UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2024
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _________ to ___________
Commission
File Number: 001-41160
ALLARITY
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
Delaware | | 87-2147982 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
24 School Street, 2nd Floor, Boston, MA | | 02108 |
(Address of principal executive offices) | | (Zip Code) |
(401)
426-4664
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
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 | | ALLR | | 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 issuer 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 checkmark 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 August 5, 2024, there were 42,379,508 shares of the registrant’s common stock, par value $0.0001, outstanding.
Table
of Contents
Unless
the context indicates otherwise, references in this Quarterly Report on Form 10-Q (the “Quarterly Report”) to the “Company,”
“Allarity,” “we,” “us,” “our” and similar terms refer to Allarity Therapeutics, Inc.,
Allarity Therapeutics A/S (as predecessor) and its respective consolidated subsidiaries. On April 9, 2024, we effected a 1-for-20 reverse
stock split of the shares of our Common Stock (the “Reverse Stock Split”). All historical share and per share amounts reflected
throughout this Quarterly Report have been adjusted to reflect the Reverse Stock Split.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report contains statements we believe are “forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995. Those forward-looking statements are intended to enjoy the protection of the safe harbor for forward-looking
statements provided by that act as well as protections afforded by other federal securities laws. Generally, words such as “achieve,”
“aim,” “ambitions,” “anticipate,” “believe,” “committed,” “continue,”
“could,” “designed,” “estimate,” “expect,” “forecast,” “future,”
“goals,” “grow,” “guidance,” “intend,” “likely,” “may,” “milestone,”
“objective,” “on track,” “opportunity,” “outlook,” “pending,” “plan,”
“position,” “possible,” “potential,” “predict,” “progress,” “roadmap,”
“seek,” “should,” “strive,” “targets,” “to be,” “upcoming,” “will,”
“would,” and variations of such words and similar expressions identify forward-looking statements, which are not historical
in nature. Forward-looking statements may appear throughout this Quarterly Report and other documents we file with the Securities and
Exchange Commission (the “SEC”). Forward-looking statements involve risks and uncertainties that could cause actual results
to differ materially from those anticipated by these forward-looking statements. These risks and uncertainties include, but are not limited
to, the factors described in the section captioned “Risk Factors” in our Annual Report on Form 10-K, as amended (the
“Form 10-K”), initially filed with the SEC on March 8, 2024.
We
urge investors to consider all of the risks, uncertainties, and other factors disclosed in these filings carefully in evaluating the
forward-looking statements contained in this Quarterly Report. We cannot assure you that the results or developments anticipated by us
and reflected or implied by any forward-looking statement contained in this Quarterly Report will be realized or, even if substantially
realized, that those results or developments will result in the forecasted or expected consequences for us or affect us, our operations
or financial performance as we forecasted or expected. As a result of the matters discussed above and other matters, including changes
in facts, assumptions not being realized, or other factors, the actual results relating to the subject matter of any forward-looking
statement in this Quarterly Report may differ materially from the anticipated results expressed or implied in that forward-looking statement.
The forward-looking statements included in this Quarterly Report are made only as of the date of this Quarterly Report, and we undertake
no obligation to update any such statements to reflect subsequent events or circumstances.
PART
I—FINANCIAL INFORMATION
Item
1. Financial Statements.
ALLARITY
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
dollars in thousands, except for share and per share data)
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 19,233 | | |
$ | 166 | |
Other current assets | |
| 131 | | |
| 209 | |
Prepaid expenses | |
| 366 | | |
| 781 | |
Tax credit receivable | |
| 1,579 | | |
| 815 | |
Total current assets | |
| 21,309 | | |
| 1,971 | |
Non-current assets: | |
| | | |
| | |
Property, plant and equipment, net | |
| 17 | | |
| 20 | |
Intangible assets | |
| 9,557 | | |
| 9,871 | |
Total assets | |
$ | 30,883 | | |
$ | 11,862 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 7,753 | | |
$ | 8,416 | |
Accrued liabilities | |
| 1,465 | | |
| 1,309 | |
Warrant derivative liability | |
| 16 | | |
| 3,083 | |
Income taxes payable | |
| 57 | | |
| 59 | |
Convertible promissory notes and accrued interest, net of debt discount | |
| 1,325 | | |
| 1,300 | |
Total current liabilities | |
| 10,616 | | |
| 14,167 | |
Non-current liabilities: | |
| | | |
| | |
Deferred tax | |
| 432 | | |
| 446 | |
Total liabilities | |
| 11,048 | | |
| 14,613 | |
Commitments and contingencies (Note 15) | |
| | | |
| | |
Stockholders’ (deficit) equity | |
| | | |
| | |
Series A Preferred stock $0.0001 par value (20,000 shares designated) shares issued and outstanding at June 30, 2024 and December 31, 2023 were 0 and 1,417, respectively | |
| — | | |
| 1,742 | |
Common stock, $0.0001 par value (750,000,000 shares authorized, at June 30, 2024 and December 31, 2023); shares issued and outstanding at June 30, 2024 and December 31, 2023 were 35,039,196 and 294,347, respectively | |
| 3 | | |
| — | |
Additional paid-in capital | |
| 120,285 | | |
| 90,369 | |
Accumulated other comprehensive loss | |
| (530 | ) | |
| (411 | ) |
Accumulated deficit | |
| (99,923 | ) | |
| (94,451 | ) |
Total stockholders’ equity (deficit) | |
| 19,835 | | |
| (2,751 | ) |
Total liabilities and stockholders’ equity | |
$ | 30,883 | | |
$ | 11,862 | |
See
accompanying notes to condensed consolidated financial statements.
ALLARITY
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(U.S.
dollars in thousands, except for share and per share data)
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses: | |
| | |
| | |
| | |
| |
Research and development | |
$ | 1,058 | | |
$ | 1,105 | | |
$ | 3,228 | | |
$ | 2,532 | |
General and administrative | |
| 2,313 | | |
| 3,051 | | |
| 4,383 | | |
| 5,292 | |
Total operating expenses | |
| 3,371 | | |
| 4,156 | | |
| 7,611 | | |
| 7,824 | |
Loss from operations | |
| (3,371 | ) | |
| (4,156 | ) | |
| (7,611 | ) | |
| (7,824 | ) |
Other income (expenses) | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 53 | | |
| 3 | | |
| 53 | | |
| 7 | |
Interest expense | |
| (426 | ) | |
| (142 | ) | |
| (528 | ) | |
| (234 | ) |
Foreign exchange (losses) gains | |
| (128 | ) | |
| (26 | ) | |
| (52 | ) | |
| 69 | |
Change in fair value of derivative and warrant liabilities | |
| 2,243 | | |
| 1,941 | | |
| 2,662 | | |
| 2,250 | |
Net other income | |
| 1,742 | | |
| 1,776 | | |
| 2,135 | | |
| 2,092 | |
Net loss before tax benefit | |
| (1,629 | ) | |
| (2,380 | ) | |
| (5,476 | ) | |
| (5,732 | ) |
Income tax benefit | |
| — | | |
| — | | |
| 4 | | |
| — | |
Net loss | |
| (1,629 | ) | |
| (2,380 | ) | |
| (5,472 | ) | |
| (5,732 | ) |
Deemed dividend on Series A Convertible Preferred Stock | |
| (71 | ) | |
| (7,287 | ) | |
| (299 | ) | |
| (7,287 | ) |
Gain on extinguishment of Series A Convertible Preferred Stock | |
| 31 | | |
| — | | |
| 222 | | |
| — | |
Deemed dividend of 5% on Series C Preferred Stock | |
| — | | |
| (119 | ) | |
| — | | |
| (123 | ) |
Net loss attributable to common stockholders | |
$ | (1,669 | ) | |
$ | (9,786 | ) | |
$ | (5,549 | ) | |
$ | (13,142 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per common stock | |
$ | (0.11 | ) | |
$ | (525.53 | ) | |
$ | (0.73 | ) | |
$ | (1,336.40 | ) |
Weighted-average number of common stock outstanding, basic and diluted | |
| 14,979,095 | | |
| 18,621 | | |
| 7,641,826 | | |
| 9,834 | |
Other comprehensive loss, net of tax: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,629 | ) | |
$ | (2,380 | ) | |
$ | (5,472 | ) | |
$ | (5,732 | ) |
Change in cumulative translation adjustment | |
| (144 | ) | |
| (29 | ) | |
| (119 | ) | |
| 55 | |
Total comprehensive loss attributable to common stockholders | |
$ | (1,773 | ) | |
$ | (2,409 | ) | |
$ | (5,591 | ) | |
$ | (5,677 | ) |
See
accompanying notes to condensed consolidated financial statements.
ALLARITY
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE STOCKHOLDERS’ EQUITY (DEFICIT)
For
the three and six months ended June 30, 2024 and 2023
(Unaudited)
(U.S.
dollars in thousands, except for share data)
| | Series A Preferred Stock | | | Series B Preferred Stock | | | Series C Convertible Preferred Stock | | | Series A Preferred Stock | | | Common Stock | | | Additional Paid in | | | Accumulated Other Comprehensive | | | Accumulated | | | Total Stockholders’ Equity | |
| | Number | | | Value | | | Number | | | Value | | | Number | | | Value | | | Number | | | Value | | | Number | | | Value | | | Capital | | | Loss | | | Deficit | | | (Deficit) | |
Balance, December 31, 2022 | | | 13,586 | | | $ | 2,001 | | | | 190,786 | | | $ | 2 | | | | — | | | $ | — | | | | — | | | | — | | | | 568 | | | $ | — | | | $ | 83,158 | | | $ | (721 | ) | | $ | (82,550 | ) | | $ | (113 | ) |
Issuance of Series C Convertible Preferred Stock, net | | | — | | | | — | | | | — | | | | — | | | | 50,000 | | | | 1,160 | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | |
Deemed dividend of 5% and accretion of Series C Convertible Preferred Stock to redemption value | | | — | | | | — | | | | — | | | | — | | | | — | | | | 167 | | | | — | | | | — | | | | — | | | | — | | | | (167 | ) | | | — | | | | — | | | | (167 | ) |
Round up of common shares issued as a result of 1-for-35 and 1-for-40 reverse stock splits | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 15 | | | | — | | | | — | | | | — | | | | — | | | | — | |
Conversion of Preferred Stock into common stock, net | | | (3,838 | ) | | | (565 | ) | | | — | | | | — | | | | — | | | | — | | | | | | | | | | | | 902 | | | | — | | | | 565 | | | | — | | | | — | | | | 565 | |
Redemption of Series B Preferred Stock | | | | | | | | | | | (190,786 | ) | | | (2 | ) | | | | | | | | | | | — | | | | — | | | | — | | | | — | | | | 2 | | | | — | | | | — | | | | 2 | |
Stock based compensation (recoveries) | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | (121 | ) | | | — | | | | — | | | | (121 | ) |
Currency translation adjustment | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 84 | | | | — | | | | 84 | |
Loss for the period | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | (3,352 | ) | | | (3,352 | ) |
Balance, March 31, 2023 | | | 9,748 | | | $ | 1,436 | | | | — | | | $ | — | | | | 50,000 | | | $ | 1,327 | | | | — | | | $ | — | | | | 1,485 | | | $ | — | | | $ | 83,437 | | | $ | (637 | ) | | $ | (85,902 | ) | | $ | (3,102 | ) |
| | Series A Preferred Stock | | | Series C Convertible Preferred Stock | | | Series A Preferred Stock | | | Common Stock | | | Additional Paid in | | | Accumulated Other Comprehensive | | | Accumulated | | | Total Stockholders’ Equity | |
| | Number | | | Value | | | Number | | | Value | | | Number | | | Value | | | Number | | | Value | | | Capital | | | Loss | | | Deficit | | | (Deficit) | |
Issuance of common stock, net, April 2023 Financing | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 12,500 | | | | — | | | | 6,815 | | | | — | | | | — | | | | 6,815 | |
Round up of common shares issued as a result of 1-for-40 reverse stock split | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 33 | | | | — | | | | — | | | | — | | | | — | | | | — | |
Fair value of April Warrants allocated to liabilities, net of financing costs | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | (3,772 | ) | | | — | | | | — | | | | (3,772 | ) |
Conversion of Series A Preferred Stock into common stock | | | (5,509 | ) | | | (812 | ) | | | — | | | | — | | | | (2,705 | ) | | | (2,522 | ) | | | 11,210 | | | | — | | | | 3,334 | | | | — | | | | — | | | | 812 | |
Deemed dividends on Series C Preferred Stock | | | — | | | | — | | | | — | | | | 119 | | | | — | | | | — | | | | — | | | | — | | | | (119 | ) | | | — | | | | — | | | | (119 | ) |
Elimination of Series A redemption rights | | | (4,239 | ) | | | (624 | ) | | | | | | | | | | | 4,239 | | | | 3,952 | | | | — | | | | — | | | | (3,328 | ) | | | — | | | | — | | | | 624 | |
Issuance of Series A Preferred Stock as repayment of debt | | | — | | | | — | | | | — | | | | — | | | | 486 | | | | 453 | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 453 | |
Redemption of Series A Preferred Stock for cancellation of debt | | | — | | | | — | | | | — | | | | — | | | | (1,550 | ) | | | (1,445 | ) | | | — | | | | — | | | | (207 | ) | | | — | | | | — | | | | (1,652 | ) |
Exchange of Series C Preferred stock for Series A Preferred stock | | | — | | | | — | | | | (50,000 | ) | | | (1,446 | ) | | | 5,577 | | | | 5,199 | | | | — | | | | — | | | | (3,752 | ) | | | — | | | | — | | | | 1,447 | |
Stock based compensation | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | 180 | | | | — | | | | — | | | | 180 | |
Currency translation adjustment | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | (29 | ) | | | — | | | | (29 | ) |
Loss for the period | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | | | (2,380 | ) | | | (2,380 | ) |
Balance, June 30, 2023 | | | — | | | $ | — | | | | — | | | $ | — | | | | 6,047 | | | $ | 5,637 | | | | 25,228 | | | $ | — | | | $ | 82,588 | | | $ | (666 | ) | | $ | (88,282 | ) | | $ | (723 | ) |
See
accompanying notes to condensed consolidated financial statements.
