Release Date: December 04, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Theralase Technologies Inc (TLTFF, Financial) has demonstrated strong clinical data in their phase two bladder cancer study, with a 61.9% complete response rate and a 43.6% duration of response at 450 days.
- The company has successfully reduced its net loss by 7% year over year, primarily due to decreased spending on research and development expenses.
- Theralase Technologies Inc (TLTFF) has raised approximately $3.9 million through private placements, strengthening its financial position.
- The company plans to expand its clinical study sites and increase patient enrollment, which could accelerate the completion of its phase two bladder cancer study.
- Theralase Technologies Inc (TLTFF) is exploring new indications for its technology, including brain, lung, and blood cancers, which could significantly expand its market potential.
Negative Points
- Theralase Technologies Inc (TLTFF) experienced a 12% decrease in total revenue for the nine-month period ended September 30, 2024, compared to the same period in 2023.
- The company's gross margin decreased from 49% to 47% year over year, attributed to an increase in material costs.
- Selling expenses increased by 33%, primarily due to higher spending on sales salaries and advertising.
- The company faces significant costs, estimated between $15 million and $30 million, to complete its phase two bladder cancer clinical study.
- Theralase Technologies Inc (TLTFF) has not yet secured breakthrough therapy designation (BTD) from the FDA, which could delay potential regulatory approvals.
Q & A Highlights
Q: How much is it going to cost to complete the phase two clinical study for bladder cancer, and how do you plan to finance it?
A: The company estimates the cost to complete the 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. - Christina Hatchie, CFO
Q: How does the company plan to fund the brain cancer and lung cancer clinical studies?
A: A phase one B clinical study for both brain and lung cancer is estimated to cost approximately $5 million. This funding would be available through the base shelf prospectus. - Christina Hatchie, CFO
Q: How many patients are required to complete enrollment and finish the clinical study?
A: Theralase has enrolled 75 patients to date and plans to enroll an additional 20 to 25 patients in 2025. This will allow for a significant sample size and potentially achieve regulatory approval by the end of 2026. - Roger Duan White, CEO
Q: Why is the duration of response so important to the FDA?
A: Duration of response is crucial because it indicates how long a treatment can maintain a complete response, which is vital for preventing bladder cancer recurrence and progression. The FDA and Health Canada are particularly interested in this metric to ensure long-term efficacy. - Roger Duan White, CEO
Q: What is the status of breakthrough designation (BTD) approval?
A: Theralase submitted a pre-BTD submission to the FDA in July 2023 and resubmitted it in September after collecting additional clinical data. The company expects to submit a BTD application by late December or early January, with hopes of receiving approval by the end of Q1 2025. - Roger Duan White, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
