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 ...

FDA Approval and Product Development - FDA approved LYMPHIR™ for the treatment of cutaneous T-cell lymphoma, marking the first FDA-approved product in the company's portfolio[1][3] - Achieved primary and secondary endpoints in Phase 3 Pivotal Trial of Mino-Lok, designed to salvage central venous catheters in patients with catheter-related bloodstream infections[1] - Citius Oncology is expected to transition from a development stage company to a commercial biopharmaceutical organization following the FDA approval of LYMPHIR[3] Financial Performance and Expenses - Cash and cash equivalents of $17.9 million as of June 30, 2024, with $15 million raised in a registered direct offering extending cash runway through December 2024[2][5] - R&D expenses decreased to $2.8 million for Q3 2024 from $3.8 million in Q3 2023, primarily due to completion of Mino-Lok Phase 3 trial and Halo-Lido Phase 2b trial[6] - G&A expenses increased to $4.8 million for Q3 2024 from $3.7 million in Q3 2023, driven by pre-launch and market research activities for LYMPHIR[8] - Stock-based compensation expense rose to $3.1 million for Q3 2024 from $1.2 million in Q3 2023, primarily due to the Citius Oncology stock plan[9] - Net loss increased to $10.6 million for Q3 2024 from $8.5 million in Q3 2023, driven by higher G&A and stock-based compensation expenses[10] - Total assets decreased from $103.61 million as of September 30, 2023, to $97.09 million as of June 30, 2024[14] - Net loss for the nine months ended June 30, 2024, was $28.35 million, compared to $22.60 million for the same period in 2023[16] - Research and development expenses decreased from $11.94 million for the nine months ended June 30, 2023, to $8.99 million for the same period in 2024[16] - General and administrative expenses increased from $11.13 million for the nine months ended June 30, 2023, to $12.76 million for the same period in 2024[16] - Stock-based compensation expense increased from $3.54 million for the nine months ended June 30, 2023, to $9.20 million for the same period in 2024[16] - Net cash used in operating activities was $22.29 million for the nine months ended June 30, 2024, compared to $22.26 million for the same period in 2023[17] - Net proceeds from registered direct offering were $13.72 million for the nine months ended June 30, 2024[17] - Cash and cash equivalents decreased from $26.48 million as of September 30, 2023, to $17.91 million as of June 30, 2024[14] - In-process research and development remained constant at $59.40 million as of June 30, 2024, and September 30, 2023[14] - Total liabilities decreased from $12.18 million as of September 30, 2023, to $10.81 million as of June 30, 2024[14] Corporate Strategy and Capital Allocation - Completed merger with TenX Keane to form Citius Oncology, Inc., expected to begin trading on Nasdaq under ticker CTOR on August 13, 2024[1] - The company is evaluating opportunities to optimize capital allocation, cash runway, and potential non-dilutive sources of capital for future growth[4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Nevada 27-3425913 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common stock, $0.001 par value CTXR Nasdaq Capital Market 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, 2024 OR ☐ TRANSITION REPORT PURSUAN ...

LYMPHIR™ for the treatment of cutaneous T-cell lymphoma approved by the FDA Citius Pharmaceuticals, Inc. holds approximately 90% of publicly traded Citius Oncology, Inc. Shares of Citius Oncology, Inc. anticipated to begin trading on Nasdaq under the ticker "CTOR" on August 13, 2024 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 of first-in- ...