Theralase Releases Q221 Unaudited Financial Statements and Quarterly Newsletter
August 30 2021 - 6:15PM
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 Q22021 condensed interim
consolidated financial statements and Quarterly Newsletter
(“
Newsletter”) which provides updates on the
previous quarter and progress 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 August 23,
2021, John Trikola assumed the role of Chief Operating Officer
(“COO”) and Interim CEO for the Company. John
brings over 25 years of technology experience working with
companies ranging from startups to Global 500. Most recently, John
was the president of Gardner Ross Corp., where he provided
turnaround and restructuring engagements to various organizations
in the technology, manufacturing, and retail sectors. In addition
to his senior management roles, John currently serves as a Board
Director for Waypoint Centre for Mental Health Care and has served
on the Board of Directors and as Chair of the Fundraising Committee
for The Sandbox Project, the Board of Directors and Governance
Committee for the Lougheed House Conservation Society.Effective
August 23, 2021, Arkady Mandel, M.D., Ph.D., D.Sc., Chief
Scientific Officer, Theralase® has assumed the lead for the Phase
II NonMuscle Invasive Bladder Cancer (“NMIBC”)
clinical study (“Study II”), in addition to all
current preclinical and future clinical research, development and
commercialization initiatives of the Company.
- Q221 Financial Statement HighlightsTotal
revenue increased 47%, year over year and is primarily attributed
to the COVID-19 pandemic as most health care practitioners in 2020
elected to temporarily close their practices and place any
purchasing decisions on temporary or permanent hold.Net loss
decreased 37%, year over year and is 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 ACT division represented $1,619,636 of this
loss (79%) for the six-month period ended June 30, 2021.
Financial highlights for the 6 month period
ended June 30, 2021:
Unaudited Consolidated Statements of
Operations |
2021 |
|
2020 |
|
Change |
In Canadian
Dollars |
$ |
|
$ |
|
% |
|
|
|
|
|
|
Revenue |
|
|
|
|
|
Canada |
384,154 |
|
255,146 |
|
51 |
% |
United
States |
32,656 |
|
12,267 |
|
166 |
% |
International |
13,189 |
|
26,041 |
|
-49 |
% |
Total Revenue |
429,999 |
|
293,453 |
|
47 |
% |
|
|
|
|
|
|
Cost of
Sales |
230,370 |
|
230,095 |
|
0.1 |
% |
Gross Margin |
199,629 |
|
63,358 |
|
215 |
% |
Gross
Margin as a percentage of sales |
46% |
|
22% |
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
Selling
Expenses |
197,400 |
|
229,998 |
|
-14 |
% |
Administrative Expenses |
802,271 |
|
965,824 |
|
-17 |
% |
Research
and Development Expenses – CLT Division |
88,141 |
|
209,154 |
|
-58 |
% |
Research
and Development Expenses – ACT Division |
1,305,437 |
|
2,009,903 |
|
-35 |
% |
Other(1) |
(131,344) |
|
(83,897) |
|
57 |
% |
Total Operating Expenses |
2,261,905 |
|
3,330,982 |
|
-32 |
% |
|
|
|
|
|
|
Net Loss |
(2,062,276) |
|
(3,267,624) |
|
-37 |
% |
|
|
|
|
|
|
- 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.
- Patients
TreatedStudy II has enrolled and provided the primary
study treatment for 24 patients (including three patients from the
Phase Ib study treated at the Therapeutic Dose) for a total of 27
patients.
- Study II Preliminary
ResultsAs of August 30, 2021, Study II has enrolled and
provided the primary study treatment for 24 patients (including
three patients from the Study treated at the Therapeutic Dose) for
a total of 27 patients, demonstrating the following interim
results, with significant clinical data still pending:
A chart accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/5d6e6542-bb71-4cff-9358-f1f96724f4ae
The current interim analysis of the clinical data (with
significant clinical data still pending and based on only 27
patients) demonstrates that Study II’s primary (33.3%) and tertiary
objectives (1 Severe AE) demonstrate a strong initial efficacy,
strong durable efficacy and a high safety profile. There is
insufficient data to comment on the Study II secondary
objective.
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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