SOF-SKN™ Clears Final Preclinical Tests as Noxopharm Secures A$2.6M Funding

Clinical Progress Marks a Key Milestone

Australian biotech company Noxopharm Limited (ASX:NOX) has reported significant progress in its drug development pipeline during the first quarter of 2025. Most notably, its novel autoimmune drug candidate SOF-SKN™ has successfully passed all required preclinical safety studies, clearing the path for the upcoming Phase 1 HERACLES clinical trial. This milestone is critical, as it confirms the drug’s safety profile across a comprehensive range of toxicity and functional assessments, including cardiac, respiratory, neurological, and genetic safety parameters.

The company has engaged Doherty Clinical Trials Ltd, a specialist Phase 1 unit affiliated with the Peter Doherty Institute for Infection and Immunity, to conduct the HERACLES trial in Melbourne. This partnership underscores Noxopharm’s commitment to rigorous clinical standards and leverages Doherty’s expertise in immunology and infectious diseases.

Expanding the Sofra™ Platform Through Strategic Collaborations

Noxopharm’s Sofra™ technology platform, which focuses on inflammation, autoimmunity, and mRNA vaccine enhancement, continues to attract international interest. During the quarter, the company signed a follow-on Material Transfer Agreement (MTA) with an overseas partner to broaden the scope of collaborative research initiated in 2024. This agreement will see the partner invest additional resources into further testing, highlighting the versatility and commercial potential of the Sofra™ platform across vaccines and therapeutics.

Simultaneously, Noxopharm deepened its collaboration with Melbourne’s Hudson Institute of Medical Research. The expanded partnership will accelerate research into key inflammation sensors such as TLR7, TLR8, RIG-I, and cGAS, as well as promising targets like TLR3 and TLR9. This work not only strengthens the Sofra™ pipeline but also opens avenues for cancer research applications, reflecting the platform’s broad therapeutic potential.

Financial Position and Funding Strategy

Financially, Noxopharm reported a net operating cash outflow of A$2.1 million for the quarter ending 31 March 2025, with cash reserves standing at A$1.51 million. To support ongoing operations and clinical development, the company issued A$2.6 million in convertible notes to sophisticated investors, carrying a 12% interest rate capitalised until repayment or conversion. This funding provides a runway to advance SOF-SKN™ into clinical trials and continue expanding the Sofra™ platform.

Management remains vigilant about cash management and is actively exploring additional capital options, including non-dilutive funding and grants. The company’s strategic plan anticipates short-term catalysts that may influence the timing and nature of follow-on funding, reflecting a prudent approach amid the inherent uncertainties of biotech development.

Engagement and Industry Recognition

Noxopharm has also maintained a strong presence in the scientific and patient communities. The company participated in the 'Spotlight on Lupus' event at Parliament House, Canberra, engaging with patient advocacy groups and leading lupus experts. CEO Dr Gisela Mautner presented the Sofra™ program at the 3rd ANZ Biologics Festival 2025 in Melbourne, receiving positive industry feedback.

Additionally, Associate Professor Michael Gantier, a key collaborator from the Hudson Institute, was elected to the Executive Board of the International Society of Nucleic Acid Immunity, further cementing Noxopharm’s scientific credibility and network.

Looking Ahead

With SOF-SKN™ poised to enter human trials and the Sofra™ platform gaining momentum through strategic partnerships and international interest, Noxopharm is positioning itself at the forefront of innovative treatments for autoimmune diseases and beyond. The company’s focus on rigorous clinical validation, coupled with a diversified pipeline and prudent financial management, sets a solid foundation for future growth and value creation.