Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 03, 2022 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36279 | |
Entity Registrant Name | CARA THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 75-3175693 | |
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 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | CARA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 53,733,607 | |
Entity Central Index Key | 0001346830 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 42,806 | $ 13,453 |
Marketable securities | 112,806 | 153,582 |
Accounts receivable, net - related party | 9,623 | |
Inventory, net | 1,835 | 2,584 |
Income tax receivable | 697 | 697 |
Other receivables | 451 | 455 |
Prepaid expenses | 18,562 | 2,519 |
Total current assets | 186,780 | 173,290 |
Operating lease right-of-use assets | 1,918 | 2,973 |
Marketable securities, non-current | 23,916 | 69,754 |
Property and equipment, net | 487 | 631 |
Restricted cash | 408 | 408 |
Total assets | 213,509 | 247,056 |
Current liabilities: | ||
Accounts payable and accrued expenses | 26,316 | 15,861 |
Operating lease liabilities, current | 1,876 | 1,755 |
Total current liabilities | 28,192 | 17,616 |
Operating lease liabilities, non-current | 497 | 1,918 |
Commitments and contingencies (Note 16) | ||
Stockholders' equity: | ||
Preferred stock; $0.001 par value; 5,000,000 shares authorized at September 30, 2022 and December 31, 2021, zero shares issued and outstanding at September 30, 2022 and December 31, 2021 | ||
Common stock; $0.001 par value; 100,000,000 shares authorized at September 30, 2022 and December 31, 2021, 53,733,607 shares and 53,480,812 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 53 | 53 |
Additional paid-in capital | 722,808 | 708,585 |
Accumulated deficit | (535,893) | (480,758) |
Accumulated other comprehensive loss | (2,148) | (358) |
Total stockholders' equity | 184,820 | 227,522 |
Total liabilities and stockholders' equity | $ 213,509 | $ 247,056 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
CONDENSED BALANCE SHEETS | ||
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 | 53,733,607 | 53,480,812 |
Common stock, shares outstanding | 53,733,607 | 53,480,812 |
CONDENSED STATEMENTS OF COMPREH
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue: | ||||
Total revenue | $ 10,813 | $ 20,272 | $ 38,606 | $ 22,207 |
Operating expenses: | ||||
Cost of goods sold | 3,055 | 5,136 | ||
Research and development | 24,691 | 15,514 | 65,869 | 59,870 |
General and administrative | 6,912 | 5,882 | 23,829 | 17,898 |
Total operating expenses | 34,658 | 21,396 | 94,834 | 77,768 |
Operating loss | (23,845) | (1,124) | (56,228) | (55,561) |
Other income, net | 665 | 111 | 1,093 | 502 |
Net loss | $ (23,180) | $ (1,013) | $ (55,135) | $ (55,059) |
Net loss per share: | ||||
Basic | $ (0.43) | $ (0.02) | $ (1.03) | $ (1.10) |
Diluted | $ (0.43) | $ (0.02) | $ (1.03) | $ (1.10) |
Weighted average shares: | ||||
Basic | 53,726,123 | 50,114,710 | 53,616,753 | 50,031,615 |
Diluted | 53,726,123 | 50,114,710 | 53,616,753 | 50,031,615 |
Other comprehensive income (loss), net of tax of $0: | ||||
Change in unrealized gains (losses) on available-for-sale marketable securities | $ (101) | $ 6 | $ (1,790) | $ (72) |
Total comprehensive loss | (23,281) | (1,007) | (56,925) | (55,131) |
Collaborative Revenue | ||||
Revenue: | ||||
Total revenue | 7,443 | 15,446 | 706 | |
License and Milestone Fees | ||||
Revenue: | ||||
Total revenue | 20,031 | 15,000 | 21,223 | |
Commercial Supply Revenue | ||||
Revenue: | ||||
Total revenue | $ 3,370 | $ 8,160 | ||
Clinical Compound Revenue | ||||
Revenue: | ||||
Total revenue | $ 241 | $ 278 |
CONDENSED STATEMENTS OF COMPR_2
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Other comprehensive income (loss) tax | $ 0 | $ 0 | $ 0 | $ 0 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDER'S EQUITY - USD ($) $ in Thousands | Common Stock Common Stock Subscribed in Private Offering | Common Stock | Additional Paid-In Capital | Stock Subscription Receivable | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
Balance, Value at Dec. 31, 2020 | $ 50 | $ 641,195 | $ (392,317) | $ 73 | $ 249,001 | ||
Balance, Shares at Dec. 31, 2020 | 49,872,213 | ||||||
Stock-based compensation expense | 2,744 | 2,744 | |||||
Shares issued upon exercise of stock options, value | 688 | 688 | |||||
Shares issued upon exercise of stock options, shares | 45,035 | ||||||
Shares issued upon vesting of restricted stock units, value | 1,388 | 1,388 | |||||
Shares issued upon vesting of restricted stock units, shares | 109,419 | ||||||
Net loss | (23,301) | (23,301) | |||||
Other comprehensive loss | (61) | (61) | |||||
Balance, Value at Mar. 31, 2021 | $ 50 | 646,015 | (415,618) | 12 | 230,459 | ||
Balance, Shares at Mar. 31, 2021 | 50,026,667 | ||||||
Balance, Value at Dec. 31, 2020 | $ 50 | 641,195 | (392,317) | 73 | 249,001 | ||
Balance, Shares at Dec. 31, 2020 | 49,872,213 | ||||||
Net loss | (55,059) | ||||||
Other comprehensive loss | (72) | ||||||
Balance, Value at Sep. 30, 2021 | $ 3 | $ 50 | 699,482 | $ (44,969) | (447,376) | 1 | 207,191 |
Balance, Shares at Sep. 30, 2021 | 3,282,391 | 50,175,988 | |||||
Balance, Value at Mar. 31, 2021 | $ 50 | 646,015 | (415,618) | 12 | 230,459 | ||
Balance, Shares at Mar. 31, 2021 | 50,026,667 | ||||||
Stock-based compensation expense | 3,376 | 3,376 | |||||
Shares issued upon exercise of stock options, value | 293 | 293 | |||||
Shares issued upon exercise of stock options, shares | 25,494 | ||||||
Shares issued upon vesting of restricted stock units, value | 100 | 100 | |||||
Shares issued upon vesting of restricted stock units, shares | 36,000 | ||||||
Net loss | (30,745) | (30,745) | |||||
Other comprehensive loss | (17) | (17) | |||||
Balance, Value at Jun. 30, 2021 | $ 50 | 649,784 | (446,363) | (5) | 203,466 | ||
Balance, Shares at Jun. 30, 2021 | 50,088,161 | ||||||
Subscription of common stock in Vifor stock purchase, value | $ 3 | 44,966 | (44,969) | ||||
Subscription of common stock in Vifor stock purchase, shares | 3,282,391 | ||||||
Stock-based compensation expense | 3,487 | 3,487 | |||||
Shares issued upon exercise of stock options, value | 339 | 339 | |||||
Shares issued upon exercise of stock options, shares | 43,825 | ||||||
Shares issued upon vesting of restricted stock units, value | 906 | 906 | |||||
Shares issued upon vesting of restricted stock units, shares | 44,002 | ||||||
Net loss | (1,013) | (1,013) | |||||
Other comprehensive loss | 6 | 6 | |||||
Balance, Value at Sep. 30, 2021 | $ 3 | $ 50 | 699,482 | $ (44,969) | (447,376) | 1 | 207,191 |
Balance, Shares at Sep. 30, 2021 | 3,282,391 | 50,175,988 | |||||
Balance, Value at Dec. 31, 2021 | $ 53 | 708,585 | (480,758) | (358) | 227,522 | ||
Balance, Shares at Dec. 31, 2021 | 53,480,812 | ||||||
Stock-based compensation expense | 4,266 | 4,266 | |||||
Shares issued upon exercise of stock options, value | 3 | 3 | |||||
Shares issued upon exercise of stock options, shares | 470 | ||||||
Shares issued upon vesting of restricted stock units, value | 1,438 | 1,438 | |||||
Shares issued upon vesting of restricted stock units, shares | 109,943 | ||||||
Net loss | (27,749) | (27,749) | |||||
Other comprehensive loss | (1,365) | (1,365) | |||||
Balance, Value at Mar. 31, 2022 | $ 53 | 714,292 | (508,507) | (1,723) | 204,115 | ||
Balance, Shares at Mar. 31, 2022 | 53,591,225 | ||||||
Balance, Value at Dec. 31, 2021 | $ 53 | 708,585 | (480,758) | (358) | 227,522 | ||
Balance, Shares at Dec. 31, 2021 | 53,480,812 | ||||||
Net loss | (55,135) | ||||||
Other comprehensive loss | (1,790) | ||||||
Balance, Value at Sep. 30, 2022 | $ 53 | 722,808 | (535,893) | (2,148) | 184,820 | ||
Balance, Shares at Sep. 30, 2022 | 53,733,607 | ||||||
Balance, Value at Mar. 31, 2022 | $ 53 | 714,292 | (508,507) | (1,723) | 204,115 | ||
Balance, Shares at Mar. 31, 2022 | 53,591,225 | ||||||
Stock-based compensation expense | 4,232 | 4,232 | |||||
Shares issued upon exercise of stock options, value | 182 | 182 | |||||
Shares issued upon exercise of stock options, shares | 30,000 | ||||||
Shares issued upon vesting of restricted stock units, value | 423 | 423 | |||||
Shares issued upon vesting of restricted stock units, shares | 89,075 | ||||||
Net loss | (4,206) | (4,206) | |||||
Other comprehensive loss | (324) | (324) | |||||
Balance, Value at Jun. 30, 2022 | $ 53 | 719,129 | (512,713) | (2,047) | 204,422 | ||
Balance, Shares at Jun. 30, 2022 | 53,710,300 | ||||||
Stock-based compensation expense | 3,520 | 3,520 | |||||
Shares issued upon exercise of stock options, value | 104 | 104 | |||||
Shares issued upon exercise of stock options, shares | 15,807 | ||||||
Shares issued upon vesting of restricted stock units, value | 55 | 55 | |||||
Shares issued upon vesting of restricted stock units, shares | 7,500 | ||||||
Net loss | (23,180) | (23,180) | |||||
Other comprehensive loss | (101) | (101) | |||||
Balance, Value at Sep. 30, 2022 | $ 53 | $ 722,808 | $ (535,893) | $ (2,148) | $ 184,820 | ||
Balance, Shares at Sep. 30, 2022 | 53,733,607 |
CONDENSED STATEMENTS OF STOCK_2
CONDENSED STATEMENTS OF STOCKHOLDER'S EQUITY (Parenthetical) | Sep. 30, 2021 $ / shares |
CONDENSED STATEMENTS OF STOCKHOLDER'S EQUITY | |
Price per share for subscription of common stock | $ 15.23 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Operating activities | ||
Net loss | $ (55,135) | $ (55,059) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 13,933 | 12,001 |
Depreciation and amortization | 187 | 186 |
Amortization expense component of lease expense | 1,055 | 969 |
Amortization of available-for-sale marketable securities, net | 498 | 590 |
Realized gain on sale of available-for-sale marketable securities | (39) | |
Realized gain on sale of property and equipment | (70) | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net - related party | (9,623) | |
Inventory, net | 749 | |
Income tax receivable | 810 | |
Other receivables | 4 | (19,793) |
Prepaid expenses | (16,043) | 5,818 |
Accounts payable and accrued expenses | 10,455 | (3,069) |
Operating lease liabilities | (1,300) | (1,186) |
Net cash used in operating activities | (55,220) | (58,842) |
Investing activities | ||
Proceeds from maturities of available-for-sale marketable securities | 162,185 | 134,220 |
Proceeds from redemptions of available-for-sale marketable securities, at par | 13,500 | |
Proceeds from sale of available-for-sale marketable securities | 0 | 10,029 |
Purchases of available-for-sale marketable securities | (77,858) | (108,989) |
Purchases of property and equipment | (43) | |
Proceeds from sale of property and equipment | 70 | |
Net cash provided by investing activities | 84,284 | 48,830 |
Financing activities | ||
Proceeds from the exercise of stock options | 289 | 1,320 |
Net cash provided by financing activities | 289 | 1,320 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 29,353 | (8,692) |
Cash, cash equivalents and restricted cash at beginning of period | 13,861 | 32,091 |
Cash, cash equivalents and restricted cash at end of period | $ 43,214 | 23,399 |
Noncash investing and financing activities | ||
Stock subscription receivable from Vifor International | $ 44,969 |
Business
Business | 9 Months Ended |
Sep. 30, 2022 | |
Business. | |
Business | 1. Business Cara Therapeutics, Inc., or the Company, is a commercial-stage biopharmaceutical corporation formed on July 2, 2004. The Company is leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company’s primary activities to date have been organizing and staffing the Company, developing its lead product and product candidates, including conducting preclinical and clinical trials of difelikefalin-based product candidates, and raising capital. In August 2021, the Company received U.S. Food and Drug Administration, or FDA, approval for KORSUVA® Collaboration and Licensing Agreements) In April 2022, the European Commission granted marketing authorization to difelikefalin injection under the brand name Kapruvia® (difelikefalin), or Kapruvia, for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients. The marketing authorization approves Kapruvia for use in all member states of the European Union, or EU, as well as Iceland, Liechtenstein, and Norway. Kapruvia was also approved in the UK in April 2022. In addition, as part of the Access Consortium, the product was approved in August 2022 in Switzerland as Kapruvia, as well as Singapore and Canada as KORSUVA. In 2018, the Company entered into a license agreement with Vifor that provides full commercialization rights of Kapruvia, and where applicable KORSUVA, to Vifor worldwide (excluding the U.S., Japan and South Korea). In markets outside of the U.S., the Company is eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in the agreement with Vifor, of difelikefalin injection in the licensed territories. In the U.S. market, the agreement with Vifor provides that Vifor will promote difelikefalin injection in the dialysis clinics of Fresenius Medical Care North America, or FMCNA, under a profit-sharing arrangement, whereby the Company is generally entitled to 50% of the annual net profits (as defined in the agreement with Vifor) based on net FMCNA clinic sales (as defined in the agreement with Vifor) and Vifor is entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions (see Note 11, Collaboration and Licensing Agreements The Company also has a license agreement with Maruishi Pharmaceutical Co. Ltd., or Maruishi, under which the Company granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. In September 2022, Maruishi submitted a New Drug Application in Japan for approval of difelikefalin injection for the treatment of pruritus in hemodialysis patients (see Note 11, Collaboration and Licensing Agreements) As of September 30, 2022, the Company had raised aggregate net proceeds of approximately $519,600 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, respectively, and the issuance of convertible preferred stock and debt prior to the IPO. Including profit share revenue, the Company had also earned approximately $263,500 under its license and supply agreements for difelikefalin, primarily with Vifor International, Vifor, Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and an earlier product candidate for which development efforts ceased in 2007. In October 2021, the Company received net proceeds of $44,969 from the issuance and sale of 3,282,391 shares of the Company’s common stock to Vifor International in connection with U.S. regulatory approval for KORSUVA injection in August 2021. Additionally, in October 2020, the Company received net proceeds of $38,449 from the issuance and sale of 2,939,552 shares of the Company’s common stock to Vifor International in connection with the Company’s license agreement with Vifor International. Furthermore, 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 in connection with the Company’s license agreement with Vifor (see Note 11, Collaboration and Licensing Agreements As of September 30, 2022, the Company had unrestricted cash and cash equivalents and marketable securities of $179,528 and an accumulated deficit of $535,893. 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 $23,180 and $1,013 for the three months ended September 30, 2022 and 2021, respectively, and $55,135 and $55,059 for the nine months ended September 30, 2022 and 2021, respectively, and had net cash used in operating activities of $55,220 and $58,842 for the nine months ended September 30, 2022 and 2021, 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 FDA and other government regulations. If the Company does not successfully commercialize KORSUVA injection, Kapruvia or any of its other product candidates, it will be unable to generate additional recurring product revenue or achieve profitability. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Business. | |
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, 2021 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, 2021. 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. The more significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, revenue recognition associated with profit-sharing arrangements, the amount and periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, accounts receivable, net – related party, inventory valuation and related reserves, 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, the incremental borrowing rate used in lease calculations and the likelihood of realization of deferred tax assets. The COVID-19 pandemic and geopolitical tensions, such as Russia’s incursion into Ukraine, resulted in a global slowdown of economic activity, decades-high inflation, rising interest rates, and a potential recession in the U.S. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these condensed financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the reported amounts of assets and liabilities or the disclosure of contingent assets and liabilities. These estimates, however, may change as new events occur and additional information is obtained, and are recognized in the condensed financial statements as soon as they become known. Actual results could differ materially from the Company’s estimates and assumptions. 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, 2021, except as disclosed below. Accounts Receivable, Net – Related Party Accounts receivable, net – related party consists of amounts due from sales of KORSUVA injection under the Company’s supply agreements with Vifor, as well as revenues earned from its profit-sharing agreement from sales of KORSUVA injection in the U.S. under the licensing agreements with Vifor. The Company does not obtain collateral for its accounts receivable. The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for credit losses when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not specifically reviewed. The Company believes that credit risk associated with its licensing partner, Vifor, is not significant. The Company reviews the need for an allowance for credit losses for any receivable based on various factors including payment history and historical bad debt experience. The Company had an insignificant allowance for credit losses as of September 30, 2022. Revenue Recognition – Profit-Sharing Arrangement The Company receives its share of the net profits from Vifor’s sale of KORSUVA injection to third parties in the U.S. under its existing license agreements. The Company has adopted a policy to recognize revenue net of tax withholdings, as applicable. The Company determined that Vifor is a customer under Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers (Topic 606) In accordance with ASC 606-10-55, Principal Agent Considerations Collaboration and Licensing Agreements) |
Available-for-Sale Marketable S
Available-for-Sale Marketable Securities | 9 Months Ended |
Sep. 30, 2022 | |
Available-for-Sale Marketable Securities | |
Available-for-Sale Marketable Securities | 3. Available-for-Sale Marketable Securities As of September 30, 2022 and December 31, 2021, 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, 2022 and December 31, 2021: As of September 30, 2022 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 4,004 $ — $ (7) $ 3,997 U.S. government agency obligations 9,500 — (646) 8,854 Corporate bonds 39,955 — (838) 39,117 Commercial paper 62,884 — (64) 62,820 Municipal bonds 22,527 — (593) 21,934 Total available-for-sale marketable securities $ 138,870 $ — $ (2,148) $ 136,722 As of December 31, 2021 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 11,573 $ — $ (3) $ 11,570 U.S. government agency obligations 17,020 — (45) 16,975 Corporate bonds 66,495 — (171) 66,324 Commercial paper 106,914 5 (31) 106,888 Municipal bonds 21,692 — (113) 21,579 Total available-for-sale marketable securities $ 223,694 $ 5 $ (363) $ 223,336 The following tables summarize the fair value and gross unrealized losses of the Company’s available-for-sale marketable securities by investment category and disaggregated by the length of time that individual debt securities have been in a continuous unrealized loss position as of September 30, 2022 and December 31, 2021: As of September 30, 2022 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 $ 3,997 $ (7) $ — $ — $ 3,997 $ (7) U.S. government agency obligations 4,646 (354) 4,208 (292) 8,854 (646) Corporate bonds 23,606 (606) 15,511 (232) 39,117 (838) Commercial paper 62,820 (64) — — 62,820 (64) Municipal bonds 7,912 (204) 14,022 (389) 21,934 (593) Total $ 102,981 $ (1,235) $ 33,741 $ (913) $ 136,722 $ (2,148) As of December 31, 2021 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 $ 11,570 $ (3) $ — $ — $ 11,570 $ (3) U.S. government agency obligations 9,456 (45) — — 9,456 (45) Corporate bonds 62,704 (170) 2,020 (1) 64,724 (171) Commercial paper 52,163 (31) — — 52,163 (31) Municipal bonds 20,562 (105) 1,017 (8) 21,579 (113) Total $ 156,455 $ (354) $ 3,037 $ (9) $ 159,492 $ (363) As of September 30, 2022 and December 31, 2021, no allowance for credit losses were recognized on the Company’s available-for-sale debt securities as no portion of the unrealized losses associated with those securities were due to credit losses. The information that the Company considered in reaching the conclusion that an allowance for credit losses was not necessary is as follows: As of September 30, 2022 and December 31, 2021, the Company held a total of 57 out of 57 positions and 58 out of 76 positions, respectively, that were in an unrealized loss position, 18 of which had been in an unrealized loss position for 12 months or greater as of September 30, 2022. Unrealized losses individually and in aggregate were not considered to be material for each respective period. 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. U.S. Treasury and U.S. government agency obligations. three out of three positions for its U.S. government agency obligations, that were in unrealized loss positions as of September 30, 2022. Corporate bonds, commercial paper, and municipal bonds. The Company classifies its marketable debt securities based on their contractual maturity dates. As of September 30, 2022, the Company’s marketable debt securities mature at various dates through November 2024. The amortized cost and fair values of marketable debt securities by contractual maturity were as follows. As of September 30, 2022 As of December 31, 2021 Contractual maturity Amortized Cost Fair Value Amortized Cost Fair Value Less than one year $ 113,967 $ 112,806 $ 153,631 $ 153,582 One year to three years 24,903 23,916 70,063 69,754 Total $ 138,870 $ 136,722 $ 223,694 $ 223,336 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. Other income, net includes interest and dividends, accretion/amortization of discounts/premiums, realized gains and losses on sales of securities and credit loss expense due to declines in the fair value of securities, if any. The cost of securities sold is based on the specific identification method. There were no sales of available-for-sale marketable securities during the three and nine months ended September 30, 2022. During the three and nine months ended September 30, 2021, the Company sold certain shares of its available-for-sale debt securities with a total fair value of $1,000 and $10,029, respectively, which resulted in no realized gains or losses for the three months ended September 30, 2021, and $39 of realized gains for the nine months ended September 30, 2021, respectively. As of September 30, 2022 and December 31, 2021, accrued interest receivables on the Company’s available-for-sale debt securities were $451 and $455, respectively. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive (Loss) Income | 9 Months Ended |
Sep. 30, 2022 | |
Accumulated Other Comprehensive (Loss) Income | |
Accumulated Other Comprehensive (Loss) Income | 4. Accumulated Other Comprehensive (Loss) Income The following table summarizes the changes in accumulated other comprehensive (loss) income, net of tax, from unrealized gains (losses) on available-for-sale marketable securities, the Company’s only component of accumulated other comprehensive (loss) income, for the nine months ended September 30, 2022 and 2021, respectively. Total Accumulated Other Comprehensive (Loss) Income Balance, December 31, 2021 $ (358) Other comprehensive loss before reclassifications (1,790) Amount reclassified from accumulated other comprehensive loss — Net current period other comprehensive loss (1,790) Balance, September 30, 2022 $ (2,148) Balance, December 31, 2020 $ 73 Other comprehensive loss before reclassifications (33) Amount reclassified from accumulated other comprehensive income (39) Net current period other comprehensive loss (72) Balance, September 30, 2021 $ 1 Amounts reclassified out of accumulated other comprehensive (loss) income into net loss are determined by specific identification. The reclassifications out of accumulated other comprehensive (loss) income and into net loss were as follows: Three Months Ended Nine Months Ended Affected Line Item in the Component of Accumulated Other September 30, September 30, Condensed Statements of Comprehensive (Loss) Income 2022 2021 2022 2021 Comprehensive Loss Unrealized gains (losses) on available-for-sale marketable securities: Realized gains on sales of securities $ — $ — $ — $ 39 Other income, net Income tax effect — — — — Benefit from income taxes Realized gains on sales of securities, net of tax $ — $ — $ — $ 39 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | 5. Fair Value Measurements As of September 30, 2022 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, 2022 The following tables summarize the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2022 Fair value measurement as of September 30, 2022 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 $ 42,806 $ 42,806 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 3,997 — 3,997 — U.S. government agency obligations 8,854 — 8,854 — Corporate bonds 39,117 — 39,117 — Commercial paper 62,820 — 62,820 — Municipal bonds 21,934 — 21,934 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 179,936 $ 43,214 $ 136,722 $ — Fair value measurement as of December 31, 2021: 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 $ 13,453 $ 13,453 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 11,570 — 11,570 — U.S. government agency obligations 16,975 — 16,975 — Corporate bonds 66,324 — 66,324 — Commercial paper 106,888 — 106,888 — Municipal bonds 21,579 — 21,579 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 237,197 $ 13,861 $ 223,336 $ — 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 during the three and nine months ended September 30, 2022 and 2021, respectively September 30, 2022 and 2021, respectively |
Restricted Cash
Restricted Cash | 9 Months Ended |
Sep. 30, 2022 | |
Restricted Cash | |
Restricted Cash | 6. Restricted Cash The Company is required to maintain a stand-by letter of credit as a security deposit under its leases for its office space in Stamford, Connecticut (refer to Note 16, Commitments and Contingencies: Leases As of September 30, 2022 and December 31, 2021, the Company had $408 of restricted cash related to the Stamford Lease in long-term assets. 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, 2022 December 31, 2021 Cash and cash equivalents $ 42,806 $ 13,453 Restricted cash, long-term assets 408 408 Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows $ 43,214 $ 13,861 |
Inventory, net
Inventory, net | 9 Months Ended |
Sep. 30, 2022 | |
Inventory, net | |
Inventory, net | 7. Inventory, net Inventory, net consists of the following: September 30, 2022 December 31, 2021 Raw materials $ 1,833 $ 927 Work-in-process 2 1,657 Total $ 1,835 $ 2,584 As of September 30, 2022 and December 31, 2021, inventory balances include inventory costs subsequent to regulatory approval of KORSUVA injection on August 23, 2021. There were no write-downs of commercial supply inventory during the three and nine months ended September 30, 2022. |
Prepaid expenses
Prepaid expenses | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid expenses | |
Prepaid Expenses | 8. Prepaid expenses As of September 30, 2022, prepaid expenses were $18,562, consisting of $17,090 of prepaid R&D clinical costs, $858 of prepaid insurance and $614 of other prepaid costs. As of December 31, 2021, prepaid expenses were $2,519, consisting of $1,481 of prepaid R&D clinical costs, $369 of prepaid insurance, and $669 of other prepaid costs. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 9 Months Ended |
Sep. 30, 2022 | |
Accounts Payable and Accrued Expenses | |
Accounts Payable and Accrued Expenses | 9. Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following: September 30, 2022 December 31, 2021 Accounts payable $ 15,218 $ 5,625 Accrued research projects 5,149 4,648 Accrued compensation and benefits 4,228 4,959 Accrued professional fees and other 1,721 629 Total $ 26,316 $ 15,861 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 10. Stockholders’ Equity In September 2022, as a result of the appointment of the Company’s new Chief Financial Officer, or CFO, 7,500 time-based restricted stock units held by the Company’s interim principal financial and accounting officer vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In June 2022, as a result of the accelerated vesting of restricted stock units associated with the former Chief Executive Officer’s, or CEO’s, modification of equity awards, an aggregate of 33,999 restricted stock units vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In June 2022, as a result of the completion of the one-year vesting period, an aggregate of 43,200 restricted stock units of members of the Board of Directors vested and were settled in shares of the Company’s common stock. Also in June 2022, the Company granted 11,876 fully vested restricted stock units, which were immediately settled in shares of common stock, to the Company’s chairman in consideration of his effort in connection with the Company’s CEO transition in 2021 (see Note 14, Stock-Based Compensation In March 2022, as a result of the achievement of certain performance targets, an aggregate of 37,999 performance-based restricted stock units of certain employees vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In March 2022, as a result of the completion of the first year of the three-year vesting period for restricted stock units granted in March 2021 and the full vesting of the CEO’s second tranche of restricted stock units granted in October 2021, an aggregate of 39,278 time-based restricted stock units vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In March 2022, the Company filed a universal shelf registration statement, or the Shelf Registration Statement, which provides for aggregate offerings of up to $300,000 of common stock, preferred stock, debt securities, warrants or any combination thereof. The Shelf Registration Statement was declared effective on May 11, 2022. The securities registered under the Shelf Registration Statement include $154,525 of unsold securities that had been registered under the Company’s previous Registration Statement on Form S-3 (File No. 333-230333) that was declared effective on April 4, 2019. The Company may offer additional securities under its Shelf Registration Statement from time to time in response to market conditions or other circumstances if it believes such a plan of financing is in the best interests of its stockholders. Also in March 2022, the Company entered into an open market sales agreement, or the Sales Agreement, with Jefferies LLC, as sales agent, pursuant to which it may, from time to time, issue and sell common stock with an aggregate value of up to $80,000 in an at-the-market offering. Jefferies is acting as sole sales agent for any sales made under the Sales Agreement for a 3% commission on gross proceeds. The common stock will be sold at prevailing market prices at the time of the sale, and, as a result, prices may vary. Unless otherwise terminated earlier, the Sales Agreement continues until all shares available under the Sales Agreement have been sold. No shares were sold under the Sales Agreement during the nine months ended September 30, 2022. In February 2022, as a result of the completion of the second year of the three-year vesting period for restricted stock units granted in February 2020, an aggregate of 32,666 time-based restricted stock units vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In August 2021, the Company earned a $50,000 regulatory milestone from Vifor for the purchase of the Company’s common stock at a price of $15.23 per share. As of September 30, 2021, the Company recorded a stock subscription receivable of $44,969 in connection with the U.S. regulatory approval of KORSUVA injection, representing $15.23 per share, as well as license and milestone fees revenue of $5,031 representing the excess of the stock purchase price over the cost of the purchased shares, based on the closing price of the Company’s common stock on the date of the achievement of the milestone. In October 2021, after the expiration of the requisite waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, or the HSR Act, the Company received the $50,000 payment and issued 3,282,391 shares of its common stock in connection with U.S. regulatory approval of KORSUVA injection on August 23, 2021 (see Note 11, Collaboration and Licensing Agreements In August 2021, as a result of the achievement of certain performance targets, an aggregate of 44,002 performance-based restricted stock units of various executive officers vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation) In June 2021, as a result of the completion of the one-year vesting period, an aggregate of 36,000 restricted stock units held by members of the Board of Directors vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In February and March 2021, as a result of the achievement of certain performance targets, an aggregate of 76,750 performance-based restricted stock units vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In February 2021, as a result of the completion of the first year of the three-year vesting period for restricted stock units granted in February 2020, an aggregate of 32,669 time-based restricted stock units vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation |
Collaboration and Licensing Agr
Collaboration and Licensing Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Collaboration and Licensing Agreements. | |
Collaboration and Licensing Agreements | Vifor (International) Ltd. (Vifor International) In October 2020, the Company entered into a license agreement with Vifor International, or Vifor Agreement No. 1, under which the Company granted Vifor International an exclusive license solely in the U.S. to use, distribute, offer for sale, promote, sell and otherwise commercialize difelikefalin injection for all therapeutic uses relating to the inhibition, prevention or treatment of itch associated with pruritus in hemodialysis and peritoneal dialysis patients in the U.S. Under Vifor Agreement No. 1, the Company retains all rights with respect to the clinical development of, and activities to gain regulatory approvals of, difelikefalin injection in the U.S. Vifor Agreement No. 1 provides full commercialization rights in dialysis clinics to Vifor International in the U.S. under a profit-sharing arrangement. Pursuant to the profit-sharing arrangement, the Company is generally entitled to 60% of the net profits (as defined in Vifor Agreement No. 1) from sales of difelikefalin injection in the U.S. and Vifor International is entitled to 40% of such net profits (excluding sales to Fresenius Medical Center dialysis clinics, compensation for which is governed by Vifor Agreement No. 2, as defined below), subject to potential temporary adjustment in future years based on certain conditions. Under Vifor Agreement No. 1, in consideration of Vifor’s conduct of the marketing, promotion, selling and distribution of difelikefalin injection in the U.S., the Company pays a marketing and distribution fee to Vifor based on the level of annual net sales. This fee as well as Vifor’s COGS are deducted from net sales in calculating the net profits that are subject to the profit-sharing arrangement under Vifor Agreement No. 1. Under the terms of Vifor Agreement No. 1, the Company received from Vifor International an upfront payment of $100,000 and an additional payment of $50,000 for the purchase of an aggregate of 2,939,552 shares of the Company’s common stock at a price of $17.0094 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, or the Vifor Stock Purchase Agreement. After U.S. regulatory approval of KORSUVA injection in August 2021, the Company received an additional $50,000 in October 2021 for the purchase of an aggregate of 3,282,391 shares of the Company’s common stock at a price of $15.23 per share, which represents a 20% premium to the 30-day In addition, pursuant to Vifor Agreement No. 1, the Company is eligible to receive payments of up to $240,000 upon the achievement of certain sales-based milestones. The Company retains the rights to make and have made difelikefalin injection, or the Licensed Product, on a non-exclusive basis, in the U.S. for commercial sale of the Licensed Product for use in all therapeutic uses to prevent, inhibit or treat itch associated with pruritus in hemodialysis and peritoneal-dialysis patients, or the Field, anywhere in the world and for supply of Licensed Product to Vifor International under the terms of a supply agreement, or the Vifor International Supply Agreement, which was executed in September 2021. The supply price is the Company’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor International Supply Agreement will co-terminate with Vifor Agreement No. 1. The Vifor International Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor International Supply Agreement is the Company’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that the Company would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of commercial supply to Vifor International is not a performance obligation under Vifor Agreement No. 1 but rather the Vifor International Supply Agreement is a separate agreement from Vifor Agreement No. 1. The only performance obligation under the Vifor International Supply Agreement is the delivery of the Licensed Product to Vifor International for commercialization. In May 2022, as permitted by Vifor Agreement No. 1 and the Vifor International Supply Agreement, Vifor International assigned its rights and obligations under these agreements to Vifor. The Company’s rights and obligations under these agreements were unaffected by this assignment, and the assignment does not affect the Company’s economic rights under the agreements. Throughout the Notes to Condensed Financial Statements, unless the context requires otherwise, references to Vifor’s commercialization of KORSUVA injection pursuant to the license agreement, and the Company’s provision of KORSUVA injection under this supply agreement, should be understood to refer to Vifor International prior to the assignment and to Vifor following the assignment, as applicable. Vifor International was acquired by CSL Limited in August 2022. The acquisition of Vifor International by CSL did not affect any of the Company’s rights and obligations pursuant to these agreements. Vifor Fresenius Medical Care Renal Pharma Ltd. (Vifor) In May 2018, the Company entered into a license agreement, or Vifor Agreement No. 2, with Vifor under which the Company granted Vifor an exclusive, royalty-bearing license, or the Vifor License, to seek regulatory approval to commercialize, import, export, use, distribute, offer for sale, promote, sell and otherwise commercialize the Licensed Product for all therapeutic uses to prevent, inhibit or treat itch associated with pruritus in the Field worldwide (excluding the U.S., Japan and South Korea), or the Territory. Upon entry into Vifor Agreement No. 2, Vifor made a non-refundable, non-creditable $50,000 upfront payment to the Company and Vifor International 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. As a result of the European Commission’s regulatory approval of Kapruvia in April 2022, the Company received a $15,000 regulatory milestone payment from Vifor under Vifor Agreement No. 2 during the nine months ended September 30, 2022. In addition, after U.S. regulatory approval of KORSUVA injection in August 2021, the Company earned a $15,000 regulatory milestone payment from Vifor under Vifor Agreement No. 2 during the three and nine months ended September 30, 2021. The Company is eligible to receive from Vifor commercial milestone payments in the aggregate of up to $440,000, 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 Vifor Agreement No. 2, of difelikefalin injection in the licensed territories. The Company retained full commercialization rights for difelikefalin injection for the treatment of chronic kidney disease associated pruritus, or CKD-aP, in the U.S. except in the dialysis clinics of FMCNA, where Vifor will promote difelikefalin injection under a profit-sharing arrangement, whereby the Company is generally entitled to 50% of the annual net profits (as defined in Vifor Agreement No. 2) based on net FMCNA clinic sales (as defined in Vifor Agreement No. 2) and Vifor is entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions. Subsequently, the remaining commercialization rights in the U.S. were assigned to Vifor by Vifor International, as permitted by Vifor Agreement No. 1, as discussed above. The Company retains the rights to make and have made the Licensed Product in the Territory for commercial sale by Vifor in the Field in or outside the Territory and for supply of Licensed Product to Vifor under the terms of a supply agreement, or the Vifor Supply Agreement, which was executed in May 2020. The supply price is the Company’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor Supply Agreement will co-terminate with Vifor Agreement No. 2. The Vifor Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor Supply Agreement is the Company’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that the Company would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of compound to Vifor is not a performance obligation under Vifor Agreement No. 2 but rather the Vifor Supply Agreement is a separate agreement from Vifor Agreement No. 2. The only performance obligation under the Vifor Supply Agreement is the delivery of the Licensed Product to Vifor for commercialization. Vifor International was acquired by CSL Limited in August 2022. The acquisition of Vifor International by CSL did not affect any of the Company’s rights or obligations pursuant to these agreements. Maruishi Pharmaceutical Co., Ltd. (Maruishi) 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 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 difelikefalin in the U.S. and Japan, respectively. In addition, the Company provided Maruishi specific clinical development services for 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. In September 2022, Maruishi submitted a New Drug Application in Japan for approval of difelikefalin injection for the treatment of pruritus in hemodialysis patients. Chong Kun Dang Pharmaceutical Corporation (CKDP) In April 2012, the Company entered into a license agreement, or the CKDP Agreement, with CKDP in South Korea, under which the Company granted CKDP an exclusive license to develop, manufacture and commercialize drug products containing 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 difelikefalin in the U.S. 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 difelikefalin in South Korea, if any, and share in any sub-license fees. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2022 | |
Revenue Recognition | |
Revenue Recognition | 12. Revenue Recognition The Company has primarily recognized revenue under its license and collaboration agreements from (1) profit-sharing revenue following its commercial launch of KORSUVA injection in April 2022; (2) upfront license fees and milestone payments, including development and regulatory milestones; (3) commercial supply revenue from Vifor; and (4) clinical compound sales from certain license agreements. As of September 30, 2022, the Company has not yet received any royalty payments or earned any sales-based milestones under its collaboration agreements. As of September 30, 2022, the Company had license and collaboration agreements with Vifor, Maruishi and CKDP. The following table provides amounts included in the Company’s Condensed Statements of Comprehensive Loss as revenue for the three and nine months ended September 30, 2022 and 2021: Three Months Ended Nine Months Ended September 30, 2022 September 30, 2021 September 30, 2022 September 30, 2021 Collaborative revenue Vifor (KORSUVA injection profit sharing) $ 7,443 $ — $ 15,446 $ — Maruishi — — — 706 Total collaborative revenue $ 7,443 $ — $ 15,446 $ 706 License and milestone fees Vifor $ — $ 20,031 $ 15,000 $ 20,031 Maruishi — — — 1,192 Total license and milestone fees $ — $ 20,031 $ 15,000 $ 21,223 Commercial supply revenue Vifor (KORSUVA injection) $ 3,370 $ — $ 8,160 $ — Total commercial supply revenue $ 3,370 $ — $ 8,160 $ — Clinical compound revenue Vifor (difelikefalin injection) $ — $ 241 $ — $ 241 Maruishi — — — 37 Total clinical compound revenue $ — $ 241 $ — $ 278 Collaborative revenue Beginning in April 2022, the Company began recording its profit-sharing revenue from the sales of KORSUVA injection by Vifor to third parties in the U.S. Under the license agreements with Vifor, KORSUVA injection net sales are calculated and recorded by Vifor in accordance with U.S. GAAP and include gross sales net of discounts, rebates, allowances, sales taxes, freight and insurance charges, and other applicable deductions. These amounts include the use of estimates and judgments, which could be adjusted based on actual results in the future. The Company records its share of the net profits from the sales of KORSUVA injection in the U.S. on a net basis and presents the revenue earned each period as Collaborative revenue. This treatment is in accordance with the Company’s revenue recognition policy, given that the Company is not the primary obligor and does not have the inventory risks in the collaboration agreement with Vifor in the U.S. The Company relies on Vifor to provide accurate and complete information related to the profit-sharing calculation of sales of KORSUVA injection in order to record its collaborative revenue (see Note 2, Basis of Presentation – Revenue Recognition – Profit-Sharing Arrangement 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 difelikefalin, for acute pain and uremic pruritus indications in Japan, which occurred at inception of the contract in 2013 (considered license and milestone fees revenue), and performance of R&D services, which occurred from 2013 to 2015 (considered collaborative revenue), as those services were rendered. The Company agreed to conduct limited work on an oral tablet formulation of difelikefalin and to conduct Phase 1 and proof-of-concept Phase 2 clinical trials of an intravenous formulation of 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 and are included as collaborative revenue (see Note 11, Collaboration and Licensing Agreements There was no collaborative revenue recognized under the Maruishi Agreement during the three and nine months ended September 30, 2022, or during the three months ended September 30, 2021. During the nine months ended September 30 2021, the criteria for revenue recognition for a milestone event set forth in the Maruishi Agreement was achieved, and the Company recorded $706 as collaborative revenue based on the relative standalone selling prices described above at contract inception. License and milestone fees revenue Under Vifor Agreement No. 2, the Company’s performance obligations of granting a license to allow Vifor to commercialize difelikefalin injection worldwide, except in the U.S., 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 were shared with Vifor to allow them to receive regulatory approval to sell difelikefalin in the licensed territory, were not distinct, and were accounted for as a single performance obligation during the period that the R&D services were rendered (see Note 11, Collaboration and Licensing 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. As a result of the European Commission’s regulatory approval of Kapruvia in April 2022, the Company received a $15,000 regulatory milestone payment from Vifor under Vifor Agreement No. 2, which was recorded as license and milestone fees revenue for the nine months ended September 30, 2022. In addition, after U.S. regulatory approval of KORSUVA injection in August 2021, the Company achieved a $15,000 regulatory milestone payment which was received in October 2021 and was recorded as license and milestone fees revenue for the three and nine months ended September 30, 2021. These regulatory milestone payments were considered variable consideration due to the uncertainty of occurrence of these events as specified at inception of the agreement. Therefore, these potential regulatory milestone payments were not included in the transaction price at the inception of the agreement. There were no license and milestone fees recognized under Vifor Agreement No. 2 for the three months ended September 30, 2022. After U.S. regulatory approval of KORSUVA injection in August 2021, the Company received an additional $50,000 in October 2021 for the purchase of an aggregate of 3,282,391 shares of the Company’s common stock at a price of $15.23 per share, which represents a 20% premium to the 30-day There were no license and milestone fees revenue recognized under the Maruishi Agreement during the three and nine months ended September 30, 2022, or the three months ended September 30, 2021. During the nine months ended September 30, 2021, the criteria for revenue recognition for a milestone event set forth in the Maruishi Agreement was achieved, and the Company recorded $1,192 as license and milestone fees revenue based on the relative standalone selling prices described above at contract inception. Commercial supply revenue Under the Vifor International Supply Agreement, the Company’s only performance obligation is the delivery of KORSUVA injection to Vifor in accordance with the receipt of purchase orders. Revenue from the sale of the Licensed Product to Vifor is recognized as delivery of the Licensed Product occurs. The Company had commercial supply revenue of $3,370 for the three months ended September 30, 2022 with associated COGS of $3,055. The Company has commercial supply revenue of $8,160 for the nine months ended September 30, 2022, of which $2,295 was recognized in January 2022 with no associated COGS since these inventory costs were incurred prior to regulatory approval on August 23, 2021, and $5,865 was recognized with associated COGS of $5,136 since these inventory costs were capitalized as inventory subsequent to regulatory approval. Clinical compound revenue The Company’s only performance obligation under the Vifor Supply Agreement is to deliver clinical compound to Vifor in accordance with the receipt of purchase orders. There were no sales of clinical compound under the Vifor Supply Agreement during the three and nine months ended September 30, 2022. During each of the three and nine months ended September 30, 2021, the Company recognized clinical compound revenue of $241 from the sale of clinical compound to Vifor and as a result, the Company incurred R&D expense of $228 during these periods. 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. There were no sales of clinical compound to Maruishi during the three and nine months ended September 30, 2022, or during the three months ended September 30, 2021. During the nine months ended September 30, 2021, the Company recognized clinical compound revenue of $37 from the sale of clinical compound to Maruishi and as a result, the Company incurred R&D expense of $33 during this period. Contract balances As of September 30, 2022, the Company recorded accounts receivable, net – related party of $9,623 which related to its profit-sharing revenue from sales of KORSUVA injection in the U.S. by Vifor and its commercial supply of KORSUVA injection to Vifor during the three months ended September 30, 2022. There were no material balances of receivables as of December 31, 2021, and no other contract assets or contract liabilities related to the Vifor, Vifor International, Maruishi and CKDP agreements as of September 30, 2022 and December 31, 2021. The Company routinely assesses the creditworthiness of its license and collaboration partners. The Company has not experienced any losses related to receivables from its license and collaboration partners as of September 30, 2022 and December 31, 2021. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Share | |
