- Initiating Phase 3 oral insulin trial in the United States under a new
protocol
- JV with Chinese Partner, HTIT
- Scilex Senior Secured Note
- PeriTech Asset Purchase & Strategic
Out-licensing
NEW
YORK, Feb. 20, 2024 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com),
a clinical-stage pharmaceutical company focused on the development
of oral drug delivery platforms, today issued a Letter to
Shareholders from its President and Chief Executive Officer,
Nadav Kidron.
Dear Shareholders,
I am pleased to share with you an update regarding Oramed.
Despite the unexpected negative results we received for our U.S.
based Phase 3 trial at the outset of last year, I am happy to
report that we stand today on solid ground with many opportunities
through which we seek to increase shareholder value.
Oramed's Chinese Partner, HTIT, Successfully Completed Phase
3 Trial and Advances Production Facilities:
Hefei Tianhui Biotechnology Co. Ltd. ("HTIT"), a strategic
partner of Oramed, achieved a noteworthy milestone by successfully
completing its Phase 3 trials of oral insulin for type 2 diabetes
in China, currently in the final
stages of regulatory approval.
In addition, HTIT has made substantial investments in facilities
to enable commercial-scale production of the oral insulin capsule.
This development underscores our belief in HTIT's commitment to
advancing the accessibility of innovative oral insulin solutions
for patients in China and
potentially beyond, as evidenced by the proposed Joint Venture
described below.
Phase 3 Oral Insulin Program:
In January 2023, Oramed announced
that its U.S.-based, Phase 3 oral insulin trial for the treatment
of type 2 diabetes did not meet its primary or secondary endpoints.
Oramed has since completed an in-depth review of the trial data and
the analysis found that subpopulations of patients with specific
parameters, such as body mass index (BMI), baseline HbA1c, and age
responded well to oral insulin. These subsets exhibited an over 1%
placebo adjusted, statistically significant, reduction in HbA1c and
closely approximate the patient population in the HTIT trials.
We are encouraged by the results of our analysis and have begun
discussions with the FDA. We intend to initiate a Phase 3 oral
insulin trial in the U.S. under a differentiated protocol that
aligns with this positive data later this year.
Oramed and HTIT Joint Venture:
In January 2024, Oramed entered
into a definitive agreement with HTIT, marking a milestone in the
creation of a joint venture ("JV"), centered around Oramed's
cutting-edge oral drug delivery technology. The JV is poised to be
a dynamic force, focusing on the development, marketing, and global
commercialization of innovative products derived from Oramed's oral
insulin and POD™ (Protein Oral Delivery) pipeline. This strategic
partnership will harness HTIT's advanced manufacturing capabilities
and technologies.
The joint venture will receive a significant capital infusion,
with HTIT committing a notable $70
million investment, supplemented by a $20 million investment from Oramed (comprised of
$10 million in cash and $10 million in shares of Oramed common stock).
This robust financial foundation is intended to help with the
completion of clinical trials in the
United States and to support various clinical and business
activities crucial to the venture's overall success. Additionally,
we are exploring further strategies with HTIT to leverage their
top-of-the-line production capabilities and capitalize on the
expected launch of oral insulin sales in China. While there are evident synergies and
logical collaborations on many levels, the proposed transactions
contemplated by the JV are intricate and are still in process.
There is no certainty that we will be able to close some or all of
these transactions. We will keep you informed as we make progress
in this regard.
Scilex Senior Secured Note:
In September 2023, Scilex Holding
Company ("Scilex") issued an 18-month Senior Secured Promissory
Note to Oramed (the "Note"), carrying an initial principal balance
of $101,875,000 and an interest rate
of SOFR plus 8.5% (currently ~13.8%). Oramed secured a senior
lien on nearly all assets of Scilex and its subsidiaries as
collateral for the Note. Concurrently, Scilex granted Oramed new
warrants for up to 13 million shares of Scilex common stock at an
exercise price of $0.01 per share,
subject to vesting as well as certain ownership and other
restrictions. Repayment of the principal balance began on
December 21, 2023, with fixed
increments due every three months thereafter. In addition, a
failure to fully repay the Note by March 21,
2024, triggers an exit fee of $3,056,250 upon full repayment.
Peritech Asset Acquisition and Strategic
Out-Licensing:
In December 2023, Oramed executed
and completed an agreement with PeriTech Pharma Ltd. ("PeriTech"),
acquiring the rights to their cutting-edge film-forming technology
tailored for the delivery of topical/dermatology agents. This
includes a once-daily over-the-counter treatment for hemorrhoids,
surpassing existing market alternatives. The PeriTech pipeline
extends its potential applications to include indications such as
pruritus ani, anal warts, anal fissures and herpes labialis.
In emphasizing the potential benefits of this acquisition,
Oramed has entered into an exclusive Licensing Agreement with an
international consumer product and pharmaceutical group, pursuant
to which Oramed granted the development and commercialization
rights to the PeriTech pipeline in exchange for a royalty based on
net sales. Oramed's shareholders stand to benefit from the
worldwide potential inherent in this transaction.
In summary, Oramed is well positioned in terms of its balance
sheet and is currently taking active steps to continue the
development of its oral insulin program as well as continuing to
take advantage of strategic opportunities in order to increase
shareholder value. We thank you for your support and look forward
to keeping our shareholders updated on the important milestones
ahead.
Sincerely,
Nadav Kidron
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) is a platform
technology pioneer in the field of oral delivery solutions for
drugs currently delivered via injection. Oramed's novel Protein
Oral Delivery (POD™) technology is designed to protect drug
integrity and increase absorption. Oramed has offices in
Israel. For more information,
please visit www.oramed.com.
Forward-looking statements: This press
release contains forward-looking statements within the meaning of
the "safe harbor" provisions 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 Oramed's
opportunities and ability to increase shareholder value, the
anticipated regulatory approval of HTIT's clinical trial data and
the timing of such approval, the expected timing and achievement of
milestones, the potential development, benefits, safety, efficacy
and timing of our oral insulin program, our intention to begin a
Phase 3 oral insulin trial in the U.S. and the timing of such
trial, the potential benefits, capabilities and overall success of
our JV with HTIT, the closing of the transactions contemplated by
the JV including receipt of expected capital contributions, the
completion of clinical trials related to the JV and the expected
launch of oral insulin sales in China, the potential benefits in connection
with our Licensing Agreement, and the ability of our balance sheet
to allow us to continue to the development of our oral insulin
program and take advantage of strategic opportunities. 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 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; 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 close the transactions
contemplated by our JV with HTIT in a timely manner or at all;
inability of Scilex to repay the Note or our inability to realize
the value of the Scilex warrants issued or transferred to us;
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 finally 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:
+1-844-9-ORAMED
ir@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.