Vander Baan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
|
|
|
|
|
|
$ 1,667
|
|
$ 1,667
|
|
|
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X |
- DefinitionThe estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term.
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v3.23.3
Summmary of Stock-based Compensation Costs (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
Total stock-based compensation costs |
$ 112,106
|
$ 396,883
|
$ 669,146
|
$ 1,160,649
|
Related Parties [Member] |
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
Total stock-based compensation costs |
112,106
|
396,883
|
669,146
|
1,160,649
|
Non Related Parties [Member] |
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
Total stock-based compensation costs |
|
|
|
|
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v3.23.3
Summary of Stock Option Activity Including Options Form of Warrants (Details) - $ / shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Share-Based Payment Arrangement [Abstract] |
|
|
Number of shares, stock options outstanding, at the beginning |
389,479
|
|
Weighted average exercise price, stock options outstanding, at the beginning |
$ 29.1826
|
|
Number of shares, Granted |
290,000
|
|
Weighted average exercise price, granted |
$ 2.4920
|
|
Number of shares, Exercised |
(1,250)
|
|
Weighted average exercise price, exercised |
$ 5.0250
|
|
Number of shares, Expired |
(3,333)
|
|
Weighted average exercise price, expired |
$ 16.800
|
|
Number of shares, stock options outstanding, at the end |
674,896
|
|
Weighted average exercise price, stock options outstanding, at the end |
$ 17.8197
|
|
Weighted average remaining contractual life (in years), stock options outstanding |
4 years 11 months 15 days
|
|
Number of shares, stock options exercisable, at the end |
313,959
|
281,979
|
Weighted average exercise price, stock options exercisable, at the end |
$ 31.8997
|
$ 32.8335
|
Weighted average remaining contractual life (in years), stock options exercisable |
1 year 11 months 4 days
|
|
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v3.23.3
Schedule of Exercise Prices of Common Stock Options Outstanding and Exercisable Including Options Form of Warrants (Details)
|
9 Months Ended |
Sep. 30, 2023
$ / shares
shares
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Options Outstanding (Shares) |
674,896
|
Options Exercisable (Shares) |
313,959
|
Exercise Price One [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 1.950
|
Options Outstanding (Shares) |
250,000
|
Options Exercisable (Shares) |
|
Exercise Price Two [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 5.025
|
Options Outstanding (Shares) |
8,750
|
Options Exercisable (Shares) |
8,750
|
Exercise Price Three [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 5.880
|
Options Outstanding (Shares) |
40,000
|
Options Exercisable (Shares) |
5,000
|
Exercise Price Four [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 7.400
|
Options Outstanding (Shares) |
57,500
|
Options Exercisable (Shares) |
41,563
|
Exercise Price Five [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 20.000
|
Options Outstanding (Shares) |
80,000
|
Options Exercisable (Shares) |
20,000
|
Exercise Price Six [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 20.600
|
Options Outstanding (Shares) |
20,000
|
Options Exercisable (Shares) |
20,000
|
Exercise Price Seven [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 28.000
|
Options Outstanding (Shares) |
25,000
|
Options Exercisable (Shares) |
25,000
|
Exercise Price Eight [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 30.000
|
Options Outstanding (Shares) |
66,667
|
Options Exercisable (Shares) |
66,667
|
Exercise Price Nine [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 30.300
|
Options Outstanding (Shares) |
42,500
|
Options Exercisable (Shares) |
42,500
|
Exercise Price Ten [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 32.000
|
Options Outstanding (Shares) |
20,313
|
Options Exercisable (Shares) |
20,313
|
Exercise Price Eleven [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 32.100
|
Options Outstanding (Shares) |
15,000
|
Options Exercisable (Shares) |
15,000
|
Exercise Price Twelve [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 60.000
|
Options Outstanding (Shares) |
16,667
|
Options Exercisable (Shares) |
16,667
|
ExercisePriceThirteen [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 66.000
|
Options Outstanding (Shares) |
4,167
|
Options Exercisable (Shares) |
4,167
|
Exercise Price Fourteen [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 71.400
|
Options Outstanding (Shares) |
20,000
|
Options Exercisable (Shares) |
20,000
|
Exercise Price Fifteen [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercise Prices | $ / shares |
$ 120.000
|
Options Outstanding (Shares) |
8,332
|
Options Exercisable (Shares) |
8,332
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.23.3
Stock-Based Compensation (Details Narrative) - USD ($)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
9 Months Ended |
|
|
|
Nov. 27, 2023 |
Sep. 26, 2023 |
Jun. 30, 2023 |
Nov. 06, 2022 |
Oct. 07, 2022 |
Jun. 30, 2022 |
Jun. 17, 2022 |
Jun. 30, 2021 |
May 11, 2021 |
Apr. 09, 2021 |
Aug. 12, 2020 |
Aug. 07, 2020 |
Aug. 01, 2020 |
Jul. 15, 2020 |
Jul. 14, 2020 |
Jun. 30, 2022 |
