Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF), a pioneer in the research and development of light and/or radiation-activated small molecules targeting cancers, bacteria and viruses, has reported its financial results for the second quarter and provided an update on its research activities.
The company said that to date, it has enrolled and treated 72 patients in Study II, which is evaluating its patented drug Rudivar and proprietary device in patients with Bacille Calmette–Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS).
90% of patients have been evaluated at the 90-day assessment visit for treatment safety and efficacy per the study protocol.
63% of treated patients achieved a complete response (CR) and 44% maintained their CR for at least 12 months.
Additionally, 100% of patients experienced no serious adverse events related to the study drug or device.
"The interim clinical data of Study II, to date, has proven to be world-class,” Theralase chief scientific officer Dr Arkady Mandel said in a statement.
CEO Dr Roger DuMoulin-White added that based on the interim clinical data to date, Study II has achieved its primary, secondary, and tertiary endpoints and requires only a few additional patients enrolled and follow-up on all patients to complete the study.
“Theralase expects to complete patient follow-up by mid-2026 with review by Health Canada and the FDA on a marketing approval by end of 2026,” DuMoulin-White said.
“The Theralase bladder cancer treatment has been proven clinically to be safe and effective in the treatment of BCG-Unresponsive NMIBC CIS, fulfilling an unmet need of the medical community."
For Q2, the company said it decreased its administrative expenses by 10% year-over-year to $907,378, due to less spending on general and administrative expenses and stock-based compensation. Theralase also decreased its selling expenses by 1% to $145,915.
It narrowed its net loss by 6% year-over-year to $2,400,461, compared to $2,564,187.
Revenue was $276,401, compared to $426,087 in the year-ago quarter.