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Citius Pharmaceuticals Inc. (Nasdaq: CTXR) is a specialty biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Founded in 2007 and headquartered in Cranford, New Jersey, Citius focuses on providing innovative treatments in areas such as anti-infectives, oncology, and stem cell therapy.
The company's diversified pipeline includes several late-stage product candidates:
- Mino-Lok®: An antibiotic lock solution used to salvage infected catheters in patients with catheter-related bloodstream infections. This product is currently in pivotal Phase 3 clinical trials.
- Mino-Wrap®: A liquifying gel-based wrap designed to reduce tissue expander infections following breast reconstructive surgeries.
- Halo-Lido®: A topical corticosteroid-lidocaine formulation intended to provide anti-inflammatory and anesthetic relief for individuals suffering from hemorrhoids. Enrollment in its Phase 2b trial has been completed.
- LYMPHIR™ (denileukin diftitox): An IL-2-based immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). The Biologics License Application (BLA) for LYMPHIR is currently under review by the FDA, with a PDUFA target action date set for August 13, 2024.
- NoveCite™: A mesenchymal stem cell therapy aimed at treating acute respiratory distress syndrome.
Recently, Citius has made significant advancements:
- Completed the Phase 3 trial recruitment for Mino-Lok.
- Resubmitted the BLA for LYMPHIR, addressing FDA comments with no safety or efficacy concerns noted.
- Announced a merger of its oncology subsidiary with TenX to form a publicly listed company, enhancing financial flexibility and potential value for stakeholders.
- Secured $2.4 million in non-dilutive capital through New Jersey’s Net Operating Loss (NOL) program.
Financially, as of March 31, 2024, Citius reported $12.6 million in cash and cash equivalents and has recently expanded its cash runway by successfully completing a $15 million registered direct offering. The company remains focused on the commercialization of LYMPHIR, completion of the Mino-Lok Phase 3 trial, and planning for the Phase 3 trial of Halo-Lido.
With a commitment to innovation and a strong pipeline, Citius Pharmaceuticals continues to strive towards providing effective treatments for critical care needs across various medical fields.
Citius Pharmaceuticals (Nasdaq: CTXR) announced promising interim data from a proof-of-concept study on its proprietary induced mesenchymal stem cell (i-MSC) therapy for acute inflammatory respiratory conditions, such as COVID-19 related ARDS. The study showed significant improvements in oxygenation, reduced lung injury, and systemic shock in treated subjects compared to controls. Citius has partnered with Novellus Therapeutics for the development of i-MSCs and established a subsidiary, NoveCite, which has filed a Pre-IND with the FDA, indicating strong progress in their therapeutic approach.
Citius Pharmaceuticals (Nasdaq: CTXR) announced its participation in the Benzinga Global Small Cap Conference on December 8-9, 2020. Citius Chairman Leonard Mazur will present on December 8 at 11:30 am ET and conduct one-on-one meetings with investors. The company is advancing four proprietary product candidates, including Mino-Lok®, which is in Phase 3 trials, and Halo-Lido, expected to enter Phase 2b trials in early 2021. Recent developments include a positive interim analysis for Mino-Lok and an exclusive agreement with Novellus Therapeutics for a therapy related to COVID-19.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced results from a Boston Analytical study showing that Mino-Lok, a novel antiseptic solution, is more effective than standard EDTA/ethanol solutions in eradicating resistant Staphylococcal biofilms. The study revealed that Mino-Lok significantly reduced CFU/Disk counts in two strains of Staphylococcus aureus across various exposure times. This promising data supports the potential of Mino-Lok to transform the treatment of central venous catheter infections and underscores its significance in the ongoing Phase 3 pivotal trial.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced participation in the Virtual Fall Investor Summit from November 16-18, 2020. Chairman Leonard Mazur will present a corporate overview on November 16 at 1:00 p.m. ET and engage in one-on-one investor meetings. Updates on Mino-Wrap, focused on reducing surgical infection risks, and Mino-Lok®, aimed at treating catheter-related infections, will be discussed. The company recently licensed induced mesenchymal stem cells for potential COVID-19 treatment, indicating an expansion of its critical care drug portfolio.
Citius Pharmaceuticals, a late-stage specialty pharmaceutical company, announced its participation in the H.C. Wainwright 6th Annual Israel Conference on November 12, 2020. CEO Myron Holubiak will present an update on the company’s product pipeline at 2:30 p.m. ET and conduct one-on-one investor meetings. This follows the release of their October 2020 Letter to Shareholders, detailing recent business and clinical developments. For more information, visit the corporate update.
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) announced recent updates in its October 2020 Letter to Shareholders, highlighting significant developments in its drug pipeline. The company secured an exclusive license with Novellus Therapeutics for a therapy targeting acute respiratory distress syndrome (ARDS), a COVID-19 complication. It also received a positive report from the Drug Monitoring Committee for its Mino-Lok Phase 3 trial and submitted a pre-investigational new drug request for Mino-Wrap, with FDA guidance expected in November 2020. A Phase 2b trial for Halo-Lido is slated to start in Q1 2021.
Novellus Therapeutics has licensed its induced mesenchymal stem cells (iMSCs) to NoveCite, a new subsidiary of Citius Pharmaceuticals (Nasdaq: CTXR). The agreement includes a $5 million upfront payment and potential milestone payments totaling up to $51 million, alongside low double-digit royalties. NoveCite aims to utilize these iMSCs to address acute respiratory conditions, particularly Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. Novellus holds a 25% equity stake in NoveCite, indicating a significant collaborative effort to innovate treatment options in critical care.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced on October 7, 2020, an exclusive licensing agreement with Novellus Therapeutics for iPSC-derived mesenchymal stem cells (NC-iMSCs), targeting acute respiratory conditions like Acute Respiratory Distress Syndrome (ARDS) related to COVID-19. This collaboration forms a new subsidiary, NoveCite, which aims to develop NC-iMSCs, believed to have superior potency and unlimited supply compared to traditional donor-derived stem cells. With over 3 million ARDS cases annually, this therapy holds potential for significant impact in critical care.
Citius Pharmaceuticals (CTXR) announced on September 30, 2020, that the Mino-Lok Clinical Trial Material at clinical sites has been replaced with registration batch product. This transition allows trial participants to receive Mino-Lok manufactured with the same process intended for commercial use post-FDA approval. CEO Myron Holubiak expressed satisfaction in providing common packaging for Mino-Lok components and indicated readiness for commercial manufacturing following successful Phase 3 trials and FDA clearance.
Citius Pharmaceuticals (Nasdaq: CTXR) announced positive outcomes from a Data Monitoring Committee (DMC) meeting regarding its Mino-Lok phase 3 trial. The DMC found no safety signals and recommended continuing the trial without modifications. Despite challenges in patient recruitment during the COVID-19 pandemic, the company is nearing the late stage of the pivotal study. CEO Myron Holubiak expressed confidence in Mino-Lok's safety and efficacy, highlighting the dedication of study investigators amidst challenges.
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