Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 11, 2023 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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 $0.001 per share | |
Trading Symbol | CARA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 53,983,227 | |
Entity Central Index Key | 0001346830 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 47,391 | $ 63,741 |
Marketable securities | 66,892 | 81,658 |
Accounts receivable, net - related party | 6,066 | 3,260 |
Inventory, net | 3,515 | 2,383 |
Income tax receivable | 697 | 697 |
Other receivables | 495 | 496 |
Prepaid expenses | 17,195 | 16,267 |
Restricted cash | 408 | 408 |
Total current assets | 142,659 | 168,910 |
Operating lease right-of-use assets | 1,175 | 1,551 |
Marketable securities, non-current | 9,074 | 11,350 |
Property and equipment, net | 368 | 426 |
Total assets | 153,276 | 182,237 |
Current liabilities: | ||
Accounts payable and accrued expenses | 15,222 | 21,540 |
Operating lease liabilities, current | 1,456 | 1,918 |
Total current liabilities | 16,678 | 23,458 |
Commitments and contingencies (Note 16) | ||
Stockholders' equity: | ||
Preferred stock; $0.001 par value; 5,000,000 shares authorized at March 31, 2023 and December 31, 2022, zero shares issued and outstanding at March 31, 2023 and December 31, 2022 | ||
Common stock; $0.001 par value; 100,000,000 shares authorized at March 31, 2023 and December 31, 2022, 53,974,352 shares and 53,797,341 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 54 | 53 |
Additional paid-in capital | 730,542 | 726,630 |
Accumulated deficit | (592,897) | (566,232) |
Accumulated other comprehensive loss | (1,101) | (1,672) |
Total stockholders' equity | 136,598 | 158,779 |
Total liabilities and stockholders' equity | $ 153,276 | $ 182,237 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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 | 53,974,352 | 53,797,341 |
Common stock, shares outstanding | 53,974,352 | 53,797,341 |
CONDENSED STATEMENTS OF COMPREH
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue: | ||
Total revenue | $ 6,165 | $ 4,790 |
Operating expenses: | ||
Cost of goods sold | 2,590 | 2,081 |
Research and development | 24,334 | 21,273 |
General and administrative | 6,891 | 9,347 |
Total operating expenses | 33,815 | 32,701 |
Operating loss | (27,650) | (27,911) |
Other income, net | 985 | 162 |
Net loss | $ (26,665) | $ (27,749) |
Net loss per share: | ||
Basic | $ (0.49) | $ (0.52) |
Diluted | $ (0.49) | $ (0.52) |
Weighted average shares: | ||
Basic | 53,872,038 | 53,507,060 |
Diluted | 53,872,038 | 53,507,060 |
Other comprehensive income (loss), net of tax of $0: | ||
Change in unrealized gains (losses) on available-for-sale marketable securities | $ 571 | $ (1,365) |
Total comprehensive loss | (26,094) | (29,114) |
Collaborative Revenue | ||
Revenue: | ||
Total revenue | 2,750 | |
Commercial Supply Revenue | ||
Revenue: | ||
Total revenue | 3,191 | $ 4,790 |
Royalty Revenue | ||
Revenue: | ||
Total revenue | 125 | |
Clinical Compound Revenue | ||
Revenue: | ||
Total revenue | $ 99 |
CONDENSED STATEMENTS OF COMPR_2
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | ||
Other comprehensive income (loss) tax | $ 0 | $ 0 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income. | Total |
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 income (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, 2022 | $ 53 | 726,630 | (566,232) | (1,672) | 158,779 |
Balance, Shares at Dec. 31, 2022 | 53,797,341 | ||||
Stock-based compensation expense | 2,972 | 2,972 | |||
Shares issued upon exercise of stock options, value | $ 1 | 559 | $ 560 | ||
Shares issued upon exercise of stock options, shares | 93,218 | 93,218 | |||
Shares issued upon vesting of restricted stock units, value | 381 | $ 381 | |||
Shares issued upon vesting of restricted stock units, shares | 83,793 | ||||
Net loss | (26,665) | (26,665) | |||
Other comprehensive income (loss) | 571 | 571 | |||
Balance, Value at Mar. 31, 2023 | $ 54 | $ 730,542 | $ (592,897) | $ (1,101) | $ 136,598 |
Balance, Shares at Mar. 31, 2023 | 53,974,352 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities | ||
Net loss | $ (26,665) | $ (27,749) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 3,353 | 5,704 |
Depreciation and amortization | 58 | 63 |
Amortization expense component of lease expense | 375 | 344 |
(Accretion)/amortization of available-for-sale marketable securities, net | (94) | 292 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net - related party | (2,806) | (2,496) |
Inventory, net | (1,132) | 677 |
Other receivables | 1 | 17 |
Prepaid expenses | (928) | (2,594) |
Accounts payable and accrued expenses | (6,318) | 640 |
Operating lease liabilities | (462) | (423) |
Net cash used in operating activities | (34,618) | (25,525) |
Investing activities | ||
Proceeds from maturities of available-for-sale marketable securities | 29,500 | 44,000 |
Proceeds from redemptions of available-for-sale marketable securities, at par | 4,000 | |
Purchases of available-for-sale marketable securities | (15,792) | (10,526) |
Purchases of property and equipment | (43) | |
Net cash provided by investing activities | 17,708 | 33,431 |
Financing activities | ||
Proceeds from the exercise of stock options | 560 | 3 |
Net cash provided by financing activities | 560 | 3 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (16,350) | 7,909 |
Cash, cash equivalents and restricted cash at beginning of period | 64,149 | 13,861 |
Cash, cash equivalents and restricted cash at end of period | $ 47,799 | $ 21,770 |
Business
Business | 3 Months Ended |
Mar. 31, 2023 | |
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 studies 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® 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 approved 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 United Kingdom in April 2022. Commercial launches in Austria, Germany, Sweden, France, the Netherlands, and Finland have commenced. In August 2022, as part of the Access Consortium, difelikefalin injection was approved in Switzerland under the brand name Kapruvia, as well as Singapore and Canada under the brand name KORSUVA. Commercial launch in Switzerland has also commenced. In November 2022, difelikefalin injection was approved in the last Access Consortium country, Australia, under the brand name KORSUVA. The Company expects additional commercial launches to commence over the next 12-18 months. In 2018, the Company entered into a license and collaboration agreement with a joint venture between Vifor Pharma Group and Fresenius Medical Care Renal Pharmaceutical Ltd., or Vifor Fresenius Medical Care Renal Pharma Ltd., that provides full commercialization rights of Kapruvia, and where applicable KORSUVA, to Vifor Fresenius Medical Care Renal Pharma Ltd. worldwide (excluding the United States, Japan and South Korea). In markets outside of the United States, the Company is eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd., of difelikefalin injection in the licensed territories. In the U.S. market, the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. provides that Vifor Fresenius Medical Care Renal Pharma Ltd. 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 Fresenius Medical Care Renal Pharma Ltd.) based on net FMCNA clinic sales (as defined in the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.) and Vifor Fresenius Medical Care Renal Pharma Ltd. 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 In 2020, the Company entered into a second licensing and collaboration agreement, along with stock purchase agreements, with Vifor (International) Ltd., or Vifor International, that provides full commercialization rights of KORSUVA injection to Vifor International in dialysis clinics in the United States under a profit-sharing arrangement, whereby total net sales of KORSUVA injection in the United States, as recorded by Vifor International, are reduced by Vifor International’s cost of goods sold, or COGS, as well as a marketing and distribution fee owed by the Company based on the level of annual net sales, and the resulting amount is shared according to a 60% (Company)/40% (Vifor International) profit split (excluding sales to Fresenius Medical Center dialysis clinics, compensation for which is governed by the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd.), subject to potential temporary adjustment in future years based on certain conditions (see Note 11, Collaboration and Licensing Agreements) In May 2022, Vifor International assigned its rights and obligations under the license agreement and a supply agreement, as permitted under the agreements, to Vifor Fresenius Medical Care Renal Pharma Ltd. The Company’s rights and obligations under these agreements were unaffected by this assignment and the assignment did not affect the Company’s economic rights under the agreements with Vifor International. In August 2022, Vifor Pharma Group (which includes Vifor International) was acquired by CSL Limited and subsequently renamed CSL Vifor as part of the acquisition. The acquisition of Vifor Pharma Group did not affect any of the Company’s rights and obligations pursuant to these 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 March 31, 2023, 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 and royalties, the Company has also earned approximately $273,000 under its license and supply agreements for difelikefalin, primarily with CSL Vifor, Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and an earlier product candidate for which development efforts ceased in 2007. The Company has also received aggregate net proceeds of approximately $98,000 from the issuance and sale of the Company’s common stock to Vifor International in connection with the Company’s licensing agreement with CSL Vifor (see Note 11, Collaboration and Licensing Agreements As of March 31, 2023, the Company had unrestricted cash and cash equivalents and marketable securities of $123,357 and an accumulated deficit of $592,897. 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 $26,665 and $27,749 for the three months ended March 31, 2023 and 2022, respectively, and had net cash used in operating activities of $34,618 and $25,525 for the three months ended March 31, 2023 and 2022, 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 | 3 Months Ended |
Mar. 31, 2023 | |
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, 2022 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, 2022. 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, 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, related party accounts receivable reserve, as applicable, inventory valuation and related reserves, research and development, or R&D, clinical costs and accrued research projects included in prepaid expenses and accounts payable and accrued expenses, 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 impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted, including impacts from the COVID-19 pandemic or future public health crises, geopolitical tensions, such as the ongoing military conflict between Russia and Ukraine and related sanctions against Russia, decades-high inflation, rising interest rates, uncertainty and liquidity concerns in the broader financial services industry, such as those caused by certain recent banking failures, and a potential recession in the United States. 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, 2022. |
Available-for-Sale Marketable S
Available-for-Sale Marketable Securities | 3 Months Ended |
Mar. 31, 2023 | |
Available-for-Sale Marketable Securities | |
Available-for-Sale Marketable Securities | 3. Available-for-Sale Marketable Securities As of March 31, 2023 and December 31, 2022, the Company’s available-for-sale marketable securities consisted of debt securities issued by 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 March 31, 2023 and December 31, 2022: As of March 31, 2023 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. government agency obligations $ 9,500 $ — $ (483) $ 9,017 Corporate bonds 35,704 — (403) 35,301 Commercial paper 15,943 1 (1) 15,943 Municipal bonds 15,920 — (215) 15,705 Total available-for-sale marketable securities $ 77,067 $ 1 $ (1,102) $ 75,966 As of December 31, 2022 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. government agency obligations $ 9,500 $ — $ (623) $ 8,877 Corporate bonds 35,828 — (643) 35,185 Commercial paper 26,879 2 (6) 26,875 Municipal bonds 22,473 — (402) 22,071 Total available-for-sale marketable securities $ 94,680 $ 2 $ (1,674) $ 93,008 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 March 31, 2023 and December 31, 2022: As of March 31, 2023 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. government agency obligations $ — $ — $ 9,017 $ (483) $ 9,017 $ (483) Corporate bonds 4,000 (4) 31,301 (399) 35,301 (403) Commercial paper 4,975 (1) — — 4,975 (1) Municipal bonds — — 15,705 (215) 15,705 (215) Total $ 8,975 $ (5) $ 56,023 $ (1,097) $ 64,998 $ (1,102) As of December 31, 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. government agency obligations $ — $ — $ 8,877 $ (623) $ 8,877 $ (623) Corporate bonds 1,470 (26) 33,715 (617) 35,185 (643) Commercial paper 15,906 (6) — — 15,906 (6) Municipal bonds 982 (16) 19,589 (386) 20,571 (402) Total $ 18,358 $ (48) $ 62,181 $ (1,626) $ 80,539 $ (1,674) As of March 31, 2023 and December 31, 2022, 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 March 31, 2023 and December 31, 2022, the Company held a total of 30 out of 35 positions and 35 out of 39 positions, respectively, that were in an unrealized loss position, 27 of which had been in an unrealized loss position for 12 months or greater as of March 31, 2023. Unrealized losses individually and in aggregate, including any in an unrealized loss position for 12 months or greater, 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. government agency obligations. positions for its U.S. government agency obligations, that were in unrealized loss positions as of March 31, 2023. Corporate bonds, commercial paper, and municipal bonds. The Company classifies its marketable debt securities based on their contractual maturity dates. As of March 31, 2023, 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 March 31, 2023 As of December 31, 2022 Contractual maturity Amortized Cost Fair Value Amortized Cost Fair Value Less than one year $ 67,565 $ 66,892 $ 82,678 $ 81,658 One year to two years 9,502 9,074 12,002 11,350 Total $ 77,067 $ 75,966 $ 94,680 $ 93,008 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 months ended March 31, 2023 and 2022. As of March 31, 2023 and December 31, 2022, accrued interest receivables on the Company’s available-for-sale debt securities were $495 and $489, respectively, and were included within other receivables. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 3 Months Ended |
Mar. 31, 2023 | |
Accumulated Other Comprehensive Loss | |
Accumulated Other Comprehensive Loss | 4. Accumulated Other Comprehensive Loss The following table summarizes the changes in accumulated other comprehensive loss, net of tax, from unrealized gains (losses) on available-for-sale marketable securities, the Company’s only component of accumulated other comprehensive loss, for the three months ended March 31, 2023 and 2022, respectively. Total Accumulated Other Comprehensive Loss Balance, December 31, 2022 $ (1,672) Other comprehensive income before reclassifications 571 Amount reclassified from accumulated other comprehensive loss — Net current period other comprehensive income 571 Balance, March 31, 2023 $ (1,101) Balance, December 31, 2021 $ (358) Other comprehensive loss before reclassifications (1,365) Amount reclassified from accumulated other comprehensive loss — Net current period other comprehensive loss (1,365) Balance, March 31, 2022 $ (1,723) Amounts reclassified out of accumulated other comprehensive loss into net loss are determined by specific identification. There were |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | 5. Fair Value Measurements As of March 31, 2023 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 March 31, 2023 The following tables summarize the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2023 Fair value measurement as of March 31, 2023 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 $ 47,391 $ 47,391 $ — $ — Available-for-sale marketable securities: U.S. government agency obligations 9,017 — 9,017 — Corporate bonds 35,301 — 35,301 — Commercial paper 15,943 — 15,943 — Municipal bonds 15,705 — 15,705 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 123,765 $ 47,799 $ 75,966 $ — Fair value measurement as of December 31, 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 $ 63,741 $ 63,741 $ — $ — Available-for-sale marketable securities: U.S. government agency obligations 8,877 — 8,877 — Corporate bonds 35,185 — 35,185 — Commercial paper 26,875 — 26,875 — Municipal bonds 22,071 — 22,071 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 157,157 $ 64,149 $ 93,008 $ — 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 months ended March 31, 2023 and 2022, respectively March 31, 2023 and 2022, respectively |
Restricted Cash
Restricted Cash | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023 and December 31, 2022, the Company had $408 of restricted cash related to the Stamford Lease in current 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. March 31, 2023 December 31, 2022 Cash and cash equivalents $ 47,391 $ 63,741 Restricted cash, current assets 408 408 Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows $ 47,799 $ 64,149 |
Inventory, net
Inventory, net | 3 Months Ended |
Mar. 31, 2023 | |
Inventory, net | |
Inventory, net | 7. Inventory, net Inventory, net consists of the following: March 31, 2023 December 31, 2022 Raw materials $ 2,504 $ 1,918 Work-in-process 1,009 499 Finished goods 2 — 3,515 2,417 Less Inventory Reserve for Obsolescence — (34) Total $ 3,515 $ 2,383 As of March 31, 2023 and December 31, 2022, 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 months ended March 31, 2023. |
Prepaid expenses
Prepaid expenses | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid expenses | |
Prepaid expenses | 8. Prepaid expenses As of March 31, 2023, prepaid expenses were $17,195, consisting of $14,407 of prepaid R&D clinical costs, $1,887 of prepaid insurance and $901 of other prepaid costs. As of December 31, 2022, prepaid expenses were $16,267, consisting of $15,188 of prepaid R&D clinical costs, $543 of prepaid insurance, and $536 of other prepaid costs. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
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: March 31, 2023 December 31, 2022 Accounts payable $ 4,424 $ 9,604 Accrued research projects 5,824 5,200 Accrued compensation and benefits 2,947 5,219 Accrued professional fees and other 2,027 1,517 Total $ 15,222 $ 21,540 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | 10. Stockholders’ Equity In March 2023, as a result of the completion of the second year of the three-year vesting period for restricted stock units granted in March 2021, an aggregate of 15,999 time-based restricted stock units vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In February 2023, as a result of the completion of the first year of the three-year vesting period for restricted stock units granted in February 2022, an aggregate of 42,920 time-based restricted stock units vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation Also in February 2023, as a result of the completion of the third year of the three-year vesting period for restricted stock units granted in February 2020, an aggregate of 15,999 time-based restricted stock units vested and were settled in shares of the Company’s common stock (see Note 14, Stock-Based Compensation In January 2023, as a result of satisfaction of the quarterly vesting period for restricted stock units granted in October 2021, an aggregate 8,875 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, 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 second tranche of restricted stock units granted to the new Chief Executive Officer 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. 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 as of March 31, 2023. 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. 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 |
Collaboration and Licensing Agr
Collaboration and Licensing Agreements | 3 Months Ended |
Mar. 31, 2023 | |
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 United States 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 United States. 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 United States. After the assignment of rights of Vifor Agreement No. 1 from Vifor International to Vifor Fresenius Medical Care Renal Pharma Ltd. in May 2022, Vifor Agreement No. 1 provides full commercialization rights in dialysis clinics to CSL Vifor in the United States 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 United States and CSL Vifor 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 CSL Vifor’s conduct of the marketing, promotion, selling and distribution of difelikefalin injection in the United States, the Company pays a marketing and distribution fee to CSL Vifor based on the level of annual net sales. This fee as well as CSL 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. 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 United States for commercial sale of the Licensed Product for use in all therapeutic areas 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 CSL Vifor 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 Company also retains the rights to import, distribute, promote, sell and otherwise commercialize the Licensed Product on an exclusive basis outside of the Field either in or outside of the United States. 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 CSL Vifor 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 CSL Vifor for commercialization. Vifor Fresenius Medical Care Renal Pharma Ltd. In May 2018, the Company entered into a license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd., or Vifor Agreement No. 2, under which the Company granted Vifor Fresenius Medical Care Renal Pharma Ltd. 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 in the Field worldwide (excluding the United States, Japan and South Korea), or the Territory. The Company is eligible to receive from Vifor Fresenius Medical Care Renal Pharma Ltd. additional 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 in the United States except in the dialysis clinics of FMCNA, where Vifor Fresenius Medical Care Renal Pharma Ltd. will promote difelikefalin injection under a profit-sharing arrangement (as defined in Vifor Agreement No. 2), based on net FMCNA clinic sales (as defined in Vifor Agreement No. 2) and the Company and Vifor Fresenius Medical Care Renal Pharma Ltd. are each entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions. The Company retains the rights to make and have made the Licensed Product in the Territory for commercial sale by Vifor Fresenius Medical Care Renal Pharma Ltd. in the Field in or outside the Territory and for supply of Licensed Product to Vifor Fresenius Medical Care Renal Pharma Ltd. 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 Fresenius Medical Care Renal Pharma Ltd. 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 Fresenius Medical Care Renal Pharma Ltd. for commercialization. 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 United States 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 with CKDP, or the CKDP Agreement, 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 United States and South Korea, respectively. 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 | 3 Months Ended |
Mar. 31, 2023 | |
Revenue Recognition | |
Revenue Recognition | 12. Revenue Recognition The Company primarily recognizes revenue under its license and collaboration agreements from (1) collaborative revenue from its share of the profit generated by KORSUVA injection sales in the United States; (2) commercial supply revenue from the Company’s sales of commercial product to CSL Vifor, which is subsequently sold to wholesalers; (3) royalty revenue from net sales of Kapruvia in Europe; (4) sales-based or regulatory milestone payments, which could be earned in the future in accordance with certain licensing agreements. As of March 31, 2023, the Company has not earned any sales-based milestones under its collaboration agreements. As of March 31, 2023, the Company had license and collaboration agreements with CSL Vifor, Maruishi and CKDP. The following table provides amounts included in the Company’s Condensed Statements of Comprehensive Loss as revenue for the three months ended March 31, 2023 and 2022, respectively: Three Months Ended March 31, 2023 2022 Collaborative revenue CSL Vifor (KORSUVA injection profit sharing) $ 2,750 $ — Total collaborative revenue $ 2,750 $ — Commercial supply revenue CSL Vifor* (KORSUVA injection) $ 3,191 $ 4,790 Total commercial supply revenue $ 3,191 $ 4,790 Royalty revenue CSL Vifor (Kapruvia ex U.S.) $ 125 $ — Total royalty revenue $ 125 $ — Clinical compound revenue Maruishi $ 99 $ — Total clinical compound revenue $ 99 $ — _____________________________ * Includes amounts earned from Vifor International prior to Vifor International’s assignment of its rights and obligations to Vifor Fresenius Medical Care Renal Pharma Ltd. in May 2022. Collaborative revenue Beginning in April 2022, the Company began recording its share of the profit generated by KORSUVA injection sales by CSL Vifor to third parties in the United States. Under the license agreements with CSL Vifor, KORSUVA injection net sales are calculated by CSL Vifor which are net of discounts, rebates, and allowances. 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 United States on a net basis (since the Company is not the primary obligor and does not retain inventory risk) and presents the revenue earned each period as collaborative revenue. During the three months ended March 31, 2023, the Company recorded $2,750 as collaborative revenue for its profit-share from the sales of KORSUVA injection in the United States. There was no profit share revenue recorded during the three months ended March 31, 2022. Commercial supply revenue Under the Vifor International Supply Agreement, the Company’s only performance obligation is the delivery of KORSUVA injection to CSL Vifor in accordance with the receipt of purchase orders. Revenue from the sale of commercial supply product to CSL Vifor is recognized as delivery of the product occurs. The Company had commercial supply revenue of $3,191 for the three months ended March 31, 2023 with associated COGS of $2,590. The Company had commercial supply revenue of $4,790 for the three months ended March 31, 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 $2,495 was recognized with associated COGS of $2,081 since these inventory costs were capitalized as inventory subsequent to regulatory approval. Royalty revenue Royalty revenue includes amounts related to the Company’s royalties earned from CSL Vifor on the net sales of Kapruvia in Europe, based on the amount of net sales in a licensed territory during a calendar year. Sales-based royalty payments related to a license of IP are recognized as revenue when the respective sales occur, and the net sales tier is achieved. During the three months ended March 31, 2023, the Company recorded $125 as royalty revenue based on net sales of Kapruvia. There was no royalty revenue during the three months ended March 31, 2022. Clinical compound revenue 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. During the three months ended March 31, 2023, the Company recognized clinical compound revenue of $99 from the sale of clinical compound to Maruishi. There were no sales of clinical compound to Maruishi during the three months ended March 31, 2022. Contract balances As of March 31, 2023 and December 31, 2022, respectively, the Company recorded accounts receivable, net – related party of $6,066 and $3,260 which primarily related to its profit-sharing revenue from sales of KORSUVA injection in the United States by CSL Vifor and its commercial supply of KORSUVA injection to CSL Vifor. There were no other contract assets or contract liabilities related to the CSL Vifor, Maruishi and CKDP agreements as of March 31, 2023 and December 31, 2022. 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 March 31, 2023 and December 31, 2022. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss Per Share | |
Net Loss Per Share | 13. Net Loss Per Share The Company computes basic net income (loss) per share by dividing net income (loss) by the weighted-average number of shares of common stock outstanding. Diluted net income (loss) 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 months ended March 31, 2023 and 2022, 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 March 31, 2023 2022 Basic: Weighted average common shares outstanding 53,872,038 53,507,060 Diluted: Weighted average common shares outstanding - Basic 53,872,038 53,507,060 Common stock equivalents* — — Denominator for diluted net loss per share 53,872,038 53,507,060 * 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 March 31, 2023 2022 Net loss - basic and diluted $ (26,665) $ (27,749) Weighted-average common shares outstanding: Basic and diluted 53,872,038 53,507,060 Net loss per share, basic and diluted: $ (0.49) $ (0.52) As of March 31, 2023, 8,992,759 stock options and 695,720 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 March 31, 2022, 7,430,629 stock options and 736,272 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 | 3 Months Ended |
Mar. 31, 2023 | |
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. In November 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, 2023, the aggregate number of shares of common stock that may be issued pursuant to Stock Awards under the 2014 Plan automatically increased from 10,589,103 to 12,203,023. 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 March 1, 2023, the Compensation Committee of the Company’s Board of Directors, or the Compensation Committee, approved and granted a total of 407,000 restricted stock units to certain employees under the 2014 Plan with a grant date fair value of $10.06 per share. Vesting of the restricted stock units is contingent on the achievement of certain performance targets, 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 months ended March 31, 2023, no stock compensation expense relating to these restricted stock units was recognized. As of March 31, 2023, 407,000 restricted stock units were outstanding and available to vest and settle in shares of the Company’s common stock. On October 12, 2022, the Compensation Committee of the Company’s Board of Directors, or the Compensation Committee, approved and granted a total of 7,267 time-based restricted stock units under the 2014 Plan, with a grant date fair value of $9.42 per share, to an executive officer of the Company. The restricted stock unit grant fully vests on August 31, 2023, subject to the recipient’s continued service through such date. For the three months ended March 31, 2023, the Company recognized $19 of stock compensation expense associated with these awards, all of which was recorded within G&A expense. As of March 31, 2023, 7,267 restricted stock units were outstanding and available to vest and settle in shares of the Company’s common stock. 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 months ended March 31, 2023, stock compensation expense associated with these awards of $123 was recognized in G&A expense. As of March 31, 2023, 59,380 restricted stock units were outstanding and available to vest and settle in shares of the Company’s common stock. 