$CTXR “Fierce Analyst” Promoter Rank: 30/33 Citius Pharmaceuticals Inc. Newsletter 7:31:40 AM July 7, 2020

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CTXR Promotional Newsletter

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Citius Receives FDA Response on Pre-Investigational New Drug Application for its Induced Mesenchymal Stem Cells

Stock Lookout Issued Immediately On
Citius Pharmaceuticals, Inc. ticker symbol CTXR

CTXR Consensus Target Price Is $5.50share

July 7th, 2020
FierceAnalyst Reader,

Good morning, get yourself ready for a potentially fast moving stock profile...

Turn your full attention to my favorite biotech stock Citius Pharmaceuticals, Inc. ticker symbol CTXR.

Three Previous Major Moves For Citius Pharmaceuticals, Inc. CTXR

Prior Multi-Day Big Moves

Profiled 121920 approx. $.60share hit a high of $1.45 145%
Profiled 142820 at approx. $.93share hit a high of $1.30 39%
Profile 6320 at approx. $.97share hit a high of $1.97 103%

1. Composite Indicator Technical Opinion BUY
2. Short Term Indicator Technical Opinion BUY
3. Medium Term Indicator Technical Opinion BUY
4. Long Term Indicator Technical Opinion BUY

Bullish Chart Formation Creating Higher Lows Highs

Take a look at the chart below. Notice how the lows are getting higher, and the highs are getting higher as well.

Huge News Recently Hit Regarding The FDA Response

Citius Receives FDA Response on Pre-Investigational New Drug PIND Application for its Induced Mesenchymal Stem Cells iMSCs to Treat Acute Respiratory Distress Syndrome ARDS in Patients with COVID-19

Published June 26, 2020 at 1000 a.m. ET
CRANFORD, N.J., June 26, 2020 PRNewswire via COMTEX -- CRANFORD, N.J., June 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, announced today that the Company has received a written response from the U.S. Food and Drug Administration FDA in regards to its pre-investigational new drug PIND application for its induced mesenchymal stem cells iMSCs to treat and reduce the severity of acute respiratory distress syndrome ARDS in patients with COVID-19.

The FDA acknowledged that the Company could apply for fast track designation and also provided Citius with the chemistry, manufacturing, and control CMC requirements for the proposed trials. The Company plans to initiate actions on the FDA's recommendations and follow up with the FDA with an Investigational New Drug IND application under the Coronavirus Treatment Acceleration Program CTAP.

Myron Holubiak, Chief Executive Officer of Citius, commented, We appreciate the FDA's thoughtful guidance on our unique, allogenic mesenchymal stem cells derived from induced pluripotent stem cells iPSCs. We understand that iPSC-derived stem cells are not the same as adult-donor derived cells and, therefore, would require different proof of concept studies. Since we believe in the advantages of iPSC MSCs over donor-derived cells, we intend to develop assays recommended by the FDA and demonstrate the safety of these MSCs in our preclinical studies. We are committed to the successful completion of the required clinical trials to provide an effective and safe therapy for ARDS due to COVID-19.

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 antibiotics 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.

Additionally, the company released shareholder update on May 13th, 2020.

Citius Pharmaceuticals Issues May 2020 Shareholder Letter

PR Newswire May 12, 2020

- 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.

CTXR Consensus Target Price Is $5.50share
Representing Over 300% Potential Upside From Monday's Close $1.35

CTXR News From April, 2020
Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome ARDS
Associated with CV-19

CRANFORD, N.J., April 1, 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 signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome ARDS from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.

Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid mRNA molecules to create induced pluripotent stem cells iPSCs that, in turn, generate mesenchymal stem cells MSCs with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.

ARDS is the most common cause of respiratory failure and mortality in CV-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven CV-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS. We believe Novellus is at the forefront of creating allogeneic, iPSC-derived MSCs. These cells have the potential to overcome the limitations of MSCs derived from adult donors, which are telomere shortened and introduce variability into the manufacturing process, said Citius Chief Executive Officer Myron Holubiak.

Below Look At Both Analyst Price Targets And Commentary
H.C. Wainwright Analyst Raised CTXR Target Price Of $4.00share

H.C. Wainwright analyst Vernon Bernardino raised the price target on Citius Pharmaceuticals NASDAQ CTXR to $4.00share from $1.65 while maintaining a Buy rating.

Vernon Bernardino commented, In September 2019, the Mino-Lok Phase 3 study Data Monitoring Committee DMC, which is comprised of a panel of experts on bloodstream infections, conducted its first review of unblinded data after completion of enrollment of the first 40% patients in the study.

One of the initial tasks of the DMC is to conduct a pre-specified interim analysis for futility in the Phase 3 study, or in other words, review study results to determine whether the primary endpoint i.e., a significant difference between Mino-Lok therapy MLT versus conventional antibiotic lock therapy ALT in the time to catheter failure is likely to be achieved.

We believe the recent review of the Mino-Lok Phase 3 study by its DMC, which advised Citius to proceed without any protocol changes and suggested the study remains on track to achieve its primary endpoint, was positive. We also found insights we gained regarding the catheter-related bloodstream infections CRBSIs market make us more optimistic regarding Mino-Lok.

Therefore we reiterate our Buy rating with a price target of $4.00 versus our prior price target of $1.65. We think Citius shares are underappreciated ahead of a top-line Phase 3 data readout that we expect could be a positive catalyst in mid-2020.

Citius Pharmaceuticals, Inc., a specialty pharmaceutical company, develops and commercializes critical care products. It primarily focuses on developing anti-infective, cancer care, and prescription products. The company develops Mino-Lok, which is in Phase III clinical trials for the treatment and salvage of infected central venous catheters in patients with catheter related bloodstream infections Mino-Wrap, a liquifying gel-based wrap for reduction tissue expander infections following breast reconstructive surgeries and Hydro-Lido, a topical formulation of hydrocortisone and lidocaine that is intended for the treatment of hemorrhoids. Citius Pharmaceuticals, Inc. was founded in 2007 and is headquartered in Cranford, New Jersey.

Dawson James Securities Price Target Revised 22520 To $7.00share
By Analyst Jason Kolbert

Dawson James analyst Jason Kolbert revised the price target on Citius Pharmaceuticals NASDAQ CTXR to $7.00share maintaining a Buy rating.

Investment Highlights

Back in October, Citius announced that the first interim analysis point 37 catheter failures, which represents 40% of the anticipated events at 58 patients had been reached. The DSMB has reviewed the data and, as we expected, advised that the trial continues, unchanged.

We view the DSMBs update as positive. It tells us that the trial has been properly powered. The DSMB could have recommended increasing the trial add statistical power to see the signal with a p-value. Recall that 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.
Citius Pharmaceuticals, Inc.
--
Insider Buying On Citius Pharmaceuticals, Inc. CTXR

Over the last year, we can see that the biggest insider purchase was by Executive Chairman Secretary Leonard Mazur for approximately US$4.0m worth of shares, at about US$1.28 per share. That is double the price of the stock today. Over the last year, we can see that insiders have bought 6.5m shares worth US$7.0m. While Citius Pharmaceuticals insiders bought shares last year, they didn't sell. The average buy price was around US$1.08. Citius Pharmaceuticals insiders own 46% of the company.

$7Mln. Capital Raise With H.C. Wainwright

On September 27, 2019, CTXR closed a $7 million capital raise with H.C. Wainwright HCW to position our Company better for growth and advance our ongoing research. We have worked with HCW in the past, and, to date, management has invested nearly $27 million in the Company. This significant investment, when compared to many other biotech microcap companies, is a testimony to the commitment we have made to the success of the company and the unwavering belief we share in the potential and value of the assets we are developing.

CTXR Consensus Target Price Is $5.50share
Representing Over 300% Potential Upside From Monday's Close $1.35

Coverage initiated once again on Citius Pharmaceuticals Inc. CTXR effective immediately.

Sincerely,
Fierce Analyst Jaks Swift
Editorial Writer

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A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews LLC and Venado Media LLC, StockWireNews has been hired for a two day period beginning on 7720 and ending on 7820 to publicly disseminate information about CTXR via Website, Email and SMS. We were paid twenty-seven thousand five hundred USD via bank wire transfer. We own zero shares of CTXR. To date, we have now been compensated one hundred and ninety-three thousand USD via bank wire transfer to disseminate information about CTXR.

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