Theralase Provides Bladder Cancer Clinical Study Update
Nine patients still await secondary endpoint assessment as Theralase prepares Canadian and U.S. drug applications.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Theralase Technologies (TLTFF) reported interim Phase II bladder cancer results showing a complete response in 64.5% of assessed patients.
Study II enrolled 96 patients with bladder cancer unresponsive to BCG treatment; 87 completed the study and nine await secondary endpoint assessment. Complete responses occurred in 60/93 patients at any time and 22/54 (40.7%) at 450 days. Median response duration was 14.9 months. Complete response rates at two and three years were 22.4% and 18.4%, respectively, among 49 patients. There were 25 serious adverse events, including three Grade V events; 92% were not treatment-emergent.
Theralase is preparing Canadian and U.S. drug applications and anticipates marketing decisions in 2027, when it also plans licensing efforts. Rutherrin toxicology work is expected to finish in 1Q2027. Further cancer and cold-sore trials are planned for 2027, subject to regulatory approval.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointComplete response at any time reached 64.5% (60/93) in the interim Phase II analysis.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Canadian and U.S. drug applications are being prepared; Theralase anticipates marketing decisions in 2027.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Theralase plans to pursue global licensing agreements in 2027 for bladder cancer marketing and distribution.
- Minor pointTotal response, including indeterminate responses, reached 73.1% (68/93) at any time.
- Minor pointAt 450 days, complete response was 40.7% (22/54); total response was 44.4% (24/54).
8 minor points
- Minor pointMedian response duration was 14.9 months, with a 95% confidence interval of 12.1–17.7 months.
- Minor pointExtended complete response rates were 22.4% (11/49) at two years and 18.4% (9/49) at three years.
- Minor pointOne patient maintained a complete response for seven years after one procedure.
- Minor pointStudy enrollment is complete, with 96 patients enrolled and complete clinical data collected on 87.
- Minor point. Forward-looking: it has not happened yet and may not happen.Rutherrin toxicology studies are underway, with completion expected in 1Q2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.Theralase intends 2027 Phase 0/I/II adaptive trials for glioblastoma, non-small cell lung cancer and muscle-invasive bladder cancer.
- Minor point. Forward-looking: it has not happened yet and may not happen.Topical Ruvidar toxicology studies for HSV-1 cold sores are planned for 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.Theralase intends 2027 Phase I/II/III adaptive trials for HSV-1 cold sores.
Negative
- Moderate pointSerious adverse events totaled 25 (26.9%), including three Grade V events; 92% were not treatment-emergent.
- Minor pointTreatment-emergent hematuria affected 47.9%, urinary frequency 39.5% and urinary urgency 32.3% of patients.
- Minor pointSecondary endpoint assessment remains pending for nine patients.
- Minor point. Forward-looking: it has not happened yet and may not happen.Planned 2027 cancer and cold-sore clinical studies are subject to regulatory approval.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Toronto, Ontario--(Newsfile Corp. - October 26, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical-stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of various cancers, bacteria and viruses, is providing an update on its Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") clinical study (with or without resected Ta/T1 papillary disease) ("Study II") and in addition its expanding oncology pipeline.
Study II Interim Clinical Data
Study II has enrolled 96 patients (statistical analysis plan calculated a population size of 90 patients). 87 patients have completed Study II and 9 remain on study, pending secondary endpoint assessment.
93 patients have been assessed for the primary endpoint, 54 for the secondary endpoint and 87 for the tertiary endpoint.
| Primary Endpoint Performance (CR at any Point in Time) | |||
| # | % | Confidence Interval ( | |
| Complete Response ("CR") | 60/93 | [49.2, 79.9] | |
| Total Response (CR and IR) | 68/93 | [56.8, 89.5] | |
Table 1: Primary Endpoint Performance
Approximately 2 out of 3 patients in Study II achieved a CR following the Theralase® procedure. Approximately 3 out of 4 patients achieved a Total Response.
Note: Indeterminate Response ("IR") is defined as negative cystoscopy (no evidence of Urothelial Cell Carcinoma ("UCC") in the bladder) and positive / suspicious urine cytology (detection of cancer in the urine, without a negative confirmatory bladder biopsy, suggesting UCC in the renal system other than the bladder).
