2026-02-20, 5:08:47 a.m.
Toronto, Ontario — February 20, 2026 — Leads & Copy — Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) has announced that its interim clinical data has been selected for presentation at the 2026 European Association of Urology Congress (EAU26). The company is a clinical-stage pharmaceutical company focused on researching and developing energy-activated small molecules for cancer, bacteria, and virus destruction.
The EAU 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 in London, United Kingdom, scheduled for March 13-16, 2026.
Dr. Girish Kulkarni, the principal investigator, will present the interim clinical data from Theralase®’s international, multicenter Phase II Bacillus Calmette-Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS) study (Study II) in an oral presentation.
Enrollment has been completed for Study II. Theralase® anticipates beginning the clinical data submission in a rolling review to Health Canada and the FDA in 3Q2026. Regulatory approval is expected in 2027. The company says this technology could significantly advance bladder cancer therapy, offering a safe, effective treatment for patients who have exhausted standard therapeutic options and face radical cystectomy (bladder removal).
Interim clinical data indicates potential safety and efficacy, with two out of three patients achieving a complete response and two out of five maintaining it for 15 months or longer. Post-study analysis showed one out of five patients demonstrating a duration of response of three years or more with a single treatment.
According to the company, these preliminary findings support the use of light-activated Ruvidar® by the international urology community to treat patients with BCG-Unresponsive NMIBC CIS safely and effectively, which could revolutionize bladder cancer treatment.
Dr. Kulkarni, a urologic surgeon at the Princess Margaret Cancer Centre, University Health Network, and Professor at the University of Toronto, stated that the early data supports light-activated Ruvidar® as a treatment modality for BCG-Unresponsive NMIBC CIS, potentially allowing patients to preserve their bladders and maintain their quality of life.
Dr. Arkady Mandel, Chief Scientific Officer, Theralase®, noted the high efficacy and favorable safety profile observed in bladder cancer patients treated across Canada and the U.S. He added that the data supports the use of light-activated Ruvidar® in treating patients with high-grade, high-risk NMIBC and demonstrates a long-lasting duration of complete response induced by this technology. The treatment can 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 face radical cystectomy.
Roger DuMoulin-White, President and CEO, Theralase®, said the acceptance of the abstract for presentation at the EAU26 Annual Conference highlights the significant impact this research could have on bladder cancer patients’ lives. He looks forward to the presentation and the continued development of Ruvidar® for bladder cancer patients. With patient enrollment completed, clinical data is expected to be submitted to Health Canada and the FDA in a rolling review starting in 3Q2026. Theralase® plans to make this technology commercially available to the urological community, beginning with Canada and the United States, pending regulatory approval expected in 2027.
Study II uses the therapeutic dose of Ruvidar® (TLD-1433), a patented drug activated by the TLC-3200 Medical Laser System. The study has enrolled and treated 90 BCG-Unresponsive NMIBC CIS patients at 12 clinical study sites in Canada and the United States.
NMIBC is bladder cancer found in the inner layer cells of the bladder that does not invade into or beyond the muscle wall. In the United States, bladder cancer is the sixth most common cancer. Historically, 75% of bladder cancer presents as NMIBC. Current treatment options for BCG-unresponsive patients are limited, and guidelines recommend cystectomy.
Ruvidar® is a small molecule activated by energy for the safe and effective destruction of cancer, bacteria, and viruses.
Theralase® is a clinical-stage pharmaceutical company dedicated to researching and developing energy-activated small molecules for the safe and effective destruction of cancer, bacteria, and viruses.
Additional information is available at www.theralase.com and www.sedarplus.ca
Source: Theralase® Technologies Inc.
