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]

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]

Core Insights - Oruka Therapeutics successfully completed a go-public transaction, raising over $475 million, which provides a cash runway through multiple clinical inflection points [1][2] - The company is advancing its lead programs, ORKA-001 and ORKA-002, with accelerated clinical timelines [1][2] Corporate Updates - Oruka began trading on Nasdaq under the ticker ORKA after consummating its go-public transaction [2] - The company raised $275 million from a private placement and an additional $200 million from new and existing investors [2] Pipeline Developments - ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody, is set to initiate a Phase 1 trial in Q1 2025, with interim data expected in H2 2025 [3] - ORKA-002, a novel half-life extended IL-17A/F monoclonal antibody, plans to start a Phase 1 trial in Q3 2025, with interim data anticipated in H1 2026 [4] Financial Performance - As of September 30, 2024, Oruka had cash and cash equivalents of $410.9 million, with a net cash usage of $27.8 million for Q3 2024 [5] - Research and Development (R&D) expenses for Q3 2024 totaled $25.7 million, including $7.8 million in non-cash stock-based compensation [6] - General and Administrative (G&A) expenses for Q3 2024 were $3.8 million, which included $2.4 million in personnel-related costs [7] - The net loss for Q3 2024 was $28.6 million, which included $9.0 million in non-cash stock-based compensation [8] Shares and Equity - Oruka has approximately 55.1 million shares of common stock and equivalents outstanding [9] - The company aims to provide patients with chronic skin diseases, such as plaque psoriasis, with high rates of complete disease clearance through infrequent dosing [10]