-- Recent Positive Topline Data Reported from Exploratory Phase 2 Trial of FLX-787 in ALS --
-- Two US Phase 2b Trials in ALS and CMT Initiated under IND; Data Readouts in 2018 --
-- Development Efforts Expanding into Dysphasia --
Conference Call Scheduled Today at
“We are encouraged by the consistently positive impact of FLX-787 across
multiple efficacy endpoints related to cramping and the associated pain
from our small, exploratory Phase 2 trial in Australian ALS patients
that provides the first clinical evidence of effect for our lead
candidate in patients with underlying neurological disease. Our
development programs are steadily advancing. We have initiated our Phase
2b ALS trial under Fast Track designation, and, more recently, our Phase
2b CMT trial. These two studies, as well as the ongoing exploratory
spasticity study in MS in
Recent Business Highlights
In November, the Company announced positive topline data for
FLX-787 from its Australian ALS trial of patients who cramp
frequently. In the 8 patients who completed the trial per
protocol, FLX-787 demonstrated a statistically significant
percentage reduction from baseline in both cramp-associated pain
intensity (p<0.05) and stiffness (p<0.05), relative to placebo
control, based on Numerical Rating Scales (NRS). Strong and
consistent trends were demonstrated on multiple endpoints,
including: percentage reduction in the number of cramps from
baseline (p=0.08), increase in cramp free days from baseline
(p=0.09), and improvements on both Patient (PGIC; p=0.06) and
Clinician (CGIC; p=0.06) Global Impression of Change. FLX-787 was
generally well tolerated in all patients. In
July 2017, the Company announced that it had stopped this study after 12 patients were randomized.
- In October, the Company initiated a Phase 2b randomized, controlled, double-blinded, parallel design trial in the US, referred to as the COMMIT trial. The COMMIT trial will evaluate FLX-787, the Company’s co-activator of TRPA1 and TRPV1, in patients with Charcot-Marie-Tooth, who suffer from painful, debilitating cramps. The Company expects to report topline results from this study in the third quarter of 2018.
- In August, the Company initiated its Phase 2b randomized, controlled, double-blinded, parallel design trial in the US, referred to as the COMMEND trial, to evaluate FLX-787, the Company’s co-activator of TRPA1 and TRPV1, in patients with motor neuron disease (MND), focused on ALS, who suffer from cramps. The Company expects to report topline results from this study in the third quarter of 2018.
In July, the Company announced that the
Food and Drug Administration( FDA) granted Fast Track Designation for the development of FLX-787 to treat severe muscle cramps in patients with ALS. There are currently no drugs approved in the US for this condition. Fast Track Designation is intended to accelerate the clinical development and review of drugs to treat serious conditions that address an unmet medical need.
- In November, the Company announced positive topline data for FLX-787 from its Australian ALS trial of patients who cramp frequently. In the 8 patients who completed the trial per protocol, FLX-787 demonstrated a statistically significant percentage reduction from baseline in both cramp-associated pain intensity (p<0.05) and stiffness (p<0.05), relative to placebo control, based on Numerical Rating Scales (NRS). Strong and consistent trends were demonstrated on multiple endpoints, including: percentage reduction in the number of cramps from baseline (p=0.08), increase in cramp free days from baseline (p=0.09), and improvements on both Patient (PGIC; p=0.06) and Clinician (CGIC; p=0.06) Global Impression of Change. FLX-787 was generally well tolerated in all patients. In
For the quarter ended
September 30, 2017, the Company recorded approximately $414,000in total revenue for its consumer product, HOTSHOT®, launched in June 2016. The Company expects full year revenues for 2017 to exceed 2016.
- For the quarter ended
Strengthened Leadership Team
Flex Pharmaannounced that Roger Tung, Ph.D. was appointed to its Board of Directors. Dr. Tung is the scientific co-founder of Concert Pharmaceuticals, where he serves as President and CEO. Prior to Concert, Dr. Tung was a founding scientist at Vertex. Dr. Tung has more than 30 years of experience in the global biopharmaceutical industry.
