Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | Apr. 30, 2024 | |
Document And Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-37852 | |
Entity Registrant Name | PROTAGONIST THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 98-0505495 | |
Entity Address, Address Line One | 7707 Gateway Boulevard, Suite 140 | |
Entity Address, City or Town | Newark | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94560-1160 | |
City Area Code | 510 | |
Local Phone Number | 474-0170 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | PTGX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 58,652,133 | |
Entity Central Index Key | 0001377121 | |
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 | $ 172,568 | $ 186,727 |
Marketable securities | 150,067 | 154,890 |
Receivable from collaboration partner | 300,043 | 10,000 |
Prepaid expenses and other current assets | 4,875 | 3,960 |
Total current assets | 627,553 | 355,577 |
Property and equipment, net | 1,111 | 1,195 |
Restricted cash - noncurrent | 225 | 225 |
Operating lease right-of-use asset | 387 | 954 |
Total assets | 629,276 | 357,951 |
Current liabilities: | ||
Accounts payable | 3,507 | 772 |
Payable to collaboration partner | 3 | 3 |
Accrued expenses and other payables | 16,487 | 19,358 |
Deferred revenue - current | 16,125 | |
Income taxes payable | 3,326 | |
Operating lease liability - current | 462 | 1,141 |
Total current liabilities | 39,910 | 21,274 |
Deferred revenue, noncurrent | 28,922 | |
Total liabilities | 68,832 | 21,274 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.00001 par value, 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.00001 par value, 90,000,000 shares authorized; 58,600,787 and 57,708,613 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 1 | 1 |
Additional paid-in capital | 969,042 | 952,491 |
Accumulated other comprehensive loss | (229) | (105) |
Accumulated deficit | (408,370) | (615,710) |
Total stockholders' equity | 560,444 | 336,677 |
Total liabilities and stockholders' equity | $ 629,276 | $ 357,951 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Consolidated Balance Sheets | ||
Preferred stock, par value | $ 0.00001 | $ 0.00001 |
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 | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 90,000,000 | 90,000,000 |
Common stock, shares issued | 58,600,787 | 57,708,613 |
Common stock, shares outstanding | 58,600,787 | 57,708,613 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Consolidated Statements of Operations | ||
License and collaboration revenue | $ 254,953 | $ 0 |
Revenue from Contract with Customer, Product and Service [Extensible List] | License and Collaboration Agreement | License and Collaboration Agreement |
Operating expenses: | ||
Research and development | $ 33,734 | $ 27,416 |
General and administrative | 14,910 | 8,605 |
Total operating expenses | 48,644 | 36,021 |
Income (loss) from operations | 206,309 | (36,021) |
Interest income | 4,376 | 2,491 |
Other expense, net | (19) | (195) |
Income (loss) before income tax expense | 210,666 | (33,725) |
Income tax expense | (3,326) | 0 |
Net income (loss) | $ 207,340 | $ (33,725) |
Net income (loss) per share, basic | $ 3.41 | $ (0.67) |
Net income (loss) per share, diluted | $ 3.26 | $ (0.67) |
Weighted-average shares used to compute net income (loss) per share, basic | 60,855,689 | 50,573,650 |
Weighted-average shares used to compute net income (loss) per share, diluted | 63,595,328 | 50,573,650 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Consolidated Statements of Comprehensive Loss | ||
Net income (loss) | $ 207,340 | $ (33,725) |
Other comprehensive income (loss): | ||
Gain on translation of foreign operations | 194 | |
Unrealized (loss) gain on marketable securities | (124) | 43 |
Comprehensive income (loss) | $ 207,216 | $ (33,488) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock At-the-market offering | Common Stock | Additional Paid-In Capital At-the-market offering | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit | At-the-market offering | Total |
Balance, Beginning at Dec. 31, 2022 | $ 752,722 | $ (359) | $ (536,755) | $ 215,608 | ||||
Balance, Beginning (in shares) at Dec. 31, 2022 | 49,339,252 | |||||||
Increase (Decrease) in Stockholders' Equity | ||||||||
Issuance of common stock, net of issuance costs | $ 1 | $ 24,301 | $ 24,302 | |||||
Issuance of common stock, net of issuance costs (in shares) | 1,749,199 | |||||||
Issuance of common stock under equity incentive and employee stock purchase plans | (2,261) | (2,261) | ||||||
Issuance of common stock under equity incentive and employee stock purchase plans (in shares) | (358,211) | |||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units | (100) | (100) | ||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units (in shares) | (6,159) | |||||||
Stock-based compensation expense | 7,584 | 7,584 | ||||||
Other comprehensive income (loss) | 237 | 237 | ||||||
Net income (loss) | (33,725) | (33,725) | ||||||
Balance, Ending at Mar. 31, 2023 | $ 1 | 786,768 | (122) | (570,480) | 216,167 | |||
Balance, Ending (in shares) at Mar. 31, 2023 | 51,440,503 | |||||||
Balance, Beginning at Dec. 31, 2023 | $ 1 | 952,491 | (105) | (615,710) | $ 336,677 | |||
Balance, Beginning (in shares) at Dec. 31, 2023 | 57,708,613 | 57,708,613 | ||||||
Increase (Decrease) in Stockholders' Equity | ||||||||
Issuance of common stock under equity incentive and employee stock purchase plans | 7,799 | $ 7,799 | ||||||
Issuance of common stock under equity incentive and employee stock purchase plans (in shares) | 827,978 | |||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units | (600) | $ (600) | ||||||
Shares withheld for net settlement of tax withholding upon vesting of restricted stock units (in shares) | (20,793) | |||||||
Issuance of common stock upon exercise of Pre-Funded Warrants (in shares) | 84,989 | 84,992 | ||||||
Issuance of common stock upon exercise of Pre-Funded Warrants (in shares) | 84,989 | 84,992 | ||||||
Stock-based compensation expense | 9,352 | $ 9,352 | ||||||
Other comprehensive income (loss) | (124) | (124) | ||||||
Net income (loss) | 207,340 | 207,340 | ||||||
Balance, Ending at Mar. 31, 2024 | $ 1 | $ 969,042 | $ (229) | $ (408,370) | $ 560,444 | |||
Balance, Ending (in shares) at Mar. 31, 2024 | 58,600,787 | 58,600,787 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash Flows from Operating Activities | ||
Net income (loss) | $ 207,340 | $ (33,725) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Stock-based compensation | 9,352 | 7,584 |
Operating lease right-of-use asset amortization | 584 | 584 |
Accretion of discount on marketable securities | (1,615) | (1,255) |
Depreciation | 236 | 248 |
Other | 194 | |
Changes in operating assets and liabilities: | ||
Receivable from collaboration partner | (290,043) | (41) |
Prepaid expenses and other assets | (915) | 787 |
Accounts payable | 2,825 | 381 |
Payable to collaboration partner | (47) | |
Accrued expenses and other payables | (2,870) | (8,383) |
Deferred revenue | 45,047 | |
Income taxes payable | 3,326 | |
Operating lease liability | (696) | (674) |
Net cash used in operating activities | (27,429) | (34,347) |
Cash Flows from Investing Activities | ||
Purchase of marketable securities | (65,671) | (28,060) |
Proceeds from maturities of marketable securities | 71,984 | 37,896 |
Purchases of property and equipment | (242) | (10) |
Net cash provided by investing activities | 6,071 | 9,826 |
Cash Flows from Financing Activities | ||
Proceeds from at-the-market offering, net of issuance costs | 24,302 | |
Proceeds from issuance of common stock upon exercise of stock options and purchases under employee stock purchase plan | 7,799 | 2,261 |
Tax withholding payments related to net settlement of restricted stock units | (600) | (100) |
Net cash provided by financing activities | 7,199 | 26,463 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (14,159) | 1,942 |
Cash, cash equivalents and restricted cash, beginning of period | 186,952 | 125,969 |
Cash, cash equivalents and restricted cash, end of period | 172,793 | 127,911 |
Supplemental Disclosure of Non-Cash Financing and Investing Information: | ||
Purchases of property and equipment in accounts payable and accrued liabilities | $ 45 | $ 15 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2024 | |
Organization and Description of Business | |
Organization and Description of Business | PROTAGONIST THERAPEUTICS, INC. Notes to Unaudited Condensed Consolidated Financial Statements Note 1. Protagonist Therapeutics, Inc. (the “Company”) is headquartered in Newark, California. The Company is a biopharmaceutical company with peptide-based new chemical entities rusfertide and JNJ-2113 in advanced Phase 3 stages of clinical development, both derived from the Company’s proprietary technology platform. The Company’s Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Chief Executive Officer, the Company’s chief operating decision maker, in deciding how to allocate resources and assessing performance. Liquidity As of March 31, 2024, the Company had cash, cash equivalents and marketable securities of $322.6 million. The Company has incurred cumulative net losses from inception through March 31, 2024 of $408.4 million. The Company’s ultimate success depends upon the outcome of its research and development and collaboration activities. The Company may incur additional losses in the future and may need to raise additional capital to continue to execute its long-range business plan. Since the Company’s initial public offering in August 2016, it has financed its operations primarily through proceeds from offerings of common stock and payments received under license and collaboration agreements. Risks and Uncertainties The Company is currently operating in a period of macroeconomic uncertainty and capital markets disruption, which has been impacted by domestic and global monetary and fiscal policy, geopolitical instability, including ongoing military conflicts between Russia and Ukraine and in Israel and surrounding areas, rising tensions between China and Taiwan, and high interest rates. The Company’s future results of operations and liquidity could be adversely impacted by outbreaks of disease, epidemics and pandemics, including potential delays in existing and planned clinical trials, difficulty in recruiting patients for these clinical trials, delays in manufacturing and collaboration activities and supply chain disruptions. The conflict in Ukraine has exacerbated market disruptions, including significant volatility in commodity prices as well as supply chain interruptions. The U.S. Federal Reserve and other central banks may be unable to contain inflation through more restrictive monetary policy and inflation may increase or continue for a prolonged period of time. Inflationary factors, such as increases in the cost of clinical supplies, interest rates, overhead costs and transportation costs may adversely affect the Company’s operating results. The Company continues to monitor these events and the potential impact on its business. Although the Company does not believe that inflation has had a material adverse impact on its financial position or results of operations to date, its financial position or results of operations may be adversely affected in the future due to numerous factors, including domestic and global monetary and fiscal policy, supply chain constraints, the ongoing conflicts between Russia and Ukraine and in Israel and surrounding areas and other factors, and such factors may lead to increases in the cost of manufacturing for and delays in the initiation of studies in the Company’s product candidates. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the condensed consolidated balance sheet as of March 31, 2024 has been derived from the Company’s unaudited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair presentation of the Company’s condensed consolidated financial statements. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future period. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 27, 2024. Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, accruals for research and development activities, stock-based compensation, income taxes, marketable securities and leases. Estimates related to revenue recognition include assumptions used to determine standalone selling price utilized to allocate the transaction price between distinct performance obligations, assumptions used to recognize revenue over time for certain performance obligations for which a cost-based input method is used as the measure of progress and estimates of whether contingent consideration should be included in the transaction price at each reporting period. Management bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to forecasted amounts and future events. Actual results may differ materially from these estimates. There has been uncertainty and disruption in the global economy and financial markets due to a number of factors, including geopolitical instability, inflationary pressures, high interest rates, a recessionary environment, domestic and global monetary and fiscal policy and other factors. The Company has taken into consideration any known impacts in its accounting estimates to date and is not aware of any additional specific events or circumstances that would require any additional updates to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the filing date of this Quarterly Report on Form 10-Q. These estimates may change as new events occur and additional information is obtained. Actual results could differ materially from these estimates under different assumptions or conditions. Cash as Reported in Condensed Consolidated Statements of Cash Flows Cash as reported in the condensed consolidated statements of cash flows includes the aggregate amounts of cash and cash equivalents and the restricted cash as presented on the condensed consolidated balance sheets. Cash as reported in the condensed consolidated statements of cash flows consisted of (in thousands): March 31, 2024 2023 Cash and cash equivalents $ 172,568 $ 127,686 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 172,793 $ 127,911 Stock-Based Compensation Expense The Company has granted stock options, restricted stock units (“RSUs”) and performance share units (“PSUs”). Stock-based compensation expense associated with stock options is based on the estimated grant date fair value using the Black-Scholes valuation model, which requires the use of subjective assumptions related to expected stock price volatility, option term, risk-free interest rate and dividend yield. The Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. Stock-based compensation expense associated with RSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date. For RSUs, the Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. PSUs allow the recipients of such awards to earn fully vested shares of the Company’s common stock upon the achievement of pre-established performance objectives. Stock-based compensation expense associated with PSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date and is recognized when the performance objective is expected to be achieved. The Company evaluates on a quarterly basis the probability of achieving the performance criteria. The cumulative effect on current and prior periods of a change in the estimated number of PSUs expected to be earned is recognized as compensation expense or as reduction of previously recognized compensation expense in the period of the revised estimate. The Company recognizes forfeitures of stock-based awards as they occur. Total stock-based compensation expense was as follows (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 5,288 $ 4,582 General and administrative 4,064 3,002 Total stock-based compensation expense $ 9,352 $ 7,584 Significant Accounting Policies Collaborative Arrangements The Company analyzes its collaborative arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards, and therefore are within the scope of Accounting Standards Codification Topic 808 - Collaborative Arrangements (“Topic 808”). For collaborative arrangements that contain multiple elements, the Company determines which units of account are deemed to be within the scope of Topic 808 and which units of account are more reflective of a vendor-customer relationship, and therefore are within the scope of Accounting Standards Codification Topic 606 – Revenue from Contracts with Customers There have been no other material changes to the Company’s significant accounting policies during the three months ended March 31, 2024, as compared to those disclosed in Note 2. Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Recently Adopted Accounting Pronouncements In August 2020, the FASB issued Accounting Standards Update No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it simplifies the diluted earnings per share calculation in certain areas. - is effective for the Company beginning on January 1, 2024. The Company adopted ASU 2020-06 effective January 1, 2024. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated Recently Issued Accounting Pronouncements Not Yet Adopted as of March 31, 2024 In November 2023, the FASB issued Accounting Standards Update No. 2023-07 Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires public entities to disclose incremental segment information on an annual and interim basis. ASU 2023-07 requires public entities with a single reportable segment to provide all the disclosures required by the amendments in ASU 2023-07 and all existing segment disclosures in Segment Reporting (Topic 280) . ASU 2023-07 is effective for the Company for fiscal years beginning on January 1, 2024, and interim periods within fiscal years beginning on January 1, 2025. The Company is currently evaluating the impact of the adoption of this guidance on its financial position, results of operations and cash flow. In December 2023, the FASB issued Accounting Standards Update No. 2023-09 Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires public business entities to disclose specific categories in the income tax rate reconciliation annually and provide additional information for reconciling items that meet a qualitative threshold. ASU 2023-09 also requires that entities disclose annually additional information about income taxes paid and disaggregated information for certain items. ASU 2023-09 is effective for the Company beginning on January 1, 2025. The Company is currently evaluating the impact of the adoption of this guidance on its financial position, results of operations and cash flows . |
License and Collaboration Agree
License and Collaboration Agreement | 3 Months Ended |
Mar. 31, 2024 | |
License and Collaboration Agreement.. | |
License and Collaboration Agreement | |
License and Collaboration Agreement | Note 3. License and Collaboration Agreements Takeda Collaboration Agreement In January 2024, the Company entered into a worldwide license and collaboration agreement for the development and commercialization of rusfertide with Takeda Pharmaceuticals USA, Inc. (“Takeda”) (“the Takeda Collaboration Agreement”), which became effective in March 2024. The Company and Takeda will jointly develop and commercialize rusfertide and potentially other specified second-generation injectable hepcidin mimetic compounds (the “Licensed Products”) in the United States (the “Profit-Share Territory”). Takeda is solely and exclusively responsible for the development and commercialization of the Licensed Products in all other countries (the “Takeda Territory”). The Company and Takeda will share costs of the development, manufacture and commercialization activities for the Licensed Products in the Profit-Share Territory, provided that (i) the Company will lead, and will be responsible for its costs associated with, completion of the ongoing Phase 3 VERIFY program evaluating rusfertide for the treatment of polycythemia vera (“PV’) as well as associated U.S. regulatory activities; (ii) Takeda will lead, and will be solely responsible for its costs associated with, pre-commercialization activities related to rusfertide in the Profit-Share Territory, and (iii) Takeda will lead commercialization of rusfertide in the Profit-Share Territory, with Protagonist holding an option to co-detail. Takeda is solely responsible for all costs for the development, manufacture and commercialization of the Licensed Products in the Takeda Territory. The Company granted Takeda a non-transferable, sublicensable, and except for certain specified exceptions, exclusive license to certain intellectual property of the Company to exercise its rights and perform its obligations under the Takeda Collaboration Agreement. Within 30 days after the effectiveness of the Takeda Collaboration Agreement, the Company will receive an upfront payment of $300.0 million. In addition, the Company is eligible to receive additional worldwide development, regulatory and commercial milestone payments for rusfertide of up to $330.0 million, and tiered royalties from 10% to 17% on net sales of the Licensed Products in the Takeda Territory. The Company and Takeda will also share equally in profits and losses (50% to the Company and 50% to Takeda) for Licensed Products in the Profit-Share Territory. Takeda will book sales of the Licensed Products globally. The Company has the right to opt-out entirely of profit- and loss-sharing in the Profit-Share Territory for rusfertide and all other Licensed Products (the “Full Opt-out Right”) (i) during the 90-day period beginning 120 days after filing of a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for rusfertide for polycythemia vera (“PV’) (the “Initial Opt-out Period”); and (ii) for convenience without receipt of the Opt-out Payment (as defined below) (generally following the Initial Opt-out Period). In addition, if the Company does not exercise the Full Opt-out Right, the Company may opt-out of any Licensed Product other than rusfertide on a Licensed Product-by-Licensed Product basis (each, a “Partial Opt-out Right” and either the Full Opt-out Right or a Partial Opt-out right being an “Opt-out Right”). Following the Company’s exercise of an Opt-out Right, the Company has agreed to transition applicable development and commercial activities to Takeda, and Takeda has agreed to assume sole operational and financial responsibility for such activities in the United States. The Takeda Collaboration Agreement provides for aggregate development, regulatory and commercial milestone payments from Takeda to the Company for rusfertide of up to $975 million if the Company exercises the Full Opt-out Right. In addition to these milestone payments, in the event the Company exercises the Full Opt-out Right during the Initial Opt-out Period, the Company will receive: (i) a $200 million payment following its exercise of the Full Opt-out Right; and (ii) an additional $200 million payment following FDA approval of the NDA for rusfertide for PV (together, the “Opt-out Payment”). If the Company exercises an Opt-out Right, Takeda has agreed to pay the Company royalties of 14% to 29% on worldwide net sales of Licensed Products with respect to which the Company has exercised an Opt-out Right. Upcoming potential development and regulatory milestones under the Takeda Collaboration Agreement include: ● $25.0 million upon successful achievement of the primary endpoint in the Phase 3 VERIFY clinical trial for rusfertide in PV; and ● $50.0 million upon FDA approval of an NDA for rusfertide in PV (or $75.0 million if the Company exercises the Full Opt-out Right). The Company has evaluated the Takeda Collaboration Agreement and concluded that it has elements that are within the scope of Topic 606 and Topic 808. As of the effective date of the Takeda Collaboration Agreement, the Company identified two distinct performance obligations: (i) the rusfertide license delivered upon the effectiveness of the Takeda Collaboration Agreement and (ii) certain development services to be provided prior to the Initial Opt-out Period, including the Company’s responsibilities to complete the VERIFY Phase 3 clinical trial in PV and to file an NDA with the FDA upon successful completion of the VERIFY trial and associated manufacturing services. The Company has determined that the initial transaction price totaled $300.0 million, comprised of the upfront payment. The Company has excluded any future estimated milestones or royalties from this transaction price to date, all of which are either currently constrained or subject to the sales-and usage-based royalty exception. As part of the Company’s evaluation of this variable consideration constraint, it determined that the potential payments are contingent upon developmental and regulatory milestones that are uncertain and are highly susceptible to factors outside of its control. The Company allocated $254.1 million of the initial transaction price to the license and $45.9 million to the development services based upon the relative standalone selling price of each performance obligation. The amount allocated to the license, which represents functional intellectual property that was transferred at a point in time, was satisfied upon transfer of the license to Takeda. The amount allocated to development services will be recognized over time based on a measure of the Company’s efforts toward satisfying the performance obligation relative to the total expected efforts or inputs to satisfy the performance obligation (e.g., costs incurred compared to total budget). The Company recognized $0.9 million with respect to the period from effective date of the contract through March 31, 2024. The Company determined that the Takeda Collaboration Agreement met the definition of a collaborative arrangement under Topic 808. Both parties are active participants in directing and carrying out the development of the Licensed Products and both are exposed to the significant risk and rewards related to the commercial success of the Products. If the Company does not exercise an Opt-out Right (“Company Opt-in”), the Company and Takeda would co-detail the Licensed Products in the U.S. and share in the economic results through a profit-sharing structure. The Company has determined that development costs subsequent to the Company Opt-in date are within the