Theralase Releases 3Q21 Financial Statements and Newsletter

On November 29, 2021 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 reported the Company’s unaudited 3Q2021 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") (Press release, Theralase, NOV 29, 2021, View Source [SID1234597697]).

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The Financial Statements can be found on the Company’s Website at

The Newsletter can be found on the Company’s website at

Highlights from the Newsletter:

Leadership Transition

Effective October 25, 2021, 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, 2021, 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, 2021, 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 Highlights

Total 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, 2021.

12 CSS’s have been launched in Canada (5) and the US (7) for patient enrollment and treatment for Study II.
Study II Preliminary Results

As of November 29, 2021, 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.
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.