TORONTO, Nov. 29, 2023 (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 3Q2023 condensed interim consolidated Financial Statements (“Financial Statements”), which provides financial information on the previous fiscal quarter and the quarterly Newsletter (“Newsletter”) which provides an interim clinical data analysis 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 TransitionEffective October 25, 2023, Vera Madzarevic, Ph.D. assumed the role of Director of Clinical Development and Quality Assurance. Dr. Madzarevic holds a Ph.D. in both clinical pharmacology and biochemistry and brings over 25 years of global experience in clinical research and quality assurance from the biopharmaceutical and medical device industry to Theralase®.
Effective, November 15, 2023, Mr. John Trikola agreed to resign from his positions as the Chief Operating Officer (“COO”) and interim Chief Executive Officer (“CEO”) of the Company, as a result of certain facts that came to the Company’s attention concerning Mr. Trikola’s background that the Company’s vetting process failed to detect. The Company has taken steps to improve its vetting process for incoming officers and directors.
Effective November 15, 2023, Arkady Mandel, M.D., Ph.D., D.Sc., who is currently the Chief Scientific Officer (“CSO”) of the Company, assumed the role of interim CEO, replacing Mr. Trikola.
- 3Q21 Financial Statement HighlightsTotal revenue increased 7%, year over year and is primarily attributed to a recovery in the Canadian and United States (“US”) economies from the COVID-19 pandemic, as a majority of healthcare practitioners in 2020 elected to temporarily close their practices and place any purchasing decisions on temporary or permanent hold.
Net loss decreased 34%, year over year and is primarily 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 Anti-Cancer Therapy (“ACT”) division represented $2,325,340 of this loss (74%) for the nine-month period ended September 30, 2023.
Financial highlights for the 9 month period ended September 30, 2023:
| Unaudited Consolidated Statements of Operations | 2021 | 2020 | Change | |
| In Canadian Dollars | $ | $ | % | |
| Revenue | ||||
| Canada | 501,523 | 449,359 | +12 | % |
| United States | 52,100 | 52,074 | 0 | % |
| International | 13,189 | 26,041 | -49 | % |
| Total Revenue | 566,812 | 527,474 | +7 | % |
| Cost of Sales | 317,397 | 383,990 | -17 | % |
| Gross Margin | 249,415 | 143,484 | +74 | % |
| Gross Margin as a percentage of sales | 44% | 27% | ||
| Operating Expenses | ||||
| Selling Expenses | 271,708 | 333,863 | -19 | % |
| Administrative Expenses | 1,211,834 | 1,522,179 | -20 | % |
| Research and Development Expenses – CLT Division | 254,228 | 259,507 | -2 | % |
| Research and Development Expenses – ACT Division | 1,782,187 | 2,830,417 | -37 | % |
| Other(1) | (140,810) | (86,711) | 62 | % |
| Total Operating Expenses | 3,379,146 | 4,859,255 | -30 | % |
| Net Loss | (3,129,731) | (4,715,771 | -34 | % |
- 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.
- Study II Preliminary ResultsAs of November 29, 2023, Study II has enrolled and provided the primary study treatment for 30 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 33 patients, demonstrating the following interim results:
Note: Significant clinical data is still pending in Study II and drawing conclusions from this interim clinical data set and assumptions should be done with caution, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trend.
| Assessment Day* | 90 Days | 180 Days | 270 Days | 360 Days | 450 Days | ||||||||||
| # | % | # | % | # | % | # | % | # | % | ||||||
| Complete Response (“CR”) | 14 | 42 | % | 7 | 21 | % | 7 | 21 | % | 4 | 12 | % | 4 | 12 | % |
| Partial Response (“PR”) | 4 | 12 | % | 5 | 15 | % | 2 | 6 | % | 4 | 12 | % | 2 | 6 | % |
| Pending | 7 | 21 | % | 13 | 39 | % | 15 | 45 | % | 16 | 48 | % | 17 | 52 | % |
| No Response (“NR”) | 8 | 24 | % | 8 | 24 | % | 9 | 27 | % | 9 | 27 | % | 10 | 30 | % |
| Total Treated* | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % |
*Includes three (3) patients treated at the Therapeutic Dose form Phase Ib NMIBC Clinical Study (2-CR and 1- NR at 90, 180, 270, 360, 450 days)
An analysis of the Study II clinical data (with 3 patients from Study Ib) provides the following interim assessments:
1) 7/10 patients (70.0%), who achieved a CR at 90 days continue to demonstrate CR at 180 days
2) In the total population of 33 patients (@ 90 days):
i) 42.4% achieved Complete Response (“CR”)
ii) 12.1% achieved Partial Response (“PR”)
iii) 21.2% are Pending
iv) 24.2% achieved No Response (“NR”)
Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis.
Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date.
3) In the total population of 18 patients (@ 90 days), who received the optimized treatment:
i) 44.4% achieved CR
ii) 11.1% achieved PR
iii) 38.9% are Pending
iv) 5.6% achieved NR
Hence, the potential for CR is up to 94.4%***
Note***: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date for the interim clinical data analysis.
In summary, for patients who received the primary optimized Study II Treatment versus the original Study II Treatment (90 days), there is a 5% increase in CR and a 77% decrease in NR.
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
