Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 09, 2024 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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, Postal Zip Code | 06901 | |
Entity Address, Address Line One | 400 Atlantic Street | |
Entity Address, Address Line Two | Suite 500 | |
Entity Address, City or Town | Stamford | |
Entity Address, State or Province | CT | |
City Area Code | 203 | |
Local Phone Number | 406-3700 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | CARA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 54,675,954 | |
Entity Central Index Key | 0001346830 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 46,996 | $ 51,775 |
Marketable securities | 22,777 | 48,983 |
Accounts receivable, net - related party | 1,718 | 2,765 |
Inventory, net | 2,741 | 2,821 |
Income tax receivable | 697 | 697 |
Other receivables | 506 | 555 |
Prepaid expenses | 5,790 | 8,154 |
Restricted cash | 408 | |
Total current assets | 81,225 | 116,158 |
Operating lease right-of-use assets | 3,826 | 4,864 |
Property and equipment, net | 3,548 | 3,322 |
Restricted cash, non-current | 1,500 | 1,500 |
Total assets | 90,099 | 125,844 |
Current liabilities: | ||
Accounts payable and accrued expenses | 14,875 | 25,592 |
Operating lease liability, current | 220 | |
Total current liabilities | 15,095 | 25,592 |
Liability related to sales of future royalties and milestones, net | 38,376 | 37,079 |
Operating lease liability, non-current | 6,825 | 6,088 |
Total liabilities | 60,296 | 68,759 |
Commitments and contingencies (Note 17) | ||
Stockholders' equity: | ||
Preferred stock; $0.001 par value; 5,000,000 shares authorized at March 31, 2024 and December 31, 2023, zero shares issued and outstanding at March 31, 2024 and December 31, 2023 | ||
Common stock; $0.001 par value; 100,000,000 shares authorized at March 31, 2024 and December 31, 2023, 54,667,079 shares and 54,480,704 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 54 | 54 |
Additional paid-in capital | 745,381 | 742,036 |
Accumulated deficit | (715,441) | (684,745) |
Accumulated other comprehensive loss | (191) | (260) |
Total stockholders' equity | 29,803 | 57,085 |
Total liabilities and stockholders' equity | $ 90,099 | $ 125,844 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
CONDENSED CONSOLIDATED 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 | 54,667,079 | 54,480,704 |
Common stock, shares outstanding | 54,667,079 | 54,480,704 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue: | ||
Total revenue | $ 2,135 | $ 6,165 |
Operating expenses: | ||
Cost of goods sold | 620 | 2,590 |
Research and development | 21,964 | 24,334 |
General and administrative | 6,816 | 6,891 |
Restructuring | 2,401 | |
Total operating expenses | 31,801 | 33,815 |
Operating loss | (29,666) | (27,650) |
Other income, net | 952 | 985 |
Non-cash interest expense on liability related to sales of future royalties and milestones | (1,982) | |
Net loss | $ (30,696) | $ (26,665) |
Net loss per share: | ||
Basic | $ (0.56) | $ (0.49) |
Diluted | $ (0.56) | $ (0.49) |
Weighted average shares: | ||
Basic | 54,588,090 | 53,872,038 |
Diluted | 54,588,090 | 53,872,038 |
Other comprehensive income, net of tax of $0: | ||
Change in unrealized gains on available-for-sale marketable securities | $ 69 | $ 571 |
Total comprehensive loss | (30,627) | (26,094) |
Collaborative revenue | ||
Revenue: | ||
Total revenue | 788 | 2,750 |
Commercial supply revenue | ||
Revenue: | ||
Total revenue | 640 | 3,191 |
Royalty revenue | ||
Revenue: | ||
Total revenue | 125 | |
Clinical compound revenue | ||
Revenue: | ||
Total revenue | 84 | $ 99 |
Other revenue | ||
Revenue: | ||
Total revenue | $ 623 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Other comprehensive income tax | $ 0 | $ 0 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total |
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 | ||||
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 | 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 | ||||
Balance, Value at Dec. 31, 2023 | $ 54 | 742,036 | (684,745) | (260) | 57,085 |
Balance, Shares at Dec. 31, 2023 | 54,480,704 | ||||
Stock-based compensation expense | 1,660 | 1,660 | |||
Shares issued upon vesting of restricted stock units, value | 1,685 | 1,685 | |||
Shares issued upon vesting of restricted stock units, shares | 186,375 | ||||
Net loss | (30,696) | (30,696) | |||
Other comprehensive income | 69 | 69 | |||
Balance, Value at Mar. 31, 2024 | $ 54 | $ 745,381 | $ (715,441) | $ (191) | $ 29,803 |
Balance, Shares at Mar. 31, 2024 | 54,667,079 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities | ||
Net loss | $ (30,696) | $ (26,665) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 3,345 | 3,353 |
Non-cash interest expense on liability related to sales of future royalties and milestones, net of issuance costs accretion | 1,982 | |
Depreciation and amortization | 42 | 58 |
Noncash lease expense | 269 | 375 |
Accretion of available-for-sale marketable securities, net | (510) | (94) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net - related party | 1,047 | (2,806) |
Inventory, net | 80 | (1,132) |
Other receivables | 49 | 1 |
Prepaid expenses | 2,364 | (928) |
Accounts payable and accrued expenses | (10,151) | (6,318) |
Operating lease liability | (462) | |
Reimbursement of lease incentive | 1,726 | |
Net cash used in operating activities | (30,453) | (34,618) |
Investing activities | ||
Proceeds from maturities of available-for-sale marketable securities | 59,000 | 29,500 |
Proceeds from redemptions of available-for-sale marketable securities, at par | 4,000 | |
Purchases of available-for-sale marketable securities | (32,213) | (15,792) |
Purchases of property and equipment | (836) | |
Net cash provided by investing activities | 25,951 | 17,708 |
Financing activities | ||
Payments to royalty purchase and sale agreement | (685) | |
Proceeds from the exercise of stock options | 560 | |
Net cash (used in) provided by financing activities | (685) | 560 |
Net decrease in cash, cash equivalents and restricted cash | (5,187) | (16,350) |
Cash, cash equivalents and restricted cash at beginning of period | 53,683 | 64,149 |
Cash, cash equivalents and restricted cash at end of period | 48,496 | $ 47,799 |
Noncash investing and financing activities | ||
Accrual for leasehold improvements | $ 211 |
Business
Business | 3 Months Ended |
Mar. 31, 2024 | |
Business. | |
Business | 1. Business Cara Therapeutics, Inc., or the Company, is a development-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, Finland, and Norway 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. Difelikefalin injection was also approved in the United Arab Emirates, Kuwait, Israel, Japan, and Saudi Arabia under the brand name KORSUVA in January 2023, May 2023, June 2023, September 2023, and January 2024, respectively. The Company expects additional approvals and commercial launches over the next 12 Royalty Purchase and Sale Agreement) 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 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 (see Note 12, 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 2023, Maruishi received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients (see Note 12, Collaboration and Licensing Agreements) Royalty Purchase and Sale Agreement) As of March 31, 2024, the Company has raised aggregate net proceeds of approximately $520,700 from several rounds of equity financing, including its initial public offering, or IPO, which closed in February 2014 and four follow-on public offerings of common stock, which closed in July 2019, July 2018, April 2017 and August 2015, respectively, the issuance of common stock pursuant to its open market sales agreement with Jefferies LLC as sales agent, or the Sales Agreement, in 2023, and the issuance of convertible preferred stock and debt prior to the IPO. The Company has also earned approximately $288,600 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. Under the terms of the HCR Agreement, the Company received net proceeds of $36,474 for the sale of future ex-U.S. royalties and milestones under Vifor Agreement No. 2 and the Maruishi Agreement in November and December 2023. 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 license agreement with CSL Vifor (see Note 12, Collaboration and Licensing Agreements As of March 31, 2024, the Company had unrestricted cash and cash equivalents and marketable securities of $69,773 and an accumulated deficit of $715,441. 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 $30,696 and $26,665 for the three months ended March 31, 2024 and 2023, respectively, and had net cash used in operating activities of $30,453 and $34,618 for the three months ended March 31, 2024 and 2023, 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 develop and commercialize its other product candidate, it will be unable to generate additional recurring product revenue or achieve profitability. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2024 | |
Business. | |
Basis of Presentation | 2. Basis of Presentation The Company’s condensed consolidated financial statements include the results of the financial operations of Cara Therapeutics, Inc. and its wholly-owned subsidiary, Cara Royalty Sub, LLC, or Cara Royalty Sub, a Delaware limited liability company which was formed in November 2023 for the purpose of the transactions contemplated by the HCR Agreement described in Note 10, Royalty Purchase and Sale Agreement The unaudited interim condensed consolidated 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 condensed consolidated 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 consolidated balance sheet data as of December 31, 2023 were derived from audited financial statements, but do not include all disclosures required by GAAP. These unaudited interim condensed consolidated 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, 2023. Use of Estimates The preparation of condensed consolidated 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 condensed consolidated 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 and future ex-U.S. royalties and milestones projected in relation to the HCR Agreement, 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, restructuring costs, the amount of lease incentives, as applicable, and 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 global health crises, geopolitical tensions, such as the ongoing conflicts between Russia and Ukraine, conflict in the Middle East, and increasing tensions between China and Taiwan, and government actions implemented as a result of the foregoing, fluctuations in inflation, rising interest rates, uncertainty and liquidity concerns in the broader financial services industry, 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 consolidated 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 consolidated 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 Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Accounting Pronouncements Recently Adopted In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures Accounting Pronouncements Not Yet Adopted In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Available-for-Sale Marketable S
