Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures
designed to provide reasonable assurance that information required to be disclosed in reports filed under the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized, and reported within the specified time periods
and accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate
to allow timely decisions regarding disclosure.
Our Chief Executive Officer (who is our principal
executive officer) and Chief Financial Officer (who is our principal financial officer and principal accounting officer), evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange
Act) as of September 30, 2025, the end of our fiscal year. In designing and evaluating disclosure controls and procedures, we recognize
that any disclosure controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving
the desired control objective. As of September 30, 2025, based on the evaluation of these disclosure controls and procedures, our Chief
Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective in ensuring that information
required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized,
and reported within the time periods specified in the SEC’s rules and forms.
56
Management’s Annual Report on Internal
Control over Financial Reporting
Our management is responsible for establishing
and maintaining effective internal control over financial reporting as defined in Rule 13a-15(f) under the Exchange Act. Because
of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement
of our financial statements would be prevented or detected. Under the supervision of our Chief Executive Officer and Chief Financial Officer,
the Company conducted an evaluation of the effectiveness of our internal control over financial reporting as of September 30, 2025 using
the criteria established in Internal Control- Integrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (“COSO”) (2013 Framework).
Based on this evaluation, management has concluded
that our internal controls were effective and that we maintained effective controls over our financial reporting as of September 30, 2025.
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 risks that controls may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
Changes in Internal Controls over Financial
Reporting
There were no changes in our internal controls
over financial reporting during the fourth quarter of fiscal 2025 that materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Attestation Report of Registered Public Accounting
Firm
Our independent registered public accounting firm
has not assessed the effectiveness of our internal control over financial reporting and, under SEC rules, will not be required to provide
an attestation report on the effectiveness of our internal control over financial reporting so long as we qualify as a “non-accelerated
filer”.
Item 9B. Other Information.
None .
Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections.
Not applicable.
57
PART III
Item 10. Directors, Executive Officers and
Corporate Governance
The following table sets forth information as of the date of this report
with respect to the individuals who serve as the directors and executive officers of Company, including their positions, and is followed
by a biography of each such individual.
Name
Age
Title
Leonard Mazur
80
Chairman and Chief Executive Officer and Director
Myron Holubiak
78
Secretary and Director
Suren Dutia
83
Director
Dr. Eugene Holuka
66
Director
Dennis M. McGrath
68
Director
Robert Smith
65
Director
Joel Mayersohn
67
Director
Carol Webb
79
Director
Jaime Bartushak
58
Chief Financial Officer and Treasurer
Dr. Myron S. Czuczman
66
Chief Medical Officer
Leonard Mazur
Leonard Mazur is the Chairman and Chief Executive
Officer of the Company, a position he has held since August 12, 2024. Prior thereto, he served as the Chief Executive Officer of Citius
Oncology Sub, Inc., beginning on April 1, 2022. Mr. Mazur also serves as the Executive Chairman and Secretary of Citius Pharma (Nasdaq:
CTXR) and has been a member of the board of directors of Citius Pharma since September 2014. In May 2022, Mr. Mazur became the Chief Executive
Officer of Citius Pharma. He also serves as the Secretary of Citius Pharma’s majority-owned subsidiary, NoveCite, Inc. (“NoveCite”),
and provides other guidance to Citius Pharma and NoveCite. Since August 2021, Mr. Mazur has served on the board of directors of Hillstream
BioPharma, Inc. (Nasdaq: HILS), a pre-clinical biotechnology company developing novel therapeutic candidates targeting ferroptosis, an
emerging new anti-cancer mechanism resulting in iron mediated cell death for treatment resistant cancers. Mr. Mazur is the co-founder
and Vice Chairman of Akrimax Pharmaceuticals, LLC (“Akrimax”), a privately held pharmaceutical company specializing in producing
cardiovascular and general pharmaceutical products. Akrimax was founded in September 2008 and has successfully launched prescription drugs
while acquiring drugs from major pharmaceutical companies. From January 2005 to May 2012, Mr. Mazur co-founded and served as the Chief
Operating Officer of Triax Pharmaceuticals LLC (“Triax”), a specialty pharmaceutical company producing prescription dermatological
drugs. Prior to joining Triax, he was the founder and, from 1995 to 2005, Chief Executive Officer of Genesis Pharmaceutical, Inc. (“Genesis”),
a dermatological products company that marketed its products through dermatologists’ offices as well as co-promoting products for
major pharmaceutical companies. In 2003, Mr. Mazur successfully sold Genesis to Pierre Fabre, a leading pharmaceutical company. Mr. Mazur
has extensive sales, marketing and business development experience from his tenures at Medicis Pharmaceutical Corporation as Executive
Vice President, ICN Pharmaceuticals, Inc. as Vice President, Sales & Marketing, Knoll Pharma (a division of BASF), and Cooper Laboratories,
Inc. Mr. Mazur is a member of the Board of Trustees of Manor College, is a recipient of the Ellis Island Medal of Honor and was previously
the Chairman of the board of directors of Leonard-Meron Biosciences, Inc. (“LMB”), the Company’s wholly-owned subsidiary.
Mr. Mazur received both his B.A. and M.B.A. from Temple University and has served in the U.S. Marine Corps Reserves.
The Board believes that Mr. Mazur is qualified
to serve as a director because of his entrepreneurial experience and marketing knowledge in the pharmaceutical industry.
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Myron Holubiak
Myron Holubiak is the current Secretary of the
Company and a member of the Board, a position he has held since August 12, 2024. Prior thereto, he served as Secretary and a director
of Citius Oncology Sub, Inc., beginning on April 1, 2022. Mr. Holubiak is also the Executive Vice Chairman of Citius Pharma, a position
he has held since May 2022. He has also served as a member of the board of directors of Citius Pharma since October 2015. From October
2015 through April 2022, Mr. Holubiak served as Citius Pharma’s President and Chief Executive Officer. Mr. Holubiak also serves
as the acting Chief Executive Officer of our majority-owned subsidiary, NoveCite. Mr. Holubiak has extensive experience in managing and
advising large and emerging pharmaceutical and life sciences companies. Mr. Holubiak was the President of Roche Laboratories, Inc. (“Roche”),
a major research-based pharmaceutical company, from December 1998 to August 2001. Prior to that, he held sales and marketing positions
at Roche during his 19-year tenure. From September 2002 to July 2016, Mr. Holubiak served on the board of directors and for the last two
years was the Chairman of the board of directors of BioScrip, Inc. (“BioScrip”) (Nasdaq: BIOS). BioScrip is a leading national
provider of infusion and home care management solutions. Since July 2010, Mr. Holubiak has served as a member of the board of directors
of Assembly Biosciences, Inc. (“Assembly”) (Nasdaq: ASMB) and its predecessor Ventrus Biosciences, Inc. Assembly is a biopharmaceutical
company developing innovative, small molecule therapeutics for hepatitis B virus (HBV), hepatitis delta virus (HDV) and herpes virus infections.
Additionally, Mr. Holubiak serves as a director for bioAffinity Technologies Inc., a privately held company. In March 2013, Mr. Holubiak
founded LMB, the Company’s wholly-owned subsidiary, and he served as the Chief Executive Officer and President of LMB until March
2016. In addition, Mr. Holubiak was also a trustee of the Academy of Managed Care Pharmacy Foundation from April 2013 to April 2015. Mr.
Holubiak received a B.S. in Molecular Biology and Biophysics from the University of Pittsburgh; he received advanced business training
from the Harvard Business School and the University of London; and advanced training in health economics from the University of York’s
Centre for Health Economics.
The Board believes that Mr. Holubiak is qualified
to serve as a director because of his industry knowledge and experience managing both large and small pharmaceutical companies.
Suren Dutia
Suren Dutia has been a member of the Board since
August 12, 2024. Mr. Dutia has also been a member of the board of directors of Citius Pharma since October 2015. In addition to his role
as an outside independent director of Citius Pharma, Mr. Dutia has been serving as director of Flint Rehab and Vahan Inc, since 2016.
Mr. Dutia has been involved in fostering entrepreneurship for more than 20 years and served as Senior Fellow of the Ewing Mario Kauffman
Foundation from March 2011 to December 2016 and Senior Fellow of Skandalaris Center for Entrepreneurship and Innovation at Washington
University, St. Louis from 2010 to 2013. He has served as a member of the advisory board of Center for Digital Transformation, University
of California, Irvine since May 2012. From February 2006 to May 2010, Mr. Dutia served as the Chief Executive Officer of TiE, a non-profit
organization involved in fostering entrepreneurship globally. From February 2011 to May 2013, Mr. Dutia served as a director of LifeProof
and from July 2000 to December 2011, he served as a director of Anvita Health. From 1989 to 1998, Mr. Dutia served as the Chief Executive
Officer and Chairman of the board of directors of Xscribe Corporation. Prior to his positions with Xscribe Corporation, Mr. Dutia held
several positions with Dynatech Corporation, and, in addition, he was the President of a medical instruments company. Mr. Dutia received
his B.S. and M.S. degrees in chemical engineering and B.A. in political science from Washington University, St. Louis. In addition, he
obtained an M.B.A. from the University of Dallas.
The Board believes that Mr. Dutia is qualified
to serve as a director because of his financial management background, his involvement with start-up companies and his management skills.
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Dr. Eugene Holuka
Dr. Eugene Holuka has been a member of the Board
since August 12, 2024. Dr. Holuka has also been a member of the board of directors of Citius Pharma since June 2016. Dr. Holuka is an
internist and has practiced in internal medicine for almost 35 years. He is presently an attending physician at the Staten Island University
Hospital where he has practiced since 1991. Dr. Holuka has also served as an Adjunct Clinical Assistant Professor at the Touro College
of Osteopathic Medicine since 2011 and currently serves as an associate professor at the Zucker School of Medicine at Hofstra University.
From April 2014 until the acquisition of LMB by the Company in March 2016, he was a member of the LMB Scientific Advisory Board. Dr. Holuka
received the Ellis Island Medal of Honor in 2000 and has served on the NECO Committee Board since 2005. He was an Executive Committee
Member on the Forum’s Children Foundation from 2000 until 2008.
The Board believes that Dr. Holuka is qualified
to serve as a director because of his extensive experience in the healthcare industry.
Dennis M. McGrath
Dennis M. McGrath has been a member of the Board
since August 12, 2024. Mr. McGrath has also been a member of the board of directors of Citius Pharma since February 2023. He has served
as the President of PAVmed, Inc. (Nasdaq: PAVM), a diversified commercial-stage medical technology company since March 2019 (having served
as Executive Vice President from March 2017 to March 2019) and as PAVmed’s Chief Financial Officer since March 2017. Mr. McGrath
has also served as the Chief Financial Officer of Lucid, PAVmed’s majority owned subsidiary since the consummation of Lucid’s
initial public offering. Previously, from 2000 to 2017 Mr. McGrath served in several senior level positions of PhotoMedex, Inc. (formerly,
Nasdaq: PHMD), a global manufacturer and distributor of medical device equipment and services, including from 2011 to 2017 as director,
President, and Chief Financial Officer. Prior to PhotoMedex’s reverse merger with Radiancy, Inc in December 2011, he also served
as a board member and Chief Executive Officer from 2009 to 2011 and served as Vice President of Finance and Chief Financial Officer from
2000 to 2009. He received honors as a P.A.C.T. (Philadelphia Alliance for Capital and Technology) finalist for the 2011 Investment Deal
of the Year, award winner for the SmartCEO Magazine 2012 CEO of the Year for Turnaround Company, and finalist for the Ernst & Young
2013 Entrepreneur of the Year. He has extensive experience in mergers and acquisitions, both domestically and internationally, particularly
involving public company acquisitions, including Surgical Laser Technologies, Inc, (formerly, Nasdaq: SLTI), ProCyte Corporation (formerly,
Nasdaq: PRCY), LCA Vision, Inc. (formerly, Nasdaq: LCAV) and Think New Ideas, Inc. (formerly, Nasdaq: THNK). Prior to PhotoMedex, he served
in several senior level positions of AnswerThink Consulting Group, Inc. (then, Nasdaq: ANSR, now, The Hackett Group, Nasdaq: HCKT), a
business consulting and technology integration company, including from 1999 to 2000 as Chief Operating Officer of the Internet Practice,
the largest division of AnswerThink Consulting Group, Inc., while concurrently during the merger of the companies, serving as the acting
Chief Financial Officer of Think New Ideas, Inc. (then, Nasdaq: THNK, now, Nasdaq: HCKT), an interactive marketing services and business
solutions company. Mr. McGrath also served from 1996 until 1999 as Chief Financial Officer, Executive Vice President and director of TriSpan,
Inc., an internet commerce solutions and technology consulting company, which was acquired by AnswerThink Consulting Group, Inc. in 1999.
During his tenure at Arthur Andersen & Co., where he began his career, he became a Certified Public Accountant in 1981 and he holds
a B.S., maxima cum laude, in accounting from LaSalle University. In addition, he serves as the audit and compensation committee chair
and a director of several medical device companies, including DarioHealth Corp. (Nasdaq: DRIO), and LIV Process, formerly BioVector, Inc.
Previously from 2014 to 2024, Mr. McGrath served as a director and audit chair of Cagent Vascular, Inc., and from 2007 to 2009, Mr. McGrath
served as a director of Embrella Cardiovascular, Inc. (sold to Edwards Lifesciences Corporation, NYSE: EW). He also serves on the Board
of Visitors for Taylor University and on Board of Trustees of Manor College.
The Board believes that Mr. McGrath is qualified
to serve as a director because of his background of his extensive business experience and board service with public companies.
60
Robert Smith
Robert J. Smith has been a member of the Board
since August 12, 2024. Mr. Smith has also been a member of the board of directors of Citius Pharma since March 2024. Mr. Smith is an accomplished
biopharmaceutical executive who has driven commercial, financial, and operational success at leading pharmaceutical companies, including
Pfizer Inc. (NYSE: PFE) and Wyeth Pharmaceuticals (formerly NYSE: WYE), for more than 35 years. Mr. Smith’s extensive industry expertise
has been honed by decades of executive leadership roles in business development, mergers and acquisitions, corporate and commercial strategy,
and research and development. For the past eight years (May 2016 to January 2024), Mr. Smith served as Senior Vice President, Global Gene
Therapy Business of Pfizer and was responsible for managing and leading gene therapy and rare disease early commercial development activities
in partnership with the rare disease research unit. During his tenure at Pfizer, Mr. Smith also served as Senior Vice President, Business
Development and Alliance Management (October 2009 to January 2024) and led its worldwide research and development organization and the
business development and strategy teams for Pfizer’s global animal health, Capsugel, a former subsidiary of Pfizer, consumer healthcare
and nutrition business units, as well as the alliance management function supporting all of Pfizer’s global biopharmaceutical business
units and the worldwide research and development organization. Mr. Smith joined Pfizer from Wyeth Pharmaceuticals in 2009, following Pfizer’s
acquisition of Wyeth, where he was Senior Vice President, Mergers and Acquisitions (April 2008 to October 2009) responsible for leading
and managing Wyeth’s global mergers and acquisitions group. Prior to that, in his role at Wyeth as Senior Vice President of Global
Licensing, he completed a wide variety of transactions in support of Wyeth’s commercial and research and development divisions.
Mr. Smith has served as a member of the board of directors of private companies AM Pharma B.V. (observer), Bamboo Therapeutics Inc. (January
2016 to August 2016), and Ignite Immunotherapeutics Inc. (December 2016 to October 2019), as well as Iterum Therapeutics Limited (observer)
(Nasdaq: ITRM). Mr. Smith also serves or has served as a member of Life Sciences PA - the Pennsylvania Biotechnology Association, Bio
NJ - the New Jersey State Biotechnology Association (since 2021), the Duke Margolis Value Based Agreements Advisory Board, the Alliance
for Regenerative Medicine (ARM) (since 2018) and the Foundation for Cell and Gene Medicine (FCGM) (since 2019). He is a member of the
Executive Committees of the ARM and FCGM Board of Directors and serves as the Chairman of the ARM Board’s Governance and Operations
Committee. Mr. Smith is also a member of the Business Advisory Board of Ocugen, Inc., the Investment Advisory Committee for Venture Investors
LLC, Madison, Wisconsin, and the Cell and Gene Therapy Scientific Advisory Board of the Focused Ultrasound Foundation based in Charlottesville,
Virginia. Mr. Smith obtained a B.S. in Neuroscience from the University of Rochester and an M.B.A. in Finance and Corporate Accounting
from the William E. Simon Graduate School of Business Administration at the University of Rochester, Rochester, New York.
The Board believes that Mr. Smith is qualified
to serve as a director because of his extensive background with public companies and his business experience.
Joel Mayersohn
Joel Mayersohn has served as a director of the
Company since October 2022. Mr. Mayersohn is a member at Dickinson Wright, where he specializes in corporate, securities and business
law. He advises a diversified client base in private placements, public offerings, mergers and acquisitions, financing transactions and
general securities law matters. He also has experience in venture capital, bridge loans and pipe financings. He is a member of the Florida
and New York Bars and received his J.D. and B.A. from The State University of New York at Buffalo.
The Board believes that Mr. Mayersohn is well
qualified to serve as a director due to his extensive experience in corporate and finance legal matters.
Carol Webb
Carol Webb has been a member of the Board since
August 12, 2024. Ms. Webb served as a director of Leonard-Meron Biosciences, Inc. (“LMB”), a wholly owned subsidiary of Citius
Pharma, beginning March 17, 2014 and, upon LMB’s acquisition by the Citius Pharma in March 2016, and has since been a member of
the board of directors of Citius Pharma. From 2000 to 2005, she served as Company Group Chairman of Johnson & Johnson. From 1987 to
2000, she served in various capacities at Ortho Biotech, including President, Vice President, Executive Director, Product Management and
Senior Product Director. From 1972 to 1983, Ms. Webb worked in various positions at Roche Laboratories, including Sales Representative,
Sales Trainer, Product Manager and Manager of Public Policy. Ms. Webb received her B.S. in Biology from Bowling Green State University.
The Board believes that Ms. Webb is qualified
to serve as a director because she brings over 40 years of pharmaceutical sales, marketing and business development experience to our
Board.
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Jaime Bartushak
From April 1, 2014 until November 2017, Mr. Bartushak
served as Chief Financial Officer of Leonard-Meron Biosciences, Inc. (“LMB”), a wholly-owned subsidiary of Citius Pharma.
In November 2017, he became the Chief Financial Officer of Citius Pharma upon the acquisition of LMB by Citius Pharma. In November 2022,
he was appointed Chief Business Officer of Citius Pharma. Mr. Bartushak became our Chief Financial Officer in August 2024. Mr. Bartushak
is an experienced finance professional for early-stage pharmaceutical companies, and has over 20 years of corporate finance, business
development, restructuring, and strategic planning experience. Mr. Bartushak was one of the founders of LMB in 2014 and was instrumental
in its startup as well as in obtaining initial investment capital. In 2014, prior to his work at LMB, Mr. Bartushak helped lead the sale
of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc.
Myron S. Czuczman, M.D.
Dr. Czuczman joined Citius Pharma as Chief Medical
Officer in July 2020. He became our Chief Medical Officer in August 2024. Prior to his employment with Citius Pharma, Dr. Czuczman was
Vice President, Global Clinical Research and Development, Therapeutic Area Head of Lymphoma/CLL at Celgene Corporation, a position he
held from June 2015 to January 2020. Prior to working in the pharmaceutical industry, Dr. Czuczman practiced medicine for over two decades
at Roswell Park Cancer Institute, an NCI-designated comprehensive cancer center in Buffalo, NY, where he served as chief of the Lymphoma/Myeloma
Service and head of the Lymphoma Translational Research Laboratory. In addition to his extensive publications record, membership and leadership
roles on national and international research organizations, and consulting and advisory to dozens of pharma companies, Dr. Czuczman also
attained the positions of tenured Professor of Medicine at the State University of New York at Buffalo School of Medicine and Biomedical
Sciences and Professor of Oncology at Roswell Park Comprehensive Cancer Center. Dr. Czuczman received his medical degree from the Pennsylvania
State University College of Medicine after graduating magna cum laude in Biochemistry from the University of Pittsburgh. He completed
his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology
fellowship training at Memorial Sloan-Kettering Cancer Center in New York City.
Family Relationships
There are no family relationships among our executive
officers and directors.
Code of Ethics
We have adopted a written Code of Ethics and
Business Conduct that applies to our directors, officers, and all employees. We intend to disclose any amendments to, or waivers from,
our code of ethics and business conduct that are required to be publicly disclosed pursuant to rules of the SEC by filing such amendment
or waiver with the SEC. Additionally, we have adopted an insider trading policy to establish guidelines for our employees, officers,
directors, and consultants regarding transactions in our securities and the disclosure of material nonpublic information related to our
Company, which are reasonably designed to promote compliance with insider trading laws, rules and regulations, and any listing standards
applicable to the registrant. Both can be found in the Resources-Governance-Governance Documents section of our website, www.citiusonc.com .
62
Audit and Risk Committee
Our Audit and Risk Committee currently consists
of Messrs. McGrath (Chair), Dutia and Mr. Smith. Each of Messrs. McGrath, Dutia and Smith satisfies the independence requirements of Rule
5605(a)(2) of the Nasdaq Listing Rules and SEC Rule 10A-3. Our Audit and Risk Committee is responsible for, among other things:
o appointing, terminating, compensating, and overseeing the work of any accounting firm engaged to prepare
or issue an audit report or other audit, review or attestation services;
o reviewing and approving, in advance, all audit and non-audit services to be performed by the independent
auditor, taking into consideration whether the independent auditor’s provision of non-audit services to us is compatible with maintaining
the independent auditor’s independence;
o reviewing and discussing the adequacy and effectiveness of our accounting and financial reporting processes
and controls and the audits of our financial statements;
o establishing and overseeing procedures for the receipt, retention, and treatment of complaints received
by us regarding accounting, internal accounting controls or auditing matters, including procedures for the confidential, anonymous submission
by our employees regarding questionable accounting or auditing matters;
o monitoring and evaluating the independent auditor’s qualifications, performance, and independence
on an ongoing basis; and
o reviewing and approving related-party transactions for potential conflict of interest situations on an
ongoing basis.
Our Board has affirmatively determined that Messrs.
McGrath and Dutia are designated as the “audit committee financial experts.” The designation does not impose on Messrs. McGrath
and Dutia any duties, obligations or liabilities that are greater than those generally imposed on members of our audit committee and our
Board.
Delinquent Section 16(A) Reports
Section 16(a) of the Exchange
Act requires our directors, executive officers and holders of more than 10% of our common stock to file with the SEC initial
reports of ownership and reports of changes in the ownership of our common stock and other equity securities. Such persons are
required to furnish us copies of all Section 16(a) filings. Based solely upon a review of the copies of the forms furnished to us,
we believe that our officers, directors and holders of more than 10% of our common stock complied with all applicable filing
requirements during the fiscal year ended September 30, 2025, except for Joel Mayersohn who filed a Form 4 on August 7, 2025 that
was due on July 30, 2025 to report a distribution in kind to limited partners of 10XYZ Holdings, which was the Sponsor of TenX Keane
Acquisition (“TenX”), the legacy entity of Citius Oncology, Inc. on July 28, 2025.
63
Item 11. Executive Compensation
EXECUTIVE COMPENSATION
Our Named Executive Officers (as identified below)
also are employees of Citius Pharma. The services of Citius Pharma’s employees as our Named Executive Officers are provided to us
pursuant to an amended and restated shared services agreement with Citius Pharma. For the fiscal years ended September 30, 2025 and 2024,
pursuant to the shared services agreement, Citius Pharma allocated a portion of the salary and non-equity incentive compensation paid
during each of those fiscal years to the services provided to us by its employees acting as our Named Executive Officers. No benefits
provided by Citius Pharma are allocated to any of our Named Executive Officers.
Executive Compensation Objectives
We seek to achieve the following broad goals in
our executive compensation programs and decisions regarding individual compensation:
o Attract and retain executives critical to our overall success.
o Reward executives for contributions to achieving strategic goals that enhance stockholder value.
o Foster and maintain a company culture of ownership, creativity and innovation.
o Motivate our executive officers to achieve critical long- and short-term development, product and financial
milestones set by the Board in consultation with management.
Named Executive Officers
Our “Named Executive Officers” for
the year ended September 30, 2025 consist of Mr. Mazur, our Chief Executive Officer, and Mr. Holubiak, our Secretary, and Dr. Czuczman,
our Chief Medical Officer, who were the two most highly compensated executive officers other than Mr. Mazur serving as executive officers
as of September 30, 2025.
General Compensation Process
The Compensation Committee is responsible for
determining the elements and levels of compensation for our Named Executive Officers. In doing so, the Compensation Committee reviews
our corporate performance against financial and corporate achievement measures, assesses individual performance and evaluates recommendations
of the Chief Executive Officer regarding compensation for other Named Executive Officers. Deliberations of the Compensation Committee
may occur within a meeting of the full Board at which all members of the Compensation Committee are in attendance and the Board may take
action in such meetings upon the advice of the Compensation Committee Chair and/or its members.
To assist in its deliberations regarding executive
compensation, the Compensation Committee may engage the services of an independent executive compensation advisor. The Company would anticipate
that the Compensation Committee may work with such independent executive compensation advisor to develop a peer group of companies within
the biotechnology and pharmaceuticals industries.
Components of Compensation
The key components of our executive compensation
package are cash compensation (salary) and long-term equity incentive awards. These components are administered with the goal of providing
total compensation that recognizes meaningful differences in individual performance, is competitive, varies the opportunity based on individual
and corporate performance, and is valued by our Named Executive Officers.
64
Base Salary
It is the Compensation Committee’s objective
to set a competitive rate of annual base salary for each Named Executive Officer. The Compensation Committee believes competitive base
salaries are necessary to attract and retain top quality executives, since it is common practice for public companies to provide their
named executive officers with a guaranteed annual component of compensation that is not subject to performance risk. The Compensation
Committee, on its own or with outside consultants may establish salary ranges for our Named Executive Officers, with minimum to maximum
opportunities that cover the normal range of market variability. The actual base salary for each Named Executive Officer is then derived
from those salary ranges based on his responsibility, tenure and past performance and market comparability. Annual base salaries for the
Named Executive Officers are reviewed and approved by the Compensation Committee. Changes in base salary are based on the scope of an
individual’s current job responsibilities, individual performance in the previous performance year, target pay position relative
to the peer group, and our salary budget guidelines. The Compensation Committee reviews established goals and objectives and determines
an individual’s achievement of those goals and objectives and considers the recommendations provided by the Chief Executive Officer
to assist it in determining appropriate salaries for the Named Executive Officers other than the Chief Executive Officer.
The base salary information for our Named Executive
Officers for the fiscal years ended September 30, 2025 and 2024 is set forth in the Summary Compensation Table below.
Long-Term Incentive Equity Awards
We believe that long-term corporate success is
achieved with an ownership culture that encourages high performance by our employees through the use of stock-based awards. The Plans
were each established to provide our employees, including our Named Executive Officers, with incentives to help align employees’
interests with the interests of our stockholders. The Compensation Committee believes that the use of stock-based awards offers the best
approach to achieving our compensation goals of incentivizing long-term performance. We have historically elected to use stock options
as the primary long-term equity incentive vehicle; however, the Compensation Committee has the ability under our stock plans to grant
restricted stock and other equity awards as part of our long-term incentive program, although no such awards have been granted to date.
We have selected the Black-Scholes method of valuation for stock-based compensation. The Compensation Committee generally oversees the
administration of our stock plans.
Stock Options
Our 2024 Omnibus Stock Incentive Plan (the “2024
Plan”) authorizes us to grant options to purchase shares of common stock to our employees, directors and consultants. Our 2023 Omnibus
Stock Incentive Plan (the “2023 Plan”) authorizes us to grant the same. Upon the adoption of the 2024 Plan, we ceased granting
awards under the 2023 Plan.
The Compensation Committee reviews and approves
stock option awards to Named Executive Officers based upon a review of competitive compensation data, an assessment of individual performance,
a review of each Named Executive Officer’s existing long-term incentives, and retention considerations. Periodic stock option grants
are made at the discretion of the Compensation Committee to eligible employees and, in appropriate circumstances, after consideration
of any recommendations of our Chief Executive Officer.
Stock options granted to employees have an exercise
price equal to the fair market value of our common stock on the day of grant, typically vest over a time or upon the achievement of certain
performance-based milestones and are based upon continued employment, and generally expire 10 years after the date of grant. The fair
value of the options granted to the Named Executive Officers and reflected in the Summary Compensation Table is determined in accordance
with the Black-Scholes method of valuation for share-based compensation. Incentive stock options also include certain other terms necessary
to ensure compliance with the Code.
We expect to continue to use stock options as
a long-term incentive vehicle because:
o Stock options align the interests of our Named Executive Officers with those of our stockholders, supporting
a pay-for performance culture, foster employee stock ownership, and focus the management team on increasing value for our stockholders.
o Stock options are performance-based. All of the value received by the recipient of a stock option is based
on the growth of the stock price. In addition, stock options can be issued with vesting based on the achievement of specified milestones
although we have not used such performance-based vesting to date.
o Stock options help provide balance to the overall executive compensation program as base salary and annual
bonuses focus on short-term compensation, while stock options focus on long-term compensation.
o The vesting period of stock options over time encourages executive retention and is designed to increase
stockholder value. In determining the number of stock options to be granted to our Named Executive Officers, we take into account the
individual’s position, scope of responsibility, ability to affect profits and stockholder value and the individual’s historic
and recent performance and the value of stock options in relation to other elements of the individual Named Executive Officer’s
total compensation.
65
Policies and Practices Related to the Grant
of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
While we do not have a formal written policy
in place with regard to the timing of awards of options or similar awards in relation to the disclosure of material nonpublic information,
our equity awards are generally granted on fixed dates determined in advance. On limited occasions, our Compensation Committee or
Board may grant equity awards outside of our annual grant cycle for new hires, promotions, recognition, retention or other purposes.
The Committee approves all equity award grants
on or before the grant date and does not grant equity awards in anticipation of the release of material nonpublic information. Similarly,
the Committee does not time the release of material nonpublic information based on equity award grant dates.
Executive Benefits and Perquisites
Our Named Executive Officers are not currently
parties to employment agreements. We will consider entering into employment agreements as necessary and advisable. In addition, consistent
with our compensation philosophy, we intend to establish benefits for our Named Executive Officers, including medical, dental and life
insurance and the ability to contribute to a 401(k) plan. We would expect these benefits to be comparable to benefit levels for comparable
companies.
Pension Benefits
We do not maintain any qualified or non-qualified
defined benefit plans. As a result, none of our Named Executive Officers participate in or have account balances in qualified or non-qualified
defined benefit plans sponsored by us. Our Compensation Committee or Board may elect to adopt qualified or non-qualified benefit plans
in the future if it determines that doing so is in our best interests.
Nonqualified Deferred Compensation
None of our Named Executive Officers participate
in or have account balances in nonqualified defined contribution plans or other non-qualified deferred compensation plans maintained by
us. Our Compensation Committee or Board may elect to provide our officers and other employees with non-qualified defined contribution
or other non-qualified deferred compensation benefits in the future if it determines that doing so is in our best interests.
Summary Compensation Table
The following table sets forth information regarding
compensation paid to our Named Executive Officers for the years ended September 30, 2025 and 2024.
Name & Position
Fiscal
Year
Salary (1)
Bonus
Stock
Award (2)
Option
Awards (2)
All Other
Compensation
Total
Leonard Mazur
2025
$ 166,250
$ --
$ 2,975,000
$ 647,723
$ --
$ 3,788,973
Chief Executive Officer and Executive Chairman
2024
$ 166,250
$ --
--
$ 2,035,000
$ --
$ 2,201,250
Myron Holubiak
2025
$ 450,000
$ --
$ 1,487,500
$ 242,896
$ --
$ 2,180,396
Executive Vice Chairman
2024
$ 450,000
$ --
--
$ 825,000
$ --
$ 1,275,000
Myron Czuczman
2025
$ 225,000
$ --
$ 1,443,750
$ 323,862
$ --
$ 1,992,612
Chief Medical Officer
2024
$ 225,000
$ --
--
$ 770,000
$ --
$ 995,000
(1) The
salary represents that portion of the total salary received by the Named Executive Officer from Citius Pharma that has been allocated
to Citius Oncology pursuant to the Shared Services Agreement.
(2) The
dollar amount set forth in the table above represents the aggregate grant date fair value for all restricted stock awards or option awards,
as applicable, granted to the executive officer with respect to the fiscal year in accordance with FASB ASC Topic 718 .
These amounts do not reflect the actual economic value that will be realized by the named executive officer upon the vesting of the restricted
stock awards or stock options, the exercise of the stock options, or the sale of the common stock underlying such restricted stock awards
or stock options.
66
Outstanding Equity Awards at Fiscal Year-End
2025
The following table contains certain information
concerning unexercised options for our executive officers as of September 30, 2025.
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
Leonard Mazur
2,466,667
1,233,333 (1)
$ 2.15
07/05/2033
-
-
Chief Executive Officer and Chairman
266,667
533,333 (2)
$ 1.07
12/12/2034
-
-
-
-
-
-
1,700,000 (3)
$ 3,451,000 (4)
Myron Holubiak
1,000,000
500,000 (1)
$ 2.15
07/05/2033
-
-
Executive Vice Chairman
100,000
200,000 (2)
$ 1.07
12/12/2034
-
-
-
-
-
-
850,000 (3)
$ 1,725,500 (4)
Myron Czuczman
933,333
466,667
$ 2.15
07/05/2033
-
-
Chief Medical Officer
133,333
266,667
$ 1.07
12/12/2024
-
-
-
-
-
-
825,000 (3)
$ 1,674,750 (4)
(1) This option, originally issued by Citius Oncology Sub, Inc., vests over three years, beginning July 5,
2023, with 1/36th every month for the first year, and the 1/3 each on the second and third anniversary of July 5, 2023, provided that
grantee provides continuous service to the Company or a related entity as of each such vesting date. The option was assumed by Citius
Oncology, Inc. in the Merger, which closed August 12, 2024.
(2) The options will vest in three substantially equal installments on the first, second and third anniversaries
of December 12, 2024, provided that grantee provides continuous service to the Company or a related entity as of each such vesting date.
(3) The shares will vest in total on the third anniversary of September 19, 2025, subject to the grantee’s
continuous service to the Company or a related entity as of each such vesting date.
(4) Amounts are calculated based on multiplying the number of shares shown in the table by the per share closing
price of our common stock on September 30, 2025, which was $2.03.
Option Repricing
We did not engage in any repricing or other modifications
to any of our executive officers’ outstanding options during the year ended September 30, 2025.
67
Director Compensation
Director Compensation for the Fiscal Year
ended September 30, 2025
The Board has not yet approved a compensation
plan for non-employee directors. To assist in its deliberations regarding non-employee compensation, the Compensation Committee may engage
the services of an independent compensation advisor. The Company would anticipate that the Compensation Committee may work with such independent
compensation advisor to develop a peer group of companies within the biotechnology and pharmaceuticals industries.
Also, as part of the non-employee director compensation
plan, we anticipate that non-employee directors would be entitled to receive stock options as part of their annual compensation. In December
2024, our non-employee directors were awarded stock option awards and in September 2025, our non-employee directors were awarded restricted
stock awards, each for their service as non-employee directors.
Director compensation for the year ended September
30, 2025 was as follows:
Name
Fees Earned or
Paid in Cash
(1)
Stock
Awards
(1)
Option
Awards
(1)
All Other
Compensation
Total
Suren Dutia (2)
$ -
$ 525,000
$ 95,813
-
$ 620,813
Dr. Eugene Holuka (2)
$ -
$ 525,000
$ 95,813
-
$ 620,813
Joel Mayersohn (2)
$ 10,000
$ 525,000
$ 191,626
-
$ 726,626
Dennis McGrath (2)
$ -
$ 525,000
$ 95,813
-
$ 620,813
Robert Smith (2)
$ -
$ 525,000
$ 95,813
-
$ 620,813
Carol Webb (2)
$ -
$ 525,000
$ 95,813
-
$ 620,813
(1)
The dollar amount set forth in the table above represents the aggregate grant date fair value for all restricted stock awards or option awards, as applicable, granted to the director with respect to the fiscal year in accordance with FASB ASC Topic 718 . These amounts do not reflect the actual economic value that will be realized by the director upon the vesting of the restricted stock awards or stock options, the exercise of the stock options, or the sale of the common stock underlying such restricted stock awards or stock options.
(2)
At September 30, 2025, the non-employee directors held the following
options to purchase shares of Citius Oncology common stock: Mr. Dutia, 275,000; Dr. Holuka 275,000; Mr. Mayersohn 250,000; Mr. McGrath;
275,000; Mr. Smith 125,000; and Ms. Webb 275,000.
.
68
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 shows the amount of our common
stock beneficially owned as of December 10, 2025 by (i) each person or group as those terms are used in Section 13(d)(3) of the Exchange
Act believed by us to beneficially own more than 5% of our common stock, (ii) each of our current directors, (iii) each of our Named
Executive Officers and (iv) all of our directors and executive officers as a group. Except as otherwise noted, each person named in the
table has sole voting and investment power with respect to all shares shown as beneficially owned by them, subject to applicable community
property laws.
Name and Address of Beneficial Owner (1)
Number of
Shares of
Common
Stock
Beneficially
Owned (2)
Percentage of
Shares of
Common
Stock
Beneficially
Owned (3)
Executive Officers and Directors
Leonard Mazur (4)
2,733,333
3.12 %
Myron Holubiak (4)
1,100,000
1.28 %
Suren Dutia (4)
275,000
*
Dr. Eugene Holuka (4)
275,000
*
Dennis M. McGrath (4)
275,000
*
Robert Smith (4)
125,000
*
Joel Mayersohn (5)
271,000
*
Carol Webb (4)
150,000
*
Myron Czuczman (4)
275,000
1.24 %
All directors and executive officers as a group (10 people) 6)
7,462,895
8.09 %
5% Holders
Citius Pharmaceuticals, Inc.
66,049,615
77.9 %
(1) The business address of each of the following entities or individuals is c/o of the Company, 11 Commerce
Drive, 1st Floor, Cranford, New Jersey 07016.
(2) Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting
or investment power with respect to securities. Shares of common stock subject to options or warrants currently exercisable or convertible,
or exercisable or convertible within 60 days of December 10, 2025, are deemed outstanding for computing the percentage of the person holding
such option or warrant but are not deemed outstanding for computing the percentage of any other person.
(3) Percentage based on 84,797,846 shares of common stock issued and outstanding
as of December 10, 2025.
(4) Consists entirely of shares of common stock that the director or officer has the right to acquire pursuant
to outstanding options that are exercisable within 60 days of December 10, 2025.
(5) Consists of: (i) 21,228 shares of common stock acquired by Mr. Mayersohn through a distribution in kind
to limited partners of 10XYZ Holdings, which was the Sponsor of TenX Keane Acquisition, the legacy entity of Citius Oncology, Inc., and
(ii) 250,000 shares of common stock Mr. Mayersohn has the right to acquire pursuant to outstanding options that are exercisable within
60 days of December 10, 2025.
(6) Consists of: (i) 21,228 shares of common stock, and (ii) 7,441,667 shares of common stock the directors
and executive officers have the right to acquire pursuant to outstanding options that are exercisable within 60 days of December 10, 2025.
69
Securities
authorized for issuance under equity compensation plans
The following table sets forth the indicated information
as of September 30, 2025 with respect to our equity compensation plans:
Plan Category
Number of
securities
to be issued upon
exercise of
outstanding
options,
warrants
and rights
Weighted-
average
exercise
price of
outstanding
options, warrants
and rights
Number of
securities
remaining
available for
future
issuance under equity
compensation
plans
Equity compensation plans approved by security holders
2023 Omnibus Stock Inventive Plan
18,100,000
$ 1.82
2024 Omnibus Stock Incentive Plan
11,600,000
$ -
300,000
Total
29,700,000
300,000
Our equity compensation plan consists of the 2023
Plan which was approved by shareholders of Citius Oncology, Inc. on April 29, 2023, and the 2024 Plan, which was approved by the securityholders
of TenX on August 2, 2024, in anticipation of the Merger. The 2024 Plan was subsequently amended on October 27, 2025. We do not have any
equity compensation plans or arrangements that have not been approved by stockholders.
The other information required by this Item is
incorporated by reference to the information under the section captioned “Security Ownership of Certain Beneficial Owners and
Management”.
Item 13. Certain Relationships and Related
Transactions, and Director Independence
Other than as set forth below, there were no transactions
since October 1, 2023, to which the Company was or is a party in which:
o the amount involved exceeded or exceeds the lesser of (i) $120,000 and (ii) one percent of the average
of our total assets at year-end for the last two completed fiscal years; and
o any of our directors or executive officers, any holder of 5% of our capital stock or any member of their
immediate family had or will have a direct or indirect material interest.
Agreements with Citius Pharma
The Company and Citius Pharma operate separately,
although Citius Pharma continues to control the Company. In connection with the Merger, Citius Pharma and Citius Oncology entered into
various agreements to establish the framework for the Company’s relationship with Citius Pharma, including the A&R Shared Services
Agreement.
70
A&R Shared Services Agreement
In connection with the Merger, the Company and
Citius Pharma entered into an A&R Shared Services Agreement, pursuant to which Citius Pharma and its affiliates provide to the Company
the services set forth in the therein, which services are of the type that Citius Pharma provided to the Company prior to the Merger,
including services relating to information technology, facilities, accounting and finance, business development, investor relations, human
resources, and other corporate and administrative functions, as well as certain scientific services. The fees for each of the services
are set forth in the A&R Shared Services Agreement as an aggregate quarterly fee of approximately $940,000, and the Company reimburses
Citius Pharma for all reasonable out-of-pocket costs and expenses that it incurs in connection with providing the services. The A&R
Shared Services Agreement will terminate on the earlier of (i) mutual agreement of the parties or (ii) two years from the Merger; provided
that the agreement automatically extends for additional one-year periods unless the Company or Citius Pharma provides at least 30 days
prior written notice of its desire not to automatically extend the term.
Promissory Note between the Company and
Citius Pharma
In connection with the closing of the Merger,
Citius Pharma contributed $10 million in cash to the Company, comprised of $3,800,111 in working capital of the Company, funding $6,199,889
of transaction expenses of the parties to the Merger Agreement, and $1,077,026 for the purchase of TenX Rights prior to the Closing of
the transaction (which converted into 422,353 shares of common stock at closing). Such capital contribution is evidenced by an unsecured
promissory note (the “Note”) issued by the Company, dated August 16, 2024, in the principal amount of $3,800,111 to Citius
Pharma. The Note bears no interest and prior to September 10, 2025, was repayable in full upon a financing of at least $10 million by
the Company, per the terms of the Note. On September 10, 2025, the Note was amended to be repayable in full at the date on which the Company
has closed a series of capital raises that in the aggregate provide gross proceeds of at least $30 million through the issuance of debt
or equity securities or the royalty-backed monetization of LYMPHIR™. On December 10, 2025, the Note was amended to provide that the maturity of the Note would be the date at which the Company has closed
a series of capital raises that in the aggregate provide gross proceeds of at least $50 million.
Procedures for Review and Approval of Transactions
with Related Persons
Pursuant to the Audit and Risk Committee charter,
the Audit and Risk Committee is responsible for reviewing and approving all related party transactions as defined under Item 404 of Regulation
S-K, after reviewing each such transaction for potential conflicts of interests and other improprieties. Our policies and procedures for
review and approval of transactions with related persons are in writing in our Code of Ethics and Business Conduct available under the Resources-Governance-Governance
Documents section of our website at www.citiusonc.com .
Board of Directors Independence
After review of all relevant transactions or relationships between
each nominee for director, or any of his or her family members, and the Company, its senior management and Wolf & Company, P.C., its
independent registered public accounting firm, the Board has determined that all directors of the Company are independent within the meaning
of the applicable Nasdaq listing standards, except Leonard Mazur, the Chief Executive Officer and Chairman, Myron Holubiak, the Secretary,
and Joel Mayersohn.
Because Citius Pharma continues to control a majority of the voting
power of the outstanding shares of Company common stock, the Company qualifies as a “controlled company” within the meaning
of the corporate governance standards of the Nasdaq. Under these rules, a listed company of which more than 50% of the voting power is
held by an individual, group or another company is a “controlled company” and may elect not to comply with certain corporate
governance requirements, including the requirements that (i) a majority of the Board consist of “independent directors” as
defined under Nasdaq listing rules, (ii) we have a compensation committee composed entirely of independent directors and (iii) we have
a nominating/corporate governance committee composed entirely of independent directors.
The Company does not intend to rely on these exemptions but may opt
to utilize these exemptions in the future as long as it remains a controlled company. Accordingly, Company stockholders may not have the
same protections afforded to stockholders of companies that are subject to all of the corporate governance requirements of Nasdaq.
If the Company ceases to be a “controlled company” in the
future, it will be required to comply with the Nasdaq Listing Rules, which may require replacing a number of its directors and may require
development of certain other governance-related policies and practices. These and any other actions necessary to achieve compliance with
such rules may increase the Company’s legal and administrative costs, will make some activities more difficult, time-consuming,
and costly and may also place additional strain on the Company’s personnel, systems and resources.
71
Item 14. Principal Accountant Fees and Services
AUDITOR AND AUDIT COMMITTEE MATTERS
Report of the Audit and Risk Committee
The Audit and Risk Committee has reviewed and
discussed with management our audited financial statements for the fiscal year ended September 30, 2025, which were audited by Wolf &
Company, P.C. (“Wolf”), an independent registered public accounting firm. The Audit and Risk Committee discussed with Wolf
the matters required to be discussed by the applicable requirements of the Public Company Accounting Oversight Board (“PCAOB”)
and the Commission. The Audit and Risk Committee received the written disclosures and letter from the independent registered public accounting
firm required by applicable requirements of the PCAOB regarding the independent registered public accounting firm’s communications
with the Audit and Risk Committee concerning independence, and discussed with the independent registered public accounting firm the independent
registered public accounting firm’s independence. The Audit and Risk Committee also considered whether the provision of services
other than the audit of our financial statements for the fiscal year ended September 30, 2025 were compatible with maintaining the independence
of Wolf.
Based on the review and discussions referred to
in the foregoing paragraph, the Audit and Risk Committee recommended to the Board that the audited financial statements be included in
the Original Filing.
Our Audit and Risk Committee is currently composed
of the following three directors: Mr. McGrath (Chair), Mr. Dutia, and Mr. Smith. All are independent directors as defined in Rules 5605(a)(2)
and 5605(c)(2) of the Nasdaq Listing Rules and Section 10A-3 of the Exchange Act. The Board has determined that Messrs. McGrath and
Dutia are each an “audit committee financial expert” as such term is defined in Item 407(d)(5)(ii) of Regulation
S-K promulgated by the SEC. Our Audit and Risk Committee operates under a written charter adopted by the Board, a copy of which is
available under Governance-Governance Documents section of our website at www.citiusonc.com.
Wolf has served as our auditor since we began
operations in April 2022 and audited our consolidated financial statements for the years ended September 30, 2023 through September 30,
2025.
THE AUDIT AND RISK COMMITTEE
Dennis McGrath, Chair
Suren Dutia
Robert Smith
Fees Paid to the Independent Registered Public
Accounting Firm
Audit Fees
The aggregate audit fees billed for professional
services rendered by our auditor, Wolf, an independent registered public accounting firm, for the audit of our financial statements as
of and for the years ended September 30, 2025 and 2024, our filings with the SEC and other audit fees were $271,250 and $157,080, respectively.
Audit Related Fees
The aggregate audit related fees billed for professional
services by Wolf for the years ended September 30, 2025 and 2024 were $205,250 and $229,900, respectively.
Tax Fees
There were no tax fees billed for professional
services by Wolf for the years ended September 30, 2025 and 2024. Tax fees are for the preparation of federal and state income tax returns.
All Other Fees
No other fees were billed by or paid to Wolf during
the years ended September 30, 2025 and 2024.
Pre-Approval Policies and Procedures of Audit
and Non-Audit Services of Independent Registered Public Accounting Firm
All fees reported above under the headings Audit
Fees, Audit Related Fees, Tax Fees and All Other Fees were approved by the Audit and Risk Committee before the respective services were
rendered, which concluded that the provision of such services was compatible with the maintenance of the independence of Wolf in the conduct
of its auditing functions.
72
PART IV
Item 15. Exhibits and Financial Statement Schedules
Exhibit
Number
Description of Document
Registrant’s
Form
Dated
Exhibit
Number
Filed
Herewith
2.1*
Agreement and Plan of Merger and Reorganization, dated as of October 23, 2023, by and among Citius Pharmaceuticals, Inc., Citius Oncology, Inc., TenX Keane Acquisition and TenX Merger Sub, Inc.
8-K
10/24/2023
2.1
3.1.1
Certificate of Incorporation of Citius Oncology, Inc.
8-K
08/16/2024
3.1
3.1.2
Certificate of Amendment to the Certificate of Incorporation of Citius Oncology, Inc., filed with the Secretary of State of the State of Delaware on April 7, 2025.
10-Q
08/12/2025
3.2
3.2
Bylaws of Citius Oncology, Inc.
8-K
08/16/2024
3.2
4.1
Specimen Common Stock Certificate of Citius Oncology, Inc.
S-4
07/11/2024
4.5
4.2
Warrant Agency Agreement, dated as of July 17, 2025, by and between Citius Oncology, Inc. and Equiniti Trust Company, LLC.
8-K
07/18/2025
4.1
4.3
Form of Common Warrant.
8-K
07/18/2025
4.2
4.4
Form of Placement Agent Warrant.
8-K
07/18/2025
4.3
4.5
Form of Common Warrant.
8-K
09/10/2025
4.1
4.6
Form of Placement Agent Warrant.
8-K
09/10/2025
4.2
4.7
Form of Common Warrant.
8-K
12/10/2025
4.1
4.8
Form of Pre-funded Warrant.
8-K
12/10/2025
4.2
4.9
Form of Placement Agent Warrant.
8-K
12/10/2025
4.3
4.10
Description of Common Stock.
10-K
12/27/2024
4.2
10.1
Amended and Restated Registration Rights Agreement, dated as of August 12, 2024 by and between Citius Oncology, Inc. and the signatories thereto.
8-K
08/16/2024
10.1
10.2
Amended and Restated Shared Services Agreement, dated as of August 12, 2024, by and among Citius Oncology, Inc. and Citius Pharmaceuticals, Inc.
8-K
08/16/2024
10.2
10.3†
2023 Omnibus Stock Incentive Plan.
10-K
12/27/2024
10.3
10.4.1†
2024 Omnibus Stock Incentive Plan.
8-K
08/5/2024
10.5
10.4.2†
Amendment to the Citius Oncology, Inc. 2024 Omnibus Stock Incentive Plan.
8-K
09/19/2025
10.1
10.5*
Asset Purchase Agreement, dated as of September 1, 2021, between Dr. Reddy’s Laboratories S.A. and Citius Pharmaceuticals, Inc.
S-4
11/13/2023
10.15
10.6.1*
Amended and Restated License, Development and Commercialization Agreement, dated as of February 26, 2018, between Eisai, Ltd. and Dr. Reddy’s Laboratories S.A.
S-4
11/13/2023
10.16
10.6.2*
Amendment No. 1 to Amended and Restated License, Development and Commercialization Agreement, dated as of August 9, 2018, between Eisai, Ltd. and Dr. Reddy’s Laboratories S.A.
S-4
11/13/2023
10.17
10.6.3*
Amendment No. 2 to Amended and Restated License, Development and Commercialization Agreement, dated as of August 31, 2021, between Eisai, Ltd. and Dr. Reddy’s Laboratories S.A.
S-4
11/13/2023
10.18
10.7
Side Letter Agreement, dated August 12, 2024, by and by and among Citius Pharmaceuticals, Inc., Citius Oncology, Inc., TenX Keane Acquisition and TenX Merger Sub, Inc.
8-K
08/16/2024
10.8
10.8
Promissory Note, dated July 18, 2023, issued by TenX Keane Acquisition to 10XYZ Holdings LP.
8-K
07/18/2023
10.1
73
10.9
Promissory Note, dated October 18, 2023, issued by TenX Keane Acquisition to 10XYZ Holdings LP.
8-K
10/18/2023
10.1
10.10.1
Promissory Note, dated August 16, 2024, by and between Citius Oncology, Inc. and Citius Pharmaceuticals, Inc.
8-K
08/16/2024
10.9
10.10.2
Amendment to Promissory Note, dated September 10, 2025, by and between Citius Oncology, Inc. and Citius Pharmaceuticals, Inc.
8-K
09/10/2025
10.3
10.10.3
Second Amendment to Promissory Note, dated December 10, 2025, by and between Citius Oncology, Inc. and Citius Pharmaceuticals, Inc.
8-K
12/10/2025
10.5
10.11
Placement Agency Agreement, dated as of July 16, 2025, by and between Citius Oncology, Inc. and Maxim Group LLC.
8-K
07/18/2025
10.1
10.12
Securities Purchase Agreement, dated as of July 16, 2025, by and between Citius Oncology, Inc. and the purchasers named therein.
8-K
07/18/2025
10.2
10.13
Placement Agency Agreement, dated as of September 9, 2025, by and between Citius Oncology, Inc. and Maxim Group LLC.
8-K
09/10/2025
10.1
10.14
Form of Securities Purchase Agreement, dated as of September 9, 2025, by and between Citius Oncology, Inc. and the purchaser signatory thereto.
8-K
09/10/2025
10.2
10.15
Form of Registered Direct Securities Purchase Agreement, dated as of December 9, 2025, by and between Citius Oncology, Inc. and the purchaser signatory thereto.
8-K
12/10/2025
10.1
10.16
Form of PIPE Securities Purchase Agreement, dated as of December 9, 2025, by and between Citius Oncology, Inc. and the purchaser signatory thereto.
8-K
12/10/2025
10.2
10.17
Form of Registration Rights Agreement, dated as of December 9, 2025, by and between Citius Oncology, Inc. and the purchaser signatory thereto.
8-K
12/10/2025
10.3
10.18
Form of Warrant Amendment Agreement, dated as of December 9, 2025, by and between Citius Oncology, Inc. and the purchaser signatory thereto.
8-K
12/10/2025
10.4
19.1
Insider Trading Policy.
10-K
12/27/2024
19.1
23.1
Consent of Independent Registered Public Accounting Firm.
--
--
--
X
31.1
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
--
--
--
X
31.2
Certification of the Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
--
--
--
X
32.1
Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
--
--
--
X
97.1
Policy Relating to Recovery of Erroneously Awarded Compensation
10-K
04/16/2024
97.1
EX-101.INS
INLINE XBRL INSTANCE DOCUMENT
--
--
--
X
EX-101.SCH
INLINE XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT
--
--
--
X
EX-101.CAL
INLINE XBRL TAXONOMY EXTENSION CALCULATION LINKBASE
--
--
--
X
EX-101.DEF
INLINE XBRL TAXONOMY EXTENSION CALCULATION LINKBASE
--
--
--
X
EX-101.LAB
INLINE XBRL TAXONOMY EXTENSION LABELS LINKBASE
--
--
--
X
EX-101.PRE
INLINE XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE
--
--
--
X
104
Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL)
--
--
--
X
*
Portions of this exhibit have been omitted pursuant to Item 601(b)10 of Regulation S-K or certain of the exhibits and schedules to this exhibit have been omitted in accordance with Regulation S-K Item 601(b)(2) or 601(a)(5), as applicable. Citius Oncology agrees to furnish supplementally an unredacted copy such exhibit, including any omitted exhibits and schedules, to the SEC upon its request.
†
Indicates management contract or compensatory plan.
Item 16. Form 10-K Summary.
Not applicable.
74
SIGNATURES
Pursuant to the requirements of Section 13 or
15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
CITIUS ONCOLOGY, INC.
Date: December 23, 2025
By:
/s/ Leonard Mazur
Leonard Mazur
Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and
on the dates indicated.
Signature
Title
Date
/s/ Leonard Mazur
Chief Executive Officer and Director
December 23, 2025
Leonard Mazur
(Principal Executive Officer)
/s/ Myron Holubiak
Secretary and Director
December 23, 2025
Myron Holubiak
/s/ Jaimie Bartushak
Chief Financial Officer and Treasurer
December 23, 2025
Jaime Bartushak
(Principal Financial Officer and Principal Accounting Officer)
/s/ Suren Dutia
Director
December 23, 2025
Suren Dutia
/s/ Eugene Holuka
Director
December 23, 2025
Eugene Holuka
/s/ Joel Mayersohn
Director
December 23, 2025
Joel Mayersohn
/s/ Dennis McGrath
Director
December 23, 2025
Dennis McGrath
/s/ Robert Smith
Director
December 23, 2025
Robert Smith
/s/ Carol Webb
Director
December 23, 2025
Carol Webb
75
CITIUS ONCOLOGY, INC.
CONSOLIDATED FINANCIAL STATEMENTS
INDEX
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID # 392 ) F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations F-4
Consolidated Statements of Changes in Stockholders’ Equity F-5
Consolidated Statements of Cash Flows F-6
Notes to Consolidated Financial Statements F-7
F- 1
Report of Independent Registered Public Accounting
Firm
To the Stockholders and the Board of Directors of Citius Oncology,
Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Citius
Oncology, Inc. and its subsidiaries (the Company) as of September 30, 2025 and 2024, the related consolidated statements of operations,
changes in stockholders’ equity and cash flows for the years then ended, and the related notes to the consolidated financial statements
(collectively, the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial
position of the Company as of September 30, 2025 and 2024, and the results of its operations and its cash flows for the years then ended,
in conformity with accounting principles generally accepted in the United States of America.
Emphasis of a Matter Regarding Going Concern
The accompanying financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has suffered recurring losses
and has a working capital deficit as of September 30, 2025. The Company is a majority-owned subsidiary of Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. funds the majority of the Company’s operations; therefore, the Company is economically dependent on
the continued financial support of Citius Pharmaceuticals, Inc. This raises substantial doubt about the Company’s ability to continue
as a going concern. Management’s plans in regard to these matters also are described in Note 2. The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public
accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent
with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations of the Securities
and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free
of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit
of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control
over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material
misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures
included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation
of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Wolf & Company, P.C.
We have served as the Company’s auditor since 2022.
Boston, Massachusetts
December 23, 2025
F- 2
CITIUS ONCOLOGY, INC.
CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30, 2025 AND 2024
2025
2024
Current Assets:
Cash and cash equivalents
$ 3,924,908
$ 112
Inventory
22,286,693
8,268,766
Prepaid expenses
1,331,280
2,700,000
Total Current Assets
27,542,881
10,968,878
Other Assets:
In-process research and development
73,400,000
73,400,000
Total Other Assets
73,400,000
73,400,000
Total Assets
$ 100,942,881
$ 84,368,878
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$ 13,234,684
$ 3,711,622
License payable
22,650,000
28,400,000
Accrued expenses
4,093,124
—
Due to related party
9,513,771
588,806
Total Current Liabilities
49,491,579
32,700,429
Deferred tax liability
2,784,960
1,728,000
Note payable to related party
3,800,111
3,800,111
Total Liabilities
56,076,650
38,228,540
Stockholders’ Equity:
Preferred stock - $ 0.0001 par value; 10,000,000 shares authorized: no shares issued and outstanding
—
—
Common stock - $ 0.0001 par value; 400,000,000 and 100,000,000 shares authorized at September 30, 2025 and 2024, respectively; 83,513,442 and 71,552,402 shares issued and outstanding at September 30, 2025 and 2024, respectively
8,351
7,155
Additional paid-in capital
108,897,836
85,411,771
Accumulated deficit
( 64,039,956 )
( 39,278,587 )
Total Stockholders’ Equity
44,866,231
46,140,339
Total Liabilities and Stockholders’ Equity
$ 100,942,881
$ 84,368,878
See accompanying report
of independent registered public accounting firm and notes to the financial statements.
F- 3
CITIUS ONCOLOGY, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND 2024
2025
2024
Revenues
$ —
$ —
Operating Expenses:
Research and development
6,418,334
4,925,001
General and administrative
8,783,997
8,148,929
Stock-based compensation – general and administrative
8,320,419
7,498,817
Total Operating Expenses
23,522,750
20,572,747
Operating loss
( 23,522,750 )
( 20,572,747 )
Other Income (Expense)
Interest income
36,373
—
Interest expense
( 218,032 )
—
Total Other Income (Expense), Net
( 181,659 )
—
Loss before Income Taxes
( 23,704,409 )
( 20,572,747 )
Income tax expense
1,056,960
576,000
Net Loss
$ ( 24,761,369 )
$ ( 21,148,747 )
Net Loss Per Share – Basic and Diluted
$ ( 0.34 )
$ ( 0.31 )
Weighted Average Common Shares Outstanding – Basic and Diluted
73,267,969
68,053,607
See accompanying report of independent registered
public accounting firm and notes to the financial statements.
F- 4
CITIUS ONCOLOGY, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY
FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND 2024
Preferred Stock
Common Stock
Additional
Paid-In
Accumulated
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance, September 30, 2023
-
$ -
67,500,000
$ 6,750
$ 43,658,750
$ ( 18,129,840 )
$ 25,535,660
Capital contributions by parent
-
-
-
-
37,008,905
-
37,008,905
Stock-based compensation expense
-
-
-
-
7,498,817
-
7,498,817
Merger, net of transaction costs of $ 2,358,780
-
-
4,052,402
405
( 2,754,701 )
-
( 2,754,296 )
Net loss
-
-
-
-
-
( 21,148,747 )
( 21,148,747 )
Balance, September 30,
2024
-
-
71,552,402
7,155
85,411,771
( 39,278,587 )
46,140,339
Issuance of common stock in July 2025 registered direct offering, net of costs of $ 1,453,012
-
-
6,818,182
682
7,546,306
-
7,546,988
Issuance of common stock in September 2025 registered direct offering, net of costs of $ 1,380,146
-
-
5,142,858
514
7,619,340
-
7,619,854
Stock-based compensation expense
-
-
-
-
8,320,419
-
8,320,419
Net loss
-
-
-
-
-
( 24,761,369 )
( 24,761,369 )
Balance, September 30, 2025
-
$ -
83,513,442
$ 8,351
$ 108,897,836
$ ( 64,039,956 )
$ 44,866,231
See accompanying report of independent registered
public accounting firm and notes to the financial statements.
F- 5
CITIUS ONCOLOGY, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND 2024
2025
2024
Cash Flows From Operating Activities:
Net loss
$ ( 24,761,369 )
$ ( 21,148,747 )
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Stock-based compensation expense
8,320,419
7,498,817
Deferred income tax expense
1,056,960
576,000
Changes in operating assets and liabilities:
Inventory
( 12,649,207 )
( 2,133,871 )
Prepaid expenses
-
( 1,100,000 )
Accounts payable
9,523,062
2,422,577
Accrued expenses
4,093,124
( 259,071 )
Due to related party
8,924,965
14,270,648
Net Cash (Used in) Provided By Operating Activities
( 5,492,046 )
126,353
Cash Flows From Investing Activities:
License payments
( 5,750,000 )
( 5,000,000 )
Net Cash Used In Investing Activities
( 5,750,000 )
( 5,000,000 )
Cash Flows From Financing Activities:
Net proceeds from issuance of common stock
15,166,842
-
Cash contributed by parent
-
3,827,944
Merger, net
-
( 2,754,296 )
Proceeds from issuance of note payable to related party
-
3,800,111
Net Cash Provided By Financing Activities
15,166,842
4,873,759
Net Change in Cash and Cash Equivalents
3,924,796
112
Cash and Cash Equivalents – Beginning of Year
112
-
Cash and Cash Equivalents – End of Year
$ 3,924,908
$ 112
Supplemental Disclosures of Cash Flow Information and Non-cash Activities:
IPR&D Milestones included in License Payable
$ -
$ 28,400,000
Capital Contribution of due to related party by parent
$ -
$ 33,180,961
Net Prepaid Manufacturing transferred to Inventory
$ 1,368,720
$ 6,134,895
Interest Paid
$ 187,389
$ -
See accompanying report of independent registered
public accounting firm and notes to the financial statements.
F- 6
CITIUS ONCOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND 2024
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Business
Citius Oncology, Inc. (“Citius Oncology,”
the “Company” “we” or “us”) is a specialty pharmaceutical company dedicated to the development and
commercialization of critical care products targeting unmet needs with a focus on oncology products. We have developed E7777 (denileukin
diftitox), an approved oncology immunotherapy for the treatment of cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin
lymphoma. We have obtained the trade name of LYMPHIR for E7777.
Since our inception, the Company has devoted substantially
all of its efforts to business planning, research and development, and recruiting management and technical staff. We are subject to a
number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by
the Company or its competitors of research and development stage products, market acceptance of any of its products approved for marketing,
competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s
ability to obtain additional financing and the Company’s compliance with governmental and other regulations.
Since our inception, Citius Pharmaceuticals, Inc.
(“Citius Pharma”) (Nasdaq: CTXR) has funded and continues to partially fund the Company. Citius Pharma and the Company are
party to an amended and restated shared services agreement (the “A&R Shared Services Agreement”), which governs certain
management and scientific services that Citius Pharma provides the Company.
Merger
On August 23, 2021, Citius Pharma formed Citius
Acquisition Corp. (“SpinCo”) as a wholly-owned subsidiary in conjunction with the acquisition of LYMPHIR, which began operations
in April 2022, when Citius Pharma transferred the assets related to LYMPHIR to SpinCo, including the related license agreement and asset
purchase agreement (see Note 4).
On October 23, 2023, Citius Pharma and SpinCo
entered into an agreement and plan of merger and reorganization (the “Merger Agreement”) with TenX Keane Acquisition, a Cayman
Islands exempted company (“TenX”), and TenX Merger Sub Inc., a Delaware corporation and a wholly owned subsidiary of TenX
(“Merger Sub”).
On August 12, 2024, pursuant to the terms and
conditions of the Merger Agreement, Merger Sub merged with and into SpinCo, with SpinCo surviving as a wholly owned subsidiary of TenX
(the “Merger”) which was subsequently renamed Citius Oncology Sub, Inc. Prior to closing of the Merger, TenX migrated to and
domesticated as a Delaware corporation in accordance with Section 388 of the General Corporation Law of the State of Delaware and the
Cayman Islands Companies Act (As Revised) (the “Domestication”). As part of the Domestication, TenX changed its name to “Citius
Oncology, Inc.” (Nasdaq: CTOR). Immediately after the closing of the Merger, Citius Pharma owned approximately 92 % of our outstanding
shares of common stock. As of September 30, 2025, Citius Pharma owned approximately 79 % of our outstanding shares of common stock.
F- 7
While the Merger Sub was the legal acquirer of
the Company, for accounting purposes, the Company was deemed to be the accounting acquirer. Accordingly, for accounting purposes, the
Merger was treated as the equivalent of the Company issuing stock for the assets and liabilities of the Merger Sub, accompanied by a recapitalization.
Total shares outstanding of the Company after the Merger and recapitalization increased to 71,552,402 . The net assets of the merged entities
are stated at historical cost, with no goodwill or other intangible assets recorded. Additionally, the historical financial statements
of the Company became the historical financial statements of the Registrant.
The Merger, net amount of $ 2,753,795 charged to
additional paid in capital consists of $ 395,015 of net liabilities of TenX on the date of the Merger (cash of $ 163,500 less liabilities
of $ 559,015 ) plus directly related transaction costs of $ 2,358,780 .
As part of the Merger, Citius Pharma made capital
investments in the Company through cash contributions of $ 3,827,944 to fund transactions related to the Merger and by reclassifying to
additional paid in capital intercompany receivables of $ 33,180,961 that were due from the Company to Citius Pharma. Simultaneously, Citius
Pharma advanced an additional $ 3,800,111 to the Company under the terms of a note payable (see Note 6).
Basis of Presentation
The accompanying consolidated financial statements
include the operations of Citius Oncology, Inc., and its wholly-owned subsidiary, Citius Oncology Sub, Inc., which was formed in connection
with Merger. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”).
2. GOING CONCERN UNCERTAINTY AND MANAGEMENT’S
PLAN
The accompanying financial statements have been
prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course
of business. We had a net loss of $ 24,761,369 and $ 21,148,747 for the years ended September 30, 2025 and 2024, respectively. We have no
revenue and have relied on funding from Citius Pharma to finance our operations. At September 30, 2025, we had $ 3,924,908 in cash and
a negative working capital of $ 21,948,698 . Citius Pharma and Citius Oncology have sufficient capital to fund Citius Oncology through March
2026 which raises substantial doubt about our ability to continue as a going concern within one year after the date that the accompanying
financial statements are issued.
During the three months ended September 30, 2025,
we raised net proceeds of $ 15,166,842 from the sale of common stock.
We plan to continue to rely on funding from Citius
Pharma, to raise capital through equity financings from outside investors and to generate revenue from the future sales of LYMPHIR. Both
the Company and Citius Pharma are actively engaged in capital raising efforts to extend the cash runway. We retained Jeffries LLC as our
exclusive financial advisor in evaluating strategic alternatives aimed at maximizing shareholder value. There is no assurance, however,
that Citius Pharma will have the resources to continue funding us, that we will be successful in raising the needed capital and, if funding
is available, that it will be available on terms acceptable to us, or that the we will find strategic partners, or generate substantial
revenue from the sale of LYMPHIR. The accompanying financial statements do not include any adjustments that might result from the outcome
of the above uncertainty.
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A summary of the significant accounting policies
followed by the Company in the preparation of the consolidated financial statements is as follows:
Use of Estimates
The process of preparing financial statements
in conformity U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of financial statements and the reported amounts of revenues and expenses
during the reporting period. Estimates having relatively higher significance include the accounting for in-process research and development,
stock-based compensation and income taxes. Actual results could differ from those estimates and changes in estimates may occur.
F- 8
Cash and Cash Equivalents
We consider all highly liquid instruments with
maturities of less than three months at the time of purchase to be cash equivalents. From time to time, we may have cash balances in financial
institutions in excess of insurance limits. We have never experienced any losses related to these balances.
Prepaid Expenses
Prepaid expenses at September 30, 2025 and 2024
consist of $ 1,331,280 and $ 2,700,000 of advance payments made for the preparation of long-lead time drug substance and product costs,
respectively, which will be utilized in research and development activities or in the manufacturing of LYMPHIR for sales.
Inventory
Inventory is stated at the lower of actual accumulated
costs or net realizable value as of September 30, 2025 and 2024 related to the manufacturing of LYMPHIR commercial products, which were
available for sale commencing in December 2025. No reserves against inventory were deemed necessary based on an evaluation of the product
expiration dating.
2025
2024
Finished goods
$ 10,577,876
$ 6,134,895
Work in process
11,708,817
2,133,871
Total
$ 22,286,693
$ 8,268,766
During 2024 and 2025, $ 6,134,895 and $ 1,368,720 ,
respectively, of prepaid manufacturing costs were transferred to inventory upon product approval and production commencement at our third-party
manufacturers.
Research and Development
Research and development costs, including upfront
fees and milestones paid to collaborators who are performing research and development activities under contractual agreements with us,
are expensed as incurred. We defer and capitalize our nonrefundable advance payments that are for research and development activities
until the related goods are delivered or the related services are performed. When we are reimbursed by a collaboration partner for work
we perform, we record the costs incurred as research and development expenses and the related reimbursement as a reduction to research
and development expenses in our statement of operations. Research and development expenses primarily consist of clinical and non-clinical
studies, materials and supplies, third-party costs for contracted services, and payments related to external collaborations and other
research and development related costs.
In-process Research and Development and
License Payable
We capitalize intangible assets purchased from
others for use in research and development activities as In Process Research & Development (IPR&D) when the assets acquired have
an alternative future use, we anticipate future economic benefit from that use and the assets acquired are not dependent on future development.
Milestone payments upon regulatory approval that meet the same criteria are capitalized when the payments are considered recoverable based
on expected future cash flows. Amortization of IPR&D over the exclusive regulatory period of the acquired asset commences upon revenue
generation.
F- 9
In-process research and development of $ 73,400,000
consists of an initial $ 40,000,000 payment to Dr. Reddy’s Laboratories (“DRL”) in September 2021, and $ 27,500,000 and
$ 5,900,000 for approval milestone amounts payable to DRL and Eisai, respectively, that became due during 2024. Of these amounts $ 22,650,000
and $ 28,400,000 are included in license payable at September 30, 2025 and 2024, respectively. The value of our September 2021 acquisition
of an exclusive license for LYMPHIR (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin
lymphoma, is expected to be amortized on a straight-line basis over a period of twelve years , (the FDA exclusivity period), commencing
upon revenue generation which is expected to commence in December 2025. Included in the IPR&D is the historical know-how, formula
protocols, designs, and procedures which were used in the completion of the Phase 3. In addition, the contracts acquired in connection
with Dr. Reddy’s transaction with the clinical research and manufacturing organization are at market rates and could be provided
by multiple vendors in the marketplace. Therefore, there is no fair value associated with the contracts acquired.
We review our intangible assets annually to determine
if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining
useful life of any intangible asset. If the carrying value of an asset exceeds its undiscounted cash flows, we write down the carrying
value of the intangible asset to its fair value in the period identified. No impairment has occurred since the acquisitions through September
30, 2025.
Patents and Trademarks
Certain costs of outside legal counsel related
to obtaining trademarks for the Company are capitalized. Patent costs are amortized over the legal life of the patents, generally twenty
years, starting at the patent issuance date. There are no capitalized patents and trademarks as of September 30, 2025.
The costs of unsuccessful and abandoned applications
are expensed when abandoned. The costs of maintaining existing patents are expensed as incurred.
Stock-Based Compensation
We recognize compensation costs resulting from
the issuance of stock-based awards to employees and directors as an expense in the statements of operations over the requisite service
period based on the fair value for each stock award on the grant date. The fair value of each option grant is estimated as of the date
of grant using the Black-Scholes option pricing model. Because our stock options have characteristics significantly different from those
of traded options, and because changes in the input assumptions can materially affect the fair value estimate, the existing model may
not necessarily provide a reliable single measure of fair value of our stock options.
We recognize compensation costs resulting from
the issuance of stock-based awards to non-employees as an expense in the statements of operations over the service period based on the
measurement of fair value for each stock award and records forfeitures as they occur.
Income Taxes
We file consolidated income tax returns with Citius
Pharma. We follow accounting guidance regarding the recognition, measurement, presentation, and disclosure of uncertain tax positions
in the financial statements. Tax positions taken or expected to be taken in the course of preparing our tax returns are required to be
evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authorities.
Tax positions not deemed to meet a more-likely-than-not threshold would be recorded in the financial statements. There are no uncertain
tax positions that require accrual or disclosure as of September 30, 2025. Any interest or penalties are charged to expense. During the
years ended September 30, 2025 and 2024, we did not recognize any interest and penalties. We are subject to examination by federal and
state tax authorities for all tax years since inception.
We recognize deferred tax assets and liabilities
based on differences between the financial reporting and tax basis of assets and liabilities, and operating loss and tax credit carry
forwards. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that are expected to be in effect when
the differences are expected to reverse. We provide a valuation allowance, if necessary, for deferred tax assets for which we do not consider
realization of such assets to be “more-likely-than-not.” The deferred tax benefit or expense for the period represents the
change in the deferred tax asset or liability from the beginning to the end of the period.
F- 10
Basic and Diluted Net Loss per Common Share
Basic and diluted net loss per common share applicable
to common stockholders is computed by dividing net loss in each period by the weighted average number of shares of common stock outstanding
during such period. For the periods presented, common stock equivalents, consisting of options were not included in the calculation of
the diluted loss per share because they were anti-dilutive.
Segment Reporting
The Company operates through a single operating
and reportable segment which is focused on developing and commercializing innovative targeted oncology therapies. The Company’s
lead product candidate is LYMPHIR, an engineered IL-2 diphtheria toxin fusion protein, for the treatment of patients with persistent or
recurrent CTCL, a rare form of non-Hodgkin lymphoma. LYMPHIR was approved by the FDA in August 2024. The Company manages all business
activities on a consolidated basis. The Company’s Chief Operating Decision Maker (“CODM”) is the Chief Executive Officer .
The accounting policies of the operating segment
are as described in Note 3. The CODM evaluates the performance of the operating segment and allocates resources based on amounts as reported
on the consolidated statements of operations and cash flows. Segment expenses are presented on the Company’s consolidated statements
of operations. The operating segment assets are reported on the consolidated balance sheet as total assets.
Concentrations of Credit Risk
We have no significant off-balance-sheet concentration
of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements.
Recently Adopted Accounting Standards
Reportable Segment Disclosures
In November 2023, the FASB issued ASU 2023-07,
Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures. The change in the standard improves reportable segment
disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The changes improve financial reporting
by requiring disclosure of incremental segment information on an annual and interim basis for all public entities to enable investors
to develop more decision-useful financial analyses. The guidance will be effective for annual reporting periods beginning after December
15, 2023, and for interim periods beginning after December 15, 2024. Early adoption is permitted. The standard will be applied retrospectively.
Since the Company has one reportable segment, adoption of this new standard did not have a material impact on the Company’s consolidated
financial statements.
F- 11
Recently Issued Accounting Standards
Income Tax Disclosures
In December 2023, the FASB issued ASU 2023-09,
Income Taxes (Topic 740), Improvements to Income Tax Disclosures. The standard enhances the transparency, decision usefulness and effectiveness
of income tax disclosures by requiring consistent categories and greater disaggregation of information in the reconciliation of income
taxes computed using the enacted statutory income tax rate to the actual income tax provision and effective income tax rate, as well as
the disaggregation of income taxes paid (refunded) by jurisdiction. The standard also requires disclosure of income (loss) before provision
for income taxes and income tax expense (benefit) in accordance with U.S. Securities and Exchange Commission (SEC) Regulation S-X 210.4-08(h),
Rules of General Application – General Notes to Financial Statements: Income Tax Expense, and the removal of disclosures no longer
considered cost beneficial or relevant. The guidance will be effective for annual reporting periods beginning after December 15, 2024.
Early adoption is permitted. The standard will be applied on a prospective basis, with retrospective application permitted. The Company
is currently evaluating the impact of adoption of the standard on its financial statement disclosures.
Disaggregation of Income Statement Expenses
In November 2024, the FASB issued ASU 2024-03,
Income Statement Reporting–Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income
Statement Expenses. The standard update improves the disclosures about a public business entity’s expense by requiring more detailed
information about the types of expenses (including purchases of inventory, employee compensation, depreciation and amortization) included
within income statement expense captions. The guidance will be effective for annual reporting periods beginning after December 15, 2026,
and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The standard updates are to be applied prospectively
with the option for retrospective application. We are currently evaluating the impact of adoption of the standard update on our financial
statement disclosures.
4. PATENT AND TECHNOLOGY LICENSE AGREEMENTS
In September 2021, Citius Pharma entered into
an asset purchase agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. (collectively,
“Dr. Reddy’s”) and a license agreement with Eisai Co., Ltd. (“Eisai”) to acquire an exclusive license of
E7777 (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma. Citius Pharma assigned
these agreements to us effective April 1, 2022. Citius Pharma renamed E7777 as I/ONTAK and also obtained the trade name of LYMPHIR TM
for the product. Denileukin diftitox is referred to as E7777, I/ONTAK or LYMPHIR, depending on the period of time and context that is
being discussed.
Under the terms of these
agreements, Citius Pharma acquired Dr. Reddy’s exclusive license for E7777 from Eisai and other related assets owned by Dr. Reddy’s.
The exclusive license includes rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia. Eisai
retains exclusive development and marketing rights for the agent in Japan, China, Korea, Taiwan, Hong Kong, Macau, Indonesia, Thailand,
Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh, Bhutan,
Nepal, Mongolia, and Papua New Guinea. Citius Pharma paid a $ 40,000,000 upfront payment which represents the acquisition date fair value
of the in-process research and development acquired from Dr. Reddy’s. Dr. Reddy’s is entitled to up to $ 40,000,000 in development
milestone payments related to CTCL approvals in the U.S. and other markets, up to $ 70,000,000 in development milestones for additional
indications, as well as commercial milestone payments and low double-digit tiered royalties on net product sales (within
a range of 10 % to 15 %) , and up to $ 300,000,000 for commercial sales milestones. We also must pay on a fiscal quarter basis tiered
royalties equal to low double-digit percentages of net product sales (within a range of
10 % to 15 %) . The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale of the latest indication
that received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results in the reduction of
net sales in the applicable product by 50 % in two consecutive quarters, as compared to the four quarters prior to the first commercial
sale of the biosimilar product. We will also pay to Dr. Reddy’s an amount equal to a low-thirties percentage of any sublicense upfront
consideration or milestone payments (or the like) received by us and the greater of (i) a low-thirties percentage of any sublicensee sales-based
royalties or (ii) a mid-single digit percentage of such licensee’s net sales. Citius Pharma is a guarantor of our obligations under
these agreements.
F- 12
At
the time of the FDA approval for LYMPHIR, a $ 27,500,000 milestone payment became payable to Dr. Reddy’s under the terms of the asset
purchase agreement for which a balance of $ 19,750,000 remains due as of September 30, 2025. Dr. Reddy’s agreed to a partial deferral
without penalty of this milestone payment.
Under the license agreement,
Eisai was due a $ 5,900,000 milestone payment upon FDA approval, of which $ 2,900,000 remains payable at September 30, 2025, and additional
commercial milestone payments related to the achievement of net product sales thresholds and an aggregate of up to $ 22,000,000 related
to the achievement of net product sales thresholds. Citius Pharma was also required to reimburse Eisai for up to $ 2,650,000 of its costs
to complete the Phase 3 pivotal clinical trial for LYMPHIR for the CTCL indication and reimburse Eisai for all reasonable costs associated
with the preparation of a Biologics License Application, (the “BLA”) for LYMPHIR. Eisai was responsible for completing the
CTCL clinical trial, and chemistry, manufacturing and controls (CMC) activities through the filing of a BLA for LYMPHIR with the FDA.
The BLA was approved by the FDA on August 8, 2024. We are responsible for development costs associated with potential additional indications.
On March 28, 2025, Citius Oncology and Eisai entered
into a letter agreement that amended the license agreement to provide for a payment schedule to Eisai for the milestone payment and certain
unpaid invoices. We agreed to pay Eisai on or before July 15, 2025, an aggregate amount of $ 2,535,318 and thereafter on the 15 th of
each of the next four months to pay Eisai $ 2,350,000 and make a final payment of $ 2,197,892 to Eisai on or before December 15, 2025, in
each case with interest on each obligation from its original due date through the date of actual payment under the letter agreement at
the rate of 2 % per annum. During the year ended September 30, 2025, we recorded $ 218,032 in interest expense under the agreement. The
parties released each other from any and all claims, losses, damages, costs and expenses that arise from or related to our failure to
pay the milestone payment or the other incurred costs under the license agreement except for any claims arising out of a breach of the
letter agreement. All other terms of the license agreement remain in full force and effect. During the year ended September 30, 2025 we
paid $ 3,000,000 of the development milestone and the balance of $ 2,900,000 is included in license fee payable at September 30, 2025. On
July 21, 2025, we made a payment to Eisai of $ 1,616,522 for other invoices and accumulated interest associated with the letter agreement.
The term of the license agreement will continue
until (i) March 30, 2026, if there has not been a commercial sale of a licensed product in the territory, or (ii) if there has been a
first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first commercial sale on
a country-by-country basis. We expect the first commercial sale to occur in the first quarter of 2026. The term of the license may be
extended for additional 10-year periods for all countries in the territory by notifying Eisai and paying an extension fee equal to $ 10,000,000 .
Either party may terminate the license agreement upon written notice if the other party is in material breach of the agreement, subject
to cure within the designated time periods. Either party also may terminate the license agreement immediately upon written notice if the
other party files for bankruptcy or takes related actions or is unable to pay its debts as they become due. Additionally, either party
will have the right to terminate the agreement if the other party directly or indirectly challenges the patentability, enforceability
or validity of any licensed patent.
Under the purchase agreement
with Dr. Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available products in the CTCL
indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology
trials (both of which have been initiated), (iii) use commercially reasonable efforts to achieve each of the approval milestones, and
(iv) to complete each specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the
definitive agreement. Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory
approval for such product in each such jurisdiction ; the launch of LYMPHIR in December 2025 satisfied
this requirement in the U.S .
As part of the definitive agreement with Dr. Reddy’s,
Citius Pharma acquired method of use patents in which LYMPHIR is administered in combination with the programmed cell death protein 1
(“PD-1”) pathway inhibitor drug class. PD-1 plays a vital role in inhibiting immune responses and promoting self-tolerance
through modulating the activity of T-cells, activating apoptosis of antigen-specific T cells and inhibiting apoptosis of regulatory T
cells.
F- 13
The following patents were acquired and subsequently
transferred to us:
US Provisional Application No. 63/070,645, which
was filed on August 26, 2020, and subsequently published as US 2022/0062390 A1 on March 3, 2022, entitled Methods of Treating Cancer.
International Patent Application Number: PCT/IB2021/0576733,
which was filed with the World Intellectual Property Organization on August 23, 2021, and subsequently published as WO 2022/043863 A1
on March 3, 2022, entitled, Combination for Use in Methods of Treating Cancer.
5. COMMON STOCK, STOCK OPTIONS, RESTRICTED
STOCK AWARDS AND WARRANTS
Authorized Capital Stock
The certificate of incorporation adopted on August
5, 2024, in connection with the Merger, authorized 110,000,000 shares, of which 100,000,000 shares are common stock with a par value of
$ 0.0001 , and 10,000,000 shares are preferred stock with a par value of $ 0.0001 . On April 7, 2025, pursuant to Board and stockholder approval,
we amended our certificate of incorporation to increase the authorized shares of common stock from 100,000,000 shares to 400,000,000 shares.
Common Stock Offerings
On July 17, 2025, we completed an offering of
6,818,182 shares of common stock and warrants to purchase 6,818,182 shares of common stock. The shares and warrants were sold at a per
unit price of $ 1.32 . The immediately exercisable five-year warrants have an exercise price of $ 1.32 per share. Gross proceeds from the
offering were approximately $ 9.0 million and net proceeds were $ 7,546,988 , after deducting placement agent fees and other offering expenses.
The estimated fair value of the warrants issued to the investors was approximately $ 8,197,000 .
We paid the placement agent a fee of 7.0 % of the
gross proceeds and expenses of $ 125,000 . Additionally, we issued the placement agent warrants to purchase up to 272,727 shares of common
stock at an exercise price of $ 1.65 per share. The warrants are exercisable commencing on January 17, 2026 and expire on July 17, 2030 .
We also paid an additional 7.0 % fee to a prior placement agent and issued to the prior placement agent warrants to purchase up to 477,273
shares of common stock at an exercise price of $ 1.65 per share. The placement agent warrants are exercisable commencing on August 17,
2025 and expire on July 17, 2030 . The estimated fair value of the warrants issued to the placement agents was approximately $ 905,000 .
On September 10, 2025, we completed an offering
of 5,142,858 shares of common stock and warrants to purchase 5,142,858 shares of common stock. The shares and warrants were sold at a
per unit price of $ 1.75 . The warrants are exercisable beginning on March 10, 2026 and expire on March 10, 2031 at an exercise price of
$ 1.84 per share. Gross proceeds from the offering were approximately $ 9.0 million and net proceeds were $ 7,619,854 , after deducting placement
agent fees and other offering expenses. The estimated fair value of the warrants issued to the investors was approximately $ 6,995,000 .
We paid the placement agent a fee of 7.0 % of the
gross proceeds and expenses of $ 125,000 . Additionally, we issued the placement agent warrants to purchase up to 205,714 shares of common
stock at an exercise price of $ 1.92 per share. The warrants are exercisable commencing on March 10, 2026 and expire on March 10, 2031 .
We also paid an additional 7.0 % fee to a prior placement agent and issued the prior placement agent warrants to purchase up to 360,000
shares of common stock at an exercise price of $ 2.1875 per share. The placement agent warrants are exercisable commencing on March 10,
2026 and expire on March 10, 2031. The estimated fair value of the warrants issued to the placement agents was approximately $ 717,000 .
F- 14
Stock Plans
Under the Citius Oncology 2023 Stock Plan, adopted
on April 29, 2023, we reserved 15,000,000 common shares for issuance. Under the Citius Oncology 2024 Stock Plan, adopted on August 2,
2024, we reserved 15,000,000 common shares for issuance. The stock plans provide incentives to employees, directors, and consultants through
grants of options, SARs, dividend equivalent rights, restricted stock, restricted stock units, or other rights.
The fair value of each stock option award is estimated
on the date of grant using the Black-Scholes option pricing model. Volatility is estimated using the trading activity of Citius Pharma
common stock until such time as we have sufficient history. The risk-free interest rate is based on the U.S. Treasury yield curve in effect
at the time of grant commensurate with the expected term assumption. The expected term of stock options granted to employees and directors,
all of which qualify as “plain vanilla,” is based on the average of the contractual term (generally 10 years) and the
vesting period. For non-employee options, the expected term is the contractual term.
The following assumptions were used in determining
the fair value of stock option grants for the year ended September 30, 2025 and 2024:
2025 2024
Risk-free interest rate 4.08 - 4.18 % 4.66 %
Expected dividend yield 0.00 % 0.00 %
Expected term 5.50 - 6.50 years 6.50 years
Expected volatility 85 % 87 %
A summary of option activity under the plan is presented below:
Shares Weighted-
Average
Exercise
Price Weighted-
Average
Remaining
Contractual
Term Aggregate
Intrinsic
Value
Outstanding at September 30, 2024 12,750,000 $ 2.15 8.78 years $ —
Granted 5,750,000 1.07
Forfeited ( 400,000 ) 1.75
Outstanding at September 30, 2025 18,100,000 $ 1.83 8.21 years $ 5,386,000
Exercisable at September 30, 2025 9,781,250 $ 2.02 7.94 years $ 1,136,500
On December 2, 2024, the Board of Directors granted
options to purchase 200,000 common shares at an exercise price of $ 1.02 per share. On December 12, 2024, the Board of Directors granted
options to purchase 5,550,000 common shares at an exercise price of $ 1.07 per share.
The weighted average grant date fair value of
the options granted during the year ended September 30, 2025 was estimated at $ 0.80 per share. All these options vest over terms of 12
to 36 months and have a term of 10 years.
Stock-based compensation expense for stock options
for the years ended September 30, 2025 and 2024 was $ 8,116,678 and $ 7,498,817 , respectively.
At September 30, 2025, unrecognized total compensation
cost related to unvested stock options under the stock plans of $ 7,814,682 is expected to be recognized over a weighted average period
of 1.23 years.
F- 15
Restricted stock awards
On September 19, 2025, the Board of Directors
granted restricted stock awards of 11,600,000 shares of common stock to employees and directors. The restricted stock awards vest on September
19, 2028 . The fair value of the common stock on the date of grant was $ 20,300,000 ($ 1.75 per share).
Stock-based compensation expense for restricted
stock awards for the year ended September 30, 2025 was $ 203,741 .
At September 30, 2025, unrecognized total compensation
cost related to unvested restricted stock awards under the stock plans of $ 20,096,259 is expected to be recognized over a weighted average
period of 2.97 years.
Warrants
We have reserved 13,276,754 shares of common stock
for the exercise of outstanding warrants. The following table summarizes the warrants outstanding at September 30, 2025:
Exercise
price Number Expiration Dates
July 2025 Offering Investors $ 1.32 6,818,182 July 17, 2030
July 2025 Offering Agent $ 1.65 272,727 July 17, 2030
July 2025 Prior Offering Agent $ 1.65 477,273 July 17, 2030
September 2025 Offering Investors $ 1.84 5,142,858 March 10, 2031
September 2025 Offering Agent $ 1.92 205,714 March 10, 2031
September 2025 Prior Offering Agent $ 2.1875 360,000 March 10, 2031
13,276,754
At September 30, 2025, the weighted average remaining
life of the outstanding warrants is 5.08 years, all warrants are exercisable except for the September 2025 Offering warrants which become
exercisable on March 10, 2026, and the aggregate intrinsic value of the warrants outstanding was $ 6,125,681 .
Common Stock Reserved
A summary of common stock reserved for future
issuances by the Company as of September 30, 2025 is as follows:
Stock plan options outstanding
18,100,000
Restricted stock awards
11,600,000
Stock plan shares available for future grants
300,000
Warrants outstanding
13,276,754
Total
43,276,754
6. RELATED PARTY TRANSACTIONS
Our officers and directors also serve as officers
of Citius Pharma. As of September 30, 2025, we do not have any employees. The Company and Citius Pharma have entered into the A&R
Shared Services Agreement and under the terms of the agreement, Citius Pharma provides management and scientific services to us. During
the year ended September 30, 2025, Citius Pharma charged us $ 2,201,742 for reimbursement of general and administrative payroll, $ 1,920,000
for reimbursement of research and development payroll, and $ 114,185 for the use of shared office space. During the year ended September
30, 2024, Citius Pharma charged us $ 1,846,202 for reimbursement of general and administrative payroll, $ 1,963,630 for reimbursement of
research and development payroll, and $ 121,570 for the use of shared office space.
We have had limited cash, therefore most of our
expenditures have been paid by Citius Pharma and reflected in the due to related party account. At September 30, 2025 and 2024, the net
amount due to Citius Pharma was $ 9,513,771 and $ 588,806 , respectively.
F- 16
In connection with closing of the Merger, Citius
Pharma made a contribution to our capital in the amount of $ 33,180,961 representing the balance of the due to/due from related party account
on the date of the Merger. Citius Pharma also made cash contributions to our capital, pursuant to the terms of the Merger Agreement, in
the amount of $ 3,827,944 .
Also, in connection with the Merger, Citius Pharma
advanced cash to the Company for a non-interest bearing, unsecured promissory note issued by the Company, dated August 16, 2024, as amended
September 10, 2025, in the principal amount of $ 3,800,111 . The note is repayable in full upon a financing of at least $ 30,000,000 by the
Company, per the terms of the promissory note. Management does not anticipate such repayment within the next twelve months. As a result,
this note payable is classified as non-current on the balance sheet.
7. INCOME TAXES
We file consolidated income tax returns with Citius
Pharma. We recorded deferred income tax expense of $ 1,056,960 and $ 576,000 for the years ended September 30, 2025 and 2024 related to
the amortization for taxable purposes of our in-process research and development asset.
The income tax expense differs from the amount
of income tax determined by applying the U.S. federal income tax rate to pretax income for the years ended September 30, 2025 and 2024
due to the following:
2025
2024
Computed “expected” tax benefit
( 21.00 )%
( 21.00 )%
Increase (decrease) in income taxes resulting from:
State taxes, net of federal benefit
( 7.11 )
( 7.11 )
Permanent differences
6.34
6.11
Increase in the valuation reserve
26.23
24.80
4.46 %
2.80 %
Deferred income taxes reflect the net tax effects
of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used
for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities are as follows:
September 30,
2025
September 30,
2024
Deferred tax assets:
Net operating loss carryforward
$ 12,720,000
$ 7,530,000
Capitalized research and development expense
3,189,000
2,080,000
Stock-based compensation
1,928,000
1,091,000
Research tax credit
1,581,000
1,035,000
Valuation allowance on deferred tax assets
( 19,418,000 )
( 11,736,000 )
Total deferred tax assets
-
-
Deferred tax liabilities:
In-process research and development
( 2,784,960 )
( 1,728,000 )
Total deferred tax liability
( 2,784,960 )
( 1,728,000 )
Net deferred tax liability
$ ( 2,784,960 )
$ ( 1,728,000 )
F- 17
The Company has recorded a valuation allowance
against deferred tax assets as the utilization of the net operating loss carryforward and other deferred tax assets is uncertain. During
the years ended September 30, 2025 and 2024, the valuation allowance increased by $ 7,682,000 and $ 4,928,000 , respectively. The increase
in the valuation allowance during the years ended September 30, 2025 and 2024 was primarily due to the Company’s net operating losses
and capitalized research and development expenses. At September 30, 2025, the Company has a federal net operating loss carryforward
of approximately $ 47,153,000 . Federal net operating loss carryforwards generated in tax years beginning after 2017 may be carried forward
indefinitely. Use of federal net operating losses may be limited under Section 382 of the Internal Revenue Code due to changes in ownership.
As of September 30, 2025, the Company also has
estimated federal research and development credits of $ 1,581,000 to offset future income taxes. The tax credit carryforwards will begin
to expire in 2042.
We account for uncertain tax positions in accordance
with the guidance provided in ASC 740, “Accounting for Income Taxes.” This guidance describes a recognition threshold and
measurement attribute for the financial statement disclosure of tax positions taken or expected to be taken in a tax return and requires
recognition of tax benefits that satisfy a more-likely-than-not threshold. ASC 740 also provides guidance on de-recognition, classification,
interest and penalties, accounting in interim periods and disclosure. There have been no reserves for uncertain tax positions recorded
by the Company to date.
On July 4, 2025, the “One Big Beautiful
Bill Act” (“OBBBA”) was signed into law in the United States. The OBBBA includes a broad range of tax reform provisions
for businesses, including extensions of key Tax Cuts and Jobs Act provisions, modifications to the international tax framework, and restoration
of favorable tax treatment for certain business provisions. Certain provisions of the legislation will become effective in 2025, while
others are effective in 2026. The OBBBA was enacted during our fourth fiscal quarter of 2025, and we have considered its potential effects
and reflected the impact of the OBBBA on our financial position, results of operations, and cash flows. We are in the process of evaluating
the impact of these provisions on future periods, but we do not expect the OBBBA to have a material impact on our consolidated financial
statements.
8. COMMITMENTS AND CONTINGENCIES
Commercial Manufacturing Contracts
We entered into an agreement with a Contract Manufacturing
Organization for the manufacture and supply of drug substance. The agreement runs through calendar 2026, with an automatic renewal for
a subsequent 4-year term. Under this agreement, we are obligated to purchase minimum annual quantities of batches at a set price per batch,
subject to annual increases.
Additionally, we are required to pay an annual
service fee of $ 250,000 . The agreement also includes provisions for potential price increases based on increases in the manufacturer’s
operating expenses or industry indices, as well as significant termination fees and obligations. As of September 30, 2025, the total minimum
purchase commitment under this agreement was approximately $ 16.2 million consisting of payments of approximately $ 8.5 million and $ 5.3
million for 2025 and 2026 respectively and approximately $2.4 million for 2026 pass-throughs and consumable manufacturing components.
As of September 30, 2025, we have commercial supply agreements with
two other vendors for the completion and packaging of finished drug products. Minimum purchase commitments under these two agreements
amount to approximately $ 4.9 million consisting of purchase commitment obligations of approximately $ 1.2 million in 2025, $ 1.9 million
in 2026 and $ 1.8 million in 2027.
F- 18
Legal Proceedings
We are not involved in any litigation that we
believe could have a material adverse effect on our financial position or results of operations. There is no action, suit, proceeding,
inquiry, or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to
the knowledge of our executive officers, threatened against or affecting the Company or its officers or directors in their capacities
as such.
9. SUBSEQUENT EVENTS
On October 27, 2025, we held our 2025 annual meeting of stockholders.
At the meeting, our stockholders approved an amendment to the Company’s 2024 Omnibus Stock Incentive Plan increasing the number
of shares of our common stock authorized for issuance under the plan from 15,000,000 to 30,000,000 shares.
On December 8, 2025, the Company entered into
a securities purchase agreement (the “RD Purchase Agreement”) with a certain institutional investor in a registered direct
offering for the purchase and sale of 1,284,404 shares of our common stock at an offering price of $ 1.09 per share of common stock (the
“Shares”). In a concurrent private placement, the Company also agreed to sell such institutional investor warrants to purchase
up to 1,284,404 shares of common stock (the “Common Warrants”), with an exercise price of $ 1.09 per share of our common stock,
which are exercisable upon Stockholder Approval (as defined in the Common Warrant), and have a term of five years from the date of Stockholder
Approval. The aggregate gross proceeds to the Company from the offering were approximately $ 18.0 million. Net proceeds were approximately
$ 15.2 million, after deducting placement agent fees and other offering expenses payable by the Company.
On December 8, 2025, the Company also entered
into a securities purchase agreement (the “PIPE Purchase Agreement”, together with the RD Purchase Agreement, the “Purchase
Agreements”) with such institutional investor to issue in a concurrent private placement pre-funded warrants to purchase up to 15,229,358
shares of common stock (the “Pre-funded Warrants”) and 15,229,358 Common Warrants, at a combined price of $ 1.0899 per Pre-funded
Warrant and accompanying Common Warrant. The Pre-funded Warrants are exercisable immediately, at an exercise price of $ 0.0001 per share,
and will remain valid and exercisable until all the Pre-funded Warrants are exercised in full.
In connection with the offering, the Company agreed
to pay the placement agent a cash fee of 7.0 % of the aggregate gross proceeds the Company received in the offering. In addition, the Company
granted placement agent warrants to the placement agent, or its designees, to purchase up to 1,155,963 shares of common stock (the “Placement
Agent Warrants”). The terms of the Placement Agent Warrants are substantially the same as the terms of the Common Warrants, except
that the exercise price is $ 1.3625 per share and expire five years from the commencement of sales in the offering.
F- 19
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.