Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Oct. 31, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | CBAY | |
Entity Registrant Name | CYMABAY THERAPEUTICS, INC. | |
Entity Central Index Key | 1,042,074 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 43,864,121 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 23,009 | $ 10,495 |
Marketable securities | 79,160 | 6,499 |
Prepaid expenses | 1,368 | 1,369 |
Other current assets | 122 | 165 |
Total current assets | 103,659 | 18,528 |
Property and equipment, net | 51 | 77 |
Other assets | 634 | 754 |
Total assets | 104,344 | 19,359 |
Current liabilities: | ||
Accounts payable | 1,235 | 899 |
Accrued liabilities | 3,881 | 4,501 |
Warrant liability | 5,862 | 1,145 |
Facility loan | 3,001 | 2,700 |
Accrued interest payable | 49 | 66 |
Total current liabilities | 14,028 | 9,311 |
Facility loan, less current portion | 3,809 | 6,098 |
Other liabilites | 3 | 13 |
Total liabilities | 17,840 | 15,422 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value: 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 43,846,709 and 23,447,003 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | 4 | 2 |
Additional paid-in capital | 531,986 | 426,895 |
Accumulated other comprehensive loss | (13) | (1) |
Accumulated deficit | (445,473) | (422,959) |
Total stockholders' equity | 86,504 | 3,937 |
Total liabilities and stockholders' equity | $ 104,344 | $ 19,359 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
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 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 43,846,709 | 23,447,003 |
Common stock, shares outstanding | 43,846,709 | 23,447,003 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 4,793 | |||
Operating expenses: | ||||
Research and development | $ 4,184 | $ 3,534 | 12,269 | $ 12,093 |
General and administrative | 2,210 | 2,130 | 9,493 | 6,806 |
Total operating expenses | 6,394 | 5,664 | 21,762 | 18,899 |
Loss from operations | (6,394) | (5,664) | (16,969) | (18,899) |
Other income (expense): | ||||
Interest income | 216 | 45 | 297 | 146 |
Interest expense | (258) | (341) | (846) | (1,009) |
Other (expense) income, net | (1,798) | 81 | (4,996) | 43 |
Net loss | (8,234) | (5,879) | (22,514) | (19,719) |
Net loss | (8,234) | (5,879) | (22,514) | (19,719) |
Other comprehensive (loss) income: | ||||
Unrealized (loss) gain on marketable securities, net of tax | (12) | 3 | (12) | 19 |
Other comprehensive (loss) income: | (12) | 3 | (12) | 19 |
Comprehensive loss | $ (8,246) | $ (5,876) | $ (22,526) | $ (19,700) |
Basic net loss per common share | $ (0.21) | $ (0.25) | $ (0.71) | $ (0.84) |
Diluted net loss per common share | $ (0.21) | $ (0.25) | $ (0.71) | $ (0.84) |
Weighted average common shares outstanding used to calculate basic net loss per common share | 40,035,690 | 23,447,003 | 31,848,536 | 23,447,003 |
Weighted average common shares outstanding used to calculate diluted net loss per common share | 40,035,690 | 23,447,003 | 31,848,536 | 23,447,003 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Operating activities | ||
Net loss | $ (22,514) | $ (19,719) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 26 | 21 |
Stock-based compensation expense | 3,938 | 1,797 |
Accretion and amortization of marketable securities | (47) | 128 |
Non-cash interest associated with debt discount accretion | 339 | 352 |
Change in fair value of warrant liability | 4,996 | (43) |
Changes in assets and liabilities: | ||
Other current assets | (101) | 164 |
Prepaid expenses | 1 | (466) |
Other assets | 120 | 270 |
Accounts payable | 185 | (73) |
Accrued liabilities | (486) | (381) |
Accrued interest payable | (17) | (1) |
Net cash used in operating activities | (13,560) | (17,951) |
Investing activities | ||
Purchases of property and equipment | (42) | |
Purchases of marketable securities | (88,941) | (19,304) |
Proceeds from maturities of marketable securities | 16,315 | 36,656 |
Net cash (used in) provided by investing activities | (72,626) | 17,310 |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 100,587 | |
Proceeds from issuance of common stock pursuant to equity award plans | 440 | |
Repayment of facility loan principal | (2,327) | (244) |
Net cash provided by (used in) financing activities | 98,700 | (244) |
Net increase (decrease) in cash and cash equivalents | 12,514 | (885) |
Cash and cash equivalents at beginning of period | 10,495 | 7,706 |
Cash and cash equivalents at end of period | $ 23,009 | $ 6,821 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business CymaBay Therapeutics, Inc. (the “Company” or “CymaBay”) is a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need. The Company’s two key clinical development candidates are seladelpar and arhalofenate. Seladelpar is currently being developed primarily for the treatment of primary biliary cholangitis (PBC) and further development is planned for the treatment of nonalcoholic steatohepatitis (NASH). Arhalofenate is being developed for the treatment of gout and rights to develop and commercialize arhalofenate in the U.S. (including all its possessions and territories) have been licensed to Kowa Pharmaceuticals America, Inc. (“Kowa”). The Company was incorporated in Delaware in October 1988 as Transtech Corporation. The Company’s headquarters and operations are located in Newark, California and it operates in one segment. Liquidity The Company has incurred net operating losses and negative cash flows from operations since its inception. During the nine months ended September 30, 2017, the Company incurred a net loss of $22.5 million and used $13.6 million of cash in operations. At September 30, 2017, the Company had an accumulated deficit of $445.5 million. CymaBay expects to incur substantial research and development expenses as it continues to study its product candidates in clinical trials. To date, none of the Company’s product candidates have been approved for marketing and sale, and the Company has not recorded any revenue from product sales. As a result, management expects operating losses to continue in future years. The Company’s ability to achieve profitability is dependent primarily on its ability to successfully develop, acquire or in-license As of September 30, 2017, the Company’s cash, cash equivalents and marketable securities totaled $102.2 million. Management believes these fund are sufficient to fund the Company’s liquidity requirements into 2019. The Company expects to incur substantial expenditures in the future for the development and potential commercialization of its product candidates. Because of this, the Company expects its future liquidity and capital resource needs will be impacted by numerous factors, including but not limited to, the repayment of the Company’s facility loan, the planned initiation of a phase 2 clinical trial in NASH, and most significantly, the timing and conduct of additional PBC development activities, including an ongoing phase 2 clinical trial, a planned phase 3 clinical trial, and other NDA-enabling |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying interim condensed financial statements are unaudited. These unaudited interim financial statements have been prepared in accordance with U.S. GAAP (“GAAP”) and following the requirements of the United States 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 condensed financial statements have been prepared on the same basis as the audited financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss 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 fiscal year ended December 31, 2016, which is contained in the Company’s Annual Report on Form 10-K Use of Estimates The condensed financial statements have been prepared in accordance with GAAP, which requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable estimates of actual future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from those estimates. The Company believes significant judgment is involved in estimating revenue, stock-based compensation, accrued clinical expenses, warrant liabilities, and equity instrument valuations. Fair Value of Financial Instruments The Company’s financial instruments during the periods reported consist of cash and cash equivalents, marketable securities, prepaid expenses, other current assets, other assets, accounts payable, accrued interest payable, accrued liabilities, the facility loan, and warrant liabilities. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment. The carrying amounts of financial instruments such as cash and cash equivalents, prepaid expenses, other current assets, other assets, accounts payable, accrued liabilities, and accrued interest payable approximate the related fair values due to the short maturities of these instruments. Based on prevailing borrowing rates available to the Company for loans with similar terms, the Company believes the fair value of the facility loan, considering level 2 inputs, approximates its carrying value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable and unobservable inputs and is as follows: Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. Level 3—Inputs that are significant to the fair value measurement and are unobservable (i.e. supported by little market activity), which requires the reporting entity to develop its own valuation techniques and assumptions. The following tables present the fair value of the Company’s financial assets and liabilities measured at fair value on a recurring basis using the above input categories (in thousands): As of September 30, 2017 Description Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 18,554 $ — $ — $ 18,554 Commercial paper — 2,994 — 2,994 Total cash equivalents 18,554 2,994 — 21,548 Marketable securities: Commercial paper — 44,750 — 44,750 Corporate debt securities — 22,359 — 22,359 Asset-backed securities — 8,071 — 8,071 U.S. treasury securities — 3,980 — 3,980 Total short-term investments — 79,160 — 79,160 Total assets measured at fair value $ 18,554 $ 82,154 $ — $ 100,708 Warrant liability $ — $ — $ 5,862 $ 5,862 Total liabilities measured at fair value $ — $ — $ 5,862 $ 5,862 As of December 31, 2016 Description Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 9,456 $ — $ — $ 9,456 Commercial paper — 599 — 599 Corporate debt securities — 500 — 500 Total cash equivalents 9,456 1,099 — 10,555 Marketable securities: Commercial paper — 4,295 — 4,295 Corporate debt securities — 2,204 — 2,204 Total short-term investments — 6,499 — 6,499 Total assets measured at fair value $ 9,456 $ 7,598 $ — $ 17,054 Warrant liability $ — $ — $ 1,145 $ 1,145 Total liabilities measured at fair value $ — $ — $ 1,145 $ 1,145 The Company estimates the fair value of its corporate debt, asset backed securities, and U.S. treasury securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data, and other observable inputs. There were no transfers between Level 1 and Level 2 during the periods presented. The Company holds a Level 3 liability associated with common stock warrants that were issued in connection with the Company’s financings completed in September and October 2013, January 2014, and August 2015. The warrants are accounted for as liabilities. During the quarter, the Company changed its valuation technique and began to value its warrant liability using a Black-Scholes option pricing model, the inputs for which include: exercise price of the warrants, market price of the underlying common shares, dividend yield, expected term, volatility, and a risk-free interest rate. Changes to any of these inputs can have a significant impact on the estimated fair value of the warrants. Historically, the Company used a binomial option pricing model to value its warrant liabilities. The inputs for the binomial model are similar to the Black-Scholes model but also incorporate other more complex inputs which, in the Company’s case, have previously included the expected timing, probability and valuation impact of certain potential strategic events. Management concluded that no potential strategic events were expected to occur that could significantly impact the warrant liabilities valuation prior to their expiration (beginning in late 2018 and ending in early 2019). The following table sets forth an activity summary which includes the changes in the fair value of the Company’s Level 3 financial instruments (in thousands): For the Nine Months Ended September 2017 2016 Balance, beginning of period $ 1,145 $ 1,220 Issuance of financial instrument — — Change in fair value 4,996 (43 ) Settlement of financial instrument (279 ) — Balance, end of period $ 5,862 $ 1,177 Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with a maturity at the date of purchase of 90 days or less to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest-bearing, demand money market accounts, and corporate debt securities. The Company invests excess cash in marketable securities with high credit ratings, which are classified in Level 2 of the fair value hierarchy. These securities consist primarily of corporate debt, commercial paper, asset-backed securities, and U.S. treasury securities and are classified as “available-for-sale.” Realized gains and losses from the sale of marketable securities, if any, are calculated using the specific identification method. Realized gains and losses and declines in value judged to be other-than-temporary are included in interest income or expense in the statements of operations and comprehensive loss. Unrealized holding gains and losses are reported in accumulated other comprehensive loss, in the balance sheets. To date, the Company has not recorded any impairment charges on its marketable securities related to other-than-temporary declines in market value. In determining whether a decline in market value is other-than-temporary, various factors are considered, including the cause, duration of time and severity of the impairment, any adverse changes in the investees’ financial condition, and the Company’s intent and ability to hold the security for a period of time sufficient to allow for an anticipated recovery in market value. The following tables summarize amortized cost, unrealized gain and loss, and fair value (in thousands): Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of September 30, 2017: Commercial paper 44,750 — — 44,750 Corporate debt securities 22,369 — (10 ) 22,359 Asset-backed securities 8,074 — (3 ) 8,071 U.S. treasury securities 3,980 — — 3,980 $ 79,173 $ — $ (13 ) $ 79,160 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2016: Commercial paper 4,295 — — 4,295 Corporate debt securities 2,205 — (1 ) 2,204 $ 6,500 $ — $ (1 ) $ 6,499 Concentration of Credit Risk Cash equivalents and marketable securities consist of financial instruments that potentially subject the Company to a concentration of credit risk to the extent of the fair value recorded in the balance sheets. The Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments that bear minimal risk. The Company has established guidelines relating to the quality, diversification, and maturities of securities to enable the Company to manage its credit risk. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and marketable securities and issuers of investments to the extent recorded on the balance sheets. Certain materials and key components that the Company utilizes in its operations are obtained through single suppliers. Since the suppliers of key components and materials must be named in a new drug application (NDA) filed with the U.S. Food and Drug Administration (FDA) for a product, significant delays can occur if the qualification of a new supplier is required. If delivery of material from the Company’s suppliers were interrupted for any reason, the Company may be unable to supply any of its product candidates for clinical trials. Revenue Recognition The Company recognizes revenue when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred or services have been rendered, (iii) the price is fixed or determinable, and (iv) collectability is reasonably assured. Payments received in advance of work performed are recorded as deferred revenue and recognized when earned. Collaboration and license agreements may include non-refundable If the Company determines that multiple deliverables in an arrangement exist, the consideration is allocated to one or more units of accounting based upon the relative-selling-price of each element in an arrangement. The relative-selling-price used for each deliverable is based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available. The Company identifies deliverables at the inception of the arrangement. Each deliverable is accounted for as a separate unit of accounting if both of the following criteria are met: (1) the delivered item or items have value to the customer on a standalone basis and (2) for an arrangement that includes a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and substantially in the Company’s control. Non-refundable The Company recognizes payments that are contingent upon achievement of a substantive milestone in their entirety in the period in which the milestone is achieved. Milestones are defined as events that can only be achieved based on the Company’s performance and there is substantive uncertainty about whether the event will be achieved at the inception of the arrangement. Events that are contingent only on the passage of time or only on counterparty performance are not considered milestones subject to this guidance. Further, the amounts received must relate solely to prior performance, be reasonable relative to all of the deliverables and payment terms within the agreement and commensurate with the Company’s performance to achieve the milestone after commencement of the agreement. Any contingent payment that becomes payable upon achievement of events that are not considered substantive milestones are allocated to the units of accounting previously identified at the inception of an arrangement when the contingent payment is received and revenue is recognized based on the revenue recognition criteria for each unit of accounting. Common Stock Warrant Liability The Company’s outstanding common stock warrants issued in connection with certain equity and debt financings that occurred in 2013 through 2015 are classified as liabilities in the accompanying condensed balance sheets because of certain contractual terms that preclude equity classification. The warrants are recorded at fair value using a Black-Scholes option-pricing model. The warrants are re-measured Stock-Based Compensation Employee and director stock-based compensation is measured at fair value on the grant date of the award. Compensation cost is recognized as expense on a straight-line basis over the vesting period for options and on an accelerated basis for stock options with performance conditions. For stock options with performance conditions, the Company evaluates the probability of achieving performance conditions at each reporting date. The Company begins to recognize the expense when it is deemed probable that the performance conditions will be met. The Company uses the Black-Scholes option pricing model to determine the fair value of stock option awards. The determination of fair value for stock-based awards using an option-pricing model requires management to make certain assumptions regarding subjective input variables such as expected term, dividends, volatility and risk-free interest rate. The Company is also required