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): March 11, 2019

 

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.)

 

142 W. 57th Street, New York, New York

 

10018

(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))

 

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.

 

 

 

 

 

Item 8.01. Other Events.

 

As previously disclosed, Oramed Pharmaceuticals Inc., its wholly owned subsidiary, Oramed Ltd. (collectively, the “Company”), and Hefei Tianhui Incubator of Technologies Co. Ltd. (“HTIT”) entered into an Amended and Restated Technology License Agreement (as amended, the “License Agreement”), according to which the Company granted HTIT an exclusive commercialization license in the territory of the People's Republic of China, Macau and Hong Kong, related to the Company’s oral insulin capsule, ORMD-0801. Pursuant to the License Agreement, HTIT will conduct, at its own expense, certain pre-commercialization and regulatory activities with respect to Oramed Ltd.’s technology and ORMD-0801 capsule. On March 11, 2019, the Company was formally informed by HTIT that the Center For Drug Evaluation of the China National Medical Products Administration, approved the initiation of clinical trials in China for ORMD-0801.

 

 

 

 

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

 

March 13, 2019