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Theralase Technologies Inc
Symbol TLT
Shares Issued 257,058,334
Close 2026-02-17 C$ 0.295
Market Cap C$ 75,832,209
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Theralase to present bladder cancer data set at EAU26

2026-02-17 17:40 ET - News Release

Ms. Kristina Hachey reports

THERALASE BLADDER CANCER CLINICAL DATA TO BE PRESENTED AT THE 2026 EUROPEAN ASSOCIATION OF UROLOGY CONGRESS

Theralase Technologies Inc.'s interim clinical data have been selected for presentation at the 2026 European Association of Urology Congress (EAU26).

The EAU has accepted Theralase's abstract titled, "Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ" for presentation at EAU26 to be held in London, United Kingdom, from March 13 to March 16, 2026.

The interim clinical data from Theralase's international, multicentre phase II Bacillus Calmette-Guerin-(BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS) study (study II) will be presented by principal investigator Dr. Girish Kulkarni in an oral presentation.

Enrolment has been completed in study II and Theralase expects to commence submission of the clinical data in a rolling review to Health Canada and the Food and Drug Administration in Q3 2026. Pending regulatory approval, expected in 2027, this innovative technology represents an opportunity for a significant advancement in bladder cancer therapy, providing a safe and effective treatment for patients, who have exhausted their standard of care therapeutic options and are facing radical cystectomy (bladder removal).

The interim clinical data supports potential safety and efficacy of the treatment with two out of three patients obtaining a complete response and two out of five patients maintaining that complete response for 15 months or more. In poststudy analysis, one out of five patients have demonstrated a duration of response of three years or greater with a single treatment.

These interim preliminary findings are encouraging in support of the use of light-activated Ruvidar by the international urology community to safely and effectively treat patients afflicted with BCG-unresponsive NMIBC CIS, helping to revolutionize the treatment landscape for bladder cancer.

Girish Kulkarni, MD, PhD, FRCSC, a urologic surgeon in the department of surgical oncology at the Princess Margaret Cancer Centre, University Health Network and professor at the University of Toronto, department of surgery, stated: "We are excited that our clinical study has been accepted for presentation at the EAU26 Conference. The early data is supportive of light-activated Ruvidar, as a treatment modality for BCG-unresponsive NMIBC CIS, thus having the potential to allow patients to preserve their bladders and maintain their quality of life."

Arkady Mandel, MD, PhD, DSc, chief scientific officer, Theralase, stated: "In the interim clinical data, we have observed a high efficacy and fovourable safety profile in bladder cancer patients treated at numerous clinical study sites across Canada and the U.S. The data supports the use of light-activated Ruvidar in the treatment of patients with high-grade, high-risk NMIBC. In addition, the latest results demonstrate a long-lasting duration of complete response induced by this innovative technology, which is able to be completed within a few hours and is suitable for patients with CIS of the urinary bladder, who have not responded to previous therapies and who are currently facing a life-altering option, such as radical cystectomy."

Roger DuMoulin-White, BSc, PEng, ProDir, president and chief executive officer, Theralase, stated: "The acceptance of the Theralase abstract for presentation at the EAU26 Annual Conference is a testament to the importance and significant impact that this clinical research could have on the lives of bladder cancer patients. We look forward to the presentation and the continued development of Ruvidar for bladder cancer patients. With patient enrolment completed, clinical data is expected to be submitted to Health Canada and the FDA in a rolling review commencing Q3 2026. Pending successful regulatory approval, expected in 2027, Theralase plans to make this technology commercially available to the entire urological community, commencing with Canada and the United States."

About EAU26

EAU26 is Europe's largest urological event, with researchers and scientists from around the world presenting their latest research, which is critically examined and discussed by the field's leading experts. The EAU represents the leading authority within Europe on urological practice, research and education, with over 19,000 medical professionals.

About study II

Study II utilizes the therapeutic dose of the patented drug, Ruvidar (TLD-1433) activated by the patented study device, the TLC-3200 medical laser system. Study II has enrolled and treated 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 U.S. 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 (complete removal of the bladder).

About Ruvidar

Ruvidar is a small molecule activated by energy, 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 energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.

We seek Safe Harbor.

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