- $169 Million in Cash and
Investments
- Pivotal Phase 3 Oral Insulin Data Expected January 2023
- Phase 2 NASH Data Expected This Quarter
- Oravax - Oral Vaccine
NEW
YORK, July 7, 2022 /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 Chief Executive Officer, Nadav Kidron.
Dear Shareholders,
As we enter the second half of 2022, I am pleased to share with
you updates regarding Oramed Pharmaceuticals and our subsidiary
Oravax Medical. While we find ourselves in a tumultuous
environment for the global economy, financial markets, and in
particular, the biotech sector, we consider ourselves well
positioned financially and clinically with multiple important
milestones expected over the next six months.
Robust Balance Sheet: $169
Million in Cash and Investments
Our financial
position is strong with a robust balance sheet, no debt and
approximately $169 million in cash
and investments as of March 31, 2022.
This position gives us sufficient runway to complete our pivotal
oral insulin (ORMD-0801) Phase 3 trials and advance us towards
potential FDA approval. In addition, we will continue
investing in our PODTM oral delivery pipeline, as well
as pursuing opportunities to capitalize on strategic prospects.
Phase 3 Oral Insulin Trials: Top-Line Data Expected
January 2023
In January 2023, we anticipate reaching one of the
most significant milestones of this Company's history, when we
report top-line efficacy data in the world's first-ever pivotal
Phase 3 oral insulin trial for the treatment of type 2 diabetes,
under a U.S. FDA protocol. As reported, we exceeded the number of
planned participants in the first of our two oral insulin trials
ORA-D-013-1, with 710 participants enrolled. Concurrently, our
second Phase 3 trial, ORA-D-013-2, has enrolled nearly 50% of the
planned 450 patients.
For the millions of people suffering from diabetes, we believe
ORMD-0801 will offer an easier and more efficacious way of
delivering insulin without the need for injections and doing so in
a safer and more healthy manner. In a recent IQVIA market survey,
approximately 80% of physicians said they would likely prescribe
oral insulin to their patients, if approved. If you have not had a
chance yet to see the webinar on the promise of oral insulin for
the treatment of type 2 diabetes, I invite you to view it here:
https://youtu.be/yrWtf8PSgk0
Phase 2 NASH Data Expected This Quarter
In
March 2022, we completed enrollment
in our Phase 2 trial of ORMD-0801 for the treatment of
non-alcoholic steatohepatitis (NASH). We expect to announce
top-line results later this quarter. The double-blind, multi-center
trial with clinical sites in the U.S. and Israel assesses the safety and efficacy of
ORMD-0801 in type 2 diabetes patients with NASH. There is
currently no FDA approved treatment for NASH, which is expected to
become an $84 billion market by
2029.
Oravax
The Phase 1 clinical trial of Oravax's oral
virus-like particle (VLP) COVID-19 vaccine for COVID-naive
participants is underway in South
Africa. The trial protocol calls for two cohorts each
comprised of 12 participants. The South African Health
Products Regulatory Authority (SAPHRA) requires a 42-day safety
waiting period once the last patient in Cohort A completes
enrollment and dosing, after which Cohort B may commence enrollment
and dosing.
Due to several factors, including the fact that many volunteers
did not qualify during screening due to prior asymptomatic COVID-19
infection and other conditions, the rate of enrollment was slower
than anticipated. We added an additional clinical site and we
have since completed enrollment and dosing of Cohort A with no
safety issues reported thus far and anticipate sharing top-line
data this quarter. We expect Cohort B to complete dosing this
quarter as well, with data expected in Q4 2022.
As we continue to develop our oral VLP COVID-19 vaccine as both
a first line and booster vaccine, we are also positioning Oravax to
address the broader global vaccine market and are currently
exploring opportunities for additional vaccine indications.
The vaccine market is projected to reach $125 billion by 2028.
To recap, Oramed is extremely well positioned in terms of cash
position, Phase 3 oral insulin program, IP portfolio and platform
technology - which can be used for numerous indications. We thank
you for your support and look forward to keeping our shareholders
updated on the exciting milestones ahead.
Sincerely,
Nadav Kidron
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals
(NASDAQ: ORMP) (TASE: ORMP) 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 transform the
treatment of diabetes through its proprietary lead candidate,
ORMD-0801, which is being evaluated in two pivotal Phase 3 studies
and has the potential to be the first commercial oral insulin
capsule for the treatment of diabetes. 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 pace of enrollment
and randomization and expected timing of results of our clinical
trials, the expected timing and achievement of milestones, the
potential development, benefits, safety, efficacy and timing of
Oravax's oral COVID-19 vaccine, the value of potential future
orders of such oral vaccine, the ability of our balance sheet to
allow us to complete our Phase 3 oral insulin trials and advance
Oravax's oral COVID-19 vaccine through late-stage clinical trials
and begin investing in production or the potential of ORMD-0801 to
be the first commercial oral insulin capsule for the treatment of
diabetes, as well as its potential for the treatment of people with
diabetes who also suffer from NASH. 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.
Company Contact:
Zach
Herschfus
+1-844-9-ORAMED
zach@oramed.com
Logo:
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SOURCE Oramed Pharmaceuticals Inc.