Citius Pharmaceuticals (NASDAQ: CTXR) 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. At the end of 2023, Citius completed enrollment in a Phase 3 Pivotal superiority trial of Mino-Lok(R), an antibiotic lock solution to salvage catheters in patients with bloodstream infections (CRBSI and CLABSI). Topline results are expected 1H 2024. A Biologics License Application for LYMPHIR(TM), a novel IL-2R immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma (“CTCL”), is currently under review by the FDA with August 13, 2024 assigned as the PDUFA target action date. Citius is advancing its previously announced plans to form Citius Oncology, a standalone publicly traded company with LYMPHIR as its primary asset. LYMPHIR received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In addition, Citius completed enrollment in its Phase 2b trial of CITI-002 (Halo-Lido), a topical formulation and potentially the first FDA-approved prescription therapy for the relief of hemorrhoids.
The market opportunities for the company’s pipeline are significant. The CTCL market is estimated at $300-$400+ million with additional growth potential for LYMPHIR in peripheral T-Cell lymphoma (“PTCL”) and immuno-oncology. The CRBSI/CLABSI market is estimated at over $1.8 billion worldwide, and the hemorrhoid treatment market is estimated at over $2 billion in the U.S. alone.
As of March 31, 2024, Citius has $12.6 million in cash. In April 2024, the company raise $15 million through a registered direct offering, extending the runway through the end of the year. Insiders have invested approximately $26.5 million alongside shareholders. With significant near-term catalysts on the horizon, Citius believes Mino-Lok’s topline results expected by the end of the quarter, anticipated oncology subsidiary spinoff, and the August 13, 2024 PDUFA for LYMPHIR, position the company to drive sustained value for shareholders.
For more information visit, the company’s website at www.citiuspharma.com or contact Investor Relations at ir@citiuspharma.com.
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