Theralase Technologies (TLT) investor relations material

Executive summary

• Completed enrollment of 92 patients in phase II bladder cancer clinical study, with 82 completing the study and 10 under assessment; interim data show a 65.2% complete response rate and favorable safety profile with no serious adverse events related to the drug or device.

• Plans to file a new drug application for Ruvidar with Health Canada and FDA in Q3 2026, targeting marketing approval in H1 2027.

• Strategic initiatives include pipeline expansion into nine new indications, U.S. IPO plans, and separation of drug and device divisions.

• Actively pursuing commercialization and strategic partnerships for Ruvidar globally.

Financial highlights

• Revenue for Q1 2026 was CAD 133,000 (or $132,634), up 45% year-over-year, driven by Cool Laser Therapy system sales and higher sales in Canada.

• Canadian revenue rose 62% to CAD 124,000, while U.S. revenue fell 39% to CAD 9,000.

• Gross margin improved to 49% of revenue (up from 15% year-over-year), reaching CAD 64,000, a 392% increase.

• Operating expenses decreased across selling (2%), administrative (16%), and R&D (36%) categories.

• Net loss for the quarter was CAD 1,032,000 (or $1,031,785), a 30% improvement over the prior year.

Outlook and guidance

• Expects to become a fully operational, self-sustained pharmaceutical company in 2027.

• Regulatory decisions for Ruvidar expected in H1 2027; multiple new clinical studies planned for late 2026.

• Preparing to launch a combinational clinical study with Ferring Pharmaceuticals, pending FDA approval.

• Anticipates increased investment in marketing and commercial initiatives as the balance sheet strengthens.