Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 31, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
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 | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 59,439,130 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 41,795 | $ 23,054 |
Marketable securities | 156,350 | 74,156 |
Receivable from collaboration | 5,000 | |
Accrued interest receivable | 217 | 103 |
Prepaid expenses | 1,793 | 1,208 |
Other current assets | 2,100 | 23 |
Total current assets | 202,255 | 103,544 |
Property and equipment, net | 90 | 69 |
Other assets | 1,363 | 634 |
Total assets | 203,708 | 104,247 |
Current liabilities: | ||
Accounts payable | 1,629 | 1,311 |
Accrued clinical trial expenses | 9,574 | 2,929 |
Warrant liability | 6,091 | |
Other accrued liabilities | 2,437 | 2,828 |
Facility loan | 3,108 | |
Accrued interest payable | 43 | |
Total current liabilities | 13,640 | 16,310 |
Facility loan, less current portion | 2,990 | |
Deferred rent, net of current portion | 1,937 | |
Total liabilities | 15,577 | 19,300 |
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; 59,439,130 and 44,408,796 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively | 6 | 4 |
Additional paid-in capital | 691,771 | 535,503 |
Accumulated other comprehensive loss | (31) | (44) |
Accumulated deficit | (503,615) | (450,516) |
Total stockholders’ equity | 188,131 | 84,947 |
Total liabilities and stockholders’ equity | $ 203,708 | $ 104,247 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
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 | 59,439,130 | 44,408,796 |
Common stock, shares outstanding | 59,439,130 | 44,408,796 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 4,793 | |||
Type of Revenue [Extensible List] | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember |
Operating expenses: | ||||
Research and development | $ 17,853 | $ 4,184 | $ 41,727 | $ 12,269 |
General and administrative | 3,276 | 2,210 | 10,223 | 9,493 |
Total operating expenses | 21,129 | 6,394 | 51,950 | 21,762 |
Loss from operations | (21,129) | (6,394) | (51,950) | (16,969) |
Other income (expense): | ||||
Interest income | 1,113 | 216 | 2,882 | 297 |
Interest expense | (258) | (336) | (846) | |
Loss on extinguishment of debt | (407) | |||
Other income (expense), net | 1,453 | (1,798) | (3,288) | (4,996) |
Total other income (expense) | 2,566 | (1,840) | (1,149) | (5,545) |
Net loss | (18,563) | (8,234) | (53,099) | (22,514) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on marketable securities | 36 | (12) | 13 | (12) |
Total other comprehensive income (loss) | 36 | (12) | 13 | (12) |
Comprehensive loss | $ (18,527) | $ (8,246) | $ (53,086) | $ (22,526) |
Basic net loss per common share | $ (0.31) | $ (0.21) | $ (0.93) | $ (0.71) |
Diluted net loss per common share | $ (0.34) | $ (0.21) | $ (0.93) | $ (0.71) |
Weighted average common shares outstanding used to calculate basic net loss per common share | 59,121,600 | 40,035,690 | 57,255,666 | 31,848,536 |
Weighted average common shares outstanding used to calculate diluted net loss per common share | 59,387,780 | 40,035,690 | 57,298,105 | 31,848,536 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating activities | ||
Net loss | $ (53,099) | $ (22,514) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 39 | 26 |
Stock-based compensation expense | 5,275 | 3,938 |
Net accretion and amortization of investments in marketable securities | (1,358) | (47) |
Non-cash interest associated with debt discount accretion | 148 | 339 |
Loss on extinguishment of debt | 407 | |
Change in fair value of warrant liability | 3,710 | 4,996 |
Gain on extinguishment of warrant liability | (422) | |
Accretion of tenant improvement allowance | (154) | |
Changes in assets and liabilities: | ||
Receivable from collaboration | 5,000 | |
Interest receivable and other current assets | (93) | (101) |
Prepaid expenses | (585) | 1 |
Other assets | (729) | 120 |
Accounts payable | 318 | 185 |
Accrued liabilities | 6,245 | (486) |
Accrued interest payable | (43) | (17) |
Net cash used in operating activities | (35,341) | (13,560) |
Investing activities | ||
Purchases of property and equipment | (60) | |
Purchases of marketable securities | (249,422) | (88,941) |
Proceeds from maturities of marketable securities | 168,600 | 16,315 |
Net cash used in investing activities | (80,882) | (72,626) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 135,520 | 100,587 |
Proceeds from issuance of common stock pursuant to equity award plans | 3,547 | 440 |
Proceeds from issuance of common stock upon exercise of warrants | 2,550 | |
Repayment of facility loan principal | (6,527) | (2,327) |
Payment of fees to extinguish facility loan | (126) | |
Net cash provided by financing activities | 134,964 | 98,700 |
Net increase in cash and cash equivalents | 18,741 | 12,514 |
Cash and cash equivalents at beginning of period | 23,054 | 10,495 |
Cash and cash equivalents at end of period | 41,795 | 23,009 |
Supplemental disclosure | ||
Cash paid for interest | 231 | 526 |
Supplemental non-cash investing and financing activities | ||
Lessor funded lease incentives included in other current assets | 2,100 | |
Issuance of common stock upon warrant exercises | $ 9,379 | $ 279 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2018 | |
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 key clinical development candidate is seladelpar (MBX-8025). Seladelpar is currently being developed for the treatment of primary biliary cholangitis (PBC) and the Company is also developing seladelpar for the treatment of nonalcoholic steatohepatitis (NASH). 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, 2018, the Company incurred a net loss of $53.1 million and used $35.3 million of cash in operations. At September 30, 2018, the Company had an accumulated deficit of $503.6 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 additional product candidates, continue clinical trials for product candidates currently in clinical development, obtain regulatory approvals, and support commercialization activities for partnered product candidates. Products developed by the Company will require approval of the U.S. Food and Drug Administration (FDA) or a foreign regulatory authority prior to commercial sale. The regulatory approval process is expensive, time-consuming, and uncertain, and any denial or delay of approval could have a material adverse effect on the Company. Even if approved, the Company’s products may not achieve market acceptance and will face competition from both generic and branded pharmaceutical products. From January through June 1, 2018, the Company paid $1.6 million of principal payments due under its term loan facility with Oxford Finance LLC and Silicon Valley Bank. On June 4, 2018, the Company repaid in full the remaining outstanding balance of its facility loan of $4.2 million plus a final fee of $0.7 million Note 5). As of September 30, 2018, the Company’s cash, cash equivalents and marketable securities totaled $198.1 million. The Company believes these funds are sufficient to fund the Company’s current operating plan into 2021. 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 ongoing Phase 2b clinical trial activities in NASH, and most significantly, the timing and conduct of additional PBC development activities, including an ongoing Phase 2 clinical trial, a Phase 3 clinical trial, and other new drug application (NDA)-enabling studies. The Company has obtained and expects to obtain additional funding to develop its products and fund future operating losses, as appropriate, through equity offerings; debt financing; one or more possible licenses, collaborations or other similar arrangements with respect to development and/or commercialization rights of its product candidates; or a combination of the above. It is unclear if or when any such transactions will occur, on satisfactory terms or at all. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and its ability to pursue its business strategies. If adequate funds are not available to the Company, it could have a material adverse effect on the Company’s business, results of operations, and financial condition. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying interim condensed consolidated financial statements are unaudited and are comprised of CymaBay and its wholly-owned subsidiaries. These unaudited interim condensed consolidated 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. Certain reclassifications have been made to the prior period amounts to conform to the current year presentation. “Accrued clinical trial expenses” and “Other accrued liabilities”, which previously were reported as “Accrued liabilities” on the condensed balance sheet, are now reported as separate line items. Use of Estimates The condensed consolidated 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 consolidated 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, and warrant liabilities. Fair Value of Financial Instruments The Company’s financial instruments during the periods reported consist of cash and cash equivalents, marketable securities, accounts receivable, prepaid expenses, other current assets, accounts payable, accrued interest payable, accrued expenses, 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, accounts receivable, prepaid expenses, other current assets, accounts payable, accrued expenses, 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 at December 31, 2017, 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 inputs and maximizes the use of 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, 2018 Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 40,316 $ - $ - $ 40,316 Total cash equivalents 40,316 - - 40,316 Marketable securities: Commercial paper - 70,697 - 70,697 Corporate debt securities - 39,346 - 39,346 Asset-backed securities - 28,432 - 28,432 U.S. treasury securities - 17,875 - 17,875 Total short-term investments - 156,350 - 156,350 Total assets measured at fair value $ 40,316 $ 156,350 $ - $ 196,666 As of December 31, 2017 Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 12,822 $ - $ - $ 12,822 Commercial paper - 6,035 - 6,035 Total cash equivalents 12,822 6,035 - 18,857 Marketable securities: Commercial paper - 35,886 - 35,886 Corporate debt securities - 19,760 - 19,760 Asset-backed securities - 11,060 - 11,060 U.S. treasury securities - 7,450 - 7,450 Total short-term investments - 74,156 - 74,156 Total assets measured at fair value $ 12,822 $ 80,191 $ - $ 93,013 Warrant liability $ - $ - $ 6,091 $ 6,091 Total liabilities measured at fair value $ - $ - $ 6,091 $ 6,091 The Company estimates the fair value of its corporate debt, commercial paper, 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. Historically, the Company held 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 were accounted for as liabilities until their expiration in September 2018. The Company used a binomial option pricing model to value its warrant liabilities prior to September 2017. The inputs for the binomial model are similar to the Black-Scholes model but also incorporate other more complex inputs that, in the Company’s case, included the expected timing, probability and valuation impact of certain potential strategic events. In September 2017, 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, expected 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. 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 30, 2018 2017 Balance, beginning of period $ 6,091 $ 1,145 Change in fair value 3,710 4,996 Settlement of financial instruments (9,379 ) (279 ) Extinguishment of financial instruments (422 ) - Balance, end of period $ - $ 5,862 Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with a remaining maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest-bearing, demand money market accounts, corporate debt securities, and commercial paper. The Company invests excess cash in marketable securities with high credit ratings that are classified in Level 1 and 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.” The Company considers marketable securities as short-term investments if the maturity date is less than one year from the balance sheet date. The Company considers marketable securities as long-term investments if the maturity date is in excess of one year of the balance sheet date. 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 of the Company’s available for sale marketable securities (in thousands): Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of September 30, 2018: Commercial paper $ 70,697 $ - $ - $ 70,697 Corporate debt securities 39,364 2 (20 ) 39,346 Asset-backed securities 28,439 - (7 ) 28,432 U.S. treasury securities 17,881 - (6 ) 17,875 $ 156,381 $ 2 $ (33 ) $ 156,350 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2017: Commercial paper $ 35,886 $ - $ - $ 35,886 Corporate debt securities 19,785 - (25 ) 19,760 Asset-backed securities 11,070 - (10 ) 11,060 U.S. treasury securities 7,459 - (9 ) 7,450 $ 74,200 $ - $ (44 ) $ 74,156 Concentrations of Risk Cash, 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 sheet. 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 investments 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 an NDA filed with the 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. Leases The Company leases office space facilities under non-cancelable operating lease agreements and recognizes related rent expense on a straight-line basis over the term of the lease. Incentives granted under the Company’s facilities lease, including allowances for leasehold improvements and rent holidays, are recognized as reductions to rental expense on a straight-line basis over the term of the lease. Lessor funded leasehold improvement incentives not yet received are recorded in other current assets on the balance sheet. The Company does not assume renewals in its determination of the lease term unless they are deemed to be reasonably assured at the inception of the lease and begins recognizing rent expense on the date that it obtains the legal right to use and control the leased space. Deferred rent consists of the difference between cash payments and the rent expense recognized. Revenue Recognition At the inception of an arrangement, the Company evaluates if a counterparty to a contract is a customer, if the arrangement is within the scope of revenue from contracts with customers guidance, and the term of the contract. The Company recognizes revenue when its customer obtains control of promised goods or services in a contract for an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. For contracts with customers, the Company applies the following five-step model in order to determine this amount: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. As part of the accounting for contracts with customers, the Company must develop assumptions that require judgment to determine the standalone selling price of each performance obligation identified in the contract. The Company then allocates the total transaction price to each performance obligation based on the estimated standalone selling prices of each performance obligation. The Company recognizes the amount of the transaction price as revenue that is allocated to the respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon delivery. The Company enters into collaboration arrangements, under which it licenses certain rights to its intellectual property to third parties. The terms of these agreements may include payment to the Company of one or more of the following: nonrefundable, upfront license fees; development and commercial milestone payments; funding of research and/or development activities; and royalties on net sales of licensed products. Revenues that result from these payments are classified as collaborative revenues except for royalties on net sales of licensed products, which are classified as royalty revenues. For each collaboration agreement that results in revenues, the Company identifies all material promised goods and services, which may include one or more of the following: a license to intellectual property and know-how, research and development services, and other transition support services. Promised goods or services are considered to be separate performance obligations if they are distinct. To determine the transaction price to be allocated to each performance obligation, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue, deferred revenue, or other amounts will not occur in future reporting periods. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that increase the likelihood of a significant reversal of previously recognized revenue and revenue-related amounts in future reporting periods. These estimates are re-assessed each reporting period as necessary depending on the facts and circumstances of each contract. Once the estimated transaction price is established, amounts are allocated to identified performance obligations. The transaction price is generally allocated to each separate performance obligation on a relative standalone selling price (SSP) basis. The Company must develop assumptions that require judgment to determine the SSP to account for these agreements. To determine the SSP the Company’s assumptions may include (i) assumptions regarding the probability of obtaining marketing approval for the drug candidate, (ii) estimates regarding the timing of and the expected costs to develop and commercialize the drug candidate, (iii) estimates of future cash flows from potential product sales with respect to the drug candidate and (iv) appropriate discount and tax rates. SSPs used to perform the initial allocation are not updated after contract inception. The Company does not include a financing component to its estimated transaction price at contract inception unless it estimates that certain performance obligations will not be satisfied within one year. Upfront License Fees: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, upfront license fees based on the relative value prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the collaborator and the collaborator is able to use and benefit from the license. For licenses that are not distinct from other obligations identified in the arrangement, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Development and Regulatory Milestone Payments : Depending on facts and circumstances, the Company may conclude that it is appropriate to include the milestone in the estimated transaction price using the most likely amount method or that it is appropriate to fully constrain the milestone. A milestone payment is included in the transaction price in the reporting period that the Company concludes that it is probable that recording revenue in the period will not result in a significant reversal in amounts recognized in future periods. The Company may record revenues from certain milestones in a reporting period before the milestone is achieved if the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods. The Company records a corresponding contract asset when this conclusion is reached. Until that determination is made, milestone payments that have not been included in the transaction price to date are fully constrained. The Company re-evaluates the probability of achievement of such development milestones and any related constraint each reporting period. The Company adjusts its estimate of the overall transaction price, including the amount of collaborative revenue that it has recorded, if necessary. Sales-based Milestone and Royalty Payments: The Company’s collaborators may be required to pay the Company sales-based milestone payments or royalties on future sales of commercial products. The Company recognizes revenues related to sales-based milestone and royalty payments upon the later to occur of (i) achievement of the collaborator’s underlying sales or (ii) satisfaction of any performance obligation(s) related to these sales, in each case assuming the license to the Company’s intellectual property is deemed to be the predominant item to which the sales-based milestones and/or royalties relate. Common Stock Warrant Liability Historically, the Company’s outstanding common stock warrants issued in connection with certain equity and debt financings that occurred in 2013 through 2015 were classified as liabilities in the accompanying condensed consolidated balance sheets because of certain contractual terms that preclude equity classification. As of September 30, 2018, all outstanding warrants related to these financings had been exercised or had expired. Upon expiration, the remaining fair value of the liability was extinguished and credited to other income (expense), net in the Company’s condensed consolidated statement of operations. Prior to expiration, the Company estimated the fair value of common stock warrants at each reporting period until the exercise of the warrants, at which time the liability was revalued and reclassified to stockholders’ equity. The determination of fair value of these common stock warrants required management to make certain assumptions regarding subjective input variables such as timing, probability and valuation impact of certain potential strategic events, expected term, dividends, expected volatility and risk-free interest rates. 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 stock options with time-based vesting 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 are valued using the Black-Scholes option pricing model. Stock-based compensation expense for nonemployee services is subject to remeasurement at each reporting date as the underlying equity instruments vest and is recognized as an expense over the period during which services are received. 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 and actual exercise or expiration 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 stock options and incentive awards outstanding at the end of each period 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, 2018 2017 2018 2017 Numerator: Net loss allocated to common stock-basic $ (18,563 ) $ (8,234 ) $ (53,099 ) $ (22,514 ) Adjustments for revaluation and extinguishment of common stock warrants (1,462 ) - (422 ) - Net loss allocated to common stock-diluted $ (20,025 ) $ (8,234 ) $ (53,521 ) $ (22,514 ) Denominator: Weighted average number of common stock shares outstanding - basic 59,121,600 40,035,690 57,255,666 31,848,536 Dilutive securities: Common stock warrants 266,180 - 42,439 - Weighted average number of common stock shares outstanding - diluted 59,387,780 40,035,690 57,298,105 31,848,536 Net loss per share - basic: $ (0.31 ) $ (0.21 ) $ (0.93 ) $ (0.71 ) Net loss per share - diluted: $ (0.34 ) $ (0.21 ) $ (0.93 ) $ (0.71 ) 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, 2018 2017 2018 2017 Common stock warrants - 1,604 - 1,604 Common stock options 5,365 3,788 5,365 3,788 Performance-based stock options 205 305 205 305 Incentive awards 130 226 130 226 5,700 5,923 5,700 5,923 Recently Adopted Accounting Pronouncements Accounting Standards Update 2014-09 On January 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers Accounting Standards Update 2017-09 In May 2017, the Financial Accounting Standards Board (FASB) issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718) - Scope of Modification Accounting Accounting Standards Update 2016-15 In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230: Classification of Certain Cash Receipts and Cash Payments) Staff Accounting Bulletin No. 118 On December 22, 2017, the U.S. federal government enacted the Tax Cuts and Jobs Act (Tax Act). The Tax Act contains, among other things, significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21% for tax years beginning after December 31, 2017, limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks, implementing a territorial tax system, and requiring a mandatory one-time tax on U.S. owned undistributed foreign earnings and profits known as the transition tax. In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act Recently Issued Accounting Pronouncements SEC Securities Act Release No. 33-10532 In August 2018, the SEC adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, Disclosure Update and Simplification Accounting Standards Update 2018-13 In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Accounting Standards Update 2018-07 In June 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation – Accounting Standards Update 2016-02 and 2018-11 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The Company will adopt this standard on January 1, 2019 using the modified retrospective approach with a cumulative effect adjustment to accumulated deficit at the beginning of the period of adoption. The Company will also adopt certain practical expedients provided by ASU 2018-11. Management is in the process of inventorying and scoping the Company’s population of leased assets in order to assess the impact of Topic 842. Topic 842 is expected to impact the Company’s condensed consolidated financial statements as the Company has certain operating lease arrangements for which it is the lessee. The Company is currently evaluating the impact adoption of Topic 842 will have on its financial position and results of operations but anticipates the recognition of additional assets and corresponding liabilities on its condensed consolidated balance sheet related to leases. The adoption of this accounting standard update is also expected to impact the Company’s condensed consolidated financial statement disclosures. 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 |
Certain Balance Sheet Items
Certain Balance Sheet Items | 9 Months Ended |
Sep. 30, 2018 | |
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, 2018 2017 Accrued compensation $ 1,798 $ 2,416 Accrued professional fees 319 288 Deferred rent 257 13 Other 63 111 Total other accrued liabilities $ 2,437 $ 2,828 |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2018 | |
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. 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 upfront payment of $5.0 million upon contract execution. Kowa also agreed to pay the Company $5.0 million upon initiation of a study evaluating the pharmacokinetics of arhalofenate in subjects with renal impairment, which occurred during the quarter ended December 31, 2017 and payment was received in January 2018. An additional milestone payment of $5.0 million is due on initiation of a Phase 3 study of arhalofenate, and up to $190.0 million based upon the achievement of other specific development and sales milestones. The Company concluded that Kowa is a customer, and the contract is not subject to accounting literature on collaborative arrangements. This is because the Company granted to Kowa a license to its intellectual property and provided drug product and research and pre-clinical development services, all of which are outputs of the Company’s ongoing activities, in exchange for consideration. The Company identified the following three material promises under the license agreement: 1) the transfer of a license to intellectual property, inclusive of the related technology know-how conveyance and contract manufacturing rights and privileges (license and know-how); 2) the performance of specific ongoing research and non-clinical development services, and 3) the delivery of existing on hand arhalofenate clinical product. The Company’s participation on the JAC is not a performance obligation as the Company’s participation in the JAC is not required and is primarily for the Company’s benefit to obtain updates on the progress of Kowa’s activities. The Company provided to Kowa standard indemnification and protection of licensed intellectual property, which is part of assurance that the license meets the contract’s specifications and is not an obligation to provide goods or services. The Company concluded that the license and know-how, the research and development services, and delivery of arhalofenate product were separate performance obligations since each was identified as a material promise that was by itself distinct. The Company concluded that Kowa can benefit from the license and know-how on its own by developing and commercializing arhalofenate arhalofenate. The To allocate transaction price among the three performance obligations, the Company estimated its SSP. For the license and know-how, the SSP was estimated using the income approach based on assumptions regarding Kowa’s future revenues from the licensed intellectual property, projected costs of research and development, manufacturing and commercialization expenses, as well as the discount rate, the development timeline, and probabilities of technical and regulatory success. To estimate SSP of research and non-clinical development services and arhalofenate product on hand, the Company used a cost-plus margin approach. The Company believes that a change in the assumptions used to determine its best estimate of selling price for the performance obligations would not have a significant effect on the allocation of consideration received to the performance obligations. As of January 1, 2018, the transaction price was limited to $10.0 million, consisting of a $5.0 million upfront fee due upon contract initiation and a $5.0 million development milestone payment triggered when Kowa initiated a study evaluating the pharmacokinetics of arhalofenate in subjects with renal impairment. Of these amounts, the Company allocated $9.5 million to the license; $0.4 million to the arhalofenate product; and $0.1 million to the research and pre-clinical development services. As of January 1, 2018, all these performance obligations had been completed and the associated revenue had been recognized. The variable consideration related to the remaining development milestone payments has not been included in the transaction price as these milestones were fully constrained at September 30, 2018. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and Kowa’s efforts. Any variable consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Kowa. The Company re-evaluates the The Company expensed the incremental costs of obtaining the Kowa contract prior to December 31, 2017, as substantially all costs related to the performance obligations completed by that date. Revenue recognized during the three and nine months ended September 30, 2017 was determined in accordance with the accounting rules applicable prior to the adoption of ASC 606 on January 1, 2018. There was no difference in the revenue recognized under ASC 606 or legacy GAAP for the three and nine months ended September 30, 2018. There were no contract assets or deferred revenues (contract liabilities) recorded during the nine months ended September 30, 2018. Accounts receivable from the Kowa contract consisted of the following (in thousands): September 30, December 31, 2018 2017 Accounts receivable $ - $ 5,000 As of September 30, 2018, there were no amounts included in the transaction price and allocated to goods and services not yet provided. On October 24, 2018, the Company received a notice from Kowa terminating the license agreement for the development of arhalofenate. The termination will be effective on January 22, 2019. As a result of the termination, the rights licensed to Kowa through the agreement revert to the Company on the termination date and the Company is no longer eligible to receive additional milestone payments or royalties from Kowa. As of the time of the receipt of Kowa’s notice to terminate, all remaining variable consideration under the license agreement had been fully constrained and all performance obligations had been satisfied. 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 PPARδ compounds (the PPARδ Products) with Janssen Pharmaceutical NV (Janssen NV), with the right to grant sublicenses to third parties to make, use and sell such PPARδ Products. Janssen NV has a right of first negotiation under the agreement to license particular patents covering the PPARδ Product from the Company in the event that the Company elects to seek a third party corporate partner for the research, development, promotion, and/or commercialization of such PPARδ Products. Under the terms of the agreement Janssen NV is entitled to receive up to an 8% royalty on net sales of PPARδ Products. 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 Type 2 diabetes and other disorders. The Company received a termination notice from Janssen, effectively ending these development and licensing agreements in early April 2015. In December 2015, the Company exercised an option, and Janssen granted the Company an exclusive, worldwide license with rights to sublicense, pursuant to the terms of one of the original agreements to continue to develop compounds with activity against an undisclosed metabolic disease target. No amounts were incurred or accrued for this agreement as of and for the three and nine months ended September 30, 2018 and 2017. DiaTex, Inc. In June 1998, the Company entered into a license agreement with DiaTex, Inc. (DiaTex) relating to products containing halofenate, its enantiomers, derivatives, and analogs (the licensed products). The license agreement provides that DiaTex and the Company are joint owners of all the patents and patent applications covering the licensed products and methods of producing or using such compounds, as well as certain other know-how (the covered IP). As part of the license agreement, the Company received an exclusive worldwide license, including as to DiaTex, to use the covered IP to develop and commercialize the licensed products. The Company also retained the right to sub-license the covered IP. The license agreement contains |
Facility Loans
Facility Loans | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Facility Loans | 5. Facility Loans 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) whereby $5.0 million was drawn as part of the Company’s September 2013 financing, referred to herein as the 2013 Term Loan Facility. In connection with the 2013 Term Loan Facility, the Company also 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. On August 7, 2015, the Company entered into a Loan and Security Agreement, pursuant to which the Company refinanced its existing 2013 Term Loan Facility with Oxford Finance LLC and Silicon Valley Bank, and borrowed an aggregate of $10.0 million, of which $5.9 million was outstanding on December 31, 2017. In connection with this 2015 Term Loan Facility, 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. On June 4, 2018, the Company repaid in full the outstanding balance of the 2015 Term Loan Facility of $4.2 million plus a final fee of $0.7 million and a prepayment penalty of $0.1 million. In conjunction with this prepayment, the Company recorded a $0.4 million loss on early of extinguishment of this debt. As of September 30, 2018, the Company had no further obligations under the 2015 Term Loan Facility and all warrants previously issued in connection with it had been exercised. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
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 January 15, 2019. On April 16, 2018, the Company entered into an amended lease to extend the term of its original lease by five years to January 15, 2024 and relocate and expand its office space within the same office park in Newark, California to approximately 18,000 square feet. The lease agreement includes an escalation clause for increased rent and a renewal provision allowing the Company to extend this lease for an additional five years by giving the landlord written notice of the election to exercise the option prior to the amended expiration date of January 15, 2024. The lease agreement also requires the lessor to fund and complete the construction of certain tenant improvements. The Company estimated the value of this tenant improvement allowance at $2.1 million and recorded it as deferred rent liability and other current assets on the balance sheet at September 30, 2018. It will be reclassified to leasehold improvements within property and equipment when realized, and depreciated over the remaining lease term. Rent expense was $0.1 million for the three months ended September 30, 2018 and 2017, respectively, and $0.3 million for the nine months ended September 30, 2018 and 2017, respectively. Future minimum lease payments are as follows (in thousands): Lease Payments 2018 (from October to December) $ 57 2019 627 2020 645 2021 664 2022 and beyond 1,390 Total future minimum payments $ 3,383 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity As of September 30, 2018, and December 31, 2017, the Company had reserved shares of authorized but unissued common stock as follows: September 30, December 31, 2018 2017 Common stock warrants - 1,460,955 Equity incentive plans 7,008,933 4,021,983 Total reserved shares of common stock 7,008,933 5,482,938 On February 1, 2018, pursuant to a |
Stock Plans and Stock-Based Com
Stock Plans and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Plans and Stock-Based Compensation | 8. Stock Plans and Stock-Based Compensation Stock Plans On January 1, 2018, the share reserve of the Company’s 2013 Equity Incentive Plan (2013 Plan), automatically increased by 2,220,439 shares. During the nine months ended September 30, 2018, the Company granted options to purchase 2,021,272 shares of its common stock to its employees, directors and a consultant. On June 5, 2018, the Company’s stockholders approved a 1,500,000 share increase in the number of shares to be reserved under the 2013 Plan. As of September 30, 2018, there were 1,309,403 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, 2018 2017 2018 2017 Research and development $ 741 $ 325 $ 2,045 $ 953 General and administrative 987 495 3,230 2,985 Total $ 1,728 $ 820 $ 5,275 $ 3,938 |
Related-Party Transactions
Related-Party Transactions | 9 Months Ended |
Sep. 30, 2018 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 9. Related-Party Transactions The Company paid a former member of its Board of Directors, who is also a member of its Scientific and Clinical Advisory Board, a total of $15,000 for the three months and $45,000 for the nine months ended September 30, 2018 and 2017, respectively, in monthly cash retainers. |
Organization and Description _2
Organization and Description of Business (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
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, 2018, the Company incurred a net loss of $53.1 million and used $35.3 million of cash in operations. At September 30, 2018, the Company had an accumulated deficit of $503.6 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 additional product candidates, continue clinical trials for product candidates currently in clinical development, obtain regulatory approvals, and support commercialization activities for partnered product candidates. Products developed by the Company will require approval of the U.S. Food and Drug Administration (FDA) or a foreign regulatory authority prior to commercial sale. The regulatory approval process is expensive, time-consuming, and uncertain, and any denial or delay of approval could have a material adverse effect on the Company. Even if approved, the Company’s products may not achieve market acceptance and will face competition from both generic and branded pharmaceutical products. From January through June 1, 2018, the Company paid $1.6 million of principal payments due under its term loan facility with Oxford Finance LLC and Silicon Valley Bank. On June 4, 2018, the Company repaid in full the remaining outstanding balance of its facility loan of $4.2 million plus a final fee of $0.7 million Note 5). As of September 30, 2018, the Company’s cash, cash equivalents and marketable securities totaled $198.1 million. The Company believes these funds are sufficient to fund the Company’s current operating plan into 2021. 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 ongoing Phase 2b clinical trial activities in NASH, and most significantly, the timing and conduct of additional PBC development activities, including an ongoing Phase 2 clinical trial, a Phase 3 clinical trial, and other new drug application (NDA)-enabling studies. The Company has obtained and expects to obtain additional funding to develop its products and fund future operating losses, as appropriate, through equity offerings; debt financing; one or more possible licenses, collaborations or other similar arrangements with respect to development and/or commercialization rights of its product candidates; or a combination of the above. It is unclear if or when any such transactions will occur, on satisfactory terms or at all. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and its ability to pursue its business strategies. If adequate funds are not available to the Company, it could have a material adverse effect on the Company’s business, results of operations, and financial condition. |
Basis of Presentation | Basis of Presentation The accompanying interim condensed consolidated financial statements are unaudited and are comprised of CymaBay and its wholly-owned subsidiaries. These unaudited interim condensed consolidated 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. Certain reclassifications have been made to the prior period amounts to conform to the current year presentation. “Accrued clinical trial expenses” and “Other accrued liabilities”, which previously were reported as “Accrued liabilities” on the condensed balance sheet, are now reported as separate line items. |
Use of Estimates | Use of Estimates The condensed consolidated 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 consolidated 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, and warrant liabilities. |
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, accounts receivable, prepaid expenses, other current assets, accounts payable, accrued interest payable, accrued expenses, 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, accounts receivable, prepaid expenses, other current assets, accounts payable, accrued expenses, 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 at December 31, 2017, 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 inputs and maximizes the use of 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, 2018 Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 40,316 $ - $ - $ 40,316 Total cash equivalents 40,316 - - 40,316 Marketable securities: Commercial paper - 70,697 - 70,697 Corporate debt securities - 39,346 - 39,346 Asset-backed securities - 28,432 - 28,432 U.S. treasury securities - 17,875 - 17,875 Total short-term investments - 156,350 - 156,350 Total assets measured at fair value $ 40,316 $ 156,350 $ - $ 196,666 As of December 31, 2017 Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 12,822 $ - $ - $ 12,822 Commercial paper - 6,035 - 6,035 Total cash equivalents 12,822 6,035 - 18,857 Marketable securities: Commercial paper - 35,886 - 35,886 Corporate debt securities - 19,760 - 19,760 Asset-backed securities - 11,060 - 11,060 U.S. treasury securities - 7,450 - 7,450 Total short-term investments - 74,156 - 74,156 Total assets measured at fair value $ 12,822 $ 80,191 $ - $ 93,013 Warrant liability $ - $ - $ 6,091 $ 6,091 Total liabilities measured at fair value $ - $ - $ 6,091 $ 6,091 The Company estimates the fair value of its corporate debt, commercial paper, 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. Historically, the Company held 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 were accounted for as liabilities until their expiration in September 2018. The Company used a binomial option pricing model to value its warrant liabilities prior to September 2017. The inputs for the binomial model are similar to the Black-Scholes model but also incorporate other more complex inputs that, in the Company’s case, included the expected timing, probability and valuation impact of certain potential strategic events. In September 2017, 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, expected 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. 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 30, 2018 2017 Balance, beginning of period $ 6,091 $ 1,145 Change in fair value 3,710 4,996 Settlement of financial instruments (9,379 ) (279 ) Extinguishment of financial instruments (422 ) - Balance, end of period $ - $ 5,862 |
Cash Equivalents and Marketable Securities | Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with a remaining maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest-bearing, demand money market accounts, corporate debt securities, and commercial paper. The Company invests excess cash in marketable securities with high credit ratings that are classified in Level 1 and 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.” The Company considers marketable securities as short-term investments if the maturity date is less than one year from the balance sheet date. The Company considers marketable securities as long-term investments if the maturity date is in excess of one year of the balance sheet date. 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 of the Company’s available for sale marketable securities (in thousands): Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of September 30, 2018: Commercial paper $ 70,697 $ - $ - $ 70,697 Corporate debt securities 39,364 2 (20 ) 39,346 Asset-backed securities 28,439 - (7 ) 28,432 U.S. treasury securities 17,881 - (6 ) 17,875 $ 156,381 $ 2 $ (33 ) $ 156,350 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2017: Commercial paper $ 35,886 $ - $ - $ 35,886 Corporate debt securities 19,785 - (25 ) 19,760 Asset-backed securities 11,070 - (10 ) 11,060 U.S. treasury securities 7,459 - (9 ) 7,450 $ 74,200 $ - $ (44 ) $ 74,156 |
Concentrations of Risk | Concentrations of Risk Cash, 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 sheet. 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 investments 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 an NDA filed with the 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. |
Leases | Leases The Company leases office space facilities under non-cancelable operating lease agreements and recognizes related rent expense on a straight-line basis over the term of the lease. Incentives granted under the Company’s facilities lease, including allowances for leasehold improvements and rent holidays, are recognized as reductions to rental expense on a straight-line basis over the term of the lease. Lessor funded leasehold improvement incentives not yet received are recorded in other current assets on the balance sheet. The Company does not assume renewals in its determination of the lease term unless they are deemed to be reasonably assured at the inception of the lease and begins recognizing rent expense on the date that it obtains the legal right to use and control the leased space. Deferred rent consists of the difference between cash payments and the rent expense recognized. |
Revenue Recognition | Revenue Recognition At the inception of an arrangement, the Company evaluates if a counterparty to a contract is a customer, if the arrangement is within the scope of revenue from contracts with customers guidance, and the term of the contract. The Company recognizes revenue when its customer obtains control of promised goods or services in a contract for an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. For contracts with customers, the Company applies the following five-step model in order to determine this amount: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. As part of the accounting for contracts with customers, the Company must develop assumptions that require judgment to determine the standalone selling price of each performance obligation identified in the contract. The Company then allocates the total transaction price to each performance obligation based on the estimated standalone selling prices of each performance obligation. The Company recognizes the amount of the transaction price as revenue that is allocated to the respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon delivery. The Company enters into collaboration arrangements, under which it licenses certain rights to its intellectual property to third parties. The terms of these agreements may include payment to the Company of one or more of the following: nonrefundable, upfront license fees; development and commercial milestone payments; funding of research and/or development activities; and royalties on net sales of licensed products. Revenues that result from these payments are classified as collaborative revenues except for royalties on net sales of licensed products, which are classified as royalty revenues. For each collaboration agreement that results in revenues, the Company identifies all material promised goods and services, which may include one or more of the following: a license to intellectual property and know-how, research and development services, and other transition support services. Promised goods or services are considered to be separate performance obligations if they are distinct. To determine the transaction price to be allocated to each performance obligation, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue, deferred revenue, or other amounts will not occur in future reporting periods. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that increase the likelihood of a significant reversal of previously recognized revenue and revenue-related amounts in future reporting periods. These estimates are re-assessed each reporting period as necessary depending on the facts and circumstances of each contract. Once the estimated transaction price is established, amounts are allocated to identified performance obligations. The transaction price is generally allocated to each separate performance obligation on a relative standalone selling price (SSP) basis. The Company must develop assumptions that require judgment to determine the SSP to account for these agreements. To determine the SSP the Company’s assumptions may include (i) assumptions regarding the probability of obtaining marketing approval for the drug candidate, (ii) estimates regarding the timing of and the expected costs to develop and commercialize the drug candidate, (iii) estimates of future cash flows from potential product sales with respect to the drug candidate and (iv) appropriate discount and tax rates. SSPs used to perform the initial allocation are not updated after contract inception. The Company does not include a financing component to its estimated transaction price at contract inception unless it estimates that certain performance obligations will not be satisfied within one year. Upfront License Fees: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, upfront license fees based on the relative value prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the collaborator and the collaborator is able to use and benefit from the license. For licenses that are not distinct from other obligations identified in the arrangement, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Development and Regulatory Milestone Payments : Depending on facts and circumstances, the Company may conclude that it is appropriate to include the milestone in the estimated transaction price using the most likely amount method or that it is appropriate to fully constrain the milestone. A milestone payment is included in the transaction price in the reporting period that the Company concludes that it is probable that recording revenue in the period will not result in a significant reversal in amounts recognized in future periods. The Company may record revenues from certain milestones in a reporting period before the milestone is achieved if the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods. The Company records a corresponding contract asset when this conclusion is reached. Until that determination is made, milestone payments that have not been included in the transaction price to date are fully constrained. The Company re-evaluates the probability of achievement of such development milestones and any related constraint each reporting period. The Company adjusts its estimate of the overall transaction price, including the amount of collaborative revenue that it has recorded, if necessary. Sales-based Milestone and Royalty Payments: The Company’s collaborators may be required to pay the Company sales-based milestone payments or royalties on future sales of commercial products. The Company recognizes revenues related to sales-based milestone and royalty payments upon the later to occur of (i) achievement of the collaborator’s underlying sales or (ii) satisfaction of any performance obligation(s) related to these sales, in each case assuming the license to the Company’s intellectual property is deemed to be the predominant item to which the sales-based milestones and/or royalties relate. |
Common Stock Warrant Liability | Common Stock Warrant Liability Historically, the Company’s outstanding common stock warrants issued in connection with certain equity and debt financings that occurred in 2013 through 2015 were classified as liabilities in the accompanying condensed consolidated balance sheets because of certain contractual terms that preclude equity classification. As of September 30, 2018, all outstanding warrants related to these financings had been exercised or had expired. Upon expiration, the remaining fair value of the liability was extinguished and credited to other income (expense), net in the Company’s condensed consolidated statement of operations. Prior to expiration, the Company estimated the fair value of common stock warrants at each reporting period until the exercise of the warrants, at which time the liability was revalued and reclassified to stockholders’ equity. The determination of fair value of these common stock warrants required management to make certain assumptions regarding subjective input variables such as timing, probability and valuation impact of certain potential strategic events, expected term, dividends, expected volatility and risk-free interest rates. |
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 stock options with time-based vesting 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 are valued using the Black-Scholes option pricing model. Stock-based compensation expense for nonemployee services is subject to remeasurement at each reporting date as the underlying equity instruments vest and is recognized as an expense over the period during which services are received. |
Net Income (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 and actual exercise or expiration 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 stock options and incentive awards outstanding at the end of each period 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, 2018 2017 2018 2017 Numerator: Net loss allocated to common stock-basic $ (18,563 ) $ (8,234 ) $ (53,099 ) $ (22,514 ) Adjustments for revaluation and extinguishment of common stock warrants (1,462 ) - (422 ) - Net loss allocated to common stock-diluted $ (20,025 ) $ (8,234 ) $ (53,521 ) $ (22,514 ) Denominator: Weighted average number of common stock shares outstanding - basic 59,121,600 40,035,690 57,255,666 31,848,536 Dilutive securities: Common stock warrants 266,180 - 42,439 - Weighted average number of common stock shares outstanding - diluted 59,387,780 40,035,690 57,298,105 31,848,536 Net loss per share - basic: $ (0.31 ) $ (0.21 ) $ (0.93 ) $ (0.71 ) Net loss per share - diluted: $ (0.34 ) $ (0.21 ) $ (0.93 ) $ (0.71 ) 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, 2018 2017 2018 2017 Common stock warrants - 1,604 - 1,604 Common stock options 5,365 3,788 5,365 3,788 Performance-based stock options 205 305 205 305 Incentive awards 130 226 130 226 5,700 5,923 5,700 5,923 |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements Accounting Standards Update 2014-09 On January 1, 2018, the Company adopted ASU No. 2014-09, Revenue from Contracts with Customers Accounting Standards Update 2017-09 In May 2017, the Financial Accounting Standards Board (FASB) issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718) - Scope of Modification Accounting Accounting Standards Update 2016-15 In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230: Classification of Certain Cash Receipts and Cash Payments) Staff Accounting Bulletin No. 118 On December 22, 2017, the U.S. federal government enacted the Tax Cuts and Jobs Act (Tax Act). The Tax Act contains, among other things, significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21% for tax years beginning after December 31, 2017, limitation of the deduction for net operating losses to 80% of current year taxable income and elimination of net operating loss carrybacks, implementing a territorial tax system, and requiring a mandatory one-time tax on U.S. owned undistributed foreign earnings and profits known as the transition tax. In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act Recently Issued Accounting Pronouncements SEC Securities Act Release No. 33-10532 In August 2018, the SEC adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, Disclosure Update and Simplification Accounting Standards Update 2018-13 In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Accounting Standards Update 2018-07 In June 2018, the FASB issued ASU 2018-07, Compensation – Stock Compensation – Accounting Standards Update 2016-02 and 2018-11 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The Company will adopt this standard on January 1, 2019 using the modified retrospective approach with a cumulative effect adjustment to accumulated deficit at the beginning of the period of adoption. The Company will also adopt certain practical expedients provided by ASU 2018-11. Management is in the process of inventorying and scoping the Company’s population of leased assets in order to assess the impact of Topic 842. Topic 842 is expected to impact the Company’s condensed consolidated financial statements as the Company has certain operating lease arrangements for which it is the lessee. The Company is currently evaluating the impact adoption of Topic 842 will have on its financial position and results of operations but anticipates the recognition of additional assets and corresponding liabilities on its condensed consolidated balance sheet related to leases. The adoption of this accounting standard update is also expected to impact the Company’s condensed consolidated financial statement disclosures. 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 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Fair Value Assets and Liabilities Measured on Recurring Basis | 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, 2018 Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 40,316 $ - $ - $ 40,316 Total cash equivalents 40,316 - - 40,316 Marketable securities: Commercial paper - 70,697 - 70,697 Corporate debt securities - 39,346 - 39,346 Asset-backed securities - 28,432 - 28,432 U.S. treasury securities - 17,875 - 17,875 Total short-term investments - 156,350 - 156,350 Total assets measured at fair value $ 40,316 $ 156,350 $ - $ 196,666 As of December 31, 2017 Level 1 Level 2 Level 3 Fair Value Cash equivalents: Money market funds $ 12,822 $ - $ - $ 12,822 Commercial paper - 6,035 - 6,035 Total cash equivalents 12,822 6,035 - 18,857 Marketable securities: Commercial paper - 35,886 - 35,886 Corporate debt securities - 19,760 - 19,760 Asset-backed securities - 11,060 - 11,060 U.S. treasury securities - 7,450 - 7,450 Total short-term investments - 74,156 - 74,156 Total assets measured at fair value $ 12,822 $ 80,191 $ - $ 93,013 Warrant liability $ - $ - $ 6,091 $ 6,091 Total liabilities measured at fair value $ - $ - $ 6,091 $ 6,091 |
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 30, 2018 2017 Balance, beginning of period $ 6,091 $ 1,145 Change in fair value 3,710 4,996 Settlement of financial instruments (9,379 ) (279 ) Extinguishment of financial instruments (422 ) - Balance, end of period $ - $ 5,862 |
Schedule of Amortized Cost, Unrealized Gain and Loss, and Fair Value of Available for Sale Marketable Securities | The following tables summarize amortized cost, unrealized gain and loss, and fair value of the Company’s available for sale marketable securities (in thousands): Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of September 30, 2018: Commercial paper $ 70,697 $ - $ - $ 70,697 Corporate debt securities 39,364 2 (20 ) 39,346 Asset-backed securities 28,439 - (7 ) 28,432 U.S. treasury securities 17,881 - (6 ) 17,875 $ 156,381 $ 2 $ (33 ) $ 156,350 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2017: Commercial paper $ 35,886 $ - $ - $ 35,886 Corporate debt securities 19,785 - (25 ) 19,760 Asset-backed securities 11,070 - (10 ) 11,060 U.S. treasury securities 7,459 - (9 ) 7,450 $ 74,200 $ - $ (44 ) $ 74,156 |
Computation of Basic and Diluted Net Loss per Share | In all periods presented, the Company’s stock options and incentive awards outstanding at the end of each period 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, 2018 2017 2018 2017 Numerator: Net loss allocated to common stock-basic $ (18,563 ) $ (8,234 ) $ (53,099 ) $ (22,514 ) Adjustments for revaluation and extinguishment of common stock warrants (1,462 ) - (422 ) - Net loss allocated to common stock-diluted $ (20,025 ) $ (8,234 ) $ (53,521 ) $ (22,514 ) Denominator: Weighted average number of common stock shares outstanding - basic 59,121,600 40,035,690 57,255,666 31,848,536 Dilutive securities: Common stock warrants 266,180 - 42,439 - Weighted average number of common stock shares outstanding - diluted 59,387,780 40,035,690 57,298,105 31,848,536 Net loss per share - basic: $ (0.31 ) $ (0.21 ) $ (0.93 ) $ (0.71 ) Net loss per share - diluted: $ (0.34 ) $ (0.21 ) $ (0.93 ) $ (0.71 ) |
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, 2018 2017 2018 2017 Common stock warrants - 1,604 - 1,604 Common stock options 5,365 3,788 5,365 3,788 Performance-based stock options 205 305 205 305 Incentive awards 130 226 130 226 5,700 5,923 5,700 5,923 |
Certain Balance Sheet Items (Ta
Certain Balance Sheet Items (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Accrued Liabilities | The following table shows certain balance sheet items (in thousands): September 30, December 31, 2018 2017 Accrued compensation $ 1,798 $ 2,416 Accrued professional fees 319 288 Deferred rent 257 13 Other 63 111 Total other accrued liabilities $ 2,437 $ 2,828 |
Collaboration and License Agr_2
Collaboration and License Agreements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Revenue From Contract With Customer [Abstract] | |
Accounts Receivable from the Kowa Contract | There were no contract assets or deferred revenues (contract liabilities) recorded during the nine months ended September 30, 2018. Accounts receivable from the Kowa contract consisted of the following (in thousands): September 30, December 31, 2018 2017 Accounts receivable $ - $ 5,000 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments | Future minimum lease payments are as follows (in thousands): Lease Payments 2018 (from October to December) $ 57 2019 627 2020 645 2021 664 2022 and beyond 1,390 Total future minimum payments $ 3,383 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Reserved Shares of Authorized but Unissued Common Stock | As of September 30, 2018, and December 31, 2017, the Company had reserved shares of authorized but unissued common stock as follows: September 30, December 31, 2018 2017 Common stock warrants - 1,460,955 Equity incentive plans 7,008,933 4,021,983 Total reserved shares of common stock 7,008,933 5,482,938 |
Stock Plans and Stock-Based C_2
Stock Plans and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased 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, 2018 2017 2018 2017 Research and development $ 741 $ 325 $ 2,045 $ 953 General and administrative 987 495 3,230 2,985 Total $ 1,728 $ 820 $ 5,275 $ 3,938 |
Organization and Description _3
Organization and Description of Business - Additional Information (Detail) $ in Thousands | Jun. 04, 2018USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Jun. 01, 2018USD ($) | Sep. 30, 2018USD ($)Segment | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) |
Organization And Description Of Business [Line Items] | |||||||
Number of operating segments | Segment | 1 | ||||||
Net loss | $ (18,563) | $ (8,234) | $ (53,099) | $ (22,514) | |||
Cash flows from operating activities | (35,341) | (13,560) | |||||
Accumulated deficit | (503,615) | (503,615) | $ (450,516) | ||||
Repayment of facility loan | 6,527 | $ 2,327 | |||||
Cash and cash equivalents and marketable securities | $ 198,100 | $ 198,100 | |||||
2015 Term Loan Facility [Member] | |||||||
Organization And Description Of Business [Line Items] | |||||||
Principal payments | $ 1,600 | ||||||
Repayment of facility loan | $ 4,200 | ||||||
Facility loan, final fee | $ 700 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Schedule of Fair Value Assets and Liabilities Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | $ 196,666 | $ 93,013 |
Total liabilities measured at fair value | 6,091 | |
Warrant Liability [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total liabilities measured at fair value | 6,091 | |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 40,316 | 12,822 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 156,350 | 80,191 |
Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total liabilities measured at fair value | 6,091 | |
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 | 6,091 | |
Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 40,316 | 18,857 |
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 | 40,316 | 12,822 |
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 | 6,035 | |
Cash Equivalents [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 40,316 | 12,822 |
Cash Equivalents [Member] | Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 40,316 | 12,822 |
Cash Equivalents [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 6,035 | |
Cash Equivalents [Member] | Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 6,035 | |
Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 156,350 | 74,156 |
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 | 70,697 | 35,886 |
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 | 39,346 | 19,760 |
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 | 28,432 | 11,060 |
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 | 17,875 | 7,450 |
Short-term Investments [Member] | Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 156,350 | 74,156 |
Short-term Investments [Member] | Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 70,697 | 35,886 |
Short-term Investments [Member] | Level 2 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 39,346 | 19,760 |
Short-term Investments [Member] | Level 2 [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 28,432 | 11,060 |
Short-term Investments [Member] | Level 2 [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 | $ 17,875 | $ 7,450 |
Summary of Significant Accoun_4
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, 2018 | Sep. 30, 2017 | |
Fair Value, Instruments Classified in Shareholders' Equity Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning of period | $ 6,091 | $ 1,145 |
Change in fair value | 3,710 | 4,996 |
Settlement of financial instruments | (9,379) | (279) |
Extinguishment of financial instruments | $ (422) | |
Balance, end of period | $ 5,862 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Product Information [Line Items] | ||
Cash and cash equivalents, maturity description | 90 days or less | |
US federal corporate tax rate | 21.00% | 35.00% |
Limitation of the deduction for net operating losses | 80.00% | |
Provisional amounts measurement period | 1 year | |
Maximum [Member] | ||
Product Information [Line Items] | ||
Short-term contractual maturities | 1 year | |
Minimum [Member] | ||
Product Information [Line Items] | ||
Long-term contractual maturities | 1 year |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Amortized Cost, Unrealized Gain and Loss, and Fair Value of Available for Sale Marketable Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 156,381 | $ 74,200 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (33) | (44) |
Estimated Fair Value | 156,350 | 74,156 |
Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 70,697 | 35,886 |
Estimated Fair Value | 70,697 | 35,886 |
Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 39,364 | 19,785 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (20) | (25) |
Estimated Fair Value | 39,346 | 19,760 |
Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 28,439 | 11,070 |
Gross Unrealized Losses | (7) | (10) |
Estimated Fair Value | 28,432 | 11,060 |
US Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Amortized Cost | 17,881 | 7,459 |
Gross Unrealized Losses | (6) | (9) |
Estimated Fair Value | $ 17,875 | $ 7,450 |
Summary of Significant Accoun_7
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, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Numerator: | ||||
Net loss allocated to common stock-basic | $ (18,563) | $ (8,234) | $ (53,099) | $ (22,514) |
Adjustments for revaluation and extinguishment of common stock warrants | (1,462) | (422) | ||
Net loss allocated to common stock-diluted | $ (20,025) | $ (8,234) | $ (53,521) | $ (22,514) |
Denominator: | ||||
Weighted average number of common stock shares outstanding - basic | 59,121,600 | 40,035,690 | 57,255,666 | 31,848,536 |
Dilutive securities: | ||||
Common stock warrants | 266,180 | 42,439 | ||
Weighted average number of common stock shares outstanding - diluted | 59,387,780 | 40,035,690 | 57,298,105 | 31,848,536 |
Net loss per share - basic: | $ (0.31) | $ (0.21) | $ (0.93) | $ (0.71) |
Net loss per share - diluted: | $ (0.34) | $ (0.21) | $ (0.93) | $ (0.71) |
Summary of Significant Accoun_8
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, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the computation of diluted loss per share | 5,700 | 5,923 | 5,700 | 5,923 |
Common Stock 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 | 1,604 | ||
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 | 5,365 | 3,788 | 5,365 | 3,788 |
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 | 205 | 305 | 205 | 305 |
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 | 130 | 226 | 130 | 226 |
Certain Balance Sheet Items - A
Certain Balance Sheet Items - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Accrued compensation | $ 1,798 | $ 2,416 |
Accrued professional fees | 319 | 288 |
Deferred rent | 257 | 13 |
Other | 63 | 111 |
Total other accrued liabilities | $ 2,437 | $ 2,828 |
Collaboration and License Agr_3
Collaboration and License Agreements - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
Jun. 30, 2010Agreement | Jun. 30, 2006 | Sep. 30, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Jan. 01, 2018USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Transaction price allocated to performance obligations | $ 10,000,000 | |||||||
Contract assets | $ 0 | $ 0 | ||||||
Contract liabilities | 0 | 0 | ||||||
Contract Initiation [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Transaction price allocated to performance obligations | 5,000,000 | |||||||
License [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Transaction price allocated to performance obligations | 9,500,000 | |||||||
Arhalofenate Product [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Transaction price allocated to performance obligations | 400,000 | |||||||
Research and Pre Clinical Development Services [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Transaction price allocated to performance obligations | 100,000 | |||||||
Pharmacokinetics of Arhalofenate [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Transaction price allocated to performance obligations | $ 5,000,000 | |||||||
Kowa Pharmaceuticals America Inc [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Non-refundable upfront payment | $ 5,000,000 | |||||||
Kowa Pharmaceuticals America Inc [Member] | Pharmacokinetics of Arhalofenate [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Milestone payments | 5,000,000 | |||||||
Kowa Pharmaceuticals America Inc [Member] | Phase 3 Study [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Milestone payments | 5,000,000 | |||||||
Kowa Pharmaceuticals America Inc [Member] | Achievement of Other Specific Development and Sales [Member] | Maximum [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Milestone payments | $ 190,000,000 | |||||||
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 | |||||||
Royalty payment | 0 | $ 0 | 0 | $ 0 | ||||
Accrued royalties | 0 | 0 | 0 | 0 | ||||
DiaTex, Inc. [Member] | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Royalty payment | 0 | 0 | 0 | 0 | ||||
Development payment | $ 0 | $ 0 | $ 0 | $ 0 |
Collaboration and License Agr_4
Collaboration and License Agreements - Accounts Receivable from the Kowa Contract (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Accounts receivable | $ 5,000 |
Kowa Pharmaceuticals America Inc [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Accounts receivable | $ 5,000 |
Facility Loans - Additional Inf
Facility Loans - Additional Information (Detail) - USD ($) | Jun. 04, 2018 | Sep. 30, 2013 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Aug. 07, 2015 |
Debt Instrument [Line Items] | ||||||
Facility loan, less current portion | $ 2,990,000 | |||||
Repayment of facility loan | $ 6,527,000 | $ 2,327,000 | ||||
Loss on extinguishment of debt | $ 407,000 | |||||
2013 Term Loan Facility [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Facility loan, drawn | $ 5,000,000 | |||||
2013 Term Loan Facility [Member] | 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 | |||||
2015 Term Loan Facility [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Issued warrants to purchase common stock | 114,436 | |||||
Exercise price of common stock | $ 2.84 | |||||
Warrant term | 10 years | |||||
Maximum borrowing capacity | $ 10,000,000 | |||||
Facility loan, less current portion | $ 0 | $ 5,900,000 | ||||
Repayment of facility loan | $ 4,200,000 | |||||
Facility loan, final fee | 700,000 | |||||
Prepayment penalty | 100,000 | |||||
Loss on extinguishment of debt | $ 400,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | Apr. 16, 2018USD ($)ft² | Nov. 08, 2013ft² | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) |
Loss Contingencies [Line Items] | ||||||
Lease expiration date | Jan. 15, 2024 | |||||
Lease term, option to renew period | 5 years | |||||
Area of office space to be expanded | ft² | 18,000 | |||||
Accretion of tenant improvement allowance | $ | $ 2,100 | $ 154 | ||||
Rent expenses | $ | $ 100 | $ 100 | $ 300 | $ 300 | ||
Lease Facility [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Area of office space | ft² | 8,894 | |||||
Lease start date | Jan. 16, 2014 | |||||
Lease expiration date | Jan. 15, 2019 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Lease Payments (Detail) $ in Thousands | Sep. 30, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2018 (from October to December) | $ 57 |
2,019 | 627 |
2,020 | 645 |
2,021 | 664 |
2022 and beyond | 1,390 |
Total future minimum payments | $ 3,383 |
Stockholder's Equity - Reserved
Stockholder's Equity - Reserved Shares of Authorized but Unissued Common Stock (Detail) - shares | Sep. 30, 2018 | Dec. 31, 2017 |
Class of Stock [Line Items] | ||
Total reserved shares of common stock | 7,008,933 | 5,482,938 |
Common Stock Warrants [Member] | ||
Class of Stock [Line Items] | ||
Total reserved shares of common stock | 1,460,955 | |
Equity Incentive Plans [Member] | ||
Class of Stock [Line Items] | ||
Total reserved shares of common stock | 7,008,933 | 4,021,983 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Feb. 01, 2018 | Sep. 30, 2018 | Dec. 31, 2017 |
Equity [Abstract] | |||
Common stock, shares issued | 13,340,000 | 59,439,130 | 44,408,796 |
Common stock offering price | $ 10.80 | ||
Net proceeds from public offering | $ 135.5 |
Stock Plans and Stock-Based C_3
Stock Plans and Stock-Based Compensation - Additional Information (Detail) - 2013 Equity Incentive Plan [Member] - shares | Jun. 05, 2018 | Jan. 01, 2018 | Sep. 30, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Increase in shares reserved for issuance | 1,500,000 | 2,220,439 | |
Shares available for grant | 1,309,403 | ||
Employees, Directors and Consultant [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options to purchase common stock granted | 2,021,272 |
Stock Plans and Stock-Based C_4
Stock Plans and Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 1,728 | $ 820 | $ 5,275 | $ 3,938 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 741 | 325 | 2,045 | 953 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 987 | $ 495 | $ 3,230 | $ 2,985 |
Related-Party Transactions - Ad
Related-Party Transactions - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Former Member of Board of Directors [Member] | ||||
Related Party Transaction [Line Items] | ||||
Advisory fee paid to related party | $ 15,000 | $ 15,000 | $ 45,000 | $ 45,000 |