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, 2024. 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, 2024. 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
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, 2024. 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, 2024, our internal control over financial reporting was
effective based on those criteria.
86
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, 2024 that have materially affected,
or are reasonably likely to materially affect, our internal control over financial reporting.
Item
9B. Other Information.
During
the quarter ended December 31, 2024, 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.
87
PART
III
Item
10. Directors, Executive Officers and Corporate Governance.
Executive
Officers and Directors
The following table sets
forth the names, ages as of March 6, 2025, and positions of the individuals who currently serve as executive officers and directors of
the Company.
Name
Age
Position
Executive
Officers and Employee Director
Lawrence
Klein, Ph.D.
42
President,
Chief Executive Officer and Director
Arjun
Agarwal
49
Senior
Vice President, Finance and Treasurer
Joana
Goncalves, MBChB
51
Chief
Medical Officer
Paul
Quinlan
62
General
Counsel and Corporate Secretary
Non-Employee
Directors
Samarth
Kulkarni, Ph.D. (2)(3)
46
Chair
and Director
Kristine
Ball (1)(3)
53
Director
Carl
Dambkowski, M.D. (1)
40
Director
Peter
Harwin (2)(3)
39
Director
Cameron
Turtle, D.Phil. (1)(2)
35
Director
(1) Member
of the Audit Committee.
(2) Member
of the Compensation Committee.
(3) Member
of the Nominating and Governance Committee (the “Governance Committee”).
Our
business affairs are managed under the direction of our Board, which currently consists of six members. Our Board is divided into three
classes, with members of each class holding office for staggered three-year terms. There are currently two Class I directors, who are
up for election at the 2025 Annual Meeting of Stockholders for a term expiring at the 2028 Annual Meeting of Stockholders; two Class
II directors, whose terms expire at the 2026 Annual Meeting of Stockholders; and two Class III directors, whose terms expire at the 2027
Annual Meeting of Stockholders. Each executive officer serves at the discretion of the of the Board and holds office until their successor
is duly appointed and qualified or until their earlier resignation or removal.
Biographical
and other information regarding our executive officers and directors is set forth below. There are no family relationships among any
of our executive officers or directors.
Executive
Officers and Employee Director
Lawrence
Klein, Ph.D. Dr. Klein has served as Chief Executive Officer and as a member of the board of directors of the Company since
the Merger Closing and of Pre-Merger Oruka from February 2024 through the Merger Closing. Prior to joining Pre-Merger Oruka, Dr. Klein
was a Partner at Versant Venture Management, LLC, a healthcare and biotechnology venture capital firm, from January 2023 to February 2024,
where he invested in and helped to grow early-stage biotechnology companies. Prior to Versant, Dr. Klein served in various
positions at CRISPR Therapeutics AG (Nasdaq: CRSP), a biopharmaceutical company, including Chief Operating Officer from January 2020
to October 2022, Chief Business Officer from January 2019 to January 2020, Senior Vice President, Business Development
and Strategy from November 2017 to December 2018 and as Vice President, Strategy from February 2016 to November 2017,
where he helped to initiate and execute on several transformative partnerships, establish the strategic direction of the company, oversee
important pipeline programs and led several functions, including program and portfolio management. Before joining CRISPR, Dr. Klein
was an Associate Partner at McKinsey & Company, a global management consulting firm, from October 2014 to February 2016.
Dr. Klein served as a member of the board of directors of Dyne Therapeutics, Inc. (Nasdaq: DYN) from September 2019 to May 2023
and of Jasper Therapeutics, Inc. (Nasdaq: JSPR) from September 2021 to June 2023. Dr. Klein received his B.S. in biochemistry
and physics from the University of Wisconsin-Madison and his Ph.D. in biophysics from Stanford University.
88
We
believe Dr. Klein is qualified to serve as a member of the Board because of his business development, operational and senior management
experience in the biotechnology industry and his academic expertise and accomplishments.
Joana
Goncalves, MBChB. Dr. Goncalves has served as the Chief Medical Officer of the Company since the Merger Closing and of Pre-Merger
Oruka from April 2024 through the Merger Closing. Prior to joining Pre-Merger Oruka, Dr. Goncalves served as Chief Medical
Officer of Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company, from October 2018 to April 2024, where she
was responsible for representing Cara Therapeutics in interactions with regulatory agencies, the investor and scientific communities
and the board of directors, building multifunctional terms and developing the clinical development strategy in dermatological conditions.
Prior to Cara, Dr. Goncalves held various positions at Celgene Corporation, a pharmaceutical company, which was later acquired by
Bristol-Myers Squibb Company, from April 2014 to October 2018, where she most recently served as Vice President, Medical
Affairs for Dermatology and Neurology and was instrumental in planning and executing medical support activities for a number of programs,
including OTEZLA® for psoriasis. Prior to Celgene, Dr. Goncalves served as Vice President, Medical Strategy and Scientific Affairs
at LEO Pharma Inc., the U.S. subsidiary of LEO Pharma A/S, a global healthcare company specializing in dermatology and critical
care, from February 2012 to April 2014. She began her pharmaceutical career at Novartis Pharmaceuticals, working on a range
of products across various therapeutic areas from 2001 to 2012. Dr. Goncalves received her MBChB from the University of Cape Town,
South Africa.
Paul
Quinlan. Mr. Quinlan has served as General Counsel and Corporate Secretary of the Company since the Merger Closing and of
Pre-Merger Oruka since April 2024 through the Merger Closing. Prior to joining Pre-Merger Oruka, Mr. Quinlan served as General
Counsel, Chief Compliance Officer and Corporate Secretary of CymaBay Therapeutics, Inc., a biopharmaceutical company, from October 2020
to March 2024, where he was responsible for the general supervision of the company’s legal affairs. From December 2017
to February 2020, he served as General Counsel and Corporate Secretary of CymaBay, where he was responsible for the general supervision
of the company’s legal affairs. Prior to CymaBay, Mr. Quinlan served as General Counsel and Secretary, from 2010 to January 2018,
and Chief Legal Officer from 2016 to January 2018, of TerraVia Holdings, Inc., a biotechnology company, where he was responsible
for the general supervision of the company’s legal affairs. Prior to joining TerraVia, Mr. Quinlan served as General Counsel
of Metabolex, Inc., a biopharmaceutical company, from 2005 to 2010. Prior to joining Metabolex, Mr. Quinlan held various positions
at Maxygen, Inc., a biopharmaceutical company, from 2000 to 2005. Prior to Maxygen, Mr. Quinlan practiced law at Cooley LLP and
Cravath, Swaine, & Moore LLP. Mr. Quinlan received a law degree from Columbia Law School and an M.Sc. in Medical Biophysics
from the University of Toronto.
Arjun
Agarwal. Mr. Agarwal has served as the Senior Vice President of Finance of the Company since the Merger Closing and
of Pre-Merger Oruka from March 2024 through the Merger Closing, where he is responsible for overseeing the company’s finance
and accounting functions. Prior to joining Pre-Merger Oruka, Mr. Agarwal served as VP of Finance at Jasper Therapeutics, Inc. (Nasdaq:
JSPR), a biotechnology company, from June 2021 to March 2024, including through multiple financings and the company’s
successful transition to become a publicly traded entity. Before joining Jasper, Mr. Agarwal served as Vice President, Corporate
Controller at Protagonist Therapeutics, Inc. (Nasdaq: PTGX), a biotechnology company, from August 2019 to June 2021, where
he was responsible for overseeing the company’s finance and accounting functions. Prior to joining Protagonist, Mr. Agarwal
served in various roles of increasing responsibility at McKesson Corporation (NYSE: MCK), an international healthcare services
company, from 2009 to 2019. Prior to McKesson, Mr. Agarwal worked at PricewaterhouseCoopers LLP, where he managed a portfolio of
audit clients. He is a graduate of Sydenham College of Commerce and Economics at Mumbai University, India. He is a Certified Public Accountant
(CPA) and a Chartered Accountant accredited by the Institute of Chartered Accountants of India.
89
Non-Employee
Directors
Samarth
Kulkarni, Ph.D. Dr. Kulkarni has served as Chair and a member of the board of directors of the Company since the Merger
Closing and as a member of the board of directors of Pre-Merger Oruka from February 2024 through the Merger Closing. Dr. Kulkarni
has served as the Chief Executive Officer of CRISPR Therapeutics AG (Nasdaq: CRSP), a biopharmaceutical company, since December 2017,
where he has also served as a member and chair of the board of directors since June 2018 and September 2023, respectively.
Previously, Dr. Kulkarni served as CRISPR’s President and Chief Business Officer from May 2017 to November 2017
and as Chief Business Officer from August 2015. Prior to joining CRISPR, Dr. Kulkarni was at McKinsey & Company, a
global management consulting firm, from 2006 to 2015, with various titles, his most recent being Partner within the Pharmaceuticals and
Biotechnology practice. Dr. Kulkarni has also served as a member of the boards of directors of Black Diamond Therapeutics, Inc.
(Nasdaq: BDTX), Repare Therapeutics Inc. (Nasdaq: RPTX), and Centessa Pharmaceuticals plc (Nasdaq: CNTA). Dr. Kulkarni received
a Ph.D. in Bioengineering and Nanotechnology from the University of Washington and a B. Tech. from the Indian Institute of Technology.
Dr. Kulkarni has authored several publications in leading scientific and business journals.
We
believe that Dr. Kulkarni is qualified to serve as a member of the Board because of his experience as a consultant and an executive in
the biopharmaceutical industry and his academic expertise and accomplishments.
Kristine Ball.
Ms. Ball has served as a member of the board of directors of the Company since the Merger Closing and of Pre-Merger Oruka since May 2024
through the Merger Closing. Ms. Ball has served as President and Chief Executive Officer of Antiva Biosciences, Inc., a private biopharmaceutical
company, since April 2023. Prior to Antiva, Ms. Ball served as Chief Executive Officer of Soteria Biotherapeutics, Inc., a private
biotechnology company, from September 2020 to August 2022. Prior to joining Soteria, Ms. Ball served as Senior Vice President,
Corporate Strategy and Chief Financial Officer of Menlo Therapeutics, Inc., a Nasdaq-listed biopharmaceutical company, which later
became VYNE Therapeutics Inc. (Nasdaq: VYNE), from September 2017 to March 2020, where she was responsible for leading all non-R&D
functions, including strategic planning, corporate development, commercial, human resources, legal, finance and information technology.
Prior to joining Menlo, Ms. Ball served as Chief Financial Officer and Senior Vice President of Relypsa, Inc., a Nasdaq-listed pharmaceutical
company, which was later acquired by Galenica Group, from November 2012 to October 2016. Prior to Relypsa, Ms. Ball held various
other finance roles in the life sciences industry, including Senior Vice President of Finance & Administration and Chief Financial
Officer of KAI Pharmaceuticals, Inc., a biopharmaceutical company, and Vice President of Finance at Exelixis, Inc. (Nasdaq: EXEL), a biotechnology
company. Prior to that, Ms. Ball served as a senior manager in the life sciences audit practice of Ernst & Young LLP. Ms. Ball
has previously served on the boards of directors of Atreca, Inc. (Nasdaq: BCEL), a biopharmaceutical company, from 2020 to 2024, Soteria
from 2020 to 2022 and Forty Seven, Inc. (Nasdaq: FTSV), a Nasdaq-listed biotechnology company, which was acquired by Gilead Sciences,
Inc., from 2018 to 2020. Ms. Ball received a B.S. from Babson College.
We
believe Ms. Ball is qualified to serve as a member of the Board because of her experience as an executive officer and director of life
sciences companies and her background in finance, corporate development and strategic planning.
Carl
Dambkowski, M.D. Dr. Dambkowski has served as a member of the board of directors of the Company since the Merger Closing
and of Pre-Merger Oruka from February 2024 through the Merger Closing. Dr. Dambkowski has served as the Chief Medical Officer
of Apogee Therapeutics, Inc. (Nasdaq: APGE), a biotechnology company, since September 2022. Prior to joining Apogee, Dr. Dambkowski
served as a strategic and clinical leader for a variety of companies, including as Chief Medical Officer of QED Therapeutics, Inc., a
private biotechnology company, from July 2021 to September 2022; Chief Strategy Officer and EVP of Operations of Origin Biosciences,
Inc., a private bioecology company, from March 2018 to June 2021; and Chief Medical Officer of Navire Pharma, Inc., a private
biotechnology company, from January 2020 to September 2022, where he served as the clinical lead starting prior to IND for
BBP-398 through the out licensing of the compound to Bristol-Myers Squibb based on initial clinical data and for low-dose infigratinib
in achondroplasia through initial proof-of-concept data. He was part of the core team that brought TRUSELTIQ® (infigratinib)
and NULIBRY® (fosdenopterin) through regulatory review and FDA approval at QED Therapeutics and Origin Biosciences, respectively.
From July 2016 to March 2018, Dr. Dambkowski was an associate at McKinsey & Company, a global management consulting
firm, where he advised biotech and pharmaceutical companies across the world on a range of research and development activities. Dr. Dambkowski
co-founded Novonate, Inc., a private medical device company focused on building life-saving devices for neonates, in January 2015.
Dr. Dambkowski has coauthored numerous peer-reviewed publications and scientific abstracts and is a named inventor on multiple
published and granted patents. Dr. Dambkowski was trained as a physician at Stanford University, where he also received his M.D.
with a concentration in bioengineering. He also received a B.A. (with honors) from Stanford University and an M.A. from Columbia University.
90
We
believe Dr. Dambkowski is qualified to serve as a member of the Board because of his significant experience and innovations in the biotechnology
industry and his academic expertise and accomplishments.
Peter
Harwin. Mr. Harwin has served as a member of the board of directors of the Company since the Merger Closing and of Pre-Merger
Oruka from February 2024 through the Merger Closing. Mr. Harwin is a Managing Member at Fairmount Funds Management, a healthcare
investment firm he co-founded in April 2016. Prior to Fairmount Funds Management, Mr. Harwin was a member of the investment
team at Boxer Capital, LLC, an investment fund that was part of the Tavistock Group, based in San Diego. Mr. Harwin also serves
as chairman of the board of directors of Cogent Biosciences, Inc. (Nasdaq: COGT) and is a member of the board of directors of Apogee
Therapeutics, Inc. (Nasdaq: APGE), Viridian Therapeutics, Inc. (Nasdaq: VRDN) and Spyre Therapeutics, Inc. (formerly Aeglea BioTherapeutics,
Inc.) (Nasdaq: SYRE). Mr. Harwin received a B.B.A. from Emory University.
We
believe Mr. Harwin is qualified to serve as a member of the Board because of his experience serving as a director of biotechnology companies
and as a manager of funds specializing in the area of life sciences.
Cameron
Turtle, D.Phil. Dr. Turtle has served as a member of the board of directors of the Company since the Merger Closing and
of Pre-Merger Oruka from February 2024 through the Merger Closing. Dr. Turtle has served as Chief Executive Officer and a member
of the board of directors of Spyre Therapeutics, Inc. (formerly Aeglea BioTherapeutics, Inc.) (Nasdaq: SYRE), a biotechnology company,
since November 2023 and, before that, as Chief Operating Officer from June 2023 to November 2023. Prior to joining Spyre,
Dr. Turtle was an advisor to Spyre Therapeutics, Inc., a private biotechnology company, from May 2023 to June 2023. Previously,
he served as Venture Partner at Foresite Labs, a life sciences investment firm, from July 2022 to May 2023; Chief Strategy
Officer of BridgeBio Pharma (Nasdaq: BBIO), a biotechnology company, from January 2021 to April 2022; and Chief Business Officer
of Eidos Therapeutics (Nasdaq: EIDX), a biopharmaceutical company, from November 2018 to January 2021, where he led business
development, investor relations, and multiple operational functions as the company advanced an investigational medicine for a form of
heart failure. Prior to joining BridgeBio and Eidos, he was a consultant at McKinsey & Company, a global management consulting
firm, where he worked with pharmaceutical and medical device companies on topics including M&A, growth strategy, clinical trial strategy,
and sales force optimization. Dr. Turtle received his B.S. with honors in Bioengineering from the University of Washington and his
D.Phil. in Cardiovascular Medicine from the University of Oxford, St. John’s College. He is the recipient of several awards, including
a Rhodes Scholarship, Goldwater Scholarship, Forbes 30 Under 30, San Francisco Business Times 40 Under 40, and the Biocom Life
Sciences Catalyst Award.
We
believe Dr. Turtle is qualified to serve as a member of the Board because of his experience as a leader in building, financing, and shaping
biopharmaceutical organizations from preclinical development to late-stage clinical trials and commercialization.
Code
of Business Conduct and Ethics
We
have adopted a Code of Business Conduct and Ethics that establishes the standards of ethical conduct applicable to all our directors,
officers and employees, including our principal executive officer, principal financial officer and principal accounting officer, or persons
performing similar functions. It addresses, among other matters, compliance with laws and policies, conflicts of interest, corporate
opportunities, regulatory reporting, external communications, confidentiality requirements, insider trading, proper use of assets and
how to report compliance concerns. A copy of the code is available on our website located at https://ir.oruka.com/corporate-governance under
“Governance Documents.” We intend to disclose any amendments to the code, or any waivers of its requirements, on our website
to the extent required by applicable rules. The Audit Committee is responsible for applying and interpreting the code in situations where
questions are presented to it. Information contained on, or that can be accessed through, the Company’s website is not incorporated
by reference into this report, and you should not consider information on the Company’s website to be part of this report.
Insider
Trading Policy
We
have adopted insider trading policies and procedures governing the purchase, sale and other transactions in Company securities by our
directors, officers and employees, and other covered persons, as well as the Company itself, that we believe are reasonably designed
to promote compliance with insider trading laws, rules and regulations, and Nasdaq Stock Market (“Nasdaq”) listing rules,
as applicable.
91
As
part of these policies and procedures, we prohibit any employee, director or other covered person from engaging in short sales, transactions
involving publicly traded options or other derivative securities based on the Company’s securities, hedging transactions, margin
accounts, pledges, or other inherently speculative transactions with respect to the Company’s securities at any time.
Audit
Committee and Audit Committee Financial Expert
We
have a separately designated standing Audit Committee. The members of our Audit Committee are Ms. Ball, Dr. Dambkowski, and Dr. Turtle,
each of whom qualifies as an “independent” director for audit committee purposes as defined under Nasdaq listing rules and
the rules and regulations established by the SEC. Ms. Ball chairs the Audit Committee and qualifies as an “audit committee financial
expert” as that term is defined under the rules and regulations established by the SEC, and all members of the Audit Committee
are financially literate under Nasdaq listing rules.
Delinquent
Section 16(a) Reports
Section
16(a) of the Exchange Act requires our directors, officers and persons who beneficially own more than 10% of a registered class of our
equity securities to file with the SEC initial reports of ownership and reports of changes in ownership of our common stock and other
equity securities. To our knowledge, based solely on our review of Forms 3, 4 and 5 filed with the SEC or written representations that
no Form 5 was required, during the year ended December 31, 2024, we believe that all of our directors, officers and persons who beneficially
own more than 10% of a registered class of our equity securities timely filed all reports required under Section 16(a) of the Exchange
Act.
Stockholder
Proposals and Director Nominations for 2025 Annual Meeting of Stockholders
We
will hold our 2025 Annual Meeting of Stockholders (the “Annual Meeting”) on Monday, June 2, 2025.
Pursuant
to Rule 14a-8 of the Exchange Act, stockholders who wish to submit proposals for inclusion in the proxy statement for the Annual
Meeting must send such proposals to our Corporate Secretary at the address 855 Oak Grove Avenue, Suite 100, Menlo Park, CA 94025. Such
proposals must be received by us a reasonable time before we begin to print and mail our proxy materials and must comply with Rule 14a-8
of the Exchange Act. The submission of a stockholder proposal does not guarantee that it will be included in the proxy statement.
On August 29, 2024, in connection
with the Merger Closing, the Board adopted an amendment and restatement of our Bylaws, effective as of such date, as described in our
Current Report on Form 8-K filed on September 5, 2024. As set forth in our Bylaws, if a stockholder intends to make a nomination for director
election or present a proposal for other business (other than pursuant to Rule 14a-8 of the Exchange Act) at the Annual Meeting,
the stockholder’s notice must be received by our Corporate Secretary at the address 855 Oak Grove Avenue, Suite 100, Menlo Park,
CA 94025 no earlier than the 120th day and no later than the close of business on the 90th day before the anniversary of the last
annual meeting; provided, however, that if the date of the annual meeting is more than 30 days before or more than 60 days after such
anniversary date, the stockholder’s notice must be delivered not earlier than the close of business on the 120th day prior to such
annual meeting and not later than the close of business on the later of the 90th day prior to such annual meeting or the 10th day following
the date on which the first public announcement of the date of such annual meeting is made by the Company. Therefore, notice of proposed
nominations or proposals (other than pursuant to Rule 14a-8 of the Exchange Act) must be received by our Corporate Secretary
no later than the close of business on March 16, 2025. Any such director nomination or stockholder proposal must be a proper matter for
stockholder action and must comply with the terms and conditions set forth in our Bylaws (which includes the timing and information required
under Rule 14a-19 of the Exchange Act). If a stockholder fails to meet these deadlines or fails to satisfy the requirements of Rule
14a-4 of the Exchange Act, we may exercise discretionary voting authority under proxies we solicit to vote on any such proposal as we
determine appropriate. We reserve the right to reject, rule out of order or take other appropriate action with respect to any nomination
or proposal that does not comply with these and other applicable requirements.
92
Item
11. Executive Compensation.
This
section provides information regarding the compensation of our principal executive officer (Dr. Klein), and our two other highest
paid executive officers who were serving as executive officers on December 31, 2024 (Dr. Goncalves and Mr. Quinlan). This section
also includes compensation information for certain former executives of the Company (then known as ARCA). The individuals listed below
are collectively referred to herein as the “NEOs” or “Named Executive Officers.”
Name
Title
Lawrence
Klein, Ph.D.
Chief Executive Officer (1)
Joana Goncalves,
MBChB
Chief Medical Officer (1)
Paul Quinlan
General Counsel and
Corporate Secretary (1)
Michael Bristow,
M.D.
Former President
and Chief Executive Officer (2)
Thomas A. Keuer
Former President
and Chief Operating Officer (3)
C. Jeffrey Dekker
Former Chief Financial
Officer (3)
(1) Drs.
Klein and Goncalves and Mr. Quinlan were appointed to these positions in connection with
the consummation of the Merger. Prior to the Merger, they each served in these positions
at Pre-Merger Oruka.
(2) Dr.
Bristow’s employment with the Company terminated on April 3, 2024. Following his termination,
Dr. Bristow provided transition services as a consultant.
(3) Mr.
Keuer’s and Mr. Dekker’s employment with the Company terminated in connection
with the Merger. Following the Merger, Mr. Dekker provided transition services as a consultant.
A
Year of Transition
2024
was a year of transition for the Company as we completed the Merger, shifted our drug candidate pipeline to focus on novel biologics
designed to set a new standard for the treatment of chronic skin diseases and transformed our management team. Our 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 per year. The compensation described below reflects
both compensatory decisions necessary to engage a new leadership team that is critical to lead the advancement of the Company’s
pipeline of novel biologics and improve the standard of care for the treatment of chronic skin diseases and compensatory decisions made
by ARCA prior to the consummation of the Merger with respect to the former executive officers.
93
2024
Summary Compensation Table
The
following table shows information regarding the compensation earned by the NEOs during the fiscal years ending December 31, 2024
and 2023, by our named executive officers.
Name
and Principal Position (1)
Year
Salary
($) (2)
Bonus
($) (3)
Option
Awards
($) (4)
Non-Equity
Incentive Plan
Compensation
($) (5)
All
Other
Compensation
($)
Total
($)
Lawrence
Klein, Ph.D.
2024
203,288
—
—
317,623
—
520,911
Chief
Executive Officer
Joana
Goncalves, MBChB
2024
155,854
—
—
162,132
—
317,986
Chief
Medical Officer
Paul
Quinlan
2024
155,854
—
—
154,591
—
310,445
General
Counsel
Michael
Bristow, M.D.
2024
96,865
—
39,676
—
373,875 (6)
510,416
Former
President and Chief Executive Officer
2023
345,000
—
—
—
13,800
358,800
Thomas
A. Keuer
2024
235,385
165,000
22,484
—
430,651 (7)
853,520
Former
President and Chief Operating Officer
2023
340,000
—
—
—
60,802
400,802
C.
Jeffrey Dekker
2024
206,923
165,000
24,947
—
359,734 (8)
756,604
Former
Chief Financial Officer
2023
270,000
—
—
—
53,072
323,072
(1) The
amounts reflected herein for Drs. Klein and Goncalves and Mr. Quinlan do not include any
compensation they received from Pre-Merger Oruka prior to the Merger.
(2) Includes
$157,595 of consulting fees for Dr. Bristow and $20,000 of consulting fees for Mr. Keuer,
in each case, pursuant to their respective consulting agreements as described in more detail
under “ Narrative Disclosure to Summary Compensation Table—ARCA Arrangements ”
below.
(3) Amounts
reported in this column represent retention bonuses, as described in more detail under “ Narrative
Disclosure to Summary Compensation Table—ARCA Arrangements ” below.
(4) Amounts
reported in this column represent the incremental fair value under Accounting Standards Codification
Topic 718 (“ASC 718”) resulting from the acceleration of the Named Executive
Officer’s stock options in the Merger, as described in more detail under “Narrative
to Summary Compensation Table—ARCA Arrangements” below.
(5) Amounts
reported in this column represent the annual bonuses earned under the 2024 annual bonus program,
as described in more detail under “ Narrative to Summary Compensation Table—Elements
of Compensation—Annual Bonus Program ” below.
(6) Includes
$3,875 of Company contributions under the ARCA 401(k) plan and $370,000 of severance payments
and benefits, as described in more detail under “ Narrative Disclosure to Summary
Compensation Table—ARCA Arrangements ” below.
(7) Includes
$16,800 of Company contributions under the ARCA 401(k) plan, $340,000 of severance payments
and $69,715 in COBRA continuation premiums, as described in more detail under “ Narrative
Disclosure to Summary Compensation Table—ARCA Arrangements ” below, and $4,136
for group term life insurance premiums.
(8) Includes
$14,687 of Company contributions under the ARCA 401(k) plan, $270,000 of severance payments
and $69,715 in COBRA continuation premiums, as described in more detail under “ Narrative
Disclosure to Summary Compensation Table—ARCA Arrangements ” below, $2,692
for group term life insurance premiums and $2,640 for healthcare reimbursements.
Narrative
Disclosure to Summary Compensation Table
In
December 2024, our Compensation Committee adopted a compensation philosophy to frame future compensation decisions for the Company. Under
this philosophy, compensation positioning is used to attract and retain key employees for the Company’s continued success and growth.
While market data is helpful to the Compensation Committee in setting compensation framework and guiding decisions, other factors such
as Company strategy, stockholder feedback, tenure, performance and criticality are also considered. The compensation philosophy serves
as the foundation to reinforce the Company’s business strategy and desired culture, while balancing internal and external alignment.
94
Peer
Group
In
July 2024, Pre-Merger Oruka, in consultation with Alpine, the Compensation Committee’s independent compensation consultant, established
a peer group that focuses on U.S.-based, pre-clinical or early clinical biopharma companies (with priority placed on companies with a
similar therapeutic focus) with a market capitalization ranging from $250 million to $2 billion and less than 100 employees. The peer
group, which was used in making compensation decisions in connection with establishing post-Merger executive compensation for 2024, includes
the following companies (the “Peer Group”):
Apogee
Therapeutics
Astria
Therapeutics
Cabaletta
Bio
CARGO
Therapeutics
Celldex
Therapeutics
Contineum
Therapeutics
Entrada
Therapeutics
Janux
Therapeutics
Kymera
Therapeutics
Kyverna
Therapeutics
Lexeo
Therapeutics
Longboard
Pharmaceuticals
Lyell
Immunopharma
Pliant
Therapeutics
Prime
Medicine
Spyre
Therapeutics
Structure
Therapeutics
Third
Harmonic Bio
Elements
of Compensation
Base
Salaries
Our
Compensation Committee recognizes the importance of base salary as an element of compensation to provide our executive officers with
steady cash flow during the year that is not contingent on short-term variations in our corporate performance. The setting of base salaries
also includes an evaluation of each individual’s job duties, responsibilities, performance and experience, as well as internal
pay equity among the executive officer team. The Compensation Committee reviews base salaries at least annually and may recommend adjustment
from time to time based on the results of that review. The Compensation Committee determines salary increases using a combination of
relevant competitive market data, scope of responsibilities and assessment of individual performance.
For
2024, the annual base salaries of Drs. Klein and Goncalves and Mr. Quinlan were established in connection with the consummation of their
employment with Pre-Merger Oruka as a result of negotiations in the context of a competitive recruitment process. The annual base salaries
as of December 31, 2024 for each of our continuing NEOs were as follows: $600,000 for Dr. Klein and $460,000 for each of Dr. Goncalves
and Mr. Quinlan.
Annual
Bonus Program
We
have an annual cash incentive plan under which cash incentives may be paid to each of our employees, including our executive officers,
after the end of each calendar year. The Compensation Committee generally determines target bonuses based on Peer Group practices and
each individual’s job duties. For 2024, the target bonuses for each NEO (excluding the former ARCA executive officers), which were
established by Pre-Merger Oruka in connection with the consummation of their employment with Pre-Merger Oruka, were as follows: 50% of
base salary for Dr. Klein and 40% of base salary for each of Dr. Goncalves and Mr. Quinlan, in each case, pro-rated based on their respective
start dates with Pre-Merger Oruka.
Pre-Merger
Oruka established the corporate goals and targets for the 2024 bonus program, which were heavily weighted towards the preclinical development
of ORKA-001 and ORKA-002, progress towards the commencement of their respective Phase 1 clinical studies and regulatory progress. In
addition, the corporate goals included measures designed to ensure adequate funding for the Company.
The
Board, upon the recommendation of the Compensation Committee, reviewed our achievement against our 2024 corporate goals and determined
the achievement to have been 125% of target, based on the achievement of substantially all the goals, with overperformance on several
of the goals.
Based
on our corporate performance, the 2024 annual bonuses awarded to our continuing NEOs were as follows: $317,623 for Dr. Klein, $162,132
for Dr. Goncalves and $154,591 for Mr. Quinlan.
95
Long-Term
Incentives
We
intend our equity incentive program to reward longer-term performance and to align the interests of our executive officers with those
of our stockholders. We also believe that our equity incentive program, which currently consists predominantly of time-based stock options
(or, for certain grants by Pre-Merger Oruka, time-based compensatory warrants), is an important retention tool for our employees, including
our NEOs. The Compensation Committee believes that stock options, which require increased stock price performance for value realization,
create a key connection between the interests of the NEOs and stockholders. Each of the grants described below are presented after giving
effect to the share conversion completed in the Merger and the subsequent 1-for-12 reverse stock split.
In
connection with his appointment as Chief Executive Officer of Pre-Merger Oruka, Dr. Klein purchased 852,338 shares of restricted stock
at fair market value, which vests as to 25% on February 26, 2025 and in equal monthly installments thereafter through February 26, 2028.
In accordance with the anti-dilution provisions of his offer letter, as described in more detail below, on July 15, 2024, Dr. Klein received
a compensatory warrant to purchase 1,628,513 shares of our common stock, which vests as to 25% on April 3, 2025 and in equal monthly
installments thereafter through April 3, 2028.
In
connection with her appointment as Chief Medical Officer of Pre-Merger Oruka, Dr. Goncalves was granted stock options to purchase 228,563
shares of our common stock, which vests as to 25% on April 18, 2025 and in equal monthly installments thereafter through April 18, 2028.
On July 15, 2024, Dr. Goncalves was granted a compensatory warrant to purchase 199,992 shares of our common stock, which vests on the
same schedule as her initial stock option grant.
In
connection with his appointment as General Counsel of Pre-Merger Oruka, Mr. Quinlan was granted stock options to purchase 228,563 shares
of our common stock, which vests as to 25% on April 30, 2025 and in equal monthly installments thereafter through April 30, 2028. On
July 15, 2024, Mr. Quinlan was granted a compensatory warrant to purchase 99,996 shares of our common stock, which vests on the same
schedule as his initial stock option grant.
None
of the former ARCA executive officers received grants of equity incentive awards during 2024.
Offer
Letters
In
connection with their appointments, we entered into offer letters with each of Dr. Klein, Dr. Goncalves and Mr. Quinlan, each of which
was amended and restated as of October 3, 2024 (for Dr. Klein) or October 1, 2024 (for Dr. Goncalves and Mr. Quinlan) following the Merger
(collectively, the “Offer Letters”). The Offer Letters provided for each NEO’s initial base salary, target annual bonus
and initial equity incentive award. The Offer Letter with Dr. Klein also provided for periodic grants of stock options sufficient to
maintain Dr. Klein’s ownership at approximately 5% on a fully-diluted basis until Oruka raised an aggregate of $200 million
in financing, which obligations were fully satisfied prior to the consummation of the Merger through the warrant issued on July 15, 2024.
The Offer Letter with Dr. Goncalves also provided for a sign-on bonus of $100,000, which is subject to repayment in the event of a termination
for cause or resignation without good reason prior to April 18, 2025.
Under
the Offer Letters, the NEOs are eligible for certain payments or benefits upon certain terminations of employment, as described under
“Additional Narrative Disclosure—Potential Payments Upon Termination or Change in Control” below. Each of Dr. Klein,
Dr. Goncalves and Mr. Quinlan is also party to our standard employee invention assignment, confidentiality and non-competition agreement,
which, among other things, provides standard protections regarding our ownership of intellectual property, the confidentiality of our
proprietary information, non-competition and non-solicitation.
ARCA
Arrangements
Michael
Bristow, M.D. Dr. Bristow served as the Company’s President and Chief Executive Officer through April 3, 2024. In connection
with his separation, the Company (then known as ARCA) and Dr. Bristow entered into a separation agreement pursuant to which Dr.
Bristow provided a release of claims in favor of the Company and the Company paid Dr. Bristow a lump sum severance payment of $370,000.
96
The
Company and Dr. Bristow also entered into a consulting agreement, effective April 3, 2024, pursuant to which Dr. Bristow
provided certain consulting services to the Company through the Merger. Under the consulting agreement, Dr. Bristow continued to
vest in his outstanding equity awards during the consulting term.
Thomas
A. Keuer and C. Jeffrey Dekker. Mr. Keuer served as the Company’s President and Chief Operating Officer and Mr. Dekker
served as the Company’s Chief Financial Officer, in each case, through the consummation of the Merger. Pursuant to retention bonus
letters approved by the ARCA Compensation Committee prior to the Merger, each of Messrs. Keuer and Dekker were paid a retention bonus
upon consummation of the Merger of $165,000.
As
a result of the Merger and the accompanying termination of their employment, the Company and each of Mr. Keuer and Mr. Dekker entered
into a separation agreement, pursuant to which Mr. Keuer and Mr. Dekker each provided a release of claims in favor of the Company and
the Company provided the following severance payments and benefits, in accordance with the terms of their employment agreement: (i) a
lump sum cash severance payment equal to 12 months of their respective annual base salary ($340,000 and $270,000, respectively) and (ii)
a lump sum cash payment of $69,715 in lieu of 12 months of group health plan continuation premiums.
Treatment
of ARCA Equity Awards. In connection with the Merger, all outstanding ARCA stock options held by the NEOs were accelerated and cashed
out for an amount equal to the difference between $3.9489 and the applicable per share exercise price; however, any ARCA stock options
having an exercise price in excess of $3.9489 were cancelled for no consideration.
Outstanding
Equity Awards at Fiscal Year End
The
following table presents information regarding outstanding stock options, compensatory warrants and restricted stock held by each NEO
as of December 31, 2024. The equity awards reflected below give effect to the share conversion completed in the Merger and the subsequent
1-for-12 reverse stock split. None of the former ARCA executive officers held any outstanding equity awards as of December 31, 2024.
Option
Awards
Stock
Awards
Name
Number
of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number
of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Option
Exercise Price
($)
Option
Expiration
Date
Number
of
Shares or
Units of Stock
That Have Not
Vested
(#)
Market
Value
of Shares or
Units of Stock
That Have Not
Vested
($) (1)
Lawrence Klein, Ph.D.
—
1,628,513 (2)
7.80
7/14/2034
852,338 (3)
16,526,834
Joana Goncalves, MBChB
—
228,563 (4)
6.84
10/30/2034
—
199,992 (4)
7.80
7/14/2034
Paul Quinlan
—
228,563 (5)
6.84
10/30/2034
—
99,996 (5)
7.80
7/14/2034
Michael Bristow, M.D.
—
—
—
—
—
—
Thomas A. Keuer
—
—
—
—
—
—
C. Jeffrey Dekker
—
—
—
—
—
—
(1) The
market value was determined by multiplying the numbers of shares by $19.39, the closing price
of our common stock on December 31, 2024.
(2) These
compensatory warrants vest as to 25% on April 3, 2025 and in equal monthly installments thereafter
through April 3, 2028, subject to Dr. Klein’s continued services to us.
(3) These
restricted shares vest as to 25% on February 26, 2025 and in equal monthly installments thereafter
through February 26, 2028, subject to Dr. Klein’s continued services to us.
(4) These
stock options and compensatory warrants vest as to 25% on April 18, 2025 and in equal monthly
installments thereafter through April 18, 2028, subject to Dr. Goncalves’ continued
services to us.
(5) These
stock options and compensatory warrants vest as to 25% on April 30, 2025 and in equal monthly
installments thereafter through April 30, 2028, subject to Mr. Quinlan’s continued
services to us.
97
Additional
Narrative Disclosures
Employee
Benefits and Perquisites
Our
NEOs are eligible to participate in our employee benefit plans, including our health and welfare plans, term life insurance, disability
insurance and a 401(k) plan, in each case on the same basis as all our other employees. During 2024, following the Merger, we did not
provide any Company contributions under the 401(k) plan; however, in 2025, the Company will make matching contributions of 100% of the
first 3% of eligible compensation deferred by participants, subject to legal maximum contributions.
Following
the Merger, we generally do not provide perquisites or personal benefits to our NEOs, except in limited circumstances.
Potential
Payments Upon Termination or Change in Control
Pursuant
to the terms of the Offer Letters, in the event each NEO that is a current executive officer is terminated by the Company without “cause”
or as a result of a resignation for “good reason” (collectively, an “Involuntary Termination”), such NEO will,
subject to the execution of a release in favor of the Company, receive: (i) severance payments equal to 12 months of base salary; (ii)
Company-paid continuation coverage under the Company’s group health plans for up to 12 months; and (iii) in the case of Dr. Klein,
accelerated vesting of 30% of any outstanding time-based equity. However, if the Involuntary Termination is within three months before
or 12 months after a change in control of the Company, the NEO will instead receive: (A) severance payments equal to 1.0 times (or, for
Dr. Klein, 1.5x times) the sum of the NEO’s base salary and target bonus; (B) Company-paid continuation coverage under the Company’s
group health plans for up to 12 months (or, for Dr. Klein, up to 18 months); and (C) full acceleration of all equity awards. In addition,
upon severance due to the death or disability of the named executive officer, the officer’s equity awards shall accelerate in full.
As
used in the Offer Letters:
“Cause”
generally means the NEO’s (i) dishonest statements or acts with respect to the Company or any affiliate of the Company, or any
current or prospective customers, suppliers, vendors or other third parties with which such entity does business that results in or is
reasonably anticipated to result in material harm to the Company; (ii) conviction or plea of no contest to a felony or misdemeanor involving
moral turpitude, deceit, dishonesty or fraud; (iii) failure to perform his or her duties or responsibilities, subject to a 30-day cure
period; (iv) gross negligence, willful misconduct that results in or is reasonably anticipated to result in material harm to the Company;
or (v) violation of any material provision of any agreement with the Company or any written Company policies.
“Good
reason” generally means (i) a material diminution in the named executive officer’s base salary or target bonus (excluding
across-the-board reductions of less than 10%); (ii) a material geographic relocation or requirement to change the named executive officer’s
remote work location; (iii) a material reduction in the named executive officer’s duties, authority or responsibilities; (iv) the
failure of the Company to obtain the assumption of the Offer Letter by a successor; or (v) the material breach of any agreement between
the NEO and the Company, in each case, subject to standard notice and cure periods.
Clawback
Policy
We
maintain a Compensation Recoupment (Clawback) Policy, which is intended to comply with the requirements of Nasdaq Listing Standard 5608
implementing Rule 10D-1 under the Exchange Act. In the event the Company is required to prepare an accounting restatement of the Company’s
financial statements due to material non-compliance with any financial reporting requirement under the federal securities laws, the Company
will recover, on a reasonably prompt basis, the excess incentive-based compensation received by any covered executive, including the
NEOs, during the prior three fiscal years that exceeds the amount that the executive otherwise would have received had the incentive-based
compensation been determined based on the restated financial statements.
98
Equity
Grant Practices
Following
the Merger, we generally grant annual equity awards, including stock options, in January of each year. We also grant stock options as
new hire awards as of their date of employment commencement. Employees, including the NEOs, may enroll to purchase shares under the terms
of our 2024 Employee Stock Purchase Plan, as amended (the “ESPP”), with purchase dates generally occurring during open trading
windows in June and December of each year using payroll deductions accumulated during the prior six-month period. During 2024, the Compensation
Committee did not take material nonpublic information into account when determining the timing and terms of stock options, and the Company
did not time the disclosure of material nonpublic information for the purpose of affecting the value of executive compensation.
Director
Compensation
The
following table provides information for the year ended December 31, 2024 regarding all compensation awarded to, earned by or paid to
each person who served as a non-employee director for some portion of 2024. Employees who served on our Board during 2024 did not receive
additional compensation for such service:
Name (1)(2)
Fees
Earned or
Paid in
Cash
($)
Option
Awards
($) (3)
Total
($)
Kristine Ball
20,548
-
20,548
Carl Dambkowski, M.D.
16,267
-
16,267
Peter Harwin
19,178
-
19,178
Samarth Kulkarni, Ph.D.
27,740
-
27,740
Cameron Turtle, D.Phil. (4)
20,377
-
20,377
Dan Mitchell
30,810
-
30,810
Raymond Woosley
27,500
-
27,500
Robert Conway
197,916
2,739
200,655
James Flynn
71,042
12,620
83,662
Linda Grais
168,124
2,739
170,863
Anders Hove
159,583
2,739
162,322
Jacob Ma-Weaver
119,167
8,215
127,382
(1) The
amounts reflected herein for directors who served on the Pre-Merger Oruka board of directors
do not include any compensation they received from Pre-Merger Oruka prior to the Merger.
(2) Messrs.
Woosley and Mitchell resigned from our Board effective as of February 2, 2024. In connection
with the Merger on August 29, 2024, Drs. Hove and Grais as well as Messrs. Conway, Ma-Weaver
and Flynn resigned from our Board and Drs. Turtle, Dambkowski and Kulkarni as well as Ms.
Ball and Mr. Harwin were appointed to our Board.
(3) In
connection with the Merger, all outstanding ARCA stock options held by Drs. Hove and Grais
and Messrs. Conway, Ma-Weaver and Flynn were accelerated and cashed out for an amount equal
to the difference between $3.9489 and the applicable per share exercise price; however, any
ARCA stock options having an exercise price in excess of $3.9489 were cancelled for no consideration.
Amounts reported in this column represent the incremental fair value under ASC Topic 718
resulting from the acceleration of the stock options in the Merger. As of December 31, 2024,
each of Drs. Turtle and Dambkowski and Ms. Ball held outstanding options or compensatory
warrants to purchase 94,282 shares of our common stock (which were assumed by the Company
in connection with the Merger), Dr. Kulkarni held outstanding options or compensatory warrants
to purchase 199,992 shares of our common stock (which were assumed by the Company in connection
with the Merger), and no other non-employee directors held any outstanding options or compensatory
warrants.
(4) Prior
to the Merger, Dr. Turtle purchased 85,233 shares (after giving effect to the share conversion
completed in the Merger and the subsequent 1-for-12 reverse stock split) of restricted common
stock that vest as to 25% on March 1, 2025 and in and in equal monthly installments thereafter
through March 1, 2028. All of such restricted shares were outstanding as of December 31,
2024.
99
Non-Employee
Director Compensation Program
Non-employee
members of the Board are eligible to receive cash and equity compensation in accordance with our non-employee director compensation program.
This program provides for the following annual cash retainers:
Pre-Merger
Post-Merger
Annual Cash Retainer
$ 40,000
$ 40,000
Annual Board Chair Retainer
$ 30,000
$ 30,000
Audit Committee Retainers:
Chair
$ 15,000
$ 15,000
Non-Chair Member
$ 7,500
$ 7,500
Compensation Committee Retainers:
Chair
$ 10,000
$ 12,000
Non-Chair Member
$ 5,000
$ 6,000
Nominating and Corporate Governance Committee
Retainers
Chair
$ 10,000
$ 10,000
Non-Chair Member
$ 5,000
$ 5,000
In
connection with the Company’s annual meeting of stockholders, each member of the Board will receive an annual grant of stock options
to purchase 17,500 shares of common stock, which will vest in equal monthly installments over 12 months so long as such director joined
the Board prior to January 1 of the year in which such annual meeting occurs. Prior to the Merger, the annual grant of stock options
was for 6,000 shares of common stock.
In
addition, in connection with a non-employee director’s initial appointment to the Board, they will receive an initial grant of
stock options to purchase 35,000 shares of common stock, which will vest in equal monthly installments over 36 months. Prior to the Merger,
the initial grant of stock options was for 12,000 shares of common stock.
All
members of the Board are also reimbursed for reasonable and documented out-of-pocket travel and lodging expenses incurred in connection
with attending meetings and activities of the Board and its committees.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Security
Ownership of Certain Beneficial Owners and Management
The
following table sets forth information, to the extent known by us or ascertainable from public filings, with respect to the beneficial
ownership of our Common Stock as of February 15, 2025.
● each
person or group of affiliated persons, who is known by us to be the beneficial owner of more
than 5% of Common Stock;
● each
of our directors;
● each
of our named executive officers; and
● all
of our current directors and executive officers as a group.
100
The
column entitled “Percentage of Shares Outstanding Beneficially Owned” is based on a total of 37,440,510 shares of our Common
Stock outstanding as of February 15, 2025.
Beneficial
ownership is determined in accordance with the rules and regulations of the SEC and includes voting or investment power with respect
to the Common Stock. Shares of Common Stock subject to options that are currently exercisable or exercisable within 60 days of the date
of this table are considered outstanding and beneficially owned by the person holding the options for the purpose of calculating the
percentage ownership of that person but not for the purpose of calculating the percentage ownership of any other person. Except as otherwise
noted, the persons and entities in this table have sole voting and investing power with respect to all the shares of Common Stock beneficially
owned by them, subject to community property laws, where applicable. Except as otherwise indicated in the table below, addresses of named
beneficial owners are in care of Oruka Therapeutics, Inc., 855 Oak Grove Ave., Suite 100, Menlo Park, CA 94025.
Name of
Beneficial Owner
Number
of Shares
Beneficially
Owned
Percentage
of Shares
Outstanding
Beneficially
Owned
5% Stockholders:
Entities affiliated
with Fairmount Funds Management LLC (1)
8,511,824
19.99 %
FMR LLC (2)
5,561,808
14.86 %
Entities affiliated with Venrock
Healthcare Capital Partners (3)
4,148,428
11.08 %
Entities affiliated with RTW
Investments, LP (4)
2,058,147
5.50 %
Named
Executive Officers and Directors:
Lawrence Klein (5)
1,522,440
4.02 %
Arjun Agarwal (6)
61,068
*
Joana Goncalves (7)
10,347
*
Paul Quinlan (8)
10,156
*
Michael R. Bristow (9)
399
*
Thomas A. Keuer (10)
3,394
*
C. Jeffrey Dekker (11)
3,333
*
Cameron Turtle (12)
110,579
*
Samarth Kulkarni (13)
35,713
*
Peter Harwin (1)
8,511,824
19.99 %
Carl Dambkowski (14)
25,058
*
Kristine Ball
—
*
All current executive officers
and directors as a group (9 persons) (15)
10,287,185
24.69 %
* Less
than 1%.
(1) Consists
of (i) (A) 798,614 shares of common stock, (B) 409,326 shares of common stock issuable upon
the exercise of pre-funded warrants and (C) 4,730,576 shares of common stock issuable upon
conversion of 56,767 shares of Series B Preferred Stock held by Fairmount Healthcare Fund
II L.P. (“Fairmount Fund II”) and (ii) 2,573,308 shares of common stock held
by Fairmount Healthcare Co-Invest III L.P. (“Fairmount Fund III”). Excludes (i)
4,888,338 shares of common stock issuable upon the exercise of the pre-funded warrants and
(ii) 6,697,573 shares of common stock issuable upon the conversion of 80,371 shares of Series
B Preferred Stock. The pre-funded warrants are subject to a beneficial ownership limitation
of 9.99% and the shares of Series B Preferred Stock are subject to a beneficial ownership
limitation of 19.99%, which such limitations restrict Fairmount Funds Management LLC (“Fairmount”)
and its affiliates from exercising that portion of the warrants and converting those shares
of preferred stock that would result in Fairmount and its affiliates owning, after exercise
or conversion, a number of shares of common stock in excess of the applicable ownership limitation.
At such time as Fairmount and its affiliates beneficially own 9.0% or less of the shares
of common stock, the beneficial ownership limitation applicable to the shares of Series B
Preferred Stock will automatically reduce to 9.99%. Fairmount serves as investment manager
for Fairmount Fund II and Fairmount Fund III. Fairmount Fund II and Fairmount Fund III have
delegated to Fairmount the sole power to vote and the sole power to dispose of all securities
held in Fairmount Fund II and Fairmount Fund III’s portfolios. Because Fairmount Fund
II and Fairmount Fund III have divested themselves of voting and investment power over the
securities they hold and may not revoke that delegation on less than 61 days’ notice,
Fairmount Fund II and Fairmount Fund III disclaim beneficial ownership of the securities
they hold. As managers of Fairmount, Peter Harwin and Tomas Kiselak may be deemed
to have voting and investment power over the shares held by Fairmount Fund II and Fairmount
Fund III. Fairmount, Peter Harwin and Tomas Kiselak disclaim beneficial ownership
of such shares, except to the extent of any pecuniary interest therein. The address of the
entities and individuals listed is 200 Barr Harbor Drive, Suite 400, West Conshohocken, PA
19428.
101
(2) All
of the shares listed in the table above are owned by funds or accounts managed by direct
or indirect subsidiaries of FMR LLC, all of which shares are beneficially owned, or may be
deemed to be beneficially owned, by FMR LLC, certain of its subsidiaries and affiliates,
and other companies. Abigail P. Johnson is a Director, the Chairman and the Chief Executive
Officer of FMR LLC. Members of the Johnson family, including Abigail P. Johnson, are the
predominant owners, directly or through trusts, of Series B voting common shares of FMR LLC,
representing 49% of the voting power of FMR LLC. The Johnson family group and all other Series
B shareholders have entered into a shareholders’ voting agreement under which all Series
B voting common shares will be voted in accordance with the majority vote of Series B voting
common shares. Accordingly, through their ownership of voting common shares and the execution
of the shareholders’ voting agreement, members of the Johnson family may be deemed,
under the Investment Company Act of 1940, to form a controlling group with respect to FMR
LLC. The address of FMR LLC is 245 Summer Street, Boston, MA 02210.
(3) Consists
of (i) 3,205,865 shares of common stock held by Venrock Healthcare Capital Partners EG, L.P.
(“VHCPEG”), (ii) 856,747 shares of common stock held by Venrock Healthcare Capital
Partners III, L.P. (“VHCP3”), and (iii) 85,816 shares of common stock held by
VHCP Co-Investment Holdings III, LLC (“VHCPCo3”). Excludes 405,980, 107,788 and
10,775 shares of common stock issuable upon the exercise of the pre-funded warrants held
by VHCPEG, VHCP3 and VHCPCo3, respectively. The pre-funded warrants are subject to a beneficial
ownership limitation of 9.99%, which such limitations restrict Venrock Healthcare Capital
Partners and its affiliates from exercising that portion of the warrants that would result
in Venrock Healthcare Capital Partners and its affiliates owning, after exercise, a number
of shares of common stock in excess of the applicable ownership limitation. VHCP Management
III, LLC (“VHCPM3”) is the sole general partner of VHCP3 and the sole manager
of VHCPCo3. VHCP Management EG, LLC (“VHCPM EG”) is the sole general partner
of VHCPEG. As voting members of VHCPM3 and VHCPM EG, Dr. Bong Koh and Nimish Shah may be
deemed beneficial owners of any securities beneficially owned by VHCPM3 and VHCPM EG. The
principal business address of each of these persons and entities is 7 Bryant Park, 23rd Floor,
New York, NY 10018.
(4) Consists
of 2,058,147 shares of common stock held in the aggregate by RTW Master Fund, Ltd. (“RTW
Master Fund”), RTW Innovation Master Fund, Ltd. (“RTW Innovation Master Fund”),
and RTW Biotech Opportunities Operating Ltd. (“RTW Biotech” and together with
RTW Master Fund and RTW Innovation Fund, the “RTW Funds”). RTW Investments, LP
(“RTW”), in its capacity as the investment manager of the RTW Funds, has the
power to vote and the power to direct the disposition of the shares held by the RTW Funds.
Accordingly, RTW may be deemed to be the beneficial owner of such securities. Roderick Wong,
M.D., as the Managing Partner of RTW, has the power to direct the vote and disposition of
the securities held by RTW. Dr. Wong disclaims beneficial ownership of the shares held by
the RTW Funds, except to the extent of his pecuniary interest therein. The principal business
address of RTW Investments, LP is 40 10th Avenue, Floor 7, New York, NY 10014, and the address
of Dr. Wong and each of the RTW Funds is c/o RTW Investments, LP, 40 10th Avenue, Floor 7,
New York, NY 10014.
(5) Includes
(i) 852,338 shares of common stock, (ii) 421,503 shares of common stock issuable upon the
exercise of options that will vest within 60 days of the date of this table and (iii) 248,599
shares of common stock issuable upon the vesting of restricted stock awards that will vest
within 60 days of the date of this table.
(6) Includes
61,068 shares of common stock issuable upon the exercise of options that will vest within
60 days of the date of this table.
(7) Includes
(i) 191 shares of common stock and (ii) 10,156 shares of common stock issuable upon the exercise
of options that will vest within 60 days of the date of this table
(8) Includes
10,156 shares of common stock issuable upon the exercise of options that will vest within
60 days of the date of this table
(9) Includes
(i) 92 shares owned by Investocor Trust, of which Dr. Bristow is the sole trustee and (ii) 117 shares owned by NFS as Custodian for Michael
Bristow’s IRA. Dr. Bristow and ARCA mutually agreed to conclude Dr. Bristow’s employment effective April 3, 2024.
(10) Mr.
Keuer resigned as named executive officer at the Merger Closing and his last day of employment was September 1, 2024, which termination
was considered to be without “cause” related to a change in control for purposes of his employment agreement with ARCA.
(11) Mr.
Dekker resigned as named executive officer at the Merger Closing and his last day of employment was September 1, 2024, which termination
was considered to be without “cause” related to a change in control for purposes of his employment agreement with ARCA.
(12) Includes
(i) 85,233 shares of common stock held by the Turtle Family Trust, for which Mr. Turtle serves as Trustee, (ii) 2,262 shares of common
stock issuable upon the exercise of options that will vest within 60 days of the date of this table and (iii) 23,084 shares of common
stock issuable upon the vesting of restricted stock awards that will vest within 60 days of the date of this table.
(13) Includes
35,713 shares of common stock issuable upon the exercise of options that will vest within 60 days of the date of this table
(14) Includes
25,058 shares of common stock issuable upon the exercise of options that will vest within 60 days of the date of this table
(15) See
notes (1), (5), (6), (7), (8), (12), (13) and (14) above.
102
Securities
Authorized for Issuance Under Equity Compensation Plans
The
following table provides information with respect to all our equity compensation plans in effect as of December 31, 2024.
Number of
Securities to be Issued
upon Exercise of
Outstanding
Options
Weighted Average
Exercise Price of
Outstanding
Options
Number of
Securities
Remaining
Available for
Future Issuances
under Equity
Compensation Plans
(excluding
securities
reflected in
column
(a))
Plan Category
(a)
(b)
(c)
Equity Compensation Plans Approved by Security Holders:
2024
Stock Incentive Plan
388,567
$ 26.91
4,246,324 (1)
2024
Employee Stock Purchase Plan
—
—
460,529 (2)
2024
Equity Incentive Plan (3)
1,179,193
$ 6.27
—
Equity Compensation Plans Not Approved by Security
Holders:
Non-Plan
Compensatory Warrants (4)
3,054,358
$ 7.80
—
Total
4,622,118
$ 9.02
4,706,853
(1) The
2024 Stock Incentive Plan (the “2024 SIP”) provides for an automatic increase
in the number of shares reserved for issuance thereunder on January 1 of each year through
and including January 1, 2034 equal to (a) 5% of number of issued and outstanding shares
of common stock plus outstanding preferred stock and shares underlying unexercised pre-funded
warrants on an as-converted basis) (collectively, “Shares Outstanding”) on December 31
of the immediately preceding year, or (b) a lesser amount as approved by the Board each
year. Pursuant to this provision, the number of shares available for issuance under the 2024
SIP increased by 2,753,543 shares on January 1, 2025.
(2) The
ESPP provides for an automatic annual increase in the number of shares reserved for issuance
thereunder on January 1 of each year through and including January 1, 2034 equal to
(a) 1% of the number of Shares Outstanding on December 31 of the immediately preceding
year, or (2) a lesser amount as approved by the Board each year. Pursuant to this provision,
the number of shares available for issuance under the ESPP increased by 550,709 shares on
January 1, 2025.
(3) Stock
options granted by Pre-Merger Oruka under the 2024 Equity Incentive Plan were assumed by
the Company in connection with the Merger. No further awards may be made under the 2024 Equity
Incentive Plan.
(4) Non-plan
compensatory warrants granted by Pre-Merger Oruka were assumed by the Company in connection
with the Merger. No further non-plan compensatory warrants are expected to be granted following
the Merger.
103
Item
13. Certain Relationships and Related Transactions, and Director Independence.
Certain
Relationships and Related Transactions
Other
than the compensation agreements and other arrangements disclosed above under “Executive Compensation,” below we describe
the transactions to which we or Pre-Merger Oruka were or are a party since January 1, 2023, in which the amount involved exceeds the
lesser of $120,000 or one percent of the average of our or Pre-Merger Oruka’s total assets at year-end for the last two completed
fiscal years and in which our or Pre-Merger Oruka directors, executive officers, holders of more than 5% of our common stock, or members
of their immediate family had a direct or indirect material interest.
ARCA
Transactions
Transactions
With ARCA’s Former President and Chief Executive Officer
ARCA
previously entered into unrestricted research grants with its former President and Chief Executive Officer’s academic research
laboratory at the University of Colorado. Funding of any unrestricted research grants was contingent upon ARCA’s financial condition,
and could be deferred or terminated at ARCA’s discretion. There was no expense under these arrangements for the year ended December 31,
2024. Total expense under these arrangements for the year ended December 31, 2023 was $(91,000). In December 2023, ARCA
made a payment of $125,000 for the grant period July 2022 through December 2023 under these arrangements. In April 2024,
the President and Chief Executive Officer resigned.
Pre-Merger
Oruka Transactions
Private
Placements of Securities
Pre-Merger
Oruka Series A Preferred Stock and Convertible Note Financing
On
March 6, 2024, Oruka entered into a Convertible Note Purchase Agreement with Fairmount Healthcare Fund II, L.P. (“Fairmount
Fund II”), whereby Oruka issued and sold to Fairmount Fund II (i) an aggregate of 20,000,000 shares of Pre-Merger Oruka Series
A Preferred Stock at a purchase price of $0.15 per share and (ii) a convertible note (the “Convertible Note”) with an
initial principal amount of $25.0 million at an interest rate of 12% per annum, for aggregate gross proceeds of $28 million. Fairmount
Fund II contributed the aggregate principal amount of $25.0 million and all accrued interest under the Convertible Note (unpaid accrued
interest of $1.5 million divided by the conversion price of $66.62 ($5.55 prior to the impact of the Reverse Stock Split) per share)
in exchange for Pre-Merger Oruka Common Stock and Pre-Merger Oruka pre-funded warrants in connection with the Pre-Merger Closing Financing
(as defined below), immediately prior to the completion of the Merger. Fairmount Funds Management (“Fairmount”) is the investment
manager of Fairmount Fund II. Peter Harwin, one of our directors, is a managing member of Fairmount.
104
Pre-Merger
Oruka Pre-Merger Closing Financing
On
April 3, 2024, in connection with the execution of the Merger Agreement, Pre-Merger Oruka entered into the Subscription Agreement
to consummate the Pre-Merger Closing Financing. Pursuant to the Subscription Agreement, the Financing Investors purchased 39,873,706
shares of Pre-Merger Oruka common stock and 9,664,208 Pre-Merger Oruka pre-funded warrants for gross proceeds of approximately $275.0
million (which includes $25.0 million of proceeds previously received from the issuance of the Convertible Note and accrued interest
on such note, which converted to 4,764,032 shares of Pre-Merger Oruka common stock), immediately prior to the Merger Closing and before
the effect of the Reverse Stock Split. Three of the investors or their affiliates were beneficial holders of more than 5% of Pre-Merger
Oruka’s capital stock, and the table below sets forth the number of shares of Pre-Merger Oruka common stock and Pre-Merger Oruka
pre-funded warrants purchased by such holders at the closing of the Pre-Merger Closing Financing.
Participant
Shares
of
Pre-Merger
Oruka
Common
Stock
Pre-funded
Warrants of
Pre-Merger
Oruka
Total
Purchase
Price
Entities affiliated with Fairmount
5,139,797
9,271,241
$ 79,907,282 (1)
Entities affiliated with Venrock Healthcare
Capital Partners
5,011,172
392,967
$ 29,996,067
Entities affiliated with FMR LLC
4,503,445
—
$ 24,999,974
(1) Includes
$25.0 million of proceeds previously received by Pre-Merger Oruka from the issuance of the
Convertible Note and accrued interest on such note, with the remainder of the purchase price
paid in cash.
Company
Transactions
September
2024 Private Placement
On
September 11, 2024, the Company entered into a Securities Purchase Agreement (the “SPA”) with certain selling stockholders
to consummate a private placement (the “Private Placement”). Pursuant to the SPA, the selling stockholders purchased (i)
an aggregate of 5,600,000 shares of Common Stock, at a price per share of $23.00, (ii) an aggregate of 2,439 shares of Series A Preferred
Stock, at a price per share of $23,000.00, and (iii) pre-funded warrants to purchase an aggregate of 680,000 shares of Common Stock at
a purchase price of $22.999 per pre-funded warrant, which represents the per share purchase price of the Private Placement Common Shares
less the $0.001 per share exercise price for each pre-funded warrant, for an aggregate purchase price of approximately $200.5 million.
Three of the selling stockholders or their affiliates were beneficial holders of more than 5% of the Company’s capital stock, and
the table below sets forth the number of shares of Common Stock, Series A Preferred Stock and pre-funded warrants purchased by such holders
at the closing of the Private Placement.
Participant
Shares
of
Common
Stock
Series
A
Preferred
Stock
Pre-Funded
Warrants
Total
Purchase
Price
Entities affiliated with FMR LLC
2,105,000
830
—
$ 67,505,000
Entities affiliated with Venrock Healthcare
Capital Partners
150,000
200
300,000
$ 14,949,700
Entities affiliated with Fairmount
275,000
160
—
$ 10,005,000
Our
Relationship with Paragon and Paruka
We
are party to a number of agreements with Paragon and Paruka. Paragon and Paruka do not beneficially own more than 5% of our capital stock
through their joint holdings of our Common Stock. Fairmount beneficially owns more than 5% of our capital, one of Fairmount’s employees
serves on our Board, and Fairmount beneficially owns more than 5% of Paragon. Fairmount appointed Paragon’s board of directors
and has the contractual right to approve the appointment of any executive officers of Paragon, but is not the beneficial owner of Paragon’s
securities. Paruka is an entity formed by Paragon as a vehicle to hold equity in our Company in order to share profits with certain employees
of Paragon.
105
In
March 2024, Pre-Merger Oruka entered into the Option Agreements with Paragon and Paruka.
Under the terms of the Option Agreements, Paragon identifies, evaluates and develops antibodies
directed against certain mutually agreed therapeutic targets of interest to us. The Option
Agreements include two selected targets, IL-23 (ORKA-001) and IL-17A/F (ORKA-002). Under
each of the Option Agreements, we have the exclusive option to, on a research program-by-research
program basis, be granted an exclusive, worldwide license to all of Paragon’s right,
title and interest in and to the intellectual property resulting from the applicable research
program to develop, manufacture, and commercialize the antibodies and potential products
directed to the selected targets (each, an “Option”), with the exception of pursuing
ORKA-001 for the treatment of inflammatory bowel disease. In September 2024, we exercised
our Option to acquire the rights to ORKA-001 and executed the corresponding license agreement
(the “IL-23 License Agreement”) on December 17, 2024. In December 2024 we exercised
our Option to acquire the rights to ORKA-002 and executed the corresponding license agreement
(the IL-17A/F License Agreement) on February 4, 2025. Under each license agreement we are
required to make non-refundable milestone payments to Paragon of up to $12.0 million under
each respective agreement upon the achievement of certain clinical development milestones,
up to $10.0 million under each respective agreement upon the achievement of certain regulatory
milestones, as well as a low single-digit percentage royalty for antibody products beginning
on the first commercial sale in each program. From time to time, we can choose to add additional
targets to the collaboration by mutual agreement with Paragon. During 2024, we accrued two
$1.5 million milestone payments related to the achievement of development candidates as research
and development expense in our consolidated statements of operations and comprehensive loss
for the year ended December 31, 2024. As of December 31, 2024, this amount is included under
related party accounts payable and other current liabilities on the consolidated balance
sheet.
Pursuant
to the terms of the Option Agreements, the parties initiated certain Research Programs. Each Research Program is aimed at discovering,
generating, identifying and/or characterizing antibodies directed to the respective target. For each Research Program, the parties established
a Research Plan (each, a “Research Plan”) that sets forth the activities that will be conducted, and the associated research
budget. We and Paragon agreed on initial Research Plans that outlined the services that were performed commencing at inception of the
arrangement related to IL-17 and IL-23. Our exclusive option with respect to each Research Program was exercisable at our sole discretion
at any time during the period beginning on the initiation of activities under the associated Research Program and ending a specified
number of days following the delivery of the data package from Paragon related to the results of the Research Plan activities. There
is no payment due upon exercise of an Option pursuant to the Option Agreements.
Pursuant
to the Option Agreements, on a research program-by-research program basis following the finalization of the Research Plan for each respective
research program, the Company was required to pay Paragon a one-time nonrefundable research initiation fee of $0.8 million related to
the ORKA-001 program. This amount was recognized as a research and development expense during the period from February 6 (inception)
to December 31, 2024. In June 2024, pursuant to the Option Agreements with Paragon, the Company completed the selection process of its
development candidate for IL-23 antibodies for the ORKA-001 program. The Company was responsible for 50% of the development costs incurred
through the completion of the IL-23 selection process. The Company received the rights to at least one selected IL-23 antibody in June
2024. During 2024, the Company exercised its option for ORKA-001 and recorded a $1.5 million milestone payment related to the achievement
of development candidate as research and development expense in the Company’s consolidated statement of operations and comprehensive
loss. In addition, during the period from February 6, 2024 (inception) to December 31, 2024, the Company recorded a $2.5 million milestone
payment related to the first dosing of a human subject in a Phase 1 trial of ORKA-001 in December 2024 as research and development expense
in its consolidated statement of operations and comprehensive loss. The Company’s share of development costs incurred during the
period from February 6, 2024 (inception) to December 31, 2024 was $13.5 million, which was recorded as research and development expenses.
An amount of $2.8 million related to ORKA-001 is included in related party accounts payable and other current liabilities as of December
31, 2024.
106
The
Company is also required to reimburse Paragon $3.3 million for development costs related to ORKA-002 incurred by Paragon through December
31, 2023 and certain other development costs incurred by Paragon between January 1, 2024 and March 6, 2024 as stipulated by the Option
Agreements. This amount was recognized as a research and development expense during the period from February 6 (inception) to December
31, 2024. The Company is also responsible for development costs incurred by Paragon from January 1, 2024 through the completion of the
IL-17 selection process. The Company recognized an amount of $0.8 million payable to Paragon for the research initiation fee related
to ORKA-002 following the finalization of the ORKA-002 research plan. This was recognized as research and development expenses in the
period from February 6 (inception) to December 31, 2024. During the period from February 6, 2024 (inception) to December 31, 2024, the
Company exercised its option for ORKA-002 and recorded a $1.5 million milestone payment related to the achievement of development candidate
as research and development expense in its consolidated statement of operations and comprehensive loss. The Company accounted for development
costs of $7.8 million during the period from February 6, 2024 (inception) to December 31, 2024 as research and development expenses.
An amount of $2.7 million related to ORKA-002 is included in related party accounts payable and other current liabilities as of December
31, 2024.
Furthermore,
the Option Agreements provide for an annual equity grant of warrants to purchase a number of shares equal to 1.00% of the then outstanding
shares of our stock, on a fully diluted basis, on each of December 31, 2024 and December 31, 2025, during the term of the Option Agreements,
at the fair market value determined by our Board.
Indemnification
Agreements and Insurance
We
have entered into an indemnification agreement with each of our directors and senior officers and purchased directors’ and officers’
liability insurance. The indemnification agreements require us to indemnify our directors and officers to the fullest extent permitted
under Delaware law.
Review,
Approval or Ratification of Transactions with Related Parties
Prior
to the Merger Closing, Pre-Merger Oruka did not have a formal policy regarding approval of transactions with related parties. All disclosable
transactions with related parties that occurred prior to the Merger Closing were approved by the directors not interested in such transactions,
pursuant to Section 144(a)(1) of the DGCL.
Our
Board has adopted a written related person transactions policy. Under this policy, our executive officers, directors, nominees for election
as a director, beneficial owners of more than 5% of our Common Stock, and any members of the immediate family of and any entity affiliated
with any of the foregoing persons, are not permitted to enter into a material related person transaction with us without the review and
approval of our Audit Committee, or a committee composed solely of independent directors in the event it is inappropriate for our Audit
Committee to review such transaction due to a conflict of interest. The policy provides that, subject to limited exceptions, any transaction,
arrangement or relationship or series of similar transactions, arrangements or relationships in which (1) the aggregate amount involved
since the beginning of the Company’s last completed fiscal year exceeds or is expected to exceed $120,000, (2) the Company or any
of our subsidiaries is a participant, and (3) any related person has or will have a direct or indirect interest, will be presented to
our Audit Committee for review, consideration and approval. In approving or rejecting any such proposal, our Audit Committee will consider
the material facts and other factors it deems appropriate, including, but not limited to, whether the transaction is on terms no less
favorable than terms generally available to an unaffiliated third party under the same or similar circumstances and the extent of the
related person’s interest in the transaction.
107
Director
Independence
Our
Board has reviewed the independence of all directors in light of each director’s (or any family member’s, if applicable)
affiliations with the Company and members of management, as well as significant holdings of our securities and all other facts and circumstances
that the Board has deemed relevant in determining the independence of each director. The Board has determined that each of the directors
other than Lawrence Klein, our current President and Chief Executive Officer, including Kristine Ball, Carl Dambkowski, Peter Harwin,
Samarth Kulkarni and Cameron Turtle, qualify as “independent directors” as defined by the Nasdaq listing rules.
Nasdaq
listing rules have objective tests and a subjective test for determining who is an “independent director.” The subjective
test states that an independent director must be a person who lacks a relationship that, in the opinion of the Board, would interfere
with the exercise of independent judgment in carrying out the responsibilities of a director. The Board has not established categorical
standards or guidelines to make these subjective determinations but considers all relevant facts and circumstances.
In
addition, ARCA’s board of directors determined that former directors Drs. Linda Grais, Anders Hove and Raymond Woosley, and Messrs.
Robert Conway, Daniel Mitchell and James Flynn were independent during the period each served on the Board in 2024. ARCA’s board
of directors determined Dr. Michael R. Bristow, ARCA’s former President and Chief Executive Officer, was not an independent director
in 2024 by virtue of his employment relationship with ARCA.
Item
14. Principal Accountant Fees and Services.
Principal
Accountant Fees and Services
The
following is a summary of the audit fees billed and expected to be billed for the indicated fiscal year to Oruka by PricewaterhouseCoopers
LLP (“PwC”), Pre-Merger Oruka’s independent registered public accounting firm and Oruka’s independent registered
public accounting firm on and after August 30, 2024, and the fees billed by PwC for all other services rendered during the indicated
fiscal year. All services associated with such fees on and after August 30, 2024 were pre-approved by our Audit Committee in accordance
with the “Pre-Approval Policies and Procedures” described below.
Fiscal
Year ended
December 31,
2024
Audit Fees (1)
$ 1,928,000
Audit-Related Fees
—
Tax Fees
—
All
Other Fees (2)
2,000
Total
$ 1,930,000
(1) Audit
Fees consisted of fees and expenses covering the audit of our consolidated financial statements,
reviews of our interim quarterly reports, accounting and financial reporting consultations,
and the issuance of consents and comfort letters in connection with registration statement
filings with the Securities and Exchange Commission (the “SEC”).
(2) All
Other Fees consist of all other services and fees billed for an annual subscription to PwC’s
online resource library.
Pre-Approval
Policies and Procedures
In
connection with the Merger Closing, our Board and Audit Committee adopted a policy and procedures for the pre-approval of audit
and non-audit services performed by our independent registered public accounting firm. These procedures generally approve the
performance of specific services subject to a cost limit for all such services. This general approval is reviewed, and if necessary modified,
at least annually. Management must obtain the specific prior approval of the Audit Committee for each engagement of our independent registered
public accounting firm to perform other audit-related or non-audit services. The Audit Committee does not delegate its responsibility
to pre-approve services performed by our independent registered public accounting firm to any member of management. The Audit Committee
has delegated authority to the Audit Committee chair to pre-approve audit and non-audit services to be provided to us by our independent
registered public accounting firm provided that the fees for such services do not exceed $100,000. Any pre-approval of services by the
Audit Committee chair pursuant to this delegated authority must be reported to the Audit Committee at its next regularly scheduled meeting.
108
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
Incorporation
By Reference
Exhibit
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
Filed
herewith
4.2
Investors’
Rights Agreement by and among Oruka Therapeutics, Inc. and certain investors, dated March 6, 2024
S-4
4.3
5/14/2024
4.3
Form
of Pre-Funded Warrant, dated August 29, 2024
Filed
herewith
4.4
Form
of Pre-Funded Warrant, dated September 13, 2024
8-K
4.1
9/13/2024
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#
Separation
Agreement and Release by and between Michael Bristow and ARCA biopharma, Inc., dated April 3, 2024
8-K
10.1
4/4/2024
10.10#
Second
Amendment to Retention Bonus Letter by and between ARCA biopharma, Inc. and Thomas A. Keuer, dated April 22, 2024
8-K
10.1
4/23/2024
10.11#
Second
Amendment to Retention Bonus Letter by and between ARCA biopharma, Inc. and C. Jeffrey Dekker
8-K
10.2
4/23/2024
10.12†#
Consulting
Agreement, effective as of August 30, 2024, by and between the Company and Jeff Dekker
8-K
10.25
9/5/2024
109
10.13#
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
10.14#
Director
Offer Letter, dated April 24, 2024, by and between Oruka Therapeutics, Inc. and Kristine Ball
S-4
10.44
5/14/2024
10.15#
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
10.16#
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
10.17*#
Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Paul Quinlan, dated October 1, 2024
Filed
herewith
10.18*#
Amended and Restated Employment Letter Agreement by and between Oruka Therapeutics, Inc. and Joana Goncalves, dated October 1, 2024
Filed
herewith
10.19*#
Form of Indemnification Agreement
Filed
herewith
10.20*
Non-Employee Directors Compensation Program
Filed
herewith
10.21
Form
of Lock-Up Agreement
8-K
10.4
4/3/2024
10.22
Form
of Amendment to Subscription Agreement
8-K
10.1
7/9/2024
10.23
Form
of Amended & Restated Subscription Agreement
8-K
10.2
7/9/2024
10.24
Form
of Registration Rights Agreement, dated August 29, 2024
10-Q
10.4
11/13/2024
10.25†
Securities
Purchase Agreement by and between Oruka Therapeutics, Inc. and each of the entities listed on Exhibit A thereto, dated September
11, 2024
8-K
10.1
9/13/2024
10.26
Form
of Registration Rights Agreement, dated as of September 13, 2024
8-K
10.2
9/13/2024
10.27
Asset
Purchase Agreement, dated August 14, 2024, by and between ARCA biopharma, Inc. and Genvara Biopharma, Inc.
8-K
10.1
8/15/2024
10.28†
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
10.29*†
IL-17 License Agreement by and between Paragon Therapeutics, Inc. and Oruka Therapeutics, Inc., dated February 4, 2025
Filed
herewith
10.30†
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
10.31*†
IL-23 License Agreement by and between Paragon Therapeutics, Inc. and Oruka Therapeutics, Inc., dated December 17, 2024
Filed
herewith
10.32*†
Cell
Line License Agreement by and between WuXi Biologics Ireland Limited and Oruka Therapeutics, Inc., dated March 4,
2024
Filed
herewith
10.33*†
Amendment
No. 1 to the Cell Line License Agreement by and between WuXi Biologics Ireland Limited and Oruka Therapeutics, Inc., dated November
20, 2024
Filed
herewith
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
Filed
herewith
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
110
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
Filed
herewith
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.
111
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 6, 2025
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
6, 2025
Lawrence
Klein
(Principal
Executive Officer)
/s/
Arjun Agarwal
Senior
Vice President, Finance and Treasurer
March
6, 2025
Arjun
Agarwal
(Principal
Financial Officer and Principal Accounting Officer)
/s/
Samarth Kulkarni
Chairman
of the Board
March
6, 2025
Samarth
Kulkarni
/s/
Kristine Ball
Director
March
6, 2025
Kristine
Ball
/s/
Carl Dambkowski
Director
March
6, 2025
Carl
Dambkowski
/s/
Peter Harwin
Director
March
6, 2025
Peter
Harwin
/s/
Cameron Turtle
Director
March
6, 2025
Cameron
Turtle
112