LYMPHIR Launch Preparations - Citius Pharmaceuticals and its subsidiary Citius Oncology are preparing for the commercial launch of LYMPHIR, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), with a planned launch in the first half of 2025 [1] - Key launch activities include finalizing manufacturing, marketing, reimbursement, and sales efforts, with a focus on U S market penetration and exploring international licensing partnerships [2] - The company has secured commercial supply agreements with leading contract manufacturing organizations (CMOs) and produced the first year launch supply [5] LYMPHIR Product Overview - LYMPHIR is a targeted immune therapy for Stage I-III CTCL after at least one prior systemic therapy, combining the IL-2 receptor binding domain with diphtheria toxin fragments to inhibit protein synthesis and induce cell death [4] - The therapy was approved by the FDA in August 2024 and has exclusive licensing rights in all markets except Japan and certain parts of Asia [6] Market and Disease Context - CTCL is the most common type of cutaneous non-Hodgkin lymphoma, affecting men twice as often as women and typically diagnosed in patients aged 50-60 [7] - The initial market for LYMPHIR is estimated to exceed $400 million, with robust intellectual property protections supporting its competitive positioning [31] Citius Pharmaceuticals and Oncology Overview - Citius Pharmaceuticals owns 92% of Citius Oncology, which focuses on developing and commercializing novel targeted oncology therapies [33] - Citius Pharma's pipeline includes Mino-Lok, an antibiotic lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief, both of which have completed pivotal trials [32]

CRANFORD, N.J., Jan. 6, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or "the Company") (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that it has retained Jefferies LLC as its exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value.The engagement of Jefferies underscores Citius Oncology's commitment to exploring all avenues for enhancing its strategic posit ...

Financial Performance - Net loss increased to $39.4 million, or ($5.97) per share, for the year ended September 30, 2024, compared to $32.5 million, or ($5.57) per share, in the previous year[1][8] - Net loss for the year ended September 30, 2024, was $(39,425,839), compared to $(32,542,912) in the previous year[30] - Net cash used in operating activities for the year ended September 30, 2024, was $(28,201,375), compared to $(29,060,212) in the previous year[30] - Cash and cash equivalents decreased to $3.3 million as of September 30, 2024, from $26.5 million in the previous year[16] - Cash and cash equivalents of $3.3 million as of September 30, 2024[19][32] Research and Development (R&D) - R&D expenses decreased to $11.9 million in FY 2024 from $14.8 million in FY 2023, primarily due to the completion of the Halo-Lido trial and LYMPHIR regulatory resubmission[7] - R&D expenses decreased to $11.9 million for the full year ended September 30, 2024, from $14.8 million in the previous year[19] - Research and development expenses are expected to decrease in fiscal year 2025 due to the commercialization of LYMPHIR and completion of the Phase 3 trial for Mino-Lok[22] General and Administrative (G&A) Expenses - G&A expenses increased to $18.2 million in FY 2024 from $15.3 million in FY 2023, driven by pre-launch and market research activities for LYMPHIR[12] - G&A expenses increased to $18.2 million for the full year ended September 30, 2024, from $15.3 million in the previous year[19] Stock-Based Compensation - Stock-based compensation expense rose to $11.8 million in FY 2024 from $6.6 million in FY 2023[1] - Stock-based compensation expense increased to $11.8 million for the full year ended September 30, 2024, from $6.6 million in the previous year[23] Product Development and Approvals - Achieved FDA approval for LYMPHIR™, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL)[1] - FDA approved LYMPHIR™ in August 2024 for the treatment of cutaneous T-cell lymphoma[21] - LYMPHIR is expected to launch in the first half of 2025 through Citius Oncology, a majority-owned subsidiary[6] - Met primary and secondary endpoints in the Phase 3 Pivotal Trial of Mino-Lok, showing significant improvement in time to catheter failure[18] - Mino-Lok® met primary and secondary endpoints in its Phase 3 Trial completed in 2023[21] Capital and Equity - The company received net proceeds of $13.8 million from equity issuance in FY 2024 and plans to raise additional capital[3] - The company completed a 1-for-25 reverse stock split on November 25, 2024, resulting in 7,247,243 common shares outstanding[3] - License payment of $5,000,000 was made in the year ended September 30, 2024[30]

Grade II Hemorrhoids prolapse and reduce spontaneously with or without bleeding. Development Activities to Date As part of this Phase 2 trial, information was obtained relating to the use of the GSDS as an assessment tool for measuring the effectiveness of the test articles. Individual signs and symptoms were also assessed but can vary from patient to patient. Therefore, the goal of the GSDS was to provide an assessment tool that could be used for all patients regardless of which signs and symptoms they are ...

Clinical and regulatory success in 2024 expected to drive value in 2025 CRANFORD, N.J., Dec. 27, 2024 /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 full year ended September 30, 2024. Fiscal Full Year 2024 Business Highlights and Subsequent Developments Achieved U.S. Food and Dr ...

CRANFORD, N.J., Nov. 25, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that the Company held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA). The meeting followed successful completion of the Company's pivotal Phase 3 clinical trial of Mino-Lok®, a novel catheter lock solution d ...

CRANFORD, N.J., Nov. 22, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) announced today that it will be executing a reverse stock split of its common stock, par value $0.001 per share, at a ratio of 1-for-25 ("Reverse Stock Split"). Pursuant to the laws of the State of Nevada and subject to prior approval by the Company's Board of Directors, Citius Pharma was not required to obtain shareholder approval to effectuate the Reverse Stock Split. The Reverse St ...

CRANFORD, N.J., Nov. 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today closed its previously announced registered direct offering for the purchase of an aggregate of 12,000,000 shares of its common stock and accompanying warrants to purchase up to an aggregate of 12,000,000 shares of its common stock, at a purchase price of $0.25 ...

CRANFORD, N.J., Nov. 15, 2024 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has entered into definitive agreements for the purchase of an aggregate of 12,000,000 shares of its common stock and accompanying warrants to purchase up to an aggregate of 12,000,000 shares of its common stock, at a purchase price of $0.25 p ...

CRANFORD, N.J., Sept. 5, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) and Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), today announced that LYMPHIR™ has been added to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). LYMPHIR is included based on an NCCN Category 2A recommendation which indicates a uniform NCCN consensus that the drug is appropriate as an option for patients with Cutaneous T-cell Lymphoma (CTCL). Citius O ...