Jun. 30, 2021 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Jun. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Jun. 26, 2023 |
Jun. 06, 2023 |
Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
674,896
|
|
|
674,896
|
|
|
|
389,479
|
Stock option vested exercisable term |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28 months
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 112,106
|
$ 396,883
|
|
$ 669,146
|
$ 1,160,649
|
|
|
|
Number of fully vested option exercisable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
313,959
|
|
|
313,959
|
|
|
|
281,979
|
Share based compensation vesting rights, percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12.50%
|
|
|
|
|
Total deferred compensation expense for outstanding value of unvested stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 808,000
|
|
|
|
|
Fair market value, per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 2.45
|
|
|
|
|
Intrinsic value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 0
|
|
|
$ 0
|
|
|
|
|
Outstanding stock options to acquire shares of common stock not vested |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
360,938
|
|
|
360,938
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock price per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 57.00
|
|
|
$ 57.00
|
|
|
|
|
Director [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options description |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the
Board of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 shares (a total
of 50,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $7.40 per share
(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,
subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,
was determined to be $316,700 ($6.334 per share), which is being charged to operations ratably from July 1, 2022 through June 30, 2024.
The Company recorded charges to general and administrative costs in the consolidated statement of operations of $23,916 and $39,860 for
the three months ended September 30, 2023 and 2022, respectively, and $70,965 and $39,860 for the nine months ended September 30, 2023
and 2022, respectively, with respect to these stock options.
|
|
|
|
|
|
Stock option vested exercisable term |
|
|
|
|
|
5 years
|
5 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 10,000
|
|
|
|
|
|
|
|
|
Stock price per share |
|
|
$ 5.88
|
$ 20.00
|
|
$ 50,000
|
|
$ 6.334
|
|
|
|
|
|
|
|
$ 50,000
|
$ 6.334
|
|
|
$ 50,000
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 23,916
|
39,860
|
|
$ 70,965
|
39,860
|
|
|
|
Stock options are exercisable price per share |
|
|
|
$ 5.025
|
|
$ 7.40
|
|
|
|
|
|
|
|
|
|
$ 7.40
|
|
|
|
$ 7.40
|
|
|
|
|
|
Number of fully vested option exercisable |
|
|
10,000
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Director [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of fully vested option exercisable |
|
|
|
20,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Five Non Officer Directors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options description |
|
|
|
|
|
|
|
the
Board of Directors, in accordance with the Company’s cash and equity compensation package for members of the Board of
Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000
shares (a total of 50,000
shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $30.30 per share (the
closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,
subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $1,421,095
($28.423
per share), which was charged to operations ratably from July 1, 2021 through June 30, 2023. The Company recorded charges to general
and administrative costs in the consolidated statement of operations of $0
and $179,100
for the three months ended September 30, 2023 and 2022, respectively, and $211,412
and $531,455
for the nine months ended September 30, 2023 and 2022, respectively, with respect to these stock options.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option vested exercisable term |
|
|
|
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of stock options |
|
|
|
$ 43,264
|
|
|
|
|
|
|
|
|
|
|
|
$ 316,700
|
$ 1,421,095
|
|
|
|
|
|
|
|
|
Stock price per share |
|
|
|
$ 4.326
|
|
|
|
$ 28.423
|
|
|
|
|
|
|
|
|
$ 28.423
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0
|
179,100
|
|
211,412
|
531,455
|
|
|
|
Number of fully vested option exercisable |
|
|
|
|
|
|
|
10,000
|
|
|
|
|
|
|
|
|
10,000
|
|
|
|
|
|
|
|
|
Non Officer Directors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options are exercisable price per share |
|
|
|
|
|
|
|
$ 30.30
|
|
|
|
|
|
|
|
|
$ 30.30
|
|
|
|
|
|
|
|
|
Number of fully vested option exercisable |
|
|
|
|
|
|
|
50,000
|
|
|
|
|
|
|
|
|
50,000
|
|
|
|
|
|
|
|
|
BasvanderBaan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options description |
|
|
|
|
|
|
the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to the
Board of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors,
Mr. Baan was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years
at an exercise price of $7.40 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder
vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value
of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($6.341 per share),
of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 and was therefore charged to operations
on that date. The remaining unvested portion of the fair value of the stock options is being charged to operations ratably from June
