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): February 14, 2018

ORAMED PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

 

DELAWARE		001-35813		98-0376008
(State or Other Jurisdiction		(Commission File Number)		(IRS Employer
of Incorporation)				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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 1.01. Entry into a Material Definitive Agreement.

 

On February 14, 2018, Oramed Ltd. (the “Subsidiary”), a wholly-owned subsidiary of Oramed Pharmaceuticals Inc. (the “Company”), entered into a Clinical Research Organization Services Agreement (the “Agreement”) with Integrium, LLC (“Integrium”), effective as of November 1, 2017, to retain Integrium as a clinical research organization for the Subsidiary’s planned upcoming three-month dose-ranging 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 HbA1c on approximately 240 type 2 diabetic patients. The Agreement will terminate upon the satisfactory performance of all the services as contemplated in the Agreement.

 

As consideration for its services, the Subsidiary will pay Integrium a total amount of up to $7 million that will be paid over the term of the engagement and based on the achievement of certain milestones.

 

 

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
February 20, 2018