scope of Topic 808, which does not provide recognition and measurement guidance. As such, the Company determined that Accounting Standards Codification Topic 730 – Research and Development JNJ License and Collaboration Agreement On July 27, 2021, the Company entered into an Amended and Restated License and Collaboration Agreement with J&J Innovative Medicines (“JNJ”), formerly Janssen Biotech, Inc., which amended and restated the License and Collaboration Agreement, effective July 13, 2017, by and between the Company and JNJ, as amended by the first amendment, effective May 7, 2019 (together, the “JNJ License and Collaboration Agreement”). From inception in 2017 through December 31, 2022, the Company earned a total of $112.5 million in non-refundable upfront cash payment from JNJ. During the fourth quarter of 2023, the Company earned a $50.0 million milestone payment in connection with the dosing of a third patient in the ICONIC-TOTAL Phase 3 clinical trial of JNJ-2113 in patients with moderate-to-severe psoriasis and a $10.0 million milestone payment upon t The JNJ License and Collaboration Agreement relates to the development, manufacture and commercialization of oral IL-23 receptor antagonist drug candidates and enables JNJ to develop collaboration compounds for multiple indications. Under the JNJ License and Collaboration Agreement, JNJ is required to use commercially reasonable efforts to develop at least one collaboration compound for at least two indications. Upcoming potential development and regulatory milestones include: ● $115.0 million upon a Phase 3 clinical trial for a second-generation compound for any indication meeting its primary clinical endpoint; ● $35.0 million upon the filing of an NDA for a second-generation compound with the FDA; ● $50.0 million upon FDA approval of an NDA for a second-generation compound; and ● $15.0 million upon the dosing of the third patient in a Phase 3 clinical trial for a second-generation compound for a second indication. The Company completed its performance obligation under the JNJ License and Collaboration Agreement as of June 30, 2022. Pursuant to the agreement, the Company is eligible to receive future sales milestone payments and tiered royalties on net product sales at percentages ranging from 6% to 10%. Revenue Recognition For the three months ended March 31, 2024, the Company recognized license and collaboration revenue of $255.0 million related to the Takeda Collaboration Agreement transaction price, including $254.1 million allocated to the rusfertide license delivered to Takeda upon effectiveness of the agreement in March 2024 and $0.9 million for development services provided by the Company during the period based on the cost-based input method. For the three months ended March 31, 2023, no license and collaboration revenue was recognized. The remaining unrecognized transaction price amount of $45.0 million was recorded as deferred revenue on the Company’s condensed consolidated balance sheet as of March 31, 2024 and will be recognized over time based on a measure of the Company’s efforts toward satisfying the performance obligation relative to the total expected efforts or inputs to satisfy the performance obligation (e.g. costs incurred compared to total budget). During the three months ended March 31, 2024 and 2023, the Company did not recognize revenue from any amounts included in the deferred revenue contract liability balance at the beginning of each period. None of the costs to obtain or fulfill the contracts were capitalized. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | Note 4. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1 Level 2— Level 3 In determining fair value, the Company utilizes quoted market prices, broker or dealer quotations, or valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The following tables present the fair value of the Company’s financial assets determined using the inputs defined above (in thousands): March 31, 2024 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 24,432 $ — $ — $ 24,432 Certificates of deposit — 10,661 — 10,661 Commercial paper — 170,510 — 170,510 Corporate debt securities — 12,657 — 12,657 U.S. Treasury and agency securities — 101,035 — 101,035 Total financial assets $ 24,432 $ 294,863 $ — $ 319,295 December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 19,212 $ — $ — $ 19,212 Certificates of deposit — 13,004 — 13,004 Commercial paper — 130,296 — 130,296 Corporate debt securities — 7,672 — 7,672 U.S. Treasury and agency securities — 145,085 — 145,085 Total financial assets $ 19,212 $ 296,057 $ — $ 315,269 The Company’s certificates of deposit, commercial paper, corporate debt securities, and U.S. Treasury and agency securities, including U.S. Treasury bills, are classified as Level 2 as they were valued based upon quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques, for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. The carrying amount of the Company’s remaining financial assets and liabilities, including cash, receivables and payables, approximates their fair value due to their short-term nature. |
Cash Equivalents and Marketable
Cash Equivalents and Marketable Securities | 3 Months Ended |
Mar. 31, 2024 | |
Cash Equivalents and Marketable Securities | |
Cash Equivalents and Marketable Securities | Note 5. Cash Equivalents and Marketable Securities Cash equivalents and marketable securities consisted of the following (in thousands): March 31, 2024 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 24,432 $ — $ — $ 24,432 Certificates of deposit 10,661 2 (2) 10,661 Commercial paper 170,606 1 (97) 170,510 Corporate debt securities 12,677 — (20) 12,657 U.S. Treasury and agency securities 101,037 4 (6) 101,035 Total cash equivalents and marketable securities $ 319,413 $ 7 $ (125) $ 319,295 Classified as: Cash equivalents $ 169,228 Marketable securities 150,067 Total cash equivalents and marketable securities $ 319,295 December 31, 2023 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 19,212 $ — $ — $ 19,212 Certificates of deposit 12,998 6 — 13,004 Commercial paper 130,351 5 (60) 130,296 Corporate debt securities 7,678 — (6) 7,672 U.S. Treasury and agency securities 145,024 63 (2) 145,085 Total cash equivalents and marketable securities $ 315,263 $ 74 $ (68) $ 315,269 Classified as: Cash equivalents $ 160,379 Marketable securities 154,890 Total cash equivalents and marketable securities $ 315,269 Marketable securities of $150.1 million and $154.9 million held as of March 31, 2024 and December 31, 2023, respectively, had contractual maturities of less than one year. The Company does not intend to sell its securities that are in an unrealized loss position, and it is not more likely than not that the Company will be required to sell its securities before recovery of their amortized cost basis, which may be at maturity. There were no material realized gains or realized losses on marketable securities for the periods presented. The Company evaluated securities with unrealized losses to determine whether such losses, if any, were due to credit-related factors and determined that there were no credit-related losses to be recognized as of March 31, 2024. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2024 | |
Balance Sheet Components | |
Balance Sheet Components | Note 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): March 31, December 31, 2024 2023 Prepaid clinical and research related expenses $ 1,645 $ 649 Prepaid insurance 1,335 1,410 Prepaid licenses 530 529 Other prepaid expenses 1,005 1,040 Other receivable 360 332 Prepaid expenses and other current assets $ 4,875 $ 3,960 Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): March 31, December 31, 2024 2023 Laboratory equipment $ 5,423 $ 5,323 Furniture and computer equipment 1,195 1,143 Leasehold improvements 963 963 Total property and equipment 7,581 7,429 Accumulated depreciation (6,470) (6,234) Property and equipment, net $ 1,111 $ 1,195 Accrued Expenses and Other Payables Accrued expenses and other payables consisted of the following (in thousands): March 31, December 31, 2024 2023 Accrued clinical and research related expenses $ 8,459 $ 11,841 Accrued employee related expenses 2,458 6,786 Accrued professional service fees 5,530 632 Other 40 99 Total accrued expenses and other payables $ 16,487 $ 19,358 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Equity | |
Stockholders' Equity | Note 7. Stockholders’ Equity Public Offering In April 2023, the Company completed an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $20.00 per share and issued an additional 750,000 shares of common stock at a price of $20.00 per share following the underwriters’ exercise of their option to purchase additional shares. Net proceeds, after deducting underwriting commissions and offering costs paid by the Company, were $107.8 million. ATM Offering In August 2022, the Company entered into an Open Market Sale Agreement SM , pursuant to which the Company may offer and sell up to $100.0 million shares of common stock from time to time in “at-the-market” offerings (the “2022 ATM Facility”). There were no sales of the Company’s common stock under the 2022 ATM Facility during the three months ended March 31, 2024. During the three months ended March 31, 2023, the Company sold 1,749,199 shares of its common stock under the 2022 ATM Facility for net proceeds of $24.3 million, after deducting issuance costs. Pre-Funded Warrants In August 2018, the Company entered into a Securities Purchase Agreement with certain accredited investors (each, an “Investor” and, collectively, the “Investors”), pursuant to which the Company sold an aggregate of 2,750,000 shares of its common stock at a price of $8.00 per share, for aggregate net proceeds of $21.7 million, after deducting offering expenses payable by the Company. In a concurrent private placement, the Company issued the Investors warrants to purchase an aggregate of 2,750,000 shares of its common stock (each, a “Warrant” and, collectively, the “Warrants”). Each Warrant was exercisable from August 8, 2018 through August 8, 2023. Warrants to purchase 1,375,000 shares of the Company’s common stock had an exercise price of $10.00 per share and Warrants to purchase 1,375,000 shares of the Company’s common stock had an exercise price of $15.00 per share. The common stock and Warrants met the criteria for equity classification and the net proceeds from the transaction were recorded as a credit to additional paid-in capital. In August 2023, prior to the expiration of the Warrants, the Company entered into certain agreements with the Investors and their affiliates under which the Company agreed to allow the Warrants to be exercised in exchange for pre-funded warrants representing the same number of Warrant Shares underlying the Warrants with an exercise price of $0.001 per share (the “Pre-Funded Warrants”). Subsequent to the execution of the agreements and prior to the expiration of the Warrants, all outstanding Warrants were exercised for gross proceeds of $34.4 million in exchange for 44,748 shares of the Company’s common stock and Pre-Funded Warrants to purchase 2,705,252 shares of common stock (subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Pre-Funded Warrants) with an exercise price of $0.001 per share. The Pre-Funded Warrants will expire upon the day they are exercised in full. The Pre-Funded Warrants are exercisable at any time prior to expiration except that the Pre-Funded Warrants cannot be exercised by the Investors if, after giving effect thereto, the Investors would beneficially own more than 9.99% of the Company’s common stock, subject to certain exceptions. The common stock and Pre-Funded Warrants met the criteria for equity classification and the net proceeds from the transaction were recorded as a credit to additional paid-in capital. In accordance with Accounting Standards Codification Topic 260, Earnings Per Share |
Net Income (Loss) per Share
Net Income (Loss) per Share | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share | |
Net Loss per Share | Note 9. Net Income (Loss) per Share The computation of basic net income (loss) per common share is based on the weighted-average number of common shares outstanding during each period. The computation of diluted net income (loss) per common share is based on the weighted-average number of common shares outstanding during the period plus, when their effect is dilutive, incremental shares consisting of shares subject to stock options, RSUs, PSUs, the Company’s employee stock purchase plan (“ESPP”), and warrants. In accordance with Accounting Standards Codification Topic 260, Earnings Per Share In periods when the Company has net income, the dilutive effect of all potentially outstanding shares is computed using the treasury stock method. In periods in which the Company reports a net loss, all common stock equivalents are deemed anti-dilutive such that basic net loss per common share and diluted net loss per common share are equal. The following table reconciles the numerator and denominator used to calculate diluted net income (loss) per common share Three Months Ended March 31, 2024 2023 Numerator: Net income (loss) $ 207,340 $ (33,725) Denominator: Weighted-average common share, basic 60,855,689 50,573,650 Dilutive effect of common stock equivalents 2,739,639 — Weighted-average common share, dilutive 63,595,328 50,573,650 Net income (loss) per common share Basic net income (loss) per common share $ 3.41 $ (0.67) Diluted net income (loss) per common share $ 3.26 $ (0.67) Approximately 4.2 million potentially dilutive common shares consisting of shares subject to outstanding stock options, RSUs, and ESPP were excluded from the diluted net income per common share computation for the three months ended March 31, 2024 because their effect was anti-dilutive. Approximately 12.0 million potentially dilutive common shares consisting of shares subject to outstanding stock options, RSUs, PSUs, ESPP and warrants were excluded from the diluted net loss per common share computation for the three months ended March 31, 2023 due to the Company’s net loss for the period. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes | |
Income Taxes | Note 8. Income Taxes The Company has recorded an income tax provision of $3.3 million for the three months ended March 31, 2024. No income tax provision was recorded for the three months ended March 31, 2023. The primary difference in tax expense as compared to the prior year is a result of taxable income resulting from the recognition of revenue in connection with the Takeda Collaboration Agreement. The tax provision for the three months ended March 31, 2024 was determined using an estimated annual effective tax rate, adjusted for discrete items, if any. Based on the available objective evidence during the three months ended March 31, 2024, the Company believes it is more likely than not that its net deferred tax assets may not be realized. The primary difference between the effective tax rate and the statutory tax rate relates to the Company's change in valuation allowance. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Event | |
Subsequent Event | Note 10. Subsequent Event On May 6, 2024, the Company amended its facility lease agreement dated as of March 6, 2017 (the “Amended Lease”) to lease 60,575 rentable square feet of office and laboratory space located in Newark, California. The term of the Amended Lease commences on July 1, 2024 (or such later date when tenant improvements in newly leased office space within the facility are substantially complete). Under the Amended Lease, which expires in November 2029, the Company will pay an initial monthly base rent of $3.53 per square foot, which will increase by 3.5% annually. The Amended Lease provides for an agreed-upon period of rent abatement. The Company will be responsible for its proportional share of operating expenses and tax obligations. No additional security deposit was required pursuant to the Amended Lease. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the condensed consolidated balance sheet as of March 31, 2024 has been derived from the Company’s unaudited consolidated financial statements at that date but does not include all of the information required by GAAP for complete consolidated financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair presentation of the Company’s condensed consolidated financial statements. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future period. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 27, 2024. |
Principles of Consolidation | Principles of Consolidation The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation. |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, accruals for research and development activities, stock-based compensation, income taxes, marketable securities and leases. Estimates related to revenue recognition include assumptions used to determine standalone selling price utilized to allocate the transaction price between distinct performance obligations, assumptions used to recognize revenue over time for certain performance obligations for which a cost-based input method is used as the measure of progress and estimates of whether contingent consideration should be included in the transaction price at each reporting period. Management bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to forecasted amounts and future events. Actual results may differ materially from these estimates. There has been uncertainty and disruption in the global economy and financial markets due to a number of factors, including geopolitical instability, inflationary pressures, high interest rates, a recessionary environment, domestic and global monetary and fiscal policy and other factors. The Company has taken into consideration any known impacts in its accounting estimates to date and is not aware of any additional specific events or circumstances that would require any additional updates to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the filing date of this Quarterly Report on Form 10-Q. These estimates may change as new events occur and additional information is obtained. Actual results could differ materially from these estimates under different assumptions or conditions. |
Cash as Reported in Consolidated Statements of Cash Flows | Cash as Reported in Condensed Consolidated Statements of Cash Flows Cash as reported in the condensed consolidated statements of cash flows includes the aggregate amounts of cash and cash equivalents and the restricted cash as presented on the condensed consolidated balance sheets. Cash as reported in the condensed consolidated statements of cash flows consisted of (in thousands): March 31, 2024 2023 Cash and cash equivalents $ 172,568 $ 127,686 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 172,793 $ 127,911 |
Stock-based Compensation Expense | Stock-Based Compensation Expense The Company has granted stock options, restricted stock units (“RSUs”) and performance share units (“PSUs”). Stock-based compensation expense associated with stock options is based on the estimated grant date fair value using the Black-Scholes valuation model, which requires the use of subjective assumptions related to expected stock price volatility, option term, risk-free interest rate and dividend yield. The Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. Stock-based compensation expense associated with RSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date. For RSUs, the Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest. PSUs allow the recipients of such awards to earn fully vested shares of the Company’s common stock upon the achievement of pre-established performance objectives. Stock-based compensation expense associated with PSUs is based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date and is recognized when the performance objective is expected to be achieved. The Company evaluates on a quarterly basis the probability of achieving the performance criteria. The cumulative effect on current and prior periods of a change in the estimated number of PSUs expected to be earned is recognized as compensation expense or as reduction of previously recognized compensation expense in the period of the revised estimate. The Company recognizes forfeitures of stock-based awards as they occur. Total stock-based compensation expense was as follows (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 5,288 $ 4,582 General and administrative 4,064 3,002 Total stock-based compensation expense $ 9,352 $ 7,584 |
Collaborative Arrangements | Collaborative Arrangements The Company analyzes its collaborative arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards, and therefore are within the scope of Accounting Standards Codification Topic 808 - Collaborative Arrangements (“Topic 808”). For collaborative arrangements that contain multiple elements, the Company determines which units of account are deemed to be within the scope of Topic 808 and which units of account are more reflective of a vendor-customer relationship, and therefore are within the scope of Accounting Standards Codification Topic 606 – Revenue from Contracts with Customers There have been no other material changes to the Company’s significant accounting policies during the three months ended March 31, 2024, as compared to those disclosed in Note 2. Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. |
Recently Adopted Accounting Pronouncement | Recently Adopted Accounting Pronouncements In August 2020, the FASB issued Accounting Standards Update No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it simplifies the diluted earnings per share calculation in certain areas. - is effective for the Company beginning on January 1, 2024. The Company adopted ASU 2020-06 effective January 1, 2024. The adoption of this guidance did not have a material impact on the Company’s condensed consolidated Recently Issued Accounting Pronouncements Not Yet Adopted as of March 31, 2024 In November 2023, the FASB issued Accounting Standards Update No. 2023-07 Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires public entities to disclose incremental segment information on an annual and interim basis. ASU 2023-07 requires public entities with a single reportable segment to provide all the disclosures required by the amendments in ASU 2023-07 and all existing segment disclosures in Segment Reporting (Topic 280) . ASU 2023-07 is effective for the Company for fiscal years beginning on January 1, 2024, and interim periods within fiscal years beginning on January 1, 2025. The Company is currently evaluating the impact of the adoption of this guidance on its financial position, results of operations and cash flow. In December 2023, the FASB issued Accounting Standards Update No. 2023-09 Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires public business entities to disclose specific categories in the income tax rate reconciliation annually and provide additional information for reconciling items that meet a qualitative threshold. ASU 2023-09 also requires that entities disclose annually additional information about income taxes paid and disaggregated information for certain items. ASU 2023-09 is effective for the Company beginning on January 1, 2025. The Company is currently evaluating the impact of the adoption of this guidance on its financial position, results of operations and cash flows . |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | |
Schedule of cash as reported in the condensed consolidated statements of cash flows | Cash as reported in the condensed consolidated statements of cash flows consisted of (in thousands): March 31, 2024 2023 Cash and cash equivalents $ 172,568 $ 127,686 Restricted cash - noncurrent 225 225 Total cash reported on condensed consolidated statements of cash flows $ 172,793 $ 127,911 |
Schedule of stock-based compensation expense | Total stock-based compensation expense was as follows (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 5,288 $ 4,582 General and administrative 4,064 3,002 Total stock-based compensation expense $ 9,352 $ 7,584 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Schedule of fair value of financial assets | The following tables present the fair value of the Company’s financial assets determined using the inputs defined above (in thousands): March 31, 2024 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 24,432 $ — $ — $ 24,432 Certificates of deposit — 10,661 — 10,661 Commercial paper — 170,510 — 170,510 Corporate debt securities — 12,657 — 12,657 U.S. Treasury and agency securities — 101,035 — 101,035 Total financial assets $ 24,432 $ 294,863 $ — $ 319,295 December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 19,212 $ — $ — $ 19,212 Certificates of deposit — 13,004 — 13,004 Commercial paper — 130,296 — 130,296 Corporate debt securities — 7,672 — 7,672 U.S. Treasury and agency securities — 145,085 — 145,085 Total financial assets $ 19,212 $ 296,057 $ — $ 315,269 |
Cash Equivalents and Marketab_2
Cash Equivalents and Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Cash Equivalents and Marketable Securities | |
Schedule of cash equivalents and marketable securities | Cash equivalents and marketable securities consisted of the following (in thousands): March 31, 2024 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 24,432 $ — $ — $ 24,432 Certificates of deposit 10,661 2 (2) 10,661 Commercial paper 170,606 1 (97) 170,510 Corporate debt securities 12,677 — (20) 12,657 U.S. Treasury and agency securities 101,037 4 (6) 101,035 Total cash equivalents and marketable securities $ 319,413 $ 7 $ (125) $ 319,295 Classified as: Cash equivalents $ 169,228 Marketable securities 150,067 Total cash equivalents and marketable securities $ 319,295 December 31, 2023 Amortized Gross Unrealized Cost Gains Losses Fair Value Money market funds $ 19,212 $ — $ — $ 19,212 Certificates of deposit 12,998 6 — 13,004 Commercial paper 130,351 5 (60) 130,296 Corporate debt securities 7,678 — (6) 7,672 U.S. Treasury and agency securities 145,024 63 (2) 145,085 Total cash equivalents and marketable securities $ 315,263 $ 74 $ (68) $ 315,269 Classified as: Cash equivalents $ 160,379 Marketable securities 154,890 Total cash equivalents and marketable securities $ 315,269 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Balance Sheet Components | |
Summary of prepaid expenses and other current assets | Prepaid expenses and other current assets consisted of the following (in thousands): March 31, December 31, 2024 2023 Prepaid clinical and research related expenses $ 1,645 $ 649 Prepaid insurance 1,335 1,410 Prepaid licenses 530 529 Other prepaid expenses 1,005 1,040 Other receivable 360 332 Prepaid expenses and other current assets $ 4,875 $ 3,960 |
Summary of property and equipment net | Property and equipment, net consisted of the following (in thousands): March 31, December 31, 2024 2023 Laboratory equipment $ 5,423 $ 5,323 Furniture and computer equipment 1,195 1,143 Leasehold improvements 963 963 Total property and equipment 7,581 7,429 Accumulated depreciation (6,470) (6,234) Property and equipment, net $ 1,111 $ 1,195 |
Schedule of accrued expenses and other payables | Accrued expenses and other payables consisted of the following (in thousands): March 31, December 31, 2024 2023 Accrued clinical and research related expenses $ 8,459 $ 11,841 Accrued employee related expenses 2,458 6,786 Accrued professional service fees 5,530 632 Other 40 99 Total accrued expenses and other payables $ 16,487 $ 19,358 |
Net Income (Loss) per Share (Ta
Net Income (Loss) per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share | |
Schedule of computation of the basic and diluted net loss per share attributable to common stockholders | The following table reconciles the numerator and denominator used to calculate diluted net income (loss) per common share Three Months Ended March 31, 2024 2023 Numerator: Net income (loss) $ 207,340 $ (33,725) Denominator: Weighted-average common share, basic 60,855,689 50,573,650 Dilutive effect of common stock equivalents 2,739,639 — Weighted-average common share, dilutive 63,595,328 50,573,650 Net income (loss) per common share Basic net income (loss) per common share $ 3.41 $ (0.67) Diluted net income (loss) per common share $ 3.26 $ (0.67) |
Organization and Description _2
Organization and Description of Business - Liquidity (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 USD ($) segment | Dec. 31, 2023 USD ($) | |
Organization and Description of Business | ||
Number of operating segments | segment | 1 | |
Net losses from operations since inception | ||
Cash, cash equivalents and marketable securities | $ 322,600 | |
Accumulated deficit | $ (408,370) | $ (615,710) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Restricted Cash and Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Aggregate amounts of cash and cash equivalents and the restricted cash | ||||
Cash and cash equivalents | $ 172,568 | $ 186,727 | $ 127,686 | |
Restricted cash - noncurrent | 225 | 225 | 225 | |
Total cash reported on consolidated statements of cash flows | $ 172,793 | $ 186,952 | $ 127,911 | $ 125,969 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Stock-based Compensation Expense (Details) - 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] | ||
Total stock-based compensation expense | $ 9,352 | $ 7,584 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | 5,288 | 4,582 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 4,064 | $ 3,002 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 72 Months Ended | 87 Months Ended | |||||
Mar. 31, 2024 | Feb. 29, 2024 | Jan. 31, 2024 | Jun. 30, 2022 | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2024 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
License and collaboration revenue | $ 254,953,000 | $ 0 | |||||||
Revenue from Contract with Customer, Product and Service [Extensible List] | License And Service | License And Service | |||||||
Recognized revenue from deferred revenue contract liability | $ 0 | $ 0 | |||||||
Contract with customer, deferred revenue contract liability | $ 45,000,000 | 45,000,000 | $ 45,000,000 | ||||||
Janssen | Non-refundable, upfront cash payment | Services performed for IL-23 receptor antagonist compound research costs and other services | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
License and collaboration revenue | $ 112,500,000 | ||||||||
Janssen | Restated Agreement | Iconic Total Phase | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
License and collaboration revenue | $ 50,000,000 | ||||||||
Janssen | Restated Agreement | Anthem Phase Two B Member | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
License and collaboration revenue | $ 10,000,000 | ||||||||
Janssen | Restated Agreement | Minimum | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percentage of royalties on net product sales | 6% | ||||||||
Janssen | Restated Agreement | Maximum | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percentage of royalties on net product sales | 10% | ||||||||
Janssen | Restated Agreement | License And Service | Phase 3 clinical trial for a second-generation compound for any indication | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upcoming potential development milestones | 115,000,000 | 115,000,000 | 115,000,000 | ||||||
Janssen | Restated Agreement | License And Service | Filing of New Drug Application ("NDA") for second-generation compound with the U.S. Food and Drug Administration | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upcoming potential development milestones | 35,000,000 | 35,000,000 | 35,000,000 | ||||||
Janssen | Restated Agreement | License And Service | FDA approval of NDA for second-generation compound | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upcoming potential development milestones | 50,000,000 | 50,000,000 | 50,000,000 | ||||||
Janssen | Restated Agreement | License And Service | Dosing Of Third Patient In Phase 3 Clinical Trial For Second Generation Compound For A Second Indication [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upcoming potential development milestones | 15,000,000 | 15,000,000 | 15,000,000 | ||||||
Janssen | License and collaboration agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Proceeds from Milestone Payments | $ 172,500,000 | ||||||||
Takeda Pharmaceuticals | License And Service | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Profit (loss) share on U.S. profits and losses | 50% | ||||||||
Takeda Pharmaceuticals | Development Services | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront payment | $ 45,900,000 | ||||||||
Revenue recognized | 900,000 | ||||||||
Takeda Pharmaceuticals | License and collaboration agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Final transaction price | $ 300,000,000 | 300,000,000 | |||||||
Revenue recognized | $ 254,100,000 | $ 255,000,000 | |||||||
Takeda Pharmaceuticals | License and collaboration agreement | Phase Three Clinical Trial For Rusfertide In PV [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upcoming Potential Development and Regulatory Milestones Payments | 25,000,000 | ||||||||
Takeda Pharmaceuticals | License and collaboration agreement | Food And Drug Administration Approval Of New Drug Application For Rusfertide In PV [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upcoming Potential Development and Regulatory Milestones Payments | 50,000,000 | ||||||||
Takeda Pharmaceuticals | License and collaboration agreement | Food And Drug Administration Approval Of New Drug Application For Rusfertide In PV [Member] | Exercise of Full Opt-out Right [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upcoming Potential Development and Regulatory Milestones Payments | $ 75,000,000 | ||||||||
Takeda Pharmaceuticals | License and collaboration agreement | Minimum | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Percentage of royalties on ex-U.S. net sales | 10% | 14% | |||||||
Takeda Pharmaceuticals | License and collaboration agreement | Maximum | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Collaborative Arrangement Milestone Additional Payment Eligible To Receive | $ 200,000,000 | ||||||||
Collaborative arrangement, milestone payment, eligible to receive | $ 330,000,000 | ||||||||
Percentage of royalties on ex-U.S. net sales | 17% | 29% | |||||||
Takeda Pharmaceuticals | License and collaboration agreement | Maximum | Exercise of Full Opt-out Right [Member] | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Collaborative arrangement, milestone payment, eligible to receive | $ 975,000,000 | ||||||||
Takeda Pharmaceuticals | License and collaboration agreement | Maximum | Exercise of Full Opt-out Right During The Initial Opt-out Period (Member) | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Collaborative arrangement, milestone payment, eligible to receive | 200,000,000 | ||||||||
Takeda Pharmaceuticals | License and collaboration agreement | License and Maintenance | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront payment | $ 254,100,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 319,295 | $ 315,269 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 24,432 | 19,212 |
Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 10,661 | 13,004 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 170,510 | 130,296 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 12,657 | 7,672 |
U.S. Treasury and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 101,035 | 145,085 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 24,432 | 19,212 |
Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 24,432 | 19,212 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 294,863 | 296,057 |
Level 2 | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 10,661 | 13,004 |
Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 170,510 | 130,296 |
Level 2 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | 12,657 | 7,672 |
Level 2 | U.S. Treasury and agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 101,035 | $ 145,085 |
Cash Equivalents and Marketab_3
Cash Equivalents and Marketable Securities - Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | $ 319,413 | $ 315,263 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 7 | 74 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (125) | (68) |
Total cash equivalents and marketable securities, Fair Value | 319,295 | 315,269 |
Corporate debt securities | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 12,677 | 7,678 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (20) | (6) |
Total cash equivalents and marketable securities, Fair Value | 12,657 | 7,672 |
U.S. Treasury and agency securities | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 101,037 | 145,024 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 4 | 63 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (6) | (2) |
Total cash equivalents and marketable securities, Fair Value | 101,035 | 145,085 |
Money market funds | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 24,432 | 19,212 |
Total cash equivalents and marketable securities, Fair Value | 24,432 | 19,212 |
Commercial paper | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 170,606 | 130,351 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 1 | 5 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (97) | (60) |
Total cash equivalents and marketable securities, Fair Value | 170,510 | 130,296 |
Certificates of deposit | ||
Cash Equivalents and Marketable Securities | ||
Total cash equivalents and marketable securities, Amortized Cost | 10,661 | 12,998 |
Total cash equivalents and marketable securities, Gross Unrealized Gains | 2 | 6 |
Total cash equivalents and marketable securities, Gross Unrealized Losses | (2) | |
Total cash equivalents and marketable securities, Fair Value | $ 10,661 | $ 13,004 |
Cash Equivalents and Marketab_4
Cash Equivalents and Marketable Securities - Classification of Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Classified as: | ||
Cash equivalents | $ 169,228 | $ 160,379 |
Marketable securities - current | 150,067 | 154,890 |
Total cash equivalents and marketable securities | $ 319,295 | $ 315,269 |
Contractual maturities | ||
Maximum period of current contractual maturities | 1 year | 1 year |
Realized Gain (loss) | $ 0 | $ 0 |
Credit-related losses to be recognized | $ 0 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Prepaid expenses and other current assets | ||
Prepaid clinical and research related expenses | $ 1,645 | $ 649 |
Prepaid insurance | 1,335 | 1,410 |
Prepaid licenses | 530 | 529 |
Other prepaid expenses | 1,005 | 1,040 |
Other receivable | 360 | 332 |
Prepaid expenses and other current assets | $ 4,875 | $ 3,960 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property and Equipment | ||
Total property and equipment | $ 7,581 | $ 7,429 |
Accumulated depreciation | (6,470) | (6,234) |
Property and equipment, net | 1,111 | 1,195 |
Laboratory equipment | ||
Property and Equipment | ||
Total property and equipment | 5,423 | 5,323 |
Furniture and computer equipment | ||
Property and Equipment | ||
Total property and equipment | 1,195 | 1,143 |
Leasehold improvements | ||
Property and Equipment | ||
Total property and equipment | $ 963 | $ 963 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Expenses and Other Payables (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Accrued Expenses and Other Payables | ||
Accrued clinical and research related expenses | $ 8,459 | $ 11,841 |
Accrued employee related expenses | 2,458 | 6,786 |
Accrued professional service fees | 5,530 | 632 |
Other | 40 | 99 |
Total accrued expenses and other payables | $ 16,487 | $ 19,358 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | ||||||
Aug. 08, 2018 | Aug. 31, 2023 | Apr. 30, 2023 | Aug. 31, 2022 | Aug. 31, 2018 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Stock transactions | ||||||||
Warrants issued to purchase common stock, number of shares | 2,705,252 | 2,620,260 | ||||||
Common stock, par value | $ 0.00001 | $ 0.00001 | ||||||
Exercise Price (per share) | $ 0.001 | |||||||
Proceeds from exercise of Warrants in exchange for issuance of Pre-funded Warrants | $ 34.4 | |||||||
Minimum percentage of common stock held by investors for not exercise of warrants | 9.99% | |||||||
Issuance of common stock upon exercise of Pre-Funded Warrants (in shares) | 44,748 | 84,992 | ||||||
Stock Issued During Period, Shares, Warrants Exercised | 44,748 | 84,992 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,705,252 | 2,620,260 | ||||||
2022 Sales Agreement | ||||||||
Stock transactions | ||||||||
Common stock issued (in shares) | 0 | 1,749,199 | ||||||
Maximum aggregate offering price | $ 100 | |||||||
Aggregate net proceeds | $ 24.3 | |||||||
Underwritten public offering | ||||||||
Stock transactions | ||||||||
Net proceeds from sale of common stock | $ 107.8 | |||||||
Common stock issued (in shares) | 5,000,000 | |||||||
Common stock issued, price per share | $ 20 | |||||||
Over-Allotment Option | ||||||||
Stock transactions | ||||||||
Common stock issued (in shares) | 750,000 | |||||||
Common stock issued, price per share | $ 20 | |||||||
Common Stock | ||||||||
Stock transactions | ||||||||
Issuance of common stock upon exercise of Pre-Funded Warrants (in shares) | 84,989 | |||||||
Stock Issued During Period, Shares, Warrants Exercised | 84,989 | |||||||
Investors | Private Placement | ||||||||
Stock transactions | ||||||||
Warrants exercisable date | Aug. 08, 2023 | |||||||
Aggregate gross proceeds | $ 21.7 | |||||||
Investors | Common Stock | Private Placement | ||||||||
Stock transactions | ||||||||
Warrants issued to purchase common stock, number of shares | 2,750,000 | |||||||
Common stock issued (in shares) | 2,750,000 | |||||||
Common stock issued, price per share | $ 8 | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,750,000 | |||||||
$10.00 per share | Common Stock | Private Placement | ||||||||
Stock transactions | ||||||||
Warrants to purchase common stock (in shares) | 1,375,000 | |||||||
Exercise Price (per share) | $ 10 | |||||||
$15.00 per share | Common Stock | Private Placement | ||||||||
Stock transactions | ||||||||
Warrants to purchase common stock (in shares) | 1,375,000 | |||||||
Exercise Price (per share) | $ 15 |
Net Income (Loss) per Share (De
Net Income (Loss) per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Numerator: | ||
Net income (loss) | $ 207,340 | $ (33,725) |
Denominator: | ||
Weighted-average common share, basic | 60,855,689 | 50,573,650 |
Dilutive effect of common stock equivalents | 2,739,639 | |
Weighted-average common share, dilutive | 63,595,328 | 50,573,650 |
Basic net income (loss) per common share | $ 3.41 | $ (0.67) |
Diluted net income (loss) per common share | $ 3.26 | $ (0.67) |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 4,200,000 | 12,000,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Taxes | ||
Provision for income taxes | $ 3,326 | $ 0 |
Subsequent Event (Details)
Subsequent Event (Details) $ in Millions | 1 Months Ended | ||
May 06, 2024 ft² $ / ft² | Feb. 29, 2024 USD ($) | Jan. 31, 2024 | |
Takeda Pharmaceuticals | License and collaboration agreement | Maximum | |||
Subsequent Event [Line Items] | |||
Collaborative arrangement, milestone payment, eligible to receive | $ | $ 330 | ||
Percentage of royalties on ex-U.S. net sales | 17% | 29% | |
Takeda Pharmaceuticals | License and collaboration agreement | Minimum | |||
Subsequent Event [Line Items] | |||
Percentage of royalties on ex-U.S. net sales | 10% | 14% | |
Subsequent Event | |||
Subsequent Event [Line Items] | |||
Area of Land | ft² | 60,575 | ||
Initial monthly base rent (per square foot) | $ / ft² | 3.53 | ||
Percentage annual increase | 0.035 |
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) | $ 207,340 | $ (33,725) |
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 |