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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) will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. CEO Myron Holubiak will provide updates on the company's product pipeline, including Mino-Lok, which is in Phase 3 trials. The presentation will be accessible via webcast starting March 9 at 7:00 a.m. ET, with a replay available for 90 days. The company recently issued its February 2021 Letter to Shareholders, detailing business and clinical developments. For more information, visit the company's website.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has successfully completed a registered direct offering, raising approximately $76.5 million through the sale of 50,830,566 shares of common stock and warrants to purchase 25,415,283 shares. The offering was priced at $1.505 per share, with warrants exercisable at $1.70, valid for five years. Proceeds will support pre-clinical and clinical development, along with working capital needs. H.C. Wainwright & Co. served as the exclusive placement agent. The securities were registered under an effective SEC filing.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has announced a registered direct offering to sell 50,830,566 shares of common stock at $1.505 per share, along with warrants for an additional 25,415,283 shares at an exercise price of $1.70. The offering is expected to close around February 19, 2021, with gross proceeds of approximately $76.5 million. Funds will be used for general corporate purposes, including clinical development of product candidates. H.C. Wainwright & Co. is the exclusive placement agent for this offering.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) released a shareholder letter detailing its recent achievements and plans for 2021. Key updates include expected interim analysis from the Mino-Lok® pivotal trial and filing of the Halo-Lido IND and Phase 2b protocol in Q2. The company is also progressing with Mino-Wrap™ and its NoveCite i-MSCs program. A recent private placement raised $20 million, and warrant exercises generated an additional $4.5 million. These developments reflect Citius's commitment to advancing its clinical programs, aiming for significant milestones this year.
Citius Pharmaceuticals (Nasdaq: CTXR) will present at the Virtual Investor Conferences Small and Microcap Showcase on February 4, 2021, at 1:00 p.m. ET. Chairman Leonard Mazur will provide updates on the lead candidate MinoLok, currently in Phase 3 trials, as well as three other active programs. The event is interactive, allowing real-time questions from investors. An archived version will be available post-event. Pre-registration is recommended for participation.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has completed a private placement, raising approximately $20.0 million by issuing 15,455,960 shares of common stock priced at $1.294 per share, along with warrants for an additional 7,727,980 shares. The associated warrants have an exercise price of $1.231 and are valid for five and a half years. Proceeds will support general corporate purposes, including pre-clinical and clinical development. The company has obligations to file a registration statement with the SEC to facilitate resale of the shares.
Citius Pharmaceuticals (CTXR) announces a private placement to raise approximately $20.0 million by issuing 15,455,960 shares of common stock and warrants for 7,727,980 shares at $1.294 per share. The placement is set to close around January 27, 2021, subject to closing conditions. H.C. Wainwright & Co. is the exclusive placement agent. Funds will support clinical development and working capital. Citius must file a registration statement for resale within five days, aiming for effectiveness within 75 days.
Citius Pharmaceuticals, a specialty pharmaceutical company (Nasdaq: CTXR), announced presentations at two virtual investor conferences in January 2021. The H.C. Wainwright BioConnect Conference will feature CEO Myron Holubiak from January 11-14, with a presentation available on-demand starting January 11. The MoneyShow Accredited Investors Virtual Expo will feature Chairman Leonard Mazur on January 26. Key updates will include progress on i-MSC therapy for ARDS and Mino-Lok trials for CLABSIs. Citius is committed to advancing its product candidates in critical care.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has announced a series of webinars to discuss updates on the Phase 3 trial of Mino-Lok, an antibiotic lock solution designed for treating Central Line Associated Blood Stream Infections (CLABSIs). The trial is over halfway complete, with insights shared by experts from leading medical institutions. Key topics included the challenges of conducting the trial during COVID-19 and the benefits of Mino-Lok. CEO Myron Holubiak expressed optimism about meeting the unmet need for effective alternatives to central line replacements.
Citius Pharmaceuticals (CTXR) announced receiving guidance from the FDA regarding its Mino-Wrap, aimed at reducing infections in post-mastectomy patients. The FDA's feedback included suggestions for bio absorption studies and a large animal pharmacology study to support Mino-Wrap's development. Additionally, a 28-day toxicology study was deemed appropriate. This innovation, designed to enhance protection against infections during breast reconstruction surgeries, could address a significant issue, as infection rates for tissue expanders range from 2.5% to 24%. Citius emphasizes the importance of this solution amid current inadequate preventive measures.