MENLO PARK, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that the Company will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place in San Francisco, CA from January 12-15, 2026. Presentation DetailsDate: Thursday, January 15th, 2026Time: 9:00 AM PT A webcas ...

Company Overview - Oruka Therapeutics, Inc. (ORKA) is an early-stage immunology company focused on developing therapies for psoriasis and related diseases [1] - The company's pipeline includes biologics ORKA-001 for plaque psoriasis (PsO) and ORKA-002 for PsO, psoriatic arthritis (PsA), and hidradenitis suppurativa (HS) [1] Product Pipeline - ORKA-001 and ORKA-002 are designed to have improved efficiency in treating their respective conditions [1]

Core Insights - Oruka Therapeutics has received mixed ratings from analysts, with Guggenheim initiating coverage with a "buy" rating and a target price of $60.00, while HC Wainwright lowered their target from $45.00 to $40.00, maintaining a "buy" rating [1] - The average target price for Oruka Therapeutics is $48.88, with one analyst rating it as a Strong Buy, seven as Buy, and one as Sell [1] - The company's stock has shown a recent increase of 4.1%, with a market cap of $1.47 billion and a P/E ratio of -15.95 [2] Financial Performance - Oruka Therapeutics reported earnings per share of ($0.55) for the last quarter, slightly beating analysts' expectations of ($0.56) [3] - Analysts project an earnings per share of -$3.41 for the current fiscal year [3] Insider Activity - Insider Joana Goncalves sold 7,000 shares at an average price of $30.61, totaling $214,270, which represents an 82.18% decrease in her ownership [4] Institutional Holdings - Institutional investors have increased their stakes in Oruka Therapeutics, with Woodline Partners LP boosting its stake by 46.9% and Fairmount Funds Management LLC increasing its holdings by 9.9% [5] - Institutional investors and hedge funds collectively own 56.44% of the company's stock [5] Company Overview - Oruka Therapeutics is a clinical-stage biopharmaceutical company focused on developing peptide-based therapies for oncology, utilizing a proprietary stapled peptide platform [7] - The lead candidate, ONCT-01, is currently in Phase 1 clinical trials for advanced solid tumors, assessing safety and preliminary efficacy [7]

MENLO PARK, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced the appointment of Chris Martin to its Board of Directors. Additionally, Cameron Turtle, DPhil, resigned from the Board effective December 11, 2025. “As we rapidly advance our co-lead programs through development, I’m ...

Core Insights - Oruka Therapeutics, Inc. has reported promising Phase 1 results for ORKA-001, indicating potential for once-per-year dosing, higher efficacy, and extended off-treatment remission for chronic skin diseases like plaque psoriasis [1][6][12] - The company has a strong cash position of approximately $500.9 million, providing a runway beyond key upcoming clinical readouts [1][7] - ORKA-001 and ORKA-002 are both advancing in clinical trials, with ORKA-001's Phase 2a trial expected to provide data in the second half of 2026 [1][2][6] Financial Performance - For Q3 2025, Oruka reported a net loss of $30.3 million, compared to a net loss of $28.6 million in Q3 2024, with R&D expenses increasing to $29.0 million from $25.7 million year-over-year [7][8][11] - General and administrative expenses rose to $5.1 million in Q3 2025 from $3.8 million in Q3 2024, primarily due to increased employee compensation and consulting fees [9] - Other income increased significantly to $3.8 million in Q3 2025, up from $0.8 million in Q3 2024, attributed to higher interest income from marketable securities [10] Clinical Development Updates - ORKA-001 demonstrated a half-life of approximately 100 days, significantly longer than risankizumab, enhancing the potential for less frequent dosing [6] - The Phase 2a trial, EVERLAST-A, is currently enrolling participants, with results expected in 2H 2026, while a Phase 2b trial, EVERLAST-B, is set to begin in 1H 2026 [6][14] - ORKA-002 is in a Phase 1 trial, with interim data anticipated around the end of 2025, and a Phase 2 trial planned for 1H 2026 [1][6][14] Strategic Outlook - The company aims to establish a new standard for treating chronic skin diseases, focusing on achieving high rates of complete disease clearance with infrequent dosing [12] - Oruka is also exploring a sequential combination regimen of ORKA-002 and ORKA-001, which could enhance treatment efficacy for psoriatic disease [14] - The company is progressing ORKA-003 through preclinical development, indicating a robust pipeline for future growth [14]

Financial Performance - For the three and nine months ended September 30, 2025, the company reported net losses of $30.3 million and $75.9 million, respectively[116]. - The net loss for the nine months ended September 30, 2025, was $75.9 million, a 31% increase from the net loss of $57.9 million in the prior period[157]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[137]. - Net cash used in operating activities was $65.6 million for the nine months ended September 30, 2025, compared to $39.0 million for the same period in 2024[174][175]. - The company expects to incur significant operating losses and negative cash flow for the foreseeable future as it continues clinical development[170]. Cash and Financing - The company had cash, cash equivalents, and marketable securities totaling $500.9 million as of September 30, 2025, expected to fund operations for at least twelve months[117]. - As of September 30, 2025, the company had $500.9 million in cash, cash equivalents, and marketable securities[169]. - Net cash provided by financing activities was $170.0 million for the nine months ended September 30, 2025, primarily from the 2025 PIPE Financing[177]. - In October 2025, the company entered into a Sales Agreement to potentially raise up to $200.0 million through an at-the-market equity offering program[171]. - The company anticipates needing additional financing in the future to support ongoing research and development efforts[172]. Research and Development - ORKA-001, the lead program, demonstrated a half-life of approximately 100 days and showed complete inhibition of STAT3 signaling for 24 weeks in a Phase 1 trial[120]. - The Phase 2a clinical trial of ORKA-001, named EVERLAST-A, is expected to enroll approximately 80 patients, with a primary endpoint of PASI 100 at Week 16[121]. - A Phase 2b trial of ORKA-001, named EVERLAST-B, is planned to evaluate three dose levels, with dosing projected to begin before the completion of EVERLAST-A[122]. - ORKA-002, targeting IL-17A and IL-17F, is in Phase 1 trials with plans for a Phase 2 trial in hidradenitis suppurativa in the first half of 2026[124]. - The company expects research and development expenses to increase substantially in the foreseeable future as it continues to invest in its programs[139]. Expenses - Research and development expenses increased by $3.3 million, from $25.7 million for the three months ended September 30, 2024, to $29.0 million for the three months ended September 30, 2025, representing a 13% increase[148]. - Total operating expenses increased by $4.7 million, from $29.4 million for the three months ended September 30, 2024, to $34.1 million for the three months ended September 30, 2025, a 16% increase[146]. - General and administrative expenses rose by $1.4 million, from $3.8 million for the three months ended September 30, 2024, to $5.1 million for the three months ended September 30, 2025, a 36% increase[152]. - Personnel-related expenses in general and administrative increased by $1.3 million, from $2.4 million for the three months ended September 30, 2024, to $3.8 million for the three months ended September 30, 2025, a 55% increase[153]. - For the nine months ended September 30, 2025, total operating expenses increased by 52% to $87.6 million from $57.8 million for the same period in 2024[157]. - Research and development expenses rose by 47% to $73.0 million, up from $49.6 million, with external research expenses increasing by 20% to $45.6 million[159][160]. - General and administrative expenses increased by 77% to $14.6 million from $8.2 million, driven by a 135% rise in personnel-related expenses[162][164]. Corporate Actions - The company completed a merger with Pre-Merger Oruka on August 29, 2024, and changed its name from ARCA biopharma, Inc. to Oruka Therapeutics, Inc.[127]. - The company raised approximately $275.0 million in gross proceeds from a subscription agreement prior to the merger, incurring transaction costs of $20.5 million[128]. - In the 2024 PIPE Financing, the company raised approximately $188.7 million from the sale of 5,600,000 shares at $23.00 per share[130]. - In the 2025 PIPE Financing, the company raised approximately $169.6 million from the sale of 10,933,405 shares at $15.00 per share[132]. Accounting and Compliance - There were no changes to the company's critical accounting policies and significant judgments during the three months ended September 30, 2025[181]. - The company did not have any off-balance sheet arrangements as of September 30, 2025[182]. - The financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may affect reported amounts of assets and liabilities[180]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[183]. Milestone Payments - The company incurred milestone payments of $7.0 million for ORKA-001 and $4.0 million for ORKA-002 as of September 30, 2025[136]. - The company has incurred a total of $12.0 million in non-refundable milestone payments under each License Agreement upon achieving certain clinical development milestones[135]. - The company has a royalty-bearing, world-wide, exclusive license to develop and commercialize antibodies targeting IL-23 and IL-17A/F under the License Agreements with Paragon[135].

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.

Group 1 - Oruka Therapeutics, Inc. (ORKA) shares have increased by 42.7% in the past four weeks, closing at $27.44, with a mean price target of $44.89 indicating a potential upside of 63.6% [1] - The average price target from nine analysts ranges from a low of $26.00 to a high of $60.00, with a standard deviation of $9.82, suggesting variability in estimates [2] - Analysts show strong agreement on ORKA's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - The Zacks Consensus Estimate for ORKA has increased by 1.1% due to one upward revision in earnings estimates over the last 30 days, with no negative revisions [12] - ORKA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for near-term upside [13] - While consensus price targets may not be reliable for predicting exact gains, they can provide a directional guide for price movement [14]

Group 1: Stock Market Overview - U.S. stocks exhibited mixed performance, with the Dow Jones index increasing by over 200 points on Wednesday [1] Group 2: Notable Stock Movements - Lyft, Inc. shares surged by 13.5% to $22.92 following the announcement of an expansion plan with Waymo to Nashville, where Lyft's Flexdrive will manage Waymo's fully autonomous vehicles [1] - New Fortress Energy Inc. saw its shares jump 32.3% to $2.6501 after securing a long-term gas supply agreement with the Puerto Rican government [3] - Oruka Therapeutics, Inc. experienced a 14.1% increase in shares to $17.01 after announcing interim Phase 1 results for ORKA-001 and a $180 million private placement [3] - Robo.ai Inc. shares rose by 12.9% to $1.9190 [3] - Roivant Sciences Ltd. gained 12% to $15.89 after reporting Phase 3 results for brepocitinib in treating a debilitating skin-muscle disease [3] - Opendoor Technologies Inc. shares surged by 11.1% to $9.91 [3] - Gevo, Inc. also gained 11.1%, reaching $2.1089 [3] - Blue Gold Limited saw a 10.5% increase to $11.05 [3] - Workday, Inc. shares surged by 9% to $238.63 after an upgrade from Piper Sandler, raising the price target from $220 to $235 [3] - Parsons Corporation gained 6.9% to $80.64 after being awarded a task order for Indo-Pacific Counter-Nuclear Smuggling System Deployment [3] - e.l.f. Beauty, Inc. shares increased by 4.6% to $149.91, with B of A Securities maintaining a Buy rating and raising the price target from $135 to $160 [3]

Core Viewpoint - Oruka Therapeutics has announced a PIPE financing agreement expected to generate approximately $180 million in gross proceeds to support its development of novel biologics for chronic skin diseases, particularly plaque psoriasis [1][3]. Financing Details - The PIPE financing involves the sale of 10,933,405 shares of common stock at $15.00 per share and pre-funded warrants for 1,066,666 shares at $14.999 each, with an exercise price of $0.001 per share [2]. - The transaction is anticipated to close around September 19, 2025, pending customary closing conditions [2]. Use of Proceeds - The net proceeds from the PIPE financing will be utilized for research and development, general corporate expenses, and working capital needs, with expectations that current cash will fund operations for at least one year following key clinical data readouts in 2027 [3]. Investor Participation - The PIPE financing was led by Viking Global Investors and included participation from various notable investors such as Affinity Healthcare Fund, Blackstone Multi-Asset Investing, and others [1][4]. Company Overview - Oruka Therapeutics focuses on developing biologics aimed at setting new treatment standards for chronic skin diseases, with a mission to provide significant relief to patients suffering from conditions like plaque psoriasis [7].