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): January 26, 2011
_____________________
ORAMED
PHARMACEUTICALS INC.
(Exact
name of registrant as specified in its charter)
Nevada
(State
or other jurisdiction
of
incorporation)
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000-50298
(Commission
File Number)
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98-0376008
(IRS
Employer
Identification
No.)
|
Hi-Tech
Park 2/5 Givat Ram
PO
Box 39098
Jerusalem,
Israel 91390
(Address
of principal executive offices and zip code)
Registrant’s
telephone number, including area code: 972-2-566-0001
_____________________
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 (see General Instruction A.2. below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
7.01
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REGULATION
FD DISCLOSURE
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On January 26, 2011, Oramed
Pharmaceuticals Inc. (the "Corporation") made
presentations to various investors that included the following material
information about the Corporation:
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·
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The
Corporation intends to file an Investigational New Drug (“IND”)
application with the U.S. Food and Drug Administration (the “FDA”) for
Phase 2 clinical studies of its orally ingested insulin during the third
quarter of 2011. If the Corporation does not receive comments from the FDA
on its IND application within 30 days from submission, it intends to
immediately commence an FDA approved Phase 2 study to evaluate the safety,
tolerability and efficacy of its oral insulin capsule (ORMD 0801) on type
2 diabetic volunteers.
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·
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The
Corporation expects to have expenditures in the approximate aggregate
amount of $11.1 million for the 24 month period following January 1, 2011,
of which $8.9 million (net of governmental grants received by the
Corporation from the Israeli Office of the Chief Scientist) is expected to
be expended on clinical trials.
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This
Current Report on Form 8-K contains forward-looking statements regarding
our business, financial condition, results of operations and prospects. Words
such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,”
“estimates” and similar expressions or variations of such words are intended to
identify forward-looking statements, but are not deemed to represent an
all-inclusive means of identifying forward-looking statements as denoted in this
Current Report on Form 8-K. Additionally, statements concerning
future matters are forward-looking statements. Although forward-looking
statements in this Current Report on Form 8-K reflect the good faith
judgment of our management, such statements can only be based on facts and
factors currently known by us. Consequently, forward-looking statements are
inherently subject to risks and uncertainties and actual results and outcomes
may differ materially from the results and outcomes discussed in or anticipated
by the forward-looking statements. Factors that could cause or contribute to
such differences in results and outcomes include, without limitation, those
specifically addressed under "Item 1A – Risk Factors" in our Annual Report on
Form 10-K for the year ended August 31, 2010, and filed with the Securities and
Exchange Commission (the “SEC” or the “Commission”) on November 29, 2010, as
well as those discussed elsewhere in our annual report. Readers are urged not to
place undue reliance on these forward-looking statements, which speak only as of
the date of this Current Report on Form 8-K. We undertake 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 this Current Report on Form
8-K. Readers are urged to carefully review and consider the various disclosures
made throughout the entirety of this Current Report on Form 8-K which
attempt to advise interested parties of the risks and factors that may affect
our business, financial condition, results of operations and
prospects.
The
information in this Current Report on Form 8-K furnished pursuant to
Item 7.01 shall not be deemed “filed” for the purposes of Section 18
of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section. It
may only be incorporated by reference in another filing under the Exchange Act
or the Securities Act of 1933, as amended, if such subsequent filing
specifically references the information furnished pursuant to Item 7.01 of
this report.
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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Dated:
January 26, 2011
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By:
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/s/
Nadav Kidron
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Nadav
Kidron
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President,
CEO and Director
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