Mr. Matthew Perraton reports

THERALASE PROVIDES BLADDER CANCER CLINICAL STUDY UPDATE

Theralase Technologies Inc. is providing an update on its phase II Bacillus Calmette-Guerin (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). Eighty-seven patients have completed Study II and nine remain on study, pending secondary end point assessment.

Eighty-one per cent of patients were greater than or equal to 65 years, 82 per cent male, 83 per cent white, 82 per cent diagnosed with pure CIS, 12 per cent with CIS plus T1; and 6 per cent with CIS plus Ta, 98 per cent were BCG-unresponsive and 2 per cent BCG-intolerant. The median number of BCG installations was 15.4.

Ninety-three patients have been assessed for the primary end point, 54 for the secondary end point and 87 for the tertiary end point.

Approximately two out of three patients in Study II achieved a CR following the Theralase procedure. Approximately three out of four 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).

Approximately two out of five patients who responded to the Theralase procedure maintained their CR for 15 months. The median duration of response was 14.9 months (95-per-cent confidence interval: 12.1, 17.7).

Treatment emergent adverse events (TEAEs) were noted, but did not meet the serious adverse event (SAE) criteria. TEAEs included hematuria (47.9 per cent), urinary frequency (39.5 per cent) and urinary urgency (32.3 per cent), which had a median resolution of 15, 36 and 43 days, respectively.

Twenty-five (26.9 per cent) serious adverse events have been documented: 1 x Grade I, 3 x Grade II, 14 x Grade III, 4 x Grade IV (all resolved between 1 to 82 days) and 3 x Grade V. Ninety-two per cent were not TEAEs.

Patients who completed the study were followed for up to three years after the initial procedure to further analyze duration of response. Approximately one out of five patients in Study II demonstrated a duration of response at two years and three years post the Theralase procedure. One patient demonstrated a CR for seven years, after one Theralase procedure.

The interim results support light-activated Ruvidar as a viable treatment option for patients with BCG-unresponsive NMIBC CIS (plus/minus papillary disease) with an acceptable safety profile.

Regulatory and commercialization strategy

Enrolment 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 Q1 2027. 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.

We seek Safe Harbor.