−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: to the “Company,” “us,” “our” or “we” refer to TenX Keane Acquisition.
−Removed: The following
−Removed: discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements
−Removed: and related notes included herein.
−Removed: Certain information contained in the discussion and analysis set forth below includes forward-looking
−Removed: statements that involve risks and uncertainties.
−Removed: were incorporated in the Cayman Islands on March 1, 2021 for the purpose of effecting a merger, capital stock exchange, asset acquisition,
−Removed: stock purchase, reorganization or similar business combination with one or more businesses.
−Removed: of Operations and Known Trends or Future Events
−Removed: have not generated any revenues to date, and we will not be generating any operating revenues until the closing and completion of our
−Removed: initial business combination.
−Removed: Our entire activity up to December 31, 2023 has been related to our formation, the Initial Public Offering
−Removed: and, since the closing of the Initial Public Offering, and a search for a business combination target.
−Removed: We have, and expect to continue
−Removed: to generate, non-operating income in the form of interest income and unrealized gains on investments held in the trust account.
−Removed: to continue to incur increased expenses as a result of being a public company (for legal, financial reporting, accounting and auditing
−Removed: compliance), as well as for due diligence expenses in connection with the search for a business combination target.
−Removed: have neither engaged in any operations nor generated any revenues to date.
−Removed: Our only activities since inception have been organizational
−Removed: activities and those necessary to prepare for the IPO.
−Removed: Following the IPO, we will not generate any operating revenues until after completion
−Removed: of our initial business combination.
−Removed: We will generate non-operating income in the form of interest income on cash and cash equivalents
−Removed: after the IPO.
−Removed: After the IPO, we expect to incur increased expenses as a result of being a public company (for legal, financial reporting,
−Removed: accounting and auditing compliance), as well as expenses as we conduct due diligence on prospective business combination candidates.
−Removed: We expect our expenses to increase substantially after the closing of the IPO.
−Removed: the year ended December 31, 2023, we had net income of $2,419,304, which primarily consisted of investment income on the trust assets
−Removed: of $3,432,374, partially offset by operating expenses of $1,013,070.
−Removed: Capital Resources and Going Concern
−Removed: registration statement for the IPO (the “Registration Statement”) was declared effective on October 13, 2022.
−Removed: 18, 2022, we consummated the IPO of 6,600,000 Units, including 600,000 additional Units issued pursuant to the partial exercise by
−Removed: the underwriter of its over-allotment option (with respect to the ordinary share included in the Units being offered,
−Removed: the “Public Shares”), generating gross proceeds of $66,000,000.
−Removed: Simultaneously
−Removed: with the consummation of the IPO and the sale of the Units, we consummated the Private Placement of 394,000 Placement Units to the Sponsor
−Removed: at a price of $10.00 per Placement Unit, generating total proceeds of $3,940,000.
−Removed: the closing of the IPO on October 18, 2022, an amount of $67,320,000 ($10.20 per Unit) from the net proceeds of the sale of the Units
−Removed: in the Initial Public Offering and the Private Placement was placed in the trust account.
−Removed: The funds held in the trust account may be
−Removed: invested in U.S.
−Removed: government securities, within the meaning set forth in Section 2(a)(16) of the Investment Company Act of 1940, as amended
−Removed: (the “Investment Company Act”), with a maturity of 185 days or less or in any open-ended investment company that holds itself
−Removed: out as a money market fund selected by us meeting the conditions of Rule 2a-7 of the Investment Company Act, as determined by the us,
−Removed: until the earlier of:
−Removed: (i) the completion of a business combination or (ii) the distribution of the trust account.
−Removed: intend to use substantially all of the funds held in the trust account, including any amounts representing interest earned on the trust
−Removed: account, to complete our initial business combination.
−Removed: To the extent that our capital stock or debt is used, in whole or in part, as
−Removed: consideration to complete our initial business combination, the remaining proceeds held in the trust account will be used as working
−Removed: capital to finance the operations of the target business or businesses, make other acquisitions and pursue our growth strategies.
−Removed: of December 31, 2023, we had available to us approximately $32,746 of cash held outside the trust account.
−Removed: We will use these funds
−Removed: to identify and evaluate target businesses, perform business due diligence on prospective target businesses, travel to and from the offices,
−Removed: plants or similar locations of prospective target businesses or their representatives or owners, review corporate documents and material
−Removed: agreements of prospective target businesses, and structure, negotiate and complete an initial business combination.
−Removed: order to fund working capital deficiencies or finance transaction costs in connection with an intended initial business combination,
−Removed: our Sponsor or an affiliate of our Sponsor or certain of our officers and directors may, but are not obligated to, loan us funds on a
−Removed: non-interest bearing basis as may be required.
−Removed: If we complete our initial business combination, we would repay such loaned amounts.
−Removed: the event that our initial business combination does not close, we may use a portion of the working capital held outside the trust account
−Removed: to repay such loaned amounts but no proceeds from our trust account would be used for such repayment.
−Removed: Other than as described above,
−Removed: the terms of such loans by our officers and directors, if any, have not been determined and no written agreements exist with respect
−Removed: to such loans.
−Removed: We do not expect to seek loans from parties other than our Sponsor or an affiliate of our Sponsor as we do not believe
−Removed: third parties will be willing to loan such funds and provide a waiver against any and all rights to seek access to funds in our trust
−Removed: expect our primary liquidity requirements from December 31, 2023 through the consummation of the business combination include
−Removed: $92,000 for legal, accounting, due diligence, travel and other expenses associated with structuring, negotiating and documenting
−Removed: successful business combinations as well as legal and accounting fees related to regulatory reporting requirements, and $216,800 for
−Removed: working capital that will be used for miscellaneous expenses and reserves.
−Removed: In addition, the Sponsor issued an unsecured promissory
−Removed: note to the Company (the “Promissory Note”), pursuant to which the Company may borrow up to an aggregate principal
−Removed: amount of $300,000 if we need additional capital.
−Removed: amounts are estimates and may differ materially from our actual expenses.
−Removed: In addition, we could use a portion of the funds not being
−Removed: placed in trust to pay commitment fees for financing, fees to consultants to assist us with our search for a target business or as a
−Removed: down payment or to fund a “no-shop” provision (a provision designed to keep target businesses from “shopping”
−Removed: around for transactions with other companies or investors on terms more favorable to such target businesses) with respect to a particular
−Removed: proposed initial business combination, although we do not have any current intention to do so.
−Removed: If we entered into an agreement where
−Removed: we paid for the right to receive exclusivity from a target business, the amount that would be used as a down payment or to fund a “no-shop”
−Removed: provision would be determined based on the terms of the specific business combination and the amount of our available funds at the time.
−Removed: Our forfeiture of such funds (whether as a result of our breach or otherwise) could result in our not having sufficient funds to continue
−Removed: searching for, or conducting due diligence with respect to, prospective target businesses.
−Removed: may have insufficient funds available to operate our business prior to our initial business combination.
−Removed: Moreover, we may need to obtain additional financing either to complete our initial business
−Removed: combination or because we become obligated to redeem a significant number of our Public Shares upon completion of our initial
−Removed: business combination, in which case we may issue additional securities or incur debt in connection with such business combination.
−Removed: In addition, we are targeting businesses larger than we could acquire with the net proceeds of the IPO and the sale of the Private
−Removed: Units, and may as a result be required to seek additional financing to complete such proposed initial business combination.
−Removed: to compliance with applicable securities laws, we would only complete such financing simultaneously with the completion of our
−Removed: initial business combination.
−Removed: If we are unable to complete our initial business combination because we do not have sufficient funds
−Removed: available to us, we will be forced to cease operations and liquidate the trust account.
−Removed: In addition, following our initial business
−Removed: combination, if cash on hand is insufficient, we may need to obtain additional financing in order to meet our
−Removed: is no assurance that our plans to consummate a business combination will be successful within the combination period.
−Removed: As a result, there
−Removed: is substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial
−Removed: statements are issued or are available to be issued.
−Removed: Company has incurred and expects to continue to incur significant costs in pursuit of its acquisition plans.
−Removed: In addition, the Company
−Removed: currently has less than 12 months from the date these financial statements were issued to complete a business combination transaction.
−Removed: If the Company is unsuccessful in consummating an initial business combination by April 18, 2024, per the mandatory liquidation requirement,
−Removed: the Company must cease all operations, redeem the Public Shares and thereafter liquidate and dissolve.
−Removed: In connection with the Company’s
−Removed: assessment of going concern considerations in accordance with Accounting Standards Update (“ASU”) 2014-15, “Disclosures
−Removed: of Uncertainties about an Entity’s Ability to Continue as a Going Concern,” the Company does not have adequate liquidity
−Removed: to sustain operations.
