UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2024
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission
file number: 001-35813
ORAMED
PHARMACEUTICALS INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware | | 98-0376008 |
(State or Other Jurisdiction of Incorporation or Organization) | | (I.R.S. Employer Identification No.) |
| | |
1185 Avenue of the Americas, Third Floor, New York, NY | | 10036 |
(Address of Principal Executive Offices) | | (Zip Code) |
844-967-2633
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class | | Trading symbol | | Name of each exchange on which registered |
Common Stock, par value $0.012 | | ORMP | | The Nasdaq Capital Market, Tel Aviv Stock Exchange |
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files).
Yes
☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | Emerging growth company | ☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
☐ No ☒
As
of May 9, 2024, there were 40,628,924 shares of the issuer’s common stock, $0.012 par value per share, outstanding.
ORAMED
PHARMACEUTICALS INC.
FORM
10-Q
TABLE
OF CONTENTS
As
used in this Quarterly Report on Form 10-Q, the terms “we,” “us,” “our,” “Oramed” and
the “Company” mean Oramed Pharmaceuticals Inc. and our wholly-owned subsidiaries, unless otherwise indicated. All dollar
amounts refer to U.S. Dollars unless otherwise indicated.
On
March 31, 2024, the exchange rate between the New Israeli Shekel, or NIS, and the dollar, as quoted by the Bank of Israel, was NIS 3.681
to $1.00. Unless indicated otherwise by the context, statements in this Quarterly Report on Form 10-Q that provide the dollar equivalent
of NIS amounts or provide the NIS equivalent of dollar amounts are based on such exchange rate.
Cautionary
Statement Regarding Forward-Looking Statements
The
statements contained in this Quarterly Report on Form 10-Q that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws and the Israeli securities
law. Words such as “expects,” “anticipates,” “intends,” “plans,” “planned expenditures,”
“believes,” “seeks,” “estimates,” “considers” and similar expressions or variations of
such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying
forward-looking statements as denoted in this Quarterly Report on Form 10-Q. Additionally, statements concerning future matters are forward-looking
statements. We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties
and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements,
or industry results, to be materially different from any future results, performance, levels of activity, or our achievements, or industry
results, expressed or implied by such forward-looking statements. Such forward-looking statements include, among other statements, statements
regarding the following:
|
● |
our comprehensive analysis
of data from our ORA-D-013-1 Phase 3 trial and plans to move forward with a protocol for a new Phase 3 clinical trial to be submitted
to the U.S. Food and Drug Administration, or FDA; |
|
● |
our plan to evaluate potential
strategic opportunities; |
|
● |
our ability to recover the proceeds
and/or collateral under the Note (as defined herein) and related agreements from Scilex Holding Company, or Scilex; |
|
● |
the fluctuating market price and liquidity of the
common stock of Scilex underlying the warrants we hold; |
|
● |
the possibility that the anticipated benefits of the
Scilex Transaction (as defined herein) are not realized when expected or at all, including as a result of the impact of, or problems
arising from, the ability of Scilex to repay the Note and the ability of the Company to realize the value of the warrants; |
|
● |
the ability of Oramed, Hefei Tianhui Biotech Co.,
Ltd., or HTIT Biotech, and Technowl Limited to reach agreement and enter into additional agreements within a three-month
period of the signing of the JV Agreement (as defined herein), and the ability of the parties to succeed in the goals set out for
the joint venture; |
|
● |
our exposure to potential litigation; |
|
● |
our ability to enhance value for our stockholders; |
|
● |
the expected development and potential benefits from
our products; |
|
● |
the prospects of entering into additional license agreements,
or other partnerships or forms of cooperation with other companies or medical institutions; |
|
● |
future milestones, conditions and royalties under our
license agreements; |
|
● |
the potential of the Oravax Medical Inc., or Oravax,
vaccine to protect against the coronavirus, or COVID-19; |
|
● |
our research and development plans, including preclinical
and clinical trials plans and the timing of enrollment, obtaining results and conclusion of trials; |
|
● |
our belief that our technology has the potential to
deliver medications and vaccines orally that today can only be delivered via injection; |
|
● |
the competitive ability of our technology based on
product efficacy, safety, patient convenience, reliability, value and patent position; |
|
● |
the potential market demand for our products; |
|
● |
our ability to obtain patent protection for our intellectual
property; |
|
● |
our expectation that our research and development expenses
will continue to be our major expenditure; |
|
● |
our expectations regarding our short- and long-term
capital requirements; |
|
● |
our outlook for the coming months and future periods,
including but not limited to our expectations regarding future revenue and expenses; and |
|
● |
information with respect to any other plans and strategies
for our business. |
Although
forward-looking statements in this Quarterly Report on Form 10-Q reflect the good faith judgment of our management, such statements can
only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and
uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the
forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation,
those specifically addressed under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2023, or our Annual Report, as filed with the Securities and Exchange Commission, or the SEC, on March 6, 2024,
as well as those discussed elsewhere in our Annual Report and expressed from time to time in our other filings with the SEC. In addition,
historic results of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research or
trials would not suggest different conclusions. Also, historic results referred to in this Quarterly Report on Form 10-Q could be interpreted
differently in light of additional research, clinical and preclinical trials results. Readers are urged not to place undue reliance on
these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we
undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise
after the date of this Quarterly Report on Form 10-Q. Readers are urged to carefully review and consider the various disclosures made
throughout the entirety of this Quarterly Report on Form 10-Q which attempt to advise interested parties of the risks and factors that
may affect our business, financial condition, results of operations and prospects.
PART
I – FINANCIAL INFORMATION
ITEM
1 - FINANCIAL STATEMENTS
ORAMED
PHARMACEUTICALS INC.
INTERIM
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MARCH 31, 2024
TABLE
OF CONTENTS
ORAMED
PHARMACEUTICALS INC.
INTERIM
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S.
Dollars in thousands (except share and per share data)
(UNAUDITED)
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
Assets | |
| | |
| |
| |
| | |
| |
CURRENT ASSETS: | |
| | |
| |
Cash and cash equivalents | |
$ | 18,576 | | |
$ | 9,055 | |
Short-term deposits | |
| 80,285 | | |
| 95,279 | |
Investments at fair value | |
| 77,733 | | |
| 57,713 | |
Prepaid expenses and other current assets | |
| 501 | | |
| 537 | |
Total current assets | |
| 177,095 | | |
| 162,584 | |
| |
| | | |
| | |
LONG-TERM ASSETS: | |
| | | |
| | |
Long-term deposits | |
| 7 | | |
| 7 | |
Investments at fair value | |
| 19,544 | | |
| 51,035 | |
Marketable securities | |
| 2,026 | | |
| 1,807 | |
Other non-marketable equity securities | |
| 3,524 | | |
| 3,524 | |
Amounts funded in respect of employee rights upon retirement | |
| 29 | | |
| 27 | |
Property and equipment, net | |
| 819 | | |
| 873 | |
Operating lease right-of-use assets | |
| 608 | | |
| 694 | |
Total long-term assets | |
| 26,557 | | |
| 57,967 | |
Total assets | |
$ | 203,652 | | |
$ | 220,551 | |
| |
| | | |
| | |
Liabilities and stockholders’ equity | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 1,267 | | |
$ | 1,609 | |
Short-term borrowings | |
| 32,034 | | |
| 51,013 | |
Payable to related parties | |
| 1 | | |
| 325 | |
Operating lease liabilities | |
| 254 | | |
| 267 | |
Total current liabilities | |
| 33,556 | | |
| 53,214 | |
| |
| | | |
| | |
LONG-TERM LIABILITIES: | |
| | | |
| | |
Long-term deferred revenues | |
| 4,000 | | |
| 4,000 | |
Employee rights upon retirement | |
| 29 | | |
| 28 | |
Provision for uncertain tax position | |
| 11 | | |
| 11 | |
Operating lease liabilities | |
| 272 | | |
| 342 | |
Other liabilities | |
| 63 | | |
| 63 | |
Total long-term liabilities | |
| 4,375 | | |
| 4,444 | |
| |
| | | |
| | |
COMMITMENTS (note 3) | |
| | | |
| | |
| |
| | | |
| | |
Equity | |
| | | |
| | |
| |
| | | |
| | |
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS: | |
| | | |
| | |
Common stock, $0.012 par value (60,000,000 authorized shares; 40,519,160 and 40,338,979 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively) | |
| 487 | | |
| 485 | |
Additional paid-in capital | |
| 322,172 | | |
| 320,892 | |
Accumulated deficit | |
| (156,020 | ) | |
| (157,556 | ) |
Total stockholders’ equity | |
| 166,639 | | |
| 163,821 | |
Non-controlling interests | |
| (918 | ) | |
| (928 | ) |
Total equity | |
| 165,721 | | |
| 162,893 | |
Total liabilities and equity | |
$ | 203,652 | | |
$ | 220,551 | |
The
accompanying notes are an integral part of the condensed consolidated financial statements.
ORAMED
PHARMACEUTICALS INC.
INTERIM
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
U.S.
Dollars in thousands (except share and per share data)
(UNAUDITED)
| |
Three months ended
March 31, | |
| |
2024 | | |
2023 | |
REVENUES | |
$ | - | | |
$ | 666 | |
RESEARCH AND DEVELOPMENT EXPENSES | |
| (1,179 | ) | |
| (4,427 | ) |
SALES AND MARKETING EXPENSES | |
| - | | |
| (184 | ) |
GENERAL AND ADMINISTRATIVE EXPENSES | |
| (1,783 | ) | |
| (1,263 | ) |
OPERATING LOSS | |
| (2,962 | ) | |
| (5,208 | ) |
| |
| | | |
| | |
INTEREST EXPENSES | |
| (592 | ) | |
| - | |
FINANCIAL INCOME, NET | |
| 5,088 | | |
| 1,597 | |
NET INCOME (LOSS) | |
$ | 1,534 | | |
$ | (3,611 | ) |
NET INCOME (LOSS) ATTRIBUTABLE TO NON-CONTROLLING INTERESTS | |
| (2 | ) | |
| (216 | ) |
NET INCOME (LOSS) ATTRIBUTABLE TO STOCKHOLDERS | |
$ | 1,536 | | |
$ | (3,395 | ) |
| |
| | | |
| | |
BASIC INCOME (LOSS) PER SHARE OF COMMON STOCK | |
$ | 0.04 | | |
$ | (0.08 | ) |
DILUTED INCOME (LOSS) PER SHARE OF COMMON STOCK | |
$ | 0.04 | | |
$ | (0.08 | ) |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC INCOME (LOSS) PER SHARE OF COMMON STOCK | |
| 40,835,953 | | |
| 40,041,258 | |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING DILUTED INCOME (LOSS) PER SHARE OF COMMON STOCK | |
| 41,564,007 | | |
| 40,041,258 | |
The
accompanying notes are an integral part of the condensed consolidated financial statements.
ORAMED
PHARMACEUTICALS INC.
INTERIM
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
U.S.
