Kardigan, Inc. 10-Q

10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2026 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-43354 Kardigan, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 93-2994203 ( State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 506 Carnegie Center Drive, Suite 201 Princeton , NJ 08540 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: ( 415 ) 573-3220 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.00001 per share KARD Nasdaq Global Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ As of August 7, 2026, the registrant had 93,503,699 shares of common stock, $ 0.00001 par value per share, outstanding. Table of Contents Page PART I. FINANCIAL INFORMATION 4 Item 1. Condensed Consolidated Financial Statements (Unaudited) 4 Condensed Consolidated Balance Sheets 4 Condensed Consolidated Statements of Operations and Comprehensive Loss 5 Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) 6 Condensed Consolidated Statements of Cash Flows 7 Notes to Condensed Consolidated Financial Statements 8 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 41 Item 3. Quantitative and Qualitative Disclosures About Market Risk 55 Item 4. Controls and Procedures 55 PART II. OTHER INFORMATION 57 Item 1. Legal Proceedings 57 Item 1A. Risk Factors 58 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 132 Item 3. Defaults Upon Senior Securities 133 Item 4. Mine Safety Disclosures 133 Item 5. Other Information 133 Item 6. Exhibits 133 Signatures 135 i CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q (“Quarterly Report”), of Kardigan, Inc. (the “Company”) contains or incorporates statements that constitute forward-looking statements within the meaning of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this Quarterly Report on Form 10-Q may include, for example, statements about: • the initiation, timing, progress and results of our research and development programs, preclinical studies and clinical trials; • the anticipated timing of release of topline data from the ongoing Phase 2b Cohort 1 trial of Danicamtiv KINSHIP-DCM, the ongoing Phase 2b clinical trial of KATALYST-AV, and the ongoing KARDINAL-ASH Phase 2 clinical trial; • the ability of clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results, and the ability of our preclinical studies to predict later clinical trial results; • the timing, scope and likelihood of regulatory filings and approvals of our product candidates; • our ability to deploy and develop our Prolaio platform; • the implementation of our business model, and strategic plans for our business, programs, and current and future product candidates; • our ability to obtain additional financing and the sufficiency of our existing cash, cash equivalents and investments to fund our future operating expenses and capital expenditure requirements; • the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; • the size and growth potential of the markets for our product candidates, and our ability to serve those markets; • our potential and ability to successfully manufacture and supply our current and future product candidates for clinical trials and for commercial use, if approved; • the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates; • developments relating to our competitors and our industry, including competing product candidates and therapies; • existing regulations and regulatory developments in the U.S. and other jurisdictions; • expectations regarding future events under collaboration and licensing agreements, including potential future payments, as well as our plans and strategies for entering into further collaboration and licensing agreements; • general economic, industry and market conditions, including fluctuating interest rates and rising inflation; • our ability to attract and retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; • our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; • our expectations regarding expenses and financial results, including our expected cash runway and financial performance; and • our anticipated use of our existing cash, cash equivalents and investments, including the proceeds from our initial public offering. These forward-looking statements are based on information available to us at the time of this Quarterly Report and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. The outcome of the events described in these forward-looking statements is subject to known and unknown risks, uncertainties, and other factors. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Factors that could cause actual results to differ include, but are not limited to, those discussed in the section titled “Risk Factors” included within this Quarterly Report on Form 10-Q. 1 SUMMARY OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS Our business is subject to numerous risks and uncertainties, which include, but are not limited to, the following: • We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability. • We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future. • We will require substantial additional capital in order to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts. • Our business is highly dependent on the success of our product candidates, particularly Danicamtiv for genetic DCM, Ataciguat for moderate CAVS, and Tonlamarsen for post-hospitalization management of ASH. • If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materially harmed. • The successful development of pharmaceutical products involves a lengthy and expensive process and is highly uncertain. • We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our Prolaio platform. • The regulatory approval processes of the FDA, the European Medicines Agency (“EMA”), and other comparable regulatory authorities are lengthy, time-consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. • We are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical studies and clinical trials that were previously conducted for our product candidates. • Our use of the Prolaio platform to enhance clinical trial design and execution is a novel approach that may not result in anticipated efficiencies or regulatory acceptance, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development. • If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates. • We have concentrated our research and development efforts on the treatment of cardiovascular diseases, a field that faces certain challenges in drug development. • The number of patients with certain cardiovascular diseases for which we are developing our product candidates has not been established with precision. If the actual number of patients with the diseases we elect to pursue with our product candidates is smaller than we anticipate, we may have difficulties in enrolling patients in our clinical trials, which may delay or prevent development of our product candidates. Even if such product candidates are successfully developed and approved, the markets for our product candidates may be smaller than we expect, and our revenue potential and ability to achieve profitability may be materially adversely affected. • We rely on third parties to assist in conducting our clinical trials. If they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed. • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, or if any of our material license agreements are terminated, we could lose our rights to key intellectual property and components enabling our technologies. • Our success depends upon our ability to obtain and protect our intellectual property and proprietary information. If we or our licensors are unable to obtain, maintain, defend and enforce patent or other intellectual property protection for any of our current or future product candidates or platform technologies, or if the scope of the patent or other 2 intellectual property protection obtained is not sufficiently broad or if our intellectual property protection is not sufficiently broad or enforceable, third parties could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize any of our current or future product candidates and platform technologies may be adversely affected. • An active trading market for our common stock may not be sustained. • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for investors. The summary risk factors described above should be read together with the full risk factors in the section titled “Risk Factors” and the other information set forth in this Quarterly Report, including our consolidated financial statements and related notes, as well as in other documents that we file with the Securities and Exchange Commission (“SEC”). The risks summarized above or described elsewhere in this Quarterly Report are not the only risks that we face. Additional risks and uncertainties not presently known to us, or that we currently deem to be immaterial, may also materially adversely affect our business, financial condition, results of operations, and future growth prospects. 3 PART I—FIN ANCIAL INFORMATION Ite m 1. Condensed Consolidated Financial Statements. Kardigan, Inc. C ondensed consolidated balance sheets (in thousands, except share and per share amounts) (unaudited) June 30, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 384,005 $ 108,989 Short-term investments 213,590 226,496 Prepaid expenses and other current assets 12,568 9,868 Total current assets 610,163 345,353 Long-term investments 63,097 — Restricted cash 540 540 Property and equipment, net 7,568 6,493 Operating lease right-of-use assets, net 11,224 11,741 Intangible assets, net 26,418 23,225 Other non-current assets 2,776 3,590 Total assets $ 721,786 $ 390,942 Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) Current liabilities: Accounts payable $ 14,018 $ 7,990 Accrued expenses and other current liabilities 26,167 23,903 Operating lease liabilities, current 3,752 3,143 Contingent milestone liabilities, current 26,066 2,500 Total current liabilities 70,003 37,536 Operating lease liabilities, net of current portion 9,595 10,689 Contingent milestone liabilities, net of current portion 25,305 5,243 Other non-current liabilities 1,361 1,659 Total liabilities 106,264 55,127 Commitments and contingencies (Note 8) Redeemable convertible preferred stock, par value of $ 0.00001 per share; zero shares and 29,519,423 shares authorized as of June 30, 2026 and December 31, 2025, respectively; zero shares and 29,519,423 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively; aggregate liquidation preference of zero and $ 597,168 as of June 30, 2026 and December 31, 2025, respectively — 586,150 Stockholders’ equity (deficit): Preferred stock, par value of $ 0.00001 per share; 10,000,000 shares and zero shares authorized as of June 30, 2026 and December 31, 2025, respectively; zero shares and zero shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively — — Common stock, par value of $ 0.00001 per share; 700,000,000 shares and 53,365,000 shares authorized as of June 30, 2026, and December 31, 2025, respectively; 93,467,940 shares and 16,351,102 shares issued and outstanding as of June 30, 2026, and December 31, 2025, respectively 1 — Additional paid-in capital 1,069,152 30,691 Accumulated other comprehensive income (loss) ( 235 ) 63 Accumulated deficit ( 453,396 ) ( 281,089 ) Total stockholders' equity (deficit) 615,522 ( 250,335 ) Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) $ 721,786 $ 390,942 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 4 Kardigan, Inc. Condensed consolidated statements of o perations and comprehensive loss (in thousands, except share and per share amounts) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development $ 56,365 $ 35,839 $ 101,432 $ 54,613 General and administrative 18,867 21,286 32,510 28,590 Change in fair value of contingent milestone liabilities 43,529 — 43,529 — Total operating expenses 118,761 57,125 177,471 83,203 Loss from operations ( 118,761 ) ( 57,125 ) ( 177,471 ) ( 83,203 ) Other income (expense): Interest income 2,765 1,068 5,558 1,900 Change in fair value of preferred stock tranche obligations — ( 1,341 ) — ( 3,912 ) Bargain purchase gain — — — 5,232 Other income (expense), net ( 240 ) ( 47 ) ( 394 ) 352 Loss before income taxes ( 116,236 ) ( 57,445 ) ( 172,307 ) ( 79,631 ) Income tax benefit — — — 4,167 Net loss $ ( 116,236 ) $ ( 57,445 ) $ ( 172,307 ) $ ( 75,464 ) Net loss per share attributable to common stockholders, basic and diluted $ ( 4.61 ) $ ( 4.64 ) $ ( 8.66 ) $ ( 6.27 ) Weighted average common shares outstanding used in calculating net loss per share attributable to common stockholders, basic and diluted 25,196,212 12,380,388 19,896,149 12,043,978 Other comprehensive loss Unrealized loss on investments ( 145 ) — ( 298 ) — Total comprehensive loss $ ( 116,381 ) $ ( 57,445 ) $ ( 172,605 ) $ ( 75,464 ) The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 5 Kardigan, Inc. Condensed consolidated statements of redeemable convertible preferred stock and stockholders’ equity (deficit) (in thousands, except share and per share amounts) (unaudited) Redeemable Convertible Preferred Stock Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Income Accumulated Deficit Total Stockholders' Equity (Deficit) Shares Amount Shares Amount Balance as of December 31, 2025 29,519,423 $ 586,150 16,351,102 $ — $ 30,691 $ 63 $ ( 281,089 ) $ ( 250,335 ) Issuance of Series B Preferred Stock 468,053 11,397 — — — — — — Issuance of common stock as consideration for acquired in-process research and development — — 44,729 — — — — — Issuance of common stock upon exercise of stock options — — 179,266 — 427 — — 427 Vesting of early-exercised stock options — — — — 148 — — 148 Stock-based compensation expense — — — — 5,358 — — 5,358 Unrealized loss on investments, net of tax — — — — — ( 153 ) — ( 153 ) Net loss — — — — — — ( 56,071 ) ( 56,071 ) Balance as of March 31, 2026 29,987,476 $ 597,547 16,575,097 $ — $ 36,624 $ ( 90 ) $ ( 337,160 ) $ ( 300,626 ) Conversion of redeemable convertible preferred stock to common stock upon IPO ( 29,987,476 ) ( 597,547 ) 47,764,024 1 597,546 — — 597,547 Issuance of common stock from initial public offering, net of issuance costs of $ 5.4 million — — 28,750,000 — 422,422 — — 422,422 Issuance of common stock upon exercise of stock options — — 363,215 — 806 — — 806 Vesting of early-exercised stock options — — — — 149 — — 149 Issuance of common stock upon vesting of restricted stock units, net — — 15,604 — — — — — Shares repurchased for tax withholdings on vesting of restricted stock units — — — — ( 90 ) — — ( 90 ) Stock-based compensation expense — — — — 11,695 — — 11,695 Unrealized loss on investments, net of tax — — — — — ( 145 ) — ( 145 ) Net loss — — — — — — ( 116,236 ) ( 116,236 ) Balance as of June 30, 2026 — $ — 93,467,940 $ 1 $ 1,069,152 $ ( 235 ) $ ( 453,396 ) $ 615,522 Redeemable Convertible Preferred Stock Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Income Accumulated Deficit Total Stockholders' Equity (Deficit) Shares Amount Shares Amount Balance as of December 31, 2024 6,959,334 $ 120,022 16,103,207 $ — $ 5,954 $ — $ ( 89,148 ) $ ( 83,194 ) Issuance of Series A Preferred Stock upon settlement of tranche obligations 5,148,587 98,339 — — — — — — Stock-based compensation expense — — — — 2,938 — — 2,938 Net loss — — — — — — ( 18,019 ) ( 18,019 ) Balance as of March 31, 2025 12,107,921 $ 218,361 16,103,207 $ — $ 8,892 $ — $ ( 107,167 ) $ ( 98,275 ) Issuance of common stock upon exercise of stock options — — 66,305 — 120 — — 120 Stock-based compensation expense — — — — 4,291 — — 4,291 Net loss — — — — — — ( 57,445 ) ( 57,445 ) Balance as of June 30, 2025 12,107,921 $ 218,361 16,169,512 $ — $ 13,303 $ — $ ( 164,612 ) $ ( 151,309 ) The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 6 Kardigan, Inc. Condensed consolidated statements of cash flows (in thousands) (unaudited) Six Months Ended June 30, 2026 2025 Cash flows from operating activities Net loss $ ( 172,307 ) $ ( 75,464 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 17,053 7,229 Integration bonus expense — 14,360 Depreciation and amortization expense 3,221 1,527 Amortization of premiums and accretion of discounts on investments ( 1,848 ) — Change in fair value of preferred stock tranche obligations — 3,912 Change in fair value of contingent milestone liabilities 43,529 — Acquired intellectual property rights 1,400 — Bargain purchase gain — ( 5,232 ) Deferred income tax benefit — ( 4,167 ) Amortization of right-of-use assets 1,078 709 Other non-cash charges ( 2,570 ) — Changes in operating assets and liabilities: Prepaid expenses and other current assets ( 1,348 ) ( 3,710 ) Other non-current assets 814 ( 797 ) Accounts payable 3,776 796 Accrued expenses and other current liabilities 920 7,620 Operating lease liabilities ( 1,045 ) 442 Net cash used in operating activities ( 107,327 ) ( 52,775 ) Cash flows from investing activities Proceeds from maturities of investments 185,226 — Purchases of investments ( 235,218 ) — Purchases of property and equipment ( 2,090 ) ( 2,561 ) Purchases of intangible assets — ( 41 ) Capitalized software development costs ( 2,810 ) — Acquisition of Prolaio, net of cash acquired — ( 3,961 ) Net cash used in investing activities ( 54,892 ) ( 6,563 ) Cash flows from financing activities Proceeds from issuance of preferred stock, net of issuance cost 9,997 100,000 Proceeds from issuance of common stock upon IPO, net of underwriting discounts and commissions 427,800 — Payments of offering costs ( 1,795 ) — Proceeds from exercise of stock options 1,233 184 Net cash provided by financing activities 437,235 100,184 Net increase in cash, cash equivalents and restricted cash 275,016 40,846 Cash, cash equivalents and restricted cash at beginning of period 109,529 49,815 Cash, cash equivalents and restricted cash at end of period $ 384,545 $ 90,661 Reconciliation of cash, cash equivalents and restricted cash: Cash and cash equivalents 384,005 90,121 Restricted cash 540 540 Total cash, cash equivalents and restricted cash $ 384,545 $ 90,661 Supplemental disclosure of non-cash financing and investing activities Right-of-use asset obtained in exchange for lease obligation $ 560 $ 278 Purchases of property and equipment included in accounts payable and accrued expenses 272 704 Conversion of redeemable convertible preferred stock to common stock upon IPO 597,547 IPO offering costs included in accounts payable and accrued expenses 3,583 — Issuance of preferred stock as consideration for intellectual property rights 1,400 — Settlement of preferred stock tranche obligations — ( 1,662 ) Vesting of early-exercised stock options and restricted common stock 268 120 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 7 Kardigan, Inc. Notes to Condensed Consolidated Financial Statements (unaudited) 1. Organization and principal activities Description of business Kardigan, Inc. (the “Company”) is a clinical-stage precision therapeutics company developing medicines that target the root cause of specific cardiovascular diseases where no approved treatments exist. The Company’s mission is to develop multiple targeted cardiovascular treatments in parallel that bring people with cardiovascular diseases closer to the cures they deserve. The Company was incorporated in Delaware in August 2023 under the name EnCarda, Inc., and changed its name to Kardigan, Inc. in December 2024. The Company is headquartered in Princeton, New Jersey. Stock split On June 9, 2026 the Company effected a 1.5928 -for-1 forward stock split of its issued and outstanding shares of common stock, which also resulted in a proportional adjustment to the existing conversion ratios for each series of its redeemable convertible preferred stock, and to the exercise prices and number of outstanding stock options and warrants. Accordingly, all shares of common stock, stock options, warrants, and per share information presented in the accompanying financial statements and notes thereto have been retroactively adjusted, where applicable, to reflect the stock split for all periods presented. The per share par value and authorized numbers of shares of the common stock and redeemable convertible preferred stock were not adjusted as a result of the stock split. Initial Public Offering On June 22, 2026, the Company completed its initial public offering (“IPO”) and issued 28,750,000 shares of common stock, including 3,750,000 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price of $ 16.00 per share. In connection with the IPO, the Company received net proceeds of $ 422.4 million, after deducting $ 32.2 million in underwriting discounts and commissions, and $ 5.4 million in other offering costs. Immediately prior to the closing of the IPO, all shares of the Company’s outstanding redeemable convertible preferred stock automatically converted into 47,764,024 shares of common stock. In connection with the closing of the IPO, the Company’s certificate of incorporation was amended and restated to authorize 500,000,000 shares of voting common stock, par value $ 0.00001 per share, 200,000,000 shares of non-voting common stock, par value $ 0.00001 per share and 10,000,000 shares of preferred stock, par value of $ 0.00001 per share. Liquidity and capital resources The Company has a limited operating history and has incurred significant net losses and negative cash flows from operations since inception. As of June 30, 2026, the Company had an accumulated deficit of $ 453.4 m illion and expects to continue incurring substantial losses for the foreseeable future as it advances its research and development programs. Historically, the Company has financed its operations principally through the issuance and sale of redeemable convertible preferred stock and, most recently, through the proceeds from the IPO. The Company may seek to raise additional capital in the future through equity or debt financings, license agreements, or other sources of financing, although there can be no assurance that such financing will be available on terms acceptable to the Company, or at all. Even if the Company is able to acquire additional financing, the financial terms may not be satisfactory or sufficient to support its operations. Failure to generate sufficient cash flows from operations, upon approval and commercialization of one of its product candidates, if ever, raise additional capital, and reduce discretionary spending, should additional capital not become available, could have a material adverse effect on the Company’s ability to achieve its intended business objectives. As discussed in the Company's audited financial statements for the year ended December 31, 2025, included in the Company's final prospectus dated June 17, 2026, filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended, the Company previously concluded that recurring losses, negative cash flows from operations, and limited liquidity raised substantial doubt about its ability to continue as a going concern. In June 2026, the Company completed its IPO and received net proceeds of approximately $ 422.4 million. Upon closing of the IPO and receipt of the associated net proceeds, the Company alleviated the substantial doubt that previously existed. As of June 30, 2026, the Company’s cash, cash equivalents and investments totaled $ 660.7 million, which the Company expects will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated financial statements. 8 2. Summary of significant accounting policies Basis of presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance refers to the authoritative pronouncements contained in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASUs”) of the Financial Accounting Standards Board (“FASB”). The condensed consolidated financial statements include the accounts of Kardigan, Inc. and its wholly owned subsidiaries, Rancho Santa Fe Bio, Inc. (“RSF”) and Prolaio, Inc. (“Prolaio”), which were acquired in June 2024 and February 2025, respectively. Refer to Note 5, “ Acquisitions and Licensing Agreements ”. All intercompany balances and transactions have been eliminated upon consolidation. Unaudited Interim Financial Information These interim condensed consolidated financial statements have been prepared on the same basis as the Company's audited consolidated financial statements and, in the opinion of management, include all adjustments, consisting solely of normal recurring adjustments, considered necessary for a fair statement of the Company’s financial position as of June 30, 2026, and its results of operations and cash flows for the three and six months ended June 30, 2026 and 2025. The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of results to be expected for the full year ending December 31, 2026 or any other subsequent period. The condensed consolidated balance sheet as of December 31, 2025 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2025, included in our final prospectus dated June 17, 2026 filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended. Use of estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. The Company bases its estimates on historical experience and various other assumptions believed to be reasonable under the circumstances. Significant estimates and assumptions include, but are not limited to: the fair value of common stock prior to the Company's initial public offering, the fair value of common stock warrants, the fair value of preferred stoc k tranche obligations, purchase price allocations for acquisitions, the fair value of contingent milestone liabilities, the valuation of stock-based awards, the assessment of useful life and recoverability of long-lived assets, the estimated incremental borrowing rate used in operating lease calculations, the accrual of research and development costs, and the valuation allowance for deferred tax assets. Actual results could differ from those estimates and assumptions, and such differences could be material to the Company’s financial position and results of operations. Operating segments The Company operates and manages its business as a single operating and reportable segment, focused on the discovery and development of novel therapeutic products to treat cardiovascular disease. The Company’s Chief Executive Officer, who serves as the Chief Operating Decision Maker (“CODM”), reviews condensed consolidated financial information based on net income, for purposes of making operating decisions, allocating resources and assessing financial performance. Risks and uncertainties Global economic and business activities continue to face widespread macroeconomic uncertainties, including the potential for health epidemics, labor shortages, bank failures, inflation and monetary supply shifts, tariffs, changes in interest rates, recession risks and potential disruptions from the geopolitical conflicts. The Company continues to actively monitor the impact of these macroeconomic factors on its financial condition, liquidity, operations, and workforce. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected timeframe, will depend on future developments, which are uncertain and cannot be 9 predicted; however, any continued or renewed disruption resulting from these factors could negatively impact the Company’s business. The Company’s future results of operations involve a number of risks and uncertainties common to clinical stage companies in the biotechnology industry. The Company’s product candidates are in development and the Company operates in an environment of rapid technological change and substantial competition from other pharmaceutical and biotechnology companies. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidates, uncertainty of market acceptance of any of the Company’s product candidates that receive regulatory approval, competition from new technological innovations, substitute products and market competition, securing and protecting proprietary technology, the ability to obtain and maintain intellectual property protection, strategic relationships and dependence on key individuals and vendors. Products developed by the Company require approvals from the U.S. Food and Drug Administration (the “FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that any of the Company’s product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approvals, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company expects to incur substantial operating losses for the foreseeable future and will require additional financing to complete its clinical trials, perform other research and development activities, and further develop its Prolaio technology platform, and, if regulatory approval is obtained, to launch and commercialize its product candidates. There can be no assurance that such financing will be available when needed or will be on terms acceptable to the Company. Concentration of credit risk and of significant suppliers Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and investments. The Company maintains its cash, cash equivalents and investments, which at times exceed insurance limits, at major financial institutions. The Company is exposed to credit risk in the event of default by the financial institution holding its cash to the extent recorded in the condensed consolidated balance sheets. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company’s investment policy limits investments to high credit quality securities issued by the U.S. government, U.S. government-sponsored agencies, highly rated banks, and corporate issuers, subject to certain concentration limits and restrictions on maturities. The Company is dependent on third-party contract manufacturing organizations (“CMOs”) to supply drug substance and drug product for all of the Company’s product candidates, for use in the preclinical studies, clinical trials and related testing. The Company currently relies, and expects to continue to rely, on a limited number of qualified manufacturers for these activities. The progress and completion of the ongoing and planned preclinical studies and clinical trials could be adversely affected by a significant interruption in the supply. Cash, cash equivalents and restricted cash The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash equivalents primarily consist of investments in money market accounts. Restricted cash represents amounts that are legally restricted as to withdrawal or use under the terms of certain contractual agreements. The Company’s restricted cash consists of cash deposited with a financial institution as collateral for a letter of credit required under the Company’s lease agreements. Restricted cash is presented separately on the condensed consolidated balance sheets. Investments The Company’s investments consist of marketable debt securities. Marketable debt securities with contractual maturities of less than 12 months at the balance sheet date are considered short-term marketable securities. Marketable debt securities with contractual maturities of 12 months or greater at the balance sheet date are considered long-term marketable 10 securities. The Company classifies all investments held as available-for-sale. Available-for-sale securities are recorded at fair value based upon market prices at period end, with the unrealized gains and losses reported in other comprehensive loss. The amortized cost of debt securities classified as available-for-sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income in the condensed consolidated statements of operations and comprehensive loss. Realized gains and losses and declines in value due to credit-related factors on available-for-sale securities are included in other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The cost of securities sold is based on the specific identification method. Interest on securities classified as available-for-sale is included in interest income in the condensed consolidated statements of operations and comprehensive loss. At each balance sheet date, the Company assesses available-for-sale debt securities in an unrealized loss position to determine whether the unrealized loss or any potential credit losses should be recognized in other income (expense), net. The Company evaluates whether it intends to sell, or whether it is more likely than not that it will be required to sell, the security before recovery of its amortized cost basis. The Company also evaluates whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the Company considers the severity of the impairment, any changes in interest rates, changes to the underlying credit ratings and forecasted recovery, among other factors. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in other income (expense), net. No impairment charges or credit losses were recognized during any of the periods presented. Internal use software The Company capitalizes costs related to the development of internal use of enterprise-level business software in support of its clinical trials and other operational needs. Costs incurred in the application development phase are capitalized, and presented within intangible assets, net on the condensed consolidated balance sheets. These costs are amortized on a straight-line basis over the estimated useful lives, which are generally three to seven years , beginning when the software is available for its intended use. Costs related to planning and preliminary project activities, as well as post-implementation activities are expensed as incurred, and recorded within research and development (“R&D”) expenses in the condensed consolidated statements of operations and comprehensive loss. Deferred offering costs The Company capitalizes certain legal, accounting and other third-party fees that are incremental and directly attributable to in-process equity financings until such financings are consummated. Upon consummation of an equity financing, deferred offering costs are offset against the related financing proceeds within additional paid-in capital. Should the planned financing be abandoned, the deferred offering costs are expensed immediately as a charge to general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss. No deferred offering costs were capitalized as of December 31, 2025. In connection with the Company’s IPO, which closed on June 22, 2026, the Company incurred $ 5.4 million of offering costs, which were recorded as a reduction to additional paid-in capital within stockholders’ equity (deficit) in the accompanying condensed consolidated balance sheets as of June 30, 2026 . Fair value measurement The Company accounts for recurring and non-recurring fair value measurements in accordance with ASC 820, which defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value, and requires expanded disclosures about fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The ASC 820 hierarchy ranks the quality of reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following three categories: • Level 1—Quoted prices in active markets for identical assets or liabilities 11 • Level 2—Observable inputs (other than Level 1 quoted prices), including quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other observable market data. • Level 3—Unobservable inputs that are significant to determining the fair value and supported by little or no market activity, including pricing models, discounted cash flow methodologies, and similar techniques. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The carrying amounts of cash equivalents, prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their fair values because of their short-term nature. Property and equipment, net Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the shorter of their estimated useful lives or the remaining lease term of the related asset. Expenditures that extend an asset’s useful life or improve its functionality are capitalized, while routine repairs and maintenance are expensed as incurred. Upon disposal or retirement of assets, the cost and related accumulated depreciation are removed from the condensed consolidated balance sheets, and the resulting gain or loss is recognized in the condensed consolidated statements of operations and comprehensive loss in the period realized. Property and equipment held for sale are carried at fair value less costs to sell. The estimated useful lives of the Company’s property and equipment are as follows: Asset Classification Estimated Useful Life Laboratory equipment 5 years Furniture and fixtures 5 years Office equipment 3 years Computer equipment 3 years Leasehold improvements Shorter of remaining lease term or estimated useful life Business acquisitions, including goodwill, intangible assets and contingent consideration The Company evaluates mergers, acquisitions of assets, and other similar transactions to assess whether the transaction should be accounted for as a business combination or asset acquisition, by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen is not met, the Company further evaluates whether it has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business. The Company accounts for transactions that meet the definition of a business as business combinations using the acquisition method of accounting. Under this method, the identifiable assets acquired, including identifiable intangible assets, and liabilities assumed are recognized at their estimated fair values as of the acquisition date. Any excess of the consideration transferred over the estimated fair value of the net identifiable assets acquired is recorded as goodwill. Excess of the fair value of the net assets acquired over the purchase price is recorded as a bargain purchase gain. Intangible assets acquired in a business combination related to in-process research and development (“IPR&D”) are classified as indefinite-lived until the underlying research and development activities are completed or abandoned. In circumstances where the Company is required to pay future consideration that is contingent upon the achievement of specified milestone events, the Company recognizes a liability equal to the estimated fair value of the contingent payments as of the acquisition date. The liability is remeasured at each reporting period, with fair value changes recorded in R&D expenses in the condensed consolidated statements of operations and comprehensive loss. 12 Transaction costs associated with business combinations are expensed as they are incurred, and are recorded within general and administrative expenses in the condensed consolidated statement of operations and comprehensive loss. Asset acquisitions and acquired in-process research and development The Company accounts for acquisitions of assets or a group of assets as asset acquisitions when substantially all of the fair value of the gross assets acquired are concentrated in a single asset or group of similar assets or when the definition of a business is not met. In an asset acquisition, the cost to acquire the asset or group of assets, including certain transaction costs, is allocated to the identifiable assets acquired and liabilities assumed based on their relative fair values as of the acquisition date. No goodwill is recognized in asset acquisitions. Assets acquired for use in research and development activities that have an alternative future use are capitalized as IPR&D assets. Acquired IPR&D with no alternative future use is recognized as R&D expense on the acquisition date. The Company recognizes future payments such as those upon the achievement of certain regulatory, development, or sales milestones in an asset acquisition when the underlying milestones are probable to be achieved. Milestone payments made to third parties subsequent to regulatory approval may be capitalized as intangible assets, if deemed to have alternative future use, and amortized over the estimated remaining useful life of the related product. Royalties will be recognized as cost of sales when the covered products are sold and royalties are payable. Upfront payments are presented as investing outflows within the condensed consolidated statement of cash flows, when they are made in connection with the acquisition of an asset, regardless of whether the acquired asset is expensed as IPR&D or capitalized. Intangible assets Intangible assets consist of developed technology, other finite-lived intangible assets acquired in business combinations, as well as capitalized internal-use software development costs. Amortization is recognized using the straight-line method over the estimated useful lives of the related assets. Developed technology is amortized over a seven-year period. All other intangible assets subject to amortization are amortized over a three-year period. Impairment of long-lived assets The Company evaluates its long-lived assets, including property and equipment, finite-lived intangible assets and right-of-use assets, whenever events or changes in circumstances indicate that the carrying amount of assets may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is required, recoverability is measured by comparing the carrying value of the asset group to the estimated future undiscounted cash flows expected to be generated over its remaining economic life. If an asset group is considered to be impaired, the impairment recognized equals the amount by which the carrying value of the asset group exceeds its fair value. If the useful life is shorter than originally estimated, the Company amortizes the remaining carrying value over the revised shorter useful life. Leases The Company determines whether an arrangement is or contains a lease at inception. Operating lease right-of-use (“ROU”) assets represent the Company’s right to use underlying assets during the lease term, and corresponding lease liabilities represent the obligation to make lease payments. ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term, using the discount rate implicit in the lease, if readily determinable. When the implicit rate is not readily determinable, the Company uses its incremental borrowing rate, which reflects the rate it would pay to borrow on a collateralized basis over a similar term in a comparable economic environment. ROU assets further include initial direct costs and prepaid lease payments, and are reduced by lease incentives received. Lease terms may include options to extend or terminate when it is reasonably certain such options will be exercised. Lease expense is recognized on a straight-line basis over the lease term. Variable lease costs are recorded as an expense in the period incurred. 13 The Company elected not to separate lease and non-lease components for any leases within its existing classes of assets and as a result, accounts for lease and non-lease components as a single lease component. For short-term leases, defined as leases with a term of twelve months or less, for which there is no purchase option that the company is reasonably certain to exercise, the Company elected the practical expedient to not recognize an associated lease liability and ROU asset. Payments for short-term leases are expensed on a straight-line basis throughout the lease term and presented as operating expenses in the condensed consolidated statements of operations and comprehensive loss. Classification and accretion of redeemable convertible preferred stock The Company’s preferred stock did not have redemption rights, except for the contingent redemption in the event of a deemed liquidation, that, in certain situations, was not solely within the control of the Company and would have called for the redemption of the then outstanding preferred stock. Therefore, prior to its conversion, the preferred stock was classified as mezzanine equity outside of stockholders’ equity (deficit) on the condensed consolidated balance sheets. The Company recorded the preferred stock at fair value upon issuance, net of tranche obligations and associated issuance costs. The preferred stock was not redeemable, and a deemed liquidation event was not probable at any point prior to its conversion. As such, the carrying values of the preferred stock were not accreted to the redemption values during the periods it was outstanding. Upon the closing of the Company's initial public offering in June 2026, all outstanding shares of preferred stock automatically converted into shares of common stock. Preferred stock tranche obligations The purchase agreement for the Company’s Series A Preferred Stock (as defined below) provided the Company with an obligation to issue and certain investors to purchase additional Series A Preferred Stock in subsequent closings upon satisfaction of certain conditions (the “preferred stock tranche obligations”). The Company determined the obligations met the definition of a freestanding instrument and recognized an associated asset or liability at fair value upon the initial issuance of the preferred stock. The preferred stock tranche obligations were subject to remeasurement at each balance sheet date, with changes in fair value recognized in the change in fair value of preferred stock tranche obligations in the condensed consolidated statement of operations and comprehensive loss. Upon settlement of each tranche, the related preferred stock tranche obligations were derecognized and the shares of preferred stock issued in connection with the settlement were recorded at fair value. Both the Second and Third Tranches of the Series A Preferred Stock subsequently closed, and no preferred stock tranche obligations remained outstanding thereafter. Research and development expenses and related accruals R&D expenses are recognized in the period in which the related services are rendered or goods are received. R&D expenses primarily consist of personnel-related costs, including salaries, benefits, and stock-based compensation expense; laboratory supplies and facility costs; and fees paid to third parties conducting research, preclinical, and clinical activities on behalf of the Company. Non-refundable advance payments for future R&D activities are recorded in prepaid and other assets on the balance sheet, and expensed as the related goods are delivered or services are performed. The Company estimates accrued R&D expenses based on its evaluation of services performed but not yet invoiced, using available information such as progress reports, contractual terms, and communication with vendors. These estimates include costs related to clinical research organizations (“CROs”), investigative sites, CMOs, and professional service providers. Because contractual payment schedules may not align with the timing of services rendered, expense recognition is based on the estimated level of effort or stage of completion. Historically, the Company’s estimates of accrued R&D expenses have not differed materially from actual amounts incurred; however, changes in estimates are recognized in the period in which additional information becomes available. Stock-based compensation expense The Company measures compensation expense for all share-based awards based on the estimated fair value of the award on the grant date. For awards that vest solely based on continued service, stock-based compensation is recognized on a straight-line basis over the requisite service period. The Company recognizes expense related to stock options that contain performance conditions only when it is considered probable that the performance condition will be achieved. For 14 performance and market awards, stock-based compensation expense is recognized over the requisite service period using the accelerated attribution method. The Company accounts for forfeitures as they occur. The fair value of service-based stock options is determined on the grant date using the Black-Scholes option pricing model, which incorporates assumptions including the fair value of the Company’s common stock, expected term, expected volatility, risk-free interest rate, and expected dividend yield. Awards containing market-based conditions are valued using a Monte Carlo simulation model at the grant date, which uses assumptions similar to the Black-Scholes model and incorporates Level 3 inputs related to the likelihood of satisfying market conditions. Compensation expense for awards with market conditions is recognized using the accelerated attribution method over the requisite service period, regardless of whether the market condition is ultimately satisfied. The Company records proceeds from the early exercise of options as a non-current liability in the condensed consolidated balance sheets, and reclassifies this liability to additional paid-in capital as the Company’s repurchase right lapses. The shares purchased by the option holders pursuant to the early exercise of stock options are not deemed, for accounting purposes, to be outstanding until those shares have vested. Determination of fair value of common stock The Company’s common stock is listed on the Nasdaq Global Market and its fair value is based on the closing price of the Company's common stock as reported on Nasdaq as of the applicable measurement date. Prior to the Company's IPO, in the absence of an active market for the Company’s common stock, the estimated fair value of our common stock has been determined by the board of directors as of the date of each applicable measurement date, with input from management, considering our most recently available third-party valuations of common stock, and the board of directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the applicable measurement date. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. • Option Pricing Method (“OPM”). Under the OPM, shares are valued by creating a series of call options with exercise prices based on the liquidation preferences and conversion terms of each equity class. The estimated fair values of the redeemable convertible preferred stock and common stock are inferred by analyzing these options. This method is appropriate to use when the range of possible future outcomes is so difficult to predict that estimates would be highly speculative, and dissolution or liquidation is not imminent. • Probability-Weighted Expected Return Method (“PWERM”). The PWERM is a scenario-based analysis that estimates value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to us, as well as the economic and control rights of each share class. • Hybrid Method. The Hybrid Method is a hybrid between PWERM and OPM, where the equity value is estimated based on probability-weighted value across multiple scenarios where the OPM is used to estimate the allocation of value within one or more of those scenarios. Based on our early stage of development, the difficulty in predicting the range of specific outcomes (and their likelihood), and other relevant factors, the OPM allocation method was considered most appropriate for valuations prior to December 31, 2025 . The OPM treats common stock and redeemable convertible preferred stock as call options on the equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under the OPM, the common stock has value only if the funds available for distribution to stockholders exceeded the value of the redeemable convertible preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. Beginning with our February 12, 2026 valuation, we transitioned from an OPM approach to a hybrid valuation method, which we determined was most appropriate based on our stage of development and increased visibility into potential liquidity outcomes. Under the hybrid method, the overall equity value is probability weighted across multiple potential future outcomes, including an initial public offering and a remain private scenario. 15 Income taxes The Company accounts for income taxes under an asset and liability approach for deferred income taxes, which requires recognition of deferred income tax assets and liabilities for the expected future tax consequences of events that have been recognized in the condensed consolidated financial statements but have not been reflected in taxable income. Estimates and judgments occur in the calculation of certain tax liabilities and in the determination of the recoverability of certain deferred tax assets, which arise from temporary differences and carryforwards. Deferred tax assets and liabilities are measured using the currently enacted tax rates that apply to taxable income in effect for the years in which those temporary differences are expected to be realized or settled. The Company regularly assesses the likelihood that deferred tax assets will be realized. To the extent that any amounts are believed to not be more-likely-than-not to be realized, a valuation allowance is recorded to reduce the deferred tax assets. The Company regularly assesses the need for a valuation allowance on deferred tax assets, and to the extent that an adjustment is needed, such adjustment will be recorded in the period that the determination is made. The Company recognizes tax benefits from uncertain tax positions only if it believes the position is more likely than not to be sustained upon examination by the taxing authorities based on the technical merits. The tax benefits recognized are measured as the largest amount of tax benefit that is more likely than not to be realized upon settlement. The Company recognizes interest and penalties related to income tax matters as income tax expense. To date, there have been no interest charges or penalties related to unrecognized tax benefits. Net loss per share Net loss per share attributable to common stockholders is calculated using the two-class method, as the Company’s preferred stock represents participating securities that participate in earnings on a non-cumulative basis when dividends are declared on common stock. Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, excluding shares subject to vesting or forfeiture, without consideration for potentially dilutive securities. Diluted net loss per share attributable to common stockholders is calculated by giving effect to all potentially dilutive securities outstanding for the period utilizing the treasury stock method or the if-converted method based on the nature of such securities. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive shares of common stock are antidilutive. In periods of net income, distributed and undistributed earnings are allocated to participating securities based on their contractual participation rights. Comprehensive loss Comprehensive loss includes all changes in equity (net assets) during a period from non-owner sources, including unrealized gains and losses on investments. Comprehensive gains and losses have been reflected in the condensed consolidated statements of operations and comprehensive loss. Emerging growth company The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company and (2) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act, unless early adoption is permitted. As a result, these condensed consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Recent accounting pronouncements - Not yet adopted In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) , which requires new tabular disclosures for specified categories of expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the potential impact of this guidance on its condensed consolidated financial statements and disclosures. 16 In September 2025, the FASB issued ASU 2025-06, Intangibles — Goodwill and Other — Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software , which amends certain aspects of the accounting for, and disclosure of, internal-use software costs under ASC 350-40, Intangibles — Goodwill and Other - Internal-Use Software . ASU 2025-06 is intended to simplify and modernize the accounting for internal-use software costs by removing all references to prescriptive and sequential software development stages under Subtopic 350-40. The amendments in ASU 2025-06 are effective for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those annual reporting periods, with early adoption permitted as of the beginning of an annual reporting period. The guidance can be applied prospectively, retrospectively or under a modified transition approach. The Company is currently assessing the impact of the adoption of this guidance on its condensed consolidated financial statements and disclosures. In September 2025, the FASB issued ASU 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract , which clarifies the application of derivative accounting to certain contracts and refines the guidance for share-based noncash consideration received from customers. Specifically, ASU 2025-07 introduces a scope exception for contracts that are not exchange-traded and whose underlying is tied to operations or activities specific to one party. ASU 2025-07 is effective for fiscal years beginning after December 15, 2026 and interim periods within those fiscal years, with early adoption permitted. The guidance may be applied prospectively or under a modified retrospective transition approach, and the Company is currently assessing the impact of adoption on its condensed consolidated financial statements and disclosures. 3. Fair value measurements The following tables summarize the types of financial assets and liabilities measured at fair value on a recurring basis by level within the fair value hierarchy. As of June 30, 2026 and December 31, 2025, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): June 30, 2026 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 376,979 $ — $ — $ 376,979 Short-term investments: U.S. treasury bills — 82,246 — 82,246 U.S. government bonds — 33,012 — 33,012 Corporate bonds — 98,332 — 98,332 Long-term investments: U.S. government agency bonds — 9,896 — 9,896 Corporate bonds — 53,201 — 53,201 Total assets measured at fair value $ 376,979 $ 276,687 $ — $ 653,666 Liabilities: Contingent milestone liabilities — — 47,346 47,346 Total liabilities measured at fair value $ — $ — $ 47,346 $ 47,346 17 December 31, 2025 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 99,195 $ — $ — $ 99,195 Corporate bonds — 5,996 — 5,996 Short-term investments: U.S. treasury bills — 94,108 — 94,108 U.S. government bonds — 43,927 — 43,927 Corporate bonds — 88,462 — 88,462 Total assets measured at fair value $ 99,195 $ 232,493 $ — $ 331,688 Liabilities: Contingent milestone liabilities — — 3,817 3,817 Total liabilities measured at fair value $ — $ — $ 3,817 $ 3,817 There were no transfers between Level 1, 2, or 3 during the three and six months ended June 30, 2026 and during the year ended December 31, 2025. The following table summarizes the Company’s marketable securities, that are classified as available-for-sale, as of June 30, 2026 and December 31, 2025 (in thousands): As of June 30, 2026 Amortized Cost Unrealized Gains Unrealized Losses Aggregate Fair Value Short-term investments: U.S. treasury bills $ 82,280 $ — $ ( 34 ) $ 82,246 U.S. government bonds 33,023 — ( 11 ) 33,012 Corporate bonds 98,421 — ( 89 ) 98,332 Long-term investments: U.S. government agency bonds $ 9,913 $ — $ ( 17 ) $ 9,896 Corporate bonds 53,285 — ( 84 ) 53,201 Total investments $ 276,922 $ — $ ( 235 ) $ 276,687 As of December 31, 2025 Amortized Cost Unrealized Gains Unrealized Losses Aggregate Fair Value Short-term investments: U.S. treasury bills $ 94,045 $ 63 $ — $ 94,108 U.S. government agency bonds 43,927 — — 43,927 Corporate bonds 88,461 — — 88,461 Total investments $ 226,433 $ 63 $ — $ 226,496 The fair values of available-for-sale securities by contractual maturity were as follows (in thousands): June 30, December 31, 2026 2025 Due in 1 year or less $ 213,590 $ 226,496 Due in 1 to 2 years 63,097 — Total $ 276,687 $ 226,496 As of June 30, 2026, no significant facts or circumstances were present to indicate a deterioration in the creditworthiness of the issuers of the marketable securities, and the Company has no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. The Company considered the current and expected future 18 economic and market conditions and determined that its investments were not significantly impacted. For the three and six months ended June 30, 2026 and 2025 the Company did no t recognize any impairment losses on its investments. Series A Preferred Stock Tranche Obligations In June 2024, the Company entered into a Series A Preferred Stock purchase agreement (Note 9, “Redeemable Convertible Preferred Stock” ). The preferred stock tranche asset and liability represented the fair value of the Company’s obligations to issue Series A Preferred Stock in two subsequent closings upon satisfaction of certain conditions. These instruments were measured at fair value on a recurring basis and were classified within Level 3 of the fair value hierarchy as the valuation incorporates significant unobservable inputs. The fair value was determined using a probability-weighted expected return method as it represents a contingent commitment for the additional shares. The valuation reflected market-participant assumptions, and considered, among other inputs, the estimated fair value per share of the Series A Preferred Stock as of each measurement date, probability of meeting certain milestone events, the expected time until certain milestone events would be met, and the discount rate. The most significant unobservable inputs were the estimated fair value of the Company’s Series A Preferred Stock and the probability and expected timing of achieving certain milestone events as of the measurement dates. The Company determined the fair value per share of the underlying Series A Preferred Stock by taking into consideration the most recent sales of its Series A Preferred Stock, results obtained from third-party valuations and additional factors the Company deemed relevant. Changes in these inputs can materially affect the fair value of the preferred stock tranche obligations. The following table presents the most significant assumptions used in the probability-weighted expected return model to determine the fair value of the Series A Preferred Stock tranche obligations during the periods presented: June 30, 2025 Second Tranche Third Tranche Probability of achieving milestone 90 % 100 % Risk free rate 4.45 % N/a Term until milestone is achieved (years) 0.3 N/a Fair value of Series A Preferred Stock was $ 21.24 per share as of June 30, 2025. The following table presents a summary of the changes in the fair value of the Series A Preferred Stock tranche obligations, asset/(liability) for the six months ended June 30, 2025 (in thousands): Second Tranche Third Tranche Balance as of December 31, 2024 $ ( 7,284 ) $ 1,662 Change in fair value ( 3,912 ) — Settlement of preferred stock tranche obligation — ( 1,662 ) Balance as of June 30, 2025 $ ( 11,196 ) $ — During the six months ended June 30, 2025 , upon the closing of the Third Tranche, the related preferred stock tranche obligation was derecognized and the shares of preferred stock issued in connection with the settlement were recorded at the fair value as of settlement date. No change in fair value was recognized in the condensed consolidated statement of operations and comprehensive loss upon settlement of the Third Tranche obligation. During the six months ended June 30, 2025, the Company remeasured the Second Tranche obligation, and the associated change in fair value of preferred stock tranche obligation of $ 3.9 million was recognized in the condensed consolidated statement of operations and comprehensive loss. Both the Second and Third Tranches of the Series A Preferred Stock were closed during the year ended December 31, 2025 , and accordingly, no change in fair value was recorded for the six months ended June 30, 2026. 19 Prolaio Contingent Milestone Liabilities On February 24, 2025, the Company acquired Prolaio, Inc., and, as part of the consideration transferred in the acquisition, recognized a contingent consideration liability. The liability represented the estimated fair value of future milestone payments of up to $ 200.0 million payable to Prolaio's former stockholders upon the achievement of specified post-closing operational, financial and regulatory milestones . On May 1, 2026, the Company entered into an amendment to the Agreement and Plan of Merger with Prolaio's former stockholders to amend the applicable milestone provisions, which replaced the original milestones with new milestones tied to the Company's achievement of specified valuation thresholds through May 2032, while keeping the aggregate maximum milestone payments unchanged at $ 200.0 million (Note 5, " Acquisitions and Licensing Agreements "). The following table presents a summary of the changes in the fair value of the Prolaio contingent milestone liabilities (in thousands): Amount Balance as of December 31, 2024 $ — Initial recognition upon acquisition 4,585 Change in fair value — Balance as of June 30, 2025 $ 4,585 Amount Balance as of December 31, 2025 $ 3,817 Change in fair value 43,529 Balance as of June 30, 2026 $ 47,346 The Company utilizes significant estimates and assumptions it believes would be made by a market participant in determining the estimated fair value of contingent milestone liabilities at each balance sheet date. Prior to the amendment, the fair value of the Prolaio contingent consideration was determined by calculating the probability-weighted estimated value of the specified milestone payments, based on the assessment of the likelihood and estimated timing that the milestones would be achieved and the applicable discount rates. The discount rate captured the credit risk associated with the payment of the contingent consideration when earned and due. As of the amendment date and subsequently, the fair value of the Prolaio contingent milestone liabilities was determined based on the Monte Carlo valuation method, reflecting the shift to valuation-based milestones tied to the Company's market valuation thresholds through May 2032. The fair value of the Prolaio contingent milestone liabilities as of the respective dates were calculated using the following unobservable inputs: December 31, 2025 June 30, 2025 Range Weighted Average Range Weighted Average Discount rates 14.99 % 14.99 % 9.90 %- 10.19 % 10.14 % Probability of milestone achievement 0.3 %- 4.9 % 1.98 % 0.3 %- 4.9 % 1.98 % June 30, 2026 May 1, 2026 Expiration date 5/1/2032 5/1/2032 Starting stock price $ 23.85 $ 21.37 Risk-free rate 4.15 % 4.30 % Cost of debt rate 19.00 % 14.40 % Volatility 95 % 95 % 20 The estimated fair value of contingent milestone liabilities may change significantly as development progresses and additional data is obtained, impacting the assumptions regarding probabilities of successful achievement of the Company's valuation thresholds used to estimate the fair value of the liability and the timing in which they are expected to be achieved. In evaluating the fair value assumptions, judgment is required to interpret the market data used to develop the estimates. Accordingly, the use of different market assumptions, inputs and/or different valuation techniques could result in materially different fair value estimates. PhysIQ Contingent Consideration (Assumed Liability) The Company utilized significant estimates and assumptions it believes would be made by a market participant in determining the estimated fair value of the contingent consideration liability. The fair value of the PhysIQ contingent consideration, as of the acquisition date, was determined by calculating the probability-weighted estimated value of the specified milestone payments, based on the assessment of the likelihood and estimated timing that the milestones would be achieved and the applicable discount rates. The discount rate captures the credit risk associated with the payment of the contingent consideration when earned and due. The fair value of the PhysIQ contingent consideration as of the acquisition date was $ 3.3 million and was calculated using the following unobservable inputs: February 24, 2025 Range Weighted Average Discount rates 9.90 %- 10.15 % 10.10 % Probability of milestone achievement 10.0 %- 80.0 % 20.63 % The weighted-average unobservable inputs were calculated based on the relative value of the specified milestones. The estimated fair value of contingent consideration liabilities may change significantly as development progresses and additional data is obtained, impacting the assumptions regarding probabilities of successful achievement of the milestones used to estimate the fair value of the liability and the timing in which they are expected to be achieved. In evaluating the fair value assumptions, judgment is required to interpret the market data used to develop the estimates. Accordingly, the use of different market assumptions, inputs and/or different valuation techniques could result in materially different fair value estimates. Following the initial recognition at the acquisition date, the acquired contingency is not subsequently measured at fair value. Refer to Note 5, “ Acquisitions and Licensing Agreements ” for further details on the change in the carrying value of the PhyslQ contingent consideration. 4. Balance sheet components Property and equipment, net Property and equipment, net, consisted of the following (in thousands): June 30, December 31, 2026 2025 Laboratory equipment 6,275 $ 5,251 Computer equipment 946 798 Furniture & fixtures 570 507 Leasehold improvements 649 396 Office equipment 243 184 Construction in progress 833 370 Property and equipment, gross $ 9,516 $ 7,506 Less: accumulated depreciation ( 1,948 ) ( 1,013 ) Property and equipment, net $ 7,568 $ 6,493 Depreciation expense was $ 0.4 million, $ 0.9 million for the three and six months ended June 30, 2026, and $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2025, respectively. 21 Accrued liabilities Accrued liabilities consisted of the following (in thousands): June 30, December 31, 2026 2025 Accrued clinical trial expenses 12,995 $ 9,154 Accrued personnel and related expenses 8,197 9,128 Accrued manufacturing expenses 917 2,355 Other 4,058 3,266 Total accrued expenses and other current liabilities $ 26,167 $ 23,903 5. Acquisitions and licensing agreements Acquisition of Prolaio, Inc. On February 24, 2025 (the “Acquisition Date”), the Company acquired 100 % of the outstanding shares of Prolaio, Inc., a healthcare technology company focused on cardiovascular data collection and analytics. The acquisition provides the Company with access to Prolaio, Inc.’s cardiovascular data platform, to enhance and accelerate the Company’s research and development portfolio of late-stage cardiovascular disease assets. At the time of the acquisition, Tassos Gianakakos, the Company’s Chief Executive Officer and member of the Company’s board of directors, also served as Prolaio, Inc.’s Chief Executive Officer and as a member of its board of directors and Jay Edelberg, the Company’s Chief Medical Officer, served as its Head of Research & Development and as a member of its board of directors. Mr. Gianakakos and Dr. Edelberg beneficially owned 55.7 % and 17.1 %, respectively, of Prolaio at the time of its acquisition. Accordingly, the Prolaio acquisition itself constituted a related-party transaction. Refer to Note 15, “Related Party Transactions” for further details. The Company concluded that Prolaio constituted a business under ASC 805 and the transaction was accounted for as a business combination. The total purchase consideration transferred was approximately $ 8.6 million, consisting of approximately $ 4.0 million in cash, primarily used to repay $ 4.0 million of promissory notes held by Mr. Gianakakos’ family’s trusts, and fair value of contingent consideration of $ 4.6 million, representing the estimated acquisition date fair value of milestone payments of up to $ 200.0 million, payable in cash or shares, contingent on the achievement of various post-closing milestones (the “Prolaio Contingent Consideration”). The Prolaio Contingent Consideration was recognized as contingent milestone liabilities on the condensed consolidated balance sheet. Acquisition related costs of approximately $ 0.8 million, consisting primarily of legal, accounting, and valuation fees, were expensed as incurred and recorded within general and administrative expenses in the condensed consolidated statement of operations and comprehensive loss. 22 The following table summarizes the fair values of the identifiable assets acquired and liabilities assumed as of the Acquisition Date (in thousands): Amount Assets acquired: Cash and cash equivalents $ 14 Inventory 244 Prepaid expenses and other current assets 390 Property and software 175 Developed technology 25,400 In‑process research and development (IPR&D) 1,100 Operating lease right-of-use assets, net 255 Other non-current assets 57 Total assets acquired 27,635 Liabilities assumed: Accounts payable 2,710 Accrued expenses and other current liabilities 2,717 Deferred revenue 270 Operating lease liability 109 Assumed contingent consideration liability 3,300 Deferred income tax liability 4,512 Other liabilities, non-current 205 Total liabilities assumed 13,823 Net assets acquired $ 13,812 In connection with this acquisition, the Company recorded $ 13.8 million of net assets acquired, primarily consisting of developed technology with a fair value of $ 25.4 million, IPR&D with a fair value of $ 1.1 million, and $ 13.8 million in liabilities assumed, including $ 4.5 million of deferred income tax liability and $ 3.3 million of assumed contingent consideration liability. Because the fair value of net identifiable assets acquired exceeded the fair value of the consideration transferred, the Company recognized a gain on bargain purchase in the amount of $ 5.2 million in the condensed consolidated statement of operations and comprehensive loss for the six months ended June 30, 2025. The bargain purchase gain reflects the Company’s ability to acquire Prolaio at a purchase price below the fair value of the acquired net assets due to a combination of factors, including Prolaio’s limited operating scale, historical operating losses, liquidity constraints at the time of the transaction, and the structure of the consideration transferred. In particular, concurrent with the acquisition, the Company entered into integration bonus arrangements with the Company’s Chief Executive Officer and Chief Medical Officer (“Integration Bonus”), both of whom were co-founders and Prolaio shareholders. These arrangements were contingent upon post-combination services and successful integration and, accordingly were accounted for as compensation expense rather than consideration transferred. Prolaio’s results of operations were included in the Company’s condensed consolidated statement of operations and comprehensive loss from the date of acquisition, February 24, 2025. Pro forma financial information The following pro forma combined financial information has been prepared to give effect to the Prolaio acquisition as if it had been consummated on January 1, 2024, and was prepared using the historical results of Kardigan and Prolaio for the three and six months ended June 30, 2025 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2025 2025 Net loss $ ( 43,085 ) $ ( 73,604 ) 23 The pro forma amounts have been adjusted for: • transaction costs of $ 1.0 million were excluded from the six months ended June 30, 2025 pro forma results, as if these costs were incurred during the 2024 period; • gain on bargain purchase of $ 5.2 million was excluded from the six months ended June 30, 2025 pro forma results, as if such gain was recognized during the 2024 period; • income tax benefit of $ 4.2 million was excluded from the six months ended June 30, 2025 pro forma results, as if such benefit was recognized during the 2024 period; • incremental stock-based compensation expense related to the accelerated vesting of Prolaio options upon acquisition of $ 1.6 million was excluded from the six months ended June 30, 2025 pro forma results, as if this expense was incurred during the 2024 period; • incremental intangible assets amortization expense resulting from the fair value adjustment recognized for developed technology in the amount of $ 0.6 million was included in six months ended June 30, 2025 pro forma results; • incremental stock-based compensation expense related to the integration bonus of $ 14.4 million was excluded from the three and six months ended June 30, 2025 pro forma results; • immaterial inter-company transactions between the Company and Prolaio during the six months ended June 30, 2025 were eliminated. The Company had no revenue for the three and six months ended June 30, 2025. The pro forma data is presented for informational purposes only and is not intended to represent or be indicative of the results of operations that would have been reported had the acquisition occurred on that date, nor is it intended to be representative of future results of operations of the combined company. Acquired developed technology Developed technology acquired consists of the cardiovascular analytics data platform originally obtained by Prolaio in November 2023 through its purchase of certain assets from PhysIQ (defined below). Subsequent to the asset purchase and prior to the Company’s acquisition of Prolaio, Prolaio’s engineering team enhanced the acquired technology and expanded the platform capabilities through the addition of new features and functional improvements. As of the Acquisition Date, the fair value of the developed technology was estimated using the cost method, which incorporates management’s estimates of the costs that would be incurred to develop the technology from scratch, including assumptions regarding required personnel, annual compensation, and the expected development timeline. The Company estimated that it would require approximately 3.7 years for a team of approximately 50 employees, with an estimated average annual cost ranging from $ 0.1 million to $ 0.2 million per employee, to recreate the technology, resulting in a total valuation of $ 25.4 million. Prolaio contingent milestone liabilities As part of the consideration transferred in the acquisition, the Company was required to make contingent cash payments up to $ 200.0 million , dependent upon the achievement of certain specified post-closing operational, financial and regulatory milestones (“Prolaio milestones”) prior to February 2029. Specifically, Prolaio milestones depended on the success of the Company’s clinical trials, achievement of certain Prolaio revenue targets (excluding intercompany revenue), and adoption and performance of the Prolaio platform. The fair value of the Prolaio Contingent Consideration at the acquisition date was $ 4.6 million. It was estimated using a probability weighted discounted cash flow model, which incorporated management’s estimates of the probability and timing of milestone achievement as of the acquisition date. The milestones were contractually required to be achieved within four years from the date of acquisition, discounted at a rate of approximately 10 %. On May 1, 2026, the Company entered into an amendment to the Agreement and Plan of Merger with the former stockholders of Prolaio in order to amend the milestone provisions applicable to such stockholders, including Mr. Gianakakos and Dr. Edelberg (“Prolaio amendment”) . In particular, the milestones were revised to: (i) better align the incentives of the former stockholders of Prolaio, Inc., in their capacities as executive officers and employees of Kardigan, with the creation of stockholder value for the Company; and (ii) better reflect the Company’s current operations and strategic direction following 24 the acquisition, including the Company’s focus on deploying the Prolaio platform in support of its own clinical trials, and (iii) ensure that the milestones remained aligned with the Company’s business. Pursuant to the amendment and subject to the conditions therein, the former stockholders of Prolaio, Inc., including Mr. Gianakakos and Dr. Edelberg, are entitled to milestone payments based on certain Company valuations, as defined in the agreement, as follows: (i) up to $ 50 million upon the Company’s achievement of a valuation equal to or greater than $ 5.0 billion; (ii) up to $ 50 million upon the Company’s achievement of a valuation equal to or greater than $ 6.0 billion; and (iii) up to $ 100 million upon the Company’s achievement of a valuation equal to or greater than $ 12.0 billion; in each case to the extent such milestones are achieved on or before May 1, 2032. If such milestone payments become payable in full, Mr. Gianakakos is entitled to receive payments of up to $ 12.9 million, $ 31.3 million and $ 62.4 million, respectively, pursuant to each milestone, for a total of up to $ 106.6 million; and Dr. Edelberg is entitled to receive payments of up to $ 3.6 million, $ 9.8 million, and $ 19.5 million, respectively, pursuant to each milestone, for a total of up to $ 32.9 million. No ne of the Prolaio milestones, original or amended, have been achieved and no milestone payments have been made. The Prolaio contingent payments are classified as Level 3 within the fair value hierarchy, due to the use of significant unobservable inputs and remeasured at fair value at each reporting date. Prior to the Prolaio amendment, changes in the fair value of the contingent consideration were recognized in R&D expenses in the condensed consolidated statements of operations and comprehensive loss. Subsequent to the Prolaio amendment, changes in the fair value of the contingent milestone liabilities are recognized in change in fair value of contingent milestone liabilities, in the condensed consolidated statements of operations and comprehensive loss. The fair value of the Prolaio Contingent Consideration was $ 3.8 million as of December 31, 2025. Upon the Prolaio amendment, on May 1, 2026, the Prolaio Contingent Consideration was settled and the new contingent milestone liabilities were recognized at an initial fair value of $ 13.7 million. The fair value of the contingent milestone liabilities was $ 47.3 million as of June 30, 2026. The Company recognized a $ 43.5 million increase in the fair value of contingent milestone liabilities, which is presented within change in fair value of contingent milestone liabilities in the condensed consolidated statements of operations, for both the three and six months ended June 30, 2026 . No change in fair value was recorded in the three and six months ended June 30, 2025. PhysIQ contingent consideration (assumed liability) Liabilities assumed as part of the Company’s acquisition of Prolaio included a contingent consideration liability associated with Prolaio’s historical acquisition of certain assets of PhysIQ, Inc. (“PhysIQ contingent consideration”), a health technology company specializing in cloud-based predictive analytics for personalized physiology. The obligation of up to $ 20.0 million, payable in cash, is contingent upon the achievement of certain sales milestones (“PhysIQ milestones”). As of the acquisition date, the Company recognized this contingent consideration at fair value using a probability-weighted approach, which incorporates management’s estimates of the probability and timing of milestone achievement. The milestones are expected to be achieved within 4 years from the date of acquisition of Prolaio, and are discounted at a rate of approximately 10 %. The estimated fair value of the PhysIQ contingent consideration at the acquisition date was $ 3.3 million, which was recorded within contingent milestone liabilities on the condensed consolidated balance sheet. Following the acquisition date, the Company applies a systematic and rational approach and recognizes additional amounts related to the PhysIQ contingent consideration when the underlying milestones are considered probable of achievement and reasonably estimable. Amounts are written off only when it is resolved that the Company will not be required to make payment or when the obligation legally expires. As such, the PhysIQ contingent consideration recorded will not be reduced below the amount recorded at the acquisition date until the obligation expires or the liability is paid. The PhysIQ contingent consideration was $ 3.9 million as of June 30, 2026 and December 31, 2025 . The Company recorded no expense in the condensed consolidated statement of operations and comprehensive loss for the three and six months ended June 30, 2026. As of December 31, 2025 , the milestone with a value of $ 2.5 million was considered probable of achievement and was expected to be achieved within 12 months of the reporting date. Accordingly, it was classified within current liabilities on the condensed consolidated balance sheet as of December 31, 2025. As of June 30, 2026, this milestone was still considered probable of achievement but was expected to be achieved within more than 12 months of the reporting date, and, accordingly, was classified within non-current liabilities on the condensed consolidated balance sheet. As of June 30, 2026 , no milestone payments have been made. 25 Prolaio bonus integration agreements Concurrent with the acquisition of Prolaio, the Company entered into agreements (the “Bonus Agreements”) with the Company’s Chief Executive Officer and Chief Medical Officer, that provided a right to a bonus in the amount of $ 9.0 million and $ 2.0 million, respectively, of shares of common stock issued in our initial public offering or convertible preferred stock, as applicable, as well as additional cash amounts intended to cover related federal, state, and local tax obligations. The Bonus Agreements also provided that, if the equity securities issued were not freely tradeable, the Company would loan each executive an amount sufficient to cover applicable tax obligations. The awards were contingent upon the closing and successful integration of Prolaio, as determined by the Company’s board of directors. The Bonus Agreements became payable upon completion of the Series B Initial Closing (as defined below). On September 4, 2025, in connection with the Series B Initial Closing, the Company entered into bonus integration agreements (the “Bonus Integration Agreements”) with each executive. The Bonus Integration Agreements modified the Bonus Agreements such that (i) each recipient agreed to forfeit Series B Preferred Stock (as defined below) to satisfy the tax withholding obligations, (ii) certain payments required to be made under the Bonus Agreements would be remitted to federal and state tax authorities via payroll for certain tax liabilities required to be satisfied by us through payroll and (iii) no loan will be issued to the recipient. Pursuant to the Bonus Integration Agreements, and net of tax withholding obligations, on September 4, 2025, the Company issued an aggregate of 374,360 shares of Series B Preferred Stock, with an estimated grant date fair value of approximately $ 8.0 million, and subsequently remitted approximately $ 6.4 million in cash to satisfy the related tax obligations. As the integration bonus payment was contingent upon post-combination services, the arrangement was accounted for as compensation. The integration bonus was deemed probable as of June 30, 2025, and the Company recognized related compensation expense of $ 2.6 million within research and development expenses and $ 11.7 million within general and administrative expenses in the three and six months ended June 30, 2025 in the condensed consolidated statement of operations and comprehensive loss. No related compensation expense was recognized in the three and six months ended June 30, 2026. Acquisition of RSF On June 6, 2024, the Company acquired 100 % of the outstanding shares of Rancho Santa Fe Bio, Inc. (“RSF”) in order to obtain certain of RSF’s existing intellectual properties, including (i) a license agreement relating to Ataciguat (i.e., HMR1766) with Sanofi (“Sanofi”); and (ii) a patent license and know-how agreement with the Mayo Foundation for Medical Education and Research (“Mayo”). Total consideration was $ 14.8 million, and included cash of $ 3.5 million, the settlement of RSF’s outstanding indebtedness of $ 10.6 million on the acquisition date and the payment of certain transaction costs of $ 0.7 million incurred by RSF. In addition, the former stockholders of RSF are entitled to milestone payments of up to $ 26.5 million in development and regulatory milestones and up to $ 249.5 million in sales milestones (“RSF milestones”), in each case to be allocated among such former stockholders on a pro rata basis in accordance with their respective ownership interests in RSF immediately prior to the acquisition. The Company is additionally obligated to pay to the former stockholders of RSF low single-digit royalties on worldwide net sales of any pharmaceutical product containing Ataciguat. Under ASC 805, the Company determined that the acquisition did not meet the definition of a business at the time of the acquisition as substantially all of the fair value of the gross assets acquired were concentrated in a single identifiable asset. The Company determined that RSF was a variable interest entity (“VIE”) under ASC 810 because it lacked sufficient equity to finance its activities. Upon acquisition, the Company became the primary beneficiary of RSF, and therefore was required to consolidate RSF. Accordingly, the transaction was accounted for as the acquisition of a VIE that is not a business. The net assets acquired consisted primarily of the IPR&D asset, cash and cash equivalents in the amount of $ 0.2 million, and assumed accounts payable for an amount of $ 1.3 million. Accordingly, the consideration allocated to the IPR&D asset amounted to $ 15.9 million. The acquired licensed technology was determined to be an IPR&D asset that did not have alternative future use as of the acquisition date, and the full amount was recognized as R&D expense in the condensed consolidated statement of operations and comprehensive loss for the year ended December 31, 2024. The Company achieved the first development milestone associated with Ataciguat upon dosing of the first patient in the Phase 3 clinical trial in September 2025. This milestone triggered a payment obligation of $ 3.0 million. In September 2025, $ 1.5 million was settled in cash, and the remaining $ 1.5 million was accrued for in the Company’s condensed consolidated balance sheet as of December 31, 2025 and as of June 30, 2026 within accrued and other current liabilities. 26 No ne of the other RSF milestones have been achieved nor were deemed probable and estimable as of June 30, 2026 , and no other milestone payments have been made. Under the Sanofi and the Mayo agreements, the Company is obligated to make certain additional milestone, royalty and sublicense-related payments under these agreements, summarized further below. License agreement with Sanofi On June 2, 2021, RSF entered into a license agreement with Sanofi, as subsequently amended on March 18, 2022, January 9, 2023, and November 7, 2025 (collectively, the “Sanofi License”), under which RSF received a worldwide, exclusive, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain Sanofi know-how to exploit Ataciguat and pharmaceutical products containing Ataciguat (“Ataciguat Products”) for all human and mammalian therapeutic, prophylactic and diagnostic uses (the “Sanofi License Field”). If the Company succeeds in developing and commercializing Ataciguat Products, it will be obligated to pay Sanofi up to an aggregate of $ 14.8 million in potential commercial milestone payments (“Sanofi milestones”). The Company is also obligated to pay Sanofi tiered royalties ranging from low-single digit to mid-single digit percentages on worldwide annual net sales of Ataciguat Products by the Company or its affiliates and sublicensees. As of June 30, 2026 , no ne of the Sanofi milestones had been achieved nor were deemed probable and estimable, and no milestone payments have been made. Patent license and know-how agreement with the Mayo Foundation for Medical Education and Research (“Mayo”) On December 6, 2019, RSF entered into a license agreement with Mayo, as amended on May 20, 2021, August 23, 2023, March 10, 2024, June 6, 2024 and December 22, 2025 (collectively, the “Mayo License”), under which RSF received (i) a worldwide exclusive license with the right to sublicense (through multiple tiers) under certain Mayo patent rights, (ii) a nonexclusive license with the right to sublicense (through multiple tiers in connection with a sublicense of the Mayo patent rights or know-how) to use certain know-how and materials, and (iii) a nonexclusive worldwide license, with the right to sublicense (through multiple tiers), subject to approval from Mayo, to use certain Mayo data, in each case in (i) through (iii), to develop, make, have made, use, offer for sale, sell, and import certain licensed products, including Ataciguat, for the prevention, diagnosis, and/or treatment of any and all human diseases and conditions. The Company is obligated to pay Mayo up to $ 0.3 million in development and regulatory milestone payments and up to $ 1.3 million in commercial milestone payments (“Mayo milestones”) for each licensed product. The Company is also obligated to pay Mayo royalties ranging from a mid-single digit to subteen percentage of worldwide annual net sales by the Company, its affiliates and sublicensees of licensed products. In the event that the Company is required to pay a non-affiliate third party certain consideration for a license under intellectual property rights owned or controlled by such non-affiliate third party that are required for the manufacture, use or sale of the licensed products, the Company can deduct a certain amount of such consideration from the royalty payments due to Mayo under the Mayo License, subject to a customary reduction floor. The Company’s obligation to pay Mayo royalties for licensed products will expire upon the expiration date of the last to expire of the licensed patents or the last to expire regulatory exclusivity for a licensed product. Mayo is also eligible to receive a mid-double digit percentage of certain non-royalty sublicense income as well as a certain percentage of any consideration received by the Company for the sale or transfer of an FDA priority review voucher or similar transferable asset. As of June 30, 2026 , no ne of the Mayo milestones had been achieved nor were deemed probable and estimable, and no milestone payments have been made. License agreement with Ionis On June 7, 2024, the Company entered into a License Agreement (the “Ionis License Agreement”) with Ionis Pharmaceuticals, Inc. (“Ionis”), pursuant to which the Company was granted an exclusive, worldwide, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain Ionis intellectual property to develop and commercialize Tonlamarsen (formerly ION904) and products containing Tonlamarsen (the “Licensed Ionis Products”) in the field of prophylactic or therapeutic use in humans (the “Ionis Licensed Field”). The Company also received a non-exclusive, worldwide, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain Ionis intellectual property to manufacture Tonlamarsen and Licensed Ionis Products in the Ionis Licensed Field. Until the third 27 anniversary of the effective date of the Ionis License Agreement, or June 2027, neither party may develop or commercialize, or assist or grant a third party rights to develop or commercialize certain ASOs designed to bind to the RNA encoded by the human angiotensinogen gene, subject to certain conditions and exceptions. As initial consideration for the Ionis License Agreement, the Company made an upfront payment of $ 20.0 million to Ionis. As additional consideration for the licenses and rights granted to us by Ionis, the Company is required to pay Ionis: (i) milestone payments in the event of successful achievement of specified development, regulatory and sales milestones of up to an aggregate of $ 375.0 million (up to $ 35.0 million in development and regulatory milestone payments and up to $ 340.0 million in sales milestone payments) (“Ionis milestones”); (ii) tiered royalties on net sales of Ionis Licensed Products by the Company, its affiliates and sublicensees with a rate based on net sales per calendar year, ranging from a subteen percentage to high teen percentage. The royalties are subject to potential reductions under certain scenarios. In the event that the Company undergoes a change of control prior to receiving regulatory approval from the FDA and are acquired by one of certain top biopharmaceutical or pharmaceutical companies, if the acquisition price exceeds a certain dollar value, the Company will be required to pay Ionis a one-time change of control payment based on the acquisition price, ranging in the low tens of millions of dollars. The payment will accrue interest at a subteen percentage rate per annum, compounded annually, from the date of the Ionis License Agreement through the date such payment is made. The Company determined that the licenses represent an acquired IPR&D asset that did not have alternative future use as of the acquisition date, and, accordingly, the total amount of the upfront payment of $ 20.0 million was recognized as R&D expense in the condensed consolidated statement of operations and comprehensive loss for the year ended December 31, 2024. As of June 30, 2026, none of the Ionis milestones had been achieved nor were deemed probable and estimable, and no milestone payments have been made. License agreements with BMS Co. In November 2024, the Company entered into a License Agreement with MyoKardia, Inc. (“MyoKardia”), a wholly-owned subsidiary of Bristol-Myers Squibb Company (“BMS Co.”), related to Danicamtiv and other compounds (the “Dani Agreement”), and a separate License Agreement with BMS Co. related to KAR-141 (formerly known as BMS-986141) (“Par4”) and other compounds (the “Par4 Agreement”). Under the Dani Agreement, the Company received an exclusive, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain MyoKardia patents and know-how to develop, manufacture, and commercialize Danicamtiv (formerly known as MYK-491) and certain related compounds (collectively, the “Dani Licensed Compounds”) and pharmaceutical products containing such Dani Licensed Compounds (the “Dani Licensed Products”) for all human uses worldwide. As partial consideration for the rights granted to the Company under the Dani Agreement, the Company entered into a Subscription Agreement with MyoKardia pursuant to which the Company issued 1,251,107 shares of Series A Preferred Stock to MyoKardia. As additional consideration for the licenses granted under the Dani Agreement, the Company is required to pay MyoKardia: (i) tiered royalties at a rate based on aggregate annual net sales by the Company, its affiliates and sublicensees of each Dani Licensed Product containing the same Dani Licensed Compound; (ii) a low double-digit percentage of any sublicensing revenue received by the Company, if the Company sublicenses rights under MyoKardia patents or know-how for the development, manufacture or commercialization of any Dani Lead Compound or Dani Lead Compound Licensed Product to a third-party within a certain number of months from the effective date, or November 2026; (iii) up to $ 42.5 million in the aggregate in development and regulatory milestone payments across all Dani Licensed Products and (iv) up to $ 265.0 million in sales milestone payments for each of the first two Dani Licensed Products to achieve the applicable sales milestones ((iii) and (iv), collectively, “Dani milestones”). The Company’s tiered royalties range from a subteen to high teen percentage of annual net sales of the Dani Licensed Products, subject to potential reductions following the expiration of valid patent claims, due to competition from generic products, for certain third-party license fees, and in the event of a limit on the maximum price as a result of the Inflation Reduction Act of 2022 (the “Inflation Reduction Act”), subject to a customary reduction floor and potential carry forward. Under the Par4 Agreement, the Company received an exclusive, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain BMS Co. patents and know-how to develop, manufacture, and commercialize KAR-141 and certain related compounds thereto (the “Par4 Lead Compounds”), certain back-up compounds and certain related compounds thereto (such compounds, collectively, with the Par4 Lead Compounds, the “Par4 Licensed Compounds”, pharmaceutical products containing the Par4 Lead Compounds (the “Par4 Lead Compound Licensed 28 Products”) and pharmaceutical products containing the Par4 Back-Up Compounds (such products, collectively with the Par4 Lead Compound Licensed Products, the “Par4 Licensed Products” for all human uses worldwide. As partial consideration for the rights granted under the Par4 Agreement, the Company issued 293,469 shares of Series A Preferred Stock. As additional consideration for the licenses granted under the Par4 Agreement, the Company is required to pay BMS Co.: (i) tiered royalties at a rate based on aggregate annual net sales by the Company, its affiliates and sublicensees of each Par4 Licensed Product containing the same Par4 Licensed Compound; (ii) a low double-digit percentage of any sublicensing revenue received by the Company, if the Company sublicenses rights under BMS Co. patents or know-how for the development, manufacture or commercialization of any Par4 Lead Compound or Par4 Lead Compound Licensed Product to a third-party a certain number of months from the effective date, or November 2026; (iii) up to $ 10.0 million in the aggregate in development and regulatory milestone payments across all Par4 Licensed Products and (iv) up to $ 265.0 million in sales milestone payments for each of the first two Par4 Licensed Products to achieve the applicable sales milestones ((iii) and (iv), collectively, “Par4 milestones”). The Company’s tiered royalties range from a subteen to high teen percentage of annual net sales of the Par4 Licensed Products, subject to potential reductions following the expiration of valid patent claims, due to competition from generic products, for certain third-party license fees, and in the event of a limit on the maximum price as a result of the Inflation Reduction Act, subject to a customary reduction floor and potential carry-forward. Additionally, certain BMS Co. patents and know-how are sublicensed by BMS Co. pursuant to an upstream license agreement with a university and the Company is responsible for reimbursing BMS Co. for certain milestone payments and other amounts payable under such upstream agreement that arise from its development, manufacturing or commercialization activities under the Par4 Agreement. The milestone reimbursement obligations include up to (i) $ 12.5 million in the aggregate in development and regulatory milestone payments per certain Par4 Licensed Products and (ii) $ 13.625 million in the aggregate in development and regulatory milestone payments per certain other Par4 Licensed Products. In connection with the license agreements, the Company issued an aggregate of 1,544,576 shares of Series A Preferred Stock to MyoKardia and BMS Co., including 1,251,107 shares of Series A Preferred Stock under the Dani Agreement, and 293,469 shares of Series A Preferred Stock under Par4 Agreement, at the estimated fair value of $ 19.10 per share as of issuance date, with a total estimated fair value of $ 29.5 million. The Company determined that the Dani and Par4 licenses represent acquired IPR&D assets that did not have alternative future use as of the acquisition date, and, accordingly, an amount of $ 29.5 million was recognized as R&D expense in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2024. As of June 30, 2026 , no ne of the Dani milestones or Par4 milestones had been achieved nor were deemed probable or estimable, and no milestone payments have been made. As part of the Company's initial public offering, all outstanding shares of the Company's redeemable convertible preferred stock converted into an equivalent number of shares of common stock, after giving effect to the forward stock split. 6. Intangible assets The following table summarizes the intangible assets, net (in thousands): June 30, 2026 December 31, 2025 Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Finite-lived intangible assets: Developed technology $ 29,829 $ ( 5,049 ) $ 24,780 25,400 ( 3,024 ) 22,376 Other 2,215 ( 577 ) 1,638 1,165 ( 316 ) 849 Total finite-lived intangible assets 32,044 ( 5,626 ) 26,418 26,565 ( 3,340 ) 23,225 Total intangible assets $ 32,044 $ ( 5,626 ) $ 26,418 $ 26,565 $ ( 3,340 ) $ 23,225 Developed technology primarily consists of the cardiovascular analytics data platform originally recognized upon acquisition of Prolaio, Inc. during the three months ended June 30, 2025 . The developed technology, with a gross carrying amount of $ 25.4 million, was assigned an estimated useful life of seven years . The acquired IPR&D assets, also recognized upon the Prolaio acquisition, and presented within the other category, were initially classified as indefinite-lived intangible 29 assets. By December 31, 2025 , the Company determined that the underlying projects had reached technological feasibility and accordingly reclassified these assets as finite-lived intangible assets with an estimated useful life of three years . Subsequent to the Prolaio acquisition, the Company’s engineering team continued to enhance the acquired technology and expand the platform capabilities through the addition of new features and functional improvements. The Company capitalizes certain qualifying costs related to the development of computer software for internal use. The Company capitalized internal-use software costs totaling $ 5.4 million for the six months ended June 30, 2026. Capitalized internal-use software costs related to the development of the Prolaio platform are included within the developed technology category and amounted to $ 4.4 million for the six months ended June 30, 2026. Capitalized internal-use software costs related to other development projects are included within the other category, and amounted to $ 1.0 million for the six months ended June 30, 2026. As of June 30, 2026, the other finite-lived intangible assets category includes $ 2.8 million of software development costs related to projects not yet placed in service. No amortization expense was recorded in relation to these costs for the three and six months ended June 30, 2026. Amortization expense related to finite-lived intangible assets was $ 1.1 million, $ 2.2 million for the three and six months ended June 30, 2026, and $ 1.0 million and $ 1.3 million for the three and six months ended June 30, 2025, respectively, and was primarily included in R&D expenses on the condensed consolidated statements of operations and comprehensive loss. The following table summarizes the estimated future amortization expense associated with the finite-lived intangible assets as of June 30, 2026 (in thousands): Amount 2026 (six months remaining) $ 2,237 2027 4,473 2028 4,157 2029 3,953 2030 3,953 Thereafter 4,834 Total estimated future amortization expense $ 23,607 As of June 30, 2026 and December 31, 2025 , there were no accumulated impairment losses related to intangible assets. 7. Leases The Company leases office and laboratory spaces which are classified as operating leases on the condensed consolidated balance sheets. Cove Lease In September 2024, the Company entered into a facility lease in South San Francisco, California (the “Cove Lease”), for approximately 36,000 rentable square feet. The lease commenced in October 2024 and has a contractual term of 66 full calendar months, expiring in April 2030. The Cove Lease includes an option to extend the lease term for an additional five years . At lease commencement, the Company evaluated the renewal option and concluded that it is not reasonably certain that the renewal option will be exercised. Under the terms of the Cove Lease, the landlord has made available a tenant improvement allowance of up to $ 0.7 million for qualifying permanent improvements to the leased premises. The allowance is structured as a landlord-funded improvement option that, if utilized, becomes subject to repayment by the Company as additional rent over the remaining lease term at a contractually specified interest rate. As of the reporting date, the Company has not elected to utilize any portion of the allowance, has not incurred any qualifying improvement expenditures, and has not received any landlord-initiated improvements requiring reimbursement. Accordingly, no related adjustments to ROU asset or lease liability have been recognized in the Company’s condensed consolidated financial statements. 30 Princeton Lease In February 2025, the Company entered into an office space lease for approximately 21,500 square feet in Princeton, New Jersey (the “Princeton Lease”). The lease commenced in September 2025 and has a contractual term of 90 full calendar months, expiring in March 2033. The Princeton Lease includes an option to extend the lease term for an additional five years . At lease commencement, the Company evaluated the renewal option and concluded that it is not reasonably certain that the renewal option will be exercised. Concurrent with the execution of the Princeton lease, the Company executed a temporary swing-space lease, that provided approximately 9,000 square feet of office space in its ‘as is’ condition to support business operations while the main premises underwent landlord-performed improvements. The swing-space lease commenced in February 2025 and ended in September 2025 when the Company took possession of the main Princeton Lease premises. The arrangement met the definition of a lease under ASC 842 and qualified as a separate lease, however it met the short-term lease exemption criteria. Accordingly, the Company recognized lease expense for the swing-space as incurred, with no recognition of a ROU asset or lease liability for this arrangement. The Company maintains letters of credit related to the above leases totaling $ 0.5 million and $ 0.5 million as of June 30, 2026 and December 31, 2025, respectively. These lease-related letters of credit are reflected within restricted cash, non-current on the Company’s condensed consolidated balance sheets as of June 30, 2026 and December 31, 2025. The lease expenses, which are included in operating expenses in the condensed consolidated statements of operations and comprehensive loss, were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating lease expense $ 838 $ 602 $ 1,700 $ 1,187 Variable lease expense 444 342 705 650 Short-term lease expense 5 4 20 64 Total lease expense $ 1,287 $ 948 $ 2,425 $ 1,901 Supplemental disclosure of cash flow information related to leases was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Cash paid for amounts included in the measurement of lease liabilities $ 905 $ 30 $ 1,726 $ 40 Right-of-use assets obtained in exchange for new operating lease liabilities — — 560 278 As of June 30, 2026 and December 31, 2025 , the weighted-average remaining lease term for operating leases was 4.7 years and 5.2 years, respectively, and the weighted-average discount rate was 10.04 % and 10.02 % , respectively. The following table reconciles the undiscounted future minimum lease payments required for the operating leases as of June 30, 2026 (in thousands): Amount 2026 (six months remaining) $ 1,939 2027 3,816 2028 3,666 2029 3,644 2030 1,774 Thereafter 1,821 Total minimum lease payments 16,660 Less: imputed interest ( 3,313 ) Present value of operating lease liabilities $ 13,347 31 8. Commitments and contingencies Research and development agreements The Company enters into various agreements in the ordinary course of business, such as those with suppliers, clinical research organizations, contract manufacturing organizations, and clinical trial sites. These agreements provide for termination at the request of either party, generally with less than one-year notice and are, therefore, cancellable contracts and, if cancelled, are not anticipated to have a material effect on the Company’s financial condition, results of operations, or cash flows. Legal proceedings From time to time, the Company may become involved in legal proceedings arising from the ordinary course of business. The Company accrues a liability for such matters when it is probable that the loss has been incurred and the amount of the loss can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. As of June 30, 2026, and December 31, 2025 , the Company was no t a party to any material legal proceedings. Legal fees are expensed as incurred. Indemnification In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In accordance with the Company’s amended and restated certificate of incorporation and amended and restated bylaws, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. The Company has not incurred any material indemnification claims to date. The Company maintains directors’ and officers’ liability insurance, which may reduce its exposure in the event of future claims. Future milestone and royalty payments In 2025 and 2024, the Company entered into certain acquisition and licensing agreements. These agreements include potential future milestone payments, royalties and other contingent consideration, payable upon the achievement of specified development, regulatory and commercial milestones. Refer to Note 5, “Acquisition and Licensing Agreements” . 9. Redeemable convertible preferred stock Redeemable convertible preferred stock The Company had previously issued Series A redeemable convertible preferred stock (the “Series A Preferred Stock”), Series B redeemable convertible preferred stock (the “Series B Preferred Stock”) and Series B-1 redeemable convertible preferred stock (the “Series B-1 Preferred Stock”), which are collectively referred to as "Preferred Stock". In connection with the Company's initial public offering, all outstanding shares of the Preferred Stock were converted into an equivalent number of shares of common stock, after giving effect to the forward stock split. Series A Preferred Stock In June 2024, the Company entered into a Series A preferred stock purchase agreement (the “Series A SPA”) under which it issued and sold 2,487,790 shares of Series A Preferred Stock, at a price of $ 19.42 per share, for gross cash proceeds of $ 48.3 million (the “Series A Initial Closing”). Contemporaneously, investors converted their Simple Agreements for Future Equity (“SAFEs”) with a principal amount of $ 0.9 million into 43,762 shares of Series A Preferred Stock, bringing the total number of shares of Series A Preferred Stock issued at the Series A Initial Closing to 2,531,552 shares. An initial additional closing under the Series A SPA occurred in July 2024, at which the Company sold 2,883,206 additional shares of Series A Preferred Stock at a price of $ 19.42 per share for gross cash proceeds of $ 56.0 million. 32 Pursuant to the Series A SPA, the Company had an obligation to issue and certain Series A investors were obligated to purchase additional shares in two additional closings of $ 100.0 million each, subject to the satisfaction of specified milestone and cash-related conditions. The Second Tranche closing was to be funded upon the Company’s successful enrollment of the first patient in a Phase 3 clinical trial of either the Tonlamarsen Product or the Ataciguat Product, whichever occurs first (the “Second Tranche”). The Third Tranche closing was to be funded at the earlier of enrollment of the first patient in a Phase 3 clinical trial or an acquisition of any other clinical-stage pharmaceutical product or compound other than Tonlamarsen Product or Ataciguat Product or compound other than Ataciguat (the “Third Tranche”). Each investor could elect to voluntarily fund their share of the two tranches prior to the achievement of the milestones. In November 2024, the Company determined, that the conditions related to the Third Tranche had become probable of achievement, subject to meeting the required cash-balance condition. In February 2025, following the satisfaction of the cash-balance condition, the Third Tranche closing was consummated, pursuant to which the Company sold 5,148,587 additional shares of Series A Preferred Stock, resulting in total gross cash proceeds of $ 100.0 million. In August 2025, the condition applicable to the Second Tranche was waived, and the tranche closed, pursuant to which the Company sold 5,148,587 additional shares of Series A Preferred Stock, resulting in additional gross cash proceeds of $ 100.0 million. Preferred stock tranche obligations Upon the initial closing of the Series A Preferred Stock, with respect to the Second Tranche, the Company recorded a preferred stock tranche obligation liability of $ 3.2 million, and, with respect to the Third Tranche, the Company recorded a preferred stock tranche liability of $ 9.2 million. The fair value of the Series A Preferred Stock tranche obligations was allocated from the gross cash proceeds of the Series A Preferred Stock issuance, and the residual value was then allocated to the Series A Preferred Stock. As of December 31, 2024 , the fair value of the Second Tranche obligation was estimated as a liability in an amount of $ 7.3 million, and the fair value of the Third Tranche was estimated as an asset in an amount of $ 1.7 million. In February 2025, upon closing of the Third Tranche, the Company remeasured the preferred stock tranche obligation as of the closing date. The estimated fair value of the preferred stock tranche asset in an amount of $ 1.7 million was settled and the shares of Series A Preferred Stock issued in the Third Tranche were recorded at fair value on the date of issuance. As of June 30, 2025, the estimated fair value of the Second Tranche preferred stock tranche liability was $ 11.2 million. Accordingly, the Company recognized a loss in an amount of $ 3.9 million which was recorded within change in fair value of preferred stock tranche obligations in its condensed consolidated financial statements. Both the Second and Third Tranches of the Series A Preferred Stock were closed during the year ended December 31, 2025, and accordingly, no change in fair value was recorded for the six months ended June 30, 2026. Refer to Note 3, “ Fair Value Measurements ” for further details on valuation methodology and assumptions used. BMS Co. license In November 2024, in connection with license agreements, the Company issued an aggregate of 1,544,576 shares of Series A Preferred Stock to MyoKardia and BMS Co., at the estimated fair value of $ 19.10 per share as of issuance date, with a total estimated fair value of $ 29.5 million. Refer to Note 5, “ Acquisitions and Licensing Agreements ” for more details. Series B Preferred Stock and Series B-1 Preferred Stock In September 2025, the Company entered into a Series B preferred stock purchase agreement (the “Series B SPA”) under which it issued and sold 4,082,529 shares of Series B Preferred Stock and 2,610,635 shares of Series B-1 Preferred Stock, at a price of $ 21.37 per share for each series, for gross cash proceeds of $ 143.0 million (the “Series B Initial Closing”). In addition, the Company issued warrants to purchase 1,752,080 shares of the Company’s common stock to certain investors. Refer to Note 10, “Common Stock” for more details. Subsequent to the Series B Initial Closing, the first additional closing occurred on October 9, 2025, at which the Company sold 4,025,257 additional shares of Series B Preferred Stock at the same price of $ 21.37 per share for gross cash proceeds of $ 86.0 million. Additionally, the second additional closing was consummated on October 15, 2025, at which the Company sold 1,170,134 additional shares of Series B-1 Preferred Stock at a price of $ 21.37 per share for gross cash proceeds of $ 25.0 million. 33 In March 2026, the Company amended its certificate of incorporation to authorize the issuance of additional shares of Series B Preferred Stock and sold 468,053 shares of Series B Preferred Stock at the original price of $ 21.37 per share, for gross cash proceeds of $ 10.0 million. At the closing date, the estimated fair value of the Series B Preferred Stock was $ 24.36 per share. As additional consideration, the investor agreed to provide the Company with access to certain intellectual property pursuant to a license that was subject to final documentation and expected to be executed within 90 days of the closing date. Based on the stage of negotiations and the Company’s existing relationship with the investor, management concluded that execution of the license was probable and that the Company had a present right to future economic benefits at issuance. Accordingly, the Company recorded the issuance of shares of the Series B Preferred Stock at fair value of $ 11.4 million. The excess of the fair value over the cash proceeds of $ 1.4 million was initially recorded as an other current asset within prepaid and other current assets on its condensed consolidated balance sheet. The definitive license agreement was executed in June 2026. Upon execution, the Company reassessed the prepaid asset and concluded that the rights received relate to research and development activities; accordingly, the $ 1.4 million was expensed as research and development costs during the three months ended June 30, 2026. Summary Preferred stock as of December 31, 2025 consisted of the following: Series Shares authorized Shares issued and outstanding Original issue price per share Aggregate liquidation amount Net carrying value Series A Preferred Stock 17,256,508 17,256,508 19.42 335,170 324,544 Series B Preferred Stock 8,482,146 8,482,146 21.37 181,222 180,954 Series B-1 Preferred Stock 3,780,769 3,780,769 21.37 80,776 80,652 Total as of December 31, 2025 29,519,423 29,519,423 $ 597,168 $ 586,150 Immediately prior to the closing of the Company's initial public offering on June 22, 2026, pursuant to the stock split and proportional adjustment reflecting the 1.5928 -for-1 conversion ratio, all of the Company's outstanding Preferred Stock was converted into an aggregate of 47,764,024 shares of common stock. 10. Stockholders' Equity Common Stock As of June 30, 2026 , the Company’s certificate of incorporation, as amended and restated on June 22, 2026, authorized the Company to issue 700,000,000 shares of common stock, $ 0.00001 par value, with 500,000,000 of such shares designated as voting common stock and 200,000,000 of such shares designated as non-voting common stock. As of June 30, 2026, 93,467,940 shares of voting common stock and no shares of non-voting common stock were issued and outstanding. The voting, dividend and liquidation rights of the holders of the Company’s common stock may be subject to and qualified by the rights, powers and preferences of the holders of the Company’s preferred stock, if issued. Each share of voting common stock is entitled to one vote on all matters submitted to stockholders, except that, pursuant to the Company’s certificate of incorporation, holders of common stock are not entitled to vote on amendments to the certificate that relate solely to the terms of the outstanding preferred stock if the holders of such preferred stock are entitled to vote separately on those amendments. Each holder of non-voting common stock shall be treated equally to that of the voting common stock except that the holders thereof shall have no right to vote for the election of directors or on any other matters requiring stockholder action, except as required by law. Each holder of non-voting common stock shall also be entitled to convert such stock to voting common stock, at a 1 -to-1 ratio, provided such holder's beneficial ownership, as defined under Section 13(d) of the Exchange Act, does not exceed 9.99 % of the shares then outstanding. Prior to the June 22, 2026 amendment, the Company's certificate of incorporation, as amended and restated, authorized the Company to issue 55,133,053 shares of common stock, $ 0.00001 par value. The voting, dividend and liquidation rights of the holders of the Company’s common stock were subject to and qualified by the rights, powers and preferences of the holders of the Company’s preferred stock set forth above. Each share of common stock was entitled to one vote on all matters submitted to stockholders, except that, pursuant to the Company’s certificate of incorporation, holders of common stock are not entitled to vote on amendments to the certificate that relate solely to the terms of the outstanding preferred stock if the holders of such preferred stock are entitled to vote separately on those amendments. 34 The holders of common stock are entitled to receive dividends, if any, as declared by the Company’s board of directors, subject to the preferential dividend rights of the preferred stock. As of June 30, 2026, and December 31, 2025 no dividends have been declared or paid. Preferred Stock As of June 30, 2026 , the Company’s certificate of incorporation, as amended and restated on June 22, 2026, authorized the Company to issue 10,000,000 shares of undesignated preferred stock, $ 0.00001 par value. No shares of preferred stock have been issued and no shares were outstanding as of June 30, 2026. Warrants In connection with the issuance of Series B Preferred Stock, the Company issued warrants to purchase up to 1,752,080 shares of Company’s common stock (the “Warrants”) with an exercise price of $ 13.41 per share, exercisable, in whole or in part, only upon the first date the Company achieves a valuation of $ 5.0 billion and until the tenth anniversary of the issuance date ( September 4, 2035 ). The warrants, which were classified as equity, were initially recorded at fair value and do not require subsequent remeasurement. The warrants were granted only to a select group of investors that led the Series B Preferred Stock financing round as an economic incentive for their role. The fair value of the warrants, totaling $ 7.4 million, was recognized as a warrant issuance expense within the condensed consolidated statement of operations and comprehensive loss in the period of issuance. The fair value of the warrants was measured using the Monte Carlo pricing model. Significant inputs into the model as of September 4, 2025 were as follows: September 4, 2025 Exercise price $ 13.41 Expected liquidity event date June 6, 2027 Warrant expiration date September 4, 2035 Common stock IPO threshold price $ 13.41 Interest rate (annual) 4.17 % As of June 30, 2026 , no warrants were exercised and all remain outstanding. 11. Stock-based compensation 2023 stock option and grant plan (as amended and restated) The Company adopted the 2023 Stock Option and Grant Plan (as amended and restated, the “2023 Plan”) on August 18, 2023. The 2023 Plan remained in effect until June 17, 2026. The 2023 Plan provided for the grant of incentive stock options, non-qualified stock options, restricted stock awards, unrestricted stock awards and restricted stock units to the employees, directors and consultants of the Company. The option exercise price of each option was determined by the administrator of the 2023 Plan and could not be less than 100 % of the fair market value of the Company’s common stock on the date of grant, or in the case of an incentive stock option granted to a 10 % owner, the exercise price could not be less than 110 % of the fair market value of the Company’s common stock on the date of grant. The maximum term of the options granted under the 2023 Plan was no more than ten years . Service-based awards generally vest at 25 % one year from the vesting commencement date and ratably each month thereafter for a period of 36 months , subject to continuous service. Performance and market-based awards would have individual vesting conditions. The shares of common stock underlying any awards that are forfeited, cancelled, reacquired by the Company prior to vesting, satisfied without the issuance of stock, or otherwise terminated (other than by exercise), or held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding under the 2023 Plan were added back to the shares of common stock available for issuance under the 2023 Plan and, following June 17, 2026, will be added back to the shares of common stock available for issuance under the 2026 Plan. As of June 30, 2026 and December 31, 2025, the Company had reserved 26,224,708 and 33,752,354 shares of common stock for issuance under the 2023 Plan, respectively. As of June 30, 2026 and December 31, 2025, the number of shares remaining for grant under the 2023 Plan were zero and 4,375,891 shares, respectively. 35 2026 stock option and incentive plan The Company adopted the 2026 Stock Option and Incentive Plan (the "2026 Plan") on June 17, 2026, upon the cessation of the 2023 Plan. The 2026 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights ("SARs"), restricted stock awards, restricted stock units, and cash or other stock-based awards to the employees, directors, consultants and other service providers of the Company, provided that incentive stock options may be granted only to employees. The option exercise price of each option will be determined by the administrator of the 2026 Plan and shall not be less than 100 % of the fair market value of the Company's common stock on the date of grant, or in the case of an incentive stock option granted to a 10 % owner, the exercise price shall not be less than 110 % of the fair market value of the Company's common stock on the date of grant. The maximum term of the options granted under the 2026 Plan shall not be more than ten years . Service-based awards generally vest at 25 % one year from the vesting commencement date and ratably each month thereafter for a period of 36 months , subject to continuous service. Performance and market-based awards will have individual vesting conditions. Shares subject to 2023 Plan or 2026 Plan awards that are forfeited, cancelled, reacquired by the Company prior to vesting, satisfied without the issuance of stock, or otherwise terminated (other than by exercise), or held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, will be added (or added back) to the shares of common stock available for issuance under the 2026 Plan. A total of 10,620,000 shares of common stock were initially reserved for issuance under the 2026 Plan, and such reserve will automatically increase on January 1 of each year, beginning January 1, 2027, by the lesser of (i) 5 % of the total shares of common stock outstanding (including shares issuable upon exercise of any outstanding pre-funded warrants with a nominal exercise price) as of the immediately preceding December 31, or (ii) a smaller number of shares as determined by the Company's board of directors or compensation committee. As of June 30, 2026, the Company had reserved 10,620,000 shares of common stock for issuance under the 2026 Plan. As of June 30, 2026, the number of shares remaining for grant under the 2026 Plan were 8,469,613 shares. 2026 employee stock purchase plan On June 17, 2026, the Company adopted the 2026 Employee Stock Purchase Plan (the "ESPP"), which permits participants to contribute up to 15 % of their eligible compensation during defined rolling six-month periods to purchase the Company’s common stock. The purchase price of the shares will be 85 % of the lower of the fair market value of the Company’s common stock on the first day of trading of the offering period or on the applicable purchase date. A total of 1,180,000 shares of common stock were initially reserved for issuance under the ESPP, and such reserve will increase on January 1 of each year, beginning January 1, 2027, by the least of (i) 2,360,000 shares of common stock, (ii) 1 % of the shares of common stock outstanding as of the immediately preceding December 31, or (iii) such lesser number of shares as determined by the compensation committee. As of June 30, 2026, the Company has no t issued any shares under the ESPP. The following table summarizes stock options activity, inclusive of early exercises, for the six months ended June 30, 2026 (in thousands, except per share data and years): Number of Options Weighted average exercise price Weighted average remaining contractual term Aggregate Intrinsic value Outstanding at December 31, 2025 13,025,261 $ 2.74 8.98 $ 39,810 Granted 13,971,473 8.62 Exercised ( 542,484 ) 2.27 Forfeited ( 828,533 ) 3.49 Expired ( 8,602 ) 2.35 Outstanding at June 30, 2026 25,617,115 $ 5.93 9.11 $ 458,989 Exercisable as of June 30, 2026 9,700,842 $ 3.84 8.55 $ 194,144 Vested and expected to vest at June 30, 2026 25,617,115 $ 5.93 9.11 $ 458,989 The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the estimated fair value of the Company’s common stock for those stock options that had exercise prices lower than the estimated fair value of the Company’s common stock. 36 Performance-based and market-based options In June 2024, the Company’s Chief Executive Officer was granted an early-exercisable non-qualified option to purchase up to 4,277,389 shares of the Company’s common stock at a price per share of $ 1.35 . The options vest contingent upon the satisfaction of the service, performance and market conditions. The service condition is satisfied if the optionee maintains continuous service as the Company’s Chief Executive Officer through June 6, 2027. The market condition is structured in five tranches, under which certain percentage of the options vest upon the Company achieving market valuation thresholds at specified levels. The performance condition applies only to 932,676 shares and is satisfied upon the occurrence of specified acquisition by a predetermined date. This performance condition has been met upon the closing of the license agreement with BMS (refer to Note 5, “ Acquisitions and Licensing Agreements” ). In October 2025, the Company’s Chief Executive Officer was granted an early-exercisable non-qualified option to purchase up to 1,400,974 shares of the Company’s common stock at the price per share of $ 5.80 , with vesting tied to specific service and market conditions. The service condition is satisfied if the optionee maintains continuous service as the Company’s Chief Executive Officer through June 6, 2027. The market condition is structured in four tranches, under which certain percentage of the options vest upon the Company achieving market valuation thresholds at specified levels. In April 2026, the Company’s Chief Executive Officer was granted an early-exercisable non-qualified option to purchase up to 7,268,112 shares of the Company’s common stock at the price per share of $ 9.42 , with vesting tied to specific service and market conditions . The service condition is satisfied if the optionee maintains continuous service relationship with the Company. The market condition is structured in four tranches, under which certain percentage of the options vest upon the Company achieving market valuation thresholds at specified levels. The fair value of these awards was determined using a Monte Carlo simulation. The valuation assumptions utilized in the Monte Carlo model are generally consistent with the inputs discussed in the valuation of stock options below, except for volatility ranging from 80.0 % to 90.0 % and expected term of 9.0 to 10.0 years. No options vested, and no options were exercised as of and for the six months ended June 30, 2026 and 2025. Early exercise liability The Company's equity plans allow for the early exercise of all stock options granted if authorized by the Company's board of directors at the time of grant. Any shares of common stock issued from the early exercise of stock options are restricted and vest over time. The Company has the option to repurchase any unvested shares at the lower of the original issue price or current fair value upon any voluntary or involuntary termination of such optionee. For accounting purposes, the early exercise of options is not considered to be a substantive exercise until the underlying awards vest and are not considered to be outstanding until those shares vest. The early-exercise liability is included within other non-current liabilities on the condensed consolidated balance sheets. As of June 30, 2026 and December 31, 2025, unvested shares issued under early exercise provisions and subject to repurchase by the Company totaled 953,572 and 1,173,066 , respectively, with related liabilities of $ 1.4 million and $ 1.7 million, respectively, included in other non-current liabilities. Restricted stock activity The Company’s equity plans allow for the grant of restricted stock awards and restricted stock units to certain employees, executives, non-employee scientific advisors, and third-party service providers. The restrictions lapse over time primarily according to service-based vesting conditions of each award. In the event of a voluntary or involuntary termination of the holder’s continuous provision of services to the Company, any unvested portion of the restricted stock award is automatically forfeited. The following table summarizes restricted stock activity for the six months ended June 30, 2026: Shares of Restricted Stock Awards Weighted Average Grant date FV Shares of Restricted Stock Units Weighted Average Grant date FV Unvested restricted stock as of December 31, 2025 995,506 $ 5.20 — $ — Granted 2,205,481 15.77 Vested ( 331,831 ) 5.20 ( 19,684 ) 9.42 Forfeited — — Unvested restricted stock as of June 30, 2026 663,675 $ 5.20 2,185,797 $ 15.82 37 During six months ended June 30, 2026 , the Company granted a total of 2,205,481 restricted stock units, including 78,748 restricted stock units subject to both service-based and performance-based vesting conditions (the performance condition was satisfied upon the Company's IPO in June 2026), and 2,126,733 restricted stock units granted to certain employees and directors that vest in full on the two-year anniversary of the grant date, subject in each case to the applicable continued service relationship through the vesting date . Modification of Chief Medical Officer Restricted Stock Award The original vesting terms of the Chief Medical Officer’s award of 3,982,000 shares granted in August 2023 provided for 80 % of the shares to vest immediately, with the remaining 20 % vesting in equal monthly installments over a 24-month period. On June 6, 2024, in connection with the Company’s Series A financing and adoption of the 2023 Plan, the Company revised the vesting terms of the award to provide for 50 % immediate vesting, with the remaining 50 % vesting monthly over 36 months from the new vesting commencement date. The Company determined that this was an escrowed share arrangement under ASC 718 and determined that the shares were a new compensatory award. The incremental compensation cost of $ 7.8 million was measured as the excess of the fair value of the modified award over the fair value of the original award immediately prior to modification, to be recognized over a 36-month service period starting on June 6, 2024. For purposes of the net loss per share calculation, the Company determined that the modification is equivalent to a reverse stock split and, accordingly, adjusted the weighted-average number of unvested restricted stock shares under the Chief Medical Officer’s award as if those terms had been in effect for all periods presented. Stock-based compensation expense Stock-based compensation expense was included in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Research and development $ 3,434 $ 4,605 $ 5,766 $ 5,841 General and administrative 8,261 14,046 11,287 15,748 Total stock-based compensation expense $ 11,695 $ 18,651 $ 17,053 $ 21,589 As of June 30, 2026, unrecognized stock-based compensation expense related to unvested awards totaled $ 159.2 million, which is expected to be recognized over a weighted-average period of 2.72 years. 12. Income taxes The Company determines its income tax provision for interim periods using an estimate of its annual effective tax rate, adjusted for discrete items occurring in the periods presented. The Company recorded no income tax expense or benefit for the three months ended June 30, 2026 and 2025, representing effective tax rates of 0.0 % for both periods. The Company recorded no income tax expense and an income tax benefit of $ 4.2 million for the six months ended June 30, 2026 and 2025 , representing effective tax rates of 0.0 % and 5.2 % , respectively. There was no change in income tax expense or benefit for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. For the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, the change from an income tax benefit to income tax expense was primarily due to a discrete release of valuation allowance in the prior-year period attributable to deferred tax liabilities acquired in a business combination, which provided a source of future taxable income supporting realization of a portion of the Company's existing deferred tax assets. 38 For the three and six months ended June 30, 2026, the effective tax rate differs from the U.S. federal statutory rate primarily because the Company maintains a full valuation allowance against its net deferred tax assets, as the Company has determined that realization of those assets is not more likely than not based on available evidence. The Company had no material unrecognized tax benefits as of June 30, 2026 . 13. Net loss per share The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Numerator: Net loss - basic and diluted $ ( 116,236 ) $ ( 57,445 ) $ ( 172,307 ) $ ( 75,464 ) Denominator: Weighted-average number of shares of common stock outstanding 26,914,705 16,119,196 21,751,721 16,111,246 Less: Weighted-average number of shares of common stock subject to repurchase ( 990,398 ) ( 1,756,313 ) ( 1,044,927 ) ( 1,754,208 ) Less: Weighted-average number of shares of unvested restricted common stock ( 728,095 ) ( 1,982,495 ) ( 810,645 ) ( 2,313,060 ) Weighted-average number of shares of common stock outstanding - basic and diluted 25,196,212 12,380,388 19,896,149 12,043,978 Net loss per share - basic and diluted $ ( 4.61 ) $ ( 4.64 ) $ ( 8.66 ) $ ( 6.27 ) The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding because such securities have an anti-dilutive effect due to the Company’s net loss, in common stock equivalent shares: As of June 30, 2026 2025 Redeemable convertible preferred stock — 19,285,484 Shares subject to outstanding stock options 25,501,973 11,160,711 Shares subject to outstanding common stock warrants 1,752,080 — Unvested exercised options subject to repurchase 953,572 1,772,353 Unvested restricted stock awards 663,675 1,659,170 Unvested restricted stock units 2,185,797 — Total 31,057,097 33,877,718 14. Segment reporting The Company views its operations and manages its business as one operating segment, focused on the discovery and development of novel cardiovascular drugs for the treatment of heart diseases. The CODM, is responsible for making decisions regarding resource allocation and assessing performance. The Company’s CODM is its Chief Executive Officer. No revenue has been generated since inception, and all assets are held in the United States. The CODM assesses performance of the business, monitors budget versus actual results and manages and allocates resources to the Company’s operations using condensed consolidated net loss as the primary measurement. The CODM is regularly provided with entity-wide expense categories that are largely consistent with those found on the Company’s condensed consolidated statements of operations and comprehensive loss. The measure of segment assets is reported on the condensed consolidated balance sheets as total consolidated assets. 39 The table below is a summary of the segment loss, including significant segment expenses (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Program expenses: Danicamtiv $ 13,228 $ 884 $ 23,555 $ 884 Ataciguat 7,975 7,889 16,617 9,834 Tonlamarsen 3,925 4,744 7,870 8,408 Research and development - compensation and benefits * 18,505 14,801 32,293 22,450 Research and development - other 12,732 7,521 21,097 13,037 Total Research and development expense 56,365 35,839 101,432 54,613 General and administrative expense - compensation and benefits * 13,516 16,995 21,420 20,949 General and administrative expense - other 5,351 4,291 11,090 7,641 Total general and administrative expense 18,867 21,286 32,510 28,590 Change in fair value of contingent milestone liabilities 43,529 — 43,529 — Total operating expense 118,761 57,125 177,471 83,203 Other income/expense ** ( 2,525 ) 320 ( 5,164 ) ( 3,572 ) Loss before income taxes $ 116,236 $ 57,445 $ 172,307 $ 79,631 * Includes stock-based compensation expense ** Other income (expense) for the three and six months ended June 30, 2026 primarily includes interest income. Other income (expense) for the six months ended June 30, 2025 primarily includes bargain purchase gain, change in fair value of Series A Preferred Stock tranche obligations and interest income. 15. Related party transactions Prolaio transactions On February 24, 2025, the Company acquired 100 % of the outstanding shares of Prolaio, Inc. At the time of the acquisition, Tassos Gianakakos, the Company’s Chief Executive Officer and member of its board of directors, also served as Prolaio, Inc.’s Chief Executive Officer and as a member of its board of directors and Jay Edelberg, the Company’s Chief Medical Officer, served as its Head of Research & Development and as a member of its board of directors. Mr. Gianakakos and Dr. Edelberg beneficially owned 55.7 % and 17.1 %, respectively, of Prolaio, Inc. at the time of its acquisition. Accordingly, Prolaio, Inc. was considered a related party during the pre-acquisition period, and the Prolaio acquisition itself constituted a related-party transaction. In addition, the amendment to the Agreement and Plan of Merger entered into on May 1, 2026 with the former Prolaio stockholders also constituted a related-party transaction. Refer to Note 5, “ Acquisitions and Licensing Agreements ” for additional information. During the pre-acquisition period, Prolaio, Inc. provided services to the Company utilizing its proprietary device, data monitoring, and analytics platform in support of the development of the Company’s cardiovascular product candidates. For the period from January 1, 2025 through February 24, 2025 (the respective acquisition date), the Company made a prepayment of $ 0.3 million, and recognized $ 0.3 million of expense related to services performed by Prolaio, Inc. The Company had a prepaid expense balance of $ 0.3 million as of the acquisition date. Subsequent balances and transactions between Prolaio, Inc. and the Company are eliminated at consolidated level. 40 Ite m 2. Management’s discussion and analysis of financial condition and results of operations You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes and other financial information included in Part I of this Quarterly Report on Form 10-Q as well as our audited consolidated financial statements and related notes for the year ended December 31, 2025 included in our final prospectus dated June 17, 2026 filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended. This discussion and analysis and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements based upon our current plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, strategies, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. You should carefully read the section titled “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. Overview We are a clinical-stage precision therapeutics company developing medicines that target the root cause of specific cardiovascular diseases where no approved treatments exist. Our mission is to develop multiple targeted cardiovascular treatments in parallel that bring people with cardiovascular diseases closer to the cures they deserve. Our team is values-based and mission-driven, led by a proven and experienced management team applying a new philosophy to cardiovascular drug development. We have three late-stage programs, Danicamtiv, Ataciguat, and Tonlamarsen, in clinical development for indications for which no approved therapies currently exist. These programs are designed to create new standards of care for high-need patients. Our management team, including leaders from MyoKardia, Inc. (“MyoKardia”), has deep-domain knowledge of, and proven ability to, navigate the complexity of cardiovascular disease and translate that insight into an innovative drug development approach, enhanced by proprietary data and analytics technology through our Prolaio platform, to deliver with exceptional speed and execution. We believe this uniquely enables us to apply a high degree of precision to cardiovascular drug development, targeting the root causes of disease, rather than later onset cardiovascular symptoms. By applying our differentiated understanding of cardiovascular clinical endpoints, prioritizing indications with high regulatory clarity and significant unmet need, and focusing on biology-led patient selection for our trials, we believe we are uniquely positioned to maximize our probability of clinical success and efficiently develop and deliver multiple novel medicines with the greatest possible therapeutic impact for patients and healthcare providers alike. Cardiovascular disease is the leading cause of death worldwide, yet innovation has lagged due to drug development focused on broad, downstream, symptom-focused approaches despite disease heterogeneity and genetic variability. Furthermore, clinical trial design has depended on infrequent in-office measurements, failing to capture between visit changes that are critical to understanding cardiovascular disease, including symptoms and variability over time. These factors often result in development requiring lengthy, large and expensive outcomes trials with modest treatment effects. Kardigan’s approach is designed to address these challenges through differentiated clinical trial designs with near real-time continuous data collection that enable more modern and efficient development, including reduced enrollment size and trial duration relative to traditional cardiovascular outcomes trials. The intended result is faster and more cost-effective trials designed to achieve a higher probability of success, although there is no guarantee that these results will be achieved. Our mission is to apply Kardigan’s purpose-built cardiovascular development model to advance multiple late-stage programs in parallel, targeting “3 in 4”—three high-impact medicines through pivotal studies in roughly four years, subject to regulatory approval—enabling a credible, standalone and attractive value–creation path. By executing with discipline across portfolio selection, development strategy and trial execution, we aim to deliver better patient outcomes and build a durable, fully integrated, leading cardiovascular-focused biotechnology company. Our three late-stage programs include Danicamtiv, which we are developing for the treatment of genetic dilated cardiomyopathy (“DCM”), Ataciguat, which is aimed at slowing the progression of calcific aortic valve stenosis (“CAVS”) in patients with moderate disease, and Tonlamarsen, which we are developing for the management of blood pressure (“BP”) in acute severe hypertension (“ASH”) post-hospitalization. Each of these medicines is designed specifically for well-defined patient populations with well-defined regulatory pathways. In the second quarter, we randomized the first patient in the KARDINAL-ASH Phase 2 clinical trial that is evaluating Tonlamarsen for the management of blood pressure in acute severe hypertension ("ASH") post-hospitalization. Additionally, in July, we completed enrollment of Cohort 1 (myosin heavy chain 41 7, MYH7, and titin, TTN, patients) of the Phase 2b KINSHIP-DCM clinical trial and enrollment of the Phase 3 portion is now underway. We expect to report clinical data from our three late-stage programs in the first half of 2027: Danicamtiv Phase 2b topline data from the KINSHIP-DCM trial, Ataciguat Phase 2b topline data (interim 24-week analysis) from the KATALYST-AV trial and Tonlamarsen Phase 2 topline data in the KARDINAL-ASH trial. Since our inception, we have not generated any revenue from product sales or other sources and have incurred significant operating losses and negative cash flows from our operations. Our primary uses of cash to date have been conducting research and development, acquisitions, building infrastructure, developing intellectual property, hiring personnel and providing general and administrative support for our expanding operations. To date, we have funded our operations primarily through private placements of our redeemable convertible preferred stock and, most recently, through the net proceeds from our initial public offering ("IPO"). We have incurred operating losses since our inception. Our net losses were $172.3 million and $75.5 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $453.4 million. Our operating results also reflect significant period-over-period and year-over-year increases in research and development and general and administrative expenses, driven by the progression of our therapeutic programs, increased headcount, integration of acquired assets, and expanded clinical and operational activities. We expect our expenses and operating losses will increase substantially as we advance our three late-stage candidates clinical development and seek regulatory approvals, manufacture drug product and drug supply, maintain and expand our intellectual property portfolio, as well as hire additional personnel, pay for further accounting, audit, legal, regulatory and consulting services, and pay costs associated with director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company. In addition, we have preclinical and clinical development, regulatory and commercial milestone payment obligations under our licensing arrangements. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies and our ongoing and planned clinical trials and our expenditures on other research and development activities. Furthermore, we expect to incur additional costs associated with operating as a public company. On June 22, 2026, we completed our IPO and issued 28,750,000 shares of common stock, including 3,750,000 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price of $16.00 per share. In connection with the IPO, we received net proceeds of $422.4 million, after deducting $32.2 million in underwriting discounts and commissions, and $5.4 million in other offering costs. As of June 30, 2026, we had cash, cash equivalents and investments of $660.7 million. Based on our current operating plan, we believe that our existing cash, cash equivalents and investments will be sufficient to fund our operations for at least the next 12 months from the date of this Quarterly Report on Form 10-Q. See the section titled “ —Liquidity and Capital Resources .” We do not expect to generate any revenue from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our current or future product candidates, which will not be for at least the next several years, if ever. If we obtain regulatory approval for any of our current or future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our current or future product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. See the section titled “ —Liquidity and Capital Resources .” However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market current or future product candidates that we would otherwise prefer to develop and market ourselves. 42 Components of results of operations Revenue We currently have no products approved for sale, and we have not generated any revenue to date. In the future, we may generate revenue from collaboration or license agreements we may enter into with respect to our current or future product candidates, as well as product sales from any approved product, which approval we do not expect to occur for at least the next several years, if ever. Our ability to generate product revenue will depend on the successful development and eventual commercialization of any current or future product candidates we may pursue. If we fail to complete preclinical and clinical development of our current or future product candidates or obtain regulatory approval for them, our ability to generate future revenues and our results of operations and financial position would be adversely affected. Operating expenses Research and development expenses Research and development expenses consist primarily of internal and external costs associated with our research and development activities, our discovery and research efforts and the preclinical and clinical development of our current and future product candidates. In particular, our research and development expenses include personnel-related costs, including stock-based compensation for employees engaged in research and development functions, manufacturing costs for our product candidates, including fees paid to contract manufacturing organizations (“CMOs”), expenses incurred under arrangements with third parties such as contract research organizations (“CROs”), costs associated with developing and validating our manufacturing process for use in our preclinical studies and ongoing and future clinical trials, costs incurred to obtain licenses to intellectual property and any future payments related to development or regulatory milestones thereto, expenses related to compliance with regulatory requirements and the research and development of our Prolaio platform, internal research and development preclinical costs, and direct and allocated overhead costs for laboratory supplies, research materials, reagents, facility costs, depreciation and other expenses. We expense research and development costs as incurred. Non-refundable advance payments for future research and development services are recorded as prepaid expenses and recognized as the related goods are delivered or the services are performed. We record accruals for research costs based on estimates of work performed, invoices received and contracted costs, updating these estimates as additional information becomes available from our third-party service providers. A significant portion of our research and development costs are external costs, which we track on a product candidate-by-product candidate basis once a preclinical asset is designated as a product candidate. Due to our ability to use certain resources across several programs, personnel-related expenses and indirect or shared operating costs incurred for our research and development programs are not recorded or maintained on a product candidate-by-product candidate basis. We expect our research and development expenses to increase substantially for the foreseeable future as we continue to conduct our ongoing research and development activities, expand our pipeline, advance our preclinical research programs toward clinical development and conduct our current and planned clinical trials. The timing and amount of these expenses are inherently difficult to predict, and we make funding determinations for each program on an ongoing basis based on preclinical and clinical results, regulatory developments and ongoing assessments of each program’s commercial potential. Our future development costs may vary significantly depending on the scope, timing and outcome of clinical development and regulatory review for Danicamtiv, Ataciguat, Tonlamarsen and any future product candidates, our ability to maintain or establish CMO and other third-party arrangements, milestone and collaboration-based payments, and the costs of developing our Prolaio platform. For example, if the FDA, the European Medicines Agency (the “EMA”) or another regulatory authority were to require clinical trials beyond those we currently anticipate, or if we experience significant delays in patient enrollment, we would be required to expend significant additional financial resources and time on the completion of clinical development. General and administrative expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and stock-based compensation charges for those individuals in executive, legal, finance, human resources, facility operations and other administrative functions. Other significant costs include legal fees relating to intellectual property and corporate matters, professional fees for auditing, accounting, tax and consulting services, office and information technology costs, insurance costs, and facilities, depreciation and other general and administrative expenses, which include direct or allocated expenses for rent and maintenance of facilities and utilities. 43 We anticipate that our general and administrative expenses will increase for the foreseeable future to support our increased research, development and commercialization activities. These increases will likely include costs related to the hiring of additional personnel and fees paid to outside consultants, pre-launch costs and regulatory filing fees, among other expenses. We also anticipate increased expenses related to audit, accounting, legal, regulatory and tax-related services associated with maintaining compliance with the stock exchange and SEC requirements, director and officer insurance premiums and investor relations costs associated with operating as a public company. Change in fair value of contingent milestone liabilities Change in fair value of contingent milestone liabilities reflects the remeasurement of potential future payments due upon our achievement of specified market valuation thresholds within defined contractual periods. These obligations are recorded as liabilities at fair value and remeasured each reporting period, with changes in fair value recognized in our condensed consolidated statements of operations and comprehensive loss. This measurement relies on estimates, including the probability and timing of milestone achievement and expected future Company valuations, and may fluctuate significantly as these estimates and market conditions change. Other income (expense) Other income (expense) primarily consists of interest income generated from interest bearing cash, cash equivalents and investments, change in fair value associated with the financial instruments, and various income or expense items. These amounts may fluctuate significantly from period to period due to changes in market conditions, interest rates, the timing of financing transactions, and the remeasurement of instruments carried at fair value, and therefore may not be indicative of future results. Income tax benefit Since we generally establish a full valuation allowance against our deferred tax balances, our income tax benefit primarily consists of tax impacts of our deferred income tax assessments resulting from our acquisitions. Results of operations Comparison of the three months ended June 30, 2026 and 2025: The following table summarizes our results of operations for the periods presented (in thousands): Three Months Ended June 30, Change 2026 2025 $ % Operating expenses: Research and development $ 56,365 $ 35,839 $ 20,526 57 % General and administrative 18,867 21,286 (2,419 ) (11 %) Change in fair value of contingent milestone liabilities 43,529 — 43,529 100 % Total operating expenses 118,761 57,125 61,636 108 % Loss from operations (118,761 ) (57,125 ) (61,636 ) 108 % Other income (expense): Interest income 2,765 1,068 1,697 159 % Change in fair value of preferred stock tranche obligations — (1,341 ) 1,341 (100 %) Other expense, net (240 ) (47 ) (193 ) 411 % Loss before income taxes (116,236 ) (57,445 ) (58,791 ) 102 % Income tax benefit — — — 100 % Net loss $ (116,236 ) $ (57,445 ) $ (58,791 ) 102 % 44 Research and development expenses The following table summarizes our research and development expenses for the periods presented (in thousands): Three Months Ended June 30, Change 2026 2025 $ % Program expenses: Danicamtiv $ 13,228 $ 884 $ 12,344 1396 % Ataciguat 7,975 7,889 86 1 % Tonlamarsen 3,925 4,744 (819 ) (17 %) Research and development - compensation and benefits 18,505 14,801 3,704 25 % Research and development - other 12,732 7,521 5,211 69 % Total Research and development expense $ 56,365 $ 35,839 $ 20,526 57 % Research and development expenses were $56.4 million for the three months ended June 30, 2026, compared to $35.8 million for the three months ended June 30, 2025, representing an increase of $20.6 million period over period. This increase was primarily driven by an increase in total program expenses, reflecting expanded clinical activity across our pipeline. Danicamtiv program expenses increased by $12.3 million, reflecting the initiation of the Phase 2b/3 clinical trial in October 2025. Ataciguat and Tonlamarsen programs spending was relatively flat, as development activities continued at a consistent level. In addition to program expenses, our compensation and benefits expenses for personnel engaged in research and development efforts increased by $3.7 million, largely attributable to the headcount growth supporting our expanding research and development operations. The remaining $5.2 million increase in other research and development expenses mainly consisted of $2.5 million of higher outside consulting costs and $1.4 million of acquired IPR&D expense. General and administrative expenses General and administrative expenses were $18.9 million for the three months ended June 30, 2026, compared to $21.3 million for the three months ended June 30, 2025, representing a decrease of $2.4 million period over period. The decrease was primarily driven by one-time stock-based compensation expense related to integration bonus of $11.7 million recognized in general and administrative expenses for three months ended June 30, 2025, offset by $8.2 million of higher personnel-related costs and $1.1 million of higher other expenses, including professional services, insurance, facilities-related costs and other corporate overhead. Change in fair value of contingent milestone liabilities Change in fair value of contingent milestone liabilities was $43.5 million for the three months ended June 30, 2026, primarily driven by the increase in our market valuation following the completion of our IPO in June 2026, which increased the probability of achieving our market valuation thresholds underlying the amended milestones. No change in fair value of contingent milestone liabilities was recognized for the three months ended June 30, 2025. Interest income Interest income was $2.8 million for the three months ended June 30, 2026, compared to $1.1 million for the three months ended June 30, 2025. The increase of $1.7 million period over period was primarily attributable to higher average balances of cash, cash equivalents and investments following the proceeds from our initial public offering and from redeemable convertible preferred stock issuances completed after June 30, 2025. Change in fair value of preferred stock tranche obligations Change in fair value of Series A redeemable convertible preferred stock tranche obligations was a loss of $1.3 million for the three months ended June 30, 2025, related to the remeasurement of the Second Tranche obligation prior to its closing. The Second Tranche of the Series A Preferred Stock closed in August 2025, and accordingly, no change in fair value was recorded for the three months ended June 30, 2026. 45 Comparison of the six months ended June 30, 2026 and 2025: The following table summarizes our results of operations for the periods presented (in thousands): Six Months Ended June 30, Change 2026 2025 $ % Operating expenses: Research and development $ 101,432 $ 54,613 $ 46,819 86 % General and administrative 32,510 28,590 3,920 14 % Change in fair value of contingent milestone liabilities 43,529 — 43,529 100 % Total operating expenses 177,471 83,203 94,268 113 % Loss from operations (177,471 ) (83,203 ) (94,268 ) 113 % Other income (expense): Interest income 5,558 1,900 3,658 193 % Change in fair value of preferred stock tranche obligations — (3,912 ) 3,912 (100 %) Bargain purchase gain — 5,232 (5,232 ) (100 %) Other expense, net (394 ) 352 (746 ) (212 %) Loss before income taxes (172,307 ) (79,631 ) (92,676 ) 116 % Income tax benefit — 4,167 (4,167 ) (100 %) Net loss $ (172,307 ) $ (75,464 ) $ (96,843 ) 128 % Research and development expenses The following table summarizes our research and development expenses for the periods presented (in thousands): Six Months Ended June 30, Change 2026 2025 $ % Program expenses: Danicamtiv $ 23,555 $ 884 $ 22,671 2565 % Ataciguat 16,617 9,834 6,783 69 % Tonlamarsen 7,870 8,408 (538 ) (6 %) Research and development - compensation and benefits 32,293 22,450 9,843 44 % Research and development - other 21,097 13,037 8,060 62 % Total Research and development expense $ 101,432 $ 54,613 $ 46,819 86 % Research and development expenses were $101.4 million for the six months ended June 30, 2026, compared to $54.6 million for the six months ended June 30, 2025, representing an increase of $46.8 million period over period. This increase was primarily driven by an increase in total program expenses, reflecting expanded clinical activity across our pipeline. Ataciguat program expenses increased by $6.8 million, primarily due to the initiation and ramp-up of the Phase 2b clinical trial commencing in June 2025. Danicamtiv program expenses increased by $22.7 million, reflecting the initiation of the Phase 2b/3 clinical trial in October 2025. Tonlamarsen program spending was relatively flat, as development activities continued at a consistent level. In addition to program expenses, our compensation and benefits expenses for personnel engaged in research and development efforts increased by $9.8 million, largely attributable to the headcount growth supporting our expanding research and development operations. The remaining $8.0 million increase in other research and development expenses mainly consisted of $4.0 million of higher outside consulting costs, $2.5 million of higher facilities costs, $1.7 million of additional depreciation and amortization expenses. 46 General and administrative expenses General and administrative expenses were $32.5 million for the six months ended June 30, 2026, compared to $28.6 million for the six months ended June 30, 2025, representing an increase of $3.9 million period over period. The increase was primarily driven by $12.2 million of higher personnel-related costs and $3.4 million of higher other expenses, including professional services, insurance, facilities-related costs and other corporate overhead, offset by one-time stock-based compensation expense related to integration bonus of $11.7 million recognized in general and administrative expenses for three months ended June 30, 2025. Change in fair value of contingent milestone liabilities Change in fair value of contingent milestone liabilities was $43.5 million for the six months ended June 30, 2026, primarily driven by the increase in our market valuation following the completion of our IPO in June 2026, which increased the probability of achieving our market valuation thresholds underlying the amended milestones. No change in fair value of contingent milestone liabilities was recognized for the six months ended June 30, 2025. Interest income Interest income was $5.6 million for the six months ended June 30, 2026, compared to $1.9 million for the six months ended June 30, 2025. The increase of $3.7 million period over period was primarily attributable to higher average balances of cash, cash equivalents and investments following the proceeds from our initial public offering and redeemable convertible preferred stock issuances completed after June 30, 2025. Change in fair value of preferred stock tranche obligations Change in fair value of Series A redeemable convertible preferred stock tranche obligations was a loss of $3.9 million for the six months ended June 30, 2025, related to the remeasurement of the Second Tranche obligation prior to its closing. The Second Tranche of the Series A Preferred Stock was closed in August 2025, and accordingly, no change in fair value was recorded for the six months ended June 30, 2026. Bargain purchase gain The bargain purchase gain of $5.2 million for the six months ended June 30, 2025 was related to the bargain purchase gain recognized upon the acquisition of Prolaio, Inc. in February 2025. Income tax benefit In the six months ended June 30, 2025, we recorded an income tax benefit of $4.2 million due to deferred tax liabilities assumed in connection with our acquisition of Prolaio, Inc., which supported the realizability of our deferred tax assets and resulted in a partial release of our valuation allowance. Liquidity and capital resources Sources of liquidity Since our inception, we have incurred significant operating losses and negative cash flows from operations. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our pipeline and develop our Prolaio platform. Since the completion of our IPO, we have incurred, and expect to incur additional costs associated with operating as a public company. We have funded our operations to date principally through private placements of our redeemable convertible preferred stock and, most recently, through the net proceeds of our IPO. From our inception through June 30, 2026, we have received aggregate gross proceeds of $568.3 million from the sale of our redeemable convertible preferred stock in private placements. On June 22, 2026, we completed our IPO and issued 28,750,000 shares of common stock, including 3,750,000 shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a price of $16.00 per share. In connection with the IPO, we received net proceeds of $422.4 million, after deducting $32.2 million in underwriting discounts and commissions, and $5.4 million in other offering costs. We have not generated any revenue or received cost-sharing payments under collaboration or licensing agreements. 47 Future funding requirements As of June 30, 2026, we had cash, cash equivalents and investments of $660.7 million. Based on our current operating plan, we believe that our existing resources will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of issuance of the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. Our forecast for the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties and actual results could vary materially. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain. We will need to raise substantial additional capital in the future. Our future capital requirements will depend on many factors, including but not limited to: • the type, number, scope, progress, expansions, results, costs and timing of, discovery, preclinical studies and clinical trials of our current and future product candidates; • the costs associated with maintaining, improving and developing our Prolaio platform; • the costs and timing of manufacturing for our current and future product candidates and commercial manufacturing; • the costs, timing and outcome of regulatory review of our current and future product candidates; • the terms and timing of establishing and maintaining licenses and other similar arrangements; • the legal costs of obtaining, maintaining and enforcing our patents and other intellectual property rights; • our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company; • the costs associated with hiring additional personnel and consultants as our preclinical and potential future clinical activities increase; • the costs and timing of establishing or securing sales and marketing capabilities if any current and future product candidate is approved; • our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; and • costs associated with any products or technologies that we may in-license or acquire. Until such time, if ever, as we can generate substantial product revenue to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, potentially including collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, current or future product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our current and future product candidates even if we would otherwise prefer to develop and market such product candidates ourselves. 48 Cash flows Comparison of the six months ended June 30, 2026 and 2025 The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2026 and 2025 (in thousands): Six Months Ended June 30, 2026 2025 Net cash used in operating activities $ (107,327 ) $ (52,775 ) Net cash used in investing activities (54,892 ) (6,563 ) Net cash provided by financing activities 437,235 100,184 Net increase in cash, cash equivalents and restricted cash $ 275,016 $ 40,846 Operating activities For the six months ended June 30, 2026, net cash used in operating activities was $107.3 million, compared to $52.8 million for the six months ended June 30, 2025. The $54.5 million increase in operating cash usage primarily reflects our expanded operating scale, continued advancement of our development portfolio and organizational growth to support these initiatives. Net cash used in operating activities for the six months ended June 30, 2026 was $107.3 million, primarily driven by our net loss of $172.3 million partially offset by adjustments to the net loss totaling $61.9 million. The adjustments to the net loss included change in fair value of contingent milestone liabilities of $43.5 million, stock-based compensation expense of $17.1 million, depreciation and amortization expense of $3.2 million, acquired IPR&D expense of $1.4 million and amortization of right-of-use assets of $1.1 million, partially offset by amortization of premiums and accretion of discounts on investments by $1.8 million and other non-cash charges of $2.6 million. Operating cash flows were further impacted by $3.1 million of net cash inflows due to changes in operating assets and liabilities. Net cash used in operating activities for the six months ended June 30, 2025, was $52.8 million, primarily driven by our net loss of $75.5 million partially offset by adjustments to the net loss totaling $18.3 million. The adjustments to the net loss included non-cash charges of $14.4 million related to integration bonus expense, $7.2 million related to stock-based compensation expense, and $3.9 million related to the change in fair value of preferred stock tranche obligations, and non-cash gains, including bargain purchase gain of $5.2 million and deferred income tax benefit of $4.2 million. Changes in operating assets and liabilities resulted in an additional $4.4 million in net cash inflows. Investing activities Net cash used in investing activities was $54.9 million for the six months ended June 30, 2026, compared to $6.6 million net cash used in investing activities for the six months ended June 30, 2025. Cash used in investing activities for the six months ended June 30, 2026 consisted primarily of $50.0 million of net purchases of investments, partially offset by $2.8 million of capitalized software development costs and $2.1 million used to purchase property and equipment to support the expansion of our laboratory, and corporate infrastructure. For the six months ended June 30, 2025, net cash used in investing activities was $6.6 million, primarily reflecting the cash portion of the consideration paid for the acquisition of Prolaio, Inc. of $4.0 million and $2.6 million used to purchase property and equipment. Financing activities Net cash provided by financing activities was $437.2 million for the six months ended June 30, 2026, compared to $100.2 million for the six months ended June 30, 2025. Financing activities for the six months ended June 30, 2026 consisted primarily of IPO proceeds of $427.8 million, net of underwriters' commissions, $1.8 million of offering costs paid, and $10.0 million of proceeds from issuance of preferred stock. For the six months ended June 30, 2025, financing activities consisted primarily of $100.0 million from issuance of preferred stock, net of issuance costs. 49 Contractual obligations and commitments Leases We lease office space in South San Francisco, California under an operating lease that expires in April 2030 and lease office space in Princeton, New Jersey under an operating lease that expires in March 2033. See Note 7, “ Leases ” in our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q for more information on our lease obligations. Purchase and other obligations We enter into contracts in the normal course of business with third-party CROs, CMOs and other third-party vendors for preclinical, clinical trials and testing and manufacturing services. These contracts do not contain minimum purchase commitments and are cancellable by us upon written notice. Payments due upon cancellation generally consist of payments for services provided or expenses incurred up to the date of cancellation, including non-cancelable obligations of our service providers and, in some cases, wind-down costs. For further information regarding certain of our license agreements and amounts that could become payable in the future under those agreements, please see Note 8, “ Commitments and Contingencies ” in our unaudited condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. Merger agreements Acquisition of Prolaio, Inc. On February 24, 2025, we entered into an Agreement and Plan of Merger (the “Original Prolaio Merger Agreement”), as amended by Amendment No. 1 (as defined below) (together, the “Amended Prolaio Merger Agreement”), with Prolaio, Inc., pursuant to which we acquired 100% of the outstanding capital stock of Prolaio, Inc. Upon the consummation of the merger, Prolaio, Inc. became our wholly-owned subsidiary. Through the acquisition of Prolaio, Inc., we gained access to Prolaio, Inc.’s cardiovascular data collection and analytics platform. The total purchase consideration transferred was approximately $8.6 million, consisting of approximately $4.0 million in cash, primarily used to settle certain of Prolaio, Inc.’s outstanding debts, and fair value of contingent consideration of $4.6 million, representing the estimated acquisition date fair value of milestone payments. Pursuant to the Original Prolaio Merger Agreement, the former stockholders of Prolaio, Inc. were entitled to an aggregate of up to $200 million in milestone payments, which were payable as follows: (i) up to $50 million upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial, (B) there being at least 500 Kardigan clinical trial patients managed and screened by Prolaio, (C) our achievement of annual gross revenues of $15 million from the sale of Prolaio products and services and (D) Prolaio achieving improvements in patient screening rates; (ii) up to $100 million upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial, (B) there being at least 1,500 Kardigan clinical trial patients managed and screened by Prolaio, (C) our achievement of annual gross revenues of $25 million from the sale of Prolaio products and services and (D) Prolaio’s achievement of improvements in patient screening rates; (iii) up to $200 million upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial, (B) there being at least 5,000 Kardigan clinical trial patients managed and screened by Prolaio, (C) our achievement annual gross revenues of $25 million from the sale of Prolaio products and services and (D) Prolaio’s achievement of improvements in patient screening rates; (iv) up to $200 million upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial and (B) our achievement of annual net sales of $50 million from the sale of Prolaio products and services; and (v) 50% of Eligible Payments (as defined below) upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial and (B) the execution of a commercial transaction for Prolaio products and services that results in payments to Kardigan, as calculated in accordance with terms of the Original Prolaio Merger Agreement (“Eligible Payments”); in each case excluding intercompany transactions, to the extent such milestones are achieved on or before February 28, 2029. We concluded that Prolaio, Inc. constitutes a business and the transaction was accounted for as a business combination. In connection with the acquisition, we recorded $13.8 million of net assets acquired, primarily consisting of developed technology with a fair value of $25.4 million, acquired IPR&D asset with a fair value of $1.1 million, and $13.8 million in liabilities assumed, including $4.5 million of deferred income tax liability and $3.3 million of assumed contingent consideration liability. Because the fair value of net identifiable assets acquired exceeded the fair value of the consideration transferred, we recognized a gain on bargain purchase in an amount of $5.2 million in the condensed consolidated statement of operations and comprehensive loss for the three months ended June 30, 2025 and for the year ended December 31, 2025. The bargain purchase gain reflects our ability to acquire Prolaio at a purchase price below the fair value of the acquired net assets due to a combination of factors, including Prolaio’s limited operating scale, historical operating losses, liquidity constraints at the time of the transaction, and the structure of the consideration transferred. In particular, concurrent with the acquisition, we entered into integration bonus arrangements with our Chief Executive Officer and Chief Medical Officer 50 (“Integration Bonus”), both of whom were cofounders and Prolaio shareholders. These arrangements were contingent upon post-combination services and successful integration and, accordingly, were accounted for as compensation expense rather than consideration transferred. In May 2026, we entered into Amendment No. 1 to Agreement and Plan of Merger (“Amendment No. 1”) with the former stockholders of Prolaio, Inc. in order to amend the milestone provisions applicable to such stockholders, including Mr. Gianakakos and Dr. Edelberg. In particular, the milestones were revised to: (i) better align the incentives of the former stockholders of Prolaio, Inc., in their capacities as executive officers and employees of Kardigan, with the creation of stockholder value for us and (ii) better reflect our current operations and strategic direction following the acquisition, including our focus on deploying the Prolaio platform in support of its own clinical trials, and to ensure that the milestones remained aligned with our business. Pursuant to the Amended Prolaio Merger Agreement and subject to the conditions therein, the former stockholders of Prolaio, Inc., including Mr. Gianakakos and Dr. Edelberg, are entitled to milestone payments as follows: (i) up to $50 million upon our achievement of a valuation equal to or greater than $5.0 billion; (ii) up to $50 million upon our achievement of a valuation equal to or greater than $6.0 billion; and (iii) up to $100 million upon our achievement of a valuation equal to or greater than $12.0 billion; in each case to the extent such milestones are achieved on or before May 1, 2032. Such milestone payments shall be payable in cash or shares of our common stock, at our election. Prior to the Prolaio amendment, changes in the fair value of the contingent consideration were recognized in R&D expenses in the condensed consolidated statements of operations and comprehensive loss. Subsequent to the Prolaio amendment, changes in the fair value of the contingent milestone liabilities are recognized in change in fair value of contingent milestone liabilities, in the condensed consolidated statements of operations and comprehensive loss. The fair value of the Prolaio Contingent Consideration was $3.8 million as of December 31, 2025. Upon the Prolaio amendment, on May 1, 2026, the Prolaio Contingent Consideration was settled and the new contingent milestone liabilities were recognized at an initial fair value of $13.7 million. The fair value of the contingent milestone liabilities was $47.3 million as of June 30, 2026. We recognized a $43.5 million increase in the fair value of contingent milestone liabilities, which is presented within change in fair value of contingent milestone liabilities in the condensed consolidated statements of operations, for both the three and six months ended June 30, 2026. No change in fair value was recorded in the three and six months ended June 30, 2025. None of the Prolaio milestones, original or amended, had been achieved by June 30, 2026, and no milestone payments have been made. Acquisition of RSF On March 11, 2024, we entered into an Agreement and Plan of Merger with RSF (the “RSF Merger Agreement”), pursuant to which, on June 6, 2024, we acquired 100% of outstanding capital stock of RSF. RSF holds a patent license and know-how agreement with Mayo, originally effective December 6, 2019, as amended, granting an exclusive license to Mayo’s proprietary methods and materials for treating calcific aortic valve stenosis. RSF also holds four exclusive option agreements with Mayo covering additional small-molecule programs and indications. The acquisition included Ataciguat (HMR1766), in addition to RSF’s other existing agreements such as supply and license agreements with Sanofi and its affiliates. The closing was conditioned upon our completion of a Series A redeemable convertible preferred stock financing with gross proceeds of at least $150.0 million, which condition was satisfied on June 6, 2024. As initial consideration, the acquisition involved upfront cash payments totaling $3.5 million, the settlement of RSF’s outstanding indebtedness of $10.6 million on June 6, 2024, and the payment of certain transaction costs of $0.7 million incurred by RSF. We accounted for the transaction as the acquisition of a VIE that is not a business. The net assets acquired consisted primarily of the IPR&D asset, cash and cash equivalents in an amount of $0.2 million, and assumed accounts payable for an amount of $1.3 million. Accordingly, the consideration allocated to the IPR&D asset amounted to $15.9 million. The acquired licensed technology was determined to be an IPR&D asset that did not have alternative future use as of the acquisition date, and the full amount was recognized as research and development expense in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2024. In addition to the initial consideration, and subject to the conditions set forth in the RSF Merger Agreement, the former stockholders of RSF are entitled to milestone payments of up to $26.5 million in development and regulatory milestones, and up to $249.5 million in sales milestones, in each case to be allocated among such former stockholders on a pro rata basis in accordance with their respective ownership interests in RSF immediately prior to the acquisition. We are additionally obligated to pay to the former stockholders of RSF low-single digit tiered royalties on annual net sales of any pharmaceutical product containing Ataciguat. The royalty term ends on a product-by-product and country-by-country basis on the earliest of (i) our cessation of development or commercialization of the applicable product, (ii) the expiration of the last-to-expire valid 51 patent claim covering the product in such country, or (iii) the first commercial sale of a generic product in the same indication in such country. During the year ended December 31, 2025, we achieved the first development milestone associated with Ataciguat upon dosing of the first patient in the Phase 3 clinical trial. This milestone triggered a payment obligation of $3.0 million. As a result, we recognized $3.0 million in research and development expenses for the year ended December 31, 2025 in our consolidated statement of operations and comprehensive loss. Of the total milestone amount, $1.5 million was settled in cash and the remaining $1.5 million was accrued for in our consolidated balance sheet as of December 31, 2025 and as of June 30, 2026 within accrued and other current liabilities. None of the other RSF milestones had been achieved nor were deemed probable and estimable as of June 30, 2026, and no other milestone payments have been made. License and collaboration agreements Below is a summary of the key terms for certain of our license and collaboration agreements. For a more detailed description of these agreements, see Note 5 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. License agreements with BMS Co. In November 2024, we entered into a License Agreement with MyoKardia, a wholly owned subsidiary of BMS Co., related to Danicamtiv and other compounds (the “Dani Agreement”), and a separate License Agreement with BMS Co. related to KAR-141 (formerly known as BMS-986141) (“Par4”) and other compounds (the “Par4 Agreement”). Dani agreement Under the Dani Agreement, we received an exclusive, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain MyoKardia patents and know-how to develop, manufacture, and commercialize Danicamtiv (formerly known as MYK-491) and certain related compounds thereto (the “Dani Lead Compounds”), certain back-up compounds and certain related compounds thereto (such compounds, collectively with the Dani Lead Compounds, the “Dani Licensed Compounds”), and pharmaceutical products containing the Dani Licensed Lead Compounds (the “Dani Lead Compound Licensed Products”) and pharmaceutical products containing the Dani Back-Up Compounds (such products, collectively with the Dani Lead Compound Licensed Products, the “Dani Licensed Products”) for all human uses worldwide. As partial consideration for the rights granted to us under the Dani Agreement, we entered into a Subscription Agreement with MyoKardia pursuant to which we issued 1,251,107 shares of Series A redeemable convertible preferred stock to MyoKardia. As additional consideration for the licenses granted under the Dani Agreement, we are required to pay MyoKardia: (i) tiered royalties at a rate based on aggregate annual net sales by us, our affiliates and sublicensees of each Dani Licensed Product containing the same Dani Licensed Compound; (ii) a low double-digit percentage of any sublicensing revenue received by us, if we sublicense rights under MyoKardia patents or know-how for the development, manufacture or commercialization of any Dani Lead Compound or Dani Lead Compound Licensed Product to a third party within a certain number of months from the effective date, or November 2026; (iii) up to $42.5 million in the aggregate in development and regulatory milestone payments across all Dani Licensed Products and (iv) up to $265.0 million in sales milestone payments for each of the first two Dani Licensed Products to achieve the applicable sales milestones. Our tiered royalties range from a subteen to high teen percentage of annual net sales of the Dani Licensed Products, subject to potential reductions following the expiration of valid patent claims, due to competition from generic products, for certain third party license fees, and in the event of a limit on the maximum price as a result of the Inflation Reduction Act of 2022 (the “Inflation Reduction Act”), subject to a customary reduction floor and potential carry-forward. Par4 agreement Under the Par4 Agreement, we received an exclusive, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain BMS Co. patents and know-how to develop, manufacture, and commercialize Par4 and certain related compounds thereto (the “Par4 Lead Compounds”), certain back-up compounds and certain related compounds thereto (such compounds, collectively with the Par4 Lead Compounds, the “Par4 Licensed Compounds”), pharmaceutical products containing the Par4 Lead Compounds (the “Par4 Lead Compound Licensed Products”) and pharmaceutical products containing the Par4 Back-Up Compounds (such products, collectively with the Par4 Lead Compound Licensed Products, the “Par4 Licensed Products”) for all human uses worldwide. As partial consideration for the rights granted under the Par4 Agreement, we entered into a Subscription Agreement with BMS Co. pursuant to which we issued 293,469 shares of Series A redeemable convertible preferred stock. As additional consideration for the licenses granted under the Par4 52 Agreement, we are required to pay BMS Co.: (i) tiered royalties at a rate based on aggregate annual net sales by us, our affiliates and sublicensees of each Par4 Licensed Product containing the same Par4 Licensed Compound; (ii) a low double-digit percentage of any sublicensing revenue received by us, if we sublicense rights under BMS Co. patents or know-how for the development, manufacture or commercialization of any Par4 Lead Compound or Par4 Lead Compound Licensed Product to a third party within a certain number of months from the effective date, or November 2026; (iii) up to $10.0 million in the aggregate in development and regulatory milestone payments across all Par4 Licensed Products and (iv) up to $265.0 million in sales milestone payments for each of the first two Par4 Licensed Products to achieve the applicable sales milestones. Our tiered royalties range from a subteen to high teen percentage of annual net sales of the Par4 Licensed Products, subject to potential reductions following the expiration of valid patent claims, due to competition from generic products, for certain third party license fees, and in the event of a limit on the maximum price as a result of the Inflation Reduction Act, subject to a customary reduction floor and potential carry-forward. Additionally, certain BMS Co. patents and know-how are sublicensed by BMS Co. pursuant to an upstream license agreement with a university and we are responsible for reimbursing BMS Co. for certain milestone payments and other amounts payable under such upstream agreement that arise from our development, manufacturing or commercialization activities under the Par4 Agreement. The milestone reimbursement obligations include up to (i) $12.5 million in the aggregate in development and regulatory milestone payments per certain Par4 Licensed Products and (ii) $13.625 million in the aggregate in development and regulatory milestone payments per certain other Par4 Licensed Products. In connection with the Dani and Par4 license agreements, we issued an aggregate of 1,544,576 shares of Series A redeemable convertible preferred stock to MyoKardia and BMS Co., including 1,251,107 shares of Series A redeemable convertible preferred stock under the Dani Agreement, and 293,469 shares of Series A redeemable convertible preferred stock under Par4 Agreement, at the estimated fair value of $19.10 per share as of issuance date, with a total estimated fair value of $29.5 million. We determined that the Dani and Par4 licenses represent acquired IPR&D assets that did not have alternative future use as of the acquisition date, and, accordingly, an amount of $29.5 million was recognized as research and development expense in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2024. As of June 30, 2026, none of the Dani milestones or Par4 milestones had been achieved nor were deemed probable or estimable, and no milestone payments have been made. License agreement with Ionis On June 7, 2024, we entered into a License Agreement (the “Ionis License Agreement”) with Ionis, pursuant to which we were granted an exclusive, worldwide, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain Ionis intellectual property to develop and commercialize Tonlamarsen (formerly ION904) and products containing Tonlamarsen (the “Licensed Ionis Products”) in the field of prophylactic or therapeutic use in humans (the “Ionis Licensed Field”). We also received a non-exclusive, worldwide, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain Ionis intellectual property to manufacture Tonlamarsen and Licensed Ionis Products in the Ionis Licensed Field. Until the third anniversary of the effective date of the Ionis License Agreement, or June 2027, neither party may develop or commercialize, or assist or grant a third party rights to develop or commercialize certain ASOs designed to bind to the RNA encoded by the human angiotensinogen gene, subject to certain conditions and exceptions. As initial consideration for the Ionis License Agreement, we made an upfront payment of $20.0 million to Ionis. We determined that the licenses represent an acquired IPR&D asset that did not have alternative future use as of the acquisition date, and, accordingly, the total amount of the upfront payment of $20.0 million was recognized as research and development expense in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2024. As additional consideration for the licenses and rights granted to us by Ionis, we are required to pay Ionis: (i) milestone payments in the event of successful achievement of specified development and sales milestones of up to an aggregate of $375.0 million (up to $35.0 million in development and regulatory milestone payments and up to $340.0 million in sales milestone payments); (ii) tiered royalties on net sales of Ionis Licensed Products by us, our affiliates and sublicensees with a rate based on net sales per calendar year, ranging from a subteen percentage to high teen percentage. The royalties are subject to potential reductions under certain scenarios. In the event that we undergo a change of control prior to receiving regulatory approval by the FDA and are acquired by one of certain top biopharmaceutical or pharmaceutical companies, if the acquisition price exceeds a certain dollar value, we will be required to pay Ionis a one-time change of control payment based on the acquisition price, ranging in the low tens of millions of dollars. The payment will accrue interest at a subteen percentage per annum, compounded annually, from the date of the Ionis License Agreement through the date such payment is made. As of June 30, 2026, none of the Ionis milestones had been achieved nor were deemed probable and estimable, and no milestone payments have been made. 53 License agreement with Sanofi On June 2, 2021, RSF entered into a license agreement with Sanofi, as subsequently amended on March 18, 2022, January 9, 2023, and November 7, 2025 (collectively, the “Sanofi License”), under which RSF received a worldwide, exclusive, sublicensable (subject to certain conditions and restrictions), royalty-bearing license under certain Sanofi know-how to exploit Ataciguat (also known as HMR1766) and pharmaceutical products containing Ataciguat (“Ataciguat Products”) for all human and mammalian therapeutic, prophylactic and diagnostic uses (the “Sanofi License Field”). RSF became our wholly owned subsidiary in June 2024. If we succeed in developing and commercializing Ataciguat Products, we will be obligated to pay Sanofi up to an aggregate of $14.8 million in potential commercial milestone payments. As of June 30, 2026, none of the Sanofi milestones had been achieved nor were deemed probable and estimable, and no milestone payments have been made. We are also obligated to pay Sanofi tiered royalties ranging from low-single digit to mid-single digit percentages on worldwide annual net sales of Ataciguat Products by us or our affiliates and sublicensees. Patent license and know-how agreement with Mayo On December 6, 2019, RSF entered into a license agreement with Mayo, as amended on May 20, 2021, August 23, 2023, March 10, 2024, June 6, 2024, and December 22, 2025 (collectively, the “Mayo License”), under which RSF received (i) a worldwide exclusive license with the right to sublicense (through multiple tiers) under certain Mayo patent rights, (ii) a nonexclusive license with the right to sublicense (through multiple tiers) to use certain know-how and materials, and (iii) a nonexclusive worldwide license, with the right to sublicense (through multiple tiers) in connection with a sublicense of the Mayo patent rights or know-how, subject to approval from Mayo, to use certain Mayo data, in each case in (i) through (iii), to develop, make, have made, use, offer for sale, sell, and import certain licensed products, including Ataciguat, for the prevention, diagnosis, and/or treatment of any and all human diseases and conditions. We are also obligated to pay Mayo up to $0.3 million in development and regulatory milestone payments and up to $1.3 million in commercial milestone payments for each licensed product to achieve the corresponding milestone events. As of June 30, 2026, none of the Mayo milestones had been achieved nor were deemed probable and estimable, and no milestone payments have been made. We are also obligated to pay Mayo royalties ranging from a mid-single digit to subteen percentage of worldwide annual net sales by us, our affiliates and sublicensees of licensed products. In the event that we are required to pay a non-affiliate third party certain consideration for a license under intellectual property rights owned or controlled by such non-affiliate third party that are required for the manufacture, use or sale of the licensed products, we can deduct a certain amount of such consideration from the royalty payments due to Mayo under the Mayo Agreement, subject to a customary reduction floor. Critical accounting policies and estimates Our management’s discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements and accompanying notes. We base our estimates and assumptions on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and judgments on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions. See Note 2, “Summary of Significant Accounting Policies” to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, for information about our significant accounting policies and estimates used in the preparation of our condensed consolidated financial statements. There have been no significant and material changes in our critical accounting policies during the three and six months ended June 30, 2026, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for the year ended December 31, 2025 included in the final prospectus dated June 17, 2026 filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended. Emerging growth company and smaller reporting company status We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”), and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. We may take advantage of these exemptions until we are no longer an emerging growth company. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have elected to use the extended transition period for complying with new or revised accounting standards and 54 as a result of this election, our consolidated financial statements may not be comparable to companies that comply with public company effective dates. We may take advantage of these exemptions up until the time that we are no longer an “emerging growth company.” We will remain an emerging growth company until the earlier of the last day of the fiscal year (a) following the fifth anniversary of the completion of the IPO, (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means, among other things, the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30 th , or (d) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period. We have elected to take advantage of certain of the reduced disclosure obligations in this Quarterly Report on Form 10-Q and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different than what you might receive from other public reporting companies in which you hold equity interests. In addition, the JOBS Act provides that an “emerging growth company” can take advantage of an extended transition period for complying with new or revised accounting standards. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we can adopt the new or revised standard at the time private companies adopt the new or revised standard and may do so until such time that we either (1) irrevocably elect to “opt out” of such extended transition period or (2) no longer qualify as an “emerging growth company.” We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until for so long as either (i) our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) our annual revenues are less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter. Recent accounting pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “ Summary of Significant Accounting Policies ” to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. Off-balance sheet arrangements During the periods presented we did not have, nor do we currently have, any off-balance sheet arrangements as defined in the rules and regulations of the SEC. Ite m 3. Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company, as defined in Rule 12b-2 under the Exchange Act, and are not required to provide the information required under this item. Ite m 4. Controls and Procedures. Evaluation of Disclosure Controls and Procedures Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of June 30, 2026, the end of the period covered by this Quarterly Report on Form 10-Q. Disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. 55 In designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2026 at the reasonable assurance level. Changes in Internal Control over Financial Reporting Due to a transition period established by SEC rules applicable to newly public companies, our management is not required to evaluate the effectiveness of our internal control over financial reporting until the filing of our Annual Report on Form 10-K for the year ended December 31, 2027. As a result, this Quarterly Report on Form 10-Q does not address whether there have been any changes in our internal control over financial reporting. 56 PART II—OTHE R INFORMATION Ite m 1. Legal Proceedings. From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources, negative publicity and reputational harm. 57 Item 1A. Ris k Factors. Our business involves significant risks. Stockholders should carefully consider the risks and uncertainties described below, together with all of the other information included in this Quarterly Report on Form 10-Q, and in the other documents that we file with the SEC. Our business, financial condition, results of operations and prospects could be materially and adversely affected if any of these risks occur, and as a result, the market price of our common stock could decline, and stockholders could lose part or all of their investment. This Quarterly Report also contains forward-looking statements that involve risks and uncertainties not presently known to us or that we currently deem to be immaterial. See “Cautionary Note Regarding Forward-Looking Statements” on page 1 for more information. Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain important factors, including those set forth below. Risks related to our limited operating history, financial condition and need for additional capital We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability. We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future. We are a clinical-stage biopharmaceutical company with a limited operating history. We were formed in August 2023 as EnCarda, Inc., and our operations to date have been limited to organizing and staffing our company, business planning, including our acquisitions, raising capital, identifying, licensing and developing potential product candidates, acquiring, deploying and developing our Prolaio platform and technology, securing intellectual property rights, and planning and undertaking preclinical studies and clinical trials. Our lead product candidates include Danicamtiv for genetic dilated cardiomyopathy (“DCM”), Ataciguat for moderate calcific aortic valve stenosis (“CAVS”) and Tonlamarsen for post-hospitalization management of acute severe hypertension (“ASH”). We have not yet demonstrated an ability to generate revenues, obtain regulatory approvals, manufacture any product on a commercial scale or arrange for a third party to do so on our behalf or conduct sales and marketing activities necessary for successful product commercialization. Our limited operating history as a company makes any assessment of our future success and viability subject to significant uncertainty. We will encounter risks and difficulties frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields, and we have not yet demonstrated an ability to successfully overcome such risks and difficulties. If we do not address these risks and difficulties successfully, our business will suffer. The success of our business depends primarily upon our ability to identify, develop, and commercialize our product candidates, Danicamtiv, Ataciguat and Tonlamarsen and develop our Prolaio platform. We do not know whether we will be able to develop any product candidates that succeed through preclinical and clinical development or products of commercial value. We have no products approved for commercial sale and have not generated any revenue from product sales to date. We will continue to incur significant research and development and other expenses related to our preclinical and clinical development and ongoing operations. As a result, we are not profitable and have incurred losses in each period since our inception. Net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital. Our net losses totaled $172.3 million and $75.5 million for the six months ended June 30, 2026 and 2025, respectively, and $191.9 million and $88.7 million for the year ended December 31, 2025 and 2024, respectively. As of June 30, 2026, we had not yet generated revenues and had an accumulated deficit of $453.4 million. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates. We anticipate that our expenses will increase substantially if, and as, we: • advance our product candidates through clinical development, including as we continue to advance Danicamtiv, Ataciguat and Tonlamarsen in later-stage clinical trials; • continue to develop our Prolaio platform; • seek regulatory approvals from the U.S. Food and Drug Administration (the “FDA”) or other foreign regulatory authorities for our product candidates that successfully complete clinical trials; 58 • hire additional clinical, quality control, medical, scientific and other technical personnel to support the clinical development of our product candidates; • experience an increase in headcount as we expand our research and development organization and market development and pre-commercial planning activities; • undertake any pre-commercial or commercial activities to establish sales, marketing and distribution capabilities; • advance our existing and potential future preclinical-stage product candidates into clinical development; • seek to identify, acquire and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates, which may include opportunities to leverage our Prolaio platform; • maintain, expand and protect our intellectual property portfolio; • experience heightened regulatory scrutiny; • make milestone, royalty or other payments due under our existing license agreements with MyoKardia, Inc. (“MyoKardia”), Bristol-Myers Squibb Company (“BMS Co.”), Sanofi, the Mayo Foundation for Medical Education and Research (“Mayo”) and Ionis Pharmaceuticals, Inc. (“Ionis”) and our purchase agreements with Rancho Santa Fe Bio, Inc. (“RSF”) and Prolaio, Inc., and any future in-license or collaboration agreements; • make milestone, royalty, interest or other payments due under any future licensing, financing or other arrangements with third parties; and • incur additional legal, accounting, and other expenses associated with operating as a public company. Biopharmaceutical product development entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, secure market access and reimbursement and become commercially viable, and therefore any investment in us is highly speculative. Accordingly, before making an investment in us, our prospects, factoring in the costs, uncertainties, delays and difficulties frequently encountered by companies in clinical development, especially clinical-stage biopharmaceutical companies such as ours, should be carefully considered. Any predictions about our future success or viability may not be as accurate as they would otherwise be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives. Additionally, our expenses could increase beyond our expectations if we are required by the FDA, European Medicines Agency (the “EMA”), or other comparable regulatory authorities to perform clinical trials in addition to those that we currently expect, or if there are any delays in establishing appropriate manufacturing arrangements for or in completing our clinical trials or the development of any of our product candidates. We will require substantial additional capital to finance our operations in the future. If we are unable to raise capital when needed, or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts. Developing biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek regulatory and marketing approval for, our product candidates. Even if our current or future product candidates are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. To date, we have funded our operations through private financings and our recent initial public offering. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the clinical and preclinical development of our product candidates, continue to identify new product candidates, develop and deploy our Prolaio platform, commence additional preclinical studies and clinical trials, and continue to identify and develop additional product candidates either through internal development or through acquisitions or in-licensing product candidates. As of June 30, 2026, we had $660.7 million of cash, cash equivalents and investments. We believe that our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of issuance of the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report. Based on our current operating plan, we expect our current cash runway to support the 59 continued advancement of Danicamtiv, Ataciguat and Tonlamarsen through clinical data readouts and the initiation of Phase 3 clinical trials across all three programs. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We may also raise additional financing on an opportunistic basis in the future. For example, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop our product candidates. Our future capital requirements will depend on many factors, including but not limited to: • the scope, timing, progress, costs and results of discovery, preclinical development and clinical trials for our current or future product candidates; • the number of clinical trials required for regulatory approval of our current or future product candidates; • the costs, timing and outcome of regulatory review of any of our current or future product candidates; • the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses, as applicable; • the cost of manufacturing clinical and commercial supplies of our current or future product candidates; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights; • our ability to deploy and develop the Prolaio platform, including in connection with our current and future product candidates; • our ability to maintain existing, and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; • the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; • the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; • expenses to attract, hire and retain skilled personnel; • the costs of operating as a public company; • our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; • the effect of macroeconomic trends, including inflation, tariffs and fluctuating interest rates; • any potential supply chain interruptions or delays; • the effect of competing technological and market developments; and • the extent to which we acquire or invest in additional businesses, products and technologies. Because of the numerous risks and uncertainties associated with research and development of product candidates, we are unable to predict the timing or amount of our working capital requirements. In addition, if we obtain regulatory approval for our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution which make it difficult to predict when or if we will be able to achieve or maintain profitability. Furthermore, we have incurred and expect to continue to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in order to support our continuing operations. Our ability to raise additional funds will depend on financial, economic, political and market conditions and other factors, over which we may have no or limited control. Additional funds may not be available when we need them, on terms that are acceptable to us, or at all. If we fail to obtain necessary capital when needed on acceptable terms, or at all, it could force us to delay, limit, reduce or terminate our product development programs, future commercialization efforts or other operations. 60 Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents and short-term investments, any future equity, debt or other financings and upfront and milestone and royalty payments, if any, received under any future licenses or collaborations. If we raise additional capital through the sale of equity or convertible debt securities, or issue any equity or convertible debt securities in connection with a collaboration agreement or other contractual arrangement, the ownership interests of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. In addition, the possibility of such issuance may cause the market price of our common stock to decline. Debt financing, if available, may result in increased fixed payment obligations and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring, selling or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. We could also be required to seek funds through arrangements with collaborators or others at an earlier stage than otherwise would be desirable. Any of these occurrences may have a material adverse effect on our business, operating results and prospects. We maintain the majority of our cash and cash equivalents in accounts with major U.S. and multi-national financial institutions, and our deposits at certain of these institutions exceed insured limits. Market conditions and changes in financial regulations and policies can impact the viability of these institutions. In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position. In addition, changes in regulations governing financial institutions are beyond our control and difficult to predict; consequently, the impact of such changes on our business and results of operations is difficult to predict and may have an adverse effect on us. Risks related to our business Our business is highly dependent on the success of our product candidates, particularly Danicamtiv for genetic DCM, Ataciguat for moderate CAVS, and Tonlamarsen for post-hospitalization management of ASH. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materially harmed. To date, as an organization, we have not completed the development of any product candidates. Our future success and ability to generate revenue from our product candidates is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more of our product candidates. All of our product candidates will require substantial additional investment for clinical development, regulatory review and approval in one or more jurisdictions. If any of our product candidates, particularly Danicamtiv for genetic DCM, Ataciguat for moderate CAVS and Tonlamarsen for ASH, encounters safety or efficacy problems, development delays or regulatory issues or other problems, our development plans and business would be materially harmed. We may not have the financial resources to continue development of our product candidates if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, our product candidates, including: • our inability to demonstrate to the satisfaction of the FDA, EMA, or other comparable regulatory authorities that our product candidates are safe and effective; • insufficiency of our financial and other resources to complete the necessary clinical trials and preclinical studies; • negative or inconclusive results from our clinical trials, preclinical studies or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional clinical trials or preclinical studies or abandon a program; • future product-related adverse events (“AEs”) experienced by subjects in our clinical trials, including unexpected toxicity results, or by individuals using drugs or therapeutic biologics similar to our product candidates; 61 • delays in submitting an Investigational New Drug (“IND”) application or other regulatory submission to the FDA, EMA, or other comparable regulatory authorities, or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial or a suspension or termination, or hold, of a clinical trial once commenced; • conditions imposed by the FDA, EMA, or other comparable regulatory authorities regarding the scope or design of our clinical trials; • poor effectiveness of our product candidates during clinical trials; • better than expected performance of control arms, such as placebo groups, which could lead to negative or inconclusive results from our clinical trials; • delays in enrolling subjects in our clinical trials; • high drop-out rates of subjects from our clinical trials; • inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials; • higher than anticipated clinical trial or manufacturing costs; • unfavorable FDA, EMA or comparable regulatory authority inspection and review of our clinical trial sites; • failure of our third-party contractors or investigators to comply with regulatory requirements or the clinical trial protocol or otherwise meet their contractual obligations in a timely manner, or at all; • competition with existing platforms, product candidates or therapies; • delays and changes in regulatory requirements, policies and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our therapies in particular; • insufficiency of our financial and other resources to complete the necessary activities to prepare for launch commercialization and/or resources to address coverage and reimbursement matters to the extent any of our product candidates receive approval; or • varying interpretations of data by the FDA, EMA, or other comparable regulatory authorities. The successful development of pharmaceutical products involves a lengthy and expensive process and is highly uncertain. Successful development of pharmaceutical products involves a lengthy and expensive process, is highly uncertain, and is dependent on numerous factors, many of which are beyond our control. Failure can occur at any time during the preclinical study or clinical trial process. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies, and the historical failure rate for product candidates in our industry is high. The results from preclinical studies or early clinical trials of a product candidate may not predict the results of later clinical trials of the product candidate, and interim results of a clinical trial are not necessarily indicative of final results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including: • clinical trial results may show the product candidates to be less effective than expected (for example, a clinical trial could fail to meet its primary or key secondary endpoint(s)) or have an unacceptable safety or tolerability profile; • failure to receive the necessary regulatory approvals or a delay in receiving such approvals, which, among other things, may be caused by patients who fail the trial screening process, slow enrollment in clinical trials, patients dropping out of trials, patients lost to follow-up, length of time to achieve trial endpoints, additional time requirements for data analysis or New Drug Application (“NDA”) or similar foreign application preparation, discussions with the FDA, EMA, or other comparable regulatory authority, an FDA, EMA, or other comparable regulatory request for additional preclinical or clinical data (such as long-term toxicology studies) or unexpected safety or manufacturing issues; • preclinical study results may show the product candidate to be less effective than desired or to have harmful side effects; 62 • post-marketing approval requirements; or • the proprietary rights of others and their competing products and technologies that may prevent our product candidates from being commercialized. Even if we are successful in obtaining marketing approval, commercial success of any approved products will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations in the United States or country-specific governmental organizations in foreign countries, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare. Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources. If government and other healthcare payors were not to provide coverage and adequate reimbursement for our products once approved, market acceptance and commercial success would be reduced. Even if we are able to obtain coverage and adequate reimbursement for our products once approved, there may be features or characteristics of our products, such as dose preparation requirements, that prevent our products from achieving market acceptance by the healthcare or patient communities. In addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure that our third-party providers comply) with current Good Manufacturing Practices (“cGMPs”) and Good Clinical Practices (“GCPs”) for any clinical trials that we conduct post-approval. In addition, there is always the risk that we, a regulatory authority or a third party might identify previously unknown problems with a product post-approval, such as AEs of unanticipated severity or frequency. Compliance with these requirements is costly, and any failure to comply or other issues with our product candidates post-approval could adversely affect our business, financial condition and results of operations. Due to the significant resources required for the development of our pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others. Moreover, we may fail to expend our limited resources on product candidates or indications that may have been more profitable or for which there is a greater likelihood of success. Our lead product candidates, Danicamtiv for treatment of genetic DCM, Ataciguat for treatment of moderate CAVS, and Tonlamarsen for post-hospitalization management of ASH, are at various stages of clinical development. Danicamtiv is being evaluated in the ongoing KINSHIP-DCM Phase 2b/3 trial, Ataciguat is being evaluated in an ongoing KATALYST-AV Phase 2b trial and Tonlamarsen is being evaluated in the ongoing KARDINAL-ASH Phase 2 trial. We seek to rapidly advance discovery and development of transformational medicines for patients suffering from cardiovascular diseases. Due to the significant resources required for the development of our product candidates, we must decide which product candidates and indications to pursue and advance and the amount of resources to allocate to each. Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular product candidates, therapeutic areas or indications may not lead to the development of viable commercial products and may divert resources away from better opportunities. If we make incorrect determinations regarding the viability or market potential of any of our product candidates or misread trends in the pharmaceutical industry, in particular for cardiovascular diseases, our business, financial condition and results of operations could be materially and adversely affected. As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other product candidates or other diseases and disease pathways that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain sole development and commercialization rights. We may seek to grow our business through acquisitions or investments in new or complementary businesses, products or technologies, through the licensing of products or technologies from third parties or other strategic alliances. The failure to manage acquisitions, investments, licenses or other strategic alliances, or the failure to integrate them with our existing business, could have a material adverse effect on our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense. Our success depends on our ability to continually enhance and broaden our product offerings in response to changing clinicians’ and patients’ needs, competitive technologies and market pressures. Accordingly, from time to time we may consider opportunities to acquire, make investments in or license other technologies, products and businesses that may 63 enhance our capabilities, complement our existing products and technologies or expand the breadth of our markets or customer base. For example, in February 2025, we acquired 100% of the equity interests in Prolaio, Inc., a clinical intelligence company developing patient data collection software, and in June 2024, we acquired RSF, a clinical-stage cardiovascular platform company. Potential and completed acquisitions, strategic investments, licenses and other alliances involve numerous risks, including: • difficulty assimilating or integrating acquired or licensed technologies, products, employees or business operations; • issues maintaining uniform standards, procedures, controls and policies; • unanticipated costs associated with acquisitions or strategic alliances, including the assumption of unknown or contingent liabilities and the incurrence of debt or future write-offs of intangible assets or goodwill; • diversion of management’s attention from our core business and disruption of ongoing operations; • adverse effects on existing business relationships with suppliers, sales agents, health care facilities, surgeons and other health care providers; • risks associated with entering new markets in which we have limited or no experience; • potential losses related to investments in other companies; • potential loss of key employees of acquired businesses; and • increased legal and accounting compliance costs. We do not know if we will be able to identify acquisitions or strategic relationships we deem suitable, whether we will be able to successfully complete any such transactions on favorable terms, if at all, or whether we will be able to successfully integrate any acquired business, product or technology into our business or retain any key personnel, suppliers, sales agent, health care facilities, physicians or other health care providers. Our ability to successfully grow through strategic transactions depends upon our ability to identify, negotiate, complete and integrate suitable target businesses, technologies or products and to obtain any necessary financing. These efforts could be expensive and time-consuming and may disrupt our ongoing business and prevent management from focusing on our operations. In addition, the integration of any business that we may acquire in the future may disrupt our existing business and may be a complex, risky and costly endeavor for which we may never realize the full benefits. Furthermore, we may experience losses related to investments in other companies, including as a result of failure to realize expected benefits or the materialization of unexpected liabilities or risks, which could have a material negative effect on our results of operations and financial condition. Accordingly, although there can be no assurance that we will undertake or successfully complete any additional transactions of the nature described above, any additional transactions that we do complete could have a material adverse effect on our business, financial condition, results of operations and prospects. To finance any acquisitions, investments or strategic alliances, we may choose to issue shares of our common stock as consideration, which could dilute the ownership of our stockholders. If the price of our common stock is low or volatile, we may be unable to consummate any acquisitions, investments or strategic alliances using our common stock as consideration. Additional funds may not be available on terms that are favorable to us, or at all. We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our Prolaio platform. The Prolaio platform requires sophisticated computer systems and software for data collection, data processing, cloud-based platforms, analytics, and other applications and technologies. We are building artificial intelligence (“AI”) technologies into internal applications and solutions and we expect our use of AI to increase. Some of these technologies are changing rapidly and we must continue to adapt to these changes in a timely and effective manner at an acceptable cost. There can be no guarantee that we will be able to develop, acquire or integrate new technologies, that these new technologies will meet our needs or those of our clients’ or achieve expected investment goals, or that we will be able to do so as quickly or cost-effectively as our competitors. Our continued success will depend on our ability to adapt to changing technologies, manage and process ever-increasing amounts of data and information and improve the performance, features and reliability of our services. We may experience difficulties that could delay or prevent the successful design, development, testing, introduction or marketing of our services. New services, or enhancements to existing services, may not adequately meet our own requirements or those of current and prospective clients or achieve any degree of 64 significant market acceptance. Regulations relating to the use of AI and the interpretation of those regulations by regulators, courts and others are in the early stages of development and evolving, which may make it difficult to identify adequate compliance requirements or suitable governance practices to meet those requirements. These types of failures could have a material adverse effect on our operating results, financial condition and reputation. We have entered into, and may in the future enter into, related party transactions that may have terms that are less favorable to us. We have in the past been and may in the future be party to certain transactions with certain entities affiliated with our directors, executive officers and principal stockholders. For example, we acquired Prolaio, Inc. in February 2025 pursuant to an Agreement and Plan of Merger (the “Original Prolaio Merger Agreement”), as amended by Amendment No. 1 (as defined below) (together, the “Amended Prolaio Merger Agreement”). Pursuant to the Original Prolaio Merger Agreement, the former stockholders of Prolaio, Inc. were entitled to an aggregate of up to $200 million in milestone payments, which were payable as follows: (i) up to $50 million upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial, (B) there being at least 500 Kardigan clinical trial patients managed and screened by Prolaio, (C) our achievement of annual gross revenues of $15 million from the sale of Prolaio products and services and (D) Prolaio achieving improvements in patient screening rates; (ii) up to $100 million upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial, (B) there being at least 1,500 Kardigan clinical trial patients managed and screened by Prolaio, (C) our achievement of annual gross revenues of $25 million from the sale of Prolaio products and services and (D) Prolaio’s achievement of improvements in patient screening rates; (iii) up to $200 million upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial, (B) there being at least 5,000 Kardigan clinical trial patients managed and screened by Prolaio, (C) our achievement of annual gross revenues of $25 million from the sale of Prolaio products and services and (D) Prolaio’s achievement of improvements in patient screening rates; (iv) up to $200 million upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial and (B) our achievement of annual net sales of $50 million from the sale of Prolaio products and services; and (v) 50% of Eligible Payments (as defined below) upon (A) our completion of a qualifying Phase 2 or Phase 3 clinical trial and (B) the execution of a commercial transaction for Prolaio products and services that results in payments to Kardigan, as calculated in accordance with terms of the Original Prolaio Merger Agreement (“Eligible Payments”); in each case excluding intercompany transactions, to the extent such milestones are achieved on or before February 28, 2029. At the time of the acquisition, Tassos Gianakakos, our Chief Executive Officer, also served as the Chief Executive Officer and a member of the board of directors of Prolaio, Inc. and Jay Edelberg, our Chief Medical Officer, served as Head of Research and Development and a member of the board of directors of Prolaio, Inc. Mr. Gianakakos and Dr. Edelberg beneficially owned 55.7% and 17.1%, respectively, of Prolaio, Inc. at the time of its acquisition by us. If such milestone payments became payable, subject to the maximum aggregate limit of $200 million, Mr. Gianakakos would have been entitled to receive payments of up to $106.6 million in the aggregate, and Dr. Edelberg would have been entitled to receive payments of up to $32.9 million in the aggregate. In May 2026, we entered into Amendment No. 1 to Agreement and Plan of Merger (“Amendment No. 1”) with the former stockholders of Prolaio, Inc. in order to amend the milestone provisions applicable to such stockholders, including Mr. Gianakakos and Dr. Edelberg. In particular, the milestones were revised to: (i) better align the incentives of the former stockholders of Prolaio, Inc., in their capacities as executive officers and employees of Kardigan, with the creation of stockholder value for Kardigan; and (ii) better reflect our current operations and strategic direction following the acquisition, including our focus on deploying the Prolaio platform in support of our own clinical trials, and to ensure that the milestones remained aligned with our business. Pursuant to the Amended Prolaio Merger Agreement and subject to the conditions therein, the former stockholders of Prolaio, Inc., including Mr. Gianakakos and Dr. Edelberg, are entitled to an aggregate of up to $200 million in milestone payments as follows: (i) up to $50 million upon Kardigan’s achievement of a valuation equal to or greater than $5.0 billion; (ii) up to $50 million upon Kardigan’s achievement of a valuation equal to or greater than $6.0 billion; and (iii) up to $100 million upon Kardigan’s achievement of a valuation equal to or greater than $12.0 billion; in each case to the extent such milestones are achieved on or before May 1, 2032. If such milestone payments become payable, Mr. Gianakakos is entitled to receive payments of up to $12.9 million, $31.3 million and $62.4 million, respectively, pursuant to each milestone, for a total of up to $106.6 million; and Dr. Edelberg is entitled to receive payments of up to $3.6 million, $9.8 million, and $19.5 million, respectively, pursuant to each milestone, for a total of up to $32.9 million. Although we believe that these transactions are in our best interests, we cannot assure you that these transactions were entered into on terms as favorable to us as those that could have been obtained in an arm’s-length transaction with unaffiliated third-parties. Conversely, we may not be able to enter into transactions with third parties on terms as favorable as the terms of existing or any future transactions with related parties. Further, the appearance of conflicts of interest created by 65 related party transactions could impair the confidence of our investors. It is possible that a conflict of interest could have a material adverse effect on our business, results of operations, and financial condition. In connection with the initial public offering, we adopted a written related-person transactions policy that sets forth our policies and procedures regarding the identification, review, consideration and oversight of related-person transactions. We, third-parties on which we rely and our service providers are, or may become, subject to a variety of stringent and evolving data privacy and security laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Any actual or perceived failure to comply with such obligations could expose us to significant fines or other penalties and otherwise harm our business and operations. In the ordinary course of our business, we and the third parties upon which we rely (such as our third party Contract Research Organizations (“CROs”) and other contractors and consultants) collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, “process”) personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, sensitive third-party data, business plans, transactions, financial information and data we collect about trial participants in connection with clinical trials (collectively, sensitive data). Through our acquisition of Prolaio, Inc., we have acquired an FDA-cleared patient data collection software platform and cardiovascular clinical data, which we use to enhance data collection and analysis in our clinical trials. Prolaio’s operations significantly expand the volume and sensitivity of patient health data we process, including high-density patient data collected through Prolaio’s data collection software and clinical datasets. Our data processing activities subject us to numerous evolving data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security. The legislative and regulatory framework for the processing of personal data worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future. This evolution may create uncertainty in our business, affect our ability to operate in certain jurisdictions or to collect, store, transfer, use and share sensitive data, necessitate the acceptance of more onerous obligations in our contracts, result in liability or impose additional costs on us. The cost of compliance with these laws, regulations and standards is high and is likely to increase in the future. Any failure or perceived failure by us to comply with federal, state or foreign laws or regulations, our internal policies and procedures or our contracts governing our processing of sensitive data could result in negative publicity, government investigations and enforcement actions, claims by third parties and damage to our reputation, any of which could have a material adverse effect on our business, results of operations, and financial condition. In the United States, numerous federal, state and local laws and regulations, including federal health information privacy laws, state information security and data breach notification laws, federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws) govern the processing of health-related and other personal data. At a federal level, HIPAA imposes, among other things, certain standards relating to the privacy, security, transmission of and breach reporting related to individually protected identifiable health information (“PHI”). We may obtain health information from third parties, such as research institutions with which we collaborate, that are subject to privacy and security requirements under HIPAA. Although we do not believe that we are directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we could be subject to criminal penalties if we knowingly obtain or disclose PHI maintained by a HIPAA covered entity in a manner that is not authorized or permitted by HIPAA. We currently use the Prolaio platform for our own clinical research purposes. To the extent we obtain PHI from covered entities under HIPAA, such as hospitals or clinical trial sites, for use with the Prolaio platform or otherwise, we may be required to enter into data use agreements or business associate agreements and comply with applicable contractual and regulatory requirements for the use and disclosure of such information, including requirements related to de-identification, limited data sets, appropriate administrative, physical and technical safeguards, and breach notification. If we were to expand Prolaio, Inc.’s operations to provide services to external healthcare providers or other covered entities, we could become subject to more extensive HIPAA business associate obligations, including direct enforcement by the U.S. Department of Health and Human Services Office for Civil Rights, which could impose civil monetary penalties as well as criminal penalties for violations of HIPAA. We may also obtain patient health records through platforms that participate in the Trusted Exchange Framework and Common Agreement (“TEFCA”), a nationwide health information exchange framework established under the 21st Century Cures Act and administered by ONC. TEFCA imposes privacy, security, and individual rights requirements, including individual consent and data deletion rights, on entities that participate in TEFCA exchange activities. We obtain patient records through a third-party platform operating as an Individual Access Services provider under TEFCA, pursuant to which individuals consent to retrieval of their health records for use in our clinical research. Depending on the scope of our participation in TEFCA exchange activities, we may be subject to TEFCA’s contractual obligations, including obligations 66 that may conflict with data retention requirements under the Common Rule and FDA clinical trial regulations. The application of TEFCA’s requirements to clinical research is an area of evolving legal interpretation for which regulatory guidance remains limited. Failure to comply with applicable TEFCA requirements, or changes in how those requirements are interpreted or enforced, could require us to modify our data collection practices in ways that adversely affect our clinical operations or expose us to contractual liability or regulatory scrutiny. At the state level, numerous U.S. states have enacted comprehensive privacy laws, such as the California Consumer Privacy Act (the “CCPA”) and several others that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording individuals certain rights concerning their personal data. Similar laws and several others in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future. While these comprehensive privacy laws that are in effect at the state level generally exempt certain data processed in the context of clinical trials, the continued development of new privacy laws at the state level may further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties upon whom we rely. Further proposed privacy legislation, if enacted, may add additional complexity, variation in requirements, restrictions and potential legal risk, require additional investment of resources in compliance programs, impact strategies and the availability of data and information that could be of potential use to the growth and development of our business and could result in increased compliance costs and/or the necessity of making changes in our business practices and policies. The continued further development of privacy laws in different states could make our compliance obligations more complex and costly and may increase the likelihood that we may be subject to enforcement actions or otherwise incur liability for noncompliance that could adversely impact our financial condition. Additionally, we may be subject to laws governing the privacy of specific types of data, including, biometric information and, notably, consumer health data. For example, Washington’s My Health My Data Act broadly defines consumer health data, creates a private right of action to allow individuals to sue for violations of the law, imposes stringent consent requirements and grants consumers certain rights with respect to their health data, including to request deletion of their information. Connecticut and Nevada have also passed similar laws regulating consumer health data. These various data privacy and security laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products. Such laws could have potentially conflicting requirements that would make compliance challenging. In the event that we are subject to or affected by these U.S. state privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition. Outside the United States, an increasing number of laws, regulations, and industry standards govern data privacy and security. For example, the European Union’s General Data Protection Regulation (“EU GDPR”) and the United Kingdom’s General Data Protection Regulation and Data Protection Act 2018 (collectively, the “UK GDPR” and together with the EU GDPR, the “GDPR”) impose strict requirements for processing personal data of individuals within the European Economic Area (“EEA”) and the United Kingdom (“UK”). These European regimes include strict requirements relating to processing of sensitive data (such as health data), ensuring there is a legal basis or condition to justify the processing of personal data, obtaining consent of individuals in certain circumstances, disclosing how personal data is to be used, limiting retention of information, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, maintaining records of processing activities, documenting data protection impact assessments where there is high-risk processing and taking certain measures when engaging third-party processors. Under GDPR, companies may face temporary or definitive bans on data processing and other corrective activities, fines of up to €20 million (£17.5 million GBP) or 4% of the annual global revenues of the noncompliant undertaking, whichever is greater, private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests; or regulatory investigations, reputational damage, orders to cease/change our data processing activities, enforcement notices and/or assessment notices (for a compulsory audit). Non-compliance could also result in a material adverse effect on our business, financial position and results of operations. In addition, we may be unable to transfer personal data from Europe and other jurisdictions to the United States or other countries or we may have to implement additional measures to enable such transfers due to data localization requirements or limitations on cross-border data flows. Among other requirements, the GDPR restricts the transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States, unless a derogation exists or we implement a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses and the UK International Data Transfer Agreement/Addendum and conduct transfer impact assessments to assess whether the recipient can ensure certain guarantees under the GDPR). However, the efficacy and longevity of current transfer mechanisms remains uncertain. We expect the existing legal complexity and uncertainty regarding international personal data transfers to continue and international transfers to the United States and to other jurisdictions more generally to continue to be subject to enhanced scrutiny by 67 regulators. As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we operate our business, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results. The UK’s data protection regime is independent from but aligned to the EU’s data protection regime. However following the UK’s departure from the European Union (“Brexit”), there will be increasing scope for divergence in application, interpretation and enforcement of the data protection laws between these territories. For example, the UK Data (Use and Access) Act 2025 (the “UK Act”), now in force, further alters the similarities between the UK and EEA data protection regimes. In December 2025, the European Commission adopted a decision determining that the UK continues to provide a level of data protection that is “essentially equivalent” to the EU standards and extended the validity of the UK adequacy decision for six years, through December 2031. While this renewal reduces immediate adequacy concerns for transfers of personal data from the EEA to the UK, uncertainty remains regarding how UK data protection laws will evolve in the medium to longer term. This lack of clarity on future UK laws and regulations and their interaction with those of the EU could add legal risk, uncertainty, complexity, and cost to our handling of European personal data and our privacy and security compliance programs, and any resulting divergence in laws could increase our risk profile and may require us to implement different compliance measures for the UK and EEA. In addition, EEA Member States have adopted national laws to implement the GDPR that may partially deviate from the GDPR. Further, the competent authorities in the EEA Member States interpret GDPR obligations slightly differently from country to country (particularly in relation to the processing of health data) and therefore we do not expect to operate in a uniform legal landscape in the EEA. The European Commission has also proposed further reforms under the so-called “Digital Omnibus” package, which is intended to streamline and update aspects of the EU’s digital regulatory framework, including certain data protection obligations. While the scope and final form of these proposals remain subject to legislative negotiation, if adopted they may further modify or supplement existing GDPR-related requirements, including by further clarifying the scope of what constitutes “personal data” and the regulatory treatment of coded, key-coded or otherwise de-identified data. Any such changes could require us to reassess and adjust our European privacy compliance framework, resulting in additional legal, operational and compliance costs. Additionally, in 2025, the U.S. Department of Justice issued a rule entitled Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restrictions on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and generally prohibits data brokerage transactions involving certain sensitive personal data categories, including health data, genetic data, and biospecimens, to these countries of concern. The rule impacts certain business or management activities such as vendor engagements, licensing arrangements, partnership engagements, sale or sharing of data, employment of certain individuals and investor agreements. Violations of the rule could lead to significant civil and criminal fines and penalties. We may in the future engage in data transactions that could be subject to the rule. There is a risk that our interpretation of the rule’s applicability, scope and requirements could be incorrect, incomplete, or misapplied. The rule applies to certain data transactions even where data is anonymized, key-coded, pseudonymized, de-identified or encrypted, which may impact our ability to enter into certain agreements. In addition to data privacy and security laws, we are also bound by other contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. We may publish privacy policies and marketing materials, and other statements, such as compliance with certain certifications or self-regulatory principles, regarding data privacy and security. Regulators such as the U.S. Federal Trade Commission are increasingly scrutinizing these statements, and if these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, or other adverse consequences. We may at times fail (or be perceived to have failed) in our efforts to comply with our data privacy and security obligations. Moreover, despite our efforts, our personnel or third parties on whom we rely may fail (or be perceived to have failed) to comply with such obligations, which could negatively impact our business operations. If we or the third parties on which we rely fail, or are perceived to have failed, to address or comply with applicable data privacy and security obligations, we could face significant consequences, including but not limited to: government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims) and mass arbitration demands; additional reporting requirements and/or oversight; bans on processing personal data; and orders to destroy or not use personal data. In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the 68 volume of data and the number of violations. Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers; interruptions or stoppages in our business operations (including, as relevant, clinical trials); inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; potentially significant penalties if we are found to be in violation of our privacy obligations; adverse publicity; or substantial changes to our business model or operations. Our information technology systems and infrastructure, or those of our collaborators and service providers, or our data, may be subject to cyber-attacks, intrusions, breaches, compromises, disruptions or other cybersecurity incidents, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand, material disruption of our development programs and operations, or other adverse consequences. In the ordinary course of our business, we and the third parties upon which we rely, process sensitive data, and, as a result, we and the third parties upon which we rely face a variety of evolving threats that could cause cyber-attacks, intrusions, breaches, compromises, disruptions or other cybersecurity incidents. Although we take steps to develop and maintain systems and controls designed to protect our sensitive data, systems and infrastructure, there can be no assurance that our internal technology systems and infrastructure, or those of third parties upon which we rely, will be sufficient to protect against a cyber-attack, intrusion, breach, compromise, disruption or other cybersecurity incident such as an industrial espionage attack, ransomware, or insider threat attack such as wrongful conduct by employees or vendors, which may compromise our system infrastructure or lead to the loss, destruction, alteration or dissemination of, or damage to, our sensitive data. Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors. The risk of a cyber-attack, intrusion, breach, compromise, disruption or other cybersecurity incident has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have grown. Such risks come from a variety of evolving threats, including but not limited to, social engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), misconfigurations, “bugs” or other vulnerabilities in software that is integrated into our technology systems and infrastructure, malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing, credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by AI, telecommunications failures, earthquakes, fires, floods, and other similar threats. Further, there can also be no assurance that our and our third-party service providers’, strategic partners’, contractors’, consultants’, CROs’ and collaborators’ cybersecurity risk management program and processes, including policies, controls or procedures, will be fully implemented, complied with or effective in protecting our systems, networks and sensitive data. Threat actors engage in and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we and the third parties upon which we rely, may be vulnerable to a heightened risk of cyber-attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our services. Additionally, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations, ability to provide our products or services, loss of sensitive data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments. We also face increased risks of a cyber-attack, intrusion, breach, compromise, disruption or other cybersecurity incident due to our reliance on internet technology and the number of our employees who work on a hybrid basis at home, in the office, or other public spaces. This may create additional opportunities for cybercriminals to exploit vulnerabilities. Additionally, business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies that were not found during due diligence of such acquired or integrated entities. In addition, our reliance on third-party service providers could introduce new cybersecurity risks and vulnerabilities, including supply-chain attacks. We rely on third-party service providers and technologies to operate critical business systems to process sensitive data in a variety of contexts and our ability to monitor these third parties’ information security practices is limited. These third parties may not have adequate information security measures in place and if our third-party service 69 providers experience a cyber-attack, security breach, compromise, disruption or other cybersecurity incident, we could experience adverse consequences. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or cybersecurity-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award. We may be unable to detect vulnerabilities in our information technology systems and infrastructure on a timely basis or until after a cyber-attack, intrusion, breach, compromise, disruption or other cybersecurity incident has occurred, and it may be difficult and/or costly to investigate, mitigate, contain, and remediate a cybersecurity incident. Further, we may experience delays in developing and deploying remedial measures designed to adequately address any such identified vulnerabilities. Our efforts to do so may not be successful. Actions taken by us or the third parties with whom we work to detect, investigate, mitigate, contain, and remediate a cybersecurity incident could result in outages, data losses, and disruptions of our business. Threat actors may also gain access to other networks and systems after a compromise of our networks and systems. For example, threat actors may use an initial compromise of one part of our environment to gain access to other parts of our environment, or leverage a compromise of our networks or systems to gain access to the networks or systems of third parties with whom we work, such as through phishing or supply chain attacks. We have in the past experienced threats related to our data and systems, and we may in the future experience additional threats, compromises, breaches or other cybersecurity incidents. If we, or a third party upon whom we rely, experience a cyber-attack, intrusion, breach, compromise, disruption or other cybersecurity incident, or are perceived to have experienced one, we may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including individual and group claims); significant incident response, system restoration or remediation costs; indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in our operations (including availability of data); financial loss; and other potentially significant harms. Further, applicable data privacy and cybersecurity obligations may require us to notify individuals, regulators, or other relevant stakeholders of a cyber-attack, intrusion, breach, compromise, disruption, or other cybersecurity incident. Such disclosures are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences. In addition, cyber-attacks, intrusions, breaches, compromises, disruptions or other cybersecurity incidents may cause stakeholders (including investors and potential customers) to stop supporting our business, deter new customers from using our products, and negatively impact our ability to grow and operate our business. Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and cybersecurity obligations. Further, our existing general liability and cyber liability insurance policies may not cover, or may cover only a portion of, any potential claims related to cybersecurity breaches to which we are exposed or may not be adequate to indemnify us for all or any portion of liabilities that may be imposed. We also cannot be certain that our existing insurance coverage will continue to be available on acceptable terms or in amounts sufficient to cover the potentially significant losses that may result from a cybersecurity incident or breach or that the insurer will not deny coverage of any future claim. Accordingly, if our cybersecurity measures, and those of our service providers, fail to protect against unauthorized access, attacks (which may include sophisticated cyberattacks) and the mishandling of data by our employees and third-party service providers, then our reputation, business, results of operations and financial condition could be adversely affected. The use of new and evolving technologies, such as AI and machine learning (“ML”), in our operations, and the operations of third parties upon which we rely, may result in spending additional resources and present new risks and challenges that can impact our business including by posing cybersecurity and other risks to our sensitive data, and as a result we may be exposed to reputational harm, other adverse consequences, and liability. We use and integrate AI/ML systems in our business, primarily in our Prolaio platform. The use of new and evolving technologies, such as AI/ML, in our operations, and the operations of third parties upon which we rely, presents new risks and challenges that could negatively impact our business, including cybersecurity, data privacy, IT, intellectual property, regulatory, legal, operational, competitive, reputational, and other risks and challenges. Specifically, risks related to bias, AI hallucinations, discrimination, harmful content, misinformation, fraud, scams, targeted attacks such as model poisoning or data poisoning, surveillance, data leakage, loss of consensus reality, inequality, environmental harms, and other harms may flow from our development, use, or deployment of AI technologies. 70 We expect that increased investment will be required in the future to continuously improve our AI/ML systems. As with many technological innovations, there are significant risks involved in developing, maintaining and deploying these technologies and there can be no assurance that the usage of our investments in such technologies will always enhance our products or services or be beneficial to our business, including our efficiency or profitability. The use of certain AI/ML technology can give rise to intellectual property risks, including by disclosing or otherwise compromising our confidential or proprietary intellectual property and intellectual property infringement, or by undermining our ability to assert or defend ownership rights in intellectual property created with the assistance of AI/ML tools. For example, we may experience difficulties in enforcing the intellectual property rights in output generated by AI/ML technologies. The United States Copyright Office has previously denied copyright protection for content generated by AI/ML technologies, and the United States Patent and Trademark Office has similarly stated that an AI/ML tool cannot be an “inventor” of a patent, rendering it impossible to obtain patent protection for inventions created solely by AI/ML technologies. The Supreme Court of the United Kingdom has reached a similar conclusion, stating that AI/ML systems cannot be named as an “inventor” for UK patent law purposes. Additionally, several jurisdictions around the globe, including in Europe and the U.S., have proposed, enacted, or are considering, laws governing the development and use of AI/ML, such as the EU’s AI Act. As amended by the Digital Omnibus package, which received final Council approval in June 2026, the obligations applicable to providers and deployers of high-risk AI systems under the EU AI Act have been deferred and are now scheduled to apply from December 2, 2027. If we use AI/ML systems that are governed by the EU AI Act, it may necessitate ensuring higher standards of data quality, transparency, and human oversight, as well as adhering to specific and potentially burdensome and costly ethical, accountability, and administrative requirements. We expect other jurisdictions will adopt similar laws. In the U.S., the regulatory framework for AI/ML technologies faces significant uncertainty. At the federal level, Congress has yet to enact meaningful AI legislation. In the absence of federal AI legislation, states have filled the void by enacting laws regulating different aspects of AI/ML technologies. For example, California has enacted laws and regulations related to AI/ML safety protocols, reporting and transparency, among other AI-related topics. In addition, Colorado’s Automated Decision-Making Technology Act will impose various disclosure and transparency requirements on developers and deployers of various AI/ML systems. Numerous other states have enacted, passed, or are considering AI-focused legislation, creating a patchwork of regulations and a complex compliance challenge. The current administration has endorsed a federal moratorium on the enforcement of state AI laws, including through a December 11, 2025, executive order on “Ensuring a National Policy Framework for Artificial Intelligence.” So far, these efforts have not been successful at curtailing state action on AI regulation, contributing to a complicated legislative patchwork, which may be litigated in state and federal courts. Any failure or perceived failure by us to comply with existing or newly enacted laws, regulations and other requirements relating to AI/ML technologies could result in legal claims or proceedings (including class actions), regulatory investigations or enforcement actions. Additionally, certain privacy laws extend rights to consumers (such as the right to delete certain personal data) and regulate automated decision making, which may be incompatible with our use of AI/ML. These obligations may make it harder for us to conduct our business using AI/ML, lead to regulatory fines or penalties, require us to change our business practices, retrain our AI/ML, or prevent or limit our use of AI/ML. For example, the Federal Trade Commission has required other companies to turn over (or disgorge) valuable insights or trainings generated through the use of AI/ML where they allege the company has violated certain privacy and consumer protection laws. If we cannot use AI/ML or that use is restricted, our business may be less efficient, or we may be at a competitive disadvantage. The rapid evolution of AI/ML will require the application of significant resources to design, develop, test and maintain our products and services to help ensure that AI/ML is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts. Our vendors may in turn incorporate AI/ML tools into their own offerings, and the providers of these AI/ML tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to data privacy and cybersecurity. Further, bad actors around the world use increasingly sophisticated methods, including the use of AI/ML, to expand potential attack surfaces and otherwise engage in illegal activities involving the theft and misuse of sensitive data. Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and adversely impact our business. 71 Risks related to the discovery and development of our current or future product candidates The regulatory approval processes of the FDA, EMA, and other comparable regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining regulatory approval from the FDA. Foreign regulatory authorities, such as the EMA and national competent authorities in EU Member States, impose similar requirements. The time required to obtain approval by the FDA, EMA, or other comparable regulatory authorities is inherently unpredictable, but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. For instance, jurisdictions outside of the United States, such as the European Union or Japan, may have different requirements for regulatory approval, which may require us to conduct additional clinical, nonclinical or chemistry, manufacturing and control studies. To date, we have not submitted an NDA to the FDA or similar drug approval submissions to comparable foreign regulatory authorities for any product candidate. We must complete additional preclinical studies and clinical trials to demonstrate the safety and efficacy of our product candidates in humans before we will be able to obtain these approvals. Before obtaining approval from regulatory authorities for the commercialization of any of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidate in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. The clinical development of our initial and potential additional product candidates is susceptible to the risk of failure inherent at any stage of development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of AEs that are severe or medically or commercially unacceptable, failure to comply with protocols or applicable regulatory requirements and determination by the FDA, EMA, or other comparable regulatory authorities that a product candidate may not continue development or is not approvable. It is possible that even if any of our product candidates have a beneficial effect, that effect will not be detected during clinical evaluation as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical trials. Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of such product candidate that is greater than the actual positive effect, if any. Similarly, in our clinical trials we may fail to detect toxicity of, or intolerability caused by, such product candidate, or mistakenly believe that our product candidates are toxic or not well-tolerated when that is not in fact the case. Serious AEs or other AEs, as well as tolerability issues, could hinder or prevent market acceptance of the product candidate at issue. Our current and future product candidates could fail to receive regulatory approval for many reasons, including the following: • the FDA, EMA, or other comparable regulatory authorities may disagree as to the design or implementation of our clinical trials; • we may be unable to demonstrate to the satisfaction of the FDA, EMA, or other comparable regulatory authorities that a product candidate is safe and effective for its proposed indication; • the results of clinical trials may not meet the level of statistical significance required by the FDA, EMA, or other comparable regulatory authorities for approval; • we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; • the FDA, EMA, or other comparable regulatory authorities may disagree with our interpretation of data from clinical trials or preclinical studies; • the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA to the FDA or other submission or to obtain regulatory approval in the United States, the European Union or elsewhere; • the FDA, EMA, or other comparable regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and • the approval policies or regulations of the FDA, EMA, or other comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. 72 This lengthy approval process as well as the unpredictability of clinical trial results may result in our failing to obtain regulatory approval to market any product candidate we develop, which would substantially harm our business, financial condition, results of operations and prospects. The FDA, EMA, and other comparable regulatory authorities have substantial discretion in the approval process and determining when or whether regulatory approval will be granted for any product candidate that we develop. Even if we believe the data collected from future clinical trials of our product candidates are promising, such data may not be sufficient to support approval by the FDA, EMA, or other comparable regulatory authorities. Furthermore, the U.S. Supreme Court’s July 2024 decision to overturn prior established case law giving deference to regulatory agencies’ interpretations of ambiguous statutory language has introduced uncertainty regarding the extent to which FDA’s regulations, policies and decisions may become subject to increasing legal challenges, delays, and/or changes. In addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates. In addition, FDA and foreign regulatory authorities may change their approval policies and new regulations may be enacted. For instance, the EU pharmaceutical legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020. The European Commission’s proposal for revision of several legislative instruments related to medicinal products (potentially reducing the duration of regulatory data protection, revising the eligibility for expedited pathways, etc.) was published on April 26, 2023. In April 2024, the European Parliament adopted its position on the legislative proposals and, in June 2025, the Council of the European Union adopted its position. A common position on the text was agreed upon on December 11, 2025, in the context of subsequent inter-institutional trilogue negotiations. The proposed revisions remain to be adopted into EU law, and are not expected to become applicable before 2028. The revisions may, however, have a significant impact on the pharmaceutical industry and our business in the long term. The FDA, EMA or comparable regulatory authorities may disagree with our regulatory plan for our product candidates. The general approach for FDA approval of a new drug is dispositive data from two or more adequate and well-controlled clinical trials of the product candidate in the relevant patient population. Adequate and well-controlled clinical trials typically involve a large number of patients, have significant costs and take years to complete. The FDA, EMA or other comparable regulatory authorities may disagree with us about whether a clinical trial is adequate and well-controlled or may request that we conduct additional clinical trials prior to regulatory approval. In addition, there is no assurance that the doses, endpoints and trial designs that we intend to use for our planned clinical trials, including those that we have developed based on feedback from regulatory agencies or those that have been used for the approval of similar drugs, will be acceptable for future approvals. For instance, we may seek FDA regulatory flexibility and pursue marketing approval based on data from only one adequate and well-controlled clinical investigation. However, the FDA may not agree with our proposed development plans, and our clinical trial results may not support approval of our product candidates for our target indications. In addition, our product candidates could fail to receive regulatory approval, or regulatory approval could be delayed, for many reasons, including the following: • the FDA, EMA, or comparable regulatory authorities may not file or accept our NDA or marketing application for substantive review; • the FDA, EMA, or comparable regulatory authorities may disagree with the dosing regimen, design or implementation of our clinical trials; • the FDA, EMA, or comparable regulatory authorities may determine there is not substantial evidence of effectiveness to support approval; • we may be unable to demonstrate to the satisfaction of the FDA, EMA, or comparable regulatory authorities that our product candidates are safe and effective for any of their proposed indications; • the results of our clinical trials may not meet the level of statistical significance required by the FDA, EMA, or comparable regulatory authorities for approval; • we may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks; • the FDA, EMA, or comparable regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; 73 • the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA, EMA, or comparable regulatory authorities to support the submission of an NDA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere; • the FDA, EMA, or comparable regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and • the approval policies or regulations of the FDA, EMA, or comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. We are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical studies and clinical trials that were previously conducted for our product candidates. All of our lead product candidates were initially developed by third parties. For example, Danicamtiv was initially developed by MyoKardia and further developed by BMS Co., Ataciguat was initially developed by Sanofi and Mayo and Tonlamarsen was developed by Ionis. We in-licensed each of these product candidates pursuant to license agreements with BMS Co., Sanofi and Mayo, and Ionis, respectively. We entered into these licenses on the basis of our interpretation of the medical and scientific meaningfulness of each product candidate’s initial data. Therefore, we are dependent on third-parties such as MyoKardia, BMS Co., Sanofi, Mayo and Ionis having designed certain preclinical studies and clinical trials and conducted their research and development in accordance with the applicable protocols, legal and regulatory requirements, and scientific standards; having accurately reported the results of all preclinical studies conducted with respect to such product candidates; and having correctly collected and interpreted the data from these studies and trials. These risks also apply to any additional product candidates that we may acquire or in-license in the future. If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of our product candidates will be adversely affected and the earlier-reported results may not support data that we generate in our own preclinical or clinical work with those product candidates. Our use of the Prolaio platform to enhance clinical trial design and execution is a novel approach that may not result in the anticipated efficiencies or regulatory acceptance, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development. A key element of our strategy is utilizing our Prolaio platform, which leverages AI-enabled tools to optimize the development of our product candidates in clinical development, including by enhancing the design and execution of our clinical trials through improved patient identification and enrollment, and continuous real world data collection. While we believe the Prolaio platform has the potential to expand patient access and accelerate patient recruitment and trial execution for our own trials and when sold to third-parties for use in third-party clinical trials, the Prolaio platform is a novel approach to trial design and execution. As a result, we are exposed to a number of unforeseen risks related to our Prolaio platform, and these risks could impact each of our product candidates. For example, digital clinical endpoints collected through our Prolaio platform may not be accepted by the FDA as valid primary or secondary endpoints, which could require additional validation work, modification of trial design or the collection of additional clinical endpoint data, potentially delaying development timelines. The regulatory framework for digital health technologies and digitally-obtained endpoints continues to evolve. Because it is a novel approach, to date, we have not used Prolaio to support regulatory decision-making, and the use of Prolaio in our clinical trials to support regulatory decision-making for our therapeutic candidates has not yet been validated by the FDA. While our clinical studies of Danicamtiv and Ataciguat are exploring the use of Prolaio to capture eVO2peak (our novel estimate of pVO 2 , which is a clinically accepted measure of a patient’s functional capacity derived from Cardiopulmonary Exercise Testing (“CPET”), our primary endpoint evaluates pVO 2 to support regulatory decision-making and we do not intend to seek approval on the basis of the eVO2peak measurements collected by Prolaio. In the future, we will need to validate Prolaio biomarkers with the FDA to be used as endpoints for a given disease. Even if validated by the FDA, we may not realize Prolaio’s potential to support smaller, faster, and more capital efficient clinical trials, and it may not meet our expectations in speeding the development of our programs and increasing the probability of success. Although our research and development efforts to date have resulted in a development portfolio of programs and product candidates, we may not be able to discover or identify additional candidates or clinical research that could appropriately utilize our Prolaio platform. Even if we are successful in continuing to build and expand our development portfolio, the potential product candidates that we identify may not be successful in clinical development. If we do not successfully deploy the Prolaio platform to develop and commercialize additional product candidates, we may not realize the anticipated benefits of developing and utilizing our Prolaio platform, which likely would result in significant harm to our financial position and adversely affect our stock price. 74 If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidates. The results observed from preclinical studies or early-stage clinical trials of our product candidates may not necessarily be predictive of the results of later-stage clinical trials that we conduct. Similarly, positive results from such preclinical studies or early-stage clinical trials may not be replicated in our subsequent preclinical studies or clinical trials. For instance, results seen in our Phase 2 trial of Danicamtiv for DCM may not translate to similar results in our ongoing KINSHIP-DCM Phase 2b/3 clinical trial. Furthermore, our product candidates may not be able to demonstrate similar activity or adverse event profiles as other product candidates that we believe may have similar profiles. In addition, in our ongoing and planned future clinical trials, we may utilize clinical trial designs or dosing regimens that have not been routinely tested in prior clinical trials similar to ours. For instance, in our KATALYST-AV trial for Ataciguat, we are exploring novel endpoints, including change in valve area calcium and peak VO 2 , in patients with aortic stenosis. In our KINSHIP-DCM study for Danicamtiv, we are deploying an adaptive trial design where the effects observed in the Phase 2b portion of the study may impact the statistical analysis and sample size of the Phase 3 portion of the study. In our KARDINAL-ASH study for Tonlamarsen, we plan to leverage Prolaio data collection during the post-discharge period to characterize blood pressure control, blood pressure excursions and cardiovascular parameters. There can be no assurance that any of our clinical trials will ultimately be successful or support further clinical development of any of our product candidates. There is a high failure rate for drugs proceeding through clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse effects or AEs. Additionally, we may utilize an “open-label” clinical trial design for certain of our clinical trials. For example, our Phase 2 trial for Danicamtiv was an open-label clinical trial. An “open-label” clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Most open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. A common concern with open-label clinical trials is an increased susceptibility to bias, including “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an open-label trial may not be predictive of future clinical trial results of a product candidate when studied in a controlled environment with a placebo or active control. Accordingly, data from our Phase 2 trial for Danicamtiv may not be predictive of data from our planned clinical trials for Danicamtiv. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA, EMA or comparable foreign regulatory authority approval. We intend to conduct certain clinical trials for our product candidates outside of the U.S. However, the FDA and comparable foreign regulatory authorities may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business. We may conduct certain clinical trials for our product candidates outside of the U.S. Although the FDA may accept data from clinical trials conducted outside the U.S., acceptance of this data is subject to certain conditions imposed by the FDA or may not be accepted at all. Where data from foreign clinical trials are intended to serve as the basis for marketing approval in the U.S., the FDA will not approve the application on the basis of foreign data alone unless those data are applicable to the U.S. population and U.S. medical practice; the studies were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and the data are considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, if the study was not otherwise subject to an IND, the FDA will not accept the data as support for an application for regulatory approval unless the study is well-designed and well-conducted in accordance with 75 GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. For studies that are conducted only at sites outside of the U.S. and not subject to an IND, the FDA generally does not provide advance comment on the clinical protocols for the studies, and therefore there is an additional potential risk that the FDA could determine that the study design or protocol for a non-U.S. clinical trial was inadequate, which could require us to conduct additional clinical trials. Conducting clinical trials outside the U.S. also exposes us to additional risks, including risks associated with: • additional foreign regulatory requirements; • foreign exchange fluctuations; • compliance with foreign manufacturing, customs, shipment and storage requirements; • cultural differences in medical practice and clinical research; and • diminished protection of intellectual property in some countries. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country. We currently have clinical trial sites for Danicamtiv, Ataciguat, and Tonlamarsen outside the United States and may in the future conduct further clinical trials with one or more trial sites that are located outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to conditions imposed by the FDA, and there can be no assurance that the FDA will accept data from trials conducted outside of the United States. If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and could delay or permanently halt our development of the applicable product candidates. We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. To obtain the requisite regulatory approvals to commercialize any of our product candidates, we must demonstrate through extensive preclinical studies and clinical trials that our product candidates are safe and effective in humans. We may experience delays in completing our clinical trials or preclinical studies and initiating or completing additional clinical trials or preclinical studies, including as a result of regulators not allowing or delay in allowing clinical trials to proceed under an IND or similar foreign authorization, or not approving or delaying approval for any clinical trial grant or similar approval we need to initiate a clinical trial. We may also experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive marketing approval or commercialize the product candidates we develop, including: • regulators, institutional review boards (“IRBs”) or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site; • we may not reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • we may experience challenges or delays in recruiting principal investigators or study sites to lead our clinical trials; • the number of subjects or patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available patients for any given clinical trial, or patients may drop out of these clinical trials at a higher rate than we anticipate; • our third-party contractors, including those manufacturing our product candidates or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; • we may have to amend clinical trial protocols submitted to regulatory authorities or conduct additional studies to reflect changes in regulatory requirements or guidance, which may be required to resubmit to an IRB and regulatory authorities for re-examination; 76 • regulators or other reviewing bodies may find deficiencies with, fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies, or the supply or quality of any product candidate or other materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; and • the potential for approval policies or regulations of the FDA, EMA, or other comparable regulatory authorities to significantly change in a manner rendering our clinical data insufficient for approval. Clinical trials must be conducted in accordance with the FDA, EMA, and other applicable regulatory authorities’ legal requirements, regulations and guidelines, and remain subject to oversight by these governmental agencies and ethics committees or IRBs at the medical institutions where such clinical trials are conducted. Regulators or IRBs of the institutions in which clinical trials are being conducted may suspend, limit or terminate a clinical trial, or data monitoring committees may recommend that we suspend or terminate a clinical trial, due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, EMA, or other comparable regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to regulators or to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial. Negative or inconclusive results from our clinical trials or preclinical studies could mandate repeated or additional clinical trials and, to the extent we choose to conduct clinical trials in other indications, could result in changes to or delays in clinical trials of our product candidates in such other indications. We do not know whether any clinical trials that we conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our product candidates for the indications that we are pursuing. If later-stage clinical trials do not produce favorable results, our ability to obtain regulatory approval for our product candidates will be adversely impacted. Further, conducting clinical trials in foreign countries, as we may do for our product candidates, presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled subjects in foreign countries to adhere to clinical protocols as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, and political and economic risks, including war, relevant to such foreign countries. Additionally, recent policy proposals in the U.S., if enacted in the future, may make acceptance by the FDA or inclusion in a marketing application of foreign data more difficult or costly. Our failure to successfully initiate and complete clinical trials and to demonstrate the efficacy and safety necessary to obtain regulatory approval to market our product candidates would significantly harm our business. Our product candidate development costs will also increase if we experience delays in testing or regulatory approvals and we may be required to obtain additional funds to complete clinical trials. There can be no assurance that our clinical trials will begin as planned or be completed on schedule, if at all, or that we will not need to restructure or otherwise modify our trials after they have begun. In addition, many of the factors that cause, or lead to, the termination, suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates, which may harm our business, financial condition and results of operations. In addition, many of the factors that cause, or lead to, delays of clinical trials may ultimately lead to the denial of regulatory approval of our product candidates. Our product candidates may be associated with AEs or other undesirable properties or safety risks, which could delay or prevent their regulatory approval, cause us to suspend or discontinue clinical trials or abandon a product candidate, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if obtained, or result in other significant negative consequences that could severely harm our business, financial condition, results of operations, and prospects. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by any of our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and, if such product candidates are approved, could result in a more restrictive label, the inclusion of a risk evaluation and mitigation strategy (“REMS”), or the delay or denial of regulatory approval by the FDA, EMA, or other comparable regulatory authorities. Any treatment-related side effects could also affect patient recruitment or 77 the ability of enrolled patients to complete the trial, or could result in potential product liability claims. Any of these occurrences may harm our business, financial condition, and prospects significantly. We may observe safety or tolerability issues beyond those we anticipate with our current or future product candidates in ongoing or future clinical trials. Additionally, it is possible that human subjects with cardiovascular diseases may experience greater side effects in our clinical programs than observed in healthy volunteers. We continue to learn more about our product candidates, and unfavorable pharmacology profiles, including extended half-lives, could lead to adverse outcomes or concerns by the FDA, EMA, or other comparable regulatory authorities. Many compounds that initially showed promise in clinical or earlier-stage testing are later found to cause undesirable or unexpected side effects that prevented further development of the compound. Results of future clinical trials of our product candidates could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics, despite a favorable tolerability profile observed in earlier-stage testing. At any time, we may decide to terminate or greatly narrow the target population for a clinical development program due to unacceptable side effects or safety concerns. If unacceptable side effects arise in the development of our product candidates, we, the FDA, EMA, or other comparable regulatory authorities, the IRBs, or independent ethics committees at the institutions in which our trials are conducted, could suspend, limit or terminate our clinical trials, or the independent safety monitoring committee could recommend that we suspend, limit or terminate our trials, or the FDA, EMA, or other comparable regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications. We may be unable to overcome any such suspensions or holds that are placed on our clinical trials. Treatment-emergent side effects that are deemed to be drug-related could delay recruitment of clinical trial subjects or may cause subjects that enroll in our clinical trials to discontinue participation in our clinical trials. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We may need to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in harm to patients that are administered our product candidates. Any of these occurrences may materially adversely affect our business, financial condition, results of operations and prospects. Moreover, clinical trials of our product candidates are conducted in carefully defined sets of patients who have agreed to enter into clinical trials. Consequently, it is possible that our clinical trials may indicate an apparent positive effect of a product candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects. Additionally, if any of our product candidates receives regulatory approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result. For example, the FDA could require us to adopt a REMS to ensure that the benefits of treatment with such product candidate outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive, and more costly than what is typical for the industry. We or our collaborators may also be required to adopt a REMS or engage in similar actions, such as patient education, certification of health care professionals or specific monitoring, if we or others later identify undesirable side effects caused by any product that we develop alone. Other potentially significant negative consequences associated with AEs include: • we may be required to suspend marketing of a product, or we may decide to remove such product from the marketplace; • regulatory authorities may withdraw or change their approvals of a product; • regulatory authorities may require additional warnings on the label or limit access of a product to selective specialized centers with additional safety reporting and with requirements that patients be geographically close to these centers for all or part of their treatment; • we may be required to create a medication guide outlining the risks of a product for patients, or to conduct post-marketing studies; • we may be required to change the way a product is administered; • we could be subject to fines, injunctions, or the imposition of criminal or civil penalties, or be sued and held liable for harm caused to subjects or patients; and 78 • a product may become less competitive, and our reputation may suffer. Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of our product candidates, if approved by the FDA or other regulatory authorities. Our product candidates have been associated with treatment-related serious adverse events in clinical trials, and such events may delay or prevent regulatory approval, cause us to suspend or discontinue clinical trials, or otherwise harm our business. We have not yet completed any pivotal clinical trials with our product candidates. While the data reported to date from the ongoing clinical evaluation of our product candidates indicate that they have been generally well tolerated, there remains a risk of treatment-related serious adverse events (“TRSAEs”) for all of our product candidates. As of August 6, 2026, TRSAEs have been observed in clinical trials conducted with our product candidates, as described below. It is possible that additional or increased occurrences or severity of TRSAEs and serious adverse events will occur in human subjects during ongoing and planned clinical trials, and the severity and rate of these events may not be acceptable in patients with cardiovascular diseases. • Danicamtiv. In clinical trials conducted with Danicamtiv, two participants had a total of three TRSAEs as assessed by the investigator. One participant had complete atrioventricular (“AV”) block (mild, recovered) and one participant had two TRSAEs: liver injury (severe, resolved) and acute kidney injury (moderate, recovered). After a careful review of these two SAEs, other confounding factors, such as comorbidities, drug allergy, nitrofurantoin use, and hypotension, were identified as possible causes of liver injury and acute kidney injury. Based on this review, the Sponsor at the time (BMS Co.) considered these two SAEs to be not related to Danicamtiv. • Ataciguat. In clinical trials conducted with Ataciguat, nine TRSAEs have been reported, each occurring in one participant except for two hepatic events occurring in two participants (increased hepatic enzymes, drug-induced liver injury). Eight TRSAEs were recovered and/or resolving, with one TRSAE (hematuria) whose outcome was unknown. Three TRSAEs were categorized severe and included one report each of atrial fibrillation, increased serum creatine phosphokinase, and cerebrovascular disorder. Two TRSAEs were categorized as moderate severity, and included one report each of drug-induced liver injury and hypersensitivity. A single TRSAE was categorized as mild, which was reported as chronic kidney disease. The three remaining TRSAEs (dizziness, hematuria, and increased hepatic enzymes) were of unknown severity. • Tonlamarsen. In clinical trials conducted with Tonlamarsen, three SAEs were reported as related to the study medication by the investigator, each occurring in one participant. The reported TRSAEs were increased blood glucose, which was categorized as serious, loss of consciousness, which was categorized as moderate severity, and one TRSAE of fatal renal failure. Both the increased blood glucose TRSAE and loss of consciousness were recovered and resolved. The SAE of fatal renal failure occurred many weeks after the end of study visit. After careful review the sponsor considered this SAE to be unrelated to Tonlamarsen due to the prolonged time lapse from last dose of study medication and onset of symptoms. Undesirable side effects caused by any of our product candidates could cause us, the data safety monitoring boards for such trials, IRBs or ethics committees of the institutions in which such trials are being conducted, or regulatory authorities to interrupt, delay, suspend, halt or place on clinical hold the associated clinical trials and could result in a more restrictive label, the imposition of distribution or use restrictions, requirements to conduct additional studies, dose de-escalation, or additional protocol amendments, or the delay or denial of regulatory approval by the FDA, EMA, or other comparable regulatory authorities. Treatment-related side effects could also affect site initiation, patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Even if serious adverse events are unrelated to study treatment, such occurrences could affect patient enrollment or the ability of enrolled patients to complete the clinical trial. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics, and we may not be able to complete a clinical trial for any of our product candidates on the timeline we expect, or at all. Furthermore, clinical trials by their nature utilize a sample of the potential patient population. With a limited number of patients and limited duration of exposure, rare and severe side effects of our product candidates may only be uncovered when a significantly larger number of patients have been exposed to the drug candidate, including post-approval, and there can be no assurance that our product candidates will not cause more severe and/or serious side effects in a greater proportion of patients. 79 If unexpected adverse events occur in any of our clinical trials, we may need to abandon development of our product candidates, or limit development to lower doses or to certain uses or subpopulations in which the undesirable side effects or other unfavorable characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff, and we may need to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and, upon any commercialization of our product candidates, if approved. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. Any such findings could cause delays in completion or cancellation of our clinical programs, and may harm our business, financial condition, results of operations, and prospects significantly. Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our product candidates. Any product candidate we develop and the activities associated with its development and commercialization, including its design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the United States, and by the EMA and other comparable regulatory authorities in other countries. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction. We have not received approval to market any product candidates from regulatory authorities in any jurisdiction and it is possible that none of the product candidates we are developing or may seek to develop in the future will ever obtain regulatory approval. Our team expects to rely on third-party CROs or regulatory consultants to assist us in submitting and supporting the applications necessary to gain marketing approvals. Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Any product candidates we develop may not be effective, may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude its obtaining marketing approval or prevent or limit commercial use. The process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. The FDA, EMA, and other comparable regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit, or prevent marketing approval of a product candidate. Any marketing approval that we may ultimately obtain could be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable. If we experience delays in obtaining approval or if we fail to obtain approval of any product candidates we may develop, the commercial prospects for those product candidates may be harmed, and our ability to generate revenues will be materially impaired. Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we may publish interim, topline or preliminary data from our clinical trials and preclinical studies. Such announcements or publications are typically based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, topline, or preliminary results that we report may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline and preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from 80 the topline or preliminary data we previously published. As a result, topline and preliminary data should be viewed with caution until the final data are available. Interim data from clinical trials that we may complete are further subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse differences between interim, topline or preliminary data and final data could significantly harm our reputation and business prospects. Further, disclosure of such data by us or by our competitors could result in volatility in the price of our common stock. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities, or otherwise regarding a particular product candidate or our business. If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, financial condition, results of operations, and prospects. If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the development and commercialization of our product candidates may be delayed, and our business, financial condition and results of operations may be harmed. For planning purposes, we sometimes estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development objectives. These milestones may include our expectations regarding the commencement or completion of scientific studies and clinical trials, the submission of regulatory filings or commercialization objectives. From time to time, we may publicly announce the expected timing of some of these milestones, such as the completion of an ongoing clinical trial, the initiation of other clinical programs, receipt of marketing approval or a commercial launch of a product. The achievement of many of these milestones may be outside of our control. All of these milestones are based on a variety of assumptions which, if not realized as expected, may cause the timing of achievement of the milestones to vary considerably from our estimates, including: • our available capital resources or capital constraints we experience; • the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators; • our ability to identify and enroll patients who meet clinical trial eligibility criteria; • our receipt of approvals by the FDA, EMA, and other comparable regulatory authorities, if at all, and the timing thereof; • other actions, decisions or rules issued by regulators; • our ability to access sufficient, reliable and affordable supplies of materials used to manufacture our product candidates; • the efforts of our collaborators with respect to the commercialization of our product candidates; and • the securing of, costs related to, and timing issues associated with, product manufacturing as well as sales and marketing activities. If we fail to achieve announced milestones in the timeframes we expect, the development and commercialization of our product candidates may be delayed, and our business, financial condition and results of operations may be harmed. We have concentrated our research and development efforts on the treatment of cardiovascular diseases, a field that faces certain challenges in drug development. We have focused our research and development efforts on addressing cardiovascular diseases. Developing a product candidate for treatment of the cardiovascular diseases we currently target is extremely difficult and subjects us to a number of 81 unique challenges, including obtaining regulatory approval from the FDA and other regulatory authorities who have only a limited set of precedents to rely on. Efforts by pharmaceutical companies in this field have faced certain challenges in drug development. In particular, cardiovascular disease conditions present similarly but stem from diverse disease biology and genetic variability. In addition, traditional clinical trials in cardiovascular diseases have resulted in large, expensive trials. Further, background medications commonly prescribed for aortic stenosis patients, such as beta blockers, may impact pulmonary function measurements and can impact our results. Moreover, given the history of clinical failures in this field, future clinical or regulatory failures by us or others may have resulted in further negative perception of the likelihood of success in this field, which may significantly and adversely affect the market price of our common stock. We intend to work closely with the FDA, EMA and comparable foreign regulatory authorities to perform the requisite scientific analyses and evaluation in an effort to obtain regulatory approval for our product candidates; however, the process of developing our product candidates may be more complex and time-consuming relative to other more well-known approaches to drug development. We cannot be certain that our approach will lead to the development of product candidates that effectively and safely address our target indications. We may be subject to additional risks because we may in the future evaluate our product candidates in combination with the standard of care for the indications that we are pursuing. We may in the future evaluate our product candidates in combination with other compounds, specifically the standard of care for the indications that we are pursuing. The use of our product candidates in combination with such other compounds may subject us to risks that we would not face if our product candidates were being administered as a monotherapy. The outcome and cost of developing a product candidate to be used with other compounds is difficult to predict and dependent on a number of factors that are outside our control. If we experience efficacy or safety issues in our clinical trials in which our product candidates are being administered with other compounds, we may not receive regulatory approval for our product candidates, which could prevent us from ever generating revenue or achieving profitability. For example, the combination of our product candidates and the standard of care may result in unexpected adverse side effects or toxicities. In addition, the product candidates may interact with other companies’ products or product candidates that the patients receiving our product candidates may also be receiving, in undesirable ways. Testing product candidates in patients already receiving other treatments may increase the risk of significant adverse effects or failed clinical trials. The timing, outcome and cost of the potential adverse effects of developing products to be used in patients already receiving other therapies is difficult to predict and dependent on a number of factors that are outside our reasonable control. If serious adverse or unexpected side effects are identified during development and are determined to be attributed to our product candidates, or the result of drug-drug interactions between our product candidate and any of the concomitant therapies given to the trial subjects, we, the FDA, EMA, comparable foreign regulatory authorities, or IRBs and other reviewing entities could interrupt, delay, or halt clinical trials. Such findings could also result in delays in, or denial of, regulatory approval by the FDA, the EMA, or comparable foreign regulatory authorities. Further, even if our product candidates are approved, these findings could result in a more restrictive label or particularly narrow indication (substantially limiting the product’s commercial opportunities) or a REMS. Moreover, any safety, efficacy, regulatory, manufacturing or supply issues that could arise with respect to an already approved therapy with which our product candidates are developed for use could have an adverse impact on us. Prescribing information for the approved therapy, such as risk information like a boxed warning, or limitations of use, could negatively impact our ability to commercialize a product as an add-on or as further supportive care to the approved therapy. If the approved therapy is replaced as the standard of care, the FDA, EMA or comparable foreign regulatory authorities may require us to conduct additional clinical trials, or we may not be able to obtain adequate reimbursement from third-party payors. The occurrence of any of these events could result in our product candidate, if successfully developed and approved, being removed from the market or being less successful commercially. If the FDA, EMA or comparable foreign regulatory authorities revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with respect to, therapies we choose to evaluate in conjunction with or as background or standard of care therapy for any of our product candidates, we may be unable to obtain regulatory approval of or to commercialize such product candidates in combination with these therapies. If we experience safety, tolerability or toxicity issues in any of our ongoing or planned clinical trials that allow patients to remain on other therapies, or if the efficacy or safety data from these trials of our candidates administered to patients on other therapies are not favorable, our clinical development plans could be materially negatively affected or delayed, or we may not receive regulatory approval for our product candidates, which would materially harm our business and likely cause the market price of our common stock to decline. 82 Even if our product candidate demonstrates clinical benefit as part of a combination regimen, payors may determine that the incremental value is insufficient to justify the overall cost and may refuse to reimburse at levels that are acceptable to us o