Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) continued to make progress in its Study II clinical trial, which focuses on the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with a light-activated small molecule, during the third quarter of 2024.
To date, 75 patients have been enrolled and treated, with the majority demonstrating promising outcomes.
Interim data shows that 61.9% of evaluable patients achieved a complete response (CR), and 43.6% of those maintained their CR for at least 450 days.
The trial has also achieved its secondary and tertiary objectives, with a 100% safety profile free of serious adverse events directly linked to the treatment.
Theralase plans to expand the trial by adding up to five new clinical study sites and completing enrollment by 2025, positioning the company to submit data for regulatory approvals by 2026.
“The interim clinical data has been able to demonstrate that greater than two out of three patients (68.3%), treated with the Theralase technology have been able to have the cancer in their bladder completely destroyed,” Theralase CEO Roger DuMoulin-White said in a statement.
“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. "
Dr Arkady Mandel, Theralase’s chief scientific officer, described the interim clinical data from Study II as “world-class.”
“The Theralase technology has the opportunity to become a safe, effective alternative therapy for patients, who are at high risk of having their bladder removed,” Mandel said.
Theralase reported that for the nine-month period ended September 30, 2024, its total revenue decreased by 12% year-over-year, with a gross margin of about $290,000, representing 47% of revenue, compared to 49% in the same period in 2023.
Selling expenses rose by 33% from the year-ago quarter to about $258,000 due to increased spending on sales salaries and advertising.
Administrative expenses declined by 11% year-over-year to $1.29 million driven by reductions in general expenses, professional fees, and stock-based compensation.
Research and development costs for the company's Drug Division fell by 13% year-over-year to $1.96 million, primarily due to reduced Study II patient enrollment costs, while R&D expenses for the Device Division were up 297% year-over-year to about $138,000 due to new software development.
The company narrowed its net loss to $3.34 million, attributed mainly to reduced Drug Division R&D expenses, compared to a $3.58 million loss in 2023.