| Secondary Endpoint Performance (Duration of CR) (450 Days) | |||
| # | % | Confidence Interval ( | |
| Complete Response (CR) | 22/54 | [24.6, 56.9] | |
| Total Response (CR and IR) | 24/54 | [28.6, 60.3] | |
Table 2: Secondary Endpoint Performance
Approximately 2 out of 5 patients who responded to the Theralase® procedure maintained their CR for 15 months. The median duration of response was 14.9 months [
| Tertiary Endpoint Performance (Safety) (450 Days) | ||
| # | % | |
| Safety | 87/87 | |
Table 3: Tertiary Endpoint Performance
Treatment Emergent Adverse Events ("TEAEs") were noted, but did not meet the Serious Adverse Event ("SAE") criteria. TEAEs included hematuria (
25 (
Patients who completed the study were followed for up to 3 years after the initial procedure to further analyze duration of response. Approximately 1 out of 5 patients in Study II demonstrated a duration of response at 2 years and 3 years post the Theralase® procedure. One patient demonstrated a CR for 7 years, after one Theralase® procedure.
| Duration of CR | |||
| Time | # | % | Confidence Interval ( |
| 2 Years | 11/49 | [10.5, 34.4] | |
| 3 Years | 9/49 | [7.5, 29.2] | |
Table 4: Duration of CR at Extended Time Points
The interim results support light-activated Ruvidar® as a viable treatment option for patients with BCG-Unresponsive NMIBC CIS (+/- papillary disease) with an acceptable safety profile.
Regulatory and Commercialization Strategy
Enrollment into Study II has been completed with complete clinical data collected on 87 patients. Theralase® is currently analyzing and compiling the clinical data for submission of a New Drug Submission ("NDS") to Health Canada and a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") with marketing decisions anticipated in 2027.
In 2027, Theralase® will pursue licensing agreements of the bladder cancer technology for global marketing and distribution of light-activated Ruvidar®.
Oncology Pipeline Expansion
Theralase® is working with a Good Laboratory Practices ("GLP") laboratory, in the completion of GLP toxicology studies for Rutherrin®, to determine the Maximum Tolerated Dose ("MTD") and corresponding Human Equivalent Dose ("HED") for additional oncological conditions. This work is expected to be completed in 1Q2027. In 2027, subject to regulatory approval, the Company intends to commence clinical development through Phase 0/I/II adaptive clinical studies for: Glioblastoma Multiforme ("GBM"), Non-Small Cell Lung Cancer ("NSCLC") and Muscle Invasive Bladder Cancer ("MIBC").
Topical Ruvidar® GLP Toxicology and Pipeline Expansion
In 2027, Theralase® plans to commence GLP toxicology studies for topical Ruvidar® to determine the MTD and corresponding HED for the treatment of Herpes Simplex Virus-1 ("HSV-1") derived cold sores. In 2027, subject to regulatory approval, the Company intends to commence Phase I/II/III adaptive clinical studies for HSV-1 derived cold sores.
About Study II
Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433), activated by the TLC-3200 Medical Laser System. Study II has enrolled and treated 96 BCG-Unresponsive NMIBC CIS (with or without resected Ta/T1) patients across 11 clinical study sites located in Canada and the United States.
About Theralase® Technologies Inc.
Theralase® is a clinical-stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.
Additional information is available at www.theralase.com and www.sedarplus.ca.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information (collectively, "FLS") within the meaning of applicable Canadian securities laws. Such statements; include, but are not limited to statements regarding the Company's proposed development plans with respect to energy-activated small molecules and their drug formulations. FLS may be identified by the use of the words "may", "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals.
These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks to the Company include: successful commercialization of its energy-activated small molecules and drug formulations; access to sufficient capital to fund the Company's operations on terms that are commercially favorable to the Company or at all; the safety and effectiveness of the Company's energy-activated small molecules and formulations against the diseases tested in its clinical studies; the failure to comply with the terms of license agreements with third parties and as a result lose the right to use key intellectual property in its business; the ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.
Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors, which may cause actual results or future events to differ materially from the FLS.
Although the FLS contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these FLS.
All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS.
For investor information on the Company, please feel to reach out Investor Inquiries – Theralase Technologies.
For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.com
Matthew Perraton
Investor Relations Manager X229
mperraton@theralase.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/320824
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Theralase's Phase II bladder cancer study show?
Study II reported a 64.5% complete response rate (60/93) at any time and a 40.7% complete response rate (22/54) at 450 days. Median response duration was 14.9 months. These are interim results, with nine patients still awaiting secondary endpoint assessment.
What does an indeterminate response mean in Theralase's bladder cancer study?
An indeterminate response means cystoscopy found no evidence of urothelial cancer in the bladder, but urine cytology was positive or suspicious without a negative confirmatory bladder biopsy. This suggests urothelial cancer elsewhere in the renal system. Total response combines complete and indeterminate responses.
How long did treatment-emergent urinary symptoms last in Theralase's bladder cancer study?
Median resolution times were 15 days for hematuria, 36 days for urinary frequency and 43 days for urinary urgency. These treatment-emergent adverse events did not meet serious adverse event criteria.