Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 02, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | Aclaris Therapeutics, Inc. | |
Entity Central Index Key | 1,557,746 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 21,432,907 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 17,796 | $ 9,851 |
Marketable securities | 66,246 | 75,017 |
Prepaid expenses and other current assets | 1,548 | 1,656 |
Total current assets | 85,590 | 86,524 |
Marketable securities | 7,170 | |
Property and equipment, net | 461 | 360 |
Other assets | 20 | 22 |
Total assets | 86,071 | 94,076 |
Current liabilities: | ||
Accounts payable | 1,774 | 810 |
Accrued expenses | 2,817 | 745 |
Total current liabilities | 4,591 | 1,555 |
Other liabilities | 358 | |
Total liabilities | 4,949 | 1,555 |
Stockholders' Equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued or outstanding at September 30, 2016 and December 31, 2015 | ||
Common stock, $0.00001 par value; 100,000,000 shares authorized at September 30, 2016 and December 31, 2015; 21,423,995 and 20,157,503 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | ||
Additional paid-in capital | 160,613 | 135,503 |
Accumulated other comprehensive income (loss) | (54) | (149) |
Accumulated deficit | (79,437) | (42,833) |
Total stockholders’ equity | 81,122 | 92,521 |
Total liabilities and stockholders’ equity | $ 86,071 | $ 94,076 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 21,423,995 | 20,157,503 |
Common stock, shares outstanding | 21,423,995 | 20,157,503 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Operating expenses: | ||||
Research and development | $ 7,162 | $ 9,407 | $ 26,533 | $ 12,937 |
General and administrative | 3,650 | 1,233 | 10,407 | 2,928 |
Total operating expenses | 10,812 | 10,640 | 36,940 | 15,865 |
Loss from operations | (10,812) | (10,640) | (36,940) | (15,865) |
Other income, net | 118 | 8 | 336 | 16 |
Net loss | (10,694) | (10,632) | (36,604) | (15,849) |
Accretion of convertible preferred stock | (1,020) | (2,353) | ||
Net loss attributable to common stockholders | $ (10,694) | $ (11,652) | $ (36,604) | $ (18,202) |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.50) | $ (5.12) | $ (1.76) | $ (8.44) |
Weighted average common shares outstanding, basic and diluted (in shares) | 21,415,871 | 2,274,617 | 20,752,590 | 2,155,685 |
Other comprehensive (loss) income: | ||||
Unrealized (loss) gain on marketable securities, net of tax of $0 | $ (12) | $ 1 | $ 144 | $ 7 |
Foreign currency translation adjustments | (43) | (49) | ||
Total other comprehensive (loss) income | (55) | 1 | 95 | 7 |
Comprehensive loss | $ (10,749) | $ (10,631) | $ (36,509) | $ (15,842) |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Condensed Consolidated Statements Of Operations And Comprehensive Loss | ||
Unrealized (loss) gain on marketable securities, tax | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY - 9 months ended Sep. 30, 2016 - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Balance at Dec. 31, 2015 | $ 135,503 | $ (149) | $ (42,833) | $ 92,521 | |
Balance (in shares) at Dec. 31, 2015 | 20,157,503 | 20,157,503 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock in connection with Vixen acquisition | 2,355 | $ 2,355 | |||
Issuance of common stock in connection with Vixen acquisition, shares | 159,420 | ||||
Issuance of common stock in connection with private placement, net of offering costs | 18,547 | 18,547 | |||
Issuance of common stock in connection with private placement, shares | 1,081,082 | ||||
Exercise of stock options | 14 | $ 14 | |||
Exercise of stock options, shares | 25,990 | 25,990 | |||
Unrealized gain on marketable securities | 144 | $ 144 | |||
Foreign currency translation adjustment | (49) | (49) | |||
Stock-based compensation expense | 4,194 | 4,194 | |||
Net loss | (36,604) | (36,604) | |||
Balance at Sep. 30, 2016 | $ 160,613 | $ (54) | $ (79,437) | $ 81,122 | |
Balance (in shares) at Sep. 30, 2016 | 21,423,995 | 21,423,995 |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Condensed Consolidated Statement Of Stockholders' Equity | |
Offering costs offset against additional paid in capital | $ 1,453 |
CONDENSED CONSOLIDATED STATEME8
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (36,604) | $ (15,849) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 80 | 57 |
Stock-based compensation expense | 4,194 | 243 |
Non-cash charges related to Vixen acquisition | 2,784 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 110 | (764) |
Accounts payable | 915 | (491) |
Accrued expenses | 1,990 | 572 |
Net cash used in operating activities | (26,531) | (16,232) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (170) | (375) |
Purchases of marketable securities | (33,747) | (13,002) |
Proceeds from sales and maturities of marketable securities | 49,832 | 5,914 |
Net cash provided by (used in) investing activities | 15,915 | (7,463) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock in connection with private placement, net of issuance costs | 18,547 | |
Proceeds from issuance of convertible preferred stock, net of issuance costs | 39,864 | |
Proceeds from the exercise of employee stock options | 14 | |
Payment of deferred offering costs | (1,507) | |
Net cash provided by financing activities | 18,561 | 38,357 |
Net increase in cash and cash equivalents | 7,945 | 14,662 |
Cash and cash equivalents at beginning of period | 9,851 | 10,757 |
Cash and cash equivalents at end of period | 17,796 | 25,419 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Additions to property and equipment included in accounts payable | 13 | 19 |
Accretion of convertible preferred stock to redemption value | 1,764 | |
Fair value of stock issued in connection with Vixen acquisition on date of issuance | $ 2,355 | |
Deferred offering costs included in accounts payable | $ 436 |
Organization and Nature of Busi
Organization and Nature of Business | 9 Months Ended |
Sep. 30, 2016 | |
Organization and Nature of Business | |
Organization and Nature of Business | 1. Organization and Nature of Business Aclaris Therapeutics, Inc. was incorporated under the laws of the State of Delaware in 2012. On July 17, 2015, Aclaris Therapeutics International Limited (“ATIL”) was established under the laws of the United Kingdom as a wholly-owned subsidiary of Aclaris Therapeutics, Inc. On March 24, 2016, Vixen Pharmaceuticals, Inc. (“Vixen”) became a wholly-owned subsidiary of Aclaris Therapeutics, Inc. (see Note 11). Aclaris Therapeutics, Inc., together with ATIL and Vixen, are referred to collectively as the “Company”. The Company is a clinical‑stage specialty pharmaceutical company focused on identifying, developing and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology. The Company’s lead drug candidate, A‑101, is a proprietary high‑concentration hydrogen peroxide topical solution that is being developed as a prescription treatment for seborrheic keratosis (“SK”), a common non‑malignant skin tumor. The Company has completed three Phase 2 clinical trials and is currently conducting three Phase 3 clinical trials of A-101 in patients with SK. Initial Public Offering On October 6, 2015, the Company’s registration statement on Form S-1 relating to its initial public offering of its common stock (the “IPO”) was declared effective by the Securities and Exchange Commission (“SEC”). The Company’s common stock began trading on the NASDAQ Global Select Market on October 7, 2015. The IPO closed on October 13, 2015, and 5,000,000 shares of common stock were sold at a price to the public of $11.00 per share, for aggregate gross proceeds of $55,000. In addition, upon the closing of the IPO, all of the Company’s outstanding convertible preferred stock was converted into an aggregate total of 11,677,076 shares of common stock. On October 12, 2015, the underwriters of the IPO exercised in full their option to purchase additional shares, and on October 13, 2015, the Company sold 750,000 additional shares of common stock at a price to the public of $11.00 per share, for aggregate gross proceeds of $8,250. The Company paid underwriting discounts and commissions of $4,428 to the underwriters in connection with the IPO, including the underwriters’ exercise of their option to purchase additional shares. In addition, the Company incurred expenses of $2,272 in connection with the IPO. The net offering proceeds received by the Company, after deducting underwriting discounts, commissions and offering expenses, were $56,550. Private Placement On June 2, 2016, pursuant to a securities purchase agreement with certain accredited investors dated May 27, 2016, the Company closed a private placement in which it sold an aggregate of 1,081,082 shares of common stock at a price of $18.50 per share, for gross proceeds of $20,000. The Company incurred placement agent fees of $1,300 and expenses of $153 in connection with the private placement. The net offering proceeds received by the Company, after deducting placement agent fees and transaction expenses, were $18,547. Reverse Stock Split On September 24, 2015, the Company effected a 1‑for‑3.45 reverse stock split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios for each series of the Company’s then-outstanding convertible preferred stock. Accordingly, all share and per share amounts for all periods presented in these condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this reverse stock split and adjustment of the preferred stock conversion ratios. Liquidity The Company’s condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. At September 30, 2016, the Company had cash, cash equivalents and marketable securities of $84,042 and an accumulated deficit of $79,437. The Company has not generated any product revenues and has not achieved profitable operations. There is no assurance that profitable operations will ever be achieved, and, if achieved, will be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of the Company’s products will require significant additional financing. The future viability of the Company is dependent on its ability to generate cash from operating activities or to raise additional capital to finance its operations. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The financial statements include the consolidated accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions have been eliminated. 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, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, research and development expenses and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2016, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2016 and 2015, the condensed consolidated statement of stockholders’ equity for the nine months ended September 30, 2016, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2016 and 2015 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements contained in the Company’s annual report on Form 10-K filed with the SEC on March 23, 2016 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2016, the results of its operations and comprehensive loss for the three and nine months ended September 30, 2016 and 2015 and its cash flows for the nine months ended September 30, 2016 and 2015. The condensed consolidated balance sheet data as of December 31, 2015 was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2016 and 2015 are unaudited. The results for the three and nine months ended September 30, 2016 are not necessarily indicative of results to be expected for the year ending December 31, 2016, any other interim periods, or any future year or period. The unaudited interim financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2015 included in the Company’s annual report on Form 10-K filed with the SEC on March 23, 2016. Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2015 included in the Company’s annual report on Form 10-K filed with the SEC on March 23, 2016. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. Assets Held for Sale In order for an asset to be classified as held for sale there must be an active program to market the asset, and it must be probable the asset will be disposed of within one year. The carrying value of an asset held for sale is reported at the lower of its carrying value or its fair value less costs to sell. No additional depreciation expense is recognized once an asset is classified as held for sale. All current and historical balance sheet information for the Company’s assets held for sale is included in prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets. As of September 30, 2016 and December 31, 2015, $216 in assets were classified as held for sale. Recently Issued Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326) . This ASU introduces a new model for recognizing credit losses on financial instruments based upon estimated expected credit losses. ASU 2016-13 will apply to loans, accounts receivable, financial assets measured at amortized cost and at fair value through other comprehensive income, loan commitments and certain off-balance sheet credit exposures. ASU 2016-13 is effective for annual reporting periods beginning after December 15, 2019, including interim periods within those years, and early adoption will be permitted. The Company is assessing the potential impact of ASU 2016-13 on its consolidated financial statements. In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting . This ASU requires all tax effects of share-based payment settlements to be recorded through the income statement. Currently, tax benefits in excess of compensation cost, or “windfalls”, are recorded in equity, and tax deficiencies, or “shortfalls”, are recorded to equity to the extent of previous windfalls, and then to the income statement. In addition, under the new guidance, companies will be permitted to make a policy election to recognize the impact of forfeitures either when they occur, or on an estimated basis. Finally, this update simplifies withholding requirements to allow companies to withhold up to an employee’s maximum tax rate without resulting in liability classification for the award. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016, and early adoption is permitted. The Company has adopted the provisions of this standard early, the impact of which on its consolidated financial statements was not significant. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value of Financial Assets and Liabilities | |
Fair Value of Financial Assets and Liabilities | 3. Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values: Fair Value Measurements as of September 30, 2016 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ $ $ — $ Marketable securities — — Total $ $ $ — $ Fair Value Measurements as of December 31, 2015 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ $ $ — $ Marketable securities — — Total $ $ $ — $ As of September 30, 2016 and December 31, 2015, the Company’s cash equivalents consisted of investments with maturities of less than three months and included a money market fund, which was valued based upon Level 1 inputs, and asset-backed securities. In determining the fair value of its Level 2 investments the Company relied on quoted prices for identical securities in markets that are not active. These quoted prices were obtained by the Company with the assistance of a third-party pricing service based on available trade, bid and other observable market data for identical securities. Quarterly, the Company compares the quoted prices obtained from the third-party pricing service to other available independent pricing information to validate the reasonableness of the quoted prices provided. The Company evaluates whether adjustments to third-party pricing is necessary and, historically, the Company has not made adjustments to quoted prices obtained from the third-party pricing service. During the nine months ended September 30, 2016 and the year ended December 31, 2015, there were no transfers between Level 1, Level 2 and Level 3. As of September 30, 2016 and December 31, 2015, the fair value of the Company’s available for sale marketable securities by type of security was as follows: September 30, 2016 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Marketable securities: Corporate debt securities $ $ — $ $ Commercial paper — — Asset-backed securities — U.S. government agency debt securities Total marketable securities $ $ $ $ December 31, 2015 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Marketable securities: Corporate debt securities $ $ — $ $ Commercial paper — — Asset-backed securities — U.S. government agency debt securities — Total marketable securities $ $ — $ $ As of September 30, 2016 and December 31, 2015, the Company’s investments in corporate debt securities had credit ratings of A and above and remaining maturities of less than 12 months and less than 15 months, respectively. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2016 | |
