Summary of Oruka Therapeutics Conference Call Company Overview - Company: Oruka Therapeutics (NasdaqGM: ORKA) - Focus: Advancing the standard of care in psoriatic disease with a pipeline centered around two co-lead assets, ORCA-001 and ORCA-002, both extended half-life monoclonal antibodies targeting plaque psoriasis, psoriatic arthritis, and related conditions [2][3] Key Products and Pipeline - ORCA-001: Modeled after Risankizumab (Skyrizi), targeting IL-23p19, with a 100-day half-life, aiming for once-a-year dosing [2][6][7] - ORCA-002: Modeled after Bimekizumab (Bimzelx), targeting IL-17A/F, with expected half-life around 75 days, aiming for twice-yearly dosing [2][17] - Clinical Development: - ORCA-001 is in phase 2 development, with readouts expected in the second half of next year [3][10] - ORCA-002 is in phase 1, with data anticipated around year-end [16][17] Market Opportunity - Psoriasis Pipeline: The current pipeline for psoriasis is relatively empty, presenting a significant opportunity for Oruka to introduce new biologics [4][5] - Patient Preference: The company believes that patients and physicians would prefer less frequent dosing with biologics over oral options, which are currently being explored by competitors [5] Clinical Data and Efficacy - Efficacy Expectations: - ORCA-001 aims for PASI 100 (fully clear skin) rates potentially in the 50s or 60s, compared to Skyrizi's 43% and Bimekizumab's 62% [11][12] - The innovative design of the phase 2A study includes a primary endpoint of PASI 100 at week 16, which is a novel approach in psoriasis trials [9][10] - Durability of Response: The study will also assess how long patients can maintain clear skin without additional doses, with expectations of 20-30% of patients remaining clear for two years or more after initial doses [10][14] Financial Position - Cash Reserves: The company is well-capitalized with over $500 million in cash, providing a runway through multiple significant inflection points, including phase 2 readouts for both programs [3][27] Future Directions - Expansion into Hidradenitis Suppurativa (HS): The company plans to pursue HS after establishing its psoriasis programs, leveraging the success of Bimekizumab in psoriasis and psoriatic arthritis [21][22] - Combination Therapy Concept: ORCA-021 aims to explore the potential of using IL-17 for induction followed by IL-23 for maintenance, which has received positive feedback from experts [25][26] Conclusion - Oruka Therapeutics is positioned to capitalize on a significant market opportunity in psoriatic disease with its innovative pipeline of extended half-life monoclonal antibodies, backed by strong clinical data and a solid financial foundation. The company is strategically planning to expand its indications and explore combination therapies to enhance treatment outcomes for patients.
Oruka Therapeutics (NasdaqGM:ORKA) 2025 Conference Transcript