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].

Financial Performance - Net loss for the full year ended September 30, 2024 was $39.4 million, or ($5.97) per share, compared to a net loss of $32.5 million, or ($5.57) per share for the full year ended September 30, 2023 [19][27] - R&D expenses decreased to $11.9 million in 2024 from $14.8 million in 2023, primarily due to the completion of the Halo-Lido trial and regulatory resubmission activities for LYMPHIR [13][19] - G&A expenses increased to $18.2 million in 2024 from $15.3 million in 2023, driven by pre-launch and market research activities for LYMPHIR [19][30] - Stock-based compensation expense rose to $11.8 million in 2024 from $6.6 million in 2023, largely due to the grant of options under the Citius Oncology stock plan [15][19] Cash Position and Liquidity - Cash and cash equivalents stood at $3.3 million as of September 30, 2024 [11][19] - The company raised $13.8 million in net proceeds from equity issuance during the year ended September 30, 2024 [12] - Net cash used in operating activities was $28.2 million in 2024, compared to $29.1 million in 2023 [23] Business Highlights and Pipeline Progress - Achieved FDA approval for LYMPHIR™, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma [10] - Completed the Phase 3 Pivotal Trial for Mino-Lok®, meeting primary and secondary endpoints [10] - Formed Citius Oncology, Inc through a merger with TenX Keane, which began trading on Nasdaq under the ticker symbol CTOR on August 13, 2024 [10] - Advanced manufacturing, marketing, and sales activities in preparation for the commercial launch of LYMPHIR in the first half of 2025 [10][20] Strategic Priorities for 2025 - Launch LYMPHIR through the majority-owned subsidiary, Citius Oncology [20] - Drive clinical and regulatory strategies for Mino-Lok® and Halo-Lido [20] - Fortify the financial position and apply a disciplined approach to resource allocation [20] - Distribute CTOR shares to Citius Pharma shareholders by the end of 2025, pending favorable market conditions [20] Balance Sheet and Capital Structure - Total assets increased to $116.7 million as of September 30, 2024, from $103.6 million as of September 30, 2023 [3] - Total liabilities rose to $42.5 million as of September 30, 2024, from $12.2 million as of September 30, 2023, primarily due to the inclusion of a $28.4 million license payable [25][34] - The company had 7,247,243 common shares outstanding as of September 30, 2024, adjusted for a 1-for-25 reverse stock split effective November 25, 2024 [21][24]

Core Insights - Citius Pharmaceuticals held a productive Type C meeting with the FDA regarding Mino-Lok, a catheter lock solution aimed at treating central line-associated bloodstream infections [1][2][3] - The FDA provided actionable guidance that supports a future New Drug Application (NDA) submission for Mino-Lok, addressing critical topics such as clinical efficacy and safety data [2][3] - Mino-Lok has shown promising clinical outcomes in its Phase 3 trial, potentially offering a groundbreaking alternative to catheter removal, which could reduce healthcare costs and improve patient outcomes [3][4] Company Overview - Citius Pharmaceuticals is focused on developing first-in-class critical care products, with a late-stage pipeline that includes Mino-Lok and LYMPHIR™, an approved immunotherapy for cutaneous T-cell lymphoma [5] - The company has completed pivotal Phase 3 trials for Mino-Lok and Phase 2b trials for another product, Halo-Lido, in 2023 [5] - Mino-Lok is designed to salvage central venous catheters and is expected to be the first FDA-approved treatment for catheter-related bloodstream infections if approved [4][5]

Core Viewpoint - Citius Pharmaceuticals, Inc. is executing a reverse stock split at a ratio of 1-for-25 to increase its common stock price and regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect on November 25, 2024, at 5:00 pm Eastern Time, with trading on a split-adjusted basis starting November 26, 2024 [1][2]. - The number of authorized shares will decrease from 400 million to 16 million, while the issued and outstanding shares will reduce from approximately 193 million to about 7.7 million [4]. - Every 25 shares will be combined into one share, with no fractional shares issued; any resulting fractional shares will be rounded up to the nearest whole share [3][4]. Group 2: Impact on Stock Options and Warrants - The reverse stock split will also apply to the common stock issuable upon the exercise of outstanding warrants and stock options, with proportional adjustments to exercise prices [5]. Group 3: Company Overview - Citius Pharmaceuticals is focused on developing first-in-class critical care products, with recent FDA approval for LYMPHIR™, an immunotherapy for cutaneous T-cell lymphoma [7]. - The company has a late-stage pipeline that includes Mino-Lok®, an antibiotic lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoids [7].

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 ...

Granted FDA approval of LYMPHIR™ for the treatment of cutaneous T-cell lymphoma Completed merger of oncology subsidiary with TenX Keane; Citius Oncology expected to begin trading on Nasdaq on August 13, 2024, under ticker CTOR Achieved primary and secondary endpoints of Mino-Lok® Phase 3 Trial CRANFORD, N.J., Aug. 12, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization o ...