17, 2022 through June 30, 2024. The Company recorded charges to general and administrative costs in the consolidated statement of operations
of $9,801 and $9,801 for the three months ended September 30, 2023 and 2022, respectively, and $29,084 and $90,449 for the nine months
ended September 30, 2023 and 2022, respectively, with respect to these stock options.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of stock options |
|
|
|
|
|
|
$ 158,525
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock price per share |
|
|
|
|
|
|
$ 6.341
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,801
|
9,801
|
|
29,084
|
90,449
|
|
|
|
Stock options are exercisable price per share |
|
|
|
|
|
|
$ 7.40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of fully vested option exercisable |
|
|
|
|
|
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options granted to purchase common stock, issued |
|
|
|
|
|
|
$ 79,263
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Four Officers [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of stock options |
|
|
|
$ 262,560
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock price per share |
|
|
|
$ 3.282
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,528
|
|
|
49,053
|
|
|
|
|
Number of fully vested option exercisable |
|
|
|
80,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
|
Share based compensation vesting rights, percentage |
|
|
|
25.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share based compensation issuance, percentage |
|
|
|
25.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options granted to purchase common stock, issued |
|
|
|
80,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Four Non Officers[Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of stock options |
|
|
$ 192,593
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock price per share |
|
|
$ 4.8131
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,232
|
|
|
24,232
|
|
|
|
|
Share based compensation vesting rights, percentage |
|
|
12.50%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eric J. Forman [Member] | Employment Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options, grants in period, gross |
|
|
|
|
|
|
|
|
|
|
|
|
|
5,833
|
|
|
|
|
|
|
|
|
|
|
|
Stock options description |
|
|
|
|
|
|
|
|
|
|
|
|
|
On
July 15, 2020, as amended on August 12, 2020, in connection with the employment agreement entered into with Eric J. Forman, Mr. Forman
was granted stock options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis.
The options are exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market
price of the Company’s common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively,
with the final 25% vesting on August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant
to the Black-Scholes option-pricing model, was determined to be $400,855 ($68.718 per share), of which $100,214 was attributable to the
portion of the stock options fully vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested
portion of the fair value of the stock options was charged to operations ratably from August 12, 2020 through August 12, 2023. The Company
recorded charges to general and administrative costs in the consolidated statement of operations of $11,806 and $25,259 for the three
months ended September 30, 2023 and 2022, respectively, and $61,501 and $74,954 for the nine months ended September 30, 2023 and 2022,
respectively, with respect to these stock options.
|
|
|
|
|
|
|
|
|
|
|
|
Stock option vested exercisable term |
|
|
|
|
|
|
|
|
|
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 400,855
|
|
|
|
|
|
|
|
|
|
|
|
Stock price per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 68.718
|
|
|
|
|
|
|
|
|
|
|
|
Stock options fully vested amount, fair value |
|
|
|
|
|
|
|
|
|
|
$ 100,214
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,806
|
25,259
|
|
61,501
|
74,954
|
|
|
|
Dr. James Miser [Member] | Employment Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options, grants in period, gross |
|
|
|
|
|
|
|
|
|
|
|
|
8,333
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options description |
|
|
|
|
|
|
|
|
|
|
|
|
Dr. James S. Miser, M.D., Dr. Miser was granted stock options
to purchase 8,333 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are exercisable
for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s
common stock on the effective date of the employment agreement. The options vested 25% on August 1, 2020, 2021 and 2022, respectively,
with the final 25% vesting on August 1, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant
to the Black-Scholes option-pricing model, was determined to be $572,650 ($68.718 per share), of which $143,163 was attributable to the
portion of the stock options fully vested on August 1, 2020 and was therefore charged to operations on that date. The remaining unvested
portion of the fair value of the stock options was charged to operations ratably from August 1, 2020 through August 1, 2023. The Company
recorded charges to general and administrative costs in the consolidated statement of operations of $12,551 and $36,085 for the three
months ended September 30, 2023 and 2022, respectively, and $83,544 and $107,078 for the nine months ended September 30, 2023 and 2022,
respectively, with respect to these stock options.
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option vested exercisable term |
|
|
|
|
|
|
|
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
$ 572,650
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock price per share |
|
|
|
|
|
|
|
|
|
|
|
|
$ 68.718
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options fully vested amount, fair value |
|
|
|
|
|
|
|
|
|
|
|
|
$ 143,163
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,551
|
36,085
|
|
83,544
|
107,078
|
|
|
|
Stock options are exercisable price per share |
|
|
|
|
|
|
|
|
|
|
|
|
$ 71.40
|
|
|
|
|
|
|
|
|
|
|
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Robert N. Weingarten [Member] | Director [Member] |
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Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
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Number of fully vested option exercisable |
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5,833
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Robert N. Weingarten [Member] | Employment Agreement [Member] |
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Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
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Stock options description |
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On
August 12, 2020, in connection with the employment agreement entered into with Robert N. Weingarten, Mr. Weingarten was granted stock
options to purchase 5,833 shares of the Company’s common stock. The options can be exercised on a cashless basis. The options are
exercisable for a period of five years at an exercise price of $71.40 per share, which was equal to the closing market price of the Company’s
common stock on the grant date. The options vested 25% on August 12, 2020, 2021 and 2022, respectively, with the final 25% vesting on
August 12, 2023, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $400,855 ($68.718 per share), of which $100,214 was attributable to the portion of the stock options fully
vested on August 12, 2020 and was therefore charged to operations on that date. The remaining unvested portion of the fair value of the
stock options was charged to operations ratably from August 12, 2020 through August 12, 2023. The Company recorded charges to general
and administrative costs in the consolidated statement of operations of $11,806 and $25,259 for the three months ended September 30,
2023 and 2022, respectively, and $61,501 and $74,954 for the nine months ended September 30, 2023 and 2022, respectively, with respect
to these stock options.
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Stock option vested exercisable term |
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5 years
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Fair value of stock options |
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$ 400,855
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Stock price per share |
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$ 68.718
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Stock options fully vested amount, fair value |
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$ 100,214
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Stock based compensation |
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11,806
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25,259
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61,501
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74,954
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Stock options are exercisable price per share |
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$ 71.40
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Mr Schwartberg [Member] | Director [Member] |
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Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
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Stock options description |
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On
April 9, 2021, the Board of Directors appointed Gil Schwartzberg to fill the vacancy created by a former director’s resignation.
In connection with his appointment to the Board of Directors, and in accordance with the Company’s cash and equity compensation
package for members of the Board of Directors, Mr. Schwartzberg was granted stock options to purchase 25,000 shares of the Company’s
common stock, exercisable for a period of five years at an exercise price of $32.00 per share (the closing market price on the grant
date), vesting 50% on the grant date and the remainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully
vested, subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing
model, was determined to be $753,611 ($30.144 per share), of which $376,800 was attributable to the portion of the stock options fully
vested on April 9, 2021 and was therefore charged to operations on that date. Although the remaining unvested portion of the fair value
of the stock options was being charged to operations ratably from April 9, 2021 through June 30, 2023, the vesting of these stock options
terminated on October 30, 2022 as a result of the death of Mr. Schwartzberg on that date. The Company recorded charges to general and
administrative costs in the consolidated statement of operations of $42,692 and $126,684 for the three months and nine months ended September
30, 2022, respectively, with respect to these stock options.
