Citius In The Prevention Of Catheter-Related Bloodstream Infections (CRBSI) And Central Line-Associated Bloodstream Infections (CLABSI)
Infected catheters can become fatal, presenting patients with a host of new health problems, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge.
Currently, there are no approved therapies to salvage infected CVCs, the standard treatment is removing and replacing (R&R) infected catheters. From the 7,000,000 CVCs used annually in the U.S., up to 472,000 become infected, leading to severe, life-threatening infections called CRBSI/CLABSI. Besides, it is important to acknowledge that hospitals are penalized for reporting high infection rates. The cost to R&R is around $10k. However, if the patients get an infection, the costs and potential patient harm increases significantly.
Through Citius novel therapy Mino-Lok solution, catheters can be disinfected and salvaged to prevent the need to replace and restart a deadly and costly process. Additionally, the market opp. for this therapy treatment is estimated at $750Mn per year in the U.S. and is projected to reach $1.84Bn globally in 2028.
Clinicians and technologists developed Mino-Lok at M.D. Anderson Cancer Center. Mino-Lok is currently being tested in a Phase 3 trial with an anticipated new dr-ug application milestone expected in 2022.
Stem-Cell Therapy For Acute Respiratory Distress Syndrome (ARDS)
Another treatment being developed by Citius is stem-cell therapy for acute respiratory distress syndrome (ARDS) under the name Novellus. Matt Angel, Ph.D., CSO of the company, is working with mesenchymal stem cells (MSCs), which have been shown to be safe in over 900 clinical trials and in treating several inflammatory diseases, including ARDS.
ARDS is the most common cause of respiratory failure and mortality in CV-19 patients. Its symptoms include shortness of breath, rapid breathing, and bluish skin coloration. For those who survive, a decreased quality of life is common.
is another multi-Bn market and the company has a investigational new dr-ug milestone expected in 2022.
Now here are a few immediate term potential driver indicators to pay attention to closely:
No. 1 CTXR Potential Driver Indicator - Analyst Coverage With Major P.T.
Dawson James Securities - $8.00 Price Target
Here are the major highlights from the March Dawson James Securities updated analyst report:
Management is Focused and Understands. Now is the time to spend money on resources, FDA consultants and the like to ensure that all elements of the rolling NDA are up to par, from the culmination of component studies to CMC details, record keeping and, of course, a focus on the potential for the pivotal trial to be stopped early for efficacy.
What is Mino-Lok? Three active drug substances (minocycline, ethanol, and EDTA), which are combined into two vials, MLT01 (minocycline) and MLT02 (ethanol and EDTA). Citius has manufactured three registration lots of Mino-Lok using the commercial manufacturing process, part of the planned New Drug Application (NDA). Citius has placed all registration lots on stability at the appropriate ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) conditions to support the NDA filing. Citius has also developed a new exclusive synthesis process for disodium edetate, a chelating agent that supplants heparin as the anti-clotting agent in Mino-Lok.
Trial Background. The current Phase 3 trial being conducted compares Mino-Lok therapy (MLT) to the standard of care, which is antibiotic lock therapy (ALT). This is used to disinfect colonized catheters causing bacteremia and keep the treated catheters functioning and infection-free for eight weeks post-therapy. The current primary endpoint in the study is planned to demonstrate a significant difference in the time to catheter failure when comparing MLT to ALT. This is clinically important because eliminating the source of infection enables antibiotic treatment of the bacteremia to work more effectively and expeditiously. Additionally, if a catheter can be maintained for the time that it is needed, the patient does not need to be subjected to the procedures for removing and replacing the catheters that are associated with some serious adverse events.
Could the DMC halt the study early for Efficacy? We think so. This past September, the DMC recommended continuing the trial without any modifications. The DMC further requested to have an ad hoc meeting in the near future. Recall that the trial (Sept. 2019) reached the first interim analysis point of 37 catheter failures representing 40% of the anticipated events at ~58 patients. Recall that the trial is designed with 80% power for an assumed 17-day difference between active and standard of care (SOC). We typically expect the SOC arm to fail in 5-14 days.
Valuation. Our valuation is based on our therapeutic models and associated assumptions projected to 2028. The lead product, MiniLok, is now in a Phase 3 trial. We conservatively assume just 50% probability of success in our therapeutic model. On top of this, we also use a 30% risk rate in our free cash flow to the firm (FCFF), our discounted EPS (dEPS) and sum-of-the-parts (SOP) models. We equal weight and average these metrics and then round to the nearest whole number to derive our $8.00 price target.
From Friday's close, this $8.00 price target provides upside potential over 275%.
Now, I'm not saying CTXR is going to go soaring to $8.00 today, but you need to be aware of this analyst provided potential upside.
No. 2 CTXR Potential Driver Indicator - Bullish Technical Indicators
According to Barchart at close Friday, CTXR is packing some bullish technical indicators.
These are currently triggered as bullish:
Short Term Indicators
- 20 Day Moving Average
- 20 - 200 Day MACD Oscillator
Medium Term Indicators
- 50 - 200 Day MACD Oscillator
Long Term Indicators
- 200 Day Moving Average
- 100 - 200 Day MACD Oscillator
At close Friday, Barchart was reporting its composite "TrendSpotter" indicator to be triggered as a "BUY" too.
Could these bullish technicals be signaling an even bigger move is on the horizon?
No. 3 CTXR Potential Driver Indicator - Reporting Of Major Institutional Buying
Over as WhaleWisdom, some interesting developments are being reported over the last 30 days.
I want to point to some specific instances as to why CTXR has been the talk of the town in recent months.
(1.) State Street Corporation is an American financial services and bank holding company that is the second-oldest continually operating United States bank.
Reported on 8/16/21, the company purchased approximately 1.96Mn shares at a market value of approximately $6.85Mn.
(2.) Doubling down, American in-vestment ad-visor, Vanguard Group, added to their position with a purchase of approximately 586K shares (approx. 5.65Mn overall) as reported on 8/13/21.
(3.) Also adding to their position was Geode Capital Management, LLC and Northern Trust Corp., who further increased their totals by over 1Mn shares each (reported on 8/13/21).
Don't think twice about this. This is huge news and only the tip of the iceberg.
Just take a look at WhaleWisdom's site and you'll see how many different institutions are taking positions in CTXR.
Could it be that these institutions see a big future for this Nasdaq profile?
No. 4 CTXR Potential Driver Indicator - Company Being Added To Russell 2000® Index
Citius Pharmaceuticals to be Added to Russell 2000® Index
CRANFORD, N.J., June 7, 2021 /PRNewswire/ -- 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 announced that it is set to be added to the Russell 2000® Index at the conclusion of the Russell US Indexes annual reconstitution, effective at the opening of the U.S. equity markets on June 28, 2021.
"Our inclusion in the Russell index is an important milestone for Citius that reflects the continued progress we are making to develop and commercialize first-in-class treatment options for patients around the world. We welcome the enhanced visibility of our diversified pipeline and long-term growth potential, and look forward to sharing our future milestones with a broader investment community," said Myron Holubiak, President and Chief Executive Officer of Citius.
FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes. Membership in the small-cap Russell 2000® Index, which remains in place for one year, is based on membership in the broad-market Russell 3000® Index. Citius st-ock will also be automatically added to the appropriate growth and value indexes.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9Tn in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.
Read the full article here.
CTXR Recap: Top 4 Potential Breakout Driver Indicators
No. 1 - Analyst Coverage With Major $8.00 P.T.
No. 2 - Bullish Technical Indicators
No. 3 - Reporting Of Major Institutional Buying
No. 4 - Company Being Added To Russell 2000® Index
Coverage is officially reinitiated on CTXR. Also, when you have a moment later on, do this: