Theralase® Patient Six Cancer-Free at Nine Months After Single Anti-Cancer Treatment

Theralase Technologies Inc. (“Theralase^®” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers reports that patient six, enrolled and treated in the recently completed Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”), has demonstrated no tumour recurrence or presence of disease at the 270 day clinical and cystoscopy assessment.

The Study’s purpose was to evaluate TLD-1433, Theralase’s lead PDC, for the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy, primarily at 90 days and secondarily at 180 days post treatment.

The Study was successfully completed with patient five and six demonstrating achievement of the primary, secondary and exploratory endpoints. Patient five and six have demonstrated no tumour recurrence or presence of disease at the 90, 180 and now 270 days post treatment clinical and cystoscopy assessment, marking a new achievement for the Company.

Patient five and six were enrolled and treated in the Study at the Therapeutic Dose (0.70 mg/cm2). Theralase’s Anti-Cancer Treatment involved the intravesical instillation of a water-based solution of Theralase’s lead anti-cancer PDC, TLD-1433, via a catheter inserted through the urethra into the bladder of the patient, to allow the PDC to be preferentially absorbed by NMIBC tumours. The bladder was then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. A fibre optic assembly, comprising a Laser Emitter used to emit laser light and a proprietary Dosimetry System used to detect laser light, were then used to activate TLD-1433 resident in the NMIBC tumours.

Arkady Mandel, M.D., Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer of Theralase^® stated, “This new data from patient six mirrors the 270 days Complete Response (“CR”) efficacy data observed in patient five at the same time interval. This evidence further bolsters our understanding that even a single treatment of Theralase’s Photo Dynamic Therapy (“PDT”) is able to lead to CR at 270 days post treatment for patients presenting with Bacillus Calmete Guérin (“BCG”)-Unresponsive NMIBC. This illustrates the enormous opportunity that awaits Theralase^® in the treatment of NMIBC. For NMIBC, a CR post treatment has recently been defined by the FDA as the definitive endpoint for a single-arm intravesical study for patients who present with BCG-Unresponsive Carcinoma In-Situ (“CIS”) disease, with or without resected papillary tumours. In the Health Canada approved Phase II NMIBC clinical study, the Company is providing two treatment procedures (therapeutic procedure at Day 0 and maintenance procedure at Day 180). The latest data on patient five and six is extremely encouraging, demonstrating that CR at 270 days post-treatment is achievable in the elimination of NMIBC after only one PDT treatment procedure. If the efficacy results are able to be demonstrated at 12 months post-treatment, in a larger patient population, conducted in a well-designed Phase II NMIBC clinical study, then the Theralase^® Anti-Cancer Technology has the potential to be the next gold standard in the treatment of NMIBC. The Theralase^® Anti-Cancer Technology is also multi-faceted, in that the technology is able to be adapted to the treatment of additional cancer indications, if successfully validated in independent clinical studies. Pending successful commencement of the Phase II NMIBC clinical study, the Company plans to investigate the commencement of an additional Phase Ib clinical study for a new cancer indication.”

The Phase II NMIBC Clinical Study, entitled, “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer or Patients Who are Intolerant to BCG Therapy” will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and will focus on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC patients in approximately 20 clinical sites located in Canada, the US and internationally, with a primary endpoint of efficacy and a secondary endpoint of safety.

The endpoints of the Phase II NMIBC Clinical Study will be:

Primary (Efficacy) – Evaluated by CR in patients with CIS with or without resected papillary disease at 90 days post-treatment with duration of CR evaluated at 360 days post-treatment.

Patient CR is defined as at least one of the following: