Theralase Technologies Inc (TSX-V:TLT, OTCQB:TLTFF) is eyeing regulatory approval for its lead asset, the bladder cancer treatment Rudivar, by 2026, according to its CFO.
The Canadian pharmaceutical company plans to secure funding through various equity and debt instruments to allow it the ability to become base shelf eligible, CFO Kristina Hachey said in a statement.
“This will allow the company sufficient funding to complete enrollment into Study II by year end, data lock in mid 2026 and position the company for FDA and Health Canada approval the end of 2026,” Hachey said.
This year Theralase is focused on its Study II, which has successfully enrolled 63 patients thus far. With the aim of enrolling a total of 100 patients by the end of 2024 or the beginning of 2025, the company anticipates completing primary patient follow-up by mid-2026.
Initial efficacy results for patients with BCG-Unresponsive NMIBC CIS show promising outcomes, with a clinical complete response rate of 64% and a duration of efficacy of 36% at 15 months. Additionally, the study demonstrates a high safety profile, with no serious adverse events related to the study drug or device reported.
Advisory board meetings are scheduled during the Canadian Urologic Association Bladder Cancer Forum 2024 in Toronto on April 12, 2024, and the 2024 American Urology Association meeting in San Antonio on May 4, 2024, to provide updates on Study II's interim clinical data and discuss opportunities for patient enrollment with investigators.
Meanwhile, Theralase’s 2023 year-end financials showed a decrease in net loss compared to the previous year, which it attributed to decreased spending on research and development expenses in Study II.
The company reported a net loss of $4,570,879, inclusive of $933,790 in net non-cash expenses. This is a notable improvement from the previous year's net loss of $5,235,302, which included $554,298 in net non-cash expenses, marking a 13% decrease. The Drug Division represented the majority of this loss in 2023, totaling $4,058,764 (89%), attributed to reduced spending on research and development expenses in Study II.
The company experienced a 6% decrease in total revenue compared to the previous year.