Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 01, 2019 | |
Document And Entity Information [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 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | CARA | |
Security Exchange Name | NASDAQ | |
Entity Registrant Name | Cara Therapeutics, Inc. | |
Entity Central Index Key | 0001346830 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 46,678,977 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36279 | |
Entity Address, Address Line One | 4 Stamford Plaza | |
Entity Address, Address Line Two | 107 Elm Street | |
Entity Address, Address Line Three | 9th Floor | |
Entity Address, City or Town | Stamford | |
Entity Address, State or Province | CT | |
Entity Address, Postal Zip Code | 06902 | |
City Area Code | 203 | |
Local Phone Number | 406-3700 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 34,705 | $ 15,081 |
Marketable securities | 158,384 | 146,302 |
Income tax receivable | 1,033 | 664 |
Other receivables | 784 | 926 |
Prepaid expenses | 8,556 | 4,805 |
Restricted cash, current | 361 | |
Total current assets | 203,462 | 168,139 |
Operating lease right-of-use asset | 3,192 | |
Marketable securities, non-current | 55,985 | 21,396 |
Property and equipment, net | 748 | 880 |
Restricted cash | 408 | 408 |
Total assets | 263,795 | 190,823 |
Current liabilities: | ||
Accounts payable and accrued expenses | 20,581 | 13,622 |
Operating lease liability, current | 945 | |
Current portion of deferred revenue | 26,773 | 26,825 |
Total current liabilities | 48,299 | 40,447 |
Operating lease liability, non-current | 3,602 | |
Deferred revenue, non-current | 0 | 15,184 |
Deferred lease obligation | 1,562 | |
Commitments and contingencies (Note 15) | ||
Stockholders’ equity: | ||
Preferred stock; $0.001 par value; 5,000,000 shares authorized at September 30, 2019 and December 31, 2018, zero shares issued and outstanding at September 30, 2019 and December 31, 2018 | ||
Common stock; $0.001 par value; 100,000,000 shares authorized at September 30, 2019 and December 31, 2018, 46,673,977 shares and 39,547,558 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 46 | 39 |
Additional paid-in capital | 583,811 | 428,059 |
Accumulated deficit | (372,116) | (294,354) |
Accumulated other comprehensive income (loss) | 153 | (114) |
Total stockholders’ equity | 211,894 | 133,630 |
Total liabilities and stockholders’ equity | $ 263,795 | $ 190,823 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 46,673,977 | 39,547,558 |
Common stock, shares outstanding | 46,673,977 | 39,547,558 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue: | ||||
Total revenue | $ 5,785 | $ 5,062 | $ 15,375 | $ 7,936 |
Operating expenses: | ||||
Research and development | 35,992 | 22,303 | 83,956 | 52,732 |
General and administrative | 4,226 | 3,227 | 13,128 | 10,609 |
Total operating expenses | 40,218 | 25,530 | 97,084 | 63,341 |
Operating loss | (34,433) | (20,468) | (81,709) | (55,405) |
Other income | 1,261 | 1,002 | 3,297 | 1,780 |
Loss before benefit from income taxes | (33,172) | (19,466) | (78,412) | (53,625) |
Benefit from income taxes | 330 | 66 | 650 | 264 |
Net loss | $ (32,842) | $ (19,400) | $ (77,762) | $ (53,361) |
Net loss per share: | ||||
Basic and Diluted | $ (0.74) | $ (0.51) | $ (1.88) | $ (1.54) |
Weighted average shares: | ||||
Basic and Diluted | 44,517,134 | 38,034,216 | 41,314,044 | 34,696,835 |
Other comprehensive income, net of tax of $0: | ||||
Change in unrealized gains (losses) on available-for- sale marketable securities | $ (12) | $ 70 | $ 267 | $ 83 |
Total comprehensive loss | (32,854) | (19,330) | (77,495) | (53,278) |
License and Milestone Fees [Member] | ||||
Revenue: | ||||
Total revenue | $ 5,785 | 5,029 | 15,235 | 7,903 |
Clinical Compound Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 33 | $ 140 | $ 33 |
Condensed Statements of Compr_2
Condensed Statements of Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Income Statement [Abstract] | ||||
Other comprehensive income, tax | $ 0 | $ 0 | $ 0 | $ 0 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member]Follow-on Public Offering [Member] | Common Stock [Member] | Additional Paid-In Capital [Member]Follow-on Public Offering [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Follow-on Public Offering [Member] | Total |
Balance, Value at Dec. 31, 2017 | $ 33 | $ 307,158 | $ (220,341) | $ (70) | $ 86,780 | |||
Balance, Shares at Dec. 31, 2017 | 32,662,255 | |||||||
Stock-based compensation expense | 1,871 | 1,871 | ||||||
Shares issued upon exercise of stock options, Value | 263 | 263 | ||||||
Shares issued upon exercise of stock options, Shares | 37,688 | |||||||
Net loss | (16,767) | (16,767) | ||||||
Other comprehensive income (loss) | (44) | (44) | ||||||
Balance, Value at Mar. 31, 2018 | $ 33 | 309,292 | (237,108) | (114) | 72,103 | |||
Balance, Shares at Mar. 31, 2018 | 32,699,943 | |||||||
Balance, Value at Dec. 31, 2017 | $ 33 | 307,158 | (220,341) | (70) | 86,780 | |||
Balance, Shares at Dec. 31, 2017 | 32,662,255 | |||||||
Net loss | (53,361) | |||||||
Other comprehensive income (loss) | 83 | |||||||
Balance, Value at Sep. 30, 2018 | $ 39 | 423,180 | (273,702) | 13 | 149,530 | |||
Balance, Shares at Sep. 30, 2018 | 39,389,515 | |||||||
Balance, Value at Mar. 31, 2018 | $ 33 | 309,292 | (237,108) | (114) | 72,103 | |||
Balance, Shares at Mar. 31, 2018 | 32,699,943 | |||||||
Sale of common stock under license agreement, Value | $ 1 | 14,555 | 14,556 | |||||
Sale of common stock under license agreement, Shares | 1,174,827 | |||||||
Stock-based compensation expense | 2,069 | 2,069 | ||||||
Shares issued upon exercise of stock options, Value | 1,485 | 1,485 | ||||||
Shares issued upon exercise of stock options, Shares | 184,444 | |||||||
Net loss | (17,194) | (17,194) | ||||||
Other comprehensive income (loss) | 57 | 57 | ||||||
Balance, Value at Jun. 30, 2018 | $ 34 | 327,401 | (254,302) | (57) | 73,076 | |||
Balance, Shares at Jun. 30, 2018 | 34,059,214 | |||||||
Sale of common stock, net of underwriting discounts and commissions and offering expenses, value | $ 5 | $ 92,072 | $ 92,077 | |||||
Sale of common, net of underwriting discounts and commissions and offering expenses, shares | 5,175,000 | |||||||
Stock-based compensation expense | 1,819 | 1,819 | ||||||
Shares issued upon exercise of stock options, Value | 1,888 | 1,888 | ||||||
Shares issued upon exercise of stock options, Shares | 155,301 | |||||||
Net loss | (19,400) | (19,400) | ||||||
Other comprehensive income (loss) | 70 | 70 | ||||||
Balance, Value at Sep. 30, 2018 | $ 39 | 423,180 | (273,702) | 13 | 149,530 | |||
Balance, Shares at Sep. 30, 2018 | 39,389,515 | |||||||
Balance, Value at Dec. 31, 2018 | $ 39 | 428,059 | (294,354) | (114) | 133,630 | |||
Balance, Shares at Dec. 31, 2018 | 39,547,558 | |||||||
Stock-based compensation expense | 2,234 | 2,234 | ||||||
Shares issued upon exercise of stock options, Value | 234 | 234 | ||||||
Shares issued upon exercise of stock options, Shares | 17,291 | |||||||
Shares issued for consulting services | 197 | 197 | ||||||
Shares issued for consulting services, Shares | 10,195 | |||||||
Net loss | (21,960) | (21,960) | ||||||
Other comprehensive income (loss) | 187 | 187 | ||||||
Balance, Value at Mar. 31, 2019 | $ 39 | 430,724 | (316,314) | 73 | 114,522 | |||
Balance, Shares at Mar. 31, 2019 | 39,575,044 | |||||||
Balance, Value at Dec. 31, 2018 | $ 39 | 428,059 | (294,354) | (114) | 133,630 | |||
Balance, Shares at Dec. 31, 2018 | 39,547,558 | |||||||
Shares issued for consulting services | 197 | |||||||
Net loss | (77,762) | |||||||
Other comprehensive income (loss) | 267 | |||||||
Balance, Value at Sep. 30, 2019 | $ 46 | 583,811 | (372,116) | 153 | 211,894 | |||
Balance, Shares at Sep. 30, 2019 | 46,673,977 | |||||||
Balance, Value at Mar. 31, 2019 | $ 39 | 430,724 | (316,314) | 73 | 114,522 | |||
Balance, Shares at Mar. 31, 2019 | 39,575,044 | |||||||
Stock-based compensation expense | 2,681 | 2,681 | ||||||
Shares issued upon exercise of stock options, Value | $ 1 | 3,974 | 3,975 | |||||
Shares issued upon exercise of stock options, Shares | 378,706 | |||||||
Shares issued upon vesting of restricted stock units | 1,235 | 1,235 | ||||||
Shares issued upon vesting of restricted stock units, Shares | 74,166 | |||||||
Net loss | (22,960) | (22,960) | ||||||
Other comprehensive income (loss) | 92 | 92 | ||||||
Balance, Value at Jun. 30, 2019 | $ 40 | 438,614 | (339,274) | 165 | 99,545 | |||
Balance, Shares at Jun. 30, 2019 | 40,027,916 | |||||||
Sale of common stock under license agreement, Value | 4,000 | 4,000 | ||||||
Sale of common stock under license agreement, Shares | 170,793 | |||||||
Sale of common stock, net of underwriting discounts and commissions and offering expenses, value | $ 6 | $ 136,519 | $ 136,525 | |||||
Sale of common, net of underwriting discounts and commissions and offering expenses, shares | 6,325,000 | |||||||
Stock-based compensation expense | 2,835 | 2,835 | ||||||
Shares issued upon exercise of stock options, Value | 1,843 | 1,843 | ||||||
Shares issued upon exercise of stock options, Shares | 150,268 | |||||||
Net loss | (32,842) | (32,842) | ||||||
Other comprehensive income (loss) | (12) | (12) | ||||||
Balance, Value at Sep. 30, 2019 | $ 46 | $ 583,811 | $ (372,116) | $ 153 | $ 211,894 | |||
Balance, Shares at Sep. 30, 2019 | 46,673,977 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity (Parenthetical) - Common Stock [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Follow-on Public Offering [Member] | ||
Price per share | $ 23 | $ 19 |
Underwriting discounts and commissions and offering expenses | $ 8,950 | $ 6,248 |
License Agreements [Member] | ||
Price per share | $ 23.42 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities | ||
Net loss | $ (77,762) | $ (53,361) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Stock-based compensation expense | 9,182 | 5,759 |
Depreciation and amortization | 150 | 318 |
Amortization expense component of lease expense | 445 | |
Noncash expense related to oral formulation license agreement | 4,000 | |
Accretion of available-for-sale marketable securities | (1,168) | (1,177) |
Realized loss on sale of available-for-sale marketable securities | 32 | |
Deferred rent costs | (89) | |
Deferred revenue | (15,235) | 47,542 |
Changes in operating assets and liabilities: | ||
Income tax receivable | (369) | 192 |
Other receivables | 142 | (70) |
Prepaid expenses | (3,751) | (2,583) |
Accounts payable and accrued expenses | 6,958 | 5,497 |
Operating lease liability | (651) | |
Net cash (used in) provided by operating activities | (78,059) | 2,060 |
Investing activities | ||
Proceeds from maturities of available-for-sale marketable securities | 195,839 | 85,500 |
Proceeds from sale of available-for-sale marketable securities | 28,250 | |
Purchases of available-for-sale marketable securities | (241,075) | (138,689) |
Purchases of property and equipment | (18) | (49) |
Net cash used in investing activities | (45,254) | (24,988) |
Financing activities | ||
Proceeds from the sale of common stock in a follow-on public offering, net of issuance costs | 136,525 | 92,077 |
Proceeds from the sale of common stock under license agreement | 14,556 | |
Proceeds from the exercise of stock options | 6,051 | 3,636 |
Net cash provided by financing activities | 142,576 | 110,269 |
Net increase in cash, cash equivalents and restricted cash | 19,263 | 87,341 |
Cash, cash equivalents and restricted cash at beginning of period | 15,850 | 10,157 |
Cash, cash equivalents and restricted cash at end of period | 35,113 | $ 97,498 |
Noncash investing and financing activities | ||
Shares of common stock issued in connection with oral formulation license agreement | 4,000 | |
Shares of common stock issued in exchange for consulting services | $ 197 |
Business
Business | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Business | 1. Business Cara Therapeutics, Inc., or the Company, is a clinical-stage biopharmaceutical corporation formed on July 2, 2004. The Company is focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors. The Company’s primary activities to date have been organizing and staffing the Company, developing its product candidates and raising capital. As of September 30, 2019, the Company had raised aggregate net proceeds of approximately $519,700 from several rounds of equity financing, including its initial public offering, or IPO, which closed in February 2014 and four follow-on public offerings of common stock, which closed in July 2019, July 2018, April 2017 and August 2015, and the issuance of convertible preferred stock and debt prior to the IPO. The Company had also received $88,900 under its license agreements for CR845/difelikefalin, primarily with Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP, Maruishi Pharmaceutical Co. Ltd., or Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and an earlier product candidate for which development efforts ceased in 2007. Additionally, in May 2018, the Company received net proceeds of $14,556 from the issuance and sale of 1,174,827 shares of the Company’s common stock to Vifor (International) Ltd., or Vifor, in connection with the Company’s license agreement with VFMCRP (see Note 10, Collaboration and Licensing Agreements ). As of September 30, 2019, the Company had unrestricted cash and cash equivalents and marketable securities of $249,074 and an accumulated deficit of $372,116. The Company has incurred substantial net losses and negative cash flows from operating activities in nearly every fiscal period since inception and expects this trend to continue for the foreseeable future. The Company recognized net losses of $32,842 and $19,400 for the three months ended September 30, 2019 and 2018, respectively, and $77,762 and $53,361 for the nine months ended September 30, 2019 and 2018, respectively, and had net cash (used in) provided by operating activities of $(78,059) and $2,060 for the nine months ended September 30, 2019 and 2018, respectively. The Company is subject to risks common to other life science companies including, but not limited to, uncertainty of product development and commercialization, lack of marketing and sales history, development by its competitors of new technological innovations, dependence on key personnel, market acceptance of products, product liability, protection of proprietary technology, ability to raise additional financing, and compliance with Food and Drug Administration, or FDA, and other government regulations. If the Company does not successfully commercialize any of its product candidates, it will be unable to generate recurring product revenue or achieve profitability. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The unaudited interim condensed financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission, or SEC. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States of America, or GAAP. In the opinion of management, these unaudited interim financial statements reflect all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of results for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by SEC rules and regulations; however, the Company believes that the disclosures are adequate to make the information presented not misleading. The condensed balance sheet data as of December 31, 2018 were derived from audited financial statements, but do not include all disclosures required by GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto included in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2018. Use of Estimates The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, as of the date of the financial statements as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from the Company’s estimates and assumptions. Significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, useful lives of fixed assets, the periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, the determination of prepaid research and development, or R&D, clinical costs and accrued research projects, the amount of non-cash compensation costs related to share-based payments to employees and non-employees and the periods over which those costs are expensed, the incremental borrowing rate used in lease calculations and the likelihood of realization of deferred tax assets. Significant Accounting Policies There have been no material changes to the significant accounting policies previously disclosed in Note 2 to the Financial Statements in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2018, except for the recent adoption of new accounting pronouncements as disclosed below. Accounting Pronouncements Recently Adopted Leases On January 1, 2019, the Company adopted ASC 842, Leases , under which it elected not to adjust prior comparative periods, which are reported under ASC 840. In addition, the Company elected to adopt both the practical expedient to use hindsight when determining the lease term and the package of practical expedients available under ASC 842, including: · No re-evaluation of whether a contract is or contains a lease (embedded lease); · Lease classification is grandfathered · No reassessment of initial direct costs Upon adoption of ASC 842, the Company had only one lease, the Stamford Lease (see Note 15, Commitments and Contingencies: Leases ), which is included in operating lease right-of-use asset, or ROU asset, operating lease liability – current and operating lease liability – non-current in the Company’s Condensed Balance Sheets. In general, the Company determines if a contract, at its inception, is a lease or contains a lease based on whether the contract conveys the right to control the use of identified property, plant, or equipment (an identified asset) for a period of time in exchange for consideration. To determine whether a contract conveys the right to control the use of an identified asset for a period of time, the Company assesses whether, throughout the period of use, it has both the right to obtain substantially all of the economic benefits from use of the identified asset, and the right to direct the use of the identified asset. Both of these criteria are met by the Stamford Lease. Under ASC 842, the Company determines the amount of the operating lease liability based on the present value of the future minimum lease payments over the remaining lease term. The amount of the operating lease ROU asset is equal to the amount of the lease liability, less accrued rent and lease incentives received from the landlord. Initial direct costs were deemed to be immaterial. Since the Stamford Lease does not provide an implicit interest rate, the Company used an annual incremental borrowing rate of 7% based on the information available at the date of adoption for the purpose of determining the lease liability during the term of the lease. As noted above, upon adoption of ASC 842, the Company used hindsight in determining the term of the Stamford Lease. Although the Stamford Lease is renewable for one five-year term, upon inception of the lease the renewal term was not included in the lease term since it was not reasonably certain that the Company will exercise that option. Accordingly, the lease term of the Stamford Lease was not adjusted upon adoption of ASC 842 to determine the operating lease ROU asset and operating lease liability. The Stamford Lease contains both a lease and non-lease component which are accounted for separately. The Company allocates the consideration to the lease and the non-lease component on a relative standalone price basis. Lease expense under ASC 842 is recognized on a straight-line basis over the lease term in the Condensed Statements of Comprehensive Loss. There was no cumulative effect adjustment as a result of the adoption of ASC 842 on January 1, 2019, which reflects the difference between the amount of lease expense under ASC 842 that would have been recognized from inception of the Stamford Lease through December 31, 2018 and the amount of rent expense actually recognized under ASC 840 during that same period. Other Accounting Pronouncements Recently Adopted In June 2018, the FASB issued ASU No. 2018‑07, Compensation—Stock Compensation (Topic 718) , Improvements to Nonemployee Share-Based Payment Accounting , or ASU 2018‑07, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018‑07 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. Accordingly, under ASU 2018‑07, the fair value of stock options granted to nonemployees will be measured only on the grant date, the amount of which will be recognized as compensation expense over the nonemployee’s service (vesting) period in the same period(s) and in the same manner as if the Company had paid cash for the goods or services instead of paying with or using share-based payment awards. On an award-by-award basis, the Company may elect to use the contractual term as the expected term when estimating the fair value of a nonemployee award to satisfy the measurement objective. Prior guidance under Subtopic 505‑50 required the fair value of nonemployee stock options to be marked to market at each reporting period during the service period, which resulted in volatility of compensation expense during that period. The Company adopted ASU 2018‑07 on January 1, 2019 on a modified retrospective basis and remeasured, on that date, the fair value of all outstanding unvested stock options that had been granted to nonemployees. The adoption of ASU 2018‑07 did not have a material effect on its results of operations, financial position or cash flows because grants of stock options to nonemployees have been insignificant. Accounting Pronouncements Not Yet Adopted In November 2018, the FASB issued ASU No. 2018‑18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 , or ASU 2018‑18, which clarifies the interaction between Topic 808 and Topic 606 by (1) clarifying that certain transactions between collaborative arrangement participants should be accounted for under Topic 606; (2) adding unit-of-account guidance in Topic 808 to align with the guidance in Topic 606; and (3) clarifying presentation guidance for transactions with a collaborative arrangement participant that are not accounted for under Topic 606. ASU 2018‑18 is effective for public business entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period. The Company will adopt ASU 2018-18 on January 1, 2020, and has determined that ASU 2018‑18 will not have any effect on its financial position, results of operations or cash flows since all three of its collaboration and licensing agreements are accounted for under Topic 606 (see Note 10, Collaboration and Licensing Agreements and Note 11, Revenue Recognition ) . In August 2018, the FASB issued ASU No. 2018‑13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement , or ASU 2018‑13, which modifies the disclosure requirements on fair value measurements in Topic 820 to remove the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value measurements. ASU 2018‑13 also amends Topic 820 to clarify that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. ASU 2018‑13 also requires additional disclosure for changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period as well as the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. ASU 2018‑13 is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of ASU 2018‑13. The Company will adopt ASU 2018‑13, as applicable, on January 1, 2020. The Company does not expect that the adoption of ASU 2018‑13 will have a material effect on its results of operations, financial position or cash flows. In June 2016, the FASB issued ASU No. 2016‑13, Financial Instruments—Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments , or ASU 2016‑13, which replaces the incurred loss impairment methodology in current GAAP, that delays recognition of a credit loss until it is probable that such loss has been incurred, with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016‑13 modifies the other-than-temporary impairment model for available-for-sale debt securities by requiring (1) estimating expected credit losses only when the fair value is below the amortized cost of the asset; (2) recording a credit loss without regard to the length of time a security has been in an unrealized loss position; (3) limiting the measurement of the credit loss to the difference between the security’s amortized cost basis and its fair value and (4) presenting credit losses as an allowance rather than as a write-down, which will allow the Company to record reversals of credit losses in current period net income, a practice that is currently prohibited. In April 2019, codification improvements were issued to help clarify and correct certain portions of ASU 2016‑13. ASU 2016‑13 will be effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. The Company will adopt ASU 2016-13 on January 1, 2020 and believes ASU 2016-13 will primarily impact the Company’s assessment of any potential impairment of its investments in debt securities, specifically its assessment of whether any portion of an unrealized loss in a given period relates to a credit loss. |
Available-for-Sale Marketable S
Available-for-Sale Marketable Securities | 9 Months Ended |
Sep. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Available-for-Sale Marketable Securities | 3. Available-for-Sale Marketable Securities As of September 30, 2019 and December 31, 2018, the Company’s available-for-sale marketable securities consisted of debt securities issued by the U.S. Treasury, U.S. government-sponsored entities and investment grade institutions as well as municipal bonds. The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of September 30, 2019 and December 31, 2018: As of September 30, 2019 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 12,842 $ 27 $ (9) $ 12,860 U.S. government agency obligations 22,426 12 (11) 22,427 Corporate bonds 108,108 145 (27) 108,226 Commercial paper 65,340 19 (3) 65,356 Municipal bonds 5,500 — — 5,500 Total available-for-sale marketable securities $ 214,216 $ 203 $ (50) $ 214,369 As of December 31, 2018 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 19,540 $ — $ (1) $ 19,539 U.S. government agency obligations 17,860 — (1) 17,859 Corporate bonds 75,999 5 (94) 75,910 Commercial paper 50,413 — (23) 50,390 Municipal bonds 4,000 — — 4,000 Total available-for-sale marketable securities $ 167,812 $ 5 $ (119) $ 167,698 All available-for-sale marketable securities are classified as Marketable securities, current or Marketable securities, non-current depending on the contractual maturity date of the individual available-for-sale security. The Company classifies its marketable debt securities based on their contractual maturity dates. As of September 30, 2019, the Company’s marketable debt securities mature at various dates through September 2021. The amortized cost and fair values of marketable debt securities by contractual maturity were as follows. As of September 30, 2019 As of December 31, 2018 Contractual maturity Amortized Cost Fair Value Amortized Cost Fair Value Less than one year $ 158,274 $ 158,384 $ 146,363 146,302 One year to two years 55,942 55,985 21,449 21,396 Total $ 214,216 $ 214,369 $ 167,812 $ 167,698 The following tables show the fair value of the Company’s available-for-sale marketable securities that have unrealized losses and that are deemed to be only temporarily impaired, aggregated by investment category and length of time that the individual investments have been in a continuous unrealized loss position. As of September 30, 2019 Less than 12 Months 12 Months or Greater Total Gross Gross Gross Fair Unrealized Fair Unrealized Fair Unrealized Value Losses Value Losses Value Losses U.S. Treasury securities $ 3,177 $ (9) $ — $ — $ 3,177 $ (9) U.S. government agency obligations 5,487 (11) — — 5,487 (11) Corporate bonds 27,689 (27) — — 27,689 (27) Commercial paper 11,906 (3) — — 11,906 (3) Total $ 48,259 $ (50) $ — $ — $ 48,259 $ (50) As of December 31, 2018 Less than 12 Months 12 Months or Greater Total Gross Gross Gross Fair Unrealized Fair Unrealized Fair Unrealized Value Losses Value Losses Value Losses U.S. Treasury securities $ 16,392 $ (1) $ — $ — $ 16,392 $ (1) U.S. government agency obligations 5,596 (1) — — 5,596 (1) Corporate bonds 71,322 (94) — — 71,322 (94) Commercial paper 39,445 (23) — — 39,445 (23) Total $ 132,755 $ (119) $ — $ — $ 132,755 $ (119) As of September 30, 2019 and December 31, 2018, the Company held a total of 23 out of 84 positions and 69 out of 84 positions, respectively, that were in an unrealized loss position, none of which had been in an unrealized loss position for 12 months or greater. Based on the Company’s review of these securities, the Company believes that the cost basis of its available-for-sale marketable securities is recoverable and that, therefore, it had no other-than-temporary impairments on these securities as of September 30, 2019 and December 31, 2018. The Company does not intend to sell these debt securities before maturity and the Company believes it is not more likely than not that it will be required to sell these securities before the recovery of their amortized cost basis, which may be maturity. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income (Loss) | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Income (Loss) | 4. Accumulated Other Comprehensive Income (Loss) The following table summarizes the changes in accumulated other comprehensive income (loss), or AOCI, net of tax, from unrealized gains (losses) on available-for-sale marketable securities, the Company’s only component of AOCI, for the nine months ended September 30, 2019 and September 30, 2018. Total Accumulated Other Comprehensive Income (Loss) Balance, December 31, 2018 $ (114) Other comprehensive income before reclassifications 267 Amount reclassified from accumulated other comprehensive income — Net current period other comprehensive income 267 Balance, September 30, 2019 $ 153 Balance, December 31, 2017 $ (70) Other comprehensive income before reclassifications 51 Amount reclassified from accumulated other comprehensive loss 32 Net current period other comprehensive income 83 Balance, September 30, 2018 $ 13 The reclassifications out of AOCI and into net loss were as follows: Three Months Ended Nine Months Ended Affected Line Item in the September 30, September 30, Statements of Component of AOCI 2019 2018 2019 2018 Operations Unrealized gains (losses) on available-for- sale marketable securities Realized gains (losses) on sale of securities $ — $ (17) $ — $ (32) Other income — — — — Benefit from income taxes $ — $ (17) $ — $ (32) The amounts reclassified out of AOCI into net loss were determined by specific identification. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements As of September 30, 2019 and December 31, 2018, the Company’s financial instruments consisted of cash, cash equivalents, available-for-sale marketable securities, prepaid expenses, restricted cash, accounts payable and accrued liabilities. The fair values of cash, cash equivalents, prepaid expenses, restricted cash, accounts payable and accrued liabilities approximate their carrying values due to the short-term nature of these financial instruments. Available-for-sale marketable securities are reported on the Company’s Condensed Balance Sheets as Marketable Securities at their fair values, based upon pricing of securities with the same or similar investment characteristics as provided by third-party pricing services, as described below. Current accounting guidance defines fair value, establishes a framework for measuring fair value in accordance with ASC section 820, and requires certain disclosures about fair value measurements. The valuation techniques included in the guidance are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The Company classifies its investments in a fair value hierarchy that is intended to increase consistency and comparability in fair value measurements and related disclosures. The fair value hierarchy is divided into three levels based on the source of inputs as follows: · Level 1 – Observable inputs – quoted prices in active markets for identical assets and liabilities. · Level 2 – Observable inputs other than the quoted prices in active markets for identical assets and liabilities – such as quoted prices for similar instruments, quoted prices for identical or similar instruments in inactive markets, or other inputs that are observable or can be corroborated by observable market data. · Level 3 – Unobservable inputs – includes amounts derived from valuation models where one or more significant inputs are unobservable and require the Company to develop relevant assumptions. Valuation Techniques - Level 2 Inputs The Company estimates the fair values of its financial instruments categorized as level 2 in the fair value hierarchy, including U.S. Treasury securities, U.S. government agency obligations, corporate bonds, commercial paper and municipal bonds, by taking into consideration valuations obtained from third-party pricing services. The pricing services use 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, benchmark yields, issuer credit spreads, benchmark securities, and other observable inputs. The Company obtains a single price for each financial instrument and does not adjust the prices obtained from the pricing service. The Company validates the prices provided by its third-party pricing services by reviewing their pricing methods, obtaining market values from other pricing sources and comparing them to the share prices presented by the third-party pricing services. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by its third-party pricing services as of September 30, 2019 or December 31, 2018. The following tables summarize the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2019 and December 31, 2018. Fair value measurement as of September 30, 2019 : Quoted prices in Significant other Significant Financial assets active markets for observable unobservable identical assets inputs inputs Type of Instrument Total (Level 1) (Level 2) (Level 3) Cash and cash equivalents: Money market funds and checking accounts $ 34,705 $ 34,705 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 12,860 — 12,860 — U.S. government agency obligations 22,427 — 22,427 — Corporate bonds 108,226 — 108,226 — Commercial paper 65,356 — 65,356 — Municipal bonds 5,500 — 5,500 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 249,482 $ 35,113 $ 214,369 $ — Fair value measurement as of December 31, 2018: Quoted prices in Significant other Significant Financial assets active markets for observable unobservable identical assets inputs inputs Type of Instrument Total (Level 1) (Level 2) (Level 3) Cash and cash equivalents: Money market funds and checking accounts $ 15,081 $ 15,081 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 19,539 — 19,539 — U.S. government agency obligations 17,859 — 17,859 — Corporate bonds 75,910 — 75,910 — Commercial paper 50,390 — 50,390 — Municipal bonds 4,000 — 4,000 — Restricted cash: Commercial money market account 769 769 — — Total financial assets $ 183,548 $ 15,850 $ 167,698 $ — There were no purchases, sales or maturities of Level 3 financial assets and no unrealized gains or losses related to Level 3 available-for-sale marketable securities for the nine months ended September 30, 2019 . There were no transfers of financial assets between Levels 1, 2, or 3 classifications during the nine months ended September 30, 2019 . |
Restricted Cash
Restricted Cash | 9 Months Ended |
Sep. 30, 2019 | |
Receivables [Abstract] | |
Restricted Cash | 6. Restricted Cash The Company is required to maintain a stand-by letter of credit as a security deposit under its lease for its office space in Stamford, Connecticut (refer to Note 15, Commitments and Contingencies: Leases ). The fair value of the letter of credit approximates its contract value. The Company’s bank requires the Company to maintain a restricted cash balance to serve as collateral for the letter of credit issued to the landlord by the bank. As of September 30, 2019, the restricted cash balance for the Stamford Lease was invested in a commercial money market account. The letter of credit balance for the Stamford Lease was required to remain at $769 through May 19, 2019 and thereafter, upon request from the Company, was eligible to be reduced to $408 through the end of the lease term in November 2023. The reduction in the balance of the letter of credit for the Stamford Lease was contingent upon the Company not being in default of any provisions of that lease prior to the request for the reduction. In July 2019, the Company was granted the reduction in the balance of the letter of credit. As of September 30, 2019, the Company had $408 of restricted cash related to the Stamford Lease in long-term assets. As of December 31, 2018, the Company had $361 of restricted cash related to the Stamford Lease in current assets and $408 in long-term assets, respectively. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Balance Sheets that sum to the total of the same such amounts shown in the Condensed Statements of Cash Flows. September 30, 2019 December 31, 2018 Cash and cash equivalents $ 34,705 $ 15,081 Restricted cash, current assets — 361 Restricted cash, long-term assets 408 408 Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows $ 35,113 $ 15,850 |
Prepaid Expenses
Prepaid Expenses | 9 Months Ended |
