Product Launch and Market Potential - Citius Oncology launched LYMPHIR™, a novel immunotherapy, in the U.S. in December 2025 for treating adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy [3] - The initial market for LYMPHIR is estimated to exceed $400 million, indicating significant growth potential in an underserved market [5] - Citius Oncology secured access to LYMPHIR in 19 international markets through regional distribution partners via Named Patient Programs, marking a step in its global access strategy [6] - The company announced a collaboration with Verix to enhance commercial targeting and provider engagement for LYMPHIR's U.S. commercialization [6] Financial Performance - The net loss for the fiscal year ended September 30, 2025, was $24.8 million, or ($0.34) per share, compared to a net loss of $21.1 million, or ($0.31) per share, in 2024 [6] - Net loss for 2025 was $(24,761,369), compared to $(21,148,747) in 2024, indicating a worsening financial position [16] - Cash and cash equivalents stood at $3.9 million as of September 30, 2025, compared to $112 in 2024 [11] - Cash and cash equivalents at the end of 2025 were $3,924,908, a significant increase from $112 at the beginning of the year, indicating improved liquidity [16] Expenses and Costs - Research and development expenses increased to $6.4 million for the fiscal year ended September 30, 2025, up from $4.9 million in 2024 [6] - General and administrative expenses rose to $8.8 million for the fiscal year ended September 30, 2025, compared to $8.1 million in 2024 [6] - Stock-based compensation expense increased to $8,320,419 in 2025 from $7,498,817 in 2024, reflecting higher employee compensation costs [16] - License payments for 2025 totaled $(5,750,000), consistent with $(5,000,000) in 2024, reflecting ongoing investment in intellectual property [16] Cash Flow and Financing - Net cash used in operating activities was $(5,492,046) in 2025, a decline from a positive cash flow of $126,353 in 2024, indicating operational challenges [16] - Net cash provided by financing activities rose to $15,166,842 in 2025, up from $4,873,759 in 2024, showing increased capital raising efforts [16] - Interest paid in 2025 was $187,389, while no interest was reported in 2024, indicating new financing arrangements [16] Inventory and Assets - Citius Oncology's total assets increased to $100.9 million as of September 30, 2025, compared to $84.4 million in 2024 [11] - Inventory changes resulted in a significant increase of $(12,649,207) in 2025, compared to $(2,133,871) in 2024, suggesting potential overstock issues [16] - Net prepaid manufacturing transferred to inventory was $1,368,720 in 2025, down from $6,134,895 in 2024, indicating a shift in production strategy [16] - The company reported a capital contribution of due to related party by parent of $33,180,961 in 2024, which was not repeated in 2025 [16]

Product Development and Approval - The Company’s lead product, LYMPHIR, is projected to address a market estimated to exceed $400 million for the treatment of persistent or recurrent CTCL [28]. - LYMPHIR received FDA approval in August 2024 and was launched in December 2025, with a targeted oncology sales force established for its commercialization [28][29]. - The Phase 3 trial (E7777-G000-302) demonstrated an overall response rate (ORR) of 36.2% among 69 subjects treated with LYMPHIR at a dose of 9 µg/kg/day [39][46]. - The median duration of response for LYMPHIR was 6.5 months, with 52% of responders maintaining their response for at least 6 months [40][46]. - Serious adverse reactions occurred in 38% of patients, with capillary leak syndrome (10%) and infusion-related reactions (9%) being the most common [49]. - The pivotal trial included a diverse patient population, with a median age of 64 years and a median of 4 prior therapies per patient [43]. - The FDA accepted the trial data demonstrating both tolerability and clinical benefit, despite a marginal shortfall in the statistical confidence interval for the primary endpoint [47]. - The Phase I Clinical Trial of Pembrolizumab and LYMPHIR demonstrated a partial response rate of 27% (4 out of 15 evaluable patients) and a clinical benefit rate of 33% (5 out of 15) among evaluable patients [64][65]. - The median progression-free survival (PFS) for patients achieving clinical benefit was 57 weeks, with a range of 30 to 96 weeks [65]. - LYMPHIR was included in the National Comprehensive Cancer Network (NCCN) guidelines with a Category 2A recommendation, indicating it is an appropriate treatment option for CTCL patients [89]. Commercialization Strategy - The commercialization strategy includes direct sales revenue and royalty income, with anticipated incremental operating expenses [29]. - The Company has entered into distribution agreements with Cardinal Health, Cencora, and McKesson Corporation to support the launch and commercialization of LYMPHIR [88]. - The Company has contracted with EVERSANA to provide an integrated suite of pre- and post-launch services for LYMPHIR [88]. - The Company plans to focus its commercial efforts on a targeted group of prescribing hematologists, oncologists, and dermatologist-oncologists to facilitate the successful launch of LYMPHIR [87]. - The Company has secured supply agreements for LYMPHIR with third-party cGMP facilities, ensuring compliance with FDA standards [92]. - Contract manufacturers have sufficient capacity to support demand for LYMPHIR and future products as the business grows [93]. - The Company has contracted with third-party commercial sales and marketing organizations to assist in the commercialization of LYMPHIR, indicating reliance on external infrastructure [154]. - The market acceptance of LYMPHIR is uncertain, and its success will depend on factors such as pricing, reimbursement, and perceptions by healthcare professionals [175]. Financial Obligations and Funding - The Company is obligated to pay up to $40 million related to CTCL approvals and up to $300 million for commercial sales milestones under the asset purchase agreement with Dr. Reddy's [104]. - A $27.5 million milestone payment became payable to Dr. Reddy's upon FDA approval for LYMPHIR, with a balance of $19.75 million remaining due as of September 30, 2025 [107]. - The Company has accrued a $2.9 million unpaid balance of the development milestone payment to Eisai as of September 30, 2025 [98]. - The license agreement with Eisai includes a $5.9 million development milestone payment upon initial FDA approval and up to $22 million related to net product sales thresholds [98]. - The Company is required to make aggregate payments of $33.4 million under the license and asset purchase agreements for LYMPHIR upon FDA approval [161]. - The company has raised $6.0 million in October 2025 and $18.0 million in December 2025, estimating sufficient capital to continue operations through March 2026 [137]. - The company has raised $18 million in capital raises through December 10, 2025, with an uncertain likelihood of raising an additional $12 million to trigger repayment obligations on a $3.8 million promissory note [145]. - The company incurred a net loss of $24.7 million for the year ended September 30, 2025, with stockholders' equity of $44.9 million and an accumulated deficit of $64 million [143]. - As of September 30, 2025, the company has outstanding commitments totaling $38.4 million due to third-party suppliers and manufacturers, primarily related to the development and commercialization of LYMPHIR [144]. Regulatory and Compliance Challenges - The FDA requires substantial time and financial resources for marketing approval, including extensive testing and compliance with cGMP regulations [112]. - The company must achieve specific milestones and launch products within six months of receiving regulatory approval in each jurisdiction [105]. - The regulatory approval of LYMPHIR was granted by the FDA in August 2024, but ongoing compliance with extensive regulations will incur significant expenses and limit commercialization efforts [208]. - The FDA has substantial discretion in the drug approval process, which could impact the approval of future product candidates [172]. - The company must obtain separate approvals from foreign regulatory authorities for product marketing in other countries, which may involve different requirements than those of the FDA [132]. Market and Competitive Landscape - The competitive landscape in the pharmaceutical industry is intense, with several companies targeting the same conditions as LYMPHIR, many of which have greater resources and experience [184]. - Legislative and regulatory changes, including healthcare reform measures, could impact the pricing and reimbursement of LYMPHIR, potentially reducing demand for the product [186]. - The company faces significant uncertainty regarding the reimbursement status of LYMPHIR, which could affect its market acceptance and revenue generation [179]. - The company faces potential challenges in obtaining sufficient reimbursement rates from health administration authorities in countries outside the U.S., which could adversely affect profitability [181]. - Legislative changes, including the Inflation Reduction Act of 2022, could materially affect the healthcare industry and the company's business [129]. Operational Risks and Strategic Alternatives - The company is evaluating strategic alternatives, including partnerships, joint ventures, mergers, acquisitions, and licensing to secure additional funding [139]. - The company may face significant challenges in obtaining adequate reimbursement levels for its therapeutic product candidates due to increasing restrictions from governmental authorities and private insurers [122]. - The company is dependent on third parties and Citius Pharma under the A&R Shared Services Agreement [226]. - The company faces risks from the recruitment or departure of key scientific or management personnel [226]. - The loss of key personnel could harm the company's ability to attract capital and successfully commercialize LYMPHIR [193]. - The company anticipates needing to increase its organizational size to support the commercialization of LYMPHIR and future product candidates, which may strain existing infrastructure [197]. - Cybersecurity threats pose a risk to the company's information technology systems, which are critical for operations and could lead to significant disruptions if compromised [199]. Intellectual Property and Legal Considerations - The company is responsible for preparing, filing, and maintaining all patent applications and patents included in the licensed patents [102]. - The company anticipates filing additional patent applications in the U.S. and other countries, but the patent process is fraught with risks and uncertainties that may limit competitive advantages [215]. - The time from patent application to issuance often exceeds three years, resulting in market exclusivity that is likely less than 20 years due to regulatory delays [217]. - The company faces risks related to potential changes in patent law and regulations that could weaken its ability to obtain and enforce patents [218]. - The company relies on trade secret protections through confidentiality agreements, but breaches of these agreements could adversely affect its business [221]. - If the company infringes on third-party rights, it may incur substantial costs and be forced to abandon product candidates or pay damages [222]. - The company has registered the trademark "LYMPHIR," but inadequate protection could hinder brand recognition and market competitiveness [223]. Financial Performance and Future Outlook - The company has generated no operating revenue to date and relies on equity instruments and funding through Citius Pharma to finance operations [138]. - The commercialization of LYMPHIR is critical for the company to generate substantial revenue and continue operations beyond March 2026 [138]. - The company expects to incur additional expenses as it continues to develop future product candidates and seeks regulatory approval [139]. - The company's cash resources are critical for successfully commercializing LYMPHIR, covering costs of licensing payments and product manufacturing [226]. - The company's ability to meet contractual obligations and commercialize LYMPHIR or future product candidates is essential for performance [226]. - Marketing efforts for LYMPHIR and future product candidates will impact success and associated costs [226]. - Unanticipated serious safety concerns related to LYMPHIR or other product candidates could adversely affect the company [226]. - Announcements of significant acquisitions or strategic partnerships could impact market perception and stock performance [226]. - The company's failure to meet investment community estimates may lead to negative market reactions [226].

[Company Overview and Business Update](index=1&type=section&id=Company_Overview_and_Business_Update) Citius Oncology is preparing for the Q4 2025 U.S. commercial launch of FDA-approved LYMPHIR, targeting an underserved CTCL market exceeding $400 million [Business Highlights and LYMPHIR Commercialization](index=1&type=section&id=Business_Highlights_and_LYMPHIR_Commercialization) Citius Oncology is in the final stages of preparing for the U.S. commercial launch of LYMPHIR, planned for the fourth quarter of 2025. This initiative is supported by recent capital raises and established distribution agreements - **LYMPHIR commercial availability** is planned for the **fourth quarter of 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) - Citius Pharmaceuticals raised **$12.5 million** in gross financings during the quarter, with Citius Oncology raising an additional **$9 million** in July 2025, to facilitate LYMPHIR pre-launch initiatives[1](index=1&type=chunk) - The company has secured distribution service agreements with leading global providers and has launch supplies ready[2](index=2&type=chunk) [About Citius Oncology, Inc.](index=2&type=section&id=About_Citius_Oncology_Inc) Citius Oncology is a specialty biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies. Its primary asset, LYMPHIR, received FDA approval for relapsed or refractory CTCL, targeting an underserved market estimated to exceed $400 million - Citius Oncology is a specialty biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies[5](index=5&type=chunk) - **LYMPHIR** was approved by the FDA in **August 2024** for the treatment of adults with relapsed or refractory CTCL who had at least one prior systemic therapy[5](index=5&type=chunk) - Management estimates the initial market for LYMPHIR currently exceeds **$400 million**, is growing, and is underserved by existing therapies[5](index=5&type=chunk) [Fiscal Third Quarter 2025 Financial Performance](index=1&type=section&id=Fiscal_Third_Quarter_2025_Financial_Performance) The company reported an increased net loss of $5.4 million for Q3 2025, with significant balance sheet changes including higher inventory and liabilities, and no net cash from operations [Key Financial Highlights](index=1&type=section&id=Key_Financial_Highlights) For the fiscal third quarter ended June 30, 2025, Citius Oncology reported a net loss of $5.4 million, an increase from $4.8 million in the prior year. R&D expenses decreased while G&A and stock-based compensation expenses increased. The company also completed a public offering in July 2025, generating approximately $7.4 million in net proceeds - On July 17, 2025, Citius Oncology completed a public offering generating net proceeds of approximately **$7.4 million**[3](index=3&type=chunk) Fiscal Third Quarter 2025 Financial Highlights (YoY) | Metric | Q3 2025 (USD) | Q3 2024 (USD) | Change (YoY) (USD) | | :----------------------- | :---------- | :---------- | :----------- | | R&D expenses | $938,000 | $1.1 million | ↓ $162,000 | | G&A expenses | $1.9 million | $1.5 million | ↑ $400,000 | | Stock-based compensation | $2.1 million | $2.0 million | ↑ $100,000 | | Net loss | $(5.4) million | $(4.8) million | ↑ $(0.6) million | | Net loss per share | $(0.08) | $(0.07) | ↑ $(0.01) | - As of June 30, 2025, the Company had **$112** in cash and cash equivalents and **71,552,402** common shares outstanding[3](index=3&type=chunk) [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed_Consolidated_Balance_Sheets) As of June 30, 2025, Citius Oncology's total assets increased to $91.7 million from $84.4 million at September 30, 2024, primarily driven by a significant increase in inventory. Total liabilities also rose substantially, leading to a decrease in total stockholders' equity Condensed Consolidated Balance Sheets Summary | Metric | June 30, 2025 (USD) | September 30, 2024 (USD) | Change (USD) | | :-------------------------- | :---------------- | :------------------- | :----- | | Total Current Assets | $18,309,079 | $10,968,878 | ↑ $7,340,201 | | Total Assets | $91,709,079 | $84,368,878 | ↑ $7,340,201 | | Total Current Liabilities | $52,990,335 | $32,700,428 | ↑ $20,289,907 | | Total Liabilities | $59,311,166 | $38,228,539 | ↑ $21,082,627 | | Total Stockholders' Equity | $32,397,913 | $46,140,339 | ↓ $13,742,426 | - Inventory increased significantly from **$8,268,766** at September 30, 2024, to **$17,208,967** at June 30, 2025[9](index=9&type=chunk) - Accounts payable increased from **$3,711,622** to **$8,667,419**, and accrued expenses rose from **$0** to **$8,458,554**[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed_Consolidated_Statements_of_Operations) For the three months ended June 30, 2025, Citius Oncology reported a net loss of $5.37 million, an increase from $4.77 million in the prior year, primarily due to higher general and administrative expenses and the introduction of interest expense. For the nine-month period, the net loss widened to $19.76 million Statements of Operations (Three Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | Change (USD) | | :-------------------------- | :---------- | :---------- | :----- | | Revenues | $0 | $0 | No change | | Research and development | $938,277 | $1,131,439 | ↓ $193,162 | | General and administrative | $1,881,447 | $1,540,411 | ↑ $341,036 | | Total Operating Expenses | $4,944,961 | $4,628,850 | ↑ $316,111 | | Operating Loss | $(4,944,961) | $(4,628,850) | ↑ $(316,111) | | Interest expense | $160,755 | $0 | New expense | | Net Loss | $(5,369,956) | $(4,772,850) | ↑ $(597,106) | | Net Loss Per Share | $(0.08) | $(0.07) | ↑ $(0.01) | Statements of Operations (Nine Months Ended June 30) | Metric | 2025 (USD) | 2024 (USD) | Change (USD) | | :-------------------------- | :------------ | :------------ | :----- | | Research and development | $5,342,198 | $3,628,900 | ↑ $1,713,298 | | General and administrative | $7,446,753 | $4,443,899 | ↑ $3,002,854 | | Total Operating Expenses | $18,811,238 | $13,903,799 | ↑ $4,907,439 | | Net Loss | $(19,764,713) | $(14,335,799) | ↑ $(5,428,914) | | Net Loss Per Share | $(0.28) | $(0.21) | ↑ $(0.07) | - Stock-based compensation included in general and administrative expenses was **$2,125,237** for Q3 2025 and **$6,022,287** for the nine months ended June 30, 2025[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed_Consolidated_Statements_of_Cash_Flows) For the nine months ended June 30, 2025, Citius Oncology reported no net cash provided by operating activities, despite a net loss of $19.76 million. This was influenced by non-cash adjustments like stock-based compensation and significant changes in operating assets and liabilities, particularly an increase in inventory and accrued expenses - Net loss for the nine months ended June 30, 2025, was **$(19,764,713)**[13](index=13&type=chunk) Key Adjustments to Net Loss for Cash Flow (Nine Months Ended June 30) | Adjustment | 2025 (USD) | 2024 (USD) | | :-------------------------- | :----------- | :----------- | | Stock-based compensation expense | $6,022,287 | $5,831,000 | | Deferred income tax expense | $792,720 | $432,000 | | Inventory | $(8,940,201) | $0 | | Prepaid expenses | $1,600,000 | $(2,271,920) | | Accounts payable | $4,955,797 | $(1,289,045) | | Accrued expenses | $8,458,554 | $185,930 | | Due to related party | $6,875,556 | $11,447,834 | - Net Cash Provided By Operating Activities was **$0** for both the nine months ended June 30, 2025, and 2024[13](index=13&type=chunk) [Forward-Looking Statements and Risks](index=2&type=section&id=Forward_Looking_Statements_and_Risks) This section highlights substantial risks, including the need for additional funding, challenges in LYMPHIR commercialization, and compliance with regulatory and market standards [Forward-Looking Statements and Risks](index=2&type=section&id=Forward_Looking_Statements_and_Risks_Details) This section outlines various forward-looking statements and significant risks that could impact Citius Oncology's future performance. Key risks include the need for substantial additional funding, challenges in commercializing LYMPHIR, maintaining financing agreements, market acceptance, Nasdaq compliance, supply chain dependencies, intellectual property matters, and regulatory and competitive pressures - Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect business, operating results, financial condition, and stock price[6](index=6&type=chunk) - Key risks include the need for substantial additional funds to fund operations beyond **September 2025** and for at least the next **12 months** as a going concern[6](index=6&type=chunk) - Other significant risks involve the ability to commercialize LYMPHIR, obtain and maintain financing and strategic agreements, market acceptance, compliance with Nasdaq listing standards, dependence on third-party suppliers, intellectual property matters, government regulation, and competition[6](index=6&type=chunk) [Investor Information](index=2&type=section&id=Investor_Information) This section provides essential contact details for investor and media inquiries [Contact Information](index=2&type=section&id=Contact_Information) This section provides contact details for investor and media inquiries - Investor Contact: Ilanit Allen at ir@citiuspharma.com or **908-967-6677 x113**[7](index=7&type=chunk) - Media Contact: Greg Salsburg at Greg@STiR-communications.com[7](index=7&type=chunk)

Financial Performance - Citius Oncology reported no revenues for the three months ended June 30, 2025, and 2024[84]. - The net loss for the three months ended June 30, 2025, was $5,369,956, an increase of 12.5% from a net loss of $4,772,850 in the same period of 2024[92]. - The net loss for the nine months ended June 30, 2025, was $19,764,713, an increase of $5,428,914 from a net loss of $14,335,799 in the prior year[100]. - As of June 30, 2025, the company had an accumulated deficit of $59,043,300 and a negative working capital of approximately $34.7 million[102]. Expenses - Research and development expenses for the three months ended June 30, 2025, were $938,277, a decrease of 17% from $1,131,439 in the same period of 2024[87]. - General and administrative expenses increased by 22% to $1,881,447 for the three months ended June 30, 2025, compared to $1,540,411 for the same period in 2024[88]. - For the nine months ended June 30, 2025, research and development expenses rose to $5,342,198, up 47% from $3,628,900 in the same period of 2024[95]. - The total operating expenses for the nine months ended June 30, 2025, were $18,811,238, an increase of 35% from $13,903,799 in the same period of 2024[93]. - For the nine months ended June 30, 2025, general and administrative expenses increased by $3,002,854 to $7,446,753 compared to $4,443,899 for the same period in 2024[96]. - Interest expense for the nine months ended June 30, 2025, was $160,755, compared to $0 for the same period in 2024[90]. - The company incurred interest expense of $160,755 for the nine months ended June 30, 2025, compared to $0 for the same period in 2024[98]. - Deferred income tax expense increased to $792,720 for the nine months ended June 30, 2025, from $432,000 in the prior year[99]. Agreements and Commitments - Citius Oncology entered into a distribution services agreement with Cardinal Health on June 9, 2025, to support the anticipated U.S. commercial launch of LYMPHIR[84]. - The company has a total minimum purchase commitment of approximately $18.3 million under a manufacturing agreement for 2025 and 2026[108]. - The company has outstanding milestone payments totaling $2,535,318 due to Eisai, with additional payments scheduled through December 2025[103]. - As of June 30, 2025, a milestone payment of $22.5 million remains due to Dr. Reddy's following the FDA approval of LYMPHIR[76]. Funding and Revenue Generation - Citius Pharma received net proceeds of approximately $10.5 million from equity offerings during the three months ended June 30, 2025[105]. - A public offering completed on July 17, 2025, raised gross proceeds of $9,000,000, with net proceeds of approximately $7.44 million after expenses[106]. - The company plans to rely on funding from Citius Pharma and aims to generate revenue from future sales of LYMPHIR[104]. Commercial Launch Preparations - The company is nearing completion of preparations for the commercial launch of LYMPHIR, expected in the second half of 2025[85].

Financial Performance - For the three months ended March 31, 2025, Citius Oncology reported a net loss of $7,735,552, an increase of $2,900,006 compared to a net loss of $4,835,546 for the same period in 2024[85]. - For the six months ended March 31, 2025, Citius Oncology incurred a net loss of $14,394,757, compared to a net loss of $9,562,949 for the same period in 2024, an increase of $4,831,808[92]. - Citius Oncology did not generate any revenues for the three and six months ended March 31, 2025, and 2024[80][87]. Expenses - Research and development expenses for the three months ended March 31, 2025, were $3,139,413, up from $1,348,966 in the same period in 2024, reflecting an increase of $1,790,447[81]. - General and administrative expenses increased to $2,243,327 for the three months ended March 31, 2025, compared to $1,385,580 for the same period in 2024, an increase of $857,747[82]. - Research and development expenses for the six months ended March 31, 2025, were $4,403,921, an increase of $1,906,460 from $2,497,461 in the same period in 2024[88]. - General and administrative expenses for the six months ended March 31, 2025, rose to $5,565,306 from $2,903,488 in the same period in 2024, an increase of $2,661,818[89]. - Stock-based compensation expense for the three months ended March 31, 2025, was $2,088,572, an increase of $131,572 from $1,957,000 in the same period in 2024[83]. - The company incurred a deferred income tax expense of $264,240 for the three months ended March 31, 2025, compared to $144,000 for the same period in 2024[84]. Financial Position - As of March 31, 2025, Citius Oncology had an accumulated deficit of $53,673,344 and reported cash of only $112, with a negative working capital of approximately $31.7 million[93]. - As of March 31, 2025, the company has outstanding milestone payments and purchase commitments totaling approximately $2.5 million due to Eisai and $27.5 million milestone payment to Dr. Reddy's, with a remaining balance of $22.5 million[99]. - The company has a minimum purchase commitment of approximately $17.3 million under a manufacturing agreement, with $11.9 million and $5.4 million due for calendar years 2025 and 2026, respectively[99]. - The total minimum purchase commitments under commercial supply agreements with two vendors amount to approximately $4.5 million for 2025 and 2026[99]. - The company is obligated to make a final payment of $2,197,892 to Eisai on or before December 15, 2025, with interest at a rate of 2% per annum[99]. Capital and Funding - Citius Pharma closed a registered direct offering on April 2, 2025, generating net proceeds of approximately $1.735 million after expenses[95]. - The company expects to have sufficient funds to continue operations through May 2025 but will need to raise additional capital thereafter[96]. - There is no assurance that the company will be successful in raising the needed capital or that it will be available on favorable terms[94]. Strategic Initiatives - The company has retained Jefferies LLC as its exclusive financial advisor to evaluate strategic alternatives aimed at maximizing shareholder value[94]. Economic Factors - Inflation has not had a material effect on the company's results of operations according to management[97]. - The company has no off-balance sheet arrangements[98].

Financial Performance - Citius Oncology reported a net loss of $7.7 million, or ($0.11) per share, for Q2 2025, compared to a net loss of $4.8 million, or ($0.07) per share, for Q2 2024[9]. - Stock-based compensation expense for Q2 2025 was $2.1 million, slightly up from $2.0 million in Q2 2024[8]. Expenses - Research and Development (R&D) expenses increased to $3.1 million for Q2 2025, up from $1.3 million in Q2 2024, primarily due to costs associated with drug substance batch expenses[6]. - General and Administrative (G&A) expenses rose to $2.2 million for Q2 2025, compared to $1.4 million in Q2 2024, driven by pre-commercial and commercial launch activities for LYMPHIR[7]. Cash and Liabilities - As of March 31, 2025, Citius Oncology had $112 in cash and cash equivalents and will need to secure additional capital to support operations beyond May 2025[5]. - The total current liabilities increased to $49.7 million as of March 31, 2025, from $32.7 million as of September 30, 2024[14]. - Citius Oncology's total assets were reported at $91.4 million as of March 31, 2025, compared to $84.4 million as of September 30, 2024[14]. Strategic Focus - The company is focused on the U.S. launch of LYMPHIR, which has an estimated initial market exceeding $400 million[10]. - Citius Oncology is actively pursuing discussions with potential commercial and strategic partners to enhance financial flexibility and support the launch of LYMPHIR[3]. - The company retained Jefferies LLC as an exclusive financial advisor to evaluate strategic alternatives aimed at maximizing stockholder value[4].

Financial Performance - Citius Oncology reported a net loss of $21.1 million, or ($0.31) per share, for the fiscal year ended September 30, 2024, compared to a net loss of $12.7 million, or ($0.19) per share, for the previous year[9][18]. - Citius Oncology, Inc. reported a net loss of $21,148,747 for fiscal year 2024, compared to a net loss of $12,697,241 in 2023[30]. - The net cash provided by operating activities was $126,353 in 2024, compared to no cash provided in 2023[30]. - The company reported a net cash used in investing activities of $5,000,000 due to license payments[30]. Expenses - Research and Development (R&D) expenses increased to $4.9 million for the full year ended September 30, 2024, up from $4.2 million in the prior year, reflecting activities related to the resubmission of the Biologics License Application for LYMPHIR[4][7]. - General and Administrative (G&A) expenses rose to $8.1 million for the full year ended September 30, 2024, compared to $5.9 million for the previous year, primarily due to pre-commercial and commercial launch activities of LYMPHIR[4][16]. - Stock-based compensation expense was $7.5 million for the full year ended September 30, 2024, significantly higher than $2.0 million for the prior year, attributed to the realization of expenses over a full year[9][17]. - The company recognized stock-based compensation expense of $7,498,817 in 2024, significantly higher than $1,965,500 in 2023[30]. Assets and Liabilities - Citius Oncology's total current assets increased to $10.97 million as of September 30, 2024, compared to $7.73 million in the previous year[21]. - The company’s total liabilities rose to $38.23 million as of September 30, 2024, compared to $22.20 million in the prior year[25]. - Citius Oncology, Inc.'s total assets increased to $84.37 million as of September 30, 2024, compared to $47.73 million in the previous year[24]. Product Development and Approval - LYMPHIR, the company's primary asset, was approved by the FDA for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma, with an estimated initial market exceeding $400 million[19]. - Citius Oncology, Inc. achieved FDA approval for LYMPHIR™, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL)[36]. - The company supported two investigator-initiated trials for LYMPHIR, exploring its potential as an immuno-oncology combination therapy[2]. - The company expects promising preliminary results from a second investigator trial with CAR-T therapies in 2025, indicating potential for enhanced treatment efficacy[4]. Commercialization Efforts - The company initiated recruitment of a targeted field force with a contract sales organization to support the launch of LYMPHIR[34]. - Citius Oncology, Inc. launched a marketing awareness campaign and engaged with leading CTCL prescribers[34]. - The company applied for a unique J-code within the HCPCS to facilitate accurate reimbursement for LYMPHIR[34]. - Citius secured inclusion of LYMPHIR in the NCCN guidelines, influencing treatment practices and payor reimbursement in the U.S.[34]. - Citius Oncology, Inc. advanced manufacturing, marketing, and sales activities in preparation for the commercial launch of LYMPHIR in the first half of 2025[36].

Product Development and Approval - The lead product candidate, LYMPHIR, is approved by the FDA for the treatment of persistent or recurrent CTCL, with an estimated market exceeding $400 million[304]. - In the primary efficacy analysis, LYMPHIR demonstrated an overall response rate (ORR) of 36.2%, with 8.7% achieving a complete response and 27.5% achieving a partial response[308]. - The median progression-free survival (PFS) for patients achieving clinical benefit was reported at 57 weeks, ranging from 30 to 96 weeks[331]. - The company has accrued a $5.9 million development milestone payment to Eisai as of September 30, 2024, related to LYMPHIR's FDA approval[343]. - The company has undertaken two investigator-initiated trials to evaluate LYMPHIR's safety and efficacy as an immuno-oncology combination therapy[329]. - The efficacy population included 69 patients with a median age of 64 years, with 65% being male and 73% White[324]. - LYMPHIR was included in the NCCN guidelines based on a Category 2A recommendation, which may assist in obtaining coverage from CMS[361]. Commercialization and Market Strategy - The company plans to develop its sales and marketing capabilities by partnering with a third-party organization to assist in launching LYMPHIR[322]. - The company believes there is an opportunity to expand the addressable U.S. market for LYMPHIR with the introduction of new therapeutics[339]. - The company is dependent on third-party suppliers and must manage risks associated with commercialization and market establishment for LYMPHIR[293]. - The company is required to pay an aggregate of $27.5 million under the license agreements covering LYMPHIR upon FDA approval[346]. - The company has entered into a contract manufacturing agreement that runs through calendar 2026, with minimum annual purchase obligations[384]. - The company relies on third-party manufacturers for drug production, exposing it to risks related to supply chain and regulatory compliance[367]. Financial Position and Obligations - The company has a federal net operating loss carryforward of approximately $28.7 million as of September 30, 2024[377]. - Minimum purchase commitments under commercial supply agreements amount to approximately $4.5 million, with $2.9 million due in 2025 and $1.6 million in 2026[379]. - The weighted average grant date fair value of stock options granted during the year ended September 30, 2024, was estimated at $1.66 per share[374]. - The company has recorded a valuation allowance against deferred tax assets, increasing by $4.9 million in 2024 and $4.0 million in 2023[377]. - Citius Pharma issued an unsecured promissory note to itself for $3,800,111, which is repayable upon raising at least $10 million[388]. - The likelihood of achieving the $10 million financing raise is currently uncertain[388]. Human Resources and Support - The company has access to more than 30 professionals through consulting and collaboration arrangements for clinical and regulatory support[355]. - The company expects to hire or contract additional qualified personnel for ongoing development and commercialization efforts[348]. Adverse Reactions and Safety - Adverse reactions in patients receiving LYMPHIR included nausea (43%), fatigue (38%), and headache (25%), with most being low grade[327]. Compliance and Accounting - The company has elected to use the extended transition period under the JOBS Act for complying with new or revised accounting standards[392].

Financial Performance - As of March 31, 2024, the company reported a net income of $489,829, primarily from investment income of $758,258, offset by operating expenses of $268,429 [113]. - The change in cash for the period ended March 31, 2024, was an increase of $584, with cash used in operating activities of $191,690 [127]. Business Operations - The company has not generated any operating revenues to date and will not do so until the completion of its initial business combination [111]. - The company expects to incur approximately $300,000 for legal, accounting, and due diligence expenses related to business combinations [121]. - The company has less than 12 months to complete a business combination before mandatory liquidation requirements take effect [126]. - There is substantial doubt about the company's ability to continue as a going concern if a business combination is not completed by June 18, 2024 [125]. - The company may need to seek additional financing to complete its initial business combination due to targeting larger businesses than its current capital can support [123]. Capital and Funding - The company raised gross proceeds of $66,000,000 from its IPO of 6,600,000 Units on October 18, 2022 [115]. - An amount of $67,320,000 from the IPO and Private Placement proceeds was placed in the trust account, which may be invested in U.S. government securities [117]. - As of March 31, 2024, the company had cash of $33,330 available outside the trust account for operational expenses and due diligence [119].

Company Formation and IPO - The company was incorporated on March 1, 2021, in the Cayman Islands for the purpose of entering into a business combination, initially focusing on Asia but excluding entities headquartered in China[23]. - The company completed its IPO on October 18, 2022, issuing 6,600,000 units at $10.00 per unit, generating total gross proceeds of $66,000,000[26]. - A total of $67,320,000 from the IPO and private placement was placed in a U.S.-based trust account for the benefit of public shareholders[28]. - The company completed its IPO on October 18, 2022, raising gross proceeds of $66 million from the sale of 6,600,000 Units[118]. - A Private Placement of 394,000 Placement Units generated total proceeds of $3.94 million at a price of $10.00 per Unit[119]. Financial Performance and Projections - The company has had no revenue since inception and has incurred losses due to formation and operating costs, relying on securities sales and loans for funding[31]. - For the year ended December 31, 2023, the company reported a net income of $2,419,304, primarily from investment income on trust assets amounting to $3,432,374, offset by operating expenses of $1,013,070[116]. - The company has not generated any operating revenues to date and will not do so until the completion of its initial business combination[115]. - The company incurred increased expenses of $1,013,070 due to being a public company, including legal, financial reporting, and auditing compliance costs[115]. - The company expects primary liquidity requirements of $92,000 for legal and accounting expenses and $216,800 for working capital from December 31, 2023, until the business combination[125]. - The company incurred a cash decrease of $256,429 for the year ended December 31, 2023, with cash used in operating activities of $601,304 and cash provided by financing activities of $1,664,875[131]. - The company has less than 12 months to complete a business combination, or it must liquidate and redeem Public Shares[130]. - The company has no long-term debt obligations or capital lease obligations[132]. - The company is targeting larger businesses than it can acquire with the net proceeds from the IPO, potentially requiring additional financing[127]. Business Combination and Strategy - The company extended the deadline to complete an initial business combination to January 18, 2024, by depositing $660,000 into the trust account[34]. - The company has the option to extend the business combination period up to eight times, with specific deposit amounts required for each extension[35]. - The company intends to focus on acquiring private companies in Asia, with a total enterprise value between $200 million and $600 million[49]. - The company aims to provide target businesses with an alternative to traditional IPOs, which may be less expensive and offer greater certainty of execution[46]. - The merger agreement with Citius Oncology is expected to be completed in the first half of 2024, pending shareholder approval and regulatory conditions[59]. - Upon closing the merger, Citius Pharma will receive 67.5 million shares of the combined company, valued at $675 million based on an implied share price of $10.00[66]. - The company plans to structure its initial business combination to acquire 100% of the equity interests or assets of the target business[61]. - The company will redeem 100% of outstanding public shares at approximately $10.99 per share if it cannot complete the initial business combination within the specified time[60]. - The company aims to acquire businesses with strong management teams and significant revenue and earnings growth potential[54]. - The company will only pursue business combinations that will benefit from being publicly traded and can effectively utilize access to broader capital sources[63]. - The Holding Foreign Companies Accountable Act may impact the company's ability to complete certain business combinations due to regulatory oversight[70]. Management and Governance - The management team has extensive experience in mergers and acquisitions, with a strong track record in identifying acquisition opportunities[45]. - The management team includes experienced professionals from various sectors, enhancing the company's ability to identify attractive acquisition opportunities[48]. - The company has maintained its principal executive office in New York, NY, with a monthly cost of $10,000 for office space and related services[87]. - The company currently has 2 officers and does not intend to hire full-time employees before completing its initial business combination[89]. - The company does not intend to ensure that management maintains their positions post-initial business combination, although some may negotiate to stay[177]. - No cash compensation has been provided to officers or directors, but $10,000 per month will be paid for office space and administrative services[176]. - The board of directors is composed of five members, with each director serving a two-year term[173]. - The company has established an audit committee, which is required to be comprised solely of independent directors under Nasdaq rules[178]. - The independent directors will hold regularly scheduled meetings to ensure compliance with SEC and Nasdaq rules[175]. - The company has established an audit committee to oversee independent auditors and ensure compliance with regulations[185]. - The compensation committee is responsible for reviewing and approving the CEO's compensation and evaluating performance based on corporate goals[186]. - The company has not established specific minimum qualifications for director nominees but considers various factors such as educational background and professional experience[192]. - Directors and officers have fiduciary duties under Cayman Islands law, including acting in the best interests of the company and avoiding conflicts of interest[196]. - The company will indemnify its officers and directors to the maximum extent permitted by law, including for liabilities incurred in their capacities[207]. - The compensation committee may retain external advisers and will consider their independence before engagement[189]. - The board will consider director candidates recommended by shareholders during the nomination process for the annual meeting[191]. - The company intends to disclose any amendments to its Code of Ethics in a Current Report on Form 8-K[194]. Shareholder Information - The total number of Ordinary Shares issued and outstanding is 6,653,077[220]. - 10XYZ Holdings LP, Xiaofeng Yuan, and Taylor Zhang each own 2,044,000 Ordinary Shares, representing approximately 30.7% of the outstanding shares[221]. - All executive officers and directors as a group (5 individuals) collectively own 2,044,000 Ordinary Shares, which is 30.7% of the total[221]. - Hudson Bay Capital Management LP holds 500,000 Ordinary Shares, accounting for 7.5% of the outstanding shares[221]. - Wolverine Asset Management, LLC owns 566,713 Ordinary Shares, representing 8.5% of the total[221]. - Mizuho Financial Group, Inc. has 522,030 Ordinary Shares, which is 7.8% of the outstanding shares[221]. - The beneficial ownership interests consist of Founder Shares and Private Placement Shares[222]. Internal Controls and Compliance - A material weakness in internal control over financial reporting was identified as of December 31, 2023, which may adversely affect the accuracy and timeliness of financial reporting[156]. - Disclosure controls and procedures were deemed ineffective due to material weaknesses related to accounting for accruals and complex financial instruments[151]. - Management is assessing resource needs and roles, particularly in accounting and financial reporting, to address identified weaknesses[152]. - The company has not made any changes in internal control over financial reporting during the fiscal quarter ended December 31, 2023, that materially affected its effectiveness[159]. - The audit committee consists of independent directors, with Cathy Jiang qualifying as an "audit committee financial expert" as defined by SEC rules[179]. - The company has applied for a tax exemption from the Cayman Islands government, which would exempt it from taxes on profits for a period of 20 years[86]. - The company is classified as an "emerging growth company" and is eligible for certain exemptions from reporting requirements, including not being required to comply with auditor attestation requirements[82]. - The company has not paid any cash dividends to date and does not intend to do so prior to completing its initial business combination[102]. - The company has not identified any significant cybersecurity threats that could materially affect its business strategy or financial condition[93].