Dollars in thousands
(UNAUDITED)
| |
Common Stock | | |
Additional paid-in | | |
Accumulated | | |
Total stockholders’ | | |
Non- controlling | | |
Total | |
| |
Shares | | |
$ | | |
capital | | |
deficit | | |
equity | | |
interests | | |
equity | |
| |
In thousands | | |
| | |
| | |
| | |
| | |
| | |
| |
BALANCE AS OF DECEMBER 31, 2023 | |
| 40,339 | | |
$ | 485 | | |
$ | 320,892 | | |
$ | (157,556 | ) | |
$ | 163,821 | | |
$ | (928 | ) | |
$ | 162,893 | |
CHANGES DURING THE THREE MONTH PERIOD ENDED MARCH 31, 2024 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
STOCK-BASED COMPENSATION | |
| 180 | | |
| 2 | | |
| 1,280 | | |
| - | | |
| 1,282 | | |
| - | | |
| 1,282 | |
STOCK-BASED COMPENSATION OF SUBSIDIARY | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 12 | | |
| 12 | |
NET INCOME | |
| - | | |
| - | | |
| - | | |
| 1,536 | | |
| 1,536 | | |
| (2 | ) | |
| 1,534 | |
BALANCE AS OF MARCH 31, 2024 | |
| 40,519 | | |
$ | 487 | | |
$ | 322,172 | | |
$ | (156,020 | ) | |
$ | 166,639 | | |
$ | (918 | ) | |
$ | 165,721 | |
| |
Common Stock | | |
Additional paid-in | | |
Accumulated | | |
Total stockholders’ | | |
Non- controlling | | |
Total | |
| |
Shares | | |
$ | | |
capital | | |
deficit | | |
equity | | |
interests | | |
equity | |
| |
In thousands | | |
| | |
| | |
| | |
| | |
| | |
| |
BALANCE AS OF DECEMBER 31, 2022 | |
| 39,564 | | |
$ | 476 | | |
$ | 314,417 | | |
$ | (163,081 | ) | |
$ | 151,812 | | |
$ | (656 | ) | |
$ | 151,156 | |
CHANGES DURING THE THREE MONTH PERIOD ENDED MARCH 31, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
ISSUANCE OF COMMON STOCK, NET | |
| 193 | | |
| 2 | | |
| 2,428 | | |
| - | | |
| 2,430 | | |
| - | | |
| 2,430 | |
STOCK-BASED COMPENSATION | |
| 213 | | |
| 3 | | |
| 120 | | |
| - | | |
| 123 | | |
| - | | |
| 123 | |
STOCK-BASED COMPENSATION OF SUBSIDIARY | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 50 | | |
| 50 | |
NET LOSS | |
| - | | |
| - | | |
| - | | |
| (3,395 | ) | |
| (3,395 | ) | |
| (216 | ) | |
| (3,611 | ) |
BALANCE AS OF MARCH 31, 2023 | |
| 39,970 | | |
$ | 481 | | |
$ | 316,965 | | |
$ | (166,476 | ) | |
$ | 150,970 | | |
$ | (822 | ) | |
$ | 150,148 | |
The
accompanying notes are an integral part of the condensed consolidated financial statements.
ORAMED
PHARMACEUTICALS INC.
INTERIM
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S.
dollars in thousands
(UNAUDITED)
| |
Three months ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net income (loss) | |
$ | 1,534 | | |
$ | (3,611 | ) |
Adjustments required to reconcile net income (loss) to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 56 | | |
| 37 | |
Exchange differences and interest on deposits and held to maturity bonds | |
| (5 | ) | |
| (1,267 | ) |
Changes in fair value of investments | |
| (3,748 | ) | |
| (65 | ) |
Stock-based compensation | |
| 1,294 | | |
| 173 | |
Gain on amounts funded in respect of employee rights upon retirement | |
| (2 | ) | |
| - | |
Accrued interest on short-term borrowings to maturity | |
| 21 | | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| 36 | | |
| (34 | ) |
Accounts payable, accrued expenses and related parties | |
| (666 | ) | |
| (103 | ) |
Net changes in operating lease | |
| 3 | | |
| (16 | ) |
Deferred revenues | |
| - | | |
| (666 | ) |
Liability for employee rights upon retirement | |
| 1 | | |
| 5 | |
Other liabilities | |
| - | | |
| (2 | ) |
Total net cash used in operating activities | |
| (1,476 | ) | |
| (5,549 | ) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Purchase of short-term deposits | |
| (4,000 | ) | |
| (19,000 | ) |
Proceeds from short-term deposits | |
| 19,000 | | |
| 4,500 | |
Proceeds from maturity of held to maturity securities | |
| - | | |
| 1,496 | |
Proceeds from long-term investments | |
| 15,000 | | |
| - | |
Purchase of property and equipment | |
| (2 | ) | |
| (199 | ) |
Total net cash provided by (used in) investing activities | |
| 29,998 | | |
| (13,203 | ) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from issuance of common stock, net of issuance costs | |
| - | | |
| 2,430 | |
Loans repaid | |
| (19,000 | ) | |
| - | |
Total net cash provided by (used in) financing activities | |
| (19,000 | ) | |
| 2,430 | |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | |
| (1 | ) | |
| (38 | ) |
| |
| | | |
| | |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | |
| 9,521 | | |
| (16,360 | ) |
| |
| | | |
| | |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | |
| 9,055 | | |
| 40,464 | |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | |
$ | 18,576 | | |
$ | 24,104 | |
| |
| | | |
| | |
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS - | |
| | | |
| | |
Interest received | |
$ | 1,341 | | |
$ | 308 | |
Interest paid | |
$ | (571 | ) | |
$ | - | |
The
accompanying notes are an integral part of the condensed consolidated financial statements.
ORAMED
PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
1 - GENERAL:
|
a. |
Incorporation and Operations |
Oramed
Pharmaceuticals Inc. (collectively with its subsidiaries, the “Company”, unless the context indicates otherwise), a Delaware
corporation, was incorporated on April 12, 2002.
On
March 18, 2021, the Company entered into a license agreement (the “Oravax License Agreement”) with Oravax Medical Inc. (“Oravax”)
and into a stockholders agreement (the “Stockholders Agreement”) with Akers Biosciences Inc., Premas Biotech Pvt. Ltd., Cutter
Mill Capital LLC and Run Ridge LLC. According to the Stockholders Agreement, Oravax issued 1,890,000 shares of its capital stock to the
Company, representing 63% of the issued and outstanding share capital of Oravax as of the date of issuance. Consequently, Oramed consolidates
Oravax in its consolidated financial statements since that time.
On
November 23, 2021, Oravax incorporated a wholly-owned subsidiary in Israel, Oravax Medical Ltd., which is engaged in research and development.
Effective January 1, 2022, Oravax transferred its rights and obligations under the Oravax License Agreement to Oravax Medical Ltd.
On
January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints. As a
result, the Company terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. As these results are considered a
triggering event, the Company evaluated all of its long lived assets which include fixed assets and operating lease right-of-use
assets in the first quarter of 2023 and concluded that no impairment was required. The Company completed an analysis of the data
from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such as body mass
index (BMI), baseline HbA1c, age, gender and body weight, responded well to oral insulin. These subsets exhibited an over 1% placebo
adjusted, statistically significant, reduction in HbA1c. Based on this analysis, the Company is working on a protocol for a new
Phase 3 clinical trial to be submitted to the FDA.
On
January 22, 2024, the Company and its wholly-owned subsidiary, Oramed Ltd., entered into a joint venture agreement (the “JV Agreement”),
with Hefei Tianhui Biotech Co., Ltd. (“HTIT Biotech”) and Technowl Limited, a wholly-owned indirect subsidiary of HTIT Biotech
(“HTIT Sub” and together with HTIT Biotech, “HTIT”), pursuant to which, subject to the terms and conditions set
forth in the JV Agreement, the parties will establish a joint venture (the “JV”), based on the Company’s oral drug
delivery technology.
The
JV will focus on the development and worldwide commercialization of innovative products based on the Company’s oral insulin and
POD™ (Protein Oral Delivery) pipeline and HTIT’s manufacturing capabilities and technologies. The parties intend for the
JV to use the protocol the Company is currently working on to initiate a Phase 3 oral insulin trial in the United States.
The
Company and HTIT will initially hold equal shares in the JV, with each owning 50% of the equity. The board of directors will initially
consist of equal representation from HTIT and the Company. HTIT will contribute to the JV $70,000 in cash, while the Company will contribute
$20,000 (comprised of $10,000 in cash and $10,000 in shares of the Company’s common stock that will be subject to certain registration
rights) and will transfer intellectual property related to its oral insulin and POD™ technology, as well as other assets in the
Company’s pipeline. HTIT will have an option to invest additional funds into the JV up to an aggregate amount of $20,000, thereby
increasing its equity holdings and granting the right to increase its board representation. The Company will be entitled to receive a
3% royalty on gross revenues of the JV generated from Company-related assets.
The
consummation of the JV Agreement is subject to and contingent upon the parties entering into additional agreements within a three-month
period from the signature of the JV Agreement, including an asset transfer agreement for the transfer of the Company’s intellectual
property to the JV, a commercial supply agreement for the manufacture and supply of products by HTIT to the JV, as well as other documents
and agreements to regulate the relationship of the parties and the JV to be formed pursuant to the JV Agreement. There is no assurance
that the parties will complete and sign these additional agreements within the agreed timeline or at all. If such agreements are not
signed within the agreed timeframe, then either party may apply a 30-day extension, after which the JV Agreement may be terminated and
voided by either party. The 30-day extension was applied by the Company on April 18, 2024 and will last until May 22, 2024. Thereafter,
the consummation of the JV transaction is further subject to the satisfaction or waiver of certain other closing conditions within a
three-month period following the completion of the aforesaid ancillary agreements. If the closing conditions are not met within the agreed
timeframe, then either party may apply a 30-day extension, after which the JV Agreement may be terminated and voided by either party.
In addition, completion of the transactions contemplated under the JV Agreement is subject to the satisfaction or waiver of customary
and certain other closing conditions.
ORAMED
PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
1 - GENERAL (continued):
|
b. |
Development and Liquidity Risks |
The
Company is engaged in research and development in the biotechnology field for innovative pharmaceutical solutions, including an orally
ingestible insulin capsule to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules for delivery
of other polypeptides, and has not generated significant revenues from its operations. Following the termination of the ORA-D-013-1 and
ORA-D-013-2 Phase 3 trials, the Company’s research and development activities have been significantly reduced while it conducts
a strategic review process. As a result, the Company is currently incurring lower research and development and sales and marketing expenses.
Based
on the Company’s current cash resources and commitments, the Company believes it will be able to maintain its current planned activities
and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that the Company will
not need additional funds prior to such time. If there are unexpected increases in its operating expenses, the Company may need to seek
additional financing during the next 12 months. The Company may also need additional funds to realize the decisions made as part of its
strategic review process. The Company cannot predict the outcome of these activities.
On
August 7, 2023, the Company entered into a Stock Purchase Agreement, as subsequently amended on August 9, 2023 and August 21, 2023, (the
“Sorrento SPA”), with Sorrento Therapeutics, Inc. (“Sorrento”), to acquire certain equity securities of Scilex
Holding Company (“Scilex”), owned by Sorrento (the “Purchased Securities”), for a purchase price of $105,000.
Sorrento and its affiliated debtor, Scintilla Pharmaceuticals, Inc. (“Scintilla” and together with Sorrento, the “Debtors”)
are in Chapter 11 bankruptcy proceedings.
On
August 9, 2023, the Company entered into a Senior Secured, Super-Priority Debtor-in-Possession Loan and Security Agreement (the “Senior
DIP Loan Agreement”) with the Debtors in the principal amount of $100,000, which included a non-refundable closing fee of $450
paid in full out of the proceeds. This amount was subsequently drawn in full by the Debtors and was intended to be used by the Company
as a credit for the consideration for the Purchased Securities, with an additional $5,000 in cash to be paid by the Company at closing.
Thereafter, the Company and Sorrento continued discussions and negotiations relating to the sale contemplated under the Sorrento SPA.
On
September 21, 2023, the Company entered into and consummated the transactions contemplated by a Securities Purchase Agreement (the “Scilex
SPA”) with Scilex and Acquiom Agency Services LLC. Pursuant to the Scilex SPA, in exchange for Scilex assuming outstanding obligations
of Sorrento under the Senior DIP Loan Agreement (the “DIP Assumption”) and for the ability to credit the amounts assumed
under the DIP Assumption in exchange for certain equity securities of Scilex owned by Sorrento, Scilex (i) issued to the Company (A)
a Senior Secured Promissory Note due 18 months from the date of issuance in the principal amount of $101,875 (the “Note”),
which includes accrued and unpaid interest of $875 under the Senior DIP Loan Agreement and $1,000 of fees added to the principal amount
of the Note, (B) the Closing Penny Warrant (as defined herein), and (C) the Subsequent Penny Warrants (as defined herein), and (ii) caused
the Transferred Warrants (as defined herein) to be transferred to the Company. For further details, see note 7.
