Sixty of 93 assessed patients had a complete response at some point after treatment. At three years, nine of 49 still did.
Theralase Technologies published both figures on October 26, in what it calls an interim efficacy readout from a Phase II study it intends to put in front of regulators in Canada and the United States.
Theralase Reports Phase II Ruvidar Results in BCG-Unresponsive Bladder Cancer
Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) released updated results on October 26 from Study II, its Phase II trial of Ruvidar (TLD-1433), a light-activated small molecule used with the company’s TLC-3200 Medical Laser System. The trial enrolled patients with non-muscle invasive bladder cancer carcinoma in situ (CIS), a flat, high-grade cancer confined to the bladder lining, whose disease no longer responded to BCG. BCG is a weakened bacterium instilled into the bladder and serves as the standard first-line immunotherapy for this cancer.
Ninety-six patients were enrolled and treated at 11 sites in Canada and the United States, above the 90 the statistical analysis plan called for. The primary endpoint was a complete response at any point in time, meaning no detectable cancer on follow-up assessment. Of 93 patients assessed, 60 achieved one, or 64.5%. The company reported a 95% confidence interval of 49.2% to 79.9%. Counting indeterminate responses alongside complete ones lifts the figure to 73.1%.
These were heavily pretreated patients. The median BCG instillation count before enrollment was 15.4, and 98% were classified as BCG-unresponsive; the rest were BCG-intolerant.
The release describes no control arm. Every figure here comes from patients who received Ruvidar, with no concurrent comparison group reported, and the company itself labels the efficacy results interim, with nine patients still on study pending assessment of the secondary endpoint.
Ruvidar Complete Response Rate Falls to 18.4% at Three Years
Durability is where the numbers thin out. On the secondary endpoint, duration of complete response at 450 days, 22 of 54 assessed patients (40.7%) remained in complete response. Median duration of response was 14.9 months.
Extended follow-up narrows it further. At two years, 11 of 49 patients (22.4%) were in complete response, and at three years the count was nine of 49 (18.4%). According to the company, one patient has maintained a complete response for seven years after a single procedure.
The denominators shift at each step: 96 enrolled, 93 assessed for the primary endpoint, 54 for the secondary, 49 for extended follow-up. The release does not fully reconcile how patients moved between those groups.
Ruvidar Safety Data Lists 25 Serious Adverse Events, Three of Them Grade V
Hematuria, or blood in the urine, was the most common treatment-emergent adverse event at 47.9%, with a median resolution time of 15 days. Urinary frequency (39.5%) and urinary urgency (32.3%) followed, resolving in a median of 36 and 43 days.
Twenty-five serious adverse events (26.9%) were documented. By grade, the release lists one Grade I, three Grade II, 14 Grade III, four Grade IV and three Grade V.
Grade V is the most severe category on the standard scale used to grade adverse events in cancer trials. It denotes death. The release does not describe the three Grade V events or say whether investigators judged them related to treatment, and its statement that all serious adverse events resolved within 1 to 82 days does not explain how that applies to them. Theralase reports its tertiary safety endpoint as met in 87 of 87 patients at 450 days; that is the company’s own characterization.
Theralase Plans Health Canada and FDA Filings for Ruvidar
Theralase wrote that it is analyzing the data to file a New Drug Submission (NDS) with Health Canada and a New Drug Application (NDA) with the FDA, the applications each agency requires before a new drug can be marketed. Its corrected Q2 2026 financial release, dated September 18, says the company intends to begin those submissions in 4Q2026 under a rolling review, a process that lets a sponsor submit completed sections of an application before the whole package is finished. The original August 28 version of that release had given 3Q2026.
No submission had been announced as of October 26. Marketing decisions are anticipated in 2027, per the company. Ruvidar is investigational and has not been approved by Health Canada, the FDA or any other regulator for any indication, and filing an application does not indicate or guarantee approval.
A second track runs through Ferring Pharmaceuticals, a private company. Theralase disclosed a collaborative clinical development agreement dated January 9, 2026 that adds a cohort to the Phase II program evaluating Ruvidar in combination with Ferring’s Adstiladrin (nadofaragene firadenovec-vncg). As of August 28, Theralase described itself as preparing to launch that combination study, subject to FDA approval.
In 2027 the company plans to pursue licensing agreements for global marketing and distribution of Ruvidar in bladder cancer. No licensing partner has been announced.
Theralase Cash Stood at $5.26 Million at June 30
Cash was $5,260,832 as of June 30, 2026, up from $182,914 at December 31, 2025. The six-month net loss came to $2,093,926, down 14% from $2,423,234 a year earlier, which the company attributed mainly to lower R&D spending on Study II. Revenue for the period fell 5% to $296,927.
On August 24, after quarter-end, Theralase closed a brokered private placement under the listed issuer financing exemption for gross proceeds of $3,555,000. The release does not disclose the price or number of securities issued, so the dilution from that raise cannot be calculated from the sources reviewed.
No specific cash runway was identified in the sources reviewed. The October 26 release contains no financing information.
Theralase 4Q2026 Filing Target and 2027 Milestones
Theralase’s stated target is to begin rolling NDS and NDA submissions in 4Q2026, with marketing decisions anticipated in 2027.
The company plans to complete GLP toxicology for Rutherrin, its radiation-activated drug candidate, by 1Q2027. GLP toxicology refers to animal safety studies run under formal Good Laboratory Practice standards before human dosing. Subject to regulatory approval, Theralase plans Phase 0/I/II adaptive studies of Rutherrin in 2027 in glioblastoma, non-small cell lung cancer and muscle-invasive bladder cancer. No start date has been disclosed for the Ferring combination cohort.
Sources
- Newsfile Corp.: Theralase(R) Provides Bladder Cancer Clinical Study Update, October 26, 2026
- Newsfile Corp.: Correcting and Replacing: Theralase(R) Releases Q2 2026 Financial Statements, September 18, 2026
- BioSpace (Newsfile Corp. release reproduced in full): Theralase(R) Provides Updates on its Phase II Bladder Cancer Clinical Study and Oncology Pipeline, August 28, 2026
- Newsfile Corp.: Theralase(R) Releases 2025 Annual Financial Statements and Provides Clinical Study Update, May 4, 2026
Editorial Disclosure
This article is based entirely on publicly available information, consisting of Theralase Technologies Inc. press releases distributed by Newsfile Corp., one of which was accessed via BioSpace’s full-text reproduction with the original Newsfile dateline visible. The security discussed is Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF). Ferring Pharmaceuticals is a private company, referenced by name only, with no listed security. aktiego.com has not received any compensation from Theralase, its management, investor relations representatives, Ferring Pharmaceuticals, or any third party. No staff member or principal of aktiego.com holds a position in this security at the time of publication.
Ruvidar (TLD-1433) and Rutherrin are investigational and have not been approved by Health Canada, the FDA, or any other regulatory authority for any indication. As of the October 26, 2026 release, no NDS or NDA submission had been announced. The 4Q2026 submission start and 2027 marketing decisions are company-stated targets, not guarantees; the September 18, 2026 corrected release restated the submission start from the 3Q2026 given in the original August 28 release. Submission of an application does not indicate or guarantee approval. The Ferring combination cohort remains subject to FDA approval, and no licensing partner for Ruvidar has been announced.
The company labels the Study II efficacy results interim, with nine of 96 patients still on study. The release describes no control arm or concurrent comparison group. Patients assessed vary by endpoint (93 primary, 54 secondary, 49 extended follow-up) and the release does not fully reconcile those counts. Complete response declined from 64.5% at any point to 40.7% at 450 days, 22.4% at two years and 18.4% at three years. Of 25 serious adverse events, three were Grade V, a grade that denotes death; the release does not describe those events or their relationship to treatment. The 100% tertiary safety figure is the company’s own characterization.
Theralase reported cash of $5,260,832 at June 30, 2026 and a six-month net loss of $2,093,926. A $3,555,000 brokered private placement closed August 24, 2026; its price and share count were not disclosed in the sources reviewed, and it is dilutive to existing shareholders. No specific cash runway or going-concern disclosure was identified in the sources reviewed. Neither the TSX Venture Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of Theralase’s press releases, per the company’s own standard disclosure.
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