- Stock Repurchase Program
- Scilex Senior Secured Note
- Phase 3 Oral Insulin Trial in US
- JV with Chinese Partner, HTIT
NEW
YORK, June 26, 2024 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ("Oramed")
(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 Chief Executive Officer,
Nadav Kidron.
Dear Shareholders,
In light of our recent announcement regarding Oramed's
$20 million stock repurchase program,
we believe this is an opportune moment to provide our shareholders
with a comprehensive update on our activities and progress. As this
development demonstrates our confidence in Oramed's value and
potential, we felt it was important to contextualize this decision
within the broader landscape of our ongoing initiatives and future
plans. This letter serves to offer you insights into our current
position, strategic direction, and the exciting opportunities that
lie ahead for Oramed. We remain committed to transparent
communication and are pleased to share this overview with you.
Scilex Senior Secured Note
The repayment schedule from Scilex Holding Company for its
Senior Secured Note commenced on December
21, 2023, with fixed installments due quarterly. As of
today, Oramed has received $40
million out of the total $102
million principal (excluding interest and exit fees). This
represents a significant portion of the expected returns from this
strategic investment. The next milestone in this repayment plan is
a $20 million installment, scheduled
for September of this year.
Phase 3 Oral Insulin Program
Oramed has proactively engaged in constructive dialogue with the
U.S. Food and Drug Administration regarding a new Phase 3 protocol.
This refined approach is strategically focused on specific patient
subgroups identified as significant responders through
comprehensive analysis of both Phase 2 and Phase 3 data. By
leveraging these insights, we aim to optimize the potential for
success in our potential upcoming trial. This adaptive strategy
underscores our commitment to advancing oral insulin therapy and
potentially addressing a critical unmet need in diabetes
management.
Oramed-HTIT Joint Venture Update
Oramed and its long-term partner, Hefei Tianhui Biotech Co.,
Ltd. (HTIT), are finalizing the formation of a joint venture (JV)
centered around Oramed's cutting-edge oral drug delivery
technology. The U.S.-based JV will focus on developing, marketing,
and commercializing innovative products from Oramed's oral insulin
and POD™ (Protein Oral Delivery) pipeline, leveraging HTIT's
advanced manufacturing capabilities.
The JV will receive a significant capital infusion, with HTIT
committing $70 million in cash and
Oramed investing $25 million in cash
and stock. These funds are strategically allocated to support the
successful completion of the Phase 3 trial in the U.S., along with
other crucial clinical and business activities. Furthermore, we are
exploring strategies with HTIT to capitalize on their production
capabilities and the expected launch of oral insulin sales.
While synergies exist, the proposed transactions are complex,
and there is no certainty that we will be able to close on any or
all of them. We will keep you informed as progress is made.
In summary, Oramed maintains a strong cash position, bolstered
by solid progress on the Scilex note transaction. We are making
strides towards initiating a new Phase 3 trial for our oral insulin
program while actively pursuing the joint venture opportunity with
HTIT. These strategic initiatives position us to drive significant
shareholder value. Thank you for your continued support as we work
diligently to achieve major milestones. We look forward to
providing updates on our progress.
Sincerely,
Nadav Kidron
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform
technology pioneer in the field of oral delivery solutions for
drugs currently delivered via injection. The Company's novel
Protein Oral Delivery (POD™) technology is designed to protect drug
integrity and increase absorption. Oramed has offices in
the United States and 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, our
potential repurchase of our shares, the benefits of the Scilex note
and related transactions, the value of Scilex, its growth
trajectory, commercial portfolio and infrastructure and clinical
stage pipeline, 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, 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.