Pembrolizumab

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: Completed an $18 million (gross proceeds) concurrent registered direct offering and private placement on December 10, 2025; Completed a $9 million (gross proceeds) concurrent registered direct offering and private placement on September 10, 2025; and, Completed a $9 million (gross proceeds) public offering on July 17, 2025. 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 . 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 . 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 , 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 – SOURCE Citius Oncology, Inc. 21% more press release views with Request a Demo

NUFYMCO® BLA has been approved by the USFDA AHMEDABAD, India and ZUG, Switzerland, Dec. 23, 2025 /PRNewswire/ -- Bioeq AG (" Bioeq"), a Swiss biopharmaceutical company, and Zydus Lifesciences Limited (" Zydus"), an innovation-led life-sciences company with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Bioeq, for the licensing, supply and commercialization of Bioeq`s Vascular Endothelial Growth Factor (VEGF) inhibitor NUFYMCO®, an interchangeable biosimilar of Lucentis®1 (Ranibizumab) for the U.S. market. The Biologics License Application (BLA) for NUFYMCO® has been approved by U.S. Food and Drug Administration (USFDA) on December 18, 2025. This transaction marks an expansion of Zydus' U.S. biosimilar business, following its recent partnership with Formycon AG for a biosimilar of Keytruda®2 (Pembrolizumab). Under the terms of this agreement, Bioeq will be responsible for the development, manufacturing, registration and supply of the finished product, while Zydus will be responsible for the commercialisation of NUFYMCO® in the U.S. market. Speaking on the development, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel, said, "We are happy to collaborate with Bioeq to bring an interchangeable biosimilar to Lucentis® (Ranibizumab) in the US market. Through this partnership, we will leverage our combined expertise and resources to accelerate organisational growth while ensuring maximum value to patients through an expanded access to affordable ophthalmology care." Dr. Thiemo Schreiber, Vice President Commercial at Bioeq, stated, "We are excited about the regulatory approval of "NUFYMCO® by USFDA as an interchangeable biosimilar of Lucentis® (Ranibizumab). This latest addition to our portfolio reflects Bioeq's advanced expertise in developing complex biosimilar medicines for highly regulated markets. Our partnership with Zydus will leverage its extensive distribution network and strong sales and marketing capabilities across the US to broaden treatment options for patients. We are committed to delivering high-quality, affordable therapies and look forward to this collaboration tailored to driving innovation and improving healthcare accessibility." The total addressable market opportunity for biosimilar Ranibizumab in the US is approximately US$210 million as per IQVIA MAT Sep 2025. About Zydus Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 29,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit About Bioeq Bioeq AG is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. Established in 2014, Bioeq specializes in the development, licensing, and commercialization of high-quality biosimilars for highly regulated markets worldwide. The company focuses on creating cost-effective alternatives to leading biologics, ensuring broader patient access to advanced therapies. For more details visit 1) Lucentis® is a registered trademark of Genentech, Inc., a member of the Roche Group, South San Francisco, CA/USA. 2) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA. Logo: SOURCE Zydus Lifesciences 21% more press release views with Request a Demo