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 6, 2016
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.) |
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))
ITEM 7.01. |
REGULATION FD DISCLOSURE. |
On
January 6, 2016, Nadav Kidron, the Chief Executive Officer of Oramed Pharmaceuticals Inc., issued the letter furnished as Exhibit
99.1 to this Current Report on Form 8-K, which letter is incorporated herein by reference.
ITEM 9.01. |
FINANCIAL STATEMENTS AND EXHIBITS. |
|
99.1 |
Letter,
dated January 6, 2016. |
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 |
January
6, 2016
3
Exhibit 99.1
January
6, 2016
Dear
Shareholders,
2015
was a very significant year for us at Oramed setting the bar high for what we anticipate to be a momentous year ahead in 2016.
2015
Major Milestones Included:
| ● | Global
Out-licensing and Investment Deal Valued at $50 Million Plus 10% Royalties in China |
| ● | Initiation
of Phase IIb Study in Type 2 Diabetes for ORMD-0801 (in progress) |
| ● | Initiation
of Phase Ib Study for ORMD-0901 (in progress) |
| ● | Collaboration
with Big Pharma Partner |
| ● | Patent
Granted in U.S. |
2016
Milestones Expected to Include:
| ● | Starting
Out with Strong Balance Sheet with Roughly $40 Million Cash |
| ● | ORMD-0801
Phase IIb Study Completion: |
| ○ | Last
Patient In in Q1, 2016 |
| ○ | Topline
Data Release in Q2, 2016 |
| ● | Milestone
Achievements/Payments in China License Deal |
| ● | ORMD-0901
IND and follow on Study |
| I. | First
Global Out-licensing and Investment Deal Valued at $50 Million Plus 10% Royalties in
China |
We
recently closed a license and investment agreement with Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT) for exclusive
rights to market our oral insulin capsule, ORMD-0801, in Greater China. The agreements were signed at a ceremony which took place
at the Israeli Knesset/Parliament and included Bin Zhou, Sinopharm Vice General President and Xiaoming Gao, HTIT Chairman.
In
addition to the $12 million investment and the $38 million in milestone payments, Oramed will receive up to a 10% royalty on any
future net sales. This double digit royalty enhances the already positive financial aspects of the deal for Oramed. China currently
has more people living with diabetes than any other country in the world and this points to a tremendous market opportunities
in the area of diabetes care. We were very pleased to reach this agreement with HTIT and look forward to a long term working relationship
with them.
| II. | ORMD-0801
Phase IIb Study in Type 2 Diabetes is on Schedule for Completion in Q1/2 2016 |
The
recruitment in our Phase IIb trial of ORMD-0801 has proceeded on-schedule. The study is being conducted under an Investigational
New Drug (IND) filing with the U.S. Food and Drug Administration (FDA). We anticipate sharing topline data from this study during
the second quarter of this year
| III. | ORMD-0901
Phase Ib Study Currently in Progress |
ORMD-0901,
our proprietary oral GLP-1 analog, is a diabetes medication that mimics the natural GLP-1 hormone the body produces to regulate
blood glucose levels. In preparation for filing our IND application with the FDA for a Phase II trial, we are currently conducting
an ex-U.S. Phase Ib study and expect to announce data from this trial in the first calendar quarter of 2016. Concurrent with this
Phase Ib study, we are also conducting 90-day toxicity studies. We hope to file an IND with the FDA and initiate a Phase IIb study
in the United States later this year.
| IV. | Collaboration
with Big Pharma Partner |
We
entered into an agreement with a large international pharmaceutical company to conduct feasibility studies using one of their
propriety injectable compounds. The studies will use Oramed’s proprietary PODTM Technology to deliver the compound
orally. We are very excited about the potential that this collaboration can bring Oramed.
The
U.S. Patent and Trademark Office granted Oramed a key patent for our invention “Methods and Compositions for Oral Administrations
of Proteins” addressing our platform oral administration technology. This patent is a very important milestone that helps
pave Oramed’s entrance into the U.S. market. The United States is the single largest diabetes market in the world with annual
insulin sales of well over $8 billion.
We
Look Forward To Numerous Value-Creating Events In 2016 Including:
Strong
Balance Sheet
Kicking
off 2016 with roughly $40 million in cash should allow us to successfully execute on an enormous global opportunity which includes
bringing our oral insulin and oral GLP-1 towards commercialization. This puts Oramed in a very strong position as we enter into
and continue discussions with potential strategic partners.
Achieving
Development Milestones in our HTIT Deal in China
We
expect to receive additional milestone payments from HTIT based on achieving multiple development milestones in 2016.
ORMD-0801
Phase IIb Study Completion and Topline Data
We
expect to complete our Phase IIb study of ORMD-0801 this quarter and announce top line data by mid-2016.
ORMD-0901
IND and Phase II Study
Data
from our small Phase Ib study of ORMD-0901 is expected upon completion of the trial in the first quarter of 2016. We anticipate
finishing off the FDA requested 90-day preclinical toxicology study later this year and would look to file an IND soon thereafter;
putting us in a position to kick off a U.S. based multicenter Phase II study.
We
believe that 2016 will be an exciting and event driven year. We anticipate that numerous milestones will likely contribute to
building further value in our Company based on the advancement of our clinical pipeline. We encourage you to follow our achievements
throughout the year.
Sincerely,
Nadav
Kidron, CEO
Forward-looking
statements: This letter contains forward-looking statements within the meaning of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. 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. For example, we are using forward-looking statements when we
discuss our clinical trials and feasibility studies, including the design and expected timing thereof, including the timing of
the release of any data, as well as our use of cash and our expected milestone and royalty payments from, and ongoing relationship
with, HTIT. These forward-looking statements are based on the current expectations of the management of Oramed 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; failure to meet the conditions set forth in the HTIT license agreement; difficulties or delays in obtaining
regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies;
and our ability to obtain additional funding required to conduct our 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 our clinical trials; changes in legislation;
inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as
we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees
whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our
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; our patents may not be sufficient; and final
that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from
those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed 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 Oramed,
reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission.
Company
Contact
Oramed
Pharmaceuticals
Ariella
Vaystooch
Office:
+972-2-566-0001 ext. 2
US:
1-718-831-2512 ext. 2
Email:
ariella@oramed.com
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