Available-for-Sale Marketable Securities | 3 Months Ended |
Mar. 31, 2024 | |
Available-for-Sale Marketable Securities | |
Available-for-Sale Marketable Securities | 3. Available-for-Sale Marketable Securities As of March 31, 2024 and December 31, 2023, the Company’s available-for-sale marketable securities consisted of debt securities issued by the U.S. Treasury, U.S. government-sponsored entities and investment grade institutions (corporate bonds). The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of March 31, 2024 and December 31, 2023: As of March 31, 2024 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 13,468 $ — $ (1) $ 13,467 U.S. government agency obligations 7,500 — (190) 7,310 Corporate bonds 2,000 — — 2,000 Total available-for-sale marketable securities $ 22,968 $ — $ (191) $ 22,777 As of December 31, 2023 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 37,243 $ 3 $ — $ 37,246 U.S. government agency obligations 7,500 — (262) 7,238 Corporate bonds 4,500 — (1) 4,499 Total available-for-sale marketable securities $ 49,243 $ 3 $ (263) $ 48,983 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, 2024 and December 31, 2023: As of March 31, 2024 Less than 12 Months 12 Months or Greater Total Gross Gross Gross Fair Unrealized Fair Unrealized Fair Unrealized Value Losses Value Losses Value Losses U.S. Treasury securities $ 13,467 $ (1) $ — $ — $ 13,467 $ (1) U.S. government agency obligations — — 7,310 (190) 7,310 (190) Total $ 13,467 $ (1) $ 7,310 $ (190) $ 20,777 $ (191) As of December 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 $ — $ — $ 7,238 $ (262) $ 7,238 $ (262) Corporate bonds — — 2,000 (1) 2,000 (1) Total $ — $ — $ 9,238 $ (263) $ 9,238 $ (263) As of March 31, 2024 and December 31, 2023, 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 As of March 31, 2024 and December 31, 2023, the Company held a total of 3 out of 4 positions and 3 out of 9 positions, respectively, that were in an unrealized loss position, 2 of which had been in an unrealized loss position for 12 months or greater as of March 31, 2024. 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. Treasury and U.S. government agency obligations. government positions for its U.S. government agency obligations, that were in unrealized loss positions as of March 31, 2024. The Company classifies its marketable debt securities based on their contractual maturity dates. As of March 31, 2024, 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, 2024 As of December 31, 2023 Contractual maturity Amortized Cost Fair Value Amortized Cost Fair Value Less than one year $ 22,968 $ 22,777 $ 49,243 $ 48,983 More than one year — — — — Total $ 22,968 $ 22,777 $ 49,243 $ 48,983 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 each of the three months ended March 31, 2024 and 2023. As of March 31, 2024 and December 31, 2023, accrued interest receivables on the Company’s available-for-sale debt securities were $160 and $139, respectively, and were included within other receivables. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 3 Months Ended |
Mar. 31, 2024 | |
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 on available-for-sale marketable securities, the Company’s only component of accumulated other comprehensive loss, for the three months ended March 31, 2024 and 2023, respectively. Total Accumulated Other Comprehensive Loss Balance, December 31, 2023 $ (260) Other comprehensive income before reclassifications 69 Amount reclassified from accumulated other comprehensive loss — Net current period other comprehensive income 69 Balance, March 31, 2024 $ (191) 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) Amounts reclassified out of accumulated other comprehensive loss into net loss are determined by specific identification. There were no reclassifications out of accumulated other comprehensive loss and into net loss for the three months ended March 31, 2024 and 2023. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | 5. Fair Value Measurements As of March 31, 2024 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, 2024 The following tables summarize the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2024 Fair value measurement as of March 31, 2024 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 $ 46,996 $ 46,996 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 13,467 — 13,467 — U.S. government agency obligations 7,310 — 7,310 — Corporate bonds 2,000 — 2,000 — Restricted cash: Commercial money market account 1,500 1,500 — — Total financial assets $ 71,273 $ 48,496 $ 22,777 $ — Fair value measurement as of December 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 $ 51,775 $ 51,775 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 37,246 — 37,246 — U.S. government agency obligations 7,238 — 7,238 — Corporate bonds 4,499 — 4,499 — Restricted cash: Commercial money market account 1,908 1,908 — — Total financial assets $ 102,666 $ 53,683 $ 48,983 $ — 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, 2024 and 2023 March 31, 2024 and 2023 |
Restricted Cash
Restricted Cash | 3 Months Ended |
Mar. 31, 2024 | |
Restricted Cash | |
Restricted Cash | 6. Restricted Cash In May 2023, the Company entered into a lease agreement with 400 Atlantic Joint Venture LLC and SLJ Atlantic Stamford LLC (tenants-in-common), or the Landlord, for the lease of 26,374 square feet of office space located at 400 Atlantic Street, Stamford, Connecticut 06901 for its new principal executive offices, or the New Lease. The Company is required to maintain a stand-by letter of credit as a security deposit under the New Lease for its office space in Stamford, Connecticut (refer to Note 17, Commitments and Contingencies: Leases As of March 31, 2024, the Company had $1,500 of restricted cash related to the New Lease in long-term assets. After the first and second anniversaries of the rent commencement date, the face amount of the letter of credit relating to the New Lease can be reduced by $500 each period if the Company is not in default of its lease obligations. As of December 31, 2023, the Company had $408 of restricted cash related to its previous lease (which was terminated in December 2023 and became unrestricted in January 2024) in current assets and $1,500 of restricted cash related to the New Lease in long-term assets. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets that sum to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows. March 31, 2024 December 31, 2023 Cash and cash equivalents $ 46,996 $ 51,775 Restricted cash, current assets — 408 Restricted cash, long-term assets 1,500 1,500 Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows $ 48,496 $ 53,683 |
Inventory, net
Inventory, net | 3 Months Ended |
Mar. 31, 2024 | |
Inventory, net | |
Inventory, net | 7. Inventory, net Inventory, net consists of the following: March 31, 2024 December 31, 2023 Raw materials $ 2,142 $ 2,639 Work-in-process 644 708 2,786 3,347 Less Inventory Reserve for Obsolescence (45) (526) Total $ 2,741 $ 2,821 As of March 31, 2024 and December 31, 2023, 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, 2024 and 2023. |
Prepaid Expenses
Prepaid Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Prepaid Expenses | |
Prepaid Expenses | 8. Prepaid expenses As of March 31, 2024, prepaid expenses were $5,790, consisting of $3,770 of prepaid R&D clinical costs, $1,548 of prepaid insurance and $472 of other prepaid costs. As of December 31, 2023, prepaid expenses were $8,154, consisting of $7,245 of prepaid R&D clinical costs, $492 of prepaid insurance, and $417 of other prepaid costs. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 December 31, 2023 Accounts payable $ 4,978 $ 11,583 Accrued research projects 5,895 4,343 Accrued compensation and benefits 2,064 6,519 Accrued professional fees and other 1,938 3,147 Total $ 14,875 $ 25,592 |
Royalty Purchase and Sale Agree
Royalty Purchase and Sale Agreement | 3 Months Ended |
Mar. 31, 2024 | |
Royalty Purchase and Sale Agreement | |
Royalty Purchase and Sale Agreement | 10. Royalty Purchase and Sale Agreement During the fourth quarter of 2023, the Company, through its wholly-owned subsidiary Cara Royalty Sub, entered into the HCR Agreement with HCR, pursuant to which Cara Royalty Sub sold, or agreed to sell, to HCR certain of its rights to receive royalty payments, or the Royalties, due and payable to Cara Royalty Sub (as assignee of the Company) under the Maruishi Agreement and Vifor Agreement No. 2., collectively the Covered License Agreements, in exchange for up to $40,000. The Company has retained all of its rights, title and interest in, to and under the Covered License Agreements that relate to any non-intravenous formulation of difelikefalin. Under the terms of the HCR Agreement, Cara Royalty Sub received an upfront payment of $16,915 in November 2023, representing the $17,500 to which the Company was initially entitled, net of advisory fees and certain of HCR’s transaction-related expenses which the Company agreed to reimburse. In December 2023, Cara Royalty Sub received an additional payment of $19,770, representing the $20,000 milestone it achieved for Kapruvia (difelikefalin) pricing in Germany being approved above a certain threshold amount per dose, net of advisory fees. There were additional issuance costs of $211 related to the HCR Agreement resulting in aggregate net proceeds of $36,474. An additional $2,500 milestone payment is due to Cara Royalty Sub upon achievement of a 2024 sales milestone of KORSUVA in Japan. The HCR Agreement will automatically expire, and the payment of Royalties to HCR will cease, when HCR has received payments of Royalties equal to two times the aggregate amount of payments made by HCR under the HCR Agreement if achieved on or prior to December 31, 2029, or 2.8 times the aggregate amount of payments made by HCR under the HCR Agreement, if not achieved on or prior to December 31, 2029. After the HCR Agreement expires, all rights to receive the Royalties return to Cara Royalty Sub. Issuance costs pursuant to the HCR Agreement consisting primarily of advisory and legal fees totaled $1,025 including the amount of HCR’s transaction-related expenses that the Company reimbursed. The effective interest rate includes cash flow projections for future royalty and milestone payments, which are sensitive to certain assumptions, including market size, market penetration and sales price, that are forward looking and could be affected by future market conditions. The following table summarizes the activity of the HCR Agreement (in thousands): Royalty purchase and sale agreement balance at December 31, 2023 $ 37,079 Payments (685) Non-cash interest expense 1,982 Balance at March 31, 2024 $ 38,376 Effective interest rate 22.56 % |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Equity | |
