-- FLX-787 Granted Fast Track Designation for ALS --
-- US Phase 2 ALS Trial Initiated under IND --
-- US Phase 2 CMT Trial Commencing Third Quarter --
Conference Call Scheduled Today at
“We have accomplished a number of important development objectives over
these past few months. First and foremost, the recent Fast Track
designation represents a validation by
Recent Business Highlights
- In early August, the Company initiated its Phase 2 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 middle 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 addition, the Company announced that it has prioritized the larger US Phase 2 ALS trial over the small, exploratory Australian ALS study due to several advantages of the US Phase 2 ALS trial. As a result, the exploratory Australian ALS study will end early, with roughly a dozen patients.
In June, the
Inherited Neuropathies Consortium(INC) voted to endorse the Company’s US Phase 2 Trial of FLX-787 in CMT patients who suffer from cramps. The INC is an integrated group of academic medical centers, patient support organizations, and clinical research resources dedicated to conducting clinical research in CMT and to improving the care of patients (www.rarediseasesnetwork.org/cms/inc). There are currently no drug products approved in the US for this condition. The Company expects to begin enrolling US patients during the third quarter in this randomized, controlled, double-blinded, parallel design study, referred to as the COMMIT trial.
- In April, the Company's investigational new drug (IND) application for FLX-787 for patients with ALS became effective, allowing the Company to commence its US Phase 2 clinical trial of FLX-787 in ALS patients who suffer from cramps as a consequence of the disease.
In its abstract titled, “Chemical Neuro Stimulation by FLX-787, a
co-activator of TRPA1/TRPV1, for the Potential Treatment of
Cramps, Spasms and Spasticity,” the Company presented human
efficacy data from its study in nocturnal leg cramps (NLC) at the
American Academy of Neurology(AAN) 69th Annual Meeting in Boston, MAin April. When a neurologist evaluated, in a blinded manner, subjects likely to have NLC based upon a questionnaire administered after the study was completed, the data from first treatment exposure of these 26 subjects showed a statistically significant effect in the reduction in cramp frequency when compared to placebo (p=0.03).
For the quarter ended
June 30, 2017, the Company recorded approximately $336,000in total revenue for its consumer product, HOTSHOT®, launched in June 2016. The Company expects full year revenues for 2017 to exceed 2016.
- IRONMAN® and HOTSHOT, the only scientifically proven solution for preventing and treating muscle cramps, have partnered to designate HOTSHOT as the Official Muscle Cramp Product of the IRONMAN US Series. To aid athletes, HOTSHOT will be on-course at all the remaining 2017 IRONMAN events in the US, as well as at the 2017 IRONMAN and IRONMAN 70.3 World Championship events.
- For the quarter ended
Strengthened Leadership Team
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 as Flex Pharma'sChairman of the Board. 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 July, Flex Pharma’s Board of Directors appointed
Second Quarter 2017 Financial Results
- Cash Position: As of
June 30, 2017, Flex Pharmahad cash, cash equivalents and marketable securities of $47.1 million. During the three months ended June 30, 2017, cash, cash equivalents and marketable securities decreased by $5.7 million.
- Total Revenue: Total revenue for the three months ended
June 30, 2017was approximately $336,000, including approximately $5,000of other revenue.
- Cost of Product Revenue: Cost of product revenue for the three
June 30, 2017was approximately $145,000.
- R&D Expense: Research and development expense for the three
June 30, 2017was $4.1 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
June 30, 2017was $5.0 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 costs and external consultant costs.
- Net Loss and Cash Flow: Net loss for the three months ended
June 30, 2017was ($8.8) million, or ($0.51)per share and included $1.1 millionof stock-based compensation expense. As of June 30, 2017, Flex Pharmahad 17,285,926 shares of common stock outstanding, which excludes approximately 0.7 million shares of stock that remain subject to vesting. The net loss for the second quarter of 2017 was primarily driven by the Company’s operating expenses related to its research and development efforts, costs associated with HOTSHOT, and general and administrative costs.
Based on its current operating plans and cash, cash equivalents and
marketable securities position,
Upcoming Events and Presentations
H.C. Wainwright Rodman& Renshaw Annual Healthcare Conference, September 11-12, 2017in New York, NY Cantor Fitzgerald Global Healthcare Conference, September 25-26, 2017in New York, NY
Conference Call and Webcast
The company will host a conference call and webcast today at
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the design and timing of ongoing and anticipated clinical trials, including the timing for results of our clinical trials, the level of future interaction we may have with
|Flex Pharma, Inc.|
|Unaudited Selected Consolidated Balance Sheet Information|
|Cash and cash equivalents||$||39,127||$||22,416|
|Prepaid expenses and other current assets||1,209||926|
|Property and equipment, net||448||556|
|Liabilities and stockholders' equity:|
|Accounts payable and accrued expenses||$||4,936||$||3,780|
|Total liabilities and stockholders’ equity||$||49,630||$||63,215|
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except loss per share amounts)|
Three Months Ended
Three Months Ended
Six Months Ended
Six Months Ended
|Net product revenue||$||331||$||113||$||571||$||113|
|Costs and expenses:|
|Cost of product revenue||145||111||224||308|
|Research and development||4,076||6,095||7,991||10,482|
|Selling, general and administrative||4,991||5,378||9,586||10,490|
|Total costs and expenses||9,212||11,584||17,801||21,280|
|Loss from operations||(8,877||)||(11,471||)||(17,223||)||(21,167||)|
|Interest income, net||72||108||150||211|
|Net loss per share-basic and diluted||$||(0.51||)||$||(0.71||)||$||(1.00||)||$||(1.31||)|
|Weighted-average number of common shares outstanding (1)||17,130||16,106||17,003||15,975|
(1) As of
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications