Oruka Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
Oruka Therapeutics (NASDAQ: ORKA) reported its Q1 2025 financial results and provided updates on its pipeline programs. The company ended Q1 with a strong cash position of $373 million, providing runway through 2027. Key highlights include:
Their lead program ORKA-001, an IL-23p19 antibody, completed Phase 1 dosing with data expected in Q3 2025. Phase 2a initiation is planned for 2H 2025, with efficacy readout in 2H 2026. The company's second program, ORKA-002, targeting IL-17A/F, has accelerated its Phase 1 initiation to Q2 2025.
Financial results showed R&D expenses of $19.9 million and G&A expenses of $5.2 million for Q1 2025. The company reported a net loss of $21.0 million, which includes $4.9 million in non-cash stock-based compensation.
Oruka Therapeutics (NASDAQ: ORKA) ha comunicato i risultati finanziari del primo trimestre 2025 e fornito aggiornamenti sui programmi in pipeline. La società ha chiuso il primo trimestre con una solida posizione di cassa di 373 milioni di dollari, garantendo risorse fino al 2027. I punti salienti includono:
Il programma principale, ORKA-001, un anticorpo contro IL-23p19, ha completato la somministrazione della Fase 1 con dati attesi nel terzo trimestre 2025. L'inizio della Fase 2a è previsto per la seconda metà del 2025, con risultati di efficacia attesi nella seconda metà del 2026. Il secondo programma dell'azienda, ORKA-002, che mira a IL-17A/F, ha accelerato l'inizio della Fase 1 al secondo trimestre 2025.
I risultati finanziari mostrano spese per R&S pari a 19,9 milioni di dollari e spese generali e amministrative di 5,2 milioni di dollari nel primo trimestre 2025. L'azienda ha riportato una perdita netta di 21,0 milioni di dollari, che include 4,9 milioni di dollari di compensi azionari non monetari.
Oruka Therapeutics (NASDAQ: ORKA) informó sus resultados financieros del primer trimestre de 2025 y proporcionó actualizaciones sobre sus programas en desarrollo. La compañía cerró el primer trimestre con una sólida posición de efectivo de 373 millones de dólares, asegurando recursos hasta 2027. Los aspectos destacados incluyen:
Su programa principal, ORKA-001, un anticuerpo contra IL-23p19, completó la dosificación de la Fase 1 con datos esperados para el tercer trimestre de 2025. El inicio de la Fase 2a está planificado para la segunda mitad de 2025, con resultados de eficacia esperados en la segunda mitad de 2026. El segundo programa de la empresa, ORKA-002, dirigido a IL-17A/F, ha acelerado el inicio de la Fase 1 al segundo trimestre de 2025.
Los resultados financieros mostraron gastos en I+D de 19,9 millones de dólares y gastos generales y administrativos de 5,2 millones de dólares para el primer trimestre de 2025. La compañía reportó una pérdida neta de 21,0 millones de dólares, que incluye 4,9 millones de dólares en compensación basada en acciones no monetaria.
Oruka Therapeutics (NASDAQ: ORKA)는 2025년 1분기 재무 실적을 발표하고 파이프라인 프로그램에 대한 업데이트를 제공했습니다. 회사는 1분기를 3억 7,300만 달러의 강력한 현금 보유고로 마무리하여 2027년까지 운영 자금을 확보했습니다. 주요 내용은 다음과 같습니다:
주요 프로그램인 ORKA-001은 IL-23p19 항체로, 1상 투여를 완료했으며 데이터는 2025년 3분기에 발표될 예정입니다. 2a상 시작은 2025년 하반기로 계획되어 있으며, 효능 결과는 2026년 하반기에 나올 예정입니다. 두 번째 프로그램인 ORKA-002는 IL-17A/F를 표적으로 하며 1상 시작을 2025년 2분기로 앞당겼습니다.
재무 결과는 2025년 1분기 연구개발 비용이 1,990만 달러, 일반관리비가 520만 달러임을 보여줍니다. 회사는 2,100만 달러의 순손실을 보고했으며, 이 중 490만 달러는 비현금성 주식기반 보상입니다.
Oruka Therapeutics (NASDAQ : ORKA) a publié ses résultats financiers du premier trimestre 2025 et a fourni des mises à jour sur ses programmes en cours. La société a terminé le premier trimestre avec une solide trésorerie de 373 millions de dollars, assurant un financement jusqu'en 2027. Les points clés incluent :
Le programme principal, ORKA-001, un anticorps ciblant IL-23p19, a terminé la phase 1 de dosage avec des données attendues au troisième trimestre 2025. Le lancement de la phase 2a est prévu pour le second semestre 2025, avec des résultats d'efficacité attendus au second semestre 2026. Le deuxième programme de l'entreprise, ORKA-002, ciblant IL-17A/F, a accéléré le début de la phase 1 au deuxième trimestre 2025.
Les résultats financiers montrent des dépenses en R&D de 19,9 millions de dollars et des frais généraux et administratifs de 5,2 millions de dollars pour le premier trimestre 2025. La société a enregistré une perte nette de 21,0 millions de dollars, incluant 4,9 millions de dollars de compensation en actions non monétaire.
Oruka Therapeutics (NASDAQ: ORKA) veröffentlichte seine Finanzergebnisse für das erste Quartal 2025 und gab Updates zu seinen Pipeline-Programmen bekannt. Das Unternehmen schloss das erste Quartal mit einer starken Cash-Position von 373 Millionen US-Dollar ab, was eine Finanzierung bis 2027 sichert. Die wichtigsten Highlights sind:
Das Hauptprogramm ORKA-001, ein IL-23p19-Antikörper, hat die Dosierung der Phase 1 abgeschlossen, Daten werden im dritten Quartal 2025 erwartet. Der Start der Phase 2a ist für die zweite Hälfte 2025 geplant, der Wirksamkeitsnachweis für die zweite Hälfte 2026. Das zweite Programm des Unternehmens, ORKA-002, das auf IL-17A/F abzielt, hat den Beginn der Phase 1 auf das zweite Quartal 2025 vorgezogen.
Die Finanzergebnisse zeigten F&E-Ausgaben von 19,9 Millionen US-Dollar und Verwaltungs- und Gemeinkosten von 5,2 Millionen US-Dollar für das erste Quartal 2025. Das Unternehmen meldete einen Nettoverlust von 21,0 Millionen US-Dollar, der 4,9 Millionen US-Dollar an nicht zahlungswirksamer aktienbasierter Vergütung enthält.
- Strong cash position of $373 million providing runway through 2027
- Accelerated timeline for ORKA-002 Phase 1 trial initiation to Q2 2025
- ORKA-001's potential for 6-month to annual dosing versus current 2-3 month standard
- ORKA-002 shows 3x longer half-life than competitor bimekizumab
- Increased net loss to $21.0 million in Q1 2025 from $7.1 million in Q1 2024
- R&D expenses significantly increased to $19.9 million from $5.2 million year-over-year
Insights
Oruka shows strong pipeline momentum with accelerated timelines for ORKA-001 and ORKA-002, plus a solid $373M cash position extending runway through 2027.
Oruka Therapeutics' Q1 results reveal noteworthy acceleration across their psoriasis-focused pipeline. The completion of ORKA-001 Phase 1 dosing represents a meaningful operational achievement, with data expected in Q3 2025 - earlier than previously guided. The company's focus on extended dosing intervals could significantly differentiate their IL-23p19 inhibitor from established competitors requiring more frequent administration.
The Phase 2a study design for ORKA-001 shows scientific ambition with its PASI 100 primary endpoint versus the typical PASI 90 used in competitor studies - signaling confidence in achieving complete skin clearance. The inclusion of a non-redosing cohort to evaluate potential remission is particularly noteworthy in a disease category where continuous treatment is typically required.
For ORKA-002, the accelerated Phase 1 initiation to Q2 2025 (previously Q3) demonstrates operational efficiency. Preclinical data suggests comparable efficacy to bimekizumab but with a significantly improved dosing profile - potentially 2-3 times annually versus more frequent competitor dosing.
Financially, the $373 million cash position provides substantial runway through 2027, derisking the company through multiple value-creating clinical readouts. Q1 operating burn of $20.9 million appears reasonable given the advancing pipeline. The increase in R&D expenses to $19.9 million versus $5.2 million year-over-year reflects appropriate investment in clinical progression, while G&A expenses remain controlled at $5.2 million.
The strategic decision to withhold details on ORKA-003 signals competitive sensitivity but may create information asymmetry for investors. Overall, Oruka continues showing disciplined execution while advancing innovative approaches to chronic psoriasis treatment that focus on reduced treatment burden through extended dosing intervals.
Oruka's pipeline shows promising differentiation through extended dosing intervals and ambitious PASI 100 endpoints, representing potential paradigm shift in psoriasis treatment.
Oruka's clinical strategy demonstrates sophisticated understanding of unmet needs in psoriasis treatment. The ORKA-001 program targets a critical mechanistic pathway (IL-23p19) with proven efficacy, but aims to dramatically extend the treatment interval beyond the current standard of care. The expected half-life of potentially 50-75 days could enable semi-annual or even annual dosing compared to the bi-monthly or quarterly dosing required by current IL-23 inhibitors - addressing a major treatment burden issue.
The Phase 2a design warrants particular attention for two reasons: First, selecting PASI 100 (complete clearance) as the primary endpoint rather than the industry-standard PASI 90 represents a bold efficacy goal. Second, including a non-redosing cohort to evaluate potential disease remission is scientifically intriguing given accumulating evidence that IL-23 blockade may modify disease biology beyond symptom suppression.
For ORKA-002, targeting both IL-17A and IL-17F follows the mechanistic approach of bimekizumab but with the half-life advantage (30+ days in non-human primates vs. bimekizumab's shorter duration). This positions ORKA-002 favorably for 2-3 times yearly dosing while maintaining the dual cytokine inhibition that has shown superior efficacy to single IL-17A inhibition.
The ORKA-021 sequential combination approach represents innovative clinical thinking - leveraging IL-17A/F's rapid onset followed by IL-23p19's potentially disease-modifying effects. This sequential strategy could deliver both immediate symptom relief and durable remission, addressing two distinct patient priorities.
Psoriasis trials historically show robust signal detection with minimal placebo effects, making the upcoming Phase 2a particularly valuable for predicting ultimate efficacy. The emphasis on dosing convenience alongside efficacy suggests a patient-centered development approach that could significantly impact treatment paradigms if clinical promises materialize.
Continued operational excellence leading to acceleration of multiple timelines:
ORKA-001, targeting IL-23p19, Phase 1 trial dosing complete, with data expected in 3Q 2025
ORKA-001 Phase 2a initiation expected in 2H 2025, with efficacy readout expected in 2H 2026 that will provide multiple opportunities to show differentiation over standard of care
ORKA-002, targeting IL-17A/F, Phase 1 initiation accelerated to 2Q 2025, with initial PK data now expected around YE 2025; data will support both ORKA-002 and ORKA-021 psoriasis studies
Strong cash position of
MENLO PARK, Calif., May 14, 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, today reported first quarter 2025 financial results and provided a corporate update.
“We are thrilled with the continued rapid progress we are making to advance our co-lead programs, which we think could set a new standard in the treatment of psoriatic disease,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We’re excited to soon have both of our co-lead programs, ORKA-001 and ORKA-002, in the clinic and release our first clinical data on ORKA-001. As we ramp up preparations for our first psoriasis studies, we are energized by the reception from physicians who clearly see the potential to advance the treatment paradigm in this important disease.”
First Quarter Business and Pipeline Updates
ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody
- Oruka’s Phase 1 trial of ORKA-001 is progressing, with dosing completed for all 24 subjects across three dose levels. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001. The Company expects to share interim data from this trial, including initial PK data, in 3Q 2025 (previously 2H 2025).
- Based on PK modeling, the Company expects that a human half-life of 50 days or more will support dosing every six months whereas a half-life of 75 days or more could support dosing once per year. In comparison, currently approved IL-23p19 inhibitors require maintenance dosing every two or three months.
- Oruka plans to initiate a Phase 2a proof-of-concept study of ORKA-001 in 2H 2025 that will enroll approximately 80 patients with moderate-to-severe plaque psoriasis. The planned study design is innovative, with a primary endpoint of PASI 100 at week 16 (versus PASI 90 for prior biologics studies) and maintenance arms evaluating a six-month dosing interval alongside a cohort of patients who are not re-dosed to test the potential for off-treatment remission in some patients. The Company expects to share efficacy and response duration data from this study in the 2H 2026. Psoriasis trials historically have low placebo rates and good reproducibility across phases of development, making this Phase 2a readout particularly impactful for derisking ORKA-001.
ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody
- Oruka plans to initiate a Phase 1 trial of ORKA-002 in 2Q 2025 (previously 3Q 2025). The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and PK of ORKA-002 in approximately 24 healthy volunteers. The Company expects to share interim data from this trial, including initial PK data, around year end 2025 (previously 1H 2026).
- At the American Academy of Dermatology Annual Meeting in March, the Company presented data from its preclinical studies of ORKA-002. The data showed that ORKA-002 has a half-life in non-human primates of over 30 days, more than three times longer than bimekizumab, which is expected to support a dose interval of two to three times per year. Also, ORKA-002 has similar potency to bimekizumab and binds to nearly identical epitopes on IL-17A and IL-17F with comparable affinity.
Additional programs
- ORKA-021 (ORKA-002 → ORKA-001): Oruka continues to advance a sequential combination regimen of ORKA-002 and ORKA-001, which could deliver rapid and deep responses with an ideal maintenance profile. ORKA-021 could create another opportunity for the Company to define the best possible regimen for the treatment of psoriatic disease.
- ORKA-003: The Company continues to progress ORKA-003 through preclinical development. Based on competitive considerations, the Company is no longer planning to disclose additional details on ORKA-003 in 1H 2025.
First Quarter 2025 Financial Results
Cash Position: As of March 31, 2025, Oruka had available cash, cash equivalents, and marketable securities of
Research and Development (R&D) expenses: R&D expenses totaled
General and Administrative (G&A) expenses: G&A expenses totaled
Other income (expense), net: Other income, net for the first quarter of 2025 was
Net loss: Net loss totaled
Shares Outstanding: Oruka has approximately 55.1 million shares of the Company’s common stock and common stock equivalents issued and outstanding, including shares of common stock underlying pre-funded warrants and non-voting convertible preferred stock.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.
Forward Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001 and ORKA-002, including timelines to clinical and data release milestones as well as trial initiation timelines, the details of its planned clinical studies, the potential half-life of ORKA-001 and ORKA-002 and the potential dosing intervals of ORKA-001 and ORKA-002, as well as Oruka’s anticipated cash runway. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K, Quarterly Report on Form 10-Q and its registration statement on Form S-1. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.
Investor Contact:
Alan Lada
(650)-606-7911
alan.lada@orukatx.com
| ORUKA THERAPEUTICS, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands) | ||||||||
| (unaudited) | ||||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 83,572 | $ | 61,575 | ||||
| Marketable securities, current | 265,522 | 314,073 | ||||||
| Prepaid expenses and other current assets | 2,989 | 1,221 | ||||||
| Total current assets | 352,083 | 376,869 | ||||||
| Marketable securities, long-term | 23,953 | 18,069 | ||||||
| Property and equipment, net | 159 | 162 | ||||||
| Operating lease right-of-use assets | 814 | 876 | ||||||
| Other non-current assets | 103 | 43 | ||||||
| Total assets | $ | 377,112 | $ | 396,019 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,545 | $ | 3,462 | ||||
| Accrued expenses and other current liabilities | 5,663 | 3,346 | ||||||
| Operating lease liability, current | 283 | 213 | ||||||
| Related party common stock warrant liability | 1,415 | — | ||||||
| Related party accounts payable and other current liabilities | 817 | 6,022 | ||||||
| Total current liabilities | 11,723 | 13,043 | ||||||
| Operating lease liability, non-current | 664 | 755 | ||||||
| Total liabilities | 12,387 | 13,798 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Series B non-voting convertible preferred stock | 2,931 | 2,931 | ||||||
| Common stock | 37 | 37 | ||||||
| Additional paid-in capital | 466,486 | 463,018 | ||||||
| Accumulated other comprehensive loss | (6 | ) | (41 | ) | ||||
| Accumulated deficit | (104,723 | ) | (83,724 | ) | ||||
| Total stockholders’ equity | 364,725 | 382,221 | ||||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 377,112 | $ | 396,019 | ||||
| ORUKA THERAPEUTICS, INC. | |||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||
| (in thousands, except share and per share data) | |||||||||
| (unaudited) | |||||||||
| Three Months Ended March 31, 2025 | Period from February 6, 2024 (Inception) to March 31, 2024 | ||||||||
| Operating expenses | |||||||||
| Research and development(1) | $ | 19,925 | $ | 5,193 | |||||
| General and administrative(1) | 5,161 | 1,670 | |||||||
| Total operating expenses | 25,086 | 6,863 | |||||||
| Loss from operations | (25,086 | ) | (6,863 | ) | |||||
| Other income (expense) | |||||||||
| Interest income | 4,092 | — | |||||||
| Interest expense | — | (214 | ) | ||||||
| Other expense, net | (5 | ) | — | ||||||
| Total other income (expense), net | 4,087 | (214 | ) | ||||||
| Net Loss | (20,999 | ) | (7,077 | ) | |||||
| Net change in unrealized gains (losses) on marketable securities | 35 | - | |||||||
| Comprehensive loss | $ | (20,964 | ) | $ | (7,077 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.40 | ) | $ | (2.21 | ) | |||
| Net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted | $ | (32.95 | ) | $ | - | ||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 41,679,560 | 3,197,975 | |||||||
| Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted | 137,138 | - | |||||||
| (1) Amounts include non-cash stock based compensation expense as follows (in thousands): | |||||||||
| Three Months Ended March 31, 2025 | Period from February 6, 2024 (Inception) to March 31, 2024 | ||||||||
| Research and development | $ | 3,003 | $ | 70 | |||||
| General and administrative | 1,880 | 15 | |||||||
| Total | $ | 4,883 | $ | 85 | |||||
FAQ
What is ORKA's cash runway and financial position as of Q1 2025?
When will Oruka Therapeutics (ORKA) release ORKA-001 Phase 1 clinical data?
What are the key differences between ORKA-001 and current IL-23p19 inhibitors?
What is the timeline for ORKA's Phase 2a psoriasis trial?
How much did Oruka Therapeutics (ORKA) spend on R&D in Q1 2025?
