Citius Pharma Reports Fiscal Year 2024 Results, Highlights LYMPHIR Approval and Mino-Lok Progress
Key Insights
Citius Pharmaceuticals (Citius Pharma (search)) achieved FDA approval for LYMPHIR for relapsed or refractory cutaneous T-cell lymphoma (search) (CTCL (search)).
The company's Phase 3 trial of Mino-Lok met primary and secondary endpoints, showing statistically significant improvement in catheter failure time.
Citius Pharma (search) is preparing for the commercial launch of LYMPHIR in the first half of 2025 and plans to engage with the FDA on Mino-Lok and Halo-Lido.
Citius Pharmaceuticals, Inc. (Citius Pharma (search)) has released its financial results for the fiscal year 2024, highlighting the FDA approval of LYMPHIR™ (denileukin diftitox-cxdl) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (search) (CTCL (search)) and the positive Phase 3 results for Mino-Lok®. The company is gearing up for the commercial launch of LYMPHIR in the first half of 2025.
LYMPHIR Approval and Commercialization
LYMPHIR's approval marks a significant milestone for Citius Pharma (search). The company is actively involved in manufacturing, marketing, and sales activities to ensure a successful launch. Leonard Mazur, Chairman and CEO of Citius Pharma, stated, "The approval of LYMPHIR™ and the positive Phase 3 results for Mino-Lok® underscore our commitment to developing innovative therapies."
Citius Pharma (search) is also supporting investigator-initiated trials to explore LYMPHIR's potential as an immuno-oncology combination therapy at the University of Pittsburgh Medical Center and the University of Minnesota. Interim trial results from the University of Pittsburgh Medical Center's Phase I trial of LYMPHIR with checkpoint inhibitor pembrolizumab were shared at the Society for Immunotherapy of Cancer Conference (SITC).
Mino-Lok Phase 3 Trial Success
Mino-Lok®, an antibiotic lock solution, met its primary and secondary endpoints in a Phase 3 pivotal trial. The results demonstrated a statistically significant improvement in time to catheter failure of infected catheters compared to other physician-selected anti-infective lock solutions. This success paves the way for further discussions with the FDA to determine the next steps for the program.
Financial Overview
As of September 30, 2024, Citius Pharma (search) reported cash and cash equivalents of $3.3 million. Research and development (R&D) expenses for the full year were $11.9 million, compared to $14.8 million for the previous year. General and administrative (G&A) expenses increased to $18.2 million from $15.3 million in 2023, primarily due to pre-launch and market research activities associated with LYMPHIR. The company's net loss for the year was $39.4 million, or ($5.97) per share, compared to a net loss of $32.5 million, or ($5.57) per share in 2023.
Strategic Priorities for 2025
Looking ahead to fiscal year 2025, Citius Pharma (search)'s priorities include:
- Launching LYMPHIR™ through its majority-owned subsidiary, Citius Oncology.
- Driving the clinical and regulatory strategies for Mino-Lok® and Halo-Lido.
- Fortifying the company's financial position.
- Applying a disciplined approach to resource allocation.
Citius Pharma (search) expects to launch LYMPHIR in the first half of 2025 and distribute CTOR shares to Citius Pharma shareholders by the end of the year, pending favorable market conditions.
About Citius Pharmaceuticals
Citius Pharma (search) is dedicated to developing and commercializing first-in-class critical care products. Besides LYMPHIR and Mino-Lok, its pipeline includes CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief. The company is actively engaged with the FDA to outline the next steps for both the Mino-Lok and Halo-Lido programs.