Oruka Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update

Quarterly operating cash use rose to $44.3 million as Oruka advanced its clinical programs.

Rhea-AI Summary

Oruka Therapeutics (ORKA) reported third-quarter 2026 results and clinical updates, including a $49.965 million net loss and additional ORKA-001 trial results. The quarterly loss widened from $30.277 million a year earlier; cash, cash equivalents and marketable securities totaled $1.2 billion at September 30.

In EVERLAST-B, 61% of high-dose patients achieved complete psoriasis clearance at Week 16, versus none on placebo. In EVERLAST-A, complete clearance increased to 71% at Week 28, with no further dosing after Week 4. Oruka expects EVERLAST-A 52-week results in December 2026 and plans Phase 3 initiation in the first half of 2027, pending regulatory discussions. ORKA-002's psoriasis trial completed enrollment of 171 patients, with Week 16 results expected in the first quarter of 2027. ORKA-004 clinical development remains targeted for the fourth quarter of 2026.

14 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 11 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointEVERLAST-B high-dose ORKA-001 achieved 61% complete psoriasis clearance at Week 16, versus 0% on placebo.
• Moderate pointEVERLAST-A responses increased to 71% complete clearance and 87% PASI 90 at Week 28 without dosing after Week 4.
• Moderate point. Forward-looking: it has not happened yet and may not happen.ORKA-001 Phase 3 trials are planned for the first half of 2027 using the 600 mg dose.
• Moderate point. Forward-looking: it has not happened yet and may not happen.ORKA-002 psoriasis trial completed enrollment of 171 patients; Week 16 data are expected in first-quarter 2027.
• Moderate pointCash, cash equivalents and marketable securities totaled $1.2 billion at September 30, 2026.

9 minor points

• Minor pointEVERLAST-B high-dose ORKA-001 achieved 86% PASI 90 and IGA 0/1, versus 0% on placebo for both measures.
• Minor pointORKA-001 remained well tolerated in EVERLAST-B and maintained a favorable safety and tolerability profile in EVERLAST-A.
• Minor point. Forward-looking: it has not happened yet and may not happen.EVERLAST-A 52-week data are expected in December 2026; EVERLAST-B 52-week data are expected in second-half 2027.
• Minor pointORKA-002's Phase 2 hidradenitis suppurativa trial continues to progress.
• Minor point. Forward-looking: it has not happened yet and may not happen.ORKA-004 clinical development remains on track to begin in fourth-quarter 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.ORKA-004 combination studies with ORKA-001 or ORKA-002 are planned for 2027.
• Minor pointThird-quarter total other income increased to $12.171 million from $3.828 million a year earlier.
• Minor pointNine-month total other income increased to $25.686 million from $11.770 million a year earlier.
• Minor pointThird-quarter non-cash stock-based compensation decreased to $9.131 million from $10.165 million a year earlier.

Negative

• Minor pointThird-quarter net loss widened to $49.965 million from $30.277 million a year earlier.
• Minor pointThird-quarter common-share loss increased to $0.63 from $0.55 a year earlier, basic and diluted.
• Minor pointThird-quarter operating cash use increased to $44.3 million from $21.6 million a year earlier.
• Minor pointThird-quarter research and development expenses rose to $53.696 million from $28.988 million a year earlier.
• Minor pointThird-quarter general and administrative expenses rose to $8.440 million from $5.117 million a year earlier.

6 minor points

• Minor pointNine-month net loss widened to $122.991 million from $75.850 million a year earlier.
• Minor pointNine-month common-share loss increased to $1.67 from $1.40 a year earlier, basic and diluted.
• Minor pointNine-month research and development expenses rose to $126.098 million from $73.000 million a year earlier.
• Minor pointNine-month general and administrative expenses rose to $22.579 million from $14.620 million a year earlier.
• Minor pointNine-month non-cash stock-based compensation increased to $23.383 million from $20.125 million a year earlier.
• Minor pointORKA-001 Phase 3 initiation remains pending discussions with regulatory authorities.

News Explained

As of September 30, 2026, Oruka reported $1.2 billion in cash, cash equivalents and marketable securities and $44.3 million of third-quarter operating cash use; at that quarter’s rate, the balance equaled 2,504.3 days of use, a historical sizing, not a forecast.

Sources and calculations

• Oruka Therapeutics Q3 2026 financial results and corporate update (2026-11-09)
• Oruka Therapeutics Q3 2026 financial figures (2026-09-30)

• Available liquidity against the last reported quarterly operating outflow, in days at that rate ($191,519,000 + $728,758,000 + $286,310,000) / ($44,326,000 / 92) = 2504.3 days

Key Figures

PASI 100: 61% PASI 90: 86% PASI 100: 71% +5 more

PASI 100

61%

EVERLAST-B high-dose group at Week 16

PASI 90

86%

EVERLAST-B high-dose group at Week 16

PASI 100

71%

EVERLAST-A at Week 28

PASI 90

87%

EVERLAST-A at Week 28

Cash, cash equivalents, and marketable securities

$1.2 billion

As of September 30, 2026

Net cash used in operating activities

$44.3 million vs. $21.6 million

Third quarter 2026 vs. third quarter 2025

Net loss

$50.0 million vs. $30.3 million

Third quarter 2026 vs. third quarter 2025

Planned Phase 3 initiation

First half of 2027

ORKA-001 psoriasis trials, pending regulatory discussions

Previous Earnings Reports

1 past event · Latest: Aug 10

Same Type 1 event

1. Aug 10

   Quarterly results

   24h Move

   +6.4%

   EVERLAST-A Week 16 response established a prior PASI 100 benchmark before the current Week 28 update.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pasi 100, monoclonal antibody, placebo-controlled, open-label, +1 more

5 terms

pasi 100 medical

"achieving the primary endpoint of PASI 100 at Week 16"

PASI 100 is a clinical-trial measure meaning a patient’s psoriasis has cleared completely, showing a 100% improvement on the Psoriasis Area and Severity Index. Think of it like a before-and-after photo where all visible signs of the condition are gone. For investors, PASI 100 signals a therapy’s top-level effectiveness claim, which can drive regulatory approval prospects, market adoption and a product’s commercial value.

monoclonal antibody medical

"A novel half-life extended IL-23p19 monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

placebo-controlled medical

"a randomized, double-blind, placebo-controlled trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

open-label medical

"participants enter an open-label maintenance period"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

primary endpoint medical

"achieving the primary endpoint of PASI 100 at Week 16"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

EVERLAST-B Week 16 results showed 61% PASI 100 and 86% PASI 90 in the ORKA-001 high-dose group, highly consistent with EVERLAST-A

EVERLAST-A responses continued to deepen to 71% PASI 100 at Week 28, 6 months after last dose

EVERLAST-A 52-week data expected in December 2026; Phase 3 program on track to begin 1H 2027

ORKA-002 ORCA-SURGE Phase 2 enrollment completed with Week 16 data in psoriasis expected in 1Q 2027

MENLO PARK, Calif., Nov. 09, 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) and hidradenitis suppurativa (HS), today reported third quarter 2026 financial results and provided a corporate update.

“We continued to make rapid progress in the third quarter and shared two new datasets from the EVERLAST program with ORKA-001 that further strengthen our belief that it can set a new standard in psoriatic disease,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We look forward to sharing 52-week data from EVERLAST-A later this year and then working to rapidly initiate pivotal studies with this very promising asset. In parallel, we are building depth in our portfolio with ORKA-002 advancing in two Phase 2 studies, and ORKA-004 nearing first-in-human initiation.”

Third Quarter 2026 and Recent Business and Pipeline Updates

ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody

• In October 2026, the Company announced positive Week 16 results from EVERLAST-B, a Phase 2b dose-ranging trial of ORKA-001 in moderate-to-severe PsO. Efficacy increased across dose levels in a dose-dependent manner, with 61% of patients in the high-dose group (600 mg at Weeks 0 and 4) achieving the primary endpoint of PASI 100 at Week 16, and 86% of patients achieving each of PASI 90 and IGA 0/1 at Week 16. Placebo rates were at the lower end of what is typically seen in psoriasis studies, with no patients in the placebo group reaching PASI 100, PASI 90, or IGA 0/1 at Week 16. These results were highly consistent with the results observed in EVERLAST-A. ORKA-001 continued to be well tolerated, with a safety profile consistent with the IL-23p19 class.
• In September 2026, the Company presented Week 28 data from EVERLAST-A, a Phase 2a trial testing ORKA-001 600 mg at Weeks 0 and 4 versus placebo in moderate-to-severe PsO. Clinical responses continued to deepen through Week 28 despite participants receiving no further doses since Week 4, with PASI 100 rates increasing to 71% and PASI 90 rates increasing to 87%. ORKA-001 maintained a favorable safety and tolerability profile.
• Based on these results and pending discussions with regulatory authorities, the Company plans to initiate Phase 3 trials of ORKA-001 in moderate-to-severe PsO in the first half of 2027 with the 600 mg dose.
• The Company expects to report 52-week data from EVERLAST-A in December 2026, and 52-week data from EVERLAST-B in the second half of 2027.

ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody

• ORCA-SURGE, a Phase 2 dose-ranging trial of ORKA-002 in moderate-to-severe PsO, has completed enrollment of 171 patients, and the Company remains on track to report Week 16 data in the first quarter of 2027.
• ORCA-SPLASH, a Phase 2 trial of ORKA-002 in moderate-to-severe HS, is progressing well. ORCA-SPLASH is a randomized, double-blind, placebo-controlled trial of ORKA-002 versus placebo being conducted in the United States and Canada. The primary endpoint is HiSCR75 at Week 16, after which participants enter an open-label maintenance period evaluating ORKA-002 administered every 12 weeks.

Additional updates

• ORKA-004, a novel, subcutaneously administered, half-life extended monoclonal antibody targeting TL1A, remains on track for initiation of clinical development in the fourth quarter of 2026. The Company plans to initiate Phase 2 combination studies of ORKA-004 with ORKA-001 or ORKA-002 in 2027.
• In August 2026, the Company appointed Todd Edwards as Chief Commercial Officer. Mr. Edwards brings more than 25 years of commercial leadership experience across immunology and dermatology, joining Oruka from Arcutis Biotherapeutics, where he served as Executive Vice President and Chief Commercial Officer.

Third Quarter 2026 Financial Results

Cash Position: As of September 30, 2026, Oruka had cash, cash equivalents, and marketable securities of $1.2 billion. Net cash used in operating activities was $44.3 million for the third quarter of 2026 compared to $21.6 million for the third quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $53.7 million for the third quarter of 2026, compared to $29.0 million for the third quarter of 2025. The increase was primarily related to additional clinical trials and associated costs of Oruka’s programs and higher employee compensation expenses, including stock-based compensation driven by increased headcount. The increase in stock-based compensation was offset by the absence of expense related to the Paruka warrant obligation from the prior year.

General and Administrative (G&A) Expenses: G&A expenses were $8.4 million for the third quarter of 2026, compared to $5.1 million for the third quarter of 2025. The increase was primarily related to higher employee compensation-related expenses, including stock-based compensation, to support the operations of a growing public company.

Other income, net: Other income, net was $12.2 million for the third quarter of 2026, compared to $3.8 million for the third quarter of 2025. The increase was primarily driven by interest earned on higher cash and marketable securities balances.

Net Loss: Net loss was $50.0 million and $30.3 million for the third quarters of 2026 and 2025, respectively, which includes non-cash stock-based compensation of $9.1 million and $10.2 million for the third quarters of 2026 and 2025, respectively.

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 inflammatory diseases like plaque psoriasis and hidradenitis suppurativa the greatest possible freedom from their condition by achieving high rates of disease clearance with dosing as infrequently as once or twice a year. 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 regarding Oruka’s plans and expectations for its pipeline and business including the potential benefits, efficacy, safety, durability of response, dosing profile and therapeutic potential of its product candidates; the design, initiation, enrollment, conduct, timing, progress and results of the Company’s clinical studies, including EVERLAST-A, EVERLAST-B, ORCA-SURGE and ORCA-SPLASH; the expected timing of 52-week data from EVERLAST-A and EVERLAST-B and Week 16 data from ORCA-SURGE; the planned initiation of Phase 3 trials of ORKA-001 in the first half of 2027; the anticipated initiation of clinical development of ORKA-004 in the fourth quarter of 2026 and the planned initiation of combination studies of ORKA-004 with ORKA-001 or ORKA-002 in 2027; and the Company’s development plans and expectations for ORKA-001, ORKA-002 and ORKA-004. 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)
	September 30,				December 31,
	2026				2025
Assets
Current assets:
Cash and cash equivalents	$	191,519			$	46,935
Marketable securities, current		728,758				290,109
Prepaid expenses and other current assets		21,216				6,813
Total current assets		941,493				343,857
Marketable securities, long-term		286,310				142,539
Property and equipment, net		309				288
Operating lease right-of-use assets		2,786				1,830
Other non-current assets		128				103
Total assets	$	1,231,026			$	488,617
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	14,377			$	4,155
Accrued expenses and other current liabilities		16,516				10,591
Operating lease liability, current		838				619
Related party accounts payable and other current liabilities		50				9
Total current liabilities		31,781				15,374
Operating lease liability, non-current		2,094				1,313
Total liabilities		33,875				16,687
Commitments and contingencies
Stockholders’ equity:
Series B non-voting convertible preferred stock		2,020				2,931
Common stock		67				49
Additional paid-in capital		1,512,253				657,561
Accumulated other comprehensive income (loss)		(5,041	)			546
Accumulated deficit		(312,148	)			(189,157	)
Total stockholders’ equity		1,197,151				471,930
Total liabilities and stockholders’ equity	$	1,231,026			$	488,617

ORUKA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share and per share data)
		Three Months Ended September 30,									Nine Months Ended September 30,
		2026				2025					2026				2025
Operating expenses:
Research and development(1)		$	53,696			$	28,988				$	126,098			$	73,000
General and administrative(1)			8,440				5,117					22,579				14,620
Total operating expenses			62,136				34,105					148,677				87,620
Loss from operations			(62,136	)			(34,105	)				(148,677	)			(87,620	)
Other income (expense):
Interest income			12,166				3,832					25,669				11,781
Other income (expense), net			5				(4	)				17				(11	)
Total other income, net			12,171				3,828					25,686				11,770
Net Loss		$	(49,965	)		$	(30,277	)			$	(122,991	)		$	(75,850	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.63	)		$	(0.55	)			$	(1.67	)		$	(1.40	)
Net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted		$	(52.40	)		$	(45.46	)			$	(139.45	)		$	(116.94	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted			71,590,343				44,067,059					63,268,180				42,622,935
Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted			94,497				137,138					122,768				137,138
(1) Amounts include non-cash stock-based compensation expense as follows (in thousands):
		Three Months Ended September 30,									Nine Months Ended September 30,
		2026				2025					2026				2025
Research and development		$	4,740			$	8,341				$	12,232			$	14,712
General and administrative			4,391				1,824					11,151				5,413
Total		$	9,131			$	10,165				$	23,383			$	20,125

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Oruka's EVERLAST-B trial show for ORKA-001?

At Week 16, 61% of high-dose patients achieved PASI 100, meaning complete psoriasis clearance, versus no patients on placebo. The high-dose group received 600 mg at Weeks 0 and 4. PASI 90, meaning at least 90% improvement in psoriasis severity, and IGA 0/1, an investigator-rated skin assessment, were each achieved by 86%, versus none on placebo.

What were Oruka's third-quarter 2026 financial results?

Oruka reported a $49.965 million net loss, compared with $30.277 million a year earlier. Basic and diluted loss per common share was $0.63, versus $0.55. Cash, cash equivalents and marketable securities totaled $1.2 billion at September 30, 2026.

How is Oruka testing ORKA-002 in hidradenitis suppurativa?

The ORCA-SPLASH Phase 2 trial compares ORKA-002 with placebo in patients with moderate-to-severe hidradenitis suppurativa in the United States and Canada. It is randomized and double-blind. Its primary endpoint is HiSCR75 at Week 16, followed by an open-label maintenance period evaluating dosing every 12 weeks.

Why did Oruka's third-quarter 2026 expenses increase?

Oruka attributed higher research and development expenses primarily to additional clinical trials and associated program costs, along with higher employee compensation expenses as headcount increased. Higher general and administrative expenses primarily reflected employee compensation, including stock-based compensation, to support its growing public-company operations.