Theralase Bladder Cancer Clinical Data to be Presented at the 2026 European Association of Urology Congress

Executive Summary

• Theralase® Technologies’ interim Phase II data on light‑activated Ruvidar® (TLD‑1433) for BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) was accepted for oral presentation at the 2026 European Association of Urology Congress (EAU26).
• Enrollment in Study II is complete; interim results show a high rate of complete responses (2/3 patients) and durable responses (2/5 patients ≥15 months, 1/5 patients ≥3 years).
• The company plans to submit the full clinical data to Health Canada and the FDA in a rolling review beginning Q3 2026, with regulatory approval targeted for 2027.

Key Details

• Abstract Acceptance: EAU26 (London, UK, March 13‑16 2026) accepted 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.”
• Presentation: Oral presentation by principal investigator Dr. Girish Kulkarni.
• Study Status: Enrollment completed; 90 patients treated across 12 sites in Canada and the United States.
• Interim Efficacy Results:
• Complete response observed in 2 of 3 evaluable patients.
• 2 of 5 patients maintained complete response for ≥15 months.
• 1 of 5 patients achieved a duration of response ≥3 years after a single treatment.
• Safety Profile: Described as favorable/high efficacy with no specific adverse events disclosed.
• Regulatory Timeline: Rolling submission to Health Canada and FDA slated for Q3 2026; anticipated approval in 2027, followed by commercial launch in Canada and the U.S.
• Commercial Outlook: Pending approval, Ruvidar® aims to provide a bladder‑preserving alternative to radical cystectomy for BCG‑unresponsive NMIBC patients.

Notable Quotes

“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.” – Dr. Girish Kulkarni, MD, PhD, FRCSC

“In the interim clinical data, we have observed a high efficacy and favourable safety profile… The latest results demonstrate a long‑lasting duration of complete response induced by this innovative technology.” – Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer

“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.” – Roger DuMoulin‑White, President & CEO

Materiality Assessment: Material Positive (interim efficacy data and upcoming regulatory filing represent a materially positive development for the company).