Oramed Pharmaceuticals Advances Oral Insulin Program with New Phase 3 Trial

Key Insights

• Oramed Pharmaceuticals is set to initiate a Phase 3 trial of its oral insulin capsule, ORMD-0801, focusing on patient subpopulations that showed positive responses in prior studies.
• The trial protocol is differentiated and aligned with positive subpopulation data, informed by discussions with the FDA, and will be conducted in the U.S.
• Oramed has strengthened its financial position through strategic agreements, including a joint venture with Hefei Tianhui Biotech and refinancing initiatives, ensuring sufficient capital for ongoing R&D.

Oramed Pharmaceuticals is moving forward with its clinical research and development efforts, prioritizing the study of ORMD-0801, an oral insulin capsule, in specific patient subpopulations. These subpopulations are defined by parameters such as body mass index (BMI), baseline HbA1c, age, gender, and body weight, and have previously demonstrated a statistically significant reduction in HbA1c of over 1% compared to placebo.

Phase 3 Trial Design and Objectives

Oramed intends to launch a Phase 3 oral insulin trial in the U.S. using a refined protocol. This protocol is designed based on positive data observed in specific subpopulations and incorporates feedback received from discussions with the FDA. In September 2024, Oramed entered into a service agreement with a Clinical Research Organization (CRO) to support the execution of this trial.

Strategic Initiatives and Collaborations

To advance its assets, Oramed has formed a joint venture with Hefei Tianhui Biotech Co., Ltd. (HTIT). This strategic initiative aims to develop and commercialize innovative products globally, leveraging the combined assets and capabilities of both companies. The collaboration will focus on creating orally ingestible capsules for delivering various polypeptides, including insulin for diabetes treatment.

Expanding Therapeutic Applications

Beyond its application in diabetes, Oramed is exploring the potential of ORMD-0801 for treating nonalcoholic steatohepatitis (NASH) and obesity. Earlier studies have evaluated its efficacy as an appetite suppressant, indicating potential applications beyond diabetes management.

Financial Stability and Shareholder Value

Oramed has a strong financial position, with approximately $142 million in cash, equivalents, short-term investments, and deposits, and no long-term debt. The company is actively managing its balance sheet to optimize its cash position, including leveraging debt principal and interest payments from Scilex Holding Company and a loan agreement for a real estate project. Oramed also repurchased 539,452 of its shares for roughly $1.3 million through the end of 3Q24, reflecting its commitment to enhancing shareholder value.