UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934

For the transition period from ________ to ________

Commission file number: 000-22873

Oruka Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware		36-3855489
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

855 Oak Grove Avenue
Suite 100
Menlo Park, California		94025
(Address of principal executive offices)		(Zip Code)

(650) 606-7910

(Registrant’s telephone number, including area code)

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, par value $0.001 per share		ORKA		The Nasdaq Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		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 financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of October 31, 2025, there were 48,409,232 shares of the registrant’s common stock outstanding.

Table of Contents

		Page
	PART I. Financial Information
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss	2
	Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)	3
	Condensed Consolidated Statements of Cash Flows	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	32
Item 4.	Controls and Procedures	32
	PART II. Other Information
Item 1.	Legal Proceedings	33
Item 1A.	Risk Factors	33
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	62
Item 3.	Defaults Upon Senior Securities	62
Item 4.	Mine Safety Disclosures	62
Item 5.	Other Information	62
Item 6.	Exhibits	63
Signatures		64

Part I - Financial Information

Item 1. Financial Statements

ORUKA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share data)

	September 30,			December 31,
	2025			2024
Assets
Current assets:
Cash and cash equivalents	$	91,253		$	61,575
Marketable securities, current		257,902			314,073
Prepaid expenses and other current assets		6,008			1,221
Total current assets		355,163			376,869
Marketable securities, long-term		151,763			18,069
Property and equipment, net		253			162
Operating lease right-of-use assets		1,969			876
Other non-current assets		103			43
Total assets	$	509,251		$	396,019
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	2,208		$	3,462
Accrued expenses and other current liabilities		8,648			3,346
Operating lease liability, current		419			213
Related party common stock warrant liability		9,684			—
Related party accounts payable and other current liabilities		8			6,022
Total current liabilities		20,967			13,043
Operating lease liability, non-current		1,493			755
Total liabilities		22,460			13,798
Commitments and contingencies (Note 11)
Stockholders’ equity:
Series B non-voting convertible preferred stock, $0.001 par value; 251,504 shares authorized as of September 30, 2025 and December 31, 2024; 137,138 shares issued and outstanding as of September 30, 2025 and December 31, 2024		2,931			2,931
Common stock, $0.001 par value; 545,000,000 shares authorized as of September 30, 2025 and December 31, 2024; 48,384,150 and 37,440,510 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively		48			37
Additional paid-in capital		643,201			463,018
Accumulated other comprehensive income (loss)		185			(41	)
Accumulated deficit		(159,574	)		(83,724	)
Total stockholders’ equity		486,791			382,221
Total liabilities and stockholders’ equity	$	509,251		$	396,019

The accompanying notes are an integral part of these condensed consolidated financial statements.

ORUKA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share data)

	Three Months Ended September 30, 2025			Three Months Ended September 30, 2024			Nine Months Ended September 30, 2025			Period from February 6, 2024 (inception) to September 30, 2024
Operating expenses:
Research and development⁽¹⁾	$	28,988		$	25,691		$	73,000		$	49,557
General and administrative⁽²⁾		5,117			3,758			14,620			8,248
Total operating expenses		34,105			29,449			87,620			57,805
Loss from operations		(34,105	)		(29,449	)		(87,620	)		(57,805	)
Other income (expense):
Interest income		3,832			1,330			11,781			1,330
Interest expense⁽³⁾		—			(504	)		—			(1,468	)
Other expense, net		(4	)		—			(11	)		—
Total other income (expense), net		3,828			826			11,770			(138	)
Net loss		(30,277	)		(28,623	)		(75,850	)		(57,943	)
Net change in unrealized gains (losses) on marketable securities		212			—			226			—
Comprehensive loss	$	(30,065	)	$	(28,623	)	$	(75,624	)	$	(57,943	)

Net loss per share attributable to common stockholders, basic and diluted	$	(0.55	)	$	(1.46	)	$	(1.40	)	$	(6.08	)
Net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted	$	—		$	(1,461.10	)	$	—		$	(6,077.25	)
Net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted	$	(45.46	)	$	(121.76	)	$	(116.94	)	$	(506.44	)

Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted		44,067,059			15,013,655			42,622,935			7,765,381
Weighted-average shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted		—			477			—			184
Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted		137,138			49,191			137,138			19,015

(1)	Includes related party amounts of $9,595 and $13,537 for the three months ended September 30, 2025 and September 30, 2024, respectively, and $15,998 and $33,967 for the nine months ended September 30, 2025 and the period from February 6, 2024 (inception) to September 30, 2024, respectively

(2)	Includes related party amounts of $8 and $71 for the three months ended September 30, 2025 and September 30, 2024, respectively, and $130 and $1,339 for the nine months ended September 30, 2025 and the period from February 6, 2024 (inception) to September 30, 2024, respectively

(3)	Includes related party amounts of nil and $504 for the three months ended September 30, 2025 and September 30, 2024, respectively, and nil and $1,468 for the nine months ended September 30, 2025 and the period from February 6, 2024 (inception) to September 30, 2024, respectively

SEC Form 10-Q filed by Oruka Therapeutics Inc.