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 introductionCRANFORD, 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 commercia ...

Company Overview - Citius Oncology, Inc. is a platform focused on developing and commercializing novel targeted oncology therapies, with its primary asset, LYMPHIR, approved by the FDA for treating adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL) [5] - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [5] - Citius Pharmaceuticals, Inc. owns 92% of Citius Oncology and is dedicated to developing first-in-class critical care products [6] Recent Offering - Citius Oncology announced the closing of a public offering of 6,818,182 shares of common stock at a price of $1.32 per share, generating gross proceeds of approximately $9.0 million [1][2] - The offering included warrants to purchase shares at the same exercise price of $1.32, which are immediately exercisable and expire five years from issuance [1] Use of Proceeds - The net proceeds from the offering will primarily support the commercialization of LYMPHIR, including milestone and royalty payments under existing license agreements, as well as for working capital and general corporate purposes [2] Regulatory Information - The securities were offered under a registration statement filed with the U.S. Securities and Exchange Commission (SEC), which was declared effective on July 16, 2025 [3]

Core Viewpoint - Citius Oncology, Inc. has announced a public offering of 6,818,182 shares of common stock at a price of $1.32 per share, aiming to raise approximately $9.0 million in gross proceeds to support the commercialization of its product LYMPHIR and for general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes warrants to purchase shares at an exercise price of $1.32, which will be immediately exercisable and expire five years from issuance [1]. - Maxim Group LLC is acting as the sole placement agent for this offering [2]. - The offering is expected to close on or about July 17, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily support the commercialization of LYMPHIR, including milestone and royalty payments under existing license agreements, as well as working capital and general corporate purposes [2]. Group 3: Company Overview - Citius Oncology, Inc. focuses on developing and commercializing novel targeted oncology therapies, with its primary asset LYMPHIR approved by the FDA for treating adults with relapsed or refractory CTCL [5]. - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [5]. - Citius Pharmaceuticals, Inc. owns 92% of Citius Oncology and is dedicated to developing first-in-class critical care products, with a late-stage pipeline that includes Mino-Lok® and CITI-002 [6].

Core Insights - Citius Oncology has executed a distribution services agreement with Cencora to enhance its commercial infrastructure for the FDA-approved immunotherapy LYMPHIR [1][2][3] - The agreement aims to expand Citius Oncology's distribution network, ensuring product availability upon launch and supporting long-term scalability [2][3] - LYMPHIR is indicated for relapsed or refractory cutaneous T-cell lymphoma (CTCL) and is a targeted immune therapy that has shown antitumor activity [4][5] Company Overview - Citius Oncology is a majority-owned subsidiary of Citius Pharmaceuticals, focusing on developing and commercializing novel targeted oncology therapies [29][30] - The FDA approved LYMPHIR in August 2024, with an estimated initial market exceeding $400 million, indicating significant growth potential in an underserved market [29][30] - Citius Pharmaceuticals also has a late-stage pipeline that includes other critical care products, demonstrating a diverse portfolio [30] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a recombinant fusion protein that targets IL-2 receptors, leading to cell death in tumors expressing these receptors [4][5] - The product is indicated for adult patients with r/r Stage I-III CTCL after at least one prior systemic therapy [8][29] - The drug has received regulatory approval in Japan for CTCL and peripheral T-cell lymphoma (PTCL) prior to its FDA approval [5]

Core Insights - Citius Oncology is transitioning from a development-stage company to a commercial-stage organization following the FDA approval of its drug LYMPHIR, aimed at treating cutaneous T-cell lymphoma [2][3] - The company is focused on disciplined capital deployment and operational execution to support the U.S. launch of LYMPHIR, while also seeking additional capital to enhance financial flexibility [3][4] Financial Results - As of March 31, 2025, Citius Oncology had $112 million in cash and cash equivalents, with a total of 71,552,402 common shares outstanding [5] - Research and Development (R&D) expenses for Q2 2025 were $3.1 million, up from $1.3 million in Q2 2024, primarily due to costs associated with drug substance batch expenses [6] - General and Administrative (G&A) expenses increased to $2.2 million in Q2 2025 from $1.4 million in Q2 2024, driven by pre-commercial and commercial launch activities for LYMPHIR [7] - The net loss for Q2 2025 was $7.7 million, or ($0.11) per share, compared to a net loss of $4.8 million, or ($0.07) per share, in Q2 2024 [9] Market Position and Strategy - LYMPHIR, approved in August 2024, targets a market estimated to exceed $400 million, which is currently underserved by existing therapies [11] - The company is engaging in discussions with potential commercial and strategic partners to secure additional capital and maximize stockholder value [3][4]

Core Viewpoint - Citius Pharmaceuticals is focused on the launch of its first FDA-approved product, LYMPHIR, while actively seeking financing and strategic partnerships to support its commercialization efforts [2][4]. Financial Results - For the fiscal quarter ended March 31, 2025, Citius Pharmaceuticals reported a net loss of $11.5 million, or ($1.27) per share, compared to a net loss of $8.5 million, or ($1.34) per share, for the same quarter in 2024 [14][22]. - The company incurred a net loss of $21.8 million for the six months ended March 31, 2025, compared to a net loss of $17.8 million for the same period in 2024 [15][22]. - Research and development (R&D) expenses for the quarter were $3.8 million, up from $3.6 million in the same quarter of 2024, while total R&D expenses for the six months were $5.9 million, down from $6.3 million in the prior year [8][15]. - General and administrative (G&A) expenses increased to $4.8 million for the quarter, compared to $4.3 million in the same quarter of 2024, and totaled $10.2 million for the six months, up from $7.9 million [11][12]. Liquidity and Capital - As of March 31, 2025, the company had $26,410 in cash and cash equivalents and had raised $6 million from equity issuances during the six months [5][6]. - The company closed a registered direct offering on April 2, 2025, generating approximately $1.735 million in net proceeds [5]. - Citius Pharma plans to continue funding Citius Oncology until adequate capital is raised or revenue is generated from LYMPHIR sales [7]. Research and Development Focus - The company is preparing a submission to the FDA for its Mino-Lok program, which is a key step toward a future New Drug Application (NDA) [3]. - R&D expenses related to LYMPHIR increased to $5.3 million for the six months ended March 31, 2025, compared to $3.2 million for the same period in 2024, primarily due to costs associated with drug substance batches [9][10]. Company Overview - Citius Pharmaceuticals is dedicated to developing first-in-class critical care products, with LYMPHIR being a targeted immunotherapy approved by the FDA for cutaneous T-cell lymphoma [16]. - The company's late-stage pipeline includes Mino-Lok, an antibiotic lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief [16].