| |
Series A
Convertible Preferred Stock | | |
Common Stock | | |
Additional
Paid in | | |
Accumulated
Other Comprehensive | | |
Accumulated | | |
Total
Stockholders’ Equity | |
| |
Number | | |
Value, net | | |
Number | | |
Value | | |
Capital | | |
Loss | | |
Deficit | | |
(Deficit) | |
Balance,
December 31, 2023 | |
| 1,417 | | |
$ | 1,742 | | |
| 294,390 | | |
$ | — | | |
$ | 90,369 | | |
$ | (411 | ) | |
$ | (94,451 | ) | |
$ | (2,751 | ) |
Conversion
of preferred stock into common stock, net | |
| (202 | ) | |
| (269 | ) | |
| 27,092 | | |
| — | | |
| 269 | | |
| — | | |
| — | | |
| — | |
Extinguishment
of preferred stock | |
| — | | |
| (191 | ) | |
| | | |
| — | | |
| 191 | | |
| — | | |
| — | | |
| — | |
Deemed
dividend on preferred stock | |
| — | | |
| 228 | | |
| | | |
| — | | |
| (228 | ) | |
| — | | |
| — | | |
| — | |
Shares
issued for compensation | |
| — | | |
| — | | |
| 14,500 | | |
| — | | |
| 90 | | |
| — | | |
| — | | |
| 90 | |
Sale
of common shares, net | |
| — | | |
| — | | |
| 6,792 | | |
| — | | |
| 40 | | |
| — | | |
| — | | |
| 40 | |
Stock
based compensation (recoveries) | |
| — | | |
| — | | |
| — | | |
| — | | |
| (32 | ) | |
| — | | |
| — | | |
| (32 | ) |
Currency
translation adjustment | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 25 | | |
| | | |
| 25 | |
Loss
for the period | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (3,843 | ) | |
| (3,843 | ) |
Balance,
March 31, 2024 | |
| 1,215 | | |
$ | 1,510 | | |
| 342,774 | | |
$ | — | | |
$ | 90,699 | | |
$ | (386 | ) | |
$ | (98,294 | ) | |
$ | (6,471 | ) |
Conversion
of preferred stock into common stock, net | |
| (1,215 | ) | |
| (1,550 | ) | |
| 452,131 | | |
| — | | |
| 1,550 | | |
| — | | |
| — | | |
| — | |
Extinguishment
of preferred stock | |
| — | | |
| (31 | ) | |
| — | | |
| — | | |
| 31 | | |
| — | | |
| — | | |
| — | |
Deemed
dividend on preferred stock | |
| — | | |
| 71 | | |
| — | | |
| — | | |
| (71 | ) | |
| — | | |
| — | | |
| — | |
Cashless
exercise of 3i Exchange Warrants | |
| — | | |
| — | | |
| 2,359,650 | | |
| — | | |
| 405 | | |
| — | | |
| — | | |
| 405 | |
Sale
of common shares, net | |
| — | | |
| — | | |
| 31,884,641 | | |
| 3 | | |
| 27,649 | | |
| — | | |
| — | | |
| 27,652 | |
Stock
based compensation (recoveries) | |
| — | | |
| — | | |
| — | | |
| — | | |
| 22 | | |
| — | | |
| — | | |
| 22 | |
Currency
translation adjustment | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (144 | ) | |
| — | | |
| (144 | ) |
Loss
for the period | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,629 | ) | |
| (1,629 | ) |
Balance,
June 30, 2024 | |
| — | | |
$ | — | | |
| 35,039,196 | | |
$ | 3 | | |
$ | 120,285 | | |
$ | (530 | ) | |
$ | (99,923 | ) | |
$ | 19,835 | |
See
accompanying notes to condensed consolidated financial statements.
ALLARITY
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(U.S.
dollars in thousands)
| |
Six months ended June 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | |
| |
Net loss for the period | |
$ | (5,472 | ) | |
$ | (5,732 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 3 | | |
| 19 | |
Stock-based compensation (recoveries) | |
| (10 | ) | |
| 59 | |
Unrealized foreign exchange (gains) losses | |
| 23 | | |
| (59 | ) |
Non-cash financing cost | |
| — | | |
| 376 | |
Non-cash interest | |
| 116 | | |
| 200 | |
Change in fair value of warrant and derivative liabilities | |
| (2,662 | ) | |
| (2,250 | ) |
Deferred income taxes | |
| (14 | ) | |
| — | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Other current assets | |
| 78 | | |
| (26 | ) |
Tax credit receivable | |
| (764 | ) | |
| (762 | ) |
Prepaid expenses | |
| 415 | | |
| 371 | |
Accounts payable | |
| (573 | ) | |
| 1,838 | |
Accrued liabilities | |
| 159 | | |
| 282 | |
Income taxes payable | |
| (2 | ) | |
| (5 | ) |
Operating lease liability | |
| — | | |
| (8 | ) |
Net cash used in operating activities | |
| (8,703 | ) | |
| (5,697 | ) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from ATM sales of common stock, net of issuance costs | |
| 27,689 | | |
| — | |
Net proceeds from sale of common stock and pre-funded warrant issuance | |
| — | | |
| 6,815 | |
Proceeds from Series C Convertible Preferred Stock issuance, net of costs | |
| — | | |
| 1,160 | |
Redemption of Series B Preferred Stock | |
| — | | |
| (2 | ) |
Proceeds from 3i promissory notes | |
| 1,340 | | |
| 1,050 | |
Repayment of 3i debt and promissory notes | |
| (1,340 | ) | |
| (3,348 | ) |
Redemption of Series A Preferred Stock | |
| — | | |
| (1,652 | ) |
Net cash provided by financing activities | |
| 27,689 | | |
| 4,023 | |
Net increase (decrease) in cash | |
| 18,986 | | |
| (1,674 | ) |
Effect of exchange rate changes on cash | |
| 81 | | |
| 65 | |
Cash and cash equivalents, beginning of period | |
| 166 | | |
| 2,029 | |
Cash and cash equivalents, end of period | |
$ | 19,233 | | |
$ | 420 | |
Supplemental information | |
| | | |
| | |
Cash paid for income taxes | |
| — | | |
| 6 | |
Cash paid for interest | |
| 408 | | |
| 79 | |
Supplemental disclosure of non-cash investing and financing activities: | |
| | | |
| | |
Conversion of Series A Redeemable Preferred Stock | |
| 1,819 | | |
| 3,334 | |
Deemed dividend on Series A Preferred Stock | |
| (299 | ) | |
| (207 | ) |
Gain on extinguishment of Series A Preferred Stock | |
| 222 | | |
| — | |
Stock issued in conjunction with consulting agreement | |
| 90 | | |
| — | |
Issuance of 2,359,650 common shares on conversion of 3,632,366 3i Exchange Warrants | |
| 405 | | |
| — | |
Issuance of 5,577 Series A Preferred Stock in exchange for Series C Preferred Stock | |
| — | | |
| 5,199 | |
Issuance of Series A Preferred Stock to extinguish $350 3i Promissory Note | |
| — | | |
| 453 | |
Deemed dividend on elimination of Series A redemption rights | |
| — | | |
| (3,328 | ) |
Deemed dividend on exchange of Series C Preferred Stock for Series A Preferred Stock | |
| — | | |
| (3,752 | ) |
Deemed dividend on Series C Convertible Preferred Stock, and accretion of Series C Preferred Stock to redemption value | |
| — | | |
| (123 | ) |
See
accompanying notes to condensed consolidated financial statements.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the six months ended June 30, 2024 and June 30, 2023
(UNAUDITED)
(U.S.
dollars in thousands, except for share and per share data and where otherwise noted)
1.
Organization, Principal Activities and Basis of Presentation
Allarity
Therapeutics, Inc. and Subsidiaries (the “Company”) is a clinical stage pharmaceutical company that develops drugs for the
personalized treatment of cancer using drug specific companion diagnostics generated by its proprietary drug response predictor technology,
DRP®. Additionally, the Company, through its Danish subsidiary, Allarity Denmark (previously Oncology Venture ApS), specializes
in the research and development of anti-cancer drugs.
The
Company’s principal operations are located at Venlighedsvej 1, 2970 Horsholm, Denmark. The Company’s business address in
the Unites States is located at 24 School Street, 2nd Floor, Boston, MA 02108.
(a)
Reverse Stock Split
On
April 9, 2024, the Company effected a 1-for-20 reverse stock split of the shares of its Common Stock (the “Reverse Stock Split”).
All historical share and per share amounts reflected throughout the Financial Statements (as defined below in 1(b)) and these notes to
the financial statements have been adjusted to reflect the Reverse Stock Split. See Note 9 (a).
(b)
Liquidity
The
accompanying unaudited condensed interim consolidated financial statements (the “Financial Statements”) have been prepared
on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course
of business.
Pursuant
to the requirements of Accounting Standard Codification (ASC) 205-40, Disclosure of Uncertainties about an Entity’s Ability to
Continue as a Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise
substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited
interim condensed consolidated financial statements were issued.
As
a biopharmaceutical organization, the Company has devoted substantially all of its resources since inception to research and development
activities for its Drug Response Predictor “DRP” in conjunction with product candidates, business planning, raising capital,
establishing its intellectual property portfolio, acquiring or discovering product candidates, and providing general and administrative
support for these operations. As a result, the Company has incurred significant operating losses and negative cash flows from operations
since its inception and anticipates such losses and negative cash flows will continue for the foreseeable future.
Since inception the Company has
funded its operations primarily from sales of its stock. The Company has incurred significant losses and has an accumulated deficit of
$99.9 million as of June 30, 2024. To date the Company has not generated any significant revenues and expects to continue to generate
operating losses for the foreseeable future. As of the issuance date of these unaudited interim condensed consolidated financial
statements, the Company expects that its existing cash and cash equivalents of $19.2 million as of June 30, 2024, will be sufficient
to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the issuance date of these condensed
consolidated financial statements.
While
the Company believes its capital resources are sufficient to fund the Company’s on-going operations for the next 12 months from
the issuance date of these unaudited condensed consolidated financial statements, the Company’s liquidity could be materially affected
over this period by: (1) its ability to raise additional capital through equity offerings, debt financings, or other non-dilutive third-party
funding; (2) costs associated with new or existing strategic alliances, or licensing and collaboration arrangements; (3) negative regulatory
events or unanticipated costs related to the DRP; (4) any other unanticipated material negative events or costs. One or more of these
events or costs could materially affect the Company’s liquidity. If the Company is unable to meet its obligations when they become
due, the Company may have to delay expenditures, reduce the scope of its research and development programs, or make significant changes
to its operating plan. The accompanying unaudited interim condensed consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
(c)
Basis of Presentation
The
unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted
in the United States of America (“U.S. GAAP”) as established by the Financial Accounting Standards Board (the “FASB”)
for interim financial information and the rules and regulations of the Securities and Exchange Commission (the “SEC”).
The
unaudited interim condensed consolidated financial statements contain all normal and recurring adjustments necessary to state fairly
the consolidated balance sheet, results of operations and comprehensive loss, statements of changes in redeemable convertible preferred
stock and stockholders’ equity (deficit), and cash flows of the Company for the interim periods presented. Except as otherwise
disclosed, all such adjustments consist only of those of a normal recurring nature. Operating results for the three and six months ended
June 30, 2024, are not necessarily indicative of the results that may be expected for the current fiscal year ending December 31, 2024.
The financial data presented herein do not include all disclosures required by U.S. GAAP and should be read in conjunction with the audited
consolidated financial statements and accompanying notes as of and for the fiscal years ended December 31, 2023 and 2022, thereto included
in the Company’s Annual Report on Form 10-K, as amended (the “Form 10-K”) initially filed with the SEC on March 8,
2024.
The
preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amount of assets and disclosure of contingent assets and liabilities at the date of
the unaudited interim condensed consolidated financial statements and the reported amounts of revenue and expenses during the reported
period. Actual results could differ from these estimates and assumptions.
(d)
Risks and Uncertainties
The
Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical
studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the
need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration
partners, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations,
and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant
additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization.
Even if the Company’s research and development efforts are successful, it is uncertain when, if ever, the Company will realize
significant revenue from product sales.
2. Summary
of Significant Accounting Policies
There
have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2023, that are of significance, or potential significance, to the Company.
(a)
Organization and Principles of Consolidation
The
financial statements include the accounts of the Company and its wholly owned subsidiaries:
Name | | Country of Incorporation |
Allarity Acquisition Subsidiary Inc. | | United States |
Allarity Therapeutics Europe ApS (formerly Oncology Venture Product Development ApS)* | | Denmark |
Allarity Therapeutics Denmark ApS (formerly OV-SPV2 ApS)* | | Denmark |
MPI Inc.*(1) | | United States |
All
intercompany transactions and balances, including unrealized profits from intercompany sales, have been eliminated upon consolidation.
(b)
Foreign currency and currency translation
The
functional currency is the currency of the primary economic environment in which an entity’s operations are conducted. The Company
and its subsidiaries operate mainly in Denmark and the United States. The functional currencies of the Company’s subsidiaries
are their local currency.
The
Company’s reporting currency is the U.S. dollar. The Company translates the assets and liabilities of its Denmark subsidiaries
into the U.S. dollar at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange
rate in effect during each monthly period. Unrealized translation gains and losses are recorded as a cumulative translation adjustment,
which is included in the condensed consolidated statements of changes in stockholders’ equity (deficit) as a component of accumulated
other comprehensive loss.
Monetary
assets and liabilities denominated in currencies other than the functional currency are remeasured into the functional currency at rates
of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are re-measured
into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign
currency transactions are included in the determination of net loss for the respective periods. Adjustments that arise from exchange
rate translations are included in other comprehensive loss in the condensed consolidated statements of operations and comprehensive loss
as incurred.
Adjustments
that arise from exchange rate translations are included in other comprehensive loss in the consolidated statements of operations and
comprehensive loss as incurred. During the three months ended June 30, 2024 and 2023, the Company recorded accumulated foreign currency
translation losses of ($144) and ($29), respectively. During the six months ended June 30, 2024 and 2023, the Company recorded accumulated
foreign currency translation gains / (losses) of ($119) and $55, respectively.
(c)
Concentrations of credit risk and of significant suppliers
Financial
instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The
Company maintains its cash and cash equivalents in financial institutions in amounts that could exceed government-insured limits. The
Company does not believe it is subject to additional credit risks beyond those normally associated with commercial banking relationships.
The Company has not experienced losses on its cash and cash equivalents accounts and management believes, based upon the quality of the
financial institutions, that the credit risk regarding these deposits is not significant. The Company is dependent on third-party
manufacturers to supply products for research and development activities in its programs. In particular, the Company relies and expects
to continue to rely on a small number of manufacturers to supply its requirements for supplies and raw materials related to these programs.
These programs could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials.
(d)
Cash and cash equivalents
The
Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. The Company
maintains deposits primarily in financial institutions, which may at times exceed amounts covered by insurance provided by the U.S. Federal
Deposit Insurance Corporation (“FDIC”). The Company has not experienced any losses related to amounts in excess of FDIC limits.
(e)
Accumulated other comprehensive loss
Accumulated
other comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions
and economic events other than those with shareholders. The Company records unrealized gains and losses related to foreign currency translation
and instrument specific credit risk as components of other accumulated comprehensive loss in the condensed consolidated statements of
operations and comprehensive loss. During the three and six months ended June 30, 2024, and 2023, the Company’s other comprehensive
gain was comprised of currency translation adjustments.
(g)
Reclassification
During
the six months ended June 30, 2023, we have reclassified financing costs of $9 from other income and expenses to general and administrative
expenses with no net impact upon our operating results or cash flows for either the current or prior periods.
(h)
Recently Issued Accounting Pronouncements
Changes
to U.S. GAAP are established by the FASB in the form of accounting standards updates (“ASUs”) to the FASB’s Accounting
Standards Codification. The Company considers the applicability and impact of all ASUs. All ASUs issued through the date of the Financial
Statements were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s condensed
consolidated financial position and results of operations.
3.
Intangible assets
During
the six months ended June 30, 2024, because no impairment indicators were identified no impairment analysis was performed at June 30,
2024.
The
Company’s IPR&D assets have been classified as indefinite-lived intangible assets. The Company’s individual material
development project in progress, Stenoparib, is recorded at $9,557 and $9,871 on June 30, 2024, and December 31, 2023, respectively.