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. In February 2023, 42,920 of these restricted stock units vested and were settled in shares of the Company’s common stock in satisfaction of the first year of vesting. For the three months ended March 31, 2023 and 2022, the Company recognized $114 and $50, respectively, of stock compensation expense associated with these awards, with $47 recorded in R&D expense and $67 recorded in G&A expense for the three months ended March 31, 2023, and $18 recorded in R&D expense and $32 recorded in G&A expense for the three months ended March 31, 2022. As of March 31, 2023, 82,250 restricted stock units were outstanding and available to vest and settle 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 months ended March 31, 2023 and 2022, the Company recognized $108 and $131, respectively, of stock compensation expense associated with these awards, with $52 recorded in R&D expense and $56 recorded in G&A expense for the three months ended March 31, 2023, and $52 recorded in R&D expense and $79 recorded in G&A expense for the three months ended March 31, 2022. As of March 31, 2023, 26,199 restricted stock units were outstanding and available to vest and settle 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. In January 2023, 8,875 of these restricted stock units vested and were settled in shares of the Company’s common stock in satisfaction of the quarterly period of vesting. For the three months ended March 31, 2023 and 2022, stock compensation expense associated with these awards of $147 and $206, respectively, was recognized in G&A expense. As of March 31, 2023, 97,625 restricted stock units were outstanding and available to vest and settle 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 three months ended March 31, 2023, there was no stock compensation expense recognized as these restricted stock units were fully vested in June 2022. For the three months ended March 31, 2022, stock compensation expense of $139 was recognized in G&A expense for these restricted stock units. As of March 31, 2023, there were no outstanding restricted stock units available to vest or settle in shares of the Company’s common stock. 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, performance targets relating to 37,999 restricted stock units had been achieved and thus restricted stock units vested and the awards were settled in shares of common stock. For the three months ended March 31, 2023, there was no stock compensation expense recognized as all of these restricted stock units either vested or were forfeited prior to the current period. For the three months ended March 31, 2022, the Company recognized $729 of stock compensation expense associated with these awards in G&A expense. G&A amounts recorded for the three months ended March 31, 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. In March 2023, 15,999 of these restricted stock units vested and were settled in shares of the Company’s common stock in satisfaction of the second year of vesting. In March 2022, 33,336 of these restricted stock units vested and were settled in shares of the Company’s common stock in satisfaction of the first year of vesting. For the three months ended March 31, 2023 and 2022, the Company recognized $81 and $284, respectively, of stock compensation expense associated with these awards, with $54 recorded in R&D expense and $27 in G&A expense for the three months ended March 31, 2023, and $54 recorded in R&D expense and $230 in G&A expense for the three months ended March 31, 2022. G&A amounts recorded for the three months ended March 31, 2022 included $203 of stock compensation expense relating to the modification of certain of these restricted stock units on November 1, 2021 (see Stock Award Modifications 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. In February 2023, 15,999 of these restricted stock units vested and were settled in shares of the Company’s common stock in satisfaction of the third year of vesting. In February 2022, 32,666 of these restricted stock units vested and were settled in shares of the Company’s common stock in satisfaction of the second year of vesting. For the three months ended March 31, 2023 and 2022, the Company recognized $39 and $219, respectively, of stock compensation expense associated with these awards, with $26 recorded in R&D expense and $13 in G&A expense for the three months ended March 31, 2023, and $43 recorded in R&D expense and $176 in G&A expense for the three months ended March 31, 2022. G&A amounts recorded for the three months ended March 31, 2022 included $155 of stock compensation expense relating to the modification of certain of these restricted stock units on November 1, 2021 (see Stock Award Modifications outstanding restricted stock units available to vest or settle 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 three months ended March 31, 2023 is presented below: Weighted Number of Average Grant Units Date Fair Value Outstanding, December 31, 2022 372,513 $ 13.20 Awarded 407,000 10.06 Vested and released (83,793) 14.20 Outstanding, March 31, 2023 695,720 $ 11.24 Restricted stock units exercisable (vested and deferred), March 31, 2023 — Stock Options Under the 2014 Plan, the Company granted 1,449,154 and 977,438 stock options during the three months ended March 31, 2023 and 2022, respectively. No Three Months Ended March 31, 2023 2022 Risk-free interest rate 3.62% - 4.22% 1.70% - 2.35% Expected volatility 76.3% - 81.3% 81.4% - 81.9% Expected dividend yield 0% 0% Expected life of employee and Board options (in years) 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 March 31, 2023 and 2022 was $7.08 and $7.55. No options were granted to non-employee consultants during the three months ended March 31, 2023 and 2022. During the three months ended March 31, 2023 and 2022, the Company recognized compensation expense relating to stock options as follows: Three Months Ended March 31, 2023 2022 Research and development $ 1,480 $ 1,917 General and administrative 1,241 2,030 Total stock option expense $ 2,721 $ 3,947 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 $179 in R&D expense and $330 in G&A expense for the three months ended March 31, 2023; (ii) the vesting of certain employees’ restricted stock units for $167 in R&D expense and $1,452 in G&A expense for the three months ended March 31, 2022; (iii) compensation expense relating to the Board of Directors’ restricted stock units for $123 in G&A expense for the three months ended March 31, 2023; and (iv) compensation expense relating to the Board of Directors’ restricted stock units for $139 in G&A expense for the three months ended March 31, 2022. 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 three months ended March 31, 2023 is presented below: Weighted Number of Average Exercise Shares Price Outstanding, December 31, 2022 7,689,449 $ 14.35 Granted 1,449,154 10.06 Exercised (93,218) 6.00 Forfeited (52,626) 11.41 Outstanding, March 31, 2023 8,992,759 $ 13.76 Options exercisable, March 31, 2023 5,128,904 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 three months ended March 31, 2023 and 2022. 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 the vesting targets were achieved with respect to 17,333 performance-based restricted stock units in February 2022, which resulted in additional stock compensation expense being recorded during the three months ended March 31, 2022. During the three months ended March 31, 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 $1,564, which is included in G&A expense for the three months ended March 31, 2022. Of this total amount, $903 is included in G&A expense in the stock option compensation expense table above for the three months ended March 31, 2022. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Taxes | |
Income Taxes | 15. Income Taxes The Company has recognized a full tax valuation allowance against its deferred tax assets as of March 31, 2023 and December 31, 2022. 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 months ended March 31, 2023 and 2022. Historically, the Company’s benefit from income taxes related 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. It was not eligible to exchange its R&D tax credit for cash during the three months ended March 31, 2023 and 2022, therefore there was no benefit from income taxes for the three months ended March 31, 2023 and 2022. As of March 31, 2023, the Company recorded $697 within income tax receivable which related to the 2020 R&D credit. The Inflation Reduction Act of 2022 included tax legislation that became effective during the three months ended March 31, 2023. Significant legislation for corporate taxpayers includes a corporate alternative minimum tax of 15.0% for companies with $1,000,000 or more in average net financial statement profits over the three previous years, as well as a 1.0% indirect excise tax on the repurchase of shares by a publicly traded company. The Company does not expect this legislation to have an effect on its tax provision as of March 31, 2023; however, the Company will continue to evaluate the effect on the tax provision each reporting period. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
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. 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. During the three months ended March 31, 2023 and 2022, no milestone payments or royalties were paid to Enteris by the Company in relation to the Enteris License Agreement. 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, $407 and $406 of operating lease cost, or lease expense, was recognized for the three months ended March 31, 2023 and 2022, respectively, consisting of $284 relating to R&D lease expense and $123 relating to G&A lease expense for the 2023 period, and $284 relating to R&D lease expense and $122 relating to G&A lease expense for the 2022 period. Other information related to the leases was as follows: Three Months Ended March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows relating to operating leases $ 494 $ 485 ROU assets obtained in exchange for new operating lease liabilities $ — $ — Remaining lease term - operating leases (years) 0.8 1.8 Discount rate - operating leases 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 March 31, 2023, were as follows: Year Ending December 31, 2023 (Excluding the three months ended March 31, 2023) $ 1,498 Total future minimum lease payments, undiscounted 1,498 Less imputed interest (42) Total $ 1,456 Operating lease liabilities reported as of March 31, 2023: Operating lease liabilities - current $ 1,456 Operating lease liabilities - non-current — Total $ 1,456 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions | |
Related Party Transactions | 17. Related Party Transactions As of March 31, 2023, Vifor International owned 7,396,770 , or 13.7% , of the Company’s common stock. CSL Vifor and its affiliates are considered related parties as of March 31, 2023 and December 31, 2022 (see Note 11, Collaboration and Licensing Agreements ). As of March 31, 2023 and December 31, 2022, amounts due from CSL Vifor of $6,066 and $3,260 primarily relating to the Company’s share of the profit generated by sales of KORSUVA injection in the United States by CSL Vifor and its commercial supply of KORSUVA injection to CSL Vifor were included within accounts receivable, net – related party. The Company’s collaborative revenue of $2,750 from its share of the profit generated by sales of KORSUVA injection in the United States by CSL Vifor was included within collaborative revenue for the three months ended March 31, 2023. Sales of KORSUVA injection to CSL Vifor of $3,191 and $4,790 were included within commercial supply revenue for the three months ended March 31, 2023 and 2022, respectively. The associated COGS for the Company’s commercial supply revenue from CSL Vifor was $2,590 and $2,081 for the three months ended March 31, 2023 and 2022, respectively. The Company recorded $125 as royalty revenue based on net sales of Kapruvia during the three months ended March 31, 2023. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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, 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, related party accounts receivable reserve, as applicable, inventory valuation and related reserves, research and development, or R&D, clinical costs and accrued research projects included in prepaid expenses and accounts payable and accrued expenses, 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 impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted, including impacts from the COVID-19 pandemic or future public health crises, geopolitical tensions, such as the ongoing military conflict between Russia and Ukraine and related sanctions against Russia, decades-high inflation, rising interest rates, uncertainty and liquidity concerns in the broader financial services industry, such as those caused by certain recent banking failures, and a potential recession in the United States. 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, 2022. |
Available-for-Sale Marketable_2
Available-for-Sale Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Available-for-Sale Marketable Securities | |
Summary of Available-for-Sale Marketable Securities by Major Type of Security | As of March 31, 2023 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. government agency obligations $ 9,500 $ — $ (483) $ 9,017 Corporate bonds 35,704 — (403) 35,301 Commercial paper 15,943 1 (1) 15,943 Municipal bonds 15,920 — (215) 15,705 Total available-for-sale marketable securities $ 77,067 $ 1 $ (1,102) $ 75,966 As of December 31, 2022 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. government agency obligations $ 9,500 $ — $ (623) $ 8,877 Corporate bonds 35,828 — (643) 35,185 Commercial paper 26,879 2 (6) 26,875 Municipal bonds 22,473 — (402) 22,071 Total available-for-sale marketable securities $ 94,680 $ 2 $ (1,674) $ 93,008 |
Schedule of Fair Values and Continuous Unrealized Loss Positions of Available-for-Sale Marketable Securities | As of March 31, 2023 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. government agency obligations $ — $ — $ 9,017 $ (483) $ 9,017 $ (483) Corporate bonds 4,000 (4) 31,301 (399) 35,301 (403) Commercial paper 4,975 (1) — — 4,975 (1) Municipal bonds — — 15,705 (215) 15,705 (215) Total $ 8,975 $ (5) $ 56,023 $ (1,097) $ 64,998 $ (1,102) As of December 31, 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. government agency obligations $ — $ — $ 8,877 $ (623) $ 8,877 $ (623) Corporate bonds 1,470 (26) 33,715 (617) 35,185 (643) Commercial paper 15,906 (6) — — 15,906 (6) Municipal bonds 982 (16) 19,589 (386) 20,571 (402) Total $ 18,358 $ (48) $ 62,181 $ (1,626) $ 80,539 $ (1,674) |
Schedule of Amortized Cost and Fair Values of Marketable Debt Securities by Contractual Maturity | As of March 31, 2023 As of December 31, 2022 Contractual maturity Amortized Cost Fair Value Amortized Cost Fair Value Less than one year $ 67,565 $ 66,892 $ 82,678 $ 81,658 One year to two years 9,502 9,074 12,002 11,350 Total $ 77,067 $ 75,966 $ 94,680 $ 93,008 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Loss (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accumulated Other Comprehensive Loss | |
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 Balance, December 31, 2022 $ (1,672) Other comprehensive income before reclassifications 571 Amount reclassified from accumulated other comprehensive loss — Net current period other comprehensive income 571 Balance, March 31, 2023 $ (1,101) Balance, December 31, 2021 $ (358) Other comprehensive loss before reclassifications (1,365) Amount reclassified from accumulated other comprehensive loss — Net current period other comprehensive loss (1,365) Balance, March 31, 2022 $ (1,723) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Measurements | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | Fair value measurement as of March 31, 2023 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 $ 47,391 $ 47,391 $ — $ — Available-for-sale marketable securities: U.S. government agency obligations 9,017 — 9,017 — Corporate bonds 35,301 — 35,301 — Commercial paper 15,943 — 15,943 — Municipal bonds 15,705 — 15,705 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 123,765 $ 47,799 $ 75,966 $ — Fair value measurement as of December 31, 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 $ 63,741 $ 63,741 $ — $ — Available-for-sale marketable securities: U.S. government agency obligations 8,877 — 8,877 — Corporate bonds 35,185 — 35,185 — Commercial paper 26,875 — 26,875 — Municipal bonds 22,071 — 22,071 — Restricted cash: Commercial money market account 408 408 — — Total financial assets $ 157,157 $ 64,149 $ 93,008 $ — |
Restricted Cash (Tables)
Restricted Cash (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Restricted Cash | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | March 31, 2023 December 31, 2022 Cash and cash equivalents $ 47,391 $ 63,741 Restricted cash, current assets 408 408 Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows $ 47,799 $ 64,149 |
Inventory, net (Tables)
Inventory, net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory, net | |
Schedule of Inventory, net | Inventory, net consists of the following: March 31, 2023 December 31, 2022 Raw materials $ 2,504 $ 1,918 Work-in-process 1,009 499 Finished goods 2 — 3,515 2,417 Less Inventory Reserve for Obsolescence — (34) Total $ 3,515 $ 2,383 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounts Payable and Accrued Expenses | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following: March 31, 2023 December 31, 2022 Accounts payable $ 4,424 $ 9,604 Accrued research projects 5,824 5,200 Accrued compensation and benefits 2,947 5,219 Accrued professional fees and other 2,027 1,517 Total $ 15,222 $ 21,540 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue Recognition | |
Schedule of disaggregation of revenue | Three Months Ended March 31, 2023 2022 Collaborative revenue CSL Vifor (KORSUVA injection profit sharing) $ 2,750 $ — Total collaborative revenue $ 2,750 $ — Commercial supply revenue CSL Vifor* (KORSUVA injection) $ 3,191 $ 4,790 Total commercial supply revenue $ 3,191 $ 4,790 Royalty revenue CSL Vifor (Kapruvia ex U.S.) $ 125 $ — Total royalty revenue $ 125 $ — Clinical compound revenue Maruishi $ 99 $ — Total clinical compound revenue $ 99 $ — _____________________________ * Includes amounts earned from Vifor International prior to Vifor International’s assignment of its rights and obligations to Vifor Fresenius Medical Care Renal Pharma Ltd. in May 2022. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss Per Share | |
Computation of Denominators Used in Net Loss per Share | The denominators used in the net loss per share computations are as follows: Three Months Ended March 31, 2023 2022 Basic: Weighted average common shares outstanding 53,872,038 53,507,060 Diluted: Weighted average common shares outstanding - Basic 53,872,038 53,507,060 Common stock equivalents* — — Denominator for diluted net loss per share 53,872,038 53,507,060 * No amounts were considered as their effects would be anti-dilutive. |
Computation of Basic and Diluted Net Loss per Share | Basic and diluted net loss per share are computed as follows: Three Months Ended March 31, 2023 2022 Net loss - basic and diluted $ (26,665) $ (27,749) Weighted-average common shares outstanding: Basic and diluted 53,872,038 53,507,060 Net loss per share, basic and diluted: $ (0.49) $ (0.52) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Assumptions Used in Black-Scholes Option Pricing Model | Three Months Ended March 31, 2023 2022 Risk-free interest rate 3.62% - 4.22% 1.70% - 2.35% Expected volatility 76.3% - 81.3% 81.4% - 81.9% Expected dividend yield 0% 0% Expected life of employee and Board options (in years) 6.25 6.25 |
Summary of Compensation Expense Relating to Stock Options | Three Months Ended March 31, 2023 2022 Research and development $ 1,480 $ 1,917 General and administrative 1,241 2,030 Total stock option expense $ 2,721 $ 3,947 |
Summary of Stock Option Activity | Weighted Number of Average Exercise Shares Price Outstanding, December 31, 2022 7,689,449 $ 14.35 Granted 1,449,154 10.06 Exercised (93,218) 6.00 Forfeited (52,626) 11.41 Outstanding, March 31, 2023 8,992,759 $ 13.76 Options exercisable, March 31, 2023 5,128,904 |
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, 2022 372,513 $ 13.20 Awarded 407,000 10.06 Vested and released (83,793) 14.20 Outstanding, March 31, 2023 695,720 $ 11.24 Restricted stock units exercisable (vested and deferred), March 31, 2023 — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies | |
Schedule of Other Information related to Stamford Lease and lease amendment | Three Months Ended March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows relating to operating leases $ 494 $ 485 ROU assets obtained in exchange for new operating lease liabilities $ — $ — Remaining lease term - operating leases (years) 0.8 1.8 Discount rate - operating leases 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, 2023 (Excluding the three months ended March 31, 2023) $ 1,498 Total future minimum lease payments, undiscounted 1,498 Less imputed interest (42) Total $ 1,456 Operating lease liabilities reported as of March 31, 2023: Operating lease liabilities - current $ 1,456 Operating lease liabilities - non-current — Total $ 1,456 |
Business - Additional Informati
Business - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Oct. 31, 2020 | May 31, 2018 | Mar. 31, 2023 USD ($) item | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Nature Of Business [Line Items] | |||||
Date of formation | Jul. 02, 2004 | ||||
Proceeds from equity and debt financing | $ 519,600 | ||||
Number of follow-on public offerings | item | 4 | ||||
Payments received in connection with license and supply agreements | $ 273,000 | ||||
Unrestricted cash and cash equivalents and marketable securities | 123,357 | ||||
Accumulated deficit | 592,897 | $ 566,232 | |||
Net (loss) income | (26,665) | $ (27,749) | |||
Net cash used in operating activities | (34,618) | $ (25,525) | |||
Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 1 [Member] | |||||
Nature Of Business [Line Items] | |||||
Percentage of net profit sharing | 60% | ||||
Vifor Fresenius Medical Care Renal Pharma Ltd 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 the sale of common stock under license agreement with Vifor International | $ 98,000 | ||||
Vifor International Ltd. [Member] | Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 1 [Member] | |||||
Nature Of Business [Line Items] | |||||
Percentage of net profit sharing | 40% | ||||
Vifor Fresenius Medical Care Renal Pharma, Ltd [Member] | Vifor Fresenius Medical Care Renal Pharma Ltd 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 | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | $ 77,067 | $ 94,680 |
Gross Unrealized Gains | 1 | 2 |
Gross Unrealized Losses | (1,102) | (1,674) |
Estimated fair value | 75,966 | 93,008 |
U.S. Government Agency Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 9,500 | 9,500 |
Gross Unrealized Losses | (483) | (623) |
Estimated fair value | 9,017 | 8,877 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 35,704 | 35,828 |
Gross Unrealized Losses | (403) | (643) |
Estimated fair value | 35,301 | 35,185 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 15,943 | 26,879 |
Gross Unrealized Gains | 1 | 2 |
Gross Unrealized Losses | (1) | (6) |
Estimated fair value | 15,943 | 26,875 |
Municipal Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 15,920 | 22,473 |
Gross Unrealized Losses | (215) | (402) |
Estimated fair value | $ 15,705 | $ 22,071 |
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 | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | $ 8,975 | $ 18,358 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (5) | (48) |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 56,023 | 62,181 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (1,097) | (1,626) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 64,998 | 80,539 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (1,102) | (1,674) |
U.S. Government Agency Obligations [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 9,017 | 8,877 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (483) | (623) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 9,017 | 8,877 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (483) | (623) |
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 | 4,000 | 1,470 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (4) | (26) |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 31,301 | 33,715 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (399) | (617) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 35,301 | 35,185 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (403) | (643) |
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 | 4,975 | 15,906 |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (1) | (6) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 4,975 | 15,906 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (1) | (6) |
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 | 982 | |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (16) | |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 15,705 | 19,589 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (215) | (386) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 15,705 | 20,571 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | $ (215) | $ (402) |
Available-for-Sale Marketable_5
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 | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Debt Securities [Abstract] | |||
Amortized Cost of marketable debt securities, contractual maturity, less than one year | $ 67,565 | $ 82,678 | |
Amortized Cost of marketable debt securities, contractual maturity, One year to two years | 9,502 | 12,002 | |
Amortized cost | 77,067 | 94,680 | |
Fair value of marketable debt securities, contractual maturities, less than one year | 66,892 | 81,658 | |
Fair value of marketable debt securities, contractual maturity, One year to two years | 9,074 | 11,350 | |
Total fair Value of marketable debt securities, contractual maturity | 75,966 | 93,008 | |
Proceeds from sale of available-for-sale marketable securities | 0 | $ 0 | |
Interest receivable | $ 495 | $ 489 |
Available-for-Sale Marketable_6
Available-for-Sale Marketable Securities - Additional Information (Detail) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 USD ($) position | Dec. 31, 2022 USD ($) 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 | 30 | 35 |
Total number of positions | 35 | 39 |
Number of positions of available-for-sale in unrealized loss position for 12 months or greater | 27 | |
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 | 13 | |
Total number of positions | 13 | |
Commercial Paper [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 | 7 | |
Municipal Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale marketable securities in unrealized loss positions | 12 | |
Total number of positions | 12 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Loss - 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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Balance, Value | $ 158,779 | $ 227,522 |
Amount reclassified from accumulated other comprehensive loss | 0 | 0 |
Net current period other comprehensive income (loss) | 571 | (1,365) |
Balance, Value | 136,598 | 204,115 |
Accumulated Other Comprehensive (Loss) Income. | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Balance, Value | (1,672) | (358) |
Other comprehensive loss before reclassifications | 571 | (1,365) |
Net current period other comprehensive income (loss) | 571 | (1,365) |
Balance, Value | $ (1,101) | $ (1,723) |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Financial assets | ||
Available-for-sale marketable securities | $ 75,966 | $ 93,008 |
Restricted cash | 408 | 408 |
Recurring [Member] | ||
Financial assets | ||
Total financial assets | 123,765 | 157,157 |
U.S. Government Agency Obligations [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 9,017 | 8,877 |
U.S. Government Agency Obligations [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 9,017 | 8,877 |
Corporate Bonds [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 35,301 | 35,185 |
Corporate Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 35,301 | 35,185 |
Commercial Paper [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 15,943 | 26,875 |
Municipal Bonds [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 15,705 | 22,071 |
Municipal Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 15,705 | 22,071 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Recurring [Member] | ||
Financial assets | ||
Total financial assets | 47,799 | 64,149 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Total financial assets | 75,966 | 93,008 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Obligations [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 9,017 | 8,877 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 35,301 | 35,185 |
Significant Other Observable Inputs (Level 2) [Member] | Municipal Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 15,705 | 22,071 |
Money Market Funds [Member] | Recurring [Member] | ||
Financial assets | ||
Cash and cash equivalents | 47,391 | 63,741 |
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 | 47,391 | 63,741 |
Restricted cash | 408 | 408 |
Commercial Paper [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 15,943 | 26,875 |
Commercial Paper [Member] | Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | $ 15,943 | $ 26,875 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - Significant Unobservable Inputs (Level 3) [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Purchases of financial assets | $ 0 | $ 0 |
Sales of financial assets | 0 | 0 |
Maturities of financial assets | 0 | 0 |
Unrealized gains | 0 | 0 |
Unrealized losses | 0 | 0 |
Transfer of financial assets into or out of level 3 of fair value | $ 0 | $ 0 |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash in current assets | $ 408 | $ 408 |
Stamford Lease [Member] | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash in current assets | $ 408 | $ 408 |
Restricted Cash - Schedule of R
Restricted Cash - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Restricted Cash | ||||
Cash and cash equivalents | $ 47,391 | $ 63,741 | ||
Restricted cash in current assets | 408 | 408 | ||
Total cash, cash equivalents, and restricted cash shown in the Condensed Statements of Cash Flows | $ 47,799 | $ 64,149 | $ 21,770 | $ 13,861 |
Inventory, net - Schedule of In
Inventory, net - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory, net | ||
Raw materials | $ 2,504 | $ 1,918 |
Work-in-process | 1,009 | 499 |
Finished goods | 2 | |
Inventory gross | 3,515 | 2,417 |
Less Inventory Reserve for Obsolescence | (34) | |
Total | $ 3,515 | $ 2,383 |
Inventory, net - Additional Inf
Inventory, net - Additional Information (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Inventory, net | |
Inventory write-down | $ 0 |
Prepaid Expenses - Additional I
Prepaid Expenses - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid expenses | ||
Prepaid expenses | $ 17,195 | $ 16,267 |
Prepaid R&D clinical costs | 14,407 | 15,188 |
Prepaid insurance | 1,887 | 543 |
Other prepaid costs | $ 901 | $ 536 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 4,424 | $ 9,604 |
Accrued research projects | 5,824 | 5,200 |
Accrued compensation and benefits | 2,947 | 5,219 |
Accrued professional fees and other | 2,027 | 1,517 |
Total | $ 15,222 | $ 21,540 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||||
Mar. 31, 2023 | Feb. 28, 2023 | Jan. 31, 2023 | Mar. 31, 2022 | Feb. 28, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Sale Of Stock [Line Items] | ||||||||
Common stock, shares issued | 53,974,352 | 53,974,352 | 53,797,341 | |||||
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 | |||||||
Stock Sale Commission Percentage | 3% | |||||||
Open Market Sales Agreement [Member] | Maximum [Member] | Jeffries LLC [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Aggregate offering price of securities | $ 80,000 | 80,000 | ||||||
2022 Shelf Registration Statement [Member] | Maximum [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Aggregate offering price of securities | $ 300,000 | $ 300,000 | ||||||
Common Stock | ||||||||
Sale Of Stock [Line Items] | ||||||||
Restricted stock units vested shares | 83,793 | 109,943 | ||||||
Performance Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | March 2022 [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Restricted stock units vested shares | 37,999 | |||||||
Time-based Restricted Stock Units [Member] | 2014 Equity Incentive Plan [Member] | Executive Officers [Member] | March 2021 [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Restricted stock units, vested | 15,999 | |||||||
Time-based Restricted Stock Units [Member] | 2014 Equity Incentive Plan [Member] | Executive Officers [Member] | February 2020 [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Restricted stock units, vested | 15,999 | |||||||
Time-based Restricted Stock Units [Member] | 2014 Equity Incentive Plan [Member] | Chief Executive Officer [Member] | October 2021 [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Restricted stock units, vested | 8,875 | |||||||
Time-based 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 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 | 3 years | ||||||
Restricted stock units vested shares | 42,920 | 32,666 | ||||||
Time-based Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | October 2021 [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Restricted stock units vested shares | 8,875 | |||||||
Time-based Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | March 2021 [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Vesting period of awards granted | 3 years | |||||||
Restricted stock units vested shares | 15,999 | |||||||
Time-based Restricted Stock Units [Member] | Common Stock | Executive Officers [Member] | February 2020 [Member] | ||||||||
Sale Of Stock [Line Items] | ||||||||
Vesting period of awards granted | 3 years | |||||||
Restricted stock units vested shares | 15,999 |
Collaboration and Licensing A_2
Collaboration and Licensing Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | |
Oct. 31, 2020 | May 17, 2018 | |
CSL Vifor Maximum [Member] | Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 1 [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Potential sales-based milestone payments | $ 240,000 | |
CSL Vifor [Member] | Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 1 [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Percentage of net profit sharing due to CSL Vifor | 40% | |
CSL Vifor [Member] | Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 1 [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Percentage of net profit sharing due to the Company | 60% | |
Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 2 [Member] | Maximum [Member] | Regulatory and Commercial Milestones [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Potential milestone payments | $ 440,000 |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 6,165 | $ 4,790 |
Collaborative Revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,750 | |
Collaborative Revenue | CSL Vifor Profit Sharing [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,750 | |
Collaborative Revenue | CSL Vifor [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 2,750 | 0 |
Commercial Supply Revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 3,191 | 4,790 |
Commercial Supply Revenue | CSL Vifor [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 3,191 | 4,790 |
Clinical Compound Revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 99 | |
Clinical Compound Revenue | Maruishi Pharmaceutical Co., Ltd. [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 99 | 0 |
Royalty Revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 125 | |
Royalty Revenue | CSL Vifor Kapruvia [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 125 | |
Royalty Revenue | CSL Vifor [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 0 | |
Royalty Revenue | CSL Vifor [Member] | CSL Vifor Kapruvia [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 125 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Mar. 31, 2022 | Jan. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Collaboration Arrangement [Line Items] | |||||
Accounts receivable, net - related party | $ 6,066 | $ 3,260 | |||
Total revenue | 6,165 | $ 4,790 | |||
Commercial Supply Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 3,191 | 4,790 | |||
Royalty Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 125 | ||||
Collaborative Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 2,750 | ||||
Clinical Compound Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 99 | ||||
CSL Vifor, Maruishi and CKDP Agreements [Member] | |||||
Collaboration Arrangement [Line Items] | |||||
Other contract Assets | 0 | 0 | |||
Other contract liabilities | 0 | 0 | |||
CSL Vifor Kapruvia [Member] | Royalty Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 125 | ||||
Maruishi Pharmaceutical Co., Ltd. [Member] | Clinical Compound Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 99 | 0 | |||
CSL Vifor [Member] | |||||
Collaboration Arrangement [Line Items] | |||||
Accounts receivable, net - related party | 6,066 | $ 3,260 | |||
CSL Vifor [Member] | Commercial Supply Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 3,191 | 4,790 | |||
CSL 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 | ||||
CSL Vifor [Member] | Commercial Supply Revenue With Associated Costs Of Goods Sold [Member] | |||||
Collaboration Arrangement [Line Items] | |||||
Revenue | $ 2,495 | ||||
Cost of goods sold | $ 2,081 | 2,590 | |||
CSL Vifor [Member] | Royalty Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 0 | ||||
CSL Vifor [Member] | Collaborative Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | 2,750 | $ 0 | |||
CSL Vifor [Member] | CSL Vifor Kapruvia [Member] | Royalty Revenue | |||||
Collaboration Arrangement [Line Items] | |||||
Total revenue | $ 125 |
Net Loss Income per Share - Com
Net Loss Income per Share - Computation of Denominators Used in Net Loss per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Basic: | ||
Weighted average common shares outstanding - Basic | 53,872,038 | 53,507,060 |
Diluted: | ||
Weighted average common shares outstanding - Basic | 53,872,038 | 53,507,060 |
Common stock equivalents | 0 | 0 |
Denominator for diluted net loss per share | 53,872,038 | 53,507,060 |
Net Loss Income per Share - C_2
Net Loss Income per Share - Computation of Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net Loss Per Share | ||
Net loss - basic and diluted | $ (26,665) | $ (27,749) |
Weighted-average common shares outstanding: | ||
Basic | 53,872,038 | 53,507,060 |
Diluted | 53,872,038 | 53,507,060 |
Net loss per share: | ||
Basic | $ (0.49) | $ (0.52) |
Diluted | $ (0.49) | $ (0.52) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 |
Net Loss Per Share | |||
Number of options outstanding | 8,992,759 | 7,689,449 | 7,430,629 |
Number of restricted stock units outstanding | 695,720 | 736,272 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||||||||
Mar. 01, 2023 $ / shares shares | Oct. 12, 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 | Mar. 31, 2023 $ / shares shares | Feb. 28, 2023 shares | Jan. 31, 2023 shares | Mar. 31, 2022 shares | Feb. 28, 2022 shares | Feb. 29, 2020 installment $ / shares shares | Mar. 31, 2023 USD ($) $ / shares shares | Mar. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2015 shares | Jan. 01, 2023 shares | Dec. 31, 2022 $ / 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 | 53,974,352 | 53,974,352 | 53,797,341 | |||||||||||||||||
Common stock, shares issued | 53,974,352 | 53,974,352 | 53,797,341 | |||||||||||||||||
Number of restricted stock units outstanding | 695,720 | 736,272 | 695,720 | 736,272 | ||||||||||||||||
Number of options outstanding | 8,992,759 | 7,430,629 | 8,992,759 | 7,430,629 | 7,689,449 | |||||||||||||||
Options granted | 1,449,154 | |||||||||||||||||||
Employees [Member] | Restricted Stock Units [Member] | Research and Development [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Compensation expense | $ | $ 179 | $ 167 | ||||||||||||||||||
Employees [Member] | Restricted Stock Units [Member] | General and Administrative [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Compensation expense | $ | 330 | 1,452 | ||||||||||||||||||
Director [Member] | Restricted Stock Units [Member] | General and Administrative [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Compensation expense | $ | $ 123 | $ 139 | ||||||||||||||||||
Non-employee Consultants [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Options granted | 0 | 0 | ||||||||||||||||||
Employees And Non-Employee Members Of Board Of Directors [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Fair value of options granted | $ / shares | $ 7.55 | |||||||||||||||||||
Employees And Non-Employee Members Of Board Of Directors [Member] | Share-based Payment Arrangement, Employee [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Fair value of options granted | $ / shares | $ 7.08 | |||||||||||||||||||
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 | ||||||||||||||||||
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 | 300,000,000 | |||||||||||||||||||
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 | 12,203,023 | 10,589,103 | ||||||||||||||||||
Options granted | 1,449,154 | 977,438 | ||||||||||||||||||
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] | Employees [Member] | Performance Restricted Stock Units [Member] | March 2021 [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Awarded | 176,000 | |||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 20.59 | |||||||||||||||||||
Compensation expense | $ | $ 0 | $ 729 | ||||||||||||||||||
Restricted stock units, vested | 37,999 | |||||||||||||||||||
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] | ||||||||||||||||||||
Number of restricted stock units outstanding | 0 | 0 | ||||||||||||||||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Performance Restricted Stock Units [Member] | March 2023 [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Awarded | 407,000 | 407,000 | ||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 10.06 | |||||||||||||||||||
Compensation expense | $ | $ 0 | |||||||||||||||||||
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] | 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 | $ | $ 114 | 50 | ||||||||||||||||||
Restricted stock units, vested | 42,920 | |||||||||||||||||||
Number of restricted stock units outstanding | 82,250 | 82,250 | ||||||||||||||||||
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 | $ | $ 108 | 131 | ||||||||||||||||||
Restricted stock units, vested | 26,199 | |||||||||||||||||||
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 | |||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 20.59 | |||||||||||||||||||
Number of equal installment | installment | 3 | |||||||||||||||||||
Compensation expense | $ | $ 81 | 284 | ||||||||||||||||||
