• SOF-SKN™ dosing successfully concludes in HERACLES clinical trial
• New Material Transfer Agreement with overseas company
• High-profile Victorian government recognition

Noxopharm Limited (ASX:NOX), an Australian clinical-stage drug development company, has provided its Quarterly Activities Report and Appendix 4C for the period ending 31 December 2025. The company made rapid progress in its milestone HERACLES clinical trial, which aimed to evaluate the safety and tolerability profile of SOF-SKN™. The first multiple-dose cohort of SOF-SKN was successfully completed in early December, and further dosing took place over the Christmas period for the second and final multiple-dose cohort. Shortly after the quarter finished, Noxopharm announced that this final cohort had been successfully completed, with the Safety Steering Committee determining the treatment to be safe and well tolerated, with no clinically relevant issues found. This means the entire clinical part of the HERACLES trial has now successfully concluded, with a highly positive safety and tolerability outcome for all dosing groups. During the quarter, Noxopharm also signed another Material Transfer Agreement (MTA) with an overseas company that is developing a highly innovative system for the delivery of therapeutics into the body, with a focus on inflammatory bowel disease (IBD). Noxopharm received high-level recognition from the Victorian Government alongside its strategic partner, Melbourne's Hudson Institute of Medical Research, during a ministerial visit to Hudson Institute. The company also announced that it had been granted its first patent for the Sofra platform by the United States Patent and Trademark Office.

The company continues to be vigilant with its cash resources and is exploring a range of options in relation to securing additional capital. It is looking at its strategic plan and exploring the likelihood of short-term catalysts which may impact the timing and range of options to secure follow-on funding.

Noxopharm expects to start Phase II-enabling studies for SOF-SKN in the near future and looks forward to building on its progress in 2026, including attracting more attention, building more external relationships, having an important paper published, preparing for a Phase II trial, and developing its pipeline.