Citius Pharmaceuticals (CTXR) Provides First Half 2021 Business Update, Highlights Upcoming Milestones

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today provided a business update for the six-month period ended June 30, 2021 and reported on recent corporate developments.

Recent Highlights and Upcoming Milestones

• On July 1, 2021, Citius reported that the independent DMC recommended continuation of the Phase 3 Mino-Lok® pivotal superiority trial as planned with no modifications or safety concerns,
• Citius expects to complete the Mino-Lok® trial by the end of 2021 or early 2022, subject to continued easing of COVID-19 restrictions in the U.S.,
• Citius plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2022 following completion of its Phase 3 Mino-Lok® trial, and
• Subsequent to March 31, 2021, Citius issued 11.2 million shares of Citius common stock upon the exercise of warrants, for aggregate proceeds of $16.9 million during the quarter and a total of $127.6 million in financing activities during the first half of 2021.

"On July 1, 2021, we reported that the independent Data Monitoring Committee (DMC), following its third interim review, recommended continuing the Phase 3 trial for Mino-Lok® without modification. This recommendation affirms that there is an important efficacy signal that merits moving forward with the trial, there are no safety concerns to warrant halting the trial, and that the full data set upon trial completion may support statistically significant superiority. Whether Mino-Lok® demonstrates statistical superiority will only be known to us once the trial is finished and the data is unblinded. We view the recommendation of the DMC as a strong positive signal, and remain fully committed to completing the trial in a timely manner," stated Myron Holubiak, President and Chief Executive Officer of Citius.

"Mino-Lok® trial patients represent an extremely ill population, which is challenging to enroll under the best of circumstances. Like many clinical trials conducted during the pandemic, the timeline for our study has been impacted by COVID-19. It has taken longer than anticipated to enroll patients due to restrictions established at our trial sites during the height of the pandemic. These restrictions, in place for close to half of the duration of our trial, reflect a series of challenges including: site closures, limited site and patient access, reallocation of resources away from clinical trials to COVID-patient treatment, modifications to catheter infection treatment protocols, and lengthy approval time to qualify new study sites, resulting in fewer monthly patient screenings compared to pre-pandemic levels. The ability of sites to ramp back up for the Mino-Lok® trial depends largely on how these varied and complex factors are addressed. Several institutions have resumed our trial, and provided that COVID restrictions continue to ease and are not reinstated, we believe it would be possible for our trial sites to complete enrollment in the Mino-Lok® study as early as the end of the year. That would put us on target to submit an NDA in 2022," added Mr. Holubiak.

"We intend to aggressively pursue all options to expedite completion of the Mino-Lok® trial. During the first half of 2021, we raised more than $127 million, of which approximately $17 million was from warrants exercised since March 31, 2021. We intend to leverage these resources to accelerate our outreach efforts to advance the trial. Moreover, we believe we are well capitalized to advance Mino-Lok® beyond trial completion, and will engage closely with the FDA in the coming months to do so. Concurrently, we are actively advancing three additional first-and-only or novel pipeline products as outlined in our updated corporate presentation published on our website this morning. With a late-stage product candidate moving toward completion of its Phase 3 trial, depth in our pipeline, and the financial resources to execute our near-term strategy, we believe Citius is better positioned than ever before to deliver long-term value to shareholders," concluded Mr. Holubiak.

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