Biotech Nearing the End of Phase 3 Trial
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CTXR Nearing the End of Phase 3 Trial
CTXR shares may be in value territory
Good day everyone,
We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty pharmaceutical company that develops and commercializes critical care products.
Current price $.59
Outstanding (est.) 35.9 million shares
Float (est.) 15 million shares
Insider holdings 39%
52-week range $.40 to $1.59 per share
These data above are the core metrics we have come to like in a stock. Low float, large insider holdings and a share price that has consolidated near its 52-week low absent adverse events.
In fact, CTXR is not only absent adverse events, the company is loaded with positive events.
CTXR be presenting at this year's Spring Investor Summit on March 25th-26th in New York City.
While CTXR is developing 3 products, Mino-Lok, Mino-Wrap and Hydro-Lido, it’s Mino-Lok that we see as the impetus for near-term growth in the shares. If you are a newer member of our group, Mino-Lok is a patented, proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all FDA approved compounds.
Mino-Lok is being investigated in clinical trials for the treatment of infected central venous catheters (CVCs). A central venous catheter is a tube that doctors place in a large vein in the neck, chest, groin, or arm to give fluids, blood, or medications or to do medical tests quickly. The current standard of care is removal and replacement of the CVC, a costly and sometimes dangerous procedure.
It is being developed under the FDA's 505(b)(2) pathway for new drug approvals that bring products to market faster and with lower cost than other FDA new drug approval pathways.
Mino-Lok is in a phase III clinical trial with Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, expected in the first half of 2020. We anticipate that the Topline data results for Mino-Lok could be a catalyst that moves CTXR shares to new highs.
According to DelveInsight, the market size of CRBSIs in the global market is expected to reach $1.84 billion in 2028, up from $1.24 billion in 2017
Total Incidence of Catheter Related Bloodstream Infection (CRBSI) in the Global Market is estimated to be 4 million patients
In the Asia Pacific region there were greater than 3 million CRBSIs
U.S. incidence is over 325,000
Mino-Lok is the only treatment under investigation designed to salvage contaminated CVCs.
CTXR has been moving Mino-Lok through clinical trials for years and has been in its phase III trial for two years. The phase 2 trial indicated virtually 100% efficacy. With the Topline phase III data forthcoming soon and possible FDA approval by year end we feel Mino-Lok has never been closer to market.
1/24/2020 HC Wainwright Reiterated Rating Buy $4.00
9/6/2019 Dawson James Initiated Coverage Buy $7.00
Mino-Lok is near a significant milestone with potential FDA approval this year, and the CTXR share price is at its low end. CTXR has a product with a market valued over $1 billion and the market cap is only $20 million. Looks like there could be a lot of room for growth in these shares.
In reviewing the chart below, we note that CTXR shares have fallen below their 50 DMA and 200 DMA of $.95 and $.89 respectively. The current RSI (14) is 28.94. These data can indicate shares that have been oversold.
The Team
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