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 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”).
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, 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 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, 2021.
Financial highlights for the 9 month period
ended September 30, 2021:
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, 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.
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
Officerkhachey@theralase.comwww.theralase.com
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