Toronto, Ontario — February 4, 2026 — Leads & Copy — Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) has provided an update on its Phase II clinical study for bladder cancer, announcing that 90 patients have been enrolled and treated, meeting the patient enrollment target specified by the statistical analysis plan.
The clinical stage pharmaceutical company, focused on energy-activated small molecules for cancer, bacteria, and virus destruction, reported that 78 patients have completed the clinical study and were evaluated at all scheduled assessment visits or were prematurely removed by the principal investigator due to lack of response. Twelve patients are pending study completion.
According to the company, 56 out of 87 patients achieved Complete Response (CR) at any point in time, representing 64.4% with a confidence interval of [48.6, 80.2]. Total Response (CR and Indeterminate Response (IR)) was observed in 64 out of 87 patients, or 73.6%, with a confidence interval of [56.7, 90.5].
The company defined Indeterminate Response (IR) 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).
Interim data from 47 patients indicates that complete response rates of 21.3% at both 2 and 3 years and 2.1% at 7 years were sustained.
Regarding the secondary endpoint (Duration of CR) (450 Days), 19 out of 47 patients achieved Complete Response, representing 40.4% with a confidence interval of [23.8, 57.1]. Total Response was observed in 20 out of 47 patients, or 42.6%, with a confidence interval of [26.6, 58.5].
In terms of safety (tertiary endpoint) (450 Days), 78 out of 78 patients were deemed safe, representing 100.0%.
Theralase® believes all Serious Adverse Events (SAEs) reported to date are unrelated or unlikely related to the Study Drug or Study Device.
The company reported that these results exceed the International Bladder Cancer Group’s recommended guidelines of clinically meaningful initial complete response rates for carcinoma in situ of at least 50% at 6 months and 30% at 12 months.
Theralase® intends to compile the clinical data in 2026 for presentation to Health Canada and FDA, with an expected regulatory approval in 2027.
The Phase II clinical study focuses on patients with Bacillus Calmette-Guérin (BCG)-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS), who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) (Study II). The primary endpoint is efficacy (complete response at any point in time), the secondary endpoint is efficacy (duration of complete response of 12 months), and the tertiary endpoint is safety (serious adverse events directly related to the study drug or study device that do not resolve within 450 days). The study procedure involves Light-activated Ruvidar®.
NMIBC is a form of bladder cancer found in the inner layer cells of the bladder that does not invade into or beyond the muscle wall. The company reports that, in the United States, bladder cancer is the sixth most common cancer, and it is estimated that there will be approximately 84,870 new cases in the U.S. in 2025. Historically, 75% of bladder cancer presents as NMIBC. In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy, and 50% of those with an initial response will experience recurrence or progression of their disease. Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network guidelines recommend cystectomy (partial or complete removal of the bladder).
Ruvidar® is described as a small molecule activated by energy, intended for the safe and effective destruction of cancer, bacteria, and viruses.
Theralase® Technologies Inc. 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.
Source: Theralase® Technologies Inc.
