jeudi 3 décembre 2020


Wednesday, June 13th 2018 at 11:00am UTC

— 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 —

BOSTON–(BUSINESS WIRE)– 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.

Contacts

Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor
Relations & Corporate Communications
irdept@flex-pharma.com

Source: Flex Pharma, Inc.

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