Sona Announces Canadian Melanoma Clinical ‘Pilot’ Study Ethics Approval

Halifax, Nova Scotia–(Newsfile Corp. – July 23, 2025) – Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the “Company“, “Sona“), an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, has received Nova Scotia Health Research Ethics Board (“REB”) approval to conduct its proposed pilot human clinical trial study (the “Pilot Study”) of its Targeted Hyperthermia Therapy (“THT”) cancer treatment with late-stage melanoma patients. Sona’s THT Pilot Study is being planned as a multi-centre clinical trial for 30-40 patients and is subject to, amongst other things, securing medical device Investigational Testing Authorization (“ITA”) from Health Canada.

Sona CEO, David Regan, commented, “Cases of melanoma have tripled in 30 years in Canada where over 1,300 people die every year from this disease. For that reason, we are excited to be laying the foundation for the next steps necessary to get our THT cancer treatment into clinics. With ethics approval to conduct a Pilot Study in Canada, we now look forward to the possibility of a study of our therapy with up to 40 patients suffering from late-stage melanoma, subject to regulatory approval.”

Sona’s THT Pilot Study will be designed to incorporate various learnings from its current Early Feasibility Study and to help further evaluate the safety and preliminary efficacy of Sona’s THT therapy with a larger pool of patients. The information developed from a Pilot Study would inform the design of a larger randomized potential ‘pivotal’ clinical study which would be subject to regulatory approval. The Pilot Study is anticipated to be begin in late 2025 or early 2026.

About Sona Nanotech Inc.
Sona Nanotech is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona’s gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (42-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion – thus enabling drugs to reach all tumor compartments more effectively. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.

Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies and diagnostic testing platforms. Sona Nanotech’s gold nanorod particles are cetyltrimethylammonium (“CTAB”) free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain “forward-looking statements” under applicable Canadian securities legislation, including statements regarding the anticipated applications and potential opportunities of Targeted Hyperthermia Therapy, and Sona’s preclinical and clinical study plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to secure the remaining required regulatory approvals for the Pilot Study, enroll study participants in a timely manner, successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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