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Theralase Releases Q221 Unaudited Financial Statements and - GlobeNewswire

TORONTO, Aug. 30, 2021 (GLOBE NEWSWIRE) -- 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 compounds and their associated drug formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses has released the Company’s unaudited Q22021 condensed interim consolidated financial statements and Quarterly Newsletter (“Newsletter”) which provides updates on the previous quarter and progress on the Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC“) Clinical Study (“Study II”).

The Financial Statements can be found on the Company’s Website at www.theralase.com/financial-filings/

The Newsletter can be found on the Company’s website at www.theralase.com/quarterly-newsletters/

Highlights from the Newsletter:

  • Leadership Transition Effective August 23, 2021, John Trikola assumed the role of Chief Operating Officer (“COO”) and Interim CEO for the Company. John brings over 25 years of technology experience working with companies ranging from startups to Global 500. Most recently, John was the president of Gardner Ross Corp., where he provided turnaround and restructuring engagements to various organizations in the technology, manufacturing, and retail sectors.

    In addition to his senior management roles, John currently serves as a Board Director for Waypoint Centre for Mental Health Care and has served on the Board of Directors and as Chair of the Fundraising Committee for The Sandbox Project, the Board of Directors and Governance Committee for the Lougheed House Conservation Society. Effective August 23, 2021, Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase® has assumed the lead for the Phase II NonMuscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study II”), in addition to all current preclinical and future clinical research, development and commercialization initiatives of the Company.

  • Q221 Financial Statement Highlights

    Total revenue increased 47%, year over year and is primarily attributed to the COVID-19 pandemic as most health care practitioners in 2020 elected to temporarily close their practices and place any purchasing decisions on temporary or permanent hold.

    Net loss decreased 37%, year over year and is attributed to the following:

    1) Significant delay in patient enrollment and treatment due to the COVID-19 pandemic, resulting in decreased research and development expenses in Study II.

    2) Decreased salaries due to the COVID-19 pandemic, resulting in the resignation or termination of certain non-essential administrative, research and production personnel.

The ACT division represented $1,619,636 of this loss (79%) for the six-month period ended June 30, 2021.

Financial highlights for the 6 month period ended June 30, 2021:

Unaudited Consolidated Statements of Operations 2021   2020   Change In Canadian Dollars $   $   %             Revenue           Canada 384,154   255,146   51 % United States 32,656   12,267   166 % International 13,189   26,041   -49 % Total Revenue 429,999   293,453   47 %             Cost of Sales 230,370   230,095   0.1 % Gross Margin 199,629   63,358   215 % Gross Margin as a percentage of sales 46 %   22 %                 Operating Expenses           Selling Expenses 197,400   229,998   -14 % Administrative Expenses 802,271   965,824   -17 % Research and Development Expenses – CLT Division 88,141   209,154   -58 % Research and Development Expenses – ACT Division 1,305,437   2,009,903   -35 % Other(1) (131,344 )   (83,897)   57 % Total Operating Expenses 2,261,905   3,330,982   -32 %             Net Loss (2,062,276 )   (3,267,624)   -37 %            
  • Clinical Study Sites (“CSS”) 12 CSS’s have been launched in Canada (5) and the US (7) for patient enrollment and treatment for Study II.
  • Patients Treated Study II has enrolled and provided the primary study treatment for 24 patients (including three patients from the Phase Ib study treated at the Therapeutic Dose) for a total of 27 patients.   
  • Study II Preliminary Results As of August 30, 2021, Study II has enrolled and provided the primary study treatment for 24 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 27 patients, demonstrating the following interim results, with significant clinical data still pending:

A chart accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5d6e6542-bb71-4cff-9358-f1f96724f4ae

The current interim analysis of the clinical data (with significant clinical data still pending and based on only 27 patients) demonstrates that Study II’s primary (33.3%) and tertiary objectives (1 Severe AE) demonstrate a strong initial efficacy, strong durable efficacy and a high safety profile. There is insufficient data to comment on the Study II secondary objective.

About Theralase® Technologies Inc. Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds and their associated drug formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.

Additional information is available at  www.theralase.com  and  www.sedar.com

This news release contains " forward-looking statements " which reflect the current expectations of Company’s management for future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Wherever possible, words such as " may ", " would ", " could ", “ should ”, " will ", " anticipate ", " believe ", " plan ", " expect ", " intend ", " estimate ", " potential for " and similar expressions have been used to identify these forward-looking statements. These statements reflect management's current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to: adequately fund, secure the requisite regulatory approvals to commence and successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its development plans. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.

For More Information: 1.866.THE.LASE (843-5273) 416.699.LASE (5273) www.theralase.com 

Kristina Hachey CPA, Chief Financial Officer [email protected] www.theralase.com

Study II Clinical Data (Preliminary)* Study II Clinical Data (Preliminary)* Study II Clinical Data (Preliminary)*