NEW YORK, May 25, 2021 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com),
a clinical-stage pharmaceutical company focused on the development
of oral drug delivery systems, is pleased to provide the following
Letter to Shareholders from Chief Executive Officer Nadav Kidron.
Dear Shareholders,
I'm excited to share with you significant milestones we have
achieved over the past few months. Our oral delivery platform
technology could apply to a range of proteins and disease
modalities, and we expect over time to have a range of
programs. We are currently advancing our two primary programs:
oral insulin for diabetes and an oral COVID vaccine. We believe
these milestones create an inflection point in the value for our
company.
ORMD-0801 Positioned to be the World's First Oral Insulin
Capsule
We're pleased at the pace of our Phase 3 oral insulin
studies. Under a U.S. FDA protocol, we are advancing two
concurrent pivotal Phase 3 studies for ORMD-0801 in the treatment
of type 2 diabetes (T2D). ORA-D-013-1 has recruited close to 300 of
the planned 675 patients through 75 U.S. clinical sites, while
ORA-D-013-2 has commenced enrollment. We look forward to
keeping you updated on the progress of these studies.
We anticipate completing enrollment for the U.S. study,
ORA-D-013-1, before the end of 2021 and announcing initial results
from this study in 2022. Following results from both studies,
we expect to submit a Biologics License Approval (BLA) filing to
the FDA.
Unlocking Value with Oravax Medical
- Oral COVID-19 Vaccine Clinical Trial through Oravax Medical
to Begin H2 2021
- Oravax Expected to Bring Value to Oramed Shareholders,
Potentially Through Dividend Shares of Oravax Medical Shares to
Oramed Shareholders
Our platform technology for the oral delivery of proteins has
the potential to be transformative and is generating a lot of
interest in the vaccine industry. Oravax Medical Inc., Oramed's
venture that combines Oramed's proprietary POD™ oral delivery
technology and Premas Biotech's novel vaccine technology, is
preparing to begin clinical trials of an oral COVID-19 vaccine in
H2 2021.
A single dose of Oravax Medical's oral vaccine produced a
significant antibody response with long-retention in a preclinical
in-vivo study. We believe that Oravax Medical's novel
vaccine technology is a strong candidate for protection against
COVID-19 and its variants due to triple antigen targeting, easier
distribution, and ease of use. We are now in discussions with
potential partners for pre-orders of Oravax Medical's vaccine
candidate.
We believe there is tremendous value to be unlocked through
Oravax Medical's development of a portfolio of oral vaccines for
COVID-19 and other infectious diseases. Accordingly, we are
exploring ways to ensure that Oramed's shareholders will benefit
more directly from Oravax Medical's promise, including potentially
issuing dividend shares of some of Oramed's shares in Oravax
Medical to Oramed's shareholders, which would make Oravax Medical a
publicly held company that may then apply for listing on Nasdaq if
eligible. We look forward to updating you on developments.
Strong Balance Sheet
We are well positioned to capitalize on these market
opportunities with a balance sheet that has over $75 million in cash (as of April 13, 2021) with no debt.
2021 has started with strong momentum for Oramed. We are working
hard at delivering more clinical and corporate milestones and
generating value for our shareholders through the rest of the year
and beyond.
Sincerely,
Nadav Kidron
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in
the field of oral delivery solutions for drugs currently delivered
via injection. Established in 2006, with offices in the
United States and Israel,
Oramed has developed a novel Protein Oral Delivery (POD™)
technology. Oramed is seeking to revolutionize the treatment of
diabetes through its proprietary lead candidate, ORMD-0801,
which has the potential to be the first commercial oral insulin
capsule for the treatment of diabetes. The Company has
completed multiple Phase II clinical trials under an
Investigational New Drug application with the U.S. Food and
Drug Administration. In addition, Oramed is developing an oral
GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901.
For more information, please visit www.oramed.com.
Forward-looking statements: This press release
contains forward-looking statements. For example, we are using
forward-looking statements when we discuss the expected recruitment
and enrollment for our trials and studies, the expected timing of
initiating and completing our and Oravax Medical's trials and
studies, the potential for FDA approval of our oral insulin, our
expectation that we have enough cash to move forward, expected
updates regarding future milestones, the potential of Oravax
Medical's novel vaccine technology to be a strong candidate for
protection against COVID-19 and its variants, as well as other
infectious diseases, the potential for partners for pre-orders of
Oravax Medical's vaccine candidate, the potential benefits of
Oravax Medical to bring value to our shareholders, a potential
dividend of Oravax Medical shares to Oramed's shareholders, the
potential of ORMD-0801 to be the first commercial oral insulin
capsule for the treatment of diabetes or revolutionizing the
treatment of diabetes with our products. 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 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.
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Company Contact
Estee Yaari
+1-844-9-ORAMED Ext: 2
estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.