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]

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 September 30, 2024 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) (650) 606-7910 (Registrant's ...

MENLO PARK, Calif., Nov. 04, 2024 (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, today announced presentations at the following upcoming investor conferences: Stifel 2024 Healthcare ConferenceDate: Monday, November 18th, 2024Time: 2:25PM ET Jefferies London Healthcare ConferenceDate: Wednesday, November 20th, 2024Time: 2:00PM GMT A w ...