Property and Equipment, Net | |
Property and Equipment, Net | 4. Property and Equipment, Net Property and equipment, net consisted of the following: September 30, December 31, 2016 2015 Computer equipment $ $ Manufacturing equipment Furniture and fixtures Property and equipment, gross Less: Accumulated depreciation Property and equipment, net $ $ Depreciation expense was $32 for each of the three months ended September 30, 2016 and 2015, and was $80 and $57 for the nine months ended September 30, 2016 and 2015, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2016 | |
Accrued Expenses | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following: September 30, December 31, 2016 2015 Research and development expenses $ $ Employee-related expenses — Licensing fees — Vixen contract payable — Professional fees Other Total accrued expenses $ $ |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 9 Months Ended |
Sep. 30, 2016 | |
Stockholders' Equity (Deficit) | |
Stockholders' Equity (Deficit) | 6. Stockholders’ Equity Preferred Stock As of September 30, 2016 and December 31, 2015, the Company’s amended and restated certificate of incorporation authorized the Company to issue 10,000,000 shares of undesignated preferred stock. No shares of preferred stock were outstanding as of September 30, 2016 or December 31, 2015. Common Stock As of September 30, 2016 and December 31, 2015, the Company’s amended and restated certificate of incorporation authorized the Company to issue 100,000,000 shares of $0.00001 par value common stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to any preferential dividend rights of any series of preferred stock that may be outstanding. No dividends have been declared through September 30, 2016. |
Stock-Based Awards
Stock-Based Awards | 9 Months Ended |
Sep. 30, 2016 | |
Stock-Based Awards | |
Stock-Based Awards | 7. Stock‑Based Awards 2012 Equity Compensation Plan Upon the 2015 Equity Incentive Plan (the “2015 Plan”), described below, becoming effective, no further grants may be made under the 2012 Equity Compensation Plan, as amended and restated (the “2012 Plan”). The Company granted a total of 1,140,524 stock options under the 2012 Plan, of which 1,075,667 were outstanding as of September 30, 2016 and all of which were outstanding as of December 31, 2015. Stock options granted under the 2012 Plan vest over four years and expire after ten years. As required, the exercise price for the stock options granted under the 2012 Plan was not less than the fair value of common shares as determined by the Company as of the date of grant. 2015 Equity Incentive Plan On September 15, 2015, the Company’s board of directors adopted and on September 16, 2015, the Company’s stockholders approved the 2015 Plan, which became effective in connection with the IPO in October 2015. The 2015 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit (“RSU”) awards, performance stock awards, cash-based awards and other stock-based awards. The number of shares initially reserved for issuance under the 2015 Plan was 1,643,872 shares of common stock. The number of shares of common stock that may be issued under the 2015 Plan will automatically increase on January 1 of each year, beginning on January 1, 2016 and ending on January 1, 2025, in an amount equal to the lesser of (i) 4.0% of the shares of the Company’s common stock outstanding on December 31 of the preceding calendar year or (ii) an amount determined by the Company’s board of directors. The shares of common stock underlying any awards that expire, are otherwise terminated, settled in cash or repurchased by the Company under the 2015 Plan and the 2012 Plan will be added back to the shares of common stock available for issuance under the 2015 Plan. As of January 1, 2016, the number of shares of common stock that may be issued under the 2015 Plan was automatically increased by 806,300 shares. As of September 30, 2016, 1,608,205 shares remained available for grant under the 2015 Plan. Stock Option Valuation The weighted average assumptions the Company used to estimate the fair value of stock options granted during the nine months ended September 30, 2016 and 2015 were as follows: Nine Months Ended September 30, 2016 2015 Risk-free interest rate % % Expected term (in years) Expected volatility % % Expected dividend yield % % The Company recognizes compensation expense for awards over their vesting period. Compensation expense for awards includes the impact of forfeitures in the period when they occur. Stock Options The following table summarizes stock option activity from January 1, 2016 through September 30, 2016: Weighted Weighted Average Average Remaining Aggregate Number Exercise Contractual Intrinsic of Shares Price Term Value (in years) Outstanding as of December 31, 2015 $ $ Granted Exercised Forfeited and canceled Outstanding as of September 30, 2016 $ $ Options vested and expected to vest as of September 30, 2016 $ $ Options exercisable as of September 30, 2016 (1) $ $ (1) All options granted under the 2012 Plan are exercisable immediately, subject to a repurchase right in the Company’s favor that lapses as the option vests. This amount reflects the number of shares under options that were vested, as opposed to exercisable, as of September 30, 2016. The weighted average grant date fair value of stock options granted during the nine months ended September 30, 2016 was $15.83 per share. The intrinsic value of a stock option is calculated as the difference between the exercise price of the stock option and the fair value of the underlying common stock, and cannot be less than zero. Restricted Stock Units The following table summarizes RSU activity from January 1, 2016 through September 30, 2016: Weighted Average Grant Date Number Fair Value of Shares Per Share Outstanding as of December 31, 2015 $ Granted Vested — — Forfeited and cancelled Outstanding as of September 30, 2016 $ The Company did not grant RSUs during the nine months ended September 30, 2015. Stock‑Based Compensation The following table summarizes stock‑based compensation expense recorded by the Company for the three and nine months ended September 30, 2016 and 2015: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ $ $ $ General and administrative $ $ $ $ As of September 30, 2016, the Company had unrecognized stock‑based compensation expense for stock options and RSUs of $16,483 and $1,884, respectively, which is expected to be recognized over weighted average periods of 3.14 years and 3.36 years, respectively. |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2016 | |
Net Loss per Share | |