Stockholders' Equity | 11. Stockholders’ Equity During the three months ended March 31, 2024, an aggregate of 45,875 time-based restricted stock units of certain employees vested and were settled in shares of the Company’s common stock (See Note 15, Stock-Based Compensation During the three months ended March 31, 2024, an aggregate of 140,500 performance-based restricted stock units of certain employees vested and were settled in shares of the Company’s common stock (See Note 15, Stock-Based Compensation During the three months ended March 31, 2023, an aggregate of 83,793 time-based restricted stock units vested and were settled in shares of the Company’s common stock (see Note 15, Stock-Based Compensation |
Collaboration and Licensing Agr
Collaboration and Licensing Agreements | 3 Months Ended |
Mar. 31, 2024 | |
Collaboration and Licensing Agreements. | |
Collaboration and Licensing Agreements | 12. 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. In September 2023, Maruishi received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients. In November 2023, the Company entered into an API supply agreement with Maruishi for difelikefalin. 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, 2024 | |
Revenue Recognition | |
Revenue Recognition | 13. Revenue Recognition The Company has recognized revenue under its license and collaboration agreements from (1) its share of the profit generated by KORSUVA injection sales in the United States during the three months ended March 31, 2024 and 2023; (2) commercial supply revenue from the Company’s sales of commercial product to CSL Vifor during the three months ended March 31, 2024 and 2023; (3) royalty revenue from net sales of Kapruvia in Europe during the three months ended March 31, 2023; (4) clinical compound sales from certain license agreements during the three months ended March 31, 2024 and 2023; and (5) other revenue which represents royalty payments earned by the Company under Vifor Agreement No. 2 and the Maruishi Agreement under the HCR Agreement during the three months ended March 31, 2024. As of March 31, 2024, the Company has not earned any sales-based milestones under its collaboration agreements. As of March 31, 2024, the Company had license and collaboration agreements with CSL Vifor, Maruishi and CKDP. The following table provides amounts included in the Company’s Condensed Consolidated Statements of Comprehensive Loss as revenue for the three months ended March 31, 2024 and 2023, respectively: Three Months Ended March 31, 2024 2023 Collaborative revenue CSL Vifor (KORSUVA injection profit sharing) $ 788 $ 2,750 Total collaborative revenue $ 788 $ 2,750 Commercial supply revenue CSL Vifor* (KORSUVA injection) $ 640 $ 3,191 Total commercial supply revenue $ 640 $ 3,191 Royalty revenue CSL Vifor (Kapruvia ex-U.S.) $ — $ 125 Total royalty revenue $ — $ 125 Clinical compound revenue Maruishi $ 84 $ 99 Total clinical compound revenue $ 84 $ 99 Other revenue (non-cash) CSL Vifor (Kapruvia ex-U.S.) $ 290 $ — Maruishi 333 — Total other revenue $ 623 $ — 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, 2024 and 2023, the Company recorded $788 and $2,750, respectively, as collaborative revenue for its profit-share from the sales of KORSUVA injection in the United States. 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 $640 and $3,191 for the three months ended March 31, 2024 and 2023, respectively, with associated COGS of $620 and $2,590, respectively. 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. The Company recognized royalty revenue of approximately $125 for the three months ended March 31, 2023, which were related to the Company’s royalties on the net sales of Kapruvia in Europe. Beginning on October 1, 2023, royalty revenue is no longer recognized until the Company has fulfilled its obligations under the HCR Agreement (see Note 10, Royalty Purchase and Sale Agreement 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, 2024 and 2023, the Company recognized clinical compound revenue of $84 and $99, respectively, from the sale of clinical compound to Maruishi. Other revenue The Company recorded other non-cash revenue of $623 which represents the royalty payments earned by the Company under Vifor Agreement No. 2 and the Maruishi Agreement during the three months ended March 31, 2024 in conjunction with ex-U.S. sales of KORSUVA/Kapruvia, which will be remitted to HCR under the terms of the HCR Agreement. This non-cash revenue will continue to be recorded until the Company has fulfilled its obligations under the HCR Agreement. There was no other revenue recorded for the three months ended March 31, 2023 as the HCR Agreement went into effect during the fourth quarter of 2023 (see Note 10, Royalty Purchase and Sale Agreement Contract balances As of March 31, 2024 and December 31, 2023, the Company recorded accounts receivable, net – related party of $1,718 and $2,765, respectively, which primarily related to its profit-sharing revenue from sales of KORSUVA injection in the United States by CSL Vifor, its commercial supply of KORSUVA injection to CSL Vifor, and royalty payments from CSL Vifor. The Company also recorded $346 and $415 within other receivables which primarily related to royalty payments from Maruishi as of March 31, 2024 and December 31, 2023, respectively. There were no other contract assets or contract liabilities related to the CSL Vifor, Maruishi and CKDP agreements as of March 31, 2024 and December 31, 2023. 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, 2024 and December 31, 2023. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss Per Share | |
Net Loss Per Share | 14. Net Loss Per Share The Company computes basic net loss per share by dividing net loss by the weighted-average number of shares of common stock outstanding. Diluted net 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 each of the three months ended March 31, 2024 and 2023, 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, 2024 2023 Basic: Weighted average common shares outstanding 54,588,090 53,872,038 Diluted: Weighted average common shares outstanding - Basic 54,588,090 53,872,038 Common stock equivalents* — — Denominator for diluted net loss per share 54,588,090 53,872,038 * 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, 2024 2023 Net loss - basic and diluted $ (30,696) $ (26,665) Weighted-average common shares outstanding: Basic and diluted 54,588,090 53,872,038 Net loss per share, basic and diluted: $ (0.56) $ (0.49) As of March 31, 2024, 8,816,532 stock options and 250,267 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, 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. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation | |
Stock-Based Compensation | 15. 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 generally vest monthly over a period of four years from the grant date, or upon the probable achievement of corporate goals. 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 continued 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, 2024, the aggregate number of shares of common stock that may be issued pursuant to Stock Awards under the 2014 Plan automatically increased from 12,203,023 to 13,837,444. 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 Under the 2014 Plan, there were no restricted stock units granted during the three months ended March 31, 2024. During the three months ended March 31, 2023, the Company granted 407,000 restricted stock units. No The weighted-average grant date fair value per share of restricted stock units granted to employees during the three months ended March 31, 2023 was $10.06. As of March 31, 2024, the Company’s restricted stock units consist of time-based restricted stock units and performance-based restricted stock units. For time-based restricted stock units, the Company recognizes compensation expense associated with these restricted stock units ratably over the award’s vesting period following the grant date. For performance-based restricted stock units, vesting 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 performance-based awards begins when, and to the extent, the performance criteria are probable of achievement and the employee has met the service conditions. During the three months ended March 31, 2024 and 2023, the Company recognized compensation expense relating to restricted stock units as follows: Three Months Ended March 31, 2024 2023 Research and development $ 255 $ 179 General and administrative 1,357 453 Total restricted stock unit expense $ 1,612 $ 632 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, 2024 is presented below: Weighted Number of Average Grant Units Date Fair Value Outstanding, December 31, 2023 566,324 $ 9.27 Awarded — — Vested and released (186,375) 11.04 Forfeited (129,682) 10.57 Outstanding, March 31, 2024 250,267 $ 7.28 Restricted stock units exercisable (vested and deferred), March 31, 2024 — Stock Options Under the 2014 Plan, the Company granted 1,875,125 and 1,449,154 stock options during the three months ended March 31, 2024 and 2023, respectively. No Three Months Ended March 31, 2024 2023 Risk-free interest rate 4.12% 3.62% - 4.22% Expected volatility 89.6% 76.3% - 81.3% 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, 2024 and 2023 was $0.76 and $7.08, respectively. No options were granted to non-employee consultants during the three months ended March 31, 2024 and 2023. During the three months ended March 31, 2024 and 2023, the Company recognized compensation expense relating to stock options as follows: Three Months Ended March 31, 2024 2023 Research and development $ 504 $ 1,480 General and administrative 1,229 1,241 Total stock option expense $ 1,733 $ 2,721 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, 2024 is presented below: Weighted Number of Average Exercise Shares Price Outstanding, December 31, 2023 7,897,647 $ 12.99 Granted 1,875,125 0.99 Exercised — — Forfeited (679,165) 10.87 Expired (277,075) 13.36 Outstanding, March 31, 2024 8,816,532 $ 10.59 Options exercisable, March 31, 2024 4,827,562 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 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes | |
Income Taxes | 16. Income Taxes The Company has recognized a full tax valuation allowance against its deferred tax assets as of March 31, 2024 and December 31, 2023. 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, 2024 and 2023. 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. The Company has not exchanged its R&D tax credit for cash during the three months ended March 31, 2024, and it was not eligible to exchange its R&D tax credit for cash during the three months ended March 31, 2023. Therefore, there was no benefit from income taxes for either of the three months ended March 31, 2024 and 2023. As of March 31, 2024, 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 early in 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, 2024; 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, 2024 | |
Commitments and Contingencies | |
Commitments and Contingencies | 17. 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, 2024 and 2023, 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. In December 2023, the Company entered into an agreement with Patheon to reimburse Patheon approximately $1,700 for forecasted manufacturing commitments that are no longer needed due to the reduced demand expectations of KORSUVA in the United States. As of March 31, 2024, $246 remained within accounts payable and accrued expenses on its Condensed Consolidated Balance Sheet. In connection with the agreement with Patheon, the Company agreed to schedule additional manufacturing commitments in 2024. Restructuring Action In January 2024, the Company announced a workforce reduction of up to 50% of its employees in order to reduce its operating expenses and focus its efforts on development of oral difelikefalin in chronic pruritus associated with notalgia paresthetica. As a result, the Company has made estimates and judgements regarding its future plans, including future employee termination costs to be incurred in conjunction with involuntary separations when such separations are probable and estimable. In the first quarter of 2024, the Company recorded a pre-tax severance expense of $2,401 , which was included within restructuring expenses on the Condensed Consolidated Statements of Comprehensive Loss. The remaining amounts to be paid as of March 31, 2024 are included within accounts payable and accrued expenses on the Condensed Consolidated Balance Sheet. The detail of activity related to the Company’s restructuring action is as follows: Total expense recorded in the three months ended March 31, 2024 $ 2,401 Payments made in the three months ended March 31, 2024 (1,702) Remaining amounts to be paid as of March 31, 2024 $ 699 Leases (Original Corporate Headquarters in 2015 & Amendment for Additional Space in 2020) Lease expense was recognized on a straight-line basis over the lease term of the Company’s previous lease agreements for its original headquarters, and additional office space, in Stamford, Connecticut. As a result, $407 of operating lease cost, or lease expense, was recognized for the three months ended March 31, 2023, consisting of $284 relating to R&D lease expense and $123 relating to G&A lease expense. There was no lease expense recognized on these former lease agreements for the three months ended March 31, 2024 since these agreements terminated in December 2023. Lease New Corporate Headquarters in May 2023 On May 11, 2023, the Company entered into the New Lease for the Company’s new principal executive offices. The initial term of the New Lease commenced on November 1, 2023, or the Commencement Date, and will expire on the last day of the calendar month in which occurs the tenth anniversary of the Rent Commencement Date, as defined below, or the Term. In connection with the signing of the New Lease, the Company entered into a standby letter of credit agreement for $1,500 which serves as a security deposit for the leased office space. This standby letter of credit is secured with restricted cash in a money market account and is included within long-term assets as of March 31, 2024 (refer to Note 6, Restricted Cash The annual fixed rent rate under the New Lease is initially $1.3 million (considered by the Company to be at market rate as of the signing of the New Lease), which will commence on November 1, 2024, or the Rent Commencement Date, and will increase 2.5% annually thereafter. The Company expects to begin paying rent in November 2024. The Company is also responsible for the payment of Additional Rent, as defined in the New Lease, including its share of the operating and tax expenses for the building. As a result, the New Lease contains both a lease (the right to use the asset) and a non-lease component (common area maintenance services) which are accounted for separately. The Company allocates the consideration to the lease and non-lease component on a relative standalone price basis. The Company has the option to extend the Term under the New Lease for an additional five years on the same terms and conditions (other than with respect to the annual fixed rent at the annual fair market rental rate, as defined in the New Lease) as set forth in the New Lease. This renewable term is not included as part of the lease term as defined in ASC 842 since it is not reasonably certain that the Company will exercise that option on the Commencement Date. Since the New Lease does not provide an implicit interest rate, the Company used an incremental borrowing rate equal to the 3-month Secured Overnight Financing Rate, or SOFR, plus 7.75% per annum subject to a 3-month SOFR floor of 2.75%, which is based on the rate that the Company could obtain in the market for a fully collateralized loan equal to the term of the New Lease, or 12.83%. On July 28, 2023, the Company recorded a lease liability and a right-of-use asset, or the ROU asset, for the New Lease since it obtained control of the premises to begin work on its leasehold improvements prior to the Commencement Date. The initial lease liability of $6,672 was recorded as the sum of the present value of the future minimum lease payments over the term of the lease. Lease incentives of $2,900 were not included within lease payments since the timing of these costs being incurred and reimbursed to the Company was uncertain, and they are neither paid nor payable as of July 28, 2023. These lease incentives will reduce the lease liability and ROU asset by the costs incurred once the Company actually incurs the costs and the amounts qualify for reimbursement. The reduction to the lease liability will be reversed once the Company is reimbursed for the qualified costs. The reduction to the ROU asset will be recognized prospectively over the remainder of the lease term. The ROU asset of $6,779 was initially recorded as the amount of the lease liability plus prepaid rent paid in May 2023. In January 2024, the Company incurred $778 of costs that qualified for reimbursement as lease incentives, which were fully reimbursed in February 2024. Also in January 2024, the Company was reimbursed $947 for qualified lease incentive costs that were incurred in November 2023. Beginning on July 28, 2023 and during the entire term of the New Lease, interest expense is calculated using the effective interest method and the ROU asset (including prepaid rent) will be amortized on a straight-line basis over the lease term, and both will be recorded as lease expense. As a result, lease expense of $269 for the New Lease was recorded for the three months ended March 31, 2024, consisting of $173 relating to R&D lease expense and $96 relating to G&A lease expense. Other information related to the leases (both previous and new) was as follows: Three Months Ended March 31, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows relating to operating leases $ — $ 494 ROU assets obtained in exchange for new operating lease liabilities $ — $ — Remaining lease term - operating leases (years) 10.6 0.8 Discount rate - operating leases 12.8 % 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, 2024, were as follows: Year Ending December 31, 2024 (Excluding the three months ended March 31, 2024) $ 108 2025 1,298 2026 1,330 2027 1,363 2028 1,398 Thereafter 8,874 Total future minimum lease payments, undiscounted 14,371 Less imputed interest (7,115) Less lease incentive to be reimbursed (211) Total $ 7,045 Operating lease liability reported as of March 31, 2024: Operating lease liability - current $ 220 Operating lease liability - non-current 6,825 Total $ 7,045 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions | |
Related Party Transactions | 18. Related Party Transactions As of March 31, 2024, Vifor International owned 7,396,770 , or 13.5% , of the Company’s common stock. CSL Vifor and its affiliates are considered related parties as of March 31, 2024 and December 31, 2023 (see Note 12, Collaboration and Licensing Agreements ). As of March 31, 2024 and December 31, 2023, amounts due from CSL Vifor of $1,718 and $2,765 , respectively, primarily relating to the Company’s share of the profit generated by sales of KORSUVA injection in the United States by CSL Vifor, its commercial supply of KORSUVA injection to CSL Vifor, and royalty payments from CSL Vifor were included within accounts receivable, net – related party. The Company’s collaborative revenue of $788 and $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, 2024 and 2023, respectively. Sales of KORSUVA injection to CSL Vifor of $640 and $3,191 were included within commercial supply revenue for the three months ended March 31, 2024 and 2023, respectively. The associated COGS for the Company’s commercial supply revenue from CSL Vifor was $620 and $2,590 for the three months ended March 31, 2024 and 2023, respectively. The Company recorded $125 as royalty revenue based on net sales of Kapruvia outside of the United States during the three months ended March 31, 2023. There was no royalty revenue recorded during the three months ended March 31, 2024. The Company recorded $290 as other revenue from its royalty payments from CSL Vifor for the three months ended March 31, 2024. There was no other revenue recorded for the three months ended March 31, 2023. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Business. | |
Use of Estimates | Use of Estimates The preparation of condensed consolidated 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 condensed consolidated 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 and future ex-U.S. royalties and milestones projected in relation to the HCR Agreement, 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, restructuring costs, the amount of lease incentives, as applicable, and 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 global health crises, geopolitical tensions, such as the ongoing conflicts between Russia and Ukraine, conflict in the Middle East, and increasing tensions between China and Taiwan, and government actions implemented as a result of the foregoing, fluctuations in inflation, rising interest rates, uncertainty and liquidity concerns in the broader financial services industry, 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 consolidated 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 consolidated 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 Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. |
Accounting Pronouncements Recently Issued | Accounting Pronouncements Recently Adopted In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures Accounting Pronouncements Not Yet Adopted In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Available-for-Sale Marketable_2
Available-for-Sale Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Available-for-Sale Marketable Securities | |
Summary of Available-for-Sale Marketable Securities by Major Type of Security | As of March 31, 2024 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 13,468 $ — $ (1) $ 13,467 U.S. government agency obligations 7,500 — (190) 7,310 Corporate bonds 2,000 — — 2,000 Total available-for-sale marketable securities $ 22,968 $ — $ (191) $ 22,777 As of December 31, 2023 Gross Unrealized Estimated Fair Type of Security Amortized Cost Gains Losses Value U.S. Treasury securities $ 37,243 $ 3 $ — $ 37,246 U.S. government agency obligations 7,500 — (262) 7,238 Corporate bonds 4,500 — (1) 4,499 Total available-for-sale marketable securities $ 49,243 $ 3 $ (263) $ 48,983 |
Schedule of Fair Values and Continuous Unrealized Loss Positions of Available-for-Sale Marketable Securities | As of March 31, 2024 Less than 12 Months 12 Months or Greater Total Gross Gross Gross Fair Unrealized Fair Unrealized Fair Unrealized Value Losses Value Losses Value Losses U.S. Treasury securities $ 13,467 $ (1) $ — $ — $ 13,467 $ (1) U.S. government agency obligations — — 7,310 (190) 7,310 (190) Total $ 13,467 $ (1) $ 7,310 $ (190) $ 20,777 $ (191) As of December 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 $ — $ — $ 7,238 $ (262) $ 7,238 $ (262) Corporate bonds — — 2,000 (1) 2,000 (1) Total $ — $ — $ 9,238 $ (263) $ 9,238 $ (263) |
Schedule of Amortized Cost and Fair Values of Marketable Debt Securities by Contractual Maturity | As of March 31, 2024 As of December 31, 2023 Contractual maturity Amortized Cost Fair Value Amortized Cost Fair Value Less than one year $ 22,968 $ 22,777 $ 49,243 $ 48,983 More than one year — — — — Total $ 22,968 $ 22,777 $ 49,243 $ 48,983 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Loss (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023 $ (260) Other comprehensive income before reclassifications 69 Amount reclassified from accumulated other comprehensive loss — Net current period other comprehensive income 69 Balance, March 31, 2024 $ (191) 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) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Summary of Financial Assets Measured at Fair Value on Recurring Basis | Fair value measurement as of March 31, 2024 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 $ 46,996 $ 46,996 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 13,467 — 13,467 — U.S. government agency obligations 7,310 — 7,310 — Corporate bonds 2,000 — 2,000 — Restricted cash: Commercial money market account 1,500 1,500 — — Total financial assets $ 71,273 $ 48,496 $ 22,777 $ — Fair value measurement as of December 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 $ 51,775 $ 51,775 $ — $ — Available-for-sale marketable securities: U.S. Treasury securities 37,246 — 37,246 — U.S. government agency obligations 7,238 — 7,238 — Corporate bonds 4,499 — 4,499 — Restricted cash: Commercial money market account 1,908 1,908 — — Total financial assets $ 102,666 $ 53,683 $ 48,983 $ — |
Restricted Cash (Tables)
Restricted Cash (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Restricted Cash | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | March 31, 2024 December 31, 2023 Cash and cash equivalents $ 46,996 $ 51,775 Restricted cash, current assets — 408 Restricted cash, long-term assets 1,500 1,500 Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows $ 48,496 $ 53,683 |
Inventory, net (Tables)
Inventory, net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Inventory, net | |
Schedule of Inventory, net | Inventory, net consists of the following: March 31, 2024 December 31, 2023 Raw materials $ 2,142 $ 2,639 Work-in-process 644 708 2,786 3,347 Less Inventory Reserve for Obsolescence (45) (526) Total $ 2,741 $ 2,821 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounts Payable and Accrued Expenses | |
Schedule of Accounts Payable and Accrued Expenses | Accounts payable and accrued expenses consist of the following: March 31, 2024 December 31, 2023 Accounts payable $ 4,978 $ 11,583 Accrued research projects 5,895 4,343 Accrued compensation and benefits 2,064 6,519 Accrued professional fees and other 1,938 3,147 Total $ 14,875 $ 25,592 |
Royalty Purchase and Sale Agr_2
Royalty Purchase and Sale Agreement (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Royalty Purchase and Sale Agreement | |
Schedule of activity of the HCR agreement | The following table summarizes the activity of the HCR Agreement (in thousands): Royalty purchase and sale agreement balance at December 31, 2023 $ 37,079 Payments (685) Non-cash interest expense 1,982 Balance at March 31, 2024 $ 38,376 Effective interest rate 22.56 % |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Revenue Recognition | |
Schedule of disaggregation of revenue | Three Months Ended March 31, 2024 2023 Collaborative revenue CSL Vifor (KORSUVA injection profit sharing) $ 788 $ 2,750 Total collaborative revenue $ 788 $ 2,750 Commercial supply revenue CSL Vifor* (KORSUVA injection) $ 640 $ 3,191 Total commercial supply revenue $ 640 $ 3,191 Royalty revenue CSL Vifor (Kapruvia ex-U.S.) $ — $ 125 Total royalty revenue $ — $ 125 Clinical compound revenue Maruishi $ 84 $ 99 Total clinical compound revenue $ 84 $ 99 Other revenue (non-cash) CSL Vifor (Kapruvia ex-U.S.) $ 290 $ — Maruishi 333 — Total other revenue $ 623 $ — |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 2023 Basic: Weighted average common shares outstanding 54,588,090 53,872,038 Diluted: Weighted average common shares outstanding - Basic 54,588,090 53,872,038 Common stock equivalents* — — Denominator for diluted net loss per share 54,588,090 53,872,038 * 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, 2024 2023 Net loss - basic and diluted $ (30,696) $ (26,665) Weighted-average common shares outstanding: Basic and diluted 54,588,090 53,872,038 Net loss per share, basic and diluted: $ (0.56) $ (0.49) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Assumptions Used in Black-Scholes Option Pricing Model | Three Months Ended March 31, 2024 2023 Risk-free interest rate 4.12% 3.62% - 4.22% Expected volatility 89.6% 76.3% - 81.3% Expected dividend yield 0% 0% Expected life of employee and Board options (in years) 6.25 6.25 |
Summary of Stock Option Activity | Weighted Number of Average Exercise Shares Price Outstanding, December 31, 2023 7,897,647 $ 12.99 Granted 1,875,125 0.99 Exercised — — Forfeited (679,165) 10.87 Expired (277,075) 13.36 Outstanding, March 31, 2024 8,816,532 $ 10.59 Options exercisable, March 31, 2024 4,827,562 |
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, 2023 566,324 $ 9.27 Awarded — — Vested and released (186,375) 11.04 Forfeited (129,682) 10.57 Outstanding, March 31, 2024 250,267 $ 7.28 Restricted stock units exercisable (vested and deferred), March 31, 2024 — |
Employee Stock Option [Member] | |
Summary of Compensation Expense Recognized | Three Months Ended March 31, 2024 2023 Research and development $ 504 $ 1,480 General and administrative 1,229 1,241 Total stock option expense $ 1,733 $ 2,721 |
Restricted Stock Units [Member] | |
Summary of Compensation Expense Recognized | Three Months Ended March 31, 2024 2023 Research and development $ 255 $ 179 General and administrative 1,357 453 Total restricted stock unit expense $ 1,612 $ 632 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies | |
Schedule of related to the Company's restructuring action | Total expense recorded in the three months ended March 31, 2024 $ 2,401 Payments made in the three months ended March 31, 2024 (1,702) Remaining amounts to be paid as of March 31, 2024 $ 699 |
Schedule of Other Information related to Stamford Lease, Lease Amendment and New Lease | Three Months Ended March 31, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows relating to operating leases $ — $ 494 ROU assets obtained in exchange for new operating lease liabilities $ — $ — Remaining lease term - operating leases (years) 10.6 0.8 Discount rate - operating leases 12.8 % 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, 2024 (Excluding the three months ended March 31, 2024) $ 108 2025 1,298 2026 1,330 2027 1,363 2028 1,398 Thereafter 8,874 Total future minimum lease payments, undiscounted 14,371 Less imputed interest (7,115) Less lease incentive to be reimbursed (211) Total $ 7,045 Operating lease liability reported as of March 31, 2024: Operating lease liability - current $ 220 Operating lease liability - non-current 6,825 Total $ 7,045 |
Business - Additional Informati
Business - Additional Information (Detail) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 USD ($) item | Dec. 31, 2023 USD ($) | Mar. 31, 2023 USD ($) | |
Nature Of Business [Line Items] | |||
Date of formation | Jul. 02, 2004 | ||
Proceeds from equity and debt financing | $ 520,700 | ||
Number of follow-on public offerings | item | 4 | ||
Unrestricted cash and cash equivalents and marketable securities | $ 69,773 | ||
Accumulated deficit | 715,441 | $ 684,745 | |
Net loss | (30,696) | $ (26,665) | |
Net cash used in operating activities | (30,453) | $ (34,618) | |
HCR Agreement [Member] | |||
Nature Of Business [Line Items] | |||
Net proceeds from the royalty purchase and sale agreement | $ 36,474 | $ 36,474 | |
Minimum [Member] | |||
Nature Of Business [Line Items] | |||
Expected approvals and commercial launches period | 12 months | ||
Maximum [Member] | |||
Nature Of Business [Line Items] | |||
Expected approvals and commercial launches period | 18 months | ||
CSL Vifor, Maruishi and CKDP | License and supply agreements for difelikefalin | |||
Nature Of Business [Line Items] | |||
Payments received in connection with license and supply agreements | $ 288,600 | ||
Affiliated Entity [Member] | Vifor International Ltd. | |||
Nature Of Business [Line Items] | |||
Proceeds from the sale of common stock under license agreement with Vifor International | $ 98,000 |
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, 2024 | Dec. 31, 2023 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | $ 22,968 | $ 49,243 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | (191) | (263) |
Estimated fair value | 22,777 | 48,983 |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 13,468 | 37,243 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | (1) | |
Estimated fair value | 13,467 | 37,246 |
U.S. Government Agency Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 7,500 | 7,500 |
Gross Unrealized Losses | (190) | (262) |
Estimated fair value | 7,310 | 7,238 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized cost | 2,000 | 4,500 |
Gross Unrealized Losses | (1) | |
Estimated fair value | $ 2,000 | $ 4,499 |
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, 2024 | Dec. 31, 2023 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | $ 13,467 | |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (1) | |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 7,310 | $ 9,238 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (190) | (263) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 20,777 | 9,238 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (191) | (263) |
U.S. Treasury Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Fair Value | 13,467 | |
Available-for-sale marketable securities, continuous unrealized loss position, Less than 12 Months, Gross Unrealized Losses | (1) | |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 13,467 | |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | (1) | |
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 | 7,310 | 7,238 |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (190) | (262) |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 7,310 | 7,238 |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | $ (190) | (262) |
Corporate Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Fair Value | 2,000 | |
Available-for-sale marketable securities, continuous unrealized loss position, 12 Months or Greater, Gross Unrealized Losses | (1) | |
Available-for-sale marketable securities, continuous unrealized loss position, Fair Value | 2,000 | |
Available-for-sale marketable securities, continuous unrealized loss position, Gross Unrealized Losses | $ (1) |
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, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Debt Securities [Abstract] | |||
Amortized Cost of marketable debt securities, contractual maturity, less than one year | $ 22,968 | $ 49,243 | |
Amortized cost | 22,968 | 49,243 | |
Fair value of marketable debt securities, contractual maturities, less than one year | 22,777 | 48,983 | |
Total fair Value of marketable debt securities, contractual maturity | 22,777 | 48,983 | |
Proceeds from sale of available-for-sale marketable securities | 0 | $ 0 | |
Interest receivable | $ 160 | $ 139 |
Available-for-Sale Marketable_6
Available-for-Sale Marketable Securities - Additional Information (Detail) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 USD ($) position | Dec. 31, 2023 USD ($) 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 | 3 | 3 |
Total number of positions | 4 | 9 |
Number of positions of available-for-sale in unrealized loss position for 12 months or greater | 2 | |
U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Number of available-for-sale marketable securities in unrealized loss positions | 1 | |
Total number of positions | 1 | |
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 | 2 | |
Total number of positions | 2 |
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, 2024 | Mar. 31, 2023 | |
Accumulated Other Comprehensive Loss [Line Items] | ||
Balance, Value | $ 57,085 | $ 158,779 |
Amount reclassified from accumulated other comprehensive loss | 0 | 0 |
Net current period other comprehensive income | 69 | 571 |
Balance, Value | 29,803 | 136,598 |
Accumulated Other Comprehensive Loss | ||
Accumulated Other Comprehensive Loss [Line Items] | ||
Balance, Value | (260) | (1,672) |
Other comprehensive income before reclassifications | 69 | 571 |
Net current period other comprehensive income | 69 | 571 |
Balance, Value | $ (191) | $ (1,101) |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Financial assets | ||
Available-for-sale marketable securities | $ 22,777 | $ 48,983 |
Recurring [Member] | ||
Financial assets | ||
Total financial assets | 71,273 | 102,666 |
U.S. Treasury Securities [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 13,467 | 37,246 |
U.S. Treasury Securities [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 13,467 | 37,246 |
U.S. Government Agency Obligations [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 7,310 | 7,238 |
U.S. Government Agency Obligations [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 7,310 | 7,238 |
Corporate Bonds [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 2,000 | 4,499 |
Corporate Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 2,000 | 4,499 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Recurring [Member] | ||
Financial assets | ||
Total financial assets | 48,496 | 53,683 |
Significant Other Observable Inputs (Level 2) [Member] | Recurring [Member] | ||
Financial assets | ||
Total financial assets | 22,777 | 48,983 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Treasury Securities [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 13,467 | 37,246 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Obligations [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 7,310 | 7,238 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Bonds [Member] | Recurring [Member] | ||
Financial assets | ||
Available-for-sale marketable securities | 2,000 | 4,499 |
Money Market Funds [Member] | Recurring [Member] | ||
Financial assets | ||
Cash and cash equivalents | 46,996 | 51,775 |
Restricted cash | 1,500 | 1,908 |
Money Market Funds [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Recurring [Member] | ||
Financial assets | ||
Cash and cash equivalents | 46,996 | 51,775 |
Restricted cash | $ 1,500 | $ 1,908 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - Significant Unobservable Inputs (Level 3) [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
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) $ in Thousands | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | May 31, 2023 ft² |
Restricted Cash and Cash Equivalents Items [Line Items] | |||
Restricted cash, current assets | $ 408 | ||
Restricted cash, long-term assets | $ 1,500 | 1,500 | |
New Stamford Lease [Member] | |||
Restricted Cash and Cash Equivalents Items [Line Items] | |||
Lease for office space area (square feet) | ft² | 26,374 | ||
Restricted cash, long-term assets | 1,500 | 1,500 | |
Letters of credit, face amount that can be reduced | $ 500 | ||
Old Stamford Lease [Member] | |||
Restricted Cash and Cash Equivalents Items [Line Items] | |||
Restricted cash, current assets | $ 408 |
Restricted Cash - Schedule of R
Restricted Cash - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Restricted Cash | ||||
Cash and cash equivalents | $ 46,996 | $ 51,775 | ||
Restricted cash, current assets | 408 | |||
Restricted cash, long-term assets | 1,500 | 1,500 | ||
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows | $ 48,496 | $ 53,683 | $ 47,799 | $ 64,149 |
Inventory, net - Schedule of In
Inventory, net - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Inventory, net | ||
Raw materials | $ 2,142 | $ 2,639 |
Work-in-process | 644 | 708 |
Inventory gross | 2,786 | 3,347 |
Less Inventory Reserve for Obsolescence | (45) | (526) |
Total | $ 2,741 | $ 2,821 |
Inventory, net - Additional Inf
Inventory, net - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Inventory, net | ||
Inventory write-down | $ 0 | $ 0 |
Prepaid Expenses - Additional I
Prepaid Expenses - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Prepaid Expenses | ||
Prepaid expenses | $ 5,790 | $ 8,154 |
Prepaid R&D clinical costs | 3,770 | 7,245 |
Prepaid insurance | 1,548 | 492 |
Other prepaid costs | $ 472 | $ 417 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 4,978 | $ 11,583 |
Accrued research projects | 5,895 | 4,343 |
Accrued compensation and benefits | 2,064 | 6,519 |
Accrued professional fees and other | 1,938 | 3,147 |
Total | $ 14,875 | $ 25,592 |
Royalty Purchase and Sale Agr_3
Royalty Purchase and Sale Agreement (Details) - HCR Agreement [Member] $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Dec. 31, 2023 USD ($) | Nov. 30, 2023 USD ($) | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) agreement | |
Royalty Purchase And Sale Agreement [Line Items] | ||||
Maximum consideration for royalties sold or agreed to sell | $ 40,000 | |||
Original upfront payment amount | $ 17,500 | |||
Net proceeds after transaction costs and advisory fees | $ 16,915 | |||
Net proceeds after advisory fees | $ 19,770 | |||
Original Milestone payment amount | $ 20,000 | |||
Additional Issuance costs | 211 | |||
Net proceeds from the royalty purchase and sale agreement | $ 36,474 | 36,474 | ||
Additional milestone payments to be earned | $ 2,500 | |||
Issuance costs related to royalty purchase and sale agreement | $ 1,025 | |||
If the 2029 Threshold is achieved on or prior to December 31, 2029 | ||||
Royalty Purchase And Sale Agreement [Line Items] | ||||
Threshold number of times of aggregate payments made by HCR, considered for termination of agreement | agreement | 2 | |||
If the 2029 Threshold is not achieved on or prior to December 31, 2029 | ||||
Royalty Purchase And Sale Agreement [Line Items] | ||||
Threshold number of times of aggregate payments made by HCR, considered for termination of agreement | agreement | 2.8 |
Royalty Purchase and Sale Agr_4
Royalty Purchase and Sale Agreement - Summarizes the Activity of the HCR Agreement (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Royalty Purchase And Sale Agreement [Line Items] | |
Royalty purchase and sale agreement balance at December 31, 2023 | $ 37,079 |
Non-cash interest expense | 1,982 |
Balance at March 31, 2024 | 38,376 |
HCR Agreement [Member] | |
Royalty Purchase And Sale Agreement [Line Items] | |
Royalty purchase and sale agreement balance at December 31, 2023 | 37,079 |
Payments | (685) |
Non-cash interest expense | 1,982 |
Balance at March 31, 2024 | $ 38,376 |
Effective interest rate | 22.56% |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - Common Stock - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Performance Restricted Stock Units [Member] | ||
Sale Of Stock [Line Items] | ||
Restricted stock units, vested | 140,500 | |
Time-based Restricted Stock Units [Member] | ||
Sale Of Stock [Line Items] | ||
Restricted stock units, vested | 45,875 | 83,793 |
Collaboration and Licensing A_2
Collaboration and Licensing Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
May 31, 2022 | Oct. 31, 2020 | May 31, 2018 | Mar. 31, 2024 | Mar. 31, 2023 | May 17, 2018 | |
Collaboration and Licensing Agreements: | ||||||
Revenue from contract with customer | $ 2,135 | $ 6,165 | ||||
Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 2 | ||||||
Collaboration and Licensing Agreements: | ||||||
Percentage of net profit sharing | 50% | |||||
CSL Vifor Maximum | Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 1 | ||||||
Collaboration and Licensing Agreements: | ||||||
Potential sales-based milestone payments | $ 240,000 | |||||
CSL Vifor | Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 1 | ||||||
Collaboration and Licensing Agreements: | ||||||
Percentage of net profit sharing | 40% | |||||
Affiliated Entity | CSL Vifor | Vifor Fresenius Medical Care Renal Pharma Ltd Agreement No 1 | ||||||
Collaboration and Licensing Agreements: | ||||||
Percentage of net profit sharing | 60% | |||||
Affiliated Entity | Vifor Fresenius Medical Care Renal Pharma Ltd. | Maximum | Regulatory and Commercial Milestones [Member] | ||||||
Collaboration and Licensing Agreements: | ||||||
Potential milestone payments | $ 440,000 |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 2,135 | $ 6,165 |
Other revenue (non-cash) | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 623 | 0 |
Other revenue (non-cash) | Maruishi Agreement [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 333 | |
Other revenue (non-cash) | Affiliated Entity [Member] | CSL Vifor | CSL Vifor Kapruvia [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 290 | |
Collaborative revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 788 | 2,750 |
Collaborative revenue | Affiliated Entity [Member] | CSL Vifor | CSL Vifor Profit Sharing | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 788 | 2,750 |
Commercial supply revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 640 | 3,191 |
Commercial supply revenue | Affiliated Entity [Member] | CSL Vifor | CSL Vifor Korsuva [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 640 | 3,191 |
Clinical compound revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 84 | 99 |
Clinical compound revenue | Maruishi Agreement [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 84 | 99 |
Royalty revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | 125 | |
Royalty revenue | Affiliated Entity [Member] | CSL Vifor | CSL Vifor Kapruvia [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Total revenue | $ 0 | $ 125 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Collaboration Arrangement [Line Items] | |||
Accounts receivable, net - related party | $ 1,718 | $ 2,765 | |
Total revenue | 2,135 | $ 6,165 | |
Other receivables | 506 | 555 | |
Commercial supply revenue | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 640 | 3,191 | |
Royalty revenue | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 125 | ||
Collaborative revenue | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 788 | 2,750 | |
Clinical compound revenue | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 84 | 99 | |
Other revenue (non-cash) | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 623 | 0 | |
CSL Vifor, Maruishi and CKDP Agreements [Member] | |||
Collaboration Arrangement [Line Items] | |||
Other contract Assets | 0 | 0 | |
Other contract liabilities | 0 | 0 | |
Maruishi Agreement [Member] | |||
Collaboration Arrangement [Line Items] | |||
Other receivables | 346 | 415 | |
Maruishi Agreement [Member] | Clinical compound revenue | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 84 | 99 | |
Maruishi Agreement [Member] | Other revenue (non-cash) | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 333 | ||
Affiliated Entity [Member] | CSL Vifor | |||
Collaboration Arrangement [Line Items] | |||
Accounts receivable, net - related party | 1,718 | $ 2,765 | |
Affiliated Entity [Member] | CSL Vifor | CSL Vifor Profit Sharing | Collaborative revenue | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 788 | 2,750 | |
Affiliated Entity [Member] | CSL Vifor | CSL Vifor Korsuva [Member] | Commercial supply revenue | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 640 | 3,191 | |
Affiliated Entity [Member] | CSL Vifor | CSL Vifor Korsuva [Member] | Commercial Supply Revenue With Associated Costs Of Goods Sold [Member] | |||
Collaboration Arrangement [Line Items] | |||
Cost of goods sold | 620 | 2,590 | |
Affiliated Entity [Member] | CSL Vifor | CSL Vifor Kapruvia [Member] | Royalty revenue | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | 0 | $ 125 | |
Affiliated Entity [Member] | CSL Vifor | CSL Vifor Kapruvia [Member] | Other revenue (non-cash) | |||
Collaboration Arrangement [Line Items] | |||
Total revenue | $ 290 |
Net Loss per Share - Computatio
Net Loss per Share - Computation of Denominators Used in Net Loss per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Basic: | ||
Weighted average common shares outstanding - Basic | 54,588,090 | 53,872,038 |
Diluted: | ||
Weighted average common shares outstanding - Basic | 54,588,090 | 53,872,038 |
Common stock equivalents | 0 | 0 |
Denominator for diluted net loss per share | 54,588,090 | 53,872,038 |
Net Loss per Share - Computat_2
Net Loss per Share - Computation of Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Net Loss Per Share | ||
Net loss - basic and diluted | $ (30,696) | $ (26,665) |
Weighted-average common shares outstanding: | ||
Basic | 54,588,090 | 53,872,038 |
Diluted | 54,588,090 | 53,872,038 |
Net loss per share: | ||
Basic | $ (0.56) | $ (0.49) |
Diluted | $ (0.56) | $ (0.49) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 |
Net Loss Per Share | |||
Number of options outstanding | 8,816,532 | 7,897,647 | 8,992,759 |
Number of restricted stock units outstanding | 250,267 | 695,720 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2015 | Jan. 01, 2024 | Dec. 31, 2023 | Nov. 20, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||
Common stock, shares outstanding | 54,667,079 | 54,480,704 | ||||
Common stock, shares issued | 54,667,079 | 54,480,704 | ||||
Number of options outstanding | 8,816,532 | 8,992,759 | 7,897,647 | |||
Options granted | 1,875,125 | |||||
Employee Stock Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Compensation expense | $ 1,733 | $ 2,721 | ||||
Options Performance Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Compensation expense | 0 | |||||
Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Compensation expense | $ 1,612 | $ 632 | ||||
Employees [Member] | Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Restricted stock units, grant date fair value | $ 10.06 | |||||
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 | $ 0.76 | $ 7.08 | ||||
Non-employee Consultants [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options granted | 0 | 0 | ||||
2014 Equity Incentive Plan [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 | 13,837,444 | 12,203,023 | ||||
Number of stock options that may be granted after the tenth anniversary of the 2014 Plan | 0 | |||||
Annual increases in number of shares reserved for issuance as a percentage of shares of capital stock outstanding through January 1, 2024 | 3% | |||||
Options granted | 1,875,125 | 1,449,154 | ||||
2014 Equity Incentive Plan [Member] | Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Awarded | 0 | 407,000 | ||||
2014 Equity Incentive Plan [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Term of awards granted | 10 years | |||||
2014 Equity Incentive Plan [Member] | Maximum [Member] | Incentive Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 30,000,000 | |||||
2014 Equity Incentive Plan [Member] | Director [Member] | Incentive Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period of awards granted | 3 years | |||||
2014 Equity Incentive Plan [Member] | 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 | |||||
2019 Inducement Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, par value | $ 0.001 | |||||
