Citius Pharmaceuticals Inc (NASDAQ: CTXR) Milestones Update

Citius Pharmaceuticals Inc (NASDAQ: CTXR), a vital player in developing of critical care products, provides an update on upcoming milestones and business highlights for the six-month period ending June 30, 2021. 

Upcoming Milestones: Citus Pharmaceuticals reported that DMC (Data Monitoring Committee) stated the continuation of the Phase 3 Mino-Lok trial without any modification or safety concerns. The company expects the trial to get completed by the end of 2021 or early 2022, subject to ease of restrictions on COVID-19 in the U.S. After completing the phase 3 trial, Citius expects to submit the NDA (New Drug Application) to the FDA (The U.S Food and Drug Administration) in 2022. In addition, the company issued 11.2 million shares upon the exercise of warrants and raised $16.9 million during the quarter.

Moving ahead with the phase-3 trial: Based on the filings by the company and review by DMC (Data Monitoring Committee), DMC recommends the company proceed with the phase 3 trial of Mino-Lok without any modification. It indicates that the past trial has no side effects and gives a signal to proceed ahead. In addition, the data also suggested the superiority of the trial conducted by the company. The company takes DMC’s recommendation as a strong indication and remains committed to completing the trial by the end of 2021 or early 2022.

Citius is now moving aggressively for the completion of the Mino-Lok trial. The company intends to use the funds raised recently (~$17 million) to leverage the resources and put all our efforts into advancing the trial. As per Mr. Holubiak, Citius is better placed in the industry to execute its near-term strategy and deliver long-term value to shareholders. Next, nine to twelve months are too crucial for the company in terms of the progress of the phase 3 trial. However, if the trial gets successful, it is believed that there is no looking back for the company.

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