Net Loss per Share | 8. Net Loss per Share Basic and diluted net loss per share attributable to common stockholders is summarized in the following table: Three Months Ended Nine Months Ended September 30, September 30, 2016 2015 2016 2015 Numerator: Net loss $ $ $ $ Accretion of redeemable convertible preferred stock — — Net loss attributable to common stockholders $ $ $ $ Denominator: Weighted average shares of common stock outstanding Less: Weighted average shares of unvested restricted common stock outstanding — — Weighted average common shares outstanding used in calculating net loss per share attributable to common stockholders, basic and diluted Net loss per share attributable to common stockholders, basic and diluted $ $ $ $ The Company’s potentially dilutive securities, which included stock options, RSUs, preferred stock and shares of restricted common stock that were issued but not yet vested, have been excluded from the computation of diluted net loss per share since the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The following table presents potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders for both the three and nine months ended September 30, 2016 and 2015. All share amounts presented in the table below represent the total number outstanding as of September 30. 2016 2015 Stock options to purchase common stock Restricted stock unit awards — Unvested restricted common stock — Convertible preferred stock (as converted to common stock) — |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies | |
Commitments and Contingencies | 9. Commitments and Contingencies Sublease In August 2013, the Company entered into a sublease agreement with a related party (see Note 10) for its office space with a term ending on November 30, 2016. As part of an amendment to the sublease agreement entered into in December 2014, the Company increased the amount of office space to be subleased and agreed to new monthly terms commencing in January 2015. On August 14, 2015, the Company further amended its sublease agreement to increase the square footage of the space and to extend the term of the lease to November 2019. Effective December 1, 2015, the Company further amended its sublease agreement to increase the square footage and agreed to new monthly sublease terms. Rent expense under operating leases was $66 and $34 for the three months ended September 30, 2016 and 2015, respectively, and was $178 and $86 for the nine months ended September 30, 2016 and 2015, respectively. The Company recognizes rent expense on a straight-line basis over the lease period and has accrued for rent expense incurred but not yet paid. As of September 30, 2016, future minimum lease payments under the sublease were as follows: Years Ending December 31, 2016 $ 2017 2018 2019 2020 — Total $ |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2016 | |
Related Party Transactions | |
Related Party Transactions | 10. Related Party Transactions In August 2013, the Company entered into a sublease agreement with NeXeption, Inc. ("NeXeption"), which was subsequently amended in December 2014 and August 2015. In August 2015, pursuant to an Assignment and Assumption Agreement, NeXeption, Inc. assigned all interests, rights, duties and obligations under the sublease to NST Consulting, LLC, a wholly-owned subsidiary of NST, LLC. Mr. Stephen Tullman, the chairman of the Company’s board of directors, was an executive officer of NeXeption and is also the manager of NST Consulting, LLC and NST, LLC. Total payments made under the sublease during the three months ended September 30, 2016 and 2015 were $64 and $44, respectively, and during the nine months ended September 30, 2016 and 2015 were $179 and $97, respectively. In February 2014, the Company entered into a services agreement with NST, LLC (the “NST Services Agreement”), pursuant to which NST, LLC provided certain pharmaceutical development, management and other administrative services to the Company. Under the same agreement, the Company also provided services to another company under common control with the Company and NST LLC and was reimbursed by NST LLC for those services. In addition to Mr. Tullman’s role as manager of NST, LLC, several of the Company’s executive officers are members of NST, LLC. The NST Services Agreement was amended in January 2015 pursuant to which NST, LLC assigned all interests, rights, duties and obligations under the NST Services Agreement to NST Consulting, LLC. Under the NST Services Agreement, as amended, NST Consulting, LLC provides services to the Company and the Company provides services to another company under common control with the Company and NST Consulting, LLC. The NST Services Agreement was further amended in August 2015 and November 2015 to adjust the amount of services the Company is obligated to provide to NST Consulting, LLC and the amount of services NST Consulting, LLC is obligated to provide to the Company. The Company may offset any payments owed by the Company to NST Consulting, LLC against payments that are owed by NST Consulting, LLC to the Company for the provision of personnel, including consultants, to the Company. During the three and nine months ended September 30, 2016 and 2015, amounts included in the consolidated statement of operations for the NST Services Agreement are summarized in the following table: Three Months Ended Nine Months Ended September 30, September 30, 2016 2015 2016 2015 Services provided by NST Consulting, LLC $ $ $ $ Services provided to NST Consulting, LLC General and administrative expense, net $ $ $ $ Services provided by NST Consulting, LLC $ $ — $ $ — Services provided to NST Consulting, LLC Research and development expense, net $ $ $ $ Services provided by NST Consulting, LLC $ $ $ $ Services provided to NST Consulting, LLC Total, net $ $ $ $ Payments made to NST $ $ $ $ The Company did not have any open invoices payable to NST Consulting, LLC under the NST Services Agreement as of either September 30, 2016 or December 31, 2015. |
Agreements Related to Intellect
Agreements Related to Intellectual Property | 9 Months Ended |
Sep. 30, 2016 | |
Agreements Related to Intellectual Property | |
Agreements Related to Intellectual Property | 11. Agreements Related to Intellectual Property Assignment Agreement and Finder’s Services Agreement In August 2012, the Company entered into an assignment agreement with the Estate of Mickey Miller, or the Miller Estate, under which the Company acquired some of the intellectual property rights covering A-101. In connection with obtaining the assignment of the intellectual property from the Miller Estate, the Company also entered into a separate finder’s services agreement with KPT Consulting, LLC. In February 2016, under the terms of the assignment agreement and the finder’s services agreement, the Company made a one-time milestone payment of $300 upon the dosing of the first subject with A-101 in the Company’s Phase 3 clinical trial. The payment was recorded as general and administrative expense during the nine months ended September 30, 2016. Under the finder’s services agreement, the Company is obligated to make an additional milestone payment of $1,000 upon the submission of an NDA for A-101 and regulatory milestones and up to $4,500 upon the achievement of specified commercial milestones. Under each of the assignment agreement and the finder’s services agreement, the Company is also obligated to pay royalties on sales of A-101 or related products, at low single-digit percentages of net sales, subject to reduction in specified circumstances. The Company has not made any royalty payments to date under either agreement. Both agreements will terminate upon the expiration of the last pending, viable patent claim of the patents acquired under the assignment agreement, but no sooner than 15 years from the effective date of the agreements. Stock Purchase Agreement with Vixen Pharmaceuticals, Inc. and License Agreement with Columbia University On March 24, 2016, the Company entered into a stock purchase agreement (the “Vixen Agreement”) with Vixen, JAK1, LLC, JAK2, LLC and JAK3, LLC (together with JAK1, LLC and JAK2, LLC, the “Selling Stockholders”) and Shareholder Representative Services LLC, a Colorado limited liability company, solely in its capacity as the representative of the Selling Stockholders. Pursuant to the Vixen Agreement, the Company acquired all shares of Vixen’s capital stock from the Selling Stockholders (the “Vixen Acquisition”). Following the Vixen Acquisition, Vixen became a wholly-owned subsidiary of the Company. Pursuant to the Vixen Agreement, the Company paid $600 upfront and issued an aggregate of 159,420 shares of the Company’s common stock to the Selling Stockholders. The Company is obligated to make annual payments of $100 on March 24 th of each year, through March 24, 2022, with such amounts being creditable against specified future payments that may be paid under the Vixen Agreement. The Company is obligated to make aggregate payments of up to $18,000 to the Selling Stockholders upon the achievement of specified pre-commercialization milestones for three products in the United States, the European Union and Japan, and aggregate payments of up to $22,500 upon the achievement of specified commercial milestones. With respect to any commercialized products covered by the Vixen Agreement, the Company is obligated to pay low single-digit royalties on net sales, subject to specified reductions, limitations and other adjustments, until the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or, in specified circumstances, ten years from the first commercial sale of such product. If the Company sublicenses any of Vixen’s patent rights and know-how acquired pursuant to the Vixen Agreement, the Company will be obligated to pay a portion of any consideration the Company receives from such sublicenses in specified circumstances. As a result of the transaction with Vixen, the Company became party to the Exclusive License Agreement, by and between Vixen and the Trustees of Columbia University in the City of New York (“Columbia”), dated as of December 31, 2015 (the “License Agreement”). Under the License Agreement, the Company is obligated to pay Columbia an annual license fee of $10, subject to specified adjustments for patent expenses incurred by Columbia and creditable against any royalties that may be paid under the License Agreement. The Company is also obligated to pay up to an aggregate of $11,600 upon the achievement of specified commercial milestones, including specified levels of net sales of products covered by Columbia patent rights and/or know-how, and royalties at a sub-single-digit percentage of annual net sales of products covered by Columbia patent rights and/or know-how, subject to specified adjustments. If the Company sublicenses any of Columbia’s patent rights and know-how acquired pursuant to the License Agreement, it will be obligated to pay Columbia a portion of any consideration received from such sublicenses in specified circumstances. The royalties, as determined on a country-by-country and product-by-product basis, are payable until the date that all of the patent rights for that product have expired, the expiration of any market exclusivity period granted by a regulatory body or, in specified circumstances, ten years from the first commercial sale of such product. The License Agreement terminates on the date of expiration of all royalty obligations thereunder unless earlier terminated by either party for a material breach, subject to a specified cure period. The Company may also terminate the License Agreement without cause at any time upon advance written notice to Columbia. The Company accounted for the transaction with Vixen as an asset acquisition as the arrangement did not meet the definition of a business pursuant to the guidance prescribed in Accounting Standards Codification Topic 805, Business Combinations . The Company concluded the transaction with Vixen did not meet the definition of a business because the transaction principally resulted in the acquisition of the License Agreement. The Company did not acquire tangible assets, processes, protocols or operating systems. In addition, at the time of the transaction, there were no activities being conducted related to the licensed patents. The Company expensed the acquired intellectual property as of the acquisition date on the basis that the cost of intangible assets purchased from others for use in research and development activities, and that have no alternative future uses, are expensed at the time the costs are incurred. Accordingly, the Company recorded the $600 upfront payment, the fair value of the shares of common stock issued of $2,355, and the present value of the six non-contingent annual payments as research and development expense in the nine months ended September 30, 2016. Additionally, the Company will record as expense any contingent milestone payments or royalties in the period in which such liabilities are incurred. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2016 | |
Income Taxes | |
Income Taxes | 12. Income Taxes The Company did not record a federal or state income tax benefit for losses incurred during the three and nine months ended September 30, 2016 and 2015 due to the Company’s conclusion that a valuation allowance is required. |
Summary of Significant Accoun21
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The financial statements include the consolidated accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions have been eliminated. |
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, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, research and development expenses and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2016, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2016 and 2015, the condensed consolidated statement of stockholders’ equity for the nine months ended September 30, 2016, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2016 and 2015 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements contained in the Company’s annual report on Form 10-K filed with the SEC on March 23, 2016 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2016, the results of its operations and comprehensive loss for the three and nine months ended September 30, 2016 and 2015 and its cash flows for the nine months ended September 30, 2016 and 2015. The condensed consolidated balance sheet data as of December 31, 2015 was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2016 and 2015 are unaudited. The results for the three and nine months ended September 30, 2016 are not necessarily indicative of results to be expected for the year ending December 31, 2016, any other interim periods, or any future year or period. The unaudited interim financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2015 included in the Company’s annual report on Form 10-K filed with the SEC on March 23, 2016. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2015 included in the Company’s annual report on Form 10-K filed with the SEC on March 23, 2016. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. |
Assets Held for Sale | Assets Held for Sale In order for an asset to be classified as held for sale there must be an active program to market the asset, and it must be probable the asset will be disposed of within one year. The carrying value of an asset held for sale is reported at the lower of its carrying value or its fair value less costs to sell. No additional depreciation expense is recognized once an asset is classified as held for sale. All current and historical balance sheet information for the Company’s assets held for sale is included in prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets. As of September 30, 2016 and December 31, 2015, $216 in assets were classified as held for sale. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326) . This ASU introduces a new model for recognizing credit losses on financial instruments based upon estimated expected credit losses. ASU 2016-13 will apply to loans, accounts receivable, financial assets measured at amortized cost and at fair value through other comprehensive income, loan commitments and certain off-balance sheet credit exposures. ASU 2016-13 is effective for annual reporting periods beginning after December 15, 2019, including interim periods within those years, and early adoption will be permitted. The Company is assessing the potential impact of ASU 2016-13 on its consolidated financial statements. In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting . This ASU requires all tax effects of share-based payment settlements to be recorded through the income statement. Currently, tax benefits in excess of compensation cost, or “windfalls”, are recorded in equity, and tax deficiencies, or “shortfalls”, are recorded to equity to the extent of previous windfalls, and then to the income statement. In addition, under the new guidance, companies will be permitted to make a policy election to recognize the impact of forfeitures either when they occur, or on an estimated basis. Finally, this update simplifies withholding requirements to allow companies to withhold up to an employee’s maximum tax rate without resulting in liability classification for the award. ASU 2016-09 is effective for annual reporting periods beginning after December 15, 2016, and early adoption is permitted. The Company has adopted the provisions of this standard early, the impact of which on its consolidated financial statements was not significant. |
Fair Value of Financial Asset22
Fair Value of Financial Assets and Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value of Financial Assets and Liabilities | |
Schedule of assets and liabilities measured at fair value on a recurring basis | Fair Value Measurements as of September 30, 2016 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ $ $ — $ Marketable securities — — Total $ $ $ — $ Fair Value Measurements as of December 31, 2015 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ $ $ — $ Marketable securities — — Total $ $ $ — $ |
Schedule of the fair value of available for sale marketable securities by type of security | September 30, 2016 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Marketable securities: Corporate debt securities $ $ — $ $ Commercial paper — — Asset-backed securities — U.S. government agency debt securities Total marketable securities $ $ $ $ December 31, 2015 Gross Gross Amortized Unrealized Unrealized Fair Cost Gain Loss Value Marketable securities: Corporate debt securities $ $ — $ $ Commercial paper — — Asset-backed securities — U.S. government agency debt securities — Total marketable securities $ $ — $ $ |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Property and Equipment, Net | |
Schedule of property and equipment, net | September 30, December 31, 2016 2015 Computer equipment $ $ Manufacturing equipment Furniture and fixtures Property and equipment, gross Less: Accumulated depreciation Property and equipment, net $ $ |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accrued Expenses | |
Schedule of accrued expenses | September 30, December 31, 2016 2015 Research and development expenses $ $ Employee-related expenses — Licensing fees — Vixen contract payable — Professional fees Other Total accrued expenses $ $ |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Stock-Based Awards | |
Assumptions used to determine fair value of stock options granted | Nine Months Ended September 30, 2016 2015 Risk-free interest rate % % Expected term (in years) Expected volatility % % Expected dividend yield % % |
Summary of stock option activity | Weighted Weighted Average Average Remaining Aggregate Number Exercise Contractual Intrinsic of Shares Price Term Value (in years) Outstanding as of December 31, 2015 $ $ Granted Exercised Forfeited and canceled Outstanding as of September 30, 2016 $ $ Options vested and expected to vest as of September 30, 2016 $ $ Options exercisable as of September 30, 2016 (1) $ $ (1) All options granted under the 2012 Plan are exercisable immediately, subject to a repurchase right in the Company’s favor that lapses as the option vests. This amount reflects the number of shares under options that were vested, as opposed to exercisable, as of September 30, 2016. |
Summary of RSU activity | Weighted Average Grant Date Number Fair Value of Shares Per Share Outstanding as of December 31, 2015 $ Granted Vested — — Forfeited and cancelled Outstanding as of September 30, 2016 $ |
Stock-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development $ $ $ $ General and administrative $ $ $ $ |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Net Loss per Share | |
Basic and diluted net loss per share attributable to common stockholders | Three Months Ended Nine Months Ended September 30, September 30, 2016 2015 2016 2015 Numerator: Net loss $ $ $ $ Accretion of redeemable convertible preferred stock — — Net loss attributable to common stockholders $ $ $ $ Denominator: Weighted average shares of common stock outstanding Less: Weighted average shares of unvested restricted common stock outstanding — — Weighted average common shares outstanding used in calculating net loss per share attributable to common stockholders, basic and diluted Net loss per share attributable to common stockholders, basic and diluted $ $ $ $ |
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 2016 2015 Stock options to purchase common stock Restricted stock unit awards — Unvested restricted common stock — Convertible preferred stock (as converted to common stock) — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies | |
Schedule of future minimum lease payments under the sublease | Years Ending December 31, 2016 $ 2017 2018 2019 2020 — Total $ |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Related Party Transactions | |
Schedule of gross expenses incurred | Three Months Ended Nine Months Ended September 30, September 30, 2016 2015 2016 2015 Services provided by NST Consulting, LLC $ $ $ $ Services provided to NST Consulting, LLC General and administrative expense, net $ $ $ $ Services provided by NST Consulting, LLC $ $ — $ $ — Services provided to NST Consulting, LLC Research and development expense, net $ $ $ $ Services provided by NST Consulting, LLC $ $ $ $ Services provided to NST Consulting, LLC Total, net $ $ $ $ Payments made to NST $ $ $ $ |
Organization and Nature of Bu29
Organization and Nature of Business (Details) - A-101 | Sep. 30, 2016item |
Production information | |
Number of clinical trials completed | 3 |
Number of clinical trials in process | 3 |
Organization and Nature of Bu30
Organization and Nature of Business - IPO, Stock Split, Liquidity (Details) $ / shares in Units, $ in Thousands | Jun. 02, 2016USD ($)$ / sharesshares | Oct. 13, 2015USD ($)$ / sharesshares | Sep. 24, 2015 | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Dec. 31, 2015USD ($) |
Initial public offering | ||||||
Issuance of common stock in connection with private placement, net of offering costs | $ 18,547 | |||||
Common stock shares issued upon conversion of convertible preferred stock | shares | 11,677,076 | |||||
Offering costs | $ 1,507 | |||||
Reverse stock split | 0.2899 | |||||
Cash, cash equivalents and marketable securities | 84,042 | |||||
Accumulated deficit | $ 79,437 | $ 42,833 | ||||
IPO | ||||||
Initial public offering | ||||||
Number of shares issued | shares | 5,000,000 | |||||
Issuance price (in dollars per share) | $ / shares | $ 11 | |||||
Issuance of common stock in connection with private placement, net of offering costs | $ 55,000 | |||||
Offering costs | 2,272 | |||||
Offering proceeds, net of discounts, commissions and expenses | $ 56,550 | |||||
Exercise of over-allotment option | ||||||
Initial public offering | ||||||
Number of shares issued | shares | 750,000 | |||||
Issuance price (in dollars per share) | $ / shares | $ 11 | |||||
Issuance of common stock in connection with private placement, net of offering costs | $ 8,250 | |||||
Offering costs | $ 1,300 | $ 4,428 | ||||
Private Placement [Member] | ||||||
Initial public offering | ||||||
Number of shares issued | shares | 1,081,082 | |||||
Issuance price (in dollars per share) | $ / shares | $ 18.50 | |||||
Issuance of common stock in connection with private placement, net of offering costs | $ 20,000 | |||||
Offering costs | 153 | |||||
Offering proceeds, net of discounts, commissions and expenses | $ 18,547 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Dec. 31, 2015 | |
Assets Held for Sale | ||
Assets held for sale, maximum holding period | 1 year | |
Assets held for sale | $ 216 | $ 216 |
Fair Value of Financial Asset32
Fair Value of Financial Assets and Liabilities (Detail) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Assets: | ||
Marketable securities | $ 66,246 | $ 82,187 |
Transfers from Level 1 to Level 2 | 0 | 0 |
Transfers from Level 2 to Level 1 | 0 | 0 |
Transfers into or out of Level 3 | 0 | 0 |
Recurring | ||
Assets: | ||
Cash equivalents | 12,779 | 9,060 |
Marketable securities | 66,246 | 82,187 |
Total assets measured at fair value | 79,025 | 91,247 |
Recurring | Level 1 | ||
Assets: | ||
Cash equivalents | 11,378 | 8,810 |
Total assets measured at fair value | 11,378 | 8,810 |
Recurring | Level 2 | ||
Assets: | ||
Cash equivalents | 1,401 | 250 |
Marketable securities | 66,246 | 82,187 |
Total assets measured at fair value | $ 67,647 | $ 82,437 |
Fair Value of Financial Asset33
Fair Value of Financial Assets and Liabilities - by type (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2016 | Dec. 31, 2015 | |
Marketable securities: | ||
Amortized Cost | $ 66,256 | $ 82,341 |
Gross Unrealized Gain | 5 | |
Gross Unrealized Loss | (15) | (154) |
Fair Value | 66,246 | 82,187 |
Corporate debt securities | ||
Marketable securities: | ||
Amortized Cost | 36,963 | 46,270 |
Gross Unrealized Loss | (14) | (125) |
Fair Value | $ 36,949 | $ 46,145 |
Corporate debt securities | Maximum | ||
Marketable securities: | ||
Remaining term of maturities (in months) | 12 months | 15 months |
Commercial paper | ||
Marketable securities: | ||
Amortized Cost | $ 11,975 | $ 9,789 |
Fair Value | 11,975 | 9,789 |
Asset-backed Securities [Member] | ||
Marketable securities: | ||
Amortized Cost | 8,299 | 6,234 |
Gross Unrealized Gain | 2 | |
Gross Unrealized Loss | (14) | |
Fair Value | 8,301 | 6,220 |
U.S. government agency debt securities | ||
Marketable securities: | ||
Amortized Cost | 9,019 | 20,048 |
Gross Unrealized Gain | 3 | |
Gross Unrealized Loss | (1) | (15) |
Fair Value | $ 9,021 | $ 20,033 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Property and Equipment, net | |||||
Property and equipment | $ 583 | $ 583 | $ 402 | ||
Less: accumulated depreciation | (122) | (122) | (42) | ||
Property and equipment, net | 461 | 461 | 360 | ||
Depreciation expense | 32 | $ 32 | 80 | $ 57 | |
Computer equipment | |||||
Property and Equipment, net | |||||
Property and equipment | 340 | 340 | 262 | ||
Manufacturing equipment | |||||
Property and Equipment, net | |||||
Property and equipment | 131 | 131 | 101 | ||
Furniture and Fixtures [Member] | |||||
Property and Equipment, net | |||||
Property and equipment | $ 112 | $ 112 | $ 39 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Accrued Expenses | ||
Research and development expenses | $ 1,489 | $ 123 |
Employee-related expenses | 1,088 | |
Licensing fees | 250 | |
Vixen contract payable. | 100 | |
Professional fees | 37 | 283 |
Other | 103 | 89 |
Total accrued expenses | $ 2,817 | $ 745 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 9 Months Ended | |
Sep. 30, 2016USD ($)Vote$ / sharesshares | Dec. 31, 2015$ / sharesshares | |
Stockholders' Equity (Deficit) | ||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock shares authorized | 100,000,000 | 100,000,000 |
Common stock par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 |
Number of votes per share | Vote | 1 | |
Dividends declared | $ | $ 0 |
Stock-Based Awards (Details)
Stock-Based Awards (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2016 | Oct. 31, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2015 | Sep. 15, 2015 |
Stock-based awards | |||||||
Options granted (in shares) | 222,528 | ||||||
Options, Number of Shares | |||||||
Number of Shares, beginning balance | 1,738,524 | 1,738,524 | |||||
Number of Shares, Granted | 222,528 | ||||||
Number of Shares, Exercised | (25,990) | ||||||
Number of Shares, Forfeited and canceled | (67,561) | ||||||
Number of Shares, ending balance | 1,867,501 | 1,738,524 | 1,738,524 | ||||
Number of Shares, Options vested and expected to vest | 1,867,501 | ||||||
Number of Shares, Options exercisable | 384,223 | ||||||
Options, Weighted Average Exercise Price | |||||||
Weighted Average Exercise Price, beginning balance (in dollars per share) | $ 13.23 | $ 13.23 | |||||
Weighted Average Exercise Price, Granted (in dollars per share) | 20.10 | ||||||
Weighted Average Exercise Price, Exercised (in dollars per share) | 0.55 | ||||||
Weighted Average Exercise Price, Forfeited and canceled (in dollars per share) | 15.69 | ||||||
Weighted Average Exercise Price, ending balance (in dollars per share) | 14.13 | $ 13.23 | $ 13.23 | ||||
Weighted Average Exercise Price, Options vested and expected to vest (in dollars per share) | 14.13 | ||||||
Weighted Average Exercise Price, Options exercisable (in dollars per share) | $ 5.54 | ||||||
Options, Weighted Average Remaining Contractual Term | |||||||
Weighted Average Remaining Contractual Term (in years) | 8 years 9 months 18 days | 9 years 6 months 4 days | |||||
Weighted Average Remaining Contractual Term, Options vested and expected to vest (in years) | 8 years 9 months 18 days | ||||||
Weighted Average Remaining Contractual Term, Options exercisable (in years) | 8 years 26 days | ||||||
Aggregate Intrinsic Value | |||||||
Aggregate Intrinsic Value | $ 22,921 | $ 24,722 | $ 24,722 | ||||
Aggregate Intrinsic Value, Options vested and expected to vest | 22,921 | ||||||
Aggregate Intrinsic Value, Options exercisable | $ 7,713 | ||||||
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 15.83 | ||||||
Employee, director and consultant stock options | |||||||
Stock Option Valuation | |||||||
Risk-free interest rate (as a percent) | 1.41% | 1.73% | |||||
Expected term (in years) | 6 years 6 months | 6 years 2 months 12 days | |||||
Expected volatility (as a percent) | 96.60% | 96.65% | |||||
Expected dividend yield (as a percent) | 0.00% | 0.00% | |||||
2012 Equity Compensation Plan | |||||||
Stock-based awards | |||||||
Number of shares available for grant | 0 | ||||||
Options granted (in shares) | 1,140,524 | 1,140,524 | 1,140,524 | ||||
Options, Number of Shares | |||||||
Number of Shares, beginning balance | 1,140,524 | 1,140,524 | |||||
Number of Shares, Granted | 1,140,524 | 1,140,524 | 1,140,524 | ||||
Number of Shares, ending balance | 1,075,667 | 1,140,524 | 1,140,524 | ||||
2012 Equity Compensation Plan | Employee, director and consultant stock options | |||||||
Stock-based awards | |||||||
Term of award (in years) | 10 years | ||||||
Vesting period (in years) | 4 years | ||||||
2015 Equity Incentive Plan | |||||||
Stock-based awards | |||||||
Number of shares available for grant | 1,608,205 | ||||||
Number of shares authorized | 1,643,872 | ||||||
Percentage increase to shares available for grant from common outstanding as of preceding December 31 (as a percent) | 4.00% | ||||||
Additional shares available | 806,300 |
Stock-Based Awards - RSUs (Deta
Stock-Based Awards - RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
RSU, Weighted Average Grant Date Fair Value Per Unit | ||
Unrecognized compensation, RSUs | $ 1,884 | |
Restricted Stock Units (RSUs) [Member] | ||
RSU, Weighted Average Grant Date Fair Value Per Unit | ||
Weighted average recognition period unrecognized stock-based compensation cost (in years) | 3 years 4 months 10 days | |
2015 Equity Incentive Plan | Restricted Stock Units (RSUs) [Member] | ||
RSU, Number of Units | ||
Units outstanding, beginning of period | 53,800 | |
Granted | 37,200 | 0 |
Forfeited and cancelled | (2,000) | |
Units outstanding, end of period | 89,000 | |
RSU, Weighted Average Grant Date Fair Value Per Unit | ||
Weighted average grant date fair value, beginning balance (in dollars per share) | $ 28.68 | |
Granted, estimated grant-date fair value (in dollars per share) | 20.32 | |
Forfeited and cancelled, estimated grant date fair value (in dollars per share) | 28.68 | |
Weighted average grant date fair value, ending balance (in dollars per share) | $ 25.19 |
Stock-Based Awards - Compensati
Stock-Based Awards - Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 1,618 | $ 158 | $ 4,194 | $ 243 |
Unrecognized stock-based compensation cost, options | 16,483 | 16,483 | ||
Unrecognized compensation, RSUs | 1,884 | 1,884 | ||
Research and development expense. | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 623 | 47 | 1,577 | 74 |
General and administrative expense. | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 995 | $ 111 | $ 2,617 | $ 169 |
Employee, director and consultant stock options | ||||
Stock-based compensation expense | ||||
Weighted average recognition period unrecognized stock-based compensation cost (in years) | 3 years 1 month 21 days | |||
Restricted Stock Units (RSUs) [Member] | ||||
Stock-based compensation expense | ||||
Weighted average recognition period unrecognized stock-based compensation cost (in years) | 3 years 4 months 10 days |
Net Loss per Share (Details)
Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Numerator: | ||||
Net loss | $ (10,694) | $ (10,632) | $ (36,604) | $ (15,849) |
Accretion of convertible preferred stock to redemption value | (1,020) | (2,353) | ||
Net loss attributable to common stockholders | $ (10,694) | $ (11,652) | $ (36,604) | $ (18,202) |
Denominator: | ||||
Weighted average shares of common stock outstanding (in shares) | 21,415,871 | 2,730,427 | 20,752,590 | 2,730,427 |
Less: Weighted average shares of unvested restricted common stock outstanding (in shares) | (455,810) | (574,742) | ||
Weighted average common shares outstanding used in calculating net loss per share attributable to common stockholders, basic and diluted (in shares) | 21,415,871 | 2,274,617 | 20,752,590 | 2,155,685 |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.50) | $ (5.12) | $ (1.76) | $ (8.44) |
Net Loss per Share - Anti-dilut
Net Loss per Share - Anti-dilution (Details) - shares | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 1,956,501 | 13,217,357 |
Employee, director and consultant stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 1,867,501 | 1,140,524 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 89,000 | |
Restricted common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 399,757 | |
Convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential common shares excluded from the calculation of diluted net loss per share attributable to common stockholders | 11,677,076 |
Commitments and Contingencies42
Commitments and Contingencies (Details) - Direct sublease agreement - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Lease | ||||
Expenses incurred under related party transactions | $ 178 | $ 86 | ||
Director | ||||
Lease | ||||
Expenses incurred under related party transactions | $ 66 | $ 34 | ||
Future minimum lease payments under the sublease | ||||
2,016 | 65 | 65 | ||
2,017 | 263 | 263 | ||
2,018 | 268 | 268 | ||
2,019 | 251 | 251 | ||
Total | $ 847 | $ 847 |
Related Party Transaction (Deta
Related Party Transaction (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Direct sublease agreement | ||||
Related Party Transactions | ||||
Expenses incurred under related party transactions | $ 178 | $ 86 | ||
Direct sublease agreement | NST, LLC [Member] | ||||
Related Party Transactions | ||||
Expenses incurred under related party transactions | $ 64 | $ 44 | 179 | 97 |
Services agreement | ||||
Related Party Transactions | ||||
Net expenses (revenues) from related party transactions | 103 | (27) | 310 | (18) |
Services agreement | General and administrative expense. | ||||
Related Party Transactions | ||||
Net expenses (revenues) from related party transactions | 64 | 36 | 192 | 172 |
Services agreement | Research and development expense. | ||||
Related Party Transactions | ||||
Net expenses (revenues) from related party transactions | 39 | (63) | 118 | (190) |
Services agreement | NST, LLC [Member] | ||||
Related Party Transactions | ||||
Expenses incurred under related party transactions | 139 | 105 | 418 | 358 |
Other revenue earned from related party transactions | (36) | (132) | (108) | (376) |
Payments to related party | 88 | 263 | 13 | |
Receipts from related party | (2) | |||
Services agreement | NST, LLC [Member] | General and administrative expense. | ||||
Related Party Transactions | ||||
Expenses incurred under related party transactions | 79 | 105 | 237 | 358 |
Other revenue earned from related party transactions | (15) | (69) | (45) | (186) |
Services agreement | NST, LLC [Member] | Research and development expense. | ||||
Related Party Transactions | ||||
Expenses incurred under related party transactions | 60 | 181 | ||
Other revenue earned from related party transactions | (21) | (63) | $ (63) | $ (190) |
Director | Direct sublease agreement | ||||
Related Party Transactions | ||||
Expenses incurred under related party transactions | $ 66 | $ 34 |
Agreements Related to Intelle44
Agreements Related to Intellectual Property (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)installmentitemshares | Sep. 30, 2015USD ($) | |
License Agreement | ||||
Upfront payment recorded as research and development expense | $ 7,162 | $ 9,407 | $ 26,533 | $ 12,937 |
Assignment Agreement and Finder's Services Agreement [Member] | A-101 | ||||
License Agreement | ||||
Maximum aggregate payments owed upon achievement of specified pre-commercialization milestones | 1,000 | 1,000 | ||
Maximum additional payments owed upon achievement of second set of development milestones | 4,500 | $ 4,500 | ||
Term of Agreement, Minimum | 15 years | |||
Assignment Agreement and Finder's Services Agreement [Member] | A-101 | General and administrative expense. | ||||
License Agreement | ||||
Milestone payment | $ 300 | |||
Stock Purchase Agreement [Member] | ||||
License Agreement | ||||
Maximum aggregate payments owed upon achievement of specified pre-commercialization milestones | 18,000 | 18,000 | ||
Maximum additional payments owed upon achievement of second set of development milestones | 22,500 | 22,500 | ||
Upfront payment recorded as research and development expense | $ 600 | |||
Stock Issued During Period, Shares, Purchase of Assets | shares | 159,420 | |||
Amount Of Fixed Annual Payment | $ 100 | |||
Number Of Products | item | 3 | |||
Stock Issued During Period, Value, Purchase of Assets | $ 2,355 | |||
Number Of Payments | installment | 6 | |||
Period from first commercial product sale that royalties are owed (in years) | 10 years | |||
Commercial License Agreement | ||||
License Agreement | ||||
Maximum additional payments owed upon achievement of second set of development milestones | $ 11,600 | $ 11,600 | ||
Amount Of Fixed Annual Payment | $ 10 | |||
Period from first commercial product sale that royalties are owed (in years) | 10 years |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Income Taxes | ||||
Federal income tax benefit | $ 0 | $ 0 | $ 0 | $ 0 |
State income tax benefit | $ 0 | $ 0 | $ 0 | $ 0 |