UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01. Entry into a Material Definitive Agreement.
On September 23, 2024, Oramed Ltd. (the “Subsidiary”), a wholly-owned subsidiary of Oramed Pharmaceuticals Inc. (the “Company”), entered into a Master Services Agreement (the “Agreement”) with InClin, Inc. (“InClin”), to retain InClin as a clinical research organization. The services covered by the Agreement may include strategic planning, expert consultation, statistical programming and analysis, data processing, data management, regulatory, clerical, project management, medical writing and other research and development services requested by the Subsidiary and agreed to by InClin for the Subsidiary’s planned upcoming Phase 3 clinical trial. The trial will be conducted under an Investigational New Drug application with the U.S. Food and Drug Administration and is designed to assess the safety and evaluate the efficacy of ORMD-0801 on approximately 300 type 2 diabetic patients.
The Subsidiary can terminate the Agreement with or without cause upon 30 days written notice to InClin. Either party can terminate the Agreement upon 30 days written notice to the other party in case of a breach, and the party fails to cure such breach within 30 days following the date of such notice. As consideration for its services, the Subsidiary will pay InClin a total amount of up to approximately $11.5 million that will be paid over the term of the engagement and based on the number of hours performed by InClin per month.
The foregoing description of the Agreement is qualified in its entirety by reference to the full text of the Agreement, a copy of which is attached to this Current Report on Form 8-K as Exhibit 1.01 and is incorporated herein by reference.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains statements which constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. These forward-looking statements are based upon the Company’s present intent, beliefs or expectations, but forward-looking statements are not guaranteed to occur and may not occur for various reasons, including some reasons which are beyond the Company’s control. For example, this Report discusses our planned Phase 3 clinical trial activities for ORMD-0801. These forward-looking statements are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risk that the Company may not be able to successfully implement its strategic plans; the risks and uncertainties related to the progress, timing, cost and results of current and future clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for the Company’s product candidates; competition from other pharmaceutical or biotechnology companies; and the Company’s ability to obtain additional funding required to conduct its research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching the Company’s clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of the Company’s technology as it progresses further and lack of acceptance of its methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of the Company’s products; unforeseen scientific difficulties that may develop with its process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; the Company’s patents may not be sufficient; that products may harm recipients; and other factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, each of which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. All of these factors and uncertainties could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. For these reasons, among others, you should not place undue reliance upon the Company’s forward-looking statements. Except as required by law, the Company undertakes 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 Report.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
| 10.1 | Master Services Agreement dated September 23, 2024, between Oramed Ltd. and InClin, Inc. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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 hereunto duly authorized.
| ORAMED PHARMACEUTICALS INC. | ||
| By: | /s/ Nadav Kidron | |
| Name: | Nadav Kidron | |
| Title: | President and CEO | |
September 26, 2024
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