First patients dosed in the EVERLAST-A Phase 2a trial of ORKA-001, with data expected in 2H 2026 ORKA-001 Phase 1 data and EVERLAST-A design to be presented at EADV in September 2025 ORKA-002 Phase 1 trial ongoing, with data to be presented around YE 2025 MENLO PARK, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including p ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ________ to ________ Commission file number: 000-22873 Oruka Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Delaware | 36-3855489 | | --- | ...

IND cleared for the EVERLAST-A Phase 2a trial of ORKA-001 in moderate-to-severe psoriasis, with initial data expected 2H 2026 Interim Phase 1 data and further details on EVERLAST-A study design to be shared in an oral presentation at EADV in September MENLO PARK, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, to ...

Company Overview - Oruka Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for chronic skin diseases, particularly plaque psoriasis [1][4] - The company's mission is to provide patients with significant freedom from chronic skin conditions by achieving high rates of complete disease clearance with infrequent dosing, potentially as little as once or twice a year [4] Leadership Change - Laura Sandler has been promoted to Chief Operating Officer, having previously served as Senior Vice President of Operations since 2024 [1][2] - Ms. Sandler brings over 20 years of biopharmaceutical leadership experience, particularly in clinical operations and development strategy, and has been instrumental in advancing Oruka's programs into clinical trials [2][3] Strategic Focus - The company is advancing a proprietary portfolio of potentially best-in-class antibodies targeting the core mechanisms of plaque psoriasis and other dermatologic and inflammatory diseases [4] - Ms. Sandler expressed commitment to driving the company's programs forward with urgency, rigor, and high quality, aligning with the expectations of patients and investors [4][3]

Core Insights - Oruka Therapeutics, Inc. is a clinical stage biotechnology company focused on developing novel biologics for chronic skin diseases, particularly plaque psoriasis [1][2] - The company aims to provide patients with significant freedom from chronic skin conditions by achieving high rates of complete disease clearance with infrequent dosing, potentially as little as once or twice a year [2] - Oruka is advancing a proprietary portfolio of antibodies engineered to target the core mechanisms of plaque psoriasis and other dermatologic and inflammatory diseases [2] Event Announcement - Oruka will present at the Jefferies Global Health Care Conference in New York on June 4, 2025, at 12:50 PM ET [1] - A webcast and replay of the presentation will be available on the Oruka investor events website [1] Company Information - Oruka Therapeutics is committed to setting a new standard in the treatment of chronic skin diseases through innovative biologics [2] - The company’s mission emphasizes achieving high rates of disease clearance for patients suffering from conditions like plaque psoriasis [2]

Core Insights - Oruka Therapeutics is advancing its clinical trials for ORKA-002, a novel monoclonal antibody targeting IL-17A and IL-17F, with dosing of healthy volunteers initiated and pharmacokinetic data expected by the end of 2025 [1][2][5] - The company plans to start a Phase 2 study for ORKA-002 in moderate-to-severe psoriasis in the first half of 2026, focusing on safety and efficacy across multiple dosing regimens [3][4] Group 1: Clinical Development - ORKA-002 is currently in a Phase 1 trial, which is a double-blind, placebo-controlled study involving approximately 24 healthy volunteers [2][3] - Interim data from the Phase 1 trial is anticipated around the end of 2025, which will inform the subsequent Phase 2 study [2][3] Group 2: Product Differentiation - ORKA-002 has the potential to be dosed two to three times per year, significantly less frequent than current therapies, which typically require monthly dosing [5] - The dual inhibition of IL-17A and IL-17F by ORKA-002 is expected to provide superior efficacy compared to existing treatments that only target IL-17A [5] Group 3: Company Vision - Oruka Therapeutics aims to set a new standard for treating chronic skin diseases, particularly plaque psoriasis, by achieving high rates of complete disease clearance with infrequent dosing [6] - The company is focused on developing a proprietary portfolio of potentially best-in-class antibodies targeting the underlying mechanisms of chronic skin diseases [6]

