THERALASE TECHS INC - TLTFF STOCK NEWS

Theralase Technologies Inc. (TLTFF) announces the departure of CEO Shawn Shirazi, effective August 20, 2021. John Trikola will step in as Interim CEO and COO on August 23, 2021. Trikola brings over 25 years of technology experience, previously serving as president of Gardner Ross Corp, focusing on turnaround projects. He aims to enhance the company’s strategy, particularly in the Cool Laser Therapy division, while maximizing long-term shareholder value. The company specializes in developing light-activated compounds for cancer treatment.

Theralase Technologies Inc. (OTCQB: TLTFF) has announced the opening of a new clinical study site at UChicago Medicine for its pivotal Phase II study targeting non-muscle invasive bladder cancer (NMIBC). The study will treat approximately 100-125 patients unresponsive to BCG therapy. UChicago Medicine received IRB approval and has begun patient enrollment. To date, 23 patients have been treated, including those from an earlier phase. The company aims to submit data for Breakthrough Designation to the FDA after treating the first 25 patients.

Theralase Technologies, a clinical stage pharmaceutical company, released its 2020 audited financials, showing a 4% decline in total revenue to $929,122 due to the pandemic's impact on healthcare purchases. Cost of sales fell by 27%, improving gross margin to 29%. Operating expenses decreased by 21%, resulting in a net loss of $5,598,540, down 24% from 2019. Significant highlights include FDA Fast Track designation for their NMIBC treatment and ongoing COVID-19 research efforts. The company is collaborating with PHAC on a COVID-19 vaccine project.

Theralase Technologies has released its Quarterly Newsletter detailing progress in its Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) Clinical Study. The report highlights the launch of 11 Clinical Study Sites across Canada and the US, with 21 patients treated to date. Preliminary results show a Complete Response (CR) rate of 33.3% at 90 days and 28.6% at 180 days, with a total response rate of 42.8% and 38.1% respectively. Importantly, patient safety assessments indicate adverse events unrelated to the study drug.

Theralase Technologies Inc. has announced a Collaborative Research Agreement (CRA) with the National Microbiology Laboratory of Canada for the development of a COVID-19 vaccine. The partnership aims to utilize Theralase's patented Photo Dynamic Compounds (PDCs) and proprietary light technology to inactivate the SARS-CoV-2 virus and create vaccine building blocks. The project, named 'Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine', is set to start in mid-April 2021. Theralase's collaboration with PHAC leverages their expertise in vaccine development and aims to advance research in anti-viral solutions.

Theralase Technologies Inc. (TLTFF) announced the launch of its Anti-Cancer Therapy (ACT) research centre at the Li Ka Shing Knowledge Institute, effective April 1, 2022. This move, which relocates the research team from the University Health Network, aims to accelerate the development and commercialization of its lead Photo Dynamic Compound, TLD-1433, and its formulation Rutherrin. The centre will enhance collaboration and access to expertise, facilitating advancements in Theralase's pivotal Phase II Non-Muscle Invasive Bladder Cancer clinical study.

Theralase Technologies Inc. has received Institutional Review Board approval for its Phase II Clinical Study targeting Non-Muscle Invasive Bladder Cancer (NMIBC) at Urology San Antonio. This site marks the sixth US clinical study site to obtain such approval. Currently, 16 patients are involved in the study, with a target of 25 patients for potential Breakthrough Designation. CEO Shawn Shirazi expressed enthusiasm over meeting clinical site targets and the prospect of expanding patient enrollment in early 2021. Additional sites are anticipated to launch in Q2 and Q3 of 2021.

Theralase Technologies Inc. (TSXV:TLT, OTCQB:TLTFF) announced that the University of Wisconsin Health-Madison received IRB approval for a pivotal Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) clinical study. This study targets patients with BCG-Unresponsive Carcinoma In-Situ. The approval marks the fifth clinical site in the US for this study, with another pending. Theralase aims to treat 25 patients in 2021 to seek Breakthrough Designation Approval, with 75-100 additional patients planned for 2021/2022.

Theralase Technologies has received ethics approval from University of British Columbia to initiate a Pivotal Phase II clinical study targeting Non-Muscle Invasive Bladder Cancer (NMIBC). This study will enroll approximately 100 patients who are BCG-Unresponsive or intolerant to BCG Therapy. Currently, 14 patients have been treated across 5 clinical sites in Canada. FDA Fast Track Designation may expedite drug-device development. The primary endpoint focuses on the efficacy defined by Complete Response (CR).