Theralase Technologies Inc.

Theralase reported Q1 2025 revenue of $91,000, down from $175,000 in the prior year quarter. Gross margin was approximately $13,000, or 15% of revenue. Operating expenses included selling expenses of $68,000, administrative expenses of $555,000, and R&D expenses of $878,000, with administrative costs up 9% and R&D up 16% year over year. Net loss was $1.47 million, including $256,000 in noncash charges. On capital, the company closed private placements totaling $730,000 in the first and second quarter of 2025 and said it has raised nearly $7.5 million over the past 24 months. Forward-looking guidance: enrollment in Study II is expected to complete by summer 2025, 15-month follow-up by September 2026, and a marketing submission to Health Canada and the FDA by Q4 2026; management said approval could come in early 2027 if priority review is granted and requirements are met. The estimated cost to complete Study II is approximately CAD 8 million to CAD 10 million over the next 18 months.

Roger Dumoulin-White framed the quarter as a turning point, emphasizing that Study II remains the company’s top strategic objective. He said enrollment and the primary study procedure should finish by summer 2025, which would then allow follow-up through September 2026 and a regulatory filing in Q4 2026. He was upbeat on Ruvidar’s profile, highlighting high response rates, strong durability, a single intravesical treatment, and no directly related serious adverse events.

Kristina Hachey said Theralase is advancing its clinical platform on a “shoestring budget” while preserving financial discipline. She noted Q1 revenue of $91,000 came from Cool Laser Therapy system sales and was down from $175,000 last year because resources were directed to the bladder cancer study; gross margin was about $13,000, or 15%, and the quarterly net loss was $1.47 million, including $256,000 in noncash charges. She also cited $730,000 in private placements closed in the first and second quarter of 2025, nearly $7.5 million raised over 24 months, and said the company is exploring a U.S. institutional raise alongside a possible U.S. listing to broaden the investor base and secure capital for pipeline expansion.

Analysts/shareholders focused on when Study II will finish, how much more money is needed, and whether a U.S. listing will happen this year. Management said Study II enrollment and treatment should be done by summer 2025, with completion of follow-up and submission timing tied to 2026 and early 2027 approval timing if priority review is obtained. They estimated CAD 8 million to CAD 10 million is needed to finish Study II and said they are pursuing debt financing from Canadian institutions, while the U.S. listing remains a strategic objective if it helps fund the drug and device divisions.