-- IND Submission for FLX-787 On Track for H1
2017 ---- Phase 2 ALS & CMT Studies with FLX-787 Planned to
Initiate This Year ---- Successful Launch Year for HOTSHOT®
Consumer Brand; Revenue Exceeds Expectations --Conference Call
Scheduled Today at 8:30 a.m. ET
Click to Tweet
Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company that
is developing innovative and proprietary treatments for cramps and
spasms associated with severe neurological diseases such as
amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) and
peripheral neuropathies such as Charcot-Marie-Tooth (CMT), today
reported financial results for the year ended December 31, 2016 and
provided an update on its clinical development and corporate
activities.
“When we initiate our Phase 2 clinical studies in ALS and CMT
later this year, FLX-787 will be amongst the most advanced, novel
clinical compounds in development for these conditions,” stated
Christoph Westphal, M.D., Ph.D., Chair and CEO of Flex Pharma.
“With over $61 million in cash and investments at year end, Flex is
well funded through early 2019 to execute upon our value-creating
objectives.”
“Our IND application for FLX-787 will be submitted in the next
few weeks, and we have attracted several ALS and CMT investigators
who are enthusiastic about enrolling in our parallel-design phase 2
studies here in the United States. We are focused on accelerating
development of FLX-787 in the severe neurological diseases of ALS,
MS and CMT, all areas of high unmet medical need,” said Flex Pharma
Chief Medical Officer Thomas Wessel, M.D., Ph.D. “Since the
hyperactive alpha-motor neuron is the final common pathway involved
in fasciculations, cramps, spasms and spasticity, we believe our
approach with FLX-787, a dual TRPA1 and TRPV1 activator, may
benefit patients afflicted with numerous neurological
diseases.”
“In our clinical studies, we continue to explore the impact of
Chemical Neuro Stimulation -- the process by which a chemical
signal, acting topically, is translated into an electrical signal
for the benefit of patients -- which we hope will prove to be
helpful to those with severe neurological disorders. We are
encouraged by the initial response HOTSHOT has received from more
than 20,000 endurance and professional athlete customers, and over
200 professional, collegiate and high school sports teams,
indicating that Chemical Neuro Stimulation is helping many who
suffer from debilitating cramps,” said Dr. Rod MacKinnon, Nobel
Laureate and Flex Pharma Scientific Co-Founder, Board Member, and
Scientific Advisory Board Co-Chair.
Business Highlights
- Clinical Efforts
- In January 2017, the Company announced
that it is prioritizing its clinical programs in the severe
neurological diseases of ALS, MS and peripheral neuropathies such
as Charcot-Marie Tooth. The Company intends to initiate additional
Phase 2 studies in ALS and CMT in the US this year with FLX-787,
its transient receptor potential (TRP) ion channel activator,
formulated as an oral disintegrating tablet.
- In 2016, exploratory Phase 2 efficacy
studies were initiated in MS and ALS patients in Australia with
FLX-787, the Company’s TRP ion channel activator. The randomized,
controlled, blinded, cross-over studies are designed to evaluate
the safety and efficacy of FLX-787 in patients who suffer from
cramps, spasms and/or spasticity as a consequence of ALS and
MS.
- The Company’s results in its initial
study of NLC was selected for late-breaking oral and poster
presentations at the American Academy of Neurology (AAN)
68th Annual Meeting held in Vancouver, B.C., Canada in April
2016. Only 14 abstracts were selected as late-breaking
presentations at the AAN annual meeting. Details from the study,
titled “Orally-administered TRPV1 and TRPA1 activators reduce Night
Leg Cramps in a randomized, blinded, placebo-controlled, crossover
human trial,” were presented during the Emerging Science
Session.
- Over the past year, Flex Pharma
presented positive human efficacy data from randomized, controlled
studies at several scientific and medical meetings, including the
AAN, Experimental Biology, the American College of Sports Medicine
(ACSM), the Society for Neuroscience, and the Americas Committee
for Treatment and Research in Multiple Sclerosis (ACTRIMS).
