TORONTO, May 28, 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 PhotoDynamic Compounds (“PDC”) and their associated drug formulations intended to safely and effectively destroy various cancers released its unaudited Q12021 condensed interim consolidated financial statements.
Financial Highlights:
For the three-month periods ended March 31st:
Audited Consolidated Statements of Operations In Canadian Dollars |
2021 $ |
2020 $ |
% Change | ||
Revenue | |||||
Canada | 104,406 | 111,543 | 6% | ||
United States | 20,377 | – | |||
Total Revenue | 124,783 | 111,543 | 12% | ||
Cost of Sales | 74,463 | 99,447 | -25% | ||
Gross Margin | 50,320 | 12,096 | 316% | ||
Gross Margin as a percentage of sales | 60 | % | 89 | % | |
Operating Expenses | |||||
Selling Expenses | 95,780 | 136,894 | -30% | ||
Administrative Expenses | 418,454 | 533,329 | -22% | ||
Research and Development Expenses – CLT Division | 54,616 | 138,141 | -60% | ||
Research and Development Expenses – ACT Division | 534,951 | 909,141 | -41% | ||
Other(1) | -134,388 | -61,533 | 118% | ||
Total Operating Expenses | 969,413 | 1,655,952 | -41% | ||
Net Loss | -919,093 | -1,643,856 | -44% |
(1) Other represents (Gain) from legal settlement, (Gain) Loss on foreign exchange, interest accretion on lease liabilities and interest income
Total revenue remained predominantly flat, year over year, and is primarily attributed to the COVID-19 pandemic as most health care practitioners elected to temporarily close their practices and place any purchasing decisions on temporary or permanent hold.
Cost of sales for the three-month period ended March 31, 2021 was $74,463 or 60% of revenue resulting in a gross margin of $50,320 or 40% of revenue. In comparison cost of sales for the same period in 2020 was $99,447 or 60% of revenue resulting in a gross margin of $12,096 or 11% of revenue Cost of sales is represented by the following costs: raw materials, subcontracting, direct and indirect labour and the applicable share of manufacturing overhead. The gross margin increase, as a percentage of sales, year over year, is attributed to a decrease in labour and material costs.
The decrease in selling expenses is primarily due to the restructuring of the Canadian and US sales and marketing departments, as a result of the COVID-19 pandemic, resulting in the resignation or termination of certain non-essential sales and marketing personnel and reduced advertising and travel expenditures.
The decrease in administrative expenses is primarily attributed to decreased spending on director and advisory fees (50%) and administrative salaries (35%) due to the COVID-19 pandemic, resulting in the termination of certain non-essential administrative personnel. Stock based compensation expense decreased 54% in the three-month period ended March 31, 2021 due to a reduction in stock options granted.
The decrease in research and development expenses for the three-month period ended March 31, 2021 is attributed primarily to the delay in patient enrollment and treatment in Phase II NMIBC clinical study (“Study II”) due to the COVID-19 pandemic. Research and development expenses represented 61% of the Company’s operating expenses and represents investment into the research and development of the Company’s ACT technology.
The net loss for the three-month period ended March 31, 2021 was $919,093 which included $179,926 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss in 2020 of $1,643,856 which included $327,921 of net non-cash expenses. The ACT division represented $706,435 of this loss (77%) for the three-month period ended March 31, 2021.
The decrease in net loss is primarily attributed to the following:
Operational Highlights:
In April 2021, Theralase® executed a Collaborative Research Agreement (“CRA”) with the National Microbiology Laboratory, Public Health Agency of Canada (“PHAC”) for the research and development of a Canadian-based SARS-CoV-2 (“COVID-19”) vaccine. Under the terms of the agreement, Theralase® and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase®’s patented PDC and then light activating it with Theralase®’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, “Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine” and commenced in mid-April 2021.
* The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 Coronavirus.
About Study II
Study II utilizes the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and is focused on the enrollment and treatment of approximately 100 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the US.
Study II has a:
The FDA, in its 2018 guidance to industry has stated that, “For single-arm trials of patients with BCG-unresponsive disease, the FDA defines a CR as at least one of the following:
Intravesical instillation does not deliver the investigational drug to the upper tract or prostatic urethra; therefore, the development of disease in these areas cannot be attributed to a lack of activity of the investigational drug. Thus, sponsors can consider patients with new malignant lesions of the upper tract or prostatic urethra, who have received intravesical therapy to have achieved a CR in the primary analysis; however, sponsors should record these lesions and conduct sensitivity analyses in which these patients are not considered to have achieved a CR.“1
About Theralase® Technologies Inc.
Theralase® is 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, 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
khachey@theralase.com
www.theralase.com
Gloria Gates CARE, a new standard of healthcare for Medicaid and Medicare beneficiaries or those…
Linda Howard, Daniel Klein, and John Rushing Join The Assistance Fund's Board of DirectorsORLANDO, FL…
Rob Lowe to EmceeCenter City, Minnesota--(Newsfile Corp. - July 1, 2024) - On Friday, September…
Company offers competitive benefits and safety-focused cultureVACAVILLE, Calif., July 1, 2024 /PRNewswire/ -- Highline Warren…
New Campaign from The National Association for Healthcare Quality Raises Awareness of the Power of…
New telepathology interface will save critical hours and bolster patient safety by replacing current time-consuming…