Lease Liabilities and Expenses - Total lease liabilities decreased to $374,831 as of March 31, 2024, compared to $481,245 in the previous year[71] - Interest expense on lease liability was $17,490 for the six months ended March 31, 2024, down from $25,543 in the same period in 2023[71] - Citius Pharma entered into a 76-month lease for office space in Cranford, NJ, effective July 1, 2019, with variable lease payments for real estate taxes and operating expenses[104] Acquisitions and Licensing Agreements - Citius Pharma paid a $40 million upfront payment for the acquisition of E7777, with potential milestone payments up to $410 million and royalties ranging from 10% to 15% of net product sales[77] - NoveCite is obligated to pay Eterna up to $51,000,000 upon achieving regulatory and developmental milestones, with royalties ranging from low double-digit to upper-single digit percentages of net sales[66] - NoveCite, Inc. was formed on September 11, 2020, with Citius Pharma owning 75% of the issued and outstanding capital stock[112] - NoveCite paid an upfront payment of $5,000,000 and issued 25% of its equity to Novellus Therapeutics Limited for an exclusive license to develop and commercialize a stem cell therapy[116] - Citius Pharma acquired exclusive license rights for E7777 (LYMPHIR) for $40 million upfront, with potential milestone payments up to $410 million and royalties ranging from 10% to 15% of net product sales[123] - NoveCite is obligated to pay up to $51,000,000 in regulatory and developmental milestone payments under the license agreement, with royalties ranging from low double-digit to upper-single digit percentages of net sales[119] Financial Performance and Expenses - Citius Pharma reported no revenues for the three months ended March 31, 2024, and March 31, 2023[130] - Operating loss for the six months ended March 31, 2024, was $(20,311,024), compared to $(17,935,183) for the same period in 2023[147] - Research and development expenses decreased by $1,120,957 to $3,605,898 for the three months ended March 31, 2024, compared to the same period in 2023[136] - Mino-Lok research and development costs increased by $312,163 to $2,529,911 for the six months ended March 31, 2024, due to phase 3 trial close-out costs[151] Stock and Compensation - Stock-based compensation expense for the six months ended March 31, 2024, was $6,136,577, compared to $2,366,676 in the same period in 2023[92] - Stock-based compensation expense increased by $1,912,797 to $3,078,392 for the three months ended March 31, 2024, primarily due to the Citius Oncology stock plan[141] - Citius Oncology has options outstanding to purchase 12,600,000 shares, with a weighted average remaining contractual term of 9.27 years[100] Regulatory and Development Milestones - The FDA accepted the resubmission of the BLA for LYMPHIR on March 18, 2024, with a PDUFA goal date of August 13, 2024[126] - Citius Pharma received a Complete Response Letter from the FDA for LYMPHIR, requiring enhanced product testing and additional controls, but no concerns were raised regarding safety and efficacy[125] - Citius Pharma completed enrollment in its pivotal Phase 3 clinical trial for Mino-Lok, with 241 patients enrolled and 109 catheter failure events observed[151] Goodwill and Intangible Assets - Goodwill of $9,346,796 represents the value of LMB's industry relationships and assembled workforce, which will not be amortized but tested annually for impairment[110] Fundraising and Capital - Citius Pharma raised $15 million in gross proceeds from an offering, with net proceeds of approximately $13.8 million after deducting fees and expenses[57] Compliance and Strategic Agreements - The company is evaluating options to regain compliance with Nasdaq's $1.00 per share requirement by September 9, 2024[51] - Citius Pharma and Citius Oncology entered into a merger agreement with TenX Keane Acquisition on October 23, 2023, with Citius Oncology surviving as a wholly owned subsidiary[111] - Citius Oncology will pay Eisai a $6 million development milestone payment upon initial approval and up to $22 million in commercial milestone payments based on net product sales thresholds[124] Prepaid Expenses and Advance Payments - Prepaid expenses at March 31, 2024, included $107,309 for prepaid insurance and $8,906,815 for advance payments related to drug substance and product costs[82] Patent and Technology Licensing - LMB has a patent and technology license agreement with NAT for Mino-Lok®, with annual maintenance fees increasing from $30,000 to $90,000 and royalties ranging from mid-single to low-double digits on net sales[114]

CRANFORD, N.J., May 10, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced its participation in two upcoming investor conferences. Citius Chairman and CEO Leonard Mazur will host one-on-one investor meetings at the EF Hutton Annual Global Conference on May 15, 2024, and present and host one-on-one investor meetings at t ...

CRANFORD, N.J., April 26, 2024 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius" or the "Company"), a late-stage 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 21,428,574 shares of its common stock and accompanying warrants to purchase up to an aggregate of 21,428,574 shares of its common stock, at a purchase price of $0 ...

National Cancer Institute (NCI)-designated research and treatment center City of Hope, in Duarte, CA, to participate in the University of Minnesota (UMN) Masonic Cancer Center's ongoing Phase 1 trial to determine the maximum tolerated dose of LYMPHIR plus CAR-T therapy CRANFORD, N.J., April 11, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announc ...

CRANFORD, N.J., April 4, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that Chairman and CEO Leonard Mazur will present at the 14th Annual LD Micro Invitational investor conference being held April 8-9, 2024, in New York City. Conference Details: Presentation: 3:30pm ET on April 9, 2024 Format: In-person an ...

FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2024 CRANFORD, N.J., March 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin ...

Net operating losses converted into non-dilutive capital CRANFORD, N.J., March 7, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the Company has received $2.4 million in non-dilutive capital through New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss ...

CRANFORD, N.J., Feb. 26, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that the Company filed a Form S-3 shelf registration on February 23, 2024 with the Securities and Exchange Commission to replace its currently effective shelf registration statement that expires in April 2024 pursuant to SEC rules. About Citius ...

CRANFORD, N.J., Feb. 23, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced its participation in two upcoming investor conferences. Citius Chairman and CEO Leonard Mazur will present at the BIO CEO and Investor Conference on February 26-27, 2024, and the Sidoti Small-Cap Virtual Conference on March 13-14, 2024. BIO CEO ...

Resubmitted LYMPHIR™ Biologics License Application; awaiting PDUFA date Completed enrollment in the Mino-Lok® Pivotal Phase 3 trial CRANFORD, N.J., Feb. 14, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" 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 business and financial results for the fiscal first quarter 2024 ended December 31, 2023. First Quarter 2024 Busine ...