NEW YORK - Oramed Pharmaceuticals Inc . (NASDAQ:ORMP), a biotech firm specializing in oral drug delivery systems, has announced its intention to launch a new Phase 3 trial in the United States for its oral insulin capsule, following a comprehensive review of previous trial data. This decision comes after the company's initial Phase 3 trial did not meet primary or secondary endpoints early last year.
The re-evaluation of the trial highlighted that certain patient subgroups, categorized by specific parameters such as body mass index, baseline HbA1c levels, and age, showed a statistically significant reduction in HbA1c levels when treated with oral insulin. These findings closely align with the patient population in successful Phase 3 trials conducted by Oramed's strategic partner, Hefei Tianhui Biotechnology Co. Ltd. (HTIT) in China.
Oramed's CEO, Nadav Kidron, expressed optimism about the new protocol for the upcoming trial, which is expected to begin later this year. The company is in discussions with the FDA to align the trial protocol with the positive data observed in the subpopulations.
In addition to the trial plans, Oramed has entered into a definitive agreement with HTIT to establish a joint venture focusing on the development, marketing, and global commercialization of products based on Oramed's oral insulin and Protein Oral Delivery technology. HTIT has committed to a $70 million investment, with an additional $20 million from Oramed, to support the joint venture's clinical and business activities.
Moreover, Oramed has secured a senior lien on nearly all assets of Scilex Holding Company as collateral for an 18-month Senior Secured Promissory Note issued in September 2023. Scilex has begun repaying the principal balance, with an exit fee due if full repayment is not completed by March 21, 2024.
The company also acquired the rights to PeriTech Pharma Ltd.'s film-forming technology for topical dermatology agents and entered into an exclusive Licensing Agreement with an international consumer product and pharmaceutical group for the development and commercialization of the PeriTech pipeline.
The information in this article is based on a press release statement from Oramed Pharmaceuticals Inc.
InvestingPro Insights
Amidst Oramed Pharmaceuticals Inc.'s (NASDAQ:ORMP) strategic moves and trial plans, investors and industry observers are closely monitoring the company's financial health and market performance. According to InvestingPro data, Oramed's market capitalization stands at a modest $126.66 million, reflecting the size and growth potential of the biotech firm. Despite the challenges in its clinical trials, the company has shown a strong return over the last three months, with a price total return of 45.37%. This uptick in share price may be indicative of investor confidence in the company's strategic partnerships and technology.
Moreover, Oramed holds a notable position in terms of liquidity and financial stability. An InvestingPro Tip highlights that the company holds more cash than debt on its balance sheet, which is a reassuring sign for investors concerned about the company's ability to fund its operations and research. Additionally, the company's liquid assets exceed its short-term obligations, further underscoring its financial resilience.
However, investors should also be aware of the risks associated with investing in Oramed. Analysts do not anticipate the company to be profitable this year, and a sales decline is expected in the current year. These factors, coupled with the stock's volatility, suggest that Oramed's journey towards commercial success with its oral insulin capsule may still face hurdles.
For those interested in a deeper dive into Oramed's financial metrics and future outlook, InvestingPro offers additional insights and tips. There are currently 9 more InvestingPro Tips available, which can be accessed for a more comprehensive analysis. Readers looking to explore these insights can take advantage of an exclusive offer: use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.