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Stock option vested exercisable term |
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5 years
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Fair value of stock options |
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$ 753,611
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Stock price per share |
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$ 30.144
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Stock options fully vested amount, fair value |
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$ 376,800
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Stock based compensation |
|
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|
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42,692
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126,684
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Stock options are exercisable price per share |
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$ 32.00
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Number of fully vested option exercisable |
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25,000
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Ms.Regina Brown [Member] | Director [Member] |
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Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
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Stock options description |
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|
the Board of Directors appointed Regina Brown to the Board of Directors. In connection with her appointment to the Board
of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors,
Ms. Brown was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period of five years
at an exercise price of $28.00 per share (the closing market price on the grant date), vesting 50% on the grant date and the remainder
vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. The fair value
of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $658,363 ($26.335 per
share), of which $329,188 was attributable to the portion of the stock options fully vested on May 11, 2021 and was therefore charged
to operations on that date. The remaining unvested portion of the fair value of the stock options was charged to operations ratably from
May 11, 2021 through June 30, 2023. The Company recorded charges to general and administrative costs in the consolidated statement of
operations of $0 and $38,827 for the three months ended September 30, 2023 and 2022, respectively, and $76,388 and $115,215 for the nine
months ended September 30, 2023 and 2022, respectively, with respect to these stock options.
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Stock option vested exercisable term |
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5 years
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Fair value of stock options |
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$ 658,363
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Stock price per share |
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$ 26.335
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Stock options fully vested amount, fair value |
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$ 329,188
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Stock based compensation |
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0
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$ 38,827
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76,388
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$ 115,215
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|
Stock options are exercisable price per share |
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$ 28.00
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Number of fully vested option exercisable |
|
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25,000
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Mr Vander Baan [Member] | Employment Agreement [Member] |
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Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
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Options, grants in period, gross |
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250,000
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|
Fair value of stock options |
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$ 403,066
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Stock price per share |
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$ 1.95
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|
$ 1.612
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|
Stock based compensation |
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$ 1,466
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|
$ 1,466
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2020 Stock Incentive Plan [Member] |
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Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
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Common shares avaliable for issuable |
|
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|
180,000
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|
Options, grants in period, gross |
|
|
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|
413,333
|
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|
Shares outstanding |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
136,980
|
|
|
136,980
|
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|
2020 Stock Incentive Plan [Member] | Subsequent Event [Member] |
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|
|
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|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
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|
|
|
|
|
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|
|
Common shares avaliable for issuable |
336,667
|
|
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|
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|
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|
|
Options, grants in period, gross |
750,000
|
|
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|
|
|
|
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|
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|
Shares outstanding |
550,313
|
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|
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|
|
Shares were available for issuance |
199,687
|
|
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|
|
|
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|
|
2020 Stock Incentive Plan [Member] | Maximum [Member] |
|
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|
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|
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|
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|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Number of restricted stock issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
233,333
|
|
|
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|
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v3.23.3
Commitments and Contingencies (Details Narrative)
|
|
|
|
|
|
|
|
|
|
|
|
2 Months Ended |
3 Months Ended |
8 Months Ended |
9 Months Ended |
|
|
Oct. 05, 2023
USD ($)
|
Sep. 26, 2023
USD ($)
|
Jun. 22, 2023
USD ($)
|
Apr. 17, 2023
USD ($)
|
Nov. 06, 2022
USD ($)
|
Jun. 10, 2022
USD ($)
|
Apr. 09, 2021
USD ($)
|
Feb. 05, 2021
USD ($)
|
Aug. 20, 2018
USD ($)
|
Sep. 14, 2015
USD ($)
|
Dec. 24, 2013
USD ($)
|
Aug. 31, 2020
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Oct. 03, 2023
USD ($)
|
Oct. 03, 2023
EUR (€)
|
Oct. 08, 2021
EUR (€)
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual commitment |
|
|
|
|
|
|
|
|
|
|
|
|
$ 6,262,000
|
|
$ 6,262,000
|
$ 6,262,000
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
132,487
|
$ 272,388
|
|
749,029
|
$ 895,649
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
84,000
|
|
84,000
|
84,000
|
|
|
|
|
Forman [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
|
|
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paid office rent |
|
|
|
|
$ 1,500
|
|
|
|
|
|
|
|
7,323
|
|
|
11,436
|
|
|
|
|
Officer [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
$ 950,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Officer [Member] | Minimum [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation |
$ 700,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
City of Hope [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
74,181
|
|
74,181
|
74,181
|
|
|
|
|
Moffitt Cancer Center and Research Institute Hospital Inc [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
148,138
|
|
|
|
|
GEIS [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount related to milestone payment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
684,652
|
|
|
|
NDA Consulting Corp [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consulting and advisory fee |
|
|
|
|
|
|
|
|
|
|
$ 4,000
|
|
4,000
|
4,000
|
|
12,000
|
12,000
|
|
|
|
Clinical Trial Research Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development process costs |
|
|
|
|
|
|
|
|
|
|
|
|
0
|
9,218
|
|
0
|
18,623
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
131,074
|
|
|
|
|
|
Other Clinical Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,144,000
|
|
|
|
|
Collaboration Agreement [Member] | GEIS [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
268,829
|
0
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
3,423,000
|
|
3,423,000
|
3,423,000
|
|
|
|
|
Collaboration Agreement [Member] | Bio Pharma Works LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consulting and advisory fee |
|
|
|
|
|
|
|
|
|
$ 10,000
|
|
|
|
|
|
|
|
|
|
|
Reimbursed expense |
|
|
|
|
|
|
|
|
|
|
|
|
30,000
|
30,000
|
|
90,000
|
90,000
|
|
|
|
Clinical Research Support Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
800,000
|
|
800,000
|
800,000
|
|
|
|
|
Clinical Research Support Agreement [Member] | City of Hope [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
69,001
|
0
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
2,433,000
|
|
2,433,000
|
2,433,000
|
|
|
|
|
Total costs |
|
|
|
|
|
|
|
|
|
|
|
|
447,512
|
|
447,512
|
447,512
|
|
|
|
|
Work Order Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
144,000
|
|
144,000
|
144,000
|
|
|
|
|
Total costs |
|
|
|
|
|
|
|
|
|
|
|
|
10,000
|
|
10,000
|
10,000
|
|
|
|
|
Work Order Agreement [Member] | City of Hope [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
$ 335,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
262,000
|
|
262,000
|
262,000
|
|
|
|
|
Advance amount related to milestone payment |
|
|
|
|
|
|
|
|
|
|
|
|
4,500
|
7,731
|
|
15,740
|
23,466
|
|
|
|
Work Order Agreement [Member] | Theradex Systems, Inc. [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
3,750
|
|
|
10,000
|
|
|
|
|
Work cost |
|
|
$ 153,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of payment through services |
|
|
72.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of payment through software |
|
|
28.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Work Order Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
566
|
11,953
|
|
20,850
|
19,792
|
|
|
|
Exclusive License Agreement [Member] | Moffitt Cancer Center and Research Institute Hospital Inc [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non refundable license issue fee |
|
|
|
|
|
|
|
|
$ 25,000
|
|
|
|
|
|
|
|
|
|
|
|
Maintenance fee |
|
|
|
|
|
|
|
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
Payment on non refundable milestone |
|
|
|
|
|
|
|
|
$ 1,897,000
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
21,507
|
6,301
|
|
9,109
|
18,699
|
|
|
|
Employment Agreement [Member] | Executive Officers [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salary and compensation |
|
|
|
|
|
|
|
|
|
|
|
$ 640,000
|
|
|
|
|
|
|
|
|
Employment Agreement [Member] | Dr.James [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annual compensation |
|
|
|
|
|
|
$ 775,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employment Agreement [Member] | Bastiaan van der Baan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annual salary |
|
$ 150,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development Collaboration Agreement [Member] | Netherlands Cancer Institute [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
416,356
|
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
316,000
|
|
$ 316,000
|
316,000
|
|
|
|
€ 391,000
|
Advance amount related to milestone payment |
|
|
|
|
|
|
|
|
|
|
|
|
51,568
|
46,068
|
|
156,949
|
149,184
|
|
|
|
Development Collaboration Agreement [Member] | Netherlands Cancer Institute [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate commitments expected |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 263,000
|
€ 250,000
|
|
MRI Global [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
241,841
|
|
|
|
|
Advance amount related to milestone payment |
|
|
|
|
|
|
|
|
|
|
|
|
$ 19,845
|
$ 5,549
|
|
$ 27,028
|
$ 25,902
|
|
|
|
Contract price |
|
|
|
$ 326,274
|
|
$ 273,980
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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