Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 30, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CBAY | |
Entity Registrant Name | CymaBay Therapeutics, Inc. | |
Entity Central Index Key | 0001042074 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 97,513,179 | |
Entity Shell Company | false | |
Entity File Number | 001-36500 | |
Entity Tax Identification Number | 94-3103561 | |
Entity Address, Address Line One | 7575 Gateway Blvd | |
Entity Address, Address Line Two | Suite 110 | |
Entity Address, City or Town | Newark | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94560 | |
City Area Code | 510 | |
Local Phone Number | 293-8800 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common stock, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 59,150 | $ 20,291 |
Marketable securities | 177,215 | 115,194 |
Prepaid expenses and other current assets | 6,355 | 2,588 |
Total current assets | 242,720 | 138,073 |
Property and equipment, net | 729 | 701 |
Operating lease right-of-use asset | 137 | 169 |
Other assets | 1,733 | 2,909 |
Total assets | 245,319 | 141,852 |
Current liabilities: | ||
Accounts payable | 1,633 | 1,096 |
Accrued research and development expenses | 5,565 | 6,530 |
Deferred collaboration revenue | 33,733 | 0 |
Other accrued liabilities | 5,569 | 7,815 |
Total current liabilities | 46,500 | 15,441 |
Development financing liability | 94,630 | 90,227 |
Long-term portion of operating lease liability | 0 | 30 |
Total liabilities | 141,130 | 105,698 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value: 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.0001 par value: 200,000,000 shares authorized; 97,330,560 and 84,681,063 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 17 | 8 |
Additional paid-in capital | 1,005,877 | 909,329 |
Accumulated other comprehensive loss | (70) | (326) |
Accumulated deficit | (901,635) | (872,857) |
Total stockholders' equity | 104,189 | 36,154 |
Total liabilities and stockholders' equity | $ 245,319 | $ 141,852 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 97,330,560 | 84,681,063 |
Common stock, shares outstanding | 97,330,560 | 84,681,063 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 18,551 | $ 18,415 |
General and administrative | 8,324 | 6,087 |
Total operating expenses | 26,875 | 24,502 |
Loss from operations | (26,875) | (24,502) |
Other income (expense), net: | ||
Interest income | 2,013 | 98 |
Interest expense | (4,403) | (3,365) |
Other income | 487 | 0 |
Total other income (expense), net | (1,903) | (3,267) |
Net loss | (28,778) | (27,769) |
Other comprehensive loss: | ||
Unrealized gain (loss) on marketable securities, net of tax | 256 | (206) |
Total other comprehensive loss | 256 | (206) |
Comprehensive loss | $ (28,522) | $ (27,975) |
Basic net loss per common share | $ (0.29) | $ (0.32) |
Diluted net loss per common share | $ (0.29) | $ (0.32) |
Weighted average common shares outstanding used to calculate basic net loss per common share | 97,971,081 | 87,802,939 |
Weighted average common shares outstanding used to calculate diluted net loss per common share | 97,971,081 | 87,802,939 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities | ||
Net loss | $ (28,778) | $ (27,769) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 199 | 169 |
Stock-based compensation expense | 3,487 | 2,414 |
Accretion of development financing liability | 4,403 | 3,365 |
Net accretion and amortization of investments in marketable securities | (1,318) | 131 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (3,767) | 1,077 |
Other assets | 1,176 | (728) |
Accounts payable | 537 | (2,341) |
Deferred collaboration revenue | 33,733 | 0 |
Accrued research and development expenses | (965) | (93) |
Other accrued liabilities | (2,276) | (1,587) |
Net cash provided by (used in) operating activities | 6,431 | (25,362) |
Investing activities | ||
Purchases of property and equipment | (195) | 0 |
Purchases of marketable securities | (121,097) | (62,485) |
Proceeds from maturities of marketable securities | 60,650 | 11,495 |
Net cash (used in) investing activities | (60,642) | (50,990) |
Financing activities | ||
Proceeds from issuance of common stock pursuant to equity award plans | 710 | 0 |
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs | 92,360 | (459) |
Proceeds from development financing | 0 | 25,000 |
Net cash provided by financing activities | 93,070 | 24,541 |
Net increase (decrease) in cash and cash equivalents | 38,859 | (51,811) |
Cash and cash equivalents at beginning of period | 20,291 | 125,806 |
Cash and cash equivalents at end of period | 59,150 | 73,995 |
Supplemental disclosure | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 176 | $ 171 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Balance at beginning of period at Dec. 31, 2021 | $ 132,937 | $ 8 | $ 899,798 | $ (13) | $ (766,856) |
Balance at beginning of period (in shares) at Dec. 31, 2021 | 84,677,939 | ||||
Stock-based compensation expense | 2,414 | 2,414 | |||
Net loss | (27,769) | (27,769) | |||
Net unrealized gain (loss) on marketable securities | (206) | (206) | |||
Issuance costs related to issuance of common stock and pre-funded warrants | 5 | 5 | |||
Balance at end of period at Mar. 31, 2022 | 107,381 | $ 8 | 902,217 | (219) | (794,625) |
Balance at end of period (in shares) at Mar. 31, 2022 | 84,677,939 | ||||
Balance at beginning of period at Dec. 31, 2022 | 36,154 | $ 8 | 909,329 | (326) | (872,857) |
Balance at beginning of period (in shares) at Dec. 31, 2022 | 84,681,063 | ||||
Issuance of common stock upon exercise of options and awards | 710 | 710 | |||
Issuance of common stock upon exercise of options and awards (Shares) | 203,077 | ||||
Issuance of common stock and pre-funded warrants, net of issuance costs | 92,360 | $ 9 | 92,351 | ||
Issuance of common stock and pre-funded warrants, net of issuance costs Shares | 11,821,428 | ||||
Exercise of pre-funded warrants, Value | 0 | 0 | |||
Exercise of pre-funded warrants (Shares) | 624,992 | ||||
Stock-based compensation expense | 3,487 | 3,487 | |||
Net loss | (28,778) | (28,778) | |||
Net unrealized gain (loss) on marketable securities | 256 | 256 | |||
Balance at end of period at Mar. 31, 2023 | $ 104,189 | $ 17 | $ 1,005,877 | $ (70) | $ (901,635) |
Balance at end of period (in shares) at Mar. 31, 2023 | 97,330,560 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Stock issuance cost | $ 5,390 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business CymaBay Therapeutics, Inc. (the Company or CymaBay) is a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need. The Company’s key clinical development candidate is seladelpar. Seladelpar has been under development primarily for the treatment of primary biliary cholangitis (PBC), a rare liver disease. The Company was incorporated in Delaware in October 1988 as Transtech Corporation. The Company’s headquarters and operations are located in Newark, California and it operates in one segment. Liquidity The Company has incurred net operating losses and negative cash flows from operations since its inception. During the three months ended March 31, 2023, the Company incurred a net loss of $28.8 million and generated $6.4 million of net cash flow from operations. At March 31, 2023, the Company had an accumulated deficit of $901.6 million. Historically, the Company has incurred substantial research and development expenses in the course of studying its product candidates in clinical trials. To date, none of the Company’s product candidates have been approved for marketing and sale, and the Company has not recorded any revenue from product sales. Generally, the Company’s ability to achieve profitability is dependent on its ability to successfully develop, acquire or in-license As of March 31, 2023, the Company had cash, cash equivalents and marketable securities totaling $236.4 million, which the Company believes is sufficient to fund its current operating plan for at least twelve months from the issuance date of its financial statements. The Company has historically obtained, and expects to obtain in the future, additional financing to fund its business strategy through: future equity offerings; debt financing; one or more possible licenses, collaborations or other similar arrangements with respect to development and/or commercialization rights of the Company’s product candidates; or a combination of the above. It is unclear if or when any such transactions will occur, on satisfactory terms or at all. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and its ability to pursue its business strategies. If adequate funds are not available to the Company, it could have a material adverse effect on the Company’s business, results of operations, and financial condition. Market volatility could also adversely impact the Company’s investments as well as its ability to access capital when and as needed. Failure to raise sufficient capital when needed could require the Company to significantly delay, scale back or discontinue one or more of its product development programs or commercialization efforts, or other aspects of its business plans, and the Company’s operating results and financial condition would be adversely affected. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The accompanying interim condensed consolidated financial statements are unaudited and are comprised of the accounts of CymaBay and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The Company has no unconsolidated subsidiaries or investments accounted for under the equity method. These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP), which requires management to make informed estimates and assumptions that impact the amounts and disclosures reported in the condensed consolidated financial statements and accompanying notes, and the requirements of the United States Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by U.S. GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 2022, which is contained in the Company’s Annual Report on Form 10-K The condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, which requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from those estimates and assumptions. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each reporting period and updated to reflect current information and any changes in estimates will generally be reflected in the period first identified. Revenue Recognition As part of the Company’s drug development strategy, the Company periodically enters into collaboration arrangements with third party collaborators, under which the Company may license certain rights to our intellectual property to permit collaborators to further develop, manufacture and/or otherwise commercialize its drug candidates. The terms of these agreements typically include, but are not limited to, payments to the Company of one or more of the following: nonrefundable, upfront license fees; development and commercial milestone payments whose payment is typically contingent upon milestone achievement; funding of research and/or development activities; and royalties on net sales of licensed products. At the inception of an arrangement, the Company evaluates if a counterparty to a contract is a customer, if the arrangement is within the scope of ASC 606—Revenue from Contracts with Customers Upfront License Fees: If a performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The selection of the method to measure progress towards completion requires judgment and is based on the nature of the products or services to be provided. Revenue is recorded proportionally to the selected measure of progress either over the service period or at a point in time based on the products or services to be provided. The Company uses the cost-to-cost cost-to-cost If the arrangement includes optional goods and services, the Company assesses whether delivery of such goods and services requires the customer to pay fees consistent with their standalone selling prices, or if customer may be entitled to incremental discounts that it would not have received without entering into the agreement and committing to purchase the initial goods and services. Presence of such discounts indicates the customer has received material rights which also represent performance obligations. Development and Regulatory Milestone Payments re-evaluates Sales-based Milestone and Royalty Payments: The Company receives payments from its customers based on billing schedules established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. The Company allocates amounts included in the transaction price based on standalone selling prices of various performance obligations. Variable consideration (such as milestones and royalties) is allocated to specific performance obligations if it is triggered through our performance or represents a specific outcome from the performance associated with this performance obligation, and if such allocation would meet the allocation objective of allocating to each performance obligation an amount that depicts consideration to which the Company would be entitled in exchange for delivery of such performance obligation. The remaining consideration is generally allocated on a relative standalone selling price basis. The Company determines standalone selling prices using a variety of methods, including cost associated with our performance plus a reasonable margin, prices observed in the market for similar goods or services, and valuation techniques involving projected discounted cash flows. Fair Value of Financial Instruments The Company’s financial instruments during the periods reported consist of cash, cash equivalents, marketable securities, accounts payable, certain accrued liabilities, and the development financing liability. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs and is as follows: Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. Level 3—Inputs that are significant to the fair value measurement and are unobservable (i.e. supported by little or no market activity), which requires the reporting entity to develop its own valuation techniques and assumptions. The carrying amounts of cash equivalents approximate their related fair values due to the short-term nature of these instruments. Cash equivalents are classified as level 1 and accounts payable and accrued liabilities as level 2 under the fair value hierarchy. The following tables present the Company’s financial assets that are measured at fair value on a recurring basis using the above input categories (in thousands): As of March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 57,843 $ — $ — $ 57,843 Total cash equivalents 57,843 — — 57,843 Marketable securities: U.S. and foreign commercial paper — 85,120 — 85,120 U.S. and foreign corporate debt securities — 10,375 — 10,375 Supranational debt securities — 4,475 — 4,475 U.S. agency securities — 26,159 — 26,159 U.S. treasury securities — 51,086 — 51,086 Total marketable securities — 177,215 — 177,215 Total assets measured at fair value $ 57,843 $ 177,215 $ — $ 235,058 As of December 31, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 9,770 $ — $ — $ 9,770 Total cash equivalents 9,770 — — 9,770 Marketable securities: U.S. and foreign commercial paper — 46,121 — 46,121 U.S. and foreign corporate debt securities — 24,807 — 24,807 Supranational debt securities — 12,890 — 12,890 U.S. agency securities — 7,759 — 7,759 U.S. treasury securities — 23,617 — 23,617 Total marketable securities — 115,194 — 115,194 Total assets measured at fair value $ 9,770 $ 115,194 $ — $ 124,964 The Company estimates the fair value of its money market funds, corporate debt, asset-backed securities, commercial paper, U.S. treasury securities, U.S agency securities, and supranational debt securities by taking into consideration data obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data, and other observable inputs. The fair value of the Company’s development financing liability is $85.1 million. The development financing liability is classified as level 3 under the fair value hierarchy, as its valuation is based on a discounted cash flow model that uses unobservable inputs such as the estimated timing of regulatory approval, attainment of certain sales milestones and the discount rate. Cash, Cash Equivalents, and Marketable Securities The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest-bearing, and money market funds. The Company invests excess cash in marketable securities with high credit ratings. These securities consist primarily of corporate debt, commercial paper, asset-backed securities, U.S. treasury securities, and supranational debt securities and are classified as “available-for-sale.” Realized gains and losses from the sale of marketable securities, if any, are calculated using the specific-identification method. Expected losses judged to be related partially or in whole to declines in credit risk-related factors of the security issuer are included in interest income or expense in the condensed consolidated statements of operations and comprehensive loss at the time the factors contributing to the expected losses are identified. Unrealized holding gains and losses are reported in accumulated other comprehensive loss in the condensed consolidated balance sheets. To date, the Company has not recorded any expected losses on its marketable securities related to credit risk-related declines in market value. In determining whether a decline in market value is related to expected credit losses, various factors are considered, including the cause, duration of time and severity of the expected loss, any adverse changes in the investees’ financial condition, and the Company’s intent and ability to hold the security for a period of time sufficient to allow for an anticipated recovery in market value. Unrealized gains and losses of the Company’s available-for-sale Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of March 31, 2023: Cash equivalents: Money market funds $ 57,843 $ — $ — $ 57,843 Total cash equivalents 57,843 — — 57,843 Current marketable securities: U.S. and foreign commercial paper 85,120 — — 85,120 U.S. and foreign corporate debt securities 10,449 — (74 ) 10,375 Supranational debt securities 4,489 — (14 ) 4,475 U.S. agency securities 26,143 37 (21 ) 26,159 U.S. treasury securities 51,084 48 (46 ) 51,086 Total current marketable securities 177,285 85 (155 ) 177,215 Total marketable securities $ 235,128 $ 85 $ (155 ) $ 235,058 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2022: Cash equivalents: Money market funds $ 9,770 $ — $ — $ 9,770 Total cash equivalents 9,770 — — 9,770 Current marketable securities: U.S. and foreign commercial paper 46,121 — — 46,121 U.S. and foreign corporate debt securities 24,964 — (157 ) 24,807 Supranational debt securities 12,946 — (56 ) 12,890 U.S. agency securities 7,782 16 (39 ) 7,759 U.S. treasury securities 23,707 2 (92 ) 23,617 Total current marketable securities 115,520 18 (344 ) 115,194 Total marketable securities $ 125,290 $ 18 $ (344 ) $ 124,964 The following table shows the fair value of the Company’s marketable securities, by contractual maturity, as of March 31, 2023 (in thousands): Due less than 1 year $ 177,215 Due between 1 and 2 years — Total fair value $ 177,215 Concentration of Risk Cash, cash equivalents, and marketable securities consist of financial instruments that potentially subject the Company to a concentration of credit risk to the extent of the fair value recorded on the balance sheet. The Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments that bear minimal risk. The Company has established guidelines relating to the quality, diversification, and maturities of securities to enable the Company to manage its credit risk. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and investments and issuers of investments to the extent recorded on the condensed consolidated balance sheets. Certain materials and key components that the Company utilizes in its operations are obtained through single suppliers. Since the suppliers of key components and materials must be named in a new drug application NDA filed with the FDA for a product, significant delays can occur if the qualification of a new supplier is required. If delivery of material from the Company’s suppliers were interrupted for any reason, the Company may be unable to supply any of its product candidates for clinical trials. Research and Development Expenses Research and development expenses consist of costs incurred in identifying, developing, and testing product candidates. These expenses consist primarily of costs for research and development personnel, including related stock-based compensation; contract research organizations (CRO) and other third parties that assist in managing, monitoring, and analyzing clinical trials; investigator and site fees; laboratory services; consultants; contract manufacturing services; non-clinical The Company records expenses related to clinical studies and manufacturing development activities based on its estimates of the services received and efforts expended pursuant to contracts with multiple CROs and manufacturing vendors that conduct and manage these activities on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical trial milestones. In amortizing or accruing service fees, the Company estimates the time period over which services will be performed, enrollment of subjects, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the Company’s estimate, the Company will adjust the accrued or prepaid expense balance accordingly. To date, there have been no material differences from the Company’s estimates to the amounts actually incurred. Development Financing Agreement The There are several factors that could affect the estimated timing of regulatory approval and attainment of sales milestones, some of which are not entirely within the Company’s control. Therefore, at each reporting date, the Company reassesses the estimated timing of regulatory approval and attainment of sales milestones and the expected contractual success fee payments due therefrom. If the timing and/or amount of such expected payments is materially different than original estimates, the Company will prospectively adjust the accretion of the development financing liability and the imputed interest rate. The Company identified certain contingent repayment features in the Financing Agreement that are required to be bifurcated from the debt host instrument as embedded derivative liabilities; however, the Company determined the fair value of these features, both individually and in the aggregate, was immaterial at inception and as of March 31, 2023. The fair value of these features will be assessed at each reporting date and will be marked to market, if material. To determine the amount to record for the embedded derivative liabilities, the Company must assess the probability of occurrence of various potential future events that could affect the timing and/or amount of future cash flows related to the Financing Agreement. Stock-Based Compensation Stock-based compensation is measured at fair value on the grant date of the award. Compensation cost is recognized as expense on a straight-line basis over the vesting period for options with service conditions, and forfeitures are accounted for as they occur. The Company uses the Black-Scholes option pricing model to determine the fair value of stock option awards. The determination of fair value for stock-based awards using an option-pricing model requires management to make certain assumptions regarding subjective input variables such as expected term, dividends, volatility and risk-free rate. If actual results are not consistent with the Company’s assumptions and judgments used in making these estimates, the Company may be required to increase or decrease compensation expense, which could be material to the Company’s results of operations. Recently Issued Accounting Pronouncements ASU 2016-13 In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments available-for-sale No. 2019-10, |
Other Accrued Liabilities
Other Accrued Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Other Accrued Liabilities Current [Abstract] | |
Other Accrued Liabilities | 3. Other Accrued Liabilities Other accrued liabilities consist of (in thousands): March 31, 2023 December 31, Accrued compensation $ 2,299 $ 5,779 Accrued professional fees and other 2,733 1,372 Current portion of operating lease liability 537 664 Total other accrued liabilities $ 5,569 $ 7,815 |
Development Financing Agreement
Development Financing Agreement | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Development Financing Agreement | 4. Development Financing Agreement On July 30, 2021 (the Effective Date), the Company entered into a Development Financing Agreement (the Financing Agreement) with an affiliate of Abingworth LLP (Abingworth) to provide funding to the Company to support its development of seladelpar for the treatment of primary biliary cholangitis (PBC). The Financing Agreement provided the Company $75.0 million in base funding, of which $25.0 million was provided in August 2021, $25.0 million was provided in November 2021, and $25.0 million was provided in January 2022. The use of proceeds from the funding is limited to PBC “Development Program” costs incurred or paid as defined in the Financing Agreement. In return, the Company will pay to Abingworth: (1) contingent upon the first to occur of regulatory approval of seladelpar for the treatment of PBC in the U.S., U.K., Germany, Spain, Italy or France (Regulatory Approval), fixed success payments equal to 2.0x of the funding provided, consisting of $10 million payable in 90 days after the Regulatory Approval and thereafter, payments due on the first six anniversaries of the Regulatory Approval in the amounts of $15.0 million, $22.5 million, $22.5 million, $25.0 million, $27.5 million and $27.5 million, respectively and (2) variable success payments equal to 1.1x of the funding provided, consisting of sales milestone payments of (x) $17.5 million and $27.5 million, respectively upon first reaching certain cumulative U.S. product sales thresholds, and (y) $37.5 million upon first reaching a specified U.S. product sales run rate. Promptly following receipt of Regulatory Approval, the Company is required to execute a note agreement and deliver a promissory note to Abingworth within two business days to convert the fixed and variable success payments into a note payable. At the time that Abingworth receives, collectively, an aggregate of 3.1x of the funding provided ($232.5 million), the Company’s payment obligations under the Financing Agreement will be fully satisfied. The Company has the option to satisfy its payment obligations to Abingworth upon Regulatory Approval, or a change of control of the Company, by paying an amount equal to the remaining payments payable to Abingworth subject to a mid-single-digit Pursuant to the Financing Agreement, the Company granted Abingworth a security interest in all its assets (other than intellectual property not related to seladelpar), provided that the Company is permitted to incur certain indebtedness. The security interest will terminate when the Company has paid Abingworth 2.0x of the funding provided or upon certain terminations of the Financing Agreement. The Financing Agreement provides for negative, affirmative and additional