Financial Performance - Citius Oncology reported $3.9 million in revenue for the fiscal first quarter 2026, marking its first reported revenue following the launch of LYMPHIR in December 2025[1][7]. - The net loss for the quarter was $5.5 million, or $(0.06) per share, compared to a net loss of $6.7 million, or $(0.09) per share, for the prior-year period[7][14]. - The net loss for 2025 was $5,534,069, an improvement from a net loss of $6,659,205 in 2024[16]. - Stock-based compensation expense increased to $3,956,050 in 2025 from $1,808,478 in 2024[16]. - Net cash used in operating activities was $(7,354,946) for 2025, with significant changes in accounts receivable and inventory[16]. - License payments for investing activities amounted to $(4,400,000) in 2025[16]. - Net proceeds from the issuance of common stock were $15,125,489, contributing positively to financing activities[16]. - The net change in cash and cash equivalents for 2025 was an increase of $3,370,543[16]. - Cash and cash equivalents at the end of the period reached $7,295,451, up from $3,924,908 at the beginning[16]. - Interest paid during the period was $14,460[16]. Expenses - Research and development expenses decreased to $1.0 million from $1.3 million in the prior-year period, reflecting reduced clinical development activity[7][14]. - General and administrative expenses were $2.9 million, down from $3.3 million in the prior-year period[7][14]. Market Opportunity - The initial market for LYMPHIR is estimated to exceed $400 million and is growing, indicating a significant opportunity in an underserved market[6][7]. - Citius Oncology is advancing an international access strategy through regional distribution partners and Named Patient Programs in key European and Middle Eastern markets[7][4]. - The company is focused on expanding its field presence to support a concentrated prescriber base in the rare cancer setting, utilizing an AI-enabled commercial platform[2][7]. Strategic Focus - Citius Oncology is evaluating strategic opportunities to enhance long-term shareholder value while maintaining capital management[3][7]. - The company established a nationwide specialty distribution infrastructure to ensure immediate product availability and support rapid physician adoption of LYMPHIR[4][7].

stockholders$(8,220,785)$(9,768,246)Net Loss Per Share - Basic and Diluted$(0.38)$(1.30)Weighted Average Common Shares OutstandingBasic and diluted (include pre-funded warrants from the October 2025 offering)21,495,2747,492,460CITIUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024(Unaudited)20252024Cash Flows From Operating Activities:Net loss$(9,393,889)$(10,281,246)Adjustments to reconcile net loss to net cash used in operating acti ...

Financing Activities15,125,489-Net Change in Cash and Cash Equivalents3,370,543-Cash and Cash Equivalents – Beginning of Period3,924,908112Cash and Cash Equivalents – End of Period$7,295,451$112Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:Interest Paid$14,460$-SOURCE Citius Oncology, Inc.## 21%[more press release views with Request a Demo]## Also from this source### Citius Oncology Expands International Distribution of LYMPHIRâ"¢ to European Union Through Exclusive Agreement w ...

of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq:...]### Citius Oncology Announces Closing of $18 Million Concurrent Registered Direct Offering and Private Placement Priced At-The-Market Under Nasdaq Rules[Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius...][More Releases From This Source]## Explore[Medical Pharmaceuticals][Health Care & Hospitals][Pharmaceuticals][News Releases in Similar Topics]---- ...

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]

Core Insights - Citius Oncology has launched LYMPHIR, a novel immunotherapy for treating relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) in the U.S. as of December 2025, marking a significant transition from a pre-revenue to a revenue-generating company [1][2][6] Business Highlights - The company has executed service agreements with three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR to various healthcare organizations [6] - Citius Oncology has secured access to LYMPHIR in 19 international markets through regional distribution partners via Named Patient Programs, initiating its global access strategy [6] - A collaboration with Verix has been announced to utilize its Tovana AI-powered platform for enhancing commercial targeting and provider engagement [6] - Preliminary results from a Phase I clinical trial combining pembrolizumab and LYMPHIR in cancer patients have shown promise [6] Financial Highlights - Citius Oncology completed $36 million in strategic financings, including an $18 million private placement and registered direct offering on December 10, 2025 [1][4] - As of September 30, 2025, the company reported cash and cash equivalents of $3.9 million, with a net loss of $24.8 million, or ($0.34) per share, compared to a net loss of $21.1 million, or ($0.31) per share for the previous fiscal year [4][12] - Research and development expenses increased to $6.4 million for the fiscal year ended September 30, 2025, up from $4.9 million in the prior year [4][12] Market Potential - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies, indicating significant growth potential [7] - The company holds robust intellectual property protections, including orphan drug designation and pending patents, which support its competitive positioning in the oncology market [7]

Core Insights - Citius Pharmaceuticals successfully launched LYMPHIR, a novel cancer immunotherapy, in December 2025, marking a significant advancement in treatment options for cutaneous T-cell lymphoma (CTCL) patients [2][5][7] Business Highlights - The launch of LYMPHIR represents the first new systemic therapy for CTCL since 2018, showcasing the company's commitment to providing impactful treatments [2] - Citius Pharma has engaged with the FDA to advance other products, including Mino-Lok, and is exploring additional indications for LYMPHIR [2][5] - The company has secured distribution agreements with three leading U.S. pharmaceutical wholesalers and access to LYMPHIR in 19 international markets [5] - LYMPHIR has been included in the National Comprehensive Cancer Network (NCCN) guidelines with a Category 2A recommendation, facilitating coverage and reimbursement [5] Financial Highlights - Citius Pharma raised approximately $61 million in gross proceeds from capital raises, with $25 million from strategic financings for Citius Pharma and $36 million for Citius Oncology [5] - As of September 30, 2025, the company reported cash and cash equivalents of $4.3 million, with no revenues reported for the fiscal year [5][6] - Research and development expenses decreased to $9.2 million from $11.9 million in the previous year, while general and administrative expenses slightly increased to $18.5 million [5][6] - The net loss for the fiscal year was $39.7 million, or $3.38 per share, compared to a net loss of $40.2 million, or $5.97 per share, in the previous year [6][13] Market Potential - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies, indicating significant growth potential [7] - The company holds robust intellectual property protections, including orphan drug designation and pending patents, which enhance its competitive positioning in the oncology market [7]

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]