−Removed: These conditions raise substantial doubt about the Company’s ability to continue as a going concern for
−Removed: a period of time within one year after the date that the financial statements are issued.
−Removed: There is no assurance that the Company’s
−Removed: plans to raise capital or to consummate a business combination will be successful or successful within the Combination Period.
−Removed: The financial statements do not include any adjustments that
−Removed: might result from the outcome of the uncertainty.
−Removed: change in cash for the year ended December 31, 2023 was a decrease of $256,429 and was comprised of cash used in operating activities
−Removed: of $601,304, cash used in investing activities of $1,320,000 and cash provided by financing activities of $1,664,875.
−Removed: The cash used in investing activities was the deposit into the trust account for the Company’s extension of
−Removed: deadline to consummate the business combination.
−Removed: The cash provided by financing activities was interest or dividend derived from the investment
−Removed: held in the Company’s trust account.
−Removed: do not have any long-term debt obligations, capital lease obligations, operating lease obligations, purchase obligations or long-term
−Removed: Sponsor, officers and directors, or any of their respective affiliates, will be reimbursed for any out-of-pocket expenses incurred in
−Removed: connection with activities on our behalf such as identifying potential target businesses and performing due diligence on suitable business
−Removed: combinations.
−Removed: Our audit committee will review on a quarterly basis all payments that were made to our Sponsor, officers or directors
−Removed: or our or their affiliates and will determine which expenses and the amount of expenses that will be reimbursed.
−Removed: There is no cap or ceiling
−Removed: on the reimbursement of out-of-pocket expenses incurred by such persons in connection with activities on our behalf.
−Removed: addition, in order to finance transaction costs in connection with an intended initial business combination, our Sponsor or an affiliate
−Removed: of our Sponsor or certain of our officers and directors may, but are not obligated to, loan us funds as may be required.
−Removed: If we complete
−Removed: our initial business combination, we would repay such loaned amounts.
−Removed: In the event that our initial business combination does not close,
−Removed: we may use a portion of the working capital held outside the trust account to repay such loaned amounts, but no proceeds from our trust
−Removed: account would be used for such repayment.
−Removed: The terms of such loans by our officers and directors, if any, have not been determined and
−Removed: no written agreements exist with respect to such loans.
−Removed: We do not expect to seek loans from parties other than our Sponsor or an affiliate
−Removed: of our Sponsor as we do not believe third parties will be willing to loan such funds and provide a waiver against any and all rights
−Removed: to seek access to funds in our trust account.
−Removed: Sponsor has agreed (a) to waive its redemption rights with respect to any Founder Shares and Public Shares held by it in connection with
−Removed: the completion of a business combination and (b) not to propose an amendment to the Amended and Restated Memorandum and Articles of Association
−Removed: (i) to modify the substance or timing of the Company’s obligation to allow redemption in connection with the our initial business
−Removed: combination or to redeem 100% of the Public Shares if we do not complete a business combination within the Combination Period or (ii)
−Removed: with respect to any other provision relating to shareholders’ rights or pre-initial business combination activity, unless we provide
−Removed: the Public Shareholders with the opportunity to redeem their Public Shares upon approval of any such amendment at a per-share price,
−Removed: payable in cash, equal to the aggregate amount then on deposit in the trust account, including interest earned on the trust account and
−Removed: not previously released to pay taxes, divided by the number of then issued and outstanding Public Shares.
−Removed: Sponsor has agreed to waive its rights to liquidating distributions from the trust account with respect to the Founder Shares it will
−Removed: receive if we fail to complete a business combination within the Combination Period.
−Removed: However, if the Sponsor or any of its respective
−Removed: affiliates acquire Public Shares, such Public Shares will be entitled to liquidating distributions from the trust account if we fail
−Removed: to complete a business combination within the Combination Period.
−Removed: In the event of such distribution, it is possible that the per share
−Removed: value of the assets remaining available for distribution will be less than the Public Offering price per Unit ($10.00).
−Removed: holders of the Founder Shares, Placement Units and Units that may be issued upon conversion of Working Capital Loans (and any shares
−Removed: of Ordinary Shares issuable upon the exercise of the Private Placement Right) will be entitled to registration rights pursuant to a registration
−Removed: rights agreement signed prior to or on the effective date of the IPO requiring us to register such securities for resale.
−Removed: of these securities will be entitled to make up to three demands, excluding short form registration demands, that we register such securities.
−Removed: In addition, the holders have certain “piggy-back” registration rights with respect to registration statements filed subsequent
−Removed: to completion of a business combination and rights to require us to register for resale such securities pursuant to Rule 415 under the
−Removed: Securities Act.
−Removed: However, the registration rights agreement provides that we will not be required to effect or permit any registration
−Removed: or cause any registration statement to become effective until the securities covered thereby are released from their lock-up restrictions.
−Removed: We will bear the expenses incurred in connection with the filing of any such registration statements.
−Removed: Accounting Estimates
−Removed: preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United
−Removed: States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure
−Removed: of contingent assets and liabilities at the date of the financial statements, and income and expenses during the periods reported.
−Removed: results could materially differ from those estimates.
−Removed: consider an accounting estimate to be critical if:
−Removed: (i) the accounting estimate requires us to make assumptions about matters that were
−Removed: highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from
−Removed: period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact
−Removed: on our financial condition.
−Removed: We have not identified any
−Removed: critical accounting estimates other than below .
−Removed: Financial Instruments
−Removed: evaluate our financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded
−Removed: derivatives in accordance with ASC Topic 815, “ Derivatives and Hedging .” For derivative financial instruments
−Removed: that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is
−Removed: then re-valued at each reporting date, with changes in the fair value reported in the statements of operations.
−Removed: The classification
−Removed: of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated at the
−Removed: end of each reporting period.
−Removed: Derivative liabilities are classified in the balance sheet as current or non-current based on whether
−Removed: or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.
−Removed: over-allotment option is deemed to be a freestanding financial instrument indexed on the contingently redeemable shares and was
−Removed: accounted for as a liability pursuant to ASC 480.
+Added: Management’s Discussion and Analysis
+Added: of Financial Condition and Results of Operations
+Added: The following discussion and analysis of our
+Added: financial condition and results of operations should be read together with our audited financial statements for the years ended September
+Added: 30, 2024 and 2023 and related notes included elsewhere in this annual report.
+Added: The following discussion contains “forward-looking
+Added: statements” that reflect our future plans, estimates, beliefs and expected performance.
+Added: Our actual results may differ materially
+Added: from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors.
+Added: We caution that
+Added: assumptions, expectations, projections, intentions, or beliefs about future events may, and often do, vary from actual results and the
+Added: differences can be material.
+Added: Please see “Cautionary Note Regarding Forward-Looking Statements” as well as “Risk Factors-
+Added: Risks Related to the Company’s Business and Our Industry.”
+Added: Citius Oncology is a specialty biopharmaceutical
+Added: company focused on developing and commercializing innovative targeted oncology therapies.
+Added: We are commercializing LYMPHIR (denileukin diftitox),
+Added: an oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma.
+Added: LYMPHIR was approved by the FDA in August 2024.
+Added: We were incorporated in the Cayman Islands on
+Added: March 1, 2021, for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar
+Added: business combination with one or more businesses.
+Added: In August 2024, we reincorporated in Delaware and completed the Merger whereby we acquired
+Added: SpinCo as a wholly owned subsidiary and changed our name to Citius Oncology, Inc.
+Added: SpinCo began operations in April 2022.
+Added: Since inception, the Company has devoted substantially
+Added: all of our efforts to business planning, research and development, and recruiting management and technical staff.
+Added: The Company is subject
+Added: to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development
+Added: by the Company or our competitors of research and development stage products, market acceptance of our approved products, competition
+Added: from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s ability to
+Added: obtain additional financing and the Company’s compliance with governmental and other regulations.
+Added: License Agreement with Eisai
+Added: In September 2021, Citius Pharma entered into
+Added: an asset purchase agreement with Dr.
+Added: Reddy’s and a license agreement with Eisai to acquire an exclusive license for E7777 (denileukin
+Added: diftitox), a late-stage oncology immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma.
+Added: Citius Pharma assigned
+Added: these agreements to us effective April 1, 2022.
+Added: Citius Pharma renamed E7777 as I/ONTAK and also obtained the trade name LYMPHIR TM
+Added: for the product.
+Added: Denileukin diftitox is referred to in this annual report as E7777, I/ONTAK or LYMPHIR, depending on the period of time
+Added: and context that is being discussed.
+Added: Under the terms of the
+Added: agreements, Citius Pharma acquired Dr.
