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Share Name | Share Symbol | Market | Type |
---|---|---|---|
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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.6068 | 0.5751 | 0.6053 | 0 | 01:00:00 |
-- Exploratory Phase 2 MS & ALS Studies with FLX-787 Underway --
-- HOTSHOTTM Net Product Revenue of $586,000 --
Conference Call Scheduled Today at 8:45 a.m. ET
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Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company developing innovative and proprietary treatments for nocturnal leg cramps (NLC), spasms associated with severe neuromuscular conditions such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS), and exercise-associated muscle cramps (EAMC), today reported financial results for the quarter ended September 30, 2016 and provided an update on its clinical development, consumer product launch and corporate activities.
"Over the past year we have gained important insights from our exploratory studies that will inform our human efficacy studies moving forward," said Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. "Our single agent candidate, chemically synthesized, TRP ion channel activator, FLX-787, has been studied in over 100 human subjects treated for several weeks at therapeutic doses, which provides an unusually extensive human safety and efficacy experience for an agent at this stage of development and bodes well for our Phase 2 studies."
"Our drug development efforts with FLX-787 in NLC, MS and ALS continue to advance," stated Christoph Westphal, M.D., Ph.D., Chair and CEO of Flex Pharma. "Flex is well funded through late 2018, and we remain committed to executing upon our mission of helping patients and consumers who suffer from debilitating cramps."
"On the consumer side, in just a few short months, we have over 15,000 unique customers and well over 50 professional and collegiate teams that have ordered HOTSHOT, representing a wonderful early platform for the brand," noted Kathie Lindemann, Chief Operating Officer of Flex Pharma. "The performance of HOTSHOT in its first full quarter post-launch demonstrates a healthy start to the consumer business, following our cult brand strategy targeted at endurance athletes."
Recent Business Highlights
Third Quarter 2016 Financial Results
Financial Guidance
On the basis of Flex Pharma's current operating plans, the Company expects that its current cash, cash equivalents and marketable securities position will be sufficient to fund its operations through late 2018, assuming no receipt of proceeds from potential business development partnerships, equity financings or debt drawdowns.
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 third quarter 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 nocturnal leg cramps, cramps and spasms associated with severe neuromuscular conditions such as MS and ALS, and exercise-associated muscle cramps. 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.
Visit www.TeamHOTSHOT.com for updates and to learn more about HOTSHOTTM, the Company’s consumer product which is scientifically proven to prevent and treat muscle cramps.
HOTSHOT is a consumer product that is marketed to endurance athletes for exercise-associated muscle cramps. HOTSHOT complements the Company’s drug development business and is not intended to diagnose, treat, cure or prevent any disease.
Follow Flex Pharma (@flexpharma) and HOTSHOT (@Team_HOTSHOT) on Twitter
Forward-Looking Statements
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 studies, our expectations regarding the availability of our capital resources, and our plans regarding the commercialization of 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, the commercialization of our consumer product; anticipated positioning and product attributes of 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 product 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, 2015 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)September 30,2016
December 31,2015
Assets Cash and cash equivalents $ 27,830 $ 66,687 Marketable securities 39,504 26,965 Accounts receivable 22 — Inventory 231 — Prepaid expenses and other current assets 1,554 909 Property and equipment, net 619 382 Other assets 191 127 Total assets $ 69,951 $ 95,070 Liabilities and stockholders' equity Accounts payable and accrued expenses $ 3,806 $ 2,823 Deferred revenue 81 — Other liabilities 36 55 Stockholders’ equity 66,028 92,192 Total liabilities and stockholders’ equity $ 69,951 $ 95,070 Unaudited Condensed Consolidated Statements of Operations (in thousands, except loss per share amounts)Three MonthsEnded
September 30,2016
Three MonthsEnded
September 30,2015
Nine MonthsEnded
September 30,2016
Nine MonthsEnded
September 30,2015
Net product revenue $ 586 $ — $ 699 $ — Other revenue 13 — 13 — Total revenue 599 — 712 — Costs and expenses: Cost of product revenue 221 — 529 — Research and development 5,665 3,445 16,148 9,440 Selling, general and administrative 5,448 4,722 15,937 11,843 Total costs and expenses 11,334 8,167 32,614 21,283 Loss from operations (10,735 ) (8,167 ) (31,902 ) (21,283 ) Interest income, net 98 14 309 34 Net loss $ (10,637 ) $ (8,153 ) $ (31,593 ) $ (21,249 ) Net loss per share-basic and diluted $ (0.65 ) $ (0.53 ) $ (1.96 ) $ (1.57 ) Weighted-average number of common shares outstanding (1) 16,362 15,290 16,105 13,520(1) As of September 30, 2016, the Company had issued approximately 5.4 million shares of restricted stock that are subject to vesting. Of these shares, approximately 4.0 million shares had vested at September 30, 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 1.4 years.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161102005519/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor Relations & Corporate Communicationsirdept@flex-pharma.com
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