On
August 8, 2023, the Company borrowed an aggregate of $99,550 pursuant to loan agreements from Israel Discount Bank Ltd. For further details,
see note 6.
ORAMED
PHARMACEUTICALS INC.
NOTES
TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES:
| a. | Condensed consolidated financial statements preparation |
The
condensed consolidated financial statements included herein have been prepared in accordance with United States generally accepted accounting
principles (“U.S. GAAP”) and, on the same basis as the audited consolidated financial statements included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “2023 Form 10-K”). These condensed consolidated
financial statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair statement
of the results of the periods presented. Certain information and disclosures normally included in annual consolidated financial statements
have been omitted in this interim period report pursuant to the rules and regulations of the Securities and Exchange Commission. Because
the condensed consolidated interim financial statements do not include all of the information and disclosures required by U.S. GAAP for
annual financial statements, they should be read in conjunction with the audited consolidated financial statements and notes included
in the 2023 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results.
| b. | Earnings (loss) per common share |
Basic
net earnings (loss) per common share are computed by dividing the net earnings (loss) attributable to stockholders for the period by
the weighted average number of shares of common stock outstanding for each period, including vested restricted stock units (“RSUs”).
Outstanding stock options, warrants and RSUs have been excluded from the calculation of the diluted loss per share because all such securities
are anti-dilutive for the three month period ended March 31, 2023.
For
the diluted earnings per share calculation for the three month period ended March 31, 2024, the weighted average number of shares outstanding
during the three month period ended March 31, 2024 is adjusted for the potential dilution that could occur in connection with employee
share-based payment, using the treasury stock method.
The
weighted average number of stock options, warrants and RSUs that has been excluded from the calculation of the diluted income per share
as of March 31, 2024 was 4,846,474 shares.
The
weighted average number of stock options, warrants and RSUs excluded from the calculation of diluted net loss was 3,357,911 for the three
month period ended March 31, 2023.
ORAMED
PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| c. | Recently issued accounting pronouncements, not yet adopted |
In
November 2023, the Financial Accounting Standard Board (the “FASB”) issued Accounting Standards Update
(“ASU”) 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures.”
This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses
that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or
loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s
profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the
disclosures required under ASC 280 “Segment Reporting”. The guidance is effective for fiscal years beginning after
December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The
amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The
Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements related
disclosures.
In
December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This guidance
is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor
requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid
both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective
basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance
to determine the impact it may have on its consolidated financial statements disclosures.
The
Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price
that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the
measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value
hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described
as follows:
|
Level 1: |
Quoted prices (unadjusted) in active markets that are
accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. |
|
Level 2: |
Observable prices that
are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly
or indirectly. |
|
Level 3: |
Unobservable inputs are used when little or no market
data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
As
of March 31, 2024, the fair value of marketable equity securities as presented in note 4 and of the Transferred Warrants included in
the Scilex SPA as presented in note 7 were based on a Level 1 measurement. The fair value of the Closing Penny Warrant as presented in
note 7 were based on a Level 2 measurement. The fair value of the investment in non-marketable equity securities as presented in note
5, of the Subsequent Penny Warrants as presented in note 7 and of the Note as presented in note 7 were based on a Level 3 measurement.
As
of March 31, 2024, the carrying amounts of cash equivalents, short-term deposits, Short-Term Borrowings (as defined herein) and accounts
payable approximate their fair values due to the short-term maturities of these instruments.
The
amounts funded in respect of employee rights are stated at cash surrender value which approximates its fair value.
ORAMED
PHARMACEUTICALS INC.
NOTES
TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
3 - COMMITMENTS:
| a. | Medicox License Agreement On November 13, 2022, the Company entered into a distribution license agreement (“Medicox License Agreement”) with Medicox Co., Ltd. (“Medicox”). The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. The Medicox License Agreement is for ten years, but the parties have the right to terminate it upon 180 days’ notice. Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer price per capsule. In addition, Medicox will pay the Company up to $15,000 in developmental milestones, $2,000 of which have already been received by the Company, and up to 15% royalties on gross sales. Medicox will also be responsible for obtaining a regulatory approval in the Republic of Korea. The
Company is currently evaluating with Medicox a path forward to continue its collaboration, following the results of the ORA-D-013-1 Phase
3 trial. |
|
b. |
Grants from the Israel Innovation Authority (“IIA”) |
Under
the terms of the Company’s funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded,
up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based
on SOFR.
At
the time the grants were received, successful development of the related projects was not assured. The total amount received through
March 31, 2024 was $2,213 ($2,570 including interest).
As
of March 31, 2024, the liability to the IIA was $59.
ORAMED
PHARMACEUTICALS INC.
NOTES
TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
4 - MARKETABLE SECURITIES:
The
Company’s marketable securities include investments in equity securities of DNA GROUP (T.R.) Ltd. (formerly D.N.A Biomedical Solutions
Ltd.) (“DNA”), Entera Bio Ltd. (“Entera”), and the Transferred Warrants (as defined herein; for further details,
see note 7).
| |
March 31, 2024 | | |
December 31, 2023 | |
Long-term: | |
| | |
| |
DNA (see b below) | |
$ | 367 | | |
$ | 297 | |
Entera (see c below) | |
| 195 | | |
| 70 | |
Transferred Warrants (see note 7) | |
| 1,464 | | |
| 1,440 | |
| |
$ | 2,026 | | |
$ | 1,807 | |
The
DNA ordinary shares are traded on the Tel Aviv Stock Exchange. The fair value of those securities is measured at the quoted prices of
the securities on the measurement date.
During
the three month periods ended March 31, 2024 and March 31, 2023, the Company did not sell any of DNA’s ordinary shares. As of March
31, 2024, the Company owns approximately 1.4% of DNA’s outstanding ordinary shares.
The
cost of the securities as of both March 31, 2024 and December 31, 2023 was $595.
Entera
ordinary shares have been traded on the Nasdaq Capital Market since June 28, 2018. The Company measures the investment at fair value
from such date, since it has a readily determinable fair value (prior to such date the investment was accounted for as a cost method
investment (amounting to $1)).
ORAMED
PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
5 - OTHER NON-MARKETABLE EQUITY SECURITIES:
On
August 26, 2022, the Company entered into a stock purchase agreement with Diasome Pharmaceuticals, Inc. (“Diasome”), a privately-held
company, pursuant to which the Company purchased shares of Series B preferred stock of Diasome for an aggregate purchase price of approximately
$2,700. Following the purchase, the Company holds less than 5% of the issued and outstanding stock of Diasome. The stock purchase agreement
provides the Company with the option to purchase additional preferred shares of stock on a pro rata basis at similar terms to the terms
and conditions of that round contingent upon Diasome achieving certain milestones.
The
Company accounts for the investment under the measurement alternative in Accounting Standards Codification (“ASC”) 321 “Investments
– Equity Securities,” whereby the equity investment is recorded at cost, less impairment. The carrying amount is subsequently
remeasured to its fair value in accordance with the provisions of ASC 820 “Fair Value Measurement” when observable price
changes occur as of the date the transaction occurred, or it is impaired. Any adjustments to the carrying amount are recorded in the
statements of comprehensive income or loss.
The
Company’s non-marketable equity securities are an investment in a company without a readily determinable fair value. During fiscal
year 2023, the Company recorded an $824 increase in value due to the closing in June 2023 of a Series C investment round in Diasome.
The change was recorded using the transaction price of similar securities issued by Diasome, adjusted for contractual rights and obligations
of the securities held by the Company.
NOTE
6 - SHORT-TERM BORROWINGS:
On
August 8, 2023, the Company borrowed an aggregate of $99,550 pursuant to loan agreements from Israel Discount Bank Ltd. (the “Short-Term
Borrowings”). The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging
from 6.66% to 7.38%, and are secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount
of $99,550. The net proceeds of the Short-Term Borrowings were used to fund the Note (for further details, see note 7). The Short-Term
Borrowings are paid in one payment of principal and interest at each respective maturity. As of March 31, 2024, $70,146 was repaid under
the Short-Term Borrowings.
The aggregate remaining annual principal payments on debt until maturity is $30,550.
ORAMED
PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
7 - INVESTMENTS, AT FAIR VALUE:
Scilex
Transaction
On
September 21, 2023 (the “Closing Date”), the Company entered into and consummated the transactions (collectively, the “Transaction”)
contemplated by the Scilex SPA with Scilex and Acquiom Agency Services LLC. Pursuant to the Scilex SPA, in exchange for the DIP Assumption
and for the ability to credit the amounts assumed under the DIP Assumption in exchange for certain equity securities of Scilex owned
by Sorrento, Scilex (i) issued to the Company (A) the Note, (B) a warrant to purchase up to an aggregate of 4,500,000 shares of common
stock of Scilex, par value $0.0001 per share (“Scilex Common Stock”), with an exercise price of $0.01 per share and containing
certain restrictions on exercisability (the “Closing Penny Warrant”), and (C) warrants to purchase up to an aggregate of
8,500,000 shares of Scilex Common Stock (the “Subsequent Penny Warrants” and together with the Closing Penny Warrant, the
“Penny Warrants”), each with an exercise price of $0.01 per share and each with certain restrictions on exercisability, and
(ii) caused certain outstanding warrants to purchase up to an aggregate of 4,000,000 shares of Scilex Common Stock with an exercise price
of $11.50 per share to be transferred to the Company (the “Transferred Warrants” and together with the Penny Warrants, the
“Warrants”). In addition, on the Closing Date, Scilex reimbursed $1,910 of the Company’s Transaction expenses pursuant
to the Scilex SPA.
Pursuant
to the terms of the Scilex SPA, Scilex agreed to certain restrictions on additional issuances of equity securities. In connection with
the Transaction, the Company and Sorrento mutually agreed to terminate the Sorrento SPA and to release all claims the Company and Sorrento
may have against one another, and Scilex completed the acquisition of the Purchased Securities.
The
Note
The
principal of the Note issued on September 21, 2023 is $101,875, which includes accrued and unpaid interest of $875 under the Senior DIP
Loan Agreement and $1,000 of fees added to the principal amount of the Note. The Note matures on March 21, 2025 or upon an uncured event
of default, subject to certain mandatory prepayments, and bears interest at a rate per annum equal to Term SOFR (as defined in the Note)
plus 8.5% (subject to a Term SOFR floor of 4.0%), to be paid in-kind, by being capitalized and added to the principal amount of the Note
on a monthly basis. The Scilex SPA provides for principal payments of (i) $5,000 on December 21, 2023, (ii) $15,000 on March 21, 2024,
and (iii) $20,000 on each of June 21, 2024, September 21, 2024, and December 21, 2024, and for the entire remaining principal balance
of the Note to be paid on March 21, 2025. If the Note is not repaid in full on or prior to March 21, 2024, an exit fee equal to approximately
$3,056 shall be payable upon repayment of the Note in full.
The
Note constitutes senior secured indebtedness of Scilex and is guaranteed by all existing or future formed, direct and indirect, domestic
subsidiaries of Scilex and is secured by a first priority security interest in and liens on all of the assets of Scilex, subject to customary
and mutually agreed permitted liens and except for certain specified exemptions.
Mandatory
prepayments under the Note are required following the earlier of (a) April 1, 2024 and (b) the date upon which certain of Scilex’s
outstanding indebtedness are repaid in full. Mandatory prepayments may be triggered by certain future equity and debt issuances by Scilex.
Voluntary prepayments may be made at Scilex’s discretion; provided that, if made prior to the one-year anniversary of the Closing
Date, Scilex will also be required to pay a 50% interest make-whole on the portion of the Note so prepaid.
