Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Oct. 31, 2019 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | CBAY | |
Entity Registrant Name | CYMABAY THERAPEUTICS, INC. | |
Entity Central Index Key | 0001042074 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 68,701,043 | |
Entity Shell Company | false | |
Entity File Number | 001-36500 | |
Entity Tax Identification Number | 94-3103561 | |
Entity Address, Address Line One | 7575 Gateway Blvd | |
Entity Address, Address Line Two | Suite 110 | |
Entity Address, City or Town | Newark | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94560 | |
City Area Code | 510 | |
Local Phone Number | 293-8800 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common stock, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 43,462 | $ 48,995 |
Marketable securities | 175,132 | 129,669 |
Accrued interest receivable | 509 | 304 |
Prepaid research and development expenses | 7,900 | 1,670 |
Other prepaid expenses | 768 | 924 |
Total current assets | 227,771 | 181,562 |
Property and equipment, net | 2,549 | 2,905 |
Operating lease right-of-use asset | 219 | |
Other assets | 1,261 | 2,280 |
Total assets | 231,800 | 186,747 |
Current liabilities: | ||
Accounts payable | 1,494 | 1,973 |
Accrued research and development expenses | 10,819 | 8,588 |
Other accrued liabilities | 5,045 | 3,854 |
Total current liabilities | 17,358 | 14,415 |
Long-term portion of operating lease liability | 1,851 | |
Other liabilities | 1,914 | |
Total liabilities | 19,209 | 16,329 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value: 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 68,701,043 and 59,456,493 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively | 7 | 6 |
Additional paid-in capital | 808,866 | 693,534 |
Accumulated other comprehensive income (loss) | 177 | (58) |
Accumulated deficit | (596,459) | (523,064) |
Total stockholders’ equity | 212,591 | 170,418 |
Total liabilities and stockholders’ equity | $ 231,800 | $ 186,747 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
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 | 68,701,043 | 59,456,493 |
Common stock, shares outstanding | 68,701,043 | 59,456,493 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Operating expenses: | ||||
Research and development | $ 23,193 | $ 17,853 | $ 62,900 | $ 41,727 |
General and administrative | 4,514 | 3,276 | 14,706 | 10,223 |
Total operating expenses | 27,707 | 21,129 | 77,606 | 51,950 |
Loss from operations | (27,707) | (21,129) | (77,606) | (51,950) |
Other income (expense): | ||||
Interest income | 1,425 | 1,113 | 4,211 | 2,882 |
Interest expense | (336) | |||
Loss on extinguishment of debt | (407) | |||
Other income (expense), net | 1,453 | (3,288) | ||
Total other income (expense) | 1,425 | 2,566 | 4,211 | (1,149) |
Net loss | (26,282) | (18,563) | (73,395) | (53,099) |
Other comprehensive (loss) income: | ||||
Unrealized (loss) gain on marketable securities | (51) | 36 | 235 | 13 |
Total other comprehensive (loss) income | (51) | 36 | 235 | 13 |
Comprehensive loss | $ (26,333) | $ (18,527) | $ (73,160) | $ (53,086) |
Basic net loss per common share | $ (0.38) | $ (0.31) | $ (1.10) | $ (0.93) |
Diluted net loss per common share | $ (0.38) | $ (0.34) | $ (1.10) | $ (0.93) |
Weighted average common shares outstanding used to calculate basic net loss per common share | 68,701,043 | 59,121,600 | 66,454,750 | 57,255,666 |
Weighted average common shares outstanding used to calculate diluted net loss per common share | 68,701,043 | 59,387,780 | 66,454,750 | 57,298,105 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities | ||
Net loss | $ (73,395) | $ (53,099) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 422 | 39 |
Stock-based compensation expense | 7,483 | 5,275 |
Net accretion and amortization of investments in marketable securities | (1,909) | (1,358) |
Non-cash interest associated with debt discount accretion | 148 | |
Loss on extinguishment of debt | 407 | |
Change in fair value of warrant liability | 3,710 | |
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 | (205) | (93) |
Prepaid expenses | (6,074) | (585) |
Other assets | 1,019 | (729) |
Accounts payable | (479) | 318 |
Accrued liabilities | 3,363 | 6,245 |
Accrued interest payable | (43) | |
Net cash used in operating activities | (69,775) | (35,341) |
Investing activities | ||
Purchases of property and equipment | (289) | (60) |
Purchases of marketable securities | (246,180) | (249,422) |
Proceeds from maturities of marketable securities | 198,881 | 168,600 |
Proceeds from sale of marketable securities | 3,980 | |
Net cash used in investing activities | (43,608) | (80,882) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 107,746 | 135,520 |
Proceeds from issuance of common stock pursuant to equity award plans | 104 | 3,547 |
Proceeds from issuance of common stock upon exercise of warrants | 2,550 | |
Repayment of facility loan principal | (6,527) | |
Payment of fees to extinguish facility loan | (126) | |
Net cash provided by financing activities | 107,850 | 134,964 |
Net (decrease) increase in cash and cash equivalents | (5,533) | 18,741 |
Cash and cash equivalents at beginning of period | 48,995 | 23,054 |
Cash and cash equivalents at end of period | 43,462 | 41,795 |
Supplemental disclosure | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 470 | |
Cash paid for interest | 231 | |
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 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Balance at beginning of period at Dec. 31, 2017 | $ 84,947 | $ 4 | $ 535,503 | $ (44) | $ (450,516) |
Balance at beginning of period (in shares) at Dec. 31, 2017 | 44,408,796 | ||||
Issuance of common stock upon exercise of warrants, value | 3,753 | 3,753 | |||
Issuance of common stock upon exercise of warrants (Shares) | 297,144 | ||||
Issuance of common stock upon exercise of stock options and incentive awards | 3,276 | 3,276 | |||
Issuance of common stock upon exercise of stock options and incentive awards (Shares) | 667,656 | ||||
Stock-based compensation expense | 1,796 | 1,796 | |||
Issuance costs of common stock, net of issuance costs, value | 135,520 | $ 2 | 135,518 | ||
Issuance costs of common stock, net of issuance costs (Shares) | 13,340,000 | ||||
Net loss | (17,005) | (17,005) | |||
Net unrealized gain (loss) on marketable securities | (88) | (88) | |||
Balance at end of period at Mar. 31, 2018 | 212,199 | $ 6 | 679,846 | (132) | (467,521) |
Balance at end of period (in shares) at Mar. 31, 2018 | 58,713,596 | ||||
Balance at beginning of period at Dec. 31, 2017 | 84,947 | $ 4 | 535,503 | (44) | (450,516) |
Balance at beginning of period (in shares) at Dec. 31, 2017 | 44,408,796 | ||||
Net loss | (53,099) | ||||
Net unrealized gain (loss) on marketable securities | 13 | ||||
Balance at end of period at Sep. 30, 2018 | 188,131 | $ 6 | 691,771 | (31) | (503,615) |
Balance at end of period (in shares) at Sep. 30, 2018 | 59,439,130 | ||||
Balance at beginning of period at Mar. 31, 2018 | 212,199 | $ 6 | 679,846 | (132) | (467,521) |
Balance at beginning of period (in shares) at Mar. 31, 2018 | 58,713,596 | ||||
Issuance of common stock upon exercise of warrants, value | 2,484 | 2,484 | |||
Issuance of common stock upon exercise of warrants (Shares) | 185,507 | ||||
Issuance of common stock upon exercise of stock options and incentive awards | 245 | 245 | |||
Issuance of common stock upon exercise of stock options and incentive awards (Shares) | 60,833 | ||||
Stock-based compensation expense | 1,751 | 1,751 | |||
Net loss | (17,531) | (17,531) | |||
Net unrealized gain (loss) on marketable securities | 65 | 65 | |||
Balance at end of period at Jun. 30, 2018 | 199,213 | $ 6 | 684,326 | (67) | (485,052) |
Balance at end of period (in shares) at Jun. 30, 2018 | 58,959,936 | ||||
Issuance of common stock upon exercise of warrants, value | 5,691 | 5,691 | |||
Issuance of common stock upon exercise of warrants (Shares) | 474,194 | ||||
