TORONTO, ON/ August 29, 2019/ Theralase® Technologies Inc. (“Theralase” or “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, today released financial results and the Management Discussion and Analysis (“MD&A“) at and for the six-months period ended June 30, 2019. Financial Highlights: Condensed Consolidated Statements of Operations (Unaudited) Three-Month Ended June 30 Six-Month Ended June 30 In Canadian Dollars 2019 2018 2019 2018 Total Revenues $249,257 $469,497 $370,436 $910,690 Cost of sales $183,393 $189,464 $267,644 $432,321 Gross margin $65,864 $280,033 $102,792 $478,369 As percentage of revenue 26% 60% 28% 47% Net loss ($1,486,797) ($885,283) ($2,612,268) ($1,889,351) Loss per share ($0.01) ($0.01) ($0.02) ($0.01) Total revenue for the six-month period ended June 30, 2019 decreased to $370,437 from $910,690 for the same period in … Read More
THERALASE ANNOUNCES CLOSING OF PROSPECTUS OFFERING FOR GROSS PROCEEDS OF $17,250,000
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES Toronto, Ontario – August 22, 2019, Theralase® Technologies Inc. (“Theralase” or “Company”) (TSXV: TLT) (OTCQB: TLTFF), is pleased to announce the closing of its marketed short form prospectus offering pursuant to which the Company issued 57,500,000 units of the Company (including the exercise in full of the over-allotment option) (the “Units”) at a price of $0.30 per Unit (the “Issue Price”) for gross proceeds of $17,250,000 (the “Offering”). Each Unit consisted of one common share of the Company (the “Common Shares”) and one common share purchase warrant of the Company (the “Warrants”). Each Warrant shall be exercisable to acquire one Common Share at a price of $0.35 until August 22, 2024. The Offering was led by Mackie Research Capital Corporation as the lead agent and sole bookrunner (the “Lead Agent”), on behalf of a syndicate, … Read More
Patient Five Cancer-Free Eighteen Months After Single Anti-Cancer Treatment
Toronto, Ontario – July 31, 2019, 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 five, enrolled and treated in the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”), has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 540 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 … Read More
McGill University Health Centre Newest Clinical Study Site for Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario –July 30, 2019, Theralase® Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTCQB), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers, is pleased to announce that McGill University Health Centre (“MUHC”) Research Ethics Board (“REB”) has approved the commencement of a Phase II Clinical Study to enroll and treat Patients with Non-Muscle Invasive Bladder Cancer (“NMIBC”), who present with Carcinoma In-Situ (“CIS”) and who are considered BCG-Unresponsive or are intolerant to BCG Therapy (“Study II”), subject to a Site Initiation Visit (“SIV”) and Site Qualification Visit (“SQV’), scheduled for early September. MUHC is one of the leading academic health centres in the world and attracts clinical and research expertise from around the world, assessing the latest in medical technology and training the next generation of medical … Read More
Theralase Signs Agreement with Urology Organization to Provide US Clinical Study Sites for its Phase II Non Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario – July 24, 2019, 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 PhotoDynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers, is pleased to announce that the Company has signed an agreement with a Trial Management Organization (“TMO”) to provide 4 to 6 US based urology study sites that will be able to commence enrolling and treating patients, subject to Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) approval for its Phase II Non Muscle Invasive Bladder Cancer (“NMIBC”) Clinical Study (“Study II”). The TMO is in discussions with approximately 14 potential US based clinical study sites that are large integrated clinical urology practices. The TMO’s mandate is to expeditiously complete clinical studies in uro-oncology. Each of these individual clinical study sites has a … Read More
Theralase Receives Notice of Acceptance for Multiwavelength Photo Dynamic Therapy from Russian Patent Office
Toronto, Ontario – July 16, 2019, Theralase® Technologies Inc. (“Theralase” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated PhotoDynamic Compounds (“PDC”) and their associated drug formulations to safely and effectively destroy various cancers is pleased to announce that the Russian Patent Office has issued a Notice of Acceptance for a Multiwavelength Photo Dynamic Therapy (“PDT”) patent application. The patent application entitled, “Apparatus and Method for Multiwavelength Photo Dynamic Therapy” will issue into a patent later this year and provides additional international patent protection for the Company in the application of Theralase’s PDT technology for cancer. Russia represents an immense market opportunity for the Company as the country relies heavily on imported medical devices and is one of the largest markets for medical devices1. Russia has established a National Health Project to provide enhanced methods for early disease … Read More
Theralase Releases 2019 Annual General Meeting Video Presentations
Toronto, Ontario – June 28, 2019, Theralase® Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTCQB), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers, is pleased to release the video presentations of this year’s Annual General Meeting (“AGM”). The AGM was held at Theralase’s corporate office in Toronto, Ontario on June 27, 2019 and is available at https://youtu.be/Y_gWz2XvhuU The pre-recorded videos feature Dr. Girish Kulkarni, Assistant Professor with the Department of Surgery, Faculty of Medicine at the University of Toronto, Uro-Oncologist and Principal Investigator (“PI”), University Health Network (“UHN”) discussing the successful completion of the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“ACT-NMIBC”) and Dr. Michael Jewett, Professor of Surgery (Urology) at the University of Toronto and Uro-oncologist at Princess Margaret Cancer Centre, UHN discussing the ACT-NMIBC … Read More
Regulatory Updates from Health Canada and US FDA
Toronto, Ontario – June 27, 2019, Theralase® Technologies Inc. (“Theralase” or “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers, announced today that the Company has completed a successful Pre-Investigational New Drug (“IND”) meeting with the US Food and Drug Administration (“FDA”). In addition, Health Canada approved the amended Investigational Testing Application (“ITA”) for its Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Phase II Study”). Pre-IND Meeting The Company completed a Pre-IND meeting with the FDA and it was confirmed that the Company’s design of the Phase II ACT-NMIBC clinical study met FDA Guidance for Industry dated February 2018 on “BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment”. The guideline states that “In BCG-unresponsive NMIBC, a single-arm clinical trial with … Read More
Theralase Files Prospectus for Offering of Units
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES Toronto, Ontario – June 26, 2019, Theralase® Technologies Inc. (“Theralase” or “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers, announced today that it has filed and been receipted for a preliminary short form prospectus in connection with a marketed offering of units of the Company (the “Units”) for minimum gross proceeds of $7,500,000 and maximum gross proceeds of $15,000,000 (the “Offering”). Each Unit will be comprised of one common share of the Company (the “Common Shares”) and one common share purchase warrant (the “Warrants”). Each Warrant is expected to exercisable to acquire one Common Share at a price to be determined in the context of the market, for a period of 60 … Read More
Health Canada Approves Amended Clinical Trial Application
Toronto, Ontario – June 26, 2019, Theralase® Technologies Inc. (“Theralase” or “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers, announced today that Health Canada has issued a No Objection Letter (“NOL”) for an amended Clinical Trial Application (“CTA”) for its Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Phase II Study”). The amended CTA was submitted to Health Canada to update the current CTA, for an optimized design of the TLC-3200 medical laser system (“Study Device”) and is subject to Investigational Testing Authorization (“ITA”) by Health Canada and Review Ethics Board (“REB”) approval by each Study II site before being used in the Phase II Study. The amended CTA will not impede the Phase II Study as patients will continue to … Read More