Current Report Filing (8-k)
July 15 2020 - 9:17AM
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):
July 15, 2020
ORAMED PHARMACEUTICALS INC.
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(Exact name of registrant as specified in its charter)
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DELAWARE
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001-35813
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98-0376008
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(State or Other Jurisdiction
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(Commission
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(IRS Employer
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of Incorporation)
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File Number)
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Identification No.)
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1185
Avenue of the Americas, Suite 228, New York, New York
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10036
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(Address of Principal Executive Offices)
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(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
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Trading symbol
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Name of each exchange on which registered
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Common Stock, par value $0.012
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ORMP
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The Nasdaq Capital Market, Tel Aviv Stock Exchange
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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.
On July 15, 2020, Oramed
Pharmaceuticals Inc. (the “Company”) announced that The U.S. Food and Drug Administration (the “FDA”)
provided positive feedback during the Company’s end of Phase II meeting for the Company’s oral insulin candidate,
ORMD-0801. Based on the FDA’s feedback, the Company intends to initiate two Phase III clinical trials following FDA review
of those Phase III protocols and nonclinical documents. The FDA outlined its expectations for design of the ORMD-0801 Phase III
trials, as well as submission of the Biologics License Application (“BLA”) that would follow successful trials. The
Company plans to conduct the two phase III trials concurrently.
Forward-looking Statements
This Current Report on Form 8-K contains
forward-looking statements. For example, the Company is using forward-looking statements when it discusses the initiation of Phase
III trials, the potential submission of a BLA, and the validation of preliminary findings in future trials. In addition, historic
results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest
identical or even similar conclusions. 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 its product candidates; competition from other pharmaceutical or biotechnology companies; and its 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 its clinical trials; changes in legislation; inability
to timely develop and introduce new technologies, products and applications; lack of validation of its technology as the Company
progress 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 its 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; its 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. Except as otherwise required by law, the Company undertakes no obligation to publicly
release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect
the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting the Company, reference
is made to the Company’s reports filed from time to time with the U.S. Securities and Exchange Commission.
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
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Title:
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President and CEO
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July 15, 2020
2
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