Theralase(R) Investor Conference Call Reminder

Executive Summary

• Theralase® announced interim Phase II clinical data for Study II in BCG‑unresponsive NMIBC, showing a 64.3% complete response rate and durable responses at 450 days.
• The company released its unaudited condensed Q3 2025 financial statements, reporting $590k revenue and a net loss of $3.44 M.
• A conference call is scheduled for November 19, 2025 to discuss the clinical and financial updates; participants may submit questions in advance.

Key Details

• Study II Enrollment (as of Nov 7, 2025): 88 patients treated (97.8% of target 90); 72 completed study; 16 pending.
• Interim Clinical Results:
• 64.3% (54/84) achieved a Complete Response (CR) at any point.
• 72.6% (61/84) achieved a Total Response (TR = CR + Indeterminate Response).
• At 450‑day assessment, 40% (18/45) maintained CR; 42.2% (19/45) maintained TR.
• Timeline: Enrollment expected to finish in Q4 2025; data lock and regulatory submissions anticipated in Q1 2027.
• Financial Highlights (9 months ended Sep 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%), includes $708,521 non‑cash charges.
• Liquidity & Funding:
• $672,627 raised via a non‑brokered private placement on July 28 2025.
• Warrant extensions completed August 29 2025.
• Outstanding short‑term loans: $280,000 at 15% interest (as of Nov 7 2025).
• Conference Call Details:
• Date/Time: Wednesday, November 19, 2025 at 11:00 am ET.
• Zoom link: https://us02web.zoom.us/j/81044841120 (ID 810 4484 1120).
• Phone numbers provided for Canada and US participants; not required for Zoom attendees.
• Questions may be submitted in advance to [email protected].

Notable Quotes

No direct quotes were included in the release.