HOUSTON, Aug. 11, 2020 /PRNewswire/ -- Soliton, Inc.,
(Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device
company with a novel and proprietary platform technology, today
reported financial results for the second quarter ended
June 30, 2020.
Recent Company Highlights:
- Filed and received U.S. Food and Drug Administration ("FDA")
acceptance for Rapid Acoustic Pulse ("RAP") device 510(k) Premarket
Application for cellulite reduction.
- Named Jennifer Cook as Vice
President of Marketing to lead implementation of strategic
commercialization sales and marketing initiatives.
Second Quarter Company Milestones:
- Implemented a revised launch plan for next generation RAP
device due to COVID-19 pandemic.
- Announced positive pivotal cellulite clinical trial results
demonstrating a 32.5% average reduction in Cellulite Severity Score
("CSS") from a single treatment.
- Expanded broad patent portfolio of RAP novel and proprietary
technology.
- Secured gross proceeds of $35.0
million in a follow-on offering that is expected to extend
the Company's cash runway into the fourth quarter of 2022 and
initial revenue generation.
Dr. Chris Capelli, Soliton's
President, CEO and co-founder, commented, "During the second
quarter of 2020, Soliton pivoted to a COVID-19 adjusted
commercialization strategy. Our team continued execution on a
number of achievements, including FDA acceptance of the 510(k)
premarket notification for the Generation II RAP device for
cellulite reduction. We also completed a follow-on capital offering
that bolstered our balance sheet ahead of escalating
commercialization efforts. While we continue to monitor the
recovery of the aesthetic and financial markets, we remain focused
on driving milestone momentum into the second half of the year and
ahead of our targeted first half 2021 commercialization of the RAP
device for both tattoo removal and cellulite reduction, if the
latter is cleared by the FDA."
Second Quarter 2020 Financial Results:
Operating expenses for the second quarter ended June 30, 2020 were $3.1
million, as compared to $3.0
million in the second quarter 2019. The increase was
primarily attributable to higher research and development expenses
resulting from increases in spending with development partners and
costs related to clinical trials.
Net loss for the second quarter ended June 30, 2020 was $3.1
million, or $0.19 basic and
diluted net loss per share, compared with net loss of $3.0 million, or $0.20 basic and diluted net loss per share, for
the second quarter 2019.
Total cash, cash equivalents and restricted cash was
$37.5 million as of June 30, 2020, compared to $7.7 million as of March
31, 2020, including total gross proceeds of $35.0 million from Soliton's June 2020 follow-on offering. The Company's cash,
cash equivalents and restricted cash on hand is expected to be
sufficient to fund the Company's operations into the fourth quarter
of 2022 and is expected to allow the Company to support the first
eighteen months of the commercial launch of the RAP
device. The proceeds from the financing will fund the initial
commercialization of the product described above, including the
early manufacturing, fundamental brand development investment, and
the initiation of a sales force and practice development team
instrumental in developing relationships with key customers.
Conference Call Details:
Management will host a conference call and live webcast to
discuss Soliton's financial results at 8:30
a.m. ET today. A question and answer session will follow
management remarks.
The dial-in numbers for the conference call are (833) 423-0479
for domestic callers and (918) 922-2373 for international callers.
The conference ID is 4287640.
A replay of the call will be available following its completion
through August 18, 2020. To access
the replay, dial (855) 859-2056 for domestic callers and (404)
537-3406 for international callers and use the replay conference ID
4287640.
A live audio webcast of the call will be available on the
Investor Relations page of the Company's
website, https://ir.soliton.com/. A replay of the webcast will
be archived on Soliton's website for 30 days following the
completion of the call.
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About Soliton, Inc.
Soliton, Inc. is a medical device company with a novel and
proprietary platform technology licensed from The University of Texas MD Anderson Cancer Center. The
Company's first FDA cleared commercial product will use rapid
pulses of acoustic shockwaves as an accessory to lasers for the
removal of unwanted tattoos. The Company is based in Houston, Texas, and is actively engaged in
bringing the RAP device to the market. The Company believes this
"Soliton" method has the potential to lower tattoo removal costs
for patients, while increasing profitability to practitioners,
compared to current laser removal methods. Soliton is investigating
potential additional capabilities of the RAP technology in clinical
and preclinical testing, including the potential to improve the
appearance of cellulite by creating mechanical stress at the
cellular level and inducing significant collagen growth and the
potential to treat keloid and hypertrophic scars by targeting the
stiffened environment in the intracellular matrix.
For more information about the Company, please
visit: http://www.soliton.com
Forward-Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. Forward-looking statements in this press
release include, without limitation, the runway for our existing
cash to extend into Q4 2022, our ability to launch our RAP device
in the first half of 2021, our ability to receive FDA clearance for
the cellulite indication and to effectively commercialize our
products, and the ability of the RAP device to successfully treat
cellulite and fibrotic scars. These statements relate to
future events, future expectations, plans and prospects. Although
Soliton believes that the expectations reflected in such
forward-looking statements are reasonable as of the date made,
expectations may prove to have been materially different from the
results expressed or implied by such forward-looking statements.
Soliton has attempted to identify forward-looking statements by
terminology including ''believes,'' ''estimates,'' ''anticipates,''
''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,''
''may,'' ''could,'' ''might,'' ''will,'' ''should,''
''approximately'' or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements.
These statements are only predictions and involve known and unknown
risks, uncertainties, and other factors, including those discussed
under in our SEC filings, including under the heading "Item 1A.
Risk Factors" in the Form 10-K for year ended December 31, 2019 we filed with the SEC on
March 2, 2020 and updated from time
to time in our Form 10-Q filings and in our other public filings
with the SEC. Any forward-looking statements contained in this
release speak only as of its date. Soliton undertakes no obligation
to update any forward-looking statements contained in this release
to reflect events or circumstances occurring after its date or to
reflect the occurrence of unanticipated events.
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SOURCE Soliton, Inc.