Proprietary model informs targeted sales and marketing strategies with feedback loop that augments precision and impact of targeting and engagementCRANFORD, N.J., Aug. 22, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that it has deployed an innovative AI ...

Exhibit 99.1 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., August 12, 2025 -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late- stage biopharmaceutical company dedicated to the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 001-38174 Citius Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) | Nevada ...

$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 ...

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 preparing for the commercial launch of LYMPHIR™, an FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), expected in the second half of 2025 [1][2][36] Manufacturing and Supply Chain Readiness - The company has completed commercial-scale manufacturing of LYMPHIR, with sufficient inventory to meet projected demand for 12 to 18 months post-launch [3] - Citius Oncology has secured distribution agreements with top-tier global pharmaceutical logistics partners to ensure broad access and timely delivery across the U.S. [4] KOL Engagement - Engagement with U.S. Key Opinion Leaders (KOLs) and participation in medical congresses have informed the launch strategy and target patient profiles [5][6] - Early interest from the clinical community is evident, with 70 institutional oncology centers signed up via the LYMPHIR website [6] Commercial & Marketing Activities - A targeted launch strategy utilizing a proprietary generative AI model has been developed to enhance interactions with healthcare providers [7] - A comprehensive suite of marketing and educational materials has been created to support the introduction of LYMPHIR [8] Market Access Update - LYMPHIR's inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and the assignment of a permanent J-code under HCPCS positions the product for efficient reimbursement and coverage at launch [9] Financing and Strategic Partnerships - A recent capital raise by Citius Pharma supports the final preparations for LYMPHIR's commercialization and the planned launch [11] - The company is engaged in strategic partnership discussions to expand LYMPHIR's market reach [11] Product Information - LYMPHIR is a targeted immune therapy indicated for adults with relapsed or refractory CTCL after at least one prior systemic therapy [12][15] - The product was approved by the FDA in August 2024 and is expected to address a market currently exceeding $400 million [36]

Core Viewpoint - Citius Pharmaceuticals Inc. has successfully closed a registered direct offering, raising approximately $6 million, with potential additional proceeds of up to $9.8 million from short-term warrants [1][3]. Group 1: Offering Details - The offering consisted of 4,920,000 shares of common stock priced at $1.22 per share, along with short-term warrants to purchase an additional 9,840,000 shares [1][3]. - The short-term warrants have an exercise price of $1.00 per share, are immediately exercisable, and will expire 24 months from the initial exercise date [1][3]. Group 2: Use of Proceeds - The net proceeds from the offering are intended to support the commercial launch of LYMPHIR™, including milestone and regulatory payments, as well as general corporate purposes [3]. Group 3: Company Background - Citius Pharmaceuticals is focused on developing first-in-class critical care products, with LYMPHIR approved by the FDA for treating cutaneous T-cell lymphoma [6]. - The company also has a late-stage pipeline that includes Mino-Lok®, an antibiotic lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief [6].

Summary of Citius Pharmaceuticals (CTXR) Conference Call Company Overview - Citius Pharmaceuticals operates two companies: Sidious Pharmaceuticals and Sidious Oncology, with Sidious Oncology being a subsidiary focused on cancer treatment [3][4] - Sidious Oncology has an approved drug, LENFIR, for cutaneous T cell lymphoma (CTCL) and plans to launch it within the year [4][9] Key Products and Developments - **LENFIR**: - Approved for CTCL, with a market size of approximately $400 million [9] - Offers 12 years of BLA exclusivity as the first new systemic treatment since 2018 [9][36] - Clinical trial results show a 36% objective response rate and an 84.4% reduction in skin burden [24][25] - Expected to add to the market rather than take market share due to the nature of oncological treatments [10] - **Miniloc**: - An antibiotic lock solution for infected central venous catheters, completing a Phase III trial [5][37] - Unique in its ability to clear biofilm from catheters, with a significant market opportunity [39][42] - Results showed a p-value of 0.0006, indicating a superior outcome compared to standard care [45] - **Hemorrhoid Drug**: - A cream formulation combining halobetasol and lidocaine, currently in Phase 2b trials [48] - Aims to monetize through partnerships after demonstrating efficacy [48] Management and Investment - The management team has significant personal investments totaling $26.5 million, indicating strong commitment [7][51] - Experienced professionals lead the company, including former executives from major pharmaceutical firms [18][19] Market Strategy and Sales - A small prescriber base for CTCL, with only 25 representatives needed to cover the market [32][33] - The pricing for LENFIR is projected between $325,000 and $350,000 for a course of therapy [30] - Plans to establish a patient services hub and a sales force to support the launch of LENFIR [15][16] Regulatory and Competitive Landscape - Miniloc has received QIDP designation, reducing NDA review time and providing extended market exclusivity [46] - Competitive advantages include a unique mechanism of action for LENFIR and a lack of existing treatments for peripheral T cell lymphoma [26][30] Conclusion - Citius Pharmaceuticals is positioned to launch LENFIR, with a strong management team and significant investment backing. The company is exploring additional market opportunities and preparing for regulatory interactions to advance its product pipeline [50][51]