ORKA-001 EVERLAST-A 16-week data now expected in 2Q 2026 following rapid enrollment, with longer-term follow-up data expected in 2H 2026
ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027
$479.6 million in cash, cash equivalents and marketable securities
MENLO PARK, Calif., March 12, 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 (PsO), today reported fourth quarter and full year 2025 financial results and provided a corporate update.
"We are very pleased with the progress of both our co-lead programs as we advance into what could be a transformative year for our company," said Lawrence Klein, PhD, Chief Executive Officer of Oruka. "Given strong site engagement and enthusiasm, EVERLAST-A completed enrollment in December 2025, enabling us to bring our initial data release into the second quarter of 2026. Meanwhile, we are excited to be starting our Phase 2 efforts with ORKA-002, which we believe could be a very impactful program in psoriatic disease and HS."
Fourth Quarter 2025 and Recent Business and Pipeline Updates
ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody
- Enrollment in EVERLAST-A was completed in December 2025. As a result, the Company now expects to report Week 16 data for all patients in the second quarter of 2026. In addition, the Company plans to provide longer-term data, including Week 28 for all patients and 52-week follow-up for a portion of the cohort in the second half of 2026.
- The first patients were dosed in EVERLAST-B in December 2025 and enrollment is ongoing. EVERLAST-B is evaluating multiple induction regimens of ORKA-001, with a primary endpoint of PASI 100 at Week 16. Data from EVERLAST-B is anticipated in 2027 and will be used to support initiation of a Phase 3 program.
ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody
- In February 2026, the Company initiated ORCA-SURGE, a Phase 2 trial designed to evaluate the safety and efficacy of ORKA-002 in moderate-to-severe PsO patients. The primary endpoint will be PASI 100 at Week 16. Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. Data from ORCA-SURGE is anticipated in 2027.
- In January 2026, Oruka announced positive interim Phase 1 data demonstrating a half-life of approximately 75-80 days and pharmacokinetic modeling supporting twice-yearly maintenance dosing in psoriasis and quarterly dosing in HS.
- The Company is on track to initiate a Phase 2 trial of ORKA-002 for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in the second half of 2026.
Additional updates
- In December 2025, the Company announced the addition of Chris Martin to its Board of Directors, adding significant commercial and business development expertise.
Fourth Quarter and Full Year 2025 Financial Results
Cash Position: As of December 31, 2025, Oruka had cash, cash equivalents and marketable securities of $479.6 million. Net cash used in operating activities was $22.6 million for the fourth quarter of 2025 and $88.2 million for the full year 2025 compared to $18.8 million for the fourth quarter of 2024 and $57.8 million for the period from February 6, 2024 (inception) to December 31, 2024.
Research and Development (R&D) Expenses: R&D expenses were $27.6 million for the fourth quarter of 2025 and $100.6 million for the full year 2025, compared to $25.5 million for the fourth quarter of 2024 and $75.1 million for the period from February 6, 2024 (inception) to December 31, 2024. The increases were primarily related to additional clinical trials of Oruka's programs.
General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the fourth quarter of 2025 and $21.4 million for the full year 2025, compared to $4.8 million for the fourth quarter of 2024 and $13.1 million for the period from February 6, 2024 (inception) to December 31, 2024. The increases were primarily related to employee compensation-related expenses, including stock-based compensation from higher headcount.
Other income, net: Other income, net was $4.8 million and $16.6 million for the fourth quarter and full year 2025, respectively, compared to $4.5 million for the fourth quarter of 2024 and $4.4 million for the period from February 6, 2024 (inception) to December 31, 2024. The increases were primarily related to interest earned on the Company's cash and marketable securities.
Net Loss: Net loss was $29.6 million for the fourth quarter of 2025 and $105.4 million for the full year 2025, compared to $25.8 million for the fourth quarter of 2024 and $83.7 million for the period from February 6, 2024 (inception) to December 31, 2024.
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, the details of its planned clinical studies, the potential dosing intervals of ORKA-001 and ORKA-002, the anticipated half-life of ORKA-002, as well as the Company's 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 and Quarterly Reports on Form 10-Q. 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 | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | - | 46,935 | - | 61,575 | ||||
| Marketable securities, current | 290,109 | 314,073 | ||||||
| Prepaid expenses and other current assets | 6,813 | 1,221 | ||||||
| Total current assets | 343,857 | 376,869 | ||||||
| Marketable securities, long-term | 142,539 | 18,069 | ||||||
| Property and equipment, net | 288 | 162 | ||||||
| Operating lease right-of-use assets | 1,830 | 876 | ||||||
| Other non-current assets | 103 | 43 | ||||||
| Total assets | - | 488,617 | - | 396,019 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | - | 4,155 | - | 3,462 | ||||
| Accrued expenses and other current liabilities | 10,591 | 3,346 | ||||||
| Operating lease liability, current | 619 | 213 | ||||||
| Related party accounts payable and other current liabilities | 9 | 6,022 | ||||||
| Total current liabilities | 15,374 | 13,043 | ||||||
| Operating lease liability, non-current | 1,313 | 755 | ||||||
| Total liabilities | 16,687 | 13,798 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Series B non-voting convertible preferred stock | 2,931 | 2,931 | ||||||
| Common stock | 49 | 37 | ||||||
| Additional paid-in capital | 657,561 | 463,018 | ||||||
| Accumulated other comprehensive income (loss) | 546 | (41 | - | |||||
| Accumulated deficit | (189,157 | - | (83,724 | - | ||||
| Total stockholders' equity | 471,930 | 382,221 | ||||||
| Total liabilities and stockholders' equity | - | 488,617 | - | 396,019 | ||||
| ORUKA THERAPEUTICS, INC. | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended December 31, 2025 | Three Months Ended December 31, 2024 | Year Ended December 31, 2025 | Period from February 6, 2024 (inception) to December 31, 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development(1) | - | 27,640 | - | 25,503 | - | 100,640 | - | 75,060 | ||||||||
| General and administrative(1) | 6,791 | 4,815 | 21,411 | 13,063 | ||||||||||||
| Total operating expenses | 34,431 | 30,318 | 122,051 | 88,123 | ||||||||||||
| Loss from operations | (34,431 | - | (30,318 | - | (122,051 | - | (88,123 | - | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 4,849 | 4,533 | 16,630 | 5,863 | ||||||||||||
| Interest expense | - | - | - | (1,468 | - | |||||||||||
| Other income (expense), net | (1 | - | 4 | (12 | - | 4 | ||||||||||
| Total other income, net | 4,848 | 4,537 | 16,618 | 4,399 | ||||||||||||
| Net Loss | (29,583 | - | (25,781 | - | (105,433 | - | (83,724 | - | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | - | (0.45 | - | - | (0.49 | - | - | (1.85 | - | - | (3.87 | - | ||||
| Net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted | - | - | - | (488.06 | - | - | - | - | (3,873.25 | - | ||||||
| Net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted | - | (37.44 | - | - | (40.64 | - | - | (154.03 | - | - | (322.81 | - | ||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 54,420,045 | 40,134,008 | 45,614,142 | 16,789,362 | ||||||||||||
| Weighted-average shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted | - | 1,299 | - | 495 | ||||||||||||
| Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted | 137,138 | 137,138 | 137,138 | 51,946 | ||||||||||||
| (1) Amounts include non-cash stock based compensation expense (including Paruka warrant obligation) as follows (in thousands): | ||||||||||||||||
| Three Months Ended December 31, 2025 | Three Months Ended December 31, 2024 | Year Ended December 31, 2025 | Period from February 6, 2024 (inception) to December 31, 2024 | |||||||||||||
| Research and development | - | 2,307 | - | 3,682 | - | 17,019 | - | 11,992 | ||||||||
| General and administrative | 1,808 | 1,468 | 7,221 | 2,927 | ||||||||||||
| Total | - | 4,115 | - | 5,150 | - | 24,240 | - | 14,919 | ||||||||
