Theralase Completes GMP Manufacture of Lead Drug

Toronto, Ontario – September 8, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has completed manufacture of its lead Photo Dynamic Compound (“PDC”), TLD-1433 in compliance with Good Manufacturing Practice (“GMP”) standards. This milestone is critical for a Clinical Trial Application (“CTA”) submission to Health Canada.

Pending Health Canada approval of the CTA, Theralase would commence enrolling patients inflicted with Non-Muscle Invasive Bladder Cancer (“NMIBC”) into a Phase Ib clinical trial aimed at proving the primary objective of safety and tolerability with an exploratory objective of efficacy.

Completion of the GMP manufacturing of TLD-1433 is a major milestone for the Company and is a prerequisite for a CTA application. Supporting data includes a Chemistry, Manufacturing, and Control (“CMC”) analysis detailing pertinent specifications of the drug.

Key components required to submit a CTA to Health Canada for a new drug / device combination include:

1. GMP manufacture including CMC information for the drug;
2. Good Laboratory Practice (“GLP”) Toxicology Analysis of the drug;
3. Completion of the Clinical Protocol and Investigator’s Brochure;
4. Completion of detailed information regarding the device used in conjunction with the drug.

Roger Dumoulin-White, President and CEO, Theralase stated that, “Theralase is executing on its strategic initiative to advance our anti-cancer technology to commence destroying NMIBC this year. Theralase has now completed the first major milestone of the CTA application and is well on its way to completing all the remaining steps of the CTA application in 3Q2015 in order to allow commencement of a Phase Ib clinical study in late 4Q2015.”