Net Loss Per Share | 13. Net Loss Per Share The Company computes basic net loss per share by dividing net 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, 2022 and 2021, 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, 2022 2021 2022 2021 Basic: Weighted average common shares outstanding 53,726,123 50,114,710 53,616,753 50,031,615 Diluted: Weighted average common shares outstanding - Basic 53,726,123 50,114,710 53,616,753 50,031,615 Common stock equivalents* — — — — Denominator for diluted net loss per share 53,726,123 50,114,710 53,616,753 50,031,615 * No amounts were considered as their effects would be anti-dilutive. Basic and diluted net loss per share are computed as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Net loss - basic and diluted $ (23,180) $ (1,013) $ (55,135) $ (55,059) Weighted-average common shares outstanding: Basic and diluted 53,726,123 50,114,710 53,616,753 50,031,615 Net loss per share, basic and diluted: $ (0.43) $ (0.02) $ (1.03) $ (1.10) As of September 30, 2022, 7,654,523 stock options and 640,950 restricted stock units 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 as a result of the net loss for the period. As of September 30, 2021, 5,974,549 stock options and 365,029 restricted stock units 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 as a result of the net loss for the period. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | 14. Stock-Based Compensation 2019 Inducement Plan In October 2019, the Company’s Board of Directors adopted the 2019 Inducement Plan, or the 2019 Plan, which is a non-stockholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq Listing Rule 5635(c)(4), or Rule 5635, for the purpose of awarding (i) non-statutory stock options, (ii) restricted stock awards, (iii) restricted stock unit awards, (iv) other stock awards (collectively, the Inducement Awards) to new employees of the Company, as inducement material to such new employees entering into employment with the Company. On November 20, 2019, the Company filed a Registration Statement on Form S-8 with the SEC covering the offering of up to 300,000 shares of its common stock, par value $0.001 , pursuant to the Company’s 2019 Plan. Initial grants of Inducement Awards made to employees 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. 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 generally vest over a period of three years in equal quarterly 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 earlier of the first anniversary of the date of grant and the next Annual Meeting of Stockholders. 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, 2022, the aggregate number of shares of common stock that may be issued pursuant to Stock Awards under the 2014 Plan automatically increased from 8,984,679 to 10,589,103. 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 On June 15, 2022, the Compensation Committee of the Company’s Board of Directors, or the Compensation Committee, approved and granted a total of 7,500 time-based restricted stock units under the 2014 Plan, with a grant date fair value of $7.94 per share, to the Company’s interim principal financial and accounting officer, in connection with his assuming the responsibilities of the Company’s former Chief Financial Officer, or CFO, on an interim basis. The Company accelerated the recognition of compensation expense and the restricted stock units vested fully on September 12, 2022, when the appointment of the Company’s new CFO occurred. For the three and nine months ended September 30, 2022, the Company recognized $55 and $60, respectively, of stock compensation expense associated with these awards, all of which was recorded within general and administrative, or G&A, expense. As of September 30, 2022, all Pursuant to the Company’s non-employee director compensation policy, an aggregate of 59,380 restricted stock units were granted to non-employee directors on June 2, 2022, the date of the Company’s 2022 Annual Meeting of Stockholders, under the 2014 Plan with a grant date fair value of $8.42 per share. The restricted stock units will vest on the earlier of (i) June 2, 2023 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 recognizes 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, 2022, stock compensation expense of $126 and $164, respectively, was recognized in G&A expense. As of September 30, 2022, none of the 59,380 restricted stock units were vested or settled in shares of the Company’s common stock. Also in June 2022, the Company granted 11,876 fully vested restricted stock units, which were immediately settled in shares of common stock, to the Company’s chairman in consideration of his effort in connection with the Company’s CEO transition in 2021. For the nine months ended September 30, 2022, stock compensation expense of $100 was recognized in G&A expense associated with this award. On February 25, 2022, the Compensation Committee also approved and granted a total of 243,000 restricted stock units to certain employees under the 2014 Plan with a grant date fair value of $10.46 per share. Vesting of the restricted stock units is contingent on the achievement of certain performance targets related to commercial milestones, subject to the recipient’s continuous service through each performance target. Recognition of compensation expense associated with these awards begins when, and to the extent, the performance criteria are probable of achievement and the employee has met the service conditions. For the three and nine months ended September 30, 2022, no stock compensation expense relating to these restricted stock units was recognized. In June 2022, 29,000 of these restricted stock units were forfeited as a result of the resignation of the Company’s former CFO. As of September 30, 2022, none of the remaining 214,000 outstanding restricted stock units were vested or settled in shares of the Company’s common stock. Additionally on February 25, 2022, the Compensation Committee also approved and granted a total of 145,170 time-based restricted stock units to certain employees under the 2014 Plan with a grant date fair value of $10.46 per share. The restricted stock units vest in three equal installments annually from the date of the grant. As a result, the Company recognizes compensation expense associated with these restricted stock units ratably over the three-year vesting period following the grant date. For the three and nine months ended September 30, 2022, the Company recognized $116 and $274, respectively, of stock compensation expense associated with these awards, with $48 recorded in R&D expense and $68 recorded in G&A expense for the three months ended September 30, 2022, and $113 recorded in R&D expense and $161 recorded in G&A expense for the nine months ended September 30, 2022. In June 2022, 20,000 of these restricted stock units were forfeited as a result of the resignation of the Company’s former CFO. As of September 30, 2022, none of the remaining 125,170 outstanding restricted stock units were vested or settled in shares of the Company’s common stock. On December 17, 2021, the Compensation Committee approved and granted a total of 63,573 time-based restricted stock units to certain employees under the 2014 Plan with a grant date fair value of $12.45 per share. The restricted stock units vest in two equal installments on December 15, 2022 and June 15, 2023. As a result, the Company recognizes compensation expense associated with these restricted stock units ratably over the 18-month vesting period following the grant date. For the three and nine months ended September 30, 2022, the Company recognized $110 and $323, respectively, of stock compensation expense associated with these awards, with $53 recorded in R&D expense and $57 recorded in G&A expense for the three months ended September 30, 2022, and $157 recorded in R&D expense and $166 recorded in G&A expense for the nine months ended September 30, 2022. In June 2022, 11,170 of these restricted stock units were forfeited as a result of the resignation of the Company’s former CFO. As of September 30, 2022, none of the remaining 52,403 outstanding restricted stock units were vested or settled in shares of the Company’s common stock. On October 29, 2021, the Compensation Committee also approved and granted 147,942 time-based restricted stock units in connection with the appointment of the Company’s new CEO under the 2014 Plan with a grant date fair value of $16.83 per share. The first tranche of 142,000 restricted stock units vests 25% on the first anniversary of the date of grant and the balance quarterly over the next 36 months. The second tranche of 5,942 restricted stock units fully vested on March 31, 2022. As a result, the Company recognizes compensation expense associated with these two restricted stock unit tranches ratably over their respective vesting periods following the grant date. For the three and nine months ended September 30, 2022, stock compensation expense associated with these awards of $151 and $506, respectively, was recognized in G&A expense. As of September 30, 2022, 5,942 of the 147,942 restricted stock units were vested and settled in shares of the Company’s common stock. Pursuant to the Company’s non-employee director compensation policy, an aggregate of 43,200 restricted stock units were granted to non-employee directors on June 3, 2021, the date of the Company’s 2021 Annual Meeting of Stockholders, under the 2014 Plan with a grant date fair value of $13.06 per share. The restricted stock units vested on June 3, 2022. As a result, the Company recognized compensation expense associated with these restricted stock units ratably over the one-year vesting period following the grant date. For the nine months ended September 30, 2022, stock compensation expense associated with these awards of $239 was recognized in G&A expense. For the three and nine months ended September 30, 2021, stock compensation expense of $142 and $184, respectively, was recognized in G&A expense. All On March 30, 2021, the Compensation Committee approved and granted a total of 176,000 restricted stock units to certain employees under the 2014 Plan with a grant date fair value of $20.59 per share. Vesting of the restricted stock units was contingent on the achievement of certain performance targets related to clinical and regulatory milestones, subject to the recipient’s continuous service through each performance target. Recognition of compensation expense associated with these awards begins when, and to the extent, the performance criteria is probable of achievement and the employee has met the service conditions. In February 2022 and August 2021, performance targets relating to 37,999 and 44,002 restricted stock units, respectively, had been achieved and thus restricted stock units vested and the awards were settled in shares of common stock. For the nine months ended September 30, 2022, the Company recognized $729 of stock compensation expense associated with these awards in G&A expense. G&A amounts recorded for the nine months ended September 30, 2022 included $303 of stock compensation expense relating to the modification of certain of these restricted stock units on November 1, 2021 (see Stock Award Modifications Additionally on March 30, 2021, the Compensation Committee also approved and granted a total of 100,000 time-based restricted stock units to certain employees under the 2014 Plan with a grant date fair value of $20.59 per share. The restricted stock units vest in three equal installments annually from the date of the grant. As a result, the Company recognizes compensation expense associated with these restricted stock units ratably over the three-year vesting period following the grant date. On June 30, 2022, 17,333 of these restricted stock units vested and were settled in shares of the Company’s common stock in accordance with the acceleration of vesting provisions relating to the modification of certain of these restricted stock units on November 1, 2021 (see Stock Award Modifications Pursuant to the Company’s non-employee director compensation policy, an aggregate of 36,000 restricted stock units were granted to non-employee directors on June 4, 2020, the date of the Company’s 2020 Annual Meeting of Stockholders, under the 2014 Plan with a grant date fair value of $15.62 per share. The restricted stock units fully vested on June 3, 2021. As a result, the Company recognized compensation expense associated with these restricted stock units ratably over the one-year vesting period following the grant date. For the nine months ended September 30, 2021, stock compensation expense of $239 was recognized in G&A expense. All of the restricted stock units were vested and settled in shares of the Company’s common stock as of June 30, 2021. In February 2020, the Compensation Committee approved and granted a total of 138,000 restricted stock units to certain employees under the 2014 Plan with a grant date fair value of $16.36 per share. Vesting of the restricted stock units was contingent on the achievement of certain performance targets related to clinical and regulatory milestones, subject to the recipient’s continuous service through each performance target. Recognition of compensation expense associated with these awards begins when, and to the extent, the performance criteria is probable of achievement and the employee has met the service conditions. In February and March 2021, performance targets relating to 36,750 and 40,000 restricted stock units, respectively, were achieved and thus restricted stock units vested and the awards were settled in shares of common stock. For the nine months ended September 30, 2021, the Company recognized $1,256 of stock compensation expense relating to the vesting of these restricted stock units, with $524 recorded in R&D expense and $732 in G&A expense. As of September 30, 2022, 113,500 of the 138,000 restricted stock units had vested and were settled in shares of the Company’s common stock, while the remaining 24,500 restricted stock units had been forfeited as a result of not achieving certain defined performance targets of the awards. As a result, there were no outstanding restricted stock units as of September 30, 2022 under this grant. Additionally in February 2020, the Compensation Committee also approved and granted a total of 98,000 time-based restricted stock units to certain employees under the 2014 Plan with a grant date fair value of $16.36 per share. The restricted stock units vest in three equal installments annually from the date of the grant. As a result, the Company recognizes compensation expense associated with these restricted stock units ratably over the three-year vesting period following the grant date. On June 30, 2022, 16,666 of these restricted stock units vested and were settled in shares of the Company’s common stock in accordance with the acceleration of vesting provisions relating to the modification of certain of these restricted stock units on November 1, 2021 (see Stock Award Modifications the Company’s common stock in satisfaction of the first year of vesting. For the three and nine months ended September 30, 2022, the Company recognized $66 and $460, respectively, of stock compensation expense associated with these awards, with $44 recorded in R&D expense and $22 in G&A expense for the three months ended September 30, 2022, and $131 recorded in R&D expense and $329 in G&A expense for the nine months ended September 30, 2022. G&A amounts recorded for the nine months ended September 30, 2022 included $264 of stock compensation expense relating to the modification of certain of these restricted stock units on November 1, 2021 (see Stock Award Modifications restricted stock units were vested and settled in shares of the Company’s common stock. A summary of restricted stock unit activity related to employees and non-employee members of the Company’s Board of Directors as of and for the nine months ended September 30, 2022 is presented below: Weighted Number of Average Grant Units Date Fair Value Outstanding, December 31, 2021 576,544 $ 17.50 Awarded 466,926 10.11 Vested and released (206,518) 16.74 Forfeited (196,002) 17.06 Outstanding, September 30, 2022 640,950 $ 12.50 Restricted stock units exercisable (vested and deferred), September 30, 2022 — Stock Options Under the 2014 Plan, the Company granted 437,500 and 30,000 stock options during the three months ended September 30, 2022 and 2021, respectively, and 1,739,919 and 819,250 stock options during the nine months ended September 30, 2022 and 2021, respectively. No Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Risk-free interest rate 2.65% - 4.09% 0.92% - 1.01% 1.70% - 4.09% 0.66% - 1.23% Expected volatility 77.7% - 78.2% 83.0% - 83.4% 77.7% - 81.9% 71.6% - 83.5% Expected dividend yield 0% 0% 0% 0% Expected life of employee and Board options (in years) 6.25 6.25 6.25 6.25 The weighted-average grant date fair value per share of options granted to employees and non-employee members of the Company’s Board of Directors for their Board service during the three months ended September 30, 2022 and 2021 was $7.37 and $9.24, respectively, and during the nine months ended September 30, 2022 and 2021 was $7.27 and $12.14, respectively. No options were granted to non-employee consultants during the three and nine months ended September 30, 2022 and 2021. During the three and nine months ended September 30, 2022 and 2021, the Company recognized compensation expense relating to stock options as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 1,719 $ 1,833 $ 5,380 $ 5,228 General and administrative 1,149 1,205 5,137 3,444 Total stock option expense $ 2,868 $ 3,038 $ 10,517 $ 8,672 The following were excluded from the table above as they are not related to stock options: compensation expense for (i) the vesting of certain employees’ restricted stock units for $200 in R&D expense and $381 in G&A expense for the three months ended September 30, 2022, and $565 in R&D expense and $2,350 in G&A expense for the nine months ended September 30, 2022; (ii) the vesting of certain employees’ restricted stock units for $429 in R&D expense and $785 in G&A expense for the three months ended September 30, 2021, and $1,094 in R&D expense and $1,812 in G&A expense for the nine months ended September 30, 2021; (iii) compensation expense relating to the Board of Directors’ restricted stock units for $126 and $503 in G&A expense for the three and nine months ended September 30, 2022, respectively; and (iv) compensation expense relating to the Board of Directors’ restricted stock units for $142 and $423 in G&A expense for the three and nine months ended September 30, 2021, respectively. 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, 2022 is presented below: Weighted Number of Average Exercise Shares Price Outstanding, December 31, 2021 6,512,280 $ 15.58 Granted 1,739,919 10.28 Exercised (46,277) 6.26 Forfeited (356,819) 14.50 Expired (194,580) 16.21 Outstanding, September 30, 2022 7,654,523 $ 14.47 Options exercisable, September 30, 2022 4,764,271 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, 2022 and 2021. Stock Award Modifications In November 2021, the Company and the former President and CEO mutually agreed to a transition from CEO to a consulting role through June 30, 2022, if not terminated earlier per the terms of the consulting agreement. As a result, the Company modified the terms of its former CEO’s outstanding Stock Awards to (1) automatically vest any unvested stock options or time-based restricted stock units that would have vested in the twelve month period following the end of the consulting period if continuous service is achieved with the Company during such twelve-month period; (2) extend the period during which the vested stock options may be exercised through the earlier of (i) eighteen months following the separation date (November 8, 2021); or (ii) the original expiration date applicable to each of the stock options, unless terminated earlier in accordance with the 2014 Plan, if continuous service is achieved with the Company; and (3) extend the period in which performance-based vesting milestones for restricted stock units may be achieved through March 31, 2022, if continuous service is achieved with the Company. The consulting agreement ended on June 30, 2022. The Company determined that vested Stock Awards which had modifications due to the extension of the exercise period were Type 1 modifications pursuant to Financial Accounting Standards Board Accounting Standards Codification 718, or ASC 718, because those Stock Awards would have vested before and after the modification. Acceleration of vesting for the Stock Awards that would have vested in the twelve-month period following the consulting term was determined to be a Type 3 modification requiring stock compensation expense pursuant to ASC 718 because absent the modification terms, those Stock Awards would have been forfeited as of the last day that the former CEO provided continuous service as a consultant. In addition, Type 4 performance-based restricted stock units were not considered probable of achieving performance targets on the modification date, but 17,333 performance-based restricted stock units were achieved in February 2022, which resulted in additional stock compensation expense being recorded through June 30, 2022. As of the result of the consulting period ending on June 30, 2022, there was no incremental stock compensation expense relating to the modifications of stock options, time-based and performance-based restricted stock units recorded during the three months ended September 30, 2022. During the nine months ended September 30, 2022, total incremental stock compensation expense relating to modifications of stock options, time-based and performance-based restricted stock units of the former CEO was $2,563, which is included in G&A expense for the nine months ended September 30, 2022. Of this total amount, $1,679 is included in G&A expense in the stock option compensation expense table above for the nine months ended September 30, 2022. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Income Taxes | 15. Income Taxes The Company has recognized a full tax valuation allowance against its deferred tax assets as of September 30, 2022 and December 31, 2021. 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. As such, the Company’s effective tax rate is zero for the three and nine months ended September 30, 2022 and 2021. Historically, the Company’s benefit from income taxes 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. Because the Company’s revenue in 2020 exceeded $70,000, it was not eligible to exchange its 2021 R&D tax credit for cash, therefore there was no benefit from income taxes for the three and nine months ended September 30, 2021. As of September 30, 2022, the Company does not qualify to receive a refund of the 2022 credit, therefore no receivable or benefit from income taxes have been recorded for the 2022 credit during the three and nine months ended September 30, 2022. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | 16. Commitments and Contingencies License Agreement with Enteris Biopharma, Inc. In August 2019, the Company entered into a non-exclusive license agreement, or the Enteris License Agreement, with Enteris Biopharma, Inc., or 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 Enteris 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 with Enteris. The Company is also obligated, pursuant to the Enteris 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 Enteris License Agreement, the Company had the right, but not the obligation, to terminate its obligation to pay any royalties under the Enteris License Agreement in exchange for a lump sum payment in cash, or the Royalty Buyout. The Company did not exercise its Royalty Buyout right and such right expired in August 2021. During the three months ended September 30, 2022, Enteris earned a $5,000 milestone payment based on the first patient dosing in a Phase 3 trial, which was subsequently paid in October 2022. This milestone payment to Enteris was recorded in R&D expense for the three and nine months ended September 30, 2022. In June 2021, the Company paid a $10,000 milestone payment to Enteris based on a successful End of Phase 2 Meeting with the FDA in April 2021, which was recorded in R&D expense for the nine months ended September 30, 2021. Manufacturing Agreements In July 2021, the Company entered into an API Commercial Supply Agreement with Polypeptide Laboratories S.A., or PPL, that defines each party’s responsibilities with respect to PPL’s manufacture and supply of the active pharmaceutical ingredient difelikefalin, or API, for the difelikefalin injection product candidate. Under the API Commercial Supply Agreement, PPL shall manufacture API at its facility for sale and supply to the Company, in the amounts as set forth in purchase orders to be provided by the Company. The Company will be required to purchase its requirements of API for each year of the term of the agreement, based on internal forecasts. The API Commercial Supply Agreement will continue until the fifth anniversary of the approval by the FDA of the new drug application for KORSUVA injection, unless the API Commercial Supply Agreement is earlier terminated, and will automatically be extended for successive five-year periods unless either party gives notice to the other party of its intention to terminate. In July 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. In July 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 difelikefalin injection, the Company’s lead product candidate. Pursuant to the Product Agreements, Patheon and Patheon Greenville will manufacture commercial supplies of 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 Lease expense is recognized on a straight-line basis over the lease term of the Company’s lease agreements for its original headquarters, and additional office space, in Stamford, Connecticut. As a result, $406 of operating lease cost, or lease expense, was recognized for each of the three months ended September 30, 2022 and 2021, consisting of $284 relating to R&D lease expense and $122 relating to G&A lease expense in both periods. For each of the nine months ended September 30, 2022 and 2021, $1,218 of operating lease cost, or lease expense, was recognized, consisting of $853 relating to R&D lease expense and $365 relating to G&A lease expense in both periods. Other information related to the leases was as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows relating to operating leases $ 491 $ 482 $ 1,463 $ 1,436 ROU assets obtained in exchange for new operating lease liabilities $ — $ — $ — $ — Remaining lease term - operating leases (years) 1.3 2.3 1.3 2.3 Discount rate - operating leases 7.0 % 7.0 % 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 liabilities as of September 30, 2022, were as follows: Year Ending December 31, 2022 (Excluding the nine months ended September 30, 2022) $ 494 2023 1,992 Total future minimum lease payments, undiscounted 2,486 Less imputed interest (113) Total $ 2,373 Operating lease liabilities reported as of September 30, 2022: Operating lease liabilities - current $ 1,876 Operating lease liabilities - non-current 497 Total $ 2,373 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions | |
Related Party Transactions | 17. Related Party Transactions As of September 30, 2022, Vifor International owned 7,396,770 , or 13.8% , of the Company’s common stock. Both Vifor and Vifor International are considered related parties as of September 30, 2022 and December 31, 2021 (see Note 11, Collaboration and Licensing Agreements ). As of September 30, 2022, amounts due from Vifor of $9,623 relating to the Company’s profit-share revenue from sales of KORSUVA injection in the U.S. by Vifor and its commercial supply of KORSUVA injection to Vifor were included within Accounts receivable, net – related party on the Company’s Condensed Balance Sheet. The Company’s profit-share revenue of $7,443 and $15,446 from sales of KORSUVA injection in the U.S. by Vifor were included within Collaborative revenue on the Company’s Condensed Statements of Comprehensive Loss for the three and nine months ended September 30, 2022, respectively. Sales of KORSUVA injection to Vifor of $3,370 and $8,160 were included within Commercial supply revenue on the Company’s Condensed Statements of Comprehensive Loss for the three and nine months ended September 30, 2022, respectively. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Business. | |
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. The more significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, revenue recognition associated with profit-sharing arrangements, the amount and periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, accounts receivable, net – related party, inventory valuation and related reserves, 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, the incremental borrowing rate used in lease calculations and the likelihood of realization of deferred tax assets. The COVID-19 pandemic and geopolitical tensions, such as Russia’s incursion into Ukraine, resulted in a global slowdown of economic activity, decades-high inflation, rising interest rates, and a potential recession in the U.S. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these condensed financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the reported amounts of assets and liabilities or the disclosure of contingent assets and liabilities. These estimates, however, may change as new events occur and additional information is obtained, and are recognized in the condensed financial statements as soon as they become known. Actual results could differ materially from the Company’s estimates and assumptions. |
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, 2021, except as disclosed below. |
Accounts Receivable, net - Related Party | Accounts Receivable, Net – Related Party Accounts receivable, net – related party consists of amounts due from sales of KORSUVA injection under the Company’s supply agreements with Vifor, as well as revenues earned from its profit-sharing agreement from sales of KORSUVA injection in the U.S. under the licensing agreements with Vifor. The Company does not obtain collateral for its accounts receivable. The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for credit losses when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not specifically reviewed. The Company believes that credit risk associated with its licensing partner, Vifor, is not significant. The Company reviews the need for an allowance for credit losses for any receivable based on various factors including payment history and historical bad debt experience. The Company had an insignificant allowance for credit losses as of September 30, 2022. |
Revenue Recognition - Profit Sharing Arrangement | Revenue Recognition – Profit-Sharing Arrangement The Company receives its share of the net profits from Vifor’s sale of KORSUVA injection to third parties in the U.S. under its existing license agreements. The Company has adopted a policy to recognize revenue net of tax withholdings, as applicable. The Company determined that Vifor is a customer under Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers (Topic 606) In accordance with ASC 606-10-55, Principal Agent Considerations Collaboration and Licensing Agreements) |
Available-for-Sale Marketable_2
Available-for-Sale Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Available-for-Sale Marketable Securities | |
Summary of Available-for-Sale Marketable Securities by Major Type of Security | As of September 30, 2022 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 4,004 $ — $ (7) $ 3,997 U.S. government agency obligations 9,500 — (646) 8,854 Corporate bonds 39,955 — (838) 39,117 Commercial paper 62,884 — (64) 62,820 Municipal bonds 22,527 — (593) 21,934 Total available-for-sale marketable securities $ 138,870 $ — $ (2,148) $ 136,722 As of December 31, 2021 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 11,573 $ — $ (3) $ 11,570 U.S. government agency obligations 17,020 — (45) 16,975 Corporate bonds 66,495 — (171) 66,324 Commercial paper 106,914 5 (31) 106,888 Municipal bonds 21,692 — (113) 21,579 Total available-for-sale marketable securities $ 223,694 $ 5 $ (363) $ 223,336 |
Schedule of Fair Values and Continuous Unrealized Loss Positions of Available-for-Sale Marketable Securities | As of September 30, 2022 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 $ 3,997 $ (7) $ — $ — $ 3,997 $ (7) U.S. government agency obligations 4,646 (354) 4,208 (292) 8,854 (646) Corporate bonds 23,606 (606) 15,511 (232) 39,117 (838) Commercial paper 62,820 (64) — — 62,820 (64) Municipal bonds 7,912 (204) 14,022 (389) 21,934 (593) Total $ 102,981 $ (1,235) $ 33,741 $ (913) $ 136,722 $ (2,148) As of December 31, 2021 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 $ 11,570 $ (3) $ — $ — $ 11,570 $ (3) U.S. government agency obligations 9,456 (45) — — 9,456 (45) Corporate bonds 62,704 (170) 2,020 (1) 64,724 (171) Commercial paper 52,163 (31) — — 52,163 (31) Municipal bonds 20,562 (105) 1,017 (8) 21,579 (113) Total $ 156,455 $ (354) $ 3,037 $ (9) $ 159,492 $ (363) |
Schedule of Amortized Cost and Fair Values of Marketable Debt Securities by Contractual Maturity | As of September 30, 2022 As of December 31, 2021 Contractual maturity Amortized Cost Fair Value Amortized Cost Fair Value Less than one year $ 113,967 $ 112,806 $ 153,631 $ 153,582 One year to three years 24,903 23,916 70,063 69,754 Total $ 138,870 $ 136,722 $ 223,694 $ 223,336 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive (Loss) Income (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accumulated Other Comprehensive (Loss) Income | |
Summary of Changes in Accumulated Other Comprehensive (Loss) Income, Net of Tax, from Unrealized Gains (Losses) on Available-for-Sale Marketable Securities | Total Accumulated Other Comprehensive (Loss) Income Balance, December 31, 2021 $ (358) Other comprehensive loss before reclassifications (1,790) Amount reclassified from accumulated other comprehensive loss — Net current period other comprehensive loss (1,790) Balance, September 30, 2022 $ (2,148) Balance, December 31, 2020 $ 73 Other comprehensive loss before reclassifications (33) Amount reclassified from accumulated other comprehensive income (39) Net current period other comprehensive loss (72) Balance, September 30, 2021 $ 1 |
Schedule of Reclassification Out of Accumulated Other Comprehensive (Loss) Income | Three Months Ended Nine Months Ended Affected Line Item in the Component of Accumulated Other September 30, September 30, Condensed Statements of Comprehensive (Loss) Income 2022 2021 2022 2021 Comprehensive Loss Unrealized gains (losses) on available-for-sale marketable securities: Realized gains on sales of securities $ — $ — $ — $ 39 Other income, net Income tax effect — — — — Benefit from income taxes Realized gains on sales of securities, net of tax $ — $ — $ — $ 39 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | Fair value measurement as of September 30, 2022 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 $ 42,806 $ 42,806 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 3,997 — 3,997 — U.S. government agency obligations 8,854 — 8,854 — Corporate bonds 39,117 — 39,117 — Commercial paper 62,820 — 62,820 — Municipal bonds 21,934 — 21,934 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 179,936 $ 43,214 $ 136,722 $ — Fair value measurement as of December 31, 2021: 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 $ 13,453 $ 13,453 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 11,570 — 11,570 — U.S. government agency obligations 16,975 — 16,975 — Corporate bonds 66,324 — 66,324 — Commercial paper 106,888 — 106,888 — Municipal bonds 21,579 — 21,579 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 237,197 $ 13,861 $ 223,336 $ — |
Restricted Cash (Tables)
Restricted Cash (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Restricted Cash | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | September 30, 2022 December 31, 2021 Cash and cash equivalents $ 42,806 $ 13,453 Restricted cash, long-term assets 408 408 Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows $ 43,214 $ 13,861 |
Inventory, net (Tables)
Inventory, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory, net | |
Schedule of Inventory, net | September 30, 2022 December 31, 2021 Raw materials $ 1,833 $ 927 Work-in-process 2 1,657 Total $ 1,835 $ 2,584 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounts Payable and Accrued Expenses | |
Schedule of Accounts Payable and Accrued Expenses | September 30, 2022 December 31, 2021 Accounts payable $ 15,218 $ 5,625 Accrued research projects 5,149 4,648 Accrued compensation and benefits 4,228 4,959 Accrued professional fees and other 1,721 629 Total $ 26,316 $ 15,861 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue Recognition | |
Schedule of disaggregation of revenue | Three Months Ended Nine Months Ended September 30, 2022 September 30, 2021 September 30, 2022 September 30, 2021 Collaborative revenue Vifor (KORSUVA injection profit sharing) $ 7,443 $ — $ 15,446 $ — Maruishi — — — 706 Total collaborative revenue $ 7,443 $ — $ 15,446 $ 706 License and milestone fees Vifor $ — $ 20,031 $ 15,000 $ 20,031 Maruishi — — — 1,192 Total license and milestone fees $ — $ 20,031 $ 15,000 $ 21,223 Commercial supply revenue Vifor (KORSUVA injection) $ 3,370 $ — $ 8,160 $ — Total commercial supply revenue $ 3,370 $ — $ 8,160 $ — Clinical compound revenue Vifor (difelikefalin injection) $ — $ 241 $ — $ 241 Maruishi — — — 37 Total clinical compound revenue $ — $ 241 $ — $ 278 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Share | |
Computation of Denominators Used in Net (Loss) Income per Share | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Basic: Weighted average common shares outstanding 53,726,123 50,114,710 53,616,753 50,031,615 Diluted: Weighted average common shares outstanding - Basic 53,726,123 50,114,710 53,616,753 50,031,615 Common stock equivalents* — — — — Denominator for diluted net loss per share 53,726,123 50,114,710 53,616,753 50,031,615 * No amounts were considered as their effects would be anti-dilutive. |
Computation of Basic and Diluted Net (Loss) Income per Share | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Net loss - basic and diluted $ (23,180) $ (1,013) $ (55,135) $ (55,059) Weighted-average common shares outstanding: Basic and diluted 53,726,123 50,114,710 53,616,753 50,031,615 Net loss per share, basic and diluted: $ (0.43) $ (0.02) $ (1.03) $ (1.10) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Assumptions Used in Black-Scholes Option Pricing Model | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Risk-free interest rate 2.65% - 4.09% 0.92% - 1.01% 1.70% - 4.09% 0.66% - 1.23% Expected volatility 77.7% - 78.2% 83.0% - 83.4% 77.7% - 81.9% 71.6% - 83.5% Expected dividend yield 0% 0% 0% 0% Expected life of employee and Board options (in years) 6.25 6.25 6.25 6.25 |
Summary of Compensation Expense Relating to Stock Options | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development $ 1,719 $ 1,833 $ 5,380 $ 5,228 General and administrative 1,149 1,205 5,137 3,444 Total stock option expense $ 2,868 $ 3,038 $ 10,517 $ 8,672 |
Summary of Stock Option Activity | Weighted Number of Average Exercise Shares Price Outstanding, December 31, 2021 6,512,280 $ 15.58 Granted 1,739,919 10.28 Exercised (46,277) 6.26 Forfeited (356,819) 14.50 Expired (194,580) 16.21 Outstanding, September 30, 2022 7,654,523 $ 14.47 Options exercisable, September 30, 2022 4,764,271 |
Employees And Non-Employee Members Of Board Of Directors [Member] | |
Summary of Restricted Stock Unit Activity | Weighted Number of Average Grant Units Date Fair Value Outstanding, December 31, 2021 576,544 $ 17.50 Awarded 466,926 10.11 Vested and released (206,518) 16.74 Forfeited (196,002) 17.06 Outstanding, September 30, 2022 640,950 $ 12.50 Restricted stock units exercisable (vested and deferred), September 30, 2022 — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies | |
Schedule of Other Information related to Stamford Lease and lease amendment | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows relating to operating leases $ 491 $ 482 $ 1,463 $ 1,436 ROU assets obtained in exchange for new operating lease liabilities $ — $ — $ — $ — Remaining lease term - operating leases (years) 1.3 2.3 1.3 2.3 Discount rate - operating leases 7.0 % 7.0 % 7.0 % 7.0 % |
Schedule of Future Minimum Lease Payments under Non-cancellable Operating Leases, Reconciliation of Undiscounted Cash Flows to the Operating Lease Liabilities | Year Ending December 31, 2022 (Excluding the nine months ended September 30, 2022) $ 494 2023 1,992 Total future minimum lease payments, undiscounted 2,486 Less imputed interest (113) Total $ 2,373 Operating lease liabilities reported as of September 30, 2022: Operating lease liabilities - current $ 1,876 Operating lease liabilities - non-current 497 Total $ 2,373 |
Business - Additional Informati
Business - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||
May 17, 2018 shares | Oct. 31, 2021 USD ($) shares | Oct. 31, 2020 USD ($) shares | May 31, 2018 USD ($) shares | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Sep. 30, 2022 USD ($) item | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Nature Of Business [Line Items] | |||||||||||||
Date of formation | Jul. 02, 2004 | ||||||||||||
Proceeds from equity and debt financing | $ 519,600 | $ 519,600 | |||||||||||
Number of follow-on public offerings | item | 4 | ||||||||||||
Payments received in connection with license and supply agreements | 263,500 | $ 263,500 | |||||||||||
Unrestricted cash and cash equivalents and marketable securities | 179,528 | 179,528 | |||||||||||
Accumulated deficit | 535,893 | 535,893 | $ 480,758 | ||||||||||
Net loss | $ (23,180) | $ (4,206) | $ (27,749) | $ (1,013) | $ (30,745) | $ (23,301) | (55,135) | $ (55,059) | |||||
Net cash used in operating activities | $ (55,220) | $ (58,842) | |||||||||||
Vifor Agreement No 1 [Member] | |||||||||||||
Nature Of Business [Line Items] | |||||||||||||
Percentage of net profit sharing | 60% | ||||||||||||
Vifor Agreement No 2 [Member] | |||||||||||||
Nature Of Business [Line Items] | |||||||||||||
Percentage of net profit sharing | 50% | ||||||||||||
Vifor International Ltd. [Member] | |||||||||||||
Nature Of Business [Line Items] | |||||||||||||
Proceeds from sale of common stock in connection with license agreement | $ 38,449 | $ 14,556 | |||||||||||
Proceeds from sale of common stock in connection with regulatory milestone | $ 44,969 | ||||||||||||
Vifor International Ltd. [Member] | Vifor Agreement No 1 [Member] | |||||||||||||
Nature Of Business [Line Items] | |||||||||||||
Percentage of net profit sharing | 40% | ||||||||||||
Common stock, shares issued | shares | 2,939,552 | ||||||||||||
Vifor International Ltd. [Member] | Vifor Agreement No 2 [Member] | |||||||||||||
Nature Of Business [Line Items] | |||||||||||||
Common stock, shares issued | shares | 1,174,827 | ||||||||||||
Vifor International Ltd. [Member] | Regulatory Milestones [Member] | |||||||||||||
Nature Of Business [Line Items] | |||||||||||||
Common stock, shares issued | shares | 3,282,391 | ||||||||||||
Vifor International Ltd. [Member] | Common Stock [Member] | |||||||||||||
Nature Of Business [Line Items] | |||||||||||||
Common stock, shares issued | shares | 3,282,391 | 2,939,552 | 1,174,827 | ||||||||||
Vifor [Member] | Vifor Agreement No 2 [Member] | |||||||||||||
Nature Of Business [Line Items] | |||||||||||||
Percentage of net profit sharing | 50% |
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, 2022 | Dec. 31, 2021 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | $ 138,870 | $ 223,694 |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | (2,148) | (363) |
Estimated fair value | 136,722 | 223,336 |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 4,004 | 11,573 |
Gross Unrealized Losses | (7) | (3) |
Estimated fair value | 3,997 | 11,570 |
U.S. Government Agency Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 9,500 | 17,020 |
Gross Unrealized Losses | (646) | (45) |
Estimated fair value | 8,854 | 16,975 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 39,955 | 66,495 |
Gross Unrealized Losses | (838) | (171) |
Estimated fair value | 39,117 | 66,324 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 62,884 | 106,914 |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | (64) | (31) |
Estimated fair value | 62,820 | 106,888 |
Municipal Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 22,527 | 21,692 |
Gross Unrealized Losses | (593) | (113) |
Estimated fair value | $ 21,934 | $ 21,579 |
Available-for-Sale Marketable_4
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, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | $ 102,981 | $ 156,455 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (1,235) | (354) |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 33,741 | 3,037 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (913) | (9) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 136,722 | 159,492 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (2,148) | (363) |
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 | 3,997 | 11,570 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (7) | (3) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 3,997 | 11,570 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (7) | (3) |
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 | 4,646 | 9,456 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (354) | (45) |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 4,208 | |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (292) | |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 8,854 | 9,456 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (646) | (45) |
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 | 23,606 | 62,704 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (606) | (170) |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 15,511 | 2,020 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (232) | (1) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 39,117 | 64,724 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (838) | (171) |
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 | 62,820 | 52,163 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (64) | (31) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 62,820 | 52,163 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (64) | (31) |
Municipal 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 | 7,912 | 20,562 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (204) | (105) |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 14,022 | 1,017 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (389) | (8) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 21,934 | 21,579 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | $ (593) | $ (113) |
Available-for-Sale Marketable_5
Available-for-Sale Marketable Securities - Additional Information (Detail) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 USD ($) position | Dec. 31, 2021 USD ($) position | |
Schedule of Available-for-sale Securities [Line Items] | ||
Available-for-sale allowance for credit loss | $ | $ 0 | $ 0 |
Available-for-sale unrealized credit losses | $ | $ 0 | $ 0 |
Number of available-for-sale marketable securities in unrealized loss positions | 57 | 58 |
Total number of positions | 57 | 76 |
Number of positions of available-for-sale in unrealized loss position for 12 months or greater | 18 | |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale marketable securities in unrealized loss positions | 2 | |
Total number of positions | 2 | |
U.S. Government Agency Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale marketable securities in unrealized loss positions | 3 | |
Total number of positions | 3 | |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale marketable securities in unrealized loss positions | 15 | |
Total number of positions | 15 | |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale marketable securities in unrealized loss positions | 22 | |
Total number of positions | 22 | |
Municipal Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale marketable securities in unrealized loss positions | 15 | |
Total number of positions | 15 |
Available-for-Sale Marketable_6
Available-for-Sale Marketable Securities - Schedule of Amortized Cost and Fair Values of Marketable Debt Securities by Contractual Maturity (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Debt Securities [Abstract] | |||||
Amortized Cost of marketable debt securities, contractual maturity, less than one year | $ 113,967 | $ 113,967 | $ 153,631 | ||
Amortized Cost of marketable debt securities, contractual maturity, One year to three years | 24,903 | 24,903 | 70,063 | ||
Amortized cost | 138,870 | 138,870 | 223,694 | ||
Fair value of marketable debt securities, contractual maturities, less than one year | 112,806 | 112,806 | 153,582 | ||
Fair value of marketable debt securities, contractual maturity, One year to three years | 23,916 | 23,916 | 69,754 | ||
Total fair Value of marketable debt securities, contractual maturity | 136,722 | 136,722 | 223,336 | ||
Proceeds from sale of available-for-sale marketable securities | 0 | $ 1,000 | 0 | $ 10,029 | |
Realized gain | $ 0 | $ 39 | |||
Interest receivable | $ 451 | $ 451 | $ 455 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive (Loss) Income - Summary of Changes in Accumulated Other Comprehensive (Loss) Income, 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, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||||||||
Balance, Value | $ 204,422 | $ 204,115 | $ 227,522 | $ 203,466 | $ 230,459 | $ 249,001 | $ 227,522 | $ 249,001 |
Amount reclassified from accumulated other comprehensive income (loss) | (39) | |||||||
Net current period other comprehensive loss | (101) | (324) | (1,365) | 6 | (17) | (61) | ||
Balance, Value | 184,820 | 204,422 | 204,115 | 207,191 | 203,466 | 230,459 | 184,820 | 207,191 |
Accumulated Other Comprehensive Income (Loss) | ||||||||
Accumulated Other Comprehensive Income Loss [Line Items] | ||||||||
Balance, Value | (2,047) | (1,723) | (358) | (5) | 12 | 73 | (358) | 73 |
Other comprehensive loss before reclassifications | (1,790) | (33) | ||||||
Amount reclassified from accumulated other comprehensive income (loss) | (39) | |||||||
Net current period other comprehensive loss | (101) | (324) | (1,365) | 6 | (17) | (61) | (1,790) | (72) |
Balance, Value | $ (2,148) | $ (2,047) | $ (1,723) | $ 1 | $ (5) | $ 12 | $ (2,148) | $ 1 |
Accumulated Other Comprehensi_4
Accumulated Other Comprehensive (Loss) Income - Schedule of Reclassifications Out of Accumulated Other Comprehensive (Loss) Income (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Reclassification Adjustment Out Of Accumulated Other Comprehensive Income [Line Items] | ||||
Other income, net | $ 665 | $ 111 | $ 1,093 | $ 502 |
Benefit from income taxes | $ 0 | $ 0 | $ 0 | 0 |
Net of tax | 39 | |||
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, net | $ 39 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Financial assets | ||
Available-for-sale marketable securities | $ 136,722 | $ 223,336 |
Restricted cash | 408 | 408 |
Recurring [Member] | ||
Financial assets | ||
Total financial assets | 179,936 | 237,197 |
U.S. Government Agency Obligations [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 8,854 | 16,975 |
U.S. Government Agency Obligations [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 8,854 | 16,975 |
Corporate Bonds [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 39,117 | 66,324 |
Corporate Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 39,117 | 66,324 |
Municipal Bonds [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 21,934 | 21,579 |
Municipal Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 21,934 | 21,579 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Recurring [Member] | ||
Financial assets | ||
Total financial assets | 43,214 | 13,861 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Total financial assets | 136,722 | 223,336 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Obligations [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 8,854 | 16,975 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 39,117 | 66,324 |
Significant Other Observable Inputs (Level 2) [Member] | Municipal Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 21,934 | 21,579 |
Money Market Funds [Member] | Recurring [Member] | ||
Financial assets | ||
Cash and cash equivalents | 42,806 | 13,453 |
Restricted cash | 408 | 408 |
Money Market Funds [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Recurring [Member] | ||
Financial assets | ||
Cash and cash equivalents | 42,806 | 13,453 |
Restricted cash | 408 | 408 |
U.S. Treasury Securities [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 3,997 | 11,570 |
U.S. Treasury Securities [Member] | Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 3,997 | 11,570 |
Commercial Paper [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 62,820 | 106,888 |
Commercial Paper [Member] | Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | $ 62,820 | $ 106,888 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - Significant Unobservable Inputs (Level 3) [Member] - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||||
Purchases of financial assets | $ 0 | $ 0 | $ 0 | $ 0 |
Sales of financial assets | 0 | 0 | 0 | 0 |
Maturities of financial assets | 0 | 0 | 0 | 0 |
Unrealized gains | 0 | 0 | 0 | 0 |
Unrealized losses | 0 | 0 | 0 | 0 |
Transfer of financial assets into or out of level 3 of fair value | $ 0 | $ 0 | $ 0 | $ 0 |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash, long-term assets | $ 408 | $ 408 |
Stamford Lease [Member] | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash, long-term assets | $ 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, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Restricted Cash | ||||
Cash and cash equivalents | $ 42,806 | $ 13,453 | ||
Restricted cash, long-term assets | 408 | 408 | ||
Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows | $ 43,214 | $ 13,861 | $ 23,399 | $ 32,091 |
Inventory, net - Schedule of In
Inventory, net - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory, net | ||
Raw materials | $ 1,833 | $ 927 |
Work-in-process | 2 | 1,657 |
Total | $ 1,835 | $ 2,584 |
Inventory, net - Additional Inf
Inventory, net - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Inventory, net | ||
Inventory write-down | $ 0 | $ 0 |
Prepaid expenses - Additional I
Prepaid expenses - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid expenses | ||
Prepaid expenses | $ 18,562 | $ 2,519 |
Prepaid R&D clinical costs | 17,090 | 1,481 |
Prepaid insurance | 858 | 369 |
Other prepaid costs | $ 614 | $ 669 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 15,218 | $ 5,625 |
Accrued research projects | 5,149 | 4,648 |
Accrued compensation and benefits | 4,228 | 4,959 |
Accrued professional fees and other | 1,721 | 629 |
Total | $ 26,316 | $ 15,861 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 2 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||||
Jun. 30, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Feb. 28, 2022 | Oct. 31, 2021 | Aug. 31, 2021 | Jun. 30, 2021 | Feb. 28, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Sale Of Stock [Line Items] | ||||||||||||||||||
Stock Subscription Receivable. | $ 44,969 | $ 44,969 | ||||||||||||||||
Revenue From Contract With Customer Excluding Assessed Tax | $ 10,813 | $ 20,272 | $ 38,606 | $ 22,207 | ||||||||||||||
Regulatory Milestones [Member] | Vifor International Ltd. [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 3,282,391 | |||||||||||||||||
Share Price | $ 15.23 | $ 15.23 | $ 15.23 | |||||||||||||||
Proceeds from the sale of common stock | $ 50,000 | |||||||||||||||||
Stock subscription receivable | $ 44,969 | $ 44,969 | ||||||||||||||||
Maximum [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Aggregate offering price of securities | $ 300,000 | $ 300,000 | ||||||||||||||||
License and Milestone Fees | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Revenue From Contract With Customer Excluding Assessed Tax | 20,031 | $ 15,000 | 21,223 | |||||||||||||||
License and Milestone Fees | Regulatory Milestones [Member] | Vifor International Ltd. [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Revenue From Contract With Customer Excluding Assessed Tax | $ 5,031 | $ 5,031 | ||||||||||||||||
Unsold Securities Under Shelf Registration Statement dated April 4, 2019 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Aggregate offering price of securities | 154,525 | 154,525 | ||||||||||||||||
Open Market Sales Agreement [Member] | Jeffries LLC [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 0 | |||||||||||||||||
Aggregate offering price of securities | $ 80,000 | $ 80,000 | ||||||||||||||||
Stock Sale Commission Percentage | 3% | |||||||||||||||||
Common Stock | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Restricted stock units vested shares | 7,500 | 89,075 | 109,943 | 44,002 | 36,000 | 109,419 | ||||||||||||
Restricted Stock Units [Member] | Common Stock | Board of Directors Chairman [Member] | June 2022 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Restricted stock units vested shares | 11,876 | |||||||||||||||||
Restricted Stock Units [Member] | Common Stock | Director [Member] | June 2022 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Vesting period of awards granted | 1 year | |||||||||||||||||
Restricted stock units, vested | 43,200 | |||||||||||||||||
Restricted Stock Units [Member] | Common Stock | Director [Member] | June 2021 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Vesting period of awards granted | 1 year | |||||||||||||||||
Restricted stock units vested shares | 36,000 | |||||||||||||||||
Restricted Stock Units [Member] | Common Stock | Former Chief Executive Officer [Member] | June 2022 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Restricted stock units vested shares | 33,999 | |||||||||||||||||
Performance Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | March 2022 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Vesting period of awards granted | 3 years | |||||||||||||||||
Restricted stock units, vested | 37,999 | |||||||||||||||||
Performance Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | August 2021 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Restricted stock units, vested | 44,002 | |||||||||||||||||
Performance Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | February and March 2021 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Restricted stock units vested shares | 76,750 | |||||||||||||||||
Time-based Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | March 2022 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Restricted stock units vested shares | 39,278 | |||||||||||||||||
Time-based Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | February 2022 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Vesting period of awards granted | 3 years | |||||||||||||||||
Restricted stock units vested shares | 32,666 | |||||||||||||||||
Time-based Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | February 2021 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Vesting period of awards granted | 3 years | |||||||||||||||||
Restricted stock units vested shares | 32,669 | |||||||||||||||||
Time-based Restricted Stock Units [Member] | Common Stock | Interim Principal Financial and Accounting Officer [Member] | September 2022 [Member] | ||||||||||||||||||
Sale Of Stock [Line Items] | ||||||||||||||||||
Restricted stock units, vested | 7,500 |
Collaboration and Licensing A_2
Collaboration and Licensing Agreements - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Oct. 15, 2020 | May 17, 2018 | Oct. 31, 2021 | Oct. 31, 2020 | May 31, 2018 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Purchase common stock per share amount | $ 15.23 | $ 15.23 | |||||||
Revenues | $ 10,813 | $ 20,272 | $ 38,606 | $ 22,207 | |||||
License and Milestone Fees | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | 20,031 | 15,000 | 21,223 | ||||||
Collaborative Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | 7,443 | 15,446 | 706 | ||||||
Commercial Supply Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | 3,370 | 8,160 | |||||||
Clinical Compound Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | 241 | 278 | |||||||
Vifor Agreement No 1 [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percentage of net profit sharing | 60% | ||||||||
Vifor Agreement No 2 [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percentage of net profit sharing | 50% | ||||||||
Maximum [Member] | Vifor Agreement No 1 [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential sales-based milestone payments | $ 240,000 | ||||||||
Maximum [Member] | Vifor Agreement No 2 [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Potential milestone payments | 440,000 | 440,000 | |||||||
Maruishi Pharmaceutical Co., Ltd. [Member] | Clinical Compound Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | 0 | 0 | 0 | 37 | |||||
Vifor International Ltd. [Member] | License and Milestone Fees | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | 5,031 | 5,031 | |||||||
Vifor International Ltd. [Member] | Vifor Agreement No 1 [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percentage of net profit sharing | 40% | ||||||||
Common stock, shares issued | 2,939,552 | ||||||||
Proceeds from the sale of common stock | $ 50,000 | ||||||||
Purchase common stock per share amount | $ 17.0094 | ||||||||
Vifor International Ltd. [Member] | Vifor Agreement No 1 [Member] | License [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Non-refundable, non-creditable upfront payment | $ 100,000 | ||||||||
Vifor International Ltd. [Member] | Vifor Agreement No 2 [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Common stock, shares issued | 1,174,827 | ||||||||
Purchase of common stock value | $ 20,000 | ||||||||
Purchase common stock per share amount | $ 17.024 | ||||||||
Vifor International Ltd. [Member] | Vifor Agreement No 2 [Member] | License and Milestone Fees | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | 15,000 | 15,000 | |||||||
Vifor International Ltd. [Member] | Regulatory Milestones [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Common stock, shares issued | 3,282,391 | ||||||||
Proceeds from the sale of common stock | $ 50,000 | ||||||||
Purchase common stock per share amount | $ 15.23 | ||||||||
Percentage of premium on common stock investment | 20% | ||||||||
Stock issuance price measurement period | 30 days | ||||||||
Vifor [Member] | Collaborative Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | 7,443 | $ 0 | 15,446 | $ 0 | |||||
Vifor [Member] | Commercial Supply Revenue | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | $ 3,370 | 8,160 | |||||||
Vifor [Member] | Vifor Agreement No 2 [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percentage of net profit sharing | 50% | ||||||||
Non-refundable, non-creditable upfront payment | $ 50,000 | ||||||||
Vifor [Member] | Vifor Agreement No 2 [Member] | License and Milestone Fees | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenues | $ 15,000 |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 10,813 | $ 20,272 | $ 38,606 | $ 22,207 |
Collaborative Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 7,443 | 15,446 | 706 | |
License and Milestone Fees | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 20,031 | 15,000 | 21,223 | |
Commercial Supply Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 3,370 | 8,160 | ||
Clinical Compound Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 241 | 278 | ||
Vifor [Member] | License and Milestone Fees | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 20,031 | 15,000 | 20,031 | |
Vifor [Member] | Commercial Supply Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 3,370 | 8,160 | ||
Vifor [Member] | Clinical Compound Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 241 | 241 | ||
Vifor Profit Sharing [Member] | Collaborative Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 7,443 | 15,446 | ||
Maruishi Agreement [Member] | Collaborative Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | 0 | 0 | 0 | 706 |
Maruishi Agreement [Member] | License and Milestone Fees | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 0 | $ 0 | $ 0 | 1,192 |
Maruishi Agreement [Member] | Clinical Compound Revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenue | $ 37 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 8 Months Ended | 9 Months Ended | |||||
Apr. 30, 2022 | Jan. 31, 2022 | Oct. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Collaboration Arrangement [Line Items] | |||||||||
Accounts receivable, net - related party | $ 9,623 | $ 9,623 | $ 9,623 | ||||||
Total revenue | 10,813 | $ 20,272 | 38,606 | $ 22,207 | |||||
Price per share | $ 15.23 | $ 15.23 | |||||||
Research and development expense | 24,691 | $ 15,514 | 65,869 | $ 59,870 | |||||
Commercial Supply Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 3,370 | 8,160 | |||||||
License and Milestone Fees | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 20,031 | 15,000 | 21,223 | ||||||
Collaborative Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 7,443 | 15,446 | 706 | ||||||
Clinical Compound Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 241 | 278 | |||||||
Vifor Agreement No 2 [Member] | License and Milestone Fees | Regulatory Milestones [Member] | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 0 | ||||||||
Proceeds from milestone payments | $ 15,000 | $ 15,000 | |||||||
Vifor, Vifor International, Maruishi and CKDP Agreements [Member] | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Accounts receivable, net - related party | $ 0 | ||||||||
Other contract Assets | 0 | 0 | 0 | 0 | |||||
Other contract liabilities | 0 | 0 | 0 | $ 0 | |||||
Maruishi Agreement [Member] | License and Milestone Fees | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 0 | 0 | 0 | 1,192 | |||||
Maruishi Agreement [Member] | Collaborative Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 0 | 0 | 0 | 706 | |||||
Maruishi Agreement [Member] | Clinical Compound Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 37 | ||||||||
Maruishi Pharmaceutical Co., Ltd. [Member] | Clinical Compound Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 0 | 0 | 0 | 37 | |||||
Research and development expense | 33 | ||||||||
Vifor International Ltd. [Member] | Regulatory Milestones [Member] | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Proceeds from the sale of common stock | $ 50,000 | ||||||||
Common stock, shares issued | 3,282,391 | ||||||||
Price per share | $ 15.23 | ||||||||
Percentage of premium on common stock investment | 20% | ||||||||
Stock Issuance Price Measurement Period | 30 days | ||||||||
Vifor International Ltd. [Member] | License and Milestone Fees | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 5,031 | 5,031 | |||||||
Vifor [Member] | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Accounts receivable, net - related party | 9,623 | 9,623 | 9,623 | ||||||
Vifor [Member] | Commercial Supply Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 3,370 | 8,160 | |||||||
Vifor [Member] | Commercial Supply Revenue With No Associated Costs Of Goods Sold [Member] | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Revenue | $ 2,295 | ||||||||
Cost of goods sold | $ 0 | ||||||||
Vifor [Member] | Commercial Supply Revenue With Associated Costs Of Goods Sold [Member] | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Revenue | 5,865 | ||||||||
Cost of goods sold | 3,055 | $ 5,136 | |||||||
Vifor [Member] | Collaborative Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | 7,443 | 0 | 15,446 | 0 | |||||
Vifor [Member] | Vifor Agreement [Member] | Clinical Compound Revenue | |||||||||
Collaboration Arrangement [Line Items] | |||||||||
Total revenue | $ 0 | 241 | $ 0 | 241 | |||||
Research and development expense | $ 228 | $ 228 |
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, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Basic: | ||||
Weighted average common shares outstanding - Basic | 53,726,123 | 50,114,710 | 53,616,753 | 50,031,615 |
Diluted: | ||||
Weighted average common shares outstanding - Basic | 53,726,123 | 50,114,710 | 53,616,753 | 50,031,615 |
Common stock equivalents | 0 | 0 | 0 | 0 |
Denominator for diluted net loss per share | 53,726,123 | 50,114,710 | 53,616,753 | 50,031,615 |
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, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Net Loss Per Share | ||||||||
Net loss - basic and diluted | $ (23,180) | $ (4,206) | $ (27,749) | $ (1,013) | $ (30,745) | $ (23,301) | $ (55,135) | $ (55,059) |
Weighted-average common shares outstanding: | ||||||||
Basic | 53,726,123 | 50,114,710 | 53,616,753 | 50,031,615 | ||||
Diluted | 53,726,123 | 50,114,710 | 53,616,753 | 50,031,615 | ||||
Net loss per share: | ||||||||
Basic | $ (0.43) | $ (0.02) | $ (1.03) | $ (1.10) | ||||
Diluted | $ (0.43) | $ (0.02) | $ (1.03) | $ (1.10) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares | Sep. 30, 2022 | Sep. 30, 2021 |
Net Loss Per Share | ||
Number of options outstanding | 7,654,523 | 5,974,549 |
Number of restricted stock units outstanding | 640,950 | 365,029 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||||||||
Jun. 30, 2022 shares | Jun. 15, 2022 $ / shares shares | Jun. 02, 2022 $ / shares shares | Feb. 25, 2022 installment $ / shares shares | Dec. 17, 2021 installment $ / shares shares | Oct. 29, 2021 tranche $ / shares shares | Jun. 03, 2021 $ / shares shares | Mar. 30, 2021 installment $ / shares shares | Jun. 04, 2020 $ / shares | Jun. 30, 2022 shares | Mar. 31, 2022 shares | Feb. 28, 2022 shares | Aug. 31, 2021 shares | Mar. 31, 2021 shares | Feb. 28, 2021 shares | Jun. 30, 2020 shares | Feb. 29, 2020 installment $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Mar. 31, 2022 shares | Sep. 30, 2021 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | Dec. 31, 2015 shares | Jan. 01, 2022 shares | Dec. 31, 2021 $ / shares shares | Nov. 20, 2019 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||||||||||||||
Common stock, shares outstanding | 53,733,607 | 53,733,607 | 53,480,812 | |||||||||||||||||||||||
Common stock, shares issued | 53,733,607 | 53,733,607 | 53,480,812 | |||||||||||||||||||||||
Number of restricted stock units outstanding | 640,950 | 365,029 | 640,950 | 365,029 | ||||||||||||||||||||||
Number of options outstanding | 7,654,523 | 5,974,549 | 7,654,523 | 5,974,549 | ||||||||||||||||||||||
Restricted Stock Units [Member] | Research and Development [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 200 | $ 429 | $ 565 | $ 1,094 | ||||||||||||||||||||||
Restricted Stock Units [Member] | General and Administrative [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 381 | $ 785 | $ 2,350 | $ 1,812 | ||||||||||||||||||||||
Share-based Payment Arrangement, Employee [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Fair value of options granted | $ / shares | $ 7.37 | $ 9.24 | $ 7.27 | $ 12.14 | ||||||||||||||||||||||
Director [Member] | Restricted Stock Units [Member] | General and Administrative [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 126 | $ 142 | $ 503 | $ 423 | ||||||||||||||||||||||
Non-employee Consultants [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Options granted | 0 | 0 | 0 | 0 | ||||||||||||||||||||||
2019 Inducement Plan [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Common stock, par value | $ / shares | $ 0.001 | |||||||||||||||||||||||||
Awarded | 0 | 0 | 0 | 0 | ||||||||||||||||||||||
2019 Inducement Plan [Member] | Maximum [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 | 300,000 | |||||||||||||||||||||||||
2019 Inducement Plan [Member] | Share-based Payment Arrangement, Employee [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% | |||||||||||||||||||||||||
2019 Inducement Plan [Member] | Share-based Payment Arrangement, Employee [Member] | Share-based Compensation Award, Tranche Two [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 36 months | |||||||||||||||||||||||||
2019 Inducement Plan [Member] | Share-based Payment Arrangement, Employee [Member] | Share Based Compensation Subsequent Awards [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 4 years | |||||||||||||||||||||||||
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 | 0 | ||||||||||||||||||||||||
Annual increases in number of shares reserved for issuance as a percentage of shares of capital stock outstanding through January 1, 2024 | 3% | |||||||||||||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 10,589,103 | 8,984,679 | ||||||||||||||||||||||||
Number of options outstanding | 7,654,523 | 7,654,523 | 6,512,280 | |||||||||||||||||||||||
Options granted | 437,500 | 30,000 | 1,739,919 | 819,250 | ||||||||||||||||||||||
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] | Board of Directors Chairman [Member] | Restricted Stock Units [Member] | General and Administrative [Member] | June 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 100 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Board of Directors Chairman [Member] | Chief Executive Officer | Restricted Stock Units [Member] | June 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Awarded | 11,876 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Restricted Stock Units [Member] | February 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 0 | $ 0 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 906 | $ 906 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | February 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Awarded | 243,000 | |||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 10.46 | |||||||||||||||||||||||||
Restricted stock units, vested | 0 | |||||||||||||||||||||||||
Number of restricted stock units outstanding | 214,000 | 214,000 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | March 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Awarded | 176,000 | 176,000 | ||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 20.59 | |||||||||||||||||||||||||
Compensation expense | $ | $ 729 | |||||||||||||||||||||||||
Restricted stock units, vested | 37,999 | 44,002 | 82,001 | |||||||||||||||||||||||
Restricted stock units, Forfeited | 93,999 | |||||||||||||||||||||||||
Number of restricted stock units outstanding | 0 | 0 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | February 2020 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Awarded | 138,000 | |||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 16.36 | |||||||||||||||||||||||||
Compensation expense | $ | 1,256 | |||||||||||||||||||||||||
Restricted stock units, vested | 40,000 | 36,750 | 113,500 | |||||||||||||||||||||||
Restricted stock units, Forfeited | 24,500 | |||||||||||||||||||||||||
Number of restricted stock units outstanding | 0 | 0 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | Research and Development [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 329 | 329 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | Research and Development [Member] | February 2020 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 524 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | General and Administrative [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 577 | 577 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | General and Administrative [Member] | Modified November 2021 Awards [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 303 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | General and Administrative [Member] | February 2020 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 732 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | February 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 3 years | |||||||||||||||||||||||||
Awarded | 145,170 | |||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 10.46 | |||||||||||||||||||||||||
Number of equal installment | installment | 3 | |||||||||||||||||||||||||
Compensation expense | $ | $ 116 | $ 274 | ||||||||||||||||||||||||
Restricted stock units, vested | 0 | |||||||||||||||||||||||||
Restricted stock units, Forfeited | 20,000 | |||||||||||||||||||||||||
Number of restricted stock units outstanding | 125,170 | 125,170 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | December 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 18 months | |||||||||||||||||||||||||
Awarded | 63,573 | |||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 12.45 | |||||||||||||||||||||||||
Number of equal installment | installment | 2 | |||||||||||||||||||||||||
Compensation expense | $ | $ 110 | $ 323 | ||||||||||||||||||||||||
Restricted stock units, vested | 0 | |||||||||||||||||||||||||
Restricted stock units, Forfeited | 11,170 | |||||||||||||||||||||||||
Number of restricted stock units outstanding | 52,403 | 52,403 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | March 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 3 years | |||||||||||||||||||||||||
Awarded | 100,000 | 100,000 | ||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 20.59 | |||||||||||||||||||||||||
Number of equal installment | installment | 3 | |||||||||||||||||||||||||
Compensation expense | $ | $ 83 | 173 | $ 563 | 344 | ||||||||||||||||||||||
Restricted stock units, vested | 17,333 | 33,336 | 50,669 | |||||||||||||||||||||||
Restricted stock units, Forfeited | 17,333 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | February 2020 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 3 years | |||||||||||||||||||||||||
Awarded | 98,000 | |||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 16.36 | |||||||||||||||||||||||||
Number of equal installment | installment | 3 | |||||||||||||||||||||||||
Compensation expense | $ | 66 | 135 | $ 460 | 400 | ||||||||||||||||||||||
Restricted stock units, vested | 16,666 | 32,666 | 32,669 | 82,001 | ||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | Research and Development [Member] | February 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 48 | $ 113 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | Research and Development [Member] | December 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 53 | 157 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | Research and Development [Member] | March 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 55 | 55 | 164 | 110 | ||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | Research and Development [Member] | February 2020 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 44 | 44 | 131 | 130 | ||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | Modified February 2020 Awards [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 264 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | Modified November 2021 Awards [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 317 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | February 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 68 | 161 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | December 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 57 | 166 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | March 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 28 | 118 | 399 | 234 | ||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | February 2020 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 22 | 91 | $ 329 | 270 | ||||||||||||||||||||||
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] | June 2020 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 1 year | |||||||||||||||||||||||||
Awarded | 36,000 | |||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 15.62 | |||||||||||||||||||||||||
Restricted stock units vesting date | Jun. 03, 2021 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Chief Financial Officer [Member] | Restricted Stock Units [Member] | February 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Restricted stock units, Forfeited | 29,000 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Interim Principal Financial and Accounting Officer [Member] | Time-based Restricted Stock Units [Member] | June 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Awarded | 7,500 | 7,500 | ||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 7.94 | |||||||||||||||||||||||||
Restricted stock units, vested | 7,500 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Interim Principal Financial and Accounting Officer [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | June 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 55 | $ 60 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Chief Executive Officer [Member] | Time-based Restricted Stock Units [Member] | October 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Awarded | 147,942 | 147,942 | ||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 16.83 | |||||||||||||||||||||||||
Number of restricted stock unit tranches | tranche | 2 | |||||||||||||||||||||||||
Restricted stock units, vested | 5,942 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Chief Executive Officer [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | October 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | 151 | $ 506 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Chief Executive Officer [Member] | Share-Based Compensation Award, Tranche One [Member] | Time-based Restricted Stock Units [Member] | October 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Percentage of vested shares on first anniversary of grant date | 25% | |||||||||||||||||||||||||
Vesting period of awards granted | 36 months | |||||||||||||||||||||||||
Awarded | 142,000 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Chief Executive Officer [Member] | Share-based Compensation Award, Tranche Two [Member] | Time-based Restricted Stock Units [Member] | October 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Awarded | 5,942 | |||||||||||||||||||||||||
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% | |||||||||||||||||||||||||
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 | 36 months | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employee And Nonemployee Consultants [Member] | Share Based Compensation Subsequent Awards [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 4 years | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Non-employee Directors [Member] | Restricted Stock Units [Member] | June 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 1 year | |||||||||||||||||||||||||
Awarded | 59,380 | 59,380 | ||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 8.42 | |||||||||||||||||||||||||
Restricted stock units, vested | 0 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Non-employee Directors [Member] | Restricted Stock Units [Member] | June 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Vesting period of awards granted | 1 year | |||||||||||||||||||||||||
Awarded | 43,200 | 43,200 | ||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 13.06 | |||||||||||||||||||||||||
Restricted stock units, vested | 43,200 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Non-employee Directors [Member] | Restricted Stock Units [Member] | General and Administrative [Member] | June 2022 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 126 | $ 164 | ||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Non-employee Directors [Member] | Restricted Stock Units [Member] | General and Administrative [Member] | June 2021 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 142 | $ 239 | 184 | |||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Non-employee Directors [Member] | Restricted Stock Units [Member] | General and Administrative [Member] | June 2020 [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Compensation expense | $ | $ 239 | |||||||||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees And Non-Employee Members Of Board Of Directors [Member] | Restricted Stock Units [Member] | ||||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||||||||
Awarded | 466,926 | |||||||||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 10.11 | |||||||||||||||||||||||||
Restricted stock units, vested | 206,518 | |||||||||||||||||||||||||
Restricted stock units, Forfeited | 196,002 | |||||||||||||||||||||||||
Number of restricted stock units outstanding | 640,950 | 640,950 | 576,544 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Unit Activity (Details) - $ / shares | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021 | Sep. 30, 2022 | |
Number of Units | ||
Outstanding, Ending Balance | 365,029 | 640,950 |
2014 Equity Incentive Plan [Member] | Employees And Non-Employee Members Of Board Of Directors [Member] | Restricted Stock Units [Member] | ||
Number of Units | ||
Outstanding, Beginning Balance | 576,544 | |
Awarded | 466,926 | |
Vested and released | (206,518) | |
Forfeited | (196,002) | |
Outstanding, Ending Balance | 640,950 | |
Weighted Average Grant Date Fair Value | ||
Weighted-average grant date fair value, outstanding, Beginning Balance | $ 17.50 | |
Weighted-average grant date fair value, awarded | 10.11 | |
Weighted-average grant date fair value, vested and released | 16.74 | |
Weighted-average grant date fair value, forfeited | 17.06 | |
Weighted-average grant date fair value, outstanding, Ending Balance | $ 12.50 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Assumptions Used in Black-Scholes Option Pricing Model (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate, minimum | 2.65% | 0.92% | 1.70% | 0.66% |
Risk-free interest rate, maximum | 4.09% | 1.01% | 4.09% | 1.23% |
Expected volatility, minimum | 77.70% | 83% | 77.70% | 71.60% |
Expected volatility, maximum | 78.20% | 83.40% | 81.90% | 83.50% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Employee and Board of Directors Options [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 |
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, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Excess tax benefits from stock option activity or stock-based compensation expense recognized in cash flows from operations | $ 0 | $ 0 | ||
Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Compensation expense | $ 2,868 | $ 3,038 | 10,517 | 8,672 |
Options [Member] | Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Compensation expense | 1,719 | 1,833 | 5,380 | 5,228 |
Options [Member] | General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Compensation expense | 1,149 | 1,205 | 5,137 | 3,444 |
Restricted Stock Units [Member] | Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Compensation expense | 200 | 429 | 565 | 1,094 |
Restricted Stock Units [Member] | General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Compensation expense | 381 | 785 | 2,350 | 1,812 |
Restricted Stock Units [Member] | Director [Member] | General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Compensation expense | $ 126 | $ 142 | $ 503 | $ 423 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of Options, Outstanding, Ending Balance | 7,654,523 | 5,974,549 | 7,654,523 | 5,974,549 |
2014 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of Options, Outstanding, Beginning Balance | 6,512,280 | |||
Number of Options, Granted | 437,500 | 30,000 | 1,739,919 | 819,250 |
Number of Options, Exercised | (46,277) | |||
Number of Options, Forfeited | (356,819) | |||
Number of Options, Expired | (194,580) | |||
Number of Options, Outstanding, Ending Balance | 7,654,523 | 7,654,523 | ||
Number of Options, Options exercisable | 4,764,271 | 4,764,271 | ||
Weighted-Average Exercise Price, Outstanding, Beginning Balance | $ 15.58 | |||
Weighted-Average Exercise Price, Granted | 10.28 | |||
Weighted-Average Exercise Price, Exercised | 6.26 | |||
Weighted-Average Exercise Price, Forfeited | 14.50 | |||
Weighted-Average Exercise Price, Expired | 16.21 | |||
Weighted-Average Exercise Price, Outstanding, Ending Balance | $ 14.47 | $ 14.47 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Award Modifications (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Feb. 28, 2022 | Nov. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total incremental stock compensation expense relating to modifications of Stock Awards | $ 0 | |||
Modified Awards [Member] | Former President and C E O [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Vesting period of awards granted | 12 months | |||
Share-based Compensation Arrangement Period During Which Continuous Service Must Be Performed For Awards To Be Modified | 12 months | |||
Awards that would have vested during the period following the consulting period are deemed to be type 3 modifications | 12 months | |||
Term of modified exercise period of awards | 18 months | |||
Modified Awards [Member] | Former President and C E O [Member] | General and Administrative [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total incremental stock compensation expense relating to modifications of Stock Awards | $ 2,563 | |||
Incremental stock compensation expense relating to modification of stock options | $ 1,679 | |||
Modified Awards [Member] | Former President and C E O [Member] | Performance Restricted Stock Units [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Restricted stock units, vested | 17,333 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Taxes | ||||
Company's effective tax rate | 0% | 0% | 0% | 0% |
Income tax benefit | $ 0 | $ 0 | $ 0 | $ 0 |
Percentage of ineligible annual research and development credit for cash | 65% | 65% | 65% | 65% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Aug. 20, 2019 USD ($) | Jul. 31, 2021 | Jul. 31, 2019 agreement | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | |
Enteris Biopharma, Inc. [Member] | |||||||
Other Commitments [Line Items] | |||||||
Milestone payment earned by 3rd party | $ 5,000 | $ 10,000 | |||||
Stamford Operating Lease and New Stamford Lease [Member] | |||||||
Other Commitments [Line Items] | |||||||
Operating lease cost | 406 | $ 406 | $ 1,218 | 1,218 | |||
Stamford Operating Lease and New Stamford Lease [Member] | Research and Development [Member] | |||||||
Other Commitments [Line Items] | |||||||
Operating lease cost | 284 | 284 | 853 | 853 | |||
Stamford Operating Lease and New Stamford Lease [Member] | General and Administrative [Member] | |||||||
Other Commitments [Line Items] | |||||||
Operating lease cost | $ 122 | $ 122 | $ 365 | $ 365 | |||
Non-Exclusive License Agreement | Enteris Biopharma, Inc. [Member] | |||||||
Other Commitments [Line Items] | |||||||
Upfront fee | $ 8,000 | ||||||
Upfront fee payment, cash | 4,000 | ||||||
Upfront fee payment, stock | $ 4,000 | ||||||
MSA [Member] | Patheon and Patheon Manufacturing Services LLC [Member] | |||||||
Other Commitments [Line Items] | |||||||
Number of related product agreements | agreement | 2 | ||||||
API Commercial Supply Agreement - PPL [Member] | |||||||
Other Commitments [Line Items] | |||||||
Agreement renewal term | 5 years |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Other Information related to Stamford Lease and New Stamford Lease (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies | ||||
Operating cash outflows relating to operating leases | $ 491 | $ 482 | $ 1,463 | $ 1,436 |
ROU assets obtained in exchange for new operating lease liabilities | ||||
Remaining lease term - operating leases (years) | 1 year 3 months 18 days | 2 years 3 months 18 days | 1 year 3 months 18 days | 2 years 3 months 18 days |
Discount rate - operating leases | 7% | 7% | 7% | 7% |
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) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Operating Lease Liabilities, Payments Due [Abstract] | ||
2022 (Excluding the nine months ended September 30, 2022) | $ 494 | |
2023 | 1,992 | |
Total future minimum lease payments, undiscounted | 2,486 | |
Less imputed interest | (113) | |
Operating lease liabilities | 2,373 | |
Operating lease liabilities reported as of September 30, 2022: | ||
Operating lease liabilities - current | 1,876 | $ 1,755 |
Operating lease liabilities - non-current | 497 | $ 1,918 |
Total | $ 2,373 |
Related Party Transactions (Det
Related Party Transactions (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 USD ($) shares | Sep. 30, 2022 USD ($) shares | |
Related Party Transaction [Line Items] | ||
Accounts due from related parties | $ 9,623 | $ 9,623 |
Vifor International Ltd. [Member] | ||
Related Party Transaction [Line Items] | ||
Shares owned as a result of upfront and milestone payments | shares | 7,396,770 | 7,396,770 |
Related party ownership percentage | 13.80% | 13.80% |
Vifor [Member] | ||
Related Party Transaction [Line Items] | ||
Accounts due from related parties | $ 9,623 | $ 9,623 |
Vifor [Member] | Commercial Supply Revenue | ||
Related Party Transaction [Line Items] | ||
Revenue from related parties | 3,370 | 8,160 |
Vifor [Member] | Collaborative Revenue | ||
Related Party Transaction [Line Items] | ||
Revenue from related parties | $ 7,443 | $ 15,446 |