On February 4, 2026 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), 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, reported an update on the Phase II clinical study for bladder cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To date, 90 patients have been enrolled and treated with the Theralase Study Procedure, achieving the patient enrollment specified by the statistical analysis plan.

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. There are 12 patients pending study completion.

Primary Endpoint Performance (CR at any Point in Time)
# % Confidence Interval (95%)
Complete Response ("CR") 56/87 64.4% [48.6, 80.2]
Total Response (CR and IR) 64/87 73.6% [56.7, 90.5]
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 (95%)
Complete Response 19/47 40.4% [23.8, 57.1]
Total Response 20/47 42.6% [26.6, 58.5]
Tertiary Endpoint Performance (Safety) (450 Days)
# %
Safety 78/78 100.0%
Note: Theralase believes all Serious Adverse Events ("SAEs") reported to date are unrelated or unlikely related to the Study Drug or Study Device.

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."1

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.

Theralase will compile the clinical data in 2026 for presentation to Health Canada and FDA with an expected regulatory approval in 2027.

About Phase II Clinical Study:

Primary Endpoint: Efficacy (complete response at any point in time)

Secondary Endpoint: Efficacy (duration of complete response of 12 months)

Tertiary Endpoint: Safety (serious adverse events directly related to the study drug or study device that do not resolve within 450 days)

Study Procedure: Light-activated Ruvidar

Patient Population: 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").

About NMIBC:

NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.2 In the United States, bladder cancer is the sixth most common cancer,3 fourth among men,4 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.4 Historically, 75% of bladder cancer presents as NMIBC.5 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.6 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).7

About Ruvidar:

Ruvidar is a small molecule activated by energy, intended for the safe and effective destruction of cancer, bacteria and viruses.

(Press release, Theralase, FEB 4, 2026, View Source [SID1234662479])