The
Note includes customary events of default, upon which the Note will bear interest at a default rate of Term SOFR plus 15.0%, which shall
be payable in-kind, by being capitalized and added to the principal amount of the Note on a monthly basis. If the Note is accelerated
upon an event of default, Scilex is required to repay the principal amount of the Note at a mandatory default rate of 125% of such principal
amount (together with 100% of accrued and unpaid interest thereon and all other amounts due in respect of the Note).
Until
the obligations under the Note are repaid in full, the Company has the right to designate one non-voting observer to attend meetings
of the board of directors and committees of Scilex and its subsidiaries.
Pursuant
to the terms of the Note, the Company received the first principal payment of $5,000 on December 21, 2023 and the second principal payment
of $15,000 prior to March 21, 2024. On May 2, 2024, the Company received a payment of approximately $9,600 from Scilex in accordance
with the mandatory prepayment requirements under the Note.
ORAMED
PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
7 - INVESTMENTS, AT FAIR VALUE (continued):
Closing
Penny Warrant
The
Closing Penny Warrant will be exercisable upon the earliest of (i) March 14, 2025, (ii) the date on which the Senior Secured Note has
been repaid in full and (iii) the Management Sale Trigger Date (as defined therein), if any, and will expire on the date that is the
fifth anniversary of the issuance date (i.e., September 21, 2028). For purposes of the Penny Warrants, the Management Sale Trigger Date
is generally the first date that either Dr. Henry Ji, Scilex’s Executive Chairperson, or Mr. Jaisim Shah, Scilex’s Chief
Executive Officer and President and a member of Scilex’s Board of Directors, engages in certain sales or other similar transfers
of shares of Common Stock or other of the Issuer’s or any of its subsidiaries’ securities, subject to certain exceptions
in connection with financings or similar transactions. The exercise price of the Closing Penny Warrant is $0.01 per share, subject to
adjustment.
Subsequent
Penny Warrants
Scilex
issued four Subsequent Penny Warrants to the Company, each for 2,125,000 shares of Scilex Common Stock, one of which shall vest and become
exercisable on the date that is the later of (i) each of March 19, 2024, June 17, 2024, September 15, 2024 or December 14, 2024 (the
“Subsequent Penny Warrant Vesting Date”) and (ii) the earliest of (A) March 14, 2025, (B) the date on which the Senior Secured
Note has been repaid in full and (C) the Management Sale Trigger Date (as defined therein), if any. Each Subsequent Penny Warrant will
expire on the date that is the fifth anniversary of the issuance date; provided that, if the Senior Secured Note is repaid in full prior
to the Subsequent Penny Warrant Vesting Date applicable to such Subsequent Penny Warrant, such Subsequent Penny Warrant will expire on
the date the Senior Secured Note is repaid in full. The Company may exercise the Penny Warrants by means of a “cashless exercise.”
The
Penny Warrants may not be exercised if the Company, together with its affiliates, would beneficially own in excess of 9.9% of the number
of shares of Scilex Common Stock outstanding immediately after giving effect to such exercise; provided, that the Company may increase
or decrease such limitation upon 61 days’ prior notice to Scilex.
Transferred
Warrants
The
Transferred Warrants are listed on the Nasdaq Capital Market, have an exercise price of $11.50 per share, are fully exercisable and expire
on November 10, 2027.
The
Company accounted for the Transferred Warrants as derivatives measured at fair value.
The
Company elected the fair value option for the Note and the Penny Warrants in order to reduce operational complexity of bifurcating embedded
derivatives. Changes in value are recorded under financial income, net and include interest income on the Note.
The
valuation was performed based on several scenarios which some of them took into account a partial or full early repayment of the Note.
Each scenario took into consideration the present value of the Note’s cash flows (including the exit fee and the prepayment premium)
and the Warrants’ value. The total value of the Transaction (and of each of its components) was valued on a weighted average of
the different scenarios.
The
discount rate of the Note was based on the B- rating Zero curve in addition to a risk premium which takes into account the credit risk
of Scilex and ranged between 53.67% to 53.92%.
The
fair value of the Transferred Warrants was based on their closing price on the Nasdaq Capital Market.
The
fair value of the Penny Warrants was calculated based on the closing price of the Scilex Common Stock on the Nasdaq Capital Market, taking
into account several scenarios which assume a partial or full early repayment of the Note, when applicable.
On
the Closing Date, the fair value of the Transaction was $101,875. As of March 31, 2024, and following the aforementioned repayments
of $20,000, the fair value of the Transaction was $98,741, split between the Note ($77,733, presented under short-term investments
at fair value), the Closing Penny Warrant ($7,155), the Subsequent Penny Warrants ($12,389), both presented under long-term
investments at fair value and the Transferred Warrants ($1,464) presented under long-term marketable securities. This resulted in a
gain of $3,552 during the first quarter of 2024, attributed mainly to the change in fair value of the Warrants. The difference
between the Note’s fair value and aggregate unpaid principal balance (which includes interest payable on maturity) is
$7,654.
ORAMED
PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
8 - STOCKHOLDERS’ EQUITY:
| 1. | On January 4, 2024, the Company granted an aggregate of 150,000 RSUs representing a right to receive shares of the Company’s common stock to the Company’s board members. The RSUs granted to the board members will vest in three equal annual installments on each of January 1, 2025, 2026 and 2027. The total fair value of these RSUs on the date of grant was $359, using the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant. |
| 2. | On
January 4, 2024, the Company granted an aggregate of 37,610 RSUs representing a right to receive shares of the Company’s common
stock to the Company’s board members. The RSUs granted to certain board members will vest in four quarterly installments on each
of April 1, 2024, July 1, 2024, October 1, 2024 and January 1, 2025. The total fair value of these RSUs on the date of grant was $90,
using the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant. |
| 3. | On January 4, 2024, the Company granted an aggregate of 950,500 RSUs representing a right to receive shares of the Company’s common stock to the Company’s executive officers and one employee. The RSUs granted to executive officers and one employee will vest in twelve equal quarterly installments starting January 8, 2024. The total fair value of these RSUs on the date of grant was $2,272, using the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant. |
| 4. | On January 4, 2024, the Company granted an aggregate of 294,000 PSUs representing a right to receive shares of the Company’s common stock to executive officers of the Company. The PSUs shall vest upon the Company’s common stock achieving and maintaining a specified price per share. The total fair value of these PSUs on the date of grant was $691, using the Monte-Carlo model. |
| 5. | On January 30, 2024, the Company granted an aggregate of 3,750 RSUs representing a right to receive shares of the Company’s common stock to one of the Company’s board members. The RSUs granted to the board member will vest in four quarterly installments on each of April 1, 2024, July 1, 2024, October 1, 2024 and January 1, 2025. The total fair value of these RSUs on the date of grant was $11, using the quoted closing market share price of $2.98 on the Nasdaq Capital Market on the date of grant. |
| 6. | On March 18, 2024, the Company entered into an at the market offering agreement (the “ATM Agreement”) with Rodman & Renshaw LLC and StockBlock Securities LLC, as agents, pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $75,000, through the sales agents, subject to certain terms and conditions. Any shares sold will be sold pursuant to our effective shelf registration statement on Form S-3 including a prospectus dated July 26, 2021 and prospectus supplement dated March 18, 2024. As of March 31, 2024 and through May 9, 2024, no shares were issued under the ATM Agreement. |
ORAMED
PHARMACEUTICALS INC.
NOTES
TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
9 - LEASES:
The
Company has various operating leases for office space and vehicles that expire through 2027. Below is a summary of the Company’s
operating right-of-use assets and operating lease liabilities as of March 31, 2024 and December 31, 2023:
| |
March 31, 2024 | | |
December 31, 2023 | |
Operating right-of-use assets | |
$ | 608 | | |
$ | 694 | |
| |
| | | |
| | |
Operating lease liabilities, current | |
| 254 | | |
| 267 | |
Operating lease liabilities long-term | |
| 272 | | |
| 342 | |
Total operating lease liabilities | |
$ | 526 | | |
$ | 609 | |
Lease
payments for the Company’s right-of-use assets over the remaining lease periods as of March 31, 2024 and December 31, 2023 are
as follows:
| |
March 31, 2024 | | |
December 31, 2023 | |
2024 | |
| 200 | | |
| 282 | |
2025 | |
| 217 | | |
| 222 | |
2026 | |
| 118 | | |
| 120 | |
2027 | |
| 10 | | |
| 10 | |
Total undiscounted lease payments | |
| 545 | | |
| 634 | |
Less: Interest* | |
| (19 | ) | |
| (25 | ) |
Present value of lease liabilities | |
$ | 526 | | |
$ | 609 | |
ORAMED
PHARMACEUTICALS INC.
NOTES
TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE
10 - RELATED PARTY TRANSACTIONS:
On
July 1, 2008, the Company’s wholly-owned subsidiary, Oramed Ltd. (the “Subsidiary”), entered into a consulting
agreement with KNRY Ltd. (“KNRY”), an Israeli company owned by the Chief Scientific Officer, whereby the Chief
Scientific Officer, through KNRY, provides services to the Company (the “Consulting Agreement”). The Consulting
Agreement is terminable by either party upon 140 days prior written notice. The Consulting Agreement, as amended, provide that KNRY
will be reimbursed for reasonable expenses incurred in connection with the performance of the Consulting Agreement and the monthly
consulting fee paid to the Chief Scientific Officer is NIS 117,040 ($32).
Effective
November 1, 2022, the Company entered into a consulting agreement with Shnida Ltd., whereby the President and Chief Executive Officer,
through Shnida Ltd., provides services as President and Chief Executive Officer of the Company. The agreement is terminable by either
party upon 140 days prior written notice. The agreement, as amended, provides that Shnida Ltd. will be reimbursed for reasonable expenses
incurred in connection with performance of the agreement and that the President and Chief Executive Officer will receive a monthly consulting
fee of NIS 96,825 ($26), plus value added tax. Pursuant to the agreement, Shnida Ltd. and the President and Chief Executive Officer each
agree that during the term of the agreement and for a 12-month period thereafter, none of them will compete with the Company nor solicit
employees of the Company.
In
addition, the Company, through the Subsidiary, has entered into an employment agreement with the President and Chief Executive Officer,
effective as of November 1, 2022, as amended, pursuant to which the President and Chief Executive Officer receives gross monthly salary
of NIS 51,591 ($14) in consideration for his services as President and Chief Executive Officer of the Subsidiary. In addition, the President
and Chief Executive Officer is provided with a cellular phone and a company car pursuant to the terms of his agreement.
ITEM
2 - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed
consolidated financial statements and the related notes included elsewhere herein and in our consolidated financial statements, accompanying
notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our
Annual Report.
Overview
of Operations
We
are a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions with a technology platform
that allows for the oral delivery of therapeutic proteins.
We
have developed an oral dosage form intended to withstand the harsh environment of the stomach and effectively deliver active biological
insulin or other proteins. The excipients in the formulation are not intended to modify the proteins chemically or biologically, and
the dosage form is designed to be safe to ingest.
On
January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. As a result, we terminated
this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. In 2023, we completed an analysis of the data from the ORA-D-013-1 Phase
3 trial and found that subpopulations of patients with pooled specific parameters, such as body mass index, or BMI, baseline HbA1c and
age, responded well to oral insulin. Based on this analysis, we are working on a protocol for a new Phase 3 clinical trial to be submitted
to the FDA. We are additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities,
with the goal of enhancing value for our stockholders.
Scilex
Transaction
On
August 7, 2023, we entered into a Stock Purchase Agreement, as subsequently amended on August 9, 2023 and August 21, 2023, or the Sorrento
SPA, with Sorrento Therapeutics, Inc., or Sorrento, to acquire certain equity securities of Scilex owned by Sorrento, or the Purchased
Securities, for a purchase price of $105 million. Sorrento and its affiliated debtor, Scintilla Pharmaceuticals, Inc., or Scintilla and
together with Sorrento, the Debtors, are in Chapter 11 bankruptcy proceedings.
On
August 9, 2023, we entered into a Senior Secured, Super-Priority Debtor-in-Possession Loan and Security Agreement, or the Senior DIP
Loan Agreement, with the Debtors in the principal amount of $100 million, which included a non-refundable closing fee of $450,000 paid
in full out of the proceeds. This amount was subsequently drawn in full by the Debtors and was intended to be used by us as a credit
for the consideration for the Purchased Securities, with an additional $5,000,000 in cash to be paid by us at closing. Thereafter, we
and Sorrento continued discussions and negotiations relating to the sale contemplated under the Sorrento SPA.
On
September 21, 2023, or the Closing Date, we entered into and consummated the transactions, or, collectively, the Transaction, contemplated
by a Securities Purchase Agreement, or the Scilex SPA, with Scilex and Acquiom Agency Services LLC. Pursuant to the Scilex SPA, in exchange
for Scilex assuming Sorrento’s outstanding obligations under the Senior DIP Loan Agreement, or the DIP Assumption, and for the
ability to credit the amounts assumed under the DIP Assumption in exchange for certain equity securities of Scilex owned by Sorrento,
Scilex (i) issued to us (A) a Senior Secured Promissory Note due 18 months from the date of issuance in the principal amount of $101,875,000,
or the Note, which includes accrued and unpaid interest of $875,000 under the Senior DIP Loan Agreement and $1,000,000 of fees added
to the principal amount of the Note, (B) a warrant to purchase up to an aggregate of 4,500,000 shares of common stock of Scilex, par
value $0.0001 per share, or the Scilex Common Stock, and containing certain restrictions on exercisability, or the Closing Penny Warrant,
and (C) warrants to purchase up to an aggregate of 8,500,000 shares of Scilex Common Stock, or the Subsequent Penny Warrants, and, together
with the Closing Penny Warrant, the Penny Warrants, each with an exercise price of $0.01 per share and each with certain restrictions
on exercisability, and (ii) caused certain outstanding warrants to purchase up to an aggregate of 4,000,000 shares of Scilex Common Stock
with an exercise price of $11.50 per share to be transferred to us, or the Transferred Warrants and together with the Penny Warrants,
the Warrants. In addition, on the Closing Date, Scilex reimbursed $1,910,000 of the Company’s Transaction expenses pursuant to
the Scilex SPA.
Pursuant
to the terms of the Scilex SPA, Scilex agreed to certain restrictions on additional issuances of equity securities. In connection with
the Transaction, we and Sorrento mutually agreed to terminate the Sorrento SPA and to release all claims we and Sorrento may have against
one another, and Scilex completed the acquisition of the Purchased Securities.
Senior
Secured Promissory Note
The
Note matures on March 21, 2025 or upon an uncured event of default, subject to certain mandatory prepayments, and bears interest at a
rate per annum equal to Term SOFR (as defined in the Note) plus 8.5% (subject to a Term SOFR floor of 4.0%), to be paid in-kind, by being
capitalized and added to the principal amount of the Note on a monthly basis. The Scilex SPA provides for principal payments of (i) $5
million on December 21, 2023, (ii) $15 million on March 21, 2024, and (iii) $20 million on each of June 21, 2024, September 21, 2024,
and December 21, 2024, and for the entire remaining principal balance of the Note to be paid on March 21, 2025. If the Note is not repaid
in full on or prior to March 21, 2024, an exit fee equal to $3,056,250 shall be payable upon repayment of the Note in full.
The
Note constitutes senior secured indebtedness of Scilex and is guaranteed by all existing or future formed, direct and indirect, domestic
subsidiaries of Scilex and is secured by a first priority security interest in and liens on all of the assets of Scilex, subject to customary
and mutually agreed permitted liens and except for certain specified exemptions.
Mandatory
prepayments under the Note are required following the earlier of (a) April 1, 2024 and (b) the date upon which certain of Scilex’s
outstanding indebtedness is repaid in full). Voluntary prepayments may be made at Scilex’s discretion; provided that, if made prior
to the one-year anniversary of the Closing Date, Scilex will also be required to pay a customary 50% interest make-whole on the portion
of the Note so prepaid.
The
Note includes customary events of default, upon which the Note will bear interest at a default rate of Term SOFR plus 15.0%, which shall
be payable in-kind, by being capitalized and added to the principal amount of the Note on a monthly basis. If the Note is accelerated
upon an event of default, Scilex is required to repay the principal amount of the Note at a mandatory default rate of 125% of such principal
amount (together with 100% of accrued and unpaid interest thereon and all other amounts due in respect of the Note).
Until
the obligations under the Note are repaid in full, we have the right to designate one non-voting observer, to attend meetings of the
board of directors and committees of Scilex and its subsidiaries.
Pursuant to the terms of the Note, we
received the first principal payment of $5 million on December 21, 2023 and the second principal payment of $15 million prior to
March 21, 2024. On May 2, 2024, we received a payment of approximately $9.6 million from Scilex in accordance with the mandatory
prepayment requirements under the Note.
Warrants
The
Closing Penny Warrant will be exercisable upon the earliest of (i) March 14, 2025, (ii) the date on which the Note has been repaid in
full and (iii) the Management Sale Trigger Date (as defined therein), if any, and will expire on the date that is the fifth anniversary
of the issuance date. For purposes of the Penny Warrants, the Management Sale Trigger Date is generally the first date that either Dr.
Henry Ji, Scilex’s Executive Chairperson, or Mr. Jaisim Shah, Scilex’s Chief Executive Officer and President and a member
of Scilex’s Board of Directors, engages in certain sales or other similar transfers of shares of Scilex Common Stock or other of
Scilex’s or any of its subsidiaries’ securities, subject to certain exceptions as are customary for lock-up agreements executed
by directors and officers in connection with financings or similar transactions. The exercise price of the Closing Penny Warrant is $0.01
per share, subject to adjustment.
Oral
Insulin
Type
2 Diabetes: We conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, or T2D, with inadequate glycaemic control
who were on two or three oral glucose-lowering agents. The primary endpoint of the trial was to evaluate the efficacy of our oral insulin
capsule, ORMD-0801, compared to placebo in improving glycaemic control as assessed by HbA1c, with a secondary efficacy endpoint of assessing
the change from baseline in fasting plasma glucose at 26 weeks. On January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial
did not meet its primary or secondary endpoints. Following the results of the ORA-D-013-1 Phase 3 trial, we also terminated the ORA-D-013-2
Phase 3 trial, a second Phase 3 trial that included T2D patients with inadequate glycaemic control who were attempting to manage their
condition with either diet alone or with diet and metformin. In 2023, we completed an analysis of the data from the ORA-D-013-1 Phase
3 trial and found that subpopulations of patients with pooled specific parameters, such as BMI, baseline HbA1c and age, responded well
to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. Based on this analysis,
we are working on a protocol for a new Phase 3 clinical trial to be submitted to the FDA.
Joint
Venture Agreement: On January 22, 2024, Oramed and its wholly-owned subsidiary, Oramed Ltd., entered into a joint venture agreement,
or the JV Agreement, with HTIT Biotech and Technowl Limited, a wholly-owned indirect subsidiary of HTIT Biotech, or HTIT Sub, and together
with HTIT Biotech, HTIT, pursuant to which, subject to the terms and conditions set forth in the JV Agreement, the parties will establish
a joint venture, or the JV, based on Oramed’s oral drug delivery technology.
The
JV will focus on the development and worldwide commercialization of innovative products based on Oramed’s oral insulin and POD™
(Protein Oral Delivery) pipeline and HTIT’s manufacturing capabilities and technologies. The parties intend for the JV to use the
protocol we are currently working on to initiate a Phase 3 oral insulin trial in the United States.
Oramed
and HTIT will initially hold equal shares in the JV, with each owning 50% of the equity. The board of directors will initially consist
of equal representation from HTIT and Oramed. HTIT will contribute to the JV $70 million in cash, while Oramed will contribute $20 million
(comprised of $10 million in cash and $10 million in shares of Oramed common stock that will be subject to certain registration rights)
and will transfer intellectual property related to its oral insulin and POD™ technology, as well as other assets in the Oramed
pipeline. HTIT will have an option to invest additional funds into the JV up to an aggregate amount of $20 million, thereby increasing
its equity holdings and board representation. Oramed will be entitled to receive a 3% royalty on gross revenues of the JV generated from
Oramed related assets.
The
consummation of the JV Agreement is subject to and contingent upon the parties entering into additional agreements within a three-month
period, including an asset transfer agreement for the transfer of Oramed’s intellectual property to the JV, a commercial supply
agreement for the manufacture and supply of products by HTIT to the JV, as well as other documents and agreements to regulate the relationship
of the parties and the JV to be formed pursuant to the JV Agreement. There is no assurance that the parties will complete and sign these
additional agreements within the agreed timeline or at all. If such agreements are not signed within the agreed timeframe, then either
party may apply a 30-day extension, after which the JV Agreement may be terminated and voided by either party. The 30-day extension was
applied by the Company on April 18, 2024 and will last until May 22, 2024. Thereafter, the consummation of the JV transaction is further
subject to the satisfaction or waiver of certain other closing conditions within a three-month period following the completion of the
aforesaid ancillary agreements. If the closing conditions are not met within the agreed timeframe, then either party may apply a 30-day
extension, after which the JV Agreement may be terminated and voided by either party. In addition, completion of the transactions contemplated
under the JV Agreement is subject to the satisfaction or waiver of customary and certain other closing conditions.
Oral
Vaccine
On
March 18, 2021, we entered into a license agreement, or the Oravax License Agreement, with Oravax, a 63% owned joint venture to commercialize
oral vaccines for COVID-19 and other novel coronaviruses based on Premas Biotech Pvt. Ltd.’s proprietary vaccine technology involving
a triple antigen virus like particle.
In
October 2022, Oravax reported positive preliminary Phase 1 data for Cohort A of a Phase 1 clinical trial, meeting primary or secondary
endpoints of safety and immunogenicity. These results included significant antibody response (2-6 fold over baseline) as measured by
multiple markers of immune response to virus like particle vaccine antigens observed in the majority of the patients dosed, and no safety
issues were observed, including mild symptoms. Cohort B completed dosing in January 2023. Cohort B measured Immunoglobulin G, or IGG,
against the spike (S) protein, showing positive IGG in approximately 55% of the patients dosed. We are currently evaluating our path
forward for Oravax’s oral vaccines for COVID-19.
PeriTech
Acquisition and License
In
December 2023, we executed and completed an agreement with PeriTech Pharma Ltd., or PeriTech, acquiring the rights to their film-forming
technology tailored for the delivery of topical/dermatology agents. This includes a once-daily over-the-counter treatment for hemorrhoids.
The PeriTech pipeline extends its potential applications to include indications such as pruritus ani, anal warts, anal fissures and herpes
labialis.
We
have entered into an exclusive licensing agreement with Genomma Lab Internacional S.A.B. de C.V, or Genomma Labs, pursuant to which we
granted Genomma Labs the development and commercialization rights to the PeriTech pipeline, in exchange for a royalty based on net sales.
Raw
Materials
We
have purchased, pursuant to separate agreements with third parties, the raw materials required for the manufacturing of our oral capsule.
We generally depend upon a limited number of suppliers for the raw materials. Although alternative sources of supply for these materials
are generally available, we could incur significant costs and disruptions if we need to change suppliers. The termination of our relationships
with our suppliers or the failure of these suppliers to meet our requirements for raw materials on a timely and cost-effective basis
could have a material adverse effect on our business, prospects, financial condition and results of operations.
Impact
of Current Events
On
October 7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas. Israel has been in an ongoing
state of war with Hamas since that time. Following the attack by Hamas, Hezbollah has also launched attacks against Israel and Israel
has been responding to these attacks with targeted air strikes. It is possible that other terrorist organizations, including Palestinian
military organizations in the West Bank, as well as other hostile countries, such as Iran, will join the hostilities. As of May 9, 2024,
we believe that there is no immediate risk to our business operations related to these events. For further information, see “Item
1A. Risk Factors,” under “We are affected by the political, economic and military risks of having operations in Israel”
in our Annual Report, as filed with the Securities and Exchange Commission, or the SEC, on March 6, 2024.
Results
of Operations
Comparison
of three month periods ended March 31, 2024 and March 31, 2023
The
following table summarizes certain statements of operations data of the Company for the three month periods ended March 31, 2024 and
March 31, 2023 (in thousands of dollars except share and per share data):
| |
Three months ended | |
| |
March 31, 2024 | | |
March 31, 2023 | |
Revenues | |
$ | - | | |
$ | 666 | |
Cost of revenues | |
| - | | |
| - | |
Research and development expenses | |
| (1,179 | ) | |
| (4,427 | ) |
Sales and marketing expenses | |
| - | | |
| (184 | ) |
General and administrative expenses | |
| (1,783 | ) | |
| (1,263 | ) |
Interest expenses | |
| (592 | ) | |
| - | |
Financial income, net | |
| 5,088 | | |
| 1,597 | |
Net income (loss) for the period | |
$ | 1,534 | | |
$ | (3,611 | ) |
Basic income (loss) per share of common stock | |
$ | 0.04 | | |
$ | (0.08 | ) |
Diluted income (loss) per share of common stock | |
$ | 0.04 | | |
$ | (0.08 | ) |
Weighted average shares of common stock outstanding used in computing basic income (loss) per share of common stock | |
| 40,835,953 | | |
| 40,041,258 | |
Weighted average shares of common stock outstanding used in computing diluted income (loss) per share of common stock | |
| 41,564,007 | | |
| 40,041,258 | |
Revenues
Revenues
consist of proceeds related to the Amended and Restated Technology License Agreement, dated December 21, 2015, between the Company and
HTIT, or as further amended by the parties on June 3, 2016 and July 24, 2016, the HTIT License Agreement, that are recognized on a cumulative
basis when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, through the expected
product submission date by HTIT of June 2023, using the input method.
There
were no revenues for the three month period ended March 31, 2024 while revenues were $666,000 for the three month period ended March
31, 2023. The decrease was due to recognition of revenues until the product submission date by HTIT of June 2023.
Cost
of Revenues
Cost
of revenues consists of royalties related to the HTIT License Agreement that will be paid over the term of the HTIT License Agreement
in accordance with revenue recognition accounting and the Israeli Law for the Encouragement of Industrial Research, Development and Technological
Innovation, 1984, as amended, including any regulations or investment tracks promulgated thereunder.
There
was no cost of revenues for the three month periods ended March 31, 2024 and March 31, 2023.
Research
and Development Expenses
Research
and development expenses include costs directly attributable to the conduct of research and development programs, including the cost
of salaries, employee benefits, costs of materials, supplies, the cost of services provided by outside contractors, including services
related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research and preclinical development.
All costs associated with research and development are expensed as incurred.
Clinical
trial costs are a significant component of research and development expenses and include costs associated with third-party contractors.
We outsource a substantial portion of our clinical trial activities, utilizing external entities such as contract research organizations,
or CROs, independent clinical investigators and other third-party service providers to assist us with the execution of our clinical trials.
Clinical
activities, which relate principally to clinical sites and other administrative functions to manage our clinical trials, are performed
primarily by CROs. CROs typically perform most of the start-up activities for our trials, including document preparation, site identification,
screening and preparation, pre-trial visits, training and program management.
Clinical
trial and preclinical trial expenses include regulatory and scientific consultants’ compensation and fees, research expenses, purchase
of materials, cost of manufacturing of the oral insulin and exenatide capsules, payments for patient recruitment and treatment, as well
as salaries and related expenses of research and development staff.
Research
and development expenses for the three month period ended March 31, 2024 decreased by 73% to $1,179,000, compared to $4,427,000 for the
three month period ended March 31, 2023. The decrease was mainly due to lower expenses related to the Phase 3 trials that were terminated.
Stock-based compensation expenses for the three month period ended March 31, 2024 were $704,000, compared to $17,000 during the three
month period ended March 31, 2023. This increase was mainly due equity grants during the period ended March 31, 2024 and to performance equity awards that did not meet their performance conditions during the period ended March
31, 2023.
Following
the results of the ORA-D-013-1 Phase 3 trial, which did not meet its primary and secondary endpoints, we terminated both ORA-D-013-1
and ORA-D-013-2 Phase 3 clinical trials. We recently completed an analysis of the data from the ORA-D-013-1 Phase 3 trial and found that
subpopulations of patients with pooled specific parameters responded well to oral insulin. Based on this analysis, we are working on
a protocol for a new Phase 3 clinical trial to be submitted to the FDA. We are additionally examining our existing pipeline and have
commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.
Government
grants
In
the three month periods ended March 31, 2024 and March 31, 2023, we did not recognize any research and development grants. As of March
31, 2024, we had incurred liabilities to pay royalties to the Israel Innovation Authority of the Israeli Ministry of Economy and Industry
of $59,000.
Sales
and Marketing Expenses
Sales
and marketing expenses include the salaries and related expenses of our commercial functions, consulting expenses and other general expenses.
We
did not recognize any sales and marketing expenses for the three month period ended March 31, 2024 compared to expenses of $184,000 for
the three month period ended March 31, 2023. This was primarily due to the termination of the employment of an executive officer in fiscal
year 2023. We did not recognize any stock-based compensation expenses for the three month period ended March 31, 2024, compared to expenses
of $88,000 for the three month period ended March 31, 2023. This was primarily due to the termination of the employment of an executive
officer.
General
and Administrative Expenses
General
and administrative expenses include the salaries and related expenses of our management, consulting expenses, legal and professional
fees, travel expenses, business development expenses, insurance expenses and other general expenses.
General
and administrative expenses for the three month period ended March 31, 2024 increased by 41% to $1,783,000 compared to $1,263,000 for
the three month period ended March 31, 2023. The increase was mainly due to higher stock-based compensation expenses. Stock-based compensation
expenses for the three month period ended March 31, 2024 were $590,000, compared to $67,000 for the three month period ended March 31,
2023. This increase was mainly due to equity grants during the period ended March 31, 2024 and to performance equity awards that did not meet their performance conditions during the period ended March
31, 2023.
Interest
Expenses
Interest
expenses were $592 for the three month period ended March 31, 2024, while there were no interest expenses for the three and
three month period ended March 31, 2023. The increase was mainly due to interest on the Short-Term Borrowings.
Financial
Income, Net
Net
financial income increased by 219% to $5,088,000 for the three month period ended March 31, 2024, compared to $1,597,000 for the three
month period ended March 31, 2023. The increase was mainly due to the revaluation of the Transaction and interest from short-term bank deposits.
Basic
and Diluted Income and Loss Per Share of Common Stock
Basic
and diluted income per share of common stock for the three month period ended March 31, 2024 was $0.04 per share, compared to a
basic and diluted loss of $0.08 per share for the three month period ended March 31, 2023. This was primarily due to the changes
discussed above that caused us to have income during the three month period ended March 31, 2024, compared to a loss during the
three month period ended March 31, 2023.
Weighted
Average Shares of Common Stock Outstanding
Weighted
average shares of common stock outstanding used in computing basic income (loss) per share of common stock for the three month period
ended March 31, 2024 were 40,835,953 compared to 40,041,258 for the three month period ended March 31, 2023. The increase was mainly
due to RSUs that vested during the three month period ended March 31, 2024.
Weighted
average shares of common stock outstanding used in computing diluted income (loss) per share of common stock for the three month period
ended March 31, 2024 were 41,564,007 compared to 40,041,258 for the three month period ended March 31, 2023. The increase was mainly
due to RSUs that vested during the three month period ended March 31, 2024.
For
the diluted earnings per share calculation, the weighted average number of shares outstanding during the year is adjusted for the average
number of shares that are potentially issuable in connection with employee share-based payment, using the treasury stock method.
Liquidity
and Capital Resources
From
inception through March 31, 2024, we have incurred losses in an aggregate amount of $156,020,000. During that period and through March
31, 2024, we have financed our operations through several private placements of our common stock, as well as public offerings of our
common stock, raising a total of $255,384,000, net of transaction costs. During that period, we also received cash consideration
of $28,001,000 from the exercise of warrants and options. We expect to seek additional financing through similar sources in the future,
as needed. As of March 31, 2024, we had $18,576,000 of available cash and $80,285,000 of short-term bank deposits.
From
inception through March 31, 2024, we have not generated significant revenues from our operations. Management continues to evaluate various
financing alternatives for funding new strategic activities, future research and development activities and general and administrative
expenses through fundraising in the public or private equity markets. Although there is no assurance that we will be successful with
those initiatives, management believes that it will be able to secure the necessary financing as a result of future third party investments.
Following the termination of the ORA-D-013-1 and ORA-D-013-2 Phase 3 trials, the Company’s research and development activities
have been significantly reduced while it conducts a strategic review process. As a result, the Company is currently incurring lower research
and development and sales and marketing expenses.
Based
on our current cash resources and commitments, we believe we will be able to maintain our current planned activities and the corresponding
level of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior
to such time. If there are unexpected increases in our operating expenses, we may need to seek additional financing during the next 12
months. We may also need additional funds to realize the decisions made as part of our strategic review process. We cannot predict the
outcome of these activities.
On
August 9, 2023, we entered into the Senior DIP Loan Agreement with the Debtors in the principal amount of $100,000,000.
On
the Closing Date, we entered into and consummated the Transaction. Pursuant to the Scilex SPA, in exchange for the DIP Assumption and
for the ability to credit the amounts assumed under the DIP Assumption in exchange for certain equity securities of Scilex owned by Sorrento,
Scilex (i) issued to us (A) the Note, (B) the Closing Penny Warrant, and (C) the Subsequent Penny Warrants, and (ii) caused the Transferred
Warrants to be transferred to us. In addition, on the Closing Date, Scilex reimbursed $1,910,000 of the Company’s Transaction expenses
pursuant to the Scilex SPA.
Pursuant
to the terms of the Scilex SPA, Scilex agreed to certain restrictions on additional issuances of equity securities. In connection with
the Transaction, we and Sorrento mutually agreed to terminate the Sorrento SPA and to release all claims the Company and Sorrento may
have against one another, and Scilex completed the acquisition of the Purchased Securities.
On
August 8, 2023, we borrowed an aggregate of $99,550,000 pursuant to loan agreements from Israel Discount Bank Ltd., or the Short-Term
Borrowings. The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging from 6.66%
to 7.38%, are secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550,000.
The net proceeds of the Short-Term Borrowings were used to fund the Note. The Short-Term Borrowings are paid in one payment of principal
and interest at each respective maturity. As of March 31, 2024, approximately $70,146,000 was repaid under the Short-Term Borrowings.
As
of March 31, 2024, our total current assets were $177,095,000 and our total current liabilities were $33,556,000. On March 31, 2024,
we had a working capital surplus of $143,539,000 and an accumulated loss of $156,020,000. As of December 31, 2023, our total current
assets were $162,584,000 and our total current liabilities were $53,214,000. On December 31, 2023, we had a working capital surplus of
$109,370,000 and an accumulated loss of $157,556,000. The increase in working capital from December 31, 2023 to March 31, 2024 was mainly
due to an increase in cash and cash equivalents and in investments at fair value, together with a decrease in Short-term borrowings partially
offset by a decrease in short term deposits.
During
the three month period ended March 31, 2024, cash and cash equivalents increased to $18,576,000, from $9,055,000 as of December 31, 2023.
The increase was mainly due to the reasons described below.
Operating
activities used cash of $1,476,000 in the three month period ended March 31, 2024, compared to $5,549,000 used in the three month period
ended March 31, 2023. Cash used in operating activities primarily consisted of research and development, sales and marketing and general
and administrative expenses and changes in stock-based compensation expenses, interest on deposits, interest paid on the Short-Term Borrowings,
accounts payable and accrued expenses.
