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
Theralase Brain Cancer Pre-Clinical Research Accepted for Publication
Research Detailing Advantages of Rutherrin® PhotoDynamic Therapy in deadly brain cancer, GlioBlastoma Multiforme (“GBM”) to be Published in the Journal of Neuro-Oncology Advances Toronto, Ontario – June 25, 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 is pleased to announce that a scientific paper pertaining to the Company’s Rutherrin® based Photo Dynamic Therapy (“PDT”) has been peer reviewed and selected for publication in Neuro-Oncology Advances (“NOA”). Publication in NOA of Theralase’s latest pre-clinical research of Rutherrin® PDT treatment targeting GlioBlastoma Multiforme (“GBM”), assisted through a collaboration with researchers at University Health Network’s (“UHN”) Princess Margaret Cancer Centre, allows many specialists in the field of neuro-oncology the opportunity to learn about Theralase’s advances in this field. As an … Read More
Theralase® Releases 2018 Year End Audited Financial Statements
Toronto, Ontario – April 17, 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 (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers released the audited financial statements for the year ended December 31, 2018. Total revenue for the year ended December 31, 2018 decreased to 1,734,072 from 2,342,508 in 2017, a 26% decrease. In Canada, revenue decreased 38% to $1,205,312 from $1,942,010. In the US, revenue increased 16% to $304,785 from $261,833 and international revenue increased 62% to $223,975 from $138,665. The decrease in total revenue in 2018 is primarily due to the restructuring of the sales and marketing departments resulting in the termination of certain sales and marketing personnel and decreased spending in advertising. Cost of sales for the year ended December 31, … Read More
Theralase Releases Amended and Restated 1Q2019 Financial Statements
Toronto, Ontario – June 18, 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 filed its amended and restated condensed interim consolidated financial statements and Management Discussion and Analysis (“MD&A”) as at and for the three-months ended March 31, 2019. Management of the Company has determined that the property lease for the Company’s premises and office equipment was not properly recorded under International Financial Reporting Standards (“IFRS”) 16 Leases, which came into effect on January 1, 2019 and provides guidance on how to recognize, measure, present and disclose leases. As a result, the Company amended and restated the condensed interim consolidated financial statements and MD&A for 1Q2019. The impact of the correction is as follows: Decrease in … Read More
Theralase Releases 1Q2019 Financial Statements
Toronto, Ontario – May 30, 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 (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers released its 1Q2019 financial statements. Total revenue for the three-month period ended March 31, 2019, decreased to $121,179 from $441,193 for the same period in 2018, a 73% decrease. In Canada, revenue decreased 61% to $116,104 from $297,061. In the US, revenue decreased 94% to $5,075 from $90,354 and international revenue decreased 100% from $53,778 to $Nil during the three-month period ended March 31, 2019. The decrease in total revenue in 2019 is primarily due to the restructuring of the sales and marketing departments resulting in the termination of certain sales and marketing personnel in 2018 and the hiring of new marketing … Read More
Theralase Granted Notice of Acceptance for PhotoDynamic Compounds by Chinese Patent Office
Toronto, Ontario – May 20, 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 (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers is pleased to announce that the Company has been granted a Notice of Acceptance by the Chinese patent office for PDCs. The patent entitled, “Metal-Based Thiophene Photodynamic Compounds and Their Use” advances Theralase’s intellectual property portfolio internationally and permits the Company to expand Theralase’s advanced PhotoDynamic Therapy (“PDT”) technology in the Chinese market, subject to Chinese regulatory approvals. The patent encompasses an extensive library of PDCs, including Theralase’s lead PDC, TLD-1433, recently Health Canada Clinical Trial Authorization (“CTA”) and Investigational Testing Authorization (“ITA”) approved to be evaluated in a pivotal Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study. China is the most … Read More
Theralase’s 5th Annual Medical and Scientific Advisory Board Meeting Advances Phase II Non-Muscle Invasive Bladder Cancer Clinical Study
Toronto, Ontario – May 13, 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 (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers announced that Theralase recently met with its Medical and Scientific Advisory Board (“MSAB”), as well as potential Principal Investigators (“PIs”), who are interested in participating in the Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“ACT-NMIBC”). The meeting focused primarily on the presentation of the clinical endpoints achieved in the successfully completed Phase Ib NMIBC clinical study, as well as a discussion on the design and FDA regulatory requirements pertaining to the ACT-NMIBC. The FDA provided guidance to the industry in February 2018, entitled, “BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry”. In the guidance, the … Read More