Issuance of common stock upon exercise of stock options and incentive awards | 26 | 26 | |||
Issuance of common stock upon exercise of stock options and incentive awards (Shares) | 5,000 | ||||
Stock-based compensation expense | 1,728 | 1,728 | |||
Net loss | (18,563) | (18,563) | |||
Net unrealized gain (loss) on marketable securities | 36 | 36 | |||
Balance at end of period at Sep. 30, 2018 | 188,131 | $ 6 | 691,771 | (31) | (503,615) |
Balance at end of period (in shares) at Sep. 30, 2018 | 59,439,130 | ||||
Balance at beginning of period at Dec. 31, 2018 | 170,418 | $ 6 | 693,534 | (58) | (523,064) |
Balance at beginning of period (in shares) at Dec. 31, 2018 | 59,456,493 | ||||
Issuance of common stock upon exercise of stock options and incentive awards | 97 | 97 | |||
Issuance of common stock upon exercise of stock options and incentive awards (Shares) | 37,550 | ||||
Stock-based compensation expense | 2,342 | 2,342 | |||
Issuance costs of common stock, net of issuance costs, value | 107,746 | $ 1 | 107,745 | ||
Issuance costs of common stock, net of issuance costs (Shares) | 9,200,000 | ||||
Net loss | (23,075) | (23,075) | |||
Net unrealized gain (loss) on marketable securities | 103 | 103 | |||
Balance at end of period at Mar. 31, 2019 | 257,631 | $ 7 | 803,718 | 45 | (546,139) |
Balance at end of period (in shares) at Mar. 31, 2019 | 68,694,043 | ||||
Balance at beginning of period at Dec. 31, 2018 | 170,418 | $ 6 | 693,534 | (58) | (523,064) |
Balance at beginning of period (in shares) at Dec. 31, 2018 | 59,456,493 | ||||
Net loss | (73,395) | ||||
Net unrealized gain (loss) on marketable securities | 235 | ||||
Balance at end of period at Sep. 30, 2019 | 212,591 | $ 7 | 808,866 | 177 | (596,459) |
Balance at end of period (in shares) at Sep. 30, 2019 | 68,701,043 | ||||
Balance at beginning of period at Mar. 31, 2019 | 257,631 | $ 7 | 803,718 | 45 | (546,139) |
Balance at beginning of period (in shares) at Mar. 31, 2019 | 68,694,043 | ||||
Issuance of common stock upon exercise of stock options and incentive awards | 7 | 7 | |||
Issuance of common stock upon exercise of stock options and incentive awards (Shares) | 7,000 | ||||
Stock-based compensation expense | 2,276 | 2,276 | |||
Net loss | (24,038) | (24,038) | |||
Net unrealized gain (loss) on marketable securities | 183 | 183 | |||
Balance at end of period at Jun. 30, 2019 | 236,059 | $ 7 | 806,001 | 228 | (570,177) |
Balance at end of period (in shares) at Jun. 30, 2019 | 68,701,043 | ||||
Stock-based compensation expense | 2,865 | 2,865 | |||
Net loss | (26,282) | (26,282) | |||
Net unrealized gain (loss) on marketable securities | (51) | (51) | |||
Balance at end of period at Sep. 30, 2019 | $ 212,591 | $ 7 | $ 808,866 | $ 177 | $ (596,459) |
Balance at end of period (in shares) at Sep. 30, 2019 | 68,701,043 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement Of Stockholders Equity [Abstract] | ||
Stock issuance cost | $ 7,254 | $ 8,553 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2019 | |
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 or evaluated for the treatment of the liver diseases primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and 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, 2019, the Company incurred a net loss of $73.4 million and used $69.8 million of cash in operations. At September 30, 2019, the Company had an accumulated deficit of $596.5 million. CymaBay expects to incur substantial research and development expenses as it continues to study its product candidates in clinical trials. To date, none of the Company’s product candidates have been approved for marketing and sale, and the Company has not recorded any revenue from product sales. As a result, management expects operating losses to continue in future years. The Company’s ability to achieve profitability is dependent primarily on its ability to successfully develop, acquire or in-license additional product candidates, continue clinical trials for product candidates currently in clinical development, obtain regulatory approvals, and support commercialization activities for its 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. As of September 30, 2019, the Company had cash, cash equivalents and marketable securities totaling $218.6 million, which the Company believes is sufficient to fund its 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, costs for the Company’s Phase 2 clinical trial in PSC, the ongoing Phase 2b clinical trial activities in NASH, and most significantly, the timing and conduct of PBC development activities. The Company’s PBC development activities include two Phase 3 clinical trials, one of which is a long-term open label study, as well as 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 its business, results of operations, and financial condition. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
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. All intercompany balances and transactions have been eliminated in consolidation. The Company has no unconsolidated subsidiaries or investments accounted for under the equity method. These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. 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. “Prepaid research and development expenses” and “Other prepaid expenses”, which were previously reported together as “Prepaid expenses” on the condensed balance sheet, are now reported as separate line items. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 201 8 , which is contained in the Company’s Annual Report on Form 10-K as filed with the SEC on February 28 , 201 9 . The results for the three and nine months ended September 30 , 201 9 are not necessarily indicative of results to be expected for the entire year ending December 31, 201 9 or future operating periods. 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 the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from those estimates and assumptions. The Company believes significant judgment can be involved in estimating stock-based compensation, accrued research and development expense, and the fair value of the Company’s common stock warrants. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each reporting period and updated to reflect current information and any changes in estimates will be reflected in the period first identified. Fair Value of Financial Instruments The Company’s financial instruments during the periods reported consist of cash and cash equivalents, marketable securities, accrued interest receivable, prepaid expenses, other assets, accounts payable and accrued expenses. 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, accrued interest receivable, prepaid expenses, other assets, accounts payable, and accrued expenses approximate the related fair values due to the short maturities of these instruments. 