Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius”
or the “Company”), a neurotech company focused on neurological
wellness, today announced that it has submitted a request to the
U.S. Food and Drug Administration (“FDA”) for de novo
classification and clearance of the Portable Neuromodulation
Stimulator (PoNSTM) device and reported preliminary financial
results for the second quarter and six months ended June 30, 2020.
The PoNS device was granted Breakthrough Designation by FDA on May
7, 2020.
“Helius is excited to announce the submission of
our request for de novo classification and clearance of the PoNS
device for the treatment of gait deficit due to symptoms from
Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised
therapeutic exercise program in patients over 18 years of age,”
said Philippe Deschamps, Helius’ President, CEO and Chairman. “The
achievement of this important milestone reflects our strong pace of
progress since the first quarter of this year, when we made the
strategic decision to prioritize an MS indication as the regulatory
pathway to pursue our first U.S. breakthrough designation and
regulatory clearance. Most importantly, our submission brings us a
step closer to making our novel PoNS Treatment available for the 1
million U.S. patients estimated to be living with MS, a disease
with a significant unmet medical need, particularly in addressing
associated gait dysfunction. We look forward to the FDA’s review of
our submission, as we strive to provide patients with gait deficit
due to MS symptoms a non-drug, non-implantable treatment that has
the potential to significantly improve their ability to walk.”
Mr. Deschamps continued: “As anticipated, our
second quarter financial performance was impacted by the disruption
caused by the COVID-19 pandemic – with our clinics in Canada
affected by government mandates enacted to slow the spread of the
virus. However, we were pleased by the efforts and progress made by
our team, who worked diligently during the quarter to help mitigate
the impact of this pandemic on our business and continue pursuing
our commercial and regulatory priorities. We remain focused on
expanding access to our novel PoNS technology in Canada as
efficiently and effectively as possible for the benefit of our
patients and shareholders and look forward to discussing our recent
progress in more detail on our second quarter earnings call.”
Second Quarter 2020 Preliminary
Financial Results
Preliminary revenue for the second quarter of
2020 is expected to be approximately $0.1 million, compared to $0.5
million in the second quarter of 2019. The Company’s revenue was
generated almost exclusively through sales of the PoNS device
pursuant to supply agreements with neuroplasticity clinics in
Canada.
Gross profit for the second quarter of 2020 is
expected to be approximately $0.1 million. Operating expenses for
the second quarter of 2020 are expected to be approximately $3.7
million, compared to $6.1 million in the second quarter of 2019.
The year-over-year decrease in operating expenses was primarily
driven by an expected decrease of approximately $1.5 million, or
39%, in selling, general and administrative expenses. The decrease
in selling, general and administrative expenses was primarily due
to a reduction in commercial operations expense coupled with a
reduction in wages and salaries.
Operating loss for the second quarter of 2020 is
expected to be $3.7 million, compared to $5.8 million in the second
quarter of 2019.
Six Months Ended June 30, 2020
Preliminary Financial Results
Preliminary revenue for the six months ended
June 30, 2020 is expected to be approximately $0.3 million,
compared to $1.2 million in the prior year period. The Company’s
revenue was generated almost exclusively through sales of the PoNS
device pursuant to supply agreements with neuroplasticity clinics
in Canada.
Gross profit for the six months ended June 30,
2020 is expected to be approximately $0.2 million, compared to
gross profit of $0.7 million in the prior year period. Operating
expenses for the six months ended June 30, 2020 are expected to be
approximately $7.8 million, compared to $13.4 million in the six
months ended June 30, 2019.
Operating loss for the six months ended June 30,
2020 is expected to be $7.6 million, compared to operating loss of
$12.6 million in the prior year period.
The Company has not completed the preparation of
its financial statements for the quarter ended June 30, 2020 and
additional details with respect to the quarter ended June 30, 2020
results of operations are not yet available. The Company plans to
release quarter ended June 30, 2020 actual results after the
completion of its quarterly review.
Cash Position
As of June 30, 2020, the Company had cash of
$5.3 million, compared to $5.5 million at December 31, 2019.
The Company had no debt outstanding at June 30, 2020.
About Helius Medical Technologies,
Inc.
Helius Medical Technologies is a neurotech
company focused on neurological wellness. The Company’s purpose is
to develop, license and acquire unique and non-invasive platform
technologies that amplify the brain’s ability to heal itself. The
Company’s first commercial product is the Portable Neuromodulation
Stimulator (PoNS™). For more information, visit
www.heliusmedical.com.
About the PoNS™ Device and PoNS
Treatment™
The Portable Neuromodulation Stimulator (PoNS™)
is authorized for sale in Canada as a class II, non-implantable,
medical device intended as a short term treatment (14 weeks) of
gait deficit due to mild and moderate symptoms from multiple
sclerosis (MS), and chronic balance deficit due to mild-to-moderate
traumatic brain injury (mmTBI) and is to be used in conjunction
with physical therapy. The PoNS™ is an investigational medical
device in the United States, the European Union (“EU”), and
Australia (“AUS”). The device is currently under review for
clearance by the FDA. It is also under premarket review by the AUS
Therapeutic Goods Administration. PoNS™ is currently not
commercially available in the United States, the European Union or
Australia.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical
Technologies, Inc.Mike Piccinino,
CFA443-213-0500investorrelations@heliusmedical.com
Cautionary Disclaimer
Statement:
Certain statements in this news release are not
based on historical facts and constitute forward-looking statements
or forward-looking information within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995 and Canadian
securities laws. All statements other than statements of historical
fact included in this news release are forward-looking statements
that involve risks and uncertainties. Forward-looking statements
are often identified by terms such as “believe,” “continue,” “look
forward,” “will” and similar expressions. Such forward-looking
statements include, among others, statements regarding the
Company’s future clinical and regulatory development plans for the
PoNS device and the potential regulatory clearance of the PoNS
device, the success of the Company’s planned study, business and
commercialization initiatives and objectives, the potential receipt
of regulatory clearance of the PoNS device in the United States,
the European Union and Australia and the Company’s revenue
guidance.
There can be no assurance that such statements
will prove to be accurate and actual results and future events
could differ materially from those expressed or implied by such
statements. Important factors that could cause actual results to
differ materially from the Company’s expectations include the
uncertainties associated with clinical trial enrollments and the
results of clinical trials, uncertainties associated with the
clinical development process and FDA regulatory submission and
approval process, including the Company’s capital requirements to
achieve its business objectives and other risks detailed from time
to time in the filings made by the Company with securities
regulators, and including the risks and uncertainties about the
Company’s business described in the “Risk Factors” sections of the
Company’s Annual Report on Form 10-K for the year ended December
31, 2019, and Form 10-Q for the quarter ended March 31, 2020 filed
on May 11, 2020 and its other filings with the United States
Securities and Exchange Commission and the Canadian securities
regulators, which can be obtained from either at www.sec.gov or
www.sedar.com.
The reader is cautioned not to place undue
reliance on any forward-looking statement. The forward-looking
statements contained in this news release are made as of the date
of this news release and the Company assumes no obligation to
update any forward-looking statement or to update the reasons why
actual results could differ from such statements except to the
extent required by law.
The Toronto Stock Exchange has not reviewed and
does not accept responsibility for the adequacy or accuracy of the
content of this news release.
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