Oruka Therapeutics, Inc.

1. Nature of the Business and Basis of Presentation

Background and Basis of Presentation

Oruka Therapeutics, Inc., together with its subsidiary (collectively, the “Company”), is a clinical-stage biopharmaceutical company. The Company is headquartered in Menlo Park, California. The Company is focused on developing novel monoclonal antibody therapeutics for psoriasis (“PsO”) and other inflammatory and immunology (“I&I”) indications.

The condensed consolidated financial statements and accompanying notes reflect the operations of the Company and its wholly owned subsidiary. Intercompany balances and transactions have been eliminated in consolidation. The condensed consolidated financial statements and accompanying notes have been prepared in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”) for interim financial reporting and the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”) and therefore do not include all information and disclosures normally included in the annual consolidated financial statements. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited financial statements and the related notes thereto, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 12, 2026 (the “Annual Report”). The information as of December 31, 2025, included in the condensed consolidated balance sheets was derived from the Company’s audited financial statements. These unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements, and in the opinion of the Company’s management, reflect all adjustments, which include only normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial statements.

The results for the three and nine months ended September 30, 2026 are not necessarily indicative of results that may be expected for the year ending December 31, 2026 or for any other interim period or for any other future year.

Liquidity

As of September 30, 2026, the Company had cash, cash equivalents, and marketable securities of $1.2 billion and an accumulated deficit of $312.1 million. The Company’s management expects that the existing cash, cash equivalents, and marketable securities will be sufficient to fund the Company’s operating plans for at least twelve months from the date these condensed consolidated financial statements were issued. Since its inception, the Company has devoted substantially all of its resources to advancing the development of its portfolio of programs, organizing and staffing the Company, business planning, raising capital, and providing general and administrative support for these operations. Current and future programs will require significant research and development efforts, including preclinical and clinical trials, and regulatory approvals to commercialization. Until such time as the Company can generate significant revenue from product sales, if ever, the Company expects to finance its operating activities through a combination of equity offerings and debt financings.

The Company expects that its research and development and general and administrative costs will continue to increase significantly, including in connection with conducting future preclinical activities and clinical trials and manufacturing for its existing product candidates and any future product candidates to support commercialization and providing general and administrative support for its operations, including the costs associated with operating as a public company. The Company’s ability to access capital when needed is not assured and, if capital is not available to the Company when, and in the amounts needed, the Company may be required to significantly curtail, delay, or discontinue one or more of its research or development programs or the commercialization of any product candidate, or be unable to expand its operations or otherwise capitalize on the Company’s business opportunities, as desired, which could materially harm the Company’s business, financial condition and results of operations.

2. Summary of Significant Accounting Policies* *

There have been no significant changes from the significant accounting policies and estimates disclosed in the Note titled “2. Summary of Significant Accounting Policies” of the Company’s Annual Report. The Company uses the same accounting policies in preparing its quarterly and annual financial statements.

Use of Estimates

The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions, and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the condensed consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected within these condensed consolidated financial statements include but are not limited to research and development expenses and related prepaid or accrued costs and the valuation of stock-based compensation awards and related expenses. The Company bases its estimates on known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in circumstances, facts, and experience. Actual results could differ materially from those estimates or assumptions.

Recently Adopted Accounting Pronouncements

There have been no recent accounting pronouncements or changes in accounting pronouncements adopted during the nine months ended September 30, 2026 that are of significance or potential significance to the Company.

Recently Issued Accounting Pronouncements

In November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2024-03,Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires more detailed disclosures, on an annual and interim basis, about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. This ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. This ASU may be applied either prospectively or retrospectively. The Company is currently evaluating the impact of the adoption of this ASU on its condensed consolidated financial statements.

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. The ASU refines the scope of the guidance in Topic 815 by expanding the scope exception for certain non-exchange-traded contracts with underlyings based on the operations or activities of one of the parties to the contract and clarifies the accounting for share-based noncash consideration received from a customer under Topic 606. The ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods within those annual reporting periods. Early adoption is permitted. The amendments may be applied either prospectively or on a modified retrospective basis. The Company is currently evaluating the impact of the adoption of this ASU on its condensed consolidated financial statements.