Core Insights - Oruka Therapeutics is advancing its clinical programs ORKA-001 and ORKA-002, which target chronic skin diseases like plaque psoriasis, with the potential to set a new treatment standard [2][12] Pipeline Developments - ORKA-001, targeting IL-23p19, has completed Phase 1 trial dosing, with data expected in Q3 2025. Phase 2a initiation is anticipated in 2H 2025, with efficacy readout expected in 2H 2026 [1][5] - ORKA-002, targeting IL-17A/F, has accelerated its Phase 1 initiation to Q2 2025, with initial pharmacokinetic (PK) data expected by the end of 2025 [1][5] - The Phase 2a study for ORKA-001 will enroll approximately 80 patients and aims for a primary endpoint of PASI 100 at week 16, which is more ambitious than previous studies [5] Financial Position - As of March 31, 2025, Oruka has a strong cash position of $373 million, providing a runway through 2027 [1][7] - Research and Development (R&D) expenses for Q1 2025 totaled $19.9 million, reflecting increased investment in clinical development [8] - General and Administrative (G&A) expenses for Q1 2025 were $5.2 million, driven by employee compensation and operational growth [9] Clinical Data and Efficacy - Interim data from the ORKA-001 Phase 1 trial is expected in Q3 2025, with a focus on safety, tolerability, and pharmacokinetics [5] - ORKA-002 has shown a half-life in non-human primates of over 30 days, supporting a dosing interval of two to three times per year [5] Market Potential - The company aims to achieve high rates of complete disease clearance for patients with chronic skin diseases, with dosing as infrequently as once or twice a year [12]

PART I [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Oruka Therapeutics reported a **$21.0 million** net loss for Q1 2025, holding **$373.0 million** in liquidity, reflecting its clinical-stage status and R&D focus Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $83,572 | $61,575 | | Marketable securities | $289,475 | $332,142 | | Total current assets | $352,083 | $376,869 | | **Total assets** | **$377,112** | **$396,019** | | Total current liabilities | $11,723 | $13,043 | | **Total liabilities** | **$12,387** | **$13,798** | | **Total stockholders' equity** | **$364,725** | **$382,221** | Condensed Consolidated Statements of Operations (in thousands) | Account | Three Months Ended March 31, 2025 | Period from Feb 6, 2024 to Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $19,925 | $5,193 | | General and administrative | $5,161 | $1,670 | | **Total operating expenses** | **$25,086** | **$6,863** | | Loss from operations | ($25,086) | ($6,863) | | Interest income | $4,092 | $0 | | **Net loss** | **($20,999)** | **($7,077)** | | **Net loss per share** | **($0.40)** | **($2.21)** | Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2025 | Period from Feb 6, 2024 to Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($20,869) | ($168) | | Net cash provided by investing activities | $42,866 | $0 | | Net cash provided by financing activities | $0 | $27,911 | | **Net increase in cash** | **$21,997** | **$27,743** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail company formation, financing, accounting policies, and license agreements, confirming sufficient liquidity for 12 months - The company was formed through a reverse recapitalization with ARCA biopharma, Inc. in August 2024, focusing on biologics for psoriasis and inflammatory indications[18](index=18&type=chunk)[22](index=22&type=chunk)[25](index=25&type=chunk) - As of March 31, 2025, the company held **$373.0 million** in cash, cash equivalents, and marketable securities, expected to fund operations for at least the next twelve months[30](index=30&type=chunk) - License agreements for ORKA-001 and ORKA-002 with Paragon Therapeutics involve up to **$22.0 million** in development and regulatory milestones per program, plus royalties[75](index=75&type=chunk)[77](index=77&type=chunk)[79](index=79&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2025 | Period from Feb 6, 2024 to Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $3,003 | $70 | | General and administrative | $1,880 | $15 | | **Total** | **$4,883** | **$85** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses novel antibody therapeutics, noting increased operating expenses from clinical trials and headcount, while maintaining strong liquidity [Overview and Pipeline](index=25&type=section&id=Overview%20and%20Pipeline) Oruka is a clinical-stage biopharmaceutical company developing monoclonal antibodies for psoriasis, with lead programs ORKA-001 and ORKA-002 advancing into Phase 1 trials - **ORKA-001 (IL-23p19):** A Phase 1 trial in healthy volunteers was initiated in Q4 2024, with interim pharmacokinetic data expected in Q3 2025 and a Phase 2a trial planned for H2 2025[108](index=108&type=chunk) - **ORKA-002 (IL-17A/F):** A Phase 1 trial in healthy volunteers is planned to start in Q2 2025, with initial pharmacokinetic data expected around year-end 2025[109](index=109&type=chunk) - The company's strategy is to apply antibody engineering to validated targets to improve efficacy and dosing regimens over existing standard-of-care medicines[101](index=101&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Total operating expenses increased by **266%** to **$25.1 million** for Q1 2025, driven by higher R&D and G&A costs, resulting in a **$21.0 million** net loss Comparison of Operating Results (in thousands) | Account | Three Months Ended March 31, 2025 | Period from Feb 6, 2024 to Mar 31, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $19,925 | $5,193 | $14,732 | 284% | | General and administrative | $5,161 | $1,670 | $3,491 | 209% | | **Total operating expenses** | **$25,086** | **$6,863** | **$18,223** | **266%** | | **Net loss** | **($20,999)** | **($7,077)** | **($13,922)** | **197%** | - R&D expenses increased by **$14.7 million**, primarily due to an **$8.7 million** increase in external CRO/CMO costs for product development and manufacturing, a **$2.3 million** increase in personnel costs from hiring, and a **$2.9 million** increase in stock-based compensation[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) - G&A expenses increased by **$3.5 million**, mainly due to a **$2.8 million** rise in personnel-related costs (including **$1.9 million** in stock compensation) and a **$0.7 million** increase in professional fees for legal, audit, and consulting services[140](index=140&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$373.0 million** in cash and securities as of March 31, 2025, funded by stock issuances, and expects this to cover operations for at least the next twelve months - The company had cash, cash equivalents, and marketable securities of **$373.0 million** as of March 31, 2025[143](index=143&type=chunk) - Management expects that existing cash and securities are sufficient to fund operating plans for at least twelve months from the filing date of this report[145](index=145&type=chunk) Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2025 | | :--- | :--- | | Net cash used in operating activities | ($20,869) | | Net cash provided by investing activities | $42,866 | | Net cash provided by financing activities | $0 | [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Oruka Therapeutics is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[156](index=156&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of the end of the period covered by the report[158](index=158&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[159](index=159&type=chunk) PART II [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, and pending claims are not expected to have a material adverse effect - The company is not currently party to any material legal proceedings[161](index=161&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks related to its limited operating history, ongoing losses, capital requirements, and the uncertain development and regulatory approval of its lead programs [Risks Related to Our Financial Condition and Capital Requirements](index=36&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) The company has a limited operating history, incurred significant losses, expects continued losses, and requires substantial additional capital which may cause dilution - The company is a clinical-stage entity with a limited operating history, a history of losses, and no products approved for sale[168](index=168&type=chunk)[173](index=173&type=chunk) - Substantial additional capital will be needed to fund future operations, and current market conditions may make it difficult to raise funds[174](index=174&type=chunk)[175](index=175&type=chunk) - Raising additional capital may cause significant dilution to existing stockholders and could involve restrictive covenants[180](index=180&type=chunk) [Risks Related to Clinical Development, Regulatory Approval and Commercialization](index=39&type=section&id=Risks%20Related%20to%20Clinical%20Development%2C%20Regulatory%20Approval%20and%20Commercialization) Success depends on lead programs ORKA-001 and ORKA-002, facing long, expensive, and uncertain clinical development with risks of trial failure, competition, and unproven technology - The company is substantially dependent on the success of its two most advanced programs, ORKA-001 and ORKA-002[189](index=189&type=chunk) - The company faces significant competition from established biopharmaceutical companies with greater financial and technical resources[182](index=182&type=chunk) - Clinical trials may fail, be delayed, or produce inconclusive results, and early-stage results are not predictive of later-stage success[185](index=185&type=chunk)[196](index=196&type=chunk) - The company's half-life extension technology is unproven in its target indications, and may not translate from preclinical models to humans or could lead to prolonged side effects[193](index=193&type=chunk)[204](index=204&type=chunk) [Risks Related to Government Regulations](index=46&type=section&id=Risks%20Related%20to%20Government%20Regulations) The company faces lengthy, unpredictable, and expensive regulatory approval processes, with risks from legislative changes, drug pricing controls, agency disruptions, and biosimilar competition - The FDA and foreign regulatory approval processes are lengthy, time-consuming, and unpredictable, and there is no guarantee of approval for product candidates[213](index=213&type=chunk)[214](index=214&type=chunk) - Even if approved, products will be subject to extensive ongoing regulatory obligations, and failure to comply can result in significant penalties[219](index=219&type=chunk) - Disruptions at the FDA and other government agencies due to funding shortages, political changes, or health crises could hinder the review and approval of new products[221](index=221&type=chunk)[222](index=222&type=chunk) - Legislative reforms, particularly around drug pricing and reimbursement, could adversely affect the company's ability to generate revenue[226](index=226&type=chunk) [Risks Related to Our Intellectual Property](index=50&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on obtaining and maintaining patent protection, facing risks of invalidation, infringement claims, and challenges from evolving patent law, particularly for antibody-based therapies - The company's ability to obtain and protect its patents is uncertain, and pending applications may not result in issued patents that provide meaningful competitive advantage[233](index=233&type=chunk)[234](index=234&type=chunk) - The company may be subject to costly patent infringement claims or may need to initiate litigation to protect its own IP[241](index=241&type=chunk) - Recent changes in patent law and court rulings, particularly regarding antibody patents, have created uncertainty and could weaken the company's patent protection[248](index=248&type=chunk)[249](index=249&type=chunk) - The company relies on in-licensed technology from Paragon and other third parties, and the failure of these parties to maintain or defend the IP could harm the business[237](index=237&type=chunk)[238](index=238&type=chunk) [Risks Related to Our Reliance on Third Parties](index=54&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Heavy reliance on third parties, including licensors, CROs, and CMOs, poses risks of performance failure, regulatory non-compliance, and geopolitical impacts, especially with sole-source foreign manufacturers like WuXi Biologics - The company relies on licensing arrangements with Paragon and collaborations with other third parties; failure of these arrangements could negatively impact the business[259](index=259&type=chunk)[260](index=260&type=chunk) - Reliance on third-party CROs for preclinical and clinical trials means the company has less direct control, and any failure by these CROs to perform could delay or compromise trial results[263](index=263&type=chunk) - The company depends on third-party CMOs for manufacturing and has a sole-source relationship for its lead programs, where any disruption could halt clinical development[266](index=266&type=chunk) - Reliance on foreign CMOs, including WuXi Biologics, exposes the company to geopolitical risks, trade restrictions, and potential impacts from legislation like the proposed BIOSECURE Act[268](index=268&type=chunk) [Risks Related to Employee Matters, Managing Growth, Other Risks Related to Our Business, and Risks Related to Owning Our Common Stock](index=57&type=section&id=Risks%20Related%20to%20Employee%20Matters%2C%20Managing%20Growth%2C%20Other%20Risks%20Related%20to%20Our%20Business%2C%20and%20Risks%20Related%20to%20Owning%20Our%20Common%20Stock) The company faces risks related to managing growth, retaining key personnel, IT security, stock price volatility, insider control, anti-takeover provisions, and no anticipated dividends - The company is highly dependent on key personnel and faces intense competition for talent; failure to attract and retain qualified individuals could harm the business[271](index=271&type=chunk)[272](index=272&type=chunk) - Internal IT systems are vulnerable to security breaches, which could result in significant liabilities and disruption of operations[278](index=278&type=chunk) - The market price of the company's common stock has been and may continue to be highly volatile[296](index=296&type=chunk) - Executive officers, directors, and principal stockholders hold significant voting power, enabling them to control matters submitted for stockholder approval[309](index=309&type=chunk) - The company does not anticipate paying cash dividends in the foreseeable future[307](index=307&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=65&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the period - None[311](index=311&type=chunk) [Defaults Upon Senior Securities](index=65&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the period - None[312](index=312&type=chunk) [Mine Safety Disclosures](index=65&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[313](index=313&type=chunk) [Other Information](index=65&type=section&id=Item%205.%20Other%20Information) No director or Section 16 officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No director or Section 16 officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter[314](index=314&type=chunk) [Exhibits](index=66&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed or furnished as part of the Quarterly Report - This section provides a list of all exhibits filed with the Form 10-Q[315](index=315&type=chunk)

Core Insights - Oruka Therapeutics, Inc. is a clinical stage biotechnology company focused on developing novel biologics for chronic skin diseases, particularly plaque psoriasis [1][2] - The company aims to provide patients with significant freedom from chronic skin conditions by achieving high rates of complete disease clearance with infrequent dosing, potentially as little as once or twice a year [2] Company Overview - Oruka Therapeutics is advancing a proprietary portfolio of potentially best-in-class antibodies engineered by Paragon Therapeutics, targeting the core mechanisms of plaque psoriasis and other dermatologic and inflammatory diseases [2] - The company is set to present at the Bank of America Securities 2025 Health Care Conference on May 13th, 2025, at 3:55 PM PT, indicating its active engagement with the investment community [1]

Core Insights - Oruka Therapeutics is developing ORKA-002, a novel monoclonal antibody with an extended half-life targeting IL-17A/F, which is expected to set a new standard for treating chronic skin diseases like plaque psoriasis [1][2][3] Group 1: Product Development - ORKA-002 has a half-life in non-human primates (NHP) of more than 30 days, over three times longer than bimekizumab, allowing for potential dosing intervals of two to three times per year [1][6] - The first subject for ORKA-002 is expected to be dosed in Q3 2025 [1] - ORKA-002 demonstrates equivalent potency to bimekizumab with similar binding affinity and epitope in various preclinical assays [1][6] Group 2: Competitive Advantage - ORKA-002's dual inhibition of IL-17A and IL-17F has shown superior efficacy compared to IL-17A inhibition alone, as evidenced by the performance of bimekizumab in Phase 3 trials [3] - Unlike existing therapies that require monthly maintenance dosing, ORKA-002 could potentially be administered just two to three times a year, positioning it as a leading therapy in the IL-17 class [3][6] Group 3: Company Overview - Oruka Therapeutics aims to provide patients with chronic skin diseases the highest possible freedom from their condition, targeting complete disease clearance with infrequent dosing [4] - The company is advancing a proprietary portfolio of potentially best-in-class antibodies engineered to target the core mechanisms underlying plaque psoriasis and other dermatologic diseases [4]