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

Rhea-AI Summary

Oruka Therapeutics (Nasdaq: ORKA) reported first quarter 2026 results and clinical, financing, and partnering updates.

ORKA-001 EVERLAST-A 16-week data showed 63.5% PASI 100, strong PASI 90/IGA responses, and tolerability similar to placebo, with PK/PD supporting potential annual dosing. ORKA-002 advanced into Phase 2 psoriasis with HS Phase 2 planned for 2H 2026. A $700 million upsized public offering and a Halozyme Hypercon collaboration are expected to fund operations through an anticipated BLA for ORKA-001 and continued ORKA-002 development. Cash, cash equivalents and marketable securities were $496.0 million; Q1 2026 net loss was $31.8 million.

Positive

• EVERLAST-A: 63.5% PASI 100 at Week 16 for ORKA-001
• 83% PASI 90 and 84% IGA 0/1 at Week 16 for ORKA-001
• ORKA-001 PK/PD data support potential once-yearly dosing
• ORKA-002 Phase 2 psoriasis trial initiated; HS Phase 2 planned 2H 2026
• $700 million upsized public offering to fund BLA for ORKA-001 and ORKA-002 work
• Halozyme Hypercon collaboration with exclusive IL-23p19 psoriatic disease rights

Negative

• Net loss increased to $31.8 million from $21.0 million year over year
• R&D expenses rose to $29.1 million from $19.9 million
• G&A expenses increased to $7.3 million from $5.2 million
• Net cash used in operating activities grew to $23.6 million from $20.9 million

News Market Reaction – ORKA

+1.14%

+1.14% Session close to close

In the May 14 session, ORKA gained 1.14%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement combines Q1 2026 results with notable clinical and financing milestones. ORKA-001 ...

Analysis

This announcement combines Q1 2026 results with notable clinical and financing milestones. ORKA-001 delivered high Week 16 PASI 100, 90, and IGA 0/1 rates, while ORKA-002 advanced into Phase 2 with additional trials planned. Cash and securities of $496.0 million, plus an upsized $700 million offering and an effective $1,000,000,000 shelf, frame the funding backdrop. Investors may watch longer-term efficacy data, expense trends, and future use of the shelf registration.

Key Figures

Cash & securities: $496.0 million R&D expenses: $29.1 million G&A expenses: $7.3 million +5 more

8 metrics

Cash & securities $496.0 million As of March 31, 2026

R&D expenses $29.1 million Q1 2026 (vs. $19.9M Q1 2025)

G&A expenses $7.3 million Q1 2026 (vs. $5.2M Q1 2025)

Net loss $31.8 million Q1 2026 (vs. $21.0M Q1 2025)

PASI 100 rate 63.5% ORKA-001 EVERLAST-A Week 16 (40/63 participants)

PASI 90 rate 83% ORKA-001 EVERLAST-A Week 16

IGA 0/1 rate 84% ORKA-001 EVERLAST-A Week 16

Upsized offering $700 million Public offering priced April 2026

Previous Earnings Reports

5 past events · Latest: Mar 12 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 12	Quarterly results	Positive	+25.0%	Q4 2025 results with strong cash and clear clinical timelines.
Nov 12	Quarterly results	Positive	-6.8%	Q3 2025 update showing balance sheet strength and PK data.
Aug 11	Quarterly results	Positive	+6.9%	Q2 2025 results with EVERLAST-A initiation and solid cash.
May 14	Quarterly results	Positive	-2.6%	Q1 2025 results with strong cash and pipeline acceleration.
Mar 06	Quarterly results	Positive	+3.9%	FY 2024 update with major fundraise and ORKA-001 entering Phase 1.

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

Pattern Detected

Earnings updates have often coincided with positive moves, but reactions have been mixed, ranging from a -6.78% decline to a strong +25.04% gain.

Recent Company History

Over the past five earnings releases from March 2025 through March 2026, Oruka consistently highlighted progress for ORKA-001 and ORKA-002 alongside a strengthening cash position, including cash balances between $351.5M and $500.9M. R&D investment and net losses have trended higher as programs advanced from Phase 1 into Phase 2. Price reactions have varied, suggesting that details of clinical timing, cash runway, and guidance around key readouts influence how earnings are received.

Key Terms

pasi 100, pasi 90, monoclonal antibody, pharmacokinetics (pk), +3 more

7 terms

pasi 100 medical

"63.5% PASI 100 rate and a favorable tolerability profile"

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.

pasi 90 medical

"PASI 90 at Week 16, achieved by 83% of participants"

PASI 90 is a clinical measure showing a 90% reduction in the size and severity of a patient’s psoriasis lesions compared with where they started, based on the Psoriasis Area and Severity Index (PASI). For investors, a drug or therapy that achieves PASI 90 signals very strong effectiveness—like shrinking a visible problem to almost nothing—which can boost the chances of regulatory approval, wider doctor use, higher pricing power and larger sales potential.

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.

pharmacokinetics (pk) medical

"updated pharmacokinetics (PK) and pharmacodynamics (PD) data"

Pharmacokinetics (PK) is the study of how a drug moves through and is processed by the body over time. It tracks how quickly a drug is absorbed, how it spreads, how it is broken down, and how it exits the body—similar to following a recipe’s ingredients from start to finish. For investors, understanding pharmacokinetics helps assess a drug’s effectiveness and safety, which can influence its market potential and valuation.

pharmacodynamics (pd) medical

"updated pharmacokinetics (PK) and pharmacodynamics (PD) data"

Pharmacodynamics (PD) is the study of how a drug affects the body and how the body's response changes with different drug doses. It explains how medications work to produce their effects, similar to how a thermostat controls room temperature. Understanding PD helps investors evaluate the potential effectiveness and risks of drugs, influencing decisions in the healthcare and pharmaceutical sectors.

biologics medical

"developing novel biologics designed to set a new standard"

Biologics are medicines made from living cells or their components rather than from simple chemical recipes, more like a handcrafted product than a mass-produced pill. They matter to investors because they often command higher prices and longer patent protection but also carry greater manufacturing, regulatory and supply risks—so a successful biologic can boost a company’s revenue significantly, while setbacks can quickly affect its stock.

hidradenitis suppurativa medical

"quarterly dosing in hidradenitis suppurativa (HS)."

A chronic skin disease marked by recurring, painful lumps and tunnels under the skin that often leak and leave scars; it behaves like a slow-burning, recurring infection in areas with many sweat glands. For investors, it matters because the condition has few consistently effective treatments and causes long-term healthcare use, making successful new drugs, devices, or diagnostics potentially high-value opportunities while also carrying clinical-trial, regulatory and reimbursement risks.

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

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ORKA-001 EVERLAST-A 16-week data showed 63.5% PASI 100 rate and a favorable tolerability profile, with longer-term data expected in 2H 2026

ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027

Post-offering cash, cash equivalents and marketable securities expected to fund Company through BLA for ORKA-001

MENLO PARK, Calif., May 13, 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 first quarter 2026 financial results and provided a corporate update.

“This was an important period for our company as we saw interim data for ORKA-001 that hit the upper end of our expectations on all aspects,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Based on this data we were able to strengthen our balance sheet and provide runway through completion of late-stage development for that program. We’re looking forward to multiple readouts coming in 2026 and 2027, including additional data from ORKA-001 and the beginning of our readouts for ORKA-002 as well.”

First Quarter 2026 and Recent Business and Pipeline Updates

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

• In April 2026, the Company presented positive data from its EVERLAST-A trial in moderate-to-severe PsO showing 40 of 63 (63.5%) participants treated with ORKA-001 achieved PASI 100 at Week 16. Other key secondary endpoints included PASI 90 at Week 16, achieved by 83% of participants, and IGA 0/1 at Week 16, achieved by 84% of participants. ORKA-001 was well tolerated with a safety profile similar to placebo and consistent with prior IL-23p19 inhibitors.
  
  
• Also in April 2026, the Company presented updated pharmacokinetics (PK) and pharmacodynamics (PD) data from the Phase 1 trial of ORKA-001, which continue to support the potential for annual dosing. Following a single 600 mg dose, ORKA-001 concentrations remained well above effective trough levels for an entire year, with sustained inhibition of IL-23 pathway signaling observed throughout that time period.
  
  
• Oruka plans to share longer-term data from EVERLAST-A, including efficacy at Week 28 for all patients and 52-week follow-up for a subset of the cohort, in the second half of 2026.
  
  
• EVERLAST-B, a Phase 2b trial of ORKA-001 in moderate-to-severe PsO, is progressing well with North American and European sites active. Initial data from this study is expected in 2027 and Week 16 data is intended to support Phase 3 initiation.
  
  

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

• In March 2026, the Company announced the initiation of ORCA-SURGE, a Phase 2 trial of ORKA-002 in moderate-to-severe PsO. That study is progressing well with data 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 PsO and quarterly dosing in hidradenitis suppurativa (HS).
  
  
• The Company is on track to initiate ORCA-SPLASH, a Phase 2 trial of ORKA-002 in moderate-to-severe HS, in the second half of 2026.
  
  

Additional updates

• In April 2026, the Company announced the pricing of an upsized $700 million public offering. Proceeds from this offering, including existing cash, are expected to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.
  
  
• In May 2026, the Company announced a collaboration and license agreement with Halozyme to develop ORKA-001 with Hypercon™ technology. The agreement provides exclusive rights for IL-23p19 in psoriatic disease and an option for one additional target. This collaboration has the potential to further enhance the product profile Oruka can offer to patients over time.
  
  

First Quarter 2026 Financial Results

Cash Position: As of March 31, 2026, Oruka had cash, cash equivalents, and marketable securities of $496.0 million. Net cash used in operating activities was $23.6 million for the first quarter of 2026 compared to $20.9 million for the first quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $29.1 million for the first quarter of 2026, compared to $19.9 million for the first 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 from higher headcount.

General and Administrative (G&A) Expenses: G&A expenses were $7.3 million for the first quarter of 2026, compared to $5.2 million for the first quarter of 2025. The increase was primarily related to employee compensation-related expenses, including stock-based compensation from higher headcount.

Other income, net: Other income, net was $4.6 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025. The increase was primarily due to interest earned on higher cash and marketable securities balances.

Net Loss: Net loss was $31.8 million and $21.0 million for the first 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 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 planned design, initiation, progress and results of its clinical studies (including EVERLAST-A, EVERLAST-B, ORCA-SURGE and ORCA-SPLASH), the potential dosing intervals of ORKA-001 and ORKA-002, the anticipated half-life and pharmacokinetic profile of ORKA-002, the potential benefits of its collaboration with Halozyme, and Oruka’s expected cash runway and ability to fund operations through an anticipated BLA filing for ORKA-001. 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)
	March 31,				December 31,
	2026				2025
Assets
Current assets:
Cash and cash equivalents	$	49,520			$	46,935
Marketable securities, current		339,309				290,109
Prepaid expenses and other current assets		6,420				6,813
Total current assets		395,249				343,857
Marketable securities, long-term		107,123				142,539
Property and equipment, net		318				288
Operating lease right-of-use assets		1,687				1,830
Other non-current assets		103				103
Total assets	$	504,480			$	488,617
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	3,662			$	4,155
Accrued expenses and other current liabilities		9,287				10,591
Operating lease liability, current		680				619
Related party accounts payable and other current liabilities		3,004				9
Total current liabilities		16,633				15,374
Operating lease liability, non-current		1,127				1,313
Total liabilities		17,760				16,687
Commitments and contingencies
Stockholders’ equity:
Series B non-voting convertible preferred stock		2,931				2,931
Common stock		50				49
Additional paid-in capital		705,196				657,561
Accumulated other comprehensive income (loss)		(480	)			546
Accumulated deficit		(220,977	)			(189,157	)
Total stockholders’ equity		486,720				471,930
Total liabilities and stockholders’ equity	$	504,480			$	488,617

ORUKA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except share and per share data)
	Three Months Ended March 31, 2026				Three Months Ended March 31, 2025
Operating expenses:
Research and development(1)	$	29,145			$	19,925
General and administrative(1)		7,289				5,161
Total operating expenses		36,434				25,086
Loss from operations		(36,434	)			(25,086	)
Other income (expense):
Interest income		4,606				4,092
Other income (expense), net		8				(5	)
Total other income, net		4,614				4,087
Net Loss	$	(31,820	)		$	(20,999	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.48	)		$	(0.40	)
Net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted	$	(39.81	)		$	(32.95	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted		55,172,410				41,679,560
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
(1) Amounts include non-cash stock based compensation expense (including Paruka warrant obligation) as follows (in thousands):
	Three Months Ended March 31, 2026				Three Months Ended March 31, 2025
Research and development	$	3,579			$	3,003
General and administrative		3,389				1,880
Total	$	6,968			$	4,883

FAQ

What were Oruka Therapeutics' Q1 2026 financial results for ORKA (Nasdaq: ORKA)?

Oruka reported a Q1 2026 net loss of $31.8 million and cash, cash equivalents and marketable securities of $496.0 million. According to Oruka, net cash used in operating activities was $23.6 million, with R&D expenses of $29.1 million and G&A expenses of $7.3 million.

What did Oruka Therapeutics report about ORKA-001 EVERLAST-A psoriasis data in 2026?

Oruka reported that 63.5% of EVERLAST-A participants on ORKA-001 achieved PASI 100 at Week 16. According to Oruka, 83% reached PASI 90 and 84% achieved IGA 0/1, with tolerability similar to placebo and PK/PD data supporting potential once‑yearly dosing.

How long is Oruka Therapeutics funded after its $700 million public offering for ORKA?

Oruka expects the upsized $700 million public offering, together with existing cash, to fund operations through an anticipated BLA filing for ORKA-001. According to Oruka, proceeds also support continued development of ORKA-002 in psoriasis and hidradenitis suppurativa.

What is the status and timeline of Oruka Therapeutics' ORKA-002 clinical trials?

ORKA-002 entered the ORCA-SURGE Phase 2 psoriasis trial in March 2026, with data anticipated in 2027. According to Oruka, a second Phase 2 trial, ORCA-SPLASH in moderate-to-severe hidradenitis suppurativa, is expected to start in the second half of 2026.

When will more data from Oruka Therapeutics' ORKA-001 EVERLAST-A and EVERLAST-B trials be available?

Longer-term EVERLAST-A data, including Week 28 efficacy and 52-week follow-up, are planned for the second half of 2026. According to Oruka, initial EVERLAST-B Phase 2b data are expected in 2027, with Week 16 results intended to support Phase 3 initiation.

What is the Halozyme Hypercon collaboration announced by Oruka Therapeutics in May 2026?

Oruka entered a collaboration and license agreement with Halozyme to develop ORKA-001 using Hypercon technology. According to Oruka, the deal grants exclusive IL-23p19 rights in psoriatic disease and an option for one additional target, aiming to enhance the product profile.

How do Oruka Therapeutics' Q1 2026 expenses for ORKA compare to Q1 2025?

R&D expenses increased to $29.1 million from $19.9 million, and G&A rose to $7.3 million from $5.2 million. According to Oruka, higher costs mainly reflect expanded clinical trials, associated program expenses, and increased employee compensation including stock-based compensation.