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 research and development expenses of $878,000, with administrative up 9% and R&D up 16% year over year. Net loss for the quarter was $1.47 million, including $256,000 in noncash charges. On capital, the company closed $730,000 of private placements in the first and second quarter of 2025 and said it has raised nearly $7.5 million over the past 24 months. Forward-looking, management expects Study II enrollment to complete by summer 2025, follow-up to finish by September 2026, and an NDA-style marketing submission to Health Canada and the FDA in fourth quarter 2026; if priority review is granted and guidelines are met, approval could come in early 2027. Management also said it needs about CAD 8 million to CAD 10 million to complete enrollment, follow-up, data lock, and regulatory submissions over the next 18 months.

Roger Dumoulin-White framed the period as a turning point for the company, with the lead priority being completion of the bladder cancer study and preparation for regulatory filings. He emphasized that the company is also exploring a U.S. listing, but only if it helps fund the drug and device businesses, and said the structure could be done without a share consolidation. His tone was optimistic and strategic, with repeated references to growing investor interest, partnership discussions, and the company’s long-term goal of becoming a global leader in light- and radiation-activated therapeutics.

Kristina Hachey said Theralase continued to operate on a disciplined, pre-revenue basis, with Q1 revenue of $91,000 from Cool Laser Therapy system sales and gross margin of about $13,000. She tied the lower revenue and 15% gross margin to reduced sales volume and fixed overhead, while highlighting administrative expenses of $555,000 and R&D of $878,000 as the main cost drivers, including the ongoing bladder cancer study. On capital, she said the company closed $730,000 in private placements during the first and second quarter of 2025, and noted nearly $7.5 million raised over 24 months through non-brokered private placements, with proceeds deployed mainly to complete enrollment. She also said the company is exploring a U.S. institutional raise alongside a possible U.S. listing to broaden the investor base and improve liquidity.

Management spent most of Q&A on timing, funding, and strategy. Investors asked when Study II would finish, and management reiterated summer 2025 for enrollment, September 2026 for follow-up completion, and fourth quarter 2026 for a regulatory submission, with a minimum six-month review period if priority review is obtained. Another key question was funding: management estimated CAD 8 million to CAD 10 million is needed over the next 18 months and said it is pursuing debt financing from Canadian institutions to reduce dilution. They also addressed the U.S. listing, saying it remains a strategic objective and that they have identified a path that does not require a share consolidation.