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By M. Marin
NASDAQ:ORMP
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Leveraging protein oral delivery platform…
Earlier this month, Oramed Pharmaceuticals (NASDAQ:ORMP) CFO David Silberman announced his intention to resign from the company effective July 12, 2024, citing personal reasons. Oramed has launched a search for a new CFO and notes that it believes it has the financial flexibility and balance sheet to continue development activities of its oral insulin program and other opportunities. The company also has access to capital for development efforts, reflecting, among other factors, an agreement under which ORMP is slated to receive quarterly loan repayments that are expected to bolster its balance sheet.
ORMP also has entered into an agreement with Hefei Tianhui Biotech (HTITI) to establish a joint venture (JV) based on Oramed’s oral drug delivery technology focused on developing and commercializing innovative products based on Oramed's oral insulin and POD™ (Protein Oral Delivery) pipeline globally, leveraging HTIT's manufacturing capabilities and technologies. HTIT is a high-tech company focused on biopharmaceutical product manufacturing and R&D with an emphasis on the oral delivery of therapeutic macromolecules.
Oral insulin trial under differentiated protocol aligned with positive data …
ORMP completed an analysis of data from a terminated U.S.-based Phase 3 trial of ORMD 0801 and learned that subpopulations of patients with pooled specific parameters responded well to oral insulin. The subpopulation included patients with specific parameters such as body mass index (BMI), baseline HbA1c, age, gender and body weight. These subsets exhibited an over 1% placebo adjusted, statistically significant reduction in HbA1c. As a result of this analysis, ORMP evaluated potential ways to advance its oral insulin candidate, as well as other assets in its existing pipeline. The company has initiated discussions with the FDA and plans to launch a Phase 3 oral insulin trial in the U.S. under a differentiated protocol aligned with this positive data and believes the trial could commence in 2024.
Potential opportunity to generate royalty revenues; recent PeriTech, Genomma Lab agreements
Separately, Oramed also acquired the rights to PeriTech’s technology for the delivery of topical / dermatology agents, including a once-daily over-the-counter (OTC) hemorrhoids treatment. Oramed also entered into an exclusive licensing agreement with Genomma Lab Internacional, granting Genomma Labs development and commercialization rights to the PeriTech pipeline in exchange for a royalty based on net sales if any of the assets are commercialized. Genomma Lab is a pharmaceutical company based in Mexico that also markets a broad variety of personal care products and OTC products, including anti-hemorrhoids.