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 2, 2017. |
Flex Pharma, Inc. | ||
Dated: August 2, 2017 | ||
By: | /s/ Robert Hadfield | |
Robert Hadfield | ||
General Counsel and Secretary |
Exhibit No. | Description | ||
99.1 | Press Release of Flex Pharma, Inc. dated August 2, 2017. |
• | Clinical Efforts |
• | 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 |
• | 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, MA in 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). |
• | Consumer Business |
• | For the quarter ended June 30, 2017, the Company recorded approximately $336,000 in 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. |
• | 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's Chairman 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, FDA review, 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, Novartis and Rhone Poulenc Rorer. |
• | Cash Position: As of June 30, 2017, Flex Pharma had 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, 2017 was approximately $336,000, including approximately $5,000 of other revenue. |
• | Cost of Product Revenue: Cost of product revenue for the three months ended June 30, 2017 was approximately $145,000. |
• | R&D Expense: Research and development expense for the three months ended June 30, 2017 was $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, 2017 was $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, 2017 was ($8.8) million, or ($0.51) per share and included $1.1 million of stock-based compensation expense. As of June 30, 2017, Flex Pharma had 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. |
• | H.C. Wainwright Rodman & Renshaw Annual Healthcare Conference, September 11-12, 2017 in New York, NY |
• | Cantor Fitzgerald Global Healthcare Conference, September 25-26, 2017 in New York, NY |
Flex Pharma, Inc. | ||||||
Unaudited Selected Consolidated Balance Sheet Information | ||||||
(in thousands) | ||||||
June 30, 2017 | December 31, 2016 | |||||
Assets: | ||||||
Cash and cash equivalents | $ | 39,127 | $ | 22,416 | ||
Marketable securities | 7,996 | 38,659 | ||||
Accounts receivable | 35 | 12 | ||||
Inventory | 688 | 454 | ||||
Prepaid expenses and other current assets | 1,209 | 926 | ||||
Property and equipment, net | 448 | 556 | ||||
Other assets | 127 | 192 | ||||
Total assets | $ | 49,630 | $ | 63,215 | ||
Liabilities and stockholders' equity: | ||||||
Accounts payable and accrued expenses | $ | 4,936 | $ | 3,780 | ||
Deferred revenue | 97 | 88 | ||||
Other liabilities | 92 | 30 | ||||
Stockholders’ equity | 44,505 | 59,317 | ||||
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 June 30, 2017 | Three Months Ended June 30, 2016 | Six Months Ended June 30, 2017 | Six Months Ended June 30, 2016 | ||||||||||
Net product revenue | $ | 331 | $ | 113 | $ | 571 | $ | 113 | |||||
Other revenue | 5 | — | 7 | — | |||||||||
Total revenue | 336 | 113 | 578 | 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 | $ | (8,805 | ) | $ | (11,363 | ) | $ | (17,073 | ) | $ | (20,956 | ) | |
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. |