Theralase Technologies Inc (TLTFF) has announced encouraging results from its Phase 2 clinical study evaluating its lead technology in bladder cancer, alongside updates on its financial strategies to support ongoing research and development.
Phase 2 Bladder Cancer Study Shows Strong Results
The Phase 2 study demonstrated a 61.9% complete response rate in patients with bladder cancer. Furthermore, the duration of response was 43.6% at 450 days, a key metric for long-term efficacy. According to CEO Roger Duan White, the FDA and Health Canada are particularly interested in the duration of response as it indicates how long a treatment can maintain a complete response, which is vital for preventing bladder cancer recurrence and progression.
Financial Strategy and Funding
Theralase has successfully reduced its net loss by 7% year-over-year, primarily due to decreased spending on research and development expenses. The company has also raised approximately $3.9 million through private placements, strengthening its financial position. CFO Christina Hatchie stated that the company estimates the cost to complete the Phase 2 clinical study to range between $15 million and $30 million over the next three years, depending on patient recruitment rate and the number of clinical study sites required. The primary mandate is to secure funding through a $100 million base shelf prospectus, which would allow access to funds over 25 months. The company plans to raise approximately $10 million through debt, equity instruments, and government programs to become base shelf eligible.
Expansion into New Cancer Indications
Theralase is also exploring new indications for its technology, including brain, lung, and blood cancers. A Phase 1B clinical study for both brain and lung cancer is estimated to cost approximately $5 million, which the company plans to fund through the base shelf prospectus, according to CFO Christina Hatchie.
Enrollment and Regulatory Milestones
Theralase has enrolled 75 patients to date and plans to enroll an additional 20 to 25 patients in 2025. CEO Roger Duan White anticipates that this will allow for a significant sample size and potentially achieve regulatory approval by the end of 2026. The company submitted a pre-Breakthrough Therapy Designation (BTD) submission to the FDA in July 2023 and resubmitted it in September after collecting additional clinical data. Theralase expects to submit a BTD application by late December or early January, with hopes of receiving approval by the end of Q1 2025.
