Announcement • May 07
Sona Nanotech Inc Announces Clinical Strategy with Two THT Combination Therapy Studies in Melanoma Sona Nanotech Inc. announced its clinical strategy to further the development of its Targeted Hyperthermia Therapy ("THT") cancer treatment. Based on both the success of Sona's first-in-human clinical study with THT, which demonstrated its ability to shrink and prime tumors immunogenically when used alone, and the published results from preclinical testing of Sona's THT showing the higher and more durable response rates that were observed when THT is combined with standard immunotherapies, the Company now intends to trial advanced applications of THT in two innovative clinical studies in melanoma patients combining THT with immunotherapy drugs. Sona will undertake its next clinical study of THT, (the "IGNITE-THT Study" - Immunotherapy + THT to Generate Novel Immune Tumor Eradication). In this study, Sona's THT would be administered in conjunction with a regimen of intratumoral and systemic dosing of the same immunotherapy drugs on which a cohort of patients had previously failed. The IGNITE-THT Study is expected to demonstrate the same safety and tolerability as experienced in the Company's previous clinical study, but with enhanced efficacy and long-term durability from the combination therapy anticipated after tumors are immunogenically activated by Sona's THT treatment. A second study, (the "PRIME-THT Study" - Precision Regional Immunotherapy for Melanoma Enhanced by THT) will assess the same concept but in newly diagnosed early-stage melanoma sufferers, which represents a much larger number of affected people worldwide (estimated by management to be up to 275,000 globally each year). Patients in this study would be given THT in combination with intratumoral immunotherapy with a view to stopping tumors from spreading (metastasising) by THT activating strong immune responses prior to standard-of-care surgical tumor resection. In addition to evaluating the safety and tolerability of Sona's THT treatment in an 'up-front' (neo-adjuvant) setting, the PRIME-THT Study will also measure the immediate treatment effect and the long-term durability of responses related to this novel, early-stage, neo-adjuvant combination therapy. These new studies are designed to answer the same questions from different ends of the patient journey: can THT convert immunogenically 'cold' tumors into tumors that respond to immunotherapies? The IGNITE-THT Study will ask it for patients who have already failed on treatment and remain on immunotherapy's treatment plateau. The PRIME-THT Study asks it earlier, enabling and bringing the benefits of immunotherapy forward into the pre-resection window, where stopping metastases is still possible. Early result read-outs from the IGNITE-THT and PRIME-THT studies are expected within six and eight months of their initiation, respectively. An expansion to a second cancer indication. Demonstrating THT in both early and late-stage melanoma indications shows a greater breadth of potential treatment market size. Two near-term valuation catalysts. A clear strategy to demonstrate long-term potential to the investment community with relatively near-term deliverables. Potential for greater chances of cure. Priming tumors with THT to engage the immune system prior to the administration of today's best immunotherapy drugs could result in higher response rates to those drugs. Potential for reduced risk of metastases. Pre-treating early-stage melanoma tumors could reduce the chances that the cancer spreads to lymph nodes prior to standard-of-care resection. The Company also continues to lay the groundwork for a larger scale, clinical trial in Canada for late-stage melanoma patients, working with Health Canada to secure the required investigational testing authorization ("ITA"). Feedback received from Health Canada is guiding the Company's ITA application for a combination strategy clinical trial which it expects to begin early in 2027 and run for up to 18 months with multiple read-out milestones. Announcement • Apr 28
Sona Nanotech Inc. Showcases Targeted Hyperthermia Therapy Cancer Treatment Results At Industry Conferences Sona Nanotech Inc. announced that its Chief Medical Officer presented data from its first-in-human early feasibility study for its Targeted Hyperthermia Therapy cancer treatment at the American Association for Cancer Research last week in San Diego. The presentation highlights the initial safety, tolerability and anti-tumor activity from this study which demonstrated a complete response in treated indicative tumors in six out of ten late-stage melanoma patients who had previously failed on standard of care immunotherapy. This study is a critical milestone in the Company's mission to treat immunotherapy-resistant solid tumors in humans. A manuscript detailing these results is currently being prepared for submission to a leading peer-reviewed scientific journal. Sona's first-in-human study results speak to a persistent unmet need that remains the dominant conversation in the melanoma community. The Melanoma Research Alliance noted in October 2025 that roughly half of advanced melanoma patients still do not respond to -- or develop resistance to -- currently approved immunotherapies. Sona's study was conducted in patients from precisely this refractory group. Sona Nanotech is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. Sona's Targeted Hyperthermia Therapy (THT) uses proprietary gold nanorods that absorb infrared light to deliver precise heat directly to a tumor. This therapeutic heating (42-48°C) is designed to stimulate the immune system, shrink tumors, inactivate cancer stem cells, and increase blood flow to the site. 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 free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications. Announcement • Apr 18
Sona Nanotech Inc. Announces Appointment of Dr. Michael Smylie and Dr. Jonathan Trites to Its Scientific Advisory Board Sona Nanotech Inc. announced the appointment of two renowned oncologists to its scientific advisory board: Dr. Michael Smylie and Dr. Jonathan Trites. Dr. Michael Smylie is a leading medical oncologist at the Cross Cancer Institute in Edmonton and a clinical professor at the University of Alberta, renowned for his transformative work in melanoma research. He played a key role as a contributing investigator and co-author in the landmark CheckMate clinical trials--specifically CheckMate 067. This study is hailed as a turning point in oncology, as it proved that combining immunotherapy drugs could lead to long-term survival for patients with advanced melanoma, a condition once considered a terminal diagnosis. His work on the long-term outcomes and quality-of-life data from these trials has helped establish the current international standard of care, moving the needle from short-term treatment to the possibility of decade-long remission for many. Dr. Jonathan Trites is a head and neck oncologic and reconstructive surgeon based at the Queen Elizabeth II Health Sciences Centre in Halifax. As an Associate Professor at Dalhousie University, he has been a key figure in research advancing surgical techniques and outcomes for complex head and neck cancers. Dr. Trites's work primarily focuses on improving the precision and functional outcomes of cancer surgeries. He is a leader in using minimally invasive techniques for tumors of the upper aerodigestive tract. His research has demonstrated that Transoral Laser Microsurgery (TLM) is a viable option for advanced-stage glottic cancer, achieving high rates of laryngeal preservation and excellent functional outcomes. He has also published significant data on various squamous cell carcinomas, including early-stage laryngeal cancer and oropharyngeal cancer.