Theralase to host conference call Nov. 19

Executive Summary

• Theralase Technologies announced interim results from its Phase II Study II for BCG‑unresponsive NMIBC, showing a 64.3% complete response rate and 72.6% total response rate among evaluable patients.
• The company released unaudited Q3 2025 financial highlights, reporting revenue of $590,573 and a net loss of $3.44 million for the nine‑month period ended Sept. 30, 2025.
• An investor conference call is scheduled for Nov. 19, 2025 to discuss the clinical data, financial performance, and operational outlook; enrollment is on track for completion in Q4 2025 with regulatory filing expected in Q1 2027.

Key Details

• Study II Enrollment (as of Nov 7, 2025): 88 patients treated (97.8% of target 90); 72 completed the study; 16 pending.
• Interim Clinical Outcomes (84 evaluable patients):
• Complete response (CR) – 64.3% (54/84).
• Total response (TR = CR + indeterminate response) – 72.6% (61/84).
• Durability at 450‑day assessment (45 patients):
• CR maintained – 40% (18/45).
• TR maintained – 42.2% (19/45).
• Timeline: Enrollment expected to finish Q4 2025; data lock and regulatory submissions projected for Q1 2027.
• Financial Highlights (nine months ended Sept 30, 2025 vs. 2024):
• Revenue: $590,573 (‑5%).
• Cost of sales: $299,743 (‑10%; 51% of revenue).
• Gross margin: $290,830 (49% of revenue).
• Selling expenses: $212,421 (‑18%).
• Administrative expenses: $1,444,687 (+12%).
• R&D expenses: $2,116,540 (+1%).
• Net loss: $3,435,145 (+3%), including $708,521 non‑cash charges.
• Financing & Liquidity:
• Raised $672,627 via a non‑brokered private placement on July 28, 2025.
• Completed warrant extensions on Aug 29, 2025.
• Outstanding short‑term loans: $280,000 at 15% interest (as of Nov 7, 2025).
• Future Funding: Company evaluating additional equity and non‑dilutive financing to support upcoming clinical and commercial milestones.

Notable Quotes

(No direct quotes were provided in the release.)