Ms. Kristina Hachey reports

THERALASE PROVIDES UPDATE ON BLADDER CANCER CLINICAL STUDY

Theralase Technologies Inc. has provided an update on the phase II clinical study for bladder cancer.

To date, 90 patients have been enrolled and treated with the Theralase study procedure, achieving the patient enrolment specified by the statistical analysis plan.

Seventy-eight patients have completed the clinical study and were evaluated at all scheduled assessment visits or were prematurely removed by the principal investigator due to lack of response. There are 12 patients pending study completion.

These results exceed the International Bladder Cancer Group's recommended guidelines of clinically meaningful initial complete response rates for carcinoma in situ of at least 50 per cent at six months and 30 per cent at 12 months.

Interim data from 47 patients indicate that complete response rates of 21.3 per cent at both two and three years and 2.1 per cent at 7 years were sustained.

Theralase will compile the clinical data in 2026 for presentation to Health Canada and the FDA (U.S. Food and Drug Administration) with an expected regulatory approval in 2027.

About phase II clinical study

Primary end point:  efficacy (complete response at any point in time)

Secondary end point:  efficacy (duration of complete response of 12 months)

Tertiary end point:  safety (serious adverse events directly related to the study drug or study device that do not resolve within 450 days)

Study procedure:  light-activated Ruvidar

Patient population:  BCG-unresponsive (Bacillus Calmette-Guerin) non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) (Study II)

About NMIBC

NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall. In the United States, bladder cancer is the sixth-most common cancer, fourth among men, and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the United States in 2025. Historically, 75 per cent of bladder cancer presents as NMIBC.

In patients with high-risk NMIBC, intravesical BCG remains the first-line standard of care; however, approximately one-third of patients with NMIBC will not respond to BCG therapy and 50 per cent of those with an initial response will experience recurrence or progression of their disease. Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network guidelines recommend cystectomy (partial or complete removal of the bladder).

About Ruvidar

Ruvidar is a small molecule activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of cancer, bacteria and viruses.

About Theralase Technologies Inc.

Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of light-, radiation-, sound- and/or drug-activated small-molecule compounds and their formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of cancer, bacteria and viruses, with minimal impact on surrounding healthy tissue.

We seek Safe Harbor.