-- Positive Anti-Cramping Effect of FLX-787
Reported in Recent MS study ---- FLX-787 Phase 2 ALS & CMT
Clinical Studies Ongoing --Conference Call Scheduled Today at 9:00
a.m. ET
Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology
company that is developing innovative and proprietary treatments in
Phase 2 randomized, controlled trials for muscle cramps, spasms and
spasticity associated with severe neurological diseases such as
multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) under
FDA Fast Track designation, and Charcot-Marie-Tooth (CMT)
neuropathy, today reported financial results for the quarter ended
March 31, 2018 and provided an update on its clinical development
and corporate activities.
"The past few months have been particularly rewarding on the
clinical front, as we achieved significant milestones with positive
data in two serious and distinctly different neurological diseases:
MS and ALS. We believe these data demonstrate the clear potential
of FLX-787 to reduce painful cramps and spasms in these patient
populations,” stated Bill McVicar, Ph.D., President and CEO of Flex
Pharma. “Fueled by the consistent efficacy demonstrated by FLX-787
against cramps and spasms, and the potential to impact spasticity,
I am excited to be driving towards important readouts for our
clinical programs over the next year.”
Business Highlights
- Clinical Efforts
- In March, the Company announced
positive topline data for FLX-787 from its exploratory Phase 2
trial in MS patients with frequent muscle cramps/spasms and
spasticity. FLX-787 at a dose of 19 mg, taken orally twice daily,
in a liquid formulation was evaluated in an exploratory Phase 2
randomized, double-blinded, placebo-controlled, cross-over trial in
57 MS patients. In the evaluation of FLX-787 for its impact on MS
patients’ cramps/spasms and spasticity, pre-specified analyses of
the parallel portion of the study showed the following:
- A statistically significant 27.3%
reduction in the frequency of cramps/spasms compared with control
(p=0.001)
- A 1.4 day increase in cramp/spasm-free
days per 14 day period compared with control (p=0.046)
- Clinician-rated improvement in
spasticity with FLX-787 treatment was significantly better than
control (p=0.010)
- Treating physicians reported that 7 of
28 (25%) patients on FLX-787 had “Much Improved” or “Very Much
Improved” spasticity versus 0 of 26 (0%) on control based upon the
Clinical Global Impression of Change in Spasticity
- FLX-787 was generally well tolerated
and resulted in no drug-related serious adverse events. GI-related
adverse events (diarrhea and nausea) were infrequently reported
with FLX-787.
- In April, the Company initiated an
open-label, single dose study in ALS patients to assess the impact
of FLX-787 on bulbar functions, including swallowing.
- Consumer
- For the quarter ended March 31, 2018,
the Company recorded approximately $179,000 in total revenue for
its consumer product, HOTSHOT®.
- In January 2018, the Company announced
that it engaged an investment banking firm to assist with the
consideration of strategic alternatives for the HOTSHOT consumer
business. That review is in progress and the Company expects to
report the results of the review in the near future.
First Quarter 2018 Financial Results
- Cash Position: As of March 31,
2018, Flex Pharma had cash, cash equivalents and marketable
securities of $23.9 million, estimated to fund operations to
mid-2019. During the three months ended March 31, 2018, cash, cash
equivalents and marketable securities decreased by $9.4 million,
which is higher than the estimated spend for future quarters. The
timing of clinical trial billings and annual bonus payments related
to 2017 impacted the cash used in operations during the first
quarter, and spend on the consumer business is expected to be
lower.
- Total Revenue: Total revenue for
the three months ended March 31, 2018 was approximately
$179,000.
- Cost of Product Revenue: Cost of
product revenue for the three months ended March 31, 2018 was
approximately $84,000. There were no inventory write-offs during
the three months ended March 31, 2018.
- R&D Expense: Research and
development expense for the three months ended March 31, 2018 was
$4.7 million. Research and development expense for this period
primarily included costs associated with the Company’s clinical
studies of FLX-787, personnel costs (including salaries and
stock-based compensation costs), FLX-787 production costs, and
external consultant costs.
- SG&A Expense: Selling,
general and administrative expense for the three months ended March
31, 2018 was $3.7 million. Selling, general and administrative
expense for this period primarily included personnel costs
(including salaries and stock-based compensation costs), sales,
marketing and fulfillment costs related to HOTSHOT, legal and
professional costs, and external consultant costs.
- Net Loss and Cash Flow: Net loss
for the three months ended March 31, 2018 was ($8.2) million, or
($0.46) per share and included $0.9 million of stock-based
compensation expense. As of March 31, 2018, Flex Pharma had
17,980,852 shares of common stock outstanding. The net loss for the
first quarter of 2018 was primarily driven by the Company’s
operating expenses related to its research and development efforts,
costs associated with HOTSHOT, and general and administrative
costs.
Financial Guidance
Based on its current operating plans and cash, cash equivalents
and marketable securities position, Flex Pharma expects to have
sufficient capital to fund its operations to mid-2019.
Upcoming Events and Presentations
- Jefferies 2018 Global Healthcare
Conference, June 5-8, 2018 in New York, NY.
Conference Call and Webcast
The company will host a conference call and webcast today at
9:00 a.m. ET to provide an update on the company and discuss first
quarter 2018 financial results. To access the conference call,
please dial (855) 780-7202 (U.S. and Canada) or (631) 485-4874
(International) five minutes prior to the start time. Conference ID
number 3478819. A live webcast may be accessed in the Investors
section of the company’s website at www.flex-pharma.com. Please log
on to the Flex Pharma website approximately 15 minutes prior to the
scheduled webcast to ensure adequate time for any software
downloads that may be required. A replay of the webcast will be
available on Flex Pharma’s website for three months.
About Flex Pharma
Flex Pharma, Inc. is a clinical-stage biotechnology company that
is developing innovative and proprietary treatments in Phase 2
randomized, controlled trials for cramps, spasms and spasticity
associated with the severe neurological diseases of ALS, MS and
peripheral neuropathies such as Charcot-Marie-Tooth (CMT). The
Company’s lead candidate, FLX-787, is being developed under Fast
Track designation for the treatment of severe muscle cramps
associated with ALS. 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 design and timing of ongoing and anticipated clinical
studies; and our expectations regarding the availability of our
capital resources. 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: the status, timing,
costs, results and interpretation of our clinical studies; the
uncertainties inherent in conducting clinical studies; results from
our ongoing and planned preclinical development; expectations of
our ability to make regulatory filings and obtain and maintain
regulatory approvals; our ability to successfully commercialize our
consumer product; results of early clinical studies as indicative
of the results of future trials; 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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Flex Pharma, Inc.
Unaudited Selected Consolidated Balance Sheet Information
(in thousands)
March 31,2018
December 31,2017
Assets: Cash and cash equivalents $ 21,948 $ 19,186 Marketable
securities 1,999 14,130 Accounts receivable 13 10 Inventory 418 432
Prepaid expenses and other current assets 1,261 777 Property and
equipment, net 267 331 Other assets 127 127 Total assets $ 26,033 $
34,993 Liabilities and stockholders' equity: Accounts
payable and accrued expenses $ 4,062 $ 5,717 Deferred revenue — 72
Other liabilities 83 98 Stockholders’ equity 21,888 29,106 Total
liabilities and stockholders’ equity $ 26,033 $ 34,993
Unaudited Condensed Consolidated Statements of
Operations (in thousands, except loss per share amounts)
Three Months EndedMarch 31, 2018
Three Months EndedMarch 31, 2017
Net product revenue $ 177 $ 241 Other revenue 2 2
Total revenue 179 243 Costs and expenses: Cost of product revenue
84 79 Research and development 4,680 3,915 Selling, general and
administrative 3,697 4,595 Total costs and expenses
8,461 8,589 Loss from operations (8,282 ) (8,346 ) Interest
income, net 59 78 Net loss $ (8,223 ) $ (8,268 )
Net loss per share-basic and diluted $ (0.46 ) $ (0.49 )
Weighted-average number of common shares outstanding (1)
17,894 16,874 (1)
In 2014, the Company issued approximately
5.4 million shares of restricted stock that vested over four years,
through February 2018. These shares were considered outstanding for
purposes of computing weighted average shares as they vested. All
of these shares have vested and are considered outstanding as of
March 31, 2018.
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version on businesswire.com: https://www.businesswire.com/news/home/20180502005410/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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