48 unchanged sentences
Corporate Governance
−Removed: We have adopted a written Code of Ethics and Business
−Removed: Conduct that applies to our directors, officers, and all employees.
−Removed: We intend to disclose any amendments to, or waivers from, our code
−Removed: of ethics and business conduct that are required to be publicly disclosed pursuant to rules of the SEC by filing such amendment or waiver
−Removed: with the SEC.
−Removed: This code of ethics and business conduct can be found in the “Governance – Governance Documents” section
−Removed: of our website, www.citiusonc.com .
−Removed: The other information required by this Item concerning
−Removed: our directors and executive officers is incorporated by reference to the section captioned “Proposal No.
−Removed: 1—Election of Directors”
−Removed: and “Corporate Governance” to be contained in our proxy statement related to the 2025 Annual Meeting of Stockholders (the
−Removed: “Proxy Statement”), which information is expected to be filed with the SEC within 120 days of the end of our fiscal year pursuant
−Removed: to General Instruction G(3) of Form 10-K or as otherwise provided by amendment to this Form 10-K.
−Removed: The information required by this Item
−Removed: concerning compliance with Section 16(a) of the Exchange Act by our directors, executive officers and persons who own more than 10% of
−Removed: our outstanding common stock is incorporated by reference from the section captioned “Section 16(a) Beneficial Ownership Reporting
−Removed: Compliance” to be contained in the Proxy Statement or as otherwise provided by amendment to this Form 10-K.
+Added: The following table sets forth information as of the date of this report
+Added: with respect to the individuals who serve as the directors and executive officers of Company, including their positions, and is followed
+Added: by a biography of each such individual.
+Added: Leonard Mazur
+Added: Chairman and Chief Executive Officer and Director
+Added: Myron Holubiak
+Added: Secretary and Director
+Added: Eugene Holuka
+Added: Joel Mayersohn
+Added: Jaime Bartushak
+Added: Chief Financial Officer and Treasurer
+Added: Chief Medical Officer
+Added: Leonard Mazur
+Added: Leonard Mazur is the Chairman and Chief Executive
+Added: Officer of the Company, a position he has held since August 12, 2024.
+Added: Prior thereto, he served as the Chief Executive Officer of Citius
+Added: Oncology Sub, Inc., beginning on April 1, 2022.
+Added: Mazur also serves as the Executive Chairman and Secretary of Citius Pharma (Nasdaq:
+Added: CTXR) and has been a member of the board of directors of Citius Pharma since September 2014.
+Added: In May 2022, Mr.
+Added: Mazur became the Chief Executive
+Added: Officer of Citius Pharma.
+Added: He also serves as the Secretary of Citius Pharma’s majority-owned subsidiary, NoveCite, Inc.
+Added: (“NoveCite”),
+Added: and provides other guidance to Citius Pharma and NoveCite.
+Added: Since August 2021, Mr.
+Added: Mazur has served on the board of directors of Hillstream
+Added: BioPharma, Inc.
+Added: HILS), a pre-clinical biotechnology company developing novel therapeutic candidates targeting ferroptosis, an
+Added: emerging new anti-cancer mechanism resulting in iron mediated cell death for treatment resistant cancers.
+Added: Mazur is the co-founder
+Added: and Vice Chairman of Akrimax Pharmaceuticals, LLC (“Akrimax”), a privately held pharmaceutical company specializing in producing
+Added: cardiovascular and general pharmaceutical products.
+Added: Akrimax was founded in September 2008 and has successfully launched prescription drugs
+Added: while acquiring drugs from major pharmaceutical companies.
+Added: From January 2005 to May 2012, Mr.
+Added: Mazur co-founded and served as the Chief
+Added: Operating Officer of Triax Pharmaceuticals LLC (“Triax”), a specialty pharmaceutical company producing prescription dermatological
+Added: Prior to joining Triax, he was the founder and, from 1995 to 2005, Chief Executive Officer of Genesis Pharmaceutical, Inc.
+Added: a dermatological products company that marketed its products through dermatologists’ offices as well as co-promoting products for
+Added: major pharmaceutical companies.
+Added: Mazur successfully sold Genesis to Pierre Fabre, a leading pharmaceutical company.
+Added: has extensive sales, marketing and business development experience from his tenures at Medicis Pharmaceutical Corporation as Executive
+Added: Vice President, ICN Pharmaceuticals, Inc.
+Added: as Vice President, Sales & Marketing, Knoll Pharma (a division of BASF), and Cooper Laboratories,
+Added: 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
+Added: the Chairman of the board of directors of Leonard-Meron Biosciences, Inc.
+Added: (“LMB”), the Company’s wholly-owned subsidiary.
+Added: Mazur received both his B.A.
+Added: from Temple University and has served in the U.S.
+Added: Marine Corps Reserves.
+Added: The Board believes that Mr.
+Added: Mazur is qualified
+Added: to serve as a director because of his entrepreneurial experience and marketing knowledge in the pharmaceutical industry.
+Added: Myron Holubiak
+Added: Myron Holubiak is the current Secretary of the
+Added: Company and a member of the Board, a position he has held since August 12, 2024.
+Added: Prior thereto, he served as Secretary and a director
+Added: of Citius Oncology Sub, Inc., beginning on April 1, 2022.
+Added: Holubiak is also the Executive Vice Chairman of Citius Pharma, a position
+Added: he has held since May 2022.
+Added: He has also served as a member of the board of directors of Citius Pharma since October 2015.
+Added: 2015 through April 2022, Mr.
+Added: Holubiak served as Citius Pharma’s President and Chief Executive Officer.
+Added: Holubiak also serves
+Added: as the acting Chief Executive Officer of our majority-owned subsidiary, NoveCite.
+Added: Holubiak has extensive experience in managing and
+Added: advising large and emerging pharmaceutical and life sciences companies.
+Added: Holubiak was the President of Roche Laboratories, Inc.
+Added: a major research-based pharmaceutical company, from December 1998 to August 2001.
+Added: Prior to that, he held sales and marketing positions
+Added: at Roche during his 19-year tenure.
+Added: From September 2002 to July 2016, Mr.
+Added: Holubiak served on the board of directors and for the last two
+Added: years was the Chairman of the board of directors of BioScrip, Inc.
+Added: (“BioScrip”) (Nasdaq:
+Added: BioScrip is a leading national
+Added: provider of infusion and home care management solutions.
+Added: Since July 2010, Mr.
+Added: Holubiak has served as a member of the board of directors
+Added: of Assembly Biosciences, Inc.
+Added: (“Assembly”) (Nasdaq:
+Added: ASMB) and its predecessor Ventrus Biosciences, Inc.
+Added: Assembly is a biopharmaceutical
+Added: company developing innovative, small molecule therapeutics for hepatitis B virus (HBV), hepatitis delta virus (HDV) and herpes virus infections.
+Added: Additionally, Mr.
+Added: Holubiak serves as a director for bioAffinity Technologies Inc., a privately held company.
+Added: In March 2013, Mr.
+Added: founded LMB, the Company’s wholly-owned subsidiary, and he served as the Chief Executive Officer and President of LMB until March
+Added: In addition, Mr.
+Added: Holubiak was also a trustee of the Academy of Managed Care Pharmacy Foundation from April 2013 to April 2015.
+Added: Holubiak received a B.S.
+Added: in Molecular Biology and Biophysics from the University of Pittsburgh;
+Added: he received advanced business training
+Added: from the Harvard Business School and the University of London;
+Added: and advanced training in health economics from the University of York’s
+Added: Centre for Health Economics.
+Added: The Board believes that Mr.
+Added: Holubiak is qualified
+Added: to serve as a director because of his industry knowledge and experience managing both large and small pharmaceutical companies.
+Added: Suren Dutia has been a member of the Board since
+Added: August 12, 2024.
+Added: Dutia has also been a member of the board of directors of Citius Pharma since October 2015.
+Added: In addition to his role
+Added: as an outside independent director of Citius Pharma, Mr.
+Added: Dutia has been serving as director of Flint Rehab and Vahan Inc, since 2016.
+Added: Dutia has been involved in fostering entrepreneurship for more than 20 years and served as Senior Fellow of the Ewing Mario Kauffman
+Added: Foundation from March 2011 to December 2016 and Senior Fellow of Skandalaris Center for Entrepreneurship and Innovation at Washington
+Added: University, St.
+Added: Louis from 2010 to 2013.
+Added: He has served as a member of the advisory board of Center for Digital Transformation, University
+Added: of California, Irvine since May 2012.
+Added: From February 2006 to May 2010, Mr.
+Added: Dutia served as the Chief Executive Officer of TiE, a non-profit
+Added: organization involved in fostering entrepreneurship globally.
+Added: From February 2011 to May 2013, Mr.
+Added: Dutia served as a director of LifeProof
+Added: and from July 2000 to December 2011, he served as a director of Anvita Health.
+Added: From 1989 to 1998, Mr.
+Added: Dutia served as the Chief Executive
+Added: Officer and Chairman of the board of directors of Xscribe Corporation.
+Added: Prior to his positions with Xscribe Corporation, Mr.
+Added: several positions with Dynatech Corporation, and, in addition, he was the President of a medical instruments company.
+Added: Dutia received
+Added: degrees in chemical engineering and B.A.
+Added: in political science from Washington University, St.
+Added: In addition, he
+Added: obtained an M.B.A.
+Added: from the University of Dallas.
+Added: The Board believes that Mr.
+Added: Dutia is qualified
+Added: to serve as a director because of his financial management background, his involvement with start-up companies and his management skills.
+Added: Eugene Holuka
+Added: Eugene Holuka has been a member of the Board
+Added: since August 12, 2024.
+Added: Holuka has also been a member of the board of directors of Citius Pharma since June 2016.
+Added: internist and has practiced in internal medicine for almost 35 years.
+Added: He is presently an attending physician at the Staten Island University
+Added: Hospital where he has practiced since 1991.
+Added: Holuka has also served as an Adjunct Clinical Assistant Professor at the Touro College
+Added: of Osteopathic Medicine since 2011 and currently serves as an associate professor at the Zucker School of Medicine at Hofstra University.
+Added: From April 2014 until the acquisition of LMB by the Company in March 2016, he was a member of the LMB Scientific Advisory Board.
+Added: received the Ellis Island Medal of Honor in 2000 and has served on the NECO Committee Board since 2005.
+Added: He was an Executive Committee
+Added: Member on the Forum’s Children Foundation from 2000 until 2008.
+Added: The Board believes that Dr.
+Added: Holuka is qualified
+Added: to serve as a director because of his extensive experience in the healthcare industry.
+Added: McGrath has been a member of the Board
+Added: since August 12, 2024.
+Added: McGrath has also been a member of the board of directors of Citius Pharma since February 2023.
+Added: He has served
+Added: as the President of PAVmed, Inc.
+Added: PAVM), a diversified commercial-stage medical technology company since March 2019 (having served
+Added: as Executive Vice President from March 2017 to March 2019) and as PAVmed’s Chief Financial Officer since March 2017.
+Added: has also served as the Chief Financial Officer of Lucid, PAVmed’s majority owned subsidiary since the consummation of Lucid’s
+Added: initial public offering.
+Added: Previously, from 2000 to 2017 Mr.
+Added: McGrath served in several senior level positions of PhotoMedex, Inc.
+Added: PHMD), a global manufacturer and distributor of medical device equipment and services, including from 2011 to 2017 as director,
+Added: President, and Chief Financial Officer.
+Added: Prior to PhotoMedex’s reverse merger with Radiancy, Inc in December 2011, he also served
+Added: as a board member and Chief Executive Officer from 2009 to 2011 and served as Vice President of Finance and Chief Financial Officer from
+Added: 2000 to 2009.
+Added: He received honors as a P.A.C.T.
+Added: (Philadelphia Alliance for Capital and Technology) finalist for the 2011 Investment Deal
+Added: of the Year, award winner for the SmartCEO Magazine 2012 CEO of the Year for Turnaround Company, and finalist for the Ernst & Young
+Added: 2013 Entrepreneur of the Year.
+Added: He has extensive experience in mergers and acquisitions, both domestically and internationally, particularly
+Added: involving public company acquisitions, including Surgical Laser Technologies, Inc, (formerly, Nasdaq:
+Added: SLTI), ProCyte Corporation (formerly,
+Added: PRCY), LCA Vision, Inc.
+Added: (formerly, Nasdaq:
+Added: LCAV) and Think New Ideas, Inc.
+Added: (formerly, Nasdaq:
+Added: Prior to PhotoMedex, he served
+Added: in several senior level positions of AnswerThink Consulting Group, Inc.
+Added: (then, Nasdaq:
+Added: ANSR, now, The Hackett Group, Nasdaq:
+Added: business consulting and technology integration company, including from 1999 to 2000 as Chief Operating Officer of the Internet Practice,
+Added: the largest division of AnswerThink Consulting Group, Inc., while concurrently during the merger of the companies, serving as the acting
+Added: Chief Financial Officer of Think New Ideas, Inc.
+Added: (then, Nasdaq:
+Added: THNK, now, Nasdaq:
+Added: HCKT), an interactive marketing services and business
+Added: solutions company.
+Added: McGrath also served from 1996 until 1999 as Chief Financial Officer, Executive Vice President and director of TriSpan,
+Added: Inc., an internet commerce solutions and technology consulting company, which was acquired by AnswerThink Consulting Group, Inc.
+Added: During his tenure at Arthur Andersen & Co., where he began his career, he became a Certified Public Accountant in 1981 and he holds
+Added: a B.S., maxima cum laude, in accounting from LaSalle University.
+Added: In addition, he serves as the audit and compensation committee chair
+Added: and a director of several medical device companies, including DarioHealth Corp.
+Added: DRIO), and LIV Process, formerly BioVector, Inc.
+Added: Previously from 2014 to 2024, Mr.
+Added: McGrath served as a director and audit chair of Cagent Vascular, Inc., and from 2007 to 2009, Mr.
+Added: served as a director of Embrella Cardiovascular, Inc.
+Added: (sold to Edwards Lifesciences Corporation, NYSE:
+Added: He also serves on the Board
+Added: of Visitors for Taylor University and on Board of Trustees of Manor College.
+Added: The Board believes that Mr.
+Added: McGrath is qualified
+Added: to serve as a director because of his background of his extensive business experience and board service with public companies.
+Added: Smith has been a member of the Board
+Added: since August 12, 2024.
+Added: Smith has also been a member of the board of directors of Citius Pharma since March 2024.
+Added: Smith is an accomplished
+Added: biopharmaceutical executive who has driven commercial, financial, and operational success at leading pharmaceutical companies, including
+Added: PFE) and Wyeth Pharmaceuticals (formerly NYSE:
+Added: WYE), for more than 35 years.
