Form 8-K

8-K — Oruka Therapeutics, Inc.

Accession: 0001213900-26-086933

Filed: 2026-08-10

Period: 2026-08-10

CIK: 0000907654

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0301312-8k_oruka.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED AUGUST 10, 2026 (ea030131201ex99-1.htm)

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported):

August 10, 2026

Oruka Therapeutics, Inc.

(Exact

name of Registrant as Specified in Its Charter)

Delaware

000-22873

36-3855489

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

855 Oak Grove Avenue

Suite 100

Menlo Park, California

94025

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including

Area Code: (650) 606-7910

N/A

(Former Name or Former Address, if Changed Since

Last Report)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant

to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant

to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications

pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications

pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b)

of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, $0.001 Par Value

ORKA

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth

company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant

has elected not to use the extended transition period for complying with any new or revised Operating accounting standards provided pursuant

to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On August 10, 2026, Oruka

Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June

30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this report.

The information in this Item

2.02, including Exhibit 99.1 to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities

Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall

it be deemed incorporated by reference into any filing under the Exchange Act or under the Securities Act of 1933, as amended, except

as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release, dated August 10, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities

Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Oruka Therapeutics, Inc.

Date: August 10, 2026

By:

/s/ Lawrence Klein

Lawrence Klein

Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED AUGUST 10, 2026

EX-99.1

Filename: ea030131201ex99-1.htm · Sequence: 2

Exhibit 99.1

Oruka Therapeutics Reports Second Quarter 2026

Financial Results and Provides Corporate Update

EVERLAST-A Week 28 data expected at the end

of 3Q 2026; 52-week data for all participants expected in December 2026

EVERLAST-B fully enrolled ahead of schedule,

with Week 16 data now expected in 4Q 2026

Phase 3 program for ORKA-001 expected to begin

in 1H 2027

ORCA-SURGE Week 16 data accelerated, now expected

in 1Q 2027

ORCA-SPLASH, a Phase 2 trial of ORKA-002 in

moderate-to-severe hidradenitis suppurativa, initiated

ORKA-004, a novel half-life extended monoclonal

antibody targeting TL1A, to enter the clinic in 4Q 2026

Cash, cash equivalents and marketable securities

of $1.1 billion expected to fund the Company through a BLA filing for ORKA-001

MENLO PARK, Calif., Aug. 10, 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 second quarter 2026 financial results and provided a corporate update.

“The second quarter and recent months were highly productive

as we advanced both of our co-lead programs toward a series of important readouts,” said Lawrence Klein, PhD, Chief Executive Officer

of Oruka. “With EVERLAST-B now fully enrolled and a Phase 3 program for ORKA-001 on the horizon, alongside the initiation of ORCA-SPLASH

in HS, we are executing on our strategy to establish ORKA-001 and ORKA-002 as potentially best-in-class options across psoriatic disease

and beyond. We look forward to multiple significant clinical catalysts over the coming quarters.”

Second 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 Phase 2a 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 treated participants, and IGA 0/1 at Week 16, achieved by 84% of treated participants. ORKA-001 was well tolerated with a safety

profile similar to placebo and consistent with prior IL-23p19 inhibitors.

● The Company expects to report Week 28 data from EVERLAST-A for all participants at the end of the third quarter of 2026. These data

will provide the first look at maintenance of response out to six months and potential deepening of responses for patients who did not

reach PASI 100 at Week 16.

● The Company also expects to report 52-week data from EVERLAST-A for all participants in December 2026. These longer-term data are

designed to characterize the durability of response and continue to inform the potential for once- to twice-yearly dosing.

● EVERLAST-B, a Phase 2b dose-ranging trial in moderate-to-severe PsO, completed enrollment of 187 subjects in the second quarter. The

Company now expects to report Week 16 data for all participants in the fourth quarter of 2026. These data are intended to support the

initiation of a Phase 3 program in the first half of 2027.

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

● The Company now expects to report Week 16 data from ORCA-SURGE, a Phase 2 trial in moderate-to-severe PsO, in the first quarter of

2027.

● The Company initiated ORCA-SPLASH, a Phase 2 trial in moderate-to-severe HS. ORCA-SPLASH is a randomized, double-blind, placebo-controlled

study in approximately 160 participants. The study will enroll patients in the United States and Canada. Patients will be randomized 1:1

to receive 320 mg of ORKA-002 or placebo at Weeks 0, 4, 8, and 12. The primary endpoint is HiSCR75 at Week 16. Participants then enter

an open-label maintenance period evaluating 320 mg of ORKA-002 every 12 weeks.

Additional updates

● The Company announced ORKA-004, a novel, subcutaneously administered, half-life extended monoclonal antibody targeting TL1A that is

anticipated to enter the clinic in the fourth quarter of 2026. The Company plans to pursue ORKA-004 in combination with ORKA-001 and ORKA-002,

with Phase 2 combination studies planned to begin in 2027.

● 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, Oruka amended its IL-23 license agreement with Paragon Therapeutics to include all therapeutic areas. Prior to the amendment,

the Company’s agreement did not include inflammatory bowel disease (IBD). The amendment allows Oruka to pursue ORKA-001 or combinations

thereof in IBD, subject to certain timing restrictions on initiating clinical trials.

Second Quarter 2026 Financial Results

Cash Position: As of June 30, 2026, Oruka had cash, cash equivalents,

and marketable securities of $1.1 billion. The Company expects that its cash, cash equivalents, and marketable securities will be sufficient

to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.

Research and Development (R&D) Expenses: R&D expenses

were $43.3 million for the second quarter of 2026, compared to $24.1 million for the second quarter of 2025. The increase was primarily

related to additional clinical trials and associated costs of Oruka’s programs, a non-refundable upfront payment made to Halozyme,

and higher employee compensation expenses, including stock-based compensation driven by increased headcount.

General and Administrative (G&A) Expenses: G&A expenses

were $6.9 million for the second quarter of 2026, compared to $4.3 million for the second quarter of 2025. The increase was primarily

related to employee compensation-related expenses, including stock-based compensation, and costs associated with operating as a growing

public company.

Other income, net: Other income, net was $8.9 million for the

second quarter of 2026, compared to $3.9 million for the second quarter of 2025, driven primarily by interest earned on higher cash and

marketable securities.

Net Loss: Net loss was $41.2 million and $24.6 million for the

second 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 relating to Oruka’s expectations, hopes, beliefs, intentions

or strategies regarding the future of its pipeline and business including, without limitation, the potential benefits, efficacy, safety,

durability of response, dosing profile and therapeutic potential of ORKA-001 and ORKA-002; the planned 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 anticipated initiation of clinical development of ORKA-004 and planned combination studies of ORKA-004 with ORKA-001 and ORKA-002;

the anticipated initiation of the Phase 3 program for ORKA-001; the timing of clinical, regulatory and data milestones, including an anticipated

BLA filing for ORKA-001; the Company’s ability to develop ORKA-001 and ORKA-002 for additional indications, including hidradenitis

suppurativa and inflammatory bowel disease; the expected benefits of the amendment to the Company’s license agreement with Paragon

Therapeutics; and Oruka’s expected cash position, cash runway and ability to fund operations through an anticipated BLA filing for

ORKA-001 and continued development of ORKA-002. 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)

June 30,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 268,470

$ 46,935

Marketable securities, current

605,094

290,109

Prepaid expenses and other current assets

10,995

6,813

Total current assets

884,559

343,857

Marketable securities, long-term

252,017

142,539

Property and equipment, net

275

288

Operating lease right-of-use assets

2,415

1,830

Other non-current assets

128

103

Total assets

$ 1,139,394

$ 488,617

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 7,950

$ 4,155

Accrued expenses and other current liabilities

14,349

10,591

Operating lease liability, current

669

619

Related party accounts payable and other current liabilities

Total current liabilities

22,968

15,374

Operating lease liability, non-current

1,877

1,313

Total liabilities

24,845

16,687

Commitments and contingencies

Stockholders’ equity:

Series B non-voting convertible preferred stock

2,931

Common stock

Additional paid-in capital

1,375,443

657,561

Accumulated other comprehensive income (loss)

(1,703 )

546

Accumulated deficit

(262,183 )

(189,157 )

Total stockholders’ equity

1,114,549

471,930

Total liabilities and stockholders’ equity

$ 1,139,394

$ 488,617

ORUKA THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except share and per share

data)

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

Operating expenses:

Research and development(1)

$ 43,257

$ 24,087

$ 72,402

$ 44,012

General and administrative(1)

6,850

4,342

14,139

9,503

Total operating expenses

50,107

28,429

86,541

53,515

Loss from operations

(50,107 )

(28,429 )

(86,541 )

(53,515 )

Other income (expense):

Interest income

8,897

3,857

13,503

7,949

Other income (expense), net

(2 )

(7 )

Total other income, net

8,901

3,855

13,515

7,942

Net Loss

$ (41,206 )

$ (24,574 )

$ (73,026 )

$ (45,573 )

Net loss per share attributable to common stockholders, basic and diluted

$ (0.55 )

$ (0.46 )

$ (1.04 )

$ (0.85 )

Net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted

$ (46.22 )

$ (38.26 )

$ (86.36 )

$ (71.23 )

Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted

62,872,318

42,095,951

59,038,131

41,888,906

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

(including Paruka warrant obligation) as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

2026

2025

2026

2025

Research and development

$ 3,913

$ 3,368

$ 7,492

$ 6,371

General and administrative

3,371

1,709

6,760

3,589

Total

$ 7,284

$ 5,077

$ 14,252

$ 9,960

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