Core Viewpoint - Purcell & Lefkowitz LLP is investigating Citius Oncology, Inc. to determine if its directors breached fiduciary duties related to recent corporate actions [1] Group 1 - The investigation is on behalf of Citius Oncology's shareholders [1] - Shareholders interested in more information about their rights and options are encouraged to visit the law firm's website or contact them directly [1] - The law firm specializes in representing shareholders affected by securities fraud and corporate misconduct [2]

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 executed service agreements with three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR to healthcare organizations across the U.S.[3] - Citius Oncology 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] - Stock-based compensation expense increased to $8,320,419 in 2025 from $7,498,817 in 2024, reflecting higher employee compensation costs[16] - Inventory changes resulted in a significant increase of $(12,649,207) in 2025, compared to $(2,133,871) in 2024, indicating potential overstock issues[16] Cash Flow and Financing Activities - Net cash used in operating activities was $(5,492,046) in 2025, a decline from a positive cash flow of $126,353 in 2024[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] - Cash and cash equivalents at the end of 2025 were $3,924,908, a significant increase from $112 at the beginning of the year[16] - License payments for 2025 amounted to $(5,750,000), consistent with $(5,000,000) in 2024, indicating ongoing investment in licenses[16] - Interest paid in 2025 was $187,389, while no interest was reported in 2024, suggesting new debt obligations[16] Expenses Overview - 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] - 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] - 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]

Fiscal Full Year 2025 Financial Highlights About Citius Oncology, Inc. Launched LYMPHIRâ"¢ (denileukin diftitox-cxdl), a novel IL2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I–III cutaneous Tcell lymphoma (CTCL) after at least one prior systemic therapy; Executed service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR to healthcare organizations, including major medical centers an ...

Subsidiary, Citius Oncology, launches cancer immunotherapy, LYMPHIRâ"¢, in the U.S. in December 2025 CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal year ended September 30, 2025. "2025 was a pivotal year for Citius as we successfully launched LYMPHIR f ...

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[28]. - The Phase 3 trial for LYMPHIR demonstrated an overall response rate (ORR) of 36.2% among 69 subjects, with 8.7% achieving a complete response[39]. - The median duration of response for LYMPHIR was 6.5 months, with 52% of responders maintaining their response for at least 6 months[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 for LYMPHIR included 69 patients with a median age of 64 years, and the median number of prior therapies was 4[43]. - 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 its appropriateness for CTCL patients[89]. - The FDA assigned a PDUFA goal date of August 13, 2024, for the Biologics License Application (BLA) resubmission for LYMPHIR[81]. Commercialization Strategy - The Company has established a targeted oncology sales force for LYMPHIR, focusing on major cancer centers in the U.S.[29]. - The Company plans to commercialize products independently in the U.S. while partnering for international markets[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 plans to focus its commercial efforts on a targeted group of prescribing hematologists, oncologists, and dermatologist-oncologists[87]. - The company has contracted with Innovation Partners and three national companies to assist in the commercialization of LYMPHIR, indicating reliance on third-party infrastructure[154]. - The company has contracted with third-party organizations for sales, marketing, and distribution of LYMPHIR, which may require significant resources[176]. 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 remaining balance of $19.75 million 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 of LYMPHIR for CTCL[98]. - The Company is required to commercially launch a product within six months of receiving regulatory approval, which was satisfied with the launch of LYMPHIR in December 2025[158]. - The company has raised $6.0 million in October 2025 and $18.0 million in December 2025 to support operations through March 2026[137]. - As of September 30, 2025, the company had approximately $3.9 million in cash and cash equivalents and an accumulated deficit of approximately $64 million[140]. - The company has generated no operating revenue to date and relies on equity instruments and funding through Citius Pharma for financing[138]. - 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]. Market and Competitive Landscape - The addressable U.S. market for LYMPHIR is estimated to exceed $400 million, potentially expanding with new therapeutic introductions[85]. - The estimated incidence rate of mycosis fungoides and Sézary syndrome in the U.S. is approximately 0.5 per 100,000, translating to about 2,500 to 3,000 new cases annually[84]. - Citius Oncology's revenues are expected to depend substantially on the market acceptance of LYMPHIR, which may not be guaranteed[175]. - Market acceptance of LYMPHIR may be limited by factors such as pricing, reimbursement, and perceptions of healthcare providers[174]. - The actual market for LYMPHIR may be smaller than projected, affecting the company's ability to achieve profitability[178]. - 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]. Regulatory Compliance and Risks - The FDA requires substantial time and resources for marketing approval, including nonclinical studies and clinical trials[112]. - The Company must comply with ongoing FDA regulations post-approval, including recordkeeping and reporting of adverse experiences[116]. - 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, such as the Inflation Reduction Act of 2022, could materially affect the healthcare industry and the company's business[129]. - The company is subject to increased scrutiny over drug pricing, which may lead to legislative changes that could limit reimbursement amounts from federal health care programs[188]. - Regulatory compliance is critical, as failure to maintain compliance could result in significant costs and hinder the ability to market future products[210]. - The approval process for future product candidates may be delayed by changes in government regulation or FDA policy, impacting commercialization timelines[212]. Operational Challenges - The company faces challenges in obtaining adequate reimbursement levels for its products due to increasing restrictions from governmental authorities and private insurers[122]. - The company has a limited operating history and has not yet demonstrated the ability to successfully commercialize any product candidates beyond LYMPHIR[154]. - The company faces substantial additional costs due to milestone payments and obligations under license agreements, which could adversely affect the profitability of LYMPHIR[159]. - The company faces risks related to reliance on third-party manufacturers, which could delay clinical trials and commercialization[167]. - The company is dependent on third parties and Citius Pharma under the A&R Shared Services Agreement[226]. - Recruitment or departure of key scientific or management personnel could impact the company's operations[226]. - 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 Risks - 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 company may face substantial costs if its product candidates infringe on third-party proprietary rights, which could harm earnings and financial condition[222]. - The company has registered the trademark "LYMPHIR," but inadequate protection could impede brand recognition and market competitiveness[223]. - The company has limited product liability insurance coverage of $5 million per occurrence, which may not be sufficient to cover all liabilities from product liability claims[211]. - The company relies on trade secret protections through confidentiality agreements, but breaches could adversely affect business prospects[221]. Financial Performance - 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]. - The company recorded $218,032 in interest expense related to the payment schedule with Eisai during the year ended September 30, 2025[162]. - 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]. - Future issuances of debt or equity securities may influence the company's financial condition and operating results[226].

Core Insights - Citius Oncology has entered an exclusive distribution agreement with Er-Kim for LYMPHIR, expanding its access to patients with cutaneous T-cell lymphoma in Turkey and key Gulf Cooperation Council (GCC) countries [1][3] - The partnership increases Citius Oncology's international strategy to a total of 19 markets outside the U.S., leveraging Named Patient Programs for access [2] - LYMPHIR is a targeted immune therapy approved by the FDA for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy [5][9] Company Overview - Citius Oncology, a subsidiary of Citius Pharmaceuticals, focuses on developing and commercializing novel targeted oncology therapies, with LYMPHIR being a significant addition to its portfolio [9][10] - The initial market for LYMPHIR is estimated to exceed $400 million, indicating a growing and underserved market for this therapy [9] - Citius Pharmaceuticals holds a 79% stake in Citius Oncology and is dedicated to critical care product development [10] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a recombinant fusion protein that targets IL-2 receptors, leading to cell death in tumors expressing these receptors [5] - The therapy has shown the ability to deplete immunosuppressive regulatory T lymphocytes and has direct antitumor activity [5] - LYMPHIR was launched in the U.S. in December 2025 after receiving FDA approval [6] Partnership Significance - The agreement with Er-Kim is viewed as a significant milestone in Citius Oncology's global expansion strategy, leveraging Er-Kim's industry experience and regulatory capabilities [3][4] - Er-Kim will handle sales, marketing, and reimbursement activities in the designated territories, while Citius Oncology will supply the finished product [3] Market Context - Cutaneous T-cell lymphoma is the most common type of cutaneous lymphoma, affecting men more frequently and typically diagnosed in individuals aged 50 to 60 [7][8] - There is currently no curative therapy for advanced CTCL, making innovative treatments like LYMPHIR critical for patient care [8]

Core Insights - Citius Oncology has launched LYMPHIR, a novel treatment for relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL), which has been approved by the FDA [1][11] - The product is expected to address a significant clinical need in a market valued at over $400 million, with potential for international expansion and additional indications [2][13] Product Overview - LYMPHIR (denileukin diftitox-cxdl) is a targeted immune therapy that combines the IL-2 receptor binding domain with diphtheria toxin fragments, specifically designed to treat CTCL after at least one prior systemic therapy [10][16] - The FDA approval was based on Pivotal Study 302, which showed an Objective Response Rate (ORR) of 36.2% and a median time to response of 1.4 months [3][11] Clinical Benefits - LYMPHIR offers rapid skin relief and has shown meaningful activity against severe pruritus, a common issue for CTCL patients [2][4] - The treatment is noted for its lack of cumulative toxicity, making it a compelling option for patients and physicians [4][10] Market Potential - The U.S. market for LYMPHIR is estimated to exceed $400 million and is expected to grow, indicating a strong demand for effective CTCL therapies [2][13] - Citius Oncology has exclusive rights to develop and commercialize LYMPHIR in all global markets except India, Japan, and certain parts of Asia, with plans for international distribution [7][11] Commercial Strategy - LYMPHIR is available through specialty distributors in the U.S., with a dedicated portal for healthcare providers to access treatment resources [5][9] - The launch is supported by medical education and payer access programs, and LYMPHIR has been included in the National Comprehensive Cancer Network (NCCN) Guidelines for CTCL [6][7] Company Background - Citius Oncology is focused on developing and commercializing novel targeted oncology therapies, with LYMPHIR being its first marketed product [13][14] - The company has robust intellectual property protections and is actively engaged in expanding its market presence [13][14]

Core Insights - Citius Oncology is set to showcase its novel immunotherapy LYMPHIR at the 67th American Society of Hematology Annual Meeting in December 2025, highlighting its potential as a treatment option for cutaneous T-cell lymphoma [1][3][2] Company Overview - Citius Oncology, a subsidiary of Citius Pharmaceuticals, focuses on developing targeted oncology therapies, with LYMPHIR being its primary asset approved by the FDA in August 2024 for relapsed or refractory Stage I–III cutaneous T-cell lymphoma [8][9] - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies, supported by robust intellectual property protections [8] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a targeted immune therapy that combines IL-2 receptor binding with diphtheria toxin fragments, specifically designed to treat adult patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy [4][10] - The drug has shown the ability to deplete immunosuppressive regulatory T lymphocytes and exhibit antitumor activity [4] Market Context - Cutaneous T-cell lymphoma is the most common type of cutaneous lymphoma, affecting men more frequently than women, typically diagnosed in individuals aged 50 to 60 [6] - The disease can progress slowly, with advanced stages leading to poor prognosis, highlighting the need for effective treatment options [6] Regulatory Milestones - LYMPHIR received regulatory approval in Japan in 2021 for similar indications and was subsequently licensed by Citius for development and commercialization in all markets except India, Japan, and certain parts of Asia [5]

Core Insights - Citius Oncology is enhancing its commercial strategy for the launch of LYMPHIR, a novel immunotherapy for cutaneous T-cell lymphoma, through a collaboration with Verix and its Tovana platform, which utilizes AI and machine learning for salesforce targeting and engagement [1][2][3] Company Overview - Citius Oncology, a subsidiary of Citius Pharmaceuticals, focuses on developing and commercializing innovative oncology therapies, with LYMPHIR being its primary asset approved by the FDA in August 2024 for treating relapsed or refractory Stage I-III cutaneous T-cell lymphoma [1][34][36] - The company aims to penetrate a market estimated to exceed $400 million, which is currently underserved by existing therapies [34] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a targeted immune therapy indicated for adult patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy [10][34] - The drug works by binding to IL-2 receptors on cancer cells, leading to cell death through inhibition of protein synthesis [6][7] Collaboration and Technology - The partnership with Verix aims to leverage the Tovana platform for real-time analytics and data-driven decision-making, enhancing the efficiency of Citius Oncology's commercial team [2][4][5] - The Tovana platform integrates advanced analytics and real-world claims data to refine targeting and support predictive intelligence in sales and marketing [2][4] Market Strategy - Citius Oncology is focused on capital efficiency and sustainable value creation for shareholders while facilitating access to care for patients with cutaneous T-cell lymphoma [5] - The company has established foundational launch activities, including distribution partnerships and reimbursement codes, to support the commercialization of LYMPHIR [4][5]

Core Insights - Citius Pharmaceuticals and Citius Oncology will participate in three investor conferences in October 2025, providing opportunities for one-on-one meetings with management [1][2][3]. Company Overview - Citius Pharmaceuticals, Inc. is focused on developing first-in-class critical care products, with FDA approval for LYMPHIR, a targeted immunotherapy for cutaneous T-cell lymphoma, received in August 2024 [4]. - Citius Pharmaceuticals' late-stage pipeline includes Mino-Lok, an antibiotic lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief, with successful trial completions in 2023 [4]. - Citius Pharmaceuticals owns 79% of Citius Oncology, which specializes in novel targeted oncology therapies [4][5]. Market Potential - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies, indicating significant growth potential [5]. - Citius Oncology has robust intellectual property protections, including orphan drug designation and pending patents, which enhance its competitive positioning in the oncology market [5][6].