Sep. 30, 2019 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses | 7. Prepaid expenses As of September 30, 2019, prepaid expenses were $8,556, consisting of $7,751 of prepaid R&D clinical costs, $481 of prepaid insurance and $324 of other prepaid costs. As of December 31, 2018, prepaid expenses were $4,805, consisting of $4,377 of prepaid R&D clinical costs, $245 of prepaid insurance, and $183 of other prepaid costs. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Accounts Payable and Accrued Expenses | 8. Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following: September 30, 2019 December 31, 2018 Accounts payable $ 9,536 $ 4,371 Accrued research projects 7,748 6,079 Accrued professional fees 566 802 Accrued compensation and benefits 2,731 2,370 Total $ 20,581 $ 13,622 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity On August 20, 2019, the Company entered into a Non-Exclusive License Agreement, or the License Agreement, with Enteris Biopharma, Inc., or Enteris (see Note 15, Commitments and Contingencies for additional information regarding the License Agreement). As consideration for the licensed rights under the License Agreement, the Company paid an upfront fee equal to $8,000, consisting of $4,000 in cash and $4,000 in shares of the Company’s common stock. In connection with the License Agreement, on August 20, 2019, the Company entered into a Common Stock Purchase Agreement, or the Purchase Agreement, with Enteris and its affiliate, EBP Holdco LLC, collectively referred to as Purchaser, pursuant to which the Company issued and sold to Purchaser 170,793 shares of its common stock in a private placement in satisfaction of the $4,000 portion of the upfront fee payable in shares of the Company’s common stock pursuant to the License Agreement, and for no additional consideration, based on a purchase price of $23.42 per share, which was equal to the 30-day volume weighted average price of the Company’s common stock on August 20, 2019. In addition, if the Company exercises its right, but not obligation, to terminate its obligation to pay any royalties under the License Agreement in exchange for a lump sum payment in cash, it may elect to make 50% of the payment in stock by issuing additional shares of the Company’s common stock valued at the 30-day volume weighted average price of the Company’s common stock as of such exercise. Pursuant to its obligations under the Purchase Agreement, the Company effected the registration and sale of the shares issued and sold to Purchaser thereunder in accordance with the applicable requirements of the Securities Act of 1933, as amended, or the Securities Act, through the filing of an automatic shelf registration statement on Form S-3ASR (File No. 333-233666) with the SEC on September 9, 2019. In addition, the Purchase Agreement includes customary representations, warranties and covenants by the Company (see Note 15, Commitments and Contingencies ). On July 24, 2019, the Company entered into an underwriting agreement with J.P. Morgan Securities LLC and Jefferies LLC, as representatives of the several underwriters named therein, relating to the issuance and sale by the Company of 6,325,000 shares of its common stock, which included the exercise of the underwriters’ option to purchase 825,000 additional shares of common stock, at a public offering price of $23.00 per share. The Company closed this offering on July 29, 2019, including the full exercise of the underwriters’ option to purchase 825,000 additional shares of common stock. The Company received net proceeds of approximately $136,525, after deducting $8,950 of underwriting discounts and commissions and estimated offering expenses payable by the Company. This offering was made pursuant to the Company’s Shelf Registration Statement on Form S-3 (File No. 333-230333), or the Shelf Registration Statement, filed with the SEC on March 15, 2019 and declared effective on April 4, 2019, and a related prospectus supplement dated July 24, 2019, which was filed with the SEC on July 25, 2019. The Shelf Registration Statement provides for aggregate offerings of up to $300,000 of common stock, preferred stock, debt securities, warrants or any combination thereof. The securities registered under the Shelf Registration Statement include unsold securities that had been registered under the Company’s previous shelf registration statement (File No. 333-216657) that was declared effective on March 24, 2017. In May 2019, as a result of the achievement of a clinical performance target, an aggregate of 74,166 restricted stock units of various executive officers vested and were settled in shares of the Company’s common stock (see Note 13, Stock-Based Compensation ). On March 20, 2019, or the Effective Date, the Company entered into a consulting agreement with an existing stockholder. In accordance with the agreement, the stockholder provided various consulting services to the Company in exchange for 10,195 unregistered shares of the Company’s common stock. The closing price of the Company’s common stock on the Effective Date was $19.37 per share. The services provided by the consultant were performed during the six-month period following the Effective Date. During the three and nine months ended September 30, 2019, stock-based compensation expense of $98 and $197, respectively, was recognized in the Statements of Comprehensive Loss, all of which related to G&A expense. |
Collaboration and Licensing Agr
Collaboration and Licensing Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration and Licensing Agreements | 10. Collaboration and Licensing Agreements Vifor Fresenius Medical Care Renal Pharma Ltd. On May 17, 2018, the Company entered into a license agreement, or the VFMCRP Agreement, with VFMCRP under which the Company granted VFMCRP an exclusive, royalty-bearing license, or the VFMCRP License, to seek regulatory approval to commercialize, import, export, use, distribute, offer for sale, promote, sell and otherwise commercialize CR845/difelikefalin injection, or the Licensed Product, for all therapeutic uses to prevent, inhibit or treat itch associated with pruritus in hemodialysis and peritoneal-dialysis patients, or the Field, worldwide (excluding the United States, Japan and South Korea), or the Territory. Upon entry into the VFMCRP Agreement, VFMCRP made a non-refundable, non-creditable $50,000 upfront payment to the Company and Vifor purchased 1,174,827 shares of the Company’s common stock, or the Vifor Shares, for $20,000 at a price of $17.024 per share, which represents a premium over a pre-determined average closing price of the Company’s common stock. The purchase of the Company’s common stock was governed by a separate stock purchase agreement. The excess of the stock purchase price over the cost of the Vifor Shares at the closing price of the Company’s common stock on the purchase date of $5,444 was added to the upfront payment for accounting purposes. The Company is eligible to receive from VFMCRP regulatory and commercial milestone payments in the aggregate of up to $470,000, consisting of up to $30,000 in regulatory milestones and up to $440,000 in tiered commercial milestones, all of which are sales-related. The Company is also eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in the VFMCRP Agreement, of CR845/difelikefalin injection in the Licensed Territories. The Company retains full commercialization rights for CR845/difelikefalin injection for the treatment of CKD-aP in the United States except in the dialysis clinics of Fresenius Medical Care North America, or FMCNA, where VFMCRP and the Company will promote CR845/difelikefalin injection under a profit-sharing arrangement (subject to the terms and conditions of the VFMCRP Agreement) based on net FMCNA clinic sales recorded by the Company. At inception of the VFMCRP Agreement, the transaction price of $55,444 was allocated entirely to the one combined performance obligation, as described above, and was initially recorded as deferred revenue. License and milestone revenue will be recognized proportionately as the R&D services are conducted (i.e., prior to submission of an NDA). The license also requires VFMCRP to promote and take orders in the U.S. for sale by the Company to FMC U.S. Dialysis Clinics and allows VFMCRP to grant sub-licenses, which, in certain cases, requires the Company’s prior written consent. The Company retains the rights to import, distribute, promote, sell and otherwise commercialize the Licensed Product outside of the Field and outside of the Territory. The VFMCRP Agreement terminates upon the expiration of all royalty terms with respect to the Licensed Products, which expire on a Product-by-Product and country-by-country basis, at the latest of (a) the expiration of all patent rights licensed to VFMCRP covering such Licensed Product; (b) the expiration of all regulatory and data exclusivity applicable to such Licensed Product in such country and (c) the tenth anniversary of the first commercial sale of such Product in such country. The VFMCRP Agreement may be terminated earlier by either party for material breach that is not cured within 60 days, bankruptcy by either party and by both parties upon mutual written consent. The Company may terminate the VFMCRP Agreement if VFMCRP challenges the validity of any licensed patent rights, except if such patent challenge results from the Company’s action against VFMCRP for infringement of any licensed patent in the Territory. In addition, upon the earlier of (1) the acceptance for filing of an NDA covering Licensed Product filed with the FDA (after completion of the Phase 3 program) or (2) the third anniversary of the Effective Date, the VFMCRP Agreement may be terminated by VFMCRP in its entirety or with respect to any countries within the Territory upon written notice to the Company. Such termination will be effective twelve months following the date of such notice. If the VFMCRP Agreement terminates early for any reason stated above, VFMCRP’s licenses will terminate, VFMCRP’s rights to use the Company’s confidential information and the Company’s know-how will revert to the Company and VFMCRP will assign and transfer to the Company all right, title and interest in all regulatory applications (IND’s and NDA’s), regulatory approval applications and regulatory approvals in the Territory covering Licensed Product. Maruishi Pharmaceutical Co., Ltd. In April 2013, the Company entered into a license agreement with Maruishi, or the Maruishi Agreement, under which the Company granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing CR845/difelikefalin for acute pain and/or uremic pruritus in Japan. Maruishi has the right to grant sub-licenses in Japan, which entitles the Company to receive sub-license fees, net of prior payments made by Maruishi to the Company. Under the Maruishi Agreement, the Company and Maruishi are required to use commercially reasonable efforts, at their own expense, to develop, obtain regulatory approval for and commercialize CR845/difelikefalin in the United States and Japan, respectively. In addition, the Company provided Maruishi specific clinical development services for CR845/difelikefalin used in Maruishi’s field of use. Under the terms of the Maruishi Agreement, the Company is eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered, low double-digit royalties with respect to any sales of the licensed product sold in Japan by Maruishi, if any, and share in any sub-license fees. During the nine months ended September 30, 2019, the Company recognized clinical compound revenue of $140 from the sale of clinical compound to Maruishi and as a result, the Company incurred R&D expense of $126 during this period. There were no sales of clinical compound to Maruishi during the three months ended September 30, 2019. During each of the three and nine months ended September 30, 2018, the Company recognized clinical compound revenue of $33 from the sale of clinical compound to Maruishi and as a result, the Company incurred R&D expense of $30 during those periods. Chong Kun Dang Pharmaceutical Corporation In April 2012, the Company entered into a license agreement, or the CKDP Agreement, with Chong Kun Dang Pharmaceutical Corporation, or CKDP, in South Korea, under which the Company granted CKDP an exclusive license to develop, manufacture and commercialize drug products containing CR845/difelikefalin in South Korea. The Company and CKDP are each required to use commercially reasonable efforts, at their respective expense, to develop, obtain regulatory approval for and commercialize CR845/difelikefalin in the United States and South Korea, respectively. The Company identified the granting of the license as its only performance obligation under the CKDP Agreement. Under the terms of the CKDP Agreement, the Company is eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered royalties, with percentages ranging from the high single digits to the high teens, based on net sales of products containing CR845/difelikefalin in South Korea, if any, and share in any sub-license fees. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2019 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 11. Revenue Recognition The Company currently recognizes revenue in accordance with ASC 606, as amended, for the VFMCRP, Maruishi and CKDP agreements (see Note 10 , Collaboration and Licensing Agreements ). Under each of these agreements, the Company has recognized revenue from upfront payments and, under the Maruishi Agreement and the CKDP Agreement, from clinical development milestone payments. The Company has also recognized revenue from a sub-license payment earned under the Maruishi Agreement. Under the Maruishi Agreement and the CKDP Agreement, the Company may earn additional future milestone payments upon the achievement of defined clinical events, and under the VFMCRP Agreement, the Maruishi Agreement and the CKDP Agreement, upon the achievement of defined regulatory events, and under the VFMCRP Agreement and the Maruishi Agreement, from sales milestones. The Company may also recognize revenue in the future from royalties on net sales under all three agreements. In addition, the Company has recognized revenue upon the delivery of clinical compound to Maruishi in accordance with separate supply agreements. Contract balances As of September 30, 2019, the Company had deferred revenue, current of $26,773 related to the performance obligations from the VFMCRP Agreement and had no balances of receivables, other assets or deferred revenue, non-current related to the VFMCRP Agreement. There were no balances of receivables, other assets or deferred revenue relating to the Maruishi and CKDP agreements as of September 30, 2019. As of December 31, 2018, the Company had deferred revenue, current of $26,825 and deferred revenue, non-current of $15,184 related to the performance obligations from the VFMCRP Agreement and no balances of receivables or other assets related to the VFMCRP Agreement. There were no balances of receivables, other assets or deferred revenue relating to the Maruishi and CKDP agreements as of December 31, 2018. Performance obligations Under the VFMCRP Agreement, the Company’s performance obligations of granting a license to allow VFMCRP to commercialize CR845/difelikefalin injection worldwide, except in the United States, Japan and South Korea, which occurred at inception of the contract in May 2018, and performing R&D services by the Company to obtain sufficient clinical data which will be shared with VFMCRP to allow them to receive regulatory approval to sell CR845/difelikefalin in the licensed territory, are not distinct, and are accounted for as a single performance obligation during the period that the R&D services are rendered (see Note 10, Collaboration and Licensing Agreements ). The Company’s distinct performance obligations under the Maruishi Agreement include transfer of the license to the Company’s IP, which allowed Maruishi to develop and commercialize CR845/difelikefalin, for acute pain and uremic pruritus indications in Japan, which occurred at inception of the contract in 2013, and performance of R&D services, which occurred from 2013 to 2015, as those services were rendered. The Company agreed to conduct limited work on an oral tablet formulation of CR845/difelikefalin and to conduct Phase 1 and proof-of-concept Phase 2 clinical trials of an intravenous formulation of CR845/difelikefalin to be used to treat patients with uremic pruritus. The Company agreed to transfer the data and information from such development to Maruishi for its efforts to obtain regulatory approval in Japan. These activities are referred to as R&D services. The Company’s only performance obligation under the supply agreement with Maruishi is to deliver clinical compound to Maruishi in accordance with the receipt of purchase orders. If and when the Company enters into a supply agreement with VFMCRP, the Company’s only performance obligation under this supply agreement would be to deliver CR845/difelikefalin injection to VFMCRP in accordance with the receipt of purchase orders. Under the CKDP Agreement, the Company’s only performance obligation is to transfer the license to the Company’s IP related to CR845/difelikefalin, which occurred at inception of the contract in 2012. Upon execution of the VFMCRP Agreement, the Maruishi Agreement and the CKDP Agreement, the Company received a single fixed payment from each counterparty in exchange for granting the respective licenses and performing its other obligations. In addition, each of the counterparties made an equity investment in the Company’s common stock. Transaction price allocated to the remaining performance obligations At inception of the VFMCRP Agreement, the entire transaction price of $55,444 was allocated to the one combined performance obligation, as described above. For the three and nine months ended September 30, 2019, $5,785 and $15,235, respectively, were recognized as license and milestone fees revenue based on the percentage of R&D services that were completed during the period. As of September 30, 2019, $28,671 of the $55,444 has been recognized as license and milestone fees revenue based on the percentage of R&D services that has been completed since the inception of the VFMCRP Agreement. As of September 30, 2019, there were no remaining performance obligations under either the Maruishi Agreement or the CKDP Agreement, although the Company is eligible to receive milestone payments and sales royalties in the future. Significant judgments In applying ASC 606, as amended, to its three contracts, the Company made the following judgments that significantly affect the timing and amount of revenue recognition: 1. The VFMCRP Agreement contains one combined performance obligation, which includes the Company’s two performance obligations to grant a license to VFMCRP and conduct R&D services. Both of those performance obligations are inputs to the promise, within the context of the contract, to transfer a combined output for which VFMCRP has contracted (the ability of VFMCRP to commercialize the Licensed Product) (see Note 10, Collaboration and Licensing Agreements , for further discussion). The Maruishi Agreement contains two distinct performance obligations: the granting of the license and the promise to deliver defined R&D services. Under the Maruishi Agreement, the license and the R&D services represent distinct goods or services from each other because Maruishi is able to benefit from the license on its own or together with other resources that are readily available to it (i.e., capable of being distinct). Maruishi’s ability to benefit from the license without the R&D services is indicated by its ability to conduct clinical trials of CR845/difelikefalin on its own and by the provision in the Maruishi Agreement whereby if the Company suspends or discontinues its development activity, the Company will provide information regarding its development efforts up to that point so that Maruishi may continue development and commercialization of the product in Japan. Therefore, the R&D services do not significantly affect Maruishi’s ability to use and benefit from the license. In addition, the Company’s promise in the Maruishi contract to transfer the license is separately identifiable from the promise to provide defined R&D services (i.e., distinct within the context of the contract) because the Company is not using the goods or services as inputs to produce or deliver the combined output or outputs specified by the customer. The combined output specified by Maruishi is its right to conduct development activities related to CR845/difelikefalin in Japan, which could result in regulatory approval in Japan. That right is derived from the Company’s grant of the license. Maruishi is conducting clinical trials on its own and does not require the R&D services provided by the Company. Furthermore, the R&D services do not significantly modify or customize the license and vice versa. Finally, the license and R&D services are not highly interdependent or highly interrelated because the Company is able to fulfill its promise to transfer the initial license independently from its promise to subsequently provide the R&D services, which Maruishi can obtain on its own. The only performance obligation in the CKDP Agreement is the granting of the license. 2. The transaction price is the amount of consideration that the Company expects to be entitled to in exchange for transferring promised goods or services to the customer. The transaction price must be determined at inception of a contract and may include amounts of variable consideration. However, there is a constraint on inclusion of variable consideration, such as milestone payments or sales-based royalty payments, in the transaction price related to licenses of IP, if there is uncertainty at inception of the contract as to whether such consideration will be recognized in the future. The decision as to whether or not it is probable that a significant reversal of revenue will occur in the future, depends on the likelihood and magnitude of the reversal and is highly susceptible to factors outside the entity’s influence (for example, the Company cannot determine the outcome of clinical trials; the Company cannot determine if or when they or the counterparty will initiate or complete clinical trials; and the Company’s ability to obtain regulatory approval is difficult). In addition, the uncertainty is not expected to be resolved for a long period of time (in the order of years) and finally, the Company has limited experience in the field. Therefore, at inception of the VFMCRP Agreement, the Maruishi Agreement and the CKDP Agreement, milestones and sales-based royalty payments were not included in the transaction price based on the factors noted above. Under the VFMCRP Agreement, the single combined performance obligation will be satisfied as the R&D services are rendered and the transaction price, including the upfront payment of $50,000 and the premium on the common stock purchased by VFMCRP of $5,444, will be recognized as revenue as the R&D services are performed based on the costs incurred as a percentage of the estimated total costs to be incurred to complete the performance obligation. The remaining potential consideration was considered to be variable consideration and was constrained at inception of the contract, including regulatory and sales milestones and sales royalties (see Note 10, Collaboration and Licensing Agreements ). All performance obligations under the Maruishi Agreement and the CKDP Agreement were satisfied by the end of 2015. In the future, any milestone event will be recognized as milestone and license fee revenue and collaboration revenue based upon the relative standalone selling prices of the two performance obligations at inception of the Maruishi Agreement, and as milestone and license fee revenue under the CKDP Agreement. Under the Maruishi Agreement, the transaction price includes only the non-refundable and non-creditable upfront license fee of $15,337, including the premium of $337 from the sale of Company stock to Maruishi, that was paid to the Company at inception of the contract. The remaining potential consideration was considered to be variable consideration and was constrained at inception of the contract, including an aggregate of up to $10,500, which the Company is eligible to receive upon achievement of clinical development and regulatory milestones, a one-time sales milestone of one billion Yen when a certain sales level is attained; a mid-double-digit percentage of all non-royalty payments received by Maruishi from its sub-licensees, if any; and tiered royalties based on net sales of products containing CR845/difelikefalin in Japan, if any, with minimum royalty rates in the low double digits and maximum royalty rates in the low twenties. Under the CKDP Agreement, the transaction price includes only the non-refundable and non-creditable upfront license fee of $646, including the premium of $83 from the sale of Company stock to CKDP, that was paid to the Company at inception of the contract. The remaining consideration was considered to be variable consideration and was constrained at inception of the contract, including an aggregate of up to $3,750, which the Company is eligible to earn upon achievement of clinical development and regulatory milestones. The Company is also eligible to receive a mid-double-digit percentage of all non-royalty payments received by CKDP from its sub-licensees, if any, and tiered royalties ranging from the high single digits to the high teens based on net sales of products containing CR845/difelikefalin in South Korea, if any. 3. In order to recognize revenue under ASC 606, as amended, for contracts for which more than one distinct performance obligation has been identified, the Company must allocate the transaction price to the performance obligations based upon their standalone selling prices. The best evidence of standalone selling price is an observable price of a good or service when sold separately by an entity in similar circumstances to similar customers. If such evidence is not available, standalone selling price should be estimated so that the amount that is allocated to each performance obligation equals the amount that the entity expects to receive for transferring goods or services. The Company has identified more than one performance obligation only in the Maruishi Agreement. Since evidence based on observable prices is not available for the performance obligations under the Maruishi Agreement, the Company considered market conditions and entity-specific factors, including those contemplated in negotiating the agreements, as well as certain internally developed estimates. At inception of the Maruishi Agreement, the Company determined the estimate of standalone selling price for the license performance obligation by using the adjusted market assessment approach. Under this method, the Company forecasted and analyzed CR845/difelikefalin in the Japanese market, the phase of clinical development as well as considered recent similar license arrangements within the same phase of clinical development, therapeutic area, type of agreement, etc. To estimate the standalone selling price of the R&D services, the Company forecasted its expected costs of satisfying that performance obligation and added a margin for that service. 4. At inception of the Maruishi Agreement, the Company allocated the transaction price of $15,337 between the two performance obligations based on their relative standalone selling prices, determined as described above. The Company determined that the license and the R&D services had estimated standalone selling prices of $10,200 and $6,200, respectively. The resulting percentage allocations were applied to the $15,337 of total transaction price, which resulted in $9,637 being allocated to the license performance obligation, which was recognized immediately as license revenue, while $5,700 was allocated to the R&D services performance obligation. The amount allocated to the R&D services performance obligation was initially recorded as deferred revenue and was recognized as collaborative revenue as the R&D services were provided through July 2015. Since both the VFMCRP Agreement and the CKDP Agreement each contain only one distinct performance obligation, at the inception of each of those agreements, the entire transaction price was allocated to the respective performance obligation. 5. Revenue should be recognized when, or as, an entity satisfies a performance obligation by transferring a promised good or service to a customer; i.e., when the customer obtains control of the good or service. The licenses granted to both Maruishi and CKDP are being accounted for as distinct performance obligations. As discussed below, both licenses relate to functional IP for which revenue is recognized at a point in time – in the case of these two license agreements, the point in time is at inception of the contract because the customer obtained control of the license at that point. The licenses grant Maruishi and CKDP the right to use the Company’s IP relating to CR845/difelikefalin as it existed at the point in time that the licenses were granted. That IP has significant standalone functionality as it provides the customer with the ability to perform a function or task, such as to manufacture CR845/difelikefalin and conduct clinical trials, and is considered to be functional IP. During the license periods, the Company is continuing to develop and advance CR845/difelikefalin by conducting clinical trials. Those development efforts are for its own benefit and do not substantively change the significant standalone functionality of the licensed IP granted to Maruishi or CKDP. Therefore, the Company’s ongoing development efforts do not significantly affect the IP’s utility to which Maruishi or CKDP have rights. Furthermore, if the Company abandons its development efforts, Maruishi or CKDP may still continue to develop CR845/difelikefalin in their respective countries. The R&D services performance obligation under the Maruishi Agreement represents a separate performance obligation. The R&D services were provided to Maruishi by the Company from inception of the agreement in 2013 through the third quarter of 2015, at which time the Company had fulfilled its promise related to the R&D services. Revenue related to the R&D services performance obligation was recognized as services were performed based on the costs incurred as a percentage of the estimated total costs to be incurred to complete the performance obligation. Similarly, under the VFMCRP Agreement, revenue related to the single distinct performance obligation, which includes both granting of the license and performance of the R&D services, will be recognized as the R&D services are performed, based on the costs incurred as a percentage of the estimated total costs to be incurred to complete the performance obligation. The Company expects that the remaining amount of the transaction price that was allocated to the combined performance obligation of $26,773 at September 30, 2019 will be recognized by 2020, as the R&D services are performed, subject to certain development and regulatory uncertainties. 6. Determination of consideration as variable consideration, including factors related to inclusion in the transaction price at inception of the contract and timing of recognition as revenue. The VFMCRP Agreement, the Maruishi Agreement and the CKDP Agreement contain potential payments related to achievement of defined milestone events and royalties upon net sales of future products, which are considered to be variable consideration because of the uncertainty of occurrence of any of those events specified in those agreements at inception of the agreements. Therefore, those potential payments were not included in the transaction price at the inception of the agreements. Revenue related to achievement of milestone events is recognized when the Company has determined that it is probable that a milestone event will be achieved and there will not be a significant reversal of revenue in future periods. Upon probability of achievement of a milestone event, the most likely amount of variable consideration is included in the transaction price. Subsequent changes to the transaction price, after contract initiation, are allocated to the performance obligations in the contract on the same basis as at contract inception. Revenue for variable consideration is recognized in the same manner (point in time or over time) as for the performance obligations to which the payment amounts were allocated. The Maruishi Agreement and the CKDP Agreement specify that certain development milestones will be achieved at pre-specified defined phases of a clinical trial (such as initiation or completion or other pre-specified time during a clinical trial as specified in the agreements). During the three and nine months ended September 30, 2019 and 2018, no milestone events were probable of occurrence or achieved. Sublicense payments VFMCRP’s, Maruishi’s and CKDP’s right to grant sub-licenses is explicitly stated in their respective license agreements. The amount of any potential sub-license fees to be received by the Company, which is based on a formula, is considered to be variable consideration and is constrained from inclusion in the transaction price at inception of the contract since at that time it was probable that there would be a reversal of such revenue in the future because the Company did not know if a sublicense would be granted in the future. Sales-based Royalty Payments The VFMCRP Agreement, CKDP Agreement and Maruishi Agreement each allow the Company to earn sales-based royalty payments in exchange for a license of intellectual property. In that case, the Company will recognize revenue for a sales-based royalty only when (or as) the later of the following events occurs: a. The subsequent sale or usage occurs. b. The performance obligation to which some or all of the sales-based royalty has been allocated has been satisfied (or partially satisfied). Since the sale (item a, above) occurs after the license was delivered (item b, above), the sales-based royalty exception, to exclude such royalty payments from the transaction price, applies to the overall revenue stream. Therefore, sales-based royalty payments are recognized as revenue when the customer’s sales occur. To date, no royalties have been earned or were otherwise due to the Company. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 12. Net Loss Per Share The Company computes basic net income (loss) per share by dividing net income (loss) by the weighted-average number of shares of common stock outstanding. Diluted net income per share includes the potential dilutive effect of common stock equivalents as if such securities were exercised during the period, when the effect is dilutive. Common stock equivalents may include outstanding stock options or restricted stock units, which are included using the treasury stock method when dilutive. For the three and nine months ended September 30, 2019 and 2018, the Company excluded the effects of potentially dilutive shares that were outstanding during those respective periods from the denominator as their inclusion would be anti-dilutive due to the Company’s net losses during those periods. The denominators used in the net loss per share computations are as follows: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Basic: Weighted average common shares outstanding 44,517,134 38,034,216 41,314,044 34,696,835 Diluted: Weighted average common shares outstanding - Basic 44,517,134 38,034,216 41,314,044 34,696,835 Common stock options* — — — — Denominator for diluted net loss per share 44,517,134 38,034,216 41,314,044 34,696,835 * Basic and diluted net loss per share are computed as follows: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Net loss $ (32,842) $ (19,400) $ (77,762) $ (53,361) Weighted-average common shares outstanding: Basic and Diluted 44,517,134 38,034,216 41,314,044 34,696,835 Net loss per share, Basic and Diluted $ (0.74) $ (0.51) $ (1.88) $ (1.54) As of September 30, 2019 and 2018, 4,575,454 and 3,780,390 stock options, respectively, were outstanding, which could potentially dilute basic earnings per share in the future, but were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive. In addition, 140,834 unvested restricted stock units issued to executive officers that were outstanding at September 30, 2019 were also not included in the computation of diluted net loss per share because to do so would have been anti-dilutive. The 74,166 restricted stock units that vested and were settled in shares of common stock in May 2019 were included in the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2019. The 24,000 restricted stock units granted in June 2019 to the non-employee members of the Board of Directors were also not included in the computation of diluted net loss per share because to do so would have been anti-dilutive (see Note 13, Stock-Based Compensation ). |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 13. Stock-Based Compensation 2014 Equity Incentive Plan The Company’s 2014 Equity Incentive Plan, or the 2014 Plan, is administered by the Company’s Board of Directors or a duly authorized committee thereof, referred to as the Plan administrator. The 2014 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights, performance stock awards and other forms of equity compensation, collectively referred to as Stock Awards. Additionally, the 2014 Plan provides for the grant of performance cash awards. Incentive stock options may be granted only to employees. All other awards may be granted to employees, including officers, non-employee directors, and consultants. No incentive stock options may be granted under the 2014 Plan after the tenth anniversary of the effective date of the 2014 Plan. Stock Awards granted under the 2014 Plan vest at the rate specified by the Plan administrator. Initial grants of Stock Awards made to employees and non-employee consultants generally vest as to 25% on the first anniversary of the date of grant and the balance ratably over the next 36 months and subsequent grants vest monthly over a period of four years from the grant date. Stock options initially granted to members of the Company’s Board of Directors vest over a period of three years in equal installments from the date of the grant, subject to the option holder’s continued service as a Director through such date. Subsequent grants to Directors that are made automatically at Annual Meetings of Stockholders vest fully on the first anniversary of the date of grant. The Plan administrator determines the term of Stock Awards granted under the 2014 Plan up to a maximum of ten years. The aggregate number of shares of the Company’s common stock reserved for issuance under the 2014 Plan has automatically increased on January 1 of each year, beginning on January 1, 2015 and will continue to increase on January 1 of each year through and including January 1, 2024, by 3% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s Board of Directors. On January 1, 2019, the aggregate number of shares of common stock that may be issued pursuant to Stock Awards under the 2014 Plan automatically increased from 4,900,481 to 6,086,907. The maximum number of shares that may be issued pursuant to the exercise of incentive stock options under the 2014 Plan is 30,000,000 shares. Restricted Stock Units In June 2019, the Board of Directors, upon the recommendation of the Compensation Committee, amended the Company’s non-employee director compensation policy. Pursuant to the terms of the amended policy, each non-employee director was entitled to receive, at the time of the Company’s 2019 Annual Meeting of Stockholders, 6,000 restricted stock units. As a result, on June 4, 2019, the date of the Company’s 2019 Annual Meeting of Stockholders, an aggregate of 24,000 restricted stock units were granted to Directors under the 2014 Plan with a grant date fair value of $20.47 per share. The restricted stock units vest on the earlier of (i) June 4, 2020 and (ii) immediately prior to the Company’s next Annual Meeting of Stockholders following the grant date, subject to the recipient’s continued service through such date. As a result, the Company will recognize compensation expense associated with these restricted stock units ratably over the one-year vesting period following the grant date. For the three and nine months ended September 30, 2019, $123 and $164, respectively, of stock compensation expense relating to the Board of Directors’ restricted stock units was recognized in the Statements of Comprehensive Loss, all of which related to G&A expense. None of the 24,000 restricted stock units vested or were settled in shares of the Company’s common stock as of September 30, 2019. In March 2019, the Compensation Committee of the Company’s Board of Directors approved and granted a total of 215,000 restricted stock units to executive officers under the 2014 Plan with a grant date fair value of $16.10 per share. Vesting of the restricted stock units was contingent on the achievement of certain performance targets, subject to the recipient’s continuous service through the vesting events. At the date of grant, the Company concluded that the probability of achievement of the performance targets could not be determined until they were achieved, and accordingly, the Company would recognize compensation expense associated with these awards when, and to the extent, the restricted stock units vested in accordance with achievement of the performance targets. In May 2019, performance targets relating to 74,166 restricted stock units had been achieved and thus such restricted stock units vested and the awards were settled in shares of common stock. As a result, $1,194 of stock compensation expense relating to the vesting of these restricted stock units was recognized in the Statements of Comprehensive Loss for the nine months ended September 30, 2019, consisting of $590 relating to G&A expense and $604 relating to R&D expense. Since there was no additional vesting of these executive restricted stock units during the three months ended September 30, 2019, no additional stock-based compensation expense was recognized in the respective period. Stock Options Under the 2014 Plan, the Company granted 20,000 and 165,000 stock options during the three months ended September 30, 2019 and 