UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): May 4, 2016

 

ORAMED PHARMACEUTICALS INC.

(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.)

 

Hi-Tech Park 2/4 Givat Ram, PO Box 39098, Jerusalem, Israel   91390
(Address of Principal Executive Offices)   (Zip Code)

  

+972-2-566-0001

(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))

 

 

 

 

 

Item 7.01.      Regulation FD Disclosure.

 

Oramed Pharmaceuticals Inc. (the “Company”) expects to receive and announce results from its Phase 2b clinical trial for its ORMD-0801 oral insulin capsule in approximately two weeks’ time.

 

The double-blind, randomized Phase 2b trial of 180 patients with type 2 diabetes was conducted under a U.S. Food and Drug Administration Investigational New Drug protocol at 33 clinical sites in the United States.

 

Warning Concerning Forward Looking Statements

 

This Current Report on Form 8-K (the “Report”) 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, the Report states that the Company expects to receive and announce results from its clinical trial in approximately two weeks’ time. In fact, the timing of the receipt of these results could change due to various factors and the receipt and announcement could be delayed. For this reason, 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 the Report.

 

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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


May 4, 2016

 

 

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