Investing
activities provided cash of $29,998,000 in the three month period ended March 31, 2024, compared to cash used in investing activities
of $13,203,000 in the three month period ended March 31, 2023. Cash provided by investing activities in the three month period ended
March 31, 2024 consisted primarily of proceeds from short term investing activities and a principal repayment of the Note partially offset
by the purchase of short-term deposits.
Financing
activities used cash of $19,000,000 in the three month period ended March 31, 2024, compared to $2,430,000 provided in the three month
period ended March 31, 2023. Cash used by financing activities in the three month period ended March 31, 2024, consisted primarily of
partial repayment of the Short-Term Borrowings. Cash provided by financing activities in the three month period ended March 31, 2023,
consisted primarily of proceeds from the issuance of our common stock.
On
March 18, 2024, the Company entered into an at the market offering agreement, or the ATM Agreement, with Rodman & Renshaw LLC and
StockBlock Securities LLC, as agents, pursuant to which the Company may issue and sell shares of its common stock having an aggregate
offering price of up to $75,000,000 through a sales agent, subject to certain terms and conditions. Any shares sold will be sold pursuant
to our effective shelf registration statement on Form S-3 including a prospectus dated July 26, 2021 and prospectus supplement dated
March 18, 2024. As of March 31, 2024 and through May 9, 2024, no shares were issued under the ATM Agreement.
Critical
accounting policies and estimates
Our
critical accounting policies are described in “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” contained in our Annual Report.
Planned
Expenditures
We
have invested heavily in research and development, and we expect that in the upcoming years our research and development expenses will
continue to be our major operating expense.
Following
the results of the Phase 3 trials for our oral insulin capsule candidate, ORMD-0801 and the current strategic review initiated by the
Company, our obligations may change significantly.
ITEM
3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There
has been no significant change in our exposure to market risk during the quarter ended March 31, 2024. For a discussion of our exposure
to market risk, refer to Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” contained in
our Annual Report.
ITEM
4 - CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
Our
management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls
and procedures as of March 31, 2024. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that
our disclosure controls and procedures are effective.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2024 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II – OTHER INFORMATION
ITEM
6 - EXHIBITS
Number |
|
Exhibit
|
|
|
|
10.1* |
|
Representative Form of Indemnification Agreements between Oramed Pharmaceuticals Inc. and each of our directors and officers. |
|
|
|
10.2 |
|
At The Market Offering Agreement, dated March 18, 2024, by and among the Oramed Pharmaceuticals Inc., Rodman & Renshaw LLC and StockBlock Securities LLC (incorporated by reference from our current report on Form 8-K filed March 18, 2024). |
|
|
|
31.1* |
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. |
|
|
|
31.2* |
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and 15(d)-14(a) under the Securities Exchange Act of 1934, as amended. |
|
|
|
32.1** |
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
32.2** |
|
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350. |
|
|
|
101.1* |
|
The following financial statements from the Company’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 formatted in XBRL: (i) Condensed Consolidated Balance
Sheets, (ii) Condensed Consolidated Statements of Comprehensive Loss, (iii) Condensed Consolidated Statement of Changes
in Stockholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows and (v) the Notes to Condensed Consolidated
Financial Statements. |
|
|
|
104.1* |
|
Cover Page Interactive Data File (formatted as Inline
XBRL and contained in Exhibit 101). |
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.
|
ORAMED PHARMACEUTICALS INC. |
|
|
|
Date: May 9, 2024 |
By: |
/s/ Nadav
Kidron |
|
|
Nadav Kidron |
|
|
President and Chief Executive Officer |
|
|
|
Date: May 9, 2024 |
By: |
/s/ David
Silberman |
|
|
David Silberman |
|
|
Chief Financial Officer |
|
|
(Principal Financial and Accounting Officer) |
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WHEREAS, highly competent
persons have become more reluctant to serve corporations as directors or officers unless they are provided with adequate protection through
insurance or adequate indemnification against inordinate risks of claims and actions against them arising out of their service to and
activities on behalf of the corporation;
WHEREAS, the By-laws and/or
the Certificate of Incorporation of the Company require indemnification of the officers and directors of the Company. Indemnitee may also
be entitled to indemnification pursuant to the General Corporation Law of the State of Delaware (“DGCL”). The By-laws
and/or Certificate of Incorporation and the DGCL expressly provide that the indemnification provisions set forth therein are not exclusive,
and thereby contemplate that contracts may be entered into between the Company and members of the Board of Directors of the Company (the
“Board”) officers and other persons with respect to indemnification;
WHEREAS, the Board has determined
that the increased difficulty in attracting and retaining such persons is detrimental to the best interests of the Company’s stockholders
and that the Company should act to assure such persons that there will be increased certainty of such protection in the future;
WHEREAS, it is reasonable,
prudent and necessary for the Company contractually to obligate itself to indemnify, and to advance expenses on behalf of, such persons
to the fullest extent permitted by applicable law so that they will serve or continue to serve the Company free from undue concern that
they will not be so indemnified;
WHEREAS, this Agreement is
a supplement to and in furtherance of the By-laws and/or Certificate of Incorporation of the Company and any resolutions adopted pursuant
thereto, and shall not be deemed a substitute therefor, nor to diminish or abrogate any rights of Indemnitee thereunder; and
NOW, THEREFORE, in consideration
of Indemnitee’s agreement to serve as an officer and director from and after the date hereof, the parties hereto agree as follows:
1. Indemnity of Indemnitee.
The Company hereby agrees to hold harmless and indemnify Indemnitee to the fullest extent permitted by law, as such may be amended from
time to time. In furtherance of the foregoing indemnification, and without limiting the generality thereof:
2. Additional Indemnity.
In addition to, and without regard to any limitations on, the indemnification provided for in Section 1 of this Agreement, the
Company shall and hereby does indemnify and hold harmless Indemnitee against all Expenses, judgments, penalties, fines and amounts paid
in settlement actually and reasonably incurred by him or on his behalf if, by reason of his Corporate Status, he is, or is threatened
to be made, a party to or participant in any Proceeding (including a Proceeding by or in the right of the Company), including, without
limitation, all liability arising out of the negligence or active or passive wrongdoing of Indemnitee. The only limitation that shall
exist upon the Company’s obligations pursuant to this Agreement shall be that the Company shall not be obligated to make any payment
to Indemnitee that is finally determined (under the procedures, and subject to the presumptions, set forth in Sections 5 and 6
hereof) to be unlawful.
3. Contribution.
(b) Without diminishing or impairing
the obligations of the Company set forth in the preceding subparagraph, if, for any reason, Indemnitee shall elect or be required by law
to pay all or any portion of any judgment or settlement in any threatened, pending or completed Proceeding in which the Company is jointly
liable with Indemnitee (or would be if joined in such Proceeding), the Company shall contribute to the amount of Expenses, judgments,
fines and amounts paid in settlement actually and reasonably incurred and paid or payable by Indemnitee in proportion to the relative
benefits received by the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointly liable
with Indemnitee (or would be if joined in such Proceeding), on the one hand, and Indemnitee, on the other hand, from the transaction or
events from which such Proceeding arose; provided, however, that the proportion determined on the basis of relative benefit may, to the
extent necessary to conform to law, be further adjusted by reference to the relative fault of the Company and all officers, directors
or employees of the Company other than Indemnitee who are jointly liable with Indemnitee (or would be if joined in such Proceeding), on
the one hand, and Indemnitee, on the other hand, in connection with the transaction or events that resulted in such Expenses, judgments,
fines or settlement amounts, as well as any other equitable considerations which applicable law may require to be considered. The relative
fault of the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointly liable with Indemnitee
(or would be if joined in such Proceeding), on the one hand, and Indemnitee, on the other hand, shall be determined by reference to, among
other things, the degree to which their actions were motivated by intent to gain personal profit or advantage, the degree to which their
liability is primary or secondary and the degree to which their conduct is active or passive.
(c) The Company hereby agrees
to fully indemnify and hold Indemnitee harmless from any claims of contribution which may be brought by officers, directors or employees
of the Company, other than Indemnitee, who may be jointly liable with Indemnitee.
(d) To the fullest extent permissible
under applicable law, if the indemnification provided for in this Agreement is unavailable to Indemnitee for any reason whatsoever, the
Company, in lieu of indemnifying Indemnitee, shall contribute to the amount incurred by Indemnitee, whether for judgments, fines, penalties,
excise taxes, amounts paid or to be paid in settlement and/or for Expenses, in connection with any claim relating to an indemnifiable
event under this Agreement, in such proportion as is deemed fair and reasonable in light of all of the circumstances of such Proceeding
in order to reflect (i) the relative benefits received by the Company and Indemnitee as a result of the event(s) and/or transaction(s)
giving cause to such Proceeding; and/or (ii) the relative fault of the Company (and its directors, officers, employees and agents) and
Indemnitee in connection with such event(s) and/or transaction(s).
3. Indemnification for
Expenses of a Witness. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his Corporate
Status, a witness, or is made (or asked) to respond to discovery requests, in any Proceeding to which Indemnitee is not a party, he shall
be indemnified against all Expenses actually and reasonably incurred by him or on his behalf in connection therewith.
4. Advancement of Expenses.
Notwithstanding any other provision of this Agreement, the Company shall advance all Expenses incurred by or on behalf of Indemnitee in
connection with any Proceeding by reason of Indemnitee’s Corporate Status within thirty (30) days after the receipt by the Company
of a statement or statements from Indemnitee requesting such advance or advances from time to time, whether prior to or after final disposition
of such Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred by Indemnitee and shall include or be
preceded or accompanied by a written undertaking by or on behalf of Indemnitee to repay any Expenses advanced if it shall ultimately be
determined by a final judicial determination (as to which all rights of appeal therefrom have been exhausted or lapsed) that Indemnitee
is not entitled to be indemnified against such Expenses. Any advances and undertakings to repay pursuant to this Section 4 shall
be unsecured and interest free.
5. Procedures and Presumptions
for Determination of Entitlement to Indemnification. It is the intent of this Agreement to secure for Indemnitee rights of indemnity
that are as favorable as may be permitted under the DGCL and public policy of the State of Delaware. Accordingly, the parties agree that
the following procedures and presumptions shall apply in the event of any question as to whether Indemnitee is entitled to indemnification
under this Agreement:
(a) To obtain indemnification
under this Agreement, Indemnitee shall submit to the Company a written request, including therein or therewith such documentation and
information as is reasonably available to Indemnitee and is reasonably necessary to determine whether and to what extent Indemnitee is
entitled to indemnification, provided that Indemnitee shall not be required to provide any documentation or information which is privileged
or otherwise protected from disclosure. The Secretary of the Company shall, promptly upon receipt of such a request for indemnification,
advise the Board in writing that Indemnitee has requested indemnification. Notwithstanding the foregoing, any failure of Indemnitee to
provide such a request to the Company, or to provide such a request in a timely fashion, shall not relieve the Company of any liability
that it may have to Indemnitee unless, and to the extent that, such failure actually and materially prejudices the interests of the Company.
(b) Upon written request by
Indemnitee for indemnification pursuant to the first sentence of Section 5(a) hereof, a determination with respect to Indemnitee’s
entitlement thereto shall be made in the specific case by one of the following four methods, which shall be at the election of Indemnitee,
in his sole discretion: (1) by a majority vote of the disinterested directors, even though less than a quorum, (2) by a majority vote
of a committee of disinterested directors designated by a majority vote of the disinterested directors, even though less than a quorum,
(3) if there are no disinterested directors or if a Change of Control shall have occurred after the date hereof, by Independent Counsel
in a written opinion to the Board, a copy of which shall be delivered to the Indemnitee, or (4) by a simple majority of the stockholders
of the Company voting on the matter. For purposes hereof, disinterested directors are those members of the Board who are not parties to
the Proceeding in respect of which indemnification is sought by Indemnitee.
