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,
In light of our recent announcement regarding Oramed’s $20 million stock repurchase program, we believe this is an opportune moment to provide our shareholders with a comprehensive update on our activities and progress. As this development demonstrates our confidence in Oramed’s value and potential, we felt it was important to contextualize this decision within the broader landscape of our ongoing initiatives and future plans. This letter serves to offer you insights into our current position, strategic direction, and the exciting opportunities that lie ahead for Oramed. We remain committed to transparent communication and are pleased to share this overview with you.
Scilex Senior Secured Note
The repayment schedule from Scilex Holding Company for its Senior Secured Note commenced on December 21, 2023, with fixed installments due quarterly. As of today, Oramed has received $40 million out of the total $102 million principal (excluding interest and exit fees). This represents a significant portion of the expected returns from this strategic investment. The next milestone in this repayment plan is a $20 million installment, scheduled for September of this year.
Phase 3 Oral Insulin Program
Oramed has proactively engaged in constructive dialogue with the U.S. Food and Drug Administration regarding a new Phase 3 protocol. This refined approach is strategically focused on specific patient subgroups identified as significant responders through comprehensive analysis of both Phase 2 and Phase 3 data. By leveraging these insights, we aim to optimize the potential for success in our potential upcoming trial. This adaptive strategy underscores our commitment to advancing oral insulin therapy and potentially addressing a critical unmet need in diabetes management.
Oramed-HTIT Joint Venture Update
Oramed and its long-term partner, Hefei Tianhui Biotech Co., Ltd. (HTIT), are finalizing the formation of a joint venture (JV) centered around Oramed’s cutting-edge oral drug delivery technology. The U.S.-based JV will focus on developing, marketing, and commercializing innovative products from Oramed’s oral insulin and POD™ (Protein Oral Delivery) pipeline, leveraging HTIT’s advanced manufacturing capabilities.
The JV will receive a significant capital infusion, with HTIT committing $70 million in cash and Oramed investing $25 million in cash and stock. These funds are strategically allocated to support the successful completion of the Phase 3 trial in the U.S., along with other crucial clinical and business activities. Furthermore, we are exploring strategies with HTIT to capitalize on their production capabilities and the expected launch of oral insulin sales.
While synergies exist, the proposed transactions are complex, and there is no certainty that we will be able to close on any or all of them. We will keep you informed as progress is made.
In summary, Oramed maintains a strong cash position, bolstered by solid progress on the Scilex note transaction. We are making strides towards initiating a new Phase 3 trial for our oral insulin program while actively pursuing the joint venture opportunity with HTIT. These strategic initiatives position us to drive significant shareholder value. Thank you for your continued support as we work diligently to achieve major milestones. We look forward to providing updates on our progress.
Sincerely,
Nadav Kidron
Chief Executive Officer
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The Company’s novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit www.oramed.com.
