Theralase Files Investigational New Drug Application with the FDA

Toronto, Ontario – October 01, 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 Photo Dynamic Compounds (“PDC”) and their associated drug formulations to safely and effectively destroy various cancers is pleased to announce today that the Company has filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) to initiate a Phase II, Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”) of Theralase’s anti-cancer Photo Dynamic Therapy (“PDT”) technology in patients using the Companies patented PDC, TLD-1433 combined with it’s proprietary TLC-3200 medical laser system. Study II, entitled, “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy in Bacillus Calmette-Guerin (“BCG”) unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Patients or Patients who are Intolerant to BCG Therapy” was successfully launched at the University Health Network (“UHN”) … Read More

Patient Six Cancer-Free Eighteen Months After Single Anti-Cancer Treatment

Toronto, Ontario – September 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 (“PDCs”) and their associated drug formulations intended to safely and effectively destroy various cancers is pleased to announce that patient six, 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. Patient six has demonstrated no tumour recurrence, progression or presence of NMIBC disease at the 90, 180, 270, 360 and now 540 days post treatment clinical cystoscopy assessment and urine cytology, marking a new milestone for the Company. Shawn Shirazi, Ph.D., Chief Executive Officer – Drug Division, Theralase stated “I’m excited to share the current cancer-free status of patient 6 which … Read More

Theralase Grants Stock Options

TORONTO, ON / September 13, 2019 / Theralase® Technologies Inc. (“Theralase” or the “Company”) (TSXV:TLT) (OTCQB:TLTFF), a clinical stage biopharmaceutical company developing Anti-Cancer treatments with their light activated Photo Dynamic Compounds (“PDC”) and associated drug formulations, today announces the grant of stock options. The Company has granted an aggregate of 12,340,000 stock options to directors, officers, employees & advisory board members pursuant to the Company’s stock option plan.  Of the options granted, 2,340,000 options are exercisable ata price of CDN$0.50 per share and 10,000,000 options are exercisable at a price of CDN$0.25 per share. All of the options vest over a three year period and expire five years from the date of the grant. The stock option plan was last approved by the shareholders of the Company at the Annual General and Special Meeting of Shareholders held on June 27, 2019. About Theralase® Technologies Inc. Theralase® is a clinical stage pharmaceutical company … Read More

Theralase Annouces First Patient Treated in Phase II Non-Muscle Invasive Bladder Cancer Clinical Study

TORONTO, ON / ACCESSWIRE / September 4, 2019 / Theralase® Technologies Inc. (“Theralase” or the “Company”) (TSXV:TLT) (OTCQB:TLTFF), a clinical stage biopharmaceutical company developing Anti-Cancer treatments with their light activated Photo Dynamic Compounds (“PDC”) and associated drug formulations, announced today that, the first patient has been treated in its Phase II clinical study titled “A Phase II Clinical Study of Intravesical Photodynamic Therapy (“PDT”) in Patients with Bacillus Calmette Guérin (“BCG”) Unresponsive Non-Muscle Invasive Bladder Cancer (“NMIBC”) or Patients who are Intolerant to BCG Therapy (“Study II”)” at University Health Network (“UHN”) in Toronto. This marks the official launch of Study II which focuses on the treatment of approximately 100 BCG-Unresponsive NMIBC patients presenting with Carcinoma In-Situ (“CIS”)in approximately 20 clinical study sites located in Canada and the US, with a primary endpoint of efficacy at any point in time, measured by Complete Response (“CR”), a secondary endpoint of duration … Read More

Theralase Releases Second Quarter 2019 Financial Results and Company Update

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