Potential CTXR Major Catalyst - Positive FDA Feedback
Citius Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy
- Compatibility plan includes testing representative samples of all commercially available CVCs and PICCs
- Plan is designed to be conducted in parallel with the completion of the Phase 3 pivotal trial
- Targeted worldwide market for Mino-Lok® is expected to reach $1.84Bn by 2028
CRANFORD, N.J., June 2, 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 has received positive feedback from the Food and Drug Administration (FDA) on its proposed catheter compatibility studies for the Company's Mino-Lok® therapy. The studies, if and when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous catheters (CVCs) and peripherally inserted central catheters (PICCs) on the U.S. market. It is further assumed that these studies will meet European and world standards.
The ability to be labeled without restrictions with respect to catheter type would allow Mino-Lok unrestricted access to the full U.S. and world markets for an effective antibiotic lock therapy for central line-associated bloodstream infections (CLABSIs), which are estimated to be over $1.5Bn per year worldwide. The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study. The Company announced in early February 2020 that this pivotal trial had reached the halfway point for enrollment. The next milestone in the trial is the result of an interim efficacy analysis, which is expected to occur in the second half of 2020.
"We believe we continue to check all the boxes required for an NDA submission," commented Myron Holubiak, Chief Executive Officer of Citius. "According to our planned dosing recommendations, the Mino-Lok solution dwells in the catheter for two hours per day for 5 to 7 days. This would be between 10 to 14 hours of aggregate, but intermittent, exposure time of the catheter to Mino-Lok. We believe that this exposure is far lower than what is recommended for home-brewed antibiotic lock solutions, which should lead to less intrusive therapy and fewer days on therapy for patients."
"The shorter dwell time for Mino-Lok also means that the catheter is available for its intended purpose, allowing treatment for the underlying disease to continue. Additionally, and more importantly, our pivotal trial is designed to show the superiority of Mino-Lok to standard antibiotic locks in time-to-catheter-failure. If all these studies prove to be successful, we believe ready-to-use Mino-Lok will be superior to home-brewed antibiotic locks in both efficacy and dosing schedules," Mr. Holubiak concluded.
Mino-Lok is an antibiotic lock solution used to treat patients with CLABSIs and 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 procedures. It 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 CRBSIs in the global market is expected to reach $1.84Bn in 2028, up from $1.24Bn in 2017.
Potential CTXR Major Catalyst - May'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."
Potential CTXR Major Catalyst - $7 DJP 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.
Potential CTXR Major Catalyst - $4 H.C. Wainwright Target
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 (Monday's close of $1.35), that gives the stock approximately 307% potential upside.