CTOR
Citius OncologyFDocument history
Earnings documents stored for CTOR.
Investor releaseQuarter not tagged2026-08-14Citius Oncology, Inc. Reports Fiscal Third Quarter 2026 Financial Results and Provides Business Update
PR Newswire
Citius Oncology, Inc. Reports Fiscal Third Quarter 2026 Financial Results and Provides Business Update
$7.1 million in revenue for the first nine months of fiscal 2026 as the LYMPHIR® launch progresses Strong institutional demand drives growth in total vials ordered and number of institutions ordering LYMPHIR ordered by 44 institutions since launch CRANFORD, N.J., Aug. 14, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal third quarter ended June 30, 2026, and provided a business update. "Institutional demand (LYMPHIR vials ordered by prescribing centers from wholesalers) is accelerating. Institutional vial orders grew 31% sequentially, from 708 in the quarter ended March 31, 2026 to 926 in the quarter ended June 30, 2026. In July, institutions ordered 383 vials from wholesalers, the largest order month to date, reflecting a 25% increase over the prior quarter's monthly average order. Currently, 44 institutions have prescribed and ordered LYMPHIR," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "We expect continued institutional demand to drive new wholesaler orders. The Company recognizes revenue when wholesaler orders are fulfilled. Consequently, net revenue for any period reflects actual wholesaler orders fulfilled. In July, we began to see growth in institutional demand translate into increased wholesale orders and associated revenue. The positive trajectory of formulary approvals, institutional adoption, and unit demand gives us confidence in a robust remainder of the fiscal year," added Mazur. "We generated initial momentum with a lean internal team, maintaining healthy product margins and securing broad market access. In August, our full 29-person-strong commercial and medical affairs organizations expanded to nationwide coverage. The teams are now positioned to accelerate commercial execution and support broader adoption by leveraging the comprehensive, scalable infrastructure already established for LYMPHIR, including patient hub services, marketing and reimbursement support. Citius Oncology is now well positioned to broaden engagement with treatment centers, targeting formulary inclusion at 100 priority institutions by year-end and first-in-class support for health care providers. At the…Read full documentShow less
$7.1 million in revenue for the first nine months of fiscal 2026 as the LYMPHIR® launch progresses Strong institutional demand drives growth in total vials ordered and number of institutions ordering LYMPHIR ordered by 44 institutions since launch CRANFORD, N.J., Aug. 14, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal third quarter ended June 30, 2026, and provided a business update. "Institutional demand (LYMPHIR vials ordered by prescribing centers from wholesalers) is accelerating. Institutional vial orders grew 31% sequentially, from 708 in the quarter ended March 31, 2026 to 926 in the quarter ended June 30, 2026. In July, institutions ordered 383 vials from wholesalers, the largest order month to date, reflecting a 25% increase over the prior quarter's monthly average order. Currently, 44 institutions have prescribed and ordered LYMPHIR," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "We expect continued institutional demand to drive new wholesaler orders. The Company recognizes revenue when wholesaler orders are fulfilled. Consequently, net revenue for any period reflects actual wholesaler orders fulfilled. In July, we began to see growth in institutional demand translate into increased wholesale orders and associated revenue. The positive trajectory of formulary approvals, institutional adoption, and unit demand gives us confidence in a robust remainder of the fiscal year," added Mazur. "We generated initial momentum with a lean internal team, maintaining healthy product margins and securing broad market access. In August, our full 29-person-strong commercial and medical affairs organizations expanded to nationwide coverage. The teams are now positioned to accelerate commercial execution and support broader adoption by leveraging the comprehensive, scalable infrastructure already established for LYMPHIR, including patient hub services, marketing and reimbursement support. Citius Oncology is now well positioned to broaden engagement with treatment centers, targeting formulary inclusion at 100 priority institutions by year-end and first-in-class support for health care providers. At the same time, we continue to advance LYMPHIR's longer-term value proposition through investigator-initiated studies exploring its potential in combination regimens beyond CTCL," added Mazur. "Overall, the launch is moving in the right direction: more institutions are ordering LYMPHIR, vial demand is increasing, and our commercial footprint is expanding. We believe the underlying increasing demand trends provide a strong basis for the remainder of fiscal 2026," concluded Mazur. Fiscal Third Quarter 2026 Business Highlights and Subsequent Developments Secured prescriptions and orders from 44 institutions for LYMPHIR® (denileukin diftitox-cxdl), including academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions, and community infusion centers; Increased the number of new ordering institutions by 80% in the quarter ended June 30, 2026, compared to the quarter ended March 31, 2026; Grew the number of vials ordered by institutions from wholesalers by 31% in the quarter ended June 30, 2026, compared to the quarter ended March 31, 2026, with 383 institutional vials ordered in July 2026, the largest vial order month to date; Secured near-universal payer coverage, with no reimbursement denials or prior authorization barriers reported to date; Expanded the commercial organization by 21 additional field-based professionals and added eight medical science liaisons, executed by the Company's exclusive commercialization partner, EVERSANA; Engaged U.S. and international CTCL key opinion leaders at the Sixth World Congress of Cutaneous Lymphomas in Montreal through scientific exchange and educational initiatives; Advanced two investigator-initiated Phase 1 studies of LYMPHIR in combination settings: Appointed Jonathan Peri, Ph.D., J.D., as an independent director on August 10, 2026, bringing three decades of leadership experience across law, financial services and corporate governance. Fiscal Third Quarter 2026 Financial Highlights and Subsequent Developments Cash and cash equivalents of $16.6 million as of June 30, 2026; Received approximately $9.7 million in net proceeds from the exercise of certain warrants and funded $10.0 million under the first tranche of a senior secured term loan facility of up to $25.0 million; Revenues of $1.5 million for the three months ended June 30, 2026, compared to no revenue for the three months ended June 30, 2025; and $7.1 million for the nine months ended June 30, 2026, compared to no revenue for the nine months ended June 30, 2025; Gross profit of $1.0 million for the three months ended June 30, 2026, and $5.5 million for the nine months ended June 30, 2026; Research and development (R&D) expenses of $0.2 million for the three months ended June 30, 2026, compared to $0.9 million for the prior-year quarter; and $2.3 million for the nine months ended June 30, 2026, compared to $5.3 million for the prior-year period; General and administrative (G&A) expenses of $4.2 million for the three months ended June 30, 2026, compared to $1.9 million for the prior-year quarter, reflecting the expansion of the commercial organization; nine-month G&A of $30.7 million included a $19.7 million one-time CMO contract cancellation charge recognized in the second fiscal quarter in connection with a notice of termination; and, Net loss of $8.9 million, or $(0.08) per share, for the three months ended June 30, 2026, compared to $5.4 million, or $(0.08) per share, for the prior-year quarter; and $41.1 million, or $(0.42) per share, for the nine months ended June 30, 2026, compared to $19.8 million, or $(0.28) per share, for the prior-year period. About LYMPHIR™ (denileukin diftitox-cxdl)LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl has demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors. LYMPHIR was approved by the FDA and subsequently launched in the U.S. in December 2025. About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial CTCL market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets, and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com. About Citius Pharmaceuticals, Inc.Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 62% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com. Forward-Looking StatementsThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; our ability to regain compliance with Nasdaq's continued listing standards; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our ability to obtain, perform under, and maintain third party agreements and relationships, including obtaining a new bulk drug substance supplier; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; our ability to secure and maintain strategic partnerships and expand international access to LYMPHIR; risks relating to the results of research and development activities; our ability to procure cGMP commercial-scale supply; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings, which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. ContactsInvestor Contact: Ilanit Allen [email protected] x113 Media Contact: STiR-communicationsGreg [email protected] – Financial Tables Follow – View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-inc-reports-fiscal-third-quarter-2026-financial-results-and-provides-business-update-302852117.html
Investor releaseQuarter not tagged2026-08-14Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2026 Financial Results and Provides Business Update
PR Newswire
Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2026 Financial Results and Provides Business Update
$7.1 Million in revenue for the first nine months of fiscal 2026 from commercial sales of LYMPHIR ® $17 million in cash and cash equivalents as of June 30, 2026 Expanded LYMPHIR commercial and medical affairs organizations deployed nationwide CRANFORD, N.J., Aug. 14, 2026 /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 financial results for the fiscal third quarter ended June 30, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR). "The LYMPHIR launch continued to build momentum in our fiscal third quarter and remains the primary driver of our business. The number of institutional vial orders increased, new institutions placed orders, and LYMPHIR became available at 44 leading academic oncology centers, NCCN institutions and community infusion centers. These indicators demonstrate meaningful progress in formulary access and treatment-driven demand as physicians gain familiarity with LYMPHIR's differentiated clinical profile," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharma and Citius Oncology. "Following the quarter end, we completed the nationwide deployment of Citius Oncology's expanded commercial and medical affairs teams, which now total 29 professionals. These teams are positioned to leverage the existing platform established to support LYMPHIR's success, including patient hub services, marketing, reimbursement support, and market access. We believe our expanded organization will facilitate increased engagement with priority treatment centers, support formulary adoption and broaden access for eligible patients as the launch matures," added Mazur. "We also continued to advance LYMPHIR's longer-term value proposition. Phase 1 investigator-initiated data presented at ASCO demonstrated encouraging clinical activity and durable responses for LYMPHIR in combination with pembrolizumab in heavily pre-treated gynecologic malignancies. Additionally, Phase 1 data of LYMPHIR administered prior to CAR-T therapy in high-risk relapsed or refractory DLBCL, presented at the 2026 ASTCT® & CIBMTR® Tandem Meetings, showed an 86% objective response rate, including 57% complete response, with n…Read full documentShow less
$7.1 Million in revenue for the first nine months of fiscal 2026 from commercial sales of LYMPHIR ® $17 million in cash and cash equivalents as of June 30, 2026 Expanded LYMPHIR commercial and medical affairs organizations deployed nationwide CRANFORD, N.J., Aug. 14, 2026 /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 financial results for the fiscal third quarter ended June 30, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR). "The LYMPHIR launch continued to build momentum in our fiscal third quarter and remains the primary driver of our business. The number of institutional vial orders increased, new institutions placed orders, and LYMPHIR became available at 44 leading academic oncology centers, NCCN institutions and community infusion centers. These indicators demonstrate meaningful progress in formulary access and treatment-driven demand as physicians gain familiarity with LYMPHIR's differentiated clinical profile," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharma and Citius Oncology. "Following the quarter end, we completed the nationwide deployment of Citius Oncology's expanded commercial and medical affairs teams, which now total 29 professionals. These teams are positioned to leverage the existing platform established to support LYMPHIR's success, including patient hub services, marketing, reimbursement support, and market access. We believe our expanded organization will facilitate increased engagement with priority treatment centers, support formulary adoption and broaden access for eligible patients as the launch matures," added Mazur. "We also continued to advance LYMPHIR's longer-term value proposition. Phase 1 investigator-initiated data presented at ASCO demonstrated encouraging clinical activity and durable responses for LYMPHIR in combination with pembrolizumab in heavily pre-treated gynecologic malignancies. Additionally, Phase 1 data of LYMPHIR administered prior to CAR-T therapy in high-risk relapsed or refractory DLBCL, presented at the 2026 ASTCT® & CIBMTR® Tandem Meetings, showed an 86% objective response rate, including 57% complete response, with no dose-limiting toxicities observed. These positive signals point to LYMPHIR's potential beyond cutaneous T-cell lymphoma. As we scale, we remain focused on disciplined execution and building the long-term sustainable value of LYMPHIR," concluded Mazur. Fiscal Third Quarter 2026 Business Highlights and Subsequent Developments Continued commercial momentum for LYMPHIR, with availability in 44 institutions, including academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions and community infusion centers; Increased the number of new institutions ordering LYMPHIR by 80% and grew institutional vial orders from wholesalers by 31%; Drove continued institutional demand growth in July, with 383 vials ordered by institutions from wholesalers, the largest vial order month to date; Secured near universal payer coverage, with no reimbursement denials or preauthorization barriers reported to date; Expanded Citius Oncology's commercial organization by 21 commercial field-based professionals and added eight medical science liaisons, with nationwide deployment completed in August 2026 through EVERSANA, the Company's exclusive commercialization partner; Advanced Phase 1 investigator-initiated trials: Closed a registered direct offering in April 2026 for net proceeds of approximately $4.5 million; Received approximately $9.7 million in net proceeds from the exercise of certain warrants and funded $10.0 million under the first tranche of a Citius Oncology senior secured term loan facility of up to $25.0 million; and, Citius Oncology appointed Jonathan Peri, Ph.D., J.D., as an independent director, effective August 10, 2026, expanding the board to nine members. Fiscal Third Quarter 2026 Financial Highlights and Subsequent Developments Cash and cash equivalents of $17.0 million as of June 30, 2026; Revenues of $1.5 million for the three months ended June 30, 2026, compared with no revenue for the three months ended June 30, 2025; and $7.1 million for the nine months ended June 30, 2026, compared with no revenue for the nine months ended June 30, 2025; Gross profit of $1.0 million for the three months ended June 30, 2026, representing a gross margin of approximately 67%, and $5.5 million for the nine months ended June 30, 2026, representing a gross margin of approximately 77%; Research and development expenses of $1.1 million for the three months ended June 30, 2026, compared with $1.6 million for the three months ended June 30, 2025; and $4.3 million for the nine months ended June 30, 2026, compared with $7.5 million for the nine months ended June 30, 2025; General and administrative expenses of $6.1 million for the three months ended June 30, 2026, compared with $4.4 million for the three months ended June 30, 2025. General and administrative expenses were $38.3 million for the nine months ended June 30, 2026, compared with $14.6 million for the nine months ended June 30, 2025. The nine-month increase primarily reflects a non-recurring $19.7 million contract cancellation charge recognized in March 2026 and increased expenses related to the commercial launch of LYMPHIR; Stock-based compensation expense of $3.8 million for the three months ended June 30, 2026, compared with $2.7 million for the three months ended June 30, 2025; and $11.9 million for the nine months ended June 30, 2026, compared with $7.9 million for the nine months ended June 30, 2025; and, Net loss applicable to common stockholders of $8.9 million, or $(0.34) per share, for the three months ended June 30, 2026, compared with $8.8 million, or $(0.80) per share, for the three months ended June 30, 2025; and $38.3 million, or $(1.64) per share, for the nine months ended June 30, 2026, compared with $29.5 million, or $(3.27) per share, for the nine months ended June 30, 2025. About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 62% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com. Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to regain compliance with Nasdaq's continued listing standards; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to obtain, perform under and maintain financing, strategic and third party agreements and relationships, including obtaining a new bulk drug substance supplier; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our ability to obtain regulatory approval for and commercialize or enter into strategic partnerships with respect to Mino-Lok and Halo-Lido; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025 and as amended on January 28, 2026. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact:Ilanit [email protected] 908-967-6677 x113 Media Contact:STiR-communicationsGreg [email protected] – Financial Tables Follow – View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-reports-fiscal-third-quarter-2026-financial-results-and-provides-business-update-302852124.html
Investor releaseQuarter not tagged2026-05-16Citius Oncology, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update
PR Newswire
Citius Oncology, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update
$5.6 million in net revenue for the first half of fiscal 2026 as LYMPHIR® launch progresses Up to $36.5 million in debt and equity capital secured Broad payer coverage established with no reimbursement denials 83% of target accounts on formulary or in review CRANFORD, N.J., May 15, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal second quarter ended March 31, 2026, and provided a business update. "LYMPHIR's commercial launch gives us confidence in the trajectory ahead. In the first six months of fiscal 2026, which includes only four months of commercial sales since LYMPHIR's December 2025 launch, we generated $5.6 million in net revenue at gross margins of approximately 80%. This reflects initial orders by distributors during the first quarter, and subsequent reorders during the second quarter as we begin to see increased institutional demand for the therapy. As leading medical centers continue to add LYMPHIR to formulary and we build out our sales force, we believe we are moving through the expected transition from initial channel fill to sustained treatment-driven demand. We have achieved strong institutional penetration for a newly launched specialty therapy, with 83% of our target accounts having added LYMPHIR or actively progressing it through formulary review. Payer coverage has expanded to near 100% of covered commercial lives, with no reimbursement denials reported to date," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma. "With market access efforts underway, our focus is on establishing LYMPHIR's position in the CTCL treatment journey. The financing we secured, subsequent to quarter end, is the catalyst that provides us with resources to complete the buildout of our commercial field force. We expect to have the full commercial team deployed by mid-summer. We have ample finished goods and work-in-process inventory on hand to support anticipated commercial demand for the foreseeable future. A fully staffed sales organization, reinforced by broad market access and sufficient inventory to support anticipated demand, is how we plan to drive continued momentum. The fundamentals of a successful specialty pharmaceutical…Read full documentShow less
$5.6 million in net revenue for the first half of fiscal 2026 as LYMPHIR® launch progresses Up to $36.5 million in debt and equity capital secured Broad payer coverage established with no reimbursement denials 83% of target accounts on formulary or in review CRANFORD, N.J., May 15, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal second quarter ended March 31, 2026, and provided a business update. "LYMPHIR's commercial launch gives us confidence in the trajectory ahead. In the first six months of fiscal 2026, which includes only four months of commercial sales since LYMPHIR's December 2025 launch, we generated $5.6 million in net revenue at gross margins of approximately 80%. This reflects initial orders by distributors during the first quarter, and subsequent reorders during the second quarter as we begin to see increased institutional demand for the therapy. As leading medical centers continue to add LYMPHIR to formulary and we build out our sales force, we believe we are moving through the expected transition from initial channel fill to sustained treatment-driven demand. We have achieved strong institutional penetration for a newly launched specialty therapy, with 83% of our target accounts having added LYMPHIR or actively progressing it through formulary review. Payer coverage has expanded to near 100% of covered commercial lives, with no reimbursement denials reported to date," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma. "With market access efforts underway, our focus is on establishing LYMPHIR's position in the CTCL treatment journey. The financing we secured, subsequent to quarter end, is the catalyst that provides us with resources to complete the buildout of our commercial field force. We expect to have the full commercial team deployed by mid-summer. We have ample finished goods and work-in-process inventory on hand to support anticipated commercial demand for the foreseeable future. A fully staffed sales organization, reinforced by broad market access and sufficient inventory to support anticipated demand, is how we plan to drive continued momentum. The fundamentals of a successful specialty pharmaceutical launch, which include strong formulary and payer access, a funded commercial buildout, and healthy margins, are all moving in the right direction," added Mazur. "Building on the commercial foundation we are establishing in the U.S., we have initiated our first European shipment as part of the international distribution agreements we have in place across 19 markets in Southern Europe, the Middle East, and additional Western and Eastern European territories. At the same time, we continue to strengthen LYMPHIR's long-term value proposition through our support of clinical evidence generation. Recent preliminary topline Phase 1 investigator-initiated trial data reinforce the immuno-oncology rationale for LYMPHIR in combination settings, including its T-regulatory cell (Treg) depletion mechanism, and we look forward to additional data readouts in the future. Together, these execution milestones and data-driven catalysts reinforce our view that LYMPHIR can be developed beyond U.S. CTCL as a platform asset in combination regimens. We look forward to sharing continued positive momentum as LYMPHIR establishes itself as a meaningful new option in the treatment of relapsed or refractory CTCL, and we remain confident in its broader long-term commercial potential," concluded Mazur. Fiscal Second Quarter 2026 Business Highlights and Subsequent Developments Advanced formularly inclusion with 83% of target accounts having added or actively progressing LYMPHIR through formulary review; Secured near 100% of covered commercial lives; no reimbursement denials or prior authorization barriers reported; Initiated community infusion center penetration, with patients beginning to transition from larger academic cancer centers, a critical next phase of commercial scaling; Initiated shipment of LYMPHIR to Europe, with LYMPHIR being made available through Named Patient Programs (NPPs) per local regulations; Continued deployment of a proprietary AI-powered machine learning platform to support targeted physician engagement and efficient penetration of the highly concentrated CTCL prescriber base; Recruited and trained initial field sales team, with expanded field force recruitment underway; Announced positive topline results from two investigator-initiated Phase 1 studies evaluating LYMPHIR in combination settings, including: Phase 1 trial of LYMPHIR in combination with pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies; Phase 1 trial of LYMPHIR administered prior to CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with positive topline safety and efficacy results; and, Initiated evaluation of new bulk drug substance (BDS) suppliers with letter of intent with a new contract manufacturing organization (CMO) expected by the end of June 2026; $22.7 million of finished goods and work-in-process inventory as of March 31, 2026 to support anticipated commercial demand during the transition; Fiscal Second Quarter 2026 Financial Highlights and Subsequent Developments Cash and cash equivalents of $2.6 million as of March 31, 2026, prior to the up to $36.5 million concurrent debt and equity financings that closed in early May 2026; Secured up to $36.5 million in combined financing subsequent to quarter end, consisting of: a senior secured term loan facility of up to $25 million from Avenue Venture Opportunities Fund II, L.P. (Avenue Capital Group), with $10 million funded at close on May 6, 2026, up to $7 million available beginning October 1, 2026 subject to revenue and liquidity milestones, and up to $8 million available beginning January 1, 2027 subject to additional revenue milestones; and, approximately $11.5 million in gross proceeds received May 5, 2026 from the exercise of certain outstanding warrants; and, Net product revenues of $1.7 million for the three months ended March 31, 2026, compared to no revenue for the three months ended March 31, 2025; and $5.6 million for the six months ended March 31, 2026, compared to no revenue for the six months ended March 31, 2025; Gross profit of $1.3 million (80% margin) for the three months ended March 31, 2026, and $4.5 million (80% margin) for the six months ended March 31, 2026; R&D expenses of $1.1 million for the three months ended March 31, 2026, compared to $3.1 million for the three months ended March 31, 2025; and $2.1 million for the six months ended March 31, 2026, compared to $4.4 million for the six months ended March 31, 2025; G&A expenses of $23.6 million for the three months ended March 31, 2026, compared to $2.2 million for the three months ended March 31, 2025, primarily driven by the $19.7 million one-time CMO contract cancellation charge. G&A expenses were $26.5 million for the six months ended March 31, 2026, compared to $5.6 million for the six months ended March 31, 2025; Stock-based compensation expense of $3.5 million for the three months ended March 31, 2026, compared to $2.1 million for the three months ended March 31, 2025; and $7.5 million for the six months ended March 31, 2026, compared to $3.9 million for the six months ended March 31, 2025; Recognized a gain of $1.76 million from the sale of New Jersey state net operating losses under the New Jersey Technology Business Tax Certificate Transfer Program; and, Net loss of $26.6 million for the three months ended March 31, 2026, compared to a net loss of $7.7 million for the three months ended March 31, 2025; and a net loss of $32.1 million for the six months ended March 31, 2026, compared to a net loss of $14.4 million for the six months ended March 31, 2025. Fiscal Second Quarter 2026 Financial Results: Liquidity As of March 31, 2026, the Company had $2.6 million in cash and cash equivalents. Subsequent to quarter end, on May 5, 2026, the Company received approximately $11.5 million in gross proceeds from the exercise of certain outstanding warrants, and on May 6, 2026, the Company funded $10 million in gross proceeds under the first tranche of a senior secured term loan facility with Avenue Capital Group providing access to up to $25 million in total gross proceeds. We plan to continue to partially rely on funding from Citius Pharma, to raise capital through equity and debt financings, and to generate revenue from sales of LYMPHIR. We also have retained Jefferies LLC as our exclusive financial advisor in evaluating strategic alternatives aimed at maximizing shareholder value. After giving effect to the May 2026 equity and debt financings, we expect that Citius Oncology and Citius Pharma collectively will have sufficient funds to continue operations through November 2026. Net Revenue Net product revenues were $1.7 million for the three months ended March 31, 2026, compared to no revenue for the three months ended March 31, 2025. For the six months ended March 31, 2026, net product revenues were $5.6 million, compared to no revenue for the six months ended March 31, 2025. The Company launched LYMPHIR in December 2025. The quarterly decrease in product revenues is primarily attributable to larger initial orders in the quarter ended December 31, 2025, as US distributors established their initial inventories. We believe that revenues will increase in the future as LYMPHIR gains market acceptance and initial accounts continue placing repeat orders. At the end of April 2026, we announced an initial shipment of LYMPHIR to Europe. Research and Development (R&D) Expenses R&D expenses were $1.1 million for the three months ended March 31, 2026, compared to $3.1 million for the three months ended March 31, 2025, a decrease of $2.0 million. For the six months ended March 31, 2026, R&D expenses were $2.1 million, compared to $4.4 million for the six months ended March 31, 2025, a decrease of $2.3 million. The decrease in both periods primarily reflects reduced clinical development activity, as the prior-year periods included costs for a pre-license inspection batch of LYMPHIR previously manufactured. General and Administrative (G&A) Expenses G&A expenses were $23.6 million for the three months ended March 31, 2026, compared to $2.2 million for the three months ended March 31, 2025, an increase of $21.4 million. For the six months ended March 31, 2026, G&A expenses were $26.5 million, compared to $5.5 million for the six months ended March 31, 2025, an increase of $21.9 million. The increase in both periods was primarily driven by a $19.7 million one-time contract cancellation charge related to the CMO termination recognized in March 2026. Stock-based Compensation Expense Stock-based compensation expense was $3.5 million for the three months ended March 31, 2026, compared to $2.1 million for the three months ended March 31, 2025. For the six months ended March 31, 2026, stock-based compensation was $7.5 million, compared to $3.9 million for the six months ended March 31, 2025. Net Loss Net loss was $26.6 million for the three months ended March 31, 2026, compared to $7.7 million for the three months ended March 31, 2025, an increase of $18.9 million. For the six months ended March 31, 2026, net loss was $32.1 million, compared to $14.4 million for the six months ended March 31, 2025, an increase of $17.7 million. The increase in net loss for the three-month period was primarily attributable to the $19.7 million CMO contract cancellation charge, partially offset by $1.7 million in LYMPHIR revenues and the $1.76 million gain on the sale of New Jersey net operating losses. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com. About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 71% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com. Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to obtain, perform under and maintain financing, strategic and third party agreements and relationships, including obtaining a new bulk drug substance supplier; our ability to regain compliance with Nasdaq's continued listing standards; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] – Financial Tables Follow – View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-inc-reports-fiscal-second-quarter-2026-financial-results-and-provides-business-update-302773892.html
Investor releaseQuarter not tagged2026-05-16Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update
PR Newswire
Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update
$5.6 Million in net revenue for the first half of fiscal 2026 from ongoing launch of LYMPHIR® Citius Pharma raised $5 million in a registered direct offering; Citius Oncology secured up to $36.5 million in debt and equity financing Advanced patient access with payer coverage near 100% of commercial lives and 83% of LYMPHIR target accounts on formulary or in review CRANFORD, N.J., May 15, 2026 /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 second quarter ended March 31, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR). "The first half of fiscal 2026 demonstrated meaningful commercial progress at our majority-owned subsidiary Citius Oncology. In the four months of commercial sales since the December 2025 launch of LYMPHIR, Citius Oncology generated $5.6 million in net revenue at approximately 80% gross margins, advanced 83% of target accounts to formulary inclusion or active review, and secured payer coverage representing near 100% of covered commercial lives with no reimbursement denials reported to date. Importantly, major academic centers have begun to transition patients to local community infusion centers for treatment, a critical next phase of commercial scaling. These results reflect our efforts to build a durable patient access foundation upon which to drive growth," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharma and Citius Oncology. "Subsequent to quarter end, Citius Oncology secured up to $36.5 million in combined debt and equity financing through its senior secured credit facility with Avenue Capital and the exercise of outstanding warrants, complemented by Citius Pharma's $5 million registered direct offering. Together, these proceeds are expected to fund Citius Pharma's activities as well as the completion of the LYMPHIR commercial field force buildout by mid-summer. This will support expanded physician engagement and broader market penetration, positioning Citius Oncology to accelerate growth as the launch matures. We believe Citius Oncology maintains sufficient inventory to support anticipated commercial demand, as…Read full documentShow less
$5.6 Million in net revenue for the first half of fiscal 2026 from ongoing launch of LYMPHIR® Citius Pharma raised $5 million in a registered direct offering; Citius Oncology secured up to $36.5 million in debt and equity financing Advanced patient access with payer coverage near 100% of commercial lives and 83% of LYMPHIR target accounts on formulary or in review CRANFORD, N.J., May 15, 2026 /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 second quarter ended March 31, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR). "The first half of fiscal 2026 demonstrated meaningful commercial progress at our majority-owned subsidiary Citius Oncology. In the four months of commercial sales since the December 2025 launch of LYMPHIR, Citius Oncology generated $5.6 million in net revenue at approximately 80% gross margins, advanced 83% of target accounts to formulary inclusion or active review, and secured payer coverage representing near 100% of covered commercial lives with no reimbursement denials reported to date. Importantly, major academic centers have begun to transition patients to local community infusion centers for treatment, a critical next phase of commercial scaling. These results reflect our efforts to build a durable patient access foundation upon which to drive growth," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharma and Citius Oncology. "Subsequent to quarter end, Citius Oncology secured up to $36.5 million in combined debt and equity financing through its senior secured credit facility with Avenue Capital and the exercise of outstanding warrants, complemented by Citius Pharma's $5 million registered direct offering. Together, these proceeds are expected to fund Citius Pharma's activities as well as the completion of the LYMPHIR commercial field force buildout by mid-summer. This will support expanded physician engagement and broader market penetration, positioning Citius Oncology to accelerate growth as the launch matures. We believe Citius Oncology maintains sufficient inventory to support anticipated commercial demand, as well as additional demand outside the U.S., as we begin to see orders for product through our global distribution partners." "Moreover, we are encouraged by positive preliminary topline Phase 1 data from two investigator-initiated combination studies, with pembrolizumab and prior to CAR-T therapy, which reinforce LYMPHIR's potential as a platform asset in combination regimens. At the Citius Pharma level, we also remain focused on advancing Mino-Lok and Halo-Lido with the FDA and on disciplined execution of our mission to bring first-in-class therapies to patients," concluded Mazur. Fiscal Second Quarter 2026 Business Highlights and Subsequent Developments Reported key commercial metrics of LYMPHIR launch: 83% of target accounts had added or were actively progressing LYMPHIR through formulary review; Secured near 100% of covered commercial lives; no reimbursement denials or prior authorization barriers reported; Initial accounts placing repeat orders; Patients beginning to transition from larger academic cancer centers to community infusion centers; Announced initial shipment of LYMPHIR to Europe on April 29, 2026 through Uniphar, a leading international healthcare services company, with LYMPHIR being made available to eligible patients through Named Patient Programs (NPPs) in accordance with local regulations across 19 markets in Southern Europe, the Middle East, and additional European territories; Announced positive topline results from two investigator-initiated Phase 1 studies, including: LYMPHIR in combination with pembrolizumab in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies; LYMPHIR administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with positive topline safety and efficacy results; and, Continued FDA engagement on Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and on Halo-Lido (CITI-002), a topical formulation for hemorrhoids. Fiscal Second Quarter 2026 Financial Highlights and Subsequent Events Cash and cash equivalents of $4.6 million as of March 31, 2026; Citius Pharma closed a $5 million registered direct offering in April 2026; Citius Oncology secured up to $36.5 million in financing subsequent to quarter end, consisting of: $11.5 million in gross proceeds received May 5, 2026 from the exercise of certain outstanding warrants; a loan agreement of up to $25 million from Avenue Capital Group, with $10 million in gross proceeds funded at close on May 6, 2026, and up to $15 million available in subsequent tranches pending certain revenue and liquidity milestones; and, Citius Pharma and Citius Oncology collectively expect to have sufficient funds to continue operations through November 2026; Net product revenues of $1.7 million for the three months ended March 31, 2026, compared to no revenue in the three months ended March 31, 2025, and $5.6 million for the six months ended March 31, 2026, compared to no revenue in the six months ended March 31, 2025; quarter over quarter decline reflects larger initial orders from specialty distributors at launch in the first quarter; Gross profit of $1.3 million for the three months ended March 31, 2026, and $4.5 million for the six months ended March 31, 2026; approximately 80% in both periods, reflecting continued commercial progress since the December 2025 launch of LYMPHIR; R&D expenses of $1.6 million for the three months ended March 31, 2026, compared to $3.8 million for the three months ended March 31, 2025; and $3.2 million for the six months ended March 31, 2026, compared to $5.9 million for the six months ended March 31, 2025. The decrease in both periods primarily reflects reduced clinical development activity, as the prior-year periods included costs for a pre-license inspection batch of LYMPHIR previously manufactured; G&A expenses of $26.4 million for the three months ended March 31, 2026, compared to $4.8 million for the three months ended March 31, 2025, primarily driven by a $19.7 million one-time CMO contract cancellation charge. G&A expenses were $32.1 million for the six months ended March 31, 2026, compared to $10.2 million for the six months ended March 31, 2025; Stock-based compensation expense was $3.8 million for the three months ended March 31, 2026, compared to $2.7 million for the three months ended March 31, 2025. For the six months ended March 31, 2026, stock-based compensation was $8.1 million, compared to $5.2 million for the six months ended March 31, 2025; Recognized a gain of $3.8 million from the sale of New Jersey state net operating losses under the New Jersey Technology Business Tax Certificate Transfer Program; and, Net loss applicable to common stockholders of $21.2 million, or $(0.95) per share, for the three months ended March 31, 2026, compared to $10.9 million, or $(1.27) per share, for the three months ended March 31, 2025; and $29.5 million, or $(1.34) per share, for the six months ended March 31, 2026, compared to $20.7 million, or $(2.58) per share, for the six months ended March 31, 2025. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com. About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 71% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com. Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharmaceuticals. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to obtain, perform under and maintain financing, strategic and third party agreements and relationships, including obtaining a new bulk drug substance supplier; our ability to regain compliance with Nasdaq's continued listing standards; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025 and as amended on January 28, 2026. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] – Financial Tables Follow – View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-reports-fiscal-second-quarter-2026-financial-results-and-provides-business-update-302773890.html
Investor releaseQuarter not tagged2026-03-10Citius Oncology Announces Positive Topline Results from Investigator‑Initiated Phase 1 Study of LYMPHIR™ in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic Cancers
PR Newswire
Citius Oncology Announces Positive Topline Results from Investigator‑Initiated Phase 1 Study of LYMPHIR™ in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic Cancers
Study data from patients with relapsed or refractory gynecologic cancers signals the potential of LYMPHIR to augment immune checkpoint inhibitor efficacy Topline data of University of Pittsburgh-led trial to be presented at an upcoming international cancer conference later this year CRANFORD, N.J., March 10, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced positive topline results from a completed investigator‑initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators. This study evaluated the direct T-regulatory (Treg) cell depletion activity of LYMPHIR™ (denileukin diftitox‑cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies. Patients with relapsed or refractory gynecological cancer have poor prognoses and very limited treatment options. This dose-escalation Phase 1 non-chemotherapy based clinical study aimed to establish a recommended dose of LYMPHIR in combination with pembrolizumab for a Phase 2 study. In 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were observed at any dose level. "We are encouraged by the favorable safety profile and sustained disease control observed in this heavily pretreated patient population. Evidence from the study suggests augmented anti-tumor activity when LYMPHIR is combined with KEYTRUDA and warrants further exploration in Phase 2 settings," stated Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma. The trial explored efficacy and demonstrated a 24 % objective response rate (ORR) and a 48 % clinical benefit rate (CBR, defined as complete response, partial response and/or stable disease for six months or greater) among 21 evaluable patients. Full safety and clinical efficacy results are expected to be presented at an international cancer conference later this year. "The efficacy signal shown by this combination is incredibly exciting considering the minimal impact immuno-oncology has made in ovarian cancer thus far. If these findings are confirmed in subsequent studies,…Read full documentShow less
Study data from patients with relapsed or refractory gynecologic cancers signals the potential of LYMPHIR to augment immune checkpoint inhibitor efficacy Topline data of University of Pittsburgh-led trial to be presented at an upcoming international cancer conference later this year CRANFORD, N.J., March 10, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced positive topline results from a completed investigator‑initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators. This study evaluated the direct T-regulatory (Treg) cell depletion activity of LYMPHIR™ (denileukin diftitox‑cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies. Patients with relapsed or refractory gynecological cancer have poor prognoses and very limited treatment options. This dose-escalation Phase 1 non-chemotherapy based clinical study aimed to establish a recommended dose of LYMPHIR in combination with pembrolizumab for a Phase 2 study. In 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were observed at any dose level. "We are encouraged by the favorable safety profile and sustained disease control observed in this heavily pretreated patient population. Evidence from the study suggests augmented anti-tumor activity when LYMPHIR is combined with KEYTRUDA and warrants further exploration in Phase 2 settings," stated Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma. The trial explored efficacy and demonstrated a 24 % objective response rate (ORR) and a 48 % clinical benefit rate (CBR, defined as complete response, partial response and/or stable disease for six months or greater) among 21 evaluable patients. Full safety and clinical efficacy results are expected to be presented at an international cancer conference later this year. "The efficacy signal shown by this combination is incredibly exciting considering the minimal impact immuno-oncology has made in ovarian cancer thus far. If these findings are confirmed in subsequent studies, we may have a transformational therapy on our hands," said Dr. Alexander Olawaiye, principal investigator of the study. About the Study This open‑label, dose‑escalation, investigator‑initiated Phase 1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee‑Women's Hospital, enrolled patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days 1–3 of each 21‑day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200 mg IV) on Day 1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression. The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes. About Gynecologic Cancers Recurrent or metastatic ovarian and endometrial cancers are two of the most common gynecologic malignancies in the United States. Endometrial cancer is the most frequently diagnosed gynecologic cancer, with an estimated 70,000 new cases expected in 20261, while ovarian cancer remains the deadliest with approximately 12,700 deaths per year (51.6% 5 year survival) and approximately 20,000 new diagnoses each year2. These cancers are often detected at advanced stages, and although many patients initially respond to platinum‑based chemotherapy, most experience relapse and develop resistance. Survival rates in the recurrent setting remain poor, and responses to current immunotherapies such as PD‑1 inhibitors are limited, highlighting a significant unmet need for novel treatment approaches. LYMPHIR's transient depletion of regulatory T‑cells may enhance anti‑tumor immune responses and help overcome immunotherapy resistance in these difficult‑to‑treat tumors. About LYMPHIR™ (denileukin diftitox‑cxdl) LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com. Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; early-stage clinical data may not be predictive of results from larger or later-stage studies; our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to maintain Nasdaq's continued listing standards; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. REFERENCES: KEYTRUDA® is a registered trademark of Merck & Co., Inc. LYMPHIR™ (denileukin diftitox‑cxdl) INDICATION LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. IMPORTANT SAFETY INFORMATION BOXED WARNING: CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity. WARNINGS AND PRECAUTIONS Capillary Leak Syndrome LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome. As defined, CLS occurred in 27% of patients in the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution. The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also occurred. Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL. Visual Impairment LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual impairment. Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation. Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity. Infusion-Related Reactions LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4%. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia. Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles. Interrupt or discontinue LYMPHIR based on severity. Institute appropriate medical management. Hepatotoxicity LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved. Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%. Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity. Embryo-Fetal Toxicity Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR. ADVERSE REACTIONS The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox. Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Lactation Risk Summary No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose. Females and Males of Reproductive Potential Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose. Infertility Males Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown. Pediatric Use Safety and effectiveness of LYMPHIR in pediatric patients have not been established. Geriatric Use Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Citius Oncology at 1-844-459-6744. Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-announces-positive-topline-results-from-investigatorinitiated-phase-1-study-of-lymphir-in-combination-with-pembrolizumab-in-relapsed-or-refractory-gynecologic-cancers-302709073.html
Investor releaseQuarter not tagged2025-12-24Citius Oncology, Inc. Reports Fiscal Year 2025 Financial Results and Provides Business Update
PR Newswire
Citius Oncology, Inc. Reports Fiscal Year 2025 Financial Results and Provides Business Update
Cancer Immunotherapy, LYMPHIR™, launched in the U.S. in December 2025 Completed $36 million in strategic financings, of which $18 million was via private placement and concurrent registered direct offering on December 10, 2025, to strengthen cash position and support continued commercialization of LYMPHIR CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal year ended September 30, 2025, and provided a business update. "2025 was a landmark year for Citius Oncology. With the U.S. commercial launch of LYMPHIR now underway, we have shifted from a pre-revenue to a revenue generating company," said Leonard Mazur, Chairman and CEO of Citius Oncology and parent company Citius Pharmaceuticals. "Our focus now is on driving adoption, delivering value to patients, and realizing the full commercial potential of our first‑in‑class therapy. We intend to leverage our advanced AI-driven analytics to refine targeting, optimize field execution, and maximize commercial efficiency. In parallel, we have also begun laying the groundwork for international access with key distribution partners spanning 19 markets in Southern Europe and the Middle East via Named Patient Programs. These foundational efforts position us to scale and deliver sustained value to patients and shareholders alike." Fiscal Year 2025 Business Highlights and Subsequent Developments Launched LYMPHIR™ (denileukin diftitox-cxdl), a novel IL‑2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I–III cutaneous T‑cell 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 and specialized hospitals treating oncology patients, community oncology practices, and infusion centers throughout the U.S.; Secured access to LYMPHIR in 19 international markets through regional distribution partners via Named Patient Programs (NPPs), marking the first step in the Company's global access strategy; NPPs allow access to LYMPHIR where permitted by local law without constituting commercial appr…Read full documentShow less
Cancer Immunotherapy, LYMPHIR™, launched in the U.S. in December 2025 Completed $36 million in strategic financings, of which $18 million was via private placement and concurrent registered direct offering on December 10, 2025, to strengthen cash position and support continued commercialization of LYMPHIR CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal year ended September 30, 2025, and provided a business update. "2025 was a landmark year for Citius Oncology. With the U.S. commercial launch of LYMPHIR now underway, we have shifted from a pre-revenue to a revenue generating company," said Leonard Mazur, Chairman and CEO of Citius Oncology and parent company Citius Pharmaceuticals. "Our focus now is on driving adoption, delivering value to patients, and realizing the full commercial potential of our first‑in‑class therapy. We intend to leverage our advanced AI-driven analytics to refine targeting, optimize field execution, and maximize commercial efficiency. In parallel, we have also begun laying the groundwork for international access with key distribution partners spanning 19 markets in Southern Europe and the Middle East via Named Patient Programs. These foundational efforts position us to scale and deliver sustained value to patients and shareholders alike." Fiscal Year 2025 Business Highlights and Subsequent Developments Launched LYMPHIR™ (denileukin diftitox-cxdl), a novel IL‑2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I–III cutaneous T‑cell 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 and specialized hospitals treating oncology patients, community oncology practices, and infusion centers throughout the U.S.; Secured access to LYMPHIR in 19 international markets through regional distribution partners via Named Patient Programs (NPPs), marking the first step in the Company's global access strategy; NPPs allow access to LYMPHIR where permitted by local law without constituting commercial approval outside the U.S.; Announced a collaboration with Verix to deploy its Tovana AI-powered platform to enhance commercial targeting, real-time field execution, and provider engagement in support of LYMPHIR's U.S. commercialization and adoption; and, Announced promising preliminary results of an investigator-initiated Phase I clinical trial of pembrolizumab and LYMPHIR™ in cancer patients with recurrent solid tumors. Fiscal Full Year 2025 Financial Highlights Cash and cash equivalents of $3.9 million as of September 30, 2025; Closed $36 million in gross proceeds from strategic financings during and after the fiscal year end: Received $1 million from Citius Pharma as a note payable; R&D expenses were $6.4 million for the full year ended September 30, 2025, compared to $4.9 million for the full year ended September 30, 2024; G&A expenses were $8.8 million for the full year ended September 30, 2025, compared to $8.1 million for the full year ended September 30, 2024; Stock-based compensation expense was $8.3 million for the full year ended September 30, 2025, compared to $7.5 million for the full year ended September 30, 2024; and, Net loss was $24.8 million, or ($0.34) per share for the fiscal year ended September 30, 2025 compared to a net loss of $21.1 million, or ($0.31) per share for the full year ended September 30, 2024. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com. About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 78% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com. Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to maintain Nasdaq's continued listing standards; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] -- Financial Tables Follow – View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-inc-reports-fiscal-year-2025-financial-results-and-provides-business-update-302648892.html
Investor releaseQuarter not tagged2025-12-24Citius Oncology Fiscal 2025 Loss Widens
MT Newswires
Citius Oncology Fiscal 2025 Loss Widens
Citius Oncology (CTOR) reported a loss of $0.34 per diluted share in the 12 months ended Sept. 30, w
Investor releaseQuarter not tagged2025-08-13Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2025 Financial Results and Provides Business Update
PR Newswire
Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2025 Financial Results and Provides Business Update
$12.5 million in gross financings raised during the quarter, with an additional $9 million raised by Citius Oncology in July 2025, to facilitate LYMPHIR pre-launch initiatives and drive successful market introduction CRANFORD, N.J., Aug. 12, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today reported financial results for its fiscal third quarter ended June 30, 2025, and provided a business update. "During the third quarter, Citius advanced its strategic priorities, and we believe we are now operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization. Final preparations are underway by our oncology subsidiary for the planned U.S. launch of LYMPHIR™ in the fourth quarter of 2025," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. "In June 2025, we completed a $6 million registered direct offering, with the potential for an additional $9.8 million upon full warrant exercise, to fund commercialization activities and corporate operations. In July 2025, Citius Oncology further strengthened its capital position with $9 million in gross proceeds from a public offering. These financings, any proceeds we might receive from exercise of the June 2025 warrants and other capital raising activities during the quarter, together with the completion of major launch-enabling activities including commercial-scale manufacturing, labeling, packaging, and distribution services agreements with leading specialty pharmaceutical partners indicate we are well-prepared to deliver LYMPHIR to patients with cutaneous T-cell lymphoma, an underserved population in need of new treatment options. At the same time, we remain focused on advancing Mino-Lok and continue to engage with the U.S. Food and Drug Administration as we evaluate the best path forward for this potentially transformative antibiotic lock solutions for patients with catheter-related bloodstream infections," added Mazur. FISCAL THIRD QUARTER 2025 FINANCIAL RESULTS: R&D expenses were $1.6 million for the quarter ended June 30, 2025, compared to $2.8 million for the quarter ended June 30, 2024; G&A expenses were $4.4 million for the quarter ended June 30, 2025, as compar…Read full documentShow less
$12.5 million in gross financings raised during the quarter, with an additional $9 million raised by Citius Oncology in July 2025, to facilitate LYMPHIR pre-launch initiatives and drive successful market introduction CRANFORD, N.J., Aug. 12, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today reported financial results for its fiscal third quarter ended June 30, 2025, and provided a business update. "During the third quarter, Citius advanced its strategic priorities, and we believe we are now operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization. Final preparations are underway by our oncology subsidiary for the planned U.S. launch of LYMPHIR™ in the fourth quarter of 2025," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. "In June 2025, we completed a $6 million registered direct offering, with the potential for an additional $9.8 million upon full warrant exercise, to fund commercialization activities and corporate operations. In July 2025, Citius Oncology further strengthened its capital position with $9 million in gross proceeds from a public offering. These financings, any proceeds we might receive from exercise of the June 2025 warrants and other capital raising activities during the quarter, together with the completion of major launch-enabling activities including commercial-scale manufacturing, labeling, packaging, and distribution services agreements with leading specialty pharmaceutical partners indicate we are well-prepared to deliver LYMPHIR to patients with cutaneous T-cell lymphoma, an underserved population in need of new treatment options. At the same time, we remain focused on advancing Mino-Lok and continue to engage with the U.S. Food and Drug Administration as we evaluate the best path forward for this potentially transformative antibiotic lock solutions for patients with catheter-related bloodstream infections," added Mazur. FISCAL THIRD QUARTER 2025 FINANCIAL RESULTS: R&D expenses were $1.6 million for the quarter ended June 30, 2025, compared to $2.8 million for the quarter ended June 30, 2024; G&A expenses were $4.4 million for the quarter ended June 30, 2025, as compared to $4.8 million for the quarter ended June 30, 2024; Stock-based compensation expense was $2.7 million for the quarter ended June 30, 2025, as compared to $3.1 million for the quarter ended June 30, 2024; Net loss was $9.2 million, or ($0.80) per share, for the quarter ended June 30, 2025, as compared to a net loss of $10.6 million, or ($1.57) per share, for the quarter ended June 30, 2024, as adjusted for the reverse stock split; At June 30, 2025, Citius Pharma had cash and cash equivalents of $6.1 million available to fund its operations. During the nine months ended June 30, 2025, the Company received net proceeds of $16.5 million from the issuance of equity and $1 million from the issuance of a note payable; and, On July 17, 2025, Citius Oncology completed a public offering generating net proceeds of approximately $7.4 million, after deducting placement agent fees and other offering expenses. For a complete discussion of our financial results, please refer to our Quarterly Report on Form 10-Q for the period ended June 30, 2025, filed today with the SEC and available at www.sec.gov. About Citius Pharmaceuticals, Inc. Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR™, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. Citius Pharma owns 84% of Citius Oncology. For more information, please visit www.citiuspharma.com. Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma are: our need for substantial additional funds and our ability to raise additional money to fund our operations beyond September 2025 and for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services, through our majority-owned subsidiary and any of our other product candidates that may be approved by the FDA; our ability to maintain compliance with Nasdaq's continued listing standards; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; risks related to research using our assets but conducted by third parties; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market, economic and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025, Citius Pharma's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 12, 2025, and as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] -- Financial Tables Follow – View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-reports-fiscal-third-quarter-2025-financial-results-and-provides-business-update-302528078.html SOURCE Citius Pharmaceuticals, Inc.
Investor releaseQuarter not tagged2025-08-13Citius Oncology, Inc. Reports Fiscal Third Quarter 2025 Financial Results and Provides Business Update
PR Newswire
Citius Oncology, Inc. Reports Fiscal Third Quarter 2025 Financial Results and Provides Business Update
LYMPHIR commercial availability planned for the fourth quarter of 2025 $12.5 million in gross financings raised during the quarter by Citius Pharmaceuticals, with an additional $9 million raised by Citius Oncology in July 2025, to facilitate LYMPHIR pre-launch initiatives and drive successful market introduction CRANFORD, N.J., Aug. 12, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal third quarter ended June 30, 2025. "Citius Oncology is in the final stages of preparation for the U.S. commercial launch of LYMPHIR™," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "We successfully raised capital to support our pre-launch activities and secured distribution service agreements with leading global providers. Our launch strategy leverages cutting-edge technology and targeted marketing to reach the cutaneous T-cell lymphoma patients and providers who can benefit most from this important therapy. With launch supplies ready, distribution agreements in place, and strong engagement from key opinion leaders, we plan to make LYMPHIR available in the fourth quarter of 2025." FISCAL THIRD QUARTER 2025 FINANCIAL HIGHLIGHTS: On July 17, 2025, Citius Oncology completed a public offering generating net proceeds of approximately $7.4 million, after deducting placement agent fees and other offering expenses; R&D expenses were $938,000 for the quarter ended June 30, 2025, as compared to $1.1 million for the quarter ended June 30, 2024; G&A expenses were $1.9 million for the quarter ended June 30, 2025, as compared to $1.5 million for the quarter ended June 30, 2024; Stock-based compensation expense was $2.1 million, as compared to $2.0 million for the quarter ended June 30, 2024; Net loss was $5.4 million, or ($0.08) per share, for the quarter ended June 30, 2025, as compared to a net loss of $4.8 million, or ($0.07) per share, for the quarter ended June 30, 2024; and, As of June 30, 2025, the Company had $112 in cash and cash equivalents and 71,552,402 common shares outstanding. Citius Oncology is a subsidiary of Citius Pharma. During the three months ended June 30, 2025, Citius Pharma received net proceeds from…Read full documentShow less
LYMPHIR commercial availability planned for the fourth quarter of 2025 $12.5 million in gross financings raised during the quarter by Citius Pharmaceuticals, with an additional $9 million raised by Citius Oncology in July 2025, to facilitate LYMPHIR pre-launch initiatives and drive successful market introduction CRANFORD, N.J., Aug. 12, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal third quarter ended June 30, 2025. "Citius Oncology is in the final stages of preparation for the U.S. commercial launch of LYMPHIR™," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "We successfully raised capital to support our pre-launch activities and secured distribution service agreements with leading global providers. Our launch strategy leverages cutting-edge technology and targeted marketing to reach the cutaneous T-cell lymphoma patients and providers who can benefit most from this important therapy. With launch supplies ready, distribution agreements in place, and strong engagement from key opinion leaders, we plan to make LYMPHIR available in the fourth quarter of 2025." FISCAL THIRD QUARTER 2025 FINANCIAL HIGHLIGHTS: On July 17, 2025, Citius Oncology completed a public offering generating net proceeds of approximately $7.4 million, after deducting placement agent fees and other offering expenses; R&D expenses were $938,000 for the quarter ended June 30, 2025, as compared to $1.1 million for the quarter ended June 30, 2024; G&A expenses were $1.9 million for the quarter ended June 30, 2025, as compared to $1.5 million for the quarter ended June 30, 2024; Stock-based compensation expense was $2.1 million, as compared to $2.0 million for the quarter ended June 30, 2024; Net loss was $5.4 million, or ($0.08) per share, for the quarter ended June 30, 2025, as compared to a net loss of $4.8 million, or ($0.07) per share, for the quarter ended June 30, 2024; and, As of June 30, 2025, the Company had $112 in cash and cash equivalents and 71,552,402 common shares outstanding. Citius Oncology is a subsidiary of Citius Pharma. During the three months ended June 30, 2025, Citius Pharma received net proceeds from equity offerings of approximately $10.5 million. For a complete discussion of our financial results, please refer to our Quarterly Report on Form 10-Q for the period ended June 30, 2025, filed today with the SEC and available at www.sec.gov. About Citius Oncology, Inc. Citius Oncology specialty is a biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. Citius Oncology is a publicly traded subsidiary of Citius Pharmaceuticals. For more information, please visit www.citiusonc.com Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Oncology are: our need for substantial additional funds and our ability to raise additional money to fund our operations beyond September 2025 and for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services, and any of our other product candidates that may be approved by the FDA; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; our ability to maintain compliance with Nasdaq's continued listing standards; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; risks related to research using our assets but conducted by third parties; uncertainties relating to preclinical and clinical testing; market, economic and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025, Citius Oncology's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 12, 2025, and as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] -- Financial Tables Follow – View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-inc-reports-fiscal-third-quarter-2025-financial-results-and-provides-business-update-302528107.html SOURCE Citius Oncology, Inc.
Investor releaseQuarter not tagged2025-05-15Citius Oncology, Inc. Reports Fiscal Second Quarter 2025 Financial Results and Provides Business Update
PR Newswire
Citius Oncology, Inc. Reports Fiscal Second Quarter 2025 Financial Results and Provides Business Update
CRANFORD, N.J., May 14, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal second quarter ended March 31, 2025. "In Q2 2025, Citius Oncology advanced its transformation from a development-stage company to a commercial-stage organization. Following FDA approval of LYMPHIR, we intensified our focus on disciplined capital deployment and operational execution to support the success of our planned U.S. launch," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "This quarter's progress underscores our commitment to creating long-term value by ensuring LYMPHIR reaches patients with cutaneous T-cell lymphoma. Discussions with prospective commercial and strategic partners are underway as we concurrently pursue opportunities to secure additional capital to enhance our financial flexibility. These efforts are critical as we lay the foundation for sustained commercial success. With disciplined execution and a focused strategic vision, we believe Citius Oncology is poised to deliver meaningful near-term impact and durable shareholder value," concluded Mazur. FISCAL SECOND QUARTER 2025 FINANCIAL RESULTS: Liquidity Citius Oncology is a subsidiary of Citius Pharma. Citius Pharma plans to continue to fund Citius Oncology until Citius Oncology raises adequate capital through equity financings from outside investors and/or generates revenue from the future sales of LYMPHIR. Citius Oncology has also retained Jefferies LLC as exclusive financial advisor to evaluate strategic alternatives aimed at maximizing stockholder value. As of March 31, 2025, the Company had $112 in cash and cash equivalents and 71,552,402 common shares outstanding. Citius Oncology will need to secure additional capital to support operations beyond May 2025. Research and Development (R&D) Expenses R&D expenses were $3.1 million for the quarter ended March 31, 2025, as compared to $1.3 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, R&D expenses were $4.4 million, as compared to $2.5 million for the six months ended March 31, 2024. The increase is primarily related to costs associated with the expense of a dr…Read full documentShow less
CRANFORD, N.J., May 14, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal second quarter ended March 31, 2025. "In Q2 2025, Citius Oncology advanced its transformation from a development-stage company to a commercial-stage organization. Following FDA approval of LYMPHIR, we intensified our focus on disciplined capital deployment and operational execution to support the success of our planned U.S. launch," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "This quarter's progress underscores our commitment to creating long-term value by ensuring LYMPHIR reaches patients with cutaneous T-cell lymphoma. Discussions with prospective commercial and strategic partners are underway as we concurrently pursue opportunities to secure additional capital to enhance our financial flexibility. These efforts are critical as we lay the foundation for sustained commercial success. With disciplined execution and a focused strategic vision, we believe Citius Oncology is poised to deliver meaningful near-term impact and durable shareholder value," concluded Mazur. FISCAL SECOND QUARTER 2025 FINANCIAL RESULTS: Liquidity Citius Oncology is a subsidiary of Citius Pharma. Citius Pharma plans to continue to fund Citius Oncology until Citius Oncology raises adequate capital through equity financings from outside investors and/or generates revenue from the future sales of LYMPHIR. Citius Oncology has also retained Jefferies LLC as exclusive financial advisor to evaluate strategic alternatives aimed at maximizing stockholder value. As of March 31, 2025, the Company had $112 in cash and cash equivalents and 71,552,402 common shares outstanding. Citius Oncology will need to secure additional capital to support operations beyond May 2025. Research and Development (R&D) Expenses R&D expenses were $3.1 million for the quarter ended March 31, 2025, as compared to $1.3 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, R&D expenses were $4.4 million, as compared to $2.5 million for the six months ended March 31, 2024. The increase is primarily related to costs associated with the expense of a drug substance batch needed for the pre-license inspection of the manufacturer. General and Administrative (G&A) Expenses G&A expenses were $2.2 million for the quarter ended March 31, 2025, as compared to $1.4 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, G&A expenses were $5.5 million, as compared to $2.9 million for the six months ended March 31, 2024. The increase was primarily due to costs associated with pre-commercial and commercial launch activities of LYMPHIR including market research, marketing, distribution and drug product reimbursement from health plans and payers. Stock-based Compensation Expense For the quarter ended March 31, 2025, stock-based compensation expense was $2.1 million, as compared to $2.0 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, stock-based compensation expense was $3.9 million, as compared to $3.9 million for the six months ended March 31, 2024. The increase was primarily due to new options granted in December 2024. Net loss Net loss was $7.7 million, or ($0.11) per share, for the quarter ended March 31, 2025, as compared to a net loss of $4.8 million, or ($0.07) per share, for the quarter ended March 31, 2024. Net loss for the six months ended March 31, 2025 was $14.4 million, as compared to a net loss of $9.6 million for the six months ended March 31, 2024. The increase in net loss was primarily due to the increase in our operating expenses. About Citius Oncology, Inc. Citius Oncology specialty is a biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. Citius Oncology is a publicly traded subsidiary of Citius Pharmaceuticals. For more information, please visit www.citiusonc.com Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Oncology are: our need for substantial additional funds and our ability to raise additional money to fund our operations beyond May 2025 and for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services, and any of our other product candidates that may be approved by the FDA; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; our ability to regain compliance with Nasdaq's continued listing standards; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; risks related to research using our assets but conducted by third parties; uncertainties relating to preclinical and clinical testing; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025, Citius Oncology's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 14, 2025, and as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allen [email protected] 908-967-6677 x113 Media Contact: STiR-communications Greg Salsburg [email protected] -- Financial Tables Follow – View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-inc-reports-fiscal-second-quarter-2025-financial-results-and-provides-business-update-302455668.html SOURCE Citius Oncology, Inc.

