TORONTO, November 29, 2021 (GLOBE NEWSWIRE) – Theralase® Technologies inc. (“Theralase®“or the”Society”) (TSX Venture Exchange: 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 issued the Company’s unaudited 3Q2021 interim condensed consolidated financial statements (“financial state“), which provides financial information on the previous fiscal quarter and the Quarterly Newsletter (“Bulletin“) which provides an analysis of interim clinical data in non-invasive phase II bladder cancer (“NMIBC“) clinical study (“Study II“).

The financial statements can be viewed on the company’s website at www.theralase.com/financial-filings/

The newsletter can be viewed on the company’s website at www.theralase.com/quarterly-newsletters/

Highlights of 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 doctorate. in clinical pharmacology and biochemistry and brings over 25 years of global clinical research and quality assurance experience in the biopharmaceutical and medical device industry to Theralase®.

    Effective November 15, 2021, Mr. John Trikola has agreed to resign as Chief Operating Officer (“COO“) and Interim Chief Executive Officer (“CEO”) Of the Company, due to certain facts brought to the Company’s attention regarding Mr. Trikola’s background which the Company’s verification process failed to detect. The Company has taken steps to improve its process for selecting new officers and directors.

    As of November 15, 2021, Arkady Mandel, MD, Ph.D., D.Sc., who is currently the Scientific Director (“CSO”) Of the Company, has assumed the role of Interim CEO, replacing Mr. Trikola.

  • Highlights of 3Q21 Financial Statements

    Total revenue increased 7% year-over-year and was primarily driven by a recovery in Canada and the United States (“we”) Savings from the COVID-19 pandemic, as the majority of healthcare professionals in 2020 have chosen to temporarily close their practices and temporarily or permanently suspend any purchasing decision.

    The net loss decreased 34% year over year and is mainly due to the following:

1) Significant delay in the recruitment and treatment of patients due to the COVID-19 pandemic, leading to a decrease in research and development spending in Study II.
2) Fall in wages due to the COVID-19 pandemic, leading to the resignation or dismissal of some non-essential administrative, research and production staff.

Cancer therapy (“ACT”) Represents $ 2,325,340 of this loss (74%) for the nine-month period ended September 30, 2021.

Financial Highlights for the 9-month period ended September 30, 2021:

Unaudited Consolidated Statements of Income

2021

2020

Switch

In canadian dollars

$

$

%

Returned

Canada

501,523

449,359

+12

%

United States

52,100

52,074

0

%

International

13 189

26,041

-49

%

Total income

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 fees

271,708

333,863

-19

%

Administrative expenses

1,211,834

1,522,179

-20

%

Research and Development Costs – CLT Division

254,228

259,507

-2

%

Research and development costs – 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 were launched in Canada (5) and the United States (7) for the recruitment and treatment of patients for Study II.

  • Study II Preliminary results

    As of November 29, 2021, Study II enrolled and provided the primary study treatment for 30 patients (including three study patients treated at the therapeutic dose) for a total of 33 patients, demonstrating the following intermediate results:

    Note: Important clinical data are still pending in Study II and drawing conclusions from this provisional clinical data set and assumptions should be done with caution.because Study II is still ongoing and new clinical data collected may or may not continue to support the current trend.

Valuation day *

90 days

180 days

270 days

360 days

450 days

#

%

#

%

#

%

#

%

#

%

Complete answer (“RC”)

14

42

%

7

21

%

7

21

%

4

12

%

4

12

%

Partial response (“RP”)

4

12

%

5

15

%

2

6

%

4

12

%

2

6

%

Waiting

7

21

%

13

39

%

15

45

%

16

48

%

17

52

%

No answer (“NR”)

8

24

%

8

24

%

9

27

%

9

27

%

ten

30

%

Total processed *

33

100

%

33

100

%

33

100

%

33

100

%

33

100

%

* Includes three (3) patients treated in the Phase Ib NMIBC clinical study of the therapeutic dosage form (2-CR and 1-NR at 90, 180, 270, 360, 450 days)

An analysis of clinical data from Study II (with 3 patients from Study Ib) provides the following interim evaluations:

1) 7/10 patients (70.0%), who achieved CR at 90 days continue to have CR at 180 days

2) In the total population of 33 patients (@ 90 days):

i) 42.4% obtained a complete answer (“RC”)
ii) 12.1% obtained a partial response (“RP”)
iii) 21.2% are pending
iv) 24.2% received no response (“NR”)

Therefore, the potential for OR can reach 75.8% ** for interim analysis of clinical data.

To note**: Assumes PR and pending data is 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% reached PR
iii) 38.9% are pending
iv) 5.6% achieved NR

Therefore, the potential for CR is up to 94.4% ***

To note***: Assumes PR and pending data is clinically determined as CR at a later assessment date for analysis of provisional clinical data.

In summary, for patients who received the optimized primary treatment in Study II compared to the initial treatment in Study II (90 days), there was a 5% increase in OR and a 77% decrease in CR. the 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.

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

This press release contains “forward-looking statements“which reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities. These statements include, but are not limited to, statements regarding proposed development plans by the Company regarding photodynamic compounds and their drug formulations. Where possible, words such as “may“,”would have“,”could“,”should“,”will“,”to anticipate“,”to believe“,”plan“,”wait“,”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 risks, significant uncertainties and assumptions, including with respect to the Company’s ability to: adequately fund, obtain regulatory approvals required to initiate and successfully complete a Phase II NMIBC clinical study in a timely manner and implement its development plans Many factors could cause the actual results, performance or achievements of the Company to differ materially 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 documents filed és by the Company with the Canadian securities regulators (which can be consulted at www.sedar.com). If one or more of these risks o If uncertainties materialize or if the assumptions underlying the forward-looking statements prove to be incorrect, actual results, performance or achievements may differ materially from those expressed or implied by the forward-looking statements contained in this press release. These factors should be carefully considered and potential investors should not place undue reliance on forward-looking statements. Although the forward-looking statements contained in the press release are based on what management currently considers to be reasonable assumptions, the Company cannot assure potential 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 the 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.

For more information:
1.866.LE.LASE (843-5273)
416.699.LASE (5273)
www.theralase.com

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


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