Protagonist Therapeutics, Inc 10-Q

ITEM 1. FINANCIAL STATEMENTS PROTAGONIST THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (Unaudited) (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ ​ ​ ​ 2026 ​ ​ ​ 2025 Assets ​ ​ ​ ​ ​ ​ Current assets: ​ ​ ​ ​ ​ ​ Cash and cash equivalents ​ $ 193,712 ​ $ 128,390 Marketable securities ​ ​ 354,074 ​ ​ 438,974 Receivable from collaboration partner ​ ​ 53,663 ​ ​ 121 Prepaid expenses and other current assets ​ ​ 12,006 ​ ​ 10,089 Total current assets ​ ​ 613,455 ​ ​ 577,574 Marketable securities - noncurrent ​ ​ 72,548 ​ ​ 78,638 Property and equipment, net ​ ​ 3,778 ​ ​ 3,860 Restricted cash - noncurrent ​ ​ 288 ​ ​ 287 Operating lease right-of-use asset ​ ​ 7,390 ​ ​ 7,829 Total assets ​ $ 697,459 ​ $ 668,188 Liabilities and Stockholders’ Equity ​ ​ ​ ​ ​ ​ Current liabilities: ​ ​ ​ ​ ​ ​ Accounts payable ​ $ 8,437 ​ $ 5,339 Accrued expenses and other payables ​ ​ 17,491 ​ ​ 28,269 Deferred revenue ​ ​ 6,282 ​ ​ 9,550 Operating lease liability ​ ​ 2,339 ​ ​ 2,283 Total current liabilities ​ ​ 34,549 ​ ​ 45,441 Operating lease liability - noncurrent ​ ​ 7,437 ​ ​ 8,040 Total liabilities ​ ​ 41,986 ​ ​ 53,481 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, 180,000,000 shares authorized; 64,227,057 and 62,577,897 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively ​ ​ 1 ​ ​ 1 Additional paid-in capital ​ ​ 1,122,629 ​ ​ 1,084,736 Accumulated other comprehensive (loss) income ​ ​ ( 269 ) ​ ​ 641 Accumulated deficit ​ ​ ( 466,888 ) ​ ​ ( 470,671 ) Total stockholders’ equity ​ ​ 655,473 ​ ​ 614,707 Total liabilities and stockholders’ equity ​ $ 697,459 ​ $ 668,188 ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ 1 Table of Contents PROTAGONIST THERAPEUTICS, INC. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ ​ March 31, ​ ​ ​ ​ 2026 ​ ​ ​ 2025 License and collaboration revenue ​ $ 56,368 ​ $ 28,321 Operating expenses: ​ ​ ​ ​ ​ ​ Research and development ​ ​ 46,739 ​ ​ 35,893 General and administrative ​ 13,277 ​ 11,738 Total operating expenses ​ 60,016 ​ 47,631 Loss from operations ​ ( 3,648 ) ​ ( 19,310 ) Interest income ​ 5,876 ​ ​ 7,573 Other income, net ​ ​ 53 ​ ​ 82 Income (loss) before income tax benefit ​ ​ 2,281 ​ ​ ( 11,655 ) Income tax benefit ​ ​ 1,502 ​ ​ — Net income (loss) ​ $ 3,783 ​ $ ( 11,655 ) Net income (loss) per share, basic ​ $ 0.06 ​ $ ( 0.19 ) Net income (loss) per share, diluted ​ $ 0.05 ​ $ ( 0.19 ) Weighted-average shares used to compute net income (loss) per share, basic ​ 65,087,847 ​ 62,963,806 Weighted-average shares used to compute net income (loss) per share, diluted ​ 70,492,618 ​ 62,963,806 ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ 2 Table of Contents PROTAGONIST THERAPEUTICS, INC. Condensed Consolidated Statements of Comprehensive Incom e (Loss) (Unaudited) (In thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ ​ March 31, ​ ​ ​ ​ 2026 ​ ​ ​ 2025 Net income (loss) ​ $ 3,783 ​ $ ( 11,655 ) Other comprehensive (loss) income: ​ ​ ​ ​ ​ ​ Unrealized (loss) gain on marketable securities ​ ​ ( 910 ) ​ ​ 167 Comprehensive income (loss) ​ $ 2,873 ​ $ ( 11,488 ) ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ ​ 3 Table of Contents PROTAGONIST THERAPEUTICS, INC. Condensed Consolidated Statements of Stockhold ers’ Equity (Unaudited) (In thousands, except share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ Total ​ ​ Common ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ ​ Stock ​ Capital ​ (Loss) income ​ Deficit ​ Equity Three months ended March 31, 2026 ​ Shares ​ Amount ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2025 62,577,897 ​ $ 1 ​ $ 1,084,736 ​ $ 641 ​ $ ( 470,671 ) ​ $ 614,707 Issuance of common stock under equity incentive and employee stock purchase plans ​ 1,649,160 ​ ​ — ​ ​ 23,374 ​ ​ — ​ ​ — ​ ​ 23,374 Stock-based compensation expense — ​ — ​ 14,519 ​ — ​ — ​ 14,519 Other comprehensive loss — ​ — ​ — ​ ( 910 ) ​ — ​ ( 910 ) Net income — ​ — ​ — ​ — ​ 3,783 ​ 3,783 Balance at March 31, 2026 64,227,057 ​ $ 1 ​ $ 1,122,629 ​ $ ( 269 ) ​ $ ( 466,888 ) ​ $ 655,473 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ Total ​ ​ Common ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ ​ Stock ​ Capital ​ (Loss) income ​ Deficit ​ Equity Three months ended March 31, 2025 ​ Shares ​ Amount ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2024 ​ 61,035,139 ​ $ 1 ​ $ 1,015,898 ​ $ ( 82 ) ​ $ ( 340,522 ) ​ $ 675,295 Issuance of common stock under equity incentive and employee stock purchase plans 906,257 ​ — ​ 11,922 ​ — ​ — ​ 11,922 Shares withheld for net settlement of tax withholding upon vesting of restricted stock units ​ ( 12,636 ) ​ ​ — ​ ​ ( 479 ) ​ ​ — ​ ​ — ​ ​ ( 479 ) Stock-based compensation expense — ​ — ​ 13,802 ​ — ​ — ​ 13,802 Other comprehensive income — ​ — ​ — ​ 167 ​ — ​ 167 Net loss — ​ — ​ — ​ — ​ ( 11,655 ) ​ ( 11,655 ) Balance at March 31, 2025 61,928,760 ​ $ 1 ​ $ 1,041,143 ​ $ 85 ​ $ ( 352,177 ) ​ $ 689,052 ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ 4 Table of Contents ​ PROTAGONIST THERAPEUTICS, INC. Condensed Consolidated Statements of Cash Flows (Unaudited) (In thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ ​ March 31, ​ ​ ​ ​ 2026 ​ ​ ​ 2025 Cash Flows from Operating Activities ​ ​ ​ ​ ​ Net income (loss) ​ $ 3,783 ​ $ ( 11,655 ) Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities: ​ ​ ​ ​ ​ ​ Stock-based compensation ​ ​ 14,519 ​ ​ 13,802 Non-cash lease expense ​ ​ 439 ​ ​ 569 Depreciation ​ ​ 407 ​ ​ 239 Accretion of discount on marketable securities ​ ​ ( 1,025 ) ​ ​ ( 2,289 ) Other ​ ​ ( 2 ) ​ ​ 5 Changes in operating assets and liabilities: ​ ​ ​ ​ ​ ​ Receivable from collaboration partner ​ ​ ( 53,542 ) ​ ​ 165,000 Contract asset ​ ​ — ​ ​ ( 22,825 ) Prepaid expenses and other assets ​ ​ ( 1,918 ) ​ ​ ( 948 ) Accounts payable ​ ​ 3,003 ​ ​ 1,237 Accrued expenses and other payables ​ ​ ( 10,792 ) ​ ​ ( 11,817 ) Deferred revenue ​ ​ ( 3,268 ) ​ ​ ( 5,496 ) Income taxes payable ​ ​ — ​ ​ ( 800 ) Operating lease liability ​ ​ ( 547 ) ​ ​ 341 Net cash (used in) provided by operating activities ​ ​ ( 48,943 ) ​ ​ 125,363 Cash Flows from Investing Activities ​ ​ ​ ​ ​ ​ Purchase of marketable securities ​ ​ ( 68,968 ) ​ ​ ( 214,040 ) Proceeds from maturities of marketable securities ​ ​ 156,691 ​ ​ 113,180 Proceeds from sale of marketable securities ​ ​ 3,384 ​ ​ 7,003 Purchases of property and equipment ​ ​ ( 215 ) ​ ​ ( 545 ) Net cash provided by (used in) investing activities ​ ​ 90,892 ​ ​ ( 94,402 ) Cash Flows from Financing Activities ​ ​ ​ ​ ​ ​ Proceeds from issuance of common stock upon exercise of stock options and purchases under employee stock purchase plan ​ ​ 23,374 ​ ​ 11,922 Tax withholding payments related to net settlement of restricted stock units ​ ​ — ​ ​ ( 479 ) Net cash provided by financing activities ​ ​ 23,374 ​ ​ 11,443 Net increase in cash, cash equivalents and restricted cash ​ ​ 65,323 ​ ​ 42,404 Cash, cash equivalents and restricted cash, beginning of period ​ 128,677 ​ 97,474 Cash, cash equivalents and restricted cash, end of period ​ $ 194,000 ​ $ 139,878 Supplemental Disclosure of Non-Cash Financing and Investing Information: ​ ​ ​ ​ ​ ​ Purchases of property and equipment in accounts payable and accrued liabilities ​ $ 110 ​ $ 33 ​ The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. ​ ​ ​ ​ ​ 5 Table of Contents PROTAGONIST THERAPEUTICS, INC. Notes to Unaudited Condensed Consolidated Financial Statements Note 1. Organization and Description of Business Protagonist Therapeutics, Inc. (the “Company”) is a discovery through late-stage development biopharmaceutical company with a proprietary peptide technology platform that enables de novo discovery of peptide therapeutics. The Company’s programs fall into three broad therapeutic areas: (i) inflammation and immunology (“I&I”), (ii) hematology and (iii) metabolic diseases. The Company’s aim is to develop medicines for biologically and commercially validated targets which demonstrate a strong differentiation compared to existing therapies. ICOTYDE™ (icotrokinra) was approved in the United States in March 2026 for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older who weigh at least 40kg and are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (“IL-23R”) and is licensed to Janssen Biotech, Inc, a Johnson & Johnson company (“JNJ”). ICOTYDE was jointly discovered by the Company and JNJ scientists, with the Company having primary responsibility for the development of ICOTYDE through Phase 1, and JNJ assuming responsibility for further development and commercialization. In September 2025, JNJ submitted an application to the European Medicines Agency (“EMA”) seeking the first approval of ICOTYDE for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe plaque psoriasis. ICOTYDE is in Phase 3 development for psoriatic arthritis and ulcerative colitis, and in Phase 2b/3 for Crohn’s disease. Rusfertide, a first-in-class investigational injectable mimetic of the natural hormone hepcidin, is currently in development for the treatment of the rare blood disorder polycythemia vera (“PV”). Rusfertide is being co-developed with Takeda Pharmaceuticals, Inc. (“Takeda”). The Company holds an option to co-commercialize rusfertide in the United States through a 50/50 profit and loss share structure with Takeda or can opt out of this structure. In August 2025, rusfertide was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (the “FDA”) for the treatment of erythrocytosis in patients with PV. In December 2025, a New Drug Application (“NDA”) was submitted to the FDA by Takeda and the Company seeking the first approval of rusfertide for the treatment of adults with PV. The NDA was granted priority review by the FDA, with a Prescription Drug User Fee Act target action date in the third quarter of 2026. The Company also has a number of clinical and pre-clinical programs addressing biologically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, obesity dual agonist peptide PN-458, oral small molecule hepcidin functional mimetic PN-8047, and IL-4 and amylin programs. The Company is headquartered in Newark, California and has one wholly owned subsidiary, Protagonist Pty Limited (“Protagonist Australia”), located in Brisbane, Queensland, Australia. 6 Table of Contents Note 2. Summary of Significant Accounting Policies 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, 2026 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, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026 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, 2025 included in the Company’s Annual Report on Form 10-K, filed with the SEC on February 25, 2026. 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, estimates of whether contingent consideration should be included in the transaction price at each reporting period, and estimates related to royalty revenue recognition. 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 but not limited to geopolitical instability and changes in trade policies, including tariffs or other trade restrictions or the threat of such actions and retaliatory actions. The Company’s business may also be impacted by changes or disruptions at the FDA and other government agencies. The Company has taken into consideration any known impacts to 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. 7 Table of Contents 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 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, ​ ​ ​ ​ 2026 ​ ​ ​ 2025 Cash and cash equivalents ​ $ 193,712 ​ $ 139,653 Restricted cash - noncurrent ​ 288 ​ 225 Total cash reported on condensed consolidated statements of cash flows ​ $ 194,000 ​ $ 139,878 ​ Restricted cash as of March 31, 2026 consists of (i) a $ 225 thousand cash deposit held as security in connection with a letter of credit related to the Company’s facility lease entered into in March 2017, as subsequently amended, and (ii) a $ 63 thousand cash deposit held as security in connection with the issuance of a bank guarantee in May 2025 to maintain the active status of the Company’s value-added tax registration. ​ Stock-Based Compensation Expense ​ The Company has granted stock options, restricted stock units (“RSUs”) and performance stock 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 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 the probability of achieving the performance criteria on a quarterly basis. 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. No stock-based compensation related to PSUs was recognized for the three months ended March 31, 2026. The Company recognized $ 1.8 million of stock-based compensation expense related to PSUs for the three months ended March 31, 2025. ​ 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, ​ ​ ​ ​ 2026 ​ ​ ​ 2025 Research and development ​ $ 7,769 ​ $ 7,991 General and administrative ​ 6,750 ​ 5,811 Total stock-based compensation expense ​ $ 14,519 ​ $ 13,802 ​ 8 Table of Contents Significant Accounting Policies ​ There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2026, 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, 2025. ​ Recently Issued Accounting Pronouncements Not Yet Adopted as of March 31, 2026 In December 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2025-11 Interim Reporting (Topic 270) – Narrow Scope Improvements (“ASU 2025-11”), which clarifies interim disclosure requirements. ASU 2025-11 also requires entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. This guidance is effective for the Company for interim reporting periods within annual reporting periods beginning on January 1, 2028. Early adoption is permitted. The guidance may be applied either (1) prospectively or (2) retrospectively to any or all prior periods presented in the financial statements. The Company does not expect the adoption of this guidance to have a material effect on its consolidated financial statements and related disclosures. ​ In November 2024, the FASB issued ASU No. 2024-03 Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires detailed disclosures about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. In January 2025, the FASB issued an update to ASU 2024-03 clarifying that all public business entities should initially adopt the disclosure requirements in the first annual reporting period beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. ASU 2024-03 is effective for the Company for fiscal years beginning on January 1, 2027, and for interim periods beginning on January 1, 2028. Early adoption is permitted. The guidance may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of ASU 2024-03 or (2) retrospectively to all prior periods presented in the financial statements. The Company does not expect the adoption of this guidance to have a material effect on its consolidated financial statements and continues to evaluate disclosure presentation alternatives. ​ Note 3. License and Collaboration Agreements JNJ License and Collaboration Agreement ​ In November 2024, the Company entered into an Amended and Restated License and Collaboration Agreement with JNJ, which amended and restated the License and Collaboration Agreement, effective July 2017, by and between the Company and JNJ, as amended in May 2019 and July 2021 (together, the “JNJ License and Collaboration Agreement”). The JNJ License and Collaboration Agreement relates to the development, manufacture and commercialization of oral IL-23R 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. ​ During the first quarter of 2026, the Company earned a $ 50.0 million milestone payment upon FDA approval of ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients over 12 years of age or older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The Company has earned a total of $ 387.5 million in non-refundable payments from JNJ under the JNJ License and Collaboration Agreement from inception in 2017 through March 31, 2026. ​ Upcoming potential development milestones under the JNJ License and Collaboration Agreement include: ● $ 25.0 million upon the acceptance of an NDA filing by the FDA for a second indication; ● $ 45.0 million upon FDA approval of an NDA for a second indication; 9 Table of Contents ● $ 35.0 million upon the acceptance of an NDA filing by the FDA for a third indication; and ● $ 50.0 million upon FDA approval of an NDA for a third indication. 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 %. In addition, the Company remains eligible to receive sales milestones of up to $ 425.0 million. Takeda Collaboration Agreement In January 2024, the Company entered into a worldwide license and collaboration agreement for rusfertide with Takeda, which became effective in March 2024, and was amended in March 2025 (the “Takeda Collaboration Agreement”). Pursuant to the Takeda Collaboration Agreement, the Company and Takeda are jointly developing and commercializing 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 share the costs of the development, manufacture and commercialization activities for the Licensed Products in the Profit-Share Territory, provided that (i) the Company leads, and is solely responsible for its costs associated with, completion of the ongoing Phase 3 VERIFY trial evaluating rusfertide for the treatment of PV; (ii) Takeda leads, and is solely responsible for its costs associated with, U.S. regulatory and pre-commercialization activities related to rusfertide in the Profit-Share Territory; and (iii) Takeda leads commercialization of rusfertide in the Profit-Share Territory, with the Company 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. In March 2025, the Company and Takeda agreed, pursuant to the provisions of the Takeda Collaboration Agreement, as amended, that Takeda would assume responsibility for leading and implementing the regulatory strategy and associated activities for preparation of the NDA related to rusfertide in PV, which was submitted to the FDA in December 2025. The Company was primarily responsible for clinical development activities through the NDA filing and remains responsible for conducting ongoing rusfertide long-term extension studies. ​ The Company received a one-time, non-refundable upfront payment of $ 300.0 million in April 2024 and a $25.0 million milestone payment in September 2025. In addition, the Company is eligible to receive additional worldwide development, regulatory and commercial milestone payments for rusfertide of up to $ 305.0 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 the filing of an NDA with the FDA for rusfertide for 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 $ 975.0 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 $ 200.0 million payment following its exercise of the 10 Table of Contents Full Opt-out Right; and (ii) an additional $ 200.0 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 the Licensed Products with respect to which the Company has exercised an Opt-out Right. In addition, the Company will also be eligible to receive sales milestones of up to $ 775.0 million, should the Company exercise its Opt-out Right. Upcoming potential development milestones under the Takeda Collaboration Agreement include: ● $ 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); ● $ 15.0 million upon first regulatory approval for rusfertide in PV in three European countries, after pricing and reimbursement approval; and ● $ 10.0 million upon first regulatory approval for rusfertide in PV in Japan. The Company evaluated the Takeda Collaboration Agreement and concluded that it has elements that are within the scope of ASC Topic 606 and ASC 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 certain of the Company’s responsibilities to complete the VERIFY Phase 3 clinical trial in PV and associated manufacturing services. The Company determined that the initial transaction price totaled $ 300.0 million, which was comprised of the upfront payment. The Company initially excluded any future estimated milestones or royalties from this transaction price, all of which were either 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 were contingent upon developmental and regulatory milestones that were uncertain and were 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 estimate of standalone selling price for the license was determined based on discounted cash flows for the expected development and commercialization of rusfertide and included assumptions for forecasted revenues, development timelines and expenses, discount rates, and probabilities of technical and regulatory success. The estimate of standalone selling price for the development services was determined based on forecasted costs and expenses over the expected development period. For the license of rusfertide, the Company determined that Takeda could benefit from the license at the time the license was granted and therefore, the related performance obligation was satisfied at that point in time. ​ 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). ​ Revenue Recognition ​ For the three months ended March 31, 2026, the Company recognized license and collaboration revenue of $ 56.4 million including (i) a $ 50.0 million milestone payment related to the JNJ License and Collaboration Agreement, which was earned upon FDA approval of ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in March 2026, (ii) $ 3.3 million related to the Takeda Collaboration Agreement for development services provided by the Company during the period using the cost-based input method, and (iii) $ 3.1 million from Takeda for rusfertide clinical supplies. The remaining $ 6.3 million in deferred revenue as of March 31, 2026 will be recognized through the conclusion of the development services performance obligation. ​ 11 Table of Contents For the three months ended March 31, 2025, the Company recognized license and collaboration revenue of $ 28.3 million related to the Takeda Collaboration Agreement, including (i) $ 22.8 million related to the proportional recognition of the $ 25.0 milestone deemed probable of being achieved due to the Phase 3 VERIFY trial meeting its primary endpoint and (ii) $ 5.5 million related to the initial transaction price for development services provided by the Company during the period. Revenue recognition for the $ 25.0 million milestone, which was payable upon completion of the VERIFY clinical study report, was allocated based on the initial standalone selling price of each performance obligation under the agreement. The remaining $ 2.2 million in revenue related to the milestone is recognized through the conclusion of the development services performance obligation. The Company recorded a corresponding contract asset of $ 22.8 million on its condensed consolidated balance sheet as of March 31, 2025. ​ For the three months ended March 31, 2026, the Company recognized $ 3.3 million of revenue that was included in the deferred revenue balance at the beginning of the period. For the three months ended March 31, 2025, the Company recognized $ 5.5 million of revenue that was included in the deferred revenue balance at the beginning of the period. None of the costs to obtain or fulfill the contracts were capitalized. 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 —Inputs are unadjusted quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2— Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. Level 3 —Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. 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, 2026 ​ ​ ​ ​ Level 1 ​ ​ ​ Level 2 ​ ​ ​ Level 3 ​ ​ ​ Total Assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Money market funds ​ $ 91,204 ​ $ — ​ $ — $ 91,204 Certificates of deposit ​ — ​ ​ 12,863 ​ — 12,863 U.S. Treasury and agency securities ​ ​ — ​ ​ 309,426 ​ ​ — ​ ​ 309,426 Commercial paper ​ — ​ ​ 111,330 ​ — 111,330 Corporate debt securities ​ ​ — ​ ​ 79,157 ​ ​ — ​ ​ 79,157 Total financial assets ​ $ 91,204 ​ $ 512,776 ​ $ — $ 603,980 ​ 12 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2025 ​ ​ ​ ​ Level 1 ​ ​ ​ Level 2 ​ ​ ​ Level 3 ​ ​ ​ Total Assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Money market funds ​ $ 40,774 ​ $ — ​ $ — $ 40,774 Certificates of deposit ​ — ​ ​ 11,391 ​ — 11,391 U.S. Treasury and agency securities ​ ​ — ​ ​ 348,948 ​ ​ — ​ ​ 348,948 Commercial paper ​ — ​ 77,865 ​ — 77,865 Corporate debt securities ​ — ​ 159,211 ​ — 159,211 Total financial assets ​ $ 40,774 ​ $ 597,415 ​ $ — $ 638,189 ​ The Company’s certificates of deposit, U.S. Treasury and agency securities, including U.S. Treasury bills, commercial paper and corporate debt securities 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. Note 5. Cash Equivalents and Marketable Securities ​ Cash equivalents and marketable securities consisted of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2026 ​ ​ Amortized ​ Gross Unrealized ​ ​ ​ ​ ​ Cost ​ ​ ​ Gains ​ ​ ​ Losses ​ ​ ​ Fair Value Money market funds ​ $ 91,204 ​ $ — ​ $ — ​ $ 91,204 Certificates of deposit ​ ​ 12,875 ​ ​ 1 ​ ( 13 ) ​ 12,863 U.S. Treasury and agency securities ​ ​ 309,434 ​ ​ 194 ​ ​ ( 202 ) ​ ​ 309,426 Commercial paper ​ 111,372 ​ ​ 7 ​ ​ ( 49 ) ​ 111,330 Corporate debt securities ​ ​ 79,222 ​ ​ 7 ​ ​ ( 72 ) ​ ​ 79,157 Total cash equivalents and marketable securities ​ $ 604,107 ​ $ 209 ​ $ ( 336 ) ​ $ 603,980 Classified as: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 177,358 Marketable securities - current ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 354,074 Marketable securities - noncurrent ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 72,548 Total cash equivalents and marketable securities ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 603,980 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2025 ​ ​ Amortized ​ Gross Unrealized ​ ​ ​ ​ ​ Cost ​ ​ ​ Gains ​ ​ ​ Losses ​ ​ ​ Fair Value Money market funds ​ $ 40,774 ​ $ — ​ $ — ​ $ 40,774 Certificates of deposit ​ ​ 11,387 ​ ​ 4 ​ ​ — ​ 11,391 U.S. Treasury and agency securities ​ ​ 348,250 ​ ​ 706 ​ ​ ( 8 ) ​ ​ 348,948 Commercial paper ​ 77,868 ​ 4 ​ ( 7 ) ​ 77,865 Corporate debt securities ​ ​ 159,127 ​ 93 ​ ( 9 ) ​ 159,211 Total cash equivalents and marketable securities ​ $ 637,406 ​ $ 807 ​ $ ( 24 ) ​ $ 638,189 Classified as: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 120,577 Marketable securities - current ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 438,974 Marketable securities - noncurrent ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 78,638 Total cash equivalents and marketable securities ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 638,189 ​ 13 Table of Contents All of the Company’s marketable securities are classified as available-for-sale. Current marketable securities of $ 354.1 million and $ 439.0 million held as of March 31, 2026 and December 31, 2025, respectively, had contractual maturities of less than one year . Noncurrent marketable securities of $ 72.5 million and $ 78.6 million held as of March 31, 2026 and December 31, 2025, respectively, had contractual maturities of at least one year but no more than two years . 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. ​ The Company sold $ 3.4 million and $ 7.0 million of marketable securities and realized a net gain of $ 2.0 thousand and a net loss of $ 5.0 thousand during the three months ended March 31, 2026 and 2025, respectively. 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, 2026 and December 31, 2025. ​ Note 6. Balance Sheet Components Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ ​ 2026 ​ 2025 Accrued interest receivable ​ $ 3,459 ​ $ 4,365 Prepaid clinical and research related expenses ​ ​ 2,298 ​ ​ 3,345 Prepaid insurance ​ ​ 1,094 ​ ​ 1,061 Prepaid licenses ​ ​ 597 ​ ​ 415 Other ​ 4,558 ​ 903 Prepaid expenses and other current assets ​ $ 12,006 ​ $ 10,089 ​ Property and Equipment, Net ​ Property and equipment, net consisted of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ ​ 2026 ​ 2025 Laboratory equipment ​ $ 8,031 ​ $ 7,748 Furniture and computer equipment ​ 1,533 ​ 1,491 Leasehold improvements ​ 2,936 ​ 2,936 Total property and equipment ​ 12,500 ​ 12,175 Accumulated depreciation ​ ( 8,722 ) ​ ( 8,315 ) Property and equipment, net ​ $ 3,778 ​ $ 3,860 ​ Accrued Expenses and Other Payables ​ Accrued expenses and other payables consisted of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ ​ ​ ​ 2026 ​ 2025 Accrued clinical and research related expenses ​ $ 11,802 ​ $ 14,798 Accrued employee related expenses ​ 4,234 ​ 12,764 Accrued professional service fees ​ ​ 953 ​ ​ 522 Other ​ 502 ​ 185 Total accrued expenses and other payables ​ $ 17,491 ​ $ 28,269 ​ ​ 14 Table of Contents Note 7. Stockholders’ Equity 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”). 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 . 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 in August 2023, 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 on 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. In accordance with ASC Topic 260, “ Earnings Per Share” , outstanding Pre-Funded Warrants are included in the computation of basic net income (loss) per share because the exercise price is negligible, and they are fully vested and exercisable after the original issuance date. No Pre-Funded Warrants were exercised during the three months ended March 31, 2026 and 2025. As of March 31, 2026, Pre-Funded Warrants to purchase 1,500,000 shares of common stock remained outstanding. Note 8. Income Taxes The Company recorded income tax benefit of $ 1.5 million for the three months ended March 31, 2026. No income tax expense or benefit was recorded by the Company for the three months ended March 31, 2025. The tax provision for the three months ended March 31, 2026 was determined using an estimated annual effective tax rate, adjusted for discrete items, if any. The income tax benefit for the three months ended March 31, 2026 included a discrete item for stock-based compensation expense. Note 9. Net Income (Loss) per Share The computation of basic net income (loss) per share of common stock is based on the weighted-average number of shares of common stock outstanding during each period. The computation of diluted net income (loss) per share of common stock is based on the weighted-average number of shares of common stock 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 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 share of common stock and diluted net loss per share of common stock are equal. ​ 15 Table of Contents The following table sets forth the computation of basic and diluted net income (loss) per share (in thousands, except share and per share data): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ ​ March 31, ​ ​ ​ ​ 2026 ​ ​ ​ 2025 Numerator: ​ ​ ​ ​ ​ ​ Net income (loss) ​ $ 3,783 ​ $ ( 11,655 ) Denominator: ​ ​ ​ ​ ​ ​ Weighted-average shares of common stock, basic ​ 65,087,847 ​ 62,963,806 Dilutive effect of common stock equivalents ​ 5,404,771 ​ — Weighted-average shares of common stock, dilutive ​ ​ 70,492,618 ​ ​ 62,963,806 Net income (loss) per share of common stock ​ ​ ​ ​ ​ ​ Basic net income (loss) per share of common stock ​ $ 0.06 ​ $ ( 0.19 ) Diluted net income (loss) per share of common stock ​ $ 0.05 ​ $ ( 0.19 ) ​ Approximately 0.2 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, PSUs and under the ESPP, as applicable) were excluded from the diluted net income per share of common stock computation for the three months ended March 31, 2026 because their effect was anti-dilutive. Approximately 9.7 million potentially dilutive shares of common stock (consisting of shares subject to outstanding stock options, RSUs, PSUs, and under the ESPP, as applicable) were excluded from the diluted net loss per share of common stock computation for the three months ended March 31, 2025 due to the Company’s net loss for the period. ​ Note 10. Segment Reporting Operating segments are components of an enterprise for which separate financial information is available and which are evaluated by a company’s chief operating decision maker (“CODM”) in deciding how to allocate resources and to assess performance. The Company operates and manages its business as one operating segment, which primarily focuses on the discovery and development of innovative medicines in areas of unmet medical need. The Company’s Chief Executive Officer serves as the Company’s CODM and manages and allocates resources to the operations of the Company on an entity-wide basis. Managing and allocating resources on an entity-wide basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions and research and development projects based on unmet medical need, scientific data, probability of technical and regulatory successful development, market potential and other considerations, and, as necessary, reallocate resources among our internal research and development portfolio and external opportunities to best support the long-term growth of our business. The Company’s CODM reviews financial information on an aggregate basis for the purpose of allocating resources and evaluating financial performance, including segment net income (loss), which is also reported on the condensed consolidated statement of operations as consolidated net income (loss). 16 Table of Contents Segment information was as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ ​ March 31, ​ ​ ​ ​ 2026 ​ ​ ​ 2025 ​ ​ ​ ​ ​ Revenue ​ $ 56,368 ​ $ 28,321 Less: ​ ​ ​ ​ ​ ​ Discovery department expense (1)(2) ​ ​ ( 8,506 ) ​ ​ ( 3,746 ) Development department expense (1)(2) ​ ​ ( 17,473 ) ​ ​ ( 12,905 ) General and administrative expenses (1) ​ ​ ( 5,695 ) ​ ​ ( 5,535 ) Employee wages and benefits - discovery (2) ​ ​ ( 3,148 ) ​ ​ ( 2,327 ) Employee wages and benefits - development (2) ​ ​ ( 5,952 ) ​ ​ ( 5,485 ) Employee wages and benefits - general and administrative ​ ​ ( 4,723 ) ​ ​ ( 3,831 ) Stock-based compensation expense ​ ​ ( 14,519 ) ​ ​ ( 13,802 ) Other segment items (3) ​ ​ 53 ​ ​ 82 Interest income ​ ​ 5,876 ​ ​ 7,573 Income tax benefit ​ ​ 1,502 ​ ​ — Segment profit (loss) ​ $ 3,783 ​ $ ( 11,655 ) Reconciliation of profit (loss) ​ ​ ​ ​ ​ ​ Adjustments and reconciling items ​ $ — ​ $ — Consolidated net income (loss) ​ $ 3,783 ​ $ ( 11,655 ) (1) Amounts exclude employee wages and benefits, stock-based compensation and expense allocations. (2) As of April 1, 2025, the information regularly provided to the CODM was changed to reclassify pre-clinical expenses from development expense to discovery expense. Prior period segment information has been recast to reflect this change. (3) Other segment items include foreign currency related income (expense) and other miscellaneous income (expense). ​ The accounting policies of the Company’s operating segment are the same as those described in Note 2. Summary of Significant Accounting Policies. The measure of segment assets is reported as total assets on the Company’s condensed consolidated balance sheets for the periods presented. ​ ​ ​ Note 11. Subsequent Events ​ On April 28, 2026, the Company announced that it exercised its right to opt out of the U.S. profit and loss sharing arrangement ( 50 % to the Company and 50 % to Takeda) under the Takeda Collaboration Agreement. The opt-out election triggered a $ 200.0 million payment, with an additional $ 200.0 million opt-out fee and a separate $ 75.0 million milestone upon FDA approval of rusfertide. Following the opt-out, the Company is also eligible to receive up to $ 775 .0 million in sales milestone payments and tiered royalties ranging from 14 % to 29 % on annual net worldwide sales, with an approximate 21 % weighted-average royalty rate at $ 1.5 billion in annual net sales and a 29 % tier applying to incremental annual net sales above $ 1.5 billion. 17 Table of Contents