Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 01, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | Flex Pharma, Inc. | ||
Entity Central Index Key | 1,615,219 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Common Stock, Shares Outstanding | 18,069,476 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Shell Company | false | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 9.8 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 9,829,624 | $ 19,186,036 |
Restricted cash | 126,595 | 0 |
Marketable securities | 0 | 14,129,723 |
Accounts receivable | 9,939 | 10,385 |
Inventory | 186,920 | 431,891 |
Prepaid expenses and other current assets | 162,088 | 777,102 |
Total current assets | 10,315,166 | 34,535,137 |
Property and equipment, net | 74,460 | 331,040 |
Restricted cash | 0 | 126,595 |
Total assets | 10,389,626 | 34,992,772 |
Current liabilities: | ||
Accounts payable | 342,530 | 2,004,440 |
Accrued expenses and other current liabilities | 764,340 | 3,712,221 |
Deferred revenue | 0 | 72,188 |
Deferred rent, current portion | 0 | 58,821 |
Total current liabilities | 1,106,870 | 5,847,670 |
Deferred rent, net of current portion | 0 | 39,214 |
Total liabilities | 1,106,870 | 5,886,884 |
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at December 31, 2018 and December 31, 2017; none issued or outstanding at December 31, 2018 and December 31, 2017 | 0 | 0 |
Common stock, $0.0001 par value; 100,000,000 shares authorized at December 31, 2018 and December 31, 2017, 18,069,476 and 17,972,166 shares issued at December 31, 2018 and December 31, 2017, respectively, and 18,067,392 and 17,797,178 shares outstanding at December 31, 2018 and December 31, 2017, respectively | 1,807 | 1,780 |
Additional paid-in capital | 142,242,224 | 140,184,630 |
Accumulated other comprehensive loss | 0 | (1,247) |
Accumulated deficit | (132,961,275) | (111,079,275) |
Total stockholders' equity | 9,282,756 | 29,105,888 |
Total liabilities and stockholders' equity | $ 10,389,626 | $ 34,992,772 |
CONSOLIDATED BALANCE SHEET (PAR
CONSOLIDATED BALANCE SHEET (PARENTHETICAL) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (shares) | 0 | 0 |
Preferred stock, shares outstanding (shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (shares) | 18,069,476 | 17,972,166 |
Common stock, shares outstanding (shares) | 18,067,392 | 17,797,178 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Total revenue | $ 838,142 | $ 1,274,499 | $ 1,010,663 |
Costs and expenses: | |||
Cost of product revenue | 430,750 | 506,530 | 662,747 |
Research and development | 11,908,294 | 16,989,911 | 20,378,161 |
Selling, general and administrative | 10,573,321 | 18,503,684 | 19,855,987 |
Total costs and expenses | 22,912,365 | 36,000,125 | 40,896,895 |
Loss from operations | (22,074,223) | (34,725,626) | (39,886,232) |
Interest income, net | 152,006 | 291,964 | 393,109 |
Net loss | (21,922,217) | (34,433,662) | (39,493,123) |
Net loss attributable to common stockholders | $ (21,922,217) | $ (34,433,662) | $ (39,493,123) |
Net loss per share attributable to common stockholders - basic and diluted (in usd per share) | $ (1.22) | $ (1.99) | $ (2.43) |
Weighted-average number of common shares outstanding — basic and diluted (shares) | 18,016,841 | 17,260,626 | 16,233,985 |
Net product revenue | |||
Total revenue | $ 826,515 | $ 1,260,973 | $ 989,918 |
Other revenue | |||
Total revenue | $ 11,627 | $ 13,526 | $ 20,745 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (21,922,217) | $ (34,433,662) | $ (39,493,123) |
Other comprehensive gain: | |||
Change in net unrealized gains on available-for-sale securities | 1,247 | 367 | 23,040 |
Comprehensive loss | $ (21,920,970) | $ (34,433,295) | $ (39,470,083) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Total | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Preferred stock, shares outstanding, beginning balance at Dec. 31, 2015 | 0 | |||||
Equity, beginning balance at Dec. 31, 2015 | $ 92,192,408 | $ 0 | $ 1,574 | $ 129,367,978 | $ (24,654) | $ (37,152,490) |
Common stock, shares outstanding, beginning balance at Dec. 31, 2015 | 15,741,618 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Vesting of restricted common stock (shares) | 1,023,664 | |||||
Vesting of restricted common stock | $ 0 | $ 102 | (102) | |||
Issuance of common stock from option exercises (shares) | 8,516 | 8,516 | ||||
Issuance of common stock from option exercises | $ 22,098 | $ 2 | 22,096 | |||
Stock-based compensation expense | 6,572,963 | 6,572,963 | ||||
Unrealized gain on available-for-sale securities | 23,040 | 23,040 | ||||
Net loss | (39,493,123) | (39,493,123) | ||||
Preferred stock, shares outstanding, ending balance at Dec. 31, 2016 | 0 | |||||
Equity, ending balance at Dec. 31, 2016 | 59,317,386 | $ 0 | $ 1,678 | 135,962,935 | (1,614) | (76,645,613) |
Common stock, shares outstanding, ending balance at Dec. 31, 2016 | 16,773,798 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Vesting of restricted common stock (shares) | 1,021,804 | |||||
Vesting of restricted common stock | $ 0 | $ 102 | (102) | |||
Issuance of common stock from option exercises (shares) | 1,576 | 1,576 | ||||
Issuance of common stock from option exercises | $ 2,632 | 2,632 | ||||
Stock-based compensation expense | 4,219,165 | 4,219,165 | ||||
Unrealized gain on available-for-sale securities | 367 | 367 | ||||
Net loss | $ (34,433,662) | (34,433,662) | ||||
Preferred stock, shares outstanding, ending balance at Dec. 31, 2017 | 0 | 0 | ||||
Equity, ending balance at Dec. 31, 2017 | $ 29,105,888 | $ 0 | $ 1,780 | 140,184,630 | (1,247) | (111,079,275) |
Common stock, shares outstanding, ending balance at Dec. 31, 2017 | 17,797,178 | 17,797,178 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Vesting of restricted common stock (shares) | 172,904 | |||||
Vesting of restricted common stock | $ 0 | $ 17 | (17) | |||
Issuance of common stock from option exercises (shares) | 97,310 | 97,310 | ||||
Issuance of common stock from option exercises | $ 118,010 | $ 10 | 118,000 | |||
Stock-based compensation expense | 1,939,611 | 1,939,611 | ||||
Unrealized gain on available-for-sale securities | 1,247 | 1,247 | ||||
Net loss | $ (21,922,217) | (21,922,217) | ||||
Preferred stock, shares outstanding, ending balance at Dec. 31, 2018 | 0 | 0 | ||||
Equity, ending balance at Dec. 31, 2018 | $ 9,282,756 | $ 0 | $ 1,807 | $ 142,242,224 | $ 0 | $ (132,961,275) |
Common stock, shares outstanding, ending balance at Dec. 31, 2018 | 18,067,392 | 18,067,392 |
CONSOLIDATED STATEMENT OF CASH
CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (21,922,217) | $ (34,433,662) | $ (39,493,123) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 228,158 | 324,548 | 277,231 |
Stock-based compensation expense | 1,939,611 | 4,219,165 | 6,572,963 |
Amortization and accretion on investments | 11,537 | (68,139) | 16,161 |
Other non-cash items | 20,310 | 1,781 | 3,434 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 7,206 | 1,796 | (12,181) |
Inventory | 227,979 | 22,241 | (454,132) |
Prepaid expenses and other current assets | 600,121 | 148,881 | (17,409) |
Other assets | 0 | 64,800 | (64,800) |
Accounts payable | (1,661,910) | 819,357 | 309,437 |
Accrued expenses and other current liabilities | (2,951,420) | 1,124,648 | 746,879 |
Deferred revenue | 0 | (16,156) | 88,344 |
Deferred rent | (98,035) | 68,542 | (9,475) |
Other long term liabilities | 0 | 0 | (15,442) |
Net cash used in operating activities | (23,598,660) | (27,722,198) | (32,052,113) |
Investing activities | |||
Purchases of marketable securities | (1,997,751) | (32,987,697) | (38,682,081) |
Proceeds from maturities and sales of marketable securities | 16,117,184 | 57,585,413 | 26,995,324 |
Purchases of property and equipment | 0 | (113,498) | (559,378) |
Proceeds from sales of property and equipment | 4,805 | 5,344 | 5,255 |
Net cash provided by (used in) investing activities | 14,124,238 | 24,489,562 | (12,240,880) |
Financing activities | |||
Proceeds from exercise of common stock | 118,010 | 2,632 | 22,098 |
Net cash provided by financing activities | 118,010 | 2,632 | 22,098 |
Net decrease in cash, cash equivalents and restricted cash | (9,356,412) | (3,230,004) | (44,270,895) |
Cash, cash equivalents and restricted cash at beginning of period | 19,312,631 | 22,542,635 | 66,813,530 |
Cash, cash equivalents and restricted cash at end of period | 9,956,219 | 19,312,631 | 22,542,635 |
Supplemental cash flow information | |||
Property and equipment purchases included in accounts payable | $ 0 | $ 0 | $ 7,100 |
Organization and operations
Organization and operations | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and operations | Organization and operations The Company Flex Pharma Inc. (the “Company”) is a biotechnology company that was previously focused on developing innovative and proprietary treatments for muscle cramps, spasms and spasticity associated with severe neurological conditions. In June 2018, the Company announced that it was ending the Company's ongoing Phase 2 clinical trials of the Company's lead drug product candidate, FLX-787, in patients with motor neuron disease, or MND, primarily with amyotrophic lateral sclerosis, or ALS, and in patients with Charcot-Marie-Tooth disease, or CMT, due to oral tolerability concerns observed in both studies. The wind-down of the activities associated with these studies was completed in the third quarter of 2018. In 2016, the Company launched its consumer product, HOTSHOT®, to prevent and treat exercise-associated muscle cramps, or EAMCs. The Company continues to market and sell HOTSHOT to endurance athletes who drink it before, during and after exercise to prevent and treat EAMCs. In June 2018, the Company initiated a process to explore a range of strategic alternatives for enhancing stockholder value, including the potential sale or merger of the Company. Wedbush PacGrow was engaged to act as its strategic financial advisor at that time. The Company also announced the restructuring of its organization to reduce the Company's cost structure. In connection with the restructuring plan, the Company reduced its workforce by approximately 60% , with the reduction completed as of September 30, 2018. Following an extensive process of evaluating strategic alternatives for the Company, including identifying and reviewing potential candidates for a strategic acquisition or other transaction, on January 3, 2019, the Company entered into an Agreement and Plan of Merger, or the Merger Agreement, with Salarius Pharmaceuticals, LLC, or Salarius, under which the privately-held Salarius will merge with a wholly-owned subsidiary of the Company. If the merger is completed, the business of Salarius will continue as the business of the combined company. The Company operates as two reportable segments, Consumer Operations and Drug Development. See Note 16 for additional discussion and information on the Company's reportable segments. Liquidity The Company has incurred an accumulated deficit of $132,961,275 from February 26, 2014 (inception) through December 31, 2018 . The Company had cash and cash equivalents of $9,829,624 at December 31, 2018 . The Company's operating plan assumes limited research and development activities and that the Consumer Operations segment will continue to sell HOTSHOT. In the event that the Company does not complete the merger with Salarius, the Company (i) may elect to pursue a dissolution and liquidation of the Company, (ii) pursue another strategic transaction or (iii) may continue to market HOTSHOT and operate its consumer business. If the Company dissolves and liquidates, the Company's common stockholders may lose their entire investment. The amount of assets available for distribution to the Company's stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will be needed for commitments and contingent liabilities. Based on the Company's operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to allow the Company to fund its current operating plan for at least 12 months from the date the financial statements are issued. The Company cannot predict the outcome of the merger or whether and to what extent it will resume drug development activities for FLX-787 or other drug product candidates and to what extent it will promote and sell HOTSHOT or other consumer products in the future. Accordingly, it is difficult to predict future cash needs. Management does expect the Company to incur losses for the foreseeable future. The Company's ability to achieve profitability in the future is dependent upon achieving a level of revenues adequate to support the Company's cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital. If the Company raises funds through the sale of equity or convertible debt securities, the issuance of those securities could result in substantial dilution of the stockholders' ownership in the Company. There can be no assurances, however, that additional funding will be available on terms acceptable to the Company, or at all. |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | Summary of significant accounting policies Basis of presentation and use of estimates The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP"). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as found in the Accounting Standards Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company's management evaluates its estimates, which include, but are not limited to, estimates related to inventory write-offs, clinical study accruals, stock-based compensation expense, and amounts of expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: TK Pharma, Inc., a Massachusetts Securities Corporation, Flex Innovation Group LLC, a Delaware limited liability company which contains the Company's consumer-related operations, and Falcon Acquisition Sub, LLC, a Delaware limited liability company established for purposes of the merger. All significant intercompany balances and transactions have been eliminated in consolidation. Concentration of risk The Company outsources the manufacture of HOTSHOT to a single co-packer that produces bottled finished goods. The Company also sources certain raw materials from sole suppliers. A disruption in the supply of materials or the production of finished goods could significantly impact the Company's revenues in the future as alternative sources of raw materials and co-packing may not be available at commercially reasonable rates or within a reasonably short period of time. In addition, the inventory of HOTSHOT is concentrated in one warehouse location. Any significant disruption to the operation of the warehouse location for any reason, such as a power failure, equipment breakdown, workforce disruption, or natural or similar disasters, could materially adversely affect the Company's product distribution and sales. Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company and the Company's chief operating decision maker, the Company's Chief Executive Officer, and management, view the Company's operations and manage its business as two operating segments, Drug Development and Consumer Operations (see Note 16). The Company operates in one geographic segment, the United States. Concentrations of credit risk and off-balance sheet risk Cash and cash equivalents are financial instruments that potentially subject the Company to concentrations of credit risk. The Company held no marketable securities as of December 31, 2018 . The Company's cash and cash equivalents are held in accounts at financial institutions that management believes are creditworthy. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no financial instruments with off-balance sheet risk of loss. Revenue Revenue is comprised of net product revenue and other revenue. Net product revenue includes sales of HOTSHOT bottled finished goods to e-commerce customers, specialty retailers and sports teams, including professional and collegiate teams. Other revenue consists of payments made by customers for expedited shipping and handling. On January 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (" ASC 606 "), using the modified retrospective method applied to contracts not yet completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and are reported in accordance with the Company's historical accounting under ASC Topic 605, Revenue Recognition (" ASC 605 ") . Under ASC 605 and through December 31, 2017, revenue was recognized when persuasive evidence of an arrangement existed, delivery of the product occurred, the sales price was fixed or determinable and collectability was reasonably assured. The Company generally provided refunds to e-commerce customers, upon request, within 30 days of delivery. As the Company did not have adequate history to accurately estimate refunds, all e-commerce sales, and their related costs, were deferred and revenue was recognized once the refund period lapsed. This deferral represents total deferred revenue presented on the Company's consolidated balance sheet at December 31, 2017. For specialty retailers and sports teams, the Company did not offer a right of return or refund and revenue was recognized at the time products were delivered to customers. Discounts provided to customers were accounted for as a reduction of product revenue. Upon the adoption of ASC 606 on January 1, 2018, revenue is recognized when control of the promised goods is transferred to the customer, upon delivery to the customer, in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for those goods. See Note 3 for further discussion of revenue. Accounts receivable and allowance for doubtful accounts Accounts receivable are stated at their carrying values, net of any allowances for doubtful accounts. Accounts receivable consist primarily of amounts due from specialty retailers and sports teams, for which collectability is reasonably assured. Receivables are evaluated for collectability on a regular basis and an allowance for doubtful accounts is recorded, if necessary. No allowance for doubtful accounts was deemed necessary at December 31, 2018 and December 31, 2017 . Cost of product revenue Cost of product revenue includes the cost of raw materials utilized to produce HOTSHOT, co-packing fees, repacking fees, in-bound freight charges and warehouse and transportation costs incurred to bring HOTSHOT finished goods to salable condition. All other costs incurred after this condition is met are considered selling costs and included in selling, general and administrative expenses. Cost of product revenue also includes write-offs for inventory that has become obsolete, has a cost basis in excess of its estimated realizable value, or exceeds projected sales, as well as depreciation expense related to manufacturing equipment purchased to support production and royalty amounts payable to certain of the Company's founders on HOTSHOT sales. Inventory The Company launched HOTSHOT in the second quarter of 2016 and began capitalizing inventory costs associated with HOTSHOT in the first quarter of 2016, when it was determined that the inventory costs had probable future economic benefit. Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out ("FIFO") basis. The Company outsources the manufacture of HOTSHOT to a co-packer. Inventory at December 31, 2018 includes raw materials available for future production runs, as well as finished goods. The Company periodically analyzes its inventory levels and writes down inventory that has become obsolete, has a cost basis in excess of its estimated realizable value, or exceeds projected sales. Estimates of excess inventory consider factors such as inventory levels, production requirements, projected sales and the estimated shelf-lives of inventory components. Inventory write-offs are recorded as a component of cost of product revenue. Advertising expense Advertising expense consists of media and production costs related to print and digital advertising. All advertising is expensed as incurred. Total advertising expenses are included in selling, general and administrative and were approximately $822,000 , $3,566,000 and $2,936,000 for the years ended December 31, 2018 , December 31, 2017 and December 31, 2016 , respectively. Shipping and handling costs Shipping and handling costs related to the movement of inventory to the Company's co-packer and from the co-packer to the Company's third-party warehousing and fulfillment partners is capitalized as inventory and expensed as a cost of product revenue when revenue is recognized. Shipping and handling costs to move finished goods from the Company's warehousing and third-party fulfillment partners to customer locations are included in selling, general and administrative expense in the consolidated statement of operations, and were approximately $98,000 , $261,000 and $170,000 for the years ended December 31, 2018 , December 31, 2017 and December 31, 2016 , respectively. Restructuring-related costs The Company records employee termination costs in accordance with ASC Topic 712, Compensation - Nonretirement and Postemployment Benefits ("ASC 712"), if the termination benefits are paid as part of an ongoing benefit arrangement, which includes benefits provided as part of the Company's established severance policy or as part of an executive employment agreement. The Company accrues employee termination costs associated with an on-going benefit arrangement if the obligation is attributable to prior services rendered, the rights to the benefits have vested, the payment is probable, and the Company can reasonably estimate the liability. The Company accounts for employee termination benefits that represent a one-time benefit in accordance with ASC Topic 420, Exit or Disposal Cost Obligations ("ASC 420"). Upon communication of the termination to the employee, the Company expenses these costs over the employee’s future service period, if any. Restructuring-related costs are recorded within research and development expenses and selling, general and administrative expenses on the Company's consolidated statement of operations. Liabilities associated with the Company's restructuring activities are recorded as a component of accrued expenses and other current liabilities on its consolidated balance sheet. See Note 9 for additional information on the Company's current restructuring plan. Property and equipment Property and equipment are stated at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred, while costs of major additions and betterments are capitalized. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss is included in the results of operations. Depreciation is recorded, once assets are placed in service, using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Asset type Estimated useful life Computers and computer equipment 3 years Laboratory equipment 3 years Manufacturing equipment 3 years Website development costs 1-2 years Impairment of long-lived assets The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value. The Company has not recognized any impairment losses through December 31, 2018 . Research and development expense Research and development costs are charged to expense as incurred in performing research and development activities. The costs include employee compensation costs, clinical study costs, external consultant costs, regulatory costs and facilities and overhead costs. Facilities and overhead costs have primarily included the allocation of insurance, rent, utility and office-related expenses attributable to research and development personnel. The Company records payments made to outside vendors in advance of services performed or goods being delivered for use in research and development activities as prepaid expenses, which are expensed as services are performed or goods are delivered. Stock-based compensation expense The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation-Stock Compensation ("ASC 718"). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the statement of operations based on their grant date fair values. Compensation expense related to awards to employees with service conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to employees with performance conditions is recognized based on grant date fair value over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting date. In July 2018, the Company adopted ASU 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . Prior to the adoption of ASU 2018-07, the Company accounted for stock-based compensation arrangements with non-employees based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable, in accordance with the provisions of FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees . The measurement date for non-employee awards were generally the date performance of services required from the non-employee is complete, resulting in periodic adjustments to stock-based compensation expense during the vesting period for changes in the fair value of the awards. Stock-based compensation costs for non-employee service awards were recognized as services were provided, which was generally the vesting period, on a straight-line basis. The unvested portion of the awards was subject to re-measurement over the vesting period. Following the adoption of ASU 2018-07, the Company accounts for stock granted to non-employees in accordance with ASC 718 in the same manner as employee awards described above. The adoption did not have a material impact on the condensed consolidated financial statements and therefore a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year was not required. The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the estimated fair value of the Company's common stock on the measurement date. Due to the lack of significant trading history for the Company's common stock, it has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting the public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the volatility for the selected companies' shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options using the "simplified" method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid and does not expect to pay dividends in the foreseeable future. The Company does not apply a forfeiture rate to stock-based compensation expense and accounts for forfeitures as they occur. Income taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company has evaluated available evidence and concluded that the Company may not realize the benefit of its deferred tax assets; therefore, a valuation allowance has been established for the full amount of the deferred tax assets. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2018 and December 31, 2017 , the Company did not have any significant uncertain tax positions. The Company's practice is to recognize interest and/or penalties related to income tax matters in income tax expense. Net loss per share attributable to common stockholders Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period, determined using the treasury stock method and the if-converted method, for convertible securities, if inclusion of these is dilutive. For years ended December 31, 2018 , December 31, 2017 and December 31, 2016 , the Company has excluded the effects of all potentially dilutive shares from the weighted-average number of common shares outstanding as their inclusion in the computation for each period would be anti-dilutive due to the net loss per share incurred by the Company. Comprehensive loss Comprehensive loss is the change in equity of a company during a period from transactions and other events and circumstances, excluding transactions resulting from investments by owners and distributions to owners. Comprehensive loss includes net loss and the change in accumulated other comprehensive loss for the period. Accumulated other comprehensive loss consisted entirely of unrealized gains and losses on available-for-sale marketable securities for the years ended December 31, 2018 , December 31, 2017 and December 31, 2016 . Recent accounting pronouncements In May 2014, the FASB issued ASC 606 which supersedes the revenue recognition requirements in ASC 605 and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted ASC 606 as of January 1, 2018 using the modified retrospective transition method. See Note 3 for further details. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) ("ASU 2016-02"). The ASU requires lessees to recognize the assets and liabilities on their balance sheet for the rights and obligations created by most leases and continue to recognize expenses on their income statements over the lease term. It will also require disclosures designed to give financial statement users information on the amount, timing and uncertainty of cash flows arising from leases. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases . This ASU is intended to clarify, or correct unintended application of the guidance outlined in ASU No. 2016-02. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements . This ASU is intended to address comparative reporting requirements for initial adoption. The guidance is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those years. Based on the Company's evaluation of the effect of this standard, t he Company does not expect the adoption of this guidance to have a material effect on its consolidated financial statements and related disclosures. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”). ASU 2016-15 clarifies how entities should classify certain cash receipts and cash payments on the statement of cash flows with the objective of reducing the existing diversity in practice related to eight specific cash flow issues. The Company retrospectively adopted ASU No. 2016 in the first quarter of 2018, retrospectively , which did not impact the Company's condensed consolidated financial statements or disclosures. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (“ASU 2016-18”). ASU 2016-18 requires entities to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows. As a result, entities are no longer required to present transfers between cash and cash equivalents and restricted cash and restricted cash equivalents in the statement of cash flows. When cash, cash equivalents, restricted cash and restricted cash equivalents are presented in more than one line item on the balance sheet, the new guidance requires a reconciliation of the totals in the statement of cash flows to the related captions in the balance sheet. The Company adopted ASU No. 2016-18 in the first quarter of 2018, retrospectively, resulting in a change to the presentation of restricted cash on the condensed consolidated statement of cash flows. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of such amounts in the condensed consolidated statements of cash flows: December 31, 2018 December 31, 2017 Cash and cash equivalents $ 9,829,624 $ 19,186,036 Restricted cash 126,595 126,595 Cash, cash equivalents and restricted cash shown on the condensed consolidated statement of cash flows $ 9,956,219 $ 19,312,631 In May 2017, the FASB issued ASU No. 2017-09, Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), to provide clarity and reduce diversity in practice, cost and complexity when applying the guidance of Topic 718. The guidance is effective for fiscal years beginning after December 15, 2017 and interim periods within those years. Early adoption is permitted, and the guidance should be applied prospectively. The Company adopted ASU 2017-09 in the first quarter of 2018, which did not impact the Company's condensed consolidated financial statements or disclosures. In June 2018, the FASB issued ASU 2018-07. This ASU is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share-based compensation. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within that year. Early adoption is permitted, but not before an entity has adopted ASC 606, and the guidance should be applied using a modified retrospective transition approach. The Company early adopted ASU 2018-07 on July 1, 2018 and revalued its unvested nonemployee awards as of the July 1, 2018 adoption date. The adoption did not have a material impact on the condensed consolidated financial statements and therefore a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year was not required. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). This ASU modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement . The guidance is effective for annual reporting periods beginning after December 15, 2019, and interim periods within those years. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2018-13 on its consolidated financial statements and disclosures. The Company believes that the impact of other recently issued standards that are not yet effective will not have a material effect on its consolidated financial position or results of operations upon adoption. Subsequent events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements for potential recognition or disclosure in the consolidated financial statements. Subsequent events have been evaluated through the date these consolidated financial statements were issued for potential recognition or disclosure in the consolidated financial statements (see Note 19). |
Revenue from contracts with cus
Revenue from contracts with customers | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from contract with customers | Revenue from contracts with customers Adoption of ASC Topic 606, "Revenue from Contracts with Customers" On January 1, 2018, the Company adopted ASC 606 using the modified retrospective method applied to contracts not yet completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and are reported in accordance with the Company's historical accounting under ASC 605. The primary impact of the adoption of ASC 606 related to the timing of revenue recognized for e-commerce sales, due to e-commerce refund rights. Under ASC 606, the Company recognizes revenue when control of the promised good is transferred to the customer and reflects the consideration to which the Company expects to be entitled to receive in exchange for the good. This has resulted in accelerated revenue recognition for e-commerce sales, as under ASC 605, all revenue and related costs were deferred and recognized once the refund period lapsed. The cumulative effect of applying the new guidance to all contracts that were not completed as of January 1, 2018 was recorded as an adjustment to accumulated deficit of approximately $40,000 as of the adoption date, which was primarily the result of reducing deferred revenue by approximately $70,000 and deferred cost of product revenue and selling fees by approximately $30,000 , that were recorded on the consolidated balance sheet at December 31, 2017. The Company would have recognized approximately $44,000 of additional total revenue during the twelve months ended December 31, 2018 , respectively, if the Company had continued to recognize revenue under ASC 605. The adoption of ASC 606 did not impact income taxes, as the Company fully reserves its net deferred tax assets. Therefore, the change to the Company's net deferred tax asset position due to adoption was offset by a corresponding change to the valuation allowance. Revenue recognition Revenue includes sales of HOTSHOT bottled finished goods to e-commerce customers, specialty retailers and sports teams, including professional and collegiate teams. Revenue also consists of payments made by customers for expedited shipping and handling. The Company expenses fulfillment costs as incurred because the amortization period would be less than one year in accordance with the ASC 606 practical expedient. In accordance with ASC 606, the Company applies the following steps to recognize revenue for the sale of bottled finished goods that reflects the consideration to which the Company expects to be entitled to receive in exchange for the promised goods: 1. Identify the contract with a customer A contract with a customer exists when the Company enters into an enforceable contract with a customer. The contract is based on either the acceptance of standard terms and conditions on the websites for e-commerce customers, or the execution of terms and conditions contracts with specialty retailers and sports teams. These contracts define each party's rights, payment terms and other contractual terms and conditions of the sale. The Company applies judgment in determining the customer’s ability and intention to pay, which is based on a variety of factors including the customer’s historical payment experience and, in some circumstances, published credit and financial information pertaining to the customer. 2. Identify the performance obligations in the contract Performance obligations promised in a contract are identified based on the goods that will be transferred to the customer that are both capable of being distinct and are distinct in the context of the contract, whereby the transfer of the goods is separately identifiable from other promises in the contract. The Company has concluded the sale of bottled finished goods and related shipping and handling are accounted for as a single performance obligation. 3. Determine the transaction price The transaction price is determined based on the consideration to which the Company will be entitled to receive in exchange for transferring goods to the customer. For sales through June 18, 2018, the Company offered refunds to e-commerce customers, upon request, within 30 days of delivery. For sales subsequent to June 18, 2018, the Company now offers refunds to e-commerce customers, upon request, within 14 days of delivery. The Company estimates the amount of potential refunds at each reporting period using a portfolio approach of historical data, adjusted for changes in expected customer experience, including seasonality and changes in economic factors, as necessary. For specialty retailers and sports teams, the Company does not offer a right of return or refund and revenue is recognized at the time products are delivered to customers. Discounts provided to customers are accounted for as an element of the transaction price and as a reduction to revenue, and were approximately $38,000 , $278,000 , $135,000 and for the twelve months ended December 31, 2018 , December 31, 2017 , and December 31, 2016 , respectively. Revenue is presented net of taxes collected from customers and remitted to governmental authorities. 4. Determine the satisfaction of performance obligation Revenue is recognized when control of the bottled finished goods is transferred to the customer. Control of the bottled finished goods is transferred at a point in time, upon delivery to the customer. The period of time between the satisfaction of the performance obligation and when payment is due from the customer is not significant. Concentrations of credit risk The Company had no customers that represented greater than 10% of total revenue during the twelve months ended December 31, 2018 , December 31, 2017 , or December 31, 2016 . The vast majority of revenue was generated from sales within the United States. |
Restricted cash
Restricted cash | 12 Months Ended |
Dec. 31, 2018 | |
Cash and Cash Equivalents [Abstract] | |
Restricted cash | Restricted cash As of December 31, 2018 and December 31, 2017 , the Company had $126,595 of restricted cash in the form of a letter of credit. The Company maintained this letter of credit as a security deposit on the lease of its former corporate headquarters in Boston, Massachusetts that was set to expire on August 31, 2019. The Company terminated this lease on December 13, 2018 (see Note 10). The letter of credit was released, and the cash became unrestricted on January 4, 2019. |
Fair value measurements
Fair value measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Fair value measurements The Company records cash equivalents and marketable securities at fair value. ASC Topic 820, Fair Value Measurements and Disclosures established a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability. Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. The following table summarizes the cash equivalents and marketable securities measured at fair value on a recurring basis as of December 31, 2018 and December 31, 2017 : Level 1 Level 2 Level 3 Balance at December 31, 2018 Cash equivalents $ 2,333,771 $ — $ — $ 2,333,771 $ 2,333,771 $ — $ — $ 2,333,771 Level 1 Level 2 Level 3 Balance at December 31, 2017 Cash equivalents $ 5,046,205 $ — $ — $ 5,046,205 Marketable securities: U.S. government agency securities — 8,986,259 — 8,986,259 Commercial paper — 4,440,689 — 4,440,689 Corporate debt securities — 702,775 — 702,775 $ 5,046,205 $ 14,129,723 $ — $ 19,175,928 Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third-party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. The Company's cash equivalents consist of money market funds that are valued based on publicly available quoted market prices for identical securities as of December 31, 2018 . After completing its validation procedures, the Company did not adjust or override any fair value carrying amounts of as of December 31, 2018 . The carrying amounts reflected in the consolidated balance sheets for cash, restricted cash, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximate their fair values at December 31, 2018 and 2017 , due to their short-term nature. The Company evaluates transfers between levels at the end of each reporting period. There were no transfers of assets or liabilities between Level 1 and Level 2 during the year ended December 31, 2018 or during the year ended December 31, 2017 . The Company had no financial assets or liabilities that were classified as Level 3 at any point during the year ended December 31, 2018 or during the year ended December 31, 2017 . |
Cash equivalents and marketable
Cash equivalents and marketable securities | 12 Months Ended |
Dec. 31, 2018 | |
Cash and Cash Equivalents [Abstract] | |
Cash equivalents and marketable securities | Cash equivalents and marketable securities The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Cash equivalents as of December 31, 2018 and December 31, 2017 consisted of money market funds. The Company held no marketable securities as of December 31, 2018 . Marketable securities as of December 31, 2017 consisted of U.S. government agency securities, commercial paper and corporate debt securities. Management determines the appropriate classification of the securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. The Company classifies its marketable securities as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities . Marketable securities are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income (loss) in stockholders’ equity and a component of total comprehensive income (loss) in the consolidated statement of comprehensive income (loss), until realized. Realized gains and losses are included in investment income on a specific-identification basis. There were no realized gains on marketable securities during the years ended December 31, 2018 or December 31, 2017 . The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statement of operations if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period. The Company held no marketable securities at December 31, 2018 . Marketable securities at December 31, 2017 consisted of the following: Amortized Cost Unrealized Gains Unrealized Losses Fair Value As of December 31, 2017 Current (due within 1 year): U.S. government agency securities $ 8,987,254 $ 38 $ (1,033 ) $ 8,986,259 Commercial paper 4,440,689 — — 4,440,689 Corporate debt securities 703,027 — (252 ) 702,775 Total $ 14,130,970 $ 38 $ (1,285 ) $ 14,129,723 At December 31, 2017 , the Company held six debt securities that were in an unrealized loss position, all of which had been in a continuous loss position for less than 12 months. The aggregate fair value of securities in an unrealized loss position was $8,191,315 at and December 31, 2017 . There were no individual securities that were in a significant unrealized loss position as of December 31, 2017 . The Company evaluated its securities for other-than-temporary impairment and considered the decline in market value for the securities to be primarily attributable to economic and market conditions. The Company had the intent and ability to hold such securities until recovery. Based on this analysis, these marketable securities were not considered to be other-than-temporarily impaired as of December 31, 2017 . At December 31, 2017 , all investments held by the Company were classified as current. Investments classified as current have maturities of less than one year. Investments classified as noncurrent are those that (i) have a maturity greater than one year and (ii) management does not intend to liquidate within the next year, although these funds are available for use and therefore classified as available-for-sale. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory has been recorded at cost as of December 31, 2018 and December 31, 2017 . Costs capitalized at December 31, 2018 and December 31, 2017 relate to HOTSHOT finished goods and raw materials available to be used for future production runs. The following table presents inventory: December 31, 2018 December 31, 2017 Raw materials $ 7,247 $ 17,411 Finished goods 179,673 414,480 Total inventory $ 186,920 $ 431,891 In the second quarter of 2018, the Company wrote off raw materials that are not expected to be used in future production runs, as well as finished goods inventory no longer expected to be used. In 2017, the Company wrote off raw materials not expected to be used in future production runs and expiring finished goods not anticipated to be sold. In 2016, the Company wrote off raw materials purchased for production runs of HOTSHOT that were not expected to be used in future production runs, as well as finished goods not expected to be sold based upon projected sales, estimated product shelf life, the number of units produced and production level requirements. Write-offs totaled approximately $85,000 , $42,000 and $282,000 for the years ended December 31, 2018 , December 31, 2017 and December 31, 2016 , respectively, and are included in cost of product revenue in the accompanying consolidated statement of operations. |
Property and equipment, net
Property and equipment, net | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and equipment, net | Property and equipment, net Property and equipment, net consists of the following: December 31, 2018 December 31, 2017 Manufacturing equipment $ 421,999 $ 421,999 Computers and computer equipment 275,670 311,847 Website development costs 177,886 177,886 Laboratory equipment — 13,368 Capital in progress — 28,823 Total property and equipment 875,555 953,923 Accumulated depreciation (801,095 ) (622,883 ) Property and equipment, net $ 74,460 $ 331,040 Capital in progress consists of assets acquired but not yet placed into service. There was no capital in progress at December 31, 2018. At December 31, 2017 capital in progress consisted of computers and computer equipment. Depreciation expense was $228,158 , $324,548 and $277,231 for the years ended December 31, 2018 , December 31, 2017 , and December 31, 2016 , respectively. In 2018, the Company disposed of computer and computer equipment, laboratory equipment and capital in progress that was sold or no longer in use. Property and equipment disposals, net, for the year ended December 31, 2018 totaled $28,422 . The Company received proceeds of $4,805 related to these disposals, resulting in a loss of $23,617 , included in research and development expense and selling, general and administrative expense in the accompanying consolidated statement of operations. Disposals in prior years were immaterial. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accrued expenses and other current liabilities | Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following: December 31, 2018 December 31, 2017 Payroll and employee-related costs $ 417,997 $ 874,246 Professional fees 269,544 227,980 Restructuring-related costs 68,593 — Consumer product-related costs 5,360 107,595 Research and development costs 2,846 2,502,400 Total $ 764,340 $ 3,712,221 Restructuring-related costs In June 2018, the Company's Board of Directors ("Board") approved a corporate restructuring plan to reduce the Company's cost structure. In connection with the corporate restructuring plan, the Company reduced its workforce by approximately 60% , with the reduction completed as of September 30, 2018. Also, in June 2018, the Board approved employee retention arrangements and certain increased severance payments related to the corporate restructuring plan, to incentivize certain employees to remain with the Company through a potential sale or merger. As of December 31, 2018, the Company had paid $205,000 in retention bonuses and had paid or accrued approximately $186,000 in severance benefits associated with these arrangements. As of December 31, 2018, cash retention benefits totaling approximately $1,006,000 will be payable to the remaining employees and certain former employees who continue to provide service as consultants, upon the occurrence of a change in control event, including a sale or merger of the Company. Of this total, $603,000 relates to amounts payable to certain employees and former employees who continue to provide service as consultants only upon a change in control event, and $403,000 relates to amounts payable upon a change in control event or at certain timepoints through early 2019 if the individuals are employed by the Company and in good standing at the date of payment, even if a change in control event has not occurred. Upon a change in control event and termination without cause, the remaining employees will be eligible for up to approximately $928,000 , in the aggregate, of severance benefits. During the year ended December 31, 2018 , the Company recognized expense for restructuring-related activities of approximately $1,366,000 which is comprised of approximately $1,037,000 recorded as termination benefits under ongoing benefit arrangements for terminated employees, approximately $100,000 as one-time termination benefit costs for terminated employees, approximately $214,000 in retention benefits for retained employees and approximately $15,000 of other restructuring related costs, including consulting and legal fees. There are currently no assurances a change in control event will take place. The Company does not consider the payment of severance benefits for retained employees or the payment of retention benefits only payable upon a change in control to be probable for accounting purposes as of December 31, 2018 . On January 3, 2019, the Company entered into a Merger Agreement with Salarius. Unless and until the Company's shareholders have approved this specific transaction, the Company's probability assessment regarding a change in control event is not expected to change. The Company expects to incur between approximately $1,769,000 and $3,354,000 in total costs for its restructuring-related activities, including approximately $1,366,000 that was recorded during 2018, included in the table below and $403,000 related to the annual bonus program that was recorded during 2018, included in payroll and employee-related costs. Based on the Company's current probability assessment regarding a change in control event and termination of retained employees, there are no anticipated charges in 2019. The range noted above includes approximately $603,000 related to retention benefits only payable upon a change in control event and $928,000 of severance benefits only payable upon a change in control event and termination under certain circumstances. The following table outlines the Company's restructuring activities during the year ended December 31, 2018 : Accrued restructuring balance as of December 31, 2017 $ — Charges: Employee termination benefits 1,136,388 Employee retention benefits 214,417 Other 14,995 Payments (1,297,207 ) Accrued restructuring balance as of December 31, 2018 $ 68,593 The Company's accrued restructuring balance as of December 31, 2018 is included as a component of accrued expenses and other current liabilities on the Company's condensed consolidated balance sheet as of December 31, 2018 . For the twelve months ended December 31, 2018 , approximately $968,000 of the restructuring-related charges are included in research and development expenses and approximately $398,000 are included in selling, general and administrative expenses in the Company's condensed consolidated statement of operations. For the twelve months ended December 31, 2018 , approximately $81,000 of the restructuring-related charges were incurred by the Company's Consumer Operations segment, approximately $968,000 were incurred by the Company's Drug Development segment and the remaining charges of approximately $317,000 related to corporate costs. In total, the Company may incur restructuring-related charges of up to approximately $113,000 and $1,036,000 within the Company's Consumer Operations and Drug Development segments, respectively. The Company may incur up to $2,205,000 of corporate costs that do not relate to a reportable segment. |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies Lease commitments On April 29, 2014, the Company leased office space in Boston, Massachusetts for its former corporate headquarters. The lease for this office space was scheduled to expire on August 31, 2019 but was terminated on December 13, 2018. The company has no remaining obligations under this lease agreement as of December 31, 2018. On October 21, 2014, the Company leased office space in New York, New York under an operating lease that was originally scheduled to expire on October 31, 2018. In March 2017, the Company commenced a plan to transition its consumer operations from New York to Boston. In connection with this transition, the Company terminated its New York office operating lease and was released from any further obligations in July 2017. In November 2018, the Company leased space at a smaller office facility in Boston, Massachusetts. This lease expires upon at least one month's notice, resulting in minimum future lease payments of $2,350 . Rent expense is being recognized on a straight-line basis. The Company recorded approximately $351,000 , $522,000 and $337,000 of rent expense for the twelve months ended December 31, 2018 , December 31, 2017 and December 31, 2016 , respectively. Royalty agreement In March 2014, the Company entered into a royalty agreement with certain of its founders, or collectively the Founders. Under the agreement, the Company agreed to pay the Founders an aggregate royalty of 2% of gross sales of the Company's products in perpetuity. The Company began incurring royalty expense upon commencement of HOTSHOT sales during the second quarter of 2016. The Company recorded approximately $ 17,000 , $25,000 and $20,000 of royalty expense during the twelve months ended December 31, 2018 , December 31, 2017 and December 31, 2016 , respectively. Royalty amounts owed to the Founders as of December 31, 2018 , December 31, 2017 and December 31, 2016 were approximately $ 3,000 , $3,000 and $4,000 , respectively. In January 2019, the Founders entered into a royalty agreement with Flex Innovation Group LLC, which, in part, replaces the royalty agreement with Flex Pharma, Inc., described above, related to the sale of over the counter, non-prescription and/or nutritional supplement products. The royalty is payable over twenty years from the date of the agreement, with a 2% royalty due on product sales, as defined in the agreement, for the first ten years and a 1% royalty due for the following ten years. Litigation On March 1, 2019, a written demand was made on the Company by a purported shareholder requesting that additional information, including financial projections and valuation analyses, be made in the Company’s Registration Statement on Form S-4 relating to the proposed merger with Salarius. The demand stated, among other thing, that, if such disclosures are not made within a reasonable period of time, the shareholder intends to file a securities class action lawsuit in federal court. The Company will review the demand letter and respond appropriately. The Company does not have contingency reserves established for any litigation liabilities as of December 31, 2018 . |
Preferred stock
Preferred stock | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Preferred stock | Preferred stock As of December 31, 2018 , the Company is authorized to issue 10,000,000 shares of preferred stock ("Preferred Stock") with a par value of $0.0001 per share. The Company has not issued any shares of Preferred Stock as of December 31, 2018 . |
Common stock
Common stock | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Common stock | Common stock As of December 31, 2018 , the Company had authorized 100,000,000 shares of common stock, $0.0001 par value per share. Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors. The Company does not intend to declare dividends for the foreseeable future. Restricted common stock to founders In March 2014, the Company sold 4,553,415 shares of restricted common stock to the founders of the Company ("recipients"), for $0.0004 per share, for total proceeds of $1,950 . In April 2014, based upon anti-dilution provisions granted to the founders, an additional 867,314 shares of restricted common stock were sold to the same founders, after which the anti-dilution provisions were terminated. The restricted common stock vested 25% upon issuance, and the remaining 75% vested ratably over four years , during which time the Company had the right to repurchase the unvested shares held by a recipient if the relationship between such recipient and the Company ceased. Such shares were not accounted for as outstanding until they vested. Unvested restricted common stock awards to non-employees were re-measured at each vest date and each financial reporting date. All restricted common stock sold to the founders of the Company had vested as of December 31, 2018 and is no longer eligible for repurchase. The following is a summary of restricted common stock activity: Number of Shares Weighted-Average Grant Date Fair Value Unvested at December 31, 2017 169,654 $ 0.10 Issued — — Vested (169,654 ) 0.10 Forfeited — — Unvested at December 31, 2018 — $ — The total fair value of shares vested during the twelve months ended 2018 , 2017 and 2016 was approximately $725,000 , $3,840,000 and $9,646,000 respectively. Restricted common stock to consultants There were no shares of restricted common stock granted to non-employee consultants and advisors during 2018 or 2017 . During 2016, the Company granted a total of 18,194 of shares of restricted common stock to non-employee consultants and advisors. Such shares are not accounted for as outstanding until they vest. There were 16,110 shares of restricted common stock issued to consultants outstanding as of December 31, 2018 . Prior to July 1, 2018, unvested restricted common stock awards to non-employees were re-measured at each vest date and each financial reporting date. On July 1, 2018, the Company adopted ASU 2018-07 using a modified retrospective transition approach. As a result, the Company permanently revalued all unvested stock awards granted to non-employees as of July 1, 2018. The adoption-date fair value did not materially change from the fair value as of June 30, 2018 and therefore, a cumulative-effect adjustment was not required. The following is a summary of restricted common stock activity: Number of Shares Weighted-Average Grant Date Fair Value Unvested at December 31, 2017 5,334 $ 10.51 Issued — — Vested (3,250 ) 10.16 Forfeited — — Unvested at December 31, 2018 2,084 $ 11.05 The total fair value of shares vested during the twelve months ended 2018 , 2017 and 2016 was approximately $9,000 , $22,000 and $71,000 respectively. Employee stock purchase plan As of the December 31, 2018 , no shares of common stock have been purchased under the 2015 Employee Stock Purchase Plan (the "ESPP"). Shares reserved for future issuance The Company has reserved the following number of shares of common stock for future issuance: As of December 31, 2018 2017 Stock-based compensation awards 4,061,397 3,439,820 Vesting of restricted common stock 2,084 174,988 Employee stock purchase plan 713,996 534,274 Total 4,777,477 4,149,082 |
Stock-based compensation
Stock-based compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based compensation | Stock-based compensation In March 2014, the Company adopted the Flex Pharma, Inc. 2014 Equity Incentive Plan (the "2014 Plan"), under which it had the ability to grant incentive stock options ("ISOs"), non-qualified stock options, restricted stock awards, restricted stock units and stock appreciation rights. Terms of stock award agreements, including vesting requirements, were determined by the board of directors, subject to the provisions of the 2014 Plan. For options granted under the 2014 Plan, the exercise price equaled the fair market value of the common stock as determined by the board of directors on the date of grant. No further awards will be granted under the 2014 Plan. In January 2015, the Company's board of directors adopted, and the Company's stockholders approved, the 2015 Equity Incentive Plan (the "2015 Plan"), which became effective immediately prior to the closing of the Company's IPO. The 2015 Plan provides for the grant of ISOs, nonstatutory stock options, restricted stock awards, restricted stock units, stock appreciation rights, performance-based stock awards and other stock-based awards. Additionally, the 2015 Plan provides for the grant of performance-based cash awards. ISOs may be granted only to the Company's employees. All other awards may be granted to the Company's employees, including officers, and to non-employee directors and consultants. As of December 31, 2018 , there were 1,740,416 shares remaining available for the grant of stock awards under the 2015 Plan. During 2018 and 2016, the Company granted a total of 30,000 and 14,670 , respectively, of stock options to non-employee consultants. There were no stock options issued to non-employee consultants during 2017 . The options generally vest over a four -year period, and have a contractual term of ten years . The total stock-based compensation expense related to all non-employee stock options for the year ended December 31, 2018 , December 31, 2017 and December 31, 2016 was approximately $124,000 , $201,000 and $ 370,000 , respectively. The Company has awarded stock options to its employees, directors, advisors and consultants, pursuant to the plans described above. Stock options subsequent to the completion of the Company's IPO are granted with an exercise price equal to the closing market price of the Company's common stock on the date of grant. Stock options generally vest over one to four years and have a contractual term of ten years. Stock options are valued using the Black-Scholes option pricing model and compensation cost is recognized based on the resulting value over the service period. Prior to July 1, 2018, unvested awards to non-employees were re-measured at each vest date and at each financial reporting date. On July 1, 2018, the Company adopted ASU 2018-07 using a modified retrospective transition approach. As a result, the Company permanently revalued all unvested stock options granted to non-employees as of July 1, 2018. The adoption-date fair value did not materially change from the fair value as of June 30, 2018 and therefore, a cumulative-effect adjustment was not required. The following table summarizes stock option activity for employees and non-employees for the twelve months ended December 31, 2018 : Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at December 31, 2017 2,580,491 $ 6.65 7.55 $ 803,600 Granted 1,517,544 2.74 Exercised (97,310 ) 1.21 Forfeited (859,543 ) 5.76 Expired (820,201 ) 8.19 Outstanding at December 31, 2018 2,320,981 $ 4.10 7.61 $ — Exercisable at December 31, 2018 1,149,927 $ 5.53 6.07 $ — Vested or expected to vest at December 31, 2018 2,320,981 $ 4.10 7.53 $ — During 2018 , 2017 and 2016 , the Company granted stock options to purchase an aggregate of 1,517,544 , 1,059,500 , and 763,320 shares of its common stock, respectively. The weighted-average grant date fair value of option awards granted during 2018 , 2017 and 2016 were $1.95 , $2.80 , and $6.35 , respectively. The number of stock options exercised during 2018 , 2017 and 2016 were 97,310 , 1,576 , and 8,516 , respectively. The weighted-average exercise price of options exercised during 2018 , 2017 and 2016 was $1.21 , $1.67 , and $2.59 , respectively. The total intrinsic value of options exercised during 2018 , 2017 and 2016 was $349,974 , $2,606 , and $64,302 , respectively. The intrinsic value is calculated as the difference between the fair value of the Company's common stock and the exercise price of the options at the date of exercise. The Company estimates the fair value of each stock option award on the grant date using the Black-Scholes option-pricing model based on the following assumptions regarding the fair value of the underlying Common Stock on each measurement date: Year Ended December 31, 2018 Year Ended December 31, 2017 Year Ended December 31, 2016 Expected volatility 81.56% to 82.41% 73.87% to 81.04% 71.01% to 74.20% Risk-free interest rate 2.45% to 2.91% 1.83% to 2.40% 1.23% to 2.40% Expected term 5.3 - 10 years 5.3 - 9.5 years 5.3 - 10 years Expected dividend yield 0 % 0 % 0 % Total stock-based compensation expense recognized for employee and non-employee restricted common stock, and stock options granted to employees and non-employees is included in the Company's consolidated statements of operations and comprehensive loss as follows: Year Ended December 31, 2018 Year Ended December 31, 2017 Year Ended December 31, 2016 Research and development $ 705,687 $ 1,545,737 $ 2,435,565 Selling, general and administrative 1,233,924 2,673,428 4,137,398 Total $ 1,939,611 $ 4,219,165 $ 6,572,963 Selling, general and administrative expense for the year ended December 31, 2016 included $285,000 related to stock options that were modified in connection with an employee termination agreement. As of December 31, 2018 , there was approximately $2,160,000 of total unrecognized compensation cost related to unvested equity awards. Total unrecognized compensation cost will be adjusted for future changes in employee and non-employee forfeitures, if any. The Company expects to recognize that cost over a remaining weighted-average period of 2.74 years . In June 2018, the Company extended the three -month post termination exercisability of 877,137 option awards held by six employees and one adviser to one -year post termination. As of December 31, 2018, three of the six employees had been terminated, but continue to provide consulting services. The Company also extended the three -month post termination exercisability of 500,000 option awards held by one employee to three -years post termination. The valuation of these awards did not change as a result of the modification of these awards and as such, the Company did not recognize any additional compensation expense related to the modification. On June 14, 2018, the Company granted 654,544 stock options, in the aggregate, to seven employees as part of the Company's retention arrangements with these employees. These awards vest monthly over 48 months as the employees provide continuous service, and expense is being recognized over this period. As of December 31, 2018, three of the six employees had been terminated, but continue to provide consulting services and vest in these options. The awards are exercisable for one to three -years post termination depending on the employee to which the stock options were granted. The awards vest in full upon a change in control event and termination under certain circumstances. A change in control event is not currently considered probable for accounting purposes. On January 3, 2019, the Company entered into a Merger Agreement with Salarius. Unless and until the Company's shareholders have approved this specific transaction, the Company's probability assessment regarding a change in control event is not expected to change. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income taxes | Income taxes For the years ended December 31, 2018 , December 31, 2017 and December 31, 2016 , the Company did not record a current or deferred income tax provision or benefit. The Company's losses before income taxes for the periods presented consisted solely of domestic losses. On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118, or SAB 118, to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed, including computations, in reasonable detail to complete the accounting for certain income tax effects of the Tax Reform Act. The Company recognized the provisional tax impacts related to the revaluation of the deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017. The ultimate impact may differ from these provisional amounts due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, and actions the Company may take as a result of the Tax Reform Act. In 2018, the Company completed the analysis of the 2017 Tax Act with no material changes. The following table presents a reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate to the effective income tax rate as reflected in the consolidated financial statements: Year Ended December 31, 2018 Year Ended December 31, 2017 Year Ended December 31, 2016 Federal income tax expense at statutory rate 21.0 % 35.0 % 35.0 % State income tax, net of federal benefit 6.0 % 5.0 % 5.0 % Permanent differences (0.1 )% (0.7 )% 0.0 % Stock-based compensation (2.8 )% (1.9 )% (2.6 )% Research credits 2.6 % 2.2 % 1.9 % Other, net (1.6 )% (1.3 )% (0.1 )% Payroll tax credit election (1.1 )% (0.7 )% 0.0 % Change in valuation allowance (24.0 )% (1.1 )% (39.2 )% Deferred rate change 0.0 % (36.5 )% 0.0 % Effective tax rate 0.0 % 0.0 % 0.0 % Deferred income tax assets and liabilities are determined based upon temporary differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The following table presents the significant components of the Company's deferred tax assets and liabilities: December 31, 2018 December 31, 2017 Deferred tax assets: U.S. and state net operating loss carryforwards $ 29,902,019 $ 24,744,841 Accruals and other temporary differences 336,229 202,301 Amortization 50,688 35,783 Stock-based compensation 1,220,546 1,591,131 Tax credit carryforward 2,277,428 1,964,189 Total deferred tax assets 33,786,910 28,538,245 Less valuation allowance (33,786,910 ) (28,533,755 ) Deferred tax assets — 4,490 Deferred tax liabilities: Stock-based compensation — (4,490 ) Deferred tax liabilities — (4,490 ) Net deferred tax assets $ — $ — As of December 31, 2018 , the Company has U.S. federal net operating loss carryforwards of approximately $110,900,000 and U.S. state net operating loss carryforwards of approximately $105,400,000 ( $8,400,000 tax affected), which are available to reduce future taxable income. The Company also had federal research and development tax credit carryforwards of approximately $1,800,000 and state research and development tax credit carryforwards of approximately $570,000 , which may be used to offset future tax liabilities. The Company's pre-2018 federal loss carryforwards will expire at various dates through 2037 . Any federal net operating losses generated in 2018 or after will not expire as a result of the Tax Cuts and Jobs Act. Any state operating loss carryforwards and tax credit carryforwards will expire at various dates through 2038 . Under the provisions of the Internal Revenue Code, the net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50 percent, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has completed financings since its inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code, or the merger with Salarius could result in a change in control. The Company has not conducted an assessment to determine whether there may have been a Section 382 or 383 ownership changes. ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After considerations of all the evidence, both positive and negative, the Company continues to maintain a valuation allowance for the full amount of the 2018 deferred tax asset because it is more likely than not that the deferred tax asset will not be realized. The valuation allowance increased by approximately $5,250,000 from December 31, 2017 to December 31, 2018 , primarily due to an increase in net operating losses. The Company has no unrecognized tax benefits. Interest and penalty charges, if any, related to uncertain tax positions would be classified as income tax expenses in the accompanying consolidated statement of operations. At December 31, 2018 and 2017 , the Company had no accrued interest or penalties related to uncertain tax positions. Under the Protecting Americans from Tax Hikes Act, enacted in December 2015, certain qualified small businesses may elect to apply up to $250,000 of its federal research and development tax credit against the Social Security portion of its payroll tax liability. The Company elected the $250,000 credit on its 2016 tax return and utilized approximately $22,000 and $156,000 of the credit as a decrease to its payroll tax expense in 2017 and 2018, respectively. The Company elected an additional $250,000 credit on its 2017 tax return. |
Net loss per share
Net loss per share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net loss per share | Net loss per share Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period, determined using the treasury stock method and the if-converted method, for convertible securities, if inclusion of these is dilutive. Because the Company has reported net losses for the periods presented, diluted net loss per common share is the same as basic net loss per common share. The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding for the periods indicated, because including them would have had an anti-dilutive impact: Year Ended December 31, 2018 Year Ended December 31, 2017 Year Ended December 31, 2016 Options to purchase common stock 2,320,981 2,580,491 2,156,250 Unvested restricted common stock 2,084 174,988 1,196,792 Total 2,323,065 2,755,479 3,353,042 |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Segment Information | Segment Information Effective as of the second quarter of 2016 and in connection with the launch of HOTSHOT, the Company operates as two reportable segments: • The Consumer Operations segment, which reflects the total revenue and costs and expenses related to HOTSHOT and the Company's consumer operations. • The Drug Development segment, which reflects the costs and expenses related to the Company's efforts to develop innovative and proprietary drug products; previously to treat muscle cramps, spasms and spasticity associated with severe neurological conditions. The Company discloses information about its reportable segments based on the way that the Company's Chief Operating Decision Maker, who the Company has identified as the Chief Executive Officer, and management, organizes segments within the Company for making operating decisions and assessing financial performance. The Company evaluates the performance of its reportable segments based on revenue and operating income or loss. The accounting policies of the segments are the same as those described herein as well as those described in Note 2. Corporate and unallocated amounts that do not relate to a reportable segment have been allocated to "Corporate." No asset information has been provided for the Company's reportable segments as management does not measure or allocate such assets on a reportable segment basis. Information for the Company's reportable segments for the years ended December 31, 2018 , December 31, 2017 , and December 31, 2016 are as follows: Year Ended December 31, 2018 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 838,142 — — $ 838,142 Loss from operations $ 1,975,792 11,887,108 8,211,323 $ 22,074,223 Interest income, net $ — — 152,006 $ 152,006 Year Ended December 31, 2017 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 1,274,499 — — $ 1,274,499 Loss from operations $ 8,877,330 16,715,752 9,132,544 $ 34,725,626 Interest income, net $ — — 291,964 $ 291,964 Year Ended December 31, 2016 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 1,010,663 — — $ 1,010,663 Loss from operations $ 10,023,137 19,620,338 10,242,757 $ 39,886,232 Interest income, net $ — — 393,109 $ 393,109 |
