Correcting and Replacing: 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) CIS has been accepted for oral presentation at the 2026 European Association of Urology Congress (EAU26).
• Interim results show promising efficacy: 2/3 patients achieved a complete response, with 2/5 maintaining that response ≥15 months; one patient sustained response >3 years after a single treatment.
• Enrollment for Study II is complete; the company plans to submit the data to Health Canada and the FDA in a rolling review beginning Q3 2026, targeting regulatory approval in 2027.

Key Details

• Presentation: 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” to be presented by Dr. Girish Kulkarni at EAU26 (London, UK, March 13‑16, 2026).
• Study II Scope: Multicenter Phase II trial enrolling 90 BCG‑unresponsive NMIBC CIS patients across 12 sites in Canada and the United States; enrollment now complete.
• Interim Efficacy Data:
• Complete response observed in 2 of 3 evaluable patients.
• Durable responses: 2 of 5 patients maintained complete response ≥15 months; 1 of 5 sustained response >3 years after a single treatment.
• Regulatory Timeline: Rolling submission to Health Canada and the FDA slated for Q3 2026; anticipated approval in 2027, with commercial launch planned first in Canada and the U.S.
• Technology: Ruvidar® (TLD‑1433) activated by the TLC‑3200 Medical Laser System; designed for rapid (few‑hour) treatment of CIS lesions.
• Quotes:
• Dr. Girish Kulkarni: “We are excited that our clinical study has been accepted…potential to allow patients to preserve their bladders and maintain quality of life.”
• Arkady Mandel, CSO: Highlighted high efficacy and favorable safety profile across Canadian and U.S. sites.
• Roger DuMoulin‑White, CEO: Emphasized the significance of the abstract acceptance and outlined path to commercial availability pending regulatory approval.
• Past Advisory Role: Dr. Kulkarni previously served in a medical advisory capacity for Theralase®.

Notable Quotes

• “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
• “We have observed a high efficacy and favourable safety profile…the data supports the use of light‑activated Ruvidar® in the treatment of patients with high‑grade, high‑risk NMIBC.” – Arkady Mandel, MD, PhD, DSc, CSO

Materiality: Material – Positive (significant clinical progress and upcoming regulatory submissions).