CRANFORD, N.J., Feb. 16, 2021 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a
specialty pharmaceutical company developing and commercializing
critical care drug products, today issued a shareholder letter
providing a corporate update on the Company's recent achievements
and anticipated milestones for 2021.
Highlights from the letter include:
- Mino-Lok® pivotal trial interim analysis and review by the Data
Monitoring Committee (DMC) expected in the second quarter
- Halo-Lido IND (second quarter) and Phase 2b protocol to be filed afterwards
- Mino-Wrap™ in pre-clinical development with plans to submit IND
to the FDA by the end of the year
- NoveCite i-MSCs development is progressing with: ongoing
data generation from our proof-of-concept sheep acute respiratory
distress syndrome (ARDS) model demonstrating impressive interim
results (studies to be completed in second quarter); FDA-required
GLP animal toxicology studies have been implemented; and
development of an i-MSC master cell bank (MCB) followed by
cGMP manufacturing is underway
- Private placement for gross proceeds of $20.0 million and investors' exercise of warrants
generating $4.5 million in gross
proceeds completed in January 2021
and February 2021, respectively
"Our important achievements against the COVID headwinds last
year give us great confidence that 2021 will be a banner year for
advancing our three product platforms in the clinic, and our
corporate decision to commence the development of NoveCite
next-generation cellular therapies further expands our goal as a
specialty pharmaceutical company dedicated to the development and
commercialization of therapeutic products for significant unmet
medical needs" said Myron Holubiak, President and CEO of
Citius Pharmaceuticals. "Our advanced clinical program for
Mino-Lok is moving forward with expected full enrollment for the
Phase 3 pivotal trial this year. For Halo-Lido, we expect to file
an Investigational New Drug Application (IND) for the
combination by the second quarter and initiate our Phase
2b trial by year-end. We also plan to
start pre-clinical pharmacology and toxicology studies for
Mino-Wrap within the next few months along with chemistry,
manufacturing and controls (CMC) development, and we target filing
an IND by the end of 2021. In addition to the plans described above
for our NoveCite i-MSCs Program, we plan to submit an IND to
the FDA and initiate our Phase 1 first-in-human clinical trial in
COVID-19 ARDS by the end of the second quarter of 2022. Our recent
$20 million private round of
financing and investors' exercise of warrants for net proceeds of
approximately $4.5 million provides
significant financial runway to move forward with our three
programs in the clinic, as well as manufacturing development for
our unique induced-mesenchymal stem cell therapy for ARDS
associated with COVID-19. We are excited about the road ahead and
thankful as always for the ongoing support of our
shareholders."
To read the Shareholder Letter in its entirety, please visit the
Company's Investor Info website at ir.citiuspharma.com.
About Citius Pharmaceuticals, Inc.
Citius is a
specialty pharmaceutical company dedicated to the development and
commercialization of critical care products, with a focus on
anti-infectives and cancer care. For more information, please visit
www.citiuspharma.com.
Safe Harbor
This press release may contain
"forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Such statements are made based on our
expectations and beliefs concerning future events impacting Citius.
You can identify these statements by the fact that they use words
such as "will," "anticipate," "estimate," "plan," "expect,"
"should," and "may" and other words and terms of similar meaning or
use of future dates. Forward-looking statements are based on
management's current expectations and are subject to risks and
uncertainties that could negatively affect our business, operating
results, financial condition and stock price. Factors that could
cause actual results to differ materially from those currently
anticipated are: risks associated with conducting clinical trials
and drug development, including anticipated development timelines
and study results; risks relating to the results of research and
development activities; uncertainties relating to preclinical and
clinical testing; the early stage of products under development;
our dependence on third-party suppliers; our need for substantial
additional funds; patent and intellectual property matters; market
and other conditions; our ability to attract, integrate, and retain
key personnel; the estimated markets for our product candidates and
the acceptance thereof by any market; risks related to our growth
strategy; our ability to obtain, perform under and maintain
financing and strategic agreements and relationships; our ability
to identify, acquire, close and integrate product candidates and
companies successfully and on a timely basis; government
regulation; competition; as well as other risks described in our
SEC filings. We expressly disclaim any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in our
expectations or any changes in events, conditions or circumstances
on which any such statement is based, except as required by
law.
Contact:
Andrew
Scott
Vice President, Corporate Development
(O) 908-967-6677 x105
(M) 646-522-8410
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.