Delaware | 001-36812 | 46-5087339 | ||
(State or other jurisdiction | (Commission File Number) | (IRS Employer Identification No.) | ||
of incorporation) |
800 Boylston Street, 24th Floor Boston, MA | 02199 | |
(Address of principal executive offices) | (Zip Code) |
Exhibit No. | Description | ||
99.1 | Press Release of Flex Pharma, Inc. dated August 3, 2016. |
Flex Pharma, Inc. | ||
Dated: August 3, 2016 | ||
By: | /s/ Robert Hadfield | |
Robert Hadfield | ||
General Counsel and Secretary |
Exhibit No. | Description | ||
99.1 | Press Release of Flex Pharma, Inc. dated August 3, 2016. |
• | Clinical Efforts |
• | On July 26, 2016, the Company announced the completion of enrollment, well ahead of plan, in a human proof-of-concept efficacy study in NLC which was initiated in May. The randomized, blinded, controlled, cross-over study is designed to evaluate the safety and efficacy of its single agent - a chemically synthesized, single molecule, transient receptor potential (TRP) ion channel activator, formulated as an orally disintegrating tablet - in over 50 subjects who suffer from nocturnal leg cramps on a frequent basis. |
• | In June 2016, the Company initiated a Phase 2 efficacy study in MS patients in Australia. The randomized, controlled, blinded, cross-over study is designed to evaluate the safety and efficacy of FLX-787, the Company’s single molecule, chemically synthesized, TRP ion channel activator, in up to 50 patients who suffer from cramps, spasms and/or spasticity as a consequence of MS. |
• | The Company expects to initiate a Phase 2 efficacy study in ALS patients in Australia in the coming months. The randomized, controlled, blinded, cross-over study is designed to evaluate the safety and efficacy of FLX-787, the Company’s single molecule, chemically synthesized, TRP ion channel activator, in up to 50 patients who suffer from cramps, spasms and/or spasticity as a consequence of ALS. |
• | In April 2016, the Company presented results from its positive human NLC study, which was selected as one of only 14 abstracts for late-breaking presentations at the American Academy of Neurology (AAN) Annual Meeting. In this randomized, controlled, blinded study of subjects with frequent nocturnal leg cramps, the Company’s extract formulation demonstrated statistically significant positive human efficacy on multiple key endpoints: muscle cramp frequency (p<0.05); cramp-free days (p<0.01); the physician-rated Clinical Global Impression of Change (CGI-C) (p<0.01); specific sleep disturbance measures (p<0.05); and specific pain measures (p<0.01). The positive effects were seen across a broad range of enrolled subjects; in addition, a subset of patients showed pronounced benefit. Additionally, the product appeared to be safe and well-tolerated and there were no serious adverse events reported. The topline results from this study were first reported in February 2016. |
• | Consumer Product Launch |
• | In April 2016, leading academics at The Pennsylvania State University (PSU) presented a positive effect of the Company’s proprietary formulation on athletic human muscle cramps at the Experimental Biology conference. The Company’s proprietary consumer product formulation showed a statistically significant benefit in reducing muscle cramps in athletes as compared to vehicle control (as measured by the intensity-duration profile of voluntarily induced muscle cramps). |
• | On June 2, 2016, the Company announced the launch of its cornerstone consumer product, HOTSHOTTM, the first scientifically proven formula to prevent and treat muscle cramps, on its branded website www.TeamHOTSHOT.com. The product also became available at select specialty retailers in Boston, Boulder and Los Angeles. For more information, please refer to the press release: SCIENTIFIC BREAKTHROUGH IN SPORTS NUTRITION TO CHANGE THE GAME FOR MILLIONS OF ENDURANCE ATHLETES |
• | At the American College of Sports Medicine (ACSM) Annual Meeting in Boston on June 2, 2016, Bruce Bean, Ph.D., Harvard Medical School Professor of Neurophysiology, Flex Pharma Co-Founder and Scientific Advisory Board Co-Chair, and Tom Wessel, M.D., Neurologist and Flex Pharma Chief Medical Officer, discussed this breakthrough in sports science during the symposium, “Etiology and Treatment of Exercise Associated Muscle Cramps.” |
• | During the week of July 11th, The Wall Street Journal published the article, “A New Way to Prevent Muscle Cramps”, discussing our breakthrough science behind HOTSHOTTM. The article was a top ranked story on wsj.com for a week. HOTSHOTTM has also been featured in several recent publications: Wired.com, Men’s Fitness online, LAVA Magazine (official magazine of IRONMAN®), Esquire online, and The Daily Burn. |
• | Cash Position: As of June 30, 2016, Flex Pharma had cash, cash equivalents and marketable securities of $74.9 million. During the quarter ended June 30, 2016, cash, cash equivalents and marketable securities decreased by $9.5 million. |
• | Net Revenue: Net revenue for the three months ended June 30, 2016 was $112,685, comprised primarily of sales from pre-launch orders and online purchases from June 2-9, 2016. |
• | Cost of Revenue: Cost of revenue for the three months ended June 30, 2016 was $110,931. Cost of revenue for the quarter included product costs of $35,313, manufacturing overhead costs of $34,918 and an inventory write-off of $40,700. |
• | R&D Expense: Research and development expense for the three months ended June 30, 2016 was $6.1 million. Research and development expense for the second quarter primarily included costs associated with the Company’s clinical studies of its single molecule, chemically synthesized, TRP ion channel activator, clinical studies of FLX-787, IND-supporting |
• | SG&A Expense: Selling, general and administrative expense for the three months ended June 30, 2016 was $5.4 million. Selling, general and administrative expense for this period primarily included personnel costs (including salaries and stock-based compensation costs), costs related to developing and launching the Company’s consumer brand and product, legal costs, and external consultant costs. |
• | Net Loss: Net loss for the three months ended June 30, 2016 was ($11.4) million, or ($0.71) per share. Net loss for the three months ended June 30, 2016 included $2.0 million of stock-based compensation expense. As of June 30, 2016, Flex Pharma had 16,260,781 shares of common stock outstanding, which excludes approximately 1.7 million shares of stock that remain subject to vesting. The net loss for the second quarter of 2016 was primarily driven by the Company’s operating expenses related to its research and development efforts, costs associated with the development and launch of the Company’s consumer brand and product, and general and administrative costs. |
• | BioCentury NewsMakers conference, September 9, 2016 in New York, NY |
• | Rodman & Renshaw conference, September 12-13, 2016 in New York, NY |
Flex Pharma, Inc. | ||||
Unaudited Selected Consolidated Balance Sheet Information | ||||
(in thousands) | ||||
June 30, 2016 | December 31, 2015 | |||
Assets | ||||
Cash and cash equivalents | $ | 38,941 | $ | 66,687 |
Marketable securities | 35,913 | 26,965 | ||
Accounts receivable | 12 | - | ||
Inventory | 274 | - | ||
Prepaid expenses and other current assets | 2,259 | 909 | ||
Property and equipment, net | 637 | 382 | ||
Other assets | 192 | 127 | ||
Total assets | $ | 78,228 | $ | 95,070 |
Liabilities and stockholders' equity | ||||
Accounts payable and accrued expenses | $ | 3,307 | $ | 2,823 |
Deferred revenue | 65 | - | ||
Other liabilities | 41 | 55 | ||
Stockholders’ equity | 74,815 | 92,192 | ||
Total liabilities and stockholders’ equity | $ | 78,228 | $ | 95,070 |
Unaudited Condensed Consolidated Statements of Operations | |||||||||
(in thousands, except loss per share amounts) | |||||||||
Three Months Ended June 30, 2016 | Three Months Ended June 30, 2015 | Six Months Ended June 30, 2016 | Six Months Ended June 30, 2015 | ||||||
Net revenue | $ | 113 | $ | - | $ | 113 | $ | - | |
Costs and expenses: | |||||||||
Cost of revenue | 111 | - | 308 | - | |||||
Research and development | 6,095 | 3,190 | 10,482 | 5,995 | |||||
Selling, general and administrative | 5,378 | 3,904 | 10,490 | 7,121 | |||||
Total costs and expenses | 11,584 | 7,094 | 21,280 | 13,116 | |||||
Loss from operations | (11,471) | (7,094) | (21,167) | (13,116) | |||||
Interest income, net | 108 | 16 | 211 | 20 | |||||
Net loss | $ | (11,363) | $ | (7,078) | $ | (20,956) | $ | (13,096) | |
Net loss per share–basic and diluted | $ | (0.71) | $ | (0.47) | $ | (1.31) | $ | (1.04) | |
Weighted-average number of common shares outstanding (1) | 16,106 | 15,035 | 15,975 | 12,621 |
(1) | As of June 30, 2016, the Company had issued approximately 5.4 million shares of restricted stock that are subject to vesting. Of these shares, approximately 3.7 million shares had vested at June 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 1.67 years. |