4.
Accrued liabilities
The
Company’s accrued liabilities are comprised of the following:
| |
June 30, 2024 | | |
December 31, 2023 | |
Development cost liability | |
$ | 214 | | |
$ | 114 | |
Accrued interest on milestone liabilities | |
| 192 | | |
| 101 | |
Accrued audit and legal | |
| 660 | | |
| 425 | |
Payroll accruals | |
| 298 | | |
| 398 | |
Accrued consulting fees | |
| — | | |
| 150 | |
Other | |
| 101 | | |
| 121 | |
| |
$ | 1,465 | | |
$ | 1,309 | |
5.
Convertible promissory note due to Novartis
On
January 26, 2024, we received a termination notice from Novartis Pharma AG, a company organized under the laws of Switzerland (“Novartis”)
due to a material breach of that certain license agreement dated April 6, 2018, as amended to date (the “License Agreement”).
Accordingly, under the terms of the License Agreement, the Company ceased all development and commercialization activities with respect
to all licensed products, all rights and licenses granted by Novartis to the Company reverted to Novartis; and all liabilities due to
Novartis became immediately due and payable inclusive of interest which is continuing to accrue at 5% per annum. As of June 30, 2024,
the liability is recorded as a current liability on the Company’s condensed unaudited consolidated balance sheets as follows: $3,600
in accounts payable, $1,325 convertible promissory notes and accrued interest, net of debt discount, and $192 in accrued liabilities.
6.
Convertible senior promissory notes due to 3i, LP (3i”)
(a) |
3i Convertible Senior
Promissory Notes (2024) (collectively the “2024 Notes”) |
During
the three months ended March 31, 2024, the Company entered into a Securities Purchase Agreement (the “SPA”), as amended,
with 3i, pursuant to which three senior convertible promissory notes were issued as follows:
| i. | On January 18, 2024, in an aggregate principal amount of $440 due on January 18, 2025, and with a set conversion price of $8.95 per share, for an aggregate purchase price of $400, representing an approximate 10% original issue discount (the “First Note”). |
| ii. | On February 13, 2024, in an aggregate principal amount of $440 due on February 13, 2025, and with a set conversion price of $8.10 per share, for an aggregate purchase price of $400, representing an approximately 10% original issue discount (the “Second Note”). |
| iii. | On March 14, 2024, in an aggregate principal amount of $660 due on March 14, 2025, and with a set conversion price of $7.00 per share, for an aggregate purchase price of $600, representing an approximately 10% original issue discount (the “Third Note”). |
The
Company agreed to use the net proceeds from the sale of the 2024 Notes, among other things, for accounts payable and for working capital
purposes. Unless the transaction documents state otherwise, the Company may not prepay any portion of the principal amount of the 2024
Notes without 3i’s prior written consent.
The
Company agreed to pay interest to 3i on the aggregate unconverted and then outstanding principal amount of the 2024 Notes at the rate
of 8% per annum with interest payments commencing one month after the initial receipt of net proceeds. The interest on each of the 2024
Notes is payable in cash or, at the 3i’s option, in shares of our Common Stock, at 90% of the lowest VWAP during the previous ten
trading days that is immediately prior to the interest payment dates. Under the terms of the 2024 Notes, 3i has the exclusive right to
choose whether to receive interest payments in cash or as shares of our Common Stock.
Redemption
Subject
to the provisions of the 2024 Notes, if, at any time while the 2024 Notes are outstanding, the Company engages in one or more subsequent
financings, 3i may require us to first use up to 100% of the gross proceeds of such financing to redeem all or a portion of the 2024
Notes at 105%. However, if the Company were to raise capital in the ATM Offering, 3i may request up to 20% of the proceeds to redeem
the Series A Convertible Preferred Stock (the “Series A Preferred Stock”) at the stated value.
The
2024 Notes and accrued interest were redeemed in full and cancelled on May 6, 2024.
(b) |
3i Convertible Secured
Promissory Notes (2023) |
On
November 22, 2022, the Company entered into a Secured Note Purchase Agreement (“Purchase Agreement”) with 3i, whereby the
Company authorized the sale and issuance of three Secured Promissory Notes (each a “Note” and collectively, the “Notes”).
Effective November 28, 2022, the Company issued: (1) a Note in the principal amount of $1,667 as payment of $1,667 due to 3i in Alternative
Conversion Floor Amounts (as defined in the Notes) that began to accrue on July 14, 2022; and (2) a Note in the principal amount of $350
in exchange for cash. Effective December 30, 2022, the Company issued an additional Note in the principal amount of $650 in exchange
for cash.
Each
Note matured on January 1, 2024, carried an interest rate of 5% per annum, and was secured by all of the Company’s assets pursuant
to a security agreement (the “Security Agreement”). In addition, the Holder may exchange the Notes for the Company’s
shares of Common Stock at an exchange price equal to the lowest price per share of the equity security sold to other purchasers, rounded
down to the nearest whole share, if the Company concludes a future equity financing prior to the maturity date or other repayment of
such promissory note. Lastly, each Note and interest earned thereon may be redeemed by the Company at its option at any time or the holder
may demand redemption if a) the Company obtains gross proceeds of at least $5 million in a financing in an amount of up to 35% of the
gross proceeds of the financing or b) there is an Event of Default (as defined in the Note agreement). Discounts to the principal amounts
are included in the carrying value of the Notes and amortized to interest expense over the contractual term of the underlying debt. The
Company recorded a $34 debt discount upon issuance of the Notes related to legal fees paid that were capitalized as debt issuance costs.
For the six months ended June 30, 2023, interest expense totaled $43, comprised of $33 for contractual interest and $10 for the amortization
of the debt discount.
The
3i Convertible Secured Promissory Notes were paid in full and cancelled on April 21, 2023.
7.
Preferred Stock
A. |
Series A Convertible Preferred Stock and Common
Stock Purchase Warrants |
(a)
Amendments to Series A Convertible Preferred Stock
|
i. |
Determination of Conversion
Price Adjustments for Series A Preferred Stock |
On
December 9, 2022, the Company and 3i entered into a letter agreement (the “2022 Letter Agreement”) which provided that pursuant
to Section 8(g) of the Company’s Certificate of Designations for the Series A Preferred Stock (the “COD”), the Company
and 3i agreed that the Conversion Price (as defined in the COD) was modified to mean the lower of: (i) the Closing Sale Price (as defined
in the COD) on the trading date immediately preceding the Conversion Date (as defined in the COD) and (ii) the average Closing Sale Price
(as defined in the COD) of the common stock for the five trading days immediately preceding the Conversion Date (as defined in the COD),
for the Trading Days (as defined in the COD) through and inclusive of January 19, 2023. Any conversion which occurs shall be voluntary
at the election of 3i, which shall evidence its election as to the Series A Preferred Stock being converted in writing on a conversion
notice setting forth the then Minimum Price (as defined in the COD). Management determined that the adjustment made to the Conversion
Price is not a modification of the COD which allows for adjustments to the Conversion Price (as defined in the COD) at any time by the
Company and the other terms of the COD remained unchanged.
On
January 23, 2023, the Company and 3i amended the 2022 Letter Agreement, to provide that the modification of the term Series A Preferred
Stock Conversion Price (the “Series A Preferred Stock Conversion Price”) to mean the lower of: (i) the Closing Sale Price
(as defined in the COD) on the trading date immediately preceding the Conversion Date (as defined in the COD and (ii) the average Closing
Sale Price (as defined in the COD) of the Company’s shares of Common Stock for the five trading days immediately preceding the
Conversion Date (as defined in the COD), for the Trading Days (as defined in the COD) will be in effect until terminated by the Company
and 3i.
|
ii. |
Modification
to Conversion Price of Series A Preferred Stock and 3i Exchange Warrants |
On
January 14, 2024, pursuant to the terms of the First Note, the Company modified the conversion price of the 3i Exchange Warrants from
$20.00 to $8.95, thereby increasing the number of Exchange Warrants outstanding from 220,361 at December 31, 2023 to 492,317 outstanding
at January 14, 2024. Also on January 14, 2024, the conversion price of the outstanding 1,417 shares of Series A Preferred Stock
was revised from $20.00 to $8.95. The Company filed the Fifth Certificate of Amendment to Amended and Restated COD (the “Fifth
Amendment”) with the Secretary of State of the State of Delaware to reflect the new conversion price of the Series A Preferred
Stock of $8.95. As of January 14, 2024, the Company used the Black-Scholes option pricing model to determine the fair value of the 1,417
Series A Preferred Stock outstanding at $1,970 versus their carrying value of $1,742. Accordingly, the Company has recorded a deemed
dividend of $228 as at January 14, 2024. At a stated value of $1,080 for each share of Series A Preferred Stock, the revised price of
$8.95 per share results in the 1,417 shares being convertible into 170,952 shares of Common Stock as of January 14, 2024.
On
February 13, 2024, pursuant to the terms of the Second Note, the Company modified the conversion price of the 3i Exchange Warrants from
$8.95 to $8.10 and thereby increased the number of Exchange Warrants outstanding from 492,317 on January 18, 2024, to 544,101 on February
13, 2024. The Company filed the Sixth Certificate of Amendment to Amended and Restated COD (the “Sixth Amendment”) with the
Secretary of State of the State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $8.10. As of February
14, 2024, the Company used the Black-Scholes option pricing model to determine the fair value of the then 1,296 Series A Preferred Stock
outstanding and concluded there was a gain on extinguishment of $122. At a stated value of $1,080 for each share of Series A Preferred
Stock, the revised price of $8.10 per share results in the 1,296 shares being convertible into 493,573 shares of Common Stock.
On
March 14, 2024, pursuant to the terms of the Third Note, the Company modified the conversion price of the 3i Exchange Warrants from $8.10
to $7.00 and thereby increased the number of Exchange Warrants outstanding from 544,101 on February 13, 2024, to 829,423 on March 14,
2024. The Company filed the Seventh Certificate of Amendment to Amended and Restated COD (the “Seventh Amendment”) with the
Secretary of State of the State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $7.00. As of March
14, 2024, the Company used the Black-Scholes option pricing model to determine the fair value of the then 1,296 Series A Preferred Stock
outstanding and concluded there was a gain on extinguishment of $69. At a stated value of $1,080 for each share of Series A Preferred
Stock, the revised price of $7.00 per share results in the 1,215 shares being convertible into 535,286 shares of Common Stock.
During
the period April 1, 2024, through May 2, 2024, the Company amended the conversion prices of the Series A Convertible Preferred Stock,
the Exchange Warrants and the 2024 Notes to equal the current last sale price of its shares of Common Stock of $1.15 as of May 1, 2024.
(b) Accounting
|
i. |
Series A Preferred Stock |
As
a result of fair value adjustments during the six-month period ended June 30, 2024, the Company recognized a deemed dividend of $299
and an extinguishment gain of $222 on our outstanding Series A Preferred Stock. Inputs used in the Black-Scholes valuation models utilized
to fair value the modifications to the Series A Preferred Stock during the six-month period ended June 30, 2024, are as follows:
| |
January 14 – March 14, 2024 | |
April 5 – May 2, 2024 |
Initial exercise price | |
$20.00 - $8.10 | |
$7.00 - $1.15 |
Stock price on valuation date | |
$8.95 - $7.10 | |
$4.52 - $1.23 |
Risk-free rate | |
5.10% - 4.82% | |
5.47% - 5.49% |
Term (in years) | |
0.25 – 0.08 | |
0.08 – 0.01 |
Rounded annual volatility | |
145% - 130% | |
110% |
|
iii. |
3i Exchange Warrants |
The
3i Exchange Warrants were identified as a freestanding financial instrument and meet the criteria for derivative liability classification,
initially measured at fair value. Subsequent changes in fair value are recognized through earnings for as long as the contracts continue
to be classified as a liability. The measurement of fair value is determined utilizing an appropriate valuation model considering all
relevant assumptions current at the date of issuance and at each reporting period (i.e., share price, exercise price, term, volatility,
risk-free rate and expected dividend rate).
(c)
Series A Preferred Stock and 3i Exchange Warrant Conversions
|
i. |
Six month period ended June 30, 2024 |
During
the six-month period ended June 30, 2024:
| (a) | 3i
exercised its option to convert 1,417 shares of Series A Preferred Stock for 479,223 shares of common stock at the fair value of $1,819.
As of June 30, 2024, there were no issued and outstanding shares of Series A Preferred Stock; and |
| (b) | 3i exercised its option to convert 3,632,366 3i Exchange Warrants
for 2,359,650 shares of common stock valued at $405. As of June 30, 2024, there were no issued and outstanding 3i Exchange Warrants. |
|
i. |
Six month period ended June 30, 2023 |
During
the six-month period ended June 30, 2023, 3i exercised its option to convert 12,052 shares of Series A Preferred stock for 202,002 shares
of common stock valued at $3,899. As of June 30, 2023, there were 6,047 issued and outstanding shares of Series A Preferred Stock.
The
accounting for the Series A Preferred Stock and Warrants is illustrated in the tables below:
| |
| Consolidated
Balance Sheets | | |
| Consolidated
Statement of
Operations &
Comprehensive
Loss | |
| |
| Warrant
Derivative
liability | | |
| Series
A
Preferred
Stock | | |
| Common
Stock | | |
| Additional
paid-in
capital | | |
| Fair
value
adjustment to
derivative and warrant
liabilities | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, December
31, 2023 | |
$ | 3,083 | | |
$ | 1,742 | | |
$ | — | | |
$ | (7,208 | ) | |
$ | — | |
Conversion of 202 Series A Preferred Stock, net | |
| — | | |
| (269 | ) | |
| — | | |
| 269 | | |
| — | |
Extinguishment
of Series A Preferred Stock | |
| | | |
| (191 | ) | |
| | | |
| 191 | | |
| | |
Deemed
dividend on January 14, 2024, modification | |
| — | | |
| 228 | | |
| — | | |
| (228 | ) | |
| — | |
Fair
value adjustment | |
| (419 | ) | |
| — | | |
| — | | |
| — | | |
| 419 | |
Balances, March 31, 2024 | |
| 2,664 | | |
| 1,510 | | |
| — | | |
| (6,976 | ) | |
| 419 | |
Conversion of 1,215 Series A Preferred Stock, net | |
| — | | |
| (1,550 | ) | |
| — | | |
| 1,550 | | |
| — | |
Extinguishment
of Series A Preferred Stock | |
| — | | |
| (31 | ) | |
| — | | |
| 31 | | |
| — | |
Deemed
dividend on modification of Series A Preferred Stock | |
| — | | |
| 71 | | |
| — | | |
| (71 | ) | |
| — | |
Cashless exercise of 3i
Exchange Warrants | |
| (405 | ) | |
| — | | |
| — | | |
| 405 | | |
| — | |
Fair
value adjustment | |
| (2,243 | ) | |
| — | | |
| — | | |
| — | | |
| 2,243 | |
Balances,
June 30, 2024 | |
$ | 16 | | |
$ | — | | |
$ | — | | |
$ | (5,061 | ) | |
$ | 2,662 | |
| |
| Consolidated
Balance Sheets | | |
| Consolidated
Statement of
Operations &
Comprehensive
Loss | |
| |
| Warrant
liability | | |
| Series
A
Convertible Preferred
Stock –
Mezzanine
Equity | | |
| Series A
Preferred
Stock | | |
| Additional
paid-in
capital | | |
| Fair
value
adjustment to
derivative and warrant
liabilities | |
Balances, December
31, 2022 | |
$ | 374 | | |
$ | 2,001 | | |
$ | — | | |
$ | (3,756 | ) | |
$ | — | |
Conversion of 3,838 Series A Preferred Stock, net | |
| — | | |
| (565 | ) | |
| — | | |
| 575 | | |
| — | |
Fair
value adjustment | |
| (309 | ) | |
| — | | |
| — | | |
| — | | |
| 309 | |
Balances, March 31, 2023 | |
| 65 | | |
| 1,436 | | |
| — | | |
| (3,181 | ) | |
| 309 | |
Conversion of 8,214 Series A Preferred Stock | |
| — | | |
| (812 | ) | |
| (2,522 | ) | |
| 3,334 | | |
| — | |
Elimination of redemption rights on Series A Preferred stock; deemed dividend of $3,328 | |
| — | | |
| (624 | ) | |
| 3,952 | | |
| (3,328 | ) | |
| — | |
Redemption of 1,550 Series A Preferred Stock | |
| — | | |
| — | | |
| (1,445 | ) | |
| — | | |
| — | |
Issuance of 486 Series A Preferred stock as repayment of $350 debt; $103 charged to interest expense | |
| — | | |
| — | | |
| 453 | | |
| — | | |
| — | |
Exchange of 50,000 Series C Preferred Stock for 5,577 Series A Preferred Stock; deemed dividend of $3,959 | |
| — | | |
| — | | |
| 5,199 | | |
| (3,959 | ) | |
| — | |
Fair
value adjustment | |
| 1,078 | | |
| — | | |
| — | | |
| — | | |
| (1,078 | ) |
Balances,
June 30, 2023 | |
$ | 1,143 | | |
$ | — | | |
$ | 5,637 | | |
$ | (7,134 | ) | |
$ | (769 | ) |
B. |
Series C Convertible
Preferred Stock |
On
February 28, 2023, the Company entered into a Securities Purchase Agreement (the “2023 SPA”) with 3i for the purchase and
sale of 50,000 shares of Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”) at a purchase price
of $24.00 per share, for a subscription receivable in the aggregate amount equal to the total purchase price of $1.2 million (the “Series
C Offering”). The 50,000 shares of Series C Preferred Stock (the “Shares”) are convertible into shares of the Company’s
Common Stock, subject to the terms of the Series C Certificate of Designation (“Series C COD”).
The
Company evaluated the terms of the Series C Preferred Stock as required pursuant to ASC 570, 480, 815 and ASU 2020-06, and concluded
the Series C Preferred Stock will be recorded at fair value of $1,200, net of share issuance costs of $40, and accreted to redemption
value of $1,485 on April 21, 2023, using the effective interest method. The Company will also accrue dividends of 5%. The roll forward
of the Series C Preferred Stock as of June 30, 2023, is as follows:
| |
June 30, 2023 | |
Series C Preferred Stock, cash received | |
$ | 1,200 | |
Less debt discount, opening | |
| (40 | ) |
Plus, 5% dividend and accretion | |
| 286 | |
| |
| 1,446 | |
Exchange of Series C Preferred stock for Series A Preferred stock | |
| (1,446 | ) |
Series C Preferred Stock – net, ending balance | |
$ | — | |
8.
Derivative Liabilities
(a) |
Continuity of Common
Share Purchase Warrant and 3i Warrant Derivative Liabilities |
The
Common Share Purchase Warrants, comprised of the April 2023, July 2023 and September 2023 Inducement Warrants, and 3i Exchange Warrant
derivative liabilities are measured at fair value at each reporting period and the reconciliation of changes in fair value for the year
ended December 31, 2023, and for the six-month period ended June 30, 2024, is presented in the following tables:
| |
Common Share Purchase Warrants | | |
3i Exchange Warrants | |
Balance as of January 1, 2023 | |
$ | — | | |
$ | 374 | |
Issuance date fair value of April, July & September 2023 Common share purchase warrants | |
| 15,161 | | |
| — | |
Modifications to fair value upon exercise | |
| 592 | | |
| — | |
Change in fair value adjustment of derivative and warrant liabilities | |
| (11,911 | ) | |
| 1,477 | |
Amount transferred to Equity | |
| (1,579 | ) | |
| (1,031 | ) |
Balance as of December 31, 2023 | |
$ | 2,263 | | |
$ | 820 | |
Fair value per Common warrant / 3i Warrant / issuable at December 31, 2023 | |
$ | 8.82 | | |
$ | 3.80 | |
| |
Common Share Purchase Warrants | | |
3i Exchange Warrants | |
Balance as of January 1, 2024 | |
$ | 2,263 | | |
$ | 820 | |
Change in fair value adjustment of derivative and warrant liabilities | |
| (2,247 | ) | |
| (415 | ) |
Cashless conversion of 3i Exchange Warrants | |
| — | | |
| (405 | ) |
Balance as of June 30, 2024 | |
$ | 16 | | |
$ | — | |
Fair value per Common warrant issuable at June 30, 2024 | |
$ | 0.06 | | |
$ | — | |
(b) |
Common Share Purchase
Warrants – Valuation Inputs |
On
June 30, 2024, the Company used the Black-Scholes Merton model to estimate the fair value of the Common Share Purchase Warrants derivative
liability at $16, using the following inputs:
| |
April 2023 Warrants | | |
July 2023 Warrants | | |
September 2023 Inducement Warrants | |
Initial exercise price | |
$ | 20.00 | | |
$ | 20.00 | | |
$ | 20.00 | |
Stock price on valuation date | |
$ | 0.21 | | |
| 0.221 | | |
| 0.21 | |
Risk-free rate | |
| 4.42 | % | |
| 4.42 | % | |
| 4.42 | % |
Term (in years) | |
| 4.03 | | |
| 4.03 | | |
| 4.73 | |
Rounded annual volatility | |
| 124 | % | |
| 124 | % | |
| 124 | % |
(c) |
3i Exchange Warrants
– Valuation Inputs |
On
June 30, 2023, the Company utilized the reset strike options Type 2 model by Espen Garder Haug and Black-Scholes Merton models to estimate
the fair value of the 3i Warrants to be approximately $1,143 and $374, respectively. The 3i Warrants were valued at June 30, 2023, using
the following inputs:
| | June 30, 2023 | |
Initial exercise price | | $ | 30.00 | |
Stock price on valuation date | | $ | 6.60 | |
Risk-free rate | | | 5.02 | % |
Expected life of the Warrant to convert (years) | | | 1.48 | |
Rounded annual volatility | | | 187 | % |
Timing of liquidity event | | | Q3 - 2023 | |
Expected probability of event | | | 10 | % |
9.
Stockholders’ Equity
(a)
Amendment to Certificate of Incorporation – Reverse Share Split
On
April 4, 2024, the Company filed a Fifth Certificate of Amendment to the Certificate of Incorporation with the Delaware Secretary of
State to effect a 1-for-20 share consolidation of our shares of Common Stock effective as of April 9, 2024 (“Share Consolidation”).
No fractional shares were issued in connection with the Share Consolidation. If, as a result of the Share Consolidation, a stockholder
would otherwise have been entitled to a fractional share, each fractional share was rounded up to the next whole number. The Share Consolidation
resulted in a reduction of our outstanding shares of Common Stock as of March 31, 2024, from 6,854,604 to 342,774. The par value of our
authorized stock remained unchanged at $0.0001. As of the date of the unaudited interim condensed consolidated financial statements all
references to our Common Stock have been retrospectively adjusted to reflect the one for 20 shares, unless otherwise noted. The Company
is authorized to issue 750,500,000 shares, consisting of (i) 750,000,000 shares of Common Stock, par value $0.0001 per share, and (ii)
500,000 shares of Preferred Stock, par value of $0.0001 per share.
(b)
Share issuances
|
i. |
Three month period ended June 30, 2024 |
During
the three month period ended June 30, 2024:
| (a) | On March 19, 2024, the Company entered into an open market sale agreement (as amended, the “ATM Agreement”) with Ascendiant Capital (“Ascendiant”) pursuant to which, the Company may sell from time to time, through Ascendiant, shares of its common stock for an aggregate sales price of up to $30.0 million. Any sales of shares pursuant to this agreement are made under the Company’s effective “shelf” registration statement on Form S-3 that is on file with and has been declared effective by the SEC. During the three month period ended June 30, 2024, the Company issued and sold 31,884,641 shares of Common Stock resulting in gross proceeds of $27,652, net of fees of $855, pursuant to the terms of its ATM Agreement; |
| (b) | 3i exercised its option to convert 1,215 shares of Series A Preferred Stock for 27,092 shares of Common Stock at the fair value of $1,510. As of June 30, 2024, there were no shares of Series A Preferred Stock issued and outstanding; and |
| (c) | 3i converted 200,000 Exchange Warrants on a cashless basis for 84,712 shares of Common Stock at $2.30 per share on April 12, 2024, and 3,432,366 Exchange Warrants at $1.15 per share for 2,274,938 shares of Common Stock on May 2, 2024. As June 30, 2024, there are no outstanding Exchange Warrants. |
|
ii. |
Three month period ended June 30, 2023 |
During
the three months ended June 30, 2023, the Company issued:
(a)
11,210 shares of common stock valued at $3,334 upon the conversion of 8,214 shares of Series A Preferred stock; and
(b)
3,587 shares of our Common Stock and 3,587 common stock purchase warrants, each exercisable for one share of Common Stock, at a combined
public offering price of $600.00, and 8,913 pre-funded warrants, each exercisable for one share of Common Stock, and 8,913 common stock
purchase warrants, each exercisable for one share of common stock only (the common stock purchase warrants sold in the public offing
hereinafter referred to as the “April 2023 Common Warrants”) at a combined public offering price of $600.00 less the $0.001
for the pre-funded warrants, for aggregate gross proceeds of approximately $7.5 million, before deducting placement agents fees and offering
expenses payable by the Company, or the April Offering. The Common Stock, pre-funded warrant and April 2023 Common Warrants were sold
pursuant to a securities purchase agreement with the purchaser signatory thereto or pursuant to the prospectus which was part of an effective
registration statement on Form S-1 filed with the SEC. The Common Stock, pre-funded warrants and April 2023 Common Warrants are immediately
separable and were issued separately in the offering. As of June 30, 2023, all pre-funded warrants from the April Offering have been
exercised in exchange for 12,500 common shares.
|
iii. |
Six month period ended June 30, 2024 |
During
the six months ended June 30, 2024:
| (a) | 3i exercised its option to convert 1,417 shares of Series A Preferred Stock for 479,223 shares of Common Stock at the fair value of $1,819. As of June 30, 2024 there are no remaining Series A Preferred Stock issued and outstanding. |
| (b) | The Company issued 14,500 shares of Common Stock valued at $90 to James G. Cullem (the Company’s former CEO) in exchange for consulting services; and |
| (c) | the Company issued and sold 31,891,433 shares of Common Stock resulting in gross proceeds of $27,692, net of $857 in fees pursuant to the terms of its ATM Agreement. |
|
iv. |
Six month period ended June 30, 2023 |
During the six months ended June 30, 2023, the Company issued 241,893
shares of common stock valued at $3,899 upon the conversion of 12,052 shares of Series A Preferred Stock; and 250,000 shares of Common
Stock as a result of its April Public Offering of 71,734 shares of our Common Stock and the exercise of 178,267 pre-funded warrants.
10.
Stock-based payment plan and stock-based payments
Amended
and Restated 2021 Equity Incentive Plan (the “Plan”)
During
the six months ended June 30, 2024, pursuant to approval by the Company’s Board of Directors, the Company has amended and restated
the Plan as follows:
| i. | Number of shares available: increased the number of shares reserved and available for grant and issuance pursuant to the Plan to 108,416 Shares, plus an amount derived by the difference between 15% of the Company’s issued and outstanding shares of Common Stock issued in the Company’s Recapitalization Share Exchange covered by the Company’s registration statement on Form S-4 (SEC File No. 333-258968) and 108,416 Shares. |
| ii. | Automatic Share Reserve Increase: The number of Shares available for grant and issuance under the Plan will be increased on January 1st of each of 2022 through 2031, by the lesser of (a) 5% of the number of shares of all classes of the Company’s common stock issued and outstanding on each December 31 immediately prior to the date of increase or (b) such number of Shares determined by the Board. |
Stock-based
payments
During
the three months ended June 30, 2024, total stock-based payment expenses recorded in the condensed consolidated statement of operations
and comprehensive loss were $22, of which $14 and $8 are recognized as general and administrative and research and development recoveries,
respectively. During the three months ended June 30, 2023, total stock-based payment expenses recorded in the condensed consolidated
statement of operations and comprehensive loss were $180, of which $59 and $121 are recognized as general and administrative and research
and development recoveries, respectively.
During
the six months ended June 30, 2024, total stock-based (recoveries) recognized in the condensed consolidated statement of operations and
comprehensive loss were ($10), of which ($7) and ($3) are recognized as staffing expenses in general and administrative and research
and development expenses, respectively. During the six months ended June 30, 2023, total stock-based expenses recognized in the condensed
consolidated statement of operations and comprehensive loss were $59 of which $20 and $39 are recognized as staffing expenses in general
and administrative and research and development expenses, respectively.
Total
compensation cost for non-vested warrants as at June 30, 2024, is $14 and is expected to be realized through the end of September 30,
2025. During the six-month periods ended June 30, 2024 and 2023, no options were granted. A summary of stock option activity under
the Company’s stock option plans during the six-month period ended June 30, 2024, is presented below:
| | Options Outstanding | |
| | Number of Shares | | | Weighted Average Exercise Price Share | | | Weighted Average Life (in years) | |
Outstanding December 31, 2023 | | | 19 | | | $ | 157,520 | | | | 3.16 | |
Cancelled or expired | | | (8 | ) | | | 186,504 | | | | — | |
Outstanding as of June 30, 2024 | | | 11 | | | $ | 104,354 | | | | 2.59 | |
Options exercisable at June 30, 2024 | | | 11 | | | $ | 27,524 | | | | 2.55 | |
11.
License and Development Agreements
| (a) | License
Agreement with Novartis for Dovitinib |
On
January 26, 2024, the Company received a termination notice from Novartis due to a material breach of the License Agreement. Accordingly,
under the terms of the License Agreement, the Company ceased all development and commercialization activities with respect to all licensed
products, all rights and licenses granted by Novartis to the Company reverted to Novartis; and all liabilities due to Novartis became
immediately due and payable inclusive of interest which is continuing to accrue at 5% per annum. As of June 30, 2024, the liability is
recorded as a current liability on the Company’s condensed unaudited consolidated balance sheets as follows: $3,600 in accounts
payable, $1,325 convertible promissory notes and accrued interest, net of debt discount, and $192 in accrued liabilities.
| (b) | License
Agreement with Eisai Inc. for Stenoparib |
The
Company holds the exclusive worldwide rights to all preventative, therapeutic and/or diagnostic uses related to cancer in humans and
by amendment to the agreement on December 11, 2020, viral infections in humans (including, but not limited to, coronaviruses) for Stenoparib
from Eisai, Inc. (“Eisai”) pursuant to a license agreement (the “Eisai License Agreement”). Pursuant to the Eisai
License Agreement, the Company is solely responsible for the development of Stenoparib during the term of the Eisai License Agreement.
Eisai License Agreement also provides for a joint development committee consisting of six members, three appointed by us and three appointed
by Eisai. One of the Company’s members of the joint development committee is designated chair of the committee and has the power
to break any deadlock in decisions by the committee that must be made by a majority vote with each representative having one vote. The
purpose of the committee is to implement and oversee development activities for Stenoparib pursuant to the clinical development plan,
serving as a forum for exchanging data, information and development strategy.
Effective
July 12, 2022, the Company’s July 6, 2017 Exclusive License Agreement with Eisai Inc. (the “Third Amendment”), the
terms of the original exclusive license were further amended in order to (1) further postpone the due date of the extension payment and
extend the deadline for the Company’s successful completion of its first Phase 1b or Phase 2 clinical trial for Stenoparib beyond
December 31, 2022; and (2) amend terms related to Eisai’s right of termination of development.
On
May 26, 2023, the Company and Eisai entered into a fourth amendment to the Exclusive License Agreement with an effective date of May
16, 2023, to postpone the extension payment, restructure the payment schedule and extend the deadline to complete enrollment in a further
Phase 1b or Phase 2 Clinical Trial for the Stenoparib. The Company agreed to pay Eisai in periodic payments as follows: (i) $100, which
has been paid; (ii) $50 within 10 days of execution of the fourth amendment, which has been paid; (iii) $100 upon completion of a capital
raise, which has been paid; and (iv) $850 on or before March 1, 2024.
On
February 26, 2024, in exchange for an additional $150, paid as of May 1, 2024, the Company and Eisai entered into a fifth amendment to
the Exclusive License Agreement to postpone the payment of $850 by no later than September 1, 2024. The Company is currently in
negotiations with Eisai to further amend the terms of its Exclusive License.
Development
Milestone Payments
The
Company has agreed to make milestone payments to Eisai in connection with the development of Stenoparib by the Company or its affiliates,
or by a third-party program acquirer that assumes control of the Stenoparib development program from the Company corresponding to: (i) successful
completion of a Phase 2 clinical trial; (ii) upon dosing of the first patient in the first Phase 3 clinical trial; (iii) upon
submission of the first NDA with the FDA; (iv) submission of an MAA to the EMA; (v) submission of an NDA to the MHLW in Japan;
(vi) upon receipt of authorization by the FDA to market and sell a licensed product; (vii) upon receipt of approval of an MAA
by the EMA for a licensed product; and (viii) upon receipt of approval by the MHLW in Japan for a licensed product. If all milestones
have been achieved, the Company may be obligated to pay Eisai up to a maximum of $94 million. In addition, the Company has agreed to
pay Eisai a one-time sales milestone payment in the amount of $50 million the first time the Company’s annual sales of licensed
product is $1 billion or more.
Royalty
Payments
In
addition to the milestone payments described above, the Company has agreed to pay Eisai royalties based on annual incremental sales of
product derived from Stenoparib in an amount between 5% and 10% of annual sales of between $0 and $100 million, between 6% and 10% of
annual sales between $100 million and $250 million, between 7% and 11% of annual sales between $250 million and $500 million, and between
11% and 15% of annual sales in excess of $500 million.
The
Company is obligated to pay royalties under the agreement on a country-by-country and product-by-product basis for a period that commences
with the first commercial sale of a product until the later of (i) the expiration of the last to expire valid claim of any licensed
patent covering such licensed product in such country; or, (ii) the expiration of regulatory-based exclusivity for such licensed
product in such country or (iii) the 15 year anniversary of the date of first commercial sale of such licensed product in such country.
However, the agreement may be terminated sooner without cause by the Company upon 120 days prior written notice, or upon written
notice of a material breach of the agreement by Eisai that is not cured within 90 days (30 days for a payment default).
Eisai
also has the right to terminate the agreement upon written notice of a material breach of the agreement by the Company that is not cured
within 90 days (30 days for a payment default) or if the Company files for bankruptcy. As of the date of this filing, the Company
is currently renegotiating the terms of its Exclusive License with Eisai.
Option
to Reacquire Rights to Stenoparib
For
the period commencing with enrollment of the first five patients in a Phase 2 clinical trial pursuant to the clinical development plan
and ending 90 days following successful completion of such Phase 2 clinical trial, Eisai has the option to reacquire our licensed rights
to develop Stenoparib for a purchase price equal to the fair market value of our rights, giving effect to the stage of development of
Stenoparib that we have completed under the agreement. The Company commenced a Phase 2 clinical trial April 15, 2019, and as of the date
of the Financial Statements, Eisai has not indicated an intention to exercise its repurchase option.
12.
Related party
During
the six month periods June 30, 2024 and 2023, a director of the Company was paid $192 and $77 respectively, in fees as a consultant.
Effective June 1, 2024, the Company executed a Chief Executive Officer Management Services Agreement with the Consultant in consideration
for $525 per year and $100 as a signing bonus, which was paid in June 2024.
13.
Loss per share of common stock
Basic
loss per share is derived by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock
outstanding during each period. Diluted loss per share includes the effect, if any, of the potential exercise or conversion of securities,
such as warrants and stock options, which would result in the issuance of incremental shares of common stock unless such effect is anti-dilutive.
In calculating the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remained
the same for both calculations because when a net loss exists, dilutive shares are not included in the calculation. Potentially dilutive
securities outstanding, as determined by the latest applicable conversion price, that have been excluded from diluted loss per share
due to being anti-dilutive include the following:
| |
Three- and six-months ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | |
Warrants and stock options | |
| 256,678 | | |
| 28,275 | |
Series A Convertible Preferred stock | |
| — | | |
| 40,817 | |
| |
| 256,678 | | |
| 69,092 | |
14.
Financial Instruments
The
following tables present information about the Company’s financial instruments measured at fair value on a recurring basis and
indicate the level of the fair value hierarchy used to determine such fair values:
| |
Fair Value Measurements as of June 30, 2024, Using: | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Liabilities: | |
| | |
| | |
| | |
| |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | (16 | ) | |
$ | (16 | ) |
| |
$ | — | | |
$ | — | | |
$ | (16 | ) | |
$ | (16 | ) |
| |
Fair Value Measurements as of December 31, 2023, Using: | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Liabilities: | |
| | |
| | |
| | |
| |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | (2,263 | ) | |
$ | (2,263 | ) |
Derivative warrant liability | |
| — | | |
| — | | |
| (820 | ) | |
| (820 | ) |
| |
$ | — | | |
$ | — | | |
$ | (3,083 | ) | |
$ | (3,083 | ) |
Methods
used to estimate the fair values of our financial instruments, not disclosed elsewhere in the Financial Statements, are as follows:
When
available, the Company’s marketable securities are valued using quoted prices for identical instruments in active markets. If the
Company is unable to value its marketable securities using quoted prices for identical instruments in active markets, the Company values
its investments using broker reports that utilize quoted market prices for comparable instruments. The Company has no financial assets
or liabilities measured using Level 2 inputs. Financial assets and liabilities are considered Level 3 when their fair values are determined
using pricing models, discounted cash flow methodologies, or similar techniques, and at least one significant model assumption or input
is unobservable.
The
Company recognizes its derivative liabilities as Level 3 and values its derivatives using the methods described in Note 8. While the
Company believes that its valuation methods are appropriate and consistent with other market participants, it recognizes that the use
of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different estimate
of fair value at the reporting date. The primary assumptions that would significantly affect the fair values using terms in the notes
that are subject to volatility and market price of the underlying shares of Common Stock.
The
Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may
result in a reclassification of levels for certain securities within the fair value hierarchy. The Company’s policy is to recognize
transfers into and out of levels within the fair value hierarchy at the date the actual event or change in circumstances that caused
the transfer occurs. When a determination is made to classify an asset or liability within Level 3, the determination is based upon the
significance of the unobservable inputs to the overall fair value measurement. There were no transfers between Level 1 or Level 2 during
the six-month periods ended June 30, 2024 and 2023.
15.
Commitments and Contingencies
On July 19, 2024, the Company
received a “Wells Notice” from the Staff of the SEC relating to the Company’s previously disclosed SEC investigation.
The Wells Notice relates to the Company’s disclosures regarding meetings with the United States Food and Drug Administration (the
“FDA”) regarding the Company’s NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. The Company
understands that all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022. The Company also understands
that three of its former officers received Wells Notices from the SEC relating to the same conduct. A Wells Notice is neither a formal
charge of wrongdoing nor a final determination that the recipient has violated any law. The Wells Notice informed the Company that the
SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against the Company that would allege
certain violations of the federal securities laws. The Company is continuing to cooperate with the SEC and maintains that its actions
were appropriate, and intends to pursue the Wells Notice process, including submitting a formal response to the SEC.
| (b) | Nasdaq
Delisting Notifications |
On
June 18, 2024, the Company received a letter from the Nasdaq Listing Qualifications Staff (the “Staff”) of Nasdaq indicating
that the Company has not complied with the Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”) which is the requirement
that for 30 consecutive business days the bid price for the Company’s common stock close above the $1 per share minimum bid price
requirement for continued inclusion on the Nasdaq Capital Market. On July 30, 2024, the Company attended a hearing before a
Nasdaq Hearings Panel and presented its plan for regaining compliance with the Bid Price Rule. Nasdaq has advised the Company to expect
to receive a ruling within two weeks of July 30, 2024.
16.
Subsequent Events
For
the Financial Statements, and for the six months then ended, the Company evaluated subsequent events through the date on which the Financial
Statements were issued. All subsequent events not disclosed elsewhere in this Quarterly Report are disclosed below.
(a)
ATM Offering – Sales
During
the period July 1, 2024 through August 5, 2024, the Company has sold 7,340,312 shares of its Common Stock for net proceeds of $1,404.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Forward-Looking
Statements
You
should read the following discussion and analysis of our financial condition and results of operations together with “Cautionary
Note Regarding Forward-Looking Statements” and our condensed consolidated financial statements and related notes included under
Item 1 of this Quarterly Report as well as our most recent Annual Report on Form 10-K for the year ended December 31, 2023, as amended,
including Part 1, Item 1A “Risk Factors.”
Overview
We
are a biopharmaceutical company focused on discovering and developing highly targeted anti-cancer drug candidates. Through the use of
its Drug Response Predictor (DRP®) platform, we identify the value in drug assets that have otherwise been discontinued
by identifying patient populations where these drugs are active. Our lead drug candidate is: the poly-ADP-ribose polymerase (PARP) inhibitor
stenoparib, or Stenoparib.
Recent
Developments
Nasdaq Delisting Notifications
On
June 18, 2024, the Company received a letter from the Nasdaq Listing Qualifications Staff (the “Staff”) of Nasdaq indicating
that the Company has not complied with the Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”) which is the requirement
that for 30 consecutive business days the bid price for the Company’s common stock close above the $1 per share minimum bid price
requirement for continued inclusion on the Nasdaq Capital Market. On June 27, 2024, the Company was granted a hearing before a Nasdaq
Hearings Panel. On July 30, 2024, the Company was attended a hearing before a Nasdaq Hearings Panel and presented its plan for regaining
compliance with the Bid Price Rule. Nasdaq has advised the Company to expect to receive a ruling within two weeks of July 30, 2024.
Special
Meeting of Stockholders; Share Consolidation
We
effected a 1-for-20 share consolidation of our Common Stock on April 9, 2024 (“Share Consolidation”). No fractional shares
were issued in connection with the Share Consolidation. If, as a result of the Share Consolidation, a stockholder would otherwise have
been entitled to a fractional share, each fractional share was rounded up to the next whole number. The Share Consolidation resulted
in a reduction of our outstanding shares of Common Stock on June 30, 2024 from 6,854,604 to 342,774. The par value of our authorized
stock remained unchanged at $0.0001.
SEC Investigation
On July 19, 2024, the Company
received a “Wells Notice” from the Staff of the SEC relating to the Company’s previously disclosed SEC investigation.
The Wells Notice relates to the Company’s disclosures regarding meetings with the United States Food and Drug Administration (the
“FDA”) regarding the Company’s NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. The Company
understands that all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022. The Company also understands
that three of its former officers received Wells Notices from the SEC relating to the same conduct. A Wells Notice is neither a formal
charge of wrongdoing nor a final determination that the recipient has violated any law. The Wells Notice informed the Company that the
SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against the Company that would allege
certain violations of the federal securities laws. The Company is continuing to cooperate with the SEC and maintains that its actions
were appropriate, and intends to pursue the Wells Notice process, including submitting a formal response to the SEC.
Risks
and Uncertainties
The
Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical
studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the
need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel and collaboration
partners, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations,
and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant
additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization.
Even if the Company’s research and development efforts are successful, it is uncertain when, if ever, the Company will realize
significant revenue from product sales.
Financial
Operations Overview
Since
our inception in September of 2004, we have focused substantially all our resources on conducting research and development activities,
including drug discovery and preclinical studies, establishing, and maintaining our intellectual property portfolio, the manufacturing
of clinical and research material, hiring personnel, raising capital and providing general and administrative support for these operations.
In recent years, we have recorded very limited revenue from collaboration activities, or any other sources. We have funded our operations
to date primarily from convertible notes and the issuance and sale of our ordinary shares.
We have incurred net losses in
each year since inception. Our net losses were $5.0 million and $5.7 million for the six months ended June 30, 2024 and 2023, respectively.
As of June 30, 2024, we had an accumulated deficit of $99.9 million and cash and cash equivalents of $19.2 million. Substantially all
our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative
costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses over at least
the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:
|
● |
advance drug candidates
through clinical trials; |
|
|
|
|
● |
pursue regulatory approval
of drug candidates; |
|
● |
operate as a public company; |
|
|
|
|
● |
continue our preclinical
programs and clinical development efforts; |
|
|
|
|
● |
continue research activities
for the discovery of new drug candidates; and |
|
|
|
|
● |
manufacture supplies for
our preclinical studies and clinical trials. |
Components
of Operating Expenses
Research
and Development Expenses
Research
and development expenses include:
|
● |
expenses incurred under
agreements with third-party contract organizations, and consultants; |
|
|
|
|
● |
costs related to production
of drug substance, including fees paid to contract manufacturers; |
|
|
|
|
● |
laboratory and vendor expenses
related to the execution of preclinical trials; and |
|
|
|
|
● |
employee-related expenses,
which include salaries, benefits, and stock-based compensation. |
We
expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized
based on an evaluation of the progress to completion of specific tasks and estimates of services performed using information and data
provided to us by our vendors and third-party service providers. Non-refundable advance payments for goods or services to be received
in future periods for use in research and development activities are deferred and accounted for as prepaid expenses. The prepayments
are then expensed as the related goods are delivered and as services are performed. To date, most of these expenses have been incurred
to advance our lead drug candidate Stenoparib.
We
expect our research and development expenses on Stenoparib to increase substantially for the foreseeable future as we continue to invest
to accelerate Stenoparib in clinical trials designed to attain regulatory approval. Costs related to dovitinib and IXEMPRA will decrease
precipitously as these have been deprioritized/ terminated. We expect additional costs in research and development activities as we continue
to conduct clinical trials. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming,
and the successful development of our drug candidates is highly uncertain. As a result, we are unable to determine the duration and completion
costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale
of any of our drug candidates.
General
and Administrative Expenses
General
and administrative expenses consist primarily of personnel-related costs, facilities costs, depreciation and amortization expenses and
professional services expenses, including legal, human resources, audit, and accounting services. Personnel-related costs consist of
salaries, benefits, and stock-based compensation. Facilities costs consist of rent and maintenance of facilities. We expect our general
and administrative expenses to increase for the foreseeable future due to anticipated increases in headcount to advance our drug candidates
and as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC,
Nasdaq, additional insurance expenses, investor relations activities and other administrative and professional services.
Results
of Operations for the Three and Six Months Ended June 30, 2024 and 2023 (unaudited) (in thousands, except where otherwise noted)
The
following table summarizes our results of operations for the three and six months ended June 30, 2024 and 2023:
| |
For the three months ended June 30, | | |
Increase/ | | |
For the six months ended June 30, | | |
Increase/ | |
| |
2024 | | |
2023 | | |
(Decrease) | | |
2024 | | |
2023 | | |
(Decrease) | |
| |
(In thousands) | | |
| | |
(In thousands) | | |
| |
| |
| | |
| | |
| | |
| | |
| | |
| |
Operating costs and expenses: | |
| | |
| | |
| | |
| | |
| | |
| |
Research and development | |
$ | 1,058 | | |
$ | 1,105 | | |
$ | (47 | ) | |
$ | 3,228 | | |
$ | 2,532 | | |
$ | 696 | |
General and administrative | |
| 2,313 | | |
| 3,051 | | |
| (738 | ) | |
| 4,383 | | |
| 5,292 | | |
| (909 | ) |
Total operating costs and expenses | |
| 3,371 | | |
| 4,156 | | |
| (785 | ) | |
| 7,611 | | |
| 7,824 | | |
| (213 | ) |
Loss from operations: | |
| (3,371 | ) | |
| (4,156 | ) | |
| 785 | | |
| (7,611 | ) | |
| (7,824 | ) | |
| 213 | |
Other income | |
| 1,742 | | |
| 1,776 | | |
| (34 | ) | |
| 2,135 | | |
| 2,092 | | |
| 43 | |
Net loss | |
$ | (1,629 | ) | |
$ | (2,380 | ) | |
$ | 751 | | |
$ | (5,476 | ) | |
$ | (5,732 | ) | |
$ | 256 | |
Research
and Development Expenses
For
the three months ended June 30, 2024, compared to June 30, 2023
The
decrease of $47 in research and development expenses was primarily because research study costs increased by $204, and patents costs
increased by $27; offset by increased tax credits of $5 and decreases in all other expenses as follows: contractors and consultants by
$88, manufacturing and supplies by $82, staffing by $50, amortization by $8, and other expenses by $5. Staffing and contractor costs
have decreased because of cost-cutting measures.
For
the six months ended June 30, 2024, compared to June 30, 2023
The
increase of $696 in research and development expenses was primarily because of increased manufacturing and supplies expenses of $442,
research study costs of $317, milestone payments of $100, and patent costs of $37; offset by increased tax credits of $51 and decreases
in all other expenses as follows: contractors by $37, staffing by $93, amortization by $16 and other by $3. Manufacturing and supplies
expenses have increased because of increased drug manufacturing costs. Staffing and contractor costs have decreased because of cost-cutting
measures.
General
and Administrative Expenses
For
the three months ended June 30, 2024, compared to June 30, 2023
General and administrative expenses decreased by $738 for the three
months ended June 30, 2024, compared to June 30, 2023. The decrease was primarily due to increased audit and legal expenses of $327
and other expenses of $33; offset by decreases in financial consulting costs of $356, finance costs of $374, insurance of $188, staffing
costs of $140, communication expenses of $40.
For
the six months ended June 30, 2024, compared to June 30, 2023
General and administrative expenses decreased by $909 for the six months
ended June 30, 2024, compared to June 30, 2023. The decrease was primarily due to decreases of $495 in insurance expenses, $380 in
finance expenses, $395 in financial consultant expenses, $67 in communication expenses, $24 in staffing expenses, and $16 in other administrative
expenses; offset by an increase of $273 in audit and legal expenses, $201 in tax expense and $14 in premises expenses. Staffing costs
have decreased because of cost-cutting measures, and stock-based compensation costs have decreased because of stock option forfeitures
of recently resigned employees.
Other
Income (Expenses), Net
For
the three months ended June 30, 2024, compared to June 30, 2023
Other
income (expense) of $1,742 recognized in the three months ended June 30, 2024, consisted primarily of a $2,243 fair value adjustment
to derivative liabilities and interest income of $53, offset by interest expenses of ($426), and foreign exchange losses of ($128).
Other
income (expense) of $1,776 recognized in the three months ended June 30, 2023, consisted primarily of a $1,941 fair value adjustment
to derivative liabilities and interest income of $3, offset by interest expenses of ($142), and foreign exchange losses of ($26).
For the
six months ended June 30, 2024, and June 30, 2023
Other
income (expense) of $2,135 recognized in the six months ended June 30, 2024, consisted primarily of a $2,662 fair value adjustment to
derivative and warrant liabilities, foreign exchange losses of ($52), and interest income of $53, offset by interest expense of ($528).
Other
income (expense) of $2,092 recognized in the six months ended June 30, 2023, consisted primarily of a $2,250 fair value adjustment to
derivative and warrant liabilities, foreign exchange gains of $69, and interest income of $7, offset by interest expense of ($234).
Liquidity,
Capital Resources and Plan of Operations
Since our inception through June
30, 2024, our operations have been financed primarily by the sale of convertible promissory notes and the sale and issuance of our securities.
As of June 30, 2024, we had $19.2 million in cash and cash equivalents, and an accumulated deficit of $99.9 million.
Our
primary use of cash is to fund operating expenses, which consist of research and development as well as regulatory expenses related to
our lead drug candidate and clinical programs for Stenoparib, and to a lesser extent, general and administrative expenses. Cash used
to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts
payable and accrued expenses.
On March 21, 2024, the Company commenced an at the market offering
of shares of our Common Stock and as of June 30, 2024, had sold 31,891,433 shares of our Common Stock for net proceeds of $27,689.
Subsequent to June 30, 2024, an additional 7,340,312 shares of our common stock were sold at the market for net proceeds of
$1,404. In light of the Company’s cash position as of the date of this Quarterly Report, the Company has sufficient funds for its
current operations and planned capital expenditures. As discussed above the Company intends to seek capital through sale of its securities
or other sources. There are no assurances, however, that the Company will be successful in raising additional working capital, or if it
is able to raise additional working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to
raise capital or enter into other such arrangements if and when needed would have a negative impact on its business, results of operations
and financial condition and its ability to develop its product candidates.
Management’s
plans to mitigate the conditions or events that raise substantial doubt include additional funding through public equity, private equity,
debt financing, collaboration partnerships, or other sources. We currently plan on completing an additional public offering in the near
future, however there are no assurances that the Company will be successful in raising additional working capital, or if it is able to
raise additional working capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise capital
or enter into other such arrangements when needed would have a negative impact on its business, results of operations and financial condition
and its ability to continue its plan of operations.
We
expect to incur substantial expenses in the foreseeable future for the development and potential commercialization of our drug candidates
and ongoing internal research and development programs. At this time, we cannot reasonably estimate the nature, timing, or aggregate
amount of costs for our development, potential commercialization, and internal research and development programs. However, to complete
our current and future preclinical studies and clinical trials, and to complete the process of obtaining regulatory approval for our
drug candidates, as well as to build the sales, marketing, and distribution infrastructure that we believe will be necessary to commercialize
our drug candidates, if approved, we may require substantial additional funding in the future.
Contractual
Obligations and Commitments
We
enter into agreements in the normal course of business with vendors for preclinical studies, clinical trials, and other service providers
for operating purposes. We have not included these payments in a table of contractual obligations since these contracts are generally
cancellable at any time by us following a certain period after notice and therefore, we believe that our non-cancellable obligations
under these agreements are not material.
Cash
Flows
The
following table summarizes our cash flows for the periods indicated:
| |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
| |
(In thousands) | |
| |
| | |
| |
Net cash flows used in operating activities | |
$ | (8,703 | ) | |
$ | (5,697 | ) |
Net cash flows provided by financing activities | |
| 27,689 | | |
| 4,023 | |
Effect of foreign exchange rates on cash | |
| 81 | | |
| 65 | |
Net (decrease) increase in cash | |
$ | 19,067 | | |
$ | (1,609 | ) |
Operating
Activities
For
the six months ended June 30, 2024, net cash used in operating activities was approximately $8.7 million compared to approximately $5.7
million for the six months ended June 30, 2023. The $3.0 million increase in net cash used in operating activities was primarily the
result of higher non-cash operating expenses of $890 thousand and a decrease in cash provided by non-cash operating assets of $2.8 million,
offset by a decreased loss of $660 thousand.
Financing
Activities
For the six months ended June 30, 2024, net cash provided by financing
activities was approximately $27.7 million compared to approximately $4.0 million provided in the six months ended June 30, 2023.
The
increase in net cash provided by investing activities was primarily due to the receipt of $27,689 in net proceeds from the issuance of
common stock.
Operating
Capital and Capital Expenditure Requirements
We
believe that our existing cash and cash equivalents will be sufficient to fund our anticipated expenditures and commitments for the
next twelve months. Our estimate as to how long we expect our cash to be able to continue to fund our operations is based on
assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Further,
changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we
currently anticipate, and we may need to seek additional funds sooner than planned.
Off-Balance
Sheet Arrangements
The
Company does not have any off-balance sheet arrangements.
Critical
Accounting Policies and Significant Judgments and Estimates
Our
management’s discussion and analysis of financial condition and results of operations is based upon our unaudited condensed interim
consolidated financial statements for the three and six months ended June 30, 2024 and 2023, and our audited consolidated financial statements
for the years ended December 31, 2023 and 2022, which have been prepared in accordance with U.S. GAAP. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. On an on-going
basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other
assumptions that we believe to be reasonable in 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. Actual results may differ from these estimates
under different assumptions and conditions.
Our
significant accounting policies are described in the notes to our consolidated financial statements for the year ended December 31, 2023
included in the Form 10-K, and there have been no significant changes to our significant accounting policies during the six months ended
June 30, 2024. These unaudited condensed interim consolidated financial statements should be read in conjunction with the Company’s
audited financial statements and accompanying notes.
Recently
Issued Accounting Pronouncements
See
the sections titled “Recently adopted accounting pronouncements” in Note 2(cc) and “Recently issued
accounting pronouncements not yet adopted” in Note 2(x) to the Company’s consolidated financial statements for
the year ended December 31, 2023 and 2022, appearing in the Form 10-K; and in Note 2(g) to the Company’s unaudited condensed
interim consolidated financial statements for the three and six months ended June 30, 2024 and 2023.
Item 3. Quantitative and
Qualitative Disclosures About Market Risk.
We are
a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
Under
the supervision and with the participation of our management and consultants, including our Chief Executive Officer and our Chief Financial
Officer, we have conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures,
as of June 30, 2024, as such term is defined in Rules 13a-15I and 15d-15(e) of the Exchange Act. Based upon the foregoing, our Chief
Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30,
2024.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2024, that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II—OTHER INFORMATION
Item
1. Legal Proceedings.
From time to time in the future,
we may become involved in litigation or other legal proceedings that arise in the ordinary course of business. Except as disclosed below,
we are not currently party to any legal proceedings, and we are not aware of any pending or threatened litigation against us that we believe
could have a material adverse effect on our business, operating results or financial condition. In the event we are subject to a legal
proceeding, it could have a material adverse impact on us because of litigation costs and diversion of management resources.
SEC Investigation
On July 19, 2024, the Company
received a “Wells Notice” from the Staff of the SEC relating to the Company’s previously disclosed SEC investigation.
The Wells Notice relates to the Company’s disclosures regarding meetings with the United States Food and Drug Administration (the
“FDA”) regarding the Company’s NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. The Company
understands that all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022. The Company also understands
that three of its former officers received Wells Notices from the SEC relating to the same conduct. A Wells Notice is neither a formal
charge of wrongdoing nor a final determination that the recipient has violated any law. The Wells Notice informed the Company that the
SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against the Company that would allege
certain violations of the federal securities laws. The Company is continuing to cooperate with the SEC and maintains that its actions
were appropriate, and intends to pursue the Wells Notice process, including submitting a formal response to the SEC.
Item
1A. Risk Factors.
There
are no material changes to the “Risk Factors” set forth in the Form 10-K.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
On March 19, 2024, we entered into an At-The-Market Issuance Sales
Agreement, as may be amended from time to time (the “Sales Agreement”) with Ascendiant Capital Markets, LLC (“Ascendiant”)
under which we may, from time to time, issue and sell shares of our Common Stock having aggregate sales proceeds of up to $30 million,
in a series of one or more “at-the-market” equity offerings (the “ATM Program”). Ascendiant is not required to
sell any specific share amounts but acts as our sales agent, using commercially reasonable efforts consistent with its normal trading
and sales practices. We agreed to pay Ascendiant a commission equal to 3.0% of the aggregate gross proceeds we receive from each sale
of shares of our Common Stock. Pursuant to the Sales Agreement, any shares will be sold pursuant to our shelf registration statement on
Form S-3 (File No. 333-275282) filed with the SEC on November 2, 2023, including the base prospectus contained therein, as declared effective
by the SEC on November 29, 2023. Shares of our Common Stock will be sold at prevailing market prices at the time of the sale, and as a
result, prices may vary.
During
the period April 1, 2024, through August 5, 2024, the Company has sold 7,340,312 shares of its Common Stock for net proceeds of $1,404.
Item
3. Defaults Upon Senior Securities.
For
a discussion of the “Convertible Promissory Note Due to Novartis” refer to Note 5 to the Condensed Consolidated Financial
Statements (Unaudited) in Part I, Item 1 of this Quarterly Report.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
Our
2024 annual meeting of stockholders will be delayed by more than 30 days from February 3, the anniversary date of the 2023 annual meeting
of stockholders. On July 25, 2024, our board of directors, acting in accordance with the authority granted to our board of directors
pursuant to the applicable provisions of our bylaws, elected to postpone the 2024 annual meeting of stockholders to a date to be determined
by our board of directors in accordance with the applicable provisions of our bylaws. Our board of directors has not yet determined the
date of the postponed 2024 annual meeting of stockholders. We will provide all required information about the postponed 2024 annual meeting
of stockholders when it becomes available.
Item
6. Exhibits.
See
the Exhibit Index to this Quarterly Report immediately below and before the signature page hereto, which Exhibit Index is incorporated
by reference as if fully set forth herein.
|
|
|
|
Incorporated
by Reference |
|
|
Exhibit Number |
|
Exhibit
Description |
|
Form |
|
File
No. |
|
Exhibit |
|
Filing
Date |
|
Filed
Herewith |
3.1 |
|
Certificate of Incorporation |
|
S-4 |
|
333-258968 |
|
3.1 |
|
August 20, 2021 |
|
|
3.2 |
|
Certificate of Amendment to the Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
S-4/A |
|
333-259484 |
|
3.3 |
|
September 29, 2021 |
|
|
3.3 |
|
Second Certificate of Amendment to Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
3.1 |
|
March 20, 2023 |
|
|
3.4 |
|
Third Certificate of Amendment to Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
3.1 |
|
March 24, 2023 |
|
|
3.5 |
|
Fourth Certificate of Amendment to Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
3.1 |
|
June 28, 2023 |
|
|
3.6 |
|
Fifth Certificate of Amendment to Certificate of Incorporation of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
|
|
April 4, 2024 |
|
|
3.7 |
|
Specimen Common Stock Certificate of Allarity Therapeutics, Inc. |
|
S-4/A |
|
333-259484 |
|
4.1 |
|
September 29, 2021 |
|
|
3.8 |
|
Amended and Restated Bylaws of Allarity Therapeutics, Inc. |
|
S-4/A |
|
333-259484 |
|
3.4 |
|
October 18, 2021 |
|
|
3.9 |
|
Amendment No. 1 to Amended and Restated Bylaws of Allarity Therapeutics, Inc. |
|
8-K |
|
001-41160 |
|
3.1 |
|
July 11, 2022 |
|
|
10.1 |
|
First Comprehensive Amendment to At-The-Market Issuance Sales Agreement, dated May 17, 2024 |
|
8-K |
|
001-41160 |
|
10.1 |
|
May 21, 2024 |
|
|
10.2† |
|
Management Services Agreement, effective as of June 1, 2024 |
|
8-K |
|
001-41160 |
|
10.1 |
|
June 6, 2024 |
|
|
31.1 |
|
Certifications of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act |
|
|
|
|
|
|
|
|
|
X |
31.2 |
|
Certifications of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act |
|
|
|
|
|
|
|
|
|
X |
32.1* |
|
Certifications of the Chief Executive Officer under Section 906 of the Sarbanes-Oxley Act |
|
|
|
|
|
|
|
|
|
X |
32.2* |
|
Certifications of the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act |
|
|
|
|
|
|
|
|
|
X |
101.INS |
|
Inline XBRL Instance Document (the instance document
does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document). |
|
|
|
|
|
|
|
|
|
X |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document. |
|
|
|
|
|
|
|
|
|
X |
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase
Document. |
|
|
|
|
|
|
|
|
|
X |
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase
Document. |
|
|
|
|
|
|
|
|
|
X |
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document. |
|
|
|
|
|
|
|
|
|
X |
101PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase
Document. |
|
|
|
|
|
|
|
|
|
X |
104* |
|
Cover Page Interactive Data File (formatted as inline
XBRL and contained in Exhibit 101) |
|
|
|
|
|
|
|
|
|
— |
+ |
Certain of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601. The Registrant agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request. |
|
|
† |
Indicates management contract or compensatory plan or arrangement. |
|
|
* |
Furnished herewith. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
ALLARITY
THERAPEUTICS, INC., |
|
|
Date: August
5, 2024 |
By: |
/s/
Thomas H. Jensen |
|
|
Thomas H. Jensen |
|
|
Chief Executive
Officer
(Principal Executive Officer) |
|
|
Date: August
5, 2024 |
By: |
/s/
Joan Y. Brown |
|
|
Joan Y. Brown |
|
|
Chief
Financial Officer
(Principal Financial and Accounting Officer) |
33
1336.40
525.53
0.11
0.73
14979095
7641826
18621
9834
false
--12-31
Q2
0001860657
0001860657
2024-01-01
2024-06-30
0001860657
2024-08-05
0001860657
2024-06-30
0001860657
2023-12-31
0001860657
us-gaap:SeriesAPreferredStockMember
2024-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
2023-12-31
0001860657
2024-04-01
2024-06-30
0001860657
2023-04-01
2023-06-30
0001860657
2023-01-01
2023-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
us-gaap:PreferredStockMember
2022-12-31
0001860657
us-gaap:SeriesBPreferredStockMember
us-gaap:PreferredStockMember
2022-12-31
0001860657
allr:SeriesCConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2022-12-31
0001860657
allr:SeriesAPreferredStockOneMember
us-gaap:PreferredStockMember
2022-12-31
0001860657
us-gaap:CommonStockMember
2022-12-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2022-12-31
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2022-12-31
0001860657
us-gaap:RetainedEarningsMember
2022-12-31
0001860657
2022-12-31
0001860657
us-gaap:SeriesAPreferredStockMember
us-gaap:PreferredStockMember
2023-01-01
2023-03-31
0001860657
us-gaap:SeriesBPreferredStockMember
us-gaap:PreferredStockMember
2023-01-01
2023-03-31
0001860657
allr:SeriesCConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2023-01-01
2023-03-31
0001860657
allr:SeriesAPreferredStockOneMember
us-gaap:PreferredStockMember
2023-01-01
2023-03-31
0001860657
us-gaap:CommonStockMember
2023-01-01
2023-03-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-01-01
2023-03-31
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2023-01-01
2023-03-31
0001860657
us-gaap:RetainedEarningsMember
2023-01-01
2023-03-31
0001860657
2023-01-01
2023-03-31
0001860657
us-gaap:SeriesAPreferredStockMember
us-gaap:PreferredStockMember
2023-03-31
0001860657
us-gaap:SeriesBPreferredStockMember
us-gaap:PreferredStockMember
2023-03-31
0001860657
allr:SeriesCConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2023-03-31
0001860657
allr:SeriesAPreferredStockOneMember
us-gaap:PreferredStockMember
2023-03-31
0001860657
us-gaap:CommonStockMember
2023-03-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-03-31
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2023-03-31
0001860657
us-gaap:RetainedEarningsMember
2023-03-31
0001860657
2023-03-31
0001860657
allr:SeriesAConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2023-04-01
2023-06-30
0001860657
allr:SeriesCConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2023-04-01
2023-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
us-gaap:PreferredStockMember
2023-04-01
2023-06-30
0001860657
us-gaap:CommonStockMember
2023-04-01
2023-06-30
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-04-01
2023-06-30
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2023-04-01
2023-06-30
0001860657
us-gaap:RetainedEarningsMember
2023-04-01
2023-06-30
0001860657
allr:SeriesAConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2023-06-30
0001860657
allr:SeriesCConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2023-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
us-gaap:PreferredStockMember
2023-06-30
0001860657
us-gaap:CommonStockMember
2023-06-30
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-06-30
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2023-06-30
0001860657
us-gaap:RetainedEarningsMember
2023-06-30
0001860657
2023-06-30
0001860657
allr:SeriesAConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2023-12-31
0001860657
us-gaap:CommonStockMember
2023-12-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-12-31
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2023-12-31
0001860657
us-gaap:RetainedEarningsMember
2023-12-31
0001860657
allr:SeriesAConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2024-01-01
2024-03-31
0001860657
us-gaap:CommonStockMember
2024-01-01
2024-03-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2024-01-01
2024-03-31
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2024-01-01
2024-03-31
0001860657
us-gaap:RetainedEarningsMember
2024-01-01
2024-03-31
0001860657
2024-01-01
2024-03-31
0001860657
allr:SeriesAConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2024-03-31
0001860657
us-gaap:CommonStockMember
2024-03-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2024-03-31
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2024-03-31
0001860657
us-gaap:RetainedEarningsMember
2024-03-31
0001860657
2024-03-31
0001860657
allr:SeriesAConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2024-04-01
2024-06-30
0001860657
us-gaap:CommonStockMember
2024-04-01
2024-06-30
0001860657
us-gaap:AdditionalPaidInCapitalMember
2024-04-01
2024-06-30
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2024-04-01
2024-06-30
0001860657
us-gaap:RetainedEarningsMember
2024-04-01
2024-06-30
0001860657
allr:SeriesAConvertiblePreferredStockMember
us-gaap:PreferredStockMember
2024-06-30
0001860657
us-gaap:CommonStockMember
2024-06-30
0001860657
us-gaap:AdditionalPaidInCapitalMember
2024-06-30
0001860657
us-gaap:AccumulatedOtherComprehensiveIncomeMember
2024-06-30
0001860657
us-gaap:RetainedEarningsMember
2024-06-30
0001860657
2024-04-09
2024-04-09
0001860657
us-gaap:ReclassificationOtherMember
2023-01-01
2023-06-30
0001860657
allr:AllarityAcquisitionSubsidiaryIncMember
2024-01-01
2024-06-30
0001860657
allr:AllarityTherapeuticsEuropeApSMember
2024-01-01
2024-06-30
0001860657
allr:AllarityTherapeuticsDenmarkApSMember
2024-01-01
2024-06-30
0001860657
allr:MPIIncMember
2024-01-01
2024-06-30
0001860657
2024-01-26
0001860657
allr:ConvertiblePromissoryNoteDueToNovartisMember
2024-06-30
0001860657
2024-01-18
0001860657
allr:ThreeILPConvertibleSecuredPromissoryNotes2024Member
2024-01-18
0001860657
2024-02-13
0001860657
allr:ThreeILPConvertibleSecuredPromissoryNotes2024Member
2024-02-13
0001860657
2024-03-14
0001860657
allr:ThreeILPConvertibleSecuredPromissoryNotes2024Member
2024-03-14
0001860657
allr:ThreeILPConvertibleSecuredPromissoryNotes2024Member
2024-06-30
0001860657
allr:ThreeIConvertibleSecuredPromissoryNotes2023Member
2022-11-28
0001860657
allr:ThreeIConvertibleSecuredPromissoryNotes2023Member
2022-11-28
2022-11-28
0001860657
allr:ThreeIConvertibleSecuredPromissoryNotes2023Member
2022-07-14
0001860657
allr:ThreeIConvertibleSecuredPromissoryNotes2023Member
2022-12-30
0001860657
allr:ThreeIConvertibleSecuredPromissoryNotes2023Member
2024-01-01
2024-06-30
0001860657
allr:ThreeIConvertibleSecuredPromissoryNotes2023Member
2024-01-01
0001860657
2024-01-01
2024-01-01
0001860657
2024-01-01
0001860657
srt:MaximumMember
2024-01-14
0001860657
srt:MinimumMember
2024-01-14
0001860657
us-gaap:WarrantMember
2023-12-31
0001860657
allr:ExchangeWarrantsMember
2024-01-14
0001860657
us-gaap:WarrantMember
us-gaap:SeriesAPreferredStockMember
2024-01-14
2024-01-14
0001860657
srt:MaximumMember
us-gaap:SeriesAPreferredStockMember
2024-01-14
0001860657
srt:MinimumMember
us-gaap:SeriesAPreferredStockMember
2024-01-14
0001860657
us-gaap:SeriesAPreferredStockMember
2024-01-14
0001860657
2024-01-14
0001860657
2024-01-14
2024-01-14
0001860657
allr:ExchangeWarrantsMember
allr:SeriesAConvertiblePreferredStockMember
2024-01-14
0001860657
srt:MaximumMember
allr:ExchangeWarrantsMember
2024-02-13
0001860657
srt:MinimumMember
allr:ExchangeWarrantsMember
2024-02-13
0001860657
srt:MinimumMember
allr:ExchangeWarrantsMember
2024-01-18
0001860657
us-gaap:SeriesAPreferredStockMember
2024-02-13
0001860657
us-gaap:SeriesAPreferredStockMember
2024-02-14
0001860657
2024-02-14
2024-02-14
0001860657
allr:SeriesAConvertiblePreferredStockMember
2024-02-14
0001860657
allr:ExchangeWarrantsMember
us-gaap:SeriesAPreferredStockMember
2024-02-14
0001860657
us-gaap:SeriesAPreferredStockMember
2024-02-14
2024-02-14
0001860657
srt:MaximumMember
2024-02-14
0001860657
srt:MinimumMember
2024-02-14
0001860657
allr:ExchangeWarrantsMember
2024-02-13
0001860657
allr:ExchangeWarrantsMember
2024-03-14
0001860657
us-gaap:SeriesAPreferredStockMember
2024-03-14
0001860657
2024-03-14
2024-03-14
0001860657
us-gaap:ConvertibleCommonStockMember
2024-03-14
0001860657
allr:ExchangeWarrantsMember
us-gaap:SeriesAPreferredStockMember
2024-05-01
0001860657
us-gaap:SeriesAPreferredStockMember
2024-01-01
2024-06-30
0001860657
allr:SeriesAConvertiblePreferredStockMember
2024-01-01
2024-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
2023-01-01
2023-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
2023-06-30
0001860657
allr:SeriesCConvertibleRedeemablePreferredStockMember
2023-02-28
2023-02-28
0001860657
allr:SeriesAConvertiblePreferredStockMember
2023-02-28
0001860657
2023-02-28
2023-02-28
0001860657
us-gaap:SeriesCPreferredStockMember
2023-02-28
0001860657
2023-04-21
2023-04-21
0001860657
srt:MaximumMember
us-gaap:MeasurementInputExercisePriceMember
2024-03-14
0001860657
srt:MinimumMember
us-gaap:MeasurementInputExercisePriceMember
2024-03-14
0001860657
srt:MaximumMember
us-gaap:MeasurementInputExercisePriceMember
2024-05-02
0001860657
srt:MinimumMember
us-gaap:MeasurementInputExercisePriceMember
2024-05-02
0001860657
srt:MaximumMember
us-gaap:MeasurementInputSharePriceMember
2024-03-14
0001860657
srt:MinimumMember
us-gaap:MeasurementInputSharePriceMember
2024-03-14
0001860657
srt:MaximumMember
us-gaap:MeasurementInputSharePriceMember
2024-05-02
0001860657
srt:MinimumMember
us-gaap:MeasurementInputSharePriceMember
2024-05-02
0001860657
srt:MaximumMember
us-gaap:MeasurementInputRiskFreeInterestRateMember
2024-03-14
0001860657
srt:MinimumMember
us-gaap:MeasurementInputRiskFreeInterestRateMember
2024-03-14
0001860657
srt:MaximumMember
us-gaap:MeasurementInputRiskFreeInterestRateMember
2024-05-02
0001860657
srt:MinimumMember
us-gaap:MeasurementInputRiskFreeInterestRateMember
2024-05-02
0001860657
srt:MaximumMember
us-gaap:MeasurementInputExpectedTermMember
2024-03-14
0001860657
srt:MinimumMember
us-gaap:MeasurementInputExpectedTermMember
2024-03-14
0001860657
srt:MaximumMember
us-gaap:MeasurementInputExpectedTermMember
2024-05-02
0001860657
srt:MinimumMember
us-gaap:MeasurementInputExpectedTermMember
2024-05-02
0001860657
srt:MaximumMember
us-gaap:MeasurementInputPriceVolatilityMember
2024-03-14
0001860657
srt:MinimumMember
us-gaap:MeasurementInputPriceVolatilityMember
2024-03-14
0001860657
us-gaap:MeasurementInputPriceVolatilityMember
2024-05-02
0001860657
allr:WarrantDerivativeLiabilityMember
2023-12-31
0001860657
us-gaap:CommonStockMember
2023-12-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-12-31
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2023-12-31
0001860657
allr:WarrantDerivativeLiabilityMember
2024-01-01
2024-03-31
0001860657
us-gaap:SeriesAPreferredStockMember
2024-01-01
2024-03-31
0001860657
us-gaap:CommonStockMember
2024-01-01
2024-03-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2024-01-01
2024-03-31
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2024-01-01
2024-03-31
0001860657
allr:JanuaryFourteenTwoZeroTwoFourMember
allr:WarrantDerivativeLiabilityMember
2024-01-01
2024-03-31
0001860657
allr:JanuaryFourteenTwoZeroTwoFourMember
us-gaap:SeriesAPreferredStockMember
2024-01-01
2024-03-31
0001860657
allr:JanuaryFourteenTwoZeroTwoFourMember
us-gaap:CommonStockMember
2024-01-01
2024-03-31
0001860657
allr:JanuaryFourteenTwoZeroTwoFourMember
us-gaap:AdditionalPaidInCapitalMember
2024-01-01
2024-03-31
0001860657
allr:JanuaryFourteenTwoZeroTwoFourMember
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2024-01-01
2024-03-31
0001860657
allr:WarrantDerivativeLiabilityMember
2024-03-31
0001860657
us-gaap:SeriesAPreferredStockMember
2024-03-31
0001860657
us-gaap:CommonStockMember
2024-03-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2024-03-31
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2024-03-31
0001860657
allr:WarrantDerivativeLiabilityMember
2024-04-01
2024-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
2024-04-01
2024-06-30
0001860657
us-gaap:CommonStockMember
2024-04-01
2024-06-30
0001860657
us-gaap:AdditionalPaidInCapitalMember
2024-04-01
2024-06-30
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2024-04-01
2024-06-30
0001860657
allr:WarrantDerivativeLiabilityMember
2024-06-30
0001860657
us-gaap:CommonStockMember
2024-06-30
0001860657
us-gaap:AdditionalPaidInCapitalMember
2024-06-30
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2024-06-30
0001860657
allr:WarrantDerivativeLiabilityMember
2022-12-31
0001860657
us-gaap:SeriesAPreferredStockMember
2022-12-31
0001860657
allr:SeriesAPreferredStockOneMember
2022-12-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2022-12-31
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2022-12-31
0001860657
allr:WarrantDerivativeLiabilityMember
2023-01-01
2023-03-31
0001860657
us-gaap:SeriesAPreferredStockMember
2023-01-01
2023-03-31
0001860657
allr:SeriesAPreferredStockOneMember
2023-01-01
2023-03-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-01-01
2023-03-31
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2023-01-01
2023-03-31
0001860657
allr:WarrantDerivativeLiabilityMember
2023-03-31
0001860657
us-gaap:SeriesAPreferredStockMember
2023-03-31
0001860657
allr:SeriesAPreferredStockOneMember
2023-03-31
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-03-31
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2023-03-31
0001860657
allr:WarrantDerivativeLiabilityMember
2023-04-01
2023-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
2023-04-01
2023-06-30
0001860657
allr:SeriesAPreferredStockOneMember
2023-04-01
2023-06-30
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-04-01
2023-06-30
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2023-04-01
2023-06-30
0001860657
allr:DeemedDividendOneMember
allr:SeriesAPreferredStockOneMember
2023-04-01
2023-06-30
0001860657
allr:SeriesAPreferredStockOneMember
2023-06-30
0001860657
allr:DeemedDividendThreeMember
allr:SeriesAPreferredStockOneMember
2023-04-01
2023-06-30
0001860657
allr:WarrantDerivativeLiabilityMember
2023-06-30
0001860657
us-gaap:AdditionalPaidInCapitalMember
2023-06-30
0001860657
allr:FairValueAdjustmentToDerivativeAndWarrantLiabilitiesMember
2023-06-30
0001860657
us-gaap:SeriesCPreferredStockMember
2024-01-01
2024-06-30
0001860657
us-gaap:WarrantMember
2024-06-30
0001860657
srt:MaximumMember
2023-01-01
2023-06-30
0001860657
srt:MinimumMember
2023-01-01
2023-06-30
0001860657
allr:CommonSharePurchaseWarrantsMember
2022-12-31
0001860657
allr:ExchangeWarrantsMember
2022-12-31
0001860657
allr:CommonSharePurchaseWarrantsMember
2023-01-01
2023-12-31
0001860657
allr:ExchangeWarrantsMember
2023-01-01
2023-12-31
0001860657
allr:CommonSharePurchaseWarrantsMember
2023-12-31
0001860657
allr:ExchangeWarrantsMember
2023-12-31
0001860657
allr:CommonSharePurchaseWarrantsMember
2024-01-01
2024-06-30
0001860657
allr:ExchangeWarrantsMember
2024-01-01
2024-06-30
0001860657
allr:CommonSharePurchaseWarrantsMember
2024-06-30
0001860657
allr:ExchangeWarrantsMember
2024-06-30
0001860657
us-gaap:MeasurementInputExercisePriceMember
allr:BlackScholesMember
2023-04-30
0001860657
us-gaap:MeasurementInputExercisePriceMember
allr:BlackScholesMember
2023-07-31
0001860657
us-gaap:MeasurementInputExercisePriceMember
allr:BlackScholesMember
2023-09-30
0001860657
us-gaap:MeasurementInputSharePriceMember
allr:BlackScholesMember
2023-04-30
0001860657
us-gaap:MeasurementInputSharePriceMember
allr:BlackScholesMember
2023-07-31
0001860657
us-gaap:MeasurementInputSharePriceMember
allr:BlackScholesMember
2023-09-30
0001860657
us-gaap:MeasurementInputRiskFreeInterestRateMember
allr:BlackScholesMember
2023-04-30
0001860657
us-gaap:MeasurementInputRiskFreeInterestRateMember
allr:BlackScholesMember
2023-07-31
0001860657
us-gaap:MeasurementInputRiskFreeInterestRateMember
allr:BlackScholesMember
2023-09-30
0001860657
us-gaap:MeasurementInputExpectedTermMember
allr:BlackScholesMember
2023-04-30
0001860657
us-gaap:MeasurementInputExpectedTermMember
allr:BlackScholesMember
2023-07-31
0001860657
us-gaap:MeasurementInputExpectedTermMember
allr:BlackScholesMember
2023-09-30
0001860657
us-gaap:MeasurementInputPriceVolatilityMember
allr:BlackScholesMember
2023-04-30
0001860657
us-gaap:MeasurementInputPriceVolatilityMember
allr:BlackScholesMember
2023-07-31
0001860657
us-gaap:MeasurementInputPriceVolatilityMember
allr:BlackScholesMember
2023-09-30
0001860657
us-gaap:MeasurementInputExercisePriceMember
2023-06-30
0001860657
us-gaap:MeasurementInputSharePriceMember
2023-06-30
0001860657
us-gaap:MeasurementInputRiskFreeInterestRateMember
2023-06-30
0001860657
us-gaap:MeasurementInputExpectedTermMember
2023-06-30
0001860657
us-gaap:MeasurementInputPriceVolatilityMember
2023-06-30
0001860657
allr:ExpectedProbabilityOfEventMember
2023-06-30
0001860657
allr:ReverseShareSplitMember
2024-04-04
2024-04-04
0001860657
srt:MaximumMember
us-gaap:CommonStockMember
2024-03-31
0001860657
srt:MinimumMember
us-gaap:CommonStockMember
2024-03-31
0001860657
srt:MinimumMember
us-gaap:CommonStockMember
2024-06-30
0001860657
srt:MaximumMember
us-gaap:CommonStockMember
2024-06-30
0001860657
srt:MaximumMember
2024-06-30
0001860657
allr:ReverseShareSplitMember
us-gaap:PreferredStockMember
2024-06-30
0001860657
us-gaap:PreferredStockMember
2024-06-30
0001860657
2024-03-19
2024-03-19
0001860657
us-gaap:WarrantMember
2024-04-12
2024-04-12
0001860657
us-gaap:WarrantMember
2024-04-12
0001860657
us-gaap:WarrantMember
2024-05-02
2024-05-02
0001860657
us-gaap:WarrantMember
us-gaap:CommonStockMember
2024-05-02
0001860657
us-gaap:WarrantMember
us-gaap:CommonStockMember
2023-06-30
0001860657
us-gaap:WarrantMember
2023-06-30
0001860657
allr:PreFundedWarrantsMember
us-gaap:CommonStockMember
2023-06-30
0001860657
us-gaap:CommonStockMember
2023-06-30
0001860657
allr:PreFundedWarrantsMember
us-gaap:SeriesAPreferredStockMember
us-gaap:CommonStockMember
allr:PublicOfferingMember
2023-06-30
0001860657
allr:PreFundedWarrantsMember
2023-06-30
0001860657
us-gaap:SeriesAPreferredStockMember
us-gaap:CommonStockMember
2024-06-30
0001860657
allr:JamesGCullemMember
2024-01-01
2024-06-30
0001860657
allr:ATMMember
2024-01-01
2024-06-30
0001860657
us-gaap:CommonStockMember
2024-01-01
2024-06-30
0001860657
us-gaap:ConvertiblePreferredStockMember
2023-06-30
0001860657
allr:PreFundedWarrantsMember
us-gaap:SeriesAPreferredStockMember
us-gaap:CommonStockMember
2023-06-30
0001860657
2022-12-31
2022-12-31
0001860657
us-gaap:GeneralAndAdministrativeExpenseMember
2024-04-01
2024-06-30
0001860657
us-gaap:ResearchAndDevelopmentExpenseMember
2024-04-01
2024-06-30
0001860657
us-gaap:GeneralAndAdministrativeExpenseMember
2023-04-01
2023-06-30
0001860657
us-gaap:ResearchAndDevelopmentExpenseMember
2023-04-01
2023-06-30
0001860657
us-gaap:GeneralAndAdministrativeExpenseMember
2024-01-01
2024-06-30
0001860657
us-gaap:ResearchAndDevelopmentExpenseMember
2024-01-01
2024-06-30
0001860657
us-gaap:GeneralAndAdministrativeExpenseMember
2023-01-01
2023-06-30
0001860657
us-gaap:ResearchAndDevelopmentExpenseMember
2023-01-01
2023-06-30
0001860657
2023-12-30
0001860657
2023-12-31
2023-12-31
0001860657
2024-01-26
2024-01-26
0001860657
srt:MaximumMember
2023-05-26
0001860657
srt:MinimumMember
2023-05-26
0001860657
2023-07-18
0001860657
2024-03-01
0001860657
2024-05-01
0001860657
allr:EisaiMember
2024-09-01
2024-09-01
0001860657
allr:EisaiMember
2024-06-30
0001860657
srt:MinimumMember
2024-01-01
2024-06-30
0001860657
srt:MaximumMember
2024-01-01
2024-06-30
0001860657
srt:MinimumMember
allr:EisaiMember
2024-01-01
2024-06-30
0001860657
srt:MaximumMember
allr:EisaiMember
2024-01-01
2024-06-30
0001860657
srt:MinimumMember
allr:EisaiRoyaltiesOneMember
2024-01-01
2024-06-30
0001860657
srt:MaximumMember
allr:EisaiRoyaltiesOneMember
2024-01-01
2024-06-30
0001860657
srt:MinimumMember
allr:EisaiRoyaltiesOneMember
2024-01-01
2024-06-30
0001860657
srt:MaximumMember
allr:EisaiRoyaltiesOneMember
2024-01-01
2024-06-30
0001860657
srt:MinimumMember
allr:EisaiRoyaltiesTwoMember
2024-01-01
2024-06-30
0001860657
srt:MaximumMember
allr:EisaiRoyaltiesTwoMember
2024-01-01
2024-06-30
0001860657
srt:MinimumMember
allr:EisaiRoyaltiesTwoMember
2024-01-01
2024-06-30
0001860657
srt:MaximumMember
allr:EisaiRoyaltiesTwoMember
2024-01-01
2024-06-30
0001860657
srt:MinimumMember
allr:EisaiRoyaltiesThreeMember
2024-01-01
2024-06-30
0001860657
srt:MaximumMember
allr:EisaiRoyaltiesThreeMember
2024-01-01
2024-06-30
0001860657
allr:EisaiRoyaltiesThreeMember
2024-01-01
2024-06-30
0001860657
srt:DirectorMember
2024-01-01
2024-06-30
0001860657
us-gaap:RelatedPartyMember
2023-01-01
2023-06-30
0001860657
srt:ChiefExecutiveOfficerMember
2024-06-01
2024-06-01
0001860657
us-gaap:WarrantMember
2024-04-01
2024-06-30
0001860657
us-gaap:WarrantMember
2023-01-01
2023-06-30
0001860657
allr:SeriesAConvertiblePreferredStockMember
2024-04-01
2024-06-30
0001860657
allr:SeriesAConvertiblePreferredStockMember
2023-01-01
2023-06-30
0001860657
us-gaap:WarrantMember
us-gaap:FairValueInputsLevel1Member
us-gaap:FairValueMeasurementsRecurringMember
2024-06-30
0001860657
us-gaap:WarrantMember
us-gaap:FairValueInputsLevel2Member
us-gaap:FairValueMeasurementsRecurringMember
2024-06-30
0001860657
us-gaap:WarrantMember
us-gaap:FairValueInputsLevel3Member
us-gaap:FairValueMeasurementsRecurringMember
2024-06-30
0001860657
us-gaap:WarrantMember
us-gaap:FairValueMeasurementsRecurringMember
2024-06-30
0001860657
us-gaap:FairValueInputsLevel1Member
us-gaap:FairValueMeasurementsRecurringMember
2024-06-30
0001860657
us-gaap:FairValueInputsLevel2Member
us-gaap:FairValueMeasurementsRecurringMember
2024-06-30
0001860657
us-gaap:FairValueInputsLevel3Member
us-gaap:FairValueMeasurementsRecurringMember
2024-06-30
0001860657
us-gaap:FairValueMeasurementsRecurringMember
2024-06-30
0001860657
us-gaap:WarrantMember
us-gaap:FairValueInputsLevel1Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
us-gaap:WarrantMember
us-gaap:FairValueInputsLevel2Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
us-gaap:WarrantMember
us-gaap:FairValueInputsLevel3Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
us-gaap:WarrantMember
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
allr:DerivativeWarrantLiabilityMember
us-gaap:FairValueInputsLevel1Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
allr:DerivativeWarrantLiabilityMember
us-gaap:FairValueInputsLevel2Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
allr:DerivativeWarrantLiabilityMember
us-gaap:FairValueInputsLevel3Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
allr:DerivativeWarrantLiabilityMember
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
us-gaap:FairValueInputsLevel1Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
us-gaap:FairValueInputsLevel2Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
us-gaap:FairValueInputsLevel3Member
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
us-gaap:FairValueMeasurementsRecurringMember
2023-12-31
0001860657
us-gaap:CommonStockMember
2024-06-18
0001860657
us-gaap:SubsequentEventMember
2024-07-01
2024-08-05
xbrli:shares
iso4217:USD
iso4217:USD
xbrli:shares
xbrli:pure
I, Thomas H. Jensen, certify that:
I, Joan Y. Brown, certify that:
In connection with the Quarterly
Report of Allarity Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2024, as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), the undersigned, in the capacities and on the date indicated below,
hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his
knowledge:
In connection with the Quarterly
Report of Allarity Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2024, as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), the undersigned, in the capacities and on the date indicated below,
hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to her
knowledge: