The previous session saw an uptick in Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) shares, ending the trading at $0.8087 after increasing 6.90%. The rise in CTXR shares followed release of its annual results.
Citius (CTXR) has disclosed the business and financial results for the fiscal year ended September 30, 2023. As of August 2024, Citius has $26.5 million in cash and cash equivalents. However, Citius ended the fiscal year with a $32.5 million, or ($0.22) per share, net loss. In comparison, the full year ended September 30, 2022, had a $33.6 million net loss, or ($0.23) per share.
With noteworthy pipeline developments in 2023, CTXR is in a great position going into 2024. Focusing on performance, Citius finished two trials of enrollment. The business anticipates having topline data available in the second quarter of 2024 following the completion of the Mino-Lok pivotal Phase 3 trial enrollment. In 2023, Citius also finished the Halo-Lido Phase 2b study.
Citius filed patent applications for the high dose formulation based on the trial’s data, which showed that more patients reported meaningful improvement with the high dose formulation than with halobetasol alone. The company is also actively pursuing intellectual property protections for the ground-breaking fit for purpose PRO instrument.
CTXR has scheduled a meeting with the FDA for early 2024 to go over the trial’s outcomes and the next phase of the Halo-Lido program. Although Citius received a comprehensive response letter for its LYMPHIR BLA at the end of July 2023, the company is optimistic that the FDA addressed the problems in a timely way and that they had nothing to do with clinical effectiveness or safety.
The CTXR team has been in communication with the FDA for a number of months, working to address the agency’s concerns. In keeping with the developments on this front, CTXR intends to resubmit the BLA in the first part of 2024, with a PDUFA deadline for later this year.
Simultaneously, Citius declared a final agreement to combine TenX Kean Acquisition with its oncology division to create a new publicly listed business. The spin-out aims to align its resources relevant to oncology and unlock value for Citius shareholders; it is now undergoing SEC examination.
