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]

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 March 31, 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 | | --- ...

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]

Core Insights - Oruka Therapeutics is developing ORKA-002, a novel monoclonal antibody with an extended half-life targeting IL-17A/F, which shows potential for less frequent dosing compared to existing therapies [1][3][6] - The half-life of ORKA-002 in non-human primates (NHP) exceeds 30 days, which is over three times longer than bimekizumab, suggesting a dosing interval of two to three times per year [1][6] - ORKA-002 demonstrates equivalent potency to bimekizumab with similar binding affinity, indicating a promising profile for treating chronic skin diseases like plaque psoriasis and psoriatic arthritis [2][3][6] Company Overview - Oruka Therapeutics aims to set a new standard for treating chronic skin diseases, focusing on achieving high rates of complete disease clearance with infrequent dosing [4] - The company is advancing a proprietary portfolio of antibodies engineered to target the core mechanisms of plaque psoriasis and other dermatologic conditions [4] Product Details - ORKA-002 is administered subcutaneously and has shown superior efficacy in preclinical studies compared to existing therapies that require monthly maintenance dosing [3][6] - Projections indicate that ORKA-002 could have a human half-life of approximately 50 to 75 days, allowing for dosing intervals of once every four months or twice a year [6]

Core Insights - Oruka Therapeutics is advancing its clinical pipeline with ORKA-001 and ORKA-002, targeting chronic skin diseases like plaque psoriasis, with significant clinical data expected in the coming years [1][2][3] Financial Overview - The company successfully raised over $475 million in 2024, providing a cash runway through 2027, which is over one year past the anticipated Phase 2a data for ORKA-001 [1][12] - As of December 31, 2024, Oruka had cash, cash equivalents, and marketable securities totaling approximately $394 million [7] - The net loss for the fourth quarter of 2024 was $25.8 million, with a total net loss of $83.7 million since inception [11][18] Research and Development Updates - ORKA-001, a novel IL-23p19 monoclonal antibody, is currently in a Phase 1 trial, with interim pharmacokinetic data expected in the second half of 2025 [1][5] - A Phase 2a proof-of-concept study for ORKA-001 is planned for the second half of 2025, aiming to enroll around 80 patients with moderate-to-severe psoriasis [5] - ORKA-002, targeting IL-17A/F, is set to enter Phase 1 trials in Q3 2025, with preclinical data to be presented at the 2025 AAD Annual Meeting [1][12] Clinical Development Strategy - The company aims to deliver clinical catalysts every six months, potentially establishing ORKA-001 and ORKA-002 as leading treatment options in psoriatic disease [2] - ORKA-001 has shown a half-life in non-human primates exceeding 30 days, suggesting the potential for extended dosing intervals [5] - The innovative study design for ORKA-001 includes a primary endpoint of PASI 100 at week 16, which is more stringent than previous studies [5] Additional Programs - Oruka is developing ORKA-021, a sequential combination regimen of ORKA-002 and ORKA-001, which could enhance treatment responses [12] - The company plans to disclose further details on ORKA-003 in the first half of 2025 [12]

Financial Performance - The company generated net losses of $83.7 million from February 6, 2024 (inception) to December 31, 2024, with net cash used for operating activities amounting to $57.8 million[411]. - The company reported total operating expenses of $88.1 million for the period from February 6, 2024, to December 31, 2024, with research and development expenses accounting for $75.1 million[441]. - The company incurred a net loss of $83.7 million for the period from February 6, 2024, to December 31, 2024[441]. - Interest income for the period was $5.9 million, while interest expense related to a convertible note was $1.5 million[445]. - The company has not generated any revenue from product sales and does not expect to do so in the near future[430]. - The company anticipates needing additional financing in the future to support ongoing research and development efforts[448]. Cash and Financing - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $393.7 million, expected to fund operations for at least twelve months[413]. - Net cash used in investing activities during the same period was $330.1 million, mainly attributed to purchases of marketable securities[451]. - Net cash provided by financing activities was $449.5 million, including $228.0 million from Pre-Closing Financing and $188.7 million from PIPE Financing[452]. - The company raised approximately $188.7 million in net proceeds from a PIPE Financing on September 13, 2024, selling 5,600,000 shares of common stock at $23.00 per share[429]. - The Pre-Closing Financing raised approximately $275.0 million, with transaction costs of $20.5 million recorded as a reduction to additional paid-in capital[422]. Research and Development - The lead program, ORKA-001, targets IL-23p19 for psoriasis treatment and is designed for subcutaneous injection as infrequently as once or twice a year[414][415]. - The company initiated dosing of healthy volunteers in a Phase 1 trial of ORKA-001 in Q4 2024, with interim pharmacokinetic data expected in H2 2025 and initial efficacy data in psoriasis patients anticipated in H2 2026[416]. - ORKA-002, targeting IL-17A/F, is planned to begin dosing healthy volunteers in a Phase 1 trial in Q3 2025, with initial pharmacokinetic data expected in H1 2026[417]. - Research and development expenses included $57.7 million for external research and development, primarily related to services rendered by Paragon[442]. - The company has initiated research programs focusing on antibodies targeting IL-23 and IL-17A/F as part of its collaboration with Paragon[455]. - The company recorded a total of $13.5 million in development costs related to ORKA-001 during the reporting period[459]. - The company is obligated to pay non-refundable milestone payments of up to $12.0 million under each of the ORKA-001 and ORKA-002 License Agreements upon achieving certain clinical development milestones[466]. - The company recorded a $1.5 million milestone payment related to the achievement of a development candidate for ORKA-001 and a $2.5 million milestone payment for the first dosing of a human subject in a Phase 1 trial[459]. Corporate Actions - The merger with Pre-Merger Oruka was completed on August 29, 2024, resulting in a name change from ARCA biopharma, Inc. to Oruka Therapeutics, Inc.[421]. - The merger was accounted for as a reverse recapitalization, with Pre-Merger Oruka deemed the accounting acquirer for financial reporting purposes[426]. - The company executed a 1-for-12 reverse stock split on September 3, 2024, adjusting the share data retrospectively for all periods presented[427]. - The company entered into a Cell Line License Agreement with WuXi Biologics, agreeing to pay a non-refundable license fee of $150,000 recognized as a research and development expense[468]. - The company entered into a Series A Preferred Stock and Convertible Note Purchase Agreement, issuing a Convertible Note with an initial principal amount of $25.0 million, accruing interest at 12.0% per annum[470]. - Prior to the merger, the Convertible Note was converted into 2,722,207 shares of Company Common Stock, based on an aggregate principal amount of $25.0 million plus unpaid accrued interest of $1.5 million[471]. Stock and Valuation - Stock options granted are measured based on estimated fair values using the Black-Scholes model, with expenses recognized over the requisite service period[477]. - The fair value of Company Common Stock is determined based on the quoted market price following the completion of the merger[478]. - Prior to the merger, common stock valuations were prepared using a hybrid method, including an option pricing method and a probability-weighted expected return method[480]. - As of December 31, 2024, the company did not have any off-balance sheet arrangements[483]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[484].

Core Insights - Oruka Therapeutics, Inc. is a clinical stage biotechnology company focused on developing novel biologics for chronic skin diseases, particularly plaque psoriasis [2] - The company aims to provide patients with significant freedom from their conditions through high rates of complete disease clearance with infrequent dosing [2] Upcoming Events - Oruka will present at TD Cowen's 45th Annual Health Care Conference on March 4, 2025, at 10:30 AM ET [1] - The company will also present at the Leerink Global Healthcare Conference on March 12, 2025, at 8:40 AM ET [1] - A webcast and replay of the presentations will be available on Oruka's investor events website [1] Company Overview - Oruka 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's mission is to achieve high rates of complete disease clearance for patients suffering from chronic skin diseases [2]

Core Insights - Oruka Therapeutics has initiated dosing of healthy volunteers in its first clinical trial of ORKA-001, a novel monoclonal antibody targeting IL-23p19, with pharmacokinetic and safety data expected in the second half of 2025 [1][2] - The company plans to start a proof-of-concept study for ORKA-001 in moderate-to-severe psoriasis in the second half of 2025, with initial efficacy data anticipated in the second half of 2026 [3][4] Company Developments - The Phase 1 trial of ORKA-001 is a double-blind, placebo-controlled study involving approximately 24 healthy volunteers across three dosing cohorts, with interim data expected in the second half of 2025 [2][3] - ORKA-001 is designed for once- or twice-yearly dosing, significantly improving upon current therapies that require four to six doses per year [5][7] - The company has entered into a license agreement with Paragon Therapeutics for worldwide exclusive rights to ORKA-001, excluding inflammatory bowel disease [4] Product Information - ORKA-001 is a half-life extended monoclonal antibody that has shown potential for higher disease clearance rates compared to currently marketed IL-23p19 antibodies, which achieve fully clear skin in less than half of patients after four months [5][7] - Preclinical data indicates that ORKA-001 binds to a similar epitope as risankizumab but has a significantly extended half-life, over three times longer than risankizumab [5]

Company Overview - Oruka Therapeutics, Inc. is a biotechnology company focused on developing novel biologics aimed at treating chronic skin diseases, particularly plaque psoriasis [3] - 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 [3] Nasdaq Biotechnology Index Inclusion - Oruka Therapeutics is expected to be added to the Nasdaq Biotechnology Index (NBI), effective prior to market open on December 23, 2024 [1] - The NBI tracks the performance of securities listed on The Nasdaq Stock Market that are classified as biotechnology or pharmaceutical companies, with specific eligibility requirements including minimum market capitalization and average daily trading volume [2]