NEW YORK, April 1, 2020 /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,
As the world faces an unprecedented challenge with much
uncertainty, we at Oramed wanted to provide our shareholders and
other constituents with an update on our business. Over the past
weeks, we have closely followed the guidance of governments and
leading public health institutes to ensure the safety of our
employees. Additionally, we have conducted a business review to
assess the potential impact of COVID-19. At this time, we continue
to move ahead with all strategic initiatives and anticipate limited
long-term impact from COVID-19. As our platform technology could be
effective for protein-based vaccines, we are closely monitoring
developments on the efforts to find a vaccine for COVID-19 and any
potential partnerships on this front.
Oral Insulin (ORMD-0801)
We are moving ahead with the
planning for our oral insulin (ORMD-0801) Phase 3 clinical studies
and have accomplished several key milestones to this end. In
February, Oramed conducted its initial End-of-Phase 2 (EoP2)
meeting with the U.S. Food and Drug Administration (FDA) to discuss
Chemistry Manufacturing and Control (CMC) of ORMD-0801 (Press
Release dated March 19, 2020). The
meeting followed the successful completion of Oramed's Phase
2b study of ORMD-0801 for the
treatment of type 2 diabetes (Press Release dated November 12, 2019), which achieved its primary
endpoint. During the meeting, the FDA provided feedback on key
issues relating to Drug Product manufacturing. We are also looking
forward to the second of the EoP2 meetings with FDA. This
meeting will include a discussion of the results from the Phase 2
study and the design of the Phase 3 clinical studies proposed to
support a license application for a Type 2 diabetes indication if
the Phase 3 studies are successfully completed. During this
meeting, we anticipate receiving the FDA's guidance on the Phase 3
study design in order to take the next step of submitting the
protocols and initiate planning for the Phase 3 program at multiple
clinical sites in the U.S. and Europe. We have also requested a meeting with
the European Medicines Agency (EMA) regarding our Phase 3 study
design, as we intend to utilize clinical sites and file for
marketing approval in Europe.
NASH Exploratory Clinical Study
Our NASH exploratory
clinical study of oral insulin for the treatment of chronic liver
disease assesses the efficacy of ORMD-0801 in reducing liver fat
content, inflammation, and fibrosis. We intend to present data on
the early patient cohort in the near future. We are expanding
the trial to 30 patients and will shortly be adding additional
sites in Israel, Europe and potentially the U.S.
Leptin Exploratory Clinical Study
We previously
communicated our expectation of initiating and completing a Leptin
proof-of-concept single dose study, evaluating the pharmacokinetic
and pharmacodynamics of our oral Leptin drug candidate in 10 type 1
adult diabetic patients, during the first quarter of 2020. Due to
the COVID-19 pandemic, enrollment has been delayed. The trial,
however, is ready to resume once the health crisis is
contained.
Chinese Clinical Trial
Due to COVID-19 our Chinese
partner's (HTIT) development progress was understandably slowed
over the past few months. HTIT has confirmed that they are now
fully back to work and in contact with the Chinese regulatory
agency (NMPA) on moving forward to the next trials.
Cash Runway
Following our recent financing of
$21 million in March 2020 (Press Release dated February 27, 2020), Oramed is well funded with a
cash position of roughly $50 million,
which will allow us to progress smoothly into later-stage clinical
trials. Our balance sheet remains flexible and strong with zero
debt.
We will continue to assess the evolving COVID-19 situation
and provide our constituents appropriate updates when possible. We
are very optimistic in our business and believe that 2020 will be a
very productive and event driven year for Oramed. We look forward
to continuing the advancement of our clinical programs,
particularly the initiation this year of a U.S. Phase 3 trial for
ORMD-0801, which we believe positions Oramed to be the first to
offer an oral insulin capsule for the treatment of
diabetes.
Wishing you and yours good health,
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 New
York and Israel, Oramed has developed a novel Protein
Oral Delivery (PODâ„¢) technology that is based on more than 30 years
of research by scientists at Jerusalem's Hadassah Medical
Center. 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 Type 2 and Type 1
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 strategic initiatives
and our belief that there will be limited long-term impact from
COVID-19, future meetings with the FDA and EMA and the expected
outcome thereof, expansion of our NASH clinical study and
additional sites, the timing of our Leptin proof-of-concept study,
HTIT's future progress, the adequacy of our cash position and
balance sheet flexibility, the potential use of our oral delivery
technology in a future COVID-19 vaccine, 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.
Company Contact:
Estee Yaari
+1-844-9-ORAMED
estee@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.