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
February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development Ltd. to acquire the provisional
patent related to an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes. On
May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged
in research and development. On
July 30, 2019, the Subsidiary incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”).
As of March 31, 2023, the Hong Kong Subsidiary has no operations. 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. (“Akers”), Premas
Biotech Pvt. Ltd. (“Premas”), Cutter Mill Capital LLC (“Cutter Mill”) and Run Ridge LLC (“Run Ridge”).
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, on a fully diluted basis, 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. The Company has also initiated a comprehensive analysis of the data to understand
if there is a path forward for its oral insulin candidate. Concurrently, the Company is examining its existing pipeline and has commenced
an evaluation process of potential strategic opportunities, with the goal of enhancing value for the Company’s stockholders. 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 is required.
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. Based on the Company’s current cash resources
and commitments, the Company believes it will be able to maintain its current planned development 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. Successful completion of the Company’s development programs and its transition to normal operations is dependent
upon obtaining necessary regulatory approvals from the U.S. Food and Drug Administration prior to selling its products within the United
States, obtaining foreign regulatory approvals to sell its products internationally, or entering into licensing agreements with third
parties. There can be no assurance that the Company will receive regulatory approval of any of its product candidates, a
Free historical financial statements for Oramed Pharmaceuticals Inc..
See how revenue, income, cash flow, and balance sheet financials have changed over 37 quarters since 2015. Compare with ORMP stock chart to see long term trends.
Data imported from Oramed Pharmaceuticals Inc. SEC filings. Check original filings before making any investment decision.