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, 2019 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 38,715 $ - $ - $ 38,715 Total cash equivalents 38,715 - - 38,715 Marketable securities: U.S. and foreign commercial paper - 49,044 - 49,044 U.S. and foreign corporate debt securities - 58,877 - 58,877 Asset-backed securities - 38,746 - 38,746 U.S. treasury securities - 28,465 - 28,465 Total marketable securities - 175,132 - 175,132 Total assets measured at fair value $ 38,715 $ 175,132 $ - $ 213,847 As of December 31, 2018 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 39,481 $ - $ - $ 39,481 U.S. and foreign commercial paper - 6,469 - 6,469 Total cash equivalents 39,481 6,469 - 45,950 Marketable securities: U.S. and foreign commercial paper - 51,627 - 51,627 U.S. and foreign corporate debt securities - 34,634 - 34,634 Asset-backed securities - 25,472 - 25,472 U.S. treasury securities - 17,936 - 17,936 Total marketable securities - 129,669 - 129,669 Total assets measured at fair value $ 39,481 $ 136,138 $ - $ 175,619 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 either they were exercised or expired in September 2018. The following table sets forth a summary of the changes in the fair value of the Company’s liabilities measured using Level 3 inputs (in thousands): For the Nine Months Ended September 30, 2019 2018 Balance, beginning of period $ - $ 6,091 Change in fair value - 3,710 Settlement of financial instruments - (9,379 ) Extinguishment of financial instruments - (422 ) Balance, end of period $ - $ - Cash, 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, 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 or equal to 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 condensed consolidated statements of operations and comprehensive loss. Unrealized holding gains and losses are reported in accumulated other comprehensive loss in the condensed consolidated 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 Total Cost Gains Losses Fair Value As of September 30, 2019: U.S. and foreign commercial paper $ 49,044 $ - $ - $ 49,044 U.S. and foreign corporate debt securities 58,774 103 - 58,877 Asset-backed securities 38,695 51 - 38,746 U.S. treasury securities 28,442 23 - 28,465 Total marketable securities $ 174,955 $ 177 $ - $ 175,132 Gross Gross Amortized Unrealized Unrealized Total Cost Gains Losses Fair Value As of December 31, 2018: U.S. and foreign commercial paper $ 51,627 $ - $ - $ 51,627 U.S. and foreign corporate debt securities 34,668 - (34 ) 34,634 Asset-backed securities 25,494 - (22 ) 25,472 U.S. treasury securities 17,938 - (2 ) 17,936 Total marketable securities $ 129,727 $ - $ (58 ) $ 129,669 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 condensed consolidated 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 has one lease, a non-cancelable operating lease agreement for its corporate offices. Prior to January 1, 2019, the Company recognized 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, were recognized as reductions to rental expense on a straight-line basis over the term of the lease. Deferred rent consisted of the difference between cash payments and the rent expense recognized. Subsequent to the adoption of the new leasing standard on January 1, 2019, the Company recognizes a lease asset for its right to use the underlying asset and a lease liability for the corresponding lease obligation. The Company determines whether an arrangement is or contains a lease at contract inception. Operating leases are included in operating lease right-of-use assets, other accrued liabilities, and long-term portion of operating lease liabilities in our condensed consolidated balance sheet at September 30, 2019. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. The incremental borrowing rate represents the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease. The Company considers a lease term to be the noncancelable period that it has the right to use the underlying asset, including any periods where it is reasonably assured the Company will exercise the option to extend the contract. Periods covered by an option to extend are included in the lease term if the lessor controls the exercise of that option. The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected to not separate lease and non-lease components for its leased assets and accounts for all lease and non-lease components of its agreements as a single lease component. 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. Research and Development Expenses Research and development expenses consist of costs incurred in identifying, developing, and testing product candidates. These expenses consist primarily of costs for research and development personnel, including related stock-based compensation; contract research organizations (CRO) and other third parties that assist in managing, monitoring, and analyzing clinical trials; investigator and site fees; laboratory services; consultants; contract manufacturing services; non-clinical studies, including materials; and allocated expenses, such as depreciation of assets, and facilities and information technology that support research and development activities. Research and development costs are expensed as incurred, including expenses that may or may not be reimbursed under research and development funding arrangements. Payments made prior to the receipt of goods or services to be used in research and development are recorded as prepaid assets until the goods are received or services are rendered. Such payments are evaluated for current or long term classification based on when they will be realized. The Company records expenses related to clinical studies and manufacturing development activities based on its estimates of the services received and efforts expended pursuant to contracts with multiple CROs and manufacturing vendors that conduct and manage these activities on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical trial milestones. In amortizing or accruing service fees, the Company estimates the time period over which services will be performed, enrollment of subjects, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the Company’s estimate, the Company will adjust the accrued or prepaid expense balance accordingly. To date, there have been no material differences from the Company’s estimates to the amounts actually incurred. Stock-Based Compensation Employee and director stock-based compensation is measured at fair value on the grant date of the award. Compensation cost is recognized as expense on a straight-line basis over the vesting period for options and on an accelerated basis for stock options with performance conditions. For stock options with performance conditions, the Company evaluates the probability of achieving performance conditions at each reporting date. The Company begins to recognize the expense when it is deemed probable that the performance conditions will be met. The Company uses the Black-Scholes option pricing model to determine the fair value of stock option awards. The determination of fair value for stock-based awards using an option-pricing model requires management to make certain assumptions regarding subjective input variables such as expected term, dividends, volatility and risk-free 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 has historically been subject to remeasurement at each reporting date as the underlying equity instruments vest and was recognized as an expense over the period during which services are received. Upon the adoption of ASU 2018-07, Compensation – Stock Compensation 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 equivalents 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 earnings (net loss) per share for the period, adjustments to net income or net loss used in the calculation are required to remove the change in fair value of the common stock warrant liability for the period. Likewise, adjustments to the denominator are required to reflect the related dilutive shares. In all periods presented, the Company’s outstanding stock options were excluded from the calculation of diluted net loss per share because their effects were antidilutive. The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Numerator: Net loss allocated to common stock-basic $ (26,282 ) $ (18,563 ) $ (73,395 ) $ (53,099 ) Adjustments for revaluation and extinguishment of common stock warrants - (1,462 ) - (422 ) Net loss allocated to common stock-diluted $ (26,282 ) $ (20,025 ) $ (73,395 ) $ (53,521 ) Denominator: Weighted average number of common stock shares outstanding - basic 68,701,043 59,121,600 66,454,750 57,255,666 Dilutive securities: Common stock warrants - 266,180 - 42,439 Weighted average number of common stock shares outstanding - diluted 68,701,043 59,387,780 66,454,750 57,298,105 Net loss per share - basic: $ (0.38 ) $ (0.31 ) $ (1.10 ) $ (0.93 ) Net loss per share - diluted: $ (0.38 ) $ (0.34 ) $ (1.10 ) $ (0.93 ) The following table shows the total outstanding securities 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, 2019 2018 2019 2018 Common stock options 7,949 5,570 7,949 5,570 Incentive awards 127 130 127 130 8,076 5,700 8,076 5,700 Recently Adopted Accounting Pronouncements Accounting Standards Update 2016-02 and 2018-11 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The Company adopted this standard on January 1, 2019 using the modified retrospective approach and elected the package of practical expedients permitted under transition guidance, which allowed the Company to carry forward its historical assessments of: 1) whether contracts are or contain leases, 2) lease classification and 3) initial direct costs. The Company did not elect the practical expedient allowing the use-of-hindsight which would require the Company to reassess the lease term of its leases based on all facts and circumstances through the effective date and did not elect the practical expedient pertaining to land easements as this is not applicable to the current contract portfolio. The Company elected the post-transition practical expedient to not separate lease components from nonlease components for all existing lease classes. The Company also elected a policy of not recording leases on its condensed consolidated balance sheets when the leases have a term of 12 months or less and the Company is not reasonably certain to elect an option to purchase the leased asset. The adoption of this standard resulted in the recognition of a ROU asset and lease liabilities of $0.2 million and $2.5 million, respectively, and the derecognition of the deferred rent balance of $2.3 million as of January 1, 2019. The adoption of the standard had no impact on the Company’s condensed consolidated statements of operations and comprehensive loss or to its cash flows from or used in operating, financing, or investing activities on its condensed consolidated statements of cash flows. No cumulative-effect adjustment within accumulated deficit was required to be recorded as a result of adopting this standard. Accounting Standards Update 2018-08 On January 1, 2019 the Company adopted ASU No. 2018-08, Not-For-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made Accounting Standards Update 2018-07 On January 1, 2019, the Company adopted ASU 2018-07, Compensation – Stock Compensation – The adoption of this standard did not have a material impact on the Company’s condensed consolidated financial statements. 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 Recently Issued Accounting Pronouncements Accounting Standards Update 2018-18 In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 Accounting Standards Update 2018-15 In August 2018, the FASB issued ASU No. 2018-15, Intangibles (Topic 350): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract Accounting Standards Update 2018-13 In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement Accounting Standards Update 2016-13 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Other Accrued Liabilities
Other Accrued Liabilities | 9 Months Ended |
Sep. 30, 2019 | |
Other Accrued Liabilities Current [Abstract] | |
Other Accrued Liabilities | 3. Other Accrued Liabilities Other accrued liabilities consist of (in thousands): September 30, December 31, 2019 2018 Accrued compensation $ 3,201 $ 2,759 Accrued professional fees and other 1,455 670 Operating lease liability 389 - Deferred rent - 425 Total other accrued liabilities $ 5,045 $ 3,854 |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration and License Agreements | 4. Collaboration and License Agreements 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(s) 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. No amounts were incurred or accrued for this agreement as of and for the three or nine months ended September 30, 2019 and 2018. 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. 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 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 had 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). On October 24, 2018, the Company received a notice of Kowa’s intent to terminate the license agreement for the development of arhalofenate. The termination was effective on January 22, 2019. As a result of the termination, the rights licensed to Kowa through the agreement reverted to the Company on the termination date and the Company is no longer eligible to receive additional milestone payments or royalties from Kowa. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | 5. Leases The Company has one operating lease pertaining to 17,698 square feet of corporate office space in Newark, California pursuant to a lease agreement that commenced January 16, 2014 and was amended on April 16, 2018. At September 30, 2019 the Company’s lease portfolio had a weighted average remaining term of 4.3 years, with an option to extend for an additional 5 years. The lease requires monthly lease payments that are subject to annual increases throughout the lease term. The optional period has not been considered in the determination of the right-of-use assets or lease liabilities associated with this lease as the Company did not consider it reasonably certain it would exercise the option. The Company cannot determine the implicit rate in its lease, and therefore the Company uses its incremental borrowing rate as the discount rate when measuring operating lease liabilities. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease within a particular currency environment. The Company used an incremental borrowing rate as of the date of adoption for leases that commenced prior to January 1, 2019. The weighted average discount rate for the Company’s lease portfolio at September 30, 2019 was 12.6%. For the three and nine months ended September 30, 2019, the Company incurred $0.2 million and $0.4 million of lease costs included in operating expenses in the condensed consolidated statements of income and comprehensive income in relation to its operating lease, a portion of which was variable rent expense and not included within the measurement of the Company’s operating ROU assets and lease liabilities. The variable rent expense consists primarily of the Company’s proportionate share of operating expenses, property taxes, and insurance and is classified as lease expense due to the Company’s election to not separate lease and non-lease components. Rent expense for the three and nine months ended September 30, 2018 was $0.1 million and $0.3 million, respectively, a portion of which represents immaterial variable rent expense. As of September 30, 2019, the maturities of the Company’s operating lease liabilities were as follows (in thousands): Operating Leases Year ending December 31, 2019 (from October to December) $ 158 2020 647 2021 667 2022 686 2023 707 Thereafter 30 Total undiscounted future minimum lease payments $ 2,895 Less: Imputed interest 655 Total operating lease liability $ 2,240 Less: Current portion of operating lease liability (included in other accrued liabilities) 389 Long-term portion of operating lease liability $ 1,851 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | 6. Stockholders’ Equity On February 1, 2018, pursuant to a On March 8, 2019, pursuant to a shelf registration statement on Form S-3, the Company issued 8,000,000 shares of its common stock at $12.50 per share in an underwritten public offering (referred to as the March 2019 public offering). On March 11, 2019, the underwriters fully exercised their option to purchase additional shares resulting in the issuance of an additional 1,200,000 shares. Net proceeds to the Company from the March 2019 public offering were approximately $107.7 million after deducting underwriting discounts, commissions and other offering expenses. |
Stock Plan and Stock-Based Comp
