Regulatory Filings • Sep 13, 2022
Regulatory Filings
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Date of report (Date of earliest event reported): September 13, 2022
(Exact name of registrant as specified in its charter)
| DELAWARE | 001-35813 | 98-0376008 |
|---|---|---|
| (State or Other Jurisdiction | (Commission | (IRS Employer |
| of Incorporation) | File Number) | Identification No.) |
| 1185 Avenue of the Americas, Third Floor, New York, New York | 10036 |
(Address of Principal Executive Offices) (Zip Code)
844-967-2633
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Name of each exchange on which | ||
|---|---|---|
| Title of each class | Trading symbol | registered |
| Common Stock, par value \$0.012 | ORMP | The Nasdaq Capital Market, |
| Tel Aviv Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
On September 13, 2022, Oramed Pharmaceuticals Inc. (the "Company") announced positive Phase 2 results from its double-blind, fully randomized, placebo-controlled, multicenter trial to assess the safety and efficacy of its oral insulin candidate (ORMD-0801), to reduce liver fat content in Type 2 Diabetes ("T2D") patients with non-alcoholic steatohepatitis ("NASH").
The 12-week trial enrolled 32 patients (with 30 patients completing) and demonstrated that ORMD-0801 was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.
The trial also evaluated the effectiveness of ORMD-0801 in reducing liver fat content over the 12-week treatment period by observing several independent measures. These measurements included MR PDFF(%) as measured by MRI, Steatosis and Fibrosis as measured by Fibroscan, Lipids and HbA1c. All of the measurements showed a consistent clinically meaningful trend in favor of ORMD-0801.
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 forwardlooking 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 the potential safety and efficacy of ORMD-0801 and its ability to reduce liver fat content in T2D patients with NASH. 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 risks and uncertainties related to the progress, timing, cost and results of 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; and finally that products may harm recipients, all of which 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 forwardlooking 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.
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.
By: /s/Nadav Kidron
Name:Nadav Kidron Title: President and CEO
September 13, 2022
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