Noxopharm has successfully completed dosing in its HERACLES clinical trial for SOF-SKN™, demonstrating strong safety and tolerability. The company also secured a new overseas partnership and its first US patent for the Sofra platform.
- HERACLES trial dosing successfully completed with positive safety results
- New Material Transfer Agreement signed with overseas partner for autoimmune therapeutics
- First US patent granted for Sofra immune-modulatory oligonucleotides
- Victorian Government recognition highlights strategic collaboration
- Cash position tight at A$100K; exploring funding options including convertible notes and loans
Clinical Milestone Achieved
Australian biotech Noxopharm Limited (ASX, NOX) has marked a significant milestone with the successful completion of dosing in its HERACLES clinical trial. The trial, which evaluates the safety and tolerability of its topical drug candidate SOF-SKN™, concluded with the Safety Steering Committee confirming the treatment was safe and well tolerated across all dosing groups. This positive outcome clears a critical regulatory hurdle and sets the stage for the company to advance into Phase II-enabling studies in the near future.
Expanding Partnerships and Intellectual Property
During the quarter, Noxopharm also signed a new Material Transfer Agreement with an overseas company developing innovative delivery systems for therapeutics targeting inflammatory bowel disease. This collaboration aims to explore the potential of Noxopharm’s Sofra™ platform oligonucleotides as payloads, broadening the platform’s application beyond skin-related autoimmune diseases. Complementing these developments, the company secured its first US patent for the Sofra platform, protecting its novel immune-modulatory oligonucleotides designed to harness the immune system against certain cancers. This patent represents a foundational intellectual property asset for Noxopharm’s drug development pipeline.
Recognition and Scientific Validation
Noxopharm’s progress has attracted high-profile recognition from the Victorian Government, underscoring the strategic partnership with Melbourne’s Hudson Institute of Medical Research. The collaboration, which originated from a breakthrough discovery by Professor Michael Gantier’s team, has successfully translated laboratory science into clinical trials, offering hope for patients with lupus and other autoimmune conditions. Scientific rigour was further demonstrated when Dr Olivier Laczka received the best scientific poster award at the Lupus Academy’s annual meeting for his work on the HERACLES trial.
Financial Position and Funding Outlook
Financially, Noxopharm ended the quarter with a modest cash balance of A$100,000 and net operating cash outflows of A$835,000. The company has been prudent in managing costs, with reduced research and development expenditure compared to the prior quarter. To support ongoing operations and upcoming clinical activities, Noxopharm is actively exploring various funding avenues, including convertible notes, a short-term loan from a related party, and the anticipated receipt of a A$2.8 million research and development tax rebate from the Australian Taxation Office. The company remains confident in its ability to secure the necessary capital to advance its pipeline.
Looking Ahead
With the HERACLES trial behind it and a growing portfolio of partnerships and intellectual property, Noxopharm is poised to build momentum in 2026. The company anticipates publishing a major scientific paper detailing its breakthrough research and preparing for Phase II clinical trials. Investors and industry watchers will be keen to see how Noxopharm leverages its Sofra platform across autoimmune and oncology indications, while navigating the challenges of funding and clinical development.
Bottom Line?
Noxopharm’s successful HERACLES trial and strategic advances position it well, but funding remains a critical watchpoint.
Questions in the middle?
- When will Noxopharm initiate Phase II clinical trials for SOF-SKN™?
- What are the specifics and potential impact of the new overseas Material Transfer Agreement?
- How will Noxopharm secure sufficient funding to sustain its R&D and clinical programs?