CRANFORD, N.J., July 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 expected milestones in the second half of calendar 2024 and recapped key achievements year-to-date Citius significantly advanced its two late-stage product candidates in the first six months of 2024, and expects several key milestones in the nea ...

Management call scheduled for Monday, June 3, 2024 at 8:30 AM ET Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first- in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates: Mino-Lok® and LYMPHIR™. In May 2024, Citius announced positive topline results of Mino-Lok, its antibiotic lock solution to salvage catheters in patients with bloodstream infections. The Biologics License Application for LYMP ...

Citius Pharmaceuticals (NASDAQ:CTXR) stock is on the rise Tuesday after the company announced new results from its Phase 3 clinical trial of Mino-Lok. Mino-Lok is Citius Pharmaceuticals' antibiotic lock solution for patients with central line-associated infections or catheter-related bloodstream infections. The good news for CTXR investors is that this trail met both its primary and secondary endpoints. The primary endpoint was extending the time until catheter failure. In the control arm, the median failur ...

Trial achieves statistically significant primary endpoint (p=0.0006) Secondary endpoint demonstrates statistically significant overall success of Mino-Lok therapy with a greater percentage of patients retaining their catheters (p=0.0025) CRANFORD, N.J., May 21, 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 positive ...

Citius Pharma (NASDAQ:CTXR) just reported results for the second quarter of 2024. InvestorPlace Earnings is a project that leverages data from TradeSmith to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per share and revenue, as well as how a company stacks up to analyst estimates. These articles are published without human intervention, allowing us to inform our readers of the latest figures as quickly as possible. To report any concerns o ...

Mino-Lok data analysis on track with topline results anticipated this quarter Exhibit 99.1 Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2024 Financial Results and Provides Business Update LYMPHIR biologics license application accepted with PDUFA target action date set for August 13, 2024 CRANFORD, N.J., May 14, 2024 -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-cl ...

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 ...