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Share Name | Share Symbol | Market | Type |
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Flex Pharma, Inc. | NASDAQ:FLKS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 0.6068 | 0.5751 | 0.6053 | 0 | 01:00:00 |
-- 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
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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
Fourth Quarter & Full Year 2016 Financial Results
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
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
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