+Added: Smith’s extensive industry expertise
+Added: has been honed by decades of executive leadership roles in business development, mergers and acquisitions, corporate and commercial strategy,
+Added: and research and development.
+Added: For the past eight years (May 2016 to January 2024), Mr.
+Added: Smith served as Senior Vice President, Global Gene
+Added: Therapy Business of Pfizer and was responsible for managing and leading gene therapy and rare disease early commercial development activities
+Added: in partnership with the rare disease research unit.
+Added: During his tenure at Pfizer, Mr.
+Added: Smith also served as Senior Vice President, Business
+Added: Development and Alliance Management (October 2009 to January 2024) and led its worldwide research and development organization and the
+Added: business development and strategy teams for Pfizer’s global animal health, Capsugel, a former subsidiary of Pfizer, consumer healthcare
+Added: and nutrition business units, as well as the alliance management function supporting all of Pfizer’s global biopharmaceutical business
+Added: units and the worldwide research and development organization.
+Added: Smith joined Pfizer from Wyeth Pharmaceuticals in 2009, following Pfizer’s
+Added: acquisition of Wyeth, where he was Senior Vice President, Mergers and Acquisitions (April 2008 to October 2009) responsible for leading
+Added: and managing Wyeth’s global mergers and acquisitions group.
+Added: Prior to that, in his role at Wyeth as Senior Vice President of Global
+Added: Licensing, he completed a wide variety of transactions in support of Wyeth’s commercial and research and development divisions.
+Added: Smith has served as a member of the board of directors of private companies AM Pharma B.V.
+Added: (observer), Bamboo Therapeutics Inc.
+Added: 2016 to August 2016), and Ignite Immunotherapeutics Inc.
+Added: (December 2016 to October 2019), as well as Iterum Therapeutics Limited (observer)
+Added: Smith also serves or has served as a member of Life Sciences PA - the Pennsylvania Biotechnology Association, Bio
+Added: NJ - the New Jersey State Biotechnology Association (since 2021), the Duke Margolis Value Based Agreements Advisory Board, the Alliance
+Added: for Regenerative Medicine (ARM) (since 2018) and the Foundation for Cell and Gene Medicine (FCGM) (since 2019).
+Added: He is a member of the
+Added: Executive Committees of the ARM and FCGM Board of Directors and serves as the Chairman of the ARM Board’s Governance and Operations
+Added: Smith is also a member of the Business Advisory Board of Ocugen, Inc., the Investment Advisory Committee for Venture Investors
+Added: LLC, Madison, Wisconsin, and the Cell and Gene Therapy Scientific Advisory Board of the Focused Ultrasound Foundation based in Charlottesville,
+Added: Smith obtained a B.S.
+Added: in Neuroscience from the University of Rochester and an M.B.A.
+Added: in Finance and Corporate Accounting
+Added: from the William E.
+Added: Simon Graduate School of Business Administration at the University of Rochester, Rochester, New York.
+Added: The Board believes that Mr.
+Added: Smith is qualified
+Added: to serve as a director because of his extensive background with public companies and his business experience.
+Added: Joel Mayersohn
+Added: Joel Mayersohn has served as a director of the
+Added: Company since October 2022.
+Added: Mayersohn is a member at Dickinson Wright, where he specializes in corporate, securities and business
+Added: He advises a diversified client base in private placements, public offerings, mergers and acquisitions, financing transactions and
+Added: general securities law matters.
+Added: He also has experience in venture capital, bridge loans and pipe financings.
+Added: He is a member of the Florida
+Added: and New York Bars and received his J.D.
+Added: from The State University of New York at Buffalo.
+Added: The Board believes that Mr.
+Added: Mayersohn is well
+Added: qualified to serve as a director due to his extensive experience in corporate and finance legal matters.
+Added: Carol Webb has been a member of the Board since
+Added: August 12, 2024.
+Added: Webb served as a director of Leonard-Meron Biosciences, Inc.
+Added: (“LMB”), a wholly owned subsidiary of Citius
+Added: Pharma, beginning March 17, 2014 and, upon LMB’s acquisition by the Citius Pharma in March 2016, and has since been a member of
+Added: the board of directors of Citius Pharma.
+Added: From 2000 to 2005, she served as Company Group Chairman of Johnson & Johnson.
+Added: 2000, she served in various capacities at Ortho Biotech, including President, Vice President, Executive Director, Product Management and
+Added: Senior Product Director.
+Added: From 1972 to 1983, Ms.
+Added: Webb worked in various positions at Roche Laboratories, including Sales Representative,
+Added: Sales Trainer, Product Manager and Manager of Public Policy.
+Added: Webb received her B.S.
+Added: in Biology from Bowling Green State University.
+Added: The Board believes that Ms.
+Added: Webb is qualified
+Added: to serve as a director because she brings over 40 years of pharmaceutical sales, marketing and business development experience to our
+Added: Jaime Bartushak
+Added: From April 1, 2014 until November 2017, Mr.
+Added: served as Chief Financial Officer of Leonard-Meron Biosciences, Inc.
+Added: (“LMB”), a wholly-owned subsidiary of Citius Pharma.
+Added: In November 2017, he became the Chief Financial Officer of Citius Pharma upon the acquisition of LMB by Citius Pharma.
+Added: In November 2022,
+Added: he was appointed Chief Business Officer of Citius Pharma.
+Added: Bartushak became our Chief Financial Officer in August 2024.
+Added: is an experienced finance professional for early-stage pharmaceutical companies, and has over 20 years of corporate finance, business
+Added: development, restructuring, and strategic planning experience.
+Added: Bartushak was one of the founders of LMB in 2014 and was instrumental
+Added: in its startup as well as in obtaining initial investment capital.
+Added: In 2014, prior to his work at LMB, Mr.
+Added: Bartushak helped lead the sale
+Added: of PreCision Dermatology, Inc.
+Added: to Valeant Pharmaceuticals International, Inc.
+Added: Czuczman, M.D.
+Added: Czuczman joined Citius Pharma as Chief Medical
+Added: Officer in July 2020.
+Added: He became our Chief Medical Officer in August 2024.
+Added: Prior to his employment with Citius Pharma, Dr.
+Added: Vice President, Global Clinical Research and Development, Therapeutic Area Head of Lymphoma/CLL at Celgene Corporation, a position he
+Added: held from June 2015 to January 2020.
+Added: Prior to working in the pharmaceutical industry, Dr.
+Added: Czuczman practiced medicine for over two decades
+Added: at Roswell Park Cancer Institute, an NCI-designated comprehensive cancer center in Buffalo, NY, where he served as chief of the Lymphoma/Myeloma
+Added: Service and head of the Lymphoma Translational Research Laboratory.
+Added: In addition to his extensive publications record, membership and leadership
+Added: roles on national and international research organizations, and consulting and advisory to dozens of pharma companies, Dr.
+Added: Czuczman also
+Added: attained the positions of tenured Professor of Medicine at the State University of New York at Buffalo School of Medicine and Biomedical
+Added: Sciences and Professor of Oncology at Roswell Park Comprehensive Cancer Center.
+Added: Czuczman received his medical degree from the Pennsylvania
+Added: State University College of Medicine after graduating magna cum laude in Biochemistry from the University of Pittsburgh.
+Added: his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology
+Added: fellowship training at Memorial Sloan-Kettering Cancer Center in New York City.
+Added: Family Relationships
+Added: There are no family relationships among our executive
+Added: officers and directors.
+Added: Code of Ethics
+Added: We have adopted a written Code of Ethics and
+Added: Business Conduct that applies to our directors, officers, and all employees.
+Added: We intend to disclose any amendments to, or waivers from,
+Added: our code of ethics and business conduct that are required to be publicly disclosed pursuant to rules of the SEC by filing such amendment
+Added: or waiver with the SEC.
+Added: Additionally, we have adopted an insider trading policy to establish guidelines for our employees, officers,
+Added: directors, and consultants regarding transactions in our securities and the disclosure of material nonpublic information related to our
+Added: Company, which are reasonably designed to promote compliance with insider trading laws, rules and regulations, and any listing standards
+Added: applicable to the registrant.
+Added: Both can be found in the Resources-Governance-Governance Documents section of our website, www.citiusonc.com .
+Added: Audit and Risk Committee
+Added: Our Audit and Risk Committee currently consists
+Added: McGrath (Chair), Dutia and Mr.
+Added: Each of Messrs.
+Added: McGrath, Dutia and Smith satisfies the independence requirements of Rule
+Added: 5605(a)(2) of the Nasdaq Listing Rules and SEC Rule 10A-3.
+Added: Our Audit and Risk Committee is responsible for, among other things:
+Added: o appointing, terminating, compensating, and overseeing the work of any accounting firm engaged to prepare
+Added: or issue an audit report or other audit, review or attestation services;
+Added: o reviewing and approving, in advance, all audit and non-audit services to be performed by the independent
+Added: auditor, taking into consideration whether the independent auditor’s provision of non-audit services to us is compatible with maintaining
+Added: the independent auditor’s independence;
+Added: o reviewing and discussing the adequacy and effectiveness of our accounting and financial reporting processes
+Added: and controls and the audits of our financial statements;
+Added: o establishing and overseeing procedures for the receipt, retention, and treatment of complaints received
+Added: by us regarding accounting, internal accounting controls or auditing matters, including procedures for the confidential, anonymous submission
+Added: by our employees regarding questionable accounting or auditing matters;
+Added: o monitoring and evaluating the independent auditor’s qualifications, performance, and independence
+Added: on an ongoing basis;
+Added: o reviewing and approving related-party transactions for potential conflict of interest situations on an
+Added: ongoing basis.
+Added: Our Board has affirmatively determined that Messrs.
+Added: McGrath and Dutia are designated as the “audit committee financial experts.” The designation does not impose on Messrs.
+Added: and Dutia any duties, obligations or liabilities that are greater than those generally imposed on members of our audit committee and our
+Added: Delinquent Section 16(A) Reports
+Added: Section 16(a) of the Exchange
+Added: Act requires our directors, executive officers and holders of more than 10% of our common stock to file with the SEC initial
+Added: reports of ownership and reports of changes in the ownership of our common stock and other equity securities.
+Added: Such persons are
+Added: required to furnish us copies of all Section 16(a) filings.
+Added: Based solely upon a review of the copies of the forms furnished to us,
+Added: we believe that our officers, directors and holders of more than 10% of our common stock complied with all applicable filing
+Added: requirements during the fiscal year ended September 30, 2025, except for Joel Mayersohn who filed a Form 4 on August 7, 2025 that
+Added: 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
+Added: Acquisition (“TenX”), the legacy entity of Citius Oncology, Inc.
+Added: on July 28, 2025.
Executive Compensation
−Removed: The information required by this Item concerning
−Removed: directors and executive compensation is incorporated by reference from the sections captioned “Director Compensation” and
−Removed: “Executive Compensation”, respectively, to be contained in the Proxy Statement or as otherwise provided by amendment to the
+Added: EXECUTIVE COMPENSATION
+Added: Our Named Executive Officers (as identified below)
+Added: also are employees of Citius Pharma.
+Added: The services of Citius Pharma’s employees as our Named Executive Officers are provided to us
+Added: pursuant to an amended and restated shared services agreement with Citius Pharma.
+Added: For the fiscal years ended September 30, 2025 and 2024,
+Added: pursuant to the shared services agreement, Citius Pharma allocated a portion of the salary and non-equity incentive compensation paid
+Added: during each of those fiscal years to the services provided to us by its employees acting as our Named Executive Officers.
+Added: provided by Citius Pharma are allocated to any of our Named Executive Officers.
+Added: Executive Compensation Objectives
+Added: We seek to achieve the following broad goals in
+Added: our executive compensation programs and decisions regarding individual compensation:
+Added: o Attract and retain executives critical to our overall success.
+Added: o Reward executives for contributions to achieving strategic goals that enhance stockholder value.
+Added: o Foster and maintain a company culture of ownership, creativity and innovation.
+Added: o Motivate our executive officers to achieve critical long- and short-term development, product and financial
+Added: milestones set by the Board in consultation with management.
+Added: Named Executive Officers
+Added: Our “Named Executive Officers” for
+Added: the year ended September 30, 2025 consist of Mr.
+Added: Mazur, our Chief Executive Officer, and Mr.
+Added: Holubiak, our Secretary, and Dr.
+Added: our Chief Medical Officer, who were the two most highly compensated executive officers other than Mr.
+Added: Mazur serving as executive officers
+Added: as of September 30, 2025.
+Added: General Compensation Process
+Added: The Compensation Committee is responsible for
+Added: determining the elements and levels of compensation for our Named Executive Officers.
+Added: In doing so, the Compensation Committee reviews
+Added: our corporate performance against financial and corporate achievement measures, assesses individual performance and evaluates recommendations
+Added: of the Chief Executive Officer regarding compensation for other Named Executive Officers.
+Added: Deliberations of the Compensation Committee
+Added: 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
+Added: action in such meetings upon the advice of the Compensation Committee Chair and/or its members.
+Added: To assist in its deliberations regarding executive
+Added: compensation, the Compensation Committee may engage the services of an independent executive compensation advisor.
+Added: The Company would anticipate
+Added: that the Compensation Committee may work with such independent executive compensation advisor to develop a peer group of companies within
+Added: the biotechnology and pharmaceuticals industries.
+Added: Components of Compensation
+Added: The key components of our executive compensation
+Added: package are cash compensation (salary) and long-term equity incentive awards.
+Added: These components are administered with the goal of providing
+Added: total compensation that recognizes meaningful differences in individual performance, is competitive, varies the opportunity based on individual
+Added: and corporate performance, and is valued by our Named Executive Officers.
+Added: It is the Compensation Committee’s objective
+Added: to set a competitive rate of annual base salary for each Named Executive Officer.
+Added: The Compensation Committee believes competitive base
+Added: salaries are necessary to attract and retain top quality executives, since it is common practice for public companies to provide their
+Added: named executive officers with a guaranteed annual component of compensation that is not subject to performance risk.
+Added: The Compensation
+Added: Committee, on its own or with outside consultants may establish salary ranges for our Named Executive Officers, with minimum to maximum
+Added: opportunities that cover the normal range of market variability.
+Added: The actual base salary for each Named Executive Officer is then derived
+Added: from those salary ranges based on his responsibility, tenure and past performance and market comparability.
+Added: Annual base salaries for the
+Added: Named Executive Officers are reviewed and approved by the Compensation Committee.
+Added: Changes in base salary are based on the scope of an
+Added: individual’s current job responsibilities, individual performance in the previous performance year, target pay position relative
+Added: to the peer group, and our salary budget guidelines.
