Summary of Oruka Therapeutics FY Conference Call Company Overview - Company: Oruka Therapeutics (NasdaqGM:ORKA) - Focus: Advancing the standard of care in psoriatic diseases, including plaque psoriasis and psoriatic arthritis, as well as associated inflammatory conditions like hidradenitis suppurativa (HS) [2][3] Core Programs - Pipeline: Two co-lead programs, Orka One and Orka Two, which are extended half-life monoclonal antibodies targeting IL23P19 and IL17AF [2][3] - Market Potential: Psoriatic disease market is approximately $30 billion and growing, with a track record of rewarding biologic innovation [5] Clinical Development - Phase One Data: Recently read out phase one data for ORKA-002, with plans to initiate two phase two studies in plaque psoriasis and HS [3][4] - EVERLAST Program: Two parallel phase two studies (EVERLAST A and B) for ORKA-001 in plaque psoriasis, with data expected in the second half of 2026 [4][13] - Dosing Strategy: Potential for once-yearly dosing with Orka One and twice-yearly dosing with Orka Two, aiming for off-treatment remission [4][11][22] Efficacy and Differentiation - Efficacy Evidence: Higher exposures of IL-23 antibodies may lead to higher rates of skin clearance, with a goal of achieving PASI 100 (fully clear skin) as a primary endpoint [14][18] - Unique Profile: Orka One has a half-life of about 100 days, compared to 28 days for risankizumab, which may enable annual dosing [11][12] - Combination Strategy: Plans for a sequential combination of Orka Two and Orka One (Orka 21) to leverage the strengths of both IL-17 and IL-23 profiles [9][27] Market Comparison - Competitors: Comparison with existing products like Skyrizi and Bimzelix, highlighting the potential for Oruka's products to offer improved dosing intervals and efficacy [5][6][23] - Oral Medications: Oruka believes that biologics will remain the preferred treatment for moderate to severe disease over oral medications, which have not reached similar efficacy levels [33][34] Financial Position - Funding: Over $500 million in cash disclosed, providing a strong financial position to support ongoing and future studies [28] Regulatory Considerations - FDA Engagement: The innovative design of the EVERLAST trial and the potential for a once-yearly dosing regimen are being discussed with the FDA [35][36] - Pricing Strategy: Plans for flexible pricing arrangements based on real-world dosing outcomes, aiming to provide value-based care [40][41] Conclusion - Outlook for 2026: Anticipation of significant developments in clinical data and potential market entry, with a strong conviction in the company's innovative pipeline and commercialization strategy [29][44]
Oruka Therapeutics (NasdaqGM:ORKA) FY Conference Transcript