to make estimates as to the probability of achieving the specific performance criteria. If actual results are not consistent with the Company’s assumptions and judgments used in making these estimates, the Company may be required to increase or decrease compensation expense, which could be material to the Company’s results of operations. Equity awards granted to non-employees Net Loss Per Common Share Basic net loss per share of common stock is based on the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share of common stock is calculated as the weighted average number of shares of common stock outstanding adjusted to include the assumed exercises of stock options and common stock warrants, if dilutive. The calculation of diluted loss per share also requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the common stock warrants and the presumed exercise of such securities are dilutive to net loss per share for the period, adjustments to net loss used in the calculation are required to remove the change in fair value of the common stock warrant liability for the period. Likewise, adjustments to the denominator are required to reflect the related dilutive shares. In all periods presented, the Company’s outstanding stock options, incentive awards and warrants were excluded from the calculation of diluted net loss per share because their effects were antidilutive. The Company’s computation of basic and diluted net loss per share is as follows (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Numerator: Net loss allocated to common stock-basic $ (8,234 ) $ (5,879 ) $ (22,514 ) $ (19,719 ) Adjustments for revaluation of warrants — — — — Net loss allocated to common stock-diluted $ (8,234 ) $ (5,879 ) $ (22,514 ) $ (19,719 ) Denominator: Weighted average number of common stock shares outstanding—basic 40,035,690 23,447,003 31,848,536 23,447,003 Weighted average number of common stock shares outstanding—diluted 40,035,690 23,447,003 31,848,536 23,447,003 Net loss per share—basic: $ (0.21 ) $ (0.25 ) $ (0.71 ) $ (0.84 ) Net loss per share—diluted: $ (0.21 ) $ (0.25 ) $ (0.71 ) $ (0.84 ) The following table shows the total outstanding common stock equivalents considered anti-dilutive and therefore excluded from the computation of diluted net loss per share (in thousands). Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Warrants for common stock 1,604 1,667 1,604 1,667 Common stock options 3,788 2,422 3,788 2,422 Performace-based stock options 305 327 305 327 Incentive awards 226 241 226 241 5,923 4,657 5,923 4,657 Recent Accounting Pronouncements Accounting Standards Update 2014-09 In May 2014, the FASB issued Accounting Standards Update 2014-09, Revenue from Contracts with Customers and related amendments 2014-09: No. 2016-08, No. 2016-10, No. 2016-12, The new revenue standard permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company plans to adopt the new revenue standard in the first quarter of 2018 using the modified retrospective method. While the Company has not completed an assessment of the impact of adoption, the adoption of this guidance may have a material effect on the Company’s financial statements. At the end of 2016, the Company entered into a license agreement. Before executing this agreement, the Company had no revenues for the last two years. The consideration that the Company is eligible to receive under this agreement includes an upfront payment, milestone payments, and royalties. This license agreement is unique and will need to be assessed separately under the five-step process under the new standard. The Company is currently analyzing this agreement to determine the differences in the accounting treatment under the new revenue standard compared to that of the current accounting treatment. The new revenue standard differs from the current accounting standard in many respects, such as in the accounting for variable consideration, including milestone payments and royalties. The Company expects that its evaluation of the accounting for this agreement under the new revenue standard could identify material changes from that of the current accounting treatment and it will also impact its condensed financial statement disclosures. Additionally, the Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession and adjust its assessment and implementation plans accordingly. Accounting Standards Update 2016-02 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). Accounting Standards Update 2016-09 In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting 2016-09). 2016-09 paid-in Accounting Standards Update 2017-09 In May 2017, FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718)- Scope of Modification Accounting 2017-09 Accounting Standards Update 2017-11 In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share Distinguishing Liabilities from Equity Derivatives and Hedging 2017-11): Non-controlling |
Certain Balance Sheet Items
Certain Balance Sheet Items | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Certain Balance Sheet Items | 3. Certain Balance Sheet Items The following table shows certain balance sheet items (in thousands). September 30, December 31, (unaudited) Accrued compensation $ 1,528 $ 1,839 Accrued pre-clinical and clinical trial expenses 1,745 1,623 Accrued professional fees 336 982 Deferred revenue 207 — Other accruals 65 57 Total accrued liabilities $ 3,881 $ 4,501 |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration and License Agreements | 4. Collaboration and License Agreements Kowa Pharmaceuticals America, Inc. On December 30, 2016, the Company entered into a license agreement with Kowa Pharmaceuticals America, Inc. Pursuant to the license agreement, the Company granted to Kowa an exclusive license, and right to sublicense, certain patent rights and technology related to arhalofenate. Kowa will have exclusive rights to, among other things, develop, use, manufacture, sell and otherwise exploit the licensed technology in the United States (including all possessions and territories). At Kowa’s option, the Company may also facilitate the placement of arhalofenate product manufacturing orders under the terms of the Company’s existing contract manufacturing agreements. In addition, the Company will complete specified in-process stability testing and non-clinical development services and will participate on a Joint Advisory Committee (“JAC”). Finally, the Company will transfer to Kowa certain arhalofenate product on hand. Under the license agreement, Kowa agreed to pay the Company a non-refundable up-front payment of $5 million upon contract execution which was subsequently received in mid-January 2017. The Company is also eligible to receive up to $200 million in contingent payments based upon either the initiation or achievement of specified development and sales milestones. Finally, the Company will receive tiered, double digit royalties on any product sales and a percentage of any revenue earned by Kowa from sublicensing. The Company identified the following three performance deliverables under the license agreement: 1) transfer of intellectual property rights, inclusive of the related technology know-how conveyance and contract manufacturing rights and privileges (“license and know-how”), 2) the obligation to perform specific ongoing research and non-clinical development services, and 3) the delivery of arhalofenate product on hand. The Company’s participation on the JAC was not determined to be a deliverable because of the Company’s ability to elect to terminate its participation. The Company concluded that the license, the know-how and contract manufacturing rights and privileges together represent a single deliverable, and therefore together should be accounted for as a single unit of accounting. The research and development services and delivery of arhalofenate product each also represent separate deliverables, and therefore each should be accounted for as separate units of accounting. There was no separate consideration identified in the agreement for the deliverables and there was no right of return under the agreement. The Company considered the provisions of the multiple-element arrangement guidance in determining whether the deliverables outlined above have standalone value. The transfer of license and know-how has standalone value separate from the research and development services and delivery of arhalofenate product, as the agreement allows Kowa to sublicense its rights to the acquired license to a third party. Further, the Company believes that Kowa has research and development expertise with compounds similar to those licensed under the agreement, and the Company has also granted Kowa the rights to either order arhalofenate product from the Company’s existing contract manufacturers, or to enter into arrangements with other third parties to develop and manufacture arhalofenate product, thereby allowing Kowa to realize the value of the license and know-how. The license and know-how revenue will be recognized upon the substantial completion of the transfer of know-how. The research and development services will be recognized as revenue over the estimated period services are delivered. The arhalofenate product will be recognized as revenue upon delivery. The Company also determined the relative selling prices of the identified units of accounting in accordance with the multi-element arrangement guidance. The Company considered but did not use Vendor Specific Objective Evidence (VSOE) of fair value or third-party evidence (TPE) but instead selected management’s best estimate of selling price (BESP) due to the uniqueness of the Kowa license arrangement and its lack of comparability to other licensing arrangements in the biopharmaceutical industry. The $5 million upfront consideration paid was then allocated to the identified units of accounting using the relative selling price method, with revenue to be recognized based on the satisfaction of all revenue recognition criteria for each unit of accounting. The Company completed all activities necessary to satisfy delivery of the license and knowhow deliverable and recognized $4.8 million of upfront consideration associated with this deliverable as collaboration revenue during the nine months ended September 30, 2017. The Company determined the future contingent payments related to the development activities do not meet the definition of a milestone because the achievement of these events solely depends on Kowa’s performance. Under current revenue recognition rules, these amounts will be allocated to the Kowa arrangements’ three identified units of accounting when received and recognized as revenue based on the revenue recognition policy for those respective units of accounting. The future contingent payments related to the U.S. sales milestones are recognized upon achievement of the specific milestones. As of September 30, 2017, none of these contingent amounts had been received or recognized as revenue. Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc. In June 2006, the Company entered into an exclusive worldwide, royalty-bearing license to seladelpar and certain other PPAR d d d d d d d d In June 2010, the Company entered into two development and license agreements with Janssen Pharmaceuticals, Inc. (Janssen), a subsidiary of Johnson and Johnson, to further develop and discover undisclosed metabolic disease target agonists for the treatment of T2DM and other disorders and received a one-time know-how DiaTex, Inc. In June 1998, the Company entered into a license agreement with DiaTex, Inc. (DiaTex) relating to products containing arhalofenate, its enantiomers, derivatives, and analogs (the licensed products). The license agreement provides that DiaTex and the Company are joint owners of all of the patents and patent applications covering the licensed products and methods of producing or using such compounds, as well as certain other know-how sub-license |
Facility Loans
Facility Loans | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Facility Loans | 5. Facility Loans 2013 Term Loan Facility On September 30, 2013, the Company entered into a facility loan agreement with Silicon Valley Bank and Oxford Finance LLC (referred to herein as the lenders) for a total loan amount of $10.0 million of which the first tranche of $5.0 million was drawn as part of the Company’s September 2013 financing, referred to herein as the 2013 Term Loan Facility. The loan had a fixed interest rate of 8.75% payable as interest only for twelve months and a thirty-six At the time the first $5 million tranche of the facility loan was drawn down, the Company issued warrants exercisable for a total of 121,739 shares of the Company’s common stock to the lenders at an exercise price of $5.00 per share with a term of seven years. Upon issuance, the fair value of a warrant liability was recorded and is being revalued at each balance sheet date until the warrants are exercised or expire. 2015 Term Loan Facility On August 7, 2015, the Company entered into a Loan and Security Agreement pursuant to which it refinanced its existing 2013 Term Loan Facility with Oxford Finance LLC and Silicon Valley Bank, for an aggregate amount of up to $15 million, referred to herein as the 2015 Term Loan Facility. The first $10 million tranche of this new loan facility was made available to the Company immediately upon the closing and was used in part to retire all $4.1 million of the Company’s existing debt outstanding under the 2013 Term Loan Facility, and to settle accrued interest and closing costs with the lenders. The remaining $5 million, referred to as the second tranche, was made available to the Company until March 31, 2016, for draw down upon the announcement of a qualified out-license co-development The first loan tranche bears interest at 8.77%, a rate which was determined on the advance date as being the greater of (i) 8.75% and (ii) the sum of 8.47% and the 90 day U.S. LIBOR rate reported in the Wall Street Journal three business days prior to the funding date of the first tranche. Under the first tranche, the Company is required to make 12 monthly interest only payments after the funding date followed by a repayment schedule equal to 36 equal monthly payments of interest and principal. Upon maturity, the remaining balance of the first tranche and a final payment equal to 6.50% of the original principal amount advanced of the applicable tranche are payable. At the closing, the Company also agreed to pay a facility fee of 1.00% of the 2015 Term Loan Facility commitment. In addition, the Company issued warrants exercisable for a total of 114,436 shares of its common stock to the lenders at an exercise price of $2.84 per share, and with a term of ten years. Upon issuance, the fair value of a warrant liability of $0.3 million was recorded in the accompanying condensed balance sheets. The 2015 Term Loan Facility contains customary representations and warranties and customary affirmative and negative covenants applicable to the Company, and also includes defined customary events of default which include but are not limited to a material adverse change in the Company’s business, operations or condition (financial or otherwise), a material impairment of the prospect of repayment of any portion of the term loan, or a material impairment in the perfection or priority of the collateral agent’s lien in the collateral or in the value of such collateral. As of September 30, 2017, the Company was in compliance with the term loan covenants and there were no events of default. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies The Company leases 8,894 square feet of office space in Newark, California pursuant to a lease which commenced January 16, 2014 and expires on December 31, 2018. Rent expense was $0.1 million for each of the three months ended September 30, 2017 and 2016, and $0.3 million for each of the nine months ended September 30, 2017 and 2016. Future minimum lease payments are as follows (in thousands): Lease Payments Year ending December 31: 2017 (from October to December) $ 56 2018 228 Total future minimum payments $ 284 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity The Company is authorized to issue 10,000,000 shares of preferred stock with a par value of $0.0001 per share as of September 30, 2017. The Company is authorized to issue 100,000,000 shares of common stock with a par value of $0.0001 per share as of September 30, 2017. As of September 30, 2017, and December 31, 2016, the Company had reserved shares of authorized but unissued common stock as follows: September 30, December 31, 2017 2016 (unaudited) Common stock warrants 1,604,255 1,667,398 Equity incentive plans 4,509,606 3,456,771 Total reserved shares of common stock 6,113,861 5,124,169 On February 7, 2017, pursuant to its shelf registration statement on Form S-3, On July 24, 2017, pursuant to its shelf registration statement on Form S-3, |
Stock Plans and Stock-Based Com
Stock Plans and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Plans and Stock-Based Compensation | 8. Stock Plans and Stock-Based Compensation Stock Plans On January 1, 2017, the share reserve of the Company’s 2013 Equity Incentive Plan (“2013 Plan”), automatically increased by 1,172,350 shares. During the nine months ended September 30, 2017, the Company granted options to purchase 1,560,801 of it is common stock to its employees, directors and a consultant. As of September 30, 2017, there were 190,765 shares available for grant under the 2013 Plan. Stock-Based Compensation Expense Stock-based compensation expense recorded was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (unaudited) (unaudited) Research and development $ 325 $ 273 $ 953 $ 718 General and administrative 495 394 2,985 1,079 Total $ 820 $ 667 $ 3,938 $ 1,797 In connection with the retirement of the Company’s former President and Chief Executive Officer, the Company recognized stock-based compensation expense associated with the acceleration of vesting of his stock options of $1.8 million for the nine months ended September 30, 2017. No expense was recognized for the three months ended September 30, 2017. |
Related-Party Transactions
Related-Party Transactions | 9 Months Ended |
Sep. 30, 2017 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 9. Related-Party Transactions Scientific and Advisory Consulting Arrangement The Company paid a former member of its Board of Directors, who is also a member of its Scientific and Clinical Advisory Boards, a total of $60,000 in the year ended December 31, 2016 and $45,000 for the nine months ended September 30, 2017, in monthly cash retainers. The Company has also issued options to purchase shares of common stock and incentive awards to this individual in his capacity as a member of its Scientific Advisory Board. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Event | 10. Subsequent Event On October 27, 2017, the Board of Directors promoted Sujal Shah to serve as President and Chief Executive Officer, effective November 1, 2017. Mr. Shah was previously serving as the Company’s Interim President and Chief Executive Officer, a position held since April 14, 2017. In connection with the promotion, the Board of Directors granted Mr. Shah an option to purchase 640,000 shares of the Company’s common stock, which vests monthly over a four-year period. |
Organization and Description 16
Organization and Description of Business (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Liquidity | Liquidity The Company has incurred net operating losses and negative cash flows from operations since its inception. During the nine months ended September 30, 2017, the Company incurred a net loss of $22.5 million and used $13.6 million of cash in operations. At September 30, 2017, the Company had an accumulated deficit of $445.5 million. CymaBay expects to incur substantial research and development expenses as it continues to study its product candidates in clinical trials. To date, none of the Company’s product candidates have been approved for marketing and sale, and the Company has not recorded any revenue from product sales. As a result, management expects operating losses to continue in future years. The Company’s ability to achieve profitability is dependent primarily on its ability to successfully develop, acquire or in-license As of September 30, 2017, the Company’s cash, cash equivalents and marketable securities totaled $102.2 million. Management believes these fund are sufficient to fund the Company’s liquidity requirements into 2019. The Company expects to incur substantial expenditures in the future for the development and potential commercialization of its product candidates. Because of this, the Company expects its future liquidity and capital resource needs will be impacted by numerous factors, including but not limited to, the repayment of the Company’s facility loan, the planned initiation of a phase 2 clinical trial in NASH, and most significantly, the timing and conduct of additional PBC development activities, including an ongoing phase 2 clinical trial, a planned phase 3 clinical trial, and other NDA-enabling |
Basis of Presentation | Basis of Presentation The accompanying interim condensed financial statements are unaudited. These unaudited interim financial statements have been prepared in accordance with U.S. GAAP (“GAAP”) and following the requirements of the United States 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 condensed financial statements have been prepared on the same basis as the audited financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss 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 fiscal year ended December 31, 2016, which is contained in the Company’s Annual Report on Form 10-K |
Use of Estimates | Use of Estimates The condensed financial statements have been prepared in accordance with GAAP, which requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable estimates of actual future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from those estimates. The Company believes significant judgment is involved in estimating revenue, stock-based compensation, accrued clinical expenses, warrant liabilities, and equity instrument valuations. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments during the periods reported consist of cash and cash equivalents, marketable securities, prepaid expenses, other current assets, other assets, accounts payable, accrued interest payable, accrued liabilities, the facility loan, and warrant liabilities. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment. The carrying amounts of financial instruments such as cash and cash equivalents, prepaid expenses, other current assets, other assets, accounts payable, accrued liabilities, and accrued interest payable approximate the related fair values due to the short maturities of these instruments. Based on prevailing borrowing rates available to the Company for loans with similar terms, the Company believes the fair value of the facility loan, considering level 2 inputs, approximates its carrying value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable and unobservable inputs and is as follows: Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. Level 3—Inputs that are significant to the fair value measurement and are unobservable (i.e. supported by little market activity), which requires the reporting entity to develop its own valuation techniques and assumptions. The following tables present the fair value of the Company’s financial assets and liabilities measured at fair value on a recurring basis using the above input categories (in thousands): As of September 30, 2017 Description Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 18,554 $ — $ — $ 18,554 Commercial paper — 2,994 — 2,994 Total cash equivalents 18,554 2,994 — 21,548 Marketable securities: Commercial paper — 44,750 — 44,750 Corporate debt securities — 22,359 — 22,359 Asset-backed securities — 8,071 — 8,071 U.S. treasury securities — 3,980 — 3,980 Total short-term investments — 79,160 — 79,160 Total assets measured at fair value $ 18,554 $ 82,154 $ — $ 100,708 Warrant liability $ — $ — $ 5,862 $ 5,862 Total liabilities measured at fair value $ — $ — $ 5,862 $ 5,862 As of December 31, 2016 Description Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 9,456 $ — $ — $ 9,456 Commercial paper — 599 — 599 Corporate debt securities — 500 — 500 Total cash equivalents 9,456 1,099 — 10,555 Marketable securities: Commercial paper — 4,295 — 4,295 Corporate debt securities — 2,204 — 2,204 Total short-term investments — 6,499 — 6,499 Total assets measured at fair value $ 9,456 $ 7,598 $ — $ 17,054 Warrant liability $ — $ — $ 1,145 $ 1,145 Total liabilities measured at fair value $ — $ — $ 1,145 $ 1,145 The Company estimates the fair value of its corporate debt, asset backed securities, and U.S. treasury securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data, and other observable inputs. There were no transfers between Level 1 and Level 2 during the periods presented. The Company holds a Level 3 liability associated with common stock warrants that were issued in connection with the Company’s financings completed in September and October 2013, January 2014, and August 2015. The warrants are accounted for as liabilities. During the quarter, the Company changed its valuation technique and began to value its warrant liability using a Black-Scholes option pricing model, the inputs for which include: exercise price of the warrants, market price of the underlying common shares, dividend yield, expected term, volatility, and a risk-free interest rate. Changes to any of these inputs can have a significant impact on the estimated fair value of the warrants. Historically, the Company used a binomial option pricing model to value its warrant liabilities. The inputs for the binomial model are similar to the Black-Scholes model but also incorporate other more complex inputs which, in the Company’s case, have previously included the expected timing, probability and valuation impact of certain potential strategic events. Management concluded that no potential strategic events were expected to occur that could significantly impact the warrant liabilities valuation prior to their expiration (beginning in late 2018 and ending in early 2019). The following table sets forth an activity summary which includes the changes in the fair value of the Company’s Level 3 financial instruments (in thousands): For the Nine Months Ended September 2017 2016 Balance, beginning of period $ 1,145 $ 1,220 Issuance of financial instrument — — Change in fair value 4,996 (43 ) Settlement of financial instrument (279 ) — Balance, end of period $ 5,862 $ 1,177 |
Cash Equivalents and Marketable Securities | Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with a maturity at the date of purchase of 90 days or less to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest-bearing, demand money market accounts, and corporate debt securities. The Company invests excess cash in marketable securities with high credit ratings, which are classified in Level 2 of the fair value hierarchy. These securities consist primarily of corporate debt, commercial paper, asset-backed securities, and U.S. treasury securities and are classified as “available-for-sale.” Realized gains and losses from the sale of marketable securities, if any, are calculated using the specific identification method. Realized gains and losses and declines in value judged to be other-than-temporary are included in interest income or expense in the statements of operations and comprehensive loss. Unrealized holding gains and losses are reported in accumulated other comprehensive loss, in the balance sheets. To date, the Company has not recorded any impairment charges on its marketable securities related to other-than-temporary declines in market value. In determining whether a decline in market value is other-than-temporary, various factors are considered, including the cause, duration of time and severity of the impairment, any adverse changes in the investees’ financial condition, and the Company’s intent and ability to hold the security for a period of time sufficient to allow for an anticipated recovery in market value. The following tables summarize amortized cost, unrealized gain and loss, and fair value (in thousands): Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of September 30, 2017: Commercial paper 44,750 — — 44,750 Corporate debt securities 22,369 — (10 ) 22,359 Asset-backed securities 8,074 — (3 ) 8,071 U.S. treasury securities 3,980 — — 3,980 $ 79,173 $ — $ (13 ) $ 79,160 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2016: Commercial paper 4,295 — — 4,295 Corporate debt securities 2,205 — (1 ) 2,204 $ 6,500 $ — $ (1 ) $ 6,499 |
Concentration of Credit Risk | Concentration of Credit Risk Cash equivalents and marketable securities consist of financial instruments that potentially subject the Company to a concentration of credit risk to the extent of the fair value recorded in the balance sheets. The Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments that bear minimal risk. The Company has established guidelines relating to the quality, diversification, and maturities of securities to enable the Company to manage its credit risk. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and marketable securities and issuers of investments to the extent recorded on the balance sheets. Certain materials and key components that the Company utilizes in its operations are obtained through single suppliers. Since the suppliers of key components and materials must be named in a new drug application (NDA) filed with the U.S. Food and Drug Administration (FDA) for a product, significant delays can occur if the qualification of a new supplier is required. If delivery of material from the Company’s suppliers were interrupted for any reason, the Company may be unable to supply any of its product candidates for clinical trials. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred or services have been rendered, (iii) the price is fixed or determinable, and (iv) collectability is reasonably assured. Payments received in advance of work performed are recorded as deferred revenue and recognized when earned. Collaboration and license agreements may include non-refundable If the Company determines that multiple deliverables in an arrangement exist, the consideration is allocated to one or more units of accounting based upon the relative-selling-price of each element in an arrangement. The relative-selling-price used for each deliverable is based on vendor-specific objective evidence, if available, third-party evidence if vendor-specific objective evidence is not available, or estimated selling price if neither vendor-specific or third-party evidence is available. The Company identifies deliverables at the inception of the arrangement. Each deliverable is accounted for as a separate unit of accounting if both of the following criteria are met: (1) the delivered item or items have value to the customer on a standalone basis and (2) for an arrangement that includes a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and substantially in the Company’s control. Non-refundable The Company recognizes payments that are contingent upon achievement of a substantive milestone in their entirety in the period in which the milestone is achieved. Milestones are defined as events that can only be achieved based on the Company’s performance and there is substantive uncertainty about whether the event will be achieved at the inception of the arrangement. Events that are contingent only on the passage of time or only on counterparty performance are not considered milestones subject to this guidance. Further, the amounts received must relate solely to prior performance, be reasonable relative to all of the deliverables and payment terms within the agreement and commensurate with the Company’s performance to achieve the milestone after commencement of the agreement. Any contingent payment that becomes payable upon achievement of events that are not considered substantive milestones are allocated to the units of accounting previously identified at the inception of an arrangement when the contingent payment is received and revenue is recognized based on the revenue recognition criteria for each unit of accounting. |
Common Stock Warrant Liability | Common Stock Warrant Liability The Company’s outstanding common stock warrants issued in connection with certain equity and debt financings that occurred in 2013 through 2015 are classified as liabilities in the accompanying condensed balance sheets because of certain contractual terms that preclude equity classification. The warrants are recorded at fair value using a Black-Scholes option-pricing model. The warrants are re-measured |
Stock-Based Compensation | Stock-Based Compensation Employee and director stock-based compensation is measured at fair value on the grant date of the award. Compensation cost is recognized as expense on a straight-line basis over the vesting period for options and on an accelerated basis for stock options with performance conditions. For stock options with performance conditions, the Company evaluates the probability of achieving performance conditions at each reporting date. The Company begins to recognize the expense when it is deemed probable that the performance conditions will be met. The Company uses the Black-Scholes option pricing model to determine the fair value of stock option awards. The determination of fair value for stock-based awards using an option-pricing model requires management to make certain assumptions regarding subjective input variables such as expected term, dividends, volatility and risk-free interest rate. The Company is also required to make estimates as to the probability of achieving the specific performance criteria. If actual results are not consistent with the Company’s assumptions and judgments used in making these estimates, the Company may be required to increase or decrease compensation expense, which could be material to the Company’s results of operations. Equity awards granted to non-employees |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per share of common stock is based on the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share of common stock is calculated as the weighted average number of shares of common stock outstanding adjusted to include the assumed exercises of stock options and common stock warrants, if dilutive. The calculation of diluted loss per share also requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the common stock warrants and the presumed exercise of such securities are dilutive to net loss per share for the period, adjustments to net loss used in the calculation are required to remove the change in fair value of the common stock warrant liability for the period. Likewise, adjustments to the denominator are required to reflect the related dilutive shares. In all periods presented, the Company’s outstanding stock options, incentive awards and warrants were excluded from the calculation of diluted net loss per share because their effects were antidilutive. The Company’s computation of basic and diluted net loss per share is as follows (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Numerator: Net loss allocated to common stock-basic $ (8,234 ) $ (5,879 ) $ (22,514 ) $ (19,719 ) Adjustments for revaluation of warrants — — — — Net loss allocated to common stock-diluted $ (8,234 ) $ (5,879 ) $ (22,514 ) $ (19,719 ) Denominator: Weighted average number of common stock shares outstanding—basic 40,035,690 23,447,003 31,848,536 23,447,003 Weighted average number of common stock shares outstanding—diluted 40,035,690 23,447,003 31,848,536 23,447,003 Net loss per share—basic: $ (0.21 ) $ (0.25 ) $ (0.71 ) $ (0.84 ) Net loss per share—diluted: $ (0.21 ) $ (0.25 ) $ (0.71 ) $ (0.84 ) The following table shows the total outstanding common stock equivalents considered anti-dilutive and therefore excluded from the computation of diluted net loss per share (in thousands). Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Warrants for common stock 1,604 1,667 1,604 1,667 Common stock options 3,788 2,422 3,788 2,422 Performace-based stock options 305 327 305 327 Incentive awards 226 241 226 241 5,923 4,657 5,923 4,657 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Update 2014-09 In May 2014, the FASB issued Accounting Standards Update 2014-09, Revenue from Contracts with Customers and related amendments 2014-09: No. 2016-08, No. 2016-10, No. 2016-12, The new revenue standard permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the modified retrospective method). The Company plans to adopt the new revenue standard in the first quarter of 2018 using the modified retrospective method. While the Company has not completed an assessment of the impact of adoption, the adoption of this guidance may have a material effect on the Company’s financial statements. At the end of 2016, the Company entered into a license agreement. Before executing this agreement, the Company had no revenues for the last two years. The consideration that the Company is eligible to receive under this agreement includes an upfront payment, milestone payments, and royalties. This license agreement is unique and will need to be assessed separately under the five-step process under the new standard. The Company is currently analyzing this agreement to determine the differences in the accounting treatment under the new revenue standard compared to that of the current accounting treatment. The new revenue standard differs from the current accounting standard in many respects, such as in the accounting for variable consideration, including milestone payments and royalties. The Company expects that its evaluation of the accounting for this agreement under the new revenue standard could identify material changes from that of the current accounting treatment and it will also impact its condensed financial statement disclosures. Additionally, the Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession and adjust its assessment and implementation plans accordingly. Accounting Standards Update 2016-02 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). Accounting Standards Update 2016-09 In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting 2016-09). 2016-09 paid-in Accounting Standards Update 2017-09 In May 2017, FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718)- Scope of Modification Accounting 2017-09 Accounting Standards Update 2017-11 In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share Distinguishing Liabilities from Equity Derivatives and Hedging 2017-11): Non-controlling |
Summary of Significant Accoun17
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Fair Value Assets and Liabilities Measured on Recurring Basis | As of September 30, 2017 Description Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 18,554 $ — $ — $ 18,554 Commercial paper — 2,994 — 2,994 Total cash equivalents 18,554 2,994 — 21,548 Marketable securities: Commercial paper — 44,750 — 44,750 Corporate debt securities — 22,359 — 22,359 Asset-backed securities — 8,071 — 8,071 U.S. treasury securities — 3,980 — 3,980 Total short-term investments — 79,160 — 79,160 Total assets measured at fair value $ 18,554 $ 82,154 $ — $ 100,708 Warrant liability $ — $ — $ 5,862 $ 5,862 Total liabilities measured at fair value $ — $ — $ 5,862 $ 5,862 As of December 31, 2016 Description Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 9,456 $ — $ — $ 9,456 Commercial paper — 599 — 599 Corporate debt securities — 500 — 500 Total cash equivalents 9,456 1,099 — 10,555 Marketable securities: Commercial paper — 4,295 — 4,295 Corporate debt securities — 2,204 — 2,204 Total short-term investments — 6,499 — 6,499 Total assets measured at fair value $ 9,456 $ 7,598 $ — $ 17,054 Warrant liability $ — $ — $ 1,145 $ 1,145 Total liabilities measured at fair value $ — $ — $ 1,145 $ 1,145 |
Schedule of Changes in Fair Value of Liabilities | The following table sets forth an activity summary which includes the changes in the fair value of the Company’s Level 3 financial instruments (in thousands): For the Nine Months Ended September 2017 2016 Balance, beginning of period $ 1,145 $ 1,220 Issuance of financial instrument — — Change in fair value 4,996 (43 ) Settlement of financial instrument (279 ) — Balance, end of period $ 5,862 $ 1,177 |
Schedule of Amortized Cost, Unrealized Gain and Loss, and Fair Value | The following tables summarize amortized cost, unrealized gain and loss, and fair value (in thousands): Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of September 30, 2017: Commercial paper 44,750 — — 44,750 Corporate debt securities 22,369 — (10 ) 22,359 Asset-backed securities 8,074 — (3 ) 8,071 U.S. treasury securities 3,980 — — 3,980 $ 79,173 $ — $ (13 ) $ 79,160 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2016: Commercial paper 4,295 — — 4,295 Corporate debt securities 2,205 — (1 ) 2,204 $ 6,500 $ — $ (1 ) $ 6,499 |
Computation of Basic and Diluted Net Loss per Share | The Company’s computation of basic and diluted net loss per share is as follows (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Numerator: Net loss allocated to common stock-basic $ (8,234 ) $ (5,879 ) $ (22,514 ) $ (19,719 ) Adjustments for revaluation of warrants — — — — Net loss allocated to common stock-diluted $ (8,234 ) $ (5,879 ) $ (22,514 ) $ (19,719 ) Denominator: Weighted average number of common stock shares outstanding—basic 40,035,690 23,447,003 31,848,536 23,447,003 Weighted average number of common stock shares outstanding—diluted 40,035,690 23,447,003 31,848,536 23,447,003 Net loss per share—basic: $ (0.21 ) $ (0.25 ) $ (0.71 ) $ (0.84 ) Net loss per share—diluted: $ (0.21 ) $ (0.25 ) $ (0.71 ) $ (0.84 ) |
Anti-Dilutive Securities Excluded from the Computation of Diluted Net Loss per Share | The following table shows the total outstanding common stock equivalents considered anti-dilutive and therefore excluded from the computation of diluted net loss per share (in thousands). Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Warrants for common stock 1,604 1,667 1,604 1,667 Common stock options 3,788 2,422 3,788 2,422 Performace-based stock options 305 327 305 327 Incentive awards 226 241 226 241 5,923 4,657 5,923 4,657 |
Certain Balance Sheet Items (Ta
Certain Balance Sheet Items (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Accrued Liabilities | The following table shows certain balance sheet items (in thousands). September 30, December 31, (unaudited) Accrued compensation $ 1,528 $ 1,839 Accrued pre-clinical and clinical trial expenses 1,745 1,623 Accrued professional fees 336 982 Deferred revenue 207 — Other accruals 65 57 Total accrued liabilities $ 3,881 $ 4,501 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments | Future minimum lease payments are as follows (in thousands): Lease Payments Year ending December 31: 2017 (from October to December) $ 56 2018 228 Total future minimum payments $ 284 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Reserved Shares of Authorized but Unissued Common Stock | As of September 30, 2017, and December 31, 2016, the Company had reserved shares of authorized but unissued common stock as follows: September 30, December 31, 2017 2016 (unaudited) Common stock warrants 1,604,255 1,667,398 Equity incentive plans 4,509,606 3,456,771 Total reserved shares of common stock 6,113,861 5,124,169 |
Stock Plans and Stock-Based C21
Stock Plans and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock-Based Compensation Expense | Stock-based compensation expense recorded was as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (unaudited) (unaudited) Research and development $ 325 $ 273 $ 953 $ 718 General and administrative 495 394 2,985 1,079 Total $ 820 $ 667 $ 3,938 $ 1,797 |
Organization and Description 22
Organization and Description of Business - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)Segment | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||
Number of operating segments | Segment | 1 | ||||
Net loss | $ (8,234) | $ (5,879) | $ (22,514) | $ (19,719) | |
Cash flows from operating activities | (13,560) | $ (17,951) | |||
Accumulated deficit | (445,473) | (445,473) | $ (422,959) | ||
Cash and cash equivalents and marketable securities | $ 102,200 | $ 102,200 |
Summary of Significant Accoun23
Summary of Significant Accounting Policies - Schedule of Fair Value Assets and Liabilities Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | $ 100,708 | $ 17,054 |
Total liabilities measured at fair value | 5,862 | 1,145 |
Warrant Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total liabilities measured at fair value | 5,862 | 1,145 |
Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 21,548 | 10,555 |
Cash Equivalents [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 18,554 | 9,456 |
Cash Equivalents [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 2,994 | 599 |
Cash Equivalents [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 500 | |
Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 79,160 | 6,499 |
Short-term Investments [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 44,750 | 4,295 |
Short-term Investments [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 22,359 | 2,204 |
Short-term Investments [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 8,071 | |
Short-term Investments [Member] | U.S. Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 3,980 | |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 18,554 | 9,456 |
Level 1 [Member] | Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 18,554 | 9,456 |
Level 1 [Member] | Cash Equivalents [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 18,554 | 9,456 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 82,154 | 7,598 |
Level 2 [Member] | Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 2,994 | 1,099 |
Level 2 [Member] | Cash Equivalents [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 2,994 | 599 |
Level 2 [Member] | Cash Equivalents [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 500 | |
Level 2 [Member] | Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 79,160 | 6,499 |
Level 2 [Member] | Short-term Investments [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 44,750 | 4,295 |
Level 2 [Member] | Short-term Investments [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 22,359 | 2,204 |
Level 2 [Member] | Short-term Investments [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 8,071 | |
Level 2 [Member] | Short-term Investments [Member] | U.S. Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 3,980 | |
Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total liabilities measured at fair value | 5,862 | 1,145 |
Level 3 [Member] | Warrant Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total liabilities measured at fair value | $ 5,862 | $ 1,145 |
Summary of Significant Accoun24
Summary of Significant Accounting Policies - Schedule of Changes in Fair Value of Liabilities (Detail) - Level 3 [Member] - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Fair Value, Instruments Classified in Shareholders' Equity Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning Balance | $ 1,145 | $ 1,220 |
Issuance of financial instrument | 0 | 0 |
Change in fair value | 4,996 | (43) |
Settlement of financial instrument | (279) | |
Ending Balance | $ 5,862 | $ 1,177 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2017 | |
Product Information [Line Items] | |
Cash and cash equivalents, maturity description | 90 days or less |
Minimum [Member] | |
Product Information [Line Items] | |
Long-term contractual maturities | 1 year |
Maximum [Member] | |
Product Information [Line Items] | |
Short-term contractual maturities | 1 year |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Schedule of Amortized Cost, Unrealized Gain and Loss, and Fair Value (Detail) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 79,173 | $ 6,500 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (13) | (1) |
Estimated Fair Value | 79,160 | 6,499 |
Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 44,750 | 4,295 |
Gross Unrealized Gains | 0 | 0 |
Estimated Fair Value | 44,750 | 4,295 |
Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 22,369 | 2,205 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (10) | (1) |
Estimated Fair Value | 22,359 | $ 2,204 |
Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 8,074 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (3) | |
Estimated Fair Value | 8,071 | |
US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 3,980 | |
Gross Unrealized Gains | 0 | |
Estimated Fair Value | $ 3,980 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Computation of Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Numerator: | ||||
Net loss allocated to common stock-basic | $ (8,234) | $ (5,879) | $ (22,514) | $ (19,719) |
Adjustments for revaluation of warrants | 0 | 0 | 0 | 0 |
Net loss allocated to common stock-diluted | $ (8,234) | $ (5,879) | $ (22,514) | $ (19,719) |
Denominator: | ||||
Weighted average number of common stock shares outstanding-basic | 40,035,690 | 23,447,003 | 31,848,536 | 23,447,003 |
Weighted average number of common stock shares outstanding-diluted | 40,035,690 | 23,447,003 | 31,848,536 | 23,447,003 |
Net loss per share-basic: | $ (0.21) | $ (0.25) | $ (0.71) | $ (0.84) |
Net loss per share-diluted: | $ (0.21) | $ (0.25) | $ (0.71) | $ (0.84) |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Anti-Dilutive Securities Excluded from the Computation of Diluted Net Loss per Share (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the computation of diluted loss per share | 5,923 | 4,657 | 5,923 | 4,657 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the computation of diluted loss per share | 1,604 | 1,667 | 1,604 | 1,667 |
Common Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the computation of diluted loss per share | 3,788 | 2,422 | 3,788 | 2,422 |
Performance Based Stock Option [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the computation of diluted loss per share | 305 | 327 | 305 | 327 |
Incentive Awards [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the computation of diluted loss per share | 226 | 241 | 226 | 241 |
Certain Balance Sheet Items - A
Certain Balance Sheet Items - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Accrued compensation | $ 1,528 | $ 1,839 |
Accrued pre-clinical and clinical trial expenses | 1,745 | 1,623 |
Accrued professional fees | 336 | 982 |
Deferred revenue | 207 | |
Other accruals | 65 | 57 |
Total accrued liabilities | $ 3,881 | $ 4,501 |
Collaboration and License Agr30
Collaboration and License Agreements - Additional Information (Detail) | Dec. 30, 2016USD ($) | Jun. 30, 2010Agreement | Jun. 30, 2006USD ($) | Jun. 30, 1998USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaboration revenue | $ 4,793,000 | |||||
Kowa Pharmaceuticals America Inc [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Non-refundable up-front payment | $ 5,000,000 | |||||
Kowa Pharmaceuticals America Inc [Member] | Initiation or Achievement [Member] | Maximum [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Milestone payments | $ 200,000,000 | |||||
Janssen Pharmaceutical NV [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Royalty payment | $ 0 | |||||
Janssen Pharmaceutical NV [Member] | Maximum [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Percentage of royalty on net sales | 8.00% | |||||
Janssen Pharmaceuticals, Inc. [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Number of development and license agreements | Agreement | 2 | |||||
DiaTex, Inc. [Member] | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Royalty payment | 0 | $ 0 | ||||
Monthly license fees | $ 2,000 | |||||
Potential future development payments | $ 800,000 | |||||
Development payment | $ 0 | $ 0 |
Facility Loans - Additional Inf
Facility Loans - Additional Information (Detail) - USD ($) | Aug. 07, 2015 | Sep. 30, 2013 | Sep. 30, 2017 | Mar. 31, 2016 |
Debt Instrument [Line Items] | ||||
Issued warrants to purchase common stock | 114,436 | |||
Exercise price of common stock | $ 2.84 | |||
Warrant term | 10 years | |||
Warrants [Member] | ||||
Debt Instrument [Line Items] | ||||
Fair value of warrant liabilities | $ 300,000 | |||
Warrants, Exercise Price of $5.00 Per Share [Member] | ||||
Debt Instrument [Line Items] | ||||
Issued warrants to purchase common stock | 121,739 | |||
Exercise price of common stock | $ 5 | |||
Warrant term | 7 years | |||
Second Tranche [Member] | ||||
Debt Instrument [Line Items] | ||||
Facility loan, unused amount expired | $ 5,000,000 | |||
2015 Term Loan Facility [Member] | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | $ 15,000,000 | |||
Debt instrument payment terms | Under the first tranche, the Company is required to make 12 monthly interest only payments after the funding date followed by a repayment schedule equal to 36 equal monthly payments of interest and principal. | |||
Percentage of principal amount as final payment | 6.50% | |||
Facility fee | 1.00% | |||
2015 Term Loan Facility [Member] | Minimum [Member] | ||||
Debt Instrument [Line Items] | ||||
Upfront payment | $ 35,000,000 | |||
Present value of the future cash flows | 10.00% | |||
2015 Term Loan Facility [Member] | First Tranche [Member] | ||||
Debt Instrument [Line Items] | ||||
Facility loan, drawn | $ 10,000,000 | |||
Facility loan, fixed interest rate | 8.77% | |||
2015 Term Loan Facility [Member] | First Tranche [Member] | Minimum [Member] | ||||
Debt Instrument [Line Items] | ||||
Facility loan, fixed interest rate | 8.75% | |||
2015 Term Loan Facility [Member] | First Tranche [Member] | Wall Street Journal Prime Rate [Member] | Minimum [Member] | ||||
Debt Instrument [Line Items] | ||||
Facility loan, fixed interest rate | 8.47% | |||
2015 Term Loan Facility [Member] | Second Tranche [Member] | ||||
Debt Instrument [Line Items] | ||||
Facility loan available for draw down | $ 5,000,000 | |||
2013 Term Loan Facility [Member] | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | $ 10,000,000 | |||
Retiring of existing debt | $ 4,100,000 | |||
2013 Term Loan Facility [Member] | First Tranche [Member] | ||||
Debt Instrument [Line Items] | ||||
Facility loan, drawn | $ 5,000,000 | |||
Facility loan, fixed interest rate | 8.75% | |||
Facility loan, interest amortization period | 36 months | |||
Facility loan, final interest payment | $ 300,000 | |||
2013 Term Loan Facility [Member] | Second Tranche [Member] | ||||
Debt Instrument [Line Items] | ||||
Facility loan, fixed interest rate | 8.75% | |||
Facility loan available for draw down | $ 5,000,000 | |||
2013 Term Loan Facility [Member] | Second Tranche [Member] | Wall Street Journal Prime Rate [Member] | ||||
Debt Instrument [Line Items] | ||||
Facility loan, prime rate plus | 4.25% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Millions | Nov. 08, 2013ft² | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) |
Loss Contingencies [Line Items] | |||||
Rent expenses | $ | $ 0.1 | $ 0.1 | $ 0.3 | $ 0.3 | |
Lease Facility [Member] | |||||
Loss Contingencies [Line Items] | |||||
Area of office space | ft² | 8,894 | ||||
Lease start date | Jan. 16, 2014 | ||||
Lease expiration date | Dec. 31, 2018 |
Commitments and Contingencies33
Commitments and Contingencies - Future Minimum Lease Payments (Detail) $ in Thousands | Sep. 30, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2017 (from October to December) | $ 56 |
2,018 | 228 |
Total future minimum payments | $ 284 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Jul. 24, 2017 | Feb. 07, 2017 | Sep. 30, 2017 | Dec. 31, 2016 |
Equity [Abstract] | ||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 | ||
Common stock, par value | $ 0.0001 | $ 0.0001 | ||
Shares of common stock issued | 5,181,348 | |||
Common stock offering price | $ 6.50 | $ 1.93 | ||
Net proceeds from public offering | $ 91.1 | $ 9.2 | ||
Common stock, shares issued | 14,950,000 | 43,846,709 | 23,447,003 |
Stockholder's Equity - Reserved
Stockholder's Equity - Reserved Shares of Authorized but Unissued Common Stock (Detail) - shares | Sep. 30, 2017 | Dec. 31, 2016 |
Class of Stock [Line Items] | ||
Total reserved shares of common stock | 6,113,861 | 5,124,169 |
Common Stock Warrants [Member] | ||
Class of Stock [Line Items] | ||
Total reserved shares of common stock | 1,604,255 | 1,667,398 |
Equity Incentive Plans [Member] | ||
Class of Stock [Line Items] | ||
Total reserved shares of common stock | 4,509,606 | 3,456,771 |
Stock Plans and Stock-Based C36
Stock Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 820 | $ 667 | $ 3,938 | $ 1,797 |
Former President and Chief Executive Officer [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 0 | $ 1,800 | ||
2013 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for grant | 190,765 | 190,765 | ||
Increased in shares available for issuance | 1,172,350 | |||
2013 Equity Incentive Plan [Member] | Employees, Directors and Consultant [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options to purchase common stock granted | 1,560,801 |
Stock Plans and Stock-Based C37
Stock Plans and Stock-Based Compensation - Summary of Stock-Based Compensation Expense, Net of Estimated Forfeitures (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 820 | $ 667 | $ 3,938 | $ 1,797 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 325 | 273 | 953 | 718 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 495 | $ 394 | $ 2,985 | $ 1,079 |
Related-Party Transactions - Ad
Related-Party Transactions - Additional Information (Detail) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Former Member of Board of Directors [Member] | ||
Related Party Transaction [Line Items] | ||
Advisory fee paid to related party | $ 45,000 | $ 60,000 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - President and Chief Executive Officer [Member] - Subsequent Event [Member] | Nov. 01, 2017shares |
Subsequent Event [Line Items] | |
Options to purchase common stock granted | 640,000 |
Stock option plan, description | vests ratably on a monthly basis over a four-year period. |
Share based compensation arrangement by share based payment award, award vesting period | 4 years |