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]

Core Viewpoint - Citius Oncology has engaged Jefferies LLC as its exclusive financial advisor to explore strategic alternatives aimed at maximizing shareholder value [1][2][3] Group 1: Strategic Engagement - The engagement with Jefferies highlights Citius Oncology's commitment to enhancing its strategic positioning and improving patient outcomes in oncology [2] - Potential strategic alternatives include partnerships, joint ventures, mergers, acquisitions, licensing, or other strategic transactions [2][3] Group 2: Product Development - Citius Oncology is preparing to launch its first cancer therapy, LYMPHIR™, which has been approved by the FDA for treating relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) [3][6] - LYMPHIR is a targeted immune therapy that specifically binds to IL-2 receptors, leading to cell death in IL-2R-expressing tumors [5] - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [7] Group 3: Company Overview - Citius Oncology is a majority-owned subsidiary of Citius Pharmaceuticals, which focuses on developing and commercializing novel targeted oncology therapies [1][8] - Citius Pharmaceuticals also has a late-stage pipeline that includes Mino-Lok® and CITI-002 (Halo-Lido) [8][9]

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]

Company Overview - Citius Pharmaceuticals is primarily a late-stage development company focused on the commercialization of therapeutic product candidates, with a goal to achieve leading market positions by addressing unmet medical needs [98]. - Citius Pharma's business strategy includes the development of late-stage product candidates to reduce development risk, while focusing on innovative applications [98]. - Citius Pharma owns approximately 92.3% of the outstanding shares of Citius Oncology following a merger agreement with TenX Keane Acquisition [99]. Clinical Trials and Product Development - The company reported an overall response rate (ORR) of 36% in the pivotal trial for LYMPHIR, with a median duration of response of 6.5 months [105]. - Serious adverse reactions occurred in 38% of patients receiving LYMPHIR, with capillary leak syndrome reported in 10% of patients [109]. - The company is undertaking two investigator-initiated trials to evaluate LYMPHIR as an immuno-oncology combination therapy, with an expected enrollment of 18-30 patients in the dose escalation study [114][115]. - The pivotal trial of E7777 included a lead-in phase with 21 subjects, determining a maximum tolerated dose (MTD) of 12 µg/kg/day, with 9 µg/kg/day selected for the main phase [129]. - Among responders in the E7777 trial, the median follow-up for duration of response was 6.5 months, with a median time to response of 1.4 months [131]. - The Phase 1 study at the University of Pittsburgh reported a median progression-free survival (PFS) of 57 weeks for patients achieving clinical benefit, with a clinical benefit rate of 33% [144]. - The Phase 3 trial design was amended to compare Mino-Lok to an active control arm, reducing the required patient sample size from 700 to approximately 144 [163]. - The trial for Mino-Lok was designed to show that it is at least as effective as the removal and replacement of CVCs, with a primary endpoint of "time to catheter failure" set at 38 days for Mino-Lok versus 21 days for standard care [163]. - The Phase 2b trial for Halo-Lido enrolled approximately 300 adults with symptomatic hemorrhoids, assessing high and low dose formulations [212]. - The Phase 3 trial of Mino-Lok was initially planned for 700 patients, but the FDA accepted a sample size of approximately 144 patients [220][221]. - The DMC recommended continuing the Mino-Lok trial without modifications after reviewing safety data [223]. - The Phase 2 meeting with the FDA in April 2024 discussed the go-forward path for the Halo-Lido program following positive clinical results [249]. Regulatory and Market Developments - The FDA accepted the biologics license application (BLA) for LYMPHIR in December 2022, with a PDUFA goal date set for July 28, 2023 [153]. - In September 2023, the FDA agreed on plans to address requirements outlined in a complete response letter for LYMPHIR, providing a path for resubmission of the BLA [154]. - The FDA approved LYMPHIR in August 2024, following the completion of CRL remediation activities and resubmission in February 2024 [183][182]. - Citius Oncology plans to launch LYMPHIR in the first half of 2025, but the timeline is subject to change due to regulatory approval processes [255]. - The FDA issued a complete response letter for LYMPHIR on July 28, 2023, requiring enhanced product testing and additional controls [255]. - The FDA granted "Fast Track" status to Mino-Lok in October 2017, facilitating expedited review for drugs addressing serious conditions [198]. Financial Considerations - The company has not paid cash dividends in the past and does not expect to do so in the foreseeable future, limiting returns to capital appreciation [96]. - The company faces significant risks in product candidate development, including the need for substantial additional funds and the ability to raise those funds [79][80]. - The company anticipates that economic uncertainties may adversely affect its ability to raise capital for research and development [252]. - Upon FDA approval of LYMPHIR for CTCL indication in August 2024, Citius Oncology is required to pay a $5.9 million milestone payment to Eisai and up to $22 million related to net product sales thresholds [258]. - Citius Oncology is obligated to pay up to $40 million for CTCL approvals and up to $300 million for commercial sales milestones under agreements with Dr. Reddy's [258]. Market Potential and Competition - The addressable U.S. market for LYMPHIR is estimated to exceed $400 million, with potential expansion through new therapeutics [158]. - The potential market for Mino-Lok in the U.S. is estimated to be between $500 million and $1 billion, based on a target price of up to $400 per dose of salvage flush treatment [203]. - The market opportunity for Mino-Lok is significant, as the cost of removing and replacing an infected central venous catheter (CVC) is estimated between $8,000 and $10,000 [231]. - The estimated incidence rate of mycosis fungoides and Sézary Syndrome in the U.S. is approximately 0.5 per 100,000, translating to about 2,500 to 3,000 new cases annually, representing around 25% of all T-cell lymphomas [185]. - The company believes there are currently no FDA-approved prescription drugs for hemorrhoids, positioning Halo-Lido as a novel treatment option [215]. Risks and Challenges - The company faces significant risks in successfully developing product candidates due to high attrition rates in clinical trials [264]. - Market acceptance of any approved product may be limited, impacting revenue generation despite regulatory approval [272]. - The company faces significant uncertainty regarding the reimbursement status of newly approved healthcare products, which may affect market acceptance [276]. - Legislative and regulatory changes in healthcare systems, such as the ACA enacted in 2010, could impact the company's ability to sell products profitably [277]. - The U.S. government and other governments are pursuing healthcare reform that may adversely affect pricing and reimbursement levels for healthcare products [277]. - Insurance coverage for the company's product candidates may not be available, and reimbursement levels could be inadequate, impacting commercialization efforts [276]. - The company cannot predict the impact of potential federal or state legislation on reimbursement policies and the healthcare industry [276]. Manufacturing and Intellectual Property - The company relies exclusively on third parties for the formulation and manufacturing of its product candidates, which poses additional risks [89]. - The company relies on third parties for the formulation and manufacturing of product candidates, which poses risks if contractual obligations are not met [260]. - Citius Pharma's intellectual property protection is crucial for its business, and any failure to maintain this protection could adversely affect its financial condition [93]. - Citius Pharma is pursuing intellectual property protections for its patient-reported outcome evaluation tool developed for hemorrhoid treatment [214].