Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Management’s Evaluation of Disclosure
Controls and Procedures
Our management, with the
participation of our Principal Executive Officer and our Principal Financial Officer, evaluated the effectiveness of our disclosure controls
and procedures as of December 31, 2025. Based on the foregoing evaluation, our Principal Executive Officer and Principal Financial Officer
concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2025. The term
“disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act means controls and
other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that
it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information
required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management,
including our Principal Executive Officer and Principal Financial Officer, or persons performing similar functions, as appropriate to
allow timely decisions regarding required disclosure.
Management recognizes that
any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives,
and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Management’s Annual Report on Internal Control over Financial
Reporting
Our management is responsible
for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined
in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, our principal
executive and principal financial officers and effected by our board of directors, management and other personnel to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with U.S. GAAP. Our internal control over financial reporting includes those policies and procedures that:
● pertain
to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;
● provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S.
GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
● provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could
have a material effect on our financial statements.
Because of its inherent
limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
Our management, with the
participation of our principal executive officer and principal financial officer, assessed the effectiveness of our internal control
over financial reporting as of December 31, 2025. In making this assessment, management used the criteria set forth by the Committee
of Sponsoring Organizations of the Treadway Commission (COSO) in its 2013 Internal Control – Integrated Framework. Based on our
assessment, our management has concluded that, as of December 31, 2025, our internal control over financial reporting was effective based
on those criteria.
110
This Annual Report on Form
10-K does not include an attestation report of our independent registered public accounting firm regarding internal control over financial
reporting. For as long as we remain a “smaller reporting company” as defined by Rule 12b-2 of the Exchange Act and report
less than $100 million of annual revenues in our most recent fiscal year, we intend to take advantage of the exemption permitting us
not to comply with the requirement that our independent registered public accounting firm provide an attestation on the effectiveness
of our internal control over financial reporting.
Changes in Internal Control over Financial
Reporting
There were no changes in
our internal control over financial reporting during the quarter ended December 31, 2025 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including
our principal executive officer and principal financial officer, believes that our disclosure controls and procedures are designed to
provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, our management
does not expect that our disclosure controls and procedures will prevent or detect all errors and all fraud. A control system, no matter
how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must
be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide
absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the
realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally,
controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of
the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events,
and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over
time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate.
Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Item 9B. Other Information.
During the quarter ended
December 31, 2025, no director or Section 16 officer (as defined in Section 16 of the Securities Exchange Act of 1934, as amended) adopted
or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements (in each case, as defined in Item 408(a) of
Regulation S-K).
Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections.
Not applicable.
111
PART III
Item 10. Directors, Executive Officers and
Corporate Governance.
The information required by this Item will be included in our definitive
proxy statement for our 2026 annual meeting of stockholders (the “2026 Proxy Statement”), which will be filed with the SEC
within 120 days after the end of our fiscal year ended December 31, 2025, and is incorporated herein by reference.
Item 11. Executive Compensation.
The information required by this Item is incorporated by reference
to the 2026 Proxy Statement.
Item 12. Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters.
The information required by this Item is incorporated by reference
to the 2026 Proxy Statement.
Item 13. Certain Relationships and Related
Transactions, and Director Independence.
The information required by this Item is incorporated by reference
to the 2026 Proxy Statement.
Item 14. Principal Accountant Fees and Services.
The information required by this Item is incorporated by reference
to the 2026 Proxy Statement.
112
PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a)
The following documents
are filed as part of this Annual Report:
(1)
Financial Statements
See Index to Financial Statements included
in Part II, Item 8 of this Annual Report.
(2)
Financial Statement Schedules
All schedules are omitted because they
are not applicable or the required information is shown in the financial statements or notes thereto.
(3)
List of Exhibits required
by Item 601 of Regulation S-K
Exhibit
Incorporation By Reference
Number
Description
Form
Exhibit No.
Filing Date
2.1†
Agreement and Plan of Merger and Reorganization, dated as of April 3, 2024, by and among ARCA biopharma, Inc., Atlas Merger Sub Corp., Atlas Merger Sub II, LLC and Oruka Therapeutics, Inc.
8-K
2.1
4/3/2024
3.1
Second Amended and Restated Certificate of Incorporation
8-K
3.5
9/5/2024
3.2
Amended and Restated Bylaws
8-K
3.6
9/5/2024
3.3
Form of Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock
S-1/A
3.1(b)
5/24/2013
3.4
Certificate of Elimination of Series A Convertible Preferred Stock, dated August 29, 2024
8-K
3.8
9/5/2024
3.5
Certificate of Designation of Preferences, Rights and Limitations of Series B Non-Voting Convertible Preferred Stock
8-K
3.9
9/5/2024
3.6
Certificate of Designation of Preferences, Rights and Limitations of Series A Non-Voting Convertible Preferred Stock
8-K
3.1
9/13/2024
4.1
Description of Securities
10-K
4.1
3/6/2025
4.2
Form of Pre-Funded Warrant, dated August 29, 2024
10-K
4.3
3/6/2025
4.3
Form of Pre-Funded Warrant, dated September 13, 2024
8-K
4.1
9/13/2024
4.4
Form of Pre-Funded Warrant, dated September 17, 2025
8-K
4.1
9/22/2025
4.5
Paruka Warrant, dated December 31, 2024
10-Q
4.5
5/14/2025
4.6*
Paruka Warrant, dated December 12, 2025
Filed herewith
10.1#
Oruka Therapeutics, Inc. 2024 Stock Incentive Plan
8-K
10.10
9/5/2024
10.2#
Oruka Therapeutics, Inc. 2024 Employee Stock Purchase Plan
8-K
10.11
9/5/2024
10.3#
Amended and Restated 2024 Equity Incentive Plan
S-4
10.40
5/14/2024
10.4#
Second Amendment to the Oruka Therapeutics, Inc. Amended and Restated 2024 Equity Incentive Plan
8-K
10.13
9/5/2024
10.5#
Form of Employee Warrant Agreement
8-K
10.16
9/5/2024
10.6#
Form of Grant Notice for Nonqualified Stock Option and Standard Terms and Conditions for Stock Options (Directors)
S-8
99.2
11/14/2024
10.7#
Form of Grant Notice for Stock Option and Standard Terms and Conditions for Stock Options (Employees)
S-8
99.3
11/14/2024
10.8#
Form of Stock Option Agreement under the Oruka Therapeutics, Inc. Amended and Restated 2024 Equity Incentive Plan
S-4
10.42
5/14/2024
10.9*
Form of Grant Notice for Restricted Stock Unit Award and Standard Terms and Conditions for Restricted Stock Units
Filed herewith
113
10.10#
Amended and Restated Director Offer Letter, dated March 22, 2024, by and between Oruka Therapeutics, Inc. and Samarth Kulkarni
S-4
10.43
5/14/2024
10.11#
Director Offer Letter, dated April 24, 2024, by and between Oruka Therapeutics, Inc. and Kristine Ball
S-4
10.44
5/14/2024
10.12#
Director Offer Letter, dated December 1, 2025, by and between Oruka Therapeutics, Inc. and Chris Martin
8-K
10.1
12/11/2025
10.13#
Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Lawrence Klein, dated October 3, 2024
8-K
10.1
10/4/2024
10.14#
Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Arjun Agarwal, dated October 3, 2024
8-K
10.2
10/4/2024
10.15#
Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Paul Quinlan, dated October 1, 2024
10-K
10.17
3/6/2025
10.16#
Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Joana Goncalves, dated October 1, 2024
10-K
10.18
3/6/2025
10.17#
Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Laura Sandler, dated July 1, 2025
8-K
10.1
7/1/2025
10.18#
Form of Indemnification Agreement
10-K
10.19
3/6/2025
10.19
Non-Employee Directors Compensation Program
10-K
10.20
3/6/2025
10.20
Form of Amendment to Subscription Agreement
8-K
10.1
7/9/2024
10.21
Form of Amended & Restated Subscription Agreement
8-K
10.2
7/9/2024
10.22
Form of Registration Rights Agreement, dated August 29, 2024
10-Q
10.4
11/13/2024
10.23†
Securities Purchase Agreement by and between Oruka Therapeutics, Inc. and each of the entities listed on Exhibit A thereto, dated September 11, 2024
8-K
10.1
9/13/2024
10.24
Form of Registration Rights Agreement, dated as of September 13, 2024
8-K
10.2
9/13/2024
10.25†
Securities Purchase Agreement by and between Oruka Therapeutics, Inc. and each of the entities listed on Exhibit A thereto, dated September 17, 2025
8-K
10.1
9/22/2025
10.26
Form of Registration Rights Agreement, dated as of September 17, 2025
8-K
10.2
9/22/2025
10.27†
Amended and Restated Antibody Discovery and Option Agreement (IL-17) by and among Paragon Therapeutics, Inc., Paruka Holding, LLC, and Oruka Therapeutics, Inc. dated March 28, 2024
S-4/A
10.50
6/18/2024
10.28†
IL-17 License Agreement by and between Paragon Therapeutics, Inc. and Oruka Therapeutics, Inc., dated February 4, 2025
10-K
10.29
3/6/2025
10.29†
Amended and Restated Antibody Discovery and Option Agreement (IL-23) by and among Paragon Therapeutics, Inc., Paruka Holding, LLC, and Oruka Therapeutics, Inc. dated March 28, 2024
S-4/A
10.51
6/18/2024
10.30†
IL-23 License Agreement by and between Paragon Therapeutics, Inc. and Oruka Therapeutics, Inc., dated December 17, 2024
10-K
10.31
3/6/2025
10.31†
Cell Line License Agreement by and between WuXi Biologics Ireland Limited and Oruka Therapeutics, Inc., dated March 4, 2024
10-K
10.32
3/6/2025
10.32†
Amendment No. 1 to the Cell Line License Agreement by and between WuXi Biologics Ireland Limited and Oruka Therapeutics, Inc., dated November 20, 2024
10-K
10.33
3/6/2025
10.33
Sales Agreement between Oruka Therapeutics, Inc. and TD Securities (USA) LLC, dated October 3, 2025
S-3
1.2
10/3/2025
14.1
Code of Business Conduct and Ethics
8-K
14.1
9/5/2024
16.1
Letter from KPMG LLP, dated September 5, 2024
8-K
16.1
9/5/2024
19.1
Insider Trading Policy
10-K
19.1
3/6/2025
21.1*
List of subsidiaries of the Registrant
Filed herewith
23.1*
Consent of Independent Registered Public Accounting Firm
Filed herewith
24.1*
Power of Attorney (Incorporated by reference to the signature page of this Annual Report on Form 10-K)
Filed herewith
114
31.1*
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) promulgated under the Securities Exchange Act of 1934
Filed herewith
31.2*
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) promulgated under the Securities Exchange Act of 1934
Filed herewith
32.1**
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(B) promulgated under the Securities Exchange Act of 1934
Furnished herewith
97.1*
Incentive Compensation Clawback Policy
10-K
97.1
3/6/2025
101.INS*
Inline XBRL Instance Document
Filed herewith
101.SCH*
Inline XBRL Taxonomy Extension Schema with Embedded
Linkbases Document
Filed herewith
101.CAL*
Inline XBRL Taxonomy Extension
Calculation Linkbase Document.
Filed herewith
101.DEF*
Inline XBRL Taxonomy Extension
Definition Linkbase Document.
Filed herewith
101.LAB*
Inline XBRL Taxonomy Extension
Label Linkbase Document.
Filed herewith
101.PRE*
Inline XBRL Taxonomy Extension
Presentation Linkbase Document.
Filed herewith
104
Cover Page Interactive Data File (embedded within the
Inline XBRL document)
*
Filed herewith.
**
Furnished herewith. The certifications on Exhibit 32.1 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
# Indicates
management contract or compensatory plan.
† Exhibits and/or schedules have been omitted pursuant to Item 601(a)(5)
of Regulation S-K. The Company hereby undertakes to furnish supplementally copies of any of the omitted exhibits and schedules upon request
by the SEC; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 under the Exchange Act for any
exhibits or schedules so furnished. Certain portions of this exhibit (indicated by “***”) have been omitted because they are
both (i) not material and (ii) is the type of information that the registrant both customarily and actually treats as private and confidential.
Item 16. Form 10-K Summary
None.
115
SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on
its behalf by the undersigned, thereunto duly authorized .
Oruka
Therapeutics, Inc.
Date: March 12, 2026
By:
/s/
Lawrence Klein
Lawrence Klein
President and Chief Executive Officer
(Principal Executive Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE
PRESENTS, that each person whose signature appears below constitutes and appoints Dr. Lawrence Klein and Mr. Arjun Agarwal, jointly and
severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments
to this Report on Form 10-K and to file same, with exhibits thereto and other documents in connection therewith, with the Securities
and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitutes, may do or cause
to be done by virtue hereof.
Pursuant to the requirements
of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant
in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Lawrence Klein
Chief Executive Officer
& Director
March 12, 2026
Lawrence Klein
(Principal Executive Officer)
/s/
Arjun Agarwal
Senior Vice President, Finance
and Treasurer
March 12, 2026
Arjun Agarwal
(Principal Financial Officer
and Principal Accounting Officer)
/s/
Samarth Kulkarni
Chairman of the Board
March 12, 2026
Samarth Kulkarni
/s/
Kristine Ball
Director
March 12, 2026
Kristine Ball
/s/
Carl Dambkowski
Director
March 12, 2026
Carl Dambkowski
/s/
Peter Harwin
Director
March 12, 2026
Peter Harwin
/s/
Christopher Martin
Director
March 12, 2026
Christopher Martin
116