In July, Flex Pharma’s Board of Directors appointed
William McVicar, Ph.D., as President and CEO. Dr. McVicar brings approximately 30 years of clinical development experience to the Company, formerly serving as the Company’s President of Research and Development. In June, Christoph Westphal, M.D., Ph.D., transitioned from his role as CEO and continues to serve on Flex Pharma'sBoard. Prior to joining Flex Pharma, Dr. McVicar served as Executive Vice President of Pharmaceutical Development, Chief Scientific Officer, and President during his tenure at Inotek. As Vice President of Development Operations at Sepracor, he oversaw the development, FDAreview, and approval of multiple NDAs and SNDAs, including BROVANA®, XOPENEX MDI®, and XOPENEX’s pediatric approval, which were each approved in a single 10-month review cycle. Prior to Sepracor, Dr. McVicar held various positions of increasing responsibility at Sandoz, Novartisand Rhone Poulenc Rorer.
- In October,
Third Quarter 2017 Financial Results
- Cash Position: As of
September 30, 2017, Flex Pharmahad cash, cash equivalents and marketable securities of $38.9 million. During the three months ended September 30, 2017, cash, cash equivalents and marketable securities decreased by $8.2 million.
- Total Revenue: Total revenue for the three months ended
September 30, 2017was approximately $414,000, including approximately $7,000of other revenue.
- Cost of Product Revenue: Cost of product revenue for the three
September 30, 2017was approximately $149,000.
- R&D Expense: Research and development expense for the three
September 30, 2017was $4.7 million. Research and development expense for this quarter 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
September 30, 2017was $4.9 million. Selling, general and administrative expense for this quarter 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
September 30, 2017was ($9.3) million, or ($0.54)per share and included $1.0 millionof stock-based compensation expense. As of September 30, 2017, Flex Pharmahad 17,541,377 shares of common stock outstanding, which excludes approximately 0.4 million shares of stock that remain subject to vesting. The net loss for the third quarter of 2017 was primarily driven by the Company’s operating expenses related to its research and development efforts, costs associated with HOTSHOT, and general and administrative costs.
Based on its current operating plans and cash, cash equivalents and
marketable securities position,
Conference Call and Webcast
Dial-in: (855) 780-7202 (US or
Replay: (855) 859-2056 (US or
Conference ID: 3497649
The live webcast and accompanying slides can be under the Investors
section of the company's website at www.flex-pharma.com.
A replay of the webcast will be available on
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Forward-looking statements include statements regarding our
intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things: the design and timing of
ongoing and anticipated clinical trials, including the timing for
results of our clinical trials, the level of future interaction we may
|Flex Pharma, Inc.|
|Unaudited Selected Consolidated Balance Sheet Information|
|Cash and cash equivalents||$||20,152||$||22,416|
|Prepaid expenses and other current assets||1,057||926|
|Property and equipment, net||401||556|
|Liabilities and stockholders' equity:|
|Accounts payable and accrued expenses||$||4,816||$||3,780|
|Total liabilities and stockholders’ equity||$||41,208||$||63,215|
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except loss per share amounts)|
|Net product revenue||$||407||$||586||$||978||$||699|
|Costs and expenses:|
|Cost of product revenue||149||221||373||529|
|Research and development||4,739||5,665||12,731||16,148|
|Selling, general and administrative||4,935||5,448||14,521||15,937|
|Total costs and expenses||9,823||11,334||27,625||32,614|
|Loss from operations||(9,409||)||(10,735||)||(26,633||)||(31,902||)|
|Interest income, net||77||98||228||309|
|Net loss per share-basic and diluted||$||(0.54||)||$||(0.65||)||$||(1.54||)||$||(1.96||)|
|Weighted-average number of common shares outstanding (1)||17,386||16,362||17,132||16,105|
|(1)||As of September 30, 2017, the Company had issued approximately 5.4 million shares of restricted stock that are subject to vesting. Of these shares, approximately 5.0 million shares had vested at September 30, 2017 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 0.4 years.|
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications