Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 09, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | EVOK | |
Entity Registrant Name | Evoke Pharma Inc | |
Entity Central Index Key | 1,403,708 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 12,350,360 |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash and cash equivalents | $ 4,129,051 | $ 8,691,155 |
Prepaid expenses | 499,324 | 833,276 |
Other current assets | 7,997 | |
Total current assets | 4,636,372 | 9,524,431 |
Other assets | 7,997 | |
Total assets | 4,636,372 | 9,532,428 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 1,264,145 | 927,606 |
Accrued compensation | 499,305 | 760,782 |
Current portion of long-term debt | 4,399,835 | 146,052 |
Total current liabilities | 6,163,285 | 1,834,440 |
Long-term debt, net of current portion | 4,233,059 | |
Total liabilities | 6,163,285 | 6,067,499 |
Stockholders' equity: | ||
Common stock, $0.0001 par value; authorized shares — 50,000,000; issued and outstanding shares - 7,291,841 and 7,201,774 at June 30, 2016 and December 31, 2015, respectively | 729 | 720 |
Additional paid-in capital | 52,728,877 | 51,524,821 |
Accumulated deficit | (54,256,519) | (48,060,612) |
Total stockholders' equity (deficit) | (1,526,913) | 3,464,929 |
Total liabilities and stockholders' equity | $ 4,636,372 | $ 9,532,428 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 7,291,841 | 7,201,774 |
Common stock, shares outstanding | 7,291,841 | 7,201,774 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Operating expenses: | ||||
Research and development | $ 2,095,149 | $ 2,188,138 | $ 4,110,225 | $ 4,608,099 |
General and administrative | 802,655 | 976,418 | 1,940,408 | 2,001,679 |
Total operating expenses | 2,897,804 | 3,164,556 | 6,050,633 | 6,609,778 |
Loss from operations | (2,897,804) | (3,164,556) | (6,050,633) | (6,609,778) |
Other expense | (72,694) | (76,607) | (145,274) | (152,133) |
Net loss | $ (2,970,498) | $ (3,241,163) | $ (6,195,907) | $ (6,761,911) |
Net loss per common share, basic and diluted | $ (0.41) | $ (0.52) | $ (0.86) | $ (1.10) |
Weighted-average shares used to compute basic and diluted net loss per share | 7,217,577 | 6,212,803 | 7,192,791 | 6,157,226 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Operating activities | ||
Net loss | $ (6,195,907) | $ (6,761,911) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 846,042 | 756,138 |
Non-cash interest | 20,724 | 30,348 |
Deferred rent expense | (6,374) | |
Change in operating assets and liabilities: | ||
Prepaid expenses and other assets | 333,952 | 214,845 |
Accounts payable and accrued expenses | 75,062 | 227,700 |
Net cash used in operating activities | (4,920,127) | (5,539,254) |
Financing activities | ||
Proceeds from issuance of common stock, net | 358,023 | 1,266,533 |
Net cash provided by financing activities | 358,023 | 1,266,533 |
Net decrease in cash and cash equivalents | (4,562,104) | (4,272,721) |
Cash and cash equivalents at beginning of period | 8,691,155 | 14,155,809 |
Cash and cash equivalents at end of period | 4,129,051 | 9,883,088 |
Supplemental disclosure of cash flow information | ||
Interest paid | $ 125,813 | 104,500 |
Non-cash financing activities | ||
Deferred financing costs paid in prior year | $ 137,812 |
Organization and Basis of Prese
Organization and Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Evoke Pharma, Inc. (the “Company”) was incorporated in the state of Delaware on January 29, 2007. The Company is a publicly-held specialty pharmaceutical company focused primarily on the development of drugs to treat gastroenterological disorders and disease. Since its inception, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure, and has not realized revenues from its planned principal operations. The Company does not anticipate realizing revenues for the foreseeable future. The Company’s activities are subject to the significant risks and uncertainties associated with any specialty pharmaceutical company that has substantial expenditures for research and development, including funding its operations. The Company has incurred recurring losses and negative cash flows from operations since inception and expects to continue to incur net losses for at least the next several years. As of June 30, 2016, the Company had an accumulated deficit of approximately $54.3 million. The Company expects operating losses and negative cash flows to continue for the foreseeable future until such time, if ever, that it can generate significant revenues from the sale of Gimoti (formerly known as EVK-001). Results of Phase 3 Clinical Trial On July 18, 2016, the Company announced topline results from its Phase 3 clinical trial that evaluated the efficacy and safety of Gimoti in women with symptoms associated with diabetic gastroparesis. In this study, Gimoti did not achieve its primary endpoint of symptom improvement at Week 4. Sales of Common Stock and Warrants On July 25, 2016 and August 3, 2016, the Company completed at-the-market offerings of an aggregate of 5,048,632 shares of common stock for gross proceeds of approximately $14.5 million. Concurrently in private placements, for each share of common stock purchased by an investor, such investor received from the Company an unregistered warrant to purchase shares of common stock. See Note 5 for further description. Repayment of Debt On August 4, 2016, the Company repaid in full the entire $4.5 million of outstanding principal and interest under the Loan and Security Agreement, dated as of May 28, 2014, as amended (the “Loan Agreement”), between the Company, as borrower, and Square 1 Bank, a division of Pacific Western Bank (“Square 1”), as lender. In connection with such repayment, the Loan Agreement was terminated, and all security, liens or other encumbrances on assets of the Company were released. See Note 3 for further description. In addition to the financings that occurred in July and August 2016, the Company may need to raise additional funds to conduct further analyses of the Phase 3 trial data of its product candidate and assess continued development opportunities for this product candidate, to prepare for a meeting with the U.S. Food and Drug Administration (“FDA”), for other working capital and general corporate purposes. The Company believes that its current cash and cash equivalents, including the proceeds from the financings that occurred in July and August 2016 and after repayment of the debt, will be sufficient to meet estimated working capital requirements and fund operations through at least December 31, 2016. There can be no assurance that additional financing will be available when needed or on acceptable terms. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects. Going Concern In its report on the Company’s financial statements for the year ended December 31, 2015, the Company’s independent registered public accounting firm included an explanatory paragraph expressing substantial doubt regarding the Company’s ability to continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Though the Company was able to raise aggregate net proceeds of approximately $12.8 million through sales of its common stock and warrants to purchase its common stock in July 2016 and August 2016, as of the date of this filing the Company believes that there is substantial doubt about its ability to continue as a going concern within one year after the financial statements are issued. Should the Company’s assessment of the Phase 3 clinical trial data and/or other development opportunities result in the Company’s determination to continue the development of Gimoti, the Company anticipates that it will need to continue to complete equity or debt financings to meet future product development milestones. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The accompanying condensed balance sheet as of December 31, 2015, which has been derived from audited financial statements, and the unaudited interim condensed financial statements, have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and follow the requirements of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In management’s opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position and its results of operations and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the year ended December 31, 2015, which are contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 10, 2016. The results for interim periods are not necessarily indicative of the results expected for the full year or any other interim period. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. Stock-Based Compensation Stock-based compensation expense for stock option grants and employee stock purchases under the Company’s Employee Stock Purchase Plan (the “ESPP”) is recorded at the estimated fair value of the award as of the grant date and is recognized as expense on a straight-line basis over the employee’s requisite service period. The estimation of stock option and ESPP fair value requires management to make estimates and judgments about, among other things, employee exercise behavior, forfeiture rates and volatility of the Company’s common stock. The judgments directly affect the amount of compensation expense that will be recognized. The Company grants stock options to purchase common stock to employees and members of the board of directors with exercise prices equal to the Company’s closing market price on the date the stock options are granted. The risk-free interest rate assumption was based on the yield of an applicable rate for U.S. Treasury instruments with maturities similar to those of the expected term of the award being valued. The weighted average expected term of options and employee stock purchases was calculated using the simplified method as prescribed by accounting guidance for stock-based compensation. This decision was based on the lack of relevant historical data due to the Company’s limited historical experience. In addition, due to the Company’s limited historical data, the estimated volatility was calculated based upon the Company’s historical volatility, supplemented with historical volatility of comparable companies in the biotechnology industry whose share prices are publicly available for a sufficient period of time. The assumed dividend yield was based on the Company never paying cash dividends and having no expectation of paying cash dividends in the foreseeable future. Research and Development Expenses Research and development costs are expensed as incurred and primarily include compensation and related benefits, stock-based compensation expense and costs paid to third-party contractors to perform research, conduct clinical trials and develop drug materials and delivery devices. The Company expenses costs relating to the purchase and production of pre-approval inventories as research and development expense in the period incurred until U.S. Food and Drug Administration (“FDA”) approval is received. The Company bases its expense accruals related to clinical studies on estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations (“CROs”) that conduct and manage clinical studies on its behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors, such as the successful enrollment of patients, site initiation and the completion of clinical study milestones. Service providers typically invoice the Company monthly in arrears for services performed. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the Company does not identify costs that have begun to be incurred, or if the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ materially from estimates. To date, the Company has not experienced significant changes in estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, no assurance can be made that changes to the estimates will not be made in the future as the Company becomes aware of additional information about the status or conduct of clinical studies and other research activities. Included in research and development expenses for the three and six months ended June 30, 2015 were costs of $71,019 and $159,044, respectively, for clinical trial services incurred by a related party of one of the Company’s officers. There were no related party costs incurred during the six months ended June 30, 2016. The Company does not own or operate manufacturing facilities for the production of Gimoti, nor does it plan to develop its own manufacturing operations in the foreseeable future. The Company currently depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its preclinical research and clinical trials. Other than an agreement with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, the Company does not have any other contractual relationships for the manufacture of commercial supplies of Gimoti. If Gimoti is approved by any regulatory agency, the Company intends to enter into agreements with third-party contract manufacturers for the commercial production at that time. The Company currently utilizes a third-party consultant, which it engages on an as-needed, hourly basis, to manage its manufacturing contractors. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents and adjusted for the weighted-average number of common shares outstanding that are subject to repurchase. The Company has excluded 45,000 shares subject to repurchase from the weighted-average number of common shares outstanding for each of the three and six months ended June 30, 2016 and 2015. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of warrants for the purchase of common stock, options outstanding under the Company’s equity incentive plans and potential shares to be purchased under the ESPP. For the periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Common stock subject to repurchase 45,000 45,000 45,000 45,000 Warrants to purchase common stock 118,881 118,881 118,881 118,881 Common stock options 1,275,624 1,037,500 1,275,624 1,037,500 Employee stock purchase plan 8,272 7,208 11,032 10,529 Total excluded securities 1,447,777 1,208,589 1,450,537 1,211,910 Recent Accounting Pronouncements In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-15 (Subtopic 205-40), Presentation of Financial Statements Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. Contingencies. In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases In March 2016, the FASB issued ASU No. 2016-09 Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting |
Debt
Debt | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Debt | 3. Debt In May 2014, the Company entered into a $4.5 million loan and security agreement (the “credit facility”) with Square 1, pursuant to which Square 1 agreed to make term loans available to the Company for general corporate and working capital purposes and for capital expenditures. In December 2014, the Company drew down the entire $4.5 million. The credit facility had a fixed annual interest rate of 5.50%. On August 4, 2016, the Company repaid in full the entire $4.5 million of outstanding principal and interest under the Loan Agreement between the Company and Square 1 Bank. In connection with such repayment, the Loan Agreement was terminated, and all security, liens or other encumbrances on assets of the Company were released. The Company incurred $82,685 of loan origination costs related to this credit facility. The remaining unamortized costs of approximately $38,000 were charged to interest expense upon the payment of the loan in August 2016. In connection with the funding of the term loan, the Company issued to Square 1 a warrant to purchase 22,881 shares of the Company’s common stock at an exercise price of $5.90 per share, the closing price of the Company’s common stock on the day of funding of the credit facility. During July 2016, Square 1 converted its warrant by a “cashless” conversion and received 9,887 shares of the Company’s common stock. The value determined for the warrant at the time of the grant of $108,122 was recorded as a debt discount, as well as to stockholders’ equity. The remaining unamortized debt discount associated with the warrant of approximately $59,000 was charged to interest expense upon the payment of the loan in August 2016. |
Technology Acquisition Agreemen
Technology Acquisition Agreement | 6 Months Ended |
Jun. 30, 2016 | |
Technology Acquisition Agreement [Abstract] | |
Technology Acquisition Agreement | 4. Technology Acquisition Agreement In June 2007, the Company acquired all worldwide rights, data, patents and other related assets associated with Gimoti from Questcor Pharmaceuticals, Inc. (“Questcor”) pursuant to an Asset Purchase Agreement. The Company paid Questcor $650,000 in the form of an upfront payment and $500,000 in May 2014 as a milestone payment based upon the initiation of the first patient dosing in the Company’s Phase 3 clinical trial for Gimoti. In August 2014, Mallinckrodt, plc (“Mallinckrodt”) acquired Questcor. As a result of that acquisition, Questcor transferred its rights included in the Asset Purchase Agreement with the Company to Mallinckrodt. In addition to the payments made to Questcor, the Company may also be required to make additional milestone payments totaling up to $51.5 million. These milestones include up to $4.5 million in payments if Gimoti achieves the following development targets: · $1.5 million upon the FDA’s acceptance for review of a new drug application for Gimoti; and · $3 million upon the FDA’s approval of Gimoti. The remaining $47 million in milestone payments depend on Gimoti’s commercial success and will only apply if Gimoti receives regulatory approval. In addition, the Company will be required to pay to Mallinckrodt a low single digit royalty on net sales of Gimoti. The Company’s obligation to pay such royalties will terminate upon the expiration of the last patent right covering Gimoti, which is expected to occur in 2030. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Stockholders' Equity | 5. Stockholders’ Equity Sale of Common Stock and Warrants On July 25, 2016, the Company completed an at-the-market offering of 1,804,512 shares of common stock at a purchase price of $2.49375 per share (the “July 2016 Financing”). Concurrently in a private placement, for each share of common stock purchased by an investor, such investor received from the Company an unregistered warrant to purchase three-quarters of a share of common stock. The warrants have an exercise price of $2.41 per share, are immediately exercisable, and will expire five and a half years from the initial issuance date. The aggregate gross proceeds from the sale of the common stock and warrants were approximately $4.5 million, and the net proceeds after deduction of commissions and fees were approximately $3.9 million. On August 3, 2016, the Company completed an at-the-market offering of 3,244,120 shares of common stock at a purchase price of $3.0825 per share (the “August 2016 Financing” and together with the July 2016 Financing, the “2016 Financings”). Concurrently in a private placement, for each share of common stock purchased by an investor, such investor received from the Company an unregistered warrant to purchase one half of a share of common stock. The warrants have an exercise price of $3.03 per share, are immediately exercisable, and will expire five and a half years from the initial issuance date. The aggregate gross proceeds from the sale of the common stock and warrants were approximately $10 million, and the net proceeds after deduction of commissions and fees was approximately $8.9 million. At the Market Equity Offering Program In November 2014, the Company entered into an At Market Sales Agreement with MLV & Co. LLC (“MLV”) (“MLV Sales Agreement”), pursuant to which the Company could sell from time to time, at its option, up to an aggregate of $6.6 million worth of shares of common stock through MLV as sales agent. During September 2015, FBR & Co. (“FBR”), acquired MLV. The sales of shares of the Company’s common stock made through this equity program were made in “at-the-market” offerings as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”). During the year ended December 31, 2015, the Company sold 1,048,507 shares of common stock at a weighted average price per share of $4.78 pursuant to the MLV Sales Agreement and received proceeds of approximately $4.9 million, net of commissions and fees. The Company did not sell any shares of common stock through the MLV Sales Agreement during the six months ended June 30, 2016. The Company incurred approximately $138,000 of legal, accounting and filing fees related to its Registration Statement on Form S-3 filed in November 2014. Such costs were capitalized and included in other current assets at December 31, 2014, and were reclassified to additional paid-in capital during the first quarter of 2015 as a further offset to the net proceeds. On April 15, 2016, the Company terminated the MLV Sales Agreement and entered into a new At Market Issuance Sales Agreement with FBR (“FBR Sales Agreement”), pursuant to which the Company may sell from time to time, at its option, up to an aggregate of 649,074 shares of the Company’s common stock through FBR as the sales agent. The sales of shares made through this equity program are made in “at-the-market” offerings as defined in Rule 415 of the Securities Act. Through June 30, 2016, the Company has sold 56,000 shares of common stock at a weighted average price per share of $5.45 and received proceeds of approximately $296,000, net of commissions and fees. Future sales will depend on a variety of factors including, but not limited to, market conditions, the trading price of the Company’s common stock and the Company’s capital needs. Although sales of the Company’s common stock have taken place pursuant to the MLV Sales Agreement, and are continuing pursuant to the FBR Sales Agreement, there can be no assurance that FBR will be successful in consummating future sales based on prevailing market conditions or in the quantities or at the prices that the Company deems appropriate. In addition, the Company will not be able to make future sales of common stock pursuant to the FBR Sales Agreement unless certain conditions are met, which include the accuracy of representations and warranties made to FBR under the FBR Sales Agreement. Furthermore, FBR is permitted to terminate the FBR Sales Agreement in its sole discretion upon ten days’ notice, or at any time in certain circumstances, including the occurrence of an event that would be reasonably likely to have a material adverse effect on the Company’s assets, business, operations, earnings, properties, condition (financial or otherwise), prospects, stockholders’ equity or results of operations. Finally, under the Securities Purchase Agreements entered into in connection with the 2016 Financings, the Company agreed to not sell any shares of its common stock for a period through and including September 17, 2016, without prior consent by the 2016 Financings investors. The Company has no obligation to sell the remaining shares available for sale pursuant to the FBR Sales Agreement. Employee Stock Purchase Plan and Equity Incentive Award Plan As a result of payroll withholdings from the Company’s employees of approximately $99,000 and $111,000, the Company sold 34,067 and 23,288 shares of common stock through its ESPP during the six months ended June 30, 2016 and 2015, respectively. On April 27, 2016, the Company’s stockholders approved an amendment and restatement of the Company’s 2013 Equity Incentive Award Plan (the “Restated Plan”) to increase the number of shares of common stock reserved under the Restated Plan by 500,000 shares, to an aggregate of 4,786,425 shares, and to extend the term of the Restated Plan into 2026. Stock-Based Compensation Stock-based compensation expense includes charges related to stock option grants and employee stock purchases under the ESPP. The Company measures stock-based compensation expense based on the grant date fair value of any awards granted to its employees. Such expense is recognized over the period of time that employees provide service and earn rights to the awards. The estimated fair value of each stock option award granted was determined on the date of grant using the Black-Scholes option-pricing valuation model with the following weighted-average assumptions for option grants during the three and six months ended June 30, 2016 and 2015: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Common Stock Options Risk free interest rate 1.41% 1.50% 1.25%-1.58% 1.50%-1.87% Expected option term 5.5 years 5.5 years 5.3-6.0 years 5.5-6.0 years Expected volatility of common stock 75.03% 76.74% 74.44%-75.91% 71.99%-76.74% Expected dividend yield 0.0% 0.0% 0.0% 0.0% The estimated fair value of each ESPP award was determined on the date of grant using the Black-Scholes option-pricing valuation model with the following weighted-average assumptions for option grants during the three and six months ended June 30, 2016 and 2015. Three and Six Months Ended June 30, 2016 2015 Employee Stock Purchase Plan Risk free interest rate 0.50% 0.08% Expected term 6.0 months 6.0 months Expected volatility of common stock 83.83% 62.91% Expected dividend yield 0.0% 0.0% The Company recognized non-cash stock-based compensation expense to employees and directors in its research and development and its general and administrative functions as follows: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development $ 151,148 $ 145,509 $ 309,937 $ 288,533 General and administrative 275,982 239,029 536,105 467,605 Total stock-based compensation expense $ 427,130 $ 384,538 $ 846,042 $ 756,138 In February 2016, the Company effected a one-time option exchange, wherein employees were offered the opportunity to exchange certain outstanding stock options for the grant of a lesser number of replacement stock options. The participants received three new stock options for every four stock options tendered for exchange. As a result, 703,500 stock options were exchanged for 527,624 replacement stock options. The replacement stock options have a three-year vesting schedule and an exercise price of $3.04 per share, which was the closing price of the Company’s common stock on the date of the option exchange. All other terms of the replacement stock options remain the same as the original stock options that were exchanged. As a result of this transaction, the Company recognized an incremental stock-based compensation expense of approximately $4,700 at the time of the transaction and will recognize an additional approximately $141,000 of stock-based compensation expense over the three-year vesting term of the exchanged options. As of June 30, 2016, there were approximately $2.6 million of unrecognized compensation costs related to outstanding employee and board of director options, which are expected to be recognized over a weighted average period of 1.1 years. |
Summary of Significant Accoun11
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for stock option grants and employee stock purchases under the Company’s Employee Stock Purchase Plan (the “ESPP”) is recorded at the estimated fair value of the award as of the grant date and is recognized as expense on a straight-line basis over the employee’s requisite service period. The estimation of stock option and ESPP fair value requires management to make estimates and judgments about, among other things, employee exercise behavior, forfeiture rates and volatility of the Company’s common stock. The judgments directly affect the amount of compensation expense that will be recognized. The Company grants stock options to purchase common stock to employees and members of the board of directors with exercise prices equal to the Company’s closing market price on the date the stock options are granted. The risk-free interest rate assumption was based on the yield of an applicable rate for U.S. Treasury instruments with maturities similar to those of the expected term of the award being valued. The weighted average expected term of options and employee stock purchases was calculated using the simplified method as prescribed by accounting guidance for stock-based compensation. This decision was based on the lack of relevant historical data due to the Company’s limited historical experience. In addition, due to the Company’s limited historical data, the estimated volatility was calculated based upon the Company’s historical volatility, supplemented with historical volatility of comparable companies in the biotechnology industry whose share prices are publicly available for a sufficient period of time. The assumed dividend yield was based on the Company never paying cash dividends and having no expectation of paying cash dividends in the foreseeable future. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred and primarily include compensation and related benefits, stock-based compensation expense and costs paid to third-party contractors to perform research, conduct clinical trials and develop drug materials and delivery devices. The Company expenses costs relating to the purchase and production of pre-approval inventories as research and development expense in the period incurred until U.S. Food and Drug Administration (“FDA”) approval is received. The Company bases its expense accruals related to clinical studies on estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations (“CROs”) that conduct and manage clinical studies on its behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors, such as the successful enrollment of patients, site initiation and the completion of clinical study milestones. Service providers typically invoice the Company monthly in arrears for services performed. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the Company does not identify costs that have begun to be incurred, or if the Company underestimates or overestimates the level of services performed or the costs of these services, actual expenses could differ materially from estimates. To date, the Company has not experienced significant changes in estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, no assurance can be made that changes to the estimates will not be made in the future as the Company becomes aware of additional information about the status or conduct of clinical studies and other research activities. Included in research and development expenses for the three and six months ended June 30, 2015 were costs of $71,019 and $159,044, respectively, for clinical trial services incurred by a related party of one of the Company’s officers. There were no related party costs incurred during the six months ended June 30, 2016. The Company does not own or operate manufacturing facilities for the production of Gimoti, nor does it plan to develop its own manufacturing operations in the foreseeable future. The Company currently depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its preclinical research and clinical trials. Other than an agreement with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, the Company does not have any other contractual relationships for the manufacture of commercial supplies of Gimoti. If Gimoti is approved by any regulatory agency, the Company intends to enter into agreements with third-party contract manufacturers for the commercial production at that time. The Company currently utilizes a third-party consultant, which it engages on an as-needed, hourly basis, to manage its manufacturing contractors. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents and adjusted for the weighted-average number of common shares outstanding that are subject to repurchase. The Company has excluded 45,000 shares subject to repurchase from the weighted-average number of common shares outstanding for each of the three and six months ended June 30, 2016 and 2015. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of warrants for the purchase of common stock, options outstanding under the Company’s equity incentive plans and potential shares to be purchased under the ESPP. For the periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Common stock subject to repurchase 45,000 45,000 45,000 45,000 Warrants to purchase common stock 118,881 118,881 118,881 118,881 Common stock options 1,275,624 1,037,500 1,275,624 1,037,500 Employee stock purchase plan 8,272 7,208 11,032 10,529 Total excluded securities 1,447,777 1,208,589 1,450,537 1,211,910 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-15 (Subtopic 205-40), Presentation of Financial Statements Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. Contingencies. In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases In March 2016, the FASB issued ASU No. 2016-09 Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting |
Summary of Significant Accoun12
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Common stock subject to repurchase 45,000 45,000 45,000 45,000 Warrants to purchase common stock 118,881 118,881 118,881 118,881 Common stock options 1,275,624 1,037,500 1,275,624 1,037,500 Employee stock purchase plan 8,272 7,208 11,032 10,529 Total excluded securities 1,447,777 1,208,589 1,450,537 1,211,910 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Summary of Estimated Fair Value of Stock Option Award | The estimated fair value of each stock option award granted was determined on the date of grant using the Black-Scholes option-pricing valuation model with the following weighted-average assumptions for option grants during the three and six months ended June 30, 2016 and 2015: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Common Stock Options Risk free interest rate 1.41% 1.50% 1.25%-1.58% 1.50%-1.87% Expected option term 5.5 years 5.5 years 5.3-6.0 years 5.5-6.0 years Expected volatility of common stock 75.03% 76.74% 74.44%-75.91% 71.99%-76.74% Expected dividend yield 0.0% 0.0% 0.0% 0.0% |
Summary of Estimated Fair Value of Employee Stock Purchase Plan Award | The estimated fair value of each ESPP award was determined on the date of grant using the Black-Scholes option-pricing valuation model with the following weighted-average assumptions for option grants during the three and six months ended June 30, 2016 and 2015. Three and Six Months Ended June 30, 2016 2015 Employee Stock Purchase Plan Risk free interest rate 0.50% 0.08% Expected term 6.0 months 6.0 months Expected volatility of common stock 83.83% 62.91% Expected dividend yield 0.0% 0.0% |
Summary of Recognized Non-Cash Stock-Based Compensation Expense | The Company recognized non-cash stock-based compensation expense to employees and directors in its research and development and its general and administrative functions as follows: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development $ 151,148 $ 145,509 $ 309,937 $ 288,533 General and administrative 275,982 239,029 536,105 467,605 Total stock-based compensation expense $ 427,130 $ 384,538 $ 846,042 $ 756,138 |
Organization and Basis of Pre14
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) | Aug. 04, 2016 | Aug. 03, 2016 | Jun. 30, 2016 | Dec. 31, 2015 |
Organization And Basis Of Presentation [Line Items] | ||||
Date of incorporation | Jan. 29, 2007 | |||
Accumulated deficit | $ (54,256,519) | $ (48,060,612) | ||
Common stock, shares issued | 7,291,841 | 7,201,774 | ||
Subsequent Event [Member] | Square 1 Bank [Member] | Loan and security agreement [Member] | ||||
Organization And Basis Of Presentation [Line Items] | ||||
Repayment of principal and accrued interest | $ 4,500,000 | |||
Subsequent Event [Member] | July 2016 Financing and August 2016 Financing [Member] | ||||
Organization And Basis Of Presentation [Line Items] | ||||
Common stock, shares issued | 5,048,632 | |||
Aggregate gross proceeds from sale of common stock and warrants | $ 14,500,000 | |||
Aggregate net proceeds from sale of common stock and warrants | $ 12,800,000 |
Summary of Significant Accoun15
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Significant Accounting Policies [Line Items] | ||||
Shares subject to repurchase excluded from the weighted-average number of common shares outstanding | 45,000 | 45,000 | 45,000 | 45,000 |
Officers [Member] | Clinical Trial Services [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Related Party expenses | $ 71,019 | $ 0 | $ 159,044 |
Summary of Significant Accoun16
Summary of Significant Accounting Policies - Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 1,447,777 | 1,208,589 | 1,450,537 | 1,211,910 |
Common stock subject to repurchase [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 45,000 | 45,000 | 45,000 | 45,000 |
Warrants to purchase common stock [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 118,881 | 118,881 | 118,881 | 118,881 |
Common stock options [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 1,275,624 | 1,037,500 | 1,275,624 | 1,037,500 |
Employee stock purchase plan [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 8,272 | 7,208 | 11,032 | 10,529 |
Debt - Additional Information (
Debt - Additional Information (Detail) - Square 1 Bank [Member] - Loan and security agreement [Member] - USD ($) | Aug. 04, 2016 | Jul. 31, 2016 | May 31, 2014 | Jun. 30, 2016 | Dec. 31, 2014 |
Debt Instrument [Line Items] | |||||
Loan and security agreement, available credit | $ 4,500,000 | ||||
Loan and security agreement, amount drawn | $ 4,500,000 | ||||
Fixed interest rate | 5.50% | ||||
Line of credit facility, loan origination cost | $ 82,685 | ||||
Warrants exercisable, stock issued | 22,881 | ||||
Warrant exercise price per share | $ 5.90 | ||||
Warrants to purchase common stock [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, unamortized discount | $ 108,122 | ||||
Warrant value recorded in equity | $ 108,122 | ||||
Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Repayment of principal and accrued interest | $ 4,500,000 | ||||
Debt instrument, unamortized discount | 38,000 | ||||
Subsequent Event [Member] | Warrants to purchase common stock [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, unamortized discount | $ 59,000 | ||||
Common stock shares issued upon conversion of warrants | 9,887 |
Technology Acquisition Agreem18
Technology Acquisition Agreement - Additional Information (Detail) - USD ($) | 1 Months Ended | 6 Months Ended | |
May 31, 2014 | Jun. 30, 2007 | Jun. 30, 2016 | |
Technology Acquisition Agreement [Line Items] | |||
Payment expensed as in-process research and development | $ 650,000 | ||
Mallinckrodt Plc [Member] | Patented Technology [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Expected expiration of patent right | 2,030 | ||
Mallinckrodt Plc [Member] | Rights and Patents Acquired from Questcor Pharmaceuticals Inc [Member] | Maximum [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Milestone payments contingent amount | $ 51,500,000 | ||
Development Target One [Member] | Rights and Patents Acquired from Questcor Pharmaceuticals Inc [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Milestone payment | $ 500,000 | ||
Development targets description | Upon the initiation of the first patient dosing in the Company’s Phase 3 clinical trial for Gimoti | ||
Development Target Two And Three [Member] | Mallinckrodt Plc [Member] | Maximum [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Milestone payments contingent amount | $ 4,500,000 | ||
Development Target Two [Member] | Mallinckrodt Plc [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Development targets description | Upon the FDA’s acceptance for review of a new drug application for Gimoti | ||
Milestone payments contingent amount | $ 1,500,000 | ||
Development Target Three [Member] | Mallinckrodt Plc [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Development targets description | Upon the FDA’s approval of Gimoti | ||
Milestone payments contingent amount | $ 3,000,000 | ||
Development Target Four [Member] | Mallinckrodt Plc [Member] | Patented Technology [Member] | |||
Technology Acquisition Agreement [Line Items] | |||
Development targets description | Depend on Gimoti’s commercial success and will only apply if Gimoti receives regulatory approval. In addition, the Company will be required to pay to Mallinckrodt a low single digit royalty on net sales of Gimoti. | ||
Milestone payments contingent amount | $ 47,000,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | Aug. 03, 2016 | Jul. 25, 2016 | Apr. 27, 2016 | Apr. 15, 2016 | Feb. 29, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Nov. 30, 2014 |
Sale Of Stock [Line Items] | |||||||||
Common stock, shares issued | 7,291,841 | 7,201,774 | |||||||
Proceeds from issuance of common stock, net | $ 358,023 | $ 1,266,533 | |||||||
Legal, Accounting and Filing Fees | 138,000 | ||||||||
Payroll withholdings from employees | $ 99,000 | $ 111,000 | |||||||
Common stock for Employee Stock Purchase Plan | 34,067 | 23,288 | |||||||
Unrecognized compensation costs | $ 2,600,000 | ||||||||
Weighted average period | 1 year 1 month 6 days | ||||||||
Amended and Restated Equity Incentive Plan 2013 [Member] | |||||||||
Sale Of Stock [Line Items] | |||||||||
Increase in number of shares of common stock reserved under the plan | 500,000 | ||||||||
Aggregate number of shares of common stock reserved under the plan | 4,786,425 | ||||||||
Award plan expiration year | 2,026 | ||||||||
One-Time Option Exchange Program [Member] | |||||||||
Sale Of Stock [Line Items] | |||||||||
Number of stock options exchanged | 703,500 | ||||||||
Number of stock options exchanged, outstanding | 527,624 | ||||||||
Number of stock options exchange percentage | 75.00% | ||||||||
Options granted, vesting period | 3 years | ||||||||
Replacement stock options exercise price | $ 3.04 | ||||||||
Incremental compensation expense during period under option exchange | $ 4,700 | ||||||||
Unrecognized compensation costs | $ 141,000 | ||||||||
Weighted average period | 3 years | ||||||||
MLV Sales Agreement [Member] | |||||||||
Sale Of Stock [Line Items] | |||||||||
Common stock, shares issued | 0 | 1,048,507 | |||||||
Common stock, value of shares issuable | $ 6,600,000 | ||||||||
Common stock , weighted average price per share | $ 4.78 | ||||||||
Proceeds from issuance of common stock, net | $ 4,900,000 | ||||||||
FBR Sales Agreement [Member] | |||||||||
Sale Of Stock [Line Items] | |||||||||
Common stock, shares issued | 56,000 | ||||||||
Common stock , weighted average price per share | $ 5.45 | ||||||||
Proceeds from issuance of common stock, net | $ 296,000 | ||||||||
Common stock, shares issuable | 649,074 | ||||||||
Subsequent Event [Member] | July 2016 Financing [Member] | |||||||||
Sale Of Stock [Line Items] | |||||||||
Common stock, shares issued | 1,804,512 | ||||||||
Purchase price of common stock | $ 2.49375 | ||||||||
Warrants exercisable, stock issued | 0.75 | ||||||||
Warrant exercise price per share | $ 2.41 | ||||||||
Warrants expiration period | 5 years 6 months | ||||||||
Aggregate gross proceeds from sale of common stock and warrants | $ 4,500,000 | ||||||||
Aggregate net proceeds from sale of common stock and warrants | $ 3,900,000 | ||||||||
Subsequent Event [Member] | August 2016 Financing [Member] | |||||||||
Sale Of Stock [Line Items] | |||||||||
Common stock, shares issued | 3,244,120 | ||||||||
Purchase price of common stock | $ 3.0825 | ||||||||
Warrants exercisable, stock issued | 0.5 | ||||||||
Warrant exercise price per share | $ 3.03 | ||||||||
Warrants expiration period | 5 years 6 months | ||||||||
Aggregate gross proceeds from sale of common stock and warrants | $ 10,000,000 | ||||||||
Aggregate net proceeds from sale of common stock and warrants | $ 8,900,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Estimated Fair Value of Stock Option Award (Detail) - Common Stock Options [Member] | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk free interest rate | 1.41% | 1.50% | ||
Expected option term | 5 years 6 months | 5 years 6 months | ||
Expected volatility of common stock | 75.03% | 76.74% | ||
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Minimum [Member] | ||||
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk free interest rate | 1.25% | 1.50% | ||
Expected option term | 5 years 3 months 18 days | 5 years 6 months | ||
Expected volatility of common stock | 74.44% | 71.99% | ||
Maximum [Member] | ||||
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk free interest rate | 1.58% | 1.87% | ||
Expected option term | 6 years | 6 years | ||
Expected volatility of common stock | 75.91% | 76.74% |
Stockholders' Equity - Summar21
Stockholders' Equity - Summary of Estimated Fair Value of Employee Stock Purchase Plan Award (Detail) - Employee stock purchase plan [Member] | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Stock-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk free interest rate | 0.50% | 0.08% | 0.50% | 0.08% |
Expected term | 6 months | 6 months | 6 months | 6 months |
Expected volatility of common stock | 83.83% | 62.91% | 83.83% | 62.91% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Stockholders' Equity - Summar22
Stockholders' Equity - Summary of Recognized Non-Cash Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 427,130 | $ 384,538 | $ 846,042 | $ 756,138 |
Research and development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 151,148 | 145,509 | 309,937 | 288,533 |
General and administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 275,982 | $ 239,029 | $ 536,105 | $ 467,605 |