Fennec Pharmaceuticals Initiates Study to Evaluate PEDMARK for Cisplatin-Induced Ototoxicity
Fennec Pharmaceuticals announced the planned initiation of an investigator-sponsored study, IST, by City of Hope, a U.S. cancer research and treatment organization, to evaluate PEDMARK for the prevention of cisplatin-induced ototoxicity, CIO, in adult men with stage II-III metastatic testicular germ cell tumors. "Initiation of this study by City of Hope reflects the growing clinical interest in addressing the burden of hearing loss among patients receiving cisplatin-based chemotherapy, an indispensable treatment with high survival rates but significant long-term quality-of-life consequences," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "With cancer rates rising, especially among younger populations, the future of oncological care needs to focus on both survival and survivorship. Fennec is proud to see independent investigators driving important research that not only has the potential to change the standard of care for their patients today but also expand the evidence base for PEDMARK into metastatic disease, where cisplatin is widely used but hearing protection options remain limited."
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- Share Disposition: On December 24, 2025, Southpoint Capital Advisors disposed of 1 million common shares of Fennec Pharmaceuticals at $7.50 per share, reducing its ownership stake to approximately 8% of the outstanding shares.
- Market Strategy: This sale indicates a strategic adjustment in Southpoint's investment portfolio, as it still controls 2.7 million shares, but the reduced stake may reflect a cautious outlook on market conditions.
- Compliance Disclosure: The press release serves to comply with securities regulations, ensuring transparency and maintaining market trust, highlighting Southpoint's commitment to regulatory adherence.
- Future Outlook: Depending on market and other conditions, Southpoint may further adjust its ownership of Fennec through market transactions or other means, indicating flexibility in its investment strategy.
- Share Disposition: On December 24, 2025, Southpoint Capital Advisors disposed of 1 million common shares of Fennec Pharmaceuticals at $7.50 per share, reducing its ownership stake to approximately 8% of the total outstanding shares.
- Market Strategy: The shares sold represent about 2.93% of Fennec's total outstanding shares, indicating Southpoint's flexible investment strategy in response to changing market conditions, which could impact Fennec's stock performance.
- Ownership Adjustment: Following this transaction, Southpoint retains control over 2.7 million shares of Fennec, reflecting ongoing interest in the company, although the reduction may suggest a response to short-term market volatility.
- Future Outlook: Southpoint indicated that it may further adjust its ownership of Fennec based on market and other conditions, demonstrating its proactive and flexible approach to investment management.
- Share Disposal: On December 24, 2025, Southpoint Capital Advisors disposed of 1 million common shares of Fennec Pharmaceuticals at $7.50 per share, reducing its stake to approximately 8%, indicating a potential shift in its investment strategy regarding the company.
- Market Impact: This transaction decreases Southpoint's control to 2.7 million shares, representing about 8% of the outstanding shares, reflecting its strategy to adjust its portfolio in response to changing market conditions for optimized returns.
- Investment Purpose: The share disposal was executed for investment purposes, suggesting Southpoint's intent to seek higher returns while maintaining flexibility to respond to market dynamics.
- Future Outlook: Depending on market and other conditions, Southpoint may further adjust its ownership of Fennec through market transactions, private agreements, or other means, demonstrating its adaptability and strategic flexibility in a dynamic market environment.

- Study Initiation: Fennec Pharmaceuticals announced an investigator-sponsored study by City of Hope to evaluate PEDMARK® for preventing ototoxicity in adult men with stage II-III metastatic testicular germ cell tumors, reflecting growing clinical interest in addressing chemotherapy-induced hearing loss.
- Clinical Need: Research indicates that 60-90% of patients treated with cisplatin may experience hearing loss, and the application of PEDMARK® could significantly enhance the quality of life for these patients, addressing an increasing clinical demand.
- Market Potential: Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by cisplatin, and the FDA approval of PEDMARK® opens new market opportunities for its use in adult patients, which is expected to drive future commercial growth for the company.
- Strategic Collaborations: Fennec is collaborating with multiple research institutions to advance studies on PEDMARK® in metastatic diseases, aiming to expand its clinical evidence base and enhance its competitive position in the market.

Study Results: Fennec Pharmaceuticals announced positive topline results from the Phase 2/3 STS-J01 trial of Pedmark, showing reduced rates of cisplatin-induced ototoxicity in pediatric patients, with only 24% and 16% experiencing hearing loss compared to higher rates in previous trials.
Safety and Efficacy: The study confirmed that Pedmark does not interfere with the antitumor activity of cisplatin, maintaining a high tumor response rate of approximately 95%, and was well-tolerated with no adverse events attributed to the drug.
Future Plans: Fennec intends to pursue regulatory registration for Pedmark in Japan and explore potential partnerships or licensing opportunities, with full study results to be presented in a scientific forum and submitted for publication.
Market Reaction: Following the announcement, Fennec Pharmaceuticals' stock experienced a slight decline of 0.78%, trading at $7.85.

- Clinical Trial Success: Fennec Pharmaceuticals' PEDMARK® demonstrated a significant reduction in hearing loss among 27 patients aged 3-18 in Japan's STS-J01 trial, with only 24% and 16% experiencing ototoxicity, compared to 56%-63% in traditional chemotherapy, highlighting its effectiveness in reducing ototoxicity.
- Maintained Antitumor Activity: The study confirmed a high tumor response rate of approximately 95% with PEDMARK®, showing no adverse effects on cisplatin's antitumor efficacy, which ensures both safety and effectiveness in treatment.
- Market Registration Plans: Fennec intends to pursue registration for PEDMARK® in Japan while exploring partnering or licensing opportunities, demonstrating the company's commitment to addressing unmet medical needs in the region.
- Enhanced Global Impact: The trial results further solidify PEDMARK®'s clinical evidence base globally, enhancing its potential for application across various countries and tumor types, which may lead to broader market opportunities for the company.







