Oramed Letter to Shareholders
- Successful completion of Phase 3 trials in China by Oramed's Chinese Partner, HTIT, for oral insulin for type 2 diabetes.
- Initiation of a Phase 3 oral insulin trial in the U.S. under a differentiated protocol based on positive analysis results.
- Establishment of a joint venture with HTIT to develop and commercialize innovative products from Oramed's oral drug delivery technology.
- Securing a Senior Secured Promissory Note from Scilex with a notable principal balance and interest rate.
- Acquisition of PeriTech's film-forming technology for topical/dermatology agents, including a once-daily treatment for hemorrhoids.
- Unexpected negative results from the U.S.-based Phase 3 oral insulin trial in early 2023.
- Complexity and uncertainty surrounding the proposed transactions with HTIT for the joint venture.
Insights
Oramed Pharmaceuticals Inc.'s strategic partnership with HTIT and the initiation of a new Phase 3 oral insulin trial in the U.S. are significant developments. The successful completion of HTIT's Phase 3 trials in China may indicate a potential market expansion for Oramed's oral insulin, especially if the product receives regulatory approval. The joint venture, with a substantial investment of $70 million from HTIT and $20 million from Oramed, provides a strong financial foundation to support clinical trials and commercialization efforts, which could be a positive signal for investors. However, the acknowledgment of the intricate nature of the transactions and the lack of certainty in closing them introduces an element of risk that warrants attention.
The financial details disclosed, such as the $101.875 million Senior Secured Promissory Note issued by Scilex and the collateral securing it, are critical for evaluating Oramed's financial health. The note's interest rate of SOFR plus 8.5% is relatively high, reflecting a potentially higher risk profile. The repayment terms and the exit fee condition also suggest that Oramed is leveraging its assets to secure necessary funding, which could impact its liquidity and solvency if the repayment schedule is not met. Investors should closely monitor Oramed's ability to manage this debt obligation in conjunction with its investment activities.
The update on the U.S.-based Phase 3 oral insulin trial highlights the importance of patient subpopulations in clinical research. The identification of specific parameters such as BMI, baseline HbA1c and age that responded well to oral insulin is a significant finding that could refine the target demographic for Oramed's product and potentially improve its efficacy in future trials. This tailored approach to treatment aligns with the broader industry trend towards personalized medicine. The PeriTech asset acquisition also diversifies Oramed's portfolio into dermatology, with the licensing agreement for worldwide commercialization rights potentially providing a new revenue stream.
- Initiating Phase 3 oral insulin trial in
the United States under a new protocol - JV with Chinese Partner, HTIT
- Scilex Senior Secured Note
- PeriTech Asset Purchase & Strategic Out-licensing
Dear Shareholders,
I am pleased to share with you an update regarding Oramed. Despite the unexpected negative results we received for our
Oramed's Chinese Partner, HTIT, Successfully Completed Phase 3 Trial and Advances Production Facilities:
Hefei Tianhui Biotechnology Co. Ltd. ("HTIT"), a strategic partner of Oramed, achieved a noteworthy milestone by successfully completing its Phase 3 trials of oral insulin for type 2 diabetes in
In addition, HTIT has made substantial investments in facilities to enable commercial-scale production of the oral insulin capsule. This development underscores our belief in HTIT's commitment to advancing the accessibility of innovative oral insulin solutions for patients in
Phase 3 Oral Insulin Program:
In January 2023, Oramed announced that its
We are encouraged by the results of our analysis and have begun discussions with the FDA. We intend to initiate a Phase 3 oral insulin trial in the
Oramed and HTIT Joint Venture:
In January 2024, Oramed entered into a definitive agreement with HTIT, marking a milestone in the creation of a joint venture ("JV"), centered around Oramed's cutting-edge oral drug delivery technology. The JV is poised to be a dynamic force, focusing on the development, marketing, and global commercialization of innovative products derived from Oramed's oral insulin and POD™ (Protein Oral Delivery) pipeline. This strategic partnership will harness HTIT's advanced manufacturing capabilities and technologies.
The joint venture will receive a significant capital infusion, with HTIT committing a notable
Scilex Senior Secured Note:
In September 2023, Scilex Holding Company ("Scilex") issued an 18-month Senior Secured Promissory Note to Oramed (the "Note"), carrying an initial principal balance of
Peritech Asset Acquisition and Strategic Out-Licensing:
In December 2023, Oramed executed and completed an agreement with PeriTech Pharma Ltd. ("PeriTech"), acquiring the rights to their cutting-edge film-forming technology tailored for the delivery of topical/dermatology agents. This includes a once-daily over-the-counter treatment for hemorrhoids, surpassing existing market alternatives. The PeriTech pipeline extends its potential applications to include indications such as pruritus ani, anal warts, anal fissures and herpes labialis.
In emphasizing the potential benefits of this acquisition, Oramed has entered into an exclusive Licensing Agreement with an international consumer product and pharmaceutical group, pursuant to which Oramed granted the development and commercialization rights to the PeriTech pipeline in exchange for a royalty based on net sales. Oramed's shareholders stand to benefit from the worldwide potential inherent in this transaction.
In summary, Oramed is well positioned in terms of its balance sheet and is currently taking active steps to continue the development of its oral insulin program as well as continuing to take advantage of strategic opportunities in order to increase shareholder value. We thank you for your support and look forward to keeping our shareholders updated on the important milestones ahead.
Sincerely,
Nadav Kidron
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Oramed's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in
Forward-looking statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss Oramed's opportunities and ability to increase shareholder value, the anticipated regulatory approval of HTIT's clinical trial data and the timing of such approval, the expected timing and achievement of milestones, the potential development, benefits, safety, efficacy and timing of our oral insulin program, our intention to begin a Phase 3 oral insulin trial in the
Company Contact:
+1-844-9-ORAMED
ir@oramed.com
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SOURCE Oramed Pharmaceuticals Inc.
FAQ
What milestone did Oramed's Chinese Partner, HTIT, achieve recently?
What strategy is Oramed planning to adopt for the Phase 3 oral insulin trial in the U.S.?
What is the focus of the joint venture between Oramed and HTIT?
What financial arrangement did Oramed secure from Scilex?