*CTXR* Is A NASDAQ Biotech With An Interesting Press Release Today That Could Draw Significant Attention
Dawson James Securities Analyst Report
The World House has called on U.S. health regulators to expedite potential therapies aimed at treating CV-19 amid the fast-spreading CV outbreak, saying it could lead to a breakthrough while a vaccine is still under development.
Trials on potential CV therapies are already in the works, and FDA Commissioner Stephen Hahn said his agency was working quickly to examine all possibilities.
"In the short term, we're looking at drugs that are already approved for other indications," Hahn said. "Since this outbreak first emerged, we've been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible."
That's what makes new NASDAQ profile, Citius Pharmaceuticals, Inc. (CTXR), such an exciting stock in the short-term.
#1 CTXR Potential Catalyst - Today's Press Release
Released this morning, this press release could draw major buzz this AM.
Citius Announces Data on NoveCite Mesenchymal Stem Cells (NC-MSCs) to be Presented at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting.
#2 CTXR Potential Catalyst - Tuesday's Shareholder Letter
Citius Pharmaceuticals Issues May 2020 Shareholder Letter
- Company highlights exclusive option to license novel stem-cell therapy for ARDS related to CV-19 from Novellus, Inc.
- Status of pivotal Ph. 3 trial evaluating Company's lead-product Mino-Lok® as an antibiotic lock solution used to treat catheter-related bloodstream infections (CRBSIs) is emphasized
- Regulatory and clinical updates on Mino-Wrap™ and Halo-Lido also discussed
CRANFORD, N.J., May 12, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that the Company has issued its May 2020 Shareholder Letter. The letter highlights the Company's exclusive option to license a novel stem-cell therapy to treat acute respiratory distress syndrome (ARDS) associated with CV-19, and the clinical progress of the Company's core products: Mino-Lok®, Mino-Wrap™, and Halo-Lido.
Recent Company Highlights include:
- Submitting a pre-IND to the FDA under the CV Treatment Acceleration Program (CTAP) for a novel stem-cell therapy to treat ARDS associated with CV-19
- Obtaining an exclusive option from Novellus, Inc. to license a stem-cell therapy to treat ARDS associated with CV-19
- Achieving 50% patient enrollment in the Phase 3 Mino-Lok® pivotal trial
- Passing the interim futility analysis successfully in the ongoing Phase 3 trial of Mino-Lok vs. standard-of-care antibiotic locks
"Despite the challenges presented by CV-19, we are in the midst of an exciting time for Citius," said Myron Holubiak, Chief Executive Officer of Citius. "We're hard at work on a potentially groundbreaking treatment for ARDS associated with CV-19, and our core therapies are making steady progress through their respective clinical development timelines. I look forward to sharing the future developments with our shareholders as we move forward with our pipeline and achieve clinical and regulatory milestones."
Read The Full Letter Here.
#3 CTXR Potential Catalyst - $7.00 Dawson James Price Target
Here are some of the highlights from the Dawson James Securities updated October 2019 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.
#4 CTXR Potential Catalyst - $4 Target From H.C. Wainwright
Back On January 24th, H.C. Wainwright analyst Vernon Bernardino raised the price target on Citius Pharmaceuticals to $4.00 (from $1.65) while maintaining a Buy rating.
When you combine both the H.C. Wainwright target with the Dawson James Securities target, you get a weighted average target of $5.50.
From CTXR's current trading levels, that gives the stock over 300% potential upside.
#5 CTXR Potential Catalyst - Low Float Stock Profile
Yahoo Finance reports CTXR to have just over 17Mn shares in its float. With such few shares available for trading, you need to pay attention to volatility.
If momentum floods into this profile, its share price could see some serious spiking in the short-term.
Make sure CTXR is on your screen this second.