Theralase Technologies Inc Stock Price, News & Analysis

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).

Theralase Technologies Inc. (TLTFF) reported its 3Q2020 financial results, showing a slight revenue decline of 2% compared to the previous year, with total revenue of $514,891. The company faced challenges due to the COVID-19 pandemic, which impacted sales and operations. Gross margin remained stable at 27%, while operating expenses increased by 7%, leading to a net loss of $4,399,045, representing a 7% rise from the prior year. Notably, the FDA granted Fast Track Designation for Study II, enabling accelerated communication with regulators and potential approval pathways for its treatment of non-muscle invasive bladder cancer.

Theralase Technologies Inc. (TSXV:TLT, OTCQB:TLTFF) announced that the FDA has granted its TLD-1433 drug candidate Fast Track Designation for the Phase II study targeting BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). This designation will enhance communication with the FDA, potentially accelerating the approval process. The Phase II study aims to treat 100 patients across 20 sites in Canada and the US, focusing on safety and efficacy metrics. This recognition underscores Theralase's commitment to improving patient outcomes for this serious health condition.

Theralase Technologies Inc. (OTCQB: TLTFF) announced a significant breakthrough with its Photo Dynamic Compound (PDC) technology, showing a 99.995% kill rate against coronavirus (BSL-2) in a preclinical study. The PDC doses used were five times lower than those effective against Influenza H1N1 and Zika viruses, indicating safety for human use. This technology has potential implications for developing a COVID-19 vaccine targeting SARS-CoV-2. Currently, Theralase is progressing through its research phases with plans for in-vivo studies and potential human clinical trials in 2021.

Theralase Technologies Inc. (OTCQB: TLTFF) has published its Quarterly Newsletter, detailing updates on its Phase II Non-Muscle Invasive Bladder Cancer (NMIBC) Clinical Study. The newsletter outlines the company’s progress and can be accessed on their website. As a clinical-stage pharmaceutical firm, Theralase focuses on the research and development of light-activated Photo Dynamic Compounds (PDC) for treating cancer, bacteria, and viruses. The company is dedicated to advancing its drug formulations safely and effectively.

Theralase Technologies Inc. (TSXV:TLT, OTCQB:TLTFF) has announced a proposal to extend the expiry date of 3,157,059 share purchase warrants from October 3, 2020, to October 3, 2022. This extension pertains to warrants issued during a private placement on October 3, 2018, with an exercise price of $0.50 per share. All other terms of the warrants remain unchanged, pending final approval by the TSX Venture Exchange. Theralase focuses on developing light-activated Photo Dynamic Compounds for treating various cancers.

Theralase Technologies has announced new patient enrollment for their Phase II clinical study on non-muscle invasive bladder cancer (NMIBC) at the McGill University Health Centre. To date, 12 patients have been treated, with 25% achieving complete response and 25% showing partial response. The company is advancing discussions to open five additional clinical sites in the U.S. and has resubmitted their Fast Track Approval application to the FDA after an initial denial. The study aims to enroll approximately 100 patients and evaluate efficacy, safety, and duration of treatment responses.

Theralase Technologies Inc. (TSXV:TLT) (OTCQB:TLTFF) has provided details for registered shareholders and proxyholders to vote at its virtual Annual General and Special Meeting on September 24, 2020, at 4:30 PM EDT. Only those on record as of August 21, 2020, are eligible to vote. Attendees must connect online and dial in to participate. Each shareholder has one vote per common share. Theralase focuses on developing light-activated Photo Dynamic Compounds for treating cancers and infections.