+Added: The Compensation Committee reviews established goals and objectives and determines
+Added: an individual’s achievement of those goals and objectives and considers the recommendations provided by the Chief Executive Officer
+Added: to assist it in determining appropriate salaries for the Named Executive Officers other than the Chief Executive Officer.
+Added: The base salary information for our Named Executive
+Added: Officers for the fiscal years ended September 30, 2025 and 2024 is set forth in the Summary Compensation Table below.
+Added: Long-Term Incentive Equity Awards
+Added: We believe that long-term corporate success is
+Added: achieved with an ownership culture that encourages high performance by our employees through the use of stock-based awards.
+Added: were each established to provide our employees, including our Named Executive Officers, with incentives to help align employees’
+Added: interests with the interests of our stockholders.
+Added: The Compensation Committee believes that the use of stock-based awards offers the best
+Added: approach to achieving our compensation goals of incentivizing long-term performance.
+Added: We have historically elected to use stock options
+Added: as the primary long-term equity incentive vehicle;
+Added: however, the Compensation Committee has the ability under our stock plans to grant
+Added: restricted stock and other equity awards as part of our long-term incentive program, although no such awards have been granted to date.
+Added: We have selected the Black-Scholes method of valuation for stock-based compensation.
+Added: The Compensation Committee generally oversees the
+Added: administration of our stock plans.
+Added: Stock Options
+Added: Our 2024 Omnibus Stock Incentive Plan (the “2024
+Added: Plan”) authorizes us to grant options to purchase shares of common stock to our employees, directors and consultants.
+Added: Our 2023 Omnibus
+Added: Stock Incentive Plan (the “2023 Plan”) authorizes us to grant the same.
+Added: Upon the adoption of the 2024 Plan, we ceased granting
+Added: awards under the 2023 Plan.
+Added: The Compensation Committee reviews and approves
+Added: stock option awards to Named Executive Officers based upon a review of competitive compensation data, an assessment of individual performance,
+Added: a review of each Named Executive Officer’s existing long-term incentives, and retention considerations.
+Added: Periodic stock option grants
+Added: are made at the discretion of the Compensation Committee to eligible employees and, in appropriate circumstances, after consideration
+Added: of any recommendations of our Chief Executive Officer.
+Added: Stock options granted to employees have an exercise
+Added: 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
+Added: performance-based milestones and are based upon continued employment, and generally expire 10 years after the date of grant.
+Added: value of the options granted to the Named Executive Officers and reflected in the Summary Compensation Table is determined in accordance
+Added: with the Black-Scholes method of valuation for share-based compensation.
+Added: Incentive stock options also include certain other terms necessary
+Added: to ensure compliance with the Code.
+Added: We expect to continue to use stock options as
+Added: a long-term incentive vehicle because:
+Added: o Stock options align the interests of our Named Executive Officers with those of our stockholders, supporting
+Added: a pay-for performance culture, foster employee stock ownership, and focus the management team on increasing value for our stockholders.
+Added: o Stock options are performance-based.
+Added: All of the value received by the recipient of a stock option is based
+Added: on the growth of the stock price.
+Added: In addition, stock options can be issued with vesting based on the achievement of specified milestones
+Added: although we have not used such performance-based vesting to date.
+Added: o Stock options help provide balance to the overall executive compensation program as base salary and annual
+Added: bonuses focus on short-term compensation, while stock options focus on long-term compensation.
+Added: o The vesting period of stock options over time encourages executive retention and is designed to increase
+Added: stockholder value.
+Added: In determining the number of stock options to be granted to our Named Executive Officers, we take into account the
+Added: individual’s position, scope of responsibility, ability to affect profits and stockholder value and the individual’s historic
+Added: and recent performance and the value of stock options in relation to other elements of the individual Named Executive Officer’s
+Added: total compensation.
+Added: Policies and Practices Related to the Grant
+Added: of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information
+Added: While we do not have a formal written policy
+Added: in place with regard to the timing of awards of options or similar awards in relation to the disclosure of material nonpublic information,
+Added: our equity awards are generally granted on fixed dates determined in advance.
+Added: On limited occasions, our Compensation Committee or
+Added: Board may grant equity awards outside of our annual grant cycle for new hires, promotions, recognition, retention or other purposes.
+Added: The Committee approves all equity award grants
+Added: on or before the grant date and does not grant equity awards in anticipation of the release of material nonpublic information.
+Added: the Committee does not time the release of material nonpublic information based on equity award grant dates.
+Added: Executive Benefits and Perquisites
+Added: Our Named Executive Officers are not currently
+Added: parties to employment agreements.
+Added: We will consider entering into employment agreements as necessary and advisable.
+Added: In addition, consistent
+Added: with our compensation philosophy, we intend to establish benefits for our Named Executive Officers, including medical, dental and life
+Added: insurance and the ability to contribute to a 401(k) plan.
+Added: We would expect these benefits to be comparable to benefit levels for comparable
+Added: Pension Benefits
+Added: We do not maintain any qualified or non-qualified
+Added: defined benefit plans.
+Added: As a result, none of our Named Executive Officers participate in or have account balances in qualified or non-qualified
+Added: defined benefit plans sponsored by us.
+Added: Our Compensation Committee or Board may elect to adopt qualified or non-qualified benefit plans
+Added: in the future if it determines that doing so is in our best interests.
+Added: Nonqualified Deferred Compensation
+Added: None of our Named Executive Officers participate
+Added: in or have account balances in nonqualified defined contribution plans or other non-qualified deferred compensation plans maintained by
+Added: Our Compensation Committee or Board may elect to provide our officers and other employees with non-qualified defined contribution
+Added: or other non-qualified deferred compensation benefits in the future if it determines that doing so is in our best interests.
+Added: Summary Compensation Table
+Added: The following table sets forth information regarding
+Added: compensation paid to our Named Executive Officers for the years ended September 30, 2025 and 2024.
+Added: Name & Position
+Added: Leonard Mazur
+Added: Chief Executive Officer and Executive Chairman
+Added: Myron Holubiak
+Added: Executive Vice Chairman
+Added: Myron Czuczman
+Added: Chief Medical Officer
+Added: salary represents that portion of the total salary received by the Named Executive Officer from Citius Pharma that has been allocated
+Added: to Citius Oncology pursuant to the Shared Services Agreement.
+Added: dollar amount set forth in the table above represents the aggregate grant date fair value for all restricted stock awards or option awards,
+Added: as applicable, granted to the executive officer with respect to the fiscal year in accordance with FASB ASC Topic 718 .
+Added: These amounts do not reflect the actual economic value that will be realized by the named executive officer upon the vesting of the restricted
+Added: stock awards or stock options, the exercise of the stock options, or the sale of the common stock underlying such restricted stock awards
+Added: or stock options.
+Added: Outstanding Equity Awards at Fiscal Year-End
+Added: The following table contains certain information
+Added: concerning unexercised options for our executive officers as of September 30, 2025.
+Added: Option Awards
+Added: Unexercisable
+Added: have not vested
+Added: have not vested
+Added: Leonard Mazur
+Added: 1,233,333 (1)
+Added: Chief Executive Officer and Chairman
+Added: 1,700,000 (3)
+Added: $ 3,451,000 (4)
+Added: Myron Holubiak
+Added: Executive Vice Chairman
+Added: $ 1,725,500 (4)
+Added: Myron Czuczman
+Added: Chief Medical Officer
+Added: $ 1,674,750 (4)
+Added: (1) This option, originally issued by Citius Oncology Sub, Inc., vests over three years, beginning July 5,
+Added: 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
+Added: grantee provides continuous service to the Company or a related entity as of each such vesting date.
+Added: The option was assumed by Citius
+Added: Oncology, Inc.
+Added: in the Merger, which closed August 12, 2024.
+Added: (2) The options will vest in three substantially equal installments on the first, second and third anniversaries
+Added: of December 12, 2024, provided that grantee provides continuous service to the Company or a related entity as of each such vesting date.
+Added: (3) The shares will vest in total on the third anniversary of September 19, 2025, subject to the grantee’s
+Added: continuous service to the Company or a related entity as of each such vesting date.
+Added: (4) Amounts are calculated based on multiplying the number of shares shown in the table by the per share closing
+Added: price of our common stock on September 30, 2025, which was $2.03.
+Added: Option Repricing
+Added: We did not engage in any repricing or other modifications
+Added: to any of our executive officers’ outstanding options during the year ended September 30, 2025.
+Added: Director Compensation
+Added: Director Compensation for the Fiscal Year
+Added: ended September 30, 2025
+Added: The Board has not yet approved a compensation
+Added: plan for non-employee directors.
+Added: To assist in its deliberations regarding non-employee compensation, the Compensation Committee may engage
+Added: the services of an independent compensation advisor.
+Added: The Company would anticipate that the Compensation Committee may work with such independent
+Added: compensation advisor to develop a peer group of companies within the biotechnology and pharmaceuticals industries.
+Added: Also, as part of the non-employee director compensation
+Added: plan, we anticipate that non-employee directors would be entitled to receive stock options as part of their annual compensation.
+Added: 2024, our non-employee directors were awarded stock option awards and in September 2025, our non-employee directors were awarded restricted
+Added: stock awards, each for their service as non-employee directors.
+Added: Director compensation for the year ended September
+Added: 30, 2025 was as follows:
+Added: Fees Earned or
+Added: Suren Dutia (2)
+Added: Eugene Holuka (2)
+Added: Joel Mayersohn (2)
+Added: Dennis McGrath (2)
+Added: Robert Smith (2)
+Added: Carol Webb (2)
+Added: 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 .
+Added: 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.
+Added: At September 30, 2025, the non-employee directors held the following
+Added: options to purchase shares of Citius Oncology common stock:
+Added: Dutia, 275,000;
+Added: Holuka 275,000;
+Added: Mayersohn 250,000;
+Added: Smith 125,000;
+Added: Webb 275,000.
Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters
+Added: SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
+Added: The following table shows the amount of our common
+Added: 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
+Added: 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
+Added: Executive Officers and (iv) all of our directors and executive officers as a group.
+Added: Except as otherwise noted, each person named in the
+Added: table has sole voting and investment power with respect to all shares shown as beneficially owned by them, subject to applicable community
+Added: property laws.
+Added: Name and Address of Beneficial Owner (1)
+Added: Percentage of
+Added: Executive Officers and Directors
+Added: Leonard Mazur (4)
+Added: Myron Holubiak (4)
+Added: Suren Dutia (4)
+Added: Eugene Holuka (4)
+Added: Robert Smith (4)
+Added: Joel Mayersohn (5)
+Added: Carol Webb (4)
+Added: Myron Czuczman (4)
+Added: All directors and executive officers as a group (10 people) 6)
+Added: Citius Pharmaceuticals, Inc.
+Added: (1) The business address of each of the following entities or individuals is c/o of the Company, 11 Commerce
+Added: Drive, 1st Floor, Cranford, New Jersey 07016.
+Added: (2) Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting
+Added: or investment power with respect to securities.
+Added: Shares of common stock subject to options or warrants currently exercisable or convertible,
+Added: or exercisable or convertible within 60 days of December 10, 2025, are deemed outstanding for computing the percentage of the person holding
+Added: such option or warrant but are not deemed outstanding for computing the percentage of any other person.
+Added: (3) Percentage based on 84,797,846 shares of common stock issued and outstanding
+Added: as of December 10, 2025.
+Added: (4) Consists entirely of shares of common stock that the director or officer has the right to acquire pursuant
+Added: to outstanding options that are exercisable within 60 days of December 10, 2025.
+Added: (5) Consists of:
+Added: (i) 21,228 shares of common stock acquired by Mr.
+Added: Mayersohn through a distribution in kind
+Added: to limited partners of 10XYZ Holdings, which was the Sponsor of TenX Keane Acquisition, the legacy entity of Citius Oncology, Inc., and
+Added: (ii) 250,000 shares of common stock Mr.
+Added: Mayersohn has the right to acquire pursuant to outstanding options that are exercisable within
+Added: 60 days of December 10, 2025.
+Added: (6) Consists of:
+Added: (i) 21,228 shares of common stock, and (ii) 7,441,667 shares of common stock the directors
+Added: and executive officers have the right to acquire pursuant to outstanding options that are exercisable within 60 days of December 10, 2025.
+Added: authorized for issuance under equity compensation plans
The following table sets forth the indicated information
8 unchanged sentences
2024 Omnibus Stock Incentive Plan
−Removed: Our equity compensation plan consists of the Citius
−Removed: Oncology, Inc.
−Removed: 2023 Omnibus Stock Option Plan which was approved by shareholders of Citius Oncology, Inc.
−Removed: on April 29, 2023, and the Citius
−Removed: Oncology, Inc.
−Removed: 2024 Omnibus Stock Incentive Plan, which was approved by the securityholders of TenX on August 2, 2024, in anticipation
−Removed: of the Merger.
−Removed: We do not have any equity compensation plans or arrangements that have not been approved by stockholders.
+Added: Our equity compensation plan consists of the 2023
+Added: Plan which was approved by shareholders of Citius Oncology, Inc.
+Added: on April 29, 2023, and the 2024 Plan, which was approved by the securityholders
+Added: of TenX on August 2, 2024, in anticipation of the Merger.
+Added: The 2024 Plan was subsequently amended on October 27, 2025.
+Added: We do not have any
+Added: 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
−Removed: Management” to be contained in the Proxy Statement or as otherwise provided by amendment to this Form 10-K.
Certain Relationships and Related
Transactions, and Director Independence
−Removed: The information required by this Item is incorporated
−Removed: by reference to the information under the section captioned “Certain Relationships and Related Transactions” and “Proposal
−Removed: 1—Election of Directors” to be contained in the Proxy Statement or as otherwise provided by amendment to this Form
+Added: Other than as set forth below, there were no transactions
+Added: since October 1, 2023, to which the Company was or is a party in which:
+Added: o the amount involved exceeded or exceeds the lesser of (i) $120,000 and (ii) one percent of the average
+Added: of our total assets at year-end for the last two completed fiscal years;
+Added: o any of our directors or executive officers, any holder of 5% of our capital stock or any member of their
+Added: immediate family had or will have a direct or indirect material interest.
+Added: Agreements with Citius Pharma
+Added: The Company and Citius Pharma operate separately,
+Added: although Citius Pharma continues to control the Company.
+Added: In connection with the Merger, Citius Pharma and Citius Oncology entered into
+Added: various agreements to establish the framework for the Company’s relationship with Citius Pharma, including the A&R Shared Services
+Added: A&R Shared Services Agreement
+Added: In connection with the Merger, the Company and
+Added: Citius Pharma entered into an A&R Shared Services Agreement, pursuant to which Citius Pharma and its affiliates provide to the Company
+Added: the services set forth in the therein, which services are of the type that Citius Pharma provided to the Company prior to the Merger,
+Added: including services relating to information technology, facilities, accounting and finance, business development, investor relations, human
+Added: resources, and other corporate and administrative functions, as well as certain scientific services.
+Added: The fees for each of the services
+Added: are set forth in the A&R Shared Services Agreement as an aggregate quarterly fee of approximately $940,000, and the Company reimburses
+Added: Citius Pharma for all reasonable out-of-pocket costs and expenses that it incurs in connection with providing the services.
+Added: Shared Services Agreement will terminate on the earlier of (i) mutual agreement of the parties or (ii) two years from the Merger;
+Added: that the agreement automatically extends for additional one-year periods unless the Company or Citius Pharma provides at least 30 days
+Added: prior written notice of its desire not to automatically extend the term.
+Added: Promissory Note between the Company and
+Added: Citius Pharma
+Added: In connection with the closing of the Merger,
+Added: 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
+Added: 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
+Added: the transaction (which converted into 422,353 shares of common stock at closing).
+Added: Such capital contribution is evidenced by an unsecured
+Added: promissory note (the “Note”) issued by the Company, dated August 16, 2024, in the principal amount of $3,800,111 to Citius
+Added: The Note bears no interest and prior to September 10, 2025, was repayable in full upon a financing of at least $10 million by
+Added: the Company, per the terms of the Note.
+Added: On September 10, 2025, the Note was amended to be repayable in full at the date on which the Company
+Added: has closed a series of capital raises that in the aggregate provide gross proceeds of at least $30 million through the issuance of debt
+Added: or equity securities or the royalty-backed monetization of LYMPHIR™.
+Added: 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
+Added: a series of capital raises that in the aggregate provide gross proceeds of at least $50 million.
+Added: Procedures for Review and Approval of Transactions
+Added: with Related Persons
+Added: Pursuant to the Audit and Risk Committee charter,
+Added: the Audit and Risk Committee is responsible for reviewing and approving all related party transactions as defined under Item 404 of Regulation
+Added: S-K, after reviewing each such transaction for potential conflicts of interests and other improprieties.
+Added: Our policies and procedures for
+Added: 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
+Added: Documents section of our website at www.citiusonc.com .
+Added: Board of Directors Independence
+Added: After review of all relevant transactions or relationships between
+Added: each nominee for director, or any of his or her family members, and the Company, its senior management and Wolf & Company, P.C., its
+Added: independent registered public accounting firm, the Board has determined that all directors of the Company are independent within the meaning
+Added: of the applicable Nasdaq listing standards, except Leonard Mazur, the Chief Executive Officer and Chairman, Myron Holubiak, the Secretary,
+Added: and Joel Mayersohn.
+Added: Because Citius Pharma continues to control a majority of the voting
+Added: power of the outstanding shares of Company common stock, the Company qualifies as a “controlled company” within the meaning
+Added: of the corporate governance standards of the Nasdaq.
+Added: Under these rules, a listed company of which more than 50% of the voting power is
+Added: held by an individual, group or another company is a “controlled company” and may elect not to comply with certain corporate
+Added: governance requirements, including the requirements that (i) a majority of the Board consist of “independent directors” as
+Added: defined under Nasdaq listing rules, (ii) we have a compensation committee composed entirely of independent directors and (iii) we have
+Added: a nominating/corporate governance committee composed entirely of independent directors.
+Added: The Company does not intend to rely on these exemptions but may opt
+Added: to utilize these exemptions in the future as long as it remains a controlled company.
+Added: Accordingly, Company stockholders may not have the
+Added: same protections afforded to stockholders of companies that are subject to all of the corporate governance requirements of Nasdaq.
+Added: If the Company ceases to be a “controlled company” in the
+Added: future, it will be required to comply with the Nasdaq Listing Rules, which may require replacing a number of its directors and may require
+Added: development of certain other governance-related policies and practices.
+Added: These and any other actions necessary to achieve compliance with
+Added: such rules may increase the Company’s legal and administrative costs, will make some activities more difficult, time-consuming,
+Added: and costly and may also place additional strain on the Company’s personnel, systems and resources.
Principal Accountant Fees and Services
−Removed: The information required by this Item is incorporated
−Removed: by reference to the information under the section captioned “Auditor and Audit Committee Matters” to be contained in the Proxy
−Removed: Statement or as otherwise provided by amendment to this Form 10-K.
+Added: AUDITOR AND AUDIT COMMITTEE MATTERS
+Added: Report of the Audit and Risk Committee
+Added: The Audit and Risk Committee has reviewed and
+Added: discussed with management our audited financial statements for the fiscal year ended September 30, 2025, which were audited by Wolf &
+Added: Company, P.C.
+Added: (“Wolf”), an independent registered public accounting firm.
+Added: The Audit and Risk Committee discussed with Wolf
+Added: the matters required to be discussed by the applicable requirements of the Public Company Accounting Oversight Board (“PCAOB”)
+Added: and the Commission.
+Added: The Audit and Risk Committee received the written disclosures and letter from the independent registered public accounting
+Added: firm required by applicable requirements of the PCAOB regarding the independent registered public accounting firm’s communications
+Added: with the Audit and Risk Committee concerning independence, and discussed with the independent registered public accounting firm the independent
+Added: registered public accounting firm’s independence.
+Added: The Audit and Risk Committee also considered whether the provision of services
+Added: other than the audit of our financial statements for the fiscal year ended September 30, 2025 were compatible with maintaining the independence
+Added: Based on the review and discussions referred to
+Added: in the foregoing paragraph, the Audit and Risk Committee recommended to the Board that the audited financial statements be included in
+Added: the Original Filing.
+Added: Our Audit and Risk Committee is currently composed
+Added: of the following three directors:
+Added: McGrath (Chair), Mr.
+Added: Dutia, and Mr.
+Added: All are independent directors as defined in Rules 5605(a)(2)
+Added: and 5605(c)(2) of the Nasdaq Listing Rules and Section 10A-3 of the Exchange Act.
+Added: The Board has determined that Messrs.
+Added: Dutia are each an “audit committee financial expert” as such term is defined in Item 407(d)(5)(ii) of Regulation
+Added: S-K promulgated by the SEC.
+Added: Our Audit and Risk Committee operates under a written charter adopted by the Board, a copy of which is
+Added: available under Governance-Governance Documents section of our website at www.citiusonc.com.
+Added: Wolf has served as our auditor since we began
+Added: operations in April 2022 and audited our consolidated financial statements for the years ended September 30, 2023 through September 30,
+Added: THE AUDIT AND RISK COMMITTEE
+Added: Dennis McGrath, Chair
+Added: Fees Paid to the Independent Registered Public
+Added: Accounting Firm
+Added: The aggregate audit fees billed for professional
+Added: services rendered by our auditor, Wolf, an independent registered public accounting firm, for the audit of our financial statements as
+Added: 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.
+Added: Audit Related Fees
+Added: The aggregate audit related fees billed for professional
+Added: services by Wolf for the years ended September 30, 2025 and 2024 were $205,250 and $229,900, respectively.
+Added: There were no tax fees billed for professional
+Added: services by Wolf for the years ended September 30, 2025 and 2024.
+Added: Tax fees are for the preparation of federal and state income tax returns.
+Added: All Other Fees
+Added: No other fees were billed by or paid to Wolf during
+Added: the years ended September 30, 2025 and 2024.
+Added: Pre-Approval Policies and Procedures of Audit
+Added: and Non-Audit Services of Independent Registered Public Accounting Firm
+Added: All fees reported above under the headings Audit
+Added: Fees, Audit Related Fees, Tax Fees and All Other Fees were approved by the Audit and Risk Committee before the respective services were
+Added: rendered, which concluded that the provision of such services was compatible with the maintenance of the independence of Wolf in the conduct
+Added: of its auditing functions.
Exhibits and Financial Statement Schedules
2 unchanged sentences
Certificate of Incorporation of Citius Oncology, Inc.
+Added: 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.
Bylaws of Citius Oncology, Inc.
Specimen Common Stock Certificate of Citius Oncology, Inc.
+Added: Warrant Agency Agreement, dated as of July 17, 2025, by and between Citius Oncology, Inc.
+Added: and Equiniti Trust Company, LLC.
+Added: Form of Common Warrant.
+Added: Form of Placement Agent Warrant.
+Added: Form of Common Warrant.
+Added: Form of Placement Agent Warrant.
+Added: Form of Common Warrant.
+Added: Form of Pre-funded Warrant.
+Added: Form of Placement Agent Warrant.
Description of Common Stock.
5 unchanged sentences
2024 Omnibus Stock Incentive Plan.
+Added: Amendment to the Citius Oncology, Inc.
+Added: 2024 Omnibus Stock Incentive Plan.
Asset Purchase Agreement, dated as of September 1, 2021, between Dr.
9 unchanged sentences
Reddy’s Laboratories S.A.
−Removed: Description of Document
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.
3 unchanged sentences
and Citius Pharmaceuticals, Inc.
−Removed: Letter from Marcum LLP to the Securities and Exchange Commission, dated August 16, 2024.
+Added: Amendment to Promissory Note, dated September 10, 2025, by and between Citius Oncology, Inc.
+Added: and Citius Pharmaceuticals, Inc.
+Added: Second Amendment to Promissory Note, dated December 10, 2025, by and between Citius Oncology, Inc.
+Added: and Citius Pharmaceuticals, Inc.
+Added: Placement Agency Agreement, dated as of July 16, 2025, by and between Citius Oncology, Inc.
+Added: and Maxim Group LLC.
+Added: Securities Purchase Agreement, dated as of July 16, 2025, by and between Citius Oncology, Inc.
+Added: and the purchasers named therein.
+Added: Placement Agency Agreement, dated as of September 9, 2025, by and between Citius Oncology, Inc.
+Added: and Maxim Group LLC.
+Added: Form of Securities Purchase Agreement, dated as of September 9, 2025, by and between Citius Oncology, Inc.
+Added: and the purchaser signatory thereto.
+Added: Form of Registered Direct Securities Purchase Agreement, dated as of December 9, 2025, by and between Citius Oncology, Inc.
+Added: and the purchaser signatory thereto.
+Added: Form of PIPE Securities Purchase Agreement, dated as of December 9, 2025, by and between Citius Oncology, Inc.
+Added: and the purchaser signatory thereto.
+Added: Form of Registration Rights Agreement, dated as of December 9, 2025, by and between Citius Oncology, Inc.
+Added: and the purchaser signatory thereto.
+Added: Form of Warrant Amendment Agreement, dated as of December 9, 2025, by and between Citius Oncology, Inc.
+Added: and the purchaser signatory thereto.
Insider Trading Policy.
+Added: Consent of Independent Registered Public Accounting Firm.
Certification of the Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
2 unchanged sentences
1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
+Added: Policy Relating to Recovery of Erroneously Awarded Compensation
INLINE XBRL INSTANCE DOCUMENT
1 unchanged sentence
INLINE XBRL TAXONOMY EXTENSION CALCULATION LINKBASE
−Removed: XBRL TAXONOMY EXTENSION DEFINITION LINKBASE
−Removed: INLINE XBRL TAXONOMY EXTENSION LABEL LINKBASE
+Added: INLINE XBRL TAXONOMY EXTENSION CALCULATION LINKBASE
+Added: INLINE XBRL TAXONOMY EXTENSION LABELS LINKBASE
INLINE XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE
−Removed: Cover Page Interactive Data File, formed in Inline Extensible Business Reporting Language (iXBRL)
−Removed: * Certain portions, schedules and exhibits to this Exhibit have
−Removed: been omitted pursuant to Item 601(a)(5) or Item 601(b)(10)(iv), as applicable, of Regulation S-K.
−Removed: The Registrant agrees to furnish supplemental
−Removed: copies of all omitted portions, exhibits and schedules to the Securities and Exchange Commission upon its request.
+Added: Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL)
+Added: 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.
+Added: 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.
32 unchanged sentences
Eugene Holuka
−Removed: /s/ Joel Mayersohm
+Added: /s/ Joel Mayersohn
December 23, 2025
−Removed: Joel Mayersohm
+Added: Joel Mayersohn
/s/ Dennis McGrath
18 unchanged sentences
Oncology, Inc.
−Removed: (the Company) as of September 30, 2024 and 2023, the related consolidated statements of operations, changes in stockholders’
−Removed: equity, and cash flows for the years then ended, and the related notes to the consolidated financial statements (collectively, the financial
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company
−Removed: as of September 30, 2024 and 2023, and the results of its operations and its cash flows for the years then ended, in conformity with accounting
−Removed: principles generally accepted in the United States of America.
+Added: and its subsidiaries (the Company) as of September 30, 2025 and 2024, the related consolidated statements of operations,
+Added: changes in stockholders’ equity and cash flows for the years then ended, and the related notes to the consolidated financial statements
+Added: (collectively, the financial statements).
+Added: In our opinion, the financial statements present fairly, in all material respects, the financial
+Added: 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,
+Added: in conformity with accounting principles generally accepted in the United States of America.
Emphasis of a Matter Regarding Going Concern
8 unchanged sentences
the continued financial support of Citius Pharmaceuticals, Inc.
−Removed: These conditions raise substantial doubt about the Company’s ability
−Removed: to continue as a going concern.
−Removed: Management’s plans in regard to these matters are described in Note 2.
−Removed: The financial statements
−Removed: do not include any adjustments that might result from the outcome of this uncertainty.
+Added: This raises substantial doubt about the Company’s ability to continue
+Added: as a going concern.
+Added: Management’s plans in regard to these matters also are described in Note 2.
+Added: The financial statements do not
+Added: include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
37 unchanged sentences
Total Other Assets
+Added: $ 100,942,881
LIABILITIES AND STOCKHOLDERS’ EQUITY
13 unchanged sentences
Common stock - $ 0.0001 par value;
−Removed: 100,000,000 ;
+Added: 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
5 unchanged sentences
Total Liabilities and Stockholders’ Equity
+Added: $ 100,942,881
See accompanying report
of independent registered public accounting firm and notes to the financial statements.
−Removed: Reflects a 675,000-for-1
−Removed: stock split effective July 5, 2023.
CITIUS ONCOLOGY, INC.
6 unchanged sentences
Total Operating Expenses
+Added: Operating loss
+Added: ( 23,522,750 )
+Added: ( 20,572,747 )
+Added: Other Income (Expense)
+Added: Interest income
+Added: Interest expense
+Added: Total Other Income (Expense), Net
Loss before Income Taxes
8 unchanged sentences
public accounting firm and notes to the financial statements.
−Removed: Reflects a 675,000-for-1
−Removed: stock split effective July 5, 2023.
CITIUS ONCOLOGY, INC.
3 unchanged sentences
Stockholders’
−Removed: Balance, 30-Sep-22
+Added: Balance, September 30, 2023
$ ( 18,129,840 )
+Added: Capital contributions by parent
Stock-based compensation expense
+Added: Merger, net of transaction costs of $ 2,358,780
( 2,754,701 )
( 2,754,296 )
−Removed: Balance, 30-Sep-23
( 21,148,747 )
−Removed: Capital contributions by parent
−Removed: Stock-based compensation expense
−Removed: Merger, net of transaction costs of $ 2,358,780
( 21,148,747 )
+Added: Balance, September 30,
( 39,278,587 )
+Added: Issuance of common stock in July 2025 registered direct offering, net of costs of $ 1,453,012
+Added: Issuance of common stock in September 2025 registered direct offering, net of costs of $ 1,380,146
+Added: Stock-based compensation expense
( 24,761,369 )
( 24,761,369 )
−Removed: Balance, 30-Sep-24
+Added: Balance, September 30, 2025
$ 108,897,836
+Added: $ ( 64,039,956 )
See accompanying report of independent registered
public accounting firm and notes to the financial statements.
−Removed: Reflects a 675,000-for-1
−Removed: stock split effective July 5, 2023.
CITIUS ONCOLOGY, INC.
4 unchanged sentences
$ ( 21,148,747 )
−Removed: Adjustments to reconcile net loss to net cash provided by operating activities:
+Added: Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Stock-based compensation expense
2 unchanged sentences
( 12,649,207 )
−Removed: Prepaid expenses
( 2,133,871 )
+Added: Prepaid expenses
( 1,100,000 )
2 unchanged sentences
Due to related party
−Removed: Net Cash Provided By Operating Activities
+Added: Net Cash (Used in) Provided By Operating Activities
+Added: ( 5,492,046 )
Cash Flows From Investing Activities:
−Removed: License payment
+Added: License payments
( 5,750,000 )
+Added: ( 5,000,000 )
Net Cash Used In Investing Activities
( 5,750,000 )
+Added: ( 5,000,000 )
Cash Flows From Financing Activities:
+Added: Net proceeds from issuance of common stock
Cash contributed by parent
8 unchanged sentences
Capital Contribution of due to related party by parent
−Removed: Prepaid Manufacturing transferred to Inventory
+Added: Net Prepaid Manufacturing transferred to Inventory
+Added: Interest Paid
See accompanying report of independent registered
5 unchanged sentences
Citius Oncology, Inc.
−Removed: (formerly Citius Acquisition
−Removed: Corp.) (“Citius Oncology,” the “Company” or “we”) is a specialty pharmaceutical company dedicated
−Removed: to the development and commercialization of critical care products targeting unmet needs with a focus on oncology products.
−Removed: We are developing
−Removed: E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of cutaneous T-cell lymphoma (“CTCL”),
−Removed: a rare form of non-Hodgkin lymphoma.
+Added: (“Citius Oncology,”
+Added: the “Company” “we” or “us”) is a specialty pharmaceutical company dedicated to the development and
+Added: commercialization of critical care products targeting unmet needs with a focus on oncology products.
+Added: We have developed E7777 (denileukin
+Added: diftitox), an approved oncology immunotherapy for the treatment of cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin
We have obtained the trade name of LYMPHIR for E7777.
−Removed: Since its inception, the Company has devoted substantially
+Added: Since our inception, the Company has devoted substantially
all of its efforts to business planning, research and development, and recruiting management and technical staff.
−Removed: Citius Oncology is subject
−Removed: to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development
−Removed: by Citius Oncology or its competitors of research and development stage products, market acceptance of any of its products approved for
−Removed: marketing, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s
+Added: We are subject to a
+Added: number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by
+Added: the Company or its competitors of research and development stage products, market acceptance of any of its products approved for marketing,
+Added: 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.
−Removed: Since its inception, Citius Pharmaceuticals, Inc.
−Removed: (“Citius Pharma”) has funded and continues to fund the Company.
−Removed: Citius Pharma and the Company are party to an amended and
−Removed: restated shared services agreement (the “A&R Shared Services Agreement”), which governs certain management and scientific
−Removed: services that Citius Pharma provides the Company.
+Added: Since our inception, Citius Pharmaceuticals, Inc.
+Added: (“Citius Pharma”) (Nasdaq:
+Added: CTXR) has funded and continues to partially fund the Company.
+Added: Citius Pharma and the Company are
+Added: party to an amended and restated shared services agreement (the “A&R Shared Services Agreement”), which governs certain
+Added: management and scientific services that Citius Pharma provides the Company.
On August 23, 2021, Citius Pharma formed Citius
15 unchanged sentences
Oncology, Inc.” (Nasdaq:
−Removed: Immediately after the closing of the Merger, Citius Pharma owned approximately 92.3 % of the outstanding
−Removed: shares of common stock of the Company.
+Added: Immediately after the closing of the Merger, Citius Pharma owned approximately 92 % of our outstanding
+Added: shares of common stock.
+Added: As of September 30, 2025, Citius Pharma owned approximately 79 % of our outstanding shares of common stock.
While the Merger Sub was the legal acquirer of
15 unchanged sentences
Pharma advanced an additional $ 3,800,111 to the Company under the terms of a note payable (see Note 6).
−Removed: On July 5, 2023, the
−Removed: Company executed a stock split of its shares of common stock at a ratio of 675,000-for-1 (the “Stock Split”).
−Removed: All of the Company’s
−Removed: historical share and per share information related to issued and outstanding common stock in these financial statements have been adjusted,
−Removed: on a retroactive basis, to reflect this 675,000-for-1 stock split.
Basis of Presentation
6 unchanged sentences
prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course
−Removed: The Company had a net loss of $ 21,148,747 and $ 12,697,241 for the years ended September 30, 2024 and 2023, respectively.
−Removed: The Company has no revenue and has relied on funding from Citius Pharma to finance its operations.
−Removed: At September 30, 2024, the Company
−Removed: had $ 112 in cash and a negative working capital of $ 21,731,551 .
−Removed: Citius Pharma has sufficient capital to fund Citius Oncology through February
−Removed: 2025 which raises substantial doubt about the Company’s ability to continue as a going concern within one year after the date that
−Removed: the accompanying financial statements are issued.
−Removed: The Company plans to continue to rely on funding
−Removed: from Citius Pharma, to raise capital through equity financings from outside investors and to generate revenue from the future sales of
−Removed: There is no assurance, however, that Citius Pharmaceuticals will have the resources to continue funding the Company, that the
−Removed: Company will be successful in raising the needed capital and, if funding is available, that it will be available on terms acceptable to
−Removed: the Company or that the Company will find strategic partners or generate substantial revenue from the sale of LYMPHIR.
−Removed: The accompanying
−Removed: financial statements do not include any adjustments that might result from the outcome of the above uncertainty.
+Added: We had a net loss of $ 24,761,369 and $ 21,148,747 for the years ended September 30, 2025 and 2024, respectively.
+Added: revenue and have relied on funding from Citius Pharma to finance our operations.
+Added: At September 30, 2025, we had $ 3,924,908 in cash and
+Added: a negative working capital of $ 21,948,698 .
+Added: Citius Pharma and Citius Oncology have sufficient capital to fund Citius Oncology through March
+Added: 2026 which raises substantial doubt about our ability to continue as a going concern within one year after the date that the accompanying
+Added: financial statements are issued.
+Added: During the three months ended September 30, 2025,
+Added: we raised net proceeds of $ 15,166,842 from the sale of common stock.
+Added: We plan to continue to rely on funding from Citius
+Added: Pharma, to raise capital through equity financings from outside investors and to generate revenue from the future sales of LYMPHIR.
+Added: the Company and Citius Pharma are actively engaged in capital raising efforts to extend the cash runway.
+Added: We retained Jeffries LLC as our
+Added: exclusive financial advisor in evaluating strategic alternatives aimed at maximizing shareholder value.
+Added: There is no assurance, however,
+Added: that Citius Pharma will have the resources to continue funding us, that we will be successful in raising the needed capital and, if funding
+Added: is available, that it will be available on terms acceptable to us, or that the we will find strategic partners, or generate substantial
+Added: revenue from the sale of LYMPHIR.
+Added: The accompanying financial statements do not include any adjustments that might result from the outcome
+Added: of the above uncertainty.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3 unchanged sentences
The process of preparing financial statements
−Removed: in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to
−Removed: make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
−Removed: at the date of financial statements and the reported amounts of revenues and expenses during the reporting period.
−Removed: Estimates having relatively
−Removed: higher significance include the accounting for in-process research and development, stock-based compensation and income taxes.
−Removed: results could differ from those estimates and changes in estimates may occur.
+Added: in conformity U.S.
+Added: GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
+Added: and disclosure of contingent assets and liabilities at the date of financial statements and the reported amounts of revenues and expenses
+Added: during the reporting period.
+Added: Estimates having relatively higher significance include the accounting for in-process research and development,
+Added: stock-based compensation and income taxes.
+Added: Actual results could differ from those estimates and changes in estimates may occur.
Cash and Cash Equivalents
−Removed: The Company considers all highly liquid instruments
−Removed: with maturities of less than three months at the time of purchase to be cash equivalents.
−Removed: From time to time, the Company may have cash
−Removed: balances in financial institutions in excess of insurance limits.
−Removed: The Company has never experienced any losses related to these balances.
+Added: We consider all highly liquid instruments with
+Added: maturities of less than three months at the time of purchase to be cash equivalents.
+Added: From time to time, we may have cash balances in financial
+Added: institutions in excess of insurance limits.
+Added: We have never experienced any losses related to these balances.
Prepaid Expenses
2 unchanged sentences
respectively, which will be utilized in research and development activities or in the manufacturing of LYMPHIR for sales.
−Removed: Inventory is stated at the lower of actual
−Removed: accumulated costs or net realizable value as of September 30, 2024 consisting of finished goods of $ 6,134,895 , and work in process of
−Removed: $ 2,133,862 related to the manufacturing of LYMPHIR commercial products to be sold in 2025.
−Removed: No reserves against inventory were deemed
−Removed: necessary based on an evaluation of the product expiration dating.
−Removed: During 2024, $ 6,134,895 of prepaid manufacturing
−Removed: costs were transferred to inventory upon product approval and production commencement at our third-party manufacturers.
−Removed: The Company has not yet selected a specific inventory
−Removed: costing methodology (e.g., FIFO or weighted average).
−Removed: Management plans to implement an appropriate inventory costing method prior to the
−Removed: commencement of sales activities.
−Removed: The selection of this method may impact future financial statements once sales begin.
+Added: Inventory is stated at the lower of actual accumulated
+Added: costs or net realizable value as of September 30, 2025 and 2024 related to the manufacturing of LYMPHIR commercial products, which were
+Added: available for sale commencing in December 2025.
+Added: No reserves against inventory were deemed necessary based on an evaluation of the product
+Added: expiration dating.
+Added: Finished goods
+Added: Work in process
+Added: During 2024 and 2025, $ 6,134,895 and $ 1,368,720 ,
+Added: respectively, of prepaid manufacturing costs were transferred to inventory upon product approval and production commencement at our third-party
+Added: manufacturers.
Research and Development
Research and development costs, including upfront
−Removed: fees and milestones paid to collaborators who are performing research and development activities under contractual agreements with the
−Removed: Company, are expensed as incurred.
−Removed: The Company defers and capitalizes its nonrefundable advance payments that are for research and development
−Removed: activities until the related goods are delivered or the related services are performed.
−Removed: When the Company is reimbursed by a collaboration
−Removed: partner for work the Company performs, it records the costs incurred as research and development expenses and the related reimbursement
−Removed: as a reduction to research and development expenses in its statement of operations.
−Removed: Research and development expenses primarily consist
−Removed: of clinical and non-clinical studies, materials and supplies, third-party costs for contracted services, and payments related to external
−Removed: collaborations and other research and development related costs.
+Added: fees and milestones paid to collaborators who are performing research and development activities under contractual agreements with us,
+Added: are expensed as incurred.
+Added: We defer and capitalize our nonrefundable advance payments that are for research and development activities
+Added: until the related goods are delivered or the related services are performed.
+Added: When we are reimbursed by a collaboration partner for work
+Added: we perform, we record the costs incurred as research and development expenses and the related reimbursement as a reduction to research
+Added: and development expenses in our statement of operations.
+Added: Research and development expenses primarily consist of clinical and non-clinical
+Added: studies, materials and supplies, third-party costs for contracted services, and payments related to external collaborations and other
+Added: research and development related costs.
In-process Research and Development and
License Payable
−Removed: The Company capitalizes intangible assets purchased from others for
−Removed: use in research and development activities as In Process Research & Development (IPR&D) when the assets acquired have an alternative
−Removed: future use, the Company anticipates future economic benefit from that use and the assets acquired are not dependent on future development.
+Added: We capitalize intangible assets purchased from
+Added: others for use in research and development activities as In Process Research & Development (IPR&D) when the assets acquired have
+Added: 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
1 unchanged sentence
Amortization of IPR&D over the exclusive regulatory period of the acquired asset commences upon revenue
−Removed: In-process research and development of $ 73,400,000 consists of an
−Removed: initial $ 40,000,000 payment to Dr.
+Added: In-process research and development of $ 73,400,000
+Added: consists of an initial $ 40,000,000 payment to Dr.
Reddy’s Laboratories (“DRL”) in September 2021, and $ 27,500,000 and
−Removed: for approval milestone amounts payable to DRL and Eisai, respectively, that came due during 2024.
−Removed: Of these amounts $ 28,400,000 is
−Removed: included in license payable at September 30, 2024.
−Removed: The value of our September 2021 acquisition of an exclusive license for LYMPHIR
−Removed: (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma, is
−Removed: expected to be amortized on a straight-line basis over a period of twelve years , (the FDA exclusivity period), commencing upon
−Removed: revenue generation which is expected in the first half of 2025.
+Added: $ 5,900,000 for approval milestone amounts payable to DRL and Eisai, respectively, that became due during 2024.
+Added: Of these amounts $ 22,650,000
+Added: and $ 28,400,000 are included in license payable at September 30, 2025 and 2024, respectively.
+Added: The value of our September 2021 acquisition
+Added: of an exclusive license for LYMPHIR (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin
+Added: lymphoma, is expected to be amortized on a straight-line basis over a period of twelve years , (the FDA exclusivity period), commencing
+Added: 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.
−Removed: In addition, the contracts acquired in
−Removed: connection with Dr.
−Removed: Reddy’s transaction with the clinical research and manufacturing organization are at market rates and
−Removed: could be provided by multiple vendors in the marketplace.
−Removed: Therefore, there is no fair value associated with the contracts
−Removed: The Company reviews intangible assets annually
−Removed: to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the
−Removed: remaining useful life of any intangible asset.
−Removed: If the carrying value of an asset exceeds its undiscounted cash flows, the Company writes
−Removed: down the carrying value of the intangible asset to its fair value in the period identified.
−Removed: No impairment has occurred since the acquisitions
−Removed: through September 30, 2024.
+Added: In addition, the contracts acquired in connection
+Added: Reddy’s transaction with the clinical research and manufacturing organization are at market rates and could be provided
+Added: by multiple vendors in the marketplace.
+Added: Therefore, there is no fair value associated with the contracts acquired.
+Added: We review our intangible assets annually to determine
+Added: if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining
+Added: useful life of any intangible asset.
+Added: If the carrying value of an asset exceeds its undiscounted cash flows, we write down the carrying
+Added: value of the intangible asset to its fair value in the period identified.
+Added: No impairment has occurred since the acquisitions through September
Patents and Trademarks
8 unchanged sentences
Stock-Based Compensation
−Removed: The Company recognizes compensation costs resulting
−Removed: from the issuance of stock-based awards to employees and directors as an expense in the statements of operations over the requisite service
+Added: We recognize compensation costs resulting from
+Added: 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.
1 unchanged sentence
of grant using the Black-Scholes option pricing model.
−Removed: Because the Company’s stock options have characteristics significantly different
−Removed: from those of traded options, and because changes in the input assumptions can materially affect the fair value estimate, the existing
−Removed: model may not necessarily provide a reliable single measure of fair value of the Company’s stock options.
−Removed: The Company recognizes compensation costs resulting
−Removed: from the issuance of stock-based awards to non-employees as an expense in the statements of operations over the service period based on
−Removed: the measurement of fair value for each stock award and records forfeitures as they occur.
−Removed: The Company files consolidated income tax returns
−Removed: with Citius Pharmaceuticals.
−Removed: The Company follows accounting guidance regarding the recognition, measurement, presentation, and disclosure
−Removed: of uncertain tax positions in the financial statements.
−Removed: Tax positions taken or expected to be taken in the course of preparing the Company’s
−Removed: tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained
−Removed: by the applicable tax authorities.
−Removed: Tax positions not deemed to meet a more-likely-than-not threshold would be recorded in the financial
−Removed: There are no uncertain tax positions that require accrual or disclosure as of September 30, 2024.
−Removed: Any interest or penalties
−Removed: are charged to expense.
−Removed: During the years ended September 30, 2024 and 2023, the Company did not recognize any interest and penalties.
−Removed: The Company is subject to examination by federal and state tax authorities for all tax years since inception.
−Removed: The Company recognizes deferred tax assets and
−Removed: liabilities based on differences between the financial reporting and tax basis of assets and liabilities, and operating loss and tax credit
−Removed: carry forwards.
−Removed: Deferred tax assets and liabilities are measured using the enacted tax rates and laws that are expected to be in effect
−Removed: when the differences are expected to reverse.
−Removed: The Company provides a valuation allowance, if necessary, for deferred tax assets for which
−Removed: it does not consider realization of such assets to be “more-likely-than-not.” The deferred tax benefit or expense for the
−Removed: period represents the change in the deferred tax asset or liability from the beginning to the end of the period.
+Added: Because our stock options have characteristics significantly different from those
+Added: of traded options, and because changes in the input assumptions can materially affect the fair value estimate, the existing model may
+Added: not necessarily provide a reliable single measure of fair value of our stock options.
+Added: We recognize compensation costs resulting from
+Added: the issuance of stock-based awards to non-employees as an expense in the statements of operations over the service period based on the
+Added: measurement of fair value for each stock award and records forfeitures as they occur.
+Added: We file consolidated income tax returns with Citius
+Added: We follow accounting guidance regarding the recognition, measurement, presentation, and disclosure of uncertain tax positions
+Added: in the financial statements.
+Added: Tax positions taken or expected to be taken in the course of preparing our tax returns are required to be
+Added: evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authorities.
+Added: Tax positions not deemed to meet a more-likely-than-not threshold would be recorded in the financial statements.
+Added: There are no uncertain
+Added: tax positions that require accrual or disclosure as of September 30, 2025.
+Added: Any interest or penalties are charged to expense.
+Added: years ended September 30, 2025 and 2024, we did not recognize any interest and penalties.
+Added: We are subject to examination by federal and
+Added: state tax authorities for all tax years since inception.
+Added: We recognize deferred tax assets and liabilities
+Added: based on differences between the financial reporting and tax basis of assets and liabilities, and operating loss and tax credit carry
+Added: Deferred tax assets and liabilities are measured using the enacted tax rates and laws that are expected to be in effect when
+Added: the differences are expected to reverse.
+Added: We provide a valuation allowance, if necessary, for deferred tax assets for which we do not consider
+Added: realization of such assets to be “more-likely-than-not.” The deferred tax benefit or expense for the period represents the
+Added: change in the deferred tax asset or liability from the beginning to the end of the period.
Basic and Diluted Net Loss per Common Share
2 unchanged sentences
during such period.
−Removed: For the periods presented, common stock equivalents, consisting
−Removed: of options were not included in the calculation of the diluted loss per share because they were anti-dilutive.
+Added: For the periods presented, common stock equivalents, consisting of options were not included in the calculation of
+Added: the diluted loss per share because they were anti-dilutive.
Segment Reporting
−Removed: The Company currently operates as a single segment.
+Added: The Company operates through a single operating
+Added: and reportable segment which is focused on developing and commercializing innovative targeted oncology therapies.
+Added: The Company’s
+Added: lead product candidate is LYMPHIR, an engineered IL-2 diphtheria toxin fusion protein, for the treatment of patients with persistent or
+Added: recurrent CTCL, a rare form of non-Hodgkin lymphoma.
+Added: LYMPHIR was approved by the FDA in August 2024.
+Added: The Company manages all business
+Added: activities on a consolidated basis.
+Added: The Company’s Chief Operating Decision Maker (“CODM”) is the Chief Executive Officer .
+Added: The accounting policies of the operating segment
+Added: are as described in Note 3.
+Added: The CODM evaluates the performance of the operating segment and allocates resources based on amounts as reported
+Added: on the consolidated statements of operations and cash flows.
+Added: Segment expenses are presented on the Company’s consolidated statements
+Added: of operations.
+Added: The operating segment assets are reported on the consolidated balance sheet as total assets.
Concentrations of Credit Risk
−Removed: The Company has no significant off-balance-sheet
−Removed: concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements.
−Removed: Recently Issued Accounting Standards
+Added: We have no significant off-balance-sheet concentration
+Added: of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements.
+Added: Recently Adopted Accounting Standards
Reportable Segment Disclosures
−Removed: In November 2023, the
−Removed: FASB issued ASU 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures.
−Removed: The change in the standard improves
−Removed: reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses.
−Removed: The changes improve
−Removed: financial reporting by requiring disclosure of incremental segment information on an annual and interim basis for all public entities
−Removed: to enable investors to develop more decision-useful financial analyses.
−Removed: The guidance will be effective for annual reporting periods beginning
−Removed: after December 15, 2023, and for interim periods beginning after December 15, 2024.
+Added: In November 2023, the FASB issued ASU 2023-07,
+Added: Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures.
+Added: The change in the standard improves reportable segment
+Added: disclosure requirements, primarily through enhanced disclosures about significant segment expenses.
+Added: The changes improve financial reporting
+Added: by requiring disclosure of incremental segment information on an annual and interim basis for all public entities to enable investors
+Added: to develop more decision-useful financial analyses.
+Added: The guidance will be effective for annual reporting periods beginning after December
+Added: 15, 2023, and for interim periods beginning after December 15, 2024.
Early adoption is permitted.
−Removed: The standard will be
−Removed: applied retrospectively.
−Removed: The Company is currently evaluating the impact of adoption of the standard on its financial statement disclosures.
+Added: The standard will be applied retrospectively.
+Added: Since the Company has one reportable segment, adoption of this new standard did not have a material impact on the Company’s consolidated
+Added: financial statements.
+Added: Recently Issued Accounting Standards
Income Tax Disclosures
−Removed: In December 2023, the
−Removed: FASB issued ASU 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures.
−Removed: The standard enhances the transparency, decision
−Removed: usefulness and effectiveness of income tax disclosures by requiring consistent categories and greater disaggregation of information in
−Removed: the reconciliation of income taxes computed using the enacted statutory income tax rate to the actual income tax provision and effective
−Removed: income tax rate, as well as the disaggregation of income taxes paid (refunded) by jurisdiction.
−Removed: The standard also requires disclosure
−Removed: of income (loss) before provision for income taxes and income tax expense (benefit) in accordance with U.S.
−Removed: Securities and Exchange Commission
−Removed: (SEC) Regulation S-X 210.4-08(h), Rules of General Application – General Notes to Financial Statements:
−Removed: Income Tax Expense, and
−Removed: the removal of disclosures no longer considered cost beneficial or relevant.
−Removed: The guidance will be effective for annual reporting periods
−Removed: beginning after December 15, 2024.
+Added: In December 2023, the FASB issued ASU 2023-09,
+Added: Income Taxes (Topic 740), Improvements to Income Tax Disclosures.
+Added: The standard enhances the transparency, decision usefulness and effectiveness
+Added: of income tax disclosures by requiring consistent categories and greater disaggregation of information in the reconciliation of income
+Added: taxes computed using the enacted statutory income tax rate to the actual income tax provision and effective income tax rate, as well as
+Added: the disaggregation of income taxes paid (refunded) by jurisdiction.
+Added: The standard also requires disclosure of income (loss) before provision
+Added: for income taxes and income tax expense (benefit) in accordance with U.S.
+Added: Securities and Exchange Commission (SEC) Regulation S-X 210.4-08(h),
+Added: Rules of General Application – General Notes to Financial Statements:
+Added: Income Tax Expense, and the removal of disclosures no longer
+Added: considered cost beneficial or relevant.
+Added: The guidance will be effective for annual reporting periods beginning after December 15, 2024.
Early adoption is permitted.
−Removed: The standard will be applied on a prospective basis, with retrospective
−Removed: application permitted.
−Removed: The Company is currently evaluating the impact of adoption of the standard on its financial statement disclosures.
−Removed: Disaggregation of Income Statement Expenses
−Removed: In November 2024, the
−Removed: FASB issued ASU 2024-03, Income Statement Reporting–Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40),
+Added: The standard will be applied on a prospective basis, with retrospective application permitted.
+Added: is currently evaluating the impact of adoption of the standard on its financial statement disclosures.
Disaggregation of Income Statement Expenses
−Removed: The standard update improves the disclosures about a public business entity’s expenses
−Removed: by requiring more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation
−Removed: and amortization) included within income statement expense captions.
−Removed: The guidance will be effective for annual reporting periods beginning
−Removed: after December 15, 2026, and interim reporting periods beginning after December 15, 2027.
+Added: In November 2024, the FASB issued ASU 2024-03,
+Added: Income Statement Reporting–Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income
+Added: Statement Expenses.
+Added: The standard update improves the disclosures about a public business entity’s expense by requiring more detailed
+Added: information about the types of expenses (including purchases of inventory, employee compensation, depreciation and amortization) included
+Added: within income statement expense captions.
+Added: The guidance will be effective for annual reporting periods beginning after December 15, 2026,
+Added: and interim reporting periods beginning after December 15, 2027.
Early adoption is permitted.
−Removed: The standard updates
−Removed: are to be applied prospectively with the option for retrospective application.
−Removed: The Company is currently evaluating the impact of adoption
−Removed: of the standard update on its financial statement disclosures.
+Added: The standard updates are to be applied prospectively
+Added: with the option for retrospective application.
+Added: We are currently evaluating the impact of adoption of the standard update on our financial
+Added: statement disclosures.
PATENT AND TECHNOLOGY LICENSE AGREEMENTS
−Removed: In September 2021, Citius Pharmaceuticals entered
−Removed: into and transferred to the Company an asset purchase agreement with Dr.
+Added: In September 2021, Citius Pharma entered into
+Added: an asset purchase agreement with Dr.
Reddy’s Laboratories SA, a subsidiary of Dr.
−Removed: Reddy’s Laboratories,
−Removed: (collectively, “Dr.
+Added: Reddy’s Laboratories, Ltd.
+Added: (collectively,
Reddy’s”) and a license agreement with Eisai Co., Ltd.
−Removed: (“Eisai”) to acquire its exclusive
−Removed: license for E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma.
−Removed: Citius Pharmaceuticals assigned these agreements to us effective April 1, 2022.
−Removed: We have obtained the trade name of LYMPHIR for E7777.
+Added: (“Eisai”) to acquire an exclusive license of
+Added: E7777 (denileukin diftitox), an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma.
+Added: Citius Pharma assigned
+Added: these agreements to us effective April 1, 2022.
+Added: Citius Pharma renamed E7777 as I/ONTAK and also obtained the trade name of LYMPHIR TM
+Added: for the product.
+Added: Denileukin diftitox is referred to as E7777, I/ONTAK or LYMPHIR, depending on the period of time and context that is
+Added: being discussed.
Under the terms of these
−Removed: agreements, Citius Pharmaceuticals acquired Dr.
−Removed: Reddy’s exclusive license for LYMPHIR from Eisai and other related assets owned by Dr.
−Removed: The exclusive license includes rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts
−Removed: Additionally, we retained an option on the right to develop and market the product in India.
−Removed: Eisai retains exclusive development
−Removed: and marketing rights for the agent in Japan and Asia.
−Removed: Citius Pharmaceuticals paid $ 40 million upfront payment which represents the acquisition
−Removed: date fair value of the in-process research and development acquired from Dr.
−Removed: Reddy’s is entitled to up to $ 40
−Removed: million in development milestone payments related to CTCL approvals in the U.S.
−Removed: and other markets, up to $ 70 million in development milestones
−Removed: for additional indications, as well as commercial milestone payments and low double-digit tiered royalties on net product sales, and up
−Removed: to $ 300 million for commercial sales milestones.
−Removed: We also must pay on a fiscal quarter basis tiered royalties equal to low double-digit
−Removed: percentages of net product sales.
−Removed: The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale of
−Removed: the latest indication that received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results
−Removed: in the reduction of net sales in the applicable product by 50 % in two consecutive quarters, as compared to the four quarters prior to
−Removed: the first commercial sale of the biosimilar product.
−Removed: We are also required pay to Dr.
−Removed: Reddy’s an amount equal to a low-thirties percentage
−Removed: of any sublicense upfront consideration or milestone payments (or the like) received by us and the greater of (i) a low-thirties percentage
−Removed: of any sublicensee sales-based royalties or (ii) a mid-single digit percentage of such licensee’s net sales.
+Added: agreements, Citius Pharma acquired Dr.
+Added: Reddy’s exclusive license for E7777 from Eisai and other related assets owned by Dr.
+Added: The exclusive license includes rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia.
+Added: retains exclusive development and marketing rights for the agent in Japan, China, Korea, Taiwan, Hong Kong, Macau, Indonesia, Thailand,
+Added: Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh, Bhutan,
+Added: Nepal, Mongolia, and Papua New Guinea.
+Added: Citius Pharma paid a $ 40,000,000 upfront payment which represents the acquisition date fair value
+Added: of the in-process research and development acquired from Dr.
+Added: Reddy’s is entitled to up to $ 40,000,000 in development
+Added: milestone payments related to CTCL approvals in the U.S.
+Added: and other markets, up to $ 70,000,000 in development milestones for additional
+Added: indications, as well as commercial milestone payments and low double-digit tiered royalties on net product sales (within
+Added: a range of 10 % to 15 %) , and up to $ 300,000,000 for commercial sales milestones.
+Added: We also must pay on a fiscal quarter basis tiered
+Added: royalties equal to low double-digit percentages of net product sales (within a range of
+Added: 10 % to 15 %) .
+Added: The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale of the latest indication
+Added: that received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results in the reduction of
+Added: net sales in the applicable product by 50 % in two consecutive quarters, as compared to the four quarters prior to the first commercial
+Added: sale of the biosimilar product.
+Added: We will also pay to Dr.
+Added: Reddy’s an amount equal to a low-thirties percentage of any sublicense upfront
+Added: consideration or milestone payments (or the like) received by us and the greater of (i) a low-thirties percentage of any sublicensee sales-based
+Added: royalties or (ii) a mid-single digit percentage of such licensee’s net sales.
+Added: Citius Pharma is a guarantor of our obligations under
+Added: these agreements.
+Added: the time of the FDA approval for LYMPHIR, a $ 27,500,000 milestone payment became payable to Dr.
+Added: Reddy’s under the terms of the asset
+Added: purchase agreement for which a balance of $ 19,750,000 remains due as of September 30, 2025.
+Added: Reddy’s agreed to a partial deferral
+Added: without penalty of this milestone payment.
Under the license agreement,
−Removed: Eisai is to receive a $ 5.9 million development milestone payment upon initial approval and additional commercial milestone payments related
−Removed: to the achievement of net product sales thresholds (which increases to $ 7 million in the event we have exercised our option to add India
−Removed: to the licensed territory prior to FDA approval) and an aggregate of up to $ 22 million related to the achievement of net product sales
−Removed: Citius Pharma was also required to reimburse Eisai for up to $ 2.65 million of its costs to complete the Phase 3 pivotal clinical
−Removed: trial for LYMPHIR for the CTCL indication and reimburse Eisai for all reasonable costs associated with the preparation of a Biologics
−Removed: License Application, (the “BLA”) for LYMPHIR.
−Removed: Eisai was responsible for completing the CTCL clinical trial, and chemistry,
−Removed: manufacturing and controls (CMC) activities through the filing of a BLA for LYMPHIR with the FDA.
−Removed: The BLA was filed with the FDA on September
−Removed: We will also be responsible for development costs associated with potential additional indications.
−Removed: The term of the license
−Removed: agreement will continue until (i) if there has not been a commercial sale of a licensed product in the territory, the 10-year anniversary
−Removed: of the original license effective date, March 30, 2016, or (ii) if there has been a first commercial sale of a licensed product in the
−Removed: territory within the 10-year anniversary of the original license effective date, the 10-year anniversary of the first commercial sale
−Removed: on a country-by-country basis.
−Removed: The term of the license may be extended for additional 10-year periods for all countries in the territory
−Removed: by notifying Eisai and paying an extension fee equal to $ 10 million.
−Removed: Either party may terminate the license agreement upon written notice
−Removed: if the other party is in material breach of the agreement, subject to cure within the designated time periods.
−Removed: Either party also may terminate
−Removed: the license agreement immediately upon written notice if the other party files for bankruptcy or takes related actions or is unable to
−Removed: pay its debts as they become due.
−Removed: Additionally, either party will have the right to terminate the agreement if the other party directly
−Removed: or indirectly challenges the patentability, enforceability or validity of any licensed patent.
−Removed: Also under the
−Removed: purchase agreement with Dr.
−Removed: Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available
−Removed: products in the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two
−Removed: investigator initiated immuno-oncology trials (both of which have been initiated), (iii) use commercially reasonable efforts to
−Removed: achieve each of the approval milestones, and (iv) to complete each specified immuno-oncology investigator trial on or before the
−Removed: four-year anniversary of the effective date of the definitive agreement.
−Removed: Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory approval for such
−Removed: product in each such jurisdiction.
−Removed: On July 29, 2023, we
−Removed: received a Complete Response Letter, (“CRL”) from the FDA regarding the BLA seeking approval for LYMPHIR.
−Removed: The FDA has required
−Removed: that we incorporate enhanced product testing, and additional controls agreed to with the FDA during the market application review.
−Removed: FDA raised no concerns relating to the safety and efficacy clinical data package.
−Removed: On September 8, 2023, we announced that the FDA
−Removed: agreed with our plans to address the requirements outlined in the CRL.
−Removed: The guidance from the FDA provides a path for completing the necessary
−Removed: activities to support the resubmission of the BLA.
−Removed: No additional clinical efficacy or safety trials have been requested by FDA for the
−Removed: resubmission.
−Removed: The Company remediated the issues raised in the
−Removed: CRL by the FDA and received a BLA approval in August 2024.
+Added: 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
+Added: commercial milestone payments related to the achievement of net product sales thresholds and an aggregate of up to $ 22,000,000 related
+Added: to the achievement of net product sales thresholds.
+Added: Citius Pharma was also required to reimburse Eisai for up to $ 2,650,000 of its costs
+Added: to complete the Phase 3 pivotal clinical trial for LYMPHIR for the CTCL indication and reimburse Eisai for all reasonable costs associated
+Added: with the preparation of a Biologics License Application, (the “BLA”) for LYMPHIR.
+Added: Eisai was responsible for completing the
+Added: CTCL clinical trial, and chemistry, manufacturing and controls (CMC) activities through the filing of a BLA for LYMPHIR with the FDA.
+Added: The BLA was approved by the FDA on August 8, 2024.
+Added: We are responsible for development costs associated with potential additional indications.
+Added: On March 28, 2025, Citius Oncology and Eisai entered
+Added: into a letter agreement that amended the license agreement to provide for a payment schedule to Eisai for the milestone payment and certain
+Added: unpaid invoices.
+Added: 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
+Added: 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
+Added: each case with interest on each obligation from its original due date through the date of actual payment under the letter agreement at
+Added: the rate of 2 % per annum.
+Added: During the year ended September 30, 2025, we recorded $ 218,032 in interest expense under the agreement.
+Added: parties released each other from any and all claims, losses, damages, costs and expenses that arise from or related to our failure to
+Added: pay the milestone payment or the other incurred costs under the license agreement except for any claims arising out of a breach of the
+Added: letter agreement.
+Added: All other terms of the license agreement remain in full force and effect.
+Added: During the year ended September 30, 2025 we
+Added: 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.
+Added: July 21, 2025, we made a payment to Eisai of $ 1,616,522 for other invoices and accumulated interest associated with the letter agreement.
+Added: The term of the license agreement will continue
+Added: 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
+Added: first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first commercial sale on
+Added: a country-by-country basis.
+Added: We expect the first commercial sale to occur in the first quarter of 2026.
+Added: The term of the license may be
+Added: 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 .
+Added: Either party may terminate the license agreement upon written notice if the other party is in material breach of the agreement, subject
+Added: to cure within the designated time periods.
+Added: Either party also may terminate the license agreement immediately upon written notice if the
+Added: other party files for bankruptcy or takes related actions or is unable to pay its debts as they become due.
+Added: Additionally, either party
+Added: will have the right to terminate the agreement if the other party directly or indirectly challenges the patentability, enforceability
+Added: or validity of any licensed patent.
+Added: Under the purchase agreement
+Added: Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available products in the CTCL
+Added: indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology
+Added: trials (both of which have been initiated), (iii) use commercially reasonable efforts to achieve each of the approval milestones, and
+Added: (iv) to complete each specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the
+Added: definitive agreement.
+Added: Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory
+Added: approval for such product in each such jurisdiction ;
+Added: the launch of LYMPHIR in December 2025 satisfied
+Added: this requirement in the U.S .
As part of the definitive agreement with Dr.
−Removed: Citius Pharmaceuticals acquired method of use patents in which LYMPHIR is administered in combination with the programmed cell death protein
+Added: 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.
2 unchanged sentences
The following patents were acquired and subsequently
−Removed: transferred to Citius Oncology, Inc.:
+Added: transferred to us:
US Provisional Application No.
5 unchanged sentences
on March 3, 2022, entitled, Combination for Use in Methods of Treating Cancer.
−Removed: Upon approval of the product in August 2024, the
−Removed: Company was subject to milestone payments totaling $ 33.4 million.
−Removed: The Company paid $ 5.0 million prior to year end and the remaining balance
−Removed: is reflected as a License Payable on the balance sheet.
−Removed: The $ 33.4 million was recorded as in-process research and development asset and
−Removed: will be subject to amortization as further discussed in Note 3.
−Removed: STOCKHOLDER’S EQUITY
−Removed: Authorized Capital Stock and Stock Split
−Removed: On April 29, 2023, the Company amended its certificate
−Removed: of incorporation, (the “Prior Charter”) to authorize an increase in the total number of shares of capital stock to 110,000,000
−Removed: 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
−Removed: value of $ 0.0001 .
−Removed: On July 5, 2023, the Board of Directors approved a 675,000-for-1 stock split of the outstanding 100 shares of common
−Removed: The certificate of incorporation adopted on August 5, 2024, in connection with the Merger, also authorizes 110,000,000 shares,
−Removed: 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
−Removed: All share and per share amounts in these financial
−Removed: statements have been retroactively restated to reflect the amendment to the certificate of incorporation and the stock split.
+Added: COMMON STOCK, STOCK OPTIONS, RESTRICTED
+Added: STOCK AWARDS AND WARRANTS
+Added: Authorized Capital Stock
+Added: The certificate of incorporation adopted on August
+Added: 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
+Added: $ 0.0001 , and 10,000,000 shares are preferred stock with a par value of $ 0.0001 .
+Added: On April 7, 2025, pursuant to Board and stockholder approval,
+Added: we amended our certificate of incorporation to increase the authorized shares of common stock from 100,000,000 shares to 400,000,000 shares.
+Added: Common Stock Offerings
+Added: On July 17, 2025, we completed an offering of
+Added: 6,818,182 shares of common stock and warrants to purchase 6,818,182 shares of common stock.
+Added: The shares and warrants were sold at a per
+Added: unit price of $ 1.32 .
+Added: The immediately exercisable five-year warrants have an exercise price of $ 1.32 per share.
+Added: Gross proceeds from the
+Added: offering were approximately $ 9.0 million and net proceeds were $ 7,546,988 , after deducting placement agent fees and other offering expenses.
+Added: The estimated fair value of the warrants issued to the investors was approximately $ 8,197,000 .
+Added: We paid the placement agent a fee of 7.0 % of the
+Added: gross proceeds and expenses of $ 125,000 .
+Added: Additionally, we issued the placement agent warrants to purchase up to 272,727 shares of common
+Added: stock at an exercise price of $ 1.65 per share.
+Added: The warrants are exercisable commencing on January 17, 2026 and expire on July 17, 2030 .
+Added: 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
+Added: shares of common stock at an exercise price of $ 1.65 per share.
+Added: The placement agent warrants are exercisable commencing on August 17,
+Added: 2025 and expire on July 17, 2030 .
+Added: The estimated fair value of the warrants issued to the placement agents was approximately $ 905,000 .
+Added: On September 10, 2025, we completed an offering
+Added: of 5,142,858 shares of common stock and warrants to purchase 5,142,858 shares of common stock.
+Added: The shares and warrants were sold at a
+Added: per unit price of $ 1.75 .
+Added: The warrants are exercisable beginning on March 10, 2026 and expire on March 10, 2031 at an exercise price of
+Added: $ 1.84 per share.
+Added: Gross proceeds from the offering were approximately $ 9.0 million and net proceeds were $ 7,619,854 , after deducting placement
+Added: agent fees and other offering expenses.
+Added: The estimated fair value of the warrants issued to the investors was approximately $ 6,995,000 .
+Added: We paid the placement agent a fee of 7.0 % of the
+Added: gross proceeds and expenses of $ 125,000 .
+Added: Additionally, we issued the placement agent warrants to purchase up to 205,714 shares of common
+Added: stock at an exercise price of $ 1.92 per share.
+Added: The warrants are exercisable commencing on March 10, 2026 and expire on March 10, 2031 .
+Added: 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
+Added: shares of common stock at an exercise price of $ 2.1875 per share.
+Added: The placement agent warrants are exercisable commencing on March 10,
+Added: 2026 and expire on March 10, 2031.
+Added: The estimated fair value of the warrants issued to the placement agents was approximately $ 717,000 .
Under the Citius Oncology 2023 Stock Plan, adopted
on April 29, 2023, we reserved 15,000,000 common shares for issuance.
−Removed: The stock plan provides incentives to employees, directors, and
−Removed: consultants through grants of options, SARs, dividend equivalent rights, restricted stock, restricted stock units, or other rights.
+Added: Under the Citius Oncology 2024 Stock Plan, adopted on August 2,
+Added: 2024, we reserved 15,000,000 common shares for issuance.
+Added: The stock plans provide incentives to employees, directors, and consultants through
+Added: 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.
−Removed: Volatility is estimated using the trading activity of Citius Pharmaceuticals
−Removed: common stock.
−Removed: until such time as we have sufficient history.
+Added: Volatility is estimated using the trading activity of Citius Pharma
+Added: common stock until such time as we have sufficient history.
The risk-free interest rate is based on the U.S.
−Removed: Treasury yield curve in
−Removed: effect at the time of grant commensurate with the expected term assumption.
−Removed: The expected term of stock options granted to employees and directors, all of which qualify as “plain vanilla,” is based on
−Removed: the average of the contractual term (generally 10 years) and the vesting period.
−Removed: For non-employee options, the expected term is the
−Removed: contractual term.
+Added: Treasury yield curve in effect
+Added: at the time of grant commensurate with the expected term assumption.
+Added: The expected term of stock options granted to employees and directors,
+Added: all of which qualify as “plain vanilla,” is based on the average of the contractual term (generally 10 years) and the
+Added: vesting period.
+Added: For non-employee options, the expected term is the contractual term.
The following assumptions were used in determining
10 unchanged sentences
Granted 5,750,000 1.07
+Added: 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
+Added: On December 2, 2024, the Board of Directors granted
+Added: options to purchase 200,000 common shares at an exercise price of $ 1.02 per share.
+Added: On December 12, 2024, the Board of Directors granted
+Added: 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
2 unchanged sentences
to 36 months and have a term of 10 years.
−Removed: Stock-based compensation expense for the year
−Removed: ended September 30, 2024 was $ 7,498,817 .
+Added: Stock-based compensation expense for stock options
+Added: 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
−Removed: cost related to unvested awards under the stock plan of $ 11,592,383 is expected to be recognized over a weighted average period of 1.77
−Removed: On August 5, 2024, the Board of Directors granted
−Removed: options to purchase 150,000 common shares at an exercise price of $ 2.15 per share.
+Added: cost related to unvested stock options under the stock plans of $ 7,814,682 is expected to be recognized over a weighted average period
+Added: of 1.23 years.
+Added: Restricted stock awards
+Added: On September 19, 2025, the Board of Directors
+Added: granted restricted stock awards of 11,600,000 shares of common stock to employees and directors.
+Added: The restricted stock awards vest on September
+Added: The fair value of the common stock on the date of grant was $ 20,300,000 ($ 1.75 per share).
+Added: Stock-based compensation expense for restricted
+Added: stock awards for the year ended September 30, 2025 was $ 203,741 .
+Added: At September 30, 2025, unrecognized total compensation
+Added: cost related to unvested restricted stock awards under the stock plans of $ 20,096,259 is expected to be recognized over a weighted average
+Added: period of 2.97 years.
+Added: We have reserved 13,276,754 shares of common stock
+Added: for the exercise of outstanding warrants.
+Added: The following table summarizes the warrants outstanding at September 30, 2025:
+Added: price Number Expiration Dates
+Added: July 2025 Offering Investors $ 1.32 6,818,182 July 17, 2030
+Added: July 2025 Offering Agent $ 1.65 272,727 July 17, 2030
+Added: July 2025 Prior Offering Agent $ 1.65 477,273 July 17, 2030
+Added: September 2025 Offering Investors $ 1.84 5,142,858 March 10, 2031
+Added: September 2025 Offering Agent $ 1.92 205,714 March 10, 2031
+Added: September 2025 Prior Offering Agent $ 2.1875 360,000 March 10, 2031
+Added: At September 30, 2025, the weighted average remaining
+Added: life of the outstanding warrants is 5.08 years, all warrants are exercisable except for the September 2025 Offering warrants which become
+Added: exercisable on March 10, 2026, and the aggregate intrinsic value of the warrants outstanding was $ 6,125,681 .
+Added: Common Stock Reserved
+Added: A summary of common stock reserved for future
+Added: issuances by the Company as of September 30, 2025 is as follows:
+Added: Stock plan options outstanding
+Added: Restricted stock awards
+Added: Stock plan shares available for future grants
+Added: Warrants outstanding
RELATED PARTY TRANSACTIONS
−Removed: The Company’s officers and directors also
−Removed: serve as officers of Citius Pharma.
−Removed: As of September 30, 2024, the Company does not have any employees.
−Removed: The Company and Citius Pharma entered
−Removed: into the A&R Shared Services Agreement.
−Removed: Under the terms of the agreement, Citius Pharma provides management and scientific services
−Removed: to the Company.
−Removed: During the year ended September 30, 2024, Citius Pharma charged the Company $ 1,846,202 for reimbursement of general and
−Removed: administrative payroll, $ 1,963,630 for reimbursement of research and development payroll, and $ 121,570 for the use of shared office space.
−Removed: During the year ended September 30, 2023, Citius charged the Company $ 1,727,595 for reimbursement of general and administrative payroll,
+Added: Our officers and directors also serve as officers
+Added: of Citius Pharma.
+Added: As of September 30, 2025, we do not have any employees.
+Added: The Company and Citius Pharma have entered into the A&R
+Added: Shared Services Agreement and under the terms of the agreement, Citius Pharma provides management and scientific services to us.
+Added: 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.
−Removed: The Company has limited cash, therefore all the
−Removed: Company’s expenditures are paid by Citius Pharma and reflected in the due to related party account.
−Removed: During the years ended September
−Removed: 30, 2024 and September 30, 2023 these amounts due to Citius Pharma were $ 14,270,648 and $ 14,805,474 respectively.
+Added: During the year ended September
+Added: 30, 2024, Citius Pharma charged us $ 1,846,202 for reimbursement of general and administrative payroll, $ 1,963,630 for reimbursement of
+Added: research and development payroll, and $ 121,570 for the use of shared office space.
+Added: We have had limited cash, therefore most of our
+Added: expenditures have been paid by Citius Pharma and reflected in the due to related party account.
+Added: At September 30, 2025 and 2024, the net
+Added: amount due to Citius Pharma was $ 9,513,771 and $ 588,806 , respectively.
In connection with closing of the Merger, Citius
−Removed: Pharma made a contribution to the Company’s capital in the amount of $ 33,180,961 representing the balance of the due to/due from
−Removed: related party account on the date of the Merger.
−Removed: Citius Pharma also made cash contributions to the Company’s capital, pursuant to
−Removed: the terms of the Merger Agreement, in the amount of $ 3,827,944 .
+Added: 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
+Added: on the date of the Merger.
+Added: Citius Pharma also made cash contributions to our capital, pursuant to the terms of the Merger Agreement, in
+Added: the amount of $ 3,827,944 .
Also, in connection with the Merger, Citius Pharma
−Removed: advanced cash to the Company for a non-interest bearing, unsecured promissory note issued by the Company, dated August 16, 2024, in the
−Removed: principal amount of $ 3,800,111 .
−Removed: The note is repayable in full upon a financing of at least $ 10 million by the Company, per the terms of
−Removed: the promissory note.
+Added: advanced cash to the Company for a non-interest bearing, unsecured promissory note issued by the Company, dated August 16, 2024, as amended
+Added: September 10, 2025, in the principal amount of $ 3,800,111 .
+Added: The note is repayable in full upon a financing of at least $ 30,000,000 by the
+Added: Company, per the terms of the promissory note.
Management does not anticipate such repayment within the next twelve months.
−Removed: As a result, this note payable is classified
−Removed: as non-current on the balance sheet.
−Removed: The Company files consolidated income tax returns
−Removed: with Citius Pharma.
−Removed: The Company recorded deferred income tax expense of $ 576,000 for each of the years ended September 30, 2024 and 2023
−Removed: related to the amortization for taxable purposes of its in-process research and development asset.
+Added: this note payable is classified as non-current on the balance sheet.
+Added: We file consolidated income tax returns with Citius
+Added: We recorded deferred income tax expense of $ 1,056,960 and $ 576,000 for the years ended September 30, 2025 and 2024 related to
+Added: the amortization for taxable purposes of our in-process research and development asset.
The income tax expense differs from the amount
41 unchanged sentences
indefinitely.
+Added: 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
2 unchanged sentences
to expire in 2042.
−Removed: The Company accounts for uncertain tax positions
−Removed: in accordance with the guidance provided in ASC 740, “Accounting for Income Taxes.” This guidance describes a recognition
−Removed: threshold and measurement attribute for the financial statement disclosure of tax positions taken or expected to be taken in a tax return
−Removed: and requires recognition of tax benefits that satisfy a more-likely-than-not threshold.
−Removed: ASC 740 also provides guidance on de-recognition,
−Removed: classification, interest and penalties, accounting in interim periods and disclosure.
−Removed: There have been no reserves for uncertain tax positions
−Removed: recorded by the Company to date.
+Added: We account for uncertain tax positions in accordance
+Added: with the guidance provided in ASC 740, “Accounting for Income Taxes.” This guidance describes a recognition threshold and
+Added: measurement attribute for the financial statement disclosure of tax positions taken or expected to be taken in a tax return and requires
+Added: recognition of tax benefits that satisfy a more-likely-than-not threshold.
+Added: ASC 740 also provides guidance on de-recognition, classification,
+Added: interest and penalties, accounting in interim periods and disclosure.
+Added: There have been no reserves for uncertain tax positions recorded
+Added: by the Company to date.
+Added: On July 4, 2025, the “One Big Beautiful
+Added: Bill Act” (“OBBBA”) was signed into law in the United States.
+Added: The OBBBA includes a broad range of tax reform provisions
+Added: for businesses, including extensions of key Tax Cuts and Jobs Act provisions, modifications to the international tax framework, and restoration
+Added: of favorable tax treatment for certain business provisions.
+Added: Certain provisions of the legislation will become effective in 2025, while
+Added: others are effective in 2026.
+Added: The OBBBA was enacted during our fourth fiscal quarter of 2025, and we have considered its potential effects
+Added: and reflected the impact of the OBBBA on our financial position, results of operations, and cash flows.
+Added: We are in the process of evaluating
+Added: the impact of these provisions on future periods, but we do not expect the OBBBA to have a material impact on our consolidated financial
COMMITMENTS AND CONTINGENCIES
Commercial Manufacturing Contracts
−Removed: The Company has entered into an agreement with
−Removed: a Contract Manufacturing Organization for the manufacture and supply of drug substance.
−Removed: The agreement runs through calendar 2026, with
−Removed: an automatic renewal for a subsequent 4-year term.
−Removed: Under this agreement, the Company is obligated to purchase minimum annual quantities
−Removed: of batches at a set price per batch, subject to annual increases.
−Removed: Additionally, the Company is required to pay
−Removed: an annual service fee of $ 250,000 .
−Removed: The agreement also includes provisions for potential price increases
−Removed: based on increases in the manufacturer’s operating expenses or industry indices, as well as significant termination fees and obligations.
−Removed: As of September 30, 2024, the total minimum purchase commitment under this agreement was approximately $ 17.3 million consisting of payments
−Removed: of $ 11.9 million and $ 5.4 million for 2025 and 2026 respectively.
−Removed: As of September 30, 2024, the Company also has commercial supply agreements
−Removed: with two other vendors for the completion and packaging of finished drug products.
+Added: We entered into an agreement with a Contract Manufacturing
+Added: Organization for the manufacture and supply of drug substance.
+Added: The agreement runs through calendar 2026, with an automatic renewal for
+Added: a subsequent 4-year term.
+Added: Under this agreement, we are obligated to purchase minimum annual quantities of batches at a set price per batch,
+Added: subject to annual increases.
+Added: Additionally, we are required to pay an annual
+Added: service fee of $ 250,000 .
+Added: The agreement also includes provisions for potential price increases based on increases in the manufacturer’s
+Added: operating expenses or industry indices, as well as significant termination fees and obligations.
+Added: As of September 30, 2025, the total minimum
+Added: purchase commitment under this agreement was approximately $ 16.2 million consisting of payments of approximately $ 8.5 million and $ 5.3
+Added: million for 2025 and 2026 respectively and approximately $2.4 million for 2026 pass-throughs and consumable manufacturing components.
+Added: As of September 30, 2025, we have commercial supply agreements with
+Added: two other vendors for the completion and packaging of finished drug products.
Minimum purchase commitments under these two agreements
−Removed: amount to approximately $ 4.5 million consisting of purchase commitment obligations of $ 2.9 million in 2025 and $ 1.6 million in 2026.
+Added: amount to approximately $ 4.9 million consisting of purchase commitment obligations of approximately $ 1.2 million in 2025, $ 1.9 million
+Added: in 2026 and $ 1.8 million in 2027.
Legal Proceedings
−Removed: The Company is not involved in any litigation that it believes could have a material adverse effect on its financial
−Removed: position or results of operations.
−Removed: There is no action, suit, proceeding, inquiry, or investigation before or by any court, public board,
−Removed: government agency, self-regulatory organization or body pending or, to the knowledge of the Company’s executive officers, threatened
−Removed: against or affecting the Company or its officers or directors in their capacities as such.
+Added: We are not involved in any litigation that we
+Added: believe could have a material adverse effect on our financial position or results of operations.
+Added: There is no action, suit, proceeding,
+Added: inquiry, or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to
+Added: the knowledge of our executive officers, threatened against or affecting the Company or its officers or directors in their capacities
+Added: SUBSEQUENT EVENTS
+Added: On October 27, 2025, we held our 2025 annual meeting of stockholders.
+Added: At the meeting, our stockholders approved an amendment to the Company’s 2024 Omnibus Stock Incentive Plan increasing the number
+Added: of shares of our common stock authorized for issuance under the plan from 15,000,000 to 30,000,000 shares.
+Added: On December 8, 2025, the Company entered into
+Added: a securities purchase agreement (the “RD Purchase Agreement”) with a certain institutional investor in a registered direct
+Added: 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
+Added: In a concurrent private placement, the Company also agreed to sell such institutional investor warrants to purchase
+Added: 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,
+Added: which are exercisable upon Stockholder Approval (as defined in the Common Warrant), and have a term of five years from the date of Stockholder
+Added: The aggregate gross proceeds to the Company from the offering were approximately $ 18.0 million.
+Added: Net proceeds were approximately
+Added: $ 15.2 million, after deducting placement agent fees and other offering expenses payable by the Company.
+Added: On December 8, 2025, the Company also entered
+Added: into a securities purchase agreement (the “PIPE Purchase Agreement”, together with the RD Purchase Agreement, the “Purchase
+Added: Agreements”) with such institutional investor to issue in a concurrent private placement pre-funded warrants to purchase up to 15,229,358
+Added: shares of common stock (the “Pre-funded Warrants”) and 15,229,358 Common Warrants, at a combined price of $ 1.0899 per Pre-funded
+Added: Warrant and accompanying Common Warrant.
+Added: The Pre-funded Warrants are exercisable immediately, at an exercise price of $ 0.0001 per share,
+Added: and will remain valid and exercisable until all the Pre-funded Warrants are exercised in full.
+Added: In connection with the offering, the Company agreed
+Added: to pay the placement agent a cash fee of 7.0 % of the aggregate gross proceeds the Company received in the offering.
+Added: In addition, the Company
+Added: granted placement agent warrants to the placement agent, or its designees, to purchase up to 1,155,963 shares of common stock (the “Placement
+Added: Agent Warrants”).
+Added: The terms of the Placement Agent Warrants are substantially the same as the terms of the Common Warrants, except
+Added: that the exercise price is $ 1.3625 per share and expire five years from the commencement of sales in the offering.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.