NASDAQ Stock Profile *CTXR* Just Dropped Major News
A "Positive Outcome" Phase 3 Trial Press Release This AM Could Bring Strong Momentum To This Low Float Profile
Dawson James Securities Analyst Report
Let's jump in, because we have a lot to go over for your new breakout idea for today's trading session:
> 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.
Here's why CTXR appears undervalued and could be ready for a big-time breakout:
No. 1 Key CTXR Catalyst: Major Breaking News This AM
Released this morning, CTXR may see a surge of momentum flood into it if traders view this news positively:
Citius Announces Positive Outcome of Interim Futility Analysis for its Phase 3 Mino-Lok® Pivotal Trial
- Data Monitoring Committee recommends continuation of the trial with no changes
CRANFORD, N.J., Dec. 19, 2019 /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 a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks. The analysis was conducted by the Mino-Lok trial Data Monitoring Committee ("DMC"), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the prespecified 40% enrollment required for the interim futility analysis in late September and, based on the analysis of the data and recommendations of the DMC, will proceed with the current trial as planned. Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020. The market potential for an effective antibiotic lock therapy is estimated at $750Mn per year in the U.S. and approximately $1.5Bn per year worldwide.
"We are extremely happy and proud that the first independent expert review of the patient data in our Mino-Lok trial concludes that our study is on track. Enrollment has continued since finalizing the 40% level futility report, and we have now reached the midpoint of our study. The DMC will evaluate clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus standard-of-care antibiotic locks," said Myron Holubiak, the Chief Executive Officer of Citius. "We would also like to thank all of the patients, study investigators, and support personnel at the 32 clinical sites that are participating in our trial. Lastly, we also want to acknowledge the research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer Center in advancing this novel therapy."
No. 2 Key CTXR Catalyst: $7.00 Analyst Price Target
Dawson James Securities updated their October analyst report with important CTXR info. Here's the highlights:
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.
Read The Full Analyst Report Here.
CTXR Displays 1,000%+ Potential Upside To Its $7 Target
When calculating CTXR's current share price (approx. $.60 at the time of writing), this profile is exhibiting amazing potential upside.
Looking at CTXR's 52-Week high ($1.79), the potential upside to that level could also being extremely significant.
No. 3 Key CTXR Catalyst: November's Corporate Update
In November, the CTXR updated its shareholders as to the goings on of the company and recent developments that could become catalysts/
These are the highlights:
- Closing on a recent $7Mn capital raise to advance ongoing research
- A recent modification to the primary endpoint of the pivotal Phase III trial for Mino-Lok that substantially reduced the required trial sample size from 700 to approximately 144 subjects, significantly reducing the trial's expense and accelerating its completion
- An expanded relationship with MD Anderson Cancer Center for a worldwide license for Mino-Wrap and the preparation for a pre-IND meeting with the FDA
- Reformulating the topical formulation (now Halo-Lido) for the treatment of hemorrhoids based on results from an initial Phase II study. A toxicology study will be initiated by year-end ahead of an expanded Phase II study to start in 2020
- Other corporate initiatives that include industry events and more
No. 4 Key CTXR Catalyst: Bullish 6-Month Chart & Technical Indicators
Building momentum in the short-term, CTXR has been on the climb over the past 2 weeks. Here's the stock's 6-Month chart: