[August 05, 2015] |
|
Flex Pharma Reports Second Quarter 2015 Financial Results
Click
to Tweet this News
Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company that is
developing innovative and proprietary treatments for exercise-associated
muscle cramps, nocturnal leg cramps, and spasms associated with severe
neuromuscular conditions, today reported financial results for the
quarter ended June 30, 2015, and provided an update on its clinical
development and corporate activities.
"Based on the novel discovery by our scientific co-founders, we are
working to define the impact of chemical neuro-stimulation on reducing
cramps and spasms in several important settings. We have made
significant progress this quarter in both the development of our
clinical candidates as well as in the preparation for our consumer
launch," stated Christoph Westphal, M.D., Ph.D., Chairman and Chief
Executive Officer of Flex Pharma. "We are excited to launch our consumer
product leveraging our recent data in a real-world setting with
athletes, which we believe is the first time any consumer beverage has
shown a statistically significant reduction of naturally occurring
muscle cramps in athletes. We expect to begin commercializing in the
first half of 2016."
Second Quarter and Recent Business Highlights
-
Advanced scientific and clinical efforts
-
The Company's scientific abstracts have been accepted for
presentation at the 31st Congress of the European
Committee for Treatment and Research of Multiple Sclerosis
(October 7-10, 2015) and the 45th Annual Meeting of the
Society for Neuroscience (October 17-21, 2015).
-
The Company advanced its clinical efforts and expects to nominate
a clinical drug candidate consisting of one or two highly pure,
GMP synthesized, potent TRP activators.
-
Enrollment is on track in the human proof-of-concept study
initiated in April for nocturnal leg cramps (NLC) with the
Company's proprietary formulation. Nocturnal leg cramps can cause
severe pain, interrupted sleep, reduced quality of life and
interference with activities of daily living. The randomized,
blinded, placebo-controlled, cross-over study is expected to
enroll at least 40 subjects who experience NLC at least four
nights per week.
-
Dr. Bruce Bean, Flex Pharma Scientific Co-founder and Scientific
Advisory Board Co-Chair, presented the Company's human
proof-of-concept data in an oral platform presentation at the AAN
67th Annual Meeting held in Washington, D.C. The
abstract, titled "Orally-administered TRPV1 and TRPA1 activators
inhibit electrically-induced muscle cramps in normal healthy
volunteers," was presented on Tuesday, April 21, 2015.
-
In April, Nature published the co-crystal structure of the
TRPA1 target in the paper titled "Structure
of the TRPA1 ion channel suggests regulatory mechanisms."
The TRPV1 co-crystal structure was published by Nature in
December 2013 (TRPV1 structures in distinct
conformations reveal activation mechanisms).
-
Consumer Product
-
The Company has initiated pre-launch activities for its
cornerstone consumer product in Boston, Boulder, and Los Angeles,
and expects to launch in the first half of 2016.
-
In July, the Company announced positive results in an initial
study of athletes participating in high intensity sports. The
study showed statistically significant results (p<0.01 by Poisson
regression), demonstrating that Flex Pharma's proprietary
treatment reduced muscle cramps during a two week workout period
by more than 50% when compared to the prior two week baseline
observation period. The study also demonstrated a trend towards a
reduction in cramp duration.
-
As part of the campaign to educate endurance athletes,
professional sports teams, coaches, and trainers about Dr. Rod
MacKinnon's breakthrough discovery, the Company launched the
website ItsTheNerve.com in early June.
-
In May, the Company announced that its proprietary formulation
earned certification from NSF International's Certified for Sport®
program. NSF's Certified for Sport® program certifies ingredients
and tests products to ensure they do not contain contaminants or
banned or prohibited substances. The MLB (News - Alert), MLB Player's
Association, NFL, NFL Player's Association, PGA, LPGA and the CCES
(Canadian Centre for Ethics in Sport) have all chosen NSF's
Certified for Sport® program.
-
Expanded Directors and Advisors
-
Alfred Sandrock, Jr., M.D., Ph.D., Chief Medical Officer of Biogen
(NASDAQ: BIIB), joined our Scientific Advisory Board. Dr. Sandrock
is Biogen's Group Senior Vice President of Development Sciences
and Chief Medical Officer. At Biogen, Dr. Sandrock has been
responsible for the clinical development and approval of Tysabri®,
Plegridy®, Tecfidera®, Alprolix®, and Eloctate®.
-
John Winkelman, M.D., Ph.D., Chief of the Sleep Disorders Clinical
Research Program at Massachusetts General Hospital, joined our
Scientific Advisory Board. Dr. Winkelman is an Associate Professor
of Psychiatry at Harvard Medical School. Dr. Winkelman's clinical
research has included clinical trials in sleep-related movement
disorders, particularly extensive involvement in the development
of approved agents for restless legs syndrome.
-
Jeffrey D. Capello, former Chief Financial Officer of
Ortho-Clinical Diagnostics, Inc., joined our Board of Directors
and serves as Chair of the Audit Committee. Prior to his role at
Ortho-Clinical Diagnostics, Mr. Capello served as Chief Financial
Officer and Executive Vice President of Boston Scientific (NYSE:
BSX) from 2010 to 2013.
-
Corporate
-
On June 1, the Company's management and its co-founders hosted the
NASDAQ Stock Market Closing Bell ceremony at the NASDAQ MarketSite
in Times Square.
-
On April 1, Flex Pharma, Inc. (FLKS) was added to the Russell
3000, Russell 2000, and Russell Microcap Indices as part of
Russell Investments' first quarter 2015 IPO additions.
Second Quarter 2015 Financial Results
-
Cash Position: Flex Pharma had cash and cash equivalents of
$106.0 million as of June 30, 2015 compared to cash of $110.5 million
as of March 31, 2015, a decrease of $4.5 million, which the Company
used to fund its operations. Based on its current cash position and
assuming no revenues from product sales and no outside support via
partnering deals, the Company expects to have sufficient capital to
fund its operations until the middle of 2018.
-
R&D Expense: Research and development expense for the three
months ended June 30, 2015 was $3.2 million, compared to $1.1 million
for the three months ended June 30, 2014. Research and development
expense for the second quarter of 2015 primarily included increased
costs associated with the Company's clinical studies and research of
its proprietary treatment, as well as higher personnel costs
(including salaries and stock-based compensation costs) due to an
increased workforce.
-
G&A Expense: General and administrative expense for the
three months ended June 30, 2015 was $3.9 million, compared to $1.1
million for the three months ended June 30, 2014. General and
administrative expense for this period primarily included higher
personnel costs (including salaries and stock-based compensation
costs) due to an increased workforce, costs related to developing the
Company's consumer brand and cornerstone product, including pre-launch
activities, and increased external consulting costs and professional
service fees.
-
Net Loss: Net loss for the three months ended June 30, 2015 was
($7.1) million, or ($0.47) per share. Included in the loss for the
quarter was $1.6 million of stock-based compensation expense. The net
loss for the second quarter of 2015 was primarily driven by the
Company's operating expenses related to its research and development
efforts, costs associated with the development of the Company's
consumer brand and cornerstone product, and general and administrative
costs.
Upcoming Events and Presentations
-
Rodman & Renshaw 17th Annual Global Investment
Conference, September 8-10, 2015 in New York, NY
-
31st Congress of the European Committee for Treatment and Research of
Multiple Sclerosis, October 8, 2015 in Barcelona, Spain
-
45th Annual Meeting of the Society for Neuroscience, October 20, 2015
in Chicago, IL
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 second quarter 2015
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.
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 biotechnology company that is developing
innovative and proprietary treatments for exercise-associated muscle
cramps, nocturnal leg cramps, and spasms associated with severe
neuromuscular conditions. In three randomized, blinded,
placebo-controlled, cross-over studies, Flex Pharma's proprietary
treatment has shown a statistically significant reduction in the
intensity of muscle cramps in healthy normal volunteers. In addition,
the proprietary treatment has been demonstrated to prevent muscle cramps
in an initial study of athletes participating in high intensity sports.
Individuals can follow the Company on twitter (@flexpharma) and the
Company's website (http://ir.flex-pharma.com/)
to see the latest progress of the Company's pre-launch activities for
its consumer product to prevent and treat exercise-associated muscle
cramps.
