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Multiple Potential Catalysts Including A $7 Analyst Price Target Give (CTXR) Major Upside Potential
Dawson James Securities Analyst Report
March 11th
Good Morning,
There's no time to waste this morning as there is only one single stock (NASDAQ/Low Float/Biotech) to pay attention to:
Citius Pharmaceuticals, Inc. (CTXR)
Citius Pharmaceuticals is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care, and unique prescription products that use innovative, patented, or proprietary formulations of previously-approved active pharmaceutical ingredients.
CTXR has multiple catalysts you should familiarize yourself with. Here they are:
#1 Key Potential CTXR Catalyst - Conference Presentations
CTXR has been out there marketing, hitting up conferences left and right. Here are just a few examples of recent headlines:
- Citius Pharmaceuticals, Inc. to Present at the Spring Investor Summit on March 25th-26th in New York City
- Citius Pharmaceuticals to Present at the 2020 LD Micro Virtual Conference
- Citius Pharmaceuticals to Present at Noble Capital Markets' 16th Annual Investor Conference
The company has been providing discussion of the recent positive outcome of its interim futility analysis for the Phase 3 Mino-Lok® pivotal trial, providing an overview of its other pipeline products, Mino-Wrap™ and Halo-Lido, and answering questions from investors.
This will help the company get more eyes on it, and because of that, more potential investors.
With more potential investors, share prices could be on the rise.
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#2 Key Potential CTXR Catalyst - Phase 3 Mino-Lok Trial Update
Citius Achieves 50% Patient Enrollment in Phase 3 Mino-Lok® Pivotal Trial
Next major milestone in Mino-Lok trial is the 75% interim analysis for superior efficacy and is expected in first half of 2020
CRANFORD, N.J., Feb. 4, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical-care drug products, today announced that the Company's lead program, Mino-Lok vs. standard-of-care ("SOC") antibiotic locks, has randomized its 72nd patient, thereby passing the halfway point for enrollment in this Phase 3 trial. The Company previously announced the results of a futility analysis when it passed the threshold of 40% of patients completing end of therapy. That analysis showed a positive outcome, as it met the prespecified interim futility analysis criteria. The next major milestone in the Mino-Lok trial, expected to be achieved in the first half of 2020, will be the 75% interim analysis for superior efficacy. The endpoints for this analysis require that the time to catheter failure be at least 38 days for Mino-Lok vs. 21 days for SOC antibiotic locks.
"We are extremely happy that our trial is proceeding according to plan. The independent drug monitoring committee ("DMC") will next evaluate the clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus SOC antibiotic locks," said Myron Holubiak, Chief Executive Officer of Citius. "We believe that the Mino-Lok clinical trial will be a major contribution to the study of catheter-related bloodstream infections (CRBSI) and the utility of antibiotic locks. Effective alternatives are needed to the practice of removing and replacing infected central venous lines."
Read the full article here.
#3 Key Potential CTXR Catalyst - $7.00 Analyst Price Target
Here are some of the highlights from the Dawson James Securities updated October analyst report:
First Interim Reached: Citius announced that the first interim analysis point (37 catheter failures, which represents 40% of the anticipated events at ~ 58 patients) has been reached. The DSMB will now review the data and come back with analysis (in about six weeks). We see the most likely recommendation being that the trial continues, unchanged. The DSMB could recommend increasing the trial (add statistical power to see the signal with a p-value). 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.
Second Interim Analysis – Superiority. At 69 events, or 75% of the total events anticipated at ~108 patients, the DSMB will again review the trial. In this second analysis efficacy will be evaluated.
The FDA say’s “Go For it”. The FDA responded to the Company's proposal to refine the endpoints in the current Phase 3 pivotal trial for Mino-Lok. As a reminder, 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.
New Endpoint Saves Time and Money. The new proposed primary endpoint 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 catheter that are associated with some serious adverse events. Citius believes that the change to the primary endpoint will result in fewer than 150 total subjects in Phase 3 trial and significant cost savings (up to $10M).
Valuation. Our valuation is based on our therapeutic models and associated assumptions projected to 2030. Our model assumes multiple financial raises, and as such, our share count is based on a fully diluted out year basis. The lead product, MiniLok, is now in a Phase 3 trial. As such, we assume a 70% probability of success in our models. 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 $7.00 price target.
Link To Analyst Report.
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A $7.00 price target gives CTXR Serious Potential Upside
A rough calculation of CTXR's current price per share (approximately $.58 at the time of writing Tuesday), gives this stock profile a ton of upside potential.
If CTXR is able to find enough momentum to push through its 52-week high of $1.59 in the short-term, this stock could really start making moves.
