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]

Financial Performance - For the three months ended March 31, 2025, the company reported total operating expenses of $11,260,678, an increase from $10,970,201 in the same period of 2024, resulting in an operating loss of $(11,260,678) compared to $(10,970,201) in 2024[126]. - The company did not generate any revenues for the three months ended March 31, 2025 or 2024, maintaining a net loss of $(11,511,505) for Q1 2025, compared to $(8,544,154) in Q1 2024[128]. - The net loss for the three months ended March 31, 2025, was $11,511,505, compared to a net loss of $8,544,154 for the same period in 2024, reflecting an increase of $2,967,351[138]. - The net loss for the six months ended March 31, 2025, was $21,792,751, an increase of $4,017,412 from a net loss of $17,775,339 for the same period in 2024[150]. - As of March 31, 2025, Citius Pharma had an accumulated deficit of $222,054,969 and negative working capital of approximately $31.5 million[152]. Research and Development Expenses - Research and development expenses for the three months ended March 31, 2025 were $3,766,525, up from $3,605,898 in the same period of 2024[126]. - Research and development expenses for the three months ended March 31, 2025, were $3,766,525, an increase of $160,627 compared to $3,605,898 for the same period in 2024[129]. - Research and development costs for LYMPHIR increased by $1,880,563 to $3,641,479 for the three months ended March 31, 2025, compared to $1,760,916 for the same period in 2024[132]. - For the six months ended March 31, 2025, research and development expenses totaled $5,893,563, a decrease of $334,245 from $6,227,808 for the same period in 2024[141]. General and Administrative Expenses - General and administrative expenses increased to $4,792,122 in Q1 2025 from $4,285,911 in Q1 2024[126]. - General and administrative expenses for the three months ended March 31, 2025, were $4,792,122, an increase of $506,211 from $4,285,911 in the prior year[134]. - General and administrative expenses for the six months ended March 31, 2025, were $10,179,874, an increase of $2,233,235 compared to $7,946,639 in the prior year[146]. Stock-Based Compensation - Stock-based compensation expense decreased to $2,702,031 in Q1 2025 from $3,078,392 in Q1 2024[126]. Revenue Generation and Future Plans - The company has not yet realized any revenues from its operations as of March 31, 2025[110]. - Citius Pharma plans to continue funding Citius Oncology until adequate capital is raised or revenue is generated from LYMPHIR sales[154]. Milestone Payments and Acquisitions - The company is required to pay Dr. Reddy's a $40 million upfront payment for the acquisition of E7777, with additional milestone payments up to $300 million based on commercial sales[118]. - The FDA approved the BLA for LYMPHIR on August 8, 2024, which triggers a $27.5 million milestone payment to Dr. Reddy's, with a remaining balance of $22.5 million due as of March 31, 2025[120]. Stock Split - A reverse stock split of 1-for-25 was executed on November 25, 2024, retroactively adjusting all share amounts[111]. Equity Issuance - The company received net proceeds of $6,039,858 from equity issuance during the six months ended March 31, 2025[153]. In-Process Research and Development - The company has significant in-process research and development valued at $73,400,000 for LYMPHIR, expected to be amortized over 12 years starting from revenue generation in 2025[109].

Financial Performance - Citius Pharmaceuticals reported a net loss of $11.5 million, or ($1.27) per share, for the quarter ended March 31, 2025, compared to a net loss of $8.5 million, or ($1.34) per share, for the same quarter in 2024[13]. - 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[14]. - The net loss for the six months ended March 31, 2025, was $21,792,751, compared to a net loss of $17,775,339 for the same period in 2024, indicating a 22.5% increase in losses[21]. - The company reported a net loss per share of $(1.27) for the three months ended March 31, 2025, compared to $(1.34) for the same period in 2024[21]. Expenses - Research and Development (R&D) expenses were $3.8 million for the quarter ended March 31, 2025, an increase from $3.6 million for the same quarter in 2024[8]. - 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[9]. - General and Administrative (G&A) expenses rose to $4.8 million for the quarter ended March 31, 2025, up from $4.3 million for the same quarter in 2024[11]. - For the three months ended March 31, 2025, the total operating expenses were $11,260,678, an increase from $10,970,201 in the same period of 2024, representing a 2.6% increase[21]. - Research and development expenses for the three months ended March 31, 2025, were $3,766,525, up from $3,605,898 in 2024, reflecting a 4.4% increase[21]. - The company recorded stock-based compensation expense of $5,226,855 for the six months ended March 31, 2025, compared to $6,136,577 in 2024, showing a decrease of 14.8%[24]. Cash and Capital - Citius Pharmaceuticals had $26,410 in cash and cash equivalents as of March 31, 2025, and will need to secure additional capital to support operations beyond May 2025[6]. - Cash and cash equivalents at the end of the period were $26,410, a significant decrease from $12,559,607 at the end of the same period in 2024[24]. - The net cash used in operating activities for the six months ended March 31, 2025, was $(9,265,328), an improvement from $(13,921,321) in 2024, indicating a 33.5% reduction in cash outflow[24]. - The company generated net proceeds from common stock offerings amounting to $6,039,858 during the six months ended March 31, 2025[24]. - The company completed a registered direct offering that generated net proceeds of approximately $1.735 million on April 2, 2025[5]. Assets and Financial Strategy - The total assets of Citius Pharmaceuticals as of March 31, 2025, were $121.48 million, compared to $116.65 million as of September 30, 2024[19]. - The company has retained Jefferies LLC as its exclusive financial advisor to evaluate strategic alternatives aimed at maximizing stockholder value[7]. - Citius Pharmaceuticals plans to continue funding Citius Oncology until adequate capital is raised or revenue is generated from LYMPHIR sales[7]. Other Income and Shares - The total other income for the three months ended March 31, 2025, was $13,413, a decrease from $2,570,047 in the same period of 2024[21]. - The weighted average common shares outstanding for the three months ended March 31, 2025, were 8,581,207, compared to 6,362,890 in 2024, reflecting a 34.8% increase[21].

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].

Core Viewpoint - Citius Pharmaceuticals Inc. has announced a definitive agreement to purchase 1,739,131 shares of its common stock at a price of $1.15 per share, with expected gross proceeds of approximately $2 million to support the commercial launch of LYMPHIR™ and general corporate purposes [1][2]. Group 1 - The offering is being facilitated by H.C. Wainwright & Co. as the exclusive placement agent [2]. - The closing of the offering is anticipated to occur on or about April 2, 2025, pending customary closing conditions [1]. - The securities are being offered under a "shelf" registration statement filed with the SEC, which became effective on March 1, 2024 [3]. Group 2 - Citius Pharmaceuticals is focused on developing first-in-class critical care products, with LYMPHIR approved by the FDA in August 2024 for treating cutaneous T-cell lymphoma [5]. - The company's late-stage pipeline includes Mino-Lok®, an antibiotic lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief, with both products having completed pivotal trials in 2023 [5]. - Citius Pharma owns 92% of Citius Oncology, Inc., indicating a strong position in the oncology sector [5].

Financial Performance - For the three months ended December 31, 2024, the company reported no revenues, consistent with the same period in 2023[116]. - The company incurred a net loss of $10,281,246 for Q4 2024, compared to a net loss of $9,231,185 in Q4 2023, representing an increase of 11.4%[115]. - The net loss for the three months ended December 31, 2024, was $10,281,246, an increase of $1,050,061 compared to a net loss of $9,231,185 for the same period in 2023[125]. - Citius Pharma had an accumulated deficit of $211,138,464 as of December 31, 2024, with net cash used in operations amounting to $4,725,852 during the same period[127]. - The company reported a negative working capital of approximately $26.5 million at December 31, 2024, with cash and cash equivalents of $1,100,079 available for operations[128]. Operating Expenses - Total operating expenses for Q4 2024 were $10,039,614, an increase of 7.5% from $9,340,823 in Q4 2023[115]. - General and administrative expenses rose to $5,387,752 for the three months ended December 31, 2024, compared to $3,660,728 in the prior year, marking an increase of $1,727,024[121]. - Stock-based compensation expense decreased to $2,524,824 for the three months ended December 31, 2024, down by $533,361 from $3,058,185 in the same period of 2023[122]. Research and Development - Research and development expenses decreased by 18.9% to $2,127,038 in Q4 2024 from $2,621,910 in Q4 2023[117]. - Research and development costs for Mino-Lok decreased by 43.0% to $385,016 in Q4 2024 from $891,624 in Q4 2023[117]. - Research and development costs for Halo-Lido decreased by 56.7% to $10,696 in Q4 2024 from $246,572 in Q4 2023[118]. - Research and development costs for the three months ended December 31, 2024, were $1,727,540, an increase of $255,076 from $1,472,464 in the same period of 2023[119]. - The company has significant in-process research and development assets valued at $73,400,000 related to LYMPHIR, expected to be amortized over 12 years starting in H1 2025[99]. - The company is required to pay Dr. Reddy's up to $40 million in development milestone payments related to CTCL approvals in the U.S. and other markets[109]. Cash Flow and Capital Needs - The company expects to have sufficient funds to continue operations through March 2025 but will need to raise additional capital thereafter[129]. Other Financial Information - Interest income for the three months ended December 31, 2024, was $22,608, a significant decrease from $253,638 in the prior period[123]. - The company has not yet realized any revenues from its operations as of December 31, 2024[100]. - The company executed a reverse stock split at a ratio of 1-for-25 effective November 25, 2024[102]. - Inflation has not had a material effect on the company's results of operations according to management's assessment[130]. - The company does not have any off-balance sheet arrangements[131].

Core Insights - Citius Pharmaceuticals reported its business and financial results for the fiscal first quarter ended December 31, 2024, highlighting ongoing strategic initiatives and financial challenges [1][2][3] Business Highlights - The company is actively engaging with potential partners to enhance its pipeline and secure necessary financing for key programs [4] - Significant progress is being made in preparations for the anticipated launch of LYMPHIR™ in the first half of 2025, which is expected to create long-term value for shareholders [5] - Citius Pharma has received a new permanent J-code for LYMPHIR™, effective April 1, 2025, which will facilitate reimbursement for the therapy [8] Financial Highlights - As of December 31, 2024, the company had $1.1 million in cash and cash equivalents, down from $3.25 million at the end of the previous quarter [6][20] - The company raised $3 million from equity issuance during the quarter and an additional $3.5 million in January 2025 [7] - Research and Development (R&D) expenses decreased to $2.1 million from $2.6 million year-over-year, primarily due to the completion of certain clinical trials [8][9] - General and Administrative (G&A) expenses increased to $5.4 million from $3.7 million year-over-year, attributed to pre-launch activities for LYMPHIR [10] - The net loss for the quarter was $10.3 million, or ($1.30) per share, compared to a net loss of $9.2 million, or ($1.45) per share, in the same quarter of the previous year [12][18]

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]