Related parties
Related parties | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related parties | Related parties Royalty agreement In 2014, the Company entered into a royalty agreement with certain of the Company's founders under which these founders are paid a royalty of 2% , in the aggregate, of gross sales of any product sold by the Company or by any of the Company's licensees for use in the treatment of any neuromuscular disorder, and that uses, incorporates or embodies, or is made using, any of the Company's intellectual property, including any know-how. Upon the launch of HOTSHOT in the second quarter of 2016, the Company's founders began earning royalties under this agreement. Royalty amounts earned by the founders during the years ended December 31, 2018 , December 31, 2017 and December 31, 2016 totaled approximately $17,000 , $ 25,000 and $20,000 , respectively, including approximately $3,000 , $ 3,000 and $4,000 not yet paid as of year end, respectively. Royalty expense is recorded in cost of product revenue in the consolidated statement of operations. In January 2019, the Founders entered into a royalty agreement with Flex Innovation Group LLC, which, in part, replaces the royalty agreement with Flex Pharma, Inc. described above. The royalty is payable over twenty years from the date of the agreement, with a 2% royalty due on product sales, as defined in the agreement, for the first ten years and a 1% royalty due for the following ten years. License agreement For the period from May 2014 through July 2016, the Company licensed a portion of its office space to ECLDS, LLC, which was controlled by the Company's former Chief Executive Officer. In October 2015, the license agreement was assigned by ECLDS, LLC to a third party, that was not owned by the Company's former Chief Executive Officer, but for which a business relationship existed. In July 2016, the license agreement terminated. Under the terms of the license, the entity charged the same rental rate as that was charged to the Company. During the year ended December 31, 2016 , the Company received approximately $32,000 in license fees from the aforementioned related party, and such amounts received have been recorded as a reduction to rent expense. |
Quarterly financial information
Quarterly financial information (unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly financial information (unaudited) | Quarterly financial information (unaudited) First Quarter Second Quarter Third Quarter Fourth Quarter Net product revenue $ 176,255 $ 241,416 $ 247,284 $ 161,560 Other revenue 2,327 4,086 3,707 1,507 Total revenue 178,582 245,502 250,991 163,067 Costs and expenses: Cost of product revenue 83,934 179,945 91,937 74,934 Research and development 4,680,181 6,174,589 865,765 187,759 Selling, general and administrative 3,697,287 2,994,649 1,959,872 1,921,513 Total costs and expenses 8,461,402 9,349,183 2,917,574 2,184,206 Loss from operations (8,282,820 ) (9,103,681 ) (2,666,583 ) (2,021,139 ) Interest income, net 59,593 51,809 28,210 12,394 Net loss $ (8,223,227 ) $ (9,051,872 ) $ (2,638,373 ) $ (2,008,745 ) Net loss per share attributable to common stockholders — basic and diluted $ (0.46 ) $ (0.50 ) $ (0.15 ) $ (0.11 ) Weighted-average number of common shares outstanding — basic and diluted 17,893,912 18,037,274 18,066,548 18,067,179 First Quarter Second Quarter Third Quarter Fourth Quarter Net product revenue $ 240,292 $ 330,688 $ 407,241 $ 282,752 Other revenue 2,255 4,835 6,360 76 Total revenue 242,547 335,523 413,601 282,828 Costs and expenses: Cost of product revenue 79,106 145,325 148,756 133,343 Research and development 3,914,974 4,076,220 4,739,360 4,259,357 Selling, general and administrative 4,594,716 4,990,943 4,934,937 3,983,088 Total costs and expenses 8,588,796 9,212,488 9,823,053 8,375,788 Loss from operations (8,346,249 ) (8,876,965 ) (9,409,452 ) (8,092,960 ) Interest income, net 77,854 72,342 77,339 64,429 Net loss $ (8,268,395 ) $ (8,804,623 ) $ (9,332,113 ) $ (8,028,531 ) Net loss per share attributable to common stockholders — basic and diluted $ (0.49 ) $ (0.51 ) $ (0.54 ) $ (0.46 ) Weighted-average number of common shares outstanding — basic and diluted 16,873,512 17,130,264 17,386,249 17,642,646 On January 1, 2018, the Company adopted ASC 606 using the modified retrospective method applied to contracts not yet completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and are reported in accordance with the Company's historical accounting under ASC 605. The Company would have recognized approximately $18,000 , $10,000 , $1,000 and $15,000 of additional total revenue during the quarters ended March 31, 2018, June 30, 2018, September 30, 2018 and December 31, 2018 , respectively, if the Company had continued to recognize revenue under ASC 605. |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent events | Subsequent events The Company has completed an evaluation of all subsequent events after the balance sheet date of December 31, 2018 through the date these consolidated financial statements were issued. The Company has concluded that no subsequent events have occurred that require disclosure, except as described below. Agreement and Plan of Merger On January 3, 2019, the Company, Merger Sub, and Salarius entered into the Merger Agreement. Pursuant to the Merger Agreement, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Salarius, with Salarius continuing as a wholly owned subsidiary of the Company and the surviving corporation. The Merger Agreement (i) values the Company at $10.5 million , subject to adjustment, on a dollar-for-dollar basis, based on the Company's net cash balance at the closing of the merger compared to a target net cash of $3.3 million , and (ii) values Salarius at $36.6 million , subject to adjustment, on a dollar-for-dollar basis, based on the sale of Series A Preferred units pursuant to subscription agreements that Salarius entered into prior to the Merger Agreement compared to the target sale of $7.0 million of Series A Preferred units. At the closing of the merger, each outstanding common unit, profits interest common unit and Series A Preferred unit of Salarius will convert into the right to receive shares of the Company's common stock (subject to the payment of cash in lieu of fractional shares and after giving effect to an anticipated reverse stock split of the Company’s common stock) at the conversion ratio formulae described in the Merger Agreement. Under those formulae, immediately following the effective time of the merger, the Company's current stockholders will own approximately 19.9% of the combined company (on a partially-diluted basis, excluding the effect of certain options, the dividend or distribution of rights and warrants to the Company's current stockholders and the possible issuance of a warrant to Wedbush) and Salarius’ current members will own approximately 80.1% of the combined company (on a partially-diluted basis, excluding the effect of certain options, the dividend or distribution of rights and Warrants to our current stockholders and the possible issuance of a warrant to Wedbush). For purposes of calculating the conversion ratios, the number of outstanding shares of the Company's common stock immediately before the merger takes into account the dilutive effect of approximately 849,610 shares of the Company's common stock underlying options outstanding as of January 3, 2019 that have an exercise price less than or equal to $1.35 per share of our common stock. Approximately 1,447,426 shares of the Company's common stock that underlie options outstanding as of January 3, 2019 have an exercise price greater than $1.35 per share of the Company's common stock. In addition, at or prior to the closing of the merger, the Company will pay a dividend of or distribute one right per share of common stock to stockholders of record as of a date and time determined by the board of directors. Each right will entitle such stockholders to receive a warrant to purchase shares of the Company's common stock six months and one day following the closing date of the merger. The warrants will contain customary terms and conditions, provided that the Warrants: • will have an exercise price per share of the Company's common stock equal to the fair market value of a share of the Company's common stock on the closing date of the merger (such exercise price subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Company's common stock); • will be immediately exercisable upon receipt, which receipt will be six months and one day following the closing date of the merger; • will be exercisable for five years after receipt; • will be subject to a cashless exercise, at the Company's option, under certain circumstances; and • will be exercisable, in the aggregate, with respect to that number of shares of the Company's common stock equal to the Warrant Aggregate Value (as defined in the Merger Agreement) divided by the value (determined using the Black-Scholes-Merton option pricing formula) of a warrant to purchase a share of the Company's common stock on the closing date of the merger. The Warrant Aggregate Value generally represents the difference between (i) the Company's value and (ii) the value of the Company’s common stock that the Company’s current stockholders will have in the combined company. Accordingly, the Warrant Aggregate Value will be based in part on the Company’s net cash balance at the time of closing of the merger and adjusted for the amount of additional financing consummated by Salarius at or before the closing of the merger, as further described in the Merger Agreement. The Merger Agreement contains certain termination rights for both the Company and Salarius, and further provides that, upon termination of the Merger Agreement under specified circumstances, either party may be required to pay the other party a termination fee of $0.35 million , or in some circumstances the Company may be required to reimburse Salarius’ expenses up to a maximum of $0.2 million . In addition, in certain specified circumstances, Salarius may be required to pay us a termination fee of $1.0 million . |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of presentation | The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP"). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as found in the Accounting Standards Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). |
Use of estimates | The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company's management evaluates its estimates, which include, but are not limited to, estimates related to inventory write-offs, clinical study accruals, stock-based compensation expense, and amounts of expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Principles of consolidation | Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: TK Pharma, Inc., a Massachusetts Securities Corporation, Flex Innovation Group LLC, a Delaware limited liability company which contains the Company's consumer-related operations, and Falcon Acquisition Sub, LLC, a Delaware limited liability company established for purposes of the merger. All significant intercompany balances and transactions have been eliminated in consolidation. |
Concentrations of risk, Concentrations of credit risk and off-balance sheet risk | Concentration of risk The Company outsources the manufacture of HOTSHOT to a single co-packer that produces bottled finished goods. The Company also sources certain raw materials from sole suppliers. A disruption in the supply of materials or the production of finished goods could significantly impact the Company's revenues in the future as alternative sources of raw materials and co-packing may not be available at commercially reasonable rates or within a reasonably short period of time. In addition, the inventory of HOTSHOT is concentrated in one warehouse location. Any significant disruption to the operation of the warehouse location for any reason, such as a power failure, equipment breakdown, workforce disruption, or natural or similar disasters, could materially adversely affect the Company's product distribution and sales. Concentrations of credit risk and off-balance sheet risk Cash and cash equivalents are financial instruments that potentially subject the Company to concentrations of credit risk. The Company held no marketable securities as of December 31, 2018 . The Company's cash and cash equivalents are held in accounts at financial institutions that management believes are creditworthy. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no financial instruments with off-balance sheet risk of loss. |
Segment information | Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company and the Company's chief operating decision maker, the Company's Chief Executive Officer, and management, view the Company's operations and manage its business as two operating segments, Drug Development and Consumer Operations (see Note 16). The Company operates in one geographic segment, the United States. |
Revenue | Revenue Revenue is comprised of net product revenue and other revenue. Net product revenue includes sales of HOTSHOT bottled finished goods to e-commerce customers, specialty retailers and sports teams, including professional and collegiate teams. Other revenue consists of payments made by customers for expedited shipping and handling. On January 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers (" ASC 606 "), using the modified retrospective method applied to contracts not yet completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and are reported in accordance with the Company's historical accounting under ASC Topic 605, Revenue Recognition (" ASC 605 ") . Under ASC 605 and through December 31, 2017, revenue was recognized when persuasive evidence of an arrangement existed, delivery of the product occurred, the sales price was fixed or determinable and collectability was reasonably assured. The Company generally provided refunds to e-commerce customers, upon request, within 30 days of delivery. As the Company did not have adequate history to accurately estimate refunds, all e-commerce sales, and their related costs, were deferred and revenue was recognized once the refund period lapsed. This deferral represents total deferred revenue presented on the Company's consolidated balance sheet at December 31, 2017. For specialty retailers and sports teams, the Company did not offer a right of return or refund and revenue was recognized at the time products were delivered to customers. Discounts provided to customers were accounted for as a reduction of product revenue. Upon the adoption of ASC 606 on January 1, 2018, revenue is recognized when control of the promised goods is transferred to the customer, upon delivery to the customer, in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for those goods. |
Accounts receivable and allowance for doubtful accounts | Accounts receivable and allowance for doubtful accounts Accounts receivable are stated at their carrying values, net of any allowances for doubtful accounts. Accounts receivable consist primarily of amounts due from specialty retailers and sports teams, for which collectability is reasonably assured. Receivables are evaluated for collectability on a regular basis and an allowance for doubtful accounts is recorded, if necessary. |
Cost of product revenue | Cost of product revenue Cost of product revenue includes the cost of raw materials utilized to produce HOTSHOT, co-packing fees, repacking fees, in-bound freight charges and warehouse and transportation costs incurred to bring HOTSHOT finished goods to salable condition. All other costs incurred after this condition is met are considered selling costs and included in selling, general and administrative expenses. Cost of product revenue also includes write-offs for inventory that has become obsolete, has a cost basis in excess of its estimated realizable value, or exceeds projected sales, as well as depreciation expense related to manufacturing equipment purchased to support production and royalty amounts payable to certain of the Company's founders on HOTSHOT sales. |
Inventory | Inventory The Company launched HOTSHOT in the second quarter of 2016 and began capitalizing inventory costs associated with HOTSHOT in the first quarter of 2016, when it was determined that the inventory costs had probable future economic benefit. Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out ("FIFO") basis. The Company outsources the manufacture of HOTSHOT to a co-packer. Inventory at December 31, 2018 includes raw materials available for future production runs, as well as finished goods. The Company periodically analyzes its inventory levels and writes down inventory that has become obsolete, has a cost basis in excess of its estimated realizable value, or exceeds projected sales. Estimates of excess inventory consider factors such as inventory levels, production requirements, projected sales and the estimated shelf-lives of inventory components. Inventory write-offs are recorded as a component of cost of product revenue. |
Advertising expense | Advertising expense Advertising expense consists of media and production costs related to print and digital advertising. All advertising is expensed as incurred. |
Shipping and handling costs | Shipping and handling costs Shipping and handling costs related to the movement of inventory to the Company's co-packer and from the co-packer to the Company's third-party warehousing and fulfillment partners is capitalized as inventory and expensed as a cost of product revenue when revenue is recognized. Shipping and handling costs to move finished goods from the Company's warehousing and third-party fulfillment partners to customer locations are included in selling, general and administrative expense in the consolidated statement of operations |
Restructuring-related costs | Restructuring-related costs The Company records employee termination costs in accordance with ASC Topic 712, Compensation - Nonretirement and Postemployment Benefits ("ASC 712"), if the termination benefits are paid as part of an ongoing benefit arrangement, which includes benefits provided as part of the Company's established severance policy or as part of an executive employment agreement. The Company accrues employee termination costs associated with an on-going benefit arrangement if the obligation is attributable to prior services rendered, the rights to the benefits have vested, the payment is probable, and the Company can reasonably estimate the liability. The Company accounts for employee termination benefits that represent a one-time benefit in accordance with ASC Topic 420, Exit or Disposal Cost Obligations ("ASC 420"). Upon communication of the termination to the employee, the Company expenses these costs over the employee’s future service period, if any. Restructuring-related costs are recorded within research and development expenses and selling, general and administrative expenses on the Company's consolidated statement of operations. Liabilities associated with the Company's restructuring activities are recorded as a component of accrued expenses and other current liabilities on its consolidated balance sheet. |
Property and equipment | Property and equipment Property and equipment are stated at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred, while costs of major additions and betterments are capitalized. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss is included in the results of operations. Depreciation is recorded, once assets are placed in service, using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Asset type Estimated useful life Computers and computer equipment 3 years Laboratory equipment 3 years Manufacturing equipment 3 years Website development costs 1-2 years |
Impairment of long-lived assets | Impairment of long-lived assets The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value. |
Research and development expense | Research and development expense Research and development costs are charged to expense as incurred in performing research and development activities. The costs include employee compensation costs, clinical study costs, external consultant costs, regulatory costs and facilities and overhead costs. Facilities and overhead costs have primarily included the allocation of insurance, rent, utility and office-related expenses attributable to research and development personnel. The Company records payments made to outside vendors in advance of services performed or goods being delivered for use in research and development activities as prepaid expenses, which are expensed as services are performed or goods are delivered. |
Stock-based compensation expense | Stock-based compensation expense The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation-Stock Compensation ("ASC 718"). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the statement of operations based on their grant date fair values. Compensation expense related to awards to employees with service conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to employees with performance conditions is recognized based on grant date fair value over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting date. In July 2018, the Company adopted ASU 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . Prior to the adoption of ASU 2018-07, the Company accounted for stock-based compensation arrangements with non-employees based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable, in accordance with the provisions of FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees . The measurement date for non-employee awards were generally the date performance of services required from the non-employee is complete, resulting in periodic adjustments to stock-based compensation expense during the vesting period for changes in the fair value of the awards. Stock-based compensation costs for non-employee service awards were recognized as services were provided, which was generally the vesting period, on a straight-line basis. The unvested portion of the awards was subject to re-measurement over the vesting period. Following the adoption of ASU 2018-07, the Company accounts for stock granted to non-employees in accordance with ASC 718 in the same manner as employee awards described above. The adoption did not have a material impact on the condensed consolidated financial statements and therefore a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year was not required. The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the estimated fair value of the Company's common stock on the measurement date. Due to the lack of significant trading history for the Company's common stock, it has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting the public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the volatility for the selected companies' shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options using the "simplified" method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid and does not expect to pay dividends in the foreseeable future. The Company does not apply a forfeiture rate to stock-based compensation expense and accounts for forfeitures as they occur. |
Income taxes | Income taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company has evaluated available evidence and concluded that the Company may not realize the benefit of its deferred tax assets; therefore, a valuation allowance has been established for the full amount of the deferred tax assets. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2018 and December 31, 2017 , the Company did not have any significant uncertain tax positions. The Company's practice is to recognize interest and/or penalties related to income tax matters in income tax expense. |
Net loss per share attributable to common stockholders | Net loss per share attributable to common stockholders Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period, determined using the treasury stock method and the if-converted method, for convertible securities, if inclusion of these is dilutive. For years ended December 31, 2018 , December 31, 2017 and December 31, 2016 , the Company has excluded the effects of all potentially dilutive shares from the weighted-average number of common shares outstanding as their inclusion in the computation for each period would be anti-dilutive due to the net loss per share incurred by the Company. |
Comprehensive loss | Comprehensive loss Comprehensive loss is the change in equity of a company during a period from transactions and other events and circumstances, excluding transactions resulting from investments by owners and distributions to owners. Comprehensive loss includes net loss and the change in accumulated other comprehensive loss for the period. |
Recent accounting pronouncements | Recent accounting pronouncements In May 2014, the FASB issued ASC 606 which supersedes the revenue recognition requirements in ASC 605 and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted ASC 606 as of January 1, 2018 using the modified retrospective transition method. See Note 3 for further details. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) ("ASU 2016-02"). The ASU requires lessees to recognize the assets and liabilities on their balance sheet for the rights and obligations created by most leases and continue to recognize expenses on their income statements over the lease term. It will also require disclosures designed to give financial statement users information on the amount, timing and uncertainty of cash flows arising from leases. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases . This ASU is intended to clarify, or correct unintended application of the guidance outlined in ASU No. 2016-02. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements . This ASU is intended to address comparative reporting requirements for initial adoption. The guidance is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those years. Based on the Company's evaluation of the effect of this standard, t he Company does not expect the adoption of this guidance to have a material effect on its consolidated financial statements and related disclosures. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (“ASU 2016-15”). ASU 2016-15 clarifies how entities should classify certain cash receipts and cash payments on the statement of cash flows with the objective of reducing the existing diversity in practice related to eight specific cash flow issues. The Company retrospectively adopted ASU No. 2016 in the first quarter of 2018, retrospectively , which did not impact the Company's condensed consolidated financial statements or disclosures. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (“ASU 2016-18”). ASU 2016-18 requires entities to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows. As a result, entities are no longer required to present transfers between cash and cash equivalents and restricted cash and restricted cash equivalents in the statement of cash flows. When cash, cash equivalents, restricted cash and restricted cash equivalents are presented in more than one line item on the balance sheet, the new guidance requires a reconciliation of the totals in the statement of cash flows to the related captions in the balance sheet. The Company adopted ASU No. 2016-18 in the first quarter of 2018, retrospectively, resulting in a change to the presentation of restricted cash on the condensed consolidated statement of cash flows. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of such amounts in the condensed consolidated statements of cash flows: December 31, 2018 December 31, 2017 Cash and cash equivalents $ 9,829,624 $ 19,186,036 Restricted cash 126,595 126,595 Cash, cash equivalents and restricted cash shown on the condensed consolidated statement of cash flows $ 9,956,219 $ 19,312,631 In May 2017, the FASB issued ASU No. 2017-09, Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”), to provide clarity and reduce diversity in practice, cost and complexity when applying the guidance of Topic 718. The guidance is effective for fiscal years beginning after December 15, 2017 and interim periods within those years. Early adoption is permitted, and the guidance should be applied prospectively. The Company adopted ASU 2017-09 in the first quarter of 2018, which did not impact the Company's condensed consolidated financial statements or disclosures. In June 2018, the FASB issued ASU 2018-07. This ASU is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share-based compensation. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within that year. Early adoption is permitted, but not before an entity has adopted ASC 606, and the guidance should be applied using a modified retrospective transition approach. The Company early adopted ASU 2018-07 on July 1, 2018 and revalued its unvested nonemployee awards as of the July 1, 2018 adoption date. The adoption did not have a material impact on the condensed consolidated financial statements and therefore a cumulative-effect adjustment to retained earnings as of the beginning of the fiscal year was not required. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”). This ASU modifies the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement . The guidance is effective for annual reporting periods beginning after December 15, 2019, and interim periods within those years. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2018-13 on its consolidated financial statements and disclosures. The Company believes that the impact of other recently issued standards that are not yet effective will not have a material effect on its consolidated financial position or results of operations upon adoption. |
Subsequent events | Subsequent events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements for potential recognition or disclosure in the consolidated financial statements. Subsequent events have been evaluated through the date these consolidated financial statements were issued for potential recognition or disclosure in the consolidated financial statements |
Fair value measurements | The Company records cash equivalents and marketable securities at fair value. ASC Topic 820, Fair Value Measurements and Disclosures established a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability. Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of cash and cash equivalents | The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of such amounts in the condensed consolidated statements of cash flows: December 31, 2018 December 31, 2017 Cash and cash equivalents $ 9,829,624 $ 19,186,036 Restricted cash 126,595 126,595 Cash, cash equivalents and restricted cash shown on the condensed consolidated statement of cash flows $ 9,956,219 $ 19,312,631 |
Restrictions on cash and cash equivalents | The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of such amounts in the condensed consolidated statements of cash flows: December 31, 2018 December 31, 2017 Cash and cash equivalents $ 9,829,624 $ 19,186,036 Restricted cash 126,595 126,595 Cash, cash equivalents and restricted cash shown on the condensed consolidated statement of cash flows $ 9,956,219 $ 19,312,631 |
Depreciation over estimated useful life | Depreciation is recorded, once assets are placed in service, using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Asset type Estimated useful life Computers and computer equipment 3 years Laboratory equipment 3 years Manufacturing equipment 3 years Website development costs 1-2 years Property and equipment, net consists of the following: December 31, 2018 December 31, 2017 Manufacturing equipment $ 421,999 $ 421,999 Computers and computer equipment 275,670 311,847 Website development costs 177,886 177,886 Laboratory equipment — 13,368 Capital in progress — 28,823 Total property and equipment 875,555 953,923 Accumulated depreciation (801,095 ) (622,883 ) Property and equipment, net $ 74,460 $ 331,040 |
Fair value measurements (Tables
Fair value measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Summary of cash equivalents and marketable securities measured at fair value on a recurring basis | The following table summarizes the cash equivalents and marketable securities measured at fair value on a recurring basis as of December 31, 2018 and December 31, 2017 : Level 1 Level 2 Level 3 Balance at December 31, 2018 Cash equivalents $ 2,333,771 $ — $ — $ 2,333,771 $ 2,333,771 $ — $ — $ 2,333,771 Level 1 Level 2 Level 3 Balance at December 31, 2017 Cash equivalents $ 5,046,205 $ — $ — $ 5,046,205 Marketable securities: U.S. government agency securities — 8,986,259 — 8,986,259 Commercial paper — 4,440,689 — 4,440,689 Corporate debt securities — 702,775 — 702,775 $ 5,046,205 $ 14,129,723 $ — $ 19,175,928 |
Cash equivalents and marketab_2
Cash equivalents and marketable securities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of marketable securities | Marketable securities at December 31, 2017 consisted of the following: Amortized Cost Unrealized Gains Unrealized Losses Fair Value As of December 31, 2017 Current (due within 1 year): U.S. government agency securities $ 8,987,254 $ 38 $ (1,033 ) $ 8,986,259 Commercial paper 4,440,689 — — 4,440,689 Corporate debt securities 703,027 — (252 ) 702,775 Total $ 14,130,970 $ 38 $ (1,285 ) $ 14,129,723 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory, net | The following table presents inventory: December 31, 2018 December 31, 2017 Raw materials $ 7,247 $ 17,411 Finished goods 179,673 414,480 Total inventory $ 186,920 $ 431,891 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and equipment, net | Depreciation is recorded, once assets are placed in service, using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Asset type Estimated useful life Computers and computer equipment 3 years Laboratory equipment 3 years Manufacturing equipment 3 years Website development costs 1-2 years Property and equipment, net consists of the following: December 31, 2018 December 31, 2017 Manufacturing equipment $ 421,999 $ 421,999 Computers and computer equipment 275,670 311,847 Website development costs 177,886 177,886 Laboratory equipment — 13,368 Capital in progress — 28,823 Total property and equipment 875,555 953,923 Accumulated depreciation (801,095 ) (622,883 ) Property and equipment, net $ 74,460 $ 331,040 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses and other current liabilities consist of the following: December 31, 2018 December 31, 2017 Payroll and employee-related costs $ 417,997 $ 874,246 Professional fees 269,544 227,980 Restructuring-related costs 68,593 — Consumer product-related costs 5,360 107,595 Research and development costs 2,846 2,502,400 Total $ 764,340 $ 3,712,221 |
Schedule of other current liabilities | Accrued expenses and other current liabilities consist of the following: December 31, 2018 December 31, 2017 Payroll and employee-related costs $ 417,997 $ 874,246 Professional fees 269,544 227,980 Restructuring-related costs 68,593 — Consumer product-related costs 5,360 107,595 Research and development costs 2,846 2,502,400 Total $ 764,340 $ 3,712,221 |
Schedule of restructuring and related costs | The following table outlines the Company's restructuring activities during the year ended December 31, 2018 : Accrued restructuring balance as of December 31, 2017 $ — Charges: Employee termination benefits 1,136,388 Employee retention benefits 214,417 Other 14,995 Payments (1,297,207 ) Accrued restructuring balance as of December 31, 2018 $ 68,593 |
Common stock (Tables)
Common stock (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Restricted common stock activity | The following is a summary of restricted common stock activity: Number of Shares Weighted-Average Grant Date Fair Value Unvested at December 31, 2017 5,334 $ 10.51 Issued — — Vested (3,250 ) 10.16 Forfeited — — Unvested at December 31, 2018 2,084 $ 11.05 The following is a summary of restricted common stock activity: Number of Shares Weighted-Average Grant Date Fair Value Unvested at December 31, 2017 169,654 $ 0.10 Issued — — Vested (169,654 ) 0.10 Forfeited — — Unvested at December 31, 2018 — $ — |
Shares reserved for future issuance | The Company has reserved the following number of shares of common stock for future issuance: As of December 31, 2018 2017 Stock-based compensation awards 4,061,397 3,439,820 Vesting of restricted common stock 2,084 174,988 Employee stock purchase plan 713,996 534,274 Total 4,777,477 4,149,082 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of stock option activity | The following table summarizes stock option activity for employees and non-employees for the twelve months ended December 31, 2018 : Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at December 31, 2017 2,580,491 $ 6.65 7.55 $ 803,600 Granted 1,517,544 2.74 Exercised (97,310 ) 1.21 Forfeited (859,543 ) 5.76 Expired (820,201 ) 8.19 Outstanding at December 31, 2018 2,320,981 $ 4.10 7.61 $ — Exercisable at December 31, 2018 1,149,927 $ 5.53 6.07 $ — Vested or expected to vest at December 31, 2018 2,320,981 $ 4.10 7.53 $ — |
Schedule of fair value assumptions | The Company estimates the fair value of each stock option award on the grant date using the Black-Scholes option-pricing model based on the following assumptions regarding the fair value of the underlying Common Stock on each measurement date: Year Ended December 31, 2018 Year Ended December 31, 2017 Year Ended December 31, 2016 Expected volatility 81.56% to 82.41% 73.87% to 81.04% 71.01% to 74.20% Risk-free interest rate 2.45% to 2.91% 1.83% to 2.40% 1.23% to 2.40% Expected term 5.3 - 10 years 5.3 - 9.5 years 5.3 - 10 years Expected dividend yield 0 % 0 % 0 % |
Summary of stock-based compensation expense | Total stock-based compensation expense recognized for employee and non-employee restricted common stock, and stock options granted to employees and non-employees is included in the Company's consolidated statements of operations and comprehensive loss as follows: Year Ended December 31, 2018 Year Ended December 31, 2017 Year Ended December 31, 2016 Research and development $ 705,687 $ 1,545,737 $ 2,435,565 Selling, general and administrative 1,233,924 2,673,428 4,137,398 Total $ 1,939,611 $ 4,219,165 $ 6,572,963 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of effective income tax rate reconciliation | The following table presents a reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate to the effective income tax rate as reflected in the consolidated financial statements: Year Ended December 31, 2018 Year Ended December 31, 2017 Year Ended December 31, 2016 Federal income tax expense at statutory rate 21.0 % 35.0 % 35.0 % State income tax, net of federal benefit 6.0 % 5.0 % 5.0 % Permanent differences (0.1 )% (0.7 )% 0.0 % Stock-based compensation (2.8 )% (1.9 )% (2.6 )% Research credits 2.6 % 2.2 % 1.9 % Other, net (1.6 )% (1.3 )% (0.1 )% Payroll tax credit election (1.1 )% (0.7 )% 0.0 % Change in valuation allowance (24.0 )% (1.1 )% (39.2 )% Deferred rate change 0.0 % (36.5 )% 0.0 % Effective tax rate 0.0 % 0.0 % 0.0 % |
Schedule of deferred tax assets and liabilities | The following table presents the significant components of the Company's deferred tax assets and liabilities: December 31, 2018 December 31, 2017 Deferred tax assets: U.S. and state net operating loss carryforwards $ 29,902,019 $ 24,744,841 Accruals and other temporary differences 336,229 202,301 Amortization 50,688 35,783 Stock-based compensation 1,220,546 1,591,131 Tax credit carryforward 2,277,428 1,964,189 Total deferred tax assets 33,786,910 28,538,245 Less valuation allowance (33,786,910 ) (28,533,755 ) Deferred tax assets — 4,490 Deferred tax liabilities: Stock-based compensation — (4,490 ) Deferred tax liabilities — (4,490 ) Net deferred tax assets $ — $ — |
Net loss per share (Tables)
Net loss per share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of antidilutive securities excluded from computation of earnings per share | The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding for the periods indicated, because including them would have had an anti-dilutive impact: Year Ended December 31, 2018 Year Ended December 31, 2017 Year Ended December 31, 2016 Options to purchase common stock 2,320,981 2,580,491 2,156,250 Unvested restricted common stock 2,084 174,988 1,196,792 Total 2,323,065 2,755,479 3,353,042 |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Schedule of segment reporting information | Information for the Company's reportable segments for the years ended December 31, 2018 , December 31, 2017 , and December 31, 2016 are as follows: Year Ended December 31, 2018 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 838,142 — — $ 838,142 Loss from operations $ 1,975,792 11,887,108 8,211,323 $ 22,074,223 Interest income, net $ — — 152,006 $ 152,006 Year Ended December 31, 2017 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 1,274,499 — — $ 1,274,499 Loss from operations $ 8,877,330 16,715,752 9,132,544 $ 34,725,626 Interest income, net $ — — 291,964 $ 291,964 Year Ended December 31, 2016 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 1,010,663 — — $ 1,010,663 Loss from operations $ 10,023,137 19,620,338 10,242,757 $ 39,886,232 Interest income, net $ — — 393,109 $ 393,109 |
Quarterly financial informati_2
Quarterly financial information (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of quarterly financial information | First Quarter Second Quarter Third Quarter Fourth Quarter Net product revenue $ 176,255 $ 241,416 $ 247,284 $ 161,560 Other revenue 2,327 4,086 3,707 1,507 Total revenue 178,582 245,502 250,991 163,067 Costs and expenses: Cost of product revenue 83,934 179,945 91,937 74,934 Research and development 4,680,181 6,174,589 865,765 187,759 Selling, general and administrative 3,697,287 2,994,649 1,959,872 1,921,513 Total costs and expenses 8,461,402 9,349,183 2,917,574 2,184,206 Loss from operations (8,282,820 ) (9,103,681 ) (2,666,583 ) (2,021,139 ) Interest income, net 59,593 51,809 28,210 12,394 Net loss $ (8,223,227 ) $ (9,051,872 ) $ (2,638,373 ) $ (2,008,745 ) Net loss per share attributable to common stockholders — basic and diluted $ (0.46 ) $ (0.50 ) $ (0.15 ) $ (0.11 ) Weighted-average number of common shares outstanding — basic and diluted 17,893,912 18,037,274 18,066,548 18,067,179 First Quarter Second Quarter Third Quarter Fourth Quarter Net product revenue $ 240,292 $ 330,688 $ 407,241 $ 282,752 Other revenue 2,255 4,835 6,360 76 Total revenue 242,547 335,523 413,601 282,828 Costs and expenses: Cost of product revenue 79,106 145,325 148,756 133,343 Research and development 3,914,974 4,076,220 4,739,360 4,259,357 Selling, general and administrative 4,594,716 4,990,943 4,934,937 3,983,088 Total costs and expenses 8,588,796 9,212,488 9,823,053 8,375,788 Loss from operations (8,346,249 ) (8,876,965 ) (9,409,452 ) (8,092,960 ) Interest income, net 77,854 72,342 77,339 64,429 Net loss $ (8,268,395 ) $ (8,804,623 ) $ (9,332,113 ) $ (8,028,531 ) Net loss per share attributable to common stockholders — basic and diluted $ (0.49 ) $ (0.51 ) $ (0.54 ) $ (0.46 ) Weighted-average number of common shares outstanding — basic and diluted 16,873,512 17,130,264 17,386,249 17,642,646 |
Organization and operations (De
Organization and operations (Details) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Jun. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2018USD ($)segment | Dec. 31, 2017USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Decrease in company workforce (as a percent) | 60.00% | 60.00% | ||
Number of reportable segments | segment | 2 | |||
Accumulated deficit | $ 132,961,275 | $ 111,079,275 | ||
Cash and cash equivalents | $ 9,829,624 | $ 19,186,036 |
Summary of significant accoun_4
Summary of significant accounting policies - Narrative (Details) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Entity Location [Line Items] | |||||||||||
Number of operating segments | segment | 2 | ||||||||||
Advertising expenses | $ 822,000 | $ 3,566,000 | $ 2,936,000 | ||||||||
Cost of product revenue | $ 74,934 | $ 91,937 | $ 179,945 | $ 83,934 | $ 133,343 | $ 148,756 | $ 145,325 | $ 79,106 | 430,750 | 506,530 | 662,747 |
Shipping and handling | |||||||||||
Entity Location [Line Items] | |||||||||||
Cost of product revenue | $ 98,000 | $ 261,000 | $ 170,000 | ||||||||
UNITED STATES | |||||||||||
Entity Location [Line Items] | |||||||||||
Number of geographic segments | segment | 1 |
Summary of significant accoun_5
Summary of significant accounting policies - Depreciation over estimated useful life (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Computers and computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Manufacturing equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Minimum | Website development costs | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 1 year |
Maximum | Website development costs | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 2 years |
Summary of significant accoun_6
Summary of significant accounting policies - Reconciliation of cash, cash equivalents and restricted cash (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 9,829,624 | $ 19,186,036 | ||
Restricted cash, current | 126,595 | 0 | ||
Restricted cash | 0 | 126,595 | ||
Cash, cash equivalents and restricted cash shown on the condensed consolidated statement of cash flows | $ 9,956,219 | $ 19,312,631 | $ 22,542,635 | $ 66,813,530 |
Revenue from contracts with c_2
Revenue from contracts with customers (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Jun. 18, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2018 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||||
Increase to retained earnings due to adoption of Topic 606 | $ (132,961,275) | $ (111,079,275) | $ (132,961,275) | $ (132,961,275) | $ (111,079,275) | |||||||||
Total revenue | 163,067 | $ 250,991 | $ 245,502 | $ 178,582 | $ 282,828 | $ 413,601 | $ 335,523 | $ 242,547 | 838,142 | 1,274,499 | $ 1,010,663 | |||
Refund period | 14 days | 30 days | ||||||||||||
Discounts to customers | 38,000 | $ 278,000 | $ 135,000 | |||||||||||
Difference between revenue guidance in effect before and after Topic 606 | Accounting Standards Update 2014-09 | ||||||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||||||||||
Increase to retained earnings due to adoption of Topic 606 | $ 40,000 | |||||||||||||
Decrease in deferred revenue | 70,000 | |||||||||||||
Decrease in deferred costs from product revenue | $ 30,000 | |||||||||||||
Total revenue | $ (15,000) | $ (1,000) | $ (10,000) | $ (18,000) | $ (44,000) |
Restricted cash (Details)
Restricted cash (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash, current | $ 126,595 | $ 0 |
Restricted cash | 0 | 126,595 |
Letter of Credit | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash, current | $ 126,595 | |
Restricted cash | $ 126,595 |
Fair value measurements (Detail
Fair value measurements (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 | $ 14,129,723 |
U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 8,986,259 | |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 4,440,689 | |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 702,775 | |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 2,333,771 | 5,046,205 |
Total assets at fair value | 2,333,771 | 19,175,928 |
Fair Value, Measurements, Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 2,333,771 | 5,046,205 |
Total assets at fair value | 2,333,771 | 5,046,205 |
Fair Value, Measurements, Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Total assets at fair value | 0 | 14,129,723 |
Fair Value, Measurements, Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Total assets at fair value | $ 0 | 0 |
Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 8,986,259 | |
Fair Value, Measurements, Recurring | U.S. government agency securities | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | |
Fair Value, Measurements, Recurring | U.S. government agency securities | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 8,986,259 | |
Fair Value, Measurements, Recurring | U.S. government agency securities | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | |
Fair Value, Measurements, Recurring | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 4,440,689 | |
Fair Value, Measurements, Recurring | Commercial paper | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | |
Fair Value, Measurements, Recurring | Commercial paper | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 4,440,689 | |
Fair Value, Measurements, Recurring | Commercial paper | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | |
Fair Value, Measurements, Recurring | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 702,775 | |
Fair Value, Measurements, Recurring | Corporate debt securities | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | |
Fair Value, Measurements, Recurring | Corporate debt securities | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 702,775 | |
Fair Value, Measurements, Recurring | Corporate debt securities | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 |
Cash equivalents and marketab_3
Cash equivalents and marketable securities (Details) | 12 Months Ended | |
Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($)security | |
Cash and Cash Equivalents [Abstract] | ||
Realized gains on marketable securities | $ 0 | $ 0 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 14,130,970 | |
Unrealized Gains | 38 | |
Unrealized Losses | (1,285) | |
Fair Value | $ 0 | $ 14,129,723 |
Number of debt securities held | security | 6 | |
Aggregate fair value of securities in an unrealized loss position | $ 8,191,315 | |
Number of debt securities in a significant unrealized loss position | security | 0 | |
U.S. government agency securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 8,987,254 | |
Unrealized Gains | 38 | |
Unrealized Losses | (1,033) | |
Fair Value | 8,986,259 | |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 4,440,689 | |
Unrealized Gains | 0 | |
Unrealized Losses | 0 | |
Fair Value | 4,440,689 | |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 703,027 | |
Unrealized Gains | 0 | |
Unrealized Losses | (252) | |
Fair Value | $ 702,775 |
Inventory (Details)
Inventory (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 7,247 | $ 17,411 | |
Finished goods | 179,673 | 414,480 | |
Total inventory | 186,920 | 431,891 | |
Write-off of inventory | $ 85,000 | $ 42,000 | $ 282,000 |
Property and equipment, net (De
Property and equipment, net (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 875,555 | $ 953,923 | |
Accumulated depreciation | (801,095) | (622,883) | |
Property and equipment, net | 74,460 | 331,040 | |
Depreciation expense | 228,158 | 324,548 | $ 277,231 |
Property and equipment disposals | 28,422 | ||
Proceeds from sales of property and equipment | 4,805 | 5,344 | $ 5,255 |
Loss on disposal of property and equipment | 23,617 | ||
Manufacturing equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 421,999 | 421,999 | |
Computers and computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 275,670 | 311,847 | |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 177,886 | 177,886 | |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 0 | 13,368 | |
Capital in progress | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 0 | $ 28,823 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities - Schedule of accrued expenses and other current liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Payroll and employee-related costs | $ 417,997 | $ 874,246 |
Professional fees | 269,544 | 227,980 |
Restructuring-related costs | 68,593 | 0 |
Consumer product-related costs | 5,360 | 107,595 |
Research and development costs | 2,846 | 2,502,400 |
Total | $ 764,340 | $ 3,712,221 |
Accrued expenses and other cu_4
Accrued expenses and other current liabilities - Narrative (Details) - USD ($) | Jan. 03, 2019 | Jun. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2018 |
Restructuring Cost and Reserve [Line Items] | ||||
Decrease in company workforce (as a percent) | 60.00% | 60.00% | ||
Restructuring charges | $ 1,366,000 | |||
Corporate restructuring plan | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Cash retention bonus cost | 205,000 | |||
Severance benefits | 186,000 | |||
Cash Retention Bonuses Payable | 1,006,000 | |||
Cash retention bonuses payable upon change in control | 603,000 | |||
Cash retention bonuses payable upon employees in good standing | 403,000 | |||
Severance benefits payable upon change in control and termination without cause | 928,000 | |||
Ongoing termination benefits | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 1,037,000 | |||
One-time termination benefits | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 100,000 | |||
Retention benefits | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 214,417 | |||
Other restructuring | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 14,995 | |||
Scenario, forecast | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Severance benefits payable upon change in control and termination without cause | $ 928,000 | |||
Restructuring charges incurred upon change in control | $ 603,000 | |||
Minimum | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 1,769,000 | |||
Maximum | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 3,354,000 | |||
Research and development | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 968,000 | |||
Selling, general and administrative expenses | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 398,000 | |||
Consumer Operations | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 81,000 | |||
Consumer Operations | Maximum | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 113,000 | |||
Drug Development | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 968,000 | |||
Drug Development | Maximum | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 1,036,000 | |||
Corporate | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | 317,000 | |||
Corporate | Maximum | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring charges | $ 2,205,000 |
Accrued expenses and other cu_5
Accrued expenses and other current liabilities - Schedule of restructuring and related costs (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Restructuring Reserve [Roll Forward] | |
Accrued restructuring balance as of December 31, 2017 | $ 0 |
Restructuring charges | 1,366,000 |
Payments | (1,297,207) |
Accrued restructuring balance as of December 31, 2018 | 68,593 |
Employee severance | |
Restructuring Reserve [Roll Forward] | |
Restructuring charges | 1,136,388 |
Retention benefits | |
Restructuring Reserve [Roll Forward] | |
Restructuring charges | 214,417 |
Other restructuring | |
Restructuring Reserve [Roll Forward] | |
Restructuring charges | $ 14,995 |
Commitments and contingencies (
Commitments and contingencies (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2019 | Mar. 31, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 | |
Operating Leased Assets [Line Items] | ||||||
Future minimum lease payments | $ 2,350 | |||||
Rent expense | 351,000 | $ 522,000 | $ 337,000 | |||
Percent of gross sales due to related parties | 2.00% | 2.00% | ||||
Royalty expense | 17,000 | 25,000 | 20,000 | |||
Royalties payable | $ 3,000 | $ 3,000 | $ 4,000 | |||
Subsequent Event | ||||||
Operating Leased Assets [Line Items] | ||||||
Royalty agreement term | 20 years | |||||
Subsequent Event | Royalty agreement first ten years | ||||||
Operating Leased Assets [Line Items] | ||||||
Percent of gross sales due to related parties | 2.00% | |||||
Subsequent Event | Royalty agreement next ten years | ||||||
Operating Leased Assets [Line Items] | ||||||
Percent of gross sales due to related parties | 1.00% |
Preferred stock (Details)
Preferred stock (Details) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Equity [Abstract] | ||
Preferred stock, authorized (shares) | 10,000,000 | 10,000,000 |
Preferred stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 |
Common stock - Narrative (Detai
Common stock - Narrative (Details) | Jun. 14, 2018 | Apr. 30, 2014shares | Mar. 31, 2014USD ($)$ / sharesshares | Dec. 31, 2018USD ($)vote$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)shares |
Class of Stock [Line Items] | ||||||
Common stock, shares authorized (shares) | 100,000,000 | 100,000,000 | ||||
Common stock, par value (in usd per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Common stock, number of votes per share | vote | 1 | |||||
Restricted common stock, vesting period | 48 months | |||||
Common stock purchased under the 2015 ESPP (shares) | 0 | |||||
Unvested restricted common stock | ||||||
Class of Stock [Line Items] | ||||||
Restricted common stock, shares sold | 867,314 | 4,553,415 | ||||
Restricted common stock, price per share (in usd per share) | $ / shares | $ 0.0004 | |||||
Proceeds from sale of restricted common stock to founders | $ | $ 1,950 | |||||
Restricted common stock, fair value of shares vested | $ | $ 725,000 | $ 3,840,000 | $ 9,646,000 | |||
Restricted common stock, issued (shares) | 0 | |||||
Unvested restricted common stock | Vests upon issuance | ||||||
Class of Stock [Line Items] | ||||||
Restricted common stock, percent vested | 25.00% | |||||
Unvested restricted common stock | Vests ratably over four years | ||||||
Class of Stock [Line Items] | ||||||
Restricted common stock, percent vested | 75.00% | |||||
Restricted common stock, vesting period | 4 years | |||||
Non-employee consultants and advisers | Unvested restricted common stock | ||||||
Class of Stock [Line Items] | ||||||
Restricted common stock, fair value of shares vested | $ | $ 9,000 | $ 22,000 | $ 71,000 | |||
Restricted common stock, issued (shares) | 0 | 0 | 18,194 | |||
Restricted common stock, shares outstanding | 16,110 |
Common stock - Restricted commo
Common stock - Restricted common stock activity (Details) - Unvested restricted common stock - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Beginning balance, unvested (shares) | 169,654 | ||
Issued (shares) | 0 | ||
Vested (shares) | (169,654) | ||
Forfeited (shares) | 0 | ||
Ending balance, unvested (shares) | 0 | 169,654 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Beginning balance, unvested, weighted average grant date fair value (in usd per share) | $ 0.10 | ||
Issued, weighted average grant date fair value (in usd per share) | 0 | ||
Vested, weighted average grant date fair value (in usd per share) | 0.10 | ||
Forfeited, weighted average grant date fair value (in usd per share) | 0 | ||
Ending balance, unvested, weighted average grant date fair value (in usd per share) | $ 0 | $ 0.10 | |
Non-employee consultants and advisers | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Beginning balance, unvested (shares) | 5,334 | ||
Issued (shares) | 0 | 0 | 18,194 |
Vested (shares) | (3,250) | ||
Forfeited (shares) | 0 | ||
Ending balance, unvested (shares) | 2,084 | 5,334 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Beginning balance, unvested, weighted average grant date fair value (in usd per share) | $ 10.51 | ||
Issued, weighted average grant date fair value (in usd per share) | 0 | ||
Vested, weighted average grant date fair value (in usd per share) | 10.16 | ||
Forfeited, weighted average grant date fair value (in usd per share) | 0 | ||
Ending balance, unvested, weighted average grant date fair value (in usd per share) | $ 11.05 | $ 10.51 |
Common stock - Shares reserved
Common stock - Shares reserved for future issuance (Details) - shares | Dec. 31, 2018 | Dec. 31, 2017 |
Class of Stock [Line Items] | ||
Stock-based compensation awards (shares) | 4,061,397 | 3,439,820 |
Employee stock purchase plan (shares) | 713,996 | 534,274 |
Total (shares) | 4,777,477 | 4,149,082 |
Unvested restricted common stock | ||
Class of Stock [Line Items] | ||
Vesting of restricted common stock (shares) | 2,084 | 174,988 |
Stock-based compensation - Narr
Stock-based compensation - Narrative (Details) | Jun. 14, 2018employeeshares | Jun. 30, 2018adviseremployeeshares | Dec. 31, 2018USD ($)employee$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options, vesting period | 48 months | ||||
Stock-based compensation expense | $ | $ 1,939,611 | $ 4,219,165 | $ 6,572,963 | ||
Shares granted (shares) | 654,544 | 1,517,544 | 1,059,500 | 763,320 | |
Shares granted, weighted-average grant date fair value (in usd per share) | $ / shares | $ 1.95 | $ 2.80 | $ 6.35 | ||
Shares exercised (shares) | 97,310 | 1,576 | 8,516 | ||
Shares exercised, weighted average exercise price (in usd per share) | $ / shares | $ 1.21 | $ 1.67 | $ 2.59 | ||
Stock options exercised, intrinsic value | $ | $ 349,974 | $ 2,606 | $ 64,302 | ||
Unrecognized compensation cost | $ | $ 2,160,000 | ||||
Unrecognized compensation cost, recognition period | 2 years 8 months 27 days | ||||
Option awards held (shares) | 2,320,981 | 2,580,491 | |||
Number of employees granted options | employee | 7 | ||||
Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Post termination exercisability extended period | 1 year | ||||
Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Post termination exercisability extended period | 3 years | ||||
Non-employee stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares granted to non-employee consultants and members of the Scientific Advisory Board (shares) | 30,000 | 0 | 14,670 | ||
Stock options, vesting period | 4 years | ||||
Stock options, contractual term | 10 years | ||||
Stock-based compensation expense | $ | $ 124,000 | $ 201,000 | $ 370,000 | ||
Options to purchase common stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options, contractual term | 10 years | ||||
Options to purchase common stock | Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options, vesting period | 1 year | ||||
Options to purchase common stock | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options, vesting period | 4 years | ||||
2015 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares remaining available for grant of stock awards (shares) | 1,740,416 | ||||
Employee stock option, one-year post termination exercisability | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Post termination exercisability period | 3 months | ||||
Option awards held (shares) | 877,137 | ||||
Number of employees holding options | employee | 6 | 6 | |||
Number of advisers holding options | adviser | 1 | ||||
Post termination exercisability extended period | 1 year | ||||
Number of employees terminated | employee | 3 | ||||
Employee stock option, three-year post termination exercisability | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Post termination exercisability period | 3 months | ||||
Option awards held (shares) | 500,000 | ||||
Number of employees holding options | employee | 1 | ||||
Post termination exercisability extended period | 3 years | ||||
Selling, general and administrative expenses | Options to purchase common stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ | $ 285,000 |
Stock-based compensation - Summ
Stock-based compensation - Summary of stock option activity (Details) - USD ($) | Jun. 14, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Shares | ||||
Shares outstanding, beginning balance (shares) | 2,580,491 | |||
Shares granted (shares) | 654,544 | 1,517,544 | 1,059,500 | 763,320 |
Shares exercised (shares) | (97,310) | (1,576) | (8,516) | |
Shares forfeited (shares) | (859,543) | |||
Shares expired (shares) | (820,201) | |||
Shares outstanding, ending balance (shares) | 2,320,981 | 2,580,491 | ||
Shares exercisable (shares) | 1,149,927 | |||
Shares vested or expected to vest (shares) | 2,320,981 | |||
Weighted-Average Exercise Price | ||||
Shares outstanding, beginning balance, weighted average exercise price (in usd per share) | $ 6.65 | |||
Shares granted, weighted average exercise price (in usd per share) | 2.74 | |||
Shares exercised, weighted average exercise price (in usd per share) | 1.21 | $ 1.67 | $ 2.59 | |
Shares forfeited, weighted average exercise price (in usd per share) | 5.76 | |||
Shares expired, weighted average exercise price (in usd per share) | 8.19 | |||
Shares outstanding, ending balance, weighted average exercise price (in usd per share) | 4.10 | $ 6.65 | ||
Shares exercisable, weighted average exercise price (in usd per share) | 5.53 | |||
Shares vested or expected to vest, weighted average exercise price (in usd per share) | $ 4.10 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||||
Outstanding, weighted average remaining contractual term | 7 years 7 months 10 days | 7 years 6 months 18 days | ||
Exercisable, weighted average remaining contractual term | 6 years 26 days | |||
Vested or expected to vest, weighted average remaining contractual term | 7 years 6 months 11 days | |||
Outstanding, aggregate intrinsic value | $ 0 | $ 803,600 | ||
Exercisable, aggregate intrinsic value | 0 | |||
Vested or expected to vest, aggregate intrinsic value | $ 0 |
Stock-based compensation - Sche
Stock-based compensation - Schedule of fair value assumptions (Details) - Options to purchase common stock | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum | 2.45% | 1.83% | 1.23% |
Risk-free interest rate, maximum | 2.91% | 2.40% | 2.40% |
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility (as a percent) | 81.56% | 73.87% | 71.01% |
Expected term | 5 years 3 months 18 days | 5 years 3 months 18 days | 5 years 3 months 18 days |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility (as a percent) | 82.41% | 81.04% | 74.20% |
Expected term | 10 years | 9 years 6 months | 10 years |
Stock-based compensation - Su_2
Stock-based compensation - Summary of stock-based compensation expense (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employee Service Share-Based Compensation Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 1,939,611 | $ 4,219,165 | $ 6,572,963 |
Research and development | |||
Employee Service Share-Based Compensation Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 705,687 | 1,545,737 | 2,435,565 |
Selling, general and administrative | |||
Employee Service Share-Based Compensation Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 1,233,924 | $ 2,673,428 | $ 4,137,398 |
Income taxes - Narrative (Detai
Income taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes [Line Items] | ||
Increase (decrease) in valuation allowance | $ 5,250 | |
Payroll tax credit | 156 | $ 22 |
U.S. Federal | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | 110,900 | |
Research and development tax credit carryforwards | 1,800 | |
U.S. State | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | 105,400 | |
Operating loss carryforward tax affected | 8,400 | |
Research and development tax credit carryforwards | $ 570 |
Income taxes - Schedule of effe
Income taxes - Schedule of effective income tax rate reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Federal income tax expense at statutory rate | 21.00% | 35.00% | 35.00% |
State income tax, net of federal benefit (as a percent) | 6.00% | 5.00% | 5.00% |
Permanent differences (as a percent) | (0.10%) | (0.70%) | 0.00% |
Stock-based compensation (as a percent) | (2.80%) | (1.90%) | (2.60%) |
Research credits (as a percent) | 2.60% | 2.20% | 1.90% |
Other, net (as a percent) | (1.60%) | (1.30%) | (0.10%) |
Payroll tax credit election (as a percent) | (1.10%) | (0.70%) | 0.00% |
Change in valuation allowance (as a percent) | (24.00%) | (1.10%) | (39.20%) |
Deferred rate change | 0.00% | (36.50%) | 0.00% |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Income taxes - Schedule of defe
Income taxes - Schedule of deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
U.S. and state net operating loss carryforwards | $ 29,902,019 | $ 24,744,841 |
Accruals and other temporary differences | 336,229 | 202,301 |
Amortization | 50,688 | 35,783 |
Stock-based compensation | 1,220,546 | 1,591,131 |
Tax credit carryforward | 2,277,428 | 1,964,189 |
Total deferred tax assets | 33,786,910 | 28,538,245 |
Less valuation allowance | (33,786,910) | (28,533,755) |
Deferred tax assets | 0 | 4,490 |
Deferred tax liabilities: | ||
Stock-based compensation | 0 | (4,490) |
Deferred tax liabilities | 0 | (4,490) |
Net deferred tax assets | $ 0 | $ 0 |
Net loss per share (Details)
Net loss per share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (shares) | 2,323,065 | 2,755,479 | 3,353,042 |
Options to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (shares) | 2,320,981 | 2,580,491 | 2,156,250 |
Unvested restricted common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (shares) | 2,084 | 174,988 | 1,196,792 |
Segment Information (Details)
Segment Information (Details) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Segment Reporting [Abstract] | |||||||||||
Number of reportable segments | segment | 2 | ||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | $ 163,067 | $ 250,991 | $ 245,502 | $ 178,582 | $ 282,828 | $ 413,601 | $ 335,523 | $ 242,547 | $ 838,142 | $ 1,274,499 | $ 1,010,663 |
Loss from operations | 2,021,139 | 2,666,583 | 9,103,681 | 8,282,820 | 8,092,960 | 9,409,452 | 8,876,965 | 8,346,249 | 22,074,223 | 34,725,626 | 39,886,232 |
Interest income, net | $ 12,394 | $ 28,210 | $ 51,809 | $ 59,593 | $ 64,429 | $ 77,339 | $ 72,342 | $ 77,854 | 152,006 | 291,964 | 393,109 |
Operating Segments | Consumer Operations | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 838,142 | 1,274,499 | 1,010,663 | ||||||||
Loss from operations | 1,975,792 | 8,877,330 | 10,023,137 | ||||||||
Interest income, net | 0 | 0 | 0 | ||||||||
Operating Segments | Drug Development | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 0 | 0 | 0 | ||||||||
Loss from operations | 11,887,108 | 16,715,752 | 19,620,338 | ||||||||
Interest income, net | 0 | 0 | 0 | ||||||||
Corporate | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 0 | 0 | 0 | ||||||||
Loss from operations | 8,211,323 | 9,132,544 | 10,242,757 | ||||||||
Interest income, net | $ 152,006 | $ 291,964 | $ 393,109 |
Related parties (Details)
Related parties (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2019 | Mar. 31, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 | |
Related Party Transaction [Line Items] | ||||||
Percent of gross sales due to related parties | 2.00% | 2.00% | ||||
Royalty expense | $ 17 | $ 25 | $ 20 | |||
Royalties payable | $ 3 | $ 3 | 4 | |||
Affiliated entity | ||||||
Related Party Transaction [Line Items] | ||||||
License fees received | $ 32 | |||||
Subsequent Event | ||||||
Related Party Transaction [Line Items] | ||||||
Royalty agreement term | 20 years | |||||
Subsequent Event | Royalty agreement first ten years | ||||||
Related Party Transaction [Line Items] | ||||||
Percent of gross sales due to related parties | 2.00% | |||||
Subsequent Event | Royalty agreement next ten years | ||||||
Related Party Transaction [Line Items] | ||||||
Percent of gross sales due to related parties | 1.00% |
Quarterly financial informati_3
Quarterly financial information (unaudited) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Total revenue | $ 163,067 | $ 250,991 | $ 245,502 | $ 178,582 | $ 282,828 | $ 413,601 | $ 335,523 | $ 242,547 | $ 838,142 | $ 1,274,499 | $ 1,010,663 |
Costs and expenses: | |||||||||||
Cost of product revenue | 74,934 | 91,937 | 179,945 | 83,934 | 133,343 | 148,756 | 145,325 | 79,106 | 430,750 | 506,530 | 662,747 |
Research and development | 187,759 | 865,765 | 6,174,589 | 4,680,181 | 4,259,357 | 4,739,360 | 4,076,220 | 3,914,974 | 11,908,294 | 16,989,911 | 20,378,161 |
Selling, general and administrative | 1,921,513 | 1,959,872 | 2,994,649 | 3,697,287 | 3,983,088 | 4,934,937 | 4,990,943 | 4,594,716 | 10,573,321 | 18,503,684 | 19,855,987 |
Total costs and expenses | 2,184,206 | 2,917,574 | 9,349,183 | 8,461,402 | 8,375,788 | 9,823,053 | 9,212,488 | 8,588,796 | 22,912,365 | 36,000,125 | 40,896,895 |
Loss from operations | (2,021,139) | (2,666,583) | (9,103,681) | (8,282,820) | (8,092,960) | (9,409,452) | (8,876,965) | (8,346,249) | (22,074,223) | (34,725,626) | (39,886,232) |
Interest income, net | 12,394 | 28,210 | 51,809 | 59,593 | 64,429 | 77,339 | 72,342 | 77,854 | 152,006 | 291,964 | 393,109 |
Net loss | $ (2,008,745) | $ (2,638,373) | $ (9,051,872) | $ (8,223,227) | $ (8,028,531) | $ (9,332,113) | $ (8,804,623) | $ (8,268,395) | $ (21,922,217) | $ (34,433,662) | $ (39,493,123) |
Net loss per share attributable to common stockholders - basic and diluted (in usd per share) | $ (0.11) | $ (0.15) | $ (0.50) | $ (0.46) | $ (0.46) | $ (0.54) | $ (0.51) | $ (0.49) | $ (1.22) | $ (1.99) | $ (2.43) |
Weighted-average number of common shares outstanding — basic and diluted (shares) | 18,067,179 | 18,066,548 | 18,037,274 | 17,893,912 | 17,642,646 | 17,386,249 | 17,130,264 | 16,873,512 | 18,016,841 | 17,260,626 | 16,233,985 |
Net product revenue | |||||||||||
Total revenue | $ 161,560 | $ 247,284 | $ 241,416 | $ 176,255 | $ 282,752 | $ 407,241 | $ 330,688 | $ 240,292 | $ 826,515 | $ 1,260,973 | $ 989,918 |
Other revenue | |||||||||||
Total revenue | 1,507 | 3,707 | 4,086 | 2,327 | $ 76 | $ 6,360 | $ 4,835 | $ 2,255 | 11,627 | $ 13,526 | $ 20,745 |
Accounting Standards Update 2014-09 | Difference between revenue guidance in effect before and after Topic 606 | |||||||||||
Total revenue | $ (15,000) | $ (1,000) | $ (10,000) | $ (18,000) | $ (44,000) |
Subsequent events (Details)
Subsequent events (Details) - Subsequent Event $ / shares in Units, $ in Thousands | Jan. 03, 2019USD ($)$ / sharesshares |
Subsequent Event [Line Items] | |
Value assigned | $ 10,500 |
Target net cash | $ 3,300 |
Rights distributed (shares) | shares | 1 |
Period to receive warrants to purchase shares | 6 months 1 day |
Period which warrants are exercisable | 5 years |
Termination fee payable | $ 350 |
Termination reimbursement Expense | 200 |
Termination fee receivable | $ 1,000 |
Combined company | |
Subsequent Event [Line Items] | |
Ownership percentage | 19.90% |
Agreement and plan of merger | |
Subsequent Event [Line Items] | |
Exercise price, below threshold (shares) | shares | 849,610 |
Business Combination, Exercise Price | $ / shares | $ 1.35 |
Exercise price, above threshold (shares) | shares | 1,447,426 |
Salarius | |
Subsequent Event [Line Items] | |
Value assigned | $ 36,600 |
Ownership percentage | 80.10% |
Preferred Stock | |
Subsequent Event [Line Items] | |
Target sale price | $ 7,000 |
Uncategorized Items - flks-2018
Label | Element | Value |
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 40,217 |
Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 40,217 |