What changed in this filing

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Item 1. Business

2024-12-27 compared with 2024-04-16 · 839 added, 522 removed, 1 unchanged (100% of the section changed)

are a Cayman Islands company incorporated on March 1, 2021 as an exempted company with limited liability.

We were formed for the purpose

of entering into a merger, share exchange, asset acquisition, share purchase, recapitalization, reorganization or similar business combination

with one or more businesses or entities, which we refer to as a “target business.” Our efforts to identify a prospective

target business will not be limited to a particular industry or geographic location but will initially focus in Asia.

Despite our Chief

Executive Officer and Chairman either being currently located in or having significant ties to the People’s Republic of China (“PRC”

or “China”), for the purposes of consummating an initial business combination, we shall not undertake our initial business

combination with any entity that conducts a majority of its business or is headquartered in China (including Hong Kong and Macau).

intend to utilize cash derived from the proceeds of our initial public offering (the “IPO”), our securities, debt or a combination

of cash, securities and debt, in effecting a business combination.

Public Offering and Private Placement

March 2021, we issued an aggregate of 1,437,500 founder shares to our Sponsor for an aggregate purchase price of $25,000, or approximately

$0.017 per share.

On December 20, 2021, the Board of Directors of the Company and our Sponsor, as sole shareholder of the Company, approved,

through a special resolution, the following share capital changes:

of the authorized but unissued 150,000,000 Class A ordinary shares were cancelled and re-designated as ordinary shares of $0.0001

par value each;

of the 1,437,500 Class B ordinary shares in issue were exchanged in consideration for the issuance of 1,437,500 ordinary shares of

$0.0001 par value each;

completion of the above steps, the authorized but unissued 10,000,000 Class B ordinary shares were cancelled.

December 20, 2021, the Company issued an additional 287,500 Ordinary Shares to our Sponsor for no additional consideration, resulting

in our Sponsor holding an aggregate of 1,725,000 Ordinary Shares (the “Founder Shares”).

The issuance was considered as a

bonus share issuance, in substance a recapitalization transaction, which was recorded and presented retroactively.

The Founder Shares

include an aggregate of up to 225,000 ordinary shares subject to forfeiture to the extent that the underwriters’ over-allotment

is not exercised in full or in part.

With the consummation of the IPO (including partial exercise by the underwriter of its over-allotment

option), 75,000 Founder Shares were forfeited, resulting in our Sponsor holding an aggregate of 1,650,000 Founder Shares.

October 18, 2022 , the Company consummated its IPO of 6,600,000 units (the “Units”),

including 600,000 additional Units issued pursuant to the partial exercise by the underwriter of its over-allotment option.

consists of one ordinary share, par value $0.0001 per share, of the Company (the “Ordinary Shares”) and one right to receive

two-tenths (2/10) of one Ordinary Share upon the consummation of the Company’s initial business combination (the “Rights”).

The Units were sold at an offering price of $10.00 per Unit, generating total gross proceeds of $66,000,000.

Simultaneously

with the consummation of the IPO and the sale of the Units, the Company consummated the private placement (the “Private Placement”)

of 394,000 Units (the “Placement Units”), each Placement Unit consisting of one Ordinary Share and one right, to 10XYZ Holdings

LP (the “Sponsor”) at a price of $10.00 per Placement Unit, generating total proceeds of $3,940,000.

The issuance of the

Placement Units was made pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as amended.

total of $67,320,000 of the net proceeds from the IPO and the Private Placement were placed in a U.S.-based trust account established

for the benefit of the Company’s public shareholders and maintained by American Stock Transfer & Trust Company, acting as trustee.

management has broad discretion with respect to the specific application of the proceeds of the IPO and the Private Placement that are

held out of the trust account, although substantially all the net proceeds are intended to be applied generally towards consummating

a business combination and working capital.

our IPO, our sole business activity has been identifying and evaluating suitable acquisition transaction candidates.

We presently have

no revenue and have had losses since inception from incurring formation and operating costs.

We have relied upon the sale of our securities

and loans from the Sponsor and other parties to fund our operations.

December 6, 2022, we announced that holders of the Company’s Units sold in the IPO may elect to separately trade the Ordinary Shares

and Rights included in the Units, commencing on or about December 8, 2022.

The Ordinary Shares and Rights are trading on the Nasdaq Global

Market (“Nasdaq”) under the symbols “TENK,” and “TENKR,” respectively.

Units not separated will continue

to trade on Nasdaq under the symbol “TENKU”.

Holders of Units will need to have their brokers contact the Company’s

transfer agent, American Stock Transfer & Trust Company , in order to separate the holders’

Units into Ordinary Shares and Rights.

of Deadline to Complete an Initial Business Combination

July 18, 2023, the Company issued an unsecured promissory note in the aggregate principal amount of $660,000 (the “Extension Fee”)

to the Sponsor.

The Extension Fee was issued in connection with the Company’s amended and restated memorandum and articles of association

(the “ Second A&R Memorandum and Articles ”) which provides that the

Company may extend the period of time to consummate a business combination up to three times, each by an additional three months, subject

to our Sponsor, or its designee, depositing $660,000 into the trust account of the Company.

On July 18, 2023, the Company deposited $660,000

into the trust account of the Company to extend the date by which it must consummate an initial business combination from July 18, 2023

to October 18, 2023 (the “Extension”).

October 18, 2023, the Company issued an unsecured promissory note in the aggregate principal amount of $660,000 (“Extension Fee

2”) to the Sponsor, pursuant to the Second A&R Memorandum and Articles .

October 18, 2023, the Company deposited $660,000 into the trust account of the Company to extend the date by which it must consummate

an initial business combination from October 18, 2023 to January 18, 2024 (“Extension No.2”).

January 17, 2024, the Company held an extraordinary general meeting of shareholders (the “Meeting”), in lieu of the 2023

annual general meeting, at which the Company’s shareholders approved, among other proposals, a proposal, by special resolution,

to amend the Company’s Second A&R Memorandum and Articles in their entirety and the substitution in their place of the third

amended and restated memorandum and articles of association of the Company (the “ Third A&R Memorandum and Articles ”),

which provides that the Company may elect to extend the date by which the Company has to consummate a business combination (the “ Combination

Period ”) for a total of eight (8) times, as follows:

for a deposit into the Company’s

trust an amount equal to the lesser of $200,000 or $0.10 per public share that is not redeemed, an additional three (3) month extension

from January 18, 2024 to April 18, 2024;

for a deposit into the Company’s

trust an amount equal to the lesser of $66,667 or $0.03 per public share that is not redeemed, for each month during the subsequent additional

one (1) month extensions from April 18, 2024 to November 18, 2024.

January 17, 2024, the Company issued an unsecured promissory note in the aggregate principal amount of $200,000 (“Extension Fee

3”) to Citius Pharma, pursuant to the Third A&R Memorandum and Articles .

January 17, 2024, Citius Pharma deposited $200,000 into the trust account of the Company to extend the date by which it must consummate

an initial business combination from January 18, 2024 to April 18, 2024 (“Extension No.3”).

of an Experienced Management Team and Board of Directors

management team is led by our Chief Executive Officer, Executive Director and Chairman of our Board of Directors, Mr.

Xiaofeng Yuan,

our Chief Financial Officer and Executive Director, Mr.

Taylor Zhang, and our Independent Directors, Ms.

Cathy Jiang, Mr.

Joel Mayersohn

Brian Hartzband.

Xiaofeng Yuan has served as our Executive Director and Chairman since March 2021, and our Chief Executive Officer since July 2021.

Yuan founded 38Fule Group and served as the Chairman of Xianyang 38Fule from 1992 to 1998.

Yuan also serves as the Chairman of Shaanxi

38Fule Technology Company, a developer, manufacturer, and distributor of health and personal care products in China, since 1999.

Yuan founded 38Fule in 1992 and led the company to become one of the top 100 healthcare companies in China and has personally become

an influential leader in the healthcare industry as well.

Yuan and his team have always been devoted to women’s healthcare

and wellbeing.

“38Fule” has received several awards under Mr.

Yuan’s leadership, including “National Brand”,

“Women’s Choice Brand” and “Shaanxi’s Trademark”.

Shaanxi 38Fule Technology Group received the only

direct selling license in Shaanxi Province in 2016.

In addition, Mr.

Yuan also serves as the Deputy Chairman of China Reproductive Health

Association, the Managing Director of China Youth Volunteer Organization, Adjunct Professor at Xi’an Jiaotong University as well

as Visiting Professor at Xi’an Polytechnic University.

Yuan has won several awards in his career, including “Top Ten

Outstanding Youth in Xiangyang”, “Top Ten Outstanding Youth in Shaanxi”, “Top Ten Outstanding Entrepreneurs in

Shaanxi”, “Expert with Outstanding Contribution in Shaanxi”, “Winner of China Science and Entrepreneur Award”

and “National Outstanding Entrepreneur”.

Taylor Zhang has served as our Chief Financial Officer and Executive Director since March 2021.

Zhang served as our Chief Executive

Officer from March 2021 to July 2021.

From May 2009 to December 2021, Mr.

Zhang served as Chief Financial Officer and executive director

of the China XD Plastics Company Limited, where he oversaw CXDC’s major financial and capital market matters, including Nasdaq

listing, direct equity financing from world class institutional investors and a global bond offering.

During his tenure at CXDC, its

revenue grew at CAGR of 56% and exceeded US$1 billion in 6 years after listing on Nasdaq.

From May 2008 to March 2009, Mr.

as Chief Financial Officer of Advanced Battery Technologies, Inc.

From 2007 to 2008, he served as the Executive Vice President of Finance

of China Natural Gas, Inc.

From 2005 to 2007, Mr.

Zhang worked as a research analyst in New York Private Equity.

From 2000 to 2002, he

was employed as Finance Manager by Datong Thermal Power Limited.

Zhang contributes to our Board of Directors with extensive experience

in finance and operations.

Cathy Jiang, our director, is an experienced professional in asset management and banking industries.

Jiang serves as the Managing

Director at Alpha Square Group, a family office in New York City.

Her primary responsibility includes asset allocation, fund manager

selection, and new investment initiatives.

From 2017 to 2020, Ms.

Jiang served as the Associate Managing Director, Greater China at Federated

Hermes (NYSE:

FHI), one of the largest asset management companies in the U.S.

with $575.9 billion asset under management as of the end

of 2020, where she focused on the company’s expansion in Asia and particularly in Greater China.

Previously, she worked for Agricultural

Bank of China and Bank of China in institutional business development roles covering both Asian and U.S.

institutional investors.

Joel Mayersohn, our director, is a member at Dickinson Wright, where he specializes in corporate, securities and business law.

a diversified client base in private placements, public offerings, mergers and acquisitions, financing transactions and general securities

He also has experience in venture capital, bridge loans and pipe financings.

He is a member of the Florida and New York

Bars and received his J.D.

and B.A from The State University of New York at Buffalo.

Brian Hartzband, our director, is an experienced professional in business development and finance industry.

Hartzband is a business

development executive with large corporate and start-up experience.

He co-founded Handcrafted 4 Home in June 2017, which is a home decor

brand, specializing in handcrafted home storage products.

Under his leadership, Mr.

Hartzband grew the company to one of the top sellers

by volume of home organization products on Wayfair.com and expanded to other large retail outlets, such as Walmart and Home Depot.

to founding Handcrafted 4 Home, Brian spent over 10 years in Wall Street and worked in finance for some of the largest financial institutions

of the world.

From January 2014 to June 2016, Mr.

Hartzband worked as a Financial Advisor at Merrill Lynch, primarily responsible for

managing public company executives’ stock plans and personal wealth investment strategies.

From February 2008 to January 2014,

Hartzband worked as a Senior Investment Associate at UBS Financial Services, where his team’s assets grew to over $125 million

by developing relationships with C-Suite executives of major public companies along with international clients in China.

March 2008 Mr.

Hartzband started out at Bear Stearns (acquired by J.P.

Morgan as a Marketing Assistant, primarily responsible for building

and growing relationships with ultra-high net worth individuals, C-Suite executives at public companies.

Deal Sourcing Network

believe our management team’s strong track record will provide us with access to high quality companies.

In addition, we believe

we, through our management team, have contacts and sources from which to generate acquisition opportunities and possibly seek complementary

follow-on business arrangements.

These contacts and sources include those in government, private and public companies, private equity

and venture capital funds, investment bankers, attorneys and accountants.

as a Publicly Listed Acquisition Company

believe our structure will make us an attractive business combination partner to prospective target businesses.

As a publicly listed

company, we will offer a target business an alternative to the traditional initial public offering process.

We believe that some target

businesses will favor this alternative, which we believe is less expensive, while offering greater certainty of execution, than the traditional

initial public offering process.

During an initial public offering, there are typically underwriting fees and marketing expenses, which

would be costlier than a business combination with us.

Furthermore, once a proposed business combination is approved by our shareholders

(if applicable) and the transaction is consummated, the target business will have effectively become public, whereas an initial public

offering is always subject to the underwriter’s ability to complete the offering, as well as general market conditions that could

prevent the offering from occurring.

Once public, we believe the target business would have greater access to capital and additional

means of creating management incentives that are better aligned with shareholders’ interests than it would as a private company.

It can offer further benefits by augmenting a company’s profile among potential new customers and vendors and aid in attracting

talented management staffs.

respect to the foregoing examples and descriptions, past performance by our management team is not a guarantee either (i) of success

with respect to any business combination we may consummate or (ii) that we will be able to identify a suitable candidate for our initial

business combination.

Potential investors should not rely upon the historical record of our management as indicative of future performance.

will seek to capitalize on the strength of our management team.

Our team consists of experienced financial services, accounting and legal

professionals and senior operating executives of companies operating in multiple jurisdictions.

Collectively, our officers and directors

have decades of experience in mergers and acquisitions and operating companies.

We believe we will benefit from their accomplishments,

and specifically, their current activities, in identifying attractive acquisition opportunities.

However, there is no assurance that

we will complete a business combination.

Our officers and directors have no prior experience consummating a business combination for

a “blank check” company.

We believe that we will add value to these businesses primarily by providing them with access to

capital markets.

is no restriction in the geographic location of targets we can pursue, although we intend to initially prioritize Asia, excluding companies

located or operating in mainland China, Hong Kong or Macau.

In particular, we intend to focus our search for an initial business combination

on private companies in Asia, excluding companies located or operating in mainland China, Hong Kong or Macau, that have compelling economics

and clear paths to positive operating cash flow, significant assets, and successful management teams that are seeking access to the U.S.

public capital markets.

We will primarily seek to acquire one or more businesses with a total enterprise value of between $200,000,000

and $600,000,000.

an emerging market, Asia has experienced remarkable growth.

The Asian economy experienced sustained expansion in recent years.

that Asia is entering a new era of economic growth, which we expect will result in attractive initial business combination opportunities

We believe the growth will primarily be driven by private sector expansion, technological innovation, increasing consumption

by the middle class, structural economic and policy reforms and demographic changes in Asia.

management team intends to focus on creating shareholder value by leveraging its experience in the management, operation and financing

of businesses to improve the efficiency of operations while implementing strategies to scale revenue organically and/or through acquisitions.

We have identified the following general criteria and guidelines, which we believe are important in evaluating prospective target businesses.

While we intend to use these criteria and guidelines in evaluating prospective businesses, we may deviate from these criteria and guidelines

should we see justification to do so.

management team that can create significant value for target business .

We will seek to identify companies with strong and

experienced management teams that will complement the operating and investment abilities of our management team.

We believe we can

provide a platform for the existing management team to leverage the experience of our management team.

We also believe that the operating

expertise of our management team is well suited to complement the target’s management team.

and Earnings Growth Potential .

We will seek to acquire one or more businesses that have the potential for significant revenue

and earnings growth through a combination of both existing and new product development, increased production capacity, expense reduction

and synergistic follow-on acquisitions resulting in increased operating leverage.

for Strong Free Cash Flow Generation .

We will seek to acquire one or more businesses that have the potential to generate

strong, stable and increasing free cash flow, particularly businesses with predictable revenue streams and definable low working

capital and capital expenditure requirements.

We may also seek to prudently leverage this cash flow in order to enhance shareholder

from Being a Public Company .

We intend to only acquire a business or businesses that will benefit from being publicly traded

and which can effectively utilize access to broader sources of capital and a public profile that are associated with being a publicly

traded company.

criteria does not intend to be exhaustive.

Any evaluation relating to the merits of a particular initial business combination may be

based, to the extent relevant, on these general guidelines as well as other considerations, factors and criteria that our Sponsor and

management team may deem relevant.

In the event that we decide to enter into an initial business combination with a target business that

does not meet the above criteria and guidelines, we will disclose that the target business does not meet the above criteria in our shareholder

communications related to our initial business combination, which would be in the form of proxy solicitation or tender offer materials,

as applicable, that we would file with the U.S.

Securities and Exchange Commission, or the SEC.

Business Combination

rules require that our initial business combination must be with one or more target businesses that together have an aggregate fair market

value equal to at least 80% of the balance in the trust account (less any deferred underwriting commissions and taxes payable on interest

earned) at the time of our signing a definitive agreement in connection with our initial business combination.

If our Board of Directors

is not able to independently determine the fair market value of the target business or businesses, we will obtain an opinion from an

independent investment banking firm or another independent firm that commonly renders valuation opinions for the type of company we are

seeking to acquire or an independent accounting firm.

We do not intend to purchase multiple businesses in unrelated industries in conjunction

with our initial business combination.

October 24, 2023, the Company announced that it had entered into an agreement and plan of merger and reorganization (the “Merger

Agreement”), dated October 23, 2023, by and among TenX Merger Sub, Inc., a Delaware corporation and the Company’s wholly

owned subsidiary (“Merger Sub”), Citius Pharmaceuticals, Inc., a Nevada corporation (“Citius Pharma”), and Citius

Oncology, Inc., a Delaware corporation and wholly owned subsidiary of Citius Pharma (“Citius Oncology”), to acquire Citius

The Merger Agreement provides, among other things, on the terms and subject to the conditions set forth therein, (i) that Merger

Sub will merge with and into Citius Oncology, with Citius Oncology to be renamed and to survive as a wholly owned subsidiary of TenX

(the “Merger”), and (ii) that prior to the effective time of the Merger (the “Effective Time”), TenX will migrate

to and domesticate as a Delaware corporation in accordance with Section 388 of the General Corporation Law of the State of Delaware and

the Cayman Islands Companies Act (As Revised) (the “Domestication”).

The newly combined publicly traded company is to be

named “Citius Oncology, Inc.” (the “Combined Company”).

The Domestication, Merger and the other transactions

contemplated by the Merger Agreement are referred to in this section as the “Business Combination”.

the Merger, all shares of Citius Oncology would be converted into the right to receive ordinary share of the Combined Company.

result, upon closing, Citius Pharma would receive 67.5 million shares of ordinary share of the Combined Company which, at an implied

value of $10.00 per share, would be $675 million in equity of the Combined Company, before fees and expenses.

As part of the

transaction, Citius Pharma will contribute $10 million in cash to the Combined Company.

An additional 12.6 million existing options

will be assumed by the Combined Company.

Citius Pharma and the Combined Company will also enter into an amended and restated shared

services agreement, which, among other things, will govern certain management and scientific services that Citius Pharma will

continue to provide to the Combined Company following the Effective Time.

Merger Agreement, Business Combination and the transactions contemplated thereby were unanimously approved by the boards of

directors of each of the Company, Citius Pharma and Citius Oncology.

The transaction is expected to be completed in the first half

of 2024, subject to approval by shareholders of the Company and other customary closing conditions, including final regulatory

approvals and SEC filings.

There can be no assurance regarding the ultimate timing of the proposed transaction or that the

transaction will be completed at all.

will have until 18 months from the closing of our IPO to consummate an initial business combination (the “Combination Period”).

However, if we anticipate that we may not be able to consummate our initial business combination within 18 months, we may extend the

Combination Period up to seven (7) times, each time for an additional month (for a total of up to 25 months to complete a business combination)

without submitting such proposed extensions to our shareholders for approval or offering our public shareholders redemption rights in

connection therewith.

Pursuant to the terms of our third amended and restated memorandum and articles of association and the trust agreement

entered into between us and American Stock Transfer & Trust Company on October 13, 2022, in order to extend the time available for

us to consummate our initial business combination, our Sponsor or its affiliates or designees, upon two days advance notice prior to

the applicable deadline, must deposit into the trust account the lesser of $66,667 or $0.03 per public share that is not redeemed on

or prior to the date of the applicable deadline, for each one month extension.

Any such payments would be made in the form of a loan.

Any such loans will be non-interest bearing and payable upon the consummation of our initial business combination.

If we complete our

initial business combination, we would repay such loaned amounts out of the proceeds of the trust account released to us.

complete a business combination, we will not repay such loans.

Furthermore, the letter agreement with our initial shareholders contains

a provision pursuant to which our Sponsor has agreed to waive its right to be repaid for such loans out of the funds held in the trust

account in the event that we do not complete a business combination.

Our Sponsor and its affiliates or designees are not obligated to

fund the trust account to extend the time for us to complete our initial business combination.

Up to $1,500,000 of the loans made by

our Sponsor, our officers and directors, or our or their affiliates to us prior to or in connection with our initial business combination

(including loans made to extend our time period for consummating a business combination) may be convertible into Units at a price of

$10.00 per Unit at the option of the lender.

we are unable to consummate an initial business combination within such time period, we will, as promptly as reasonably possible but

not more than ten business days thereafter, redeem 100% of the outstanding Public Shares, at a per-share price, payable in cash, equal

to the aggregate amount then on deposit in the trust account, including any interest earned on the funds held in the trust account (net

of interest that may be used by us to pay our taxes payable and for dissolution expenses), divided by the number of then outstanding

Public Shares, which redemption will completely extinguish public shareholders’ rights as shareholders (including the right to

receive further liquidation distributions, if any), subject to applicable law and as further described herein, and then seek to dissolve

and liquidate.

We expect the pro rata redemption price to be approximately $10.99 per public share (subject to increase of up to an additional

approximately $0.03 per share for each month in the event that our Sponsor elects to extend the period of time to consummate a business

combination by the full seven months), without taking into account any interest earned on such funds.

However, we cannot assure you that

we will in fact be able to distribute such amounts as a result of claims of creditors which may take priority over the claims of our

public shareholders.

anticipate structuring our initial business combination so that the post-transaction company in which our public shareholders own shares

will own or acquire 100% of the equity interests or assets of the target business or businesses.

We may, however, structure our initial

business combination such that the post-transaction company owns or acquires less than 100% of such interests or assets of the target

business in order to meet certain objectives of the target management team or shareholders or for other reasons, but we will only complete

such business combination if the post-transaction company owns or acquires 50% or more of the outstanding voting securities of the target

or otherwise acquires a controlling interest in the target sufficient for it not to be required to register as an investment company

under the Investment Company Act of 1940, as amended, or the Investment Company Act.

Even if the post-transaction company owns or acquires

50% or more of the voting securities of the target, our shareholders prior to the business combination may collectively own a minority

interest in the post-transaction company, depending on valuations ascribed to the target and us in the business combination transaction.

For example, we could pursue a transaction in which we issue a substantial number of new shares in exchange for all of the outstanding

capital stock of a target.

In this case, we would acquire a 100% controlling interest in the target.

However, as a result of the issuance

of a substantial number of new shares, our shareholders immediately prior to our initial business combination could own less than a majority

of our outstanding shares subsequent to our initial business combination.

If less than 100% of the equity interests or assets of a target

business or businesses are owned or acquired by the post-transaction company, the portion of such business or businesses that is owned

or acquired is what will be valued for purposes of the 80% of net assets test.

If our initial business combination involves more than

one target business, the 80% of net assets test will be based on the aggregate value of all of the target businesses.

Required from the Chinese Authorities for a Business Combination

our offices are located in United States, a majority of our directors and officers have significant ties to China.

As a result, our directors

and officers who have significant ties to China may be subject to certain risks relating to regulatory oversight by the PRC government.

In particular, changes in the policies, regulations, rules, and the enforcement of laws of the PRC government may be adopted quickly

with little advance notice.

The Chinese government may also intervene or influence our search for a target business or the completion

of an initial business combination at any time through our directors and officers who have significant ties to China.

This could significantly

and negatively impact our search for a target business and/or the value of the securities.

a Cayman Islands company with no operations or subsidiaries in China and expected to conduct a target search outside of China, we are

not required to obtain permission from any Chinese authorities to operate, nor have we been contacted by any Chinese authorities in connection

with our operations, and we do not expect that permission will be required from the Chinese authorities in the future in connection with

our business combination since we will not undertake our initial business combination with any entity that is based in, located in or

with its principal business operations in China (including Hong Kong and Macau).

of the Holding Foreign Companies Accountable Act

Holding Foreign Companies Accountable Act, or the HFCAA, was enacted on December 18, 2020.

The HFCAA states that if the SEC determines

that an issuer’s audit reports issued by a registered public accounting firm have not been subject to inspection by the Public

Company Accounting Oversight Board (United States) (the “PCAOB”) for three consecutive years beginning in 2021, the SEC shall

prohibit such issuer’s securities from being traded on a national securities exchange or in the over-the-counter trading market

in the United States.

On December 29, 2022, the Accelerating Holding Foreign Companies Accountable

Act (“AHFCAA”) was enacted, which amends the HFCAA and requires the SEC to prohibit an issuer’s securities from

trading on any U.S.

stock exchanges if its auditor is not subject to PCAOB inspections for two consecutive years instead of three consecutive

PCAOB Developments

developments in U.S.

laws may restrict our ability or willingness to complete certain business combinations with companies.

For instance,

the enacted AHFCAA would restrict our ability to consummate a business combination with a target business unless that business met certain

standards of the PCAOB and would require delisting of a company from U.S.

national securities exchanges if the PCAOB is unable to inspect

its public accounting firm for two consecutive years.

The AHFCAA also requires public companies to disclose, among other things, whether

they are owned or controlled by a foreign government.

We may not be able to consummate a business combination with a favored target business

due to these laws.

documentation we may be required to submit to the SEC proving certain beneficial ownership requirements and establishing that we are

not owned or controlled by a foreign government in the event that we use a foreign public accounting firm not subject to inspection by

the PCAOB or where the PCAOB is unable to inspect or investigate our accounting practices or financial statements because of a position

taken by an authority in the foreign jurisdiction could be onerous and time consuming to prepare.

The HFCAA mandates the SEC to identify

issuers of SEC-registered securities whose audited financial reports are prepared by an accounting firm that the PCAOB is unable to inspect

due to restrictions imposed by an authority in the foreign jurisdiction where the audits are performed.

If such identified issuer’s

auditor cannot be inspected by the PCAOB for three consecutive years, the trading of such issuer’s securities on any U.S.

securities exchanges, as well as any over-the-counter trading in the U.S., will be prohibited.

March 24, 2021, the SEC adopted interim final rules relating to the implementation of certain disclosure and documentation requirements

of the HFCAA.

An identified issuer will be required to comply with these rules if the SEC identifies it as having a “non-inspection”

year under a process to be subsequently established by the SEC.

November 5, 2021, the SEC approved the PCAOB’s Rule 6100, Board Determinations Under the Holding Foreign Companies Accountable

Rule 6100 provides a framework for the PCAOB to use when determining, as contemplated under the HFCAA, whether it is unable to inspect

or investigate completely registered public accounting firms located in a foreign jurisdiction because of a position taken by one or

more authorities in that jurisdiction.

December 2, 2021, the SEC issued amendments to finalize rules implementing the submission and disclosure requirements in the Holding

Foreign Companies Accountable Act.

The rules apply to registrants that the SEC identifies as having filed an annual report with an audit

report issued by a registered public accounting firm that is located in a foreign jurisdiction and that PCAOB is unable to inspect or

investigate completely because of a position taken by an authority in foreign jurisdictions.

December 16, 2021, the PCAOB issued a Determination Report which found that the PCAOB is unable to inspect or investigate certain registered

public accounting firms headquartered in:

(i) mainland China, and (ii) Hong Kong.

In addition, the PCAOB’s report identified the

specific registered public accounting firms that are subject to these determinations.

On August 26, 2022, the PCAOB signed a Statement

of Protocol with the China Securities Regulatory Commission and the Ministry of Finance of the PRC (“SOP”), taking the first

step toward opening access for the PCAOB to inspect and investigate registered public accounting firms headquartered in mainland China

and Hong Kong completely, consistent with U.S law.

Pursuant to the SOP, the PCAOB shall have independent discretion to select any issuer

audits for inspection or investigation and has the unfettered ability to transfer information to the SEC.

December 15, 2022, the PCAOB determined that the PCAOB was able to secure complete access to inspect and investigate registered public

accounting firms headquartered in mainland China and Hong Kong and voted to vacate its previous determinations to the contrary.

should PRC authorities obstruct or otherwise fail to facilitate the PCAOB’s access in the future, the PCAOB will consider the need

to issue a new determination.

auditor, Marcum LLP, headquartered in New York, NY, is an independent registered public accounting firm with the PCAOB and has been inspected

by the PCAOB on a regular basis.

The PCAOB currently has access to inspect the working papers of our auditor.

If, for whatever reason,

the PCAOB is unable to conduct inspections or full investigations of our auditor, we could be delisted or prohibited from being traded

over the counter.

If our securities are unable to be listed on another securities exchange by then, such delisting and prohibition would

substantially impair your ability to sell or purchase our securities when you wish to do so, and the risk and uncertainty associated

with potential delisting and prohibition would have a negative impact on the price of our securities.

Also, such delisting and prohibition

could significantly affect our ability to raise capital on acceptable terms, or at all, which would have a material adverse effect on

our business, financial condition and prospects.

Future developments in respect of increased U.S.

regulatory access to audit information

are uncertain, as the legislative developments are subject to the legislative process and the regulatory developments are subject to

the rule-making process and other administrative procedures.

the event that we complete a business combination with a non-U.S.

company and any of the legislative actions or regulatory changes discussed

above were to proceed in ways that are detrimental to a non-U.S.

issuer, it could cause us to fail to be in compliance with U.S.

laws and regulations, we could cease to be listed on a U.S.

securities exchange, and U.S.

trading of our shares could be prohibited.

Any of these actions, or uncertainties in the market about the possibility of such actions, could adversely affect our prospects to successfully

complete a business combination with a non-U.S.

company, our access to the U.S.

capital markets and the price of our shares.

are an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended, or the Securities

Act, as modified by the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

As such, we are eligible to take advantage of certain

exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies”

including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley

Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy

statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and shareholder approval

of any golden parachute payments not previously approved.

If some investors find our securities less attractive as a result, there may

be a less active trading market for our securities and the prices of our securities may be more volatile.

addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended

transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.

words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise

apply to private companies.

We intend to take advantage of the benefits of this extended transition period.

will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of

the completion of our IPO, (b) in which we have total annual gross revenue of at least $1.07 billion, or (c) in which we are deemed to

be a large accelerated filer, which means the market value of our Ordinary Shares that is held by non-affiliates exceeds $700 million

as of the prior December 31, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt securities during

the prior three-year period.

References herein to “emerging growth company” shall have the meaning associated with it in

the JOBS Act.

Business Overview

The Company, headquartered in Cranford, New Jersey,

is a biopharmaceutical company focused on developing and commercializing innovative targeted oncology therapies.

The Company’s strategy

centers on achieving a market leading position by advancing innovative therapies with reduced development and clinical risks, and competitive

advantages supported by intellectual property and regulatory exclusivity protection.

This includes new formulations of previously approved

drugs with substantial existing safety and efficacy data or expanded indications for approved therapies.

The Company’s lead product candidate is

LYMPHIR TM , an engineered IL-2 diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent CTCL,

a rare form of non-Hodgkin lymphoma.

LYMPHIR was approved by the FDA in August 2024.

The Company believes there is an attractive and growing

market for LYMPHIR, estimated to exceed $400 million, that is underserved by existing treatments.

See below for more detailed information

In the future, the Company intends to commercialize

our products independently in the U.S., and partner to market products outside of the U.S.

The Company is in the process of establishing

a small, targeted oncology sales force, initially for LYMPHIR, focused on key geographies and stakeholders, primarily major cancer centers.

This commercialization strategy is anticipated to result in a combination of direct sales revenue, and royalty income, as well as incremental

operating expenses and greater working capital requirements.

Citius Oncology and the Business Combination

On August 23, 2021, Citius Pharmaceuticals, Inc.

(“Citius Pharma”), formed Citius Acquisition Corp.

(“SpinCo”) as a wholly-owned subsidiary in conjunction with

the acquisition of LYMPHIR, but SpinCo did not begin operations until April 2022, when Citius Pharma transferred the assets related to

LYMPHIR to SpinCo, including the related license agreement with Eisai Co., Ltd.

(“Eisai”) and the related asset purchase agreement

Reddy’s Laboratories SA, a subsidiary of Dr.

Reddy’s Laboratories, Ltd.

(collectively, “Dr.

On October 23, 2023, Citius Pharma and SpinCo

entered into an agreement and plan of merger and reorganization (the “Merger Agreement”) with TenX Keane Acquisition, a Cayman

Islands exempted company (“TenX”), and TenX Merger Sub Inc., a Delaware corporation and a wholly owned subsidiary of TenX

(“Merger Sub”).

On August 12, 2024, pursuant to the terms and conditions of the Merger Agreement, Merger Sub merged with and

into SpinCo, with SpinCo surviving as a wholly owned subsidiary of TenX (the “Merger”) which was subsequently renamed Citius

Oncology Sub.

Prior to closing of the Merger (the “Closing”), TenX migrated to and domesticated as a Delaware corporation

in accordance with Section 388 of the General Corporation Law of the State of Delaware and the Cayman Islands Companies Act (As Revised)

(the “Domestication”).

As part of the Domestication, TenX changed its name to “Citius Oncology, Inc.” (Nasdaq:

Immediately after the closing of the Merger, Citius Pharma owned approximately 92.3% of the outstanding shares of common stock

of the Company.

Since the SpinCo’s inception, Citius Pharma

funded SpinCo and continues to fund Citius Oncology, and Citius Pharma and Citius Oncology are party to an amended and restated shared

services agreement (the “A&R Shared Services Agreement”), which governs certain management and scientific services that

Citius Pharma provides Citius Oncology.

LYMPHIR TM (denileukin diftitox-cdxl)

In September 2021, Citius Pharma announced

that it had entered into an asset purchase agreement with Dr.

Reddy’s to acquire its exclusive license of E7777 (denileukin

E7777, an engineered IL-2-diphtheria toxin fusion protein, is an improved formulation of oncology agent, ONTAK®,

which was previously approved by the FDA for the treatment of patients with persistent or recurrent CTCL.

previously exclusively licensed E777 in select markets from Eisai and as part of the transaction, Eisai entered into a license

agreement whereby Eisai assigned all of its rights to E7777 to Citius Pharma.

Citius Pharma renamed E7777 as I/ONTAK and also

obtained the trade name LYMPHIR for the product.

Denileukin diftitox is referred to in this annual report as E7777, I/ONTAK or

LYMPHIR, depending on the period of time and context that is being discussed.

LYMPHIR is a recombinant DNA-derived fusion protein

designed to direct the cytocidal action of diphtheria toxin (DT) to cells which express the IL-2 receptor.

After uptake into the cell,

the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death.

Consequently, LYMPHIR’s

differentiated mechanism of action supports two therapeutic effects:

(1) killing tumors by binding to IL-2 receptors to deliver diphtheria

toxin directly to the tumor cells, and (2) depleting immunosuppressive regulatory T lymphocytes (Tregs) to enhance antitumor activity.

Phase 3 Trial (E7777-G000-302) Design

LYMPHIR is an improved formulation of oncology

agent, ONTAK®, which was previously approved by the FDA for the treatment of patients with persistent or recurrent CTCL.

marketed in the U.S.

The manufacturing formulation improvements were substantial enough that the FDA required a new clinical

study to be performed (Study E7777-G000-302).

The safety profile of LYMPHIR from study E7777-G000-302 is comparable to Study 93-04-11/L4389-11,

which served as the basis for the full approval of ONTAK.

Study E7777-G000-302, a global, multicenter, open-label single-arm pivotal clinical

trial for the treatment of patients with persistent or recurrent CTCL, commenced (first subject consented) in May 2013 and completed (data

cutoff for primary analysis) in December 2021.

The study was sponsored by Eisai and was conducted at 17 sites in the United States and

three sites in Australia.

Inclusion criteria for the study were to evaluate patients in advanced stage CTCL (Mycosis Fungoides or Sézary

Syndrome), who received at least one prior CTCL therapy.

The objectives were met for Study E7777-G000-302, in both the lead-in phase and

the main phase.

Overall, the primary and secondary endpoints of Study E7777-G000-302 demonstrate the tolerability and clinical benefit

of 9 µg/kg/day LYMPHIR for the treatment of adult patients with relapsed or refractory Stage I-III CTCL.

No new safety signals were

identified compared to ONTAK.

The pivotal trial of E7777 was divided into two

phases, a lead-in phase with 21 subjects that evaluated dose finding, pharmacokinetics and immunogenicity, and assessed the Objective

Response Rate (the “ORR”).

An ORR is defined as a greater than 50% reduction in tumor burden.

Patients received a daily intravenous

infusion of denileukin diftitox from Day 1 through Day 5 of each 21-day cycle.

In the lead-in phase, the main objectives were to determine

the maximum tolerated dose (MTD) of LYMPHIR and to select the dose of LYMPHIR to be used in the main phase (subjects were treated at doses

ranging from 6 to 15 µg/kg/day).

The MTD was 12 µg/kg/day and, based on data of the lead-in phase, 9 µg/kg/day was selected

for the main phase of the study.

The objectives of the main phase were to evaluate the efficacy and safety of LYMPHIR (at the dose determined

in the lead-in phase of 9 µg/kg/day).

The primary efficacy endpoint was tumor response

ORR per the Independent Review Committee (IRC) assessment based on International Society for Cutaneous Lymphomas/ European

Organization for Research and Treatment of Cancer Global Response Score (GRS;

Olsen, et al., 2011).

The secondary efficacy endpoints

of response (DOR) based on GRS;

to response based on GRS;

assessed by investigator using GRS;

response assessed by IRC using Prince (Prince, et al., 2010);

response (according to modified Severity Weighted Assessment Tool [mSWAT]);

of skin response;

to skin response.

Overall, there were 25 responders out of 69 subjects

in the Primary Efficacy Analysis Set (i.e., subjects with CTCL disease Stages I to III (9 µg/kg/day)) as assessed by the IRC, with

an ORR of 36.2% (95% CI:

25.0%, 48.7%), with 8.7% (6/69) achieving a Complete Response (CR) and 27.5% (19/69) achieving a Partial Response.

Among responders, the median follow-up for duration

of response was 6.5 months (range:

3.5+, 23.5+ months).

Median time to response was 1.4 months (range:

0.7 to 5.6 months).

ORR (95% CI) by investigator was 42.3% (30.6%,

54.6%) (30 of 71 subjects), with 8.5% (6 subjects) achieving a CR.

ORR (95% CI) by IRC assessment using the Prince (2010) criteria was

36.2% (25.0%, 48.7%) (25 of 69 subjects).

And, an ORR of 38.1% in the intent to treat population and 44.4% in the efficacy evaluable populations

were observed.

The 2-sided, exact 95% CI of ORR was calculated using the Clopper-Pearson method.

Per protocol, LYMPHIR demonstrated clinical

benefit if the lower bound of the 2-sided 95% exact CI of the ORR exceeded 25%.

Skin responses were the same as GRS objective

responses, for both IRC and investigator assessments.

Responses were deep, reflected by the substantial decrease in skin tumor burden,

including 8 subjects with 100% clearance of skin lesions per IRC.

In the second and main phase of the pivotal trial,

70 patients were administered the 9 µg/kg/day rate for 5 consecutive days in 21-day cycles.

The inclusion criteria were identical

to the lead-in phase.

Phase 3 Trial Efficacy & Safety Results

The efficacy population of the main phase included

69 patients with relapsed or refractory stage I to III CTCL.

Of the 69 patients, the median age was 64 years (range:

28 to 87 years),

65% were male, 73% were White, 19% Black or African American, 1% Asian, and 14% Hispanic or Latino.

The CTCL disease stage was IA in 7%,

IB in 23%, IIA in 13%, IIB in 35%, IIIA in 12%, and IIIB in 10%.

The median number of prior therapies was 4 (range:

1 to 18), including

both skin-directed and systemic therapies.

Prior therapies included photodynamic therapy (56%), total skin electron beam therapy (42%),

systemic retinoids (49%), methotrexate/pralatrexate (49%), histone deacetylase inhibitor (35%), brentuximab vedotin (26%) and mogamulizumab

Efficacy was established based on ORR, according

to ISCL/EORTC Global Response Score (GRS) per Independent Review Committee (Olsen 2011).

Efficacy results are shown in the table below.

Efficacy Results of E7777-G000-302

Complete Response

Partial Response

Duration of Response

Median (range), months

6.5 (3.0+, 23.5+)

Duration ≥ 6 months, n (%)

Median Time to Response, months

ORR, Objective Response Rate per Olsen, et all (2011) Global Response Score (GRS), by Independent Review Committee (IRC)

CI = confidence interval

Both the endpoints and objectives of Study E7777-G000-302

were met, while the statistical confidence interval (95% CI), resulted in a marginal shortfall (25% actual achievement vs.

the statistical plan).

Throughout the initial BLA review period, the FDA accepted the Study E7777-G000-302 data which demonstrated both

tolerability and clinical benefit.

Overall, LYMPHIR was well-tolerated with the use

of pre-medications, close patient monitoring, and prompt initiation of supportive measures and drug management.

There was no evidence

of cumulative toxicity and most patients experienced low grade 1 or 2 treatment emergent adverse events.

Serious adverse reactions occurred in 38% of

patients who received LYMPHIR.

Serious adverse reactions in > 2% of patients included capillary leak syndrome (10%), infusion-related

reaction (9%), sepsis (7%), skin infection (2.9%), pyrexia (2.9%), and rash (2.9%).

There were no Grade 5 adverse events in the Study

E7777-G000-302, Stage I-III Safety Set (which is the safety set FDA required for inclusion in the package insert/label).

Adverse Reactions (≥ 10%) in Patients

with Relapsed or Refractory Stage I-III CTCL Who Received LYMPHIR in E7777-G000-302

Adverse Reaction

Gastrointestinal disorders

General disorders and administration site conditions

Musculoskeletal and connective tissue disorders

Musculoskeletal pain d

Nervous system disorders

Mental status changes g

Injury, poisoning and procedural complications

Infusion-related reaction

Skin and subcutaneous tissue disorders

Vascular disorders

Capillary leak syndrome

Metabolism and nutrition disorders

Decreased appetite

Eye disorders

Vision changes j

Investigations

Weight increased

Infections and infestations

Skin infection

Renal and urinary disorders

Renal insufficiency l

Psychiatric disorders

Includes fatigue, asthenia, and lethargy.

Includes edema, edema peripheral generalized edema, face edema, swelling face, peripheral swelling.

Includes fever, pyrexia, tumor associated fever.

Includes musculoskeletal pain, back pain, neck pain, pain in extremity, myalgia, bone pain, flank pain.

Includes arthralgia, joint swelling, joint range of motion decreased, musculoskeletal stiffness.

Includes headache, migraine.

Includes mental status changes, amnesia, confusional state, delirium, altered state of consciousness, hallucinations (including auditory), memory impairment, disturbance in attention, somnolence, cognitive disorder.

Includes rash, dermatitis, drug eruption, erythema, palmar erythema, toxic skin eruption, rash maculo-papular, rash papular, rash pustular, rash pruritic, dermatitis exfoliative generalized, acute generalized exanthematous pustulosis.

Includes pruritis, itching.

Includes vision blurred, photopsia, visual impairment.

Includes skin infection, skin bacterial infection, staphylococcal skin infection, cellulitis, impetigo.

Includes renal failure, nephropathy, acute kidney injury, blood creatinine increased, renal impairment.

Grade refers to the severity of the adverse reaction.

The Common Terminology Criteria for Adverse Events displays Grades 1 through 5 with unique clinical descriptions of severity for each

adverse reaction based on this general guideline:

● Grade 1 - Mild;

asymptomatic or mild symptoms;

clinical or diagnostic observations only;

intervention not indicated.

● Grade 2 - Moderate;

minimal, local or noninvasive

intervention indicated;

limiting age-appropriate instrumental activities of daily living.

● Grade 3 - Severe or medically significant but

not immediately life-threatening;

hospitalization or prolongation of hospitalization indicated;

limiting self care activities

of daily living.

● Grade 4 - Life-threatening consequences;

intervention indicated.

● Grade 5 - Death related to the adverse reaction.

Investigator Initiated Trials

The Company believes there is an opportunity in

the field of immuno-oncology and has undertaken two investigator-initiated trials to evaluate the potential safety and efficacy of LYMPHIR

as an immuno-oncology combination therapy.

A Phase 1 trial was initiated in June 2021 at

the University of Minnesota, Masonic Cancer Center.

This study is a single-arm open-label trial which has an estimated enrollment of 20

participants who will be administered denileukin diftitox prior to Chimeric Antigen Receptor (“CAR-T”) therapies.

1 study consists of two components:

dose finding to establish a maximum tolerated dose (“MTD”) of denileukin diftitox in combination

with CART-T therapies and an extension component to provide an estimate of efficacy at that MTD.

Phase I/II Trial Using E7777

to Enhance Regulatory T-Cell Depletion Prior to CAR-T Therapy for Relapsed/Refractory B-Cell Lymphoma (DLBCL).

A second Phase 1 Study was initiated in September

2022 at the University of Pittsburg Medical Center, Hillman Cancer Center.

This study is an open label, Phase 1/1b study to investigate

the safety and efficacy of a combined regimen of pembrolizumab with T-regulatory cell depletion and denileukin diftitox in patients diagnosed

with recurrent or metastatic solid tumors in the second line setting.

The efficacy of T-regulatory cell depletion with E7777 combined

with immune checkpoint inhibitor, pembrolizumab, in recurrent or metastatic solid tumors:

Phase I/II Study.

NCT05200559).

The study consists of two parts.

Part I is a dose

escalation study of four cohorts (3,6,9,12 mcg of LYMPHIR) and is expected to enroll 18-30 patients.

Part II is a dose expansion study

of approximately 40 patients to evaluate the safety and tolerability of the recommended combination dose of LYMPHIR and pembrolizumab

(to include ovarian cancer and MSI-H cancer cohorts).

The study will also investigate the alteration of the immune microenvironment within

tumors and peripheral blood.

Secondary endpoints include the objective response (complete response plus partial response), progression-free

survival, and overall survival.

Trials at both the University of Minnesota, Masonic

Cancer Center and the University of Pittsburgh Medical Center, Hillman Cancer Center are enrolling patients and progressing.

In November 2024, the Company announced promising

preliminary results of the Phase I Clinical Trial of Pembrolizumab (KEYTRUDA®) and LYMPHIR™ in cancer patients with recurrent

solid tumors conducted at the University of Pittsburg Hillman Cancer Center.

Preliminary Results

The results of this chemotherapy-free regimen

combining two immuno-modulator agents, pembrolizumab (anti-PD-1) and LYMPHIR (transient Treg depletion) demonstrated:

● An overall response rate (ORR) of 27% (4/15)

and a clinical benefit rate of 33% (5/15) among evaluable patients;

● Median progression-free survival (PFS) for patients

achieving clinical benefit of 57 weeks, with a range of 30 to 96 weeks.

● Notably, two of the four patients who achieved

partial remission had received prior checkpoint inhibitors (i.e.

anti-PD-1 therapy).

This highlights the therapeutic potential of LYMPHIR

plus immune checkpoint inhibitors to be effective in patients who fail prior anti-PD-1/L1 therapy.

The trial enrolled 21 patients with recurrent

or metastatic solid tumors.

Among the evaluable participants, four patients achieved a partial response, and one patient demonstrated

durable stable disease lasting over six months.

The combination regimen was generally well tolerated, with most adverse events related

to the patients’ underlying disease.

Importantly, no significant immune-related adverse events were observed, and only one case of dose-limiting

toxicity (capillary leak syndrome) was reported at the highest dose level (12 mcg/kg).

Efficacy Data

Patients Enrolled

Patients Evaluable for Response

Partial Responses (PR)

Stable Disease (≥ 6 months)

Clinical Benefit Rate (CBR)

33% (PR + SD ≥ 6 months)

Median Progression-Free Survival (PFS)

57 weeks (range:

Dose-Limiting Toxicities (DLTs)

1 (Capillary Leak Syndrome at 12 mcg/kg)

Immune-Related Adverse Events (irAEs)

None documented (≥ Grade 3)

Adverse Events (Grade ≥ 3)

Most related to underlying disease

Regulatory Development

In the 1990s, denileukin diftitox was developed

at Boston University and the National Cancer Institute (“NCI”) in collaboration with Seragen, Inc.

In 1999, ONTAK ® (denileukin diftitox)

was granted accelerated approval by the FDA for the treatment of persistent or recurrent CTCL.

Ligand Pharmaceuticals, Inc.

acquired the marketing rights in that same year.

In 2006, Eisai acquired the commercial rights

to ONTAK from Ligand.

In 2008, the FDA granted full approval to ONTAK

In 2011, a new formulation of denileukin diftitox

was developed under the code name E7777 in response to a post-marketing condition established by the FDA upon approval.

As the FDA considered

this a new product, an Investigational New Drug Application (“IND”) was filed.

As a part of ensuing discussions, the FDA agreed

to a development plan that included a single arm, open label study to confirm the safety and efficacy of E7777 and a chemistry, manufacturing

and controls (“CMC”) development plan that demonstrates the new process results in a comparable drug product.

In 2011, the FDA Office of Orphan Products Development

granted E7777 orphan drug designation status for the treatment of Peripheral T-Cell Lymphoma (“PTCL”).

In 2013, the FDA Office of Orphan Products Development

granted E7777 orphan drug designation status for the treatment of CTCL.

In 2013, the first patient was enrolled into the

lead-in phase of the pivotal study for the E7777 U.S.

CTCL clinical trial.

In 2014, commercial sales of ONTAK were discontinued

when the product was voluntarily withdrawn from the market due to manufacturing issues at the contract manufacturer.

In 2015, the last patient enrolled exited the

lead-in phase of the E7777 U.S.

CTCL clinical trial.

In March 2016, Dr.

Reddy’s exclusively licensed

the global rights to E7777 from Eisai, other than the rights in countries retained by Eisai, which consists of Japan, China, Korea, Taiwan,

Hong Kong, Macau, Indonesia, Thailand, Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia,

Laos, Afghanistan, Bangladesh, Bhutan, Nepal, Mongolia and Papua New Guinea.

The license included an option on the right to develop and

market the product in India prior to FDA approval.

In June 2016, the first patient was enrolled in

the main phase of the Phase 3 U.S.

CTCL clinical trial for E7777.

In March 2020, Eisai filed a New Drug Application

(“NDA”) for E7777 in Japan for both CTCL and PTCL, and in March 2021 received approvals in both indications.

In September 2021, Citius

Pharma acquired the marketing rights to E7777 in selected markets.

Citius Pharma subsequently renamed E7777 as LYMPHIR.

In December 2021, patient

enrollment for the Phase 3 Pivotal study of LYMPHIR was completed.

In April 2022, Citius

Pharma reported that topline results from the Phase 3 trial were consistent with the prior formulation.

Moreover, no new safety signals

were identified.

In December 2022, a Biologics License Application

(“BLA”) for LYMPHIR was accepted for filing with the FDA and a PDUFA goal date was set for July 28, 2023.

In July 2023, the FDA issued a complete response

letter (“CRL”) requiring the Company to incorporate enhanced product testing and additional controls agreed to with the FDA

during the market application review.

There were no concerns relating to the safety and efficacy clinical data package submitted with

the BLA, or the proposed prescribing information.

In September 2023, Citius Pharma announced that

the FDA agreed with the plans to address the requirements outlined in the CRL, which guidance provided the Company with a path for completing

the necessary activities to support the resubmission of the BLA for LYMPHIR.

In February 2024, based on the feedback from the

FDA, Citius Pharma completed the CRL remediation activities and filed the resubmission.

In March 2024, Citius Pharma announced the acceptance

of the BLA by the FDA.

The FDA assigned a PDUFA goal date of August 13, 2024 and approved LYMPHIR on August 8, 2024.

In August 2024 Citius Pharma announced that the

FDA had approved LYMPHIR.

Market Opportunity

CTCL’s are a heterogeneous subset of extranodal

non-Hodgkin lymphomas (“NHL”) of mature, skin-homing T-cells that are mainly localized to the skin.

The most common types

of CTCL are mycosis fungoides (“MF”) and primary cutaneous CD30+ anaplastic large cell lymphoma (pcALCL), jointly representing

an estimated 80 to 85% of all CTCL.

Sézary Syndrome (“SS”), a very rare subtype (~2 to 5% of CTCL) characterized by

diffuse inflammatory, often exfoliative, erythroderma and by leukemic and nodal involvement, displays a significant degree of clinical

and biological overlap with MF and has long been considered a clinical variant of MF, although recent evidence suggests that it may be

a separate entity.

The rest is represented by extremely rare, generally more aggressive subtypes.

In light of the overlap between MF and SS, and

considering that many of the systemic therapy options for the two neoplasms are the same, some consider the treatment approach to MF and

SS as if they were a single disease entity (MF/SS).

However, some of the drugs currently in use, or in development, for MF/SS appear to

be more effective in clearing different anatomical compartments (skin versus blood, for example) and therefore have differential efficacy

in MF and SS.

Based on Surveillance Epidemiology and End Results

(SEER) data from 2001 to 2007, the estimated incidence rate of MF/SS in the U.S.

is 0.5/100,000 or about 2,500 to 3,000 new cases per

year representing about 25% of all T-cell lymphomas.

In total, the Company estimates that there are approximately 30,000 to 40,000 patients

living with CTCL in the U.S.

Based on internal estimates, the Company believes

the addressable U.S.

market for LYMPHIR exceeds $400,000,000 and may further expand with the introduction of a new therapeutic.

There are currently several approved targeted

therapeutics for patients with persistent or recurrent CTCL.

However, there are limitations to these targeted therapies, which often are

discontinued due to toxicity, adverse events, or a limited duration of response due to resistance over time.

Consequently, the Company

believes there continues to be an unmet medical need for patients with CTCL and an opportunity for LYMPHIR to be included among the treatment

armamentarium for advanced-stage CTCL.

The following products are approved for the systemic

treatment of advanced CTCL:

● Mogamulizumab, sold under the brand name Poteligeo,

is a humanized, afucosylated monoclonal antibody targeting CC chemokine receptor 4.

The FDA approved it for treatment of relapsed or refractory

mycosis fungoides and Sézary disease.

● Brentuximab vedotin, sold under the brand name

Adcetris, is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma and systemic anaplastic large

cell lymphoma, a type of T-cell non-Hodgkin lymphoma.

It selectively targets tumor cells expressing the CD30 antigen, a defining marker

of Hodgkin lymphoma and ALC.

● Romidepsin sold under the brand name Istodax,

is a histone deacetylase (“HDAC”) inhibitor indicated for the treatment of CTCL in adult patients who have received at least

one prior systemic therapy.

● Vorinostat sold under the brand name Zolinza,

is a HDAC inhibitor indicated for the treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent or

recurrent disease on or following two systemic therapies.

Sales and Marketing

The Company does not currently have our own commercial

infrastructure and is in the process of developing our sales or marketing capability by contracting with a large third-party commercial

sales and marketing organization with an existing commercial infrastructure and product launch experience to assist in our commercial

The Company intends to utilize a dedicated field force combined with various marketing programs which will be tailored to both

physicians and patients to launch LYMPHIR and grow our market share.

We plan to focus our commercial efforts on a concentrated group of

prescribing hematologists, oncologists and dermatologist-oncologists, along with key opinion leaders and advocacy groups who play an important

role in the CTCL treatment regimen.

In September 2024, the Company announced the inclusion

of LYMPHIR in the National Comprehensive Cancer Network (“NCCN”) guidelines and compendia.

LYMPHIR was included bases on an

NCCN Category 2A recommendation which indicates a uniform NCCN consensus that LYMPHIR is appropriate as an option for patients with CTCL.

The Company believes that LYMPHIR’s addition to the NCCN guidelines will assist LYMPHIR in obtaining coverage and reimbursement

from the Centers for Medicare and Medicaid Services (“CMS”).

Supply and Manufacturing

The Company does not currently have nor do we

intend to establish our own manufacturing facilities.

We have secured supply agreements with third-party cGMP facilities who are in compliance

with current good manufacturing practices as generally accepted by the FDA.

The Company is confident that all drug substance and drug

product materials meet or will meet specifications as agreed with the FDA.

The Company also believes our contract manufacturers

have sufficient capacity to support demand for LYMPHIR and any future clinical phase and approved products as our business grows.

In addition to our supply agreements with third-party

manufacturers, the Company has contracted with other proven suppliers for, testing, labeling, packaging, and distribution of LYMPHIR.

In general, our suppliers purchase raw materials and supplies on the open market.

Substantially all such materials are obtainable from

a number of sources so that the loss of any one source of supply would not have a material adverse effect on us.

If we elect to conduct product development and manufacturing, we will be subject to regulation under various federal and state laws, including

the Food, Drug and Cosmetic Act, Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act,

the Resource Conservation and Recovery Act, the Controlled Substances Act and other present and potential future federal, state or local

If we fail to raise additional capital, and as

a result are unable to abide by our contractual obligations with these third-party manufacturers and suppliers, including making timely

payment, the necessary third-party support to commercialize LYMPHIR could be delayed or terminated.

LYMPHIR License Agreement

On September 3, 2021, Citius Pharma acquired the

exclusive license of E7777 (denileukin diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, from Dr.

who had exclusively licensed it previously from Eisai.

The exclusive license, which was amended as part of the transaction, is with Eisai

and includes rights to develop and commercialize LYMPHIR in all markets except for Japan, China, Korea, Taiwan, Hong Kong, Macau, Indonesia,

Thailand, Malaysia, Brunei, Singapore, India, Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh,

Bhutan, Nepal, Mongolia, and Papua New Guinea.

The license includes an option on the right to develop and market the product in India.

Citius Pharma renamed E7777 as I/ONTAK and also obtained the trade name LYMPHIR for the product.

In April 2022, Citius Pharma assigned

the license agreement to SpinCo, at which time SpinCo began operations.

Upon the completion of the Merger, the Company acquired SpinCo

as our wholly owned subsidiary.

Citius Pharma remains a guarantor on all of Citius Oncology’s payment obligations thereunder.

Obligations to

Eisai under the License Agreement

Under the license agreement, Eisai is to receive

a $5.9 million development milestone payment upon initial approval by the FDA of LYMPHIR for the CTCL indication (which increases to $6.9

million in the event the Company exercises the option to add India to the licensed territory) and an aggregate of up to $22 million related

to the achievement of net product sales thresholds.

Pursuant to the terms of the license agreement, through 2022, Citius Pharma reimbursed

Eisai for approximately $2.65 million of Eisai’s costs to complete the ongoing Phase 3 pivotal clinical trial for LYMPHIR for the

CTCL indication and for all reasonable costs associated with the preparation of a BLA for LYMPHIR.

The Company has accrued the $5.9 million

development milestone payment as of September 30, 2024.

Pursuant to the terms of the license agreement,

Eisai was responsible for completing the current CTCL clinical trial, and chemistry, manufacturing and controls development activities

through the production of the BLA, which Citius Pharma filed with the FDA in September 2022.

Citius Pharma is responsible for the costs

of correcting any major deficiencies in the BLA, as well as the costs of any further studies and development costs associated with potential

additional indications.

The term of the license agreement will continue

until (i) March 30, 2026, if there has not been a commercial sale of a licensed product in the territory, or (ii) if there has been a

first commercial sale of a licensed product in the territory by March 30, 2026, the 10-year anniversary of the first commercial sale on

a country-by-country basis.

The term of the license may be extended for additional 10-year periods for all countries in the territory

by notifying Eisai and paying an extension fee equal to $10 million.

Either party may terminate the license agreement upon written notice

if the other party is in material breach of the agreement, subject to cure within the designated time periods.

Either party also may terminate

the license agreement immediately upon written notice if the other party files for bankruptcy or takes related actions or is unable to

pay its debts as they become due.

Additionally, either party will have the right to terminate the agreement if the other party directly

or indirectly challenges the patentability, enforceability, or validity of any licensed patent.

The Company is responsible for preparing, filing,

prosecuting, and maintaining all patent applications and patents included in the licensed patents that we intend to pursue within the

Obligations to

Reddy’s under the Asset Purchase Agreement

Citius Pharma and Dr.

Reddy’s entered into

an asset purchase agreement whereby Dr.

Reddy’s transferred to Citius Pharma the then-existing patents, know-how, regulatory documentation

and other assets related to LYMPHIR and Citius Pharma agreed to assume certain liabilities associated with Dr.

Reddy’s development

The agreement was assigned to the Company in April 2022.

Under the terms of the asset purchase agreement

Reddy’s, the Company will be obligated to pay up to an aggregate of $40 million related to CTCL approvals in the U.S.

other markets, up to $70 million in development milestones for additional indications, and up to $300 million for commercial sales milestones.

The Company will also be obligated to pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages of net product

sales (within a range of 10% to 15%).

The royalties will end on the earlier of (i) the 15-year anniversary of the first commercial sale

of the latest indication that received regulatory approval in the applicable country and (ii) the date on which a biosimilar product results

in the reduction of net sales in the applicable product by 50% in two consecutive quarters, as compared to the four quarters prior to

the first commercial sale of the biosimilar product.

The Company will also pay to Dr.

Reddy’s an amount equal to a low-thirties

percentage of any sublicense upfront consideration or milestone payments (or the like) received by the Company and the greater of (i)

a low-thirties percentage of any sublicensee sales-based royalties or (ii) a mid-single digit percentage of such licensee’s net

Also under the agreement with Dr.

the Company is required to (i) use commercially reasonable efforts to make commercially available products in the CTCL indication, peripheral

T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology trials, (iii) use

commercially reasonable efforts to achieve each of the approval milestones, and (iv) complete each specified immuno-oncology investigator

trial on or before the four-year anniversary of the effective date of the definitive agreement.

Additionally, the Company is required

to commercially launch a product in a territory within six months of receiving regulatory approval for such product in each such jurisdiction.

The Company is responsible for these and any and all further developmental activities relating to LYMPHIR.

Reddy’s agreed to not compete against

the Company in the development of products containing compounds in LYMPHIR in the territory covered by the license for a designated period

There are no termination provisions included in the asset purchase agreement other than those related to the term of the royalties.

To assist in the transfer of the LYMPHIR assets, the Company and Dr.

Reddy’s entered into a transition services agreement at the

closing of the transaction, which was in effect until March 2022.

At the time of the FDA approval for LYMPHIR, a

$27.5 million milestone payment became payable for which a balance of $22.5 million remains due as of September 30, 2024.

LYMPHIR Patents

As part of the definitive agreement with Dr.

Citius Pharma acquired and later transferred to the Company method of use patents in which E7777 is administered in combination with the

programmed cell death protein 1 (“PD-1”) pathway inhibitor drug class.

PD-1 plays a vital role in inhibiting immune responses

and promoting self-tolerance through modulating the activity of T-cells, activating apoptosis of antigen-specific T cells and inhibiting

apoptosis of regulatory T cells.

The following patents

were acquired:

● US Provisional Application No.

63/070,645, which

was filed on August 26, 2020, and subsequently published as US 2022/0062390 A1 on March 3, 2022, entitled Methods of Treating Cancer.

Expiration date of August 23, 2041.

● International Patent Application Number:

PCT/IB2021/0576733,

which was filed with the World Intellectual Property Organization on August 23, 2021 for Europe, and subsequently published as WO 2022/043863

A1 on March 3, 2022, entitled, Combination for Use in Methods of Treating Cancer.

Expiration date of August 23, 2041.

Government Regulation

The research, development, testing, manufacture,

labeling, promotion, advertising, distribution, and marketing, among other things, of LYMPHIR and other potential future product candidates,

is extensively regulated by governmental authorities in the U.S.

and other countries.

In the U.S., the FDA regulates drugs under the

Federal Food, Drug, and Cosmetic Act (the “FDCA”) and the agency’s implementing regulations.

If the Company fails to

comply with the applicable U.S.

requirements at any time during the product development process, including clinical testing, as well as

at any time before and after the approval process, we may become subject to administrative or judicial sanctions, or other actions, such

as the FDA’s delay in review of or refusal to approve a pending NDA or BLA, withdrawal of an approval, imposition of a clinical

hold or study termination, issuance of Warning Letters or Untitled Letters, mandated modifications to promotional materials or issuance

of corrective information, requests for product recalls, consent decrees, corporate integrity agreements, deferred prosecution agreements,

product seizures or detentions, refusal to allow product import or export, total or partial suspension of or restriction of or imposition

of other requirements relating to production or distribution, injunctions, fines, debarment from government contracts and refusal of future

orders under existing contracts, exclusion from participation in federal and state healthcare programs, FDA debarment, restitution, disgorgement

or civil or criminal penalties, including fines and imprisonment.

Any enforcement action could have a material adverse effect on the Company

and our operations.

FDA Marketing Approval

Before any one of the Company’s drug product

candidates may be marketed in the U.S., it must be approved by the FDA.

Obtaining FDA marketing approval for new products requires substantial

time, effort and financial resources .

In order for the FDA to determine that a product is safe and effective for the proposed indication,

the product must first undergo testing in animals (nonclinical studies).

The data generated from nonclinical studies is used to support

the filing of an IND under which human studies are conducted.

Human testing is generally conducted under an IND in three phases following

Good Clinical Practices (“GCP”) regulations:

● Phase 1 studies evaluate the safety and tolerability

of the drug, generally in normal, healthy volunteers;

● Phase 2 studies evaluate safety and efficacy,

as well as appropriate doses;

these studies are typically conducted in patient volunteers who suffer from the particular disease condition

that the drug is designed to treat;

● Phase 3 studies evaluate safety and efficacy

of the product at specific doses in one or more larger pivotal trials.

In addition to human testing, the manufacturing

process of the potential product must be developed in accordance with cGMP regulations.

Prior to the approval of a new product, the FDA

will inspect the facilities at which the proposed drug product is manufactured to ensure cGMP compliance.

The cumulative safety and efficacy data generated

from the clinical trials described above, chemistry, manufacturing and control (“CMC”) information, nonclinical study data

and proposed labeling are used as the basis to support approval of a marketing application (NDA or BLA) to the FDA.

The preparation of

an NDA or BLA requires the expenditure of substantial funds and the commitment of substantial resources.

Additionally, at the time of

an NDA or BLA submission a user fee is required (unless the product has ODD) to be paid.

The FDA conducts a preliminary administrative

review upon receipt of the NDA or BLA submission, the FDA either accepts the NDA or BLA submission or does not.

If the application is

not accepted for review by FDA, the Sponsor of the application must resolve the deficiencies and re-submit the application, re-starting

the review clock.

After evaluating the NDA or BLA and all

related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing

facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter

A CRL generally contains a statement of specific conditions that must be met in order to secure final approval

of the NDA or BLA and may require additional clinical or preclinical studies, or other information, in order for FDA approval.

with submission of this additional information, the FDA may decide that the NDA or BLA does not satisfy the regulatory criteria for

If and when those conditions have been met to the FDA’s satisfaction, the FDA may issue an approval letter.

approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

Data obtained from the development program are

not always conclusive and may be susceptible to varying interpretations.

These instances may delay, limit or prevent regulatory approval.

The FDA may not grant approval on a timely basis, or at all.

We may encounter difficulties or unanticipated costs in our efforts to secure

necessary governmental approvals, which could delay or preclude us from marketing our products.

The FDA may limit the indications for

use or place other conditions on any approvals that could restrict the commercial application of the product.

FDA Post - Approval Considerations

Drugs manufactured or distributed pursuant to

FDA approvals are subject to continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping,

manufacturing, periodic reporting, product sampling and distribution, advertising and promotion, and reporting of adverse experiences

with the product and drug shortages.

During the approval process, the FDA and the sponsor may agree that specific studies or clinical

trials should be conducted as post-marketing commitments, but they are not required.

The FDA may also impose post-marketing requirements

as a condition of approval of an NDA or BLA.

For example, the FDA may require post-marketing testing, including Phase 4 clinical trials

and surveillance, to further assess and monitor the product’s safety and effectiveness after commercialization.

Once an approval

is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems

occur after the product becomes available in the market.

After approval, most changes to the approved product,

such as manufacturing changes and adding new indications or other labeling claims, are subject to FDA review and approval.

There are also

annual user fee requirements for any marketed product and new application fees for supplemental applications with clinical data.

Additionally,

we are a “smaller reporting company” as defined in Rule 10(f)(1) of Regulation S-K.

Smaller reporting companies may take

advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.

We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our Ordinary Shares

held by non-affiliates equals or exceeds $250 million as of the end of the second fiscal quarter of such fiscal year, or (2) our annual

revenues equaled or exceeded $100 million during such completed fiscal year and the market value of our Ordinary Shares held by non-affiliates

equals or exceeds $700 million as of the end of the second fiscal quarter of such fiscal year.

companies are Cayman Islands companies wishing to conduct business outside the Cayman Islands and, as such, are exempted from complying

with certain provisions of the Companies Act.

As an exempted company, we have applied for and expect to receive a tax exemption undertaking

from the Cayman Islands government that, in accordance with Section 6 of the Tax Concessions Act (Revised) of the Cayman Islands, for

a period of 20 years from the date of the undertaking, no law which is enacted in the Cayman Islands imposing any tax to be levied on

profits, income, gains or appreciations shall apply to us or our operations and, in addition, that no tax to be levied on profits, income,

gains or appreciations or which is in the nature of estate duty or inheritance tax shall be payable (i) on or in respect of our shares,

debentures or other obligations or (ii) by way of the withholding in whole or in part of a payment of dividend or other distribution

of income or capital by us to our shareholders or a payment of principal or interest or other sums due under a debenture or other obligation

are a Cayman Islands exempted company incorporated on March 1, 2021.

Our executive offices are located at 420 Lexington Ave Suite 2446,

New York, NY 10170, and our telephone number is 347-627-0058.

The cost for this space is provided to us by our Sponsor, as part of the

$10,000 per month payment we make to it for office space and related services.

We consider our current office space adequate for our

current operations.

currently have 2 officers.

These individuals are not obligated to devote any specific number of hours to our matters but they intend

to devote as much of their time as they deem necessary to our affairs until we have completed our initial business combination.

of time they will devote in any time period will vary based on whether a target business has been selected for our initial business combination

and the stage of the initial business combination process we are in.

We do not intend to have any full time employees prior to the completion

of our initial business combination.

Risk Factors.

a smaller reporting company, we are not required to include risk factors in this Annual Report.

the FDA strictly regulates the labeling, advertising and promotion of products under an approved NDA or BLA.

The FDA and other agencies

actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly

marketed or promoted off-label uses may be subject to significant liability, including criminal and civil penalties under the FDCA and

False Claims Act, exclusion from participation in federal healthcare programs, debarment from government contracts, refusal of future

orders under existing contracts and mandatory compliance programs under corporate integrity agreements or deferred prosecution agreements.

Other Regulations of the Healthcare Industry

In addition to FDA regulations governing the marketing

of pharmaceutical products, there are various other state and federal laws that may restrict business practices in the biopharmaceutical

These include the following:

● The federal Anti-Kickback laws and implementing

regulations, which prohibit persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or

indirectly, in cash or in kind, to induce either the referral of an individual, or furnishing or arranging for a good or service, for

which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

● Other Medicare laws, regulations, rules, manual

provisions and policies that prescribe the requirements for coverage and payment for services performed by our customers, including the

amount of such payment;

● The federal False Claims Act, which imposes civil

and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the

● The Foreign Corrupt Practices Act (“FCPA”),

which prohibits certain payments made to foreign government officials;

● State and foreign law equivalents of the foregoing

and state laws regarding pharmaceutical company marketing compliance, reporting and disclosure obligations;

● The Patient Protection and Affordable Care Act

of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Affordable Care

Act” or “ACA”), which among other things:

changes access to healthcare products and services;

creates new fees for the

pharmaceutical and medical device industries;

changes rebates and prices for health care products and services;

and requires additional

reporting and disclosure;

● The Health Insurance Portability and Accountability

Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations

(collectively, “HIPAA”), which creates federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit

program and which also imposes certain obligations on entities with respect to the privacy, security and transmission of individually

identifiable health information;

● The federal Physician Payment Sunshine Act, which

requires certain pharmaceutical and biological manufacturers to engage in extensive tracking of payments or transfers of value to physicians

and teaching hospitals and public reporting of the payment data.

If our operations are found to be in violation

of any of these laws, regulations, rules or policies or any other law or governmental regulation, or if interpretations of the foregoing

change, we may be subject to civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment

or restructuring of our operations.

To the extent that any of our products are sold

in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing

requirements, including safety surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting

of payments or transfers of value to healthcare professionals.

This is currently not applicable as our only approved product is not currently

sold in a foreign country nor have we applied for any foreign approvals.

Coverage and Reimbursement

The commercial success of our product candidates

and our ability to commercialize any approved product candidates successfully will depend in part on the extent to which governmental

authorities, private health insurers and other third-party payers provide coverage for and establish adequate reimbursement levels for

our therapeutic product candidates.

In the United States, the European Union and other potentially significant markets for our product

candidates, government authorities and third-party payers are increasingly imposing additional requirements and restrictions on coverage,

attempting to limit reimbursement levels or regulate the price of drugs and other medical products and services, particularly for new

and innovative products and therapies, which often has resulted in average selling prices lower than they would otherwise be.

in the United States, federal and state governments reimburse covered prescription drugs at varying rates generally below average wholesale

Federal programs also impose price controls through mandatory ceiling prices on purchases by federal agencies and federally funded

hospitals and clinics and mandatory rebates on retail pharmacy prescriptions paid by Medicaid and Tricare.

These restrictions and limitations

influence the purchase of healthcare services and products.

Legislative proposals to reform healthcare or reduce costs under government

programs may result in lower reimbursement for our products and product candidates or exclusion of our products and product candidates

from coverage.

Moreover, the Medicare and Medicaid programs increasingly are used as models for how private payers and other governmental

payers develop their coverage and reimbursement policies.

In addition, the increased emphasis on managed

healthcare in the United States and on country and regional pricing and reimbursement controls in the European Union will put additional

pressure on product pricing, reimbursement and utilization, which may adversely affect our future product sales and results of operations.

These pressures can arise from rules and practices of managed care groups, competition within therapeutic classes, availability of generic

equivalents, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and healthcare reform, coverage and

reimbursement policies and pricing in general.

The cost containment measures that healthcare payers and providers are instituting and

any healthcare reform implemented in the future could significantly reduce our revenues from the sale of any approved products.

provide any assurances that we will be able to obtain and maintain third-party coverage or adequate reimbursement for our approved products

in whole or in part.

Healthcare Reform

The United States and many foreign jurisdictions

have enacted or proposed legislative and regulatory changes affecting the healthcare system.

The United States government, state legislatures

and foreign governments also have shown significant interest in implementing cost-containment programs to limit the growth of government-paid

healthcare costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded

prescription drugs.

In recent years, Congress has considered reductions

in Medicare reimbursement levels for drugs administered by physicians.

Further, the Center for Medicare & Medicaid Services (“CMS”),

the agency that administers the Medicare and Medicaid programs, also has authority to revise reimbursement rates and to implement coverage

restrictions for some drugs.

Cost reduction initiatives and changes in coverage implemented through legislation or regulation could decrease

utilization of and reimbursement for any approved products.

While Medicare regulations apply only to drug benefits for Medicare beneficiaries,

private payers often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates.

Therefore, any

reduction in reimbursement that results from federal legislation or regulation may result in a similar reduction in payments from private

The ACA substantially changed the way healthcare

is financed by both governmental and private insurers, and significantly impacts the pharmaceutical industry.

The ACA was intended to

broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and

abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical and

medical device manufacturers, and impose additional health policy reforms.

Since its passage, there have been significant ongoing efforts

to modify or eliminate the ACA.

The Trump administration pushed for modifications

In addition, the Tax Cuts and Jobs Act (the “TCJA”), enacted on December 22, 2017, repealed the shared responsibility

payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, as amended

(the “IRC”), as amended, commonly referred to as the individual mandate.

While the Biden administration has rolled back many

of the executive orders issued by former President Trump, ongoing repeal and reform efforts impacting the ACA and the healthcare sector

more broadly are likely under the incoming Trump administration.

Other legislative changes have been proposed and

adopted since passage of the ACA.

These have, among other things, reduced Medicare payments to several types of providers, including hospitals,

imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments

to providers.

Further legislative and regulatory changes

under the ACA remain possible.

The Inflation Reduction Act of 2022, enacted on August 16, 2022, includes several provisions to lower

prescription drug costs for Medicare patients and reduce drug spending by the federal government.

It is unknown what form any future

changes or any law would take under the incoming Trump administration, and how or whether it may affect our business in the future.

We expect that changes or additions to the ACA, the Medicare and Medicaid programs, changes allowing the federal government to

directly negotiate drug prices (which becomes effective in January 2026 for 10 prescription drugs) and changes stemming from other

healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could

have a material adverse effect on the healthcare industry.

In addition, the Affordable Care Act has also been subject to challenges

in the courts, which remain ongoing.

Payment methodologies may be subject to changes

in healthcare legislation and regulatory initiatives as well.

In addition, at the state level, legislatures have passed and implemented

regulations, and may pass additional legislation, designed to control pharmaceutical product pricing, including price or patient reimbursement

constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,

designed to encourage importation from other countries and bulk purchasing.

We expect that additional federal, state and foreign

healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will

pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products,

once approved, or additional pricing pressures.

Foreign Regulation

The Company and any of our collaborative partners

may be subject to widely varying foreign regulations, which may be different from those of the FDA, governing clinical trials, manufacture,

product registration and approval and pharmaceutical sales.

Whether or not FDA approval has been obtained, the Company or our collaborative

partners must obtain a separate approval for a product by the comparable regulatory authorities of foreign countries prior to the commencement

of product marketing in such countries.

In certain countries, regulatory authorities also establish pricing and reimbursement criteria.

The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval.

under current U.S.

law, there are restrictions on the export of products not approved by the FDA, depending on the country involved and

the status of the product in that country.

The Company has no employees.

Through our consulting

and collaboration arrangements, including the A&R Shared Services Agreement with Citius Pharma, we have access to more than 30 professionals

(including our executive officers), who possess significant expertise in business development, legal, accounting, regulatory affairs,

clinical operations, and manufacturing.

The Company also relies upon a network of consultants to support our clinical studies and manufacturing

Executive Officers of Citius Oncology

Leonard Mazur , Chief Executive Officer

and Director and Chairman of the Board– Mr.

Mazur, 79, was appointed Chief Executive Officer after the Merger.

He was appointed

the Chief Executive Officer of Citius Pharma effective May 1, 2022, and has been a member of its Board since September 2014.

previously served as Chief Executive Officer, President, and Chief Operating Officer from September 2014 until March 2016.

Myron Holubiak, Secretary and Director

Holubiak, 77, was appointed Secretary and Director after the Merger.

He was appointed Executive Vice Chairman of Citius Pharma

effective May 1, 2022, and has been a member of its Board since October 2015.

He previously served as President and Chief Executive Officer

of Citius Pharma from March 2016 through April 2022.

He was also the founder and Chief Executive Officer and President of Leonard-Meron

Biosciences, Inc., an acquired subsidiary of Citius Pharma, from March 2013 until March 2016.

Jaime Bartushak , Chief Financial

Officer and Treasurer – Mr.

Bartushak, 57, was appointed as Chief Financial Officer and Treasurer after the Merger.

He has served

as the Chief Business Officer and Chief Financial Officer of Citius Pharma since November 2017.

Previously, he was one of the founders

and Chief Financial Officer of Leonard-Meron Biosciences, Inc., an acquired subsidiary of Citius Pharma.

Myron Czuczman , Chief Medical Officer

President – Dr.

Czuczman, 65, was appointed as Chief Medical Officer and President after the Merger.

He has served as the Chief

Medical Officer and Executive Vice President of Citius Pharma since July 2020.

Czuczman previously served as Vice President, Global

Clinical Research and Development, Therapeutic Head of Lymphoma/CLL at Celgene Corporation.

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.

What changed 10-K

Item 1. Business