Theralase Reports 65.2% Complete Response Rate in Phase II Bladder Cancer Study, Plans NDA Filing in 3Q2026
核心洞察
Theralase's Phase II Study II of light-activated Ruvidar (TLD-1433) (搜索) achieved a 65.2% complete response rate (58/89 patients) in BCG-unresponsive NMIBC CIS, with a 95% confidence interval of 49.4–80.9.
The company plans to submit an NDA to the FDA and an NDS to Health Canada in 3Q2026 under rolling review, with marketing decisions anticipated in 2027.
A collaborative agreement with Ferring Pharmaceuticals (搜索) adds a cohort evaluating Ruvidar in combination with Adstiladrin (nadofaragene firadenovec-vncg) (搜索).
Theralase Technologies Inc. (搜索) (TSXV: TLT) (OTCQB: TLTFF), a clinical-stage pharmaceutical company developing energy-activated small molecules, reported interim clinical data from its Phase II Study II (NCT03945162) showing that approximately two out of three patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) (搜索) carcinoma in-situ (CIS) (搜索) achieved a complete response following treatment with its investigational therapy Ruvidar (TLD-1433) (搜索).
As of August 28, 2026, 89 patients had been assessed for response outcomes and were evaluable for the primary endpoint analysis. The complete response (CR) rate at any point in time was 65.2% (58/89 patients), with a 95% confidence interval of 49.4–80.9. The total response rate (CR and incomplete response) was 73.0% (65/89), with a 95% confidence interval of 56.4–89.7.
Study II has completed enrollment, with clinical study sites enrolling and providing the primary study procedure to 95 patients, of whom 82 have completed the study and 13 remain on study pending clinical data. The median number of BCG instillations was 15.3.
Durability of Response
Secondary endpoint analysis evaluated the duration of complete response at 450 days. Among 52 patients, 21 (40.4%) maintained a complete response, with a 95% confidence interval of 24.0–56.7. Total response (CR and IR) at 450 days was 42.3% (22/52), with a 95% confidence interval of 26.5–58.1.
At extended time points, patients who completed the study were followed for up to three years after initial treatment. The duration of complete response at both two and three years was 19.2% (10/52), with a 95% confidence interval of 7.9–30.5. One patient demonstrated a complete response for seven years after a single study procedure. On Kaplan-Meier analysis, if a complete response is obtained, the long-term estimated probability of remaining cancer-free at one, two, and three years was 48.6%, 34.5%, and 25.4%, respectively.
Safety Profile
The tertiary endpoint (safety) at 450 days showed a 100% safety rate (82/82 patients). Treatment-emergent adverse events (TEAEs) were noted but did not meet serious adverse event (SAE) criteria. TEAEs included urinary frequency (65%), hematuria (62.5%), and urinary urgency (53.8%), all of which resolved within one month of treatment.
A total of 24 SAEs were reported: one Grade I, three Grade II, 13 Grade III, five Grade IV (all resolved between one and 82 days), and two Grade V (unlikely related to the study drug, study device, or study procedure). The majority of SAEs were not TEAEs, and none were directly related to the study drug or study device.
Combination Cohort with Ferring Pharmaceuticals
On January 12, 2026, Theralase announced a collaborative clinical development agreement dated January 9, 2026, with Ferring Pharmaceuticals (搜索). The agreement expands the existing Phase II NMIBC clinical program through the addition of a new cohort evaluating Ruvidar in combination with Adstiladrin (nadofaragene firadenovec-vncg) (搜索) for adult patients with high-risk BCG-unresponsive NMIBC CIS with or without papillary disease (±Ta/T1).
Under the agreement, Theralase will remain the study sponsor, with both parties providing clinical oversight through a joint development committee. The new cohort is expected to be enrolled and treated initially in the United States and, subject to written agreement, may expand into Canada or other jurisdictions.
The company anticipates that the complementary mechanisms of action—Ruvidar targets bladder cancer cells directly, while Adstiladrin targets healthy bladder cells to produce interferon to stimulate the innate and adaptive immune system—will provide a strong additive effect. In the study procedure, patients will receive Ruvidar (one hour of drug instillation and one hour of light activation), followed at another visit by Adstiladrin instillation (one hour), both as outpatient procedures. Patients may receive up to four treatments of Adstiladrin, with an optional re-induction study procedure if recurrence occurs. Patients will be followed for 15 months after the initial procedure and up to three years for post-study follow-up.
Regulatory Pathway and Commercialization
Following completion of patient follow-up and final clinical data analysis, Theralase intends to commence submission of a New Drug Submission (NDS) to Health Canada and a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 3Q2026 under a rolling review, with marketing decisions anticipated in 2027.
In parallel, the company is pursuing commercialization opportunities and strategic partnerships for the global marketing and distribution of Ruvidar, including licensing arrangements across geographic territories, collaborative clinical research for broader NMIBC indications, and combination studies with other FDA-approved drugs.
Pipeline Expansion
Theralase plans to complete Good Laboratory Practices (GLP) toxicology studies for Rutherrin by 4Q2026, enabling determination of the maximum tolerated dose (MTD) and corresponding human equivalent dose (HED). Subject to regulatory approval, the company intends to commence Phase 0/I/II adaptive clinical studies in 2027. Target indications under investigation include glioblastoma multiforme (GBM) (搜索), non-small cell lung cancer (NSCLC) (搜索), muscle invasive bladder cancer (MIBC), pancreatic cancer, colorectal cancer, and herpes simplex virus-1 (HSV-1).
Financial Results
For the six-month period ended June 30, 2026, total revenue decreased 5% to $296,927 from $310,933 in the prior-year period. Net research and development expenses decreased 25% to $1,101,126 from $1,460,447, primarily due to lower Study II patient enrollment and treatment costs. R&D expenses represented 49% of the company's operating expenses.
The net loss for the period was $2,093,926, including $287,146 of net non-cash expenses, compared with a net loss of $2,423,234 in the same period of 2025. The Drug Division represented $1,684,924 (80%) of the loss. Cash was $5,260,832 as of June 30, 2026, compared with $182,914 as of December 31, 2025. Subsequent to quarter-end, on August 24, 2026, the company closed a brokered private placement for aggregate gross proceeds of $3,555,000.