(c) If the determination of
entitlement to indemnification is to be made by Independent Counsel pursuant to Section 5(b) hereof, the Independent Counsel shall
be selected as provided in this Section 5(c). The Independent Counsel shall be selected by the Board. Indemnitee may, within 10
days after such written notice of selection shall have been given, deliver to the Company a written objection to such selection; provided,
however, that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements
of “Independent Counsel” as defined in this Agreement, and the objection shall set forth with reasonable particularity
the factual basis of such assertion. Absent a proper and timely objection, the person so selected shall act as Independent Counsel. If
a written objection is made and substantiated, the Independent Counsel selected may not serve as Independent Counsel unless and until
such objection is withdrawn or a court has determined that such objection is without merit. If, within 20 days after submission by Indemnitee
of a written request for indemnification pursuant to Section 5(a) hereof, no Independent Counsel shall have been selected and not
objected to, either the Company or Indemnitee may petition the Court of Chancery of the State of Delaware or other court of competent
jurisdiction for resolution of any objection which shall have been made by the Indemnitee to the Company’s selection of Independent
Counsel and/or for the appointment as Independent Counsel of a person selected by the court or by such other person as the court shall
designate, and the person with respect to whom all objections are so resolved or the person so appointed shall act as Independent Counsel
under Section 5(b) hereof. The Company shall pay any and all reasonable fees and expenses of Independent Counsel incurred by such
Independent Counsel in connection with acting pursuant to Section 5(b) hereof, and the Company shall pay all reasonable fees and
expenses (including those incurred by Indemnitee) incident to the procedures of this Section 5(c), regardless of the manner in
which such Independent Counsel was selected or appointed.
(d) In making a determination
with respect to entitlement to indemnification hereunder, the person or persons or entity making such determination shall presume that
Indemnitee is entitled to indemnification under this Agreement. Anyone seeking to overcome this presumption shall have the burden of proof
and the burden of persuasion by clear and convincing evidence. Neither the failure of the Company (including by its directors or Independent
Counsel) to have made a determination prior to the commencement of any action pursuant to this Agreement that indemnification is proper
in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Company (including
by its directors or Independent Counsel) that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action
or create a presumption that Indemnitee has not met the applicable standard of conduct.
(i) The termination of any Proceeding
or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent,
shall not (except as otherwise expressly provided in this Agreement) of itself adversely affect the right of Indemnitee to indemnification
or create a presumption that Indemnitee did not act in good faith and in a manner which he reasonably believed to be in or not opposed
to the best interests of the Company or, with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that
his conduct was unlawful.
6. Remedies of Indemnitee.
(e) The Company shall be precluded
from asserting in any judicial proceeding commenced pursuant to this Section 6 that the procedures and presumptions of this Agreement
are not valid, binding and enforceable and shall stipulate in any such court that the Company is bound by all the provisions of this Agreement.
The Company shall indemnify Indemnitee against any and all Expenses and, if requested by Indemnitee, shall (within ten (10) days after
receipt by the Company of a written request therefore) advance, to the extent not prohibited by law, such expenses to Indemnitee, which
are incurred by Indemnitee in connection with any action brought by Indemnitee for indemnification or advance of Expenses from the Company
under this Agreement or under any directors’ and officers’ liability insurance policies maintained by the Company, regardless
of whether Indemnitee ultimately is determined to be entitled to such indemnification, advancement of Expenses or insurance recovery,
as the case may be.
(f) Notwithstanding anything
in this Agreement to the contrary, no determination as to entitlement to indemnification under this Agreement shall be required to be
made prior to the final disposition of the Proceeding.
7. Non-Exclusivity; Survival
of Rights; Insurance; Primacy of Indemnification; Subrogation.
(a) The rights of indemnification
as provided by this Agreement shall not be deemed exclusive of any other rights to which Indemnitee may at any time be entitled under
applicable law, the Certificate of Incorporation, the By-laws, any agreement, a vote of stockholders, a resolution of directors of the
Company, or otherwise. No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right
of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee in his Corporate Status prior to such
amendment, alteration or repeal. To the extent that a change in the DGCL, whether by statute or judicial decision, permits greater indemnification
than would be afforded currently under the Certificate of Incorporation, By-laws and this Agreement, it is the intent of the parties hereto
that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such change. No right or remedy herein conferred is
intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other
right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of any right
or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy.
(b) To the extent that the Company
maintains an insurance policy or policies providing liability insurance for directors, officers, employees, or agents or fiduciaries of
the Company or of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that such person
serves at the request of the Company, Indemnitee shall be covered by such policy or policies in accordance with its or their terms to
the maximum extent of the coverage available for any director, officer, employee, agent or fiduciary under such policy or policies. If,
at the time of the receipt of a notice of a claim pursuant to the terms hereof, the Company has directors’ and officers’ liability
insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the
procedures set forth in the respective policies. The Company shall thereafter take all necessary or desirable action to cause such insurers
to pay, on behalf of the Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies.
(c) In the event of any payment
under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee (other
than against the Outside Indemnitors), who shall execute all papers required and take all action necessary to secure such rights, including
execution of such documents as are necessary to enable the Company to bring suit to enforce such rights.
(d) The Company hereby acknowledges
that the Indemnitee may have other sources of indemnification or insurance, whether currently in force or established in the future (collectively,
the “Outside Indemnitors”). The Company hereby agrees: (i) that it is the indemnitor of first resort (i.e., its obligations
to the Indemnitee are primary and any obligation of the Outside Indemnitors to advance expenses or to provide indemnification for the
same expenses or liabilities incurred by the Indemnitee are secondary); (ii) that it shall be required to advance the full amount of Expenses
incurred by the Indemnitee and shall be liable in full for all indemnifiable amounts to the extent legally permitted and as required by
the Company’s Certificate of Incorporation and Bylaws or any agreement between the Company and the Indemnitee, without regard to
any rights the Indemnitee may have against the Outside Indemnitors and (iii) that it irrevocably waives, relinquishes and releases the
Outside Indemnitors from any and all claims against the Outside Indemnitors for contribution, subrogation or any other recovery of any
kind in respect thereof. The Company further agrees that no advancement or payment by the Outside Indemnitors on behalf of the Indemnitee
with respect to any claim for which the Indemnitee have sought indemnification from the Company shall affect the foregoing and the Outside
Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights
of recovery of the Indemnitee against the Company. The Company and the Indemnitee agree that the Outside Indemnitors are express third
party beneficiaries of the terms hereof.
(e) The Company’s obligation
to indemnify or advance Expenses hereunder to Indemnitee who is or was serving at the request of the Company as a director, officer, employee
or agent of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise shall be reduced by any
amount Indemnitee has actually received as indemnification or advancement of expenses from such other corporation, partnership, joint
venture, trust, employee benefit plan or other enterprise.
8. Exception to Right
of Indemnification. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make
any indemnity in connection with any claim made against Indemnitee:
(a) for an accounting of profits
made from the purchase and sale (or sale and purchase) by Indemnitee of securities of the Company within the meaning of Section 16(b)
of the Securities Exchange Act of 1934, as amended, or similar provisions of state statutory law or common law; or
(b) in connection with any Proceeding
(or any part of any Proceeding) initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee
against the Company or its directors, officers, employees or other indemnitees, unless (i) the Board authorized the Proceeding (or any
part of any Proceeding) prior to its initiation, (ii) the Company provides the indemnification, in its sole discretion, pursuant to the
powers vested in the Company under applicable law or (iii) such Proceeding is brought by Indemnitee to assert, interpret or enforce his
rights under this Agreement.
9. Duration
of Agreement. All agreements and obligations of the Company contained herein shall continue during the period Indemnitee is an officer
or director of the Company (or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise) and shall continue thereafter so long as Indemnitee shall be subject to any Proceeding
(or any proceeding commenced under Section 6 hereof) by reason of his Corporate Status, whether or not he is acting or serving
in any such capacity at the time any liability or expense is incurred for which indemnification can be provided under this Agreement.
This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors
(including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the business
or assets of the Company), assigns, spouses, heirs, executors and personal and legal representatives.
10. Security. To the
extent requested by Indemnitee and approved by the Board, the Company may at any time and from time to time provide security to Indemnitee
for the Company’s obligations hereunder through an irrevocable bank line of credit, funded trust or other collateral. Any such security,
once provided to Indemnitee, may not be revoked or released without the prior written consent of the Indemnitee.
11. Enforcement.
(a) The Company expressly confirms
and agrees that it has entered into this Agreement and assumes the obligations imposed on it hereby in order to induce Indemnitee to serve
as an officer or director of the Company, and the Company acknowledges that Indemnitee is relying upon this Agreement in serving as an
officer or director of the Company.
(b) This Agreement constitutes
the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings,
oral, written and implied, between the parties hereto with respect to the subject matter hereof.
(c) The Company shall not seek
from a court, or agree to, a “bar order” which would have the effect of prohibiting or limiting the Indemnitee’s rights
to receive advancement of expenses under this Agreement.
12. Definitions. For
purposes of this Agreement:
13. Severability.
The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision.
Without limiting the generality of the foregoing, this Agreement is intended to confer upon Indemnitee indemnification rights to the fullest
extent permitted by applicable laws. In the event any provision hereof conflicts with any applicable law, such provision shall be deemed
modified, consistent with the aforementioned intent, to the extent necessary to resolve such conflict.
14. Modification and Waiver.
No supplement, modification, termination or amendment of this Agreement shall be binding unless executed in writing by both of the parties
hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions hereof
(whether or not similar) nor shall such waiver constitute a continuing waiver.
15. Notice By Indemnitee.
Indemnitee agrees promptly to notify the Company in writing upon being served with or otherwise receiving any summons, citation, subpoena,
complaint, indictment, information or other document relating to any Proceeding or matter which may be subject to indemnification covered
hereunder. The failure to so notify the Company shall not relieve the Company of any obligation which it may have to Indemnitee under
this Agreement or otherwise unless and only to the extent that such failure or delay materially prejudices the Company.
16. Notices. All notices
and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given: (a) upon
personal delivery to the party to be notified, (b) when sent by confirmed electronic mail or facsimile if sent during normal business
hours of the recipient, and if not so confirmed, then on the next business day, (c) five (5) days after having been sent by registered
or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight
courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to Indemnitee at the address
set forth below Indemnitee signature hereto, and to the Company, at its principal executive offices to the attention of the President,
or to such other address as may have been furnished to Indemnitee by the Company or to the Company by Indemnitee, as the case may be.
17. Counterparts.
This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall
constitute one and the same Agreement. This Agreement may also be executed and delivered by facsimile signature and in two or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
18. Headings. The
headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement
or to affect the construction thereof.
19. Governing Law and
Consent to Jurisdiction. This Agreement and the legal relations among the parties with respect to the subject matter of this Agreement
shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, without regard to its conflict
of laws rules. The Company and Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising out of
or in connection with this Agreement shall be brought only in the Chancery Court of the State of Delaware (the “Delaware Court”),
and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit
to the exclusive jurisdiction of the Delaware Court for purposes of any action or proceeding arising out of or in connection with this
Agreement, (iii) waive any objection to the laying of venue of any such action or proceeding in the Delaware Court, and (iv) waive, and
agree not to plead or to make, any claim that any such action or proceeding brought in the Delaware Court has been brought in an improper
or inconvenient forum.
IN WITNESS WHEREOF, the parties
hereto have executed this Indemnification Agreement on and as of the day and year first above written.
The following executive officers and directors
are each party to an Indemnification Agreement or Amended and Restated Indemnification Agreement with the Company, each of which is substantially
identical in all material respects to the representative Indemnification Agreement filed herewith and is dated as of the respective date
listed below.
In connection with the quarterly report of Oramed
Pharmaceuticals Inc., or the Company, on Form 10-Q for the period ended March 31, 2024, as filed with the Securities and Exchange Commission
on the date hereof, or the Report, I, Nadav Kidron, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C.
Section 1350, that to my knowledge:
In connection with the quarterly report of Oramed
Pharmaceuticals Inc., or the Company, on Form 10-Q for the period ended March 31, 2024, as filed with the Securities and Exchange Commission
on the date hereof, or the Report, I, David Silberman, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section
1350, that to my knowledge: