With strong safety signals and a 67% Complete Response (“CR”) rate at 540 days; the Phase Ib NMIBC Clinical study (“Study I”) was successfully completed, meeting all three endpoints. To date, Study I demonstrates the best clinical results in a Phase Ib human study for NMIBC and is very encouraging to be used as a potential treatment for patients diagnosed with NMIBC.

The Study I data further validates our understanding that even a single treatment of Theralase’s ACT is able to lead to CR at 540 days post treatment for patients presenting with Bacillus Calmete Guérin (“BCG”)-Unresponsive NMIBC. Albeit in a small patient group, 2/3 patients enrolled and treated in Study I, treated at the Therapeutic Dose, have demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 540 day clinical and cystoscopy assessment.

Consequently, Theralase Technologies’ Anti-Cancer Therapy continues to be further evaluated in a pivotal Phase II NMIBC clinical study (“Study II”).

Principle Investigator at University Health Network, Princess Margaret Cancer Centre, Dr. Girish Kulkarni MD, Surgeon-Scientist affiliated with the Department of Surgery, Faculty of Medicine at the University of Toronto discusses the successful completion of the first human clinical study for Theralase’s Anti-Cancer Study Drug, TLD-1433.

Table of Clinical Study Sites and Number of Patients Treated

As the frontrunner in personalized ACT PDT treatments for NMIBC, the pivotal Phase II NMIBC clinical study (“Study II”) has the potential to become the next gold standard for bladder cancer treatments. Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and will focus on the enrollment and treatment of approximately 100 – 125 BCG-Unresponsive NMIBC patients presenting with Carcinoma In-Situ (“CIS”) in approximately 20 clinical sites located in Canada and the US, with a primary endpoint of efficacy at any point in time, a secondary endpoint of duration of CR and a tertiary endpoint of safety.

In Study II, all patients will receive two Study Treatments (Day 0 and Day 180).

To date, 12 patients have been enrolled and treated in Study II.

If Study II demonstrates strong endpoint results, similar to those attained in the Study I, with a high safety profile, then the evidence could support an application for commercialization with the potential of being eligible for Fast Track Approval (“FTA”), Breakthrough Therapy Designation (“BTD”) and/or Accelerated Approval (“AA”), pending Study II results.

Theralase’s® ACT platform has demonstrated the potential to provide a safe and effective treatment alternative to patients stricken with NMIBC. Theralase® is laser focused on researching, developing and commercializing light activated PDCs and their associated drug formulations to safely and effective treat various cancers.

Theralase® is advancing its PDC pipeline to include preclinical research into GBM and NSCLC.

Theralase® possesses expert scientific, clinical and engineering in-house experience in the research, development and commercialization of light-activated Photo Dynamic Compounds (“PDCs”), the laser systems that activate them and the methodology used to destroy cancer, bacteria and viruses.

These core competencies allow Theralase® to develop targeted and personalized medical technology platforms, essentially providing a one-stop solution to meet patient needs.

Theralase®’s ACT platform originates from > 17 years of scientific, preclinical and clinical research.

To protect and increase the value of the Company, Theralase® has heavily invested in a comprehensive Intellectual Property (“IP”) strategy to protect and safeguard the Company’s technology through issued international patents and patents pending.

If you are a patient interested in participating in the Phase II NMIBC clinical study (“Study II”), please feel free to contact Theralase® or the nearest participating clinical study site for more information.

If enrolled in Study II, there is a no charge for participation for patients who qualify; however, your urologist will need to contact the principal investigator to provide confidential information about your NMIBC to ensure you meet the clinical study guidelines.

For patients or practitioners wishing to learn more about Study II, please visit ClinicalTrials.gov and search for "Theralase" or by the National Clinical Trial Number: NCT03945162.