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-- 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 8:45 a.m. ET
Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology company that is developing innovative and proprietary treatments for cramps and spasticity associated with severe neurological diseases such as multiple sclerosis (MS), Charcot-Marie-Tooth (CMT) and amyotrophic lateral sclerosis (ALS) under FDA Fast Track designation, today reported financial results for the quarter ended June 30, 2017 and provided an update on its clinical development and corporate activities.
“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 FDA that cramps are a severe, unmet medical need in ALS. We see greater collaboration with FDA under Fast Track as an important catalyst in our efforts toaccelerate the development of FLX-787 to address the suffering of patients with painful, debilitating cramps as a consequence of their severe neurological disease,” stated Dr. William McVicar, President and CEO of Flex Pharma. “In addition, our IND became effective, allowing us to expand our clinical program to the US, and we have now initiated our Phase 2 ALS trial, with our Phase 2 CMT trial soon to follow. The team is focused on the execution of these new Phase 2 IND studies, as well as completion of the ongoing exploratory Phase 2 spasticity study in MS in Australia. These studies are expected to yield several important data readouts in 2018.”
Recent Business Highlights
Second Quarter 2017 Financial Results
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 into early 2019.
Upcoming Events and Presentations
Conference Call and Webcast
The company will host a conference call and webcast today at 8:45 a.m. ET to provide an update on the company and discuss financial results for the second quarter of 2017. To access the conference call, please dial (855) 780-7202 (US 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 clinical-stage biotechnology company that is developing innovative and proprietary treatments for cramps 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 Chair Christoph Westphal, M.D., Ph.D.
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 FDA, our expectations relating to HOTSHOT revenue 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 and drive customers to purchase HOTSHOT; 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|
|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 June 30, 2017, the Company had issued approximately 5.4 million shares of restricted stock that are subject to vesting. Of these shares, approximately 4.8 million shares had vested at June 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 0.7 years.
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications
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