Stock Plan and Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Plan and Stock-Based Compensation | 7. Stock Plan and Stock-Based Compensation Stock Plan In accordance with the provisions of the Company’s 2013 Equity Incentive Plan (2013 Plan), the Board of Directors reduced the automatic increase in the share reserve to 2,378,259 shares, which were automatically available for issuance on January 1, 2019. During the three and nine months ended September 30, 2019, the Company granted options to purchase 589,600 and 2,733,960 shares, respectively, of its common stock to its employees and directors. As of September 30, 2019, there were 1,249,186 shares available for grant under the 2013 Plan. Stock-Based Compensation Expense Stock-based compensation expense is included in the condensed consolidated statements of operations and comprehensive loss and is as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Research and development $ 1,504 $ 741 $ 3,602 $ 2,045 General and administrative 1,361 987 3,881 3,230 Total stock-based compensation expense $ 2,865 $ 1,728 $ 7,483 $ 5,275 |
Organization and Description _2
Organization and Description of Business (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
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, 2019, the Company incurred a net loss of $73.4 million and used $69.8 million of cash in operations. At September 30, 2019, the Company had an accumulated deficit of $596.5 million. CymaBay expects to incur substantial research and development expenses as it continues to study its product candidates in clinical trials. To date, none of the Company’s product candidates have been approved for marketing and sale, and the Company has not recorded any revenue from product sales. As a result, management expects operating losses to continue in future years. The Company’s ability to achieve profitability is dependent primarily on its ability to successfully develop, acquire or in-license additional product candidates, continue clinical trials for product candidates currently in clinical development, obtain regulatory approvals, and support commercialization activities for its 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. As of September 30, 2019, the Company had cash, cash equivalents and marketable securities totaling $218.6 million, which the Company believes is sufficient to fund its 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, costs for the Company’s Phase 2 clinical trial in PSC, the ongoing Phase 2b clinical trial activities in NASH, and most significantly, the timing and conduct of PBC development activities. The Company’s PBC development activities include two Phase 3 clinical trials, one of which is a long-term open label study, as well as 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 its 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. All intercompany balances and transactions have been eliminated in consolidation. The Company has no unconsolidated subsidiaries or investments accounted for under the equity method. These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. 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. “Prepaid research and development expenses” and “Other prepaid expenses”, which were previously reported together as “Prepaid expenses” on the condensed balance sheet, are now reported as separate line items. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 201 8 , which is contained in the Company’s Annual Report on Form 10-K as filed with the SEC on February 28 , 201 9 . The results for the three and nine months ended September 30 , 201 9 are not necessarily indicative of results to be expected for the entire year ending December 31, 201 9 or future operating periods. |
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 the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from those estimates and assumptions. The Company believes significant judgment can be involved in estimating stock-based compensation, accrued research and development expense, and the fair value of the Company’s common stock warrants. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each reporting period and updated to reflect current information and any changes in estimates will be reflected in the period first identified. |
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, accrued interest receivable, prepaid expenses, other assets, accounts payable and accrued expenses. 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, accrued interest receivable, prepaid expenses, other assets, accounts payable, and accrued expenses approximate the related fair values due to the short maturities of these instruments. 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, 2019 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 38,715 $ - $ - $ 38,715 Total cash equivalents 38,715 - - 38,715 Marketable securities: U.S. and foreign commercial paper - 49,044 - 49,044 U.S. and foreign corporate debt securities - 58,877 - 58,877 Asset-backed securities - 38,746 - 38,746 U.S. treasury securities - 28,465 - 28,465 Total marketable securities - 175,132 - 175,132 Total assets measured at fair value $ 38,715 $ 175,132 $ - $ 213,847 As of December 31, 2018 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 39,481 $ - $ - $ 39,481 U.S. and foreign commercial paper - 6,469 - 6,469 Total cash equivalents 39,481 6,469 - 45,950 Marketable securities: U.S. and foreign commercial paper - 51,627 - 51,627 U.S. and foreign corporate debt securities - 34,634 - 34,634 Asset-backed securities - 25,472 - 25,472 U.S. treasury securities - 17,936 - 17,936 Total marketable securities - 129,669 - 129,669 Total assets measured at fair value $ 39,481 $ 136,138 $ - $ 175,619 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 either they were exercised or expired in September 2018. The following table sets forth a summary of the changes in the fair value of the Company’s liabilities measured using Level 3 inputs (in thousands): For the Nine Months Ended September 30, 2019 2018 Balance, beginning of period $ - $ 6,091 Change in fair value - 3,710 Settlement of financial instruments - (9,379 ) Extinguishment of financial instruments - (422 ) Balance, end of period $ - $ - |
Cash, Cash Equivalents and Marketable Securities | Cash, 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, 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 or equal to 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 condensed consolidated statements of operations and comprehensive loss. Unrealized holding gains and losses are reported in accumulated other comprehensive loss in the condensed consolidated 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 Total Cost Gains Losses Fair Value As of September 30, 2019: U.S. and foreign commercial paper $ 49,044 $ - $ - $ 49,044 U.S. and foreign corporate debt securities 58,774 103 - 58,877 Asset-backed securities 38,695 51 - 38,746 U.S. treasury securities 28,442 23 - 28,465 Total marketable securities $ 174,955 $ 177 $ - $ 175,132 Gross Gross Amortized Unrealized Unrealized Total Cost Gains Losses Fair Value As of December 31, 2018: U.S. and foreign commercial paper $ 51,627 $ - $ - $ 51,627 U.S. and foreign corporate debt securities 34,668 - (34 ) 34,634 Asset-backed securities 25,494 - (22 ) 25,472 U.S. treasury securities 17,938 - (2 ) 17,936 Total marketable securities $ 129,727 $ - $ (58 ) $ 129,669 |
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 condensed consolidated 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 has one lease, a non-cancelable operating lease agreement for its corporate offices. Prior to January 1, 2019, the Company recognized 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, were recognized as reductions to rental expense on a straight-line basis over the term of the lease. Deferred rent consisted of the difference between cash payments and the rent expense recognized. Subsequent to the adoption of the new leasing standard on January 1, 2019, the Company recognizes a lease asset for its right to use the underlying asset and a lease liability for the corresponding lease obligation. The Company determines whether an arrangement is or contains a lease at contract inception. Operating leases are included in operating lease right-of-use assets, other accrued liabilities, and long-term portion of operating lease liabilities in our condensed consolidated balance sheet at September 30, 2019. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. The incremental borrowing rate represents the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of a lease. The Company considers a lease term to be the noncancelable period that it has the right to use the underlying asset, including any periods where it is reasonably assured the Company will exercise the option to extend the contract. Periods covered by an option to extend are included in the lease term if the lessor controls the exercise of that option. The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected to not separate lease and non-lease components for its leased assets and accounts for all lease and non-lease components of its agreements as a single lease component. |
Common Stock Warrant Liabilities | 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. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist of costs incurred in identifying, developing, and testing product candidates. These expenses consist primarily of costs for research and development personnel, including related stock-based compensation; contract research organizations (CRO) and other third parties that assist in managing, monitoring, and analyzing clinical trials; investigator and site fees; laboratory services; consultants; contract manufacturing services; non-clinical studies, including materials; and allocated expenses, such as depreciation of assets, and facilities and information technology that support research and development activities. Research and development costs are expensed as incurred, including expenses that may or may not be reimbursed under research and development funding arrangements. Payments made prior to the receipt of goods or services to be used in research and development are recorded as prepaid assets until the goods are received or services are rendered. Such payments are evaluated for current or long term classification based on when they will be realized. The Company records expenses related to clinical studies and manufacturing development activities based on its estimates of the services received and efforts expended pursuant to contracts with multiple CROs and manufacturing vendors that conduct and manage these activities on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical trial milestones. In amortizing or accruing service fees, the Company estimates the time period over which services will be performed, enrollment of subjects, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the Company’s estimate, the Company will adjust the accrued or prepaid expense balance accordingly. To date, there have been no material differences from the Company’s estimates to the amounts actually incurred. |
Stock-Based Compensation | Stock-Based Compensation Employee and director stock-based compensation is measured at fair value on the grant date of the award. Compensation cost is recognized as expense on a straight-line basis over the vesting period for options and on an accelerated basis for stock options with performance conditions. For stock options with performance conditions, the Company evaluates the probability of achieving performance conditions at each reporting date. The Company begins to recognize the expense when it is deemed probable that the performance conditions will be met. The Company uses the Black-Scholes option pricing model to determine the fair value of stock option awards. The determination of fair value for stock-based awards using an option-pricing model requires management to make certain assumptions regarding subjective input variables such as expected term, dividends, volatility and risk-free 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 has historically been subject to remeasurement at each reporting date as the underlying equity instruments vest and was recognized as an expense over the period during which services are received. Upon the adoption of ASU 2018-07, Compensation – Stock Compensation |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per share of common stock is based on the weighted average number of shares of common stock outstanding equivalents 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 earnings (net loss) per share for the period, adjustments to net income or net loss used in the calculation are required to remove the change in fair value of the common stock warrant liability for the period. Likewise, adjustments to the denominator are required to reflect the related dilutive shares. In all periods presented, the Company’s outstanding stock options were excluded from the calculation of diluted net loss per share because their effects were antidilutive. The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Numerator: Net loss allocated to common stock-basic $ (26,282 ) $ (18,563 ) $ (73,395 ) $ (53,099 ) Adjustments for revaluation and extinguishment of common stock warrants - (1,462 ) - (422 ) Net loss allocated to common stock-diluted $ (26,282 ) $ (20,025 ) $ (73,395 ) $ (53,521 ) Denominator: Weighted average number of common stock shares outstanding - basic 68,701,043 59,121,600 66,454,750 57,255,666 Dilutive securities: Common stock warrants - 266,180 - 42,439 Weighted average number of common stock shares outstanding - diluted 68,701,043 59,387,780 66,454,750 57,298,105 Net loss per share - basic: $ (0.38 ) $ (0.31 ) $ (1.10 ) $ (0.93 ) Net loss per share - diluted: $ (0.38 ) $ (0.34 ) $ (1.10 ) $ (0.93 ) The following table shows the total outstanding securities 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, 2019 2018 2019 2018 Common stock options 7,949 5,570 7,949 5,570 Incentive awards 127 130 127 130 8,076 5,700 8,076 5,700 |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements Accounting Standards Update 2016-02 and 2018-11 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The Company adopted this standard on January 1, 2019 using the modified retrospective approach and elected the package of practical expedients permitted under transition guidance, which allowed the Company to carry forward its historical assessments of: 1) whether contracts are or contain leases, 2) lease classification and 3) initial direct costs. The Company did not elect the practical expedient allowing the use-of-hindsight which would require the Company to reassess the lease term of its leases based on all facts and circumstances through the effective date and did not elect the practical expedient pertaining to land easements as this is not applicable to the current contract portfolio. The Company elected the post-transition practical expedient to not separate lease components from nonlease components for all existing lease classes. The Company also elected a policy of not recording leases on its condensed consolidated balance sheets when the leases have a term of 12 months or less and the Company is not reasonably certain to elect an option to purchase the leased asset. The adoption of this standard resulted in the recognition of a ROU asset and lease liabilities of $0.2 million and $2.5 million, respectively, and the derecognition of the deferred rent balance of $2.3 million as of January 1, 2019. The adoption of the standard had no impact on the Company’s condensed consolidated statements of operations and comprehensive loss or to its cash flows from or used in operating, financing, or investing activities on its condensed consolidated statements of cash flows. No cumulative-effect adjustment within accumulated deficit was required to be recorded as a result of adopting this standard. Accounting Standards Update 2018-08 On January 1, 2019 the Company adopted ASU No. 2018-08, Not-For-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made Accounting Standards Update 2018-07 On January 1, 2019, the Company adopted ASU 2018-07, Compensation – Stock Compensation – The adoption of this standard did not have a material impact on the Company’s condensed consolidated financial statements. 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 Recently Issued Accounting Pronouncements Accounting Standards Update 2018-18 In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 Accounting Standards Update 2018-15 In August 2018, the FASB issued ASU No. 2018-15, Intangibles (Topic 350): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract Accounting Standards Update 2018-13 In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement Accounting Standards Update 2016-13 In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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, 2019 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 38,715 $ - $ - $ 38,715 Total cash equivalents 38,715 - - 38,715 Marketable securities: U.S. and foreign commercial paper - 49,044 - 49,044 U.S. and foreign corporate debt securities - 58,877 - 58,877 Asset-backed securities - 38,746 - 38,746 U.S. treasury securities - 28,465 - 28,465 Total marketable securities - 175,132 - 175,132 Total assets measured at fair value $ 38,715 $ 175,132 $ - $ 213,847 As of December 31, 2018 Level 1 Level 2 Level 3 Total Fair Value Cash equivalents: Money market funds $ 39,481 $ - $ - $ 39,481 U.S. and foreign commercial paper - 6,469 - 6,469 Total cash equivalents 39,481 6,469 - 45,950 Marketable securities: U.S. and foreign commercial paper - 51,627 - 51,627 U.S. and foreign corporate debt securities - 34,634 - 34,634 Asset-backed securities - 25,472 - 25,472 U.S. treasury securities - 17,936 - 17,936 Total marketable securities - 129,669 - 129,669 Total assets measured at fair value $ 39,481 $ 136,138 $ - $ 175,619 |
Schedule of Changes in Fair Value of Liabilities | The following table sets forth a summary of the changes in the fair value of the Company’s liabilities measured using Level 3 inputs (in thousands): For the Nine Months Ended September 30, 2019 2018 Balance, beginning of period $ - $ 6,091 Change in fair value - 3,710 Settlement of financial instruments - (9,379 ) Extinguishment of financial instruments - (422 ) Balance, end of period $ - $ - |
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 Total Cost Gains Losses Fair Value As of September 30, 2019: U.S. and foreign commercial paper $ 49,044 $ - $ - $ 49,044 U.S. and foreign corporate debt securities 58,774 103 - 58,877 Asset-backed securities 38,695 51 - 38,746 U.S. treasury securities 28,442 23 - 28,465 Total marketable securities $ 174,955 $ 177 $ - $ 175,132 Gross Gross Amortized Unrealized Unrealized Total Cost Gains Losses Fair Value As of December 31, 2018: U.S. and foreign commercial paper $ 51,627 $ - $ - $ 51,627 U.S. and foreign corporate debt securities 34,668 - (34 ) 34,634 Asset-backed securities 25,494 - (22 ) 25,472 U.S. treasury securities 17,938 - (2 ) 17,936 Total marketable securities $ 129,727 $ - $ (58 ) $ 129,669 |
Computation of Basic and Diluted Net Loss per Share | The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Numerator: Net loss allocated to common stock-basic $ (26,282 ) $ (18,563 ) $ (73,395 ) $ (53,099 ) Adjustments for revaluation and extinguishment of common stock warrants - (1,462 ) - (422 ) Net loss allocated to common stock-diluted $ (26,282 ) $ (20,025 ) $ (73,395 ) $ (53,521 ) Denominator: Weighted average number of common stock shares outstanding - basic 68,701,043 59,121,600 66,454,750 57,255,666 Dilutive securities: Common stock warrants - 266,180 - 42,439 Weighted average number of common stock shares outstanding - diluted 68,701,043 59,387,780 66,454,750 57,298,105 Net loss per share - basic: $ (0.38 ) $ (0.31 ) $ (1.10 ) $ (0.93 ) Net loss per share - diluted: $ (0.38 ) $ (0.34 ) $ (1.10 ) $ (0.93 ) |
Anti-Dilutive Securities Excluded from the Computation of Diluted Net Loss per Share | The following table shows the total outstanding securities 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, 2019 2018 2019 2018 Common stock options 7,949 5,570 7,949 5,570 Incentive awards 127 130 127 130 8,076 5,700 8,076 5,700 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Other Accrued Liabilities Current [Abstract] | |
Summary of Other Accrued Liabilities | Other accrued liabilities consist of (in thousands): September 30, December 31, 2019 2018 Accrued compensation $ 3,201 $ 2,759 Accrued professional fees and other 1,455 670 Operating lease liability 389 - Deferred rent - 425 Total other accrued liabilities $ 5,045 $ 3,854 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Summary of Maturities of Operating Lease Liabilities | As of September 30, 2019, the maturities of the Company’s operating lease liabilities were as follows (in thousands): Operating Leases Year ending December 31, 2019 (from October to December) $ 158 2020 647 2021 667 2022 686 2023 707 Thereafter 30 Total undiscounted future minimum lease payments $ 2,895 Less: Imputed interest 655 Total operating lease liability $ 2,240 Less: Current portion of operating lease liability (included in other accrued liabilities) 389 Long-term portion of operating lease liability $ 1,851 |
Stock Plan and Stock-Based Co_2
Stock Plan and Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock-Based Compensation Expense | Stock-based compensation expense is included in the condensed consolidated statements of operations and comprehensive loss and is as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Research and development $ 1,504 $ 741 $ 3,602 $ 2,045 General and administrative 1,361 987 3,881 3,230 Total stock-based compensation expense $ 2,865 $ 1,728 $ 7,483 $ 5,275 |
Organization and Description _3
Organization and Description of Business - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Sep. 30, 2019USD ($)Segment | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||||||||
Number of operating segments | Segment | 1 | ||||||||
Net loss | $ (26,282) | $ (24,038) | $ (23,075) | $ (18,563) | $ (17,531) | $ (17,005) | $ (73,395) | $ (53,099) | |
Cash flows from operating activities | (69,775) | $ (35,341) | |||||||
Accumulated deficit | (596,459) | (596,459) | $ (523,064) | ||||||
Cash and cash equivalents and marketable securities | $ 218,600 | $ 218,600 |
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, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | $ 213,847 | $ 175,619 |
Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 38,715 | 45,950 |
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 | 38,715 | 39,481 |
Cash Equivalents [Member] | U.S. and Foreign Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 6,469 | |
Marketable Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 175,132 | 129,669 |
Marketable Securities [Member] | U.S. and Foreign Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 49,044 | 51,627 |
Marketable Securities [Member] | U.S. and Foreign Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 58,877 | 34,634 |
Marketable Securities [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 38,746 | 25,472 |
Marketable Securities [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 | 28,465 | 17,936 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 38,715 | 39,481 |
Level 1 [Member] | Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 38,715 | 39,481 |
Level 1 [Member] | Cash Equivalents [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 38,715 | 39,481 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 175,132 | 136,138 |
Level 2 [Member] | Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 6,469 | |
Level 2 [Member] | Cash Equivalents [Member] | U.S. and Foreign Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 6,469 | |
Level 2 [Member] | Marketable Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 175,132 | 129,669 |
Level 2 [Member] | Marketable Securities [Member] | U.S. and Foreign Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 49,044 | 51,627 |
Level 2 [Member] | Marketable Securities [Member] | U.S. and Foreign Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 58,877 | 34,634 |
Level 2 [Member] | Marketable Securities [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 38,746 | 25,472 |
Level 2 [Member] | Marketable Securities [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 | $ 28,465 | $ 17,936 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | Jan. 01, 2019USD ($) | Sep. 30, 2019USD ($)Facility |
Product Information [Line Items] | ||
Warrants exercise or expiration period | Sep. 30, 2018 | |
Cash and cash equivalents, maturity description | 90 days or less | |
Number of leased facilities | Facility | 1 | |
ROU assets | $ 219 | |
Lease liabilities | $ 2,240 | |
ASU 2018-11 [Member] | ||
Product Information [Line Items] | ||
ROU assets | $ 200 | |
Lease liabilities | 2,500 | |
Derecognition of the deferred rent | $ 2,300 | |
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_5
Summary of Significant Accounting Policies - Schedule of Changes in Fair Value of Liabilities (Detail) - Level 3 [Member] $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Fair Value, Instruments Classified in Shareholders' Equity Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance, beginning of period | $ 6,091 |
Change in fair value | 3,710 |
Settlement of financial instruments | (9,379) |
Extinguishment of financial instruments | $ (422) |
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, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 174,955 | $ 129,727 |
Gross Unrealized Gains | 177 | |
Gross Unrealized Losses | (58) | |
Total Fair Value | 175,132 | 129,669 |
U.S. and Foreign Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 49,044 | 51,627 |
Total Fair Value | 49,044 | 51,627 |
U.S. and Foreign Corporate Debt Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 58,774 | 34,668 |
Gross Unrealized Gains | 103 | |
Gross Unrealized Losses | (34) | |
Total Fair Value | 58,877 | 34,634 |
Asset-backed Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 38,695 | 25,494 |
Gross Unrealized Gains | 51 | |
Gross Unrealized Losses | (22) | |
Total Fair Value | 38,746 | 25,472 |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 28,442 | 17,938 |
Gross Unrealized Gains | 23 | |
Gross Unrealized Losses | (2) | |
Total Fair Value | $ 28,465 | $ 17,936 |
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, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Numerator: | ||||
Net loss allocated to common stock-basic | $ (26,282) | $ (18,563) | $ (73,395) | $ (53,099) |
Adjustments for revaluation and extinguishment of common stock warrants | (1,462) | (422) | ||
Net loss allocated to common stock-diluted | $ (26,282) | $ (20,025) | $ (73,395) | $ (53,521) |
Denominator: | ||||
Weighted average number of common stock shares outstanding - basic | 68,701,043 | 59,121,600 | 66,454,750 | 57,255,666 |
Dilutive securities: | ||||
Common stock warrants | 266,180 | 42,439 | ||
Weighted average number of common stock shares outstanding - diluted | 68,701,043 | 59,387,780 | 66,454,750 | 57,298,105 |
Net loss per share - basic: | $ (0.38) | $ (0.31) | $ (1.10) | $ (0.93) |
Net loss per share - diluted: | $ (0.38) | $ (0.34) | $ (1.10) | $ (0.93) |
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, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from the computation of diluted loss per share | 8,076 | 5,700 | 8,076 | 5,700 |
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 | 7,949 | 5,570 | 7,949 | 5,570 |
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 | 127 | 130 | 127 | 130 |
Other Accrued Liabilities - Sum
Other Accrued Liabilities - Summary of Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Other Accrued Liabilities Current [Abstract] | ||
Accrued compensation | $ 3,201 | $ 2,759 |
Accrued professional fees and other | 1,455 | 670 |
Operating lease liability | 389 | |
Deferred rent | 425 | |
Total other accrued liabilities | $ 5,045 | $ 3,854 |
Collaboration and License Agr_2
Collaboration and License Agreements - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2010Agreement | Jun. 30, 2006 | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | |
Janssen Pharmaceutical NV [Member] | ||||||
gaap:Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Royalty payment | $ 0 | $ 0 | $ 0 | $ 0 | ||
Accrued royalties | 0 | 0 | 0 | 0 | ||
Janssen Pharmaceutical NV [Member] | Maximum [Member] | ||||||
gaap:Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Percentage of royalty on net sales | 8.00% | |||||
Janssen Pharmaceuticals, Inc. [Member] | ||||||
gaap:Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Number of development and license agreements | Agreement | 2 | |||||
DiaTex, Inc. [Member] | ||||||
gaap:Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Royalty payment | 0 | 0 | 0 | 0 | ||
Development payment | $ 0 | $ 0 | $ 0 | $ 0 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019USD ($)Facility | Sep. 30, 2019USD ($)ft²Facility | |
Lessee Lease Description [Line Items] | ||
Weighted average remaining lease term | 4 years 3 months 18 days | 4 years 3 months 18 days |
Lease, option to extend | option to extend for an additional 5 years | |
Weighted average lease discount rate | 12.60% | 12.60% |
Operating lease right-of-use asset | $ 219 | $ 219 |
Operating lease liability | 2,240 | 2,240 |
Short term portion of operating lease liability | $ 389 | $ 389 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherAccruedLiabilitiesCurrent | us-gaap:OtherAccruedLiabilitiesCurrent |
Long-term portion of operating lease liability | $ 1,851 | $ 1,851 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:OperatingLeaseLiabilityNoncurrent | us-gaap:OperatingLeaseLiabilityNoncurrent |
Rent expenses | $ 100 | $ 300 |
Operating Expense [Member] | ||
Lessee Lease Description [Line Items] | ||
Lease costs | $ 200 | $ 400 |
Lease Facility [Member] | ||
Lessee Lease Description [Line Items] | ||
Number of leased facilities | Facility | 1 | 1 |
Area of office space | ft² | 17,698 | |
Lease start date | Jan. 16, 2014 |
Leases - Summary of Maturities
Leases - Summary of Maturities of Operating Lease Liabilities (Detail) $ in Thousands | Sep. 30, 2019USD ($) |
Leases [Abstract] | |
2019 (from October to December) | $ 158 |
2020 | 647 |
2021 | 667 |
2022 | 686 |
2023 | 707 |
Thereafter | 30 |
Total undiscounted future minimum lease payments | 2,895 |
Less: Imputed interest | 655 |
Lease liabilities | 2,240 |
Less: Current portion of operating lease liability (included in other accrued liabilities) | 389 |
Long-term portion of operating lease liability | $ 1,851 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Mar. 08, 2019 | Feb. 01, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Mar. 11, 2019 | Dec. 31, 2018 |
Equity [Abstract] | ||||||
Common stock, shares issued | 8,000,000 | 13,340,000 | 68,701,043 | 1,200,000 | 59,456,493 | |
Common stock offering price | $ 12.50 | $ 10.80 | ||||
Proceeds from issuance of common stock, net of issuance costs | $ 107,700 | $ 135,500 | $ 107,746 | $ 135,520 |
Stock Plan and Stock-Based Co_3
Stock Plan and Stock-Based Compensation - Additional Information (Detail) - 2013 Equity Incentive Plan [Member] - shares | Jan. 01, 2019 | Sep. 30, 2019 | Sep. 30, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Increase in shares reserved for issuance | 2,378,259 | ||
Shares available for grant | 1,249,186 | 1,249,186 | |
Employees, Directors and Consultant [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of option granted to employees | 589,600 | 2,733,960 |
Stock Plan and Stock-Based Co_4
Stock Plan and Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 2,865 | $ 1,728 | $ 7,483 | $ 5,275 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 1,504 | 741 | 3,602 | 2,045 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 1,361 | $ 987 | $ 3,881 | $ 3,230 |