Mr. Roger DuMoulin-White reports

THERALASE(R) COMPLETES ENROLLMENT IN BLADDER CANCER CLINICAL STUDY

Theralase Technologies Inc. has successfully completed its targeted milestone of enrolling and treating 90 patients in a multicentre phase II clinical study for bladder cancer.

The phase II clinical study has a primary end point of efficacy, a secondary end point of duration of response and a tertiary end point of safety in evaluating light-activated Ruvidar in the treatment of patients diagnosed with BCG-unresponsive (Bacillus Calmette-Guerin) non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal).

The enrolment and treatment of 90 patients achieves the company's statistical analysis plan and represents a significant step forward in evaluating a statistically and clinically significant data set in support of a Health Canada and FDA (U.S. Food and Drug Administration) regulatory approval. In accordance with the clinical protocol, Theralase will enroll and treat any additional patients, who are in or pending screening.

Pending Health Canada and FDA regulatory approval, light-activated Ruvidar represents a potentially transformative, bladder-sparing treatment option for patients with limited alternatives, addressing a significant unmet need in high-risk NMIBC.

Clinical data generated to date continue to demonstrate a strong efficacy, duration of response and favourable safety profile, with a majority of patients achieving durable responses with a single treatment.

Dr. Arkady Mandel, MD, PhD, DSc, chief scientific officer of Theralase, stated: "I am pleased that Theralase has completed enrolment of 90 patients in its phase II registrational clinical study for bladder cancer. This accomplishment allows the company to complete this study in 2026 and prepare for Health Canada and FDA regulatory approval submissions."

Roger DuMoulin-White, BSc, PEng, ProDir, president and chief executive officer of Theralase, added: "Enrolling and treating 90 patients in our phase II registration clinical study represents a significant milestone for the company. With the targeted enrolment now completed, we can focus on compilation of the clinical data for Health Canada and FDA regulatory approval. Two thousand twenty-six will be a pivotal year for the company as we complete our bladder cancer study, embark on a combinational clinical study for bladder cancer, and launch numerous phase I/II adaptive clinical studies for brain, lung, muscle-invasive bladder, pancreatic and colorectal cancers."

About Study II

Study II utilizes the therapeutic dose of the small molecule Ruvidar, which has been light activated by the TLC-3200 medical laser system. Study II will enroll and treat 90 BCG-unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States.

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.