3. Fair Value Measurements

The following tables present the Company’s fair value hierarchy for financial assets measured as of September 30, 2026 and December 31, 2025 (in thousands):

There were no transfers in or out of Level 3 during the three and nine months ended September 30, 2026.

The Level 2 assets include U.S. treasury securities, U.S. government agency securities, commercial paper and corporate debt securities, and are measured based on quoted prices in active markets for similar assets, quoted prices in markets that are not active for identical or similar assets, or other inputs that are observable or can be corroborated by observable market data.

4. Cash Equivalents and Marketable Securities

The following tables summarize the cash equivalents and marketable securities, which are classified as available-for-sale as of September 30, 2026 and December 31, 2025 (in thousands):

The following table summarizes the available-for-sale securities in an unrealized loss position, aggregated by major security type and length of time in a continuous unrealized loss position, for which an allowance for credit losses was not recorded as of September 30, 2026 and December 31, 2025 (in thousands):

The Company evaluated its securities for credit losses and considered the decline in market value to be primarily attributable to current economic and market conditions and not to a credit loss or other factors. Additionally, the Company does not intend to sell the securities in an unrealized loss position and it is not more likely than not that the Company will be required to sell the securities before recovery of the unamortized cost basis, which may be at maturity. There were no material realized gains or realized losses on marketable securities for the periods presented. Given the Company’s intent and ability to hold such securities until recovery, and the lack of significant change in credit risk of these investments, the Company does not consider these marketable securities to be impaired as of September 30, 2026 and December 31, 2025. As of September 30, 2026 and December 31, 2025, the Company did not record an allowance for credit losses.

The following table summarizes the contractual maturities of the Company’s marketable securities at estimated fair value (in thousands):

5. Accrued Expenses and Other Current Liabilities

The following table summarizes accrued expenses and other current liabilities (in thousands):

6. Convertible Preferred Stock and Stockholders’ Equity

Pre-Funded Warrants

In August 2024, certain investors in the Company were issued pre-funded warrants which were exercisable for shares of the Company’s common stock at an exercise price of $0.01 per share. During the three and nine months ended September 30, 2026, the Company issuednil and 199,481 shares of common stock, respectively, on net exercises ofnil and 199,519 pre-funded warrants, respectively. No pre-funded warrants were exercised during the three or nine months ended September 30, 2025. As of September 30, 2026 and December 31, 2025,5,297,664 and 5,497,183 pre-funded warrants, respectively, remain issued and outstanding from the August 2024 issuance.

In September 2024, certain investors in the Company were issued pre-funded warrants which were exercisable for shares of the Company’s common stock at an exercise price of $0.001 per share. During the three and nine months ended September 30, 2026, the Company issuednil and 379,993 shares of common stock, respectively, on net exercises ofnil and 380,000 pre-funded warrants, respectively. There wereno pre-funded warrants exercised in the three or nine months ended September 30, 2025. As of September 30, 2026 and December 31, 2025, there werenil and 380,000 pre-funded warrants that remained issued and outstanding from the September 2024 issuance.

In September 2025, certain investors in the Company were issued pre-funded warrants which were exercisable for shares of the Company’s common stock at an exercise price of $0.001 per share. During the three and nine months ended September 30, 2026, the Company issuednil and 658,131 shares of common stock on net exercises ofnil and 658,142 pre-funded warrants, respectively. As of September 30, 2026 and December 31, 2025,408,524 and 1,066,666 pre-funded warrants, respectively, remain issued and outstanding from the September 2025 issuance.

On issuance, the pre-funded warrants were recorded as a component of stockholders’ equity within additional paid-in-capital and haveno expiration date. Collectively,5,706,188 and 6,943,849 pre-funded warrants were outstanding as of September 30, 2026 and December 31, 2025, respectively.

Employee Warrants

During 2024, employee warrants were issued at an exercise price of $7.80 per warrant to the employees and directors of the Company. These warrants vest over a period offour years. The Company recognizes compensation cost related to warrants on a straight-line basis over the requisite service period, which is the period in which the related services are received. As of September 30, 2026 and December 31, 2025,2,467,590 and 3,029,510 warrants, respectively, were outstanding.

Convertible Preferred Stock

On July 1, 2026, at the request of the stockholder,42,641 shares of Series B preferred stock were converted into 3,553,410 shares of the Company’s common stock. As of September 30, 2026, Series B preferred stock consisted of the following (in thousands, except share data):

Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Series B Non-Voting Convertible Preferred Stock (the “Series B Certificate of Designation”), holders of Series B preferred stock are entitled to receive dividends on shares of Series B preferred stock equal to, on an as-if-converted-to common stock basis, and in the same form as, dividends actually paid on shares of common stock. Except as provided in the Series B Certificate of Designation or as otherwise required by law, Series B preferred stock does not have voting rights. Series B preferred stock shall rank on parity with the Company’s common stock as to the distribution of assets upon any liquidation, dissolution, or winding-up of the Company. Each share of Series B preferred stock is convertible at the option of the holder, at any time, and without the payment of additional consideration by the holder. As of September 30, 2026, and December 31, 2025, each outstanding share of Series B preferred stock was convertible into common stock at a ratio of approximately 83.3332:1.

Paruka Warrant

On December 31, 2024, the Company settled its 2024 obligations under the Paruka Warrant Obligation (defined below) by issuing Paruka Holding LLC (“Paruka”) a warrant to purchase 596,930 shares of the Company’s common stock at an exercise price of $19.39 per share. On December 12, 2025, the Company settled its 2025 obligations under the Paruka Warrant Obligation (defined below) by issuing Paruka a warrant to purchase 375,000 shares of the Company’s common stock at an exercise price of $30.18 per share. The warrants had a term of 10 years, were fully vested, and were exercisable in part or full at any time during the term of the warrants.

In September 2026, Paruka elected to exercise these warrants, which were issued in 2024 and 2025, on a cashless basis. Accordingly, the Company issued 737,692 shares of its common stock on net exercise of warrants to purchase 971,930 shares of the Company’s common stock. As of September 30, 2026, there wereno Paruka warrants outstanding. As of December 31, 2025,971,930 Paruka warrants were outstanding and unexercised. See Note 7 for additional information on the Paruka Warrant Obligation.

Common Stock

As of September 30, 2026, the Certificate of Incorporation provided for 545,000,000 authorized shares of common stock. As of September 30, 2026,67,227,572 shares of common stock were issued and outstanding, including 458,486 shares of unvested restricted common stock awards (“RSAs”) issued and outstanding.

As of September 30, 2026 and December 31, 2025, the Company had common stock reserved for future issuance as follows:

Underwritten Public Offering

In April 2026, the Company entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC, Goldman Sachs & Co. LLC, Stifel, Nicolaus & Company Incorporated, and Guggenheim Securities, LLC, as the representatives of the several underwriters named therein, relating to an underwritten public offering (the “April 2026 Offering”). The Company issued and sold 9,660,000 shares of its common stock, par value $0.001, at a public offering price of $72.50 per share for total net proceeds of $658.3 million (net of combined underwriting discounts and commissions and related issuance expenses of $42.0 million).

ATM Offering

On October 3, 2025, the Company entered into a Sales Agreement with TD Securities (USA) LLC (the “Initial Sales Agreement”), as its sales agent, pursuant to which the Company could issue and sell, from time to time, shares of common stock for aggregate gross proceeds of up to $200.0 million under an at-the-market (“ATM”) equity offering program pursuant to a registration statement on Form S-3 (the “Prior Registration Statement”). The Prior Registration Statement was deemed terminated as of August 27, 2026.

On August 21, 2026, the Company entered into an amendment to the Initial Sales Agreement (as amended, the “Sales Agreement”), pursuant to which the Company may issue and sell, from time to time, shares of common stock for aggregate gross proceeds of up to $500.0 million under the ATM equity offering program, pursuant to a registration statement on Form S-3. The Company is not obligated to make any sales of shares under the Sales Agreement.

During the three months ended September 30, 2026, the Company issued and sold an aggregate of 1,499,500 shares of the Company’s common stock pursuant to the ATM offering program and the Prior Registration Statement at a weighted-average price per share of $83.35 for total net proceeds of $122.5 million after deducting sales agents’ commissions. During the nine months ended September 30, 2026, the Company issued and sold an aggregate of 2,667,395 shares of the Company’s common stock pursuant to the ATM offering program and the Prior Registration Statement at a weighted-average price per share of $61.74 for total net proceeds of $161.4 million after deducting sales agents’ commissions.