Awarded | 0 | 0 | ||||
2019 Inducement Plan [Member] | Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Awarded | 0 | 0 | ||||
2019 Inducement Plan [Member] | Share-Based Compensation Award, Tranche One [Member] | Share-based Payment Arrangement, Employee [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 Compensation Award, Tranche Two [Member] | Share-based Payment Arrangement, Employee [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 Compensation Subsequent Awards [Member] | Share-based Payment Arrangement, Employee [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period of awards granted | 4 years | |||||
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 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Unit Compensation Expense (Detail) - Restricted Stock Units [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | $ 1,612 | $ 632 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | 255 | 179 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | $ 1,357 | $ 453 |
Stock-Based Compensation - Re_2
Stock-Based Compensation - Restricted Stock Unit Activity (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Number of Units | ||
Outstanding, Ending Balance | 250,267 | 695,720 |
2014 Equity Incentive Plan [Member] | Restricted Stock Units [Member] | ||
Number of Units | ||
Awarded | 0 | 407,000 |
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 | 566,324 | |
Vested and released | (186,375) | |
Forfeited | (129,682) | |
Outstanding, Ending Balance | 250,267 | |
Weighted Average Grant Date Fair Value | ||
Weighted-average grant date fair value, outstanding, Beginning Balance | $ 9.27 | |
Weighted-average grant date fair value, vested and released | 11.04 | |
Weighted-average grant date fair value, forfeited | 10.57 | |
Weighted-average grant date fair value, outstanding, Ending Balance | $ 7.28 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Assumptions Used in Black-Scholes Option Pricing Model (Detail) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 4.12% | |
Risk-free interest rate, minimum | 3.62% | |
Risk-free interest rate, maximum | 4.22% | |
Expected volatility | 89.60% | |
Expected volatility, minimum | 76.30% | |
Expected volatility, maximum | 81.30% | |
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 - Stoc
Stock-Based Compensation - Stock Option Compensation Expense (Detail) - Employee Stock Option [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | $ 1,733 | $ 2,721 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | 504 | 1,480 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Compensation expense | $ 1,229 | $ 1,241 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Stock-Based Compensation | ||
Number of Options, Outstanding, Beginning Balance | 7,897,647 | |
Number of Options, Granted | 1,875,125 | |
Number of Options, Forfeited | (679,165) | |
Number of Options, Expired | (277,075) | |
Number of Options, Outstanding, Ending Balance | 8,816,532 | 8,992,759 |
Number of Options, Options exercisable | 4,827,562 | |
Weighted-Average Exercise Price, Outstanding, Beginning Balance | $ 12.99 | |
Weighted-Average Exercise Price, Granted | 0.99 | |
Weighted-Average Exercise Price, Forfeited | 10.87 | |
Weighted-Average Exercise Price, Expired | 13.36 | |
Weighted-Average Exercise Price, Outstanding, Ending Balance | $ 10.59 | |
Excess tax benefits from stock option activity or stock-based compensation expense recognized in cash flows from operations | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Income Taxes | |||
Company's effective tax rate | 0% | 0% | |
Income tax receivable related to R&D credit | $ 697 | ||
Percentage of eligible annual research and development credit for cash | 65% | 65% | |
Benefit from income taxes | $ 0 | $ 0 | |
Income tax receivable | $ 697 | $ 697 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | |||||||
Jul. 28, 2023 USD ($) | May 11, 2023 USD ($) | Jul. 31, 2021 | Jul. 31, 2019 agreement | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Feb. 29, 2024 USD ($) | Jan. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | |
Other Commitments [Line Items] | |||||||||
Accounts payable and accrued expenses | $ 14,875 | $ 25,592 | |||||||
Operating lease liabilities | 7,045 | ||||||||
Operating lease right-of-use assets | 3,826 | 4,864 | |||||||
Research and development | 21,964 | $ 24,334 | |||||||
New Corporate Headquarters Office Space | |||||||||
Other Commitments [Line Items] | |||||||||
Lease, annual fixed rent | $ 1,300 | ||||||||
Lease, fixed rent, annual increase, percent | 2.50% | ||||||||
Option to extend | true | ||||||||
Operating Lease, renewable term | 5 years | ||||||||
Discount rate - operating leases | 12.83% | ||||||||
Operating lease liabilities | $ 6,672 | ||||||||
Lessee, operating lease, incentives | 2,900 | ||||||||
Operating lease right-of-use assets | $ 6,779 | ||||||||
Lease incentives reimbursed | $ 778 | $ 947 | |||||||
Operating Lease, expense | 269 | ||||||||
New Corporate Headquarters Office Space | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | |||||||||
Other Commitments [Line Items] | |||||||||
Lessee, operating lease, discount rate, basis spread on variable rate | 7.75% | ||||||||
Lessee, operating lease, discount rate, variable rate basis, floor | 2.75% | ||||||||
New Corporate Headquarters Office Space | Research and Development | |||||||||
Other Commitments [Line Items] | |||||||||
Operating Lease, expense | 173 | ||||||||
New Corporate Headquarters Office Space | General and Administrative | |||||||||
Other Commitments [Line Items] | |||||||||
Operating Lease, expense | 96 | ||||||||
Patheon and Patheon Manufacturing Services LLC | |||||||||
Other Commitments [Line Items] | |||||||||
Reduced demand payment for manufacturing commitments | $ 1,700 | ||||||||
Accounts payable and accrued expenses | 246 | ||||||||
Old Stamford Operating Lease | |||||||||
Other Commitments [Line Items] | |||||||||
Operating lease cost | 0 | 407 | |||||||
Old Stamford Operating Lease | Research and Development | |||||||||
Other Commitments [Line Items] | |||||||||
Operating lease cost | 284 | ||||||||
Old Stamford Operating Lease | General and Administrative | |||||||||
Other Commitments [Line Items] | |||||||||
Operating lease cost | 123 | ||||||||
New Stamford Lease | |||||||||
Other Commitments [Line Items] | |||||||||
Letter of credit amount outstanding | 1,500 | ||||||||
Non-Exclusive License Agreement | Enteris Biopharma, Inc. | |||||||||
Other Commitments [Line Items] | |||||||||
Payment of milestone payment | $ 0 | $ 0 | |||||||
MSA | Patheon and Patheon Manufacturing Services LLC | |||||||||
Other Commitments [Line Items] | |||||||||
Number of related product agreements | agreement | 2 | ||||||||
API Commercial Supply Agreement - PPL | |||||||||
Other Commitments [Line Items] | |||||||||
Agreement renewal term | 5 years |
Commitments and Contingencies_2
Commitments and Contingencies - Restructuring activity (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Jan. 31, 2024 | |
Commitments and Contingencies | ||
Restructuring and related cost, maximum percentage of planned workforce reduction | 50% | |
Total expense recorded in the three months ended March 31, 2024 | $ 2,401 | |
Payments made in the three months ended March 31, 2024 | (1,702) | |
Remaining amounts to be paid as of March 31, 2024 | $ 699 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Other Information related to Stamford Lease and New Stamford Lease (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Commitments and Contingencies | ||
Operating cash outflows relating to operating leases | $ 494 | |
ROU assets obtained in exchange for new operating lease liabilities | ||
Remaining lease term - operating leases (years) | 10 years 7 months 6 days | 9 months 18 days |
Discount rate - operating leases | 12.80% | 7% |
Commitments and Contingencies_4
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, 2024 | Dec. 31, 2023 |
Operating Lease Liabilities, Payments Due [Abstract] | ||
2024 (Excluding the three months ended March 31, 2024) | $ 108 | |
2025 | 1,298 | |
2026 | 1,330 | |
2027 | 1,363 | |
2028 | 1,398 | |
Thereafter | 8,874 | |
Total future minimum lease payments, undiscounted | 14,371 | |
Less imputed interest | (7,115) | |
Less lease incentive to be reimbursed | (211) | |
Total | 7,045 | |
Operating lease liability reported as of March 31, 2024: | ||
Operating lease liability - current | 220 | |
Operating lease liability - non-current | 6,825 | $ 6,088 |
Total | $ 7,045 |
Related Party Transactions (Det
Related Party Transactions (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Collaboration and licensing agreements | |||
Accounts due from related parties | $ 1,718 | $ 2,765 | |
Revenue from contract with customer | 2,135 | $ 6,165 | |
Commercial supply revenue | |||
Collaboration and licensing agreements | |||
Revenue from contract with customer | 640 | 3,191 | |
Collaborative revenue | |||
Collaboration and licensing agreements | |||
Revenue from contract with customer | $ 788 | 2,750 | |
Royalty revenue | |||
Collaboration and licensing agreements | |||
Revenue from contract with customer | 125 | ||
Affiliated Entity | Vifor International Ltd. | |||
Collaboration and licensing agreements | |||
Shares owned as a result of upfront and milestone payments | 7,396,770 | ||
Related party ownership percentage | 13.50% | ||
Affiliated Entity | CSL Vifor | |||
Collaboration and licensing agreements | |||
Accounts due from related parties | $ 1,718 | $ 2,765 | |
Affiliated Entity | CSL Vifor | Commercial supply revenue | |||
Collaboration and licensing agreements | |||
Revenue from related parties | 640 | 3,191 | |
Related party cost of goods sold | 620 | 2,590 | |
Affiliated Entity | CSL Vifor | Other Non-Cash Revenue | |||
Collaboration and licensing agreements | |||
Revenue from related parties | 290 | 0 | |
Affiliated Entity | CSL Vifor | CSL Vifor Profit Sharing | Collaborative revenue | |||
Collaboration and licensing agreements | |||
Revenue from contract with customer | 788 | 2,750 | |
Affiliated Entity | CSL Vifor | CSL Vifor Kapruvia | Royalty revenue | |||
Collaboration and licensing agreements | |||
Revenue from contract with customer | $ 0 | $ 125 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (30,696) | $ (26,665) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |