Sona Nanotech Reports 80% Response Rate in First-In-Human THT Cancer Therapy Study

Executive Summary

• Sona Nanotech completed its first‑in‑human feasibility study of Targeted Hyperthermia Therapy (THT) in ten advanced melanoma patients who were refractory to immunotherapy.
• Eight of the ten patients showed a clinical response by day 15, with six achieving complete histologic remission in biopsied tumors.
• The company announced plans for a Canadian pilot trial, an ITA filing with Health Canada, and disclosed that Chief Scientific Officer Dr. Len Pagliaro will transition to a board‑only role.

Key Details

• Study Design: Early feasibility study; up to four tumors per patient treated on days 1 and 8; efficacy assessed by day 15.
• Patient Outcomes:
• 8/10 patients experienced a significant clinical response.
• 6/8 responding patients had no detectable residual melanoma in biopsied lesions (complete response).
• 2 patients showed no response.
• Safety/Tolerability:
• One serious adverse event deemed unrelated to THT resolved.
• Two stage IV patients died from disease progression shortly after study completion.
• Regulatory Progress: Application submitted for an Investigational Testing Authorization (ITA) with Health Canada; research ethics board approval already obtained for the upcoming Canadian pilot trial.
• Leadership Change: Chief Scientific Officer Len Pagliaro, PhD, will step back from operational duties and continue as a board member.
• Investor Communication: Webinar scheduled for Monday, October 20, 2025 at 12:00 PM EST to discuss results and future plans; registration link provided.

Notable Quotes

• David Regan, CEO: “These favorable results…show that Sona’s THT therapy has successfully eliminated melanoma in tumors where leading treatments had previously failed.”
• Dr. Carlos Rojas, Principal Investigator: “We were very impressed by the rapid and measurable responses observed in patients who had exhausted standard immunotherapy options.”
• Dr. Carman Giacomantonio, CMO: “These tremendous results validate our earlier preclinical findings and provide compelling clinical evidence of efficacy and tolerability…unprecedented.”

Materiality Assessment: Material – Positive (first‑in‑human efficacy data with clear clinical impact and forward‑looking regulatory steps).