Current Report Filing (8-k)
September 09 2020 - 4:14PM
Edgar (US Regulatory)
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): September 9, 2020 (September 2, 2020)
ORAMED
PHARMACEUTICALS INC.
|
(Exact
name of registrant as specified in its charter)
|
DELAWARE
|
|
001-35813
|
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98-0376008
|
(State
or Other Jurisdiction
|
|
(Commission
|
|
(IRS
Employer
|
of
Incorporation)
|
|
File
Number)
|
|
Identification
No.)
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1185
Avenue of the Americas, Third Floor, New York, New York
|
|
10036
|
(Address
of Principal Executive Offices)
|
|
(Zip
Code)
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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:
Title
of each class
|
|
Trading
symbol
|
|
Name
of each exchange on which registered
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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. ☐
|
Item
1.01.
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Entry
into a Material Definitive Agreement.
|
On
September 2, 2020, 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 January 15, 2020, to retain Integrium as a clinical research organization 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 675
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 approximately $21.6 million
that will be paid over the term of the engagement and based on the achievement of certain milestones.
|
Item
9.01.
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Financial
Statements and Exhibits.
|
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*
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Certain
identified information in the exhibit has been excluded from the exhibit because it is
both (i) not material and (ii) would likely cause competitive harm to the Company if
publicly disclosed.
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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.
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ORAMED
PHARMACEUTICALS INC.
|
|
|
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By:
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/s/
Nadav Kidron
|
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Name:
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Nadav
Kidron
|
|
Title:
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President
and CEO
|
September
9, 2020
2
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