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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 |
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 | |
| - | | |
| 9 | |
| 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 | | |
| 2,931 | |
| Common stock | |
| 61 | | |
| 49 | |
| 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 | |
| 4 | | |
| (2 | ) | |
| 12 | | |
| (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 | | |
| 137,138 | | |
| 137,138 | | |
| 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 | |