(NASDAQ: CTXR) is now up well over 200% since our December report.
Citius Pharma (CTXR) Prepares for Phase III Data Release at the End of This Month and the Potential Catalysts are Lining Up.
Highlights
Entering the Russell 2000 Index
Cash Horde in the Bank
Late-stage Phase 3 data release in two weeks
Good day everyone,
WE are updating our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products.
Current price $2.75 per share
We issue reports on CTXR often and we have done so for quite a while. We talk about this company for a few reasons:
We like their business model.
We like their product pipeline.
We have faith in the company management.
CTXR consistently offers near term gain opportunities.
Multiple potential catalysts are about to hit.
As indicated in the company stock chart, 2021 has been a good year for the company shares thus far. Starting the year at $1.02/share, they peaked at $2.90 on February 22nd.
Now the company has announced some news that we’ve all been waiting for. The next planned interim analysis in its Phase 3 trial of Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related blood stream infections (CRBSIs/CLABSIs) has been scheduled for June 29, 2021. In accordance with the independent Data Monitoring Committee (DMC) charter, the DMC will hold a meeting to review the trial data for safety, superiority, and futility.
It’s been seven months since the DMC released results from their previous interim analysis of the Mino-Lok phase three trial. At that time, patient enrollment was at 50%, and the recommendation was to continue the trial as no adverse events were indicated. We note that the phase 2b trial resulted in 100% efficacy.
Due to difficulties in recruiting patients during the pandemic (most biopharma companies experienced this) the company and the FDA agreed to the next interim analysis being done at 65% enrollment, reduced from the previously scheduled 75%. This is the analysis we are waiting for on June 29th.
The upcoming interim analysis has the potential to be a major catalyst for the company’s value. That’s not the only potential catalyst for the end of June. On June 28th CTXR will be added to the Russell 2000 Index. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
For those new to our group, we want to describe the Mino-Lok product:
Citius is developing Mino-Lok®, an antibiotic lock solution to treat patients with catheter-related blood stream infections that was licensed from The University of Texas MD Anderson Cancer Center. Citius believes Mino-Lok® provides a superior alternative to removing and replacing a central venous catheter (CVC), leading to a reduction in serious adverse events and cost savings to the healthcare system. A multicenter Phase 3 pivotal superiority trial is currently underway. If approved, Mino-Lok® would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.
CTXR specializes in the development of biopharma products that consist of component drugs already approved by the FDA and seek FDA approval for novel combinations of those drugs. Both Mino-Lok and Mino-Wrap are licensed from the M.D. Anderson Cancer Center, a world-renowned research center.
While Mino-Lok is CTXRs lead product, they have more products in their pipeline:
Mino Wrap, also licensed from MD Anderson, to treat infections resulting from breast reconstruction, and is under review by the FDA’s Center for Drug Evaluation and Research division.
CITI-002 (Hydro-Lido) is being developed for symptomatic relief of hemorrhoids. CITI-002 combines the high-potency steroid, halobetasol, with lidocaine. There are no prescription strength treatments for hemorrhoids.
Through its subsidiary Novecite, CTXR is developing a novel stem cell therapy for the treatment of acute respiratory distress syndrome (ARDS). Recently the company received the Best Poster Award at the prestigious International Society for Cell and Gene Therapy (ISCT) 2021 Annual Meeting.
CTXT has a FYE of September 30th. As of March 31st, the company had a cash position of $103M. That cash horde may cover the expenses involved inl bringing Mino-Lok to market and bringing the company’s other products to advanced clinical trials.
3/1/2021 HC Wainwright Reiterated Rating Buy
2/25/2021 Dawson James Reiterated Rating Buy $6.00 target
Many of our members follow the biopharma sector with a keen eye. Let’s look at CTXR from an acquirer’s point of view. How much is a company worth that could generate $1.8B in annual revenues (estimated global market for Mino-Lok), has three other viable pipeline products and has $100M (est.) in the bank? We don’t know, but we think it could be significantly more than the current market value.
Stay tuned and stay informed.
The Traders News Group
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