Ms. Kristina Hachey reports

THERALASE(R) REPORTS COMPLETE RESPONSE WITH X-RAY-ACTIVATED RUTHERRIN(R) IN MUSCLE INVASIVE BLADDER CANCER PRECLINICAL STUDY

Theralase Technologies Inc. has demonstrated a complete response of all animals treated with X-ray-activated Rutherrin in a preclinical animal model of muscle invasive bladder cancer (MIBC).

Kaplan-Meier survival analysis from the orthotopic MIBC animal study demonstrated that 100 per cent of the animals treated with X-ray-activated Rutherrin exhibited a complete response and remained cancer-free at the end of the study; whereas, animals assigned to the radiation only or untreated control group did not respond as well.

The radiation only group demonstrated partial therapeutic benefit, with a progressive decline in survival over time. Animals in this group perished from the disease within 25 and 70 days.

Untreated animals in the control group perished from the disease between 20 and 23 days, consistent with aggressive tumour progression.

These findings build upon previously reported results, now demonstrating complete response and the duration of that response in animals treated with X-ray-activated Rutherrin. The addition of Kaplan-Meier survival data demonstrates 100-per-cent survival of animals, treated with X-ray-activated Rutherrin, laying the groundwork for future clinical development.

Mark Roufaiel, PhD, research scientist at Theralase, commented: "The latest survival data represents a key milestone in our preclinical program. While earlier results demonstrated a trend to complete tumour clearance, the Kaplan-Meier analysis confirms that this translates into a meaningful and durable survival benefit. These findings further support the potential of X-ray-activated Rutherrin versus radiation only to provide complete durable responses in aggressive cancers such as MIBC."

Arkady Mandel, MD, PhD, DSc, chief scientific officer, Theralase, stated: "Rutherrin combined with low-dose radiation significantly improved survival in a preclinical MIBC mouse model. These results suggest that Rutherrin may have clinical potential for locally advanced, muscle-invasive bladder cancer, where tumours invade the bladder's muscle wall. Annually, up to 21,200 Americans and up to 184,000 people globally are diagnosed with MIBC. The standard of care predominantly involves either radical cystectomy or trimodal therapy (surgery, chemotherapy and radiation), yet 20 to 40 per cent of patients still develop new pelvic tumours within two to three years, after treatment. Combining Rutherrin with radiation or chemoradiotherapy may offer an effective, bladder-sparing approach to preserve function and enhance quality of life."

Roger DuMoulin-White, BSc, PEng, ProDir, president, chief executive officer and chairman of the board of Theralase, added: "X-ray-activated Rutherrin continues to impress all of us in terms of safety and efficacy in the destruction of a wide variety of cancerous tumours. Complete and durable response in a MIBC animal model is only the latest of its accolades. Pending GLP toxicology analysis, Theralase plans to commence a phase 0/I/II adaptive clinical study evaluating X-ray-activated Rutherrin, with or without surgery, chemotherapy and/or immunotherapy, subject to regulatory approval, in patients diagnosed with MIBC, in 2026."

About Theralase Technologies Inc.

Theralase is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.

We seek Safe Harbor.