Mr. Roger DuMoulin-White reports

POST STUDY II MONITORING OF RESPONSE, OPTIONAL MAINTENANCE STUDY II TREATMENTS AND CENTRAL PATHOLOGY LABORATORY REVIEW OPTIMIZED

Theralase Technologies Inc. has been granted a clinical trial application amendment (CTA-A) by Health Canada through receipt of a no objection letter (NOL) for the optimization of the phase II non-muscle invasive bladder cancer (NMIBC) clinical study.

The Study II optimization consists of:

• Post Study II monitoring of response: Patients who achieved a complete response (CR) or indeterminate response (IR), demonstrated a duration of that response at 450 days, and remained in Study II will be monitored by the company past 450 days, to help define the long-term duration of the Study II treatment.
• Optional maintenance Study II treatment: Patients currently receive a mandatory maintenance Study II treatment at 180 days; however, this has been optimized to allow optional maintenance Study II treatments, at the discretion of the principal investigator (PI) based on the patient's response. For patients who have achieved a CR or IR at any point in time and have demonstrated a duration of that CR or IR, no further maintenance Study II treatments would be administered; however, if the patient recurs at any scheduled assessment visit (90, 180, 270, 360 or 450 days), then that patient would be eligible to receive up to two maintenance Study II treatments at the discretion of the PI to assist the patient in achieving a CR.
• Central pathology laboratory review: The company will use a central pathology laboratory to validate local pathology laboratory results.

Note: CR is defined as:

• Negative cystoscopy and negative (including atypical) urine cytology;
• Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology;
• Negative cystoscopy with malignant urine cytology, if urothelial cancer is suspected in the upper tract or prostatic urethra and random bladder biopsies are negative

Note: IR is defined as:

• Negative cystoscopy and positive urine cytology, without confirmatory negative bladder cancer biopsies.

Dr. Arkady Mandel, MD, PhD, DSc, chief scientific officer of Theralase, stated: "Based on our latest published clinical results in Study II, we are quickly approaching a critical stage in our NMIBC clinical development and commercialization program. There remains an unmet need in providing an adequate treatment option for thousands of Bacillus Calmette-Guerin (BCG) unresponsive NMIBC patients, who are facing radical cystectomy. With Health Canada's CTA-A NOL approval letter, we are a significant step closer to providing these patients around the world with a much-needed breakthrough therapy to help treat their deadly disease. The recent press release of the Study II interim clinical data analysis provides support that Ruvidar-based anti-cancer therapy (ACT) may present a safe and effective treatment option for this patient population. Theralase looks forward to sharing additional safety and efficacy clinical data generated from Theralase's Study II next month."

Roger DuMoulin-White, BSc, PEng, ProDir, president and chief executive officer of Theralase, stated: "Theralase is delighted in Health Canada's decision to grant the company a CTA-A for Study II. These recent optimizations to Study II's clinical protocol allow Study II to be in better compliance for Canadian and U.S. regulators, who will ultimately be responsible for reviewing and making the final decision on approving or denying the investigational treatment for human use. By working with Health Canada and the FDA to approve the optimization of the clinical study design, analysis and reporting structure of Study II early in the process, Theralase is able to much better align the clinical data collected in Study II with best practices and current expectations of the Canadian and U.S. regulators, thereby helping to avoid difficult to address questions at final review time. Theralase hopes that, by introducing these optimizations in Study II, future reviews with the regulators will be more efficient. In addition, Theralase is collecting the survival data for all patients, with central pathology laboratory validation, who have been previously enrolled and provided the primary Study II treatment and who have demonstrated a CR or IR at any point in time, with duration of that CR or IR at 450 days, for submission to the FDA in support of a prebreakthrough designation (BTD) submission."

About Theralase Technologies Inc.

Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of light-activated and radiation-activated compounds, their associated drug formulations, and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.

We seek Safe Harbor.