+Added: Reddy’s exclusive license for E7777 from Eisai and other related assets owned by Dr.
+Added: The exclusive license includes rights to develop and commercialize E7777 in all markets except for Japan and certain parts of Asia.
+Added: Additionally,
+Added: we retain an option on the right to develop and market the product in India.
+Added: Eisai retains exclusive development and marketing rights
+Added: for the agent in Japan, China, Korea, Taiwan, Hong Kong, Macau, Indonesia, Thailand, Malaysia, Brunei, Singapore, India (subject to the
+Added: India option), Pakistan, Sri Lanka, Philippines, Vietnam, Myanmar, Cambodia, Laos, Afghanistan, Bangladesh, Bhutan, Nepal, Mongolia, and
+Added: Papua New Guinea.
+Added: Citius Pharma paid $40 million upfront payment which represents the acquisition date fair value of the in-process research
+Added: and development acquired from Dr.
+Added: Reddy’s is entitled to up to $40 million in development milestone payments
+Added: related to CTCL approvals in the U.S.
+Added: and other markets, up to $70 million in development milestones for additional indications, as well
+Added: as commercial milestone payments and low double-digit tiered royalties on net product sales (within a range of 10% to 15%), and up to
+Added: $300 million for commercial sales milestones.
+Added: We also must pay on a fiscal quarter basis tiered royalties equal to low double-digit percentages
+Added: of net product sales (within a range of 10% to 15%).
+Added: The royalties will end on the earlier of (i) the 15-year anniversary of the first
+Added: commercial sale of the latest indication that received regulatory approval in the applicable country and (ii) the date on which a biosimilar
+Added: product results in the reduction of net sales in the applicable product by 50% in two consecutive quarters, as compared to the four quarters
+Added: prior to the first commercial sale of the biosimilar product.
+Added: We will also pay to Dr.
+Added: Reddy’s an amount equal to a low-thirties
+Added: percentage of any sublicense upfront consideration or milestone payments (or the like) received by us and the greater of (i) a low-thirties
+Added: percentage of any sublicensee sales-based royalties or (ii) a mid-single digit percentage of such licensee’s net sales.
+Added: At the time of the FDA approval for LYMPHIR, a
+Added: $27.5 million milestone payment became payable under the terms of the asset purchase agreement for which a balance of $22.5 million remains
+Added: due as of September 30, 2024.
+Added: Pending further discussions with Dr.
+Added: Reddy’s agreed to a partial deferral without
+Added: penalty of this milestone payment.
+Added: Under the license agreement, Eisai is to
+Added: receive a $5.9 million milestone payment, upon FDA approval which is included in license payable at September 30, 2024, and
+Added: additional commercial milestone payments related to the achievement of net product sales thresholds and an aggregate of up to $22
+Added: million related to the achievement of net product sales thresholds.
+Added: Citius Pharma was also required to reimburse Eisai for up to
+Added: $2.65 million of its costs to complete the Phase 3 pivotal clinical trial for LYMPHIR for the CTCL indication and reimburse Eisai
+Added: for all reasonable costs associated with the preparation of a BLA for LYMPHIR.
+Added: Eisai was responsible for completing the CTCL
+Added: clinical trial, and CMC activities through the filing of the BLA for LYMPHIR with the FDA.
+Added: The Company will be responsible for
+Added: development costs associated with potential additional indications.
+Added: The term of the license
+Added: agreement will continue until (i) if there has not been a commercial sale of a licensed product in the territory, the 10-year anniversary
+Added: of the original license effective date, March 30, 2016, or (ii) if there has been a first commercial sale of a licensed product in the
+Added: territory within the 10-year anniversary of the original license effective date, the 10-year anniversary of the first commercial sale
+Added: on a country-by-country basis.
+Added: The term of the license may be extended for additional 10-year periods for all countries in the territory
+Added: by notifying Eisai and paying an extension fee equal to $10 million.
+Added: Either party may terminate the license agreement upon written notice
+Added: if the other party is in material breach of the agreement, subject to cure within the designated time periods.
+Added: Either party also may terminate
+Added: the license agreement immediately upon written notice if the other party files for bankruptcy or takes related actions or is unable to
+Added: pay its debts as they become due.
+Added: Additionally, either party will have the right to terminate the agreement if the other party directly
+Added: or indirectly challenges the patentability, enforceability or validity of any licensed patent.
+Added: Also under the purchase
+Added: agreement with Dr.
+Added: Reddy’s, we are required to (i) use commercially reasonable efforts to make commercially available products in
+Added: the CTCL indication, peripheral T-cell lymphoma indication and immuno-oncology indication, (ii) initiate two investigator initiated immuno-oncology
+Added: trials (both of which have been initiated), (iii) use commercially reasonable efforts to achieve each of the approval milestones, and
+Added: (iv) to complete each specified immuno-oncology investigator trial on or before the four-year anniversary of the effective date of the
+Added: definitive agreement.
+Added: Additionally, we are required to commercially launch a product in a territory within six months of receiving regulatory
+Added: approval for such product in each such jurisdiction.
+Added: RESULTS OF OPERATIONS
+Added: Results of Operations for Year Ended September
+Added: 30, 2024 compared to Year Ended September 30, 2023
+Added: Year Ended September 30,
+Added: September 30,
+Added: Operating expenses:
+Added: Research and development
+Added: General and administrative
+Added: Stock-based compensation – general and administrative
+Added: Total operating expenses
+Added: Loss before income taxes
+Added: (20,572,747 )
+Added: (12,121,241 )
+Added: Income tax expense
+Added: $ (21,148,747 )
+Added: $ (12,697,241 )
+Added: We did not generate any revenues for the years
+Added: ended September 30, 2024 and 2023.
+Added: Research and Development Expenses
+Added: For the year ended September 30, 2024, research
+Added: and development expenses were $4,925,001 as compared to $4,240,451 for the year ended September 30, 2023, an increase of $684,550 due
+Added: to development activities completed for the resubmission of the BLA of LYMPHIR in January 2024 which were associated with CRL remediation.
+Added: General and Administrative Expenses
+Added: For the year ended September 30, 2024, general
+Added: and administrative expenses were $8,148,929 as compared to $5,915,290 for the year ended September 30, 2023, an increase of $2,233,639.
+Added: The primary reason for the increase was the efforts associated with the pre-commercial and commercial launch activities of LYMPHIR associated
+Added: with market research, marketing, distribution and drug product reimbursement from health plans and payers.
+Added: Stock-based Compensation Expense
+Added: For the year ended September 30, 2024, stock-based
+Added: compensation expense was $7,498,817 as compared to $1,965,500 for the year ended September 30, 2023.
+Added: The primary reason for the $5,533,317
+Added: increase in stock-based compensation expense was the amounts were realized over 12 months in the year ended September 30, 2024 as compared
+Added: to three months post-plan adoption in the year ended September 30, 2023.
+Added: The Company recorded deferred income tax expense
+Added: of $576,000 in each of the years ended September 30, 2024 and 2023 related to the amortization for taxable purposes of its in-process
+Added: research and development asset.
+Added: For the year ended September 30, 2024, we incurred
+Added: a net loss of $21,148,747 compared to a net loss of $12,697,241 for the year ended September 30, 2023.
+Added: The $8,451,506 increase in the
+Added: net loss was primarily due to the increase in our operating expenses.
+Added: LIQUIDITY AND CAPITAL RESOURCES
+Added: Liquidity and Working Capital
+Added: Citius Oncology has incurred operating losses
+Added: since inception and incurred net losses of $21,148,747 and $12,697,241 for the years ended September 30, 2024 and 2023, respectively.
+Added: At September 30, 2024, Citius Oncology had an accumulated deficit of $39,278,587.
+Added: Citius Oncology’s net cash provided by operations
+Added: during the years ended September 30, 2024 and 2023 was $126,353 and $-0-, respectively.
+Added: Investing Activities
+Added: During 2024, the Company paid $5,000,000 in connection
+Added: with a partial milestone payments due under its asset purchase agreement with Dr.
+Added: Financing Activities
+Added: In connection with closing of the Merger, Citius
+Added: Pharma, made a contribution to the Company’s capital in the amount of $33,180,961 representing the balance of the due to/due from
+Added: related party account on the date of the Merger.
+Added: Citius Pharma also made cash contributions to the Company’s capital, pursuant to
+Added: the terms of the Merger Agreement, in the amount of $3,827,944.
+Added: Also, in connection with the Merger, Citius Pharma
+Added: advanced cash to the Company for an unsecured promissory note issued by the Company in the principal amount of $3,800,111.
+Added: Our management believes that inflation
+Added: has not had a material effect on our results of operations.
+Added: Off Balance Sheet Arrangements
+Added: We do not have any off-balance sheet arrangements.
+Added: CRITICAL ACCOUNTING POLICIES
+Added: Our discussion and analysis of our financial condition
+Added: and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally
+Added: accepted in the United States.
+Added: The preparation of these financial statements requires us to make estimates and judgments that affect the
+Added: reported amounts of assets, liabilities and expenses and related disclosure of contingent assets and liabilities.
+Added: We review our estimates
+Added: on an ongoing basis.
+Added: We base our estimates on historical experience and on various other factors that we believe to be reasonable under
+Added: the circumstances.
+Added: Actual results may differ from these estimates.
+Added: We believe the judgments and estimates required by the following accounting
+Added: policies to be critical in the preparation of our financial statements.
+Added: In-process Research and Development
+Added: The Company capitalizes intangible assets purchased from others for
+Added: use in research and development activities as In Process Research & Development (IPR&D) when the assets acquired have an alternative
+Added: future use, the Company anticipates future economic benefit from that use and the assets acquired are not dependent on future development.
+Added: Milestone payments upon regulatory approval that meet the same criteria are capitalized when the payments are considered recoverable based
+Added: on expected future cash flows.
+Added: Amortization of IPR&D over the exclusive regulatory period of the acquired asset commences upon revenue
+Added: In-process research and development of $73,400,000
+Added: represents the value of our September 2021 acquisition of an exclusive license for LYMPHIR (denileukin diftitox), a late-stage oncology
+Added: immunotherapy for the treatment of CTCL, a rare form of non-Hodgkin lymphoma and is expected to be amortized on a straight-line basis
+Added: over a period of 12 years commencing upon revenue generation.
+Added: In-process research and development consists of $40,000,000 paid to Dr.
+Added: Reddy’s from the asset purchase agreement and approval milestone fees of $27,500,000 to Dr.
+Added: Reddy’s and $5,900,000 to Eisai.
+Added: Incremental costs incurred on IPR&D after
+Added: the acquisition date are expensed as incurred, unless there is an alternative future use.
+Added: The Company reviews intangible assets annually
+Added: to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the
+Added: remaining useful life of any intangible asset.
+Added: If the carrying value of an asset exceeds its undiscounted cash flows, the Company writes
+Added: down the carrying value of the intangible asset to its fair value for the period identified.
+Added: No impairments have occurred since the acquisitions
+Added: of our intangible assets through September 30, 2024.
+Added: Stock-Based Compensation
+Added: The Company recognizes compensation costs resulting from the issuance
+Added: of stock-based awards to employees and directors as an expense in the consolidated statement of operations over the requisite service
+Added: period based on the fair value for each stock award on the grant date.
+Added: The fair value of each option grant is estimated as of the date
+Added: of grant using the Black-Scholes option pricing model.
+Added: The Company estimates volatility using the trading activity of its common stock.
+Added: Because the Company’s stock options have characteristics significantly different from those of traded options, and because changes
+Added: in the input assumptions can materially affect the fair value estimate, the existing model may not necessarily provide a reliable single
+Added: measure of fair value of the Company’s stock options.
+Added: The Company recognizes compensation costs resulting from the issuance
+Added: of stock-based awards to non-employees as an expense in the consolidated statement of operations over the service period based on the
+Added: measurement of fair value for each stock award and records forfeitures as they occur.
+Added: We follow accounting guidance regarding the recognition, measurement,
+Added: presentation, and disclosure of uncertain tax positions in the financial statements.
+Added: Tax positions taken or expected to be taken in the
+Added: course of preparing our tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not”
+Added: of being sustained by the applicable tax authorities.
+Added: Tax positions not deemed to meet a more-likely-than-not threshold would be recorded
+Added: in the financial statements.
+Added: We recognize deferred tax assets and liabilities based on differences
+Added: between the financial reporting and tax basis of assets and liabilities using the enacted tax rates and laws that are expected to be in
+Added: effect when the differences are expected to reverse.
+Added: We provide a valuation allowance for deferred tax assets for which we do not consider
+Added: realization of such assets to be more likely than not.
+Added: Quantitative and Qualitative Disclosures
+Added: About Market Risk
+Added: Not required.
+Added: Financial Statements and Supplementary Data
+Added: See the financial statements included in this report beginning on page
+Added: Changes in and Disagreements with Accountants
+Added: on Accounting and Financial Disclosure
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.