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>>> Oramed Letter to Shareholders


Yahoo Finance

July 7, 2022


https://finance.yahoo.com/news/oramed-letter-shareholders-115500594.html


$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:

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).

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