$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
Dear Shareholders,
As we enter the second half of 2022, I am pleased to share with you updates regarding
Robust Balance Sheet:
Our financial position is strong with a robust balance sheet, no debt and approximately
Phase 3 Oral Insulin Trials: Top-Line Data Expected
In
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
In
Oravax
The Phase 1 clinical trial of Oravax’s oral virus-like particle (VLP) COVID-19 vaccine for COVID-naive participants is underway in
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
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,
About
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
Company Contact:
zach@oramed.com
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