Theralase to present bladder cancer data set at EAU26

Executive Summary

• Theralase Technologies' interim clinical data for its light-activated drug Ruvidar (TLD-1433) has been accepted for an oral presentation at the 2026 European Association of Urology Congress (EAU26).
• The data comes from Study II, a Phase II trial for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS), which has completed patient enrollment.
• Theralase plans to submit clinical data for rolling regulatory review to Health Canada and the FDA in Q3 2026, with commercial availability expected in 2027 pending approval.

Key Details

• Conference 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" accepted for oral presentation at EAU26 (London, UK, March 13–16, 2026).
• Presenter: Principal Investigator Dr. Girish Kulkarni.
• Study Status: Patient enrollment for Study II is complete.
• Interim Clinical Results:
  • Two out of three patients achieved a complete response.
  • Two out of five patients maintained complete response for 15 months or more.
  • One out of five patients demonstrated a duration of response of three years or greater with a single treatment.
• Regulatory Timeline:
  • Rolling submission to Health Canada and FDA expected in Q3 2026.
  • Regulatory approval expected in 2027.
  • Commercial launch planned for Canada and the United States following approval.
• Study II Specifics:
  • Utilizes Ruvidar (TLD-1433) activated by the TLC-3200 medical laser system.
  • Enrolled and treated 90 BCG-unresponsive NMIBC CIS patients.
  • Conducted across 12 clinical study sites in Canada and the U.S.
• Market Context: NMIBC is the most common form of bladder cancer (approx. 75% of cases). Approximately one-third of patients do not respond to BCG therapy, and current options for these patients are limited, often requiring radical cystectomy.

Notable Quotes

• Girish Kulkarni, MD, PhD, FRCSC: "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: "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 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: "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. ... 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."