Citius, Altius, Fortius

Citius Pharmaceuticals to Participate in the Sidoti Micro-Cap Virtual Conference on November 15, 2023

Retrieved on: 
Thursday, November 9, 2023

CRANFORD, N.J., Nov. 9, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Chairman and CEO Leonard Mazur will present at the Sidoti Micro-Cap Virtual Conference on November 15, 2023.

Key Points: 
  • CRANFORD, N.J., Nov. 9, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that Chairman and CEO Leonard Mazur will present at the Sidoti Micro-Cap Virtual Conference on November 15, 2023.

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

Retrieved on: 
Tuesday, October 24, 2023

CRANFORD, N.J. and NEW YORK, N.Y., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Citius Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition (“TenX”) (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma’s wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024.

Key Points: 
  • The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”).
  • Our majority ownership position and shared services agreement ensures that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology.
  • “We are very pleased to announce the proposed merger with Citius Oncology,” said Mr. Xiaofeng Yuan, Chairman and CEO of TenX.
  • In the transaction, all shares of Citius Pharma’s wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology.

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

Retrieved on: 
Tuesday, October 24, 2023

CRANFORD, N.J. and NEW YORK, Oct. 24, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition ("TenX") (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma's wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology"). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024. 

Key Points: 
  • The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology").
  • "We are very pleased to announce the proposed merger with Citius Oncology," said Mr. Xiaofeng Yuan, Chairman and CEO of TenX.
  • Pursuant to the proposed agreement, TenX will acquire Citius Pharma's wholly owned subsidiary via a merger, with the newly combined publicly traded company to be named Citius Oncology, Inc.
  • In the transaction, all shares of Citius Pharma's wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology.

Citius Pharmaceuticals Reschedules Participation in Sidoti Small-Cap Virtual Investor Conference for November 2023

Retrieved on: 
Monday, September 18, 2023

CRANFORD, N.J., Sept. 18, 2023 /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, has rescheduled its participation in Sidoti's Small-Cap Virtual Conference to November 2023 due to funeral services for the late Howard Safir, a long-time member of the Citius Board.

Key Points: 
  • CRANFORD, N.J., Sept. 18, 2023 /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, has rescheduled its participation in Sidoti's Small-Cap Virtual Conference to November 2023 due to funeral services for the late Howard Safir, a long-time member of the Citius Board.
  • Mr. Mazur was originally scheduled to present at the Sidoti Small-Cap Virtual Conference on Wednesday, September 20, 2023 at 2:30pm.
  • Additional details regarding participation in the Sidoti conference in November will be shared closer to the event.

Citius Pharmaceuticals Mourns the Loss of Board Member, Howard Safir

Retrieved on: 
Wednesday, September 13, 2023

CRANFORD, N.J., Sept. 13, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) mourns the loss of longtime board member, Howard Safir, who passed away on Monday.

Key Points: 
  • CRANFORD, N.J., Sept. 13, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) mourns the loss of longtime board member, Howard Safir, who passed away on Monday.
  • Mr. Safir joined the Citius Board of Directors in 2014, providing invaluable counsel to the Citius management team for nearly a decade.
  • "We are deeply saddened to announce the passing of our friend and longtime board member, Howard Safir.
  • We are honored to have worked alongside Howard on the Citius board and grateful for his thoughtful guidance, wisdom, and friendship," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharmaceuticals.

Citius Pharmaceuticals, Inc. Receives Regulatory Guidance from the U.S. Food and Drug Administration (FDA) regarding the Planned Resubmission of the BLA for LYMPHIR™

Retrieved on: 
Friday, September 8, 2023

CRANFORD, N.J., Sept. 8, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) is pleased to announce the Company has received additional guidance from the U.S. Food and Drug Administration (FDA) regarding the planned resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Key Points: 
  • The FDA has agreed with the Company's plans to address the requirements outlined in the complete response letter (CRL) received July 28, 2023.
  • The guidance from the FDA provides Citius with a path for completing the necessary activities to support the resubmission of the Company's Biologics License Application (BLA) for denileukin diftitox.
  • No additional clinical efficacy or safety trials have been requested by FDA for the resubmission.
  • "We are encouraged by the constructive engagement with the FDA," stated Leonard Mazur, Chairman and CEO of Citius.

Citius Pharmaceuticals to Participate in H.C. Wainwright and Sidoti Investor Conferences in September 2023

Retrieved on: 
Wednesday, September 6, 2023

CRANFORD, N.J., Sept. 6, 2023 /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 investor conferences in September 2023.

Key Points: 
  • CRANFORD, N.J., Sept. 6, 2023 /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 investor conferences in September 2023.
  • Citius Chairman and CEO Leonard Mazur will present at the H.C. Wainwright 25th Annual Global Investment Conference on Monday, September 11, 2023, and at the Sidoti Small-Cap Virtual Conference on Wednesday, September 20, 2023.
  • 2:00 pm ET on September 11, 2023
    Lotte New York Palace Hotel, New York City

Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 14, 2023

CRANFORD, N.J., Aug. 14, 2023 /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 third quarter ended June 30, 2023.

Key Points: 
  • $33.3 million in cash and cash equivalents as of June 30, 2023; runway through August 2024
    CRANFORD, N.J., Aug. 14, 2023 /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 third quarter ended June 30, 2023.
  • THIRD QUARTER 2023 FINANCIAL RESULTS:
    As of June 30, 2023, the Company had $33.3 million in cash and cash equivalents.
  • For the fiscal quarter ended June 30, 2023, stock-based compensation expense was $1.2 million as compared to $1.0 million for the prior year period.
  • For the nine months ended June 30, 2023, stock-based compensation expense was $3.5 million as compared to $2.9 million for the nine months ended June 30, 2022.

Citius Pharmaceuticals Reaches 92 Event Milestone in Mino-Lok® Phase 3 Trial

Retrieved on: 
Thursday, August 10, 2023

Pending confirmation from an adjudication committee of independent reviewers, the Company believes all 92 events required to complete the trial have been achieved.

Key Points: 
  • Pending confirmation from an adjudication committee of independent reviewers, the Company believes all 92 events required to complete the trial have been achieved.
  • Several patients remain in active treatment, which may result in additional events.
  • "This is a significant milestone for Citius as we approach completion of the Phase 3 Mino-Lok trial.
  • The Mino-Lok Phase 3 pivotal superiority trial ( NCT02901717 ) is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium.

Citius Pharmaceuticals, Inc. Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma

Retrieved on: 
Saturday, July 29, 2023

CRANFORD, N.J., July 29, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the Company's Biologics License Application (BLA) seeking approval for denileukin diftitox ("LYMPHIRTM"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Key Points: 
  • The FDA has required Citius to incorporate enhanced product testing, and additional controls agreed to with the FDA during the market application review.
  • Importantly, there were no concerns relating to the safety and efficacy clinical data package submitted with the BLA, or the proposed prescribing information.
  • "We appreciate the FDA's expeditious review of our application.
  • We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval.