Oruka Therapeutics, Inc. - ORKA STOCK NEWS

Oruka Therapeutics (Nasdaq: ORKA) announced preclinical data for ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, at the European Academy of Dermatology and Venereology Congress. Key findings include:

1. Non-human primate (NHP) half-life of 30.3 days (subcutaneous) and 33.8 days (intravenous), over three times longer than risankizumab.
2. Projected human half-life of ~50 days could enable dosing every six months; ~75 days could allow yearly dosing.
3. Binds to a similar epitope with comparable affinity to risankizumab (below 5 picomolar).
4. Equivalent potency across various in vitro assays.

The extended half-life could result in higher antibody exposures, potentially leading to greater efficacy in treating chronic skin diseases like plaque psoriasis.

Oruka Therapeutics (Nasdaq: ORKA) has announced a $200 million private placement financing. The biotechnology company, focused on developing novel biologics for chronic skin diseases, is selling 5,600,000 shares of common stock at $23.00 per share, 2,439 shares of Series A non-voting convertible preferred stock at $23,000 per share, and pre-funded warrants for 680,000 shares at $22.999 per warrant. The PIPE financing includes participation from both new and existing investors, including major investment firms. Upon closing, Oruka will have approximately 55.1 million shares of common stock and equivalents outstanding. The company plans to use the proceeds for research and development, general corporate expenses, and working capital, expecting to fund its operating plan through 2027.

Oruka Therapeutics (Nasdaq: ORKA) has announced accelerated timelines for its novel biologics targeting chronic skin diseases. ORKA-001, a half-life extended antibody targeting IL-23p19, is now expected to start first-in-human dosing in Q1 2025. ORKA-002, targeting IL-17A/F, is set for first-in-human dosing in Q3 2025.

ORKA-001 shows potential for once or twice yearly dosing, with higher exposures than current IL-23p19 antibodies, potentially leading to higher disease clearance rates. Preclinical data, including a half-life of over 30 days in non-human primates, will be presented at the European Academy of Dermatology and Venereology Congress (EADV) in September.

Interim data for ORKA-001 in healthy volunteers is expected in H2 2025, with initial efficacy data in psoriasis patients in H2 2026. For ORKA-002, interim data from healthy volunteers is anticipated in H1 2026.

Oruka Therapeutics, Inc. (Nasdaq: ORKA) has completed its merger with ARCA biopharma and a $275 million private placement. The company, focused on developing novel biologics for chronic skin diseases, begins trading on Nasdaq on September 3, 2024. Samarth Kulkarni, PhD, has been appointed as Chairman of Oruka's Board of Directors.

Oruka's pipeline includes two lead programs: ORKA-001, a subcutaneous IL-23p19 inhibitor potentially dosed once or twice yearly, and ORKA-002, a subcutaneous IL-17A/F inhibitor. Both aim to offer improved dosing regimens and greater clinical activity for psoriasis and related conditions. The company plans to advance these programs into clinical trials, with initial pharmacokinetic data for ORKA-001 expected next year.