As of September 30, 2026, and December 31, 2025, an amount of $500.0 million and $200.0 million, respectively, remained available under the ATM program.

7. Stock-Based Compensation

2024 Equity Incentive Plan

The 2024 Equity Incentive Plan (“2024 Plan”) was adopted on February 6, 2024. The 2024 Plan provided for the Company to grant stock options, restricted stock awards, restricted stock units, and other stock-based awards to employees, officers, directors, consultants, and advisors. Equity incentive stock options granted under the 2024 Plan generally vest over four years, subject to the participant’s continued service, and expire after ten years. As of September 30, 2026 and December 31, 2025,1,032,329 and 1,167,826 shares, respectively, were subject to options outstanding under the 2024 Plan and will become available under the 2024 Stock Incentive Plan (defined below) to the extent the options are forfeited or lapse unexercised.

2024 Stock Incentive Plan

The 2024 Stock Incentive Plan (“2024 Stock Plan”) became effective in August 2024. The 2024 Stock Plan allows for the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock units, other stockholder-based awards and incentive bonuses. An additional 3,354,715 shares became available for issuance under the 2024 Stock Plan on January 1, 2026 as a result of the annual increase pursuant to the evergreen provision.

As of September 30, 2026,10,300,005 shares were reserved for issuance under the 2024 Stock Plan, of which 5,550,076 shares were available for future grant and 4,749,929 shares were subject to outstanding options and restricted stock units. As of December 31, 2025,7,383,349 shares were reserved for issuance under the 2024 Stock Plan, of which 4,600,217 shares were available for future grant and 2,783,132 shares were subject to outstanding options.

2024 Employee Stock Purchase Plan

The 2024 Employee Stock Purchase Plan (the “ESPP”) became effective in August 2024. Eligible employees may purchase shares of common stock under the ESPP at 85% of the lower of the fair market value of the common stock as of the first or the last day of each offering period. Employees are limited to contributing 15% of the employee’s eligible compensation and may not purchase more than $25,000 of stock during any calendar year. The ESPP will terminate ten years from the first purchase date under the plan, unless terminated earlier by the Board.

The Company issuednil and 12,889 shares during the three and nine months ended September 30, 2026, respectively, and issuednil and 10,235 during the three and nine months ended September 30, 2025, respectively, out of the ESPP. As of September 30, 2026 and December 31, 2025, there were 963,033 and 975,922 shares of common stock available in the pool for future issuances, respectively.

For the three and nine months ended September 30, 2026, stock-based compensation expenses related to the ESPP was $0.1 million and $0.2 million, respectively. For the three and nine months ended September 30, 2025, stock-based compensation expenses related to the ESPP was less than $0.1 million and $0.1 million, respectively.

Stock Option Valuation

The following table summarizes the weighted-average assumptions used in calculating the fair value of the awards for the three and nine months ended September 30, 2026 and 2025:

Stock Option Activity

The following table summarizes the stock option activities under the 2024 Plan and the 2024 Stock Plan for the nine months ended September 30, 2026:

The weighted average grant-date fair value per share of stock options granted during the nine months ended September 30, 2026 was $31.77 per share.

The aggregate intrinsic value represents the difference between the closing price of the Company’s common stock and the exercise price of in-the-money stock options multiplied by the number of options outstanding.

The aggregate intrinsic value of the options exercised during the three and nine months ended September 30, 2026 was $16.2 million and $29.6 million, respectively. There wereno options exercised in the three and nine months ended September 30, 2025.

For the three months ended September 30, 2026 and 2025, stock-based compensation expenses related to stock options was $6.1 million and $2.3 million, respectively. For the nine months ended September 30, 2026 and 2025, stock-based compensation expenses related to stock options was $15.9 million and $6.3 million, respectively.

Restricted Stock Units

The Company began issuing restricted stock units (“RSUs”) under the 2024 Stock Plan during the quarter ended March 31, 2026. An RSU is an agreement to issue shares of the Company’s common stock at the time of vesting. RSUs generally vest over a four-year service period. RSUs granted during the annual refresher awards vest typically in equal quarterly installments over four years, subject to continued employment. RSUs granted to a new employee cliff vest 25% on the Company’s quarterly vesting date on or after the first anniversary of the grant date, followed by 12 equal quarterly vesting thereafter. Upon vesting, each RSU converts intoone share of the Company’s common stock.

Stock-based compensation expense associated with RSUs are based on the fair value of the Company’s common stock on the grant date, which equals the closing market price of the Company’s common stock on the grant date. For RSUs, the Company recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest.

The following table summarizes the RSU activity for the nine months ended September 30, 2026:

The fair value of RSUs that vested during the nine months ended September 30, 2026 was $5.4 million.

For the three months ended September 30, 2026 and 2025, stock-based compensation expenses related to RSUs was $1.9 million andnil, respectively. For the nine months ended September 30, 2026 and 2025, stock-based compensation expenses related to RSUs was $3.9 million andnil, respectively.

Restricted Stock Awards

The following table summarizes the restricted stock awards (“RSA”) activity for the nine months ended September 30, 2026:

The fair value of RSAs that vested during the three and nine months ended September 30, 2026 was $7.3 million and $20.4 million, respectively.

For each of the three and nine months ended September 30, 2026 and 2025, stock-based compensation expenses related to RSAs were less than $0.1 million.

Option Agreements and Paruka Warrant Obligation

As part of the Option Agreements (defined in Note 9 below), the Company granted warrants to purchase a number of shares equal to 1.00% of outstanding shares as of the date of the grant on a fully-diluted basis, or based upon the agreed number of warrants as disclosed in the Warrant Agreement, with an exercise price equal to the fair market value of the underlying shares on the grant date (the “Paruka Warrant Obligation”).

The grant dates for the issuance of warrants were expected to be December 31, 2024 and December 31, 2025 as all terms of the award, including number of shares and exercise price, will be known by all parties. The Company determined that the 2024 and 2025 grants are two separate grants, as there would be no obligation for the 2025 grant had the Company exercised or terminated all of the options under the Option Agreements prior to December 31, 2024. The service inception period for the grant precedes the grant date, with the full award being vested as of the grant date with no post-grant date service requirement. Accordingly, a liability related to the Paruka Warrant Obligation was recorded during the 2024 and 2025 interim periods. The liability was adjusted to fair value at the end of each interim reporting period, with changes in fair value recorded in the consolidated statements of operations as stock-based compensation expenses under research and development expenses.

The Company settled its 2024 and 2025 obligations under the Paruka Warrant Obligation by issuing Paruka 596,930 and 375,000 warrants, respectively, to purchase common stock at an exercise price per warrant of $19.39 and $30.18, respectively. During the three and nine months ended September 30, 2026, the Company issued 737,692 shares of its common stock on net exercises of warrants to purchase 971,930 shares of the Company’s common stock issued under the Paruka Warrant Obligation. As of September 30, 2026, there wereno Paruka warrants outstanding.

For the three months ended September 30, 2026 and 2025, nil and $6.6 million, respectively, was recognized as stock-based compensation expense related to the Paruka Warrant Obligation. For the nine months ended September 30, 2026 and 2025, nil and $9.7 million, respectively, was recognized as stock-based compensation expense related to the Paruka Warrant Obligation. As of September 30, 2026 and as of December 31, 2025, the unamortized expense related to the Paruka Warrant Obligation wasnil.

Employee Warrants

The following table summarizes the employee warrant activity during the nine months ended September 30, 2026:

The aggregate intrinsic value represents the difference between the closing price of the Company’s common stock and the exercise price of in-the-money employee warrants multiplied by the number of employee warrants outstanding.

The aggregate intrinsic value of the employee warrants exercised during the three and nine months ended September 30, 2026 was $13.2 million and $25.9 million, respectively. There wereno employee warrants exercised in the three and nine months ended September 30, 2025.

For the three months ended September 30, 2026 and 2025, stock-based compensation expenses related to employee warrants was $1.1 million and $1.2 million, respectively. For the nine months ended September 30, 2026 and 2025, stock-based compensation expenses related to employee warrants was $3.3 million and $4.0 million, respectively.

Stock-Based Compensation Expense

The following table summarizes the classification of the Company’s stock-based compensation expense in the condensed consolidated statements of operations (in thousands):

As of September 30, 2026, total unrecognized stock-based compensation expenses related to the unvested stock options, RSUs, RSAs, employee warrants, and ESPP was $111.1 million, which is expected to be recognized over a weighted average period of approximately 2.9 years.

The following table summarizes the award types of the Company’s stock-based compensation expense in the condensed consolidated statements of operations (in thousands):

8. Segment Disclosures

The Company operates and manages its business activities on a consolidated basis and operates inone reportable segment. Its Chief Executive Officer, serving as the Chief Operating Decision Maker (“CODM”), oversees operations on an aggregated basis to allocate resources effectively. In assessing the Company’s financial performance, the CODM regularly reviews total operating expenses and consolidated net loss.

The measure of segment assets is reported on the balance sheet as total consolidated assets. The Company’s long-lived assets consist primarily of property and equipment, net. As of September 30, 2026 and December 31, 2025 all long-lived assets were in the U.S.

The following table summarizes the segment loss from operations, including significant segment expenses (in thousands):

9. Option Agreements and License Agreements

Option Agreements – Paragon Therapeutics

In March 2024, the Company entered into two antibody discovery and option agreements (the “Option Agreements”) with Paragon Therapeutics, Inc. (“Paragon”) and Paruka. Under the terms of each agreement, Paragon identified, evaluated, and developed antibodies directed against certain mutually agreed therapeutic targets of interest to the Company, including for IL-23 and IL-17A/F for ORKA-001 and ORKA-002, respectively.

In December 2025, the Company entered into an additional option agreement for an antibody with Paragon and Paruka to enter into a license agreement, which the Company exercised in December 2025.

As part of the Option Agreements and the additional option agreement mentioned above, on December 31, 2024, the Company settled its 2024 obligations under the Paruka Warrant Obligation by issuing Paruka a warrant to purchase 596,930 shares of the Company’s common stock at an exercise price of $19.39 per share, and on December 12, 2025, the Company settled its 2025 obligations under the Paruka Warrant Obligation by issuing Paruka a warrant to purchase 375,000 shares of the Company’s common stock at an exercise price of $30.18 per share.

License Agreements – Paragon Therapeutics

In September 2024, the Company exercised its exclusive option to acquire certain rights to ORKA-001, and in December 2024, it entered into a corresponding license agreement with Paragon (the “ORKA-001 License Agreement”), pursuant to which Paragon granted the Company a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize, or otherwise exploit certain antibodies and products targeting IL-23 in all fields other than the field of inflammatory bowel disease (“ORKA-001 Field”). In December 2024, the Company exercised its exclusive option to acquire certain rights to ORKA-002, and in February 2025, it entered into the corresponding license agreement with Paragon (the “ORKA-002 License Agreement” and together with the ORKA-001 License Agreement, the “License Agreements”), pursuant to which Paragon granted the Company a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize, or otherwise exploit certain antibodies and products targeting IL- 17A/F in all fields (“ORKA-002 Field” and together with ORKA-001 Field, the “Fields”).

Pursuant to each of the two License Agreements, Paragon has agreed not to conduct any new campaigns that generate anti-IL-23 monospecific antibodies or anti-IL-17A/F monospecific antibodies in the respective agreed-upon Fields for five years. In May 2026, the Company amended its ORKA-001 License Agreement with Paragon, to expand the definition of ORKA-001 Field to include inflammatory bowel disease. The amendment expands the definition of ORKA-001 Field to encompass all therapeutic, prophylactic, palliative and diagnostic uses, subject to the restriction that the Company will not dose a human patient in a clinical trial of ORKA-001 for inflammatory bowel disease as part of a combination until June 1, 2028 or as a monotherapy until June 1, 2030 (the “Monotherapy Dosing Restriction”). In the event the Company or a licensee of Paragon’s retained rights under the ORKA-001 License Agreement consummates a material transaction, including a change of control of the Company or such licensee, then any remaining restrictions outside of the initial definition of ORKA-001 Field set forth in the Monotherapy Dosing Restriction shall remain in effect only until June 1, 2028.

In December 2025, the Company exercised its exclusive option to acquire certain rights to ORKA-003, and in August 2026, it entered into the corresponding license agreement with Paragon (the “ORKA-003 License Agreement”).

Pursuant to the terms of each of the License Agreements and the ORKA-003 License Agreement, the Company is obligated to pay Paragon non-refundable milestone payments of up to $12.0 million under each respective agreement upon the achievement of certain clinical development milestones and up to $10.0 million under each respective agreement upon the achievement of certain regulatory milestones. In addition, the Company is obligated to pay Paragon alow single-digit percentage royalty for antibody products for each of ORKA-001, ORKA-002 and ORKA-003. For each of the License Agreements and the ORKA-003 License Agreement, the royalty term ends on the later of (i) the last-to-expire licensed patent or our patent directed to the manufacture, use or sale of a licensed antibody in the country at issue or (ii) 12 years from the date of first sale of a Company product. There is also a royalty step-down if there is no Paragon patent in effect during the royalty term for each program. Each of the License Agreements and the ORKA-003 License Agreement may be terminated on 60 days’ notice to Paragon, on material breach without cure, and on a party’s insolvency or bankruptcy to the extent permitted by law.

During the nine months ended September 30, 2026, the Company incurred and expensed a milestone of $3.0 million related to the dosing of the first patient in a Phase 2 trial for the ORKA-002 License Agreement. As of September 30, 2026, the Company has incurred and expensed milestone payments of $7.0 million in connection with each of the ORKA-001 License Agreement and the ORKA-002 License Agreement and has not incurred or expensed any milestone payments in connection with the ORKA-003 License Agreement. As of December 31, 2025, the Company had incurred and expensed milestone payments of $7.0 million and $4.0 million for the ORKA-001 License Agreement and the ORKA-002 License Agreement, respectively. These costs were recorded as research and development expenses in the accompanying condensed consolidated statements of operations.

As of each of September 30, 2026 and December 31, 2025, the Company hadno related party accounts payable and other current liabilities related to the License Agreements.

For the three months ended September 30, 2026 and 2025, the Company recognizednil and $9.6 million, respectively, of expenses in connection with milestone payable and services provided by Paragon and Paruka under the Option and License Agreements. For the nine months ended September 30, 2026 and 2025, the Company recognized $3.0 million and $15.3 million, respectively, of expenses in connection with milestone payable and services provided by Paragon and Paruka under the Option and License Agreements.

10. Commitments and Contingencies

Leases

In April 2024, the Company entered into an operating lease agreement for the Company’s headquarters in Menlo Park, California, which commenced on June 15, 2024 with an initial term of 39.5 months. In June 2026, the Company amended its Menlo Park headquarters lease to extend the lease term by 24 months and add additional leased office space. The extension of the lease term was accounted for as a remeasurement of the operating lease, resulting in an increase to the related operating lease right-of-use asset and lease liability of $0.9 million. The additional leased office space commenced in September 2026, resulting in an increase to the related operating lease right-of-use asset and lease liability of $0.5 million.

In February 2025, the Company entered into an operating lease agreement in Waltham, Massachusetts, which commenced on April 1, 2025 with an initial term of 54 months. The Company leases office spaces under noncancelable operating lease agreements. Lease liabilities are based on the net present value of the remaining lease payments over the remaining lease terms. In determining the present value of lease payments, the Company used its incremental borrowing rate when measuring operating lease liabilities as discount rates were not implicit or readily determinable.

For the three months ended September 30, 2026 and 2025, the Company recorded operating and variable lease expenses of $0.3 million and $0.2 million, respectively, in general and administrative expenses in its condensed consolidated statements of operations. For the nine months ended September 30, 2026 and 2025, the Company recorded operating and variable lease expenses of $0.8 million and $0.6 million, respectively.

The following table presents the Company’s supplemental cash flow information related to leases (in thousands):

The following table summarizes a maturity analysis of the Company’s net operating lease liabilities showing the aggregate lease payments as of September 30, 2026 (in thousands):

Cell Line License Agreement

In March 2024, the Company entered into the Cell Line License Agreement (the “Cell Line License Agreement”) with WuXi Biologics Ireland Limited (“WuXi Ireland”). Under the Cell Line License Agreement, the Company received a non-exclusive, worldwide, sublicensable license to certain of WuXi Ireland’s know-how, cell line, biological materials (the “WuXi Biologics Licensed Technology”) and media and feeds to make, have made, use, sell and import certain therapeutic products produced through the use of the cell line licensed by WuXi Ireland under the Cell Line License Agreement (the “WuXi Biologics Licensed Products”). Specifically, the WuXi Biologics Licensed Technology is used in certain manufacturing activities in support of the ORKA-001 and ORKA-002 programs.

In consideration for the license, the Company agreed to pay WuXi Ireland a non-refundable license fee of $150,000, which was recognized as a research and development expense during the period from February 6, 2024 (inception) to December 31, 2024. Additionally, to the extent that the Company manufactures its commercial supplies of bulk drug product with a manufacturer other than WuXi Ireland or its affiliates, the Company is required to make royalty payments to WuXi Ireland at a rate of less than one percent of net sales of WuXi Biologics Licensed Products manufactured by the third-party manufacturer. Pursuant to an amendment to the Cell Line License Agreement effective in November 2024, a provision was added that permits the royalties owed under the agreement to be bought out on a product-by-product basis for a lump-sum payment.

The Cell Line License Agreement will continue indefinitely unless terminated (i) by the Company upon six months’ prior written notice and its payment of all undisputed amounts due to WuXi Ireland through the effective date of termination, (ii) by WuXi Ireland for a material breach by the Company that remains uncured for 60 days after written notice, (iii) by WuXi Ireland if the Company fails to make a payment and such failure continues for 30 days after receiving notice of such failure, or (iv) by either party upon the other party’s bankruptcy.

Halozyme Agreement

In May 2026, the Company and Halozyme Hypercon, Inc. (“Halozyme”) entered into a global exclusive collaboration and license agreement (“Halozyme License Agreement”). Under the Halozyme License Agreement, the Company has licensed Halozyme’s Hypercon TM technology for IL-23p19 in psoriatic disease and up to one additional target. Hypercon TM is an innovative microparticle technology that allows for hyperconcentration of drugs and biologics, reducing injection volume for a given dose and supporting more convenient, patient-friendly administration. Pursuant to the terms of the Halozyme License Agreement, the Company is obligated to pay Halozyme a non-refundable upfront payment of $5.0 million, milestone payments of up to $21.5 million upon the achievement of certain clinical and regulatory milestones, and up to $150.0 million upon the achievement of certain sales milestones, along with reimbursement of the costs to be incurred in the development of the licensed products. In addition, the Company is obligated to pay mid-single digit royalties on net sales of products developed using Hypercon TM technology. During the nine months ended September 30, 2026, the Company paid and expensed the non-refundable upfront payment of $5.0 million as research and development expenses in the accompanying condensed consolidated statements of operations.

Legal Proceedings

The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of FASB ASC Topic 450, Contingencies. The Company expenses as incurred the costs related to its legal proceedings.

11. Net Loss Per Share

The following table summarizes the basic and diluted net loss per share attributable to stockholders (in thousands, except share and per share data):

For the computation of basic net loss per share attributable to stockholders, the amount of weighted-average shares outstanding excludes all shares of unvested restricted common stock as such shares are not considered outstanding for accounting purposes until vested. The amount of weighted-average shares outstanding includes the pre-funded warrants as the exercise price is negligible and these warrants are fully vested and exercisable.

The potential shares of common stock that were excluded from the computation of diluted net loss per share attributable to stockholders for the periods presented because including them would have had an anti-dilutive effect were as follows:

12. Related Party Transactions

Paragon and Paruka each beneficially own less than 5% of the Company’s capital stock through their respective holdings of common stock.

Fairmount Healthcare Fund II, L.P. (“Fairmount”)beneficially owns more than 5% of the Company’s capital stock, currently has one representative appointed to the Board, andbeneficially owns more than 5% of Paragon. Fairmount appointed Paragon’s board of directors and has the contractual right to approve the appointment of any executive officers of Paragon.

The following is a summary of related party accounts payable and other current liabilities (in thousands):