Welcome to our dedicated page for Theralase Technologies news (Ticker: TLTFF), a resource for investors and traders seeking the latest updates and insights on Theralase Technologies stock.
Theralase Technologies Inc. reports company developments as a clinical-stage pharmaceutical developer of energy-activated small molecules for the destruction of cancer, bacteria and viruses. Its updates center on Ruvidar® (TLD-1433), including clinical and regulatory disclosures tied to non-muscle invasive bladder cancer and research into antiviral mechanisms such as HSV-1 inactivation.
Recurring announcements also cover operating and financial results, non-brokered private placements, line-of-credit financing, capital-structure disclosure, governance matters and development collaborations. The company’s news commonly links research progress with funding needs, regulatory pathways, intellectual-property considerations and commercialization risks for its small-molecule drug formulations.
Theralase (OTCQB: TLTFF) announced interim Phase II clinical data for light-activated Ruvidar (TLD-1433) in BCG-unresponsive non-muscle invasive bladder cancer carcinoma in-situ (NMIBC CIS), selected for oral presentation at EAU26 in London, March 13–16, 2026.
Enrollment in the international, multicenter Study II is complete. Interim findings show 2 of 3 patients achieved complete response, 2 of 5 maintained response ≥15 months, and 1 of 5 showed ≥3 years' response after one treatment. A rolling submission to Health Canada and FDA is planned to start in 3Q2026, with regulatory approval expected in 2027.
Theralase (OTCQB: TLTFF) announced interim Phase II clinical data for light-activated Ruvidar (TLD-1433) in BCG-unresponsive non-muscle invasive bladder cancer carcinoma in-situ (NMIBC CIS), accepted for interactive poster presentation at the 2026 AUA Annual Meeting (May 15-18, 2026).
The interim dataset highlights 78 patients who completed enrollment, with select responses: 2/3 complete responses in a subset, 2/5 maintaining response ≥15 months, and 1/5 showing ≥3-year duration after a single treatment. Rolling regulatory submissions to Health Canada and the FDA are expected to begin in 3Q2026, with approvals targeted in 2027.
Theralase (OTCQB: TLTFF) reported interim Phase II bladder cancer results, enrolling 90 patients with 78 completions and 12 pending. Primary endpoint: CR 64.4% (56/87), total response 73.6% at any time. Duration analysis (450 days) shows CR 40.4% (19/47). Safety: 100% (78/78) evaluated as unrelated or unlikely related to study drug/device. Company plans 2026 data compilation for submissions to Health Canada and FDA with targeted regulatory approval in 2027.
Theralase (TSXV: TLT) (OTCQB: TLTFF) completed enrollment and treatment of 90 patients in a multi-center Phase II registrational study for BCG-unresponsive NMIBC CIS using light-activated Ruvidar.
The study’s primary endpoint is efficacy; secondary is duration of response and tertiary is safety. Company expects study completion and preparation of Health Canada and FDA submissions in 2026.
Ferring Pharmaceuticals and Theralase (TSXV: TLT / OTCQB: TLTFF) announced a clinical development agreement dated January 9, 2026 to evaluate combination therapy in BCG-unresponsive non‑muscle invasive bladder cancer (NMIBC) CIS ± Ta/T1.
The study will add a new cohort to Theralase's Study II (NCT03945162) to test light‑activated Ruvidar (TLD‑1433) followed by Ferring's FDA‑approved intravesical gene therapy ADSTILADRIN (nadofaragene firadenovec‑vncg). Theralase remains sponsor; enrollment will begin in the U.S. with possible expansion pending written agreement. Study II has enrolled 88 of 90 patients with enrollment expected complete by 1Q2026 and follow‑up by 2Q2027.
Theralase (OTCQB: TLTFF) closed a non-brokered private placement on Dec 23, 2025, issuing 7,850,882 Units at CAN$0.17 per Unit for gross proceeds of approximately CAN$1,334,650. Each Unit includes one common share and one warrant exercisable at CAN$0.21 for 5 years. Proceeds will fund the ongoing Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) clinical study, working capital and general corporate purposes.
The company paid a finder's fee totalling CAN$31,658 (CAN$15,470 cash and CAN$16,188 in 95,221 common shares) and issued 186,221 non-transferable finder warrants exercisable at CAN$0.21 for 5 years. Securities are subject to a four-month plus one day hold expiring April 24, 2026, and the Offering awaits TSX Venture Exchange final acceptance.
Theralase (OTCQB: TLTFF, TSXV: TLT) commenced a non-brokered private placement to raise up to CAD 2,000,000 by issuing Units at CAD 0.17 each. Each Unit includes one common share and one warrant exercisable at CAD 0.21 for 60 months. Proceeds are earmarked to fund the ongoing Phase II NMIBC clinical study and working capital. Closing is expected the week of December 15, 2025, subject to TSXV approval. Finder compensation: 7% cash of gross proceeds plus non-transferable finder warrants equal to 7% of Units, exercisable at CAD 0.17 for 60 months. The company also mutually terminated the previously announced LIFE financing with Research Capital.
Theralase (OTCQB: TLTFF) will host a conference call on Nov 19, 2025 at 11:00 am ET to review interim Phase II Study II data for BCG-unresponsive NMIBC CIS and 3Q2025 financial results.
As of Nov 7, 2025, 88 of 90 patients treated (97.8% enrollment); 72 completed required visits. Interim efficacy: 64.3% CR (54/84) and 72.6% TR (61/84); at 450 days 40% CR durability (18/45). Company expects enrollment complete in 4Q2025 with data lock and regulatory submissions in 1Q2027.
Financials: nine-month revenue $590,573 (-5% YoY), net loss $3,435,145 (+3% YoY); company raised $672,627 via private placement and has $280,000 short-term loans at 15% interest.
Theralase (OTCQB:TLTFF) released unaudited condensed consolidated interim 3Q2025 financial statements and will host a conference call on Nov 19, 2025 at 11:00 am ET. For the nine months ended Sept 30, 2025 versus 2024: total revenue was $590,573 (down 5%), cost of sales $299,743 (51% of revenue, down 10%), and gross margin $290,830 (49% of revenue). Net loss was $3,435,145, a 3% increase, which included $708,521 in non-cash charges. Operational items: a $672,627 private placement (3,363,134 units at $0.20), extension of 1,840,000 warrants, and $280,000 short-term loans (15% interest).
Clinical: Study II is 97.8% enrolled (88/90); interim responses show CR 64.3%, Total Response 72.6%, and 40% CR durability at 450 days. Company expects enrollment complete in 4Q2025 and data lock/regulatory submissions in 1Q2027.
Theralase (OTCQB: TLTFF) reported preclinical data (Nov 3, 2025) showing X-ray-activated Rutherrin enhances radiation therapy in multiple cancer models.
Key findings: 100-fold greater cancer cell kill vs radiation alone; >10-fold tumor uptake over healthy brain; complete tumor regression and durable protection in colorectal models; increased ROS, immune cytokine activation, and modulation of drug efflux pathways. The company plans GLP toxicology in 2026 to support clinical development targeting GBM, NSCLC, pancreatic, lymphoma and colorectal cancers.