Restricted stock units, vested | 33,336 | 15,999 | ||||||||||||||||||
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 | $ | $ 39 | 219 | ||||||||||||||||||
Restricted stock units, vested | 32,666 | |||||||||||||||||||
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 | $ | 47 | 18 | ||||||||||||||||||
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 | $ | 52 | 52 | ||||||||||||||||||
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 | $ | 54 | 54 | ||||||||||||||||||
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 | $ | 26 | 43 | ||||||||||||||||||
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 | $ | 155 | |||||||||||||||||||
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 | $ | 203 | |||||||||||||||||||
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 | $ | 67 | 32 | ||||||||||||||||||
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 | $ | 56 | 79 | ||||||||||||||||||
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 | $ | 27 | 230 | ||||||||||||||||||
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 | $ | $ 13 | 176 | ||||||||||||||||||
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] | Executive Officers [Member] | Time-based Restricted Stock Units [Member] | October 2022 [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Awarded | 7,267 | |||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 9.42 | |||||||||||||||||||
Number of restricted stock units outstanding | 7,267 | 7,267 | ||||||||||||||||||
2014 Equity Incentive Plan [Member] | Executive Officers [Member] | Time-based Restricted Stock Units [Member] | March 2021 [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Restricted stock units, vested | 15,999 | |||||||||||||||||||
2014 Equity Incentive Plan [Member] | Executive Officers [Member] | Time-based Restricted Stock Units [Member] | February 2020 [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Restricted stock units, vested | 15,999 | |||||||||||||||||||
2014 Equity Incentive Plan [Member] | Executive Officers [Member] | Time-based Restricted Stock Units [Member] | General and Administrative [Member] | October 2022 [Member] | ||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||||
Compensation expense | $ | $ 19 | |||||||||||||||||||
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 | |||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 16.83 | |||||||||||||||||||
Number of restricted stock unit tranches | tranche | 2 | |||||||||||||||||||
Restricted stock units, vested | 8,875 | |||||||||||||||||||
Number of restricted stock units outstanding | 97,625 | 97,625 | ||||||||||||||||||
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 | $ | $ 147 | $ 206 | ||||||||||||||||||
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 | |||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 8.42 | |||||||||||||||||||
Number of restricted stock units outstanding | 59,380 | 59,380 | ||||||||||||||||||
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 | |||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 13.06 | |||||||||||||||||||
Compensation expense | $ | $ 0 | |||||||||||||||||||
Number of restricted stock units outstanding | 0 | 0 | ||||||||||||||||||
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 | $ | $ 123 | |||||||||||||||||||
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 | $ | $ 139 | |||||||||||||||||||
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 | 407,000 | |||||||||||||||||||
Restricted stock units, grant date fair value | $ / shares | $ 10.06 | |||||||||||||||||||
Restricted stock units, vested | 83,793 | |||||||||||||||||||
Number of restricted stock units outstanding | 695,720 | 695,720 | 372,513 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Unit Activity (Details) - $ / shares | 1 Months Ended | 3 Months Ended |
Mar. 31, 2022 | Mar. 31, 2023 | |
Number of Units | ||
Outstanding, Ending Balance | 736,272 | 695,720 |
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 | 372,513 | |
Awarded | 407,000 | |
Vested and released | (83,793) | |
Outstanding, Ending Balance | 695,720 | |
Weighted Average Grant Date Fair Value | ||
Weighted-average grant date fair value, outstanding, Beginning Balance | $ 13.20 | |
Weighted-average grant date fair value, awarded | 10.06 | |
Weighted-average grant date fair value, vested and released | 14.20 | |
Weighted-average grant date fair value, outstanding, Ending Balance | $ 11.24 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Assumptions Used in Black-Scholes Option Pricing Model (Detail) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 3.62% | 1.70% |
Risk-free interest rate, maximum | 4.22% | 2.35% |
Expected volatility, minimum | 76.30% | 81.40% |
Expected volatility, maximum | 81.30% | 81.90% |
Expected dividend yield | 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 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Compensation Expense Relating to Stock Options (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
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 | 2,721 | 3,947 |
Options [Member] | Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | 1,480 | 1,917 |
Options [Member] | General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | 1,241 | 2,030 |
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 | 123 | 139 |
Restricted Stock Units [Member] | Employees [Member] | Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | 179 | 167 |
Restricted Stock Units [Member] | Employees [Member] | General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | $ 330 | $ 1,452 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock-Based Compensation | ||
Number of Options, Outstanding, Beginning Balance | 7,689,449 | |
Number of Options, Granted | 1,449,154 | |
Number of Options, Exercised | (93,218) | |
Number of Options, Forfeited | (52,626) | |
Number of Options, Outstanding, Ending Balance | 8,992,759 | 7,430,629 |
Number of Options, Options exercisable | 5,128,904 | |
Weighted-Average Exercise Price, Outstanding, Beginning Balance | $ 14.35 | |
Weighted-Average Exercise Price, Granted | 10.06 | |
Weighted-Average Exercise Price, Exercised | 6 | |
Weighted-Average Exercise Price, Forfeited | 11.41 | |
Weighted-Average Exercise Price, Outstanding, Ending Balance | $ 13.76 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Award Modifications (Details) - Former President and C E O [Member] - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Feb. 28, 2022 | Nov. 30, 2021 | Mar. 31, 2022 | |
Modified Awards [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] | Performance Restricted Stock Units [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 | $ 1,564 | ||
Incremental stock compensation expense relating to modification of stock options | $ 903 | ||
Type 4 modification [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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Taxes | ||
Company's effective tax rate | 0% | 0% |
Percentage of ineligible annual research and development credit for cash | 65% | 65% |
Income tax benefit | $ 0 | $ 0 |
Income tax receivable related to R&D credit | $ 697 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Jul. 31, 2021 | Jul. 31, 2019 agreement | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Other Commitments [Line Items] | |||||
Research and development expense | $ 24,334 | $ 21,273 | |||
Operating lease liabilities | 1,456 | ||||
Operating lease right-of-use assets | 1,175 | $ 1,551 | |||
Stamford Operating Lease and New Stamford Lease [Member] | |||||
Other Commitments [Line Items] | |||||
Operating lease cost | 407 | 406 | |||
Stamford Operating Lease and New Stamford Lease [Member] | Research and Development [Member] | |||||
Other Commitments [Line Items] | |||||
Operating lease cost | 284 | 284 | |||
Stamford Operating Lease and New Stamford Lease [Member] | General and Administrative [Member] | |||||
Other Commitments [Line Items] | |||||
Operating lease cost | 123 | 122 | |||
Non-Exclusive License Agreement | Enteris Biopharma, Inc. [Member] | |||||
Other Commitments [Line Items] | |||||
Payment of milestone payment | $ 0 | $ 0 | |||
Patheon 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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Commitments and Contingencies | ||
Operating cash outflows relating to operating leases | $ 494 | $ 485 |
ROU assets obtained in exchange for new operating lease liabilities | ||
Remaining lease term - operating leases (years) | 9 months 18 days | 1 year 9 months 18 days |
Discount rate - operating leases | 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 | Mar. 31, 2023 | Dec. 31, 2022 |
Operating Lease Liabilities, Payments Due [Abstract] | ||
2023 (Excluding the three months ended March 31, 2023) | $ 1,498 | |
Total future minimum lease payments, undiscounted | 1,498 | |
Less imputed interest | (42) | |
Operating lease liabilities | 1,456 | |
Operating lease liabilities reported as of March 31, 2023: | ||
Operating lease liabilities - current | 1,456 | $ 1,918 |
Total | $ 1,456 |
Related Party Transactions (Det
Related Party Transactions (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||
Accounts due from related parties | $ 6,066 | $ 3,260 | |
Revenue from contract with customer | 6,165 | $ 4,790 | |
Commercial Supply Revenue | |||
Related Party Transaction [Line Items] | |||
Revenue from contract with customer | 3,191 | 4,790 | |
Collaborative Revenue | |||
Related Party Transaction [Line Items] | |||
Revenue from contract with customer | 2,750 | ||
Royalty Revenue | |||
Related Party Transaction [Line Items] | |||
Revenue from contract with customer | 125 | ||
CSL Vifor Profit Sharing [Member] | Collaborative Revenue | |||
Related Party Transaction [Line Items] | |||
Revenue from contract with customer | 2,750 | ||
CSL Vifor Kapruvia [Member] | Royalty Revenue | |||
Related Party Transaction [Line Items] | |||
Revenue from contract with customer | $ 125 | ||
Vifor International Ltd. [Member] | |||
Related Party Transaction [Line Items] | |||
Shares owned as a result of upfront and milestone payments | 7,396,770 | ||
Related party ownership percentage | 13.70% | ||
CSL Vifor [Member] | |||
Related Party Transaction [Line Items] | |||
Accounts due from related parties | $ 6,066 | $ 3,260 | |
CSL Vifor [Member] | Commercial Supply Revenue | |||
Related Party Transaction [Line Items] | |||
Revenue from related parties | 3,191 | 4,790 | |
Related party cost of goods sold | 2,590 | $ 2,081 | |
CSL Vifor [Member] | CSL Vifor Profit Sharing [Member] | Collaborative Revenue | |||
Related Party Transaction [Line Items] | |||
Revenue from contract with customer | 2,750 | ||
CSL Vifor [Member] | CSL Vifor Kapruvia [Member] | Royalty Revenue | |||
Related Party Transaction [Line Items] | |||
Revenue from contract with customer | $ 125 |