Toronto, Ontario – May 30, 2022, 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 has released the Company’s unaudited 1Q2022 condensed interim consolidated Financial Statements (“Financial Statements”).
For the three- month period ended March 31st:
|Audited Consolidated Statements of Operations In Canadian Dollars||2022||2021||% Change|
|Cost of Sales||120,430||74,463||62%|
|Gross Margin as a percentage of sales||43%||40%|
|Research and Development Expenses – CLT Division||72,832||54,616||33%|
|Research and Development Expenses – ACT Division||1,225,203||534,951||129%|
|Total Operating Expenses||1,792,721||969,413||85%|
Total revenue increased 70%, year over year, and is primarily attributed to the anticipated Canadian and US economic recovery from the COVID-19 pandemic in 2020 and 2021.
Cost of sales for the three-month period ended March 31, 2022 was $120,430 or 57% of revenue resulting in a gross margin of $91,232 or 43% of revenue. In comparison, the cost of sales in 2021 was $74,463 or 60% of revenue resulting in a gross margin of $50,320 or 40% of revenue. The gross margin increase, as a percentage of sales, year over year, is primarily attributed to a decrease in labour and material costs.
Selling expenses for the three-month period ended March 31, 2022, decreased to $87,640, from $95,780 in 2021, an 8% decrease The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (48%), and salaries (8%).
Administrative expenses for the three-month period ended March 31, 2022, decreased slightly to $418,087 from $418,454 in 2021, a 1% decrease. The decrease in administrative expenses is primarily attributed to decreased spending in administrative salaries (4%) and insurance expenses (8%). Stock based compensation expense decreased 61% in 2022 due to a reduction in stock options granted.
Net research and development expenses for the three-month period ended March 31, 2022, increased to $1,298,035 from $589,567 in 2021, a 120%. The increase in research and development expenses for the three-month period ended March 31, 2022, is primarily attributed to the costs related to Study II. Research and development expenses represented 72% 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, 2022 was $1,701,489 which included $99,600 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss in 2021 of $919,093 which included $179,925 of net non-cash expenses. The ACT division represented $1,436,985 of this loss (84%) for the three-month period ended March 31, 2022.
The increase in net loss is primarily attributed to Increased spending in research and development expenses in Study II.
- Break Through Designation Update. In 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation (“BTD”), Accelerated Approval (“AA”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.
In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites (“CSS”) availability to complete all required assessments.
- COVID-19 Pandemic Update. In the ACT division, the Company continues to experience delays in patient enrollment and treatment rates in Study II due to the ongoing COVID-19 pandemic; however, these rates have improved as Canada and the US commence their recovery from the business and economic impacts of the COVID-19 pandemic.
In the CLT division, the Company continues to experience variations in sales and the timing of these sales due to the ongoing COVID-19 pandemic and has taken actions to minimize expenses by eliminating non-essential personnel and imposing a temporary hiring freeze commencing in March 2020. The Company lifted the temporary hiring freeze in 4Q2021, now that the Canadian and United States (“US”) economies have started to demonstrate a sustainable business and economic recovery from COVID-19.
- Clinical study site status and update. The Company has successfully launched five CSS in Canada and seven CSSs in the US that are open for patient enrollment and treatment for a total of 12 CSSs.
To date, the phase II NMIBC clinical study has enrolled and provided the primary study treatment for 38 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 41 patients.
An analysis of Evaluable Patients (defined as patients who have been evaluated by the principal investigator and thus excludes data pending), Study II clinical data provides the following interim analysis:
|Assessment||90 Day||180 Day||270 Day||360 Day||450 Day|
|Complete Response (“CR”)||46%||50%||39%||22%||23%|
|Partial Response (“PR”)||22%||22%||8%||17%||9%|
|Total Response (“CR + PR”)||68%||72%||46%||39%||32%|
For all Evaluable Patients, who achieved a CR at 90 days, 88% demonstrate that CR at 180 days, 69% at 270 days, 50% at 360 days and 56% at 450 days, demonstrating a strong duration of complete response.
Note: The current interim data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with significant data still pending.
For a more comprehensive analysis of the interim data please refer to Managements Discussion and Analysis (“MD&A”) for the three-month period ended March 31, 2021.
- Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin®, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme (“GBM”) and Non-Small Cell Lung Cancer (“NSCLC”). The Company has commenced Non – Good Laboratory Practices (“GLP”) toxicology studies with Rutherrin® in animals to help determine the maximum recommended human dose of the drug, when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 4Q2022.
- COVID-19 Research Update. 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.
In February, 2022 Theralase® reported that PHAC had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.
These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase® COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, when exposed to the virus, which is expected to commence in 2Q2022 and be completed by 4Q2022.
Note: 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 of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ (“CIS”) patients in up to 15 Clinical Study Sites (“CSS”) located in Canada and the United States.
TLD-1433 is a patented PDC with over 10 years of published peer reviewed preclinical research and is currently under investigation in Study II.
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statements
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:
Kristina Hachey CPA, Chief Financial Officer