Announcement • May 06
Theralase Technologies Inc Provides Clinical Study Update
Theralase Technologies Inc. new cohort is expected to be enrolled and treated initially in the United States and, subject to written agreement, may expand into Canada or other jurisdictions. Theralase Technologies Inc. has successfully completed its targeted enrollment for Study II, exceeding expectations with 91 patients treated by Clinical Study Sites and may continue to enroll additional patients as remaining sites finalize and close to enrollment. According to the clinical study design, a patient is considered to have completed Study II, if they received the Study Procedure and have been assessed by the Principal Investigator for up to 15 months or upon earlier withdrawal by the Principal Investigator due to non-response or non-compliance. Based on this definition, 82 patients have completed Study II, while 9 remain active with pending clinical data. A total of 91 patients have been enrolled and treated. The cohort was predominantly =65 years of age (81%), male (81%), and white (83%). Tumour staging was distributed as follows: 81% carcinoma in situ (CIS) only, 12% CIS + T1, and 7% CIS + Ta. In addition, 98% of patients were classified as BCG-unresponsive and 2% as BCG-intolerant. The median number of prior BCG instillations was 15.5. As of April 30, 2026, 89 patients have been assessed for response outcomes and are evaluable for the primary endpoint analysis. The primary endpoint of Study II is the achievement of Complete Response (CR) at any point in time following administration of the Study Procedure. Interim analysis demonstrates that 65.2% (58 out of 89) evaluable patients achieved CR. Approximately, 2 out of 3 patients diagnosed with BCG-Unresponsive NMIBC CIS (with or without Ta/T1) achieved a CR following treatment with the Theralase Technologies Inc. Study Procedure. The secondary endpoint evaluates the sustainability of CR at 12 months, after initial CR determination (450 days post-treatment). Among patients evaluable for durability of response, 40.4% (21 of 52 evaluable patients) maintained a CR at 450 days. The tertiary endpoint is defined as patients who are diagnosed with a Serious Adverse Event (SAE) =4 directly caused by the Study Drug or Study Device, which did not resolve within 450 days. Theralase Technologies Inc. and the independent Data Safety Monitoring Board believe all SAEs reported to date are unrelated or unlikely related to the Study Drug or Study Device. Treatment Emergent Adverse Events (TEAEs) were noted, but did not meet the SAE criteria. TEAEs included urinary frequency (65%), hematuria (62.5%) and urinary urgency (53.8%), which resolved within 1 month of treatment. There have been 24 SAEs reported: 1 x Grade I, 3 x Grade II, 13 x Grade III, 5 x Grade IV (all resolved between 1 to 82 days) and 2 x Grade V. A high majority of SAEs were not treatment related and none were directly related to the Study Drug or Study Device. Patients who have completed the study are followed for up to 3 years after initial treatment at extended time points. One patient demonstrated CR for 7 years, after one Study Procedure. Based on Kaplan-Meier analysis, if CR is obtained, the long term estimated probability of remaining cancer free at 1, 2 and 3 years is 48.6%, 34.5% and 25.4%, respectively. If approved by Health Canada and the FDA, the clinical data collected from Study II represents a transformative therapeutic option for patients diagnosed with BCG-Unresponsive NMIBC CIS, who would otherwise face radical cystectomy (surgical removal of the bladder). The Theralase Technologies Inc. Study Procedure has demonstrated a robust CR and sustained durability of that response, with the majority of patients receiving only a single Study Procedure. Following the completion of patient follow-up and final clinical data analysis, Theralase Technologies Inc. intends to submit a New Drug Submission (NDS) to Health Canada and a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in Third Quarter 2026, under a rolling review, with regulatory decisions anticipated in First Half 2027. Theralase Technologies Inc, in conjunction with Ferring Pharmaceutical, subject to FDA approval, is preparing to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Ruvidar with Adstiladrin. In the Study Procedure, patients will be treated with Ruvidar (1 hour of drug instillation, 1 hour of light activation), then at another visit, they will be instilled with Adstiladrin (1 hour procedure), both in outpatient procedures. Under the clinical protocol, the patient may receive up to 4 treatments of Adstiladrin. The presiding uro-oncologist will have the option to deliver an additional re-induction Study Procedure, if the patient recurs. The patient will be followed for 15 months after initial Study Procedure and up to 3 years for post-study follow-up. In parallel with the finalization of Study II, Theralase Technologies Inc. is actively pursuing commercialization opportunities and strategic partnerships to support the global marketing and distribution of Ruvidar. The Company is pursuing discussions with pharmaceutical companies across multiple geographic regions regarding: Licensing arrangements for Ruvidar in the treatment of BCG-Unresponsive NMIBC CIS in various geographic territories; Collaborative clinical research initiatives focused on the application of light-activated Ruvidar for broader NMIBC indications; Collaborative clinical research combining Ruvidar, with other FDA-approved drugs to enhance treatment efficacy. Study II utilizes the therapeutic dose of the patented drug, Ruvidar (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 91 BCG-Unresponsive NMIBC CIS patients in 11 clinical study sites located in Canada and the United States.