- In October 2016, the Company announced
a strong statistical trend of FLX-787 in an exploratory human
nocturnal leg cramps (NLC) study in reducing muscle cramp frequency
(p=0.06) during the initial two-week parallel design of the study
versus placebo as compared to the baseline run-in period. This
analysis was based upon data from patients restricted to two sites
(n=37), after data from a third clinical site was excluded due to a
concentrated number of issues relating to patient selection.
- Consumer Launch
- For the year ended December 31, 2016,
the Company recorded approximately $1.0 million in total revenues
for its consumer product, HOTSHOT, and approximately $299,000 for
the fourth quarter of 2016. Launched in June 2016, HOTSHOT is a new
1.7 fluid ounce sports shot that is scientifically proven to
prevent and treat muscle cramps by stopping them where they start:
at the nerve.
- In February 2017, Tim Reed, the
reigning IRONMAN 70.3® champion, became an official brand
ambassador for HOTSHOT. Reed started racing with HOTSHOT a year ago
and, in 2016, had the most successful year of his career with wins
at the IRONMAN 70.3 Asia Pacific Championship, IRONMAN® Australia
and the IRONMAN 70.3 World Championship.
- In December 2016, James Develin, a
fullback who played on the 2015 and 2017 championship professional
football team and a Brown University graduate, became an official
brand ambassador for HOTSHOT. Develin was first introduced to
HOTSHOT through his team nutritionist and became an avid user after
trying it following several long practices.
- In August 2016, four HOTSHOT brand
ambassadors - marathoners Shalane Flanagan and Amy Cragg, and
steeplechasers Evan Jager and Colleen Quigley - competed at the Rio
Olympics. Evan Jager captured the silver medal in his event.
- HOTSHOT became available on Amazon.com
in October 2016.
- Expanded Board of Directors and
Scientific Advisory Board
- In August 2016, W. Larry Kenney, Ph.D.,
Professor of Physiology and Kinesiology at Penn State University,
joined the Company’s Scientific Advisory Board. As the Marie
Underhill Noll Chair in Human Performance and Professor of
Physiology and Kinesiology at Penn State University, Dr. Kenney is
focused on research involving human physiological responses and
adaptations to exercise and extreme environments. Dr. Kenney served
as President of the American College of Sports Medicine from
2003-2004. He serves on the American Council of Exercise Scientific
Advisory Panel, Nike’s Science Advisory Board, and chaired the
Gatorade® Sports Science Institute for several years.
- In March 2016, Michelle Stacy, former
President of Keurig Inc., joined the Board of Directors of Flex
Pharma. As the former president of Keurig, Inc. and former vice
president and general manager with Gillette/P&G, Ms. Stacy
brings a wealth of experience leading consumer businesses and
building global brands. During her five-year tenure at Keurig Inc.,
a division of Keurig Green Mountain, the company's revenue grew
from $493 million in FY2008 to $4.3 billion in FY2013.
Fourth Quarter & Full Year 2016 Financial Results
- Cash Position: As of December
31, 2016, Flex Pharma had cash, cash equivalents and marketable
securities of $61.1 million. During the three months ended December
31, 2016, cash, cash equivalents and marketable securities
decreased by $6.3 million. For the year ended December 31, 2016,
cash, cash equivalents and marketable securities decreased $32.6
million.
- Total Revenue: Total revenue for
the three months ended December 31, 2016, was approximately
$299,000, including approximately $291,000 of net product revenue
and approximately $8,000 of other revenue. Total revenue for the
year ended December 31, 2016 was approximately $1.0 million,
including approximately $990,000 of net product revenue and
approximately $21,000 of other revenue.
- Cost of Product Revenue: Cost of
product revenue for the three months ended December 31, 2016 was
approximately $134,000. Cost of product for the twelve months ended
December 31, 2016 was approximately $663,000 and included inventory
write offs of approximately $282,000.
- R&D Expense: Research and
development expense for the three months ended December 31, 2016
was $4.2 million and $20.4 million for the year ended December 31,
2016. Research and development expense for these time periods
primarily included costs associated with the Company’s clinical
studies of FLX-787, IND-supporting activities, personnel costs
(including salaries and stock-based compensation costs), and
external consultant costs.
- SG&A Expense: Selling,
general and administrative expense for the three months ended
December 31, 2016 was $3.9 million and $19.9 million for year ended
December 31, 2016. Selling, general and administrative expense for
these periods primarily included personnel costs (including
salaries and stock-based compensation costs), sales, marketing and
fulfillment costs related to launching the Company’s consumer brand
and HOTSHOT, legal costs, and external consultant costs.
- Net Loss and Cash Flow: Net loss
for the three months ended December 31, 2016 was ($7.9) million, or
($0.48) per share and included $1.2 million of stock compensation
expense. For the year ended December 31, 2016, net loss was ($39.5)
million, or ($2.43) per share and included $6.6 million of
stock-based compensation expense. As of December 31, 2016, Flex
Pharma had 16,773,798 shares of common stock outstanding. The net
loss for the fourth quarter of 2016, as well as for the year ended
December 31, 2016, was primarily driven by the Company’s operating
expenses related to its research and development efforts, costs
associated with the development and launch of the Company’s
consumer brand and 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 through early 2019.
Upcoming Events and Presentations
- Annual ROTH Conference, March 13-15,
2017 in Laguna Niguel, CA
- Oppenheimer Healthcare Conference,
March 21-22, 2017 in New York, NY
- Jefferies Healthcare Conference, June
6-9, 2017 in New York, NY
- JMP Securities Life Sciences
Conference, June 20-21, 2017 in New York, NY
Conference Call and Webcast
The company will host a conference call and webcast today at
8:30 a.m. ET to provide an update on the company and discuss full
year 2016 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 cramps and spasms
associated with the severe neurological diseases of ALS, MS and
peripheral neuropathies such as Charcot-Marie-Tooth (CMT). 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 Chair and CEO Christoph Westphal, M.D., Ph.D.
Forward-Looking StatementsThis 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: the design and timing
of ongoing and anticipated clinical studies, our expectations
regarding the availability of our capital resources, and our
commercialization plans for our consumer product. 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;
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, 2016 and subsequent filings with the Securities and
Exchange Commission (SEC). 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)
December 31,2016
December 31,2015
Assets Cash and cash equivalents $ 22,416 $ 66,687 Marketable
securities 38,659 26,965 Accounts receivable 12 — Inventory 454 —
Prepaid expenses and other current assets 926 909 Property and
equipment, net 556 382 Other assets 192 127 Total assets $
63,215 $ 95,070 Liabilities and stockholders' equity
Accounts payable and accrued expenses $ 3,780 $ 2,823 Deferred
revenue 88 — Other liabilities 30 55 Stockholders’ equity 59,317
92,192 Total liabilities and stockholders’ equity $ 63,215
$ 95,070
Unaudited Condensed
Consolidated Statements of Operations (in thousands, except
loss per share amounts) Three Months
EndedDecember 31, 2016 Three Months EndedDecember 31,
2015 Twelve Months EndedDecember 31, 2016 Twelve
Months EndedDecember 31, 2015 Net product revenue $ 291 $ — $ 990 $
— Other revenue 8 — 21 — Total revenue
299 — 1,011 — Costs and expenses: Cost of product revenue 134 — 663
— Research and development 4,231 3,309 20,378 12,749 Selling,
general and administrative 3,918 4,621 19,856
16,464 Total costs and expenses 8,283 7,930 40,897 29,213
Loss from operations (7,984 ) (7,930 ) (39,886 ) (29,213 )
Interest income, net 84 37 393 72 Net
loss $ (7,900 ) $ (7,893 ) $ (39,493 ) $ (29,141 ) Net loss
per share-basic and diluted $ (0.48 ) $ (0.51 ) $ (2.43 ) $ (2.08 )
Weighted-average number of common shares outstanding (1)
16,620 15,552 16,234 14,033
(1) As of December 31, 2016, the Company had issued
approximately 5.4 million shares of restricted stock that are
subject to vesting. Of these shares, approximately 4.2 million
shares had vested at December 31, 2016 and are outstanding for
purposes of computing weighted average shares outstanding. The
remaining shares will be included in the weighted average share
calculation as such shares vest over approximately the next 1.2
years.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170308005171/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
FLEX PHARMA, INC. (NASDAQ:FLKS)
Historical Stock Chart
From Mar 2024 to Apr 2024
FLEX PHARMA, INC. (NASDAQ:FLKS)
Historical Stock Chart
From Apr 2023 to Apr 2024