Flex Pharma was founded by National Academy of Sciences members Rod
MacKinnon, M.D. (2003 Nobel (News - Alert) Laureate), and Bruce Bean, Ph.D., recognized
leaders in the fields of ion channels and neurobiology, along with
Chairman and Chief Executive Officer 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. Forward-looking statements include statements regarding our
intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things: our expectations regarding
the identification of a drug product candidate, the design and timing of
ongoing and anticipated clinical studies, our expectations regarding the
availability of our capital resources, and our plans to develop and
commercialize our consumer products. 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
develop and commercialize our consumer products; anticipated positioning
and product attributes of our consumer products; 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; the inherent uncertainties
associated with intellectual property; and other factors discussed in
greater detail under the heading "Risk Factors" in our Annual Report on
Form 10-K for the year ended December 31, 2014 and subsequent filings
with the Securities and Exchange Commission (SEC (News - Alert)). 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.
|
|
|
|
|
|
|
|
|
|
|
Flex Pharma, Inc.
|
|
|
|
|
|
|
|
|
|
|
Unaudited Selected Consolidated Balance Sheet Information
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2015
|
|
|
December 31, 2014
|
Cash and cash equivalents
|
|
|
|
|
|
$
|
106,012
|
|
$
|
33,854
|
Prepaid expenses and other current assets
|
|
|
|
|
|
|
810
|
|
|
370
|
Property and equipment, net
|
|
|
|
|
|
|
119
|
|
|
85
|
Other assets
|
|
|
|
|
|
|
262
|
|
|
1,302
|
Total assets
|
|
|
|
|
|
$
|
107,203
|
|
$
|
35,611
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
|
|
|
$
|
2,042
|
|
$
|
995
|
Other liabilities
|
|
|
|
|
|
|
515
|
|
|
123
|
Convertible preferred stock
|
|
|
|
|
|
|
-
|
|
|
41,031
|
Stockholders' equity (deficit)
|
|
|
|
|
|
|
104,646
|
|
|
(6,538)
|
Total liabilities and stockholders' equity (deficit)
|
|
|
|
|
|
$
|
107,203
|
|
$
|
35,611
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Statements of Operations
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2015
|
|
|
Three Months Ended June 30, 2014
|
|
|
Six Months Ended June 30, 2015
|
|
|
Period from Inception to June 30, 2014
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
$
|
3,190
|
|
$
|
1,100
|
|
$
|
5,995
|
|
$
|
1,130
|
General and administrative
|
|
|
|
|
|
|
3,904
|
|
|
1,093
|
|
|
7,121
|
|
|
1,155
|
Total operating expenses
|
|
|
|
|
|
|
7,094
|
|
|
2,193
|
|
|
13,116
|
|
|
2,285
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
|
|
(7,094)
|
|
|
(2,193)
|
|
|
(13,116)
|
|
|
(2,285)
|
Interest income, net
|
|
|
|
|
|
|
16
|
|
|
3
|
|
|
20
|
|
|
3
|
Net loss
|
|
|
|
|
|
$
|
(7,078)
|
|
$
|
(2,190)
|
|
$
|
(13,096)
|
|
$
|
(2,282)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share-basic and diluted
|
|
|
|
|
|
$
|
(0.47)
|
|
$
|
(1.42)
|
|
$
|
(1.04)
|
|
$
|
(1.53)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding (1)
|
|
|
|
|
|
|
15,035
|
|
|
1,539
|
|
|
12,621
|
|
|
1,493
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) As of June 30, 2015, the Company had issued approximately 5.4
million shares of restricted stock that are subject to vesting. Of these
shares, approximately 2.7 million shares had vested as of June 30, 2015
and are outstanding for purposes of computing weighted-average shares
outstanding. The remaining shares will be included in the weighted
average shares outstanding calculation as such shares vest.
Approximately 5.5 million shares issued by the Company in its IPO in
February of 2015 are considered outstanding for the weighted-average
shares calculation at the date of issuance and approximately 7.0 million
shares of common stock issued upon conversion of all outstanding shares
of preferred stock are included in weighted-average shares outstanding
from the date of the closing of the IPO.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150805005773/en/
[ Back To TMCnet.com's Homepage ]
|