Back in late April, you can see two significant breakouts that have occurred along the way.
On 4/27, CTXR blazed its way from an open of $.83 to a high of $1.12. The following day on 4/28, CTXR caught fire again from an open of $.93 to a high of $1.30.
As you can see, this profile has major potential for short-term breakouts, but you can also see that this profile has been showing steady growth the past 2+ months.
Could a slight bit of positive news be the catalyst that sends this stock soaring?
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#2 CTXR Potential Catalyst - Last Week's Release
Citius Announces Expanded Access Program for Investigational Phase 3 Mino-Lok®
-The CV-19 pandemic has highlighted the need to provide Mino-Lok on a compassionate case basis
-Many patients in hospitals receive medication, chemotherapy and nutrition via central venous catheters that can become infected and may require a removal and replacement procedure
-These catheter replacement procedures are risky for the patients, further tax the healthcare system capacity, and compound the nurse and doctor labor shortage
-The company's Mino-Lok® solution could salvage such infected catheters and eliminate the removal and replacement procedure, thus easing the burden on patients, healthcare professionals and systems
CRANFORD, N.J., May 26, 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 it is providing free access to Mino-Lok® for healthcare providers under an Expanded Access protocol to ease the burden associated with the CV-19 pandemic.
Through the Expanded Access protocol, an infected central venous catheter can now be treated with Citius' Mino-Lok, potentially avoiding the need for the removal and replacement procedure. Given the challenges at today's hospitals, the patients, the hospital staff, and the hospital system at large stand to benefit greatly from free access to the Mino-Lok solution.
"Some of our investigators have told us that if Mino-Lok were approved by the FDA, they would already be using it – particularly in today's environment," commented Myron Holubiak, Chief Executive Officer of Citius. "We clearly must wait for the results of our clinical trial to fully market Mino-Lok, but we do believe that it can benefit patients and help ease the burden on the health care system. In these challenging times, we welcome the opportunity to help in any way we can."
Mino-Lok is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) in combination with an appropriate systemic antibiotic(s) to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion. Mino-Lok is currently in a Phase 3 clinical trial for the treatment of central line-associated bloodstream infections (CLABSIs). In early February 2020, the Company announced that the trial had reached the halfway point of enrollment.
Mino-Lok has the potential to change the standard of care, which currently calls for a procedure to remove and replace the infected catheter. Each year, up to 500,000 CVCs of the 7 million used become infected and lead to CLABSIs, increasing both patient morbidity risk and costs to the medical system. It has been shown that antibiotics alone are unable to penetrate the biofilm caused by bacteria, and there are currently no approved therapies for salvaging infected central venous catheters. According to DelveInsight, the market size of CLABSIs and closely associated catheter-related bloodstream infections (CRBSIs) in the global market is expected to reach $1.84Bn in 2028, up from $1.24Bn in 2017.
#3 CTXR Potential Catalyst - Last Month'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."
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#4 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.
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#5 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 450% potential upside.
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