covenants, which the Company must comply with for the duration of the Financing Agreement term. As of March 31, 2023, the Company was in compliance with all covenants stipulated in the Financing Agreement. In certain instances, upon the termination of the Financing Agreement, the Company will be obligated to pay Abingworth a multiple of the amounts paid to the Company under the Financing Agreement, including specifically: (i) 310% of such amounts in the event that Abingworth terminates the Financing Agreement due to (x) a Fundamental Breach, as defined in the Financing Agreement, (y) the bankruptcy of the Company, or (z) a safety concern resulting from gross negligence on the part of the Company or due to a safety concern that was material on the Effective Date and the material data showing such safety concern was not publicly known, disclosed to Abingworth, or in the diligence room made available to Abingworth, (ii) 200% of such amounts in the event the Financing Agreement is terminated due to (x) Material Breach, as defined in the Financing Agreement, by the Company or (y) the security interests of Abingworth being invalidated or terminated other than as set forth in the Financing Agreement, and (iii) 100% of such amounts in the event of certain irresolvable disagreements within the executive review committee overseeing the Company’s development of seladelpar. In addition, if, following certain terminations, the Company continues to develop seladelpar for the treatment of PBC and obtains regulatory approval, it will make the payments to Abingworth as if the Financing Agreement had not been terminated, less any payments made upon termination. The Company shall not be obligated to make any payments to Abingworth under certain instances of technical or regulatory failure of the PBC development program as defined in the Financing Agreement. As part of the arrangement, an executive review committee was established between the Company and Abingworth to discuss the Company’s development of seladelpar. The Company evaluated the Financing Agreement and determined it to be a research and development funding arrangement with the characteristics of a debt instrument, as the transfer of financial risk to Abingworth was not considered substantive and genuine. Accordingly, the Company has recorded payments received under the Financing Agreement as part of a development financing liability in its condensed consolidated balance sheets. The Company accounts for the overall development financing liability at amortized cost based on the estimated timing of regulatory approval and attainment of certain sales milestones and the contractual success fee payments expected to be due therefrom, as discounted using an imputed interest rate. The development financing liability is being accreted as interest expense to its expected future repayment amount over the expected life of the agreement using the effective interest rate method. Certain legal and financial advisory fees incurred specifically to complete the Financing Agreement were capitalized and recorded as a reduction to the carrying amount of the development financing liability and are also being amortized to interest expense using the effective interest method. There are several factors that could affect the estimated timing of regulatory approval and attainment of sales milestones, some of which are not entirely within the Company’s control. Therefore, the Company periodically reassesses the estimated timing of regulatory approval and attainment of sales milestones and the expected contractual success fee payments due therefrom. If the timing and/or amount of such expected payments is materially different than original estimates, the Company will prospectively adjust the accretion of the development financing liability and the imputed interest rate. The Company identified certain contingent repayment features in the agreement that are required to be bifurcated from the debt host instrument as embedded derivative liabilities; however, the fair value of these features was immaterial at the Effective Date and as of March 31, 2023. The fair value of the embedded derivative liabilities will be assessed at subsequent reporting dates if material. As of March 31, 2023, the development financing liability was classified as a long-term liability, as the Company expects the related repayments to take place between 2024 and 2030 for purposes of the model used to calculate its carrying value. The imputed interest rate on the unamortized portion of the development financing liability was approximately 19.2% as of March 31, 2023. |
Collaboration and License Agree
Collaboration and License Agreement | 3 Months Ended |
Mar. 31, 2023 | |
Disclosure of Collaboration and License Agreement [Abstract] | |
Collaboration and License Agreement | 5. Collaboration and License Agreement On January 6, 2023, the Company entered into a Collaboration and License Agreement (License Agreement) with Kaken Pharmaceuticals Co., Ltd (Kaken). The Company granted Kaken an exclusive license to develop and commercialize seladelpar (the Licensed Product) for the prevention or treatment of primary biliary cholangitis (PBC) in Japan. Pursuant to the terms of the License Agreement, Kaken will bear the cost of, and be responsible for, among other things, conducting the clinical studies and other developmental activities for the Licensed Product in PBC in Japan as well as preparing and filing applications for regulatory approval and commercializing the Licensed Product in Japan. Kaken is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize, the Licensed Product in Japan, including obtaining pricing approval for the Licensed Product in Japan. The Company is obligated to supply to Kaken its requirements of Licensed Product for clinical and commercial use, which may be terminated upon specified circumstances, and with appropriate technology transfer. The Company will deliver to Kaken data from its clinical trials, nonclinical studies and other pre-clinical know-how The Company is responsible for the completion of CMC development activities to enable future supply of the Licensed Product to Kaken and to enable Kaken to seek regulatory approval of the Licensed Product in Japan. The Company may also be requested by Kaken to conduct CMC activities specific to commercialization in Japan and provide other assistance. In consideration of the license and other rights granted by the Company, Kaken made an upfront cash payment to the Company of ¥ million at contract inception date) and is obligated to pay potential milestone payments to the Company totaling up to billion (approximately $ million at contract inception date) upon the achievement of certain regulatory and sales milestones. The commercial supply of the Licensed Products to Kaken will be provided based on a commercial supply agreement to be negotiated between the parties in the future. The License Agreement may be early terminated by either party for material breach, upon a party’s insolvency or bankruptcy or upon a challenge by one party of any patents of the other party, and Kaken may terminate in specified situations, including for a safety concern, clinical failure or termination of an underlying in-license to the Pursuant to the License Agreement, the Company and Kaken agreed to establish a joint steering committee to provide strategic oversight of both parties’ activities under the License Agreement. The Company concluded that Kaken is a customer and that the arrangement represents a contract with a customer under the scope of ASC 606. The Company identified the following key promised goods and services under the arrangement: (1) the exclusive license to develop and commercialize seladelpar in Japan, including the initial transfer of the underlying technology and know-how; The license granted Kaken rights to certain intellectual property of the Company and was effective upon the execution of the License Agreement. However, the parties have not completed the transfer of the licensed technology and know-how As none of the performance obligations related to the License Agreement were satisfied as of March 31, 2023, no revenue was recognized during the quarter ended March 31, 2023. The initial transaction price consists of the upfront payment of ¥4.5 billion ($33.7 million at the time of receipt) which the Company received in January 2023. This amount was recorded in deferred revenue as of March 31, 2023 and is expected to be recognized during the year ending December 31, 2023 as various performance obligations are satisfied. The Company determined that the potential milestone payments and royalties, if recognized, are probable of significant revenue reversal, as their achievement is highly dependent on factors outside the Company’s control, and therefore represent variable consideration that is fully constrained and excluded from the transaction price as of March 31, 2023. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 6. Stockholders’ Equity Preferred and Common Stock Authorized The Company is authorized to issue 10,000,000 shares of preferred stock and 200,000,000 shares of common stock as of March 31, 2023 and December 31, 2022. Sale of Common Stock and Prefunded Warrants On January 23, 2023, pursuant to a shelf registration statement on Form S-3, pre-funded pre-funded million, after deducting underwriting discounts and commissions and other offering expenses. The pre-funded paid-in pre-funded Pursuant to the Company’s public equity offering completed in , the Company issued pre-funded warrants to purchase shares of common stock at a price of $ per share. These pre-funded warrants have an exercise price of $ per share, were fully exercisable upon issuance, and have expiration date. The Company determined that the pre-funded warrants should be equity classified because they are freestanding financial instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of shares of common stock upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In , pre-funded warrants to purchase shares of common stock from the November 2021equity financing were net exercised , resulting in shares of common stock issued to the holders of the pre-funded warrants. Pre-funded warrants to purchase shares of common stock were outstanding as of March , . At-the-Market In March 2023, the Company filed a registration statement on Form S-3 at-the-market |
Net Loss Per Common Share
Net Loss Per Common Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | 7. Net Loss Per Common Share Basic net loss per share of common stock is based on the weighted-average number of shares of common stock equivalents outstanding during the period. Pre-funded shares of In all periods presented, the Company’s outstanding stock options were excluded from the calculation of net loss per share because their effect would be antidilutive. The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share amounts): Three Months Ended March 31, 2023 2022 Numerator: Net loss $ (28,778 ) $ (27,769 ) Denominator: Weighted average number of: Common stock shares outstanding 93,701,240 84,677,939 Pre-funded 4,269,841 3,125,000 Total 97,971,081 87,802,939 Net loss per share $ (0.29 ) $ (0.32 ) The following table shows the total outstanding securities considered anti-dilutive and therefore excluded from the computation of net loss per share (in thousands): Three Months Ended March 31, 2023 2022 Common stock options 17,591 14,180 Incentive awards 85 101 Total 17,676 14,281 |
Stock Plans and Stock-Based Com
Stock Plans and Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Stock Plans and Stock-Based Compensation | 8. Stock Plans and Stock-Based Compensation Stock Plans As of March 31, 2023, there were 3,067,331 shares available for future grants under the Company’s 2013 Equity Incentive Plan and no shares available for grant under the Company’s 2020 New Hire Plan. During the three months ended March 31, 2023, the Company granted stock options which related to its option grants issued to employees and directors. Stock-Based Compensation Expense Stock-based compensation expense is included in the condensed consolidated statements of operations and comprehensive loss and is as follows (in thousands): Three Months Ended 2023 2022 Research and development $ 1,601 $ 1,098 General and administrative 1,886 1,316 Total stock-based compensation expense $ 3,487 $ 2,414 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Genfit Litigation On January 15, 2021, Genfit S.A. (Genfit) filed a complaint against the Company in the U.S. District Court for the Northern District of California, alleging misappropriation of trade secrets and related causes of action based on the Company’s receipt of a Genfit protocol synopsis for Genfit’s Phase 3 clinical trial of its drug candidate elafibranor in patients with primary biliary cholangitis. An Amended Complaint was filed on April 16, 2021 with substantially the same allegations. Genfit sought The Company its |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates The accompanying interim condensed consolidated financial statements are unaudited and are comprised of the accounts of CymaBay and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The Company has no unconsolidated subsidiaries or investments accounted for under the equity method. These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP), which requires management to make informed estimates and assumptions that impact the amounts and disclosures reported in the condensed consolidated financial statements and accompanying notes, and the requirements of the United States Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. In management’s opinion, the unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by U.S. GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 2022, which is contained in the Company’s Annual Report on Form 10-K The condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, which requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from those estimates and assumptions. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each reporting period and updated to reflect current information and any changes in estimates will generally be reflected in the period first identified. |
Revenue Recognition | Revenue Recognition As part of the Company’s drug development strategy, the Company periodically enters into collaboration arrangements with third party collaborators, under which the Company may license certain rights to our intellectual property to permit collaborators to further develop, manufacture and/or otherwise commercialize its drug candidates. The terms of these agreements typically include, but are not limited to, payments to the Company of one or more of the following: nonrefundable, upfront license fees; development and commercial milestone payments whose payment is typically contingent upon milestone achievement; funding of research and/or development activities; and royalties on net sales of licensed products. At the inception of an arrangement, the Company evaluates if a counterparty to a contract is a customer, if the arrangement is within the scope of ASC 606—Revenue from Contracts with Customers Upfront License Fees: If a performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The selection of the method to measure progress towards completion requires judgment and is based on the nature of the products or services to be provided. Revenue is recorded proportionally to the selected measure of progress either over the service period or at a point in time based on the products or services to be provided. The Company uses the cost-to-cost cost-to-cost If the arrangement includes optional goods and services, the Company assesses whether delivery of such goods and services requires the customer to pay fees consistent with their standalone selling prices, or if customer may be entitled to incremental discounts that it would not have received without entering into the agreement and committing to purchase the initial goods and services. Presence of such discounts indicates the customer has received material rights which also represent performance obligations. Development and Regulatory Milestone Payments re-evaluates Sales-based Milestone and Royalty Payments: The Company receives payments from its customers based on billing schedules established in each contract. Upfront payments and fees are recorded as deferred revenue upon receipt or when due until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less. The Company allocates amounts included in the transaction price based on standalone selling prices of various performance obligations. Variable consideration (such as milestones and royalties) is allocated to specific performance obligations if it is triggered through our performance or represents a specific outcome from the performance associated with this performance obligation, and if such allocation would meet the allocation objective of allocating to each performance obligation an amount that depicts consideration to which the Company would be entitled in exchange for delivery of such performance obligation. The remaining consideration is generally allocated on a relative standalone selling price basis. The Company determines standalone selling prices using a variety of methods, including cost associated with our performance plus a reasonable margin, prices observed in the market for similar goods or services, and valuation techniques involving projected discounted cash flows. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments during the periods reported consist of cash, cash equivalents, marketable securities, accounts payable, certain accrued liabilities, and the development financing liability. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs and is as follows: Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. Level 3—Inputs that are significant to the fair value measurement and are unobservable (i.e. supported by little or no market activity), which requires the reporting entity to develop its own valuation techniques and assumptions. The carrying amounts of cash equivalents approximate their related fair values due to the short-term nature of these instruments. Cash equivalents are classified as level 1 and accounts payable and accrued liabilities as level 2 under the fair value hierarchy. The following tables present the Company’s financial assets that are measured at fair value on a recurring basis using the above input categories (in thousands): As of March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 57,843 $ — $ — $ 57,843 Total cash equivalents 57,843 — — 57,843 Marketable securities: U.S. and foreign commercial paper — 85,120 — 85,120 U.S. and foreign corporate debt securities — 10,375 — 10,375 Supranational debt securities — 4,475 — 4,475 U.S. agency securities — 26,159 — 26,159 U.S. treasury securities — 51,086 — 51,086 Total marketable securities — 177,215 — 177,215 Total assets measured at fair value $ 57,843 $ 177,215 $ — $ 235,058 As of December 31, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 9,770 $ — $ — $ 9,770 Total cash equivalents 9,770 — — 9,770 Marketable securities: U.S. and foreign commercial paper — 46,121 — 46,121 U.S. and foreign corporate debt securities — 24,807 — 24,807 Supranational debt securities — 12,890 — 12,890 U.S. agency securities — 7,759 — 7,759 U.S. treasury securities — 23,617 — 23,617 Total marketable securities — 115,194 — 115,194 Total assets measured at fair value $ 9,770 $ 115,194 $ — $ 124,964 The Company estimates the fair value of its money market funds, corporate debt, asset-backed securities, commercial paper, U.S. treasury securities, U.S agency securities, and supranational debt securities by taking into consideration data obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data, and other observable inputs. The fair value of the Company’s development financing liability is $85.1 million. The development financing liability is classified as level 3 under the fair value hierarchy, as its valuation is based on a discounted cash flow model that uses unobservable inputs such as the estimated timing of regulatory approval, attainment of certain sales milestones and the discount rate. |
Cash, Cash Equivalents, and Marketable Securities | Cash, Cash Equivalents, and Marketable Securities The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits with commercial banks in checking, interest-bearing, and money market funds. The Company invests excess cash in marketable securities with high credit ratings. These securities consist primarily of corporate debt, commercial paper, asset-backed securities, U.S. treasury securities, and supranational debt securities and are classified as “available-for-sale.” Realized gains and losses from the sale of marketable securities, if any, are calculated using the specific-identification method. Expected losses judged to be related partially or in whole to declines in credit risk-related factors of the security issuer are included in interest income or expense in the condensed consolidated statements of operations and comprehensive loss at the time the factors contributing to the expected losses are identified. Unrealized holding gains and losses are reported in accumulated other comprehensive loss in the condensed consolidated balance sheets. To date, the Company has not recorded any expected losses on its marketable securities related to credit risk-related declines in market value. In determining whether a decline in market value is related to expected credit losses, various factors are considered, including the cause, duration of time and severity of the expected loss, any adverse changes in the investees’ financial condition, and the Company’s intent and ability to hold the security for a period of time sufficient to allow for an anticipated recovery in market value. Unrealized gains and losses of the Company’s available-for-sale Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of March 31, 2023: Cash equivalents: Money market funds $ 57,843 $ — $ — $ 57,843 Total cash equivalents 57,843 — — 57,843 Current marketable securities: U.S. and foreign commercial paper 85,120 — — 85,120 U.S. and foreign corporate debt securities 10,449 — (74 ) 10,375 Supranational debt securities 4,489 — (14 ) 4,475 U.S. agency securities 26,143 37 (21 ) 26,159 U.S. treasury securities 51,084 48 (46 ) 51,086 Total current marketable securities 177,285 85 (155 ) 177,215 Total marketable securities $ 235,128 $ 85 $ (155 ) $ 235,058 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2022: Cash equivalents: Money market funds $ 9,770 $ — $ — $ 9,770 Total cash equivalents 9,770 — — 9,770 Current marketable securities: U.S. and foreign commercial paper 46,121 — — 46,121 U.S. and foreign corporate debt securities 24,964 — (157 ) 24,807 Supranational debt securities 12,946 — (56 ) 12,890 U.S. agency securities 7,782 16 (39 ) 7,759 U.S. treasury securities 23,707 2 (92 ) 23,617 Total current marketable securities 115,520 18 (344 ) 115,194 Total marketable securities $ 125,290 $ 18 $ (344 ) $ 124,964 The following table shows the fair value of the Company’s marketable securities, by contractual maturity, as of March 31, 2023 (in thousands): Due less than 1 year $ 177,215 Due between 1 and 2 years — Total fair value $ 177,215 |
Concentration of Risk | Concentration of Risk Cash, cash equivalents, and marketable securities consist of financial instruments that potentially subject the Company to a concentration of credit risk to the extent of the fair value recorded on the balance sheet. The Company invests cash that is not required for immediate operating needs primarily in highly liquid instruments that bear minimal risk. The Company has established guidelines relating to the quality, diversification, and maturities of securities to enable the Company to manage its credit risk. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and investments and issuers of investments to the extent recorded on the condensed consolidated balance sheets. Certain materials and key components that the Company utilizes in its operations are obtained through single suppliers. Since the suppliers of key components and materials must be named in a new drug application NDA filed with the FDA for a product, significant delays can occur if the qualification of a new supplier is required. If delivery of material from the Company’s suppliers were interrupted for any reason, the Company may be unable to supply any of its product candidates for clinical trials. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist of costs incurred in identifying, developing, and testing product candidates. These expenses consist primarily of costs for research and development personnel, including related stock-based compensation; contract research organizations (CRO) and other third parties that assist in managing, monitoring, and analyzing clinical trials; investigator and site fees; laboratory services; consultants; contract manufacturing services; non-clinical The Company records expenses related to clinical studies and manufacturing development activities based on its estimates of the services received and efforts expended pursuant to contracts with multiple CROs and manufacturing vendors that conduct and manage these activities on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical trial milestones. In amortizing or accruing service fees, the Company estimates the time period over which services will be performed, enrollment of subjects, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the Company’s estimate, the Company will adjust the accrued or prepaid expense balance accordingly. To date, there have been no material differences from the Company’s estimates to the amounts actually incurred. |
Development Financing Agreement | Development Financing Agreement The There are several factors that could affect the estimated timing of regulatory approval and attainment of sales milestones, some of which are not entirely within the Company’s control. Therefore, at each reporting date, the Company reassesses the estimated timing of regulatory approval and attainment of sales milestones and the expected contractual success fee payments due therefrom. If the timing and/or amount of such expected payments is materially different than original estimates, the Company will prospectively adjust the accretion of the development financing liability and the imputed interest rate. The Company identified certain contingent repayment features in the Financing Agreement that are required to be bifurcated from the debt host instrument as embedded derivative liabilities; however, the Company determined the fair value of these features, both individually and in the aggregate, was immaterial at inception and as of March 31, 2023. The fair value of these features will be assessed at each reporting date and will be marked to market, if material. To determine the amount to record for the embedded derivative liabilities, the Company must assess the probability of occurrence of various potential future events that could affect the timing and/or amount of future cash flows related to the Financing Agreement. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation is measured at fair value on the grant date of the award. Compensation cost is recognized as expense on a straight-line basis over the vesting period for options with service conditions, and forfeitures are accounted for as they occur. The Company uses the Black-Scholes option pricing model to determine the fair value of stock option awards. The determination of fair value for stock-based awards using an option-pricing model requires management to make certain assumptions regarding subjective input variables such as expected term, dividends, volatility and risk-free rate. If actual results are not consistent with the Company’s assumptions and judgments used in making these estimates, the Company may be required to increase or decrease compensation expense, which could be material to the Company’s results of operations. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements ASU 2016-13 In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments available-for-sale No. 2019-10, |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Fair Value Assets Measured on Recurring Basis | The following tables present the Company’s financial assets that are measured at fair value on a recurring basis using the above input categories (in thousands): As of March 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 57,843 $ — $ — $ 57,843 Total cash equivalents 57,843 — — 57,843 Marketable securities: U.S. and foreign commercial paper — 85,120 — 85,120 U.S. and foreign corporate debt securities — 10,375 — 10,375 Supranational debt securities — 4,475 — 4,475 U.S. agency securities — 26,159 — 26,159 U.S. treasury securities — 51,086 — 51,086 Total marketable securities — 177,215 — 177,215 Total assets measured at fair value $ 57,843 $ 177,215 $ — $ 235,058 As of December 31, 2022 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 9,770 $ — $ — $ 9,770 Total cash equivalents 9,770 — — 9,770 Marketable securities: U.S. and foreign commercial paper — 46,121 — 46,121 U.S. and foreign corporate debt securities — 24,807 — 24,807 Supranational debt securities — 12,890 — 12,890 U.S. agency securities — 7,759 — 7,759 U.S. treasury securities — 23,617 — 23,617 Total marketable securities — 115,194 — 115,194 Total assets measured at fair value $ 9,770 $ 115,194 $ — $ 124,964 |
Summary of Marketable Available-for-Sale Securities | Unrealized gains and losses of the Company’s available-for-sale Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of March 31, 2023: Cash equivalents: Money market funds $ 57,843 $ — $ — $ 57,843 Total cash equivalents 57,843 — — 57,843 Current marketable securities: U.S. and foreign commercial paper 85,120 — — 85,120 U.S. and foreign corporate debt securities 10,449 — (74 ) 10,375 Supranational debt securities 4,489 — (14 ) 4,475 U.S. agency securities 26,143 37 (21 ) 26,159 U.S. treasury securities 51,084 48 (46 ) 51,086 Total current marketable securities 177,285 85 (155 ) 177,215 Total marketable securities $ 235,128 $ 85 $ (155 ) $ 235,058 Gross Gross Amortized Unrealized Unrealized Estimated Cost Gains Losses Fair Value As of December 31, 2022: Cash equivalents: Money market funds $ 9,770 $ — $ — $ 9,770 Total cash equivalents 9,770 — — 9,770 Current marketable securities: U.S. and foreign commercial paper 46,121 — — 46,121 U.S. and foreign corporate debt securities 24,964 — (157 ) 24,807 Supranational debt securities 12,946 — (56 ) 12,890 U.S. agency securities 7,782 16 (39 ) 7,759 U.S. treasury securities 23,707 2 (92 ) 23,617 Total current marketable securities 115,520 18 (344 ) 115,194 Total marketable securities $ 125,290 $ 18 $ (344 ) $ 124,964 |
Marketable Securities | The following table shows the fair value of the Company’s marketable securities, by contractual maturity, as of March 31, 2023 (in thousands): Due less than 1 year $ 177,215 Due between 1 and 2 years — Total fair value $ 177,215 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Other Accrued Liabilities Current [Abstract] | |
Schedule Of Other Accrued Liabilities | Other accrued liabilities consist of (in thousands): March 31, 2023 December 31, Accrued compensation $ 2,299 $ 5,779 Accrued professional fees and other 2,733 1,372 Current portion of operating lease liability 537 664 Total other accrued liabilities $ 5,569 $ 7,815 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss per Share | The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share amounts): Three Months Ended March 31, 2023 2022 Numerator: Net loss $ (28,778 ) $ (27,769 ) Denominator: Weighted average number of: Common stock shares outstanding 93,701,240 84,677,939 Pre-funded 4,269,841 3,125,000 Total 97,971,081 87,802,939 Net loss per share $ (0.29 ) $ (0.32 ) |
Anti-Dilutive Securities Excluded from the Computation of Diluted Net Loss per Share | The following table shows the total outstanding securities considered anti-dilutive and therefore excluded from the computation of net loss per share (in thousands): Three Months Ended March 31, 2023 2022 Common stock options 17,591 14,180 Incentive awards 85 101 Total 17,676 14,281 |
Stock Plans and Stock-Based C_2
Stock Plans and Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock-Based Compensation Expense | Stock-based compensation expense is included in the condensed consolidated statements of operations and comprehensive loss and is as follows (in thousands): Three Months Ended 2023 2022 Research and development $ 1,601 $ 1,098 General and administrative 1,886 1,316 Total stock-based compensation expense $ 3,487 $ 2,414 |
Organization and Description _2
Organization and Description of Business - Additional Information (Detail) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 USD ($) segment | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Class of Stock [Line Items] | |||
Number of operating segments | segment | 1 | ||
Net loss | $ (28,778) | $ (27,769) | |
Cash flows from operating activities | 6,431 | $ (25,362) | |
Accumulated deficit | (901,635) | $ (872,857) | |
Cash and cash equivalents and marketable securities | $ 236,400 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Product Information [Line Items] | |
Cash and cash equivalents, maturity description | 90 days or less |
Fair value of development financing liability | $ 85.1 |
Maximum [Member] | |
Product Information [Line Items] | |
Short-term contractual maturities | 1 year |
Minimum [Member] | |
Product Information [Line Items] | |
Short-term contractual maturities | 1 year |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Fair Value Assets Measured on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | $ 235,058 | $ 124,964 |
Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 57,843 | 9,770 |
Cash Equivalents [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 57,843 | 9,770 |
Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 177,215 | 115,194 |
Short-term Investments [Member] | U.S. and Foreign Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 85,120 | 46,121 |
Short-term Investments [Member] | U.S. and Foreign Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 10,375 | 24,807 |
Short-term Investments [Member] | Supranational Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 4,475 | 12,890 |
Short-term Investments [Member] | U.S. Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 26,159 | 7,759 |
Short-term Investments [Member] | U.S. Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 51,086 | 23,617 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 57,843 | 9,770 |
Level 1 [Member] | Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 57,843 | 9,770 |
Level 1 [Member] | Cash Equivalents [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 57,843 | 9,770 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 177,215 | 115,194 |
Level 2 [Member] | Short-term Investments [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 177,215 | 115,194 |
Level 2 [Member] | Short-term Investments [Member] | U.S. and Foreign Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 85,120 | 46,121 |
Level 2 [Member] | Short-term Investments [Member] | U.S. and Foreign Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 10,375 | 24,807 |
Level 2 [Member] | Short-term Investments [Member] | Supranational Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 4,475 | 12,890 |
Level 2 [Member] | Short-term Investments [Member] | U.S. Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | 26,159 | 7,759 |
Level 2 [Member] | Short-term Investments [Member] | U.S. Treasury Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets measured at fair value | $ 51,086 | $ 23,617 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Marketable Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Estimated Fair Value | $ 177,215 | $ 115,194 |
Cash and Cash Equivalents [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 57,843 | 9,770 |
Estimated Fair Value | 57,843 | 9,770 |
Cash and Cash Equivalents [Member] | Money Market Funds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 57,843 | 9,770 |
Estimated Fair Value | 57,843 | 9,770 |
Current marketable securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 177,285 | 115,520 |
Unrealized Gains | 85 | 18 |
Unrealized Losses | (155) | (344) |
Estimated Fair Value | 177,215 | 115,194 |
Current marketable securities [Member] | U.S. and Foreign Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 85,120 | 46,121 |
Estimated Fair Value | 85,120 | 46,121 |
Current marketable securities [Member] | U.S. and Foreign Corporate Debt Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 10,449 | 24,964 |
Unrealized Gains | 0 | |
Unrealized Losses | (74) | (157) |
Estimated Fair Value | 10,375 | 24,807 |
Current marketable securities [Member] | U.S. Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 51,084 | 23,707 |
Unrealized Gains | 48 | 2 |
Unrealized Losses | (46) | (92) |
Estimated Fair Value | 51,086 | 23,617 |
Current marketable securities [Member] | U.S. agency securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 26,143 | 7,782 |
Unrealized Gains | 37 | 16 |
Unrealized Losses | (21) | (39) |
Estimated Fair Value | 26,159 | 7,759 |
Current marketable securities [Member] | Supranational Debt Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 4,489 | 12,946 |
Unrealized Gains | 0 | |
Unrealized Losses | (14) | (56) |
Estimated Fair Value | 4,475 | 12,890 |
Maketable Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 235,128 | 125,290 |
Unrealized Gains | 85 | 18 |
Unrealized Losses | (155) | (344) |
Estimated Fair Value | $ 235,058 | $ 124,964 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule Of Fair Value Of The Company Marketable Securities By Contractual Maturity (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Contractual Obligation Fiscal Year Maturity Schedule [Line Items] | ||
Due less than 1 year | $ 177,215 | |
Due between 1 and 2 years | 0 | |
Total fair value | $ 177,215 | $ 115,194 |
Other Accrued Liabilities - Sum
Other Accrued Liabilities - Summary of Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Other Accrued Liabilities Current [Abstract] | ||
Accrued compensation | $ 2,299 | $ 5,779 |
Accrued professional fees and other | 2,733 | 1,372 |
Current portion of operating lease liability | 537 | 664 |
Total other accrued liabilities | $ 5,569 | $ 7,815 |
Development Financing Agreeme_2
Development Financing Agreement - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | ||||
Jan. 31, 2022 | Nov. 30, 2021 | Aug. 31, 2021 | Mar. 31, 2023 | Jul. 30, 2021 | |
Debt Instrument [Line Items] | |||||
Description Of Percentage Fixed Success Payments | 2.0 | ||||
Repayments of Lines of Credit | $ 10 | ||||
Description Of Percentage Variable Success Payments | 1.1 | ||||
Description Of Aggregate Return From The Funds Provided | 3.1 | ||||
Aggregate Return Percentage From The Funds Provided | $ 232.5 | ||||
Percentage of Accelerate Payment Payable On Funds provided | 1.35 | ||||
Description Repayments On Funds Provided Upon Termination Of Financing Agreement | 2.0 | ||||
Percentage of Unamortized Portion of The Development Financing Liability | 19.20% | ||||
Fixed Success Payments [Member] | |||||
Debt Instrument [Line Items] | |||||
Anniversary Payments Due Year One | $ 15 | ||||
Anniversary Payments Due Year Two | 22.5 | ||||
Anniversary Payments Due Year Three | 22.5 | ||||
Anniversary Payments Due Year Four | 25 | ||||
Anniversary Payments Due Year Five | 27.5 | ||||
Anniversary Payments Due Year Six | 27.5 | ||||
Variable Success Payments [Member] | |||||
Debt Instrument [Line Items] | |||||
Payments Upon Reaching Cumulative US Product Sales Thresholds Year One | 17.5 | ||||
Payments Upon Reaching Cumulative US Product Sales Thresholds Year Two | 27.5 | ||||
Payments upon reaching product sales run rate | 37.5 | ||||
Installment Funding Number Three [Member] | |||||
Debt Instrument [Line Items] | |||||
Proceeds from Lines of Credit | $ 25 | ||||
ABW Cyclops SPV LP [Member] | |||||
Debt Instrument [Line Items] | |||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 75 | ||||
ABW Cyclops SPV LP [Member] | Installment Funding Number One [Member] | |||||
Debt Instrument [Line Items] | |||||
Proceeds from Lines of Credit | $ 25 | ||||
ABW Cyclops SPV LP [Member] | Installment Funding Number Two [Member] | |||||
Debt Instrument [Line Items] | |||||
Proceeds from Lines of Credit | $ 25 | ||||
Financing Agreement Termination Event Condition One [Member] | ABW Cyclops SPV LP [Member] | |||||
Debt Instrument [Line Items] | |||||
Percentage of amount to be paid by entity upon the termination of the agreement | 310% | ||||
Financing Agreement Termination Event Condition Two [Member] | ABW Cyclops SPV LP [Member] | |||||
Debt Instrument [Line Items] | |||||
Percentage of amount to be paid by entity upon the termination of the agreement | 200% | ||||
Financing Agreement Termination Event Condition Three [Member] | ABW Cyclops SPV LP [Member] | |||||
Debt Instrument [Line Items] | |||||
Percentage of amount to be paid by entity upon the termination of the agreement | 100% |
Collaboration and License Agr_2
Collaboration and License Agreement - Additional Information (Detail) - Jan. 06, 2023 - Collaboration and License Agreement [Member] $ in Millions, ¥ in Billions | JPY (¥) | USD ($) | USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Deferred collaboration revenue | ¥ 4.5 | $ 33.7 | |
Upfront Cash Payment | 4.5 | $ 34.2 | |
Potential Milestone Payments | ¥ 17 | $ 128 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | |||||
Feb. 28, 2023 | Jan. 23, 2023 | Feb. 28, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Nov. 30, 2021 | |
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | ||||
Number of new stock issued during the period. | 11,821,428 | |||||
Sale of Stock, Price Per Share | $ 7 | |||||
Collaboration and License Agreement [Member] | ||||||
Class of Stock [Line Items] | ||||||
Sale of Stock, Consideration Received on Transaction | $ 92.4 | |||||
Prefunded warrants [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of common stock into which the class of warrant or right may be converted | 2,142,857 | 4,642,857 | 3,125,000 | |||
Sale of Stock, Price Per Share | $ 6.9999 | $ 3.9999 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.0001 | $ 0.0001 | ||||
Class Of warrant Or right number of common stock issuable on exercise of warrants | 625,000 | |||||
Stock issued on exercise of warrants | 624,992 | |||||
ATM Offering [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common stock value subscribed | $ 100 |
Net Loss Per Common Share - Com
Net Loss Per Common Share - Computation of Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Numerator: | ||
Net loss | $ (28,778) | $ (27,769) |
Denominator: | ||
Weighted average number of common stock shares outstanding | 93,701,240 | 84,677,939 |
Weighted average number of pre-funded warrants outstanding | 4,269,841 | 3,125,000 |
Total, Basic | 97,971,081 | 87,802,939 |
Total, Diluted | 97,971,081 | 87,802,939 |
Net loss per share, Basic | $ (0.29) | $ (0.32) |
Net loss per share, Diluted | $ (0.29) | $ (0.32) |
Net Loss Per Common Share - Ant
Net Loss Per Common Share - Anti-Dilutive Securities Excluded from the Computation of Diluted Net Loss per Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted loss per share | 17,676 | 14,281 |
Common Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted loss per share | 17,591 | 14,180 |
Incentive Awards [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted loss per share | 85 | 101 |
Stock Plans and Stock-Based C_3
Stock Plans and Stock-Based Compensation - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2023 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options granted | 3,872,135 |
2013 Equity Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share reserved for issue | 3,067,331 |
Twenty Twenty New Hire Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares available for grant | 0 |
Stock Plans and Stock-Based C_4
Stock Plans and Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 3,487 | $ 2,414 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 1,601 | 1,098 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 1,886 | $ 1,316 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 3 Months Ended | ||
Mar. 12, 2021 | Jan. 15, 2021 | Mar. 31, 2023 | |
Loss Contingencies [Line Items] | |||
Loss Contingency, Lawsuit Filing Date | January 15, 2021 | ||
Loss Contingency, Name of Plaintiff | Genfit S.A | ||
Loss Contingency, Allegations | alleging misappropriation of trade secrets and related causes of action based on the Company’s receipt of a Genfit protocol synopsis for Genfit’s Phase 3 clinical trial of its drug candidate elafibranor in patients with primary biliary cholangitis | ||
Loss Contingency, Actions Taken by Defendant | On February 21, 2023, the parties entered into a Settlement Agreement and the action was dismissed with prejudice. The Company did not admit to any liability and the litigation has been resolved completely. | ||
Loss Contingency, Actions Taken by Court, Arbitrator or Mediator | On March 12, 2021, the Court granted a Temporary Restraining Order (later converted to a Preliminary Injunction), prohibiting the Company from accessing or disseminating the protocol synopsis, using any Genfit trade secrets contained therein or destroying any evidence related thereto. | ||
Pending Litigation [Member] | |||
Loss Contingencies [Line Items] | |||
Loss Contingency, Lawsuit Filing Date | April 16, 2021 |