2018, respectively, and 1,218,000 and 897,500 stock options during the nine months ended September 30, 2019 and 2018, respectively. The fair values of stock options granted during the three and nine months ended September 30, 2019 and 2018 were estimated as of the dates of grant using the Black-Scholes option pricing model with the following assumptions: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Risk-free interest rate 1.62% 2.73% - 2.99% 1.62% - 2.62% 2.51% - 2.99% Expected volatility 71.8% 82.6% - 87.6% 71.8% - 75.2% 82.6% - 92.8% Expected dividend yield 0% 0% 0% 0% Expected life of employee options (in years) 6.25 6.25 6.25 6.25 Expected life of non-employee options (in years) — — — — The weighted-average grant date fair value per share of options granted to employees, non-employee members of the Company’s Board of Directors for their Board service and non-employee consultants during the three months ended September 30, 2019 and 2018 was $15.29 and $14.51, respectively, and during the nine months ended September 30, 2019 and 2018 was $11.35 and $11.25, respectively. Prior to January 1, 2019, the Company used the Black-Scholes option valuation model to re-measure the fair value of all outstanding options that had been granted to non-employee consultants during the vesting period of each tranche in accordance with ASC 505‑50. On January 1, 2019, the Company used the Black-Scholes option valuation model to re-measure the fair value of all outstanding unvested options that had been granted to non-employee consultants in accordance with ASU 2018‑07 (see Note 2, Other Accounting Pronouncements Recently Adopted ). The range of assumptions used by the Company on January 1, 2019 and September 30, 2018 are as follows: January 1, September 30, 2019 2018 Risk-free interest rate 2.59% - 2.62% 2.06% - 3.02% Expected volatility 58.9% - 84.6% 77.4% - 80.9% Expected dividend yield 0% 0% Expected life of non-employee options (in years) 0.81 - 8.19 0.26 - 8.44 During the three and nine months ended September 30, 2019 and 2018, the Company recognized compensation expense relating to stock options as follows: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Research and development $ 1,391 $ 901 $ 3,799 2,401 General and administrative 1,322 918 3,829 3,358 Total stock option expense $ 2,713 $ 1,819 $ 7,628 $ 5,759 The following were excluded from the table above as they are not related to stock options: compensation expense for i) the issuance of common stock relating to the consulting agreement for $98 and $197, respectively, in G&A expense for the three and nine months ended September 30, 2019; ii) the vesting of executives’ restricted stock units for $604 in R&D expense and $590 in G&A expense for the nine months ended September 30, 2019; and iii) compensation expense relating to the Board of Directors’ restricted stock units for $123 and $164, respectively, in G&A expense for the three and nine months ended September 30, 2019. A summary of stock option award activity related to employees, non-employee members of the Company’s Board of Directors and non-employee consultants as of and for the nine months ended September 30, 2019 is presented below: Weighted Number of Average Exercise Shares Price Outstanding, December 31, 2018 4,004,422 $ 13.34 Granted 1,218,000 16.88 Exercised (546,265) 11.08 Forfeited (100,703) 16.22 Outstanding, September 30, 2019 4,575,454 $ 14.50 Options exercisable, September 30, 2019 2,126,935 The Company does not expect to realize any tax benefits from its stock option activity or the recognition of stock-based compensation expense because the Company currently has net operating losses and has a full valuation allowance against its deferred tax assets. Accordingly, no amounts related to excess tax benefits have been reported in cash flows from operations for the nine months ended September 30, 2019 and 2018. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes For the three months ended September 30, 2019 and 2018, pre-tax losses were $33,172 and $19,466, respectively, and for the nine months ended September 30, 2019 and 2018, pre-tax losses were $78,412 and $53,625, respectively. The Company recognized a full tax valuation allowance against its deferred tax assets as of September 30, 2019 and December 31, 2018. Upon adoption of ASU 2016‑09 on January 1, 2017, the tax benefit related to the exercise of stock options is recognized as a deferred tax asset that is offset by a corresponding valuation allowance. The benefit from income taxes of $330 and $66 for the three months ended September 30, 2019 and 2018, respectively, and $650 and $264 for the nine months ended September 30, 2019 and 2018, respectively, relates to state R&D tax credits exchanged for cash pursuant to the Connecticut R&D Tax Credit Exchange Program, which permits qualified small businesses engaged in R&D activities within Connecticut to exchange their unused R&D tax credits for a cash amount equal to 65% of the value of the exchanged credits. On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act, or the Act. The Act, which is also commonly referred to as “U.S. tax reform”, significantly changed U.S. corporate income tax laws by, among other provisions, reducing the maximum U.S. corporate income tax rate from 35% to 21% starting in 2018. In accordance with the reduction in U.S. corporate income tax rate during the period of enactment, the Company reduced its deferred tax assets, which were offset by a corresponding reduction to its valuation allowance. On September 30, 2019 and December 31, 2018, the Company did not have any foreign subsidiaries and the international aspects of the Act are not applicable for the respective periods. On December 22, 2017, Staff Accounting Bulletin 118, or SAB 118, was issued by the SEC due to the complexities involved in accounting for the Act. SAB 118 requires the Company to include in its financial statements a reasonable estimate of the impact of the Act on earnings to the extent such estimate has been determined. Accordingly, the U.S. provision for income tax for 2017 was based on the reasonable estimate guidance provided by SAB 118. The Company finalized its accounting for the Act as of December 31, 2018, which resulted in insignificant adjustments. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 15. Commitments and Contingencies License Agreement On August 20, 2019, the Company entered into the License Agreement with Enteris, pursuant to which Enteris granted to the Company a non-exclusive, royalty-bearing license, including the right to grant sublicenses, under certain proprietary technology and patent rights related to or covering formulations for oral delivery of peptide active pharmaceutical ingredients with functional excipients to enhance permeability and/or solubility, known as Enteris’s Peptelligence ® technology, to develop, manufacture and commercialize products using such technology worldwide, excluding Japan and South Korea. As consideration for the licensed rights under the License Agreement, the Company paid an upfront fee equal to $8,000, consisting of $4,000 in cash and $4,000 in shares of the Company’s common stock pursuant to the Purchase Agreement (see Note 9, Stockholders’ Equity ). As a result, the Company recognized R&D expense of $8,000 related to the License Agreement during the three and nine months ended September 30, 2019. The Company is also obligated, pursuant to the License Agreement, to pay Enteris (1) milestone payments upon the achievement of certain development, regulatory and commercial milestones and (2) low-single digit royalty percentages on net sales of licensed products, subject to reductions in specified circumstances. Until the second anniversary of the entry into the License Agreement, the Company has the right, but not the obligation, to terminate its obligation to pay any royalties under the License Agreement in exchange for a lump sum payment in cash, or the Royalty Buyout. Subject to certain conditions, the Company may elect to pay 50% of the lump sum due under the Royalty Buyout in shares of the Company’s common stock pursuant to the Purchase Agreement. During each of the three and nine months ended September 30, 2019, no milestone payments or royalties were paid to Enteris by the Company. The License Agreement will expire on a country-by-country, licensed product-by-licensed product basis upon the later of (1) the expiration (or invalidation) of all valid claims in licensed patent rights that cover such product in such country, (2) the end of the calendar quarter in which generic competition (as defined in the License Agreement) occurs for such product in such country and (3) ten years from the first commercial sale of such product. Either party may terminate the License Agreement upon written notice if the other party has failed to remedy a material breach within 60 days (or 30 days in the case of a material breach of a payment obligation). Enteris may terminate the License Agreement upon 30 days’ written notice to the Company if the Company or any of its affiliates formally challenge the validity of any licensed patent rights or assists a third party in doing so. The Company may terminate the License Agreement for any reason or no reason (a) prior to receipt of first regulatory approval for a licensed product in the United States for any indication upon 30 days’ prior written notice to Enteris or (b) on or after receipt of first regulatory approval for a licensed product in the United States for any indication upon 60 days’ prior written notice to Enteris. Manufacturing Agreement On July 8, 2019, the Company entered into a Master Manufacturing Services Agreement, or MSA, with Patheon UK Limited, or Patheon. The MSA governs the general terms under which Patheon, or one of its affiliates, will provide non-exclusive manufacturing services to the Company for the drug products specified by the Company from time to time. Pursuant to the MSA, the Company has agreed to order from Patheon at least a certain percentage of its commercial requirements for a product under a related Product Agreement. Each Product Agreement that the Company may enter into from time to time will be governed by the terms of the MSA, unless expressly modified in such Product Agreement. The MSA has an initial term ending December 31, 2023, and will automatically renew after the initial term for successive terms of two years each if there is a Product Agreement in effect, unless either party gives notice of its intention to terminate the MSA at least 18 months prior to the end of the then current term. Either party may terminate the MSA or a Product Agreement upon written notice if the other party (1) has failed to remedy a material breach within a specified time or (2) is declared insolvent or bankrupt, voluntarily files a petition of bankruptcy or assigns such agreement for the benefit of creditors. The Company may terminate a Product Agreement (a) upon 90 days’ prior written notice if any governmental agency takes any action that prevents the Company from selling the relevant product in the relevant territory, (b) upon six months’ prior written notice if it does not intend to order manufacturing services due to a product’s discontinuance in the market, or (c) upon 90 days’ prior written notice if it determines that the manufacture or supply of a product likely infringes third-party rights. Patheon may terminate the MSA or a Product Agreement (i) upon six months’ prior written notice if the Company assigns such agreement to an assignee that is unacceptable to Patheon for certain reasons, or (ii) upon 30 days’ prior written notice if, after the first year of commercial sales, the Company forecasts zero volume for 12 months. The MSA contains, among other provisions, customary representations and warranties by the parties, a grant to Patheon of certain limited license rights to the Company’s intellectual property in connection with Patheon’s performance of the services under the MSA, certain indemnification rights in favor of both parties, limitations of liability and customary confidentiality provisions. On July 8, 2019, and July 9, 2019, the Company entered into two related Product Agreements under the MSA, one with each of Patheon and Patheon Manufacturing Services LLC, or Patheon Greenville, to govern the terms and conditions of the manufacture of commercial supplies of CR845/difelikefalin injection, the Company’s lead product candidate. Pursuant to the Product Agreements, Patheon and Patheon Greenville will manufacture commercial supplies of CR845/difelikefalin injection at the Monza, Italy and Greenville, North Carolina manufacturing sites, respectively, from active pharmaceutical ingredient supplied by the Company. Patheon and Patheon Greenville will be responsible for supplying the other required raw materials and packaging components, and will also provide supportive manufacturing services such as quality control testing for raw materials, packaging components and finished product. Leases In December 2015, the Company entered into a lease agreement, or the Stamford Lease, for office space in Stamford, Connecticut, or the Premises, for the purposes of relocating its headquarters. The initial term of the Stamford Lease commenced in May 2016, or the Commencement Date, and ends in November 2023 and is renewable for one five-year term. The Stamford Lease requires monthly lease payments, including rent escalations and rent holidays, during the initial lease term. The Company began to make rental payments from the Commencement Date. Prior to January 1, 2019, the Company recorded monthly rent expense on a straight-line basis from March 2016, upon taking possession of the Premises, through December 31, 2018. As of December 31, 2018, the balance of deferred lease obligation, representing the difference between cash rent paid and straight-line rent expense, was $864. As of the Commencement Date, the Stamford Lease landlord had made tenant improvements of $1,094 to the leased premises. Such amount was included in Property and equipment, net and in Deferred lease obligation as of December 31, 2018. The portion of Deferred lease obligation that is related to tenant improvements was being amortized as a reduction to rent expense over the same term as rent expense. As of December 31, 2018, the balance of Deferred lease obligation related to tenant improvements was $698. Total rent expense under the Stamford Lease was $246 and $737 for the three and nine months ended September 30, 2018, respectively. In connection with the signing of the Stamford Lease, the Company entered into a standby letter of credit agreement which serves as a security deposit for the Premises. The standby letter of credit is automatically renewed annually through November 2023. This standby letter of credit is secured with restricted cash in a money market account (refer to Note 6, Restricted Cash ). On January 1, 2019, the Company adopted ASC 842 (see Note 2 – Basis of Presentation: Accounting Pronouncements Recently Adopted ). Under ASC 842, since the Company adopted the practical expedients not to re-evaluate whether a contract is or contains a lease and to maintain the lease classification under ASC 840, the Stamford Lease continues to be accounted for as an operating lease. Upon adoption of ASC 842, the Company was required to establish an operating lease ROU asset and operating lease liability for the Stamford Lease. In establishing the ROU asset, the operating lease liability of $5,198 was reduced by lease incentives relating to tenant improvements of $698 and deferred lease obligation of $864, which were outstanding on December 31, 2018. Under ASC 842, lease expense is recognized on a straight-line basis over the lease term. As a result, $234 of operating lease cost, or lease expense, was recognized for the three months ended September 30, 2019, consisting of $164 relating to R&D lease expense and $70 relating to G&A lease expense. For the nine months ended September 30, 2019, $702 of operating lease cost was recognized, consisting of $492 relating to R&D lease expense and $210 relating to G&A lease expense. Other information related to the Stamford Lease was as follows: Three Months Ended Nine Months Ended September 30, 2019 September 30, 2019 Cash paid for amounts included in the measurement of lease liability: Operating cash outflows relating to operating lease $ (306) $ (909) ROU assets obtained in exchange for new operating lease liabilities $ — $ 3,636 Remaining lease term-operating lease (years) 4.2 4.2 Discount rate - operating lease 7.0 % 7.0 % Future minimum lease payments under non-cancellable operating leases, as well as a reconciliation of these undiscounted cash flows to the operating lease liability as of September 30, 2019, were as follows: Year Ending December 31, 2019 (Excluding the nine months ended September 30) $ 306 2020 1,239 2021 1,264 2022 1,288 2023 1,164 Total future minimum lease payments, undiscounted 5,261 Less imputed interest (714) Total $ 4,547 Operating lease liability reported as of September 30, 2019: Operating lease liability - current $ 945 Operating lease liability - non-current 3,602 Total $ 4,547 |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, as of the date of the financial statements as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from the Company’s estimates and assumptions. Significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, useful lives of fixed assets, the periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, the determination of prepaid research and development, or R&D, clinical costs and accrued research projects, the amount of non-cash compensation costs related to share-based payments to employees and non-employees and the periods over which those costs are expensed, the incremental borrowing rate used in lease calculations and the likelihood of realization of deferred tax assets. |
Significant Accounting Policies | Significant Accounting Policies There have been no material changes to the significant accounting policies previously disclosed in Note 2 to the Financial Statements in the Company’s Annual Report on Form 10‑K for the year ended December 31, 2018, except for the recent adoption of new accounting pronouncements as disclosed below. |
Recent Accounting Pronouncements | Accounting Pronouncements Recently Adopted Leases On January 1, 2019, the Company adopted ASC 842, Leases , under which it elected not to adjust prior comparative periods, which are reported under ASC 840. In addition, the Company elected to adopt both the practical expedient to use hindsight when determining the lease term and the package of practical expedients available under ASC 842, including: · No re-evaluation of whether a contract is or contains a lease (embedded lease); · Lease classification is grandfathered · No reassessment of initial direct costs Upon adoption of ASC 842, the Company had only one lease, the Stamford Lease (see Note 15, Commitments and Contingencies: Leases ), which is included in operating lease right-of-use asset, or ROU asset, operating lease liability – current and operating lease liability – non-current in the Company’s Condensed Balance Sheets. In general, the Company determines if a contract, at its inception, is a lease or contains a lease based on whether the contract conveys the right to control the use of identified property, plant, or equipment (an identified asset) for a period of time in exchange for consideration. To determine whether a contract conveys the right to control the use of an identified asset for a period of time, the Company assesses whether, throughout the period of use, it has both the right to obtain substantially all of the economic benefits from use of the identified asset, and the right to direct the use of the identified asset. Both of these criteria are met by the Stamford Lease. Under ASC 842, the Company determines the amount of the operating lease liability based on the present value of the future minimum lease payments over the remaining lease term. The amount of the operating lease ROU asset is equal to the amount of the lease liability, less accrued rent and lease incentives received from the landlord. Initial direct costs were deemed to be immaterial. Since the Stamford Lease does not provide an implicit interest rate, the Company used an annual incremental borrowing rate of 7% based on the information available at the date of adoption for the purpose of determining the lease liability during the term of the lease. As noted above, upon adoption of ASC 842, the Company used hindsight in determining the term of the Stamford Lease. Although the Stamford Lease is renewable for one five-year term, upon inception of the lease the renewal term was not included in the lease term since it was not reasonably certain that the Company will exercise that option. Accordingly, the lease term of the Stamford Lease was not adjusted upon adoption of ASC 842 to determine the operating lease ROU asset and operating lease liability. The Stamford Lease contains both a lease and non-lease component which are accounted for separately. The Company allocates the consideration to the lease and the non-lease component on a relative standalone price basis. Lease expense under ASC 842 is recognized on a straight-line basis over the lease term in the Condensed Statements of Comprehensive Loss. There was no cumulative effect adjustment as a result of the adoption of ASC 842 on January 1, 2019, which reflects the difference between the amount of lease expense under ASC 842 that would have been recognized from inception of the Stamford Lease through December 31, 2018 and the amount of rent expense actually recognized under ASC 840 during that same period. Other Accounting Pronouncements Recently Adopted In June 2018, the FASB issued ASU No. 2018‑07, Compensation—Stock Compensation (Topic 718) , Improvements to Nonemployee Share-Based Payment Accounting , or ASU 2018‑07, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018‑07 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. Accordingly, under ASU 2018‑07, the fair value of stock options granted to nonemployees will be measured only on the grant date, the amount of which will be recognized as compensation expense over the nonemployee’s service (vesting) period in the same period(s) and in the same manner as if the Company had paid cash for the goods or services instead of paying with or using share-based payment awards. On an award-by-award basis, the Company may elect to use the contractual term as the expected term when estimating the fair value of a nonemployee award to satisfy the measurement objective. Prior guidance under Subtopic 505‑50 required the fair value of nonemployee stock options to be marked to market at each reporting period during the service period, which resulted in volatility of compensation expense during that period. The Company adopted ASU 2018‑07 on January 1, 2019 on a modified retrospective basis and remeasured, on that date, the fair value of all outstanding unvested stock options that had been granted to nonemployees. The adoption of ASU 2018‑07 did not have a material effect on its results of operations, financial position or cash flows because grants of stock options to nonemployees have been insignificant. Accounting Pronouncements Not Yet Adopted In November 2018, the FASB issued ASU No. 2018‑18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 , or ASU 2018‑18, which clarifies the interaction between Topic 808 and Topic 606 by (1) clarifying that certain transactions between collaborative arrangement participants should be accounted for under Topic 606; (2) adding unit-of-account guidance in Topic 808 to align with the guidance in Topic 606; and (3) clarifying presentation guidance for transactions with a collaborative arrangement participant that are not accounted for under Topic 606. ASU 2018‑18 is effective for public business entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period. The Company will adopt ASU 2018-18 on January 1, 2020, and has determined that ASU 2018‑18 will not have any effect on its financial position, results of operations or cash flows since all three of its collaboration and licensing agreements are accounted for under Topic 606 (see Note 10, Collaboration and Licensing Agreements and Note 11, Revenue Recognition ) . In August 2018, the FASB issued ASU No. 2018‑13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement , or ASU 2018‑13, which modifies the disclosure requirements on fair value measurements in Topic 820 to remove the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value measurements. ASU 2018‑13 also amends Topic 820 to clarify that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. ASU 2018‑13 also requires additional disclosure for changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period as well as the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. ASU 2018‑13 is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of ASU 2018‑13. The Company will adopt ASU 2018‑13, as applicable, on January 1, 2020. The Company does not expect that the adoption of ASU 2018‑13 will have a material effect on its results of operations, financial position or cash flows. In June 2016, the FASB issued ASU No. 2016‑13, Financial Instruments—Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments , or ASU 2016‑13, which replaces the incurred loss impairment methodology in current GAAP, that delays recognition of a credit loss until it is probable that such loss has been incurred, with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016‑13 modifies the other-than-temporary impairment model for available-for-sale debt securities by requiring (1) estimating expected credit losses only when the fair value is below the amortized cost of the asset; (2) recording a credit loss without regard to the length of time a security has been in an unrealized loss position; (3) limiting the measurement of the credit loss to the difference between the security’s amortized cost basis and its fair value and (4) presenting credit losses as an allowance rather than as a write-down, which will allow the Company to record reversals of credit losses in current period net income, a practice that is currently prohibited. In April 2019, codification improvements were issued to help clarify and correct certain portions of ASU 2016‑13. ASU 2016‑13 will be effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. The Company will adopt ASU 2016-13 on January 1, 2020 and believes ASU 2016-13 will primarily impact the Company’s assessment of any potential impairment of its investments in debt securities, specifically its assessment of whether any portion of an unrealized loss in a given period relates to a credit loss. |
Available-for-Sale Marketable_2
Available-for-Sale Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Available-for-Sale Marketable Securities by Major Type of Security | The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of September 30, 2019 and December 31, 2018: As of September 30, 2019 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 12,842 $ 27 $ (9) $ 12,860 U.S. government agency obligations 22,426 12 (11) 22,427 Corporate bonds 108,108 145 (27) 108,226 Commercial paper 65,340 19 (3) 65,356 Municipal bonds 5,500 — — 5,500 Total available-for-sale marketable securities $ 214,216 $ 203 $ (50) $ 214,369 As of December 31, 2018 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 19,540 $ — $ (1) $ 19,539 U.S. government agency obligations 17,860 — (1) 17,859 Corporate bonds 75,999 5 (94) 75,910 Commercial paper 50,413 — (23) 50,390 Municipal bonds 4,000 — — 4,000 Total available-for-sale marketable securities $ 167,812 $ 5 $ (119) $ 167,698 |
Schedule of Amortized Cost and Fair Values of Marketable Debt Securities by Contractual Maturity | The Company classifies its marketable debt securities based on their contractual maturity dates. As of September 30, 2019, the Company’s marketable debt securities mature at various dates through September 2021. The amortized cost and fair values of marketable debt securities by contractual maturity were as follows. As of September 30, 2019 As of December 31, 2018 Contractual maturity Amortized Cost Fair Value Amortized Cost Fair Value Less than one year $ 158,274 $ 158,384 $ 146,363 146,302 One year to two years 55,942 55,985 21,449 21,396 Total $ 214,216 $ 214,369 $ 167,812 $ 167,698 |
Schedule of Fair Values and Continuous Unrealized Loss Positions of Available-for-Sale Marketable Securities | The following tables show the fair value of the Company’s available-for-sale marketable securities that have unrealized losses and that are deemed to be only temporarily impaired, aggregated by investment category and length of time that the individual investments have been in a continuous unrealized loss position. As of September 30, 2019 Less than 12 Months 12 Months or Greater Total Gross Gross Gross Fair Unrealized Fair Unrealized Fair Unrealized Value Losses Value Losses Value Losses U.S. Treasury securities $ 3,177 $ (9) $ — $ — $ 3,177 $ (9) U.S. government agency obligations 5,487 (11) — — 5,487 (11) Corporate bonds 27,689 (27) — — 27,689 (27) Commercial paper 11,906 (3) — — 11,906 (3) Total $ 48,259 $ (50) $ — $ — $ 48,259 $ (50) As of December 31, 2018 Less than 12 Months 12 Months or Greater Total Gross Gross Gross Fair Unrealized Fair Unrealized Fair Unrealized Value Losses Value Losses Value Losses U.S. Treasury securities $ 16,392 $ (1) $ — $ — $ 16,392 $ (1) U.S. government agency obligations 5,596 (1) — — 5,596 (1) Corporate bonds 71,322 (94) — — 71,322 (94) Commercial paper 39,445 (23) — — 39,445 (23) Total $ 132,755 $ (119) $ — $ — $ 132,755 $ (119) |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Loss) (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Summary of Changes in Accumulated Other Comprehensive Income (Loss), Net of Tax, from Unrealized Gains (Losses) on Available-for-Sale Marketable Securities | The following table summarizes the changes in accumulated other comprehensive income (loss), or AOCI, net of tax, from unrealized gains (losses) on available-for-sale marketable securities, the Company’s only component of AOCI, for the nine months ended September 30, 2019 and September 30, 2018. Total Accumulated Other Comprehensive Income (Loss) Balance, December 31, 2018 $ (114) Other comprehensive income before reclassifications 267 Amount reclassified from accumulated other comprehensive income — Net current period other comprehensive income 267 Balance, September 30, 2019 $ 153 Balance, December 31, 2017 $ (70) Other comprehensive income before reclassifications 51 Amount reclassified from accumulated other comprehensive loss 32 Net current period other comprehensive income 83 Balance, September 30, 2018 $ 13 |
Schedule of Reclassification Out of Accumulated Other Comprehensive Income | The reclassifications out of AOCI and into net loss were as follows: Three Months Ended Nine Months Ended Affected Line Item in the September 30, September 30, Statements of Component of AOCI 2019 2018 2019 2018 Operations Unrealized gains (losses) on available-for- sale marketable securities Realized gains (losses) on sale of securities $ — $ (17) $ — $ (32) Other income — — — — Benefit from income taxes $ — $ (17) $ — $ (32) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | The following tables summarize the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2019 and December 31, 2018. Fair value measurement as of September 30, 2019 : Quoted prices in Significant other Significant Financial assets active markets for observable unobservable identical assets inputs inputs Type of Instrument Total (Level 1) (Level 2) (Level 3) Cash and cash equivalents: Money market funds and checking accounts $ 34,705 $ 34,705 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 12,860 — 12,860 — U.S. government agency obligations 22,427 — 22,427 — Corporate bonds 108,226 — 108,226 — Commercial paper 65,356 — 65,356 — Municipal bonds 5,500 — 5,500 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 249,482 $ 35,113 $ 214,369 $ — Fair value measurement as of December 31, 2018: Quoted prices in Significant other Significant Financial assets active markets for observable unobservable identical assets inputs inputs Type of Instrument Total (Level 1) (Level 2) (Level 3) Cash and cash equivalents: Money market funds and checking accounts $ 15,081 $ 15,081 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 19,539 — 19,539 — U.S. government agency obligations 17,859 — 17,859 — Corporate bonds 75,910 — 75,910 — Commercial paper 50,390 — 50,390 — Municipal bonds 4,000 — 4,000 — Restricted cash: Commercial money market account 769 769 — — Total financial assets $ 183,548 $ 15,850 $ 167,698 $ — |
Restricted Cash (Tables)
Restricted Cash (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Receivables [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Balance Sheets that sum to the total of the same such amounts shown in the Condensed Statements of Cash Flows. September 30, 2019 December 31, 2018 Cash and cash equivalents $ 34,705 $ 15,081 Restricted cash, current assets — 361 Restricted cash, long-term assets 408 408 Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows $ 35,113 $ 15,850 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following: September 30, 2019 December 31, 2018 Accounts payable $ 9,536 $ 4,371 Accrued research projects 7,748 6,079 Accrued professional fees 566 802 Accrued compensation and benefits 2,731 2,370 Total $ 20,581 $ 13,622 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Computation of Denominators Used in Net Loss per Share | The denominators used in the net loss per share computations are as follows: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Basic: Weighted average common shares outstanding 44,517,134 38,034,216 41,314,044 34,696,835 Diluted: Weighted average common shares outstanding - Basic 44,517,134 38,034,216 41,314,044 34,696,835 Common stock options* — — — — Denominator for diluted net loss per share 44,517,134 38,034,216 41,314,044 34,696,835 * |
Computation of Basic and Diluted Net Loss per Share | Basic and diluted net loss per share are computed as follows: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Net loss $ (32,842) $ (19,400) $ (77,762) $ (53,361) Weighted-average common shares outstanding: Basic and Diluted 44,517,134 38,034,216 41,314,044 34,696,835 Net loss per share, Basic and Diluted $ (0.74) $ (0.51) $ (1.88) $ (1.54) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Summary of Assumptions Used in Black-Scholes Option Pricing Model | The fair values of stock options granted during the three and nine months ended September 30, 2019 and 2018 were estimated as of the dates of grant using the Black-Scholes option pricing model with the following assumptions: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Risk-free interest rate 1.62% 2.73% - 2.99% 1.62% - 2.62% 2.51% - 2.99% Expected volatility 71.8% 82.6% - 87.6% 71.8% - 75.2% 82.6% - 92.8% Expected dividend yield 0% 0% 0% 0% Expected life of employee options (in years) 6.25 6.25 6.25 6.25 Expected life of non-employee options (in years) — — — — |
Summary of Compensation Expense Relating to Stock Options | During the three and nine months ended September 30, 2019 and 2018, the Company recognized compensation expense relating to stock options as follows: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Research and development $ 1,391 $ 901 $ 3,799 2,401 General and administrative 1,322 918 3,829 3,358 Total stock option expense $ 2,713 $ 1,819 $ 7,628 $ 5,759 |
Summary of Stock Option Activity | A summary of stock option award activity related to employees, non-employee members of the Company’s Board of Directors and non-employee consultants as of and for the nine months ended September 30, 2019 is presented below: Weighted Number of Average Exercise Shares Price Outstanding, December 31, 2018 4,004,422 $ 13.34 Granted 1,218,000 16.88 Exercised (546,265) 11.08 Forfeited (100,703) 16.22 Outstanding, September 30, 2019 4,575,454 $ 14.50 Options exercisable, September 30, 2019 2,126,935 |
Share-based Payment Arrangement, Nonemployee [Member] | Consultants [Member] | Re-Measurement [Member] | |
Summary of Assumptions Used in Black-Scholes Option Pricing Model | Prior to January 1, 2019, the Company used the Black-Scholes option valuation model to re-measure the fair value of all outstanding options that had been granted to non-employee consultants during the vesting period of each tranche in accordance with ASC 505‑50. On January 1, 2019, the Company used the Black-Scholes option valuation model to re-measure the fair value of all outstanding unvested options that had been granted to non-employee consultants in accordance with ASU 2018‑07 (see Note 2, Other Accounting Pronouncements Recently Adopted ). The range of assumptions used by the Company on January 1, 2019 and September 30, 2018 are as follows: January 1, September 30, 2019 2018 Risk-free interest rate 2.59% - 2.62% 2.06% - 3.02% Expected volatility 58.9% - 84.6% 77.4% - 80.9% Expected dividend yield 0% 0% Expected life of non-employee options (in years) 0.81 - 8.19 0.26 - 8.44 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Other Information related to Stamford Lease | Other information related to the Stamford Lease was as follows: Three Months Ended Nine Months Ended September 30, 2019 September 30, 2019 Cash paid for amounts included in the measurement of lease liability: Operating cash outflows relating to operating lease $ (306) $ (909) ROU assets obtained in exchange for new operating lease liabilities $ — $ 3,636 Remaining lease term-operating lease (years) 4.2 4.2 Discount rate - operating lease 7.0 % 7.0 % |
Schedule of Future Minimum Lease Payments under Non-cancellable Operating Leases, Reconciliation of Undiscounted Cash Flows to the Operating Lease Liability | Future minimum lease payments under non-cancellable operating leases, as well as a reconciliation of these undiscounted cash flows to the operating lease liability as of September 30, 2019, were as follows: Year Ending December 31, 2019 (Excluding the nine months ended September 30) $ 306 2020 1,239 2021 1,264 2022 1,288 2023 1,164 Total future minimum lease payments, undiscounted 5,261 Less imputed interest (714) Total $ 4,547 Operating lease liability reported as of September 30, 2019: Operating lease liability - current $ 945 Operating lease liability - non-current 3,602 Total $ 4,547 |
Business - Additional Informati
Business - Additional Information (Detail) - USD ($) $ in Thousands | Jul. 29, 2019 | Jul. 31, 2019 | May 31, 2018 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 |
Nature Of Business [Line Items] | ||||||||||||
Date of formation | Jul. 2, 2004 | |||||||||||
Proceeds from equity and debt financing | $ 519,700 | $ 519,700 | ||||||||||
Upfront and milestone payments received in connection with license agreements | 88,900 | 88,900 | ||||||||||
Proceeds from sale of common stock in connection with license agreement | $ 14,556 | |||||||||||
Unrestricted cash and cash equivalents and marketable securities | 249,074 | 249,074 | ||||||||||
Accumulated deficit | 372,116 | 372,116 | $ 294,354 | |||||||||
Net loss | $ 32,842 | $ 22,960 | $ 21,960 | $ 19,400 | $ 17,194 | $ 16,767 | 77,762 | 53,361 | ||||
Net cash (used in) provided by operating activities | $ (78,059) | $ 2,060 | ||||||||||
Common Stock [Member] | ||||||||||||
Nature Of Business [Line Items] | ||||||||||||
Common stock, shares issued | 6,325,000 | |||||||||||
Common Stock [Member] | Follow-on Public Offering [Member] | ||||||||||||
Nature Of Business [Line Items] | ||||||||||||
Common stock, shares issued | 6,325,000 | 5,175,000 | ||||||||||
Common Stock [Member] | Underwriter's Over-Allotment [Member] | ||||||||||||
Nature Of Business [Line Items] | ||||||||||||
Common stock, shares issued | 825,000 | 825,000 | ||||||||||
Proceeds from issuance of common stock net | $ 136,525 | |||||||||||
Vifor Fresenius Medical Care Renal Pharma Ltd. [Member] | ||||||||||||
Nature Of Business [Line Items] | ||||||||||||
Proceeds from sale of common stock in connection with license agreement | $ 14,556 | |||||||||||
Vifor Fresenius Medical Care Renal Pharma Ltd. [Member] | Common Stock [Member] | ||||||||||||
Nature Of Business [Line Items] | ||||||||||||
Common stock, shares issued | 1,174,827 |
Basis of Presentation - Additio
Basis of Presentation - Additional Information (Detail) | 9 Months Ended | |
Sep. 30, 2019lease | Jan. 01, 2019USD ($) | |
Basis Of Presentation [Line Items] | ||
Lease, Practical Expedient, Use of Hindsight [true false] | true | |
Lease, Practical Expedients, Package [true false] | true | |
Stamford Operating Lease [Member] | ||
Basis Of Presentation [Line Items] | ||
Annual incremental borrowing rate | 7.00% | |
Operating lease, renewable term | 5 years | |
Stamford Operating Lease [Member] | ASC 842 [Member] | ||
Basis Of Presentation [Line Items] | ||
Number of operating lease | lease | 1 | |
Annual incremental borrowing rate | 7.00% | |
Operating lease, renewable term | 5 years | |
Cumulative effect adjustment | $ | $ 0 |
Available-for-Sale Marketable_3
Available-for-Sale Marketable Securities - Summary of Available-for-Sale Marketable Securities by Major Type of Security (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 214,216 | $ 167,812 |
Gross Unrealized Gains | 203 | 5 |
Gross Unrealized Losses | (50) | (119) |
Estimated Fair Value | 214,369 | 167,698 |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 12,842 | 19,540 |
Gross Unrealized Gains | 27 | |
Gross Unrealized Losses | (9) | (1) |
Estimated Fair Value | 12,860 | 19,539 |
U.S. Government Agency Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 22,426 | 17,860 |
Gross Unrealized Gains | 12 | |
Gross Unrealized Losses | (11) | (1) |
Estimated Fair Value | 22,427 | 17,859 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 108,108 | 75,999 |
Gross Unrealized Gains | 145 | 5 |
Gross Unrealized Losses | (27) | (94) |
Estimated Fair Value | 108,226 | 75,910 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 65,340 | 50,413 |
Gross Unrealized Gains | 19 | |
Gross Unrealized Losses | (3) | (23) |
Estimated Fair Value | 65,356 | 50,390 |
Municipal Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 5,500 | 4,000 |
Estimated Fair Value | $ 5,500 | $ 4,000 |
Available-for-Sale Marketable_4
Available-for-Sale Marketable Securities - Schedule of Amortized Cost and Fair Values of Marketable Debt Securities by Contractual Maturity (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Investments Debt And Equity Securities [Abstract] | ||
Amortized Cost of marketable debt securities, contractual maturity, Less than one year | $ 158,274 | $ 146,363 |
Amortized Cost of marketable debt securities, contractual maturity, One year to two years | 55,942 | 21,449 |
Amortized Cost | 214,216 | 167,812 |
Fair value of marketable debt securities, contractual maturity, Less than one year | 158,384 | 146,302 |
Fair value of marketable debt securities, contractual maturity,One year to two years | 55,985 | 21,396 |
Total fair Value of marketable debt securities, contractual maturity | $ 214,369 | $ 167,698 |
Available-for-Sale Marketable_5
Available-for-Sale Marketable Securities - Schedule of Fair Values and Continuous Unrealized Loss Positions of Available-for-Sale Marketable Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | $ 48,259 | $ 132,755 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (50) | (119) |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | 0 | 0 |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 48,259 | 132,755 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (50) | (119) |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | 3,177 | 16,392 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (9) | (1) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 3,177 | 16,392 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (9) | (1) |
U.S. Government Agency Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | 5,487 | 5,596 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (11) | (1) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 5,487 | 5,596 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (11) | (1) |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | 27,689 | 71,322 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (27) | (94) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 27,689 | 71,322 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (27) | (94) |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | 11,906 | 39,445 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (3) | (23) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 11,906 | 39,445 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | $ (3) | $ (23) |
Available-for-Sale Marketable_6
Available-for-Sale Marketable Securities - Additional Information (Detail) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019USD ($)position | Dec. 31, 2018USD ($)position | |
Investments Debt And Equity Securities [Abstract] | ||
Number of available-for-sale marketable securities in unrealized loss positions | position | 23 | 69 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | $ | $ 0 | $ 0 |
Total number of positions | position | 84 | 84 |
Other-than-temporary impairments on securities | $ | $ 0 | $ 0 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Loss) - Summary of Changes in Accumulated Other Comprehensive Income (Loss), Net of Tax, from Unrealized Gains (Losses) on Available-for-Sale Marketable Securities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||||||||
Balance, Value | $ 99,545 | $ 114,522 | $ 133,630 | $ 73,076 | $ 72,103 | $ 86,780 | $ 133,630 | $ 86,780 |
Other comprehensive income before reclassifications | 267 | 51 | ||||||
Amount reclassified from accumulated other comprehensive loss (income) | 17 | 32 | ||||||
Net current period other comprehensive income | (12) | 92 | 187 | 70 | 57 | (44) | 267 | 83 |
Balance, Value | 211,894 | 99,545 | 114,522 | 149,530 | 73,076 | 72,103 | 211,894 | 149,530 |
Accumulated Other Comprehensive Income (Loss) [Member] | ||||||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||||||
Balance, Value | 165 | 73 | (114) | (57) | (114) | (70) | (114) | (70) |
Net current period other comprehensive income | (12) | 92 | 187 | 70 | 57 | (44) | ||
Balance, Value | $ 153 | $ 165 | $ 73 | $ 13 | $ (57) | $ (114) | $ 153 | $ 13 |
Accumulated Other Comprehensi_4
Accumulated Other Comprehensive Income (Loss) - Schedule of Reclassifications Out of Accumulated Other Comprehensive Income (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Other income | $ 1,261 | $ 1,002 | $ 3,297 | $ 1,780 |
Benefit from income taxes | (330) | (66) | (650) | (264) |
Net of tax | (17) | (32) | ||
Accumulated Net Unrealized Investment Gain (Loss) Attributable to Parent [Member] | Reclassification out of Accumulated Other Comprehensive Income [Member] | ||||
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Other income | (17) | (32) | ||
Benefit from income taxes | $ 0 | $ 0 | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Financial assets | ||
Available-for-sale marketable securities | $ 214,369 | $ 167,698 |
Recurring [Member] | ||
Financial assets | ||
Total financial assets | 249,482 | 183,548 |
U.S. Government Agency Obligations [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 22,427 | 17,859 |
U.S. Government Agency Obligations [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 22,427 | 17,859 |
Corporate Bonds [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 108,226 | 75,910 |
Corporate Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 108,226 | 75,910 |
Municipal Bonds [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 5,500 | 4,000 |
Municipal Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 5,500 | 4,000 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Recurring [Member] | ||
Financial assets | ||
Total financial assets | 35,113 | 15,850 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Total financial assets | 214,369 | 167,698 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Obligations [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 22,427 | 17,859 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 108,226 | 75,910 |
Significant Other Observable Inputs (Level 2) [Member] | Municipal Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 5,500 | 4,000 |
Money Market Funds [Member] | Recurring [Member] | ||
Financial assets | ||
Cash and cash equivalents | 34,705 | 15,081 |
Restricted cash | 408 | 769 |
Money Market Funds [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Recurring [Member] | ||
Financial assets | ||
Cash and cash equivalents | 34,705 | 15,081 |
Restricted cash | 408 | 769 |
U.S. Treasury Securities [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 12,860 | 19,539 |
U.S. Treasury Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 12,860 | 19,539 |
Commercial Paper [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 65,356 | 50,390 |
Commercial Paper [Member] | Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | $ 65,356 | $ 50,390 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Purchases of financial assets | $ 0 |
Sales of financial assets | 0 |
Maturities of financial assets | 0 |
Transfer of financial asset into level 3 of fair value | 0 |
Fair value assets level 2 to level 1 transfers | 0 |
Fair value assets level 1 to level 2 transfers | 0 |
Significant Unobservable Inputs (Level 3) [Member] | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Unrealized gains | 0 |
Unrealized losses | $ 0 |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash in current assets | $ 361 | |
Restricted cash balance | $ 408 | 408 |
Stamford Lease [Member] | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Letter of credit, remaining amount | 769 | |
Letter of credit, through the end of lease term | $ 408 | |
Letter of credit, remaining amount date | 2019-07 | |
Operating lease, expiration date | Nov. 30, 2023 | |
Restricted cash in current assets | 361 | |
Restricted cash balance | $ 408 | $ 408 |
Restricted Cash - Schedule of R
Restricted Cash - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 |
Cash And Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 34,705 | $ 15,081 | ||
Restricted cash in current assets | 361 | |||
Restricted cash balance | 408 | 408 | ||
Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows | $ 35,113 | $ 15,850 | $ 97,498 | $ 10,157 |
Prepaid Expenses - Additional I
Prepaid Expenses - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Prepaid expenses | $ 8,556 | $ 4,805 |
Prepaid R&D clinical costs | 7,751 | 4,377 |
Prepaid insurance | 481 | 245 |
Other prepaid costs | $ 324 | $ 183 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accounts payable | $ 9,536 | $ 4,371 |
Accrued research projects | 7,748 | 6,079 |
Accrued professional fees | 566 | 802 |
Accrued compensation and benefits | 2,731 | 2,370 |
Total | $ 20,581 | $ 13,622 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | Aug. 20, 2019 | Jul. 29, 2019 | Mar. 20, 2019 | Jul. 31, 2019 | May 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Apr. 04, 2019 | Dec. 31, 2018 |
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Restricted stock units vested shares | 74,166 | ||||||||||||
Common stock, shares issued | 74,166 | 46,673,977 | 46,673,977 | 39,547,558 | |||||||||
Unregistered common stock exchanged for consulting services | $ 197,000 | $ 197,000 | |||||||||||
Compensation expense | $ 2,713,000 | $ 1,819,000 | 7,628,000 | $ 5,759,000 | |||||||||
Shareholder Consulting Agreement [Member] | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Price per share | $ 19.37 | ||||||||||||
Number of shares of unregistered common stock exchanged for consulting services | 10,195 | ||||||||||||
Consulting services performance period | 6 months | ||||||||||||
General and Administrative [Member] | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Compensation expense | 1,322,000 | $ 918,000 | 3,829,000 | $ 3,358,000 | |||||||||
General and Administrative [Member] | Shareholder Consulting Agreement [Member] | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Compensation expense | $ 98,000 | $ 197,000 | |||||||||||
Non-Exclusive License Agreement | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Upfront fee | $ 8,000,000 | ||||||||||||
Upfront fee payable, cash | 4,000,000 | ||||||||||||
Upfront fee payable, stock | $ 4,000,000 | ||||||||||||
Price per share | $ 23.42 | ||||||||||||
Share price average, Determination period | 30 days | ||||||||||||
Percentage of payment, stock | 50.00% | ||||||||||||
Maximum [Member] | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Aggregate offering price of securities | $ 300,000,000 | ||||||||||||
Common Stock [Member] | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 6,325,000 | ||||||||||||
Restricted stock units vested shares | 74,166 | 74,166 | |||||||||||
Number of shares of unregistered common stock exchanged for consulting services | 10,195 | ||||||||||||
Common Stock [Member] | Non-Exclusive License Agreement | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 170,793 | ||||||||||||
Upfront fee payable, stock | $ 4,000,000 | ||||||||||||
Common Stock [Member] | Follow-on Public Offering [Member] | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 6,325,000 | 5,175,000 | |||||||||||
Price per share | $ 23 | $ 23 | $ 19 | $ 23 | $ 19 | ||||||||
Common Stock [Member] | Underwriter's Over-Allotment [Member] | |||||||||||||
Subsidiary Sale Of Stock [Line Items] | |||||||||||||
Common stock, shares issued | 825,000 | 825,000 | |||||||||||
Proceeds from issuance of common stock net of underwriting discounts, commissions and estimated offering expenses | $ 136,525,000 | ||||||||||||
Underwriting discounts, commission and estimated offering expenses | $ 8,950,000 |
Collaboration and Licensing A_2
Collaboration and Licensing Agreements - Additional Information (Detail) | May 17, 2018USD ($)item$ / sharesshares | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenue from contract with customer | $ 5,785,000 | $ 5,062,000 | $ 15,375,000 | $ 7,936,000 | |
Clinical Compound Revenue [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenue from contract with customer | 33,000 | $ 140,000 | 33,000 | ||
Vifor Fresenius Medical Care Renal Pharma Ltd. [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Non-refundable, non-creditable upfront payment | $ 50,000,000 | ||||
Common stock, shares issued | shares | 1,174,827 | ||||
Purchase of common stock value | $ 20,000,000 | ||||
Purchase common stock per share amount | $ / shares | $ 17.024 | ||||
Closing prices of company common stock description | over a pre-determined average closing price of the Company's common stock | ||||
Premium from sale of stock | $ 5,444,000 | ||||
Contract liabilities | $ 55,444,000 | ||||
Number of combined performance obligations for revenue recognized | item | 1 | ||||
Number of days to terminate agreement | 60 days | ||||
Termination notice effective period | 12 months | ||||
Vifor Fresenius Medical Care Renal Pharma Ltd. [Member] | Maximum [Member] | Regulatory and Commercial Milestones [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestone payments receivable | $ 470,000,000 | ||||
Vifor Fresenius Medical Care Renal Pharma Ltd. [Member] | Maximum [Member] | Regulatory Milestones [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestone payments receivable | 30,000,000 | ||||
Vifor Fresenius Medical Care Renal Pharma Ltd. [Member] | Maximum [Member] | Tiered Commercial Milestones [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestone payments receivable | $ 440,000,000 | ||||
Maruishi Pharmaceutical Co., Ltd. [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Cost of clinical compound related to R&D expense | 30,000 | $ 126,000 | 30,000 | ||
Maruishi Pharmaceutical Co., Ltd. [Member] | Clinical Compound Revenue [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Revenue from contract with customer | $ 0 | $ 33 | $ 140,000 | $ 33 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) ¥ in Billions | May 17, 2018USD ($)item | Apr. 30, 2013USD ($)item | Apr. 30, 2012USD ($) | Sep. 30, 2019USD ($)Milestone | Sep. 30, 2018USD ($)Milestone | Sep. 30, 2019USD ($)Milestoneitem | Sep. 30, 2018USD ($)Milestone | Dec. 31, 2018USD ($) | Apr. 30, 2013JPY (¥) | Apr. 30, 2013USD ($) |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Deferred revenue, current | $ 26,773,000 | $ 26,773,000 | $ 26,825,000 | |||||||
Deferred revenue, non current | 0 | 0 | 15,184,000 | |||||||
Total revenue | $ 5,785,000 | $ 5,062,000 | $ 15,375,000 | $ 7,936,000 | ||||||
Number of milestone event probable of occurrence or achieved | Milestone | 0 | 0 | 0 | 0 | ||||||
License and Milestone Fees [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Total revenue | $ 5,785,000 | $ 5,029,000 | $ 15,235,000 | $ 7,903,000 | ||||||
Royalty [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Revenue from contract with customer | 0 | |||||||||
VFMCRP Agreement [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Deferred revenue, current | 26,773,000 | 26,773,000 | 26,825,000 | |||||||
Deferred revenue, non current | 15,184,000 | |||||||||
Receivables | 0 | 0 | ||||||||
Other assets | 0 | |||||||||
Deferred revenue | $ 55,444,000 | |||||||||
Number of combined performance obligations for revenue recognized | item | 1 | |||||||||
Number of performance obligations for revenue recognized | item | 2 | |||||||||
upfront payment | $ 50,000,000 | |||||||||
Premium from sale of stock | $ 5,444,000 | |||||||||
Remaining performance obligations | $ 26,773,000 | $ 26,773,000 | ||||||||
Remaining performance obligation, expected timing of satisfaction, year | 2020 | 2020 | ||||||||
VFMCRP Agreement [Member] | License and Milestone Fees [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Total revenue | $ 5,785,000 | $ 15,235,000 | ||||||||
License and milestone fees recognized | 28,671,000 | |||||||||
Maruishi and CKDP Agreements [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Receivables | $ 0 | $ 0 | ||||||||
Other assets | 0 | |||||||||
Deferred revenue | $ 0 | |||||||||
Number of remaining performance obligations | item | 0 | |||||||||
Maruishi Agreement [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Number of performance obligations for revenue recognized | item | 2 | 2 | ||||||||
Premium from sale of stock | $ 337,000 | |||||||||
Upfront non-refundable, non-creditable license fee and premium from sale of stock | 15,337,000 | |||||||||
Maruishi Agreement [Member] | Clinical Development and Regulatory Milestones [Member] | Maximum [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Remaining potential consideration | $ 10,500,000 | |||||||||
Maruishi Agreement [Member] | One-time Sales Milestone [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Remaining potential consideration | ¥ | ¥ 1 | |||||||||
Maruishi Agreement [Member] | License [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Estimated selling price | 10,200,000 | |||||||||
Upfront payments on obligations | 9,637,000 | |||||||||
Maruishi Agreement [Member] | R&D Services [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Estimated selling price | 6,200,000 | |||||||||
Upfront payments on obligations | $ 5,700,000 | |||||||||
CKDP Agreement [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Premium from sale of stock | $ 83,000 | |||||||||
CKDP Agreement [Member] | Clinical Development and Regulatory Milestones [Member] | Maximum [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Remaining potential consideration | 3,750,000 | |||||||||
CKDP Agreement [Member] | License [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Revenue from contract with customer | $ 646,000 |
Net Loss per Share - Computatio
Net Loss per Share - Computation of Denominators Used in Net Loss per Share (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Basic: | ||||
Weighted average common shares outstanding | 44,517,134 | 38,034,216 | 41,314,044 | 34,696,835 |
Diluted: | ||||
Weighted average common shares outstanding - Basic | 44,517,134 | 38,034,216 | 41,314,044 | 34,696,835 |
Common stock options | 0 | 0 | 0 | 0 |
Denominator for diluted net loss per share | 44,517,134 | 38,034,216 | 41,314,044 | 34,696,835 |
Net Loss per Share - Computat_2
Net Loss per Share - 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 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Earnings Per Share [Abstract] | ||||||||
Net loss | $ (32,842) | $ (22,960) | $ (21,960) | $ (19,400) | $ (17,194) | $ (16,767) | $ (77,762) | $ (53,361) |
Weighted-average common shares outstanding: | ||||||||
Basic and Diluted | 44,517,134 | 38,034,216 | 41,314,044 | 34,696,835 | ||||
Net loss per share, Basic and Diluted | $ (0.74) | $ (0.51) | $ (1.88) | $ (1.54) |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Detail) - shares | Jun. 04, 2019 | Jun. 30, 2019 | May 31, 2019 | Mar. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 |
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||||||||
Restricted stock units, vested | 0 | |||||||
Restricted stock units vested shares | 74,166 | |||||||
Common Stock [Member] | ||||||||
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||||||||
Restricted stock units vested shares | 74,166 | 74,166 | ||||||
Restricted Stock Units [Member] | ||||||||
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||||||||
Restricted stock units, vested | 0 | 74,166 | ||||||
Restricted Stock Units [Member] | Executive Officers [Member] | Share-based Payment Arrangement, Employee [Member] | ||||||||
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||||||||
Anti-dilutive unvested restricted stock units outstanding | 140,834 | 140,834 | ||||||
Restricted Stock Units [Member] | 2014 Equity Incentive Plan [Member] | Executive Officers [Member] | ||||||||
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||||||||
Restricted stock units, approved and granted | 215,000 | |||||||
Restricted Stock Units [Member] | 2014 Equity Incentive Plan [Member] | Director [Member] | ||||||||
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||||||||
Restricted stock units, approved and granted | 24,000 | 24,000 | ||||||
Restricted Stock Units [Member] | 2014 Equity Incentive Plan [Member] | Director [Member] | Share-based Payment Arrangement, Nonemployee [Member] | ||||||||
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||||||||
Restricted stock units, approved and granted | 24,000 | |||||||
Employee Options [Member] | ||||||||
Earnings Per Share, Diluted, by Common Class, Including Two Class Method [Line Items] | ||||||||
Anti-dilutive common stock equivalents | 4,575,454 | 3,780,390 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | Jun. 04, 2019 | Jun. 30, 2019 | May 31, 2019 | Mar. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2015 | Jan. 01, 2019 | Dec. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense | $ 2,713,000 | $ 1,819,000 | $ 7,628,000 | $ 5,759,000 | |||||||
Restricted stock units, vested | 0 | ||||||||||
Common stock, shares outstanding | 46,673,977 | 46,673,977 | 39,547,558 | ||||||||
Common stock, shares issued | 74,166 | 46,673,977 | 46,673,977 | 39,547,558 | |||||||
Fair value of options granted | $ 15.29 | $ 14.51 | $ 11.35 | $ 11.25 | |||||||
Excess tax benefits from stock option activity or stock-based compensation expense recognized in cash flows from operations | $ 0 | $ 0 | |||||||||
General and Administrative [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense | $ 1,322,000 | $ 918,000 | 3,829,000 | 3,358,000 | |||||||
General and Administrative [Member] | Shareholder Consulting Agreement [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense | 98,000 | 197,000 | |||||||||
Research and Development [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense | 1,391,000 | $ 901,000 | 3,799,000 | $ 2,401,000 | |||||||
Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense | $ 0 | 1,194,000 | |||||||||
Restricted stock units, vested | 0 | 74,166 | |||||||||
Common stock, shares issued | 74,166 | ||||||||||
Restricted Stock Units [Member] | General and Administrative [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense | 590,000 | ||||||||||
Restricted Stock Units [Member] | Research and Development [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense | $ 604,000 | ||||||||||
Director [Member] | Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common stock, shares outstanding | 0 | 0 | |||||||||
Director [Member] | Restricted Stock Units [Member] | General and Administrative [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense | $ 123,000 | $ 164,000 | |||||||||
2014 Equity Incentive Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of stock options that may be granted after the tenth anniversary of the 2014 Plan | 0 | ||||||||||
Annual increases in number of shares reserved for issuance as a percentage of shares of capital stock outstanding through January 1, 2024 | 3.00% | ||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 6,086,907 | 4,900,481 | |||||||||
Options granted | 20,000 | 165,000 | 1,218,000 | 897,500 | |||||||
2014 Equity Incentive Plan [Member] | Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Term of awards granted | 10 years | ||||||||||
2014 Equity Incentive Plan [Member] | Maximum [Member] | Incentive Stock Options [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 30,000,000 | ||||||||||
2014 Equity Incentive Plan [Member] | Director [Member] | Incentive Stock Options [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period of awards granted | 3 years | ||||||||||
2014 Equity Incentive Plan [Member] | Director [Member] | Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period of awards granted | 1 year | ||||||||||
Restricted stock units, approved and granted | 24,000 | 24,000 | |||||||||
Restricted stock units, grant date fair value | $ 20.47 | ||||||||||
Compensation expense | $ 123,000 | $ 164,000 | |||||||||
2014 Equity Incentive Plan [Member] | Director [Member] | Minimum [Member] | Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Restricted stock units vesting date | Jun. 4, 2020 | ||||||||||
2014 Equity Incentive Plan [Member] | Director [Member] | Share-based Payment Arrangement, Nonemployee [Member] | Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Restricted stock units, approved and granted | 24,000 | ||||||||||
2014 Equity Incentive Plan [Member] | Executive Officers [Member] | Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Restricted stock units, approved and granted | 215,000 | ||||||||||
Restricted stock units, grant date fair value | $ 16.10 | ||||||||||
2014 Equity Incentive Plan [Member] | Employee And Nonemployee Consultants [Member] | Share-Based Compensation Award, Tranche One [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Percentage of vested shares on first anniversary of grant date | 25.00% | ||||||||||
Vesting period of awards granted | 36 months | ||||||||||
2014 Equity Incentive Plan [Member] | Employee And Nonemployee Consultants [Member] | Share-based Compensation Award, Tranche Two [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period of awards granted | 4 years | ||||||||||
Non-employee Director Compensation Policy [Member] | Director [Member] | Share-based Payment Arrangement, Nonemployee [Member] | Restricted Stock Units [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Restricted stock units, approved and granted | 6,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Assumptions Used in Black-Scholes Option Pricing Model (Detail) | Jan. 01, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Risk-free interest rate | 1.62% | |||||
Risk-free interest rate, minimum | 2.73% | 1.62% | 2.51% | |||
Risk-free interest rate, maximum | 2.99% | 2.62% | 2.99% | |||
Expected volatility | 71.80% | |||||
Expected volatility, minimum | 71.80% | 82.60% | 71.80% | 82.60% | ||
Expected volatility, maximum | 87.60% | 75.20% | 92.80% | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% | ||
Share-based Payment Arrangement, Nonemployee [Member] | Consultants [Member] | Re-Measurement [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Risk-free interest rate, minimum | 2.59% | 2.06% | ||||
Risk-free interest rate, maximum | 2.62% | 3.02% | ||||
Expected volatility, minimum | 58.90% | 77.40% | ||||
Expected volatility, maximum | 84.60% | 80.90% | ||||
Expected dividend yield | 0.00% | 0.00% | ||||
Share-based Payment Arrangement, Nonemployee [Member] | Consultants [Member] | Re-Measurement [Member] | Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected life of options (in years) | 3 months 4 days | |||||
Share-based Payment Arrangement, Nonemployee [Member] | Consultants [Member] | Re-Measurement [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected life of options (in years) | 8 years 5 months 9 days | |||||
Employee Options [Member] | Share-based Payment Arrangement, Employee [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected life of options (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months | 6 years 3 months | ||
Employee Options [Member] | Share-based Payment Arrangement, Nonemployee [Member] | Consultants [Member] | Re-Measurement [Member] | Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected life of options (in years) | 9 months 22 days | |||||
Employee Options [Member] | Share-based Payment Arrangement, Nonemployee [Member] | Consultants [Member] | Re-Measurement [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected life of options (in years) | 8 years 2 months 9 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Compensation Expense Relating to Stock Options (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] | ||||
Total stock option expense | $ 2,713 | $ 1,819 | $ 7,628 | $ 5,759 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock option expense | 1,391 | 901 | 3,799 | 2,401 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock option expense | $ 1,322 | $ 918 | $ 3,829 | $ 3,358 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - 2014 Equity Incentive Plan [Member] - $ / shares | 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 [Line Items] | ||||
Number of Options, Outstanding | 4,004,422 | |||
Number of Options, Granted | 20,000 | 165,000 | 1,218,000 | 897,500 |
Number of Options, Exercised | (546,265) | |||
Number of Options, Forfeited | (100,703) | |||
Number of Options, Outstanding | 4,575,454 | 4,575,454 | ||
Number of Options, Options exercisable | 2,126,935 | 2,126,935 | ||
Weighted-Average Exercise Price, Outstanding | $ 13.34 | |||
Weighted-Average Exercise Price, Granted | 16.88 | |||
Weighted-Average Exercise Price, Exercised | 11.08 | |||
Weighted-Average Exercise Price, Forfeited | 16.22 | |||
Weighted-Average Exercise Price, Outstanding | $ 14.50 | $ 14.50 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||||||
Pre-tax losses | $ 33,172 | $ 19,466 | $ 78,412 | $ 53,625 | ||
Benefit from income taxes | $ 330 | $ 66 | $ 650 | $ 264 | ||
Percentage of annual research and development credit for cash | 65.00% | |||||
Income tax rate | 21.00% | 21.00% | 35.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | Aug. 20, 2019 | Jul. 08, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Jan. 01, 2019 | Dec. 31, 2018 | May 31, 2016 |
Other Commitments [Line Items] | |||||||||
Research and development | $ 35,992 | $ 22,303 | $ 83,956 | $ 52,732 | |||||
Deferred lease obligation | $ 1,562 | ||||||||
Operating lease liability | $ 4,547 | $ 4,547 | |||||||
Stamford Operating Lease [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Operating Lease, renewable term | 5 years | 5 years | |||||||
Operating lease, expiration date | Nov. 30, 2023 | ||||||||
Operating Lease, description | The Stamford Lease requires monthly lease payments, including rent escalations and rent holidays, during the initial lease term. The Company began to make rental payments from the Commencement Date. Prior to January 1, 2019, the Company recorded monthly rent expense on a straight-line basis from March 2016, upon taking possession of the Premises, through December 31, 2018. As of December 31, 2018, the balance of deferred lease obligation, representing the difference between cash rent paid and straight-line rent expense, was $864. | ||||||||
Tenant improvement expenses | $ 1,094 | ||||||||
Deferred lease obligation | 864 | ||||||||
Lease, rent expense | $ 246 | $ 737 | |||||||
Tenant improvement incentives | 698 | ||||||||
Operating lease cost | $ 234 | $ 702 | |||||||
Stamford Operating Lease [Member] | Research and Development [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Operating lease cost | 164 | 492 | |||||||
Stamford Operating Lease [Member] | General and Administrative [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Operating lease cost | $ 70 | $ 210 | |||||||
Stamford Operating Lease [Member] | ASC 842 [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Operating Lease, renewable term | 5 years | 5 years | |||||||
Operating lease liability | $ 5,198 | ||||||||
Stamford Operating Lease [Member] | Standby Letter of Credit [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Operating lease, renewable term description | Automatically renewed annually through November 2023. | ||||||||
Stamford Operating Lease [Member] | Standby Letter of Credit [Member] | Maximum [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Letter of credit, renewal date | Nov. 30, 2023 | ||||||||
Stamford Operating Lease [Member] | Leasehold Improvements [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Deferred lease obligation | $ 698 | ||||||||
Non-Exclusive License Agreement | |||||||||
Other Commitments [Line Items] | |||||||||
Upfront fee | $ 8,000 | ||||||||
Upfront fee payable, cash | 4,000 | ||||||||
Upfront fee payable, stock | $ 4,000 | ||||||||
Research and development | $ 8,000 | $ 8,000 | |||||||
Percentage of payment, stock | 50.00% | ||||||||
Payment of milestone payment | 0 | 0 | |||||||
Payments for Royalties | $ 0 | $ 0 | |||||||
License agreement expiration period, first commercial sale | 10 years | ||||||||
Agreement Termination Notice Description | Either party may terminate the License Agreement upon written notice if the other party has failed to remedy a material breach within 60 days (or 30 days in the case of a material breach of a payment obligation). Enteris may terminate the License Agreement upon 30 days' written notice to the Company if the Company or any of its affiliates formally challenge the validity of any licensed patent rights or assists a third party in doing so. The Company may terminate the License Agreement for any reason or no reason (a) prior to receipt of first regulatory approval for a licensed product in the United States for any indication upon 30 days' prior written notice to Enteris or (b) on or after receipt of first regulatory approval for a licensed product in the United States for any indication upon 60 days' prior written notice to Enteris. | ||||||||
Agreement initial term, expiration date | Either party may terminate the License Agreement upon written notice if the other party has failed to remedy a material breach within 60 days (or 30 days in the case of a material breach of a payment obligation). Enteris may terminate the License Agreement upon 30 days' written notice to the Company if the Company or any of its affiliates formally challenge the validity of any licensed patent rights or assists a third party in doing so. The Company may terminate the License Agreement for any reason or no reason (a) prior to receipt of first regulatory approval for a licensed product in the United States for any indication upon 30 days' prior written notice to Enteris or (b) on or after receipt of first regulatory approval for a licensed product in the United States for any indication upon 60 days' prior written notice to Enteris. | ||||||||
MSA | |||||||||
Other Commitments [Line Items] | |||||||||
Agreement initial term, expiration date | Dec. 31, 2023 | ||||||||
Agreement renewal term | 2 years | ||||||||
MSA | Minimum [Member] | |||||||||
Other Commitments [Line Items] | |||||||||
Termination notice effective period | 18 months | ||||||||
MSA or Product Agreement | |||||||||
Other Commitments [Line Items] | |||||||||
Agreement Termination Notice Description | Either party may terminate the MSA or a Product Agreement upon written notice if the other party (1) has failed to remedy a material breach within a specified time or (2) is declared insolvent or bankrupt, voluntarily files a petition of bankruptcy or assigns such agreement for the benefit of creditors. The Company may terminate a Product Agreement (a) upon 90 days' prior written notice if any governmental agency takes any action that prevents the Company from selling the relevant product in the relevant territory, (b) upon six months' prior written notice if it does not intend to order manufacturing services due to a product's discontinuance in the market, or (c) upon 90 days' prior written notice if it determines that the manufacture or supply of a product likely infringes third-party rights. Patheon may terminate the MSA or a Product Agreement (i) upon six months' prior written notice if the Company assigns such agreement to an assignee that is unacceptable to Patheon for certain reasons, or (ii) upon 30 days' prior written notice if, after the first year of commercial sales, the Company forecasts zero volume for 12 months. | ||||||||
Agreement initial term, expiration date | Either party may terminate the MSA or a Product Agreement upon written notice if the other party (1) has failed to remedy a material breach within a specified time or (2) is declared insolvent or bankrupt, voluntarily files a petition of bankruptcy or assigns such agreement for the benefit of creditors. The Company may terminate a Product Agreement (a) upon 90 days' prior written notice if any governmental agency takes any action that prevents the Company from selling the relevant product in the relevant territory, (b) upon six months' prior written notice if it does not intend to order manufacturing services due to a product's discontinuance in the market, or (c) upon 90 days' prior written notice if it determines that the manufacture or supply of a product likely infringes third-party rights. Patheon may terminate the MSA or a Product Agreement (i) upon six months' prior written notice if the Company assigns such agreement to an assignee that is unacceptable to Patheon for certain reasons, or (ii) upon 30 days' prior written notice if, after the first year of commercial sales, the Company forecasts zero volume for 12 months. |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Other Information related to Stamford Lease (Detail) - Stamford Operating Lease [Member] $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | |
Other Commitments [Line Items] | ||
Operating cash outflows relating to operating lease | $ (306) | $ (909) |
ROU assets obtained in exchange for new operating lease liabilities | $ 3,636 | |
Remaining lease term-operating lease (years) | 4 years 2 months 12 days | 4 years 2 months 12 days |
Discount rate - operating lease | 7.00% | 7.00% |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Future Minimum Lease Payments under Non-cancellable Operating Leases, Reconciliation of Undiscounted Cash Flows to the Operating Lease Liability (Detail) $ in Thousands | Sep. 30, 2019USD ($) |
Operating Lease Liabilities, Payments Due [Abstract] | |
2019 (Excluding the nine months ended September 30, 2019) | $ 306 |
2020 | 1,239 |
2021 | 1,264 |
2022 | 1,288 |
2023 | 1,164 |
Total future minimum lease payments, undiscounted | 5,261 |
Less imputed interest | (714) |
Operating lease liability | 4,547 |
Operating lease liability reported as of September 30, 2019: | |
Operating lease liability - current | 945 |
Operating lease liability - non-current | 3,602 |
Total | $ 4,547 |