Aclaris Therapeutics Announces New Strategic Direction
05 September 2019 - 10:30PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory and
dermatological diseases, today announced the completion of a
strategic review of its business, as a result of which the Company
will refocus its resources on its immuno-inflammatory development
programs and actively seek commercialization partners for its
commercial products business.
This review of the Company’s overall business strategy is
intended to streamline operations and reduce costs, to position the
Company for long-term growth and maximize shareholder value. “Our
goal when we commenced this review was to find an effective way to
refocus our resources on our novel drug candidates for
immuno-inflammatory diseases,” said Dr. Neal Walker, President and
Chief Executive Officer.
This new strategic direction includes the following actions:
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1) |
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Aclaris is actively seeking partners for its commercial products
business. For its remaining marketed product, RHOFADE®
(oxymetazoline hydrochloride) cream, 1%, Aclaris will no longer
utilize a sales force to promote the product. In the interim,
Aclaris will continue to sell and distribute RHOFADE in the United
States. In addition, Aclaris will also seek strategic partners for
ESKATA® (hydrogen peroxide) topical solution, 40% (w/w). |
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2) |
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Aclaris is actively seeking a
strategic partner to commercialize its drug candidate A-101 45%
Topical Solution, an investigational compound being developed as a
potential treatment for verruca vulgaris (common warts). The
Company’s two ongoing Phase 3 pivotal clinical trials, THWART-1 and
THWART-2, in which A-101 45% Topical Solution is being evaluated as
a potential treatment for common warts, are progressing as planned.
Aclaris has completed enrollment of more than 1,000 patients across
these two trials, and data from both trials are expected in the
second half of 2019. |
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3) |
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Aclaris is actively seeking a
development and commercialization partner for its drug candidates,
ATI-501 (oral) and ATI-502 (topical), which are investigational
Janus Kinase (JAK) 1/3 inhibitor compounds for the potential
treatment of alopecia. |
In addition, Aclaris plans to focus on its
portfolio of novel kinase inhibitors and its proprietary kinase
discovery platform. To that end, Aclaris will continue the
development of its drug candidate, ATI-450, an internally
developed, investigational oral MK2 inhibitor, which is currently
in a Phase 1 clinical trial for development as a potential
treatment for rheumatoid arthritis. Aclaris also plans further
investment in its drug candidate, ATI-1777 and other preclinical
drug candidates, utilizing its robust drug discovery technology and
scientific expertise, to develop treatments that may benefit
patients suffering from immuno-inflammatory diseases.
“We believe this change in strategy will benefit Aclaris in the
near term by lowering expenses and eliminating the inherent risks
and investment related to maintaining a commercial infrastructure.
By actively seeking a commercialization partner for our commercial
products business and refocusing our resources with a view to
optimizing our immuno-inflammatory development portfolio, we
believe we can significantly reduce our costs, strengthen the
organization, and extend our cash runway,” said Dr. Walker. “Our
resources can now be dedicated to prudently advancing our pipeline
of novel drug candidates for immuno-inflammatory diseases.”
“As part of our new business strategy, we have approved a plan
to significantly reduce our workforce. We expect to complete this
reduction over the course of the next six months. This decision was
extremely difficult but necessary. I would like to personally thank
all of the affected employees for their contributions over the past
years,” said Dr. Walker.
Aclaris’ restructuring plan includes the termination of 86
employees across the organization, actively seeking
commercialization partners for its commercial products business,
and the elimination of various development programs. During the
time Aclaris is seeking a commercialization partner for RHOFADE,
Aclaris will continue to incur certain expenses related to the sale
and distribution of RHOFADE in the United States.
This restructuring plan is estimated to cost between $3.0
million and $3.5 million in total over the next 6 months, excluding
non-cash charges, with the related cash payments to be
substantially complete by March 31, 2020. Aclaris anticipates that
its current cash and cash equivalents will be sufficient to fund
its operations into the third quarter of 2021, without giving
effect to any potential new business development transactions or
financing activities. The estimates of costs that Aclaris expects
to incur and the timing thereof are subject to a number of
assumptions and actual results may differ.
Additional financial guidance will be provided when Aclaris
announces its third quarter operating results.
Aclaris also announced today that it will host an R&D
Investor Event focused on our pipeline of novel drug candidates for
immuno-inflammatory diseases on September 27, 2019 in New York, New
York.
About Aclaris Therapeutics, Inc.Aclaris
Therapeutics, Inc. is a physician-led biopharmaceutical company
committed to addressing the needs of people with
immuno-inflammatory diseases who lack satisfactory treatment
options. The company’s diverse portfolio includes one late-stage
investigational medicine and a pipeline powered by a robust R&D
engine exploring protein kinase regulation. Aclaris Therapeutics’
active development programs focus on areas where significant
treatment gaps exist. For additional information, please visit
www.aclaristx.com and follow Aclaris on LinkedIn or Twitter
@aclaristx.
Cautionary Note Regarding Forward-Looking
StatementsAny statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe,” “expect,” “may,” “plan,”
“potential,” “will,” and similar expressions, and are based on
Aclaris’ current beliefs and expectations. These forward-looking
statements include statements about changes in Aclaris’ future
corporate focus and strategy, development plans with respect to its
preclinical and clinical drug candidates, anticipated cost savings
as a result of the restructuring actions, the duration of time that
Aclaris’ cash and cash equivalents will be able to fund its
operations and anticipated costs of the restructuring. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials and in commercialization of products, Aclaris’
reliance on third parties over which it may not always have full
control, and other risks and uncertainties that are described in
the Risk Factors section of Aclaris’ Annual Report on Form 10-K for
the year ended December 31, 2018, Aclaris’ Quarterly Report on Form
10-Q for the quarter ended June 30, 2019 and other filings Aclaris
makes with the U.S. Securities and Exchange Commission from time to
time. These documents are available under the "SEC filings” section
of the Investors page of Aclaris’ website at
http://www.aclaristx.com. Any forward-looking statements speak only
as of the date of this press release and are based on information
available to Aclaris as of the date of this release, and Aclaris
assumes no obligation to, and does not intend to, update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Aclaris ContactMichael Tung, M.D.Senior Vice PresidentCorporate
Strategy/Investor Relations484-329-2140mtung@aclaristx.com
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