Flex Pharma Announces Corporate Update
June 13 2018 - 7:00AM
Business Wire
-- FLX-787 Phase 2 Clinical Programs in ALS
& CMT to Close --
-- FLX-787 Clinical Evaluation of Dysphagia to
Continue --
-- Wedbush PacGrow Retained to Guide Assessment
of Strategic Alternatives --
-- Restructuring with Workforce Reduction
--
Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology
company, today announced that the Company is ending its ongoing
Phase 2 clinical trial investigations of FLX-787 in amyotrophic
lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT) due to oral
tolerability concerns observed in both studies, in a subset of
patients being treated, with the oral disintegrating tablet
formulation at 30 mg, taken three times a day.
"In the past few months we have reported positive efficacy data
in two serious and distinctly different neurological diseases:
multiple sclerosis (MS) and ALS. We believe that these clinical
data demonstrate the clear potential of FLX-787 as a symptomatic
therapy to reduce painful cramps and spasms in these patient
populations,” stated Bill McVicar, Ph.D., President and CEO of Flex
Pharma. “However, recent observations of oral intolerability at the
current dose and formulation, in a subset of patients, in both
studies, indicate that more formulation and dose-ranging studies
are required, which is challenging for the Company based upon our
current resources.”
The Company’s Board of Directors and its management are in
alignment that the Company’s best path forward to preserve
stockholder value is to focus its resources on assessing strategic
alternatives, including the potential sale or merger of the
Company. The Board has established a Strategic Committee that will
work with management to oversee this process. Wedbush
PacGrow has been engaged to act as the Company’s strategic
financial advisor. There can be no assurance that this process will
result in any such transaction and the Company does not intend to
disclose additional details unless and until it has entered into a
specific transaction.
The Company will continue to operate with a reduced internal
team that will focus their efforts on assessing the potential of
FLX-787 in dysphagia (difficulty swallowing) and operating the
HOTSHOT consumer business while the strategic review is
ongoing.
In connection with these decisions, Flex Pharma will
restructure its organization to reduce costs, including reducing
its workforce by approximately 60 percent. Most of these changes
are anticipated to be completed by June 30, 2018. As a result,
the Company expects to realize annualized cost savings beginning in
the third quarter of 2018. The Company estimates that it
will incur one-time costs of approximately $0.8 million to
$1.1 million related to the restructuring plan.
About Flex Pharma
Flex Pharma, Inc. is a clinical-stage biotechnology company that
is developing FLX-787 for dysphagia. Flex Pharma was founded by
National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel
Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields
of ion channels and neurobiology, along with Christoph Westphal,
M.D., Ph.D.
Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include statements regarding our intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: the corporate restructuring; the reduction in force and
restructuring charges; the potential cost savings resulting from
these changes; the ability to achieve cash flow savings; the
discontinuation of the Company’s trials of FLX-787 in amyotrophic
lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT); the ability
to continue to develop FLX-787; and the potential for a sale or
merger of the Company. These forward-looking statements are based
on management's expectations and assumptions as of the date of this
press release and are subject to numerous risks and uncertainties,
which could cause actual results to differ materially from those
expressed or implied by such statements. These risks and
uncertainties include, without limitation: uncertainties regarding
whether the Company will be able to implement the restructuring in
a timely fashion and at the level of expense projected; whether the
Company will be able to effectively manage the organizational
changes brought about by the restructuring and have sufficient
capital resources to fund its continuing operations in future
periods to realize its anticipated cost savings; availability of
funding sufficient for our foreseeable and unforeseeable operating
expenses and capital expenditure requirements; other matters that
could affect the availability or commercial potential of our
consumer or drug product candidates; and the inherent uncertainties
associated with intellectual property. Other factors that may cause
actual results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
our filings with the U.S. Securities and Exchange Commission (SEC),
including the "Risk Factors" contained therein. You are encouraged
to read our filings with the SEC, available at www.sec.gov, for a
discussion of these and other risks and uncertainties. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20180613005241/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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