CTXR - Citius Pharmaceuticals

Discussion in 'Stock Message Boards NYSE, NASDAQ, AMEX' started by Dan Thunderbolt, May 15, 2020.

  1. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    CTXR is a Biotech company with a very promising product pipeline. Besides this, CTXR recently submitted a pre-IND to the FDA under the Coronavirus Treatment.

    Currently CTXR is trading lower as they have announced a $7.5 Million Offering at $1. I think it is a good entry point.

    Recent Company Highlights include:
    • Submitting a pre-IND to the FDA under the Coronavirus Treatment Acceleration Program (CTAP) for a novel stem-cell therapy to treat ARDS associated with COVID-19
    • Obtaining an exclusive option from Novellus, Inc. to license a stem-cell therapy to treat ARDS associated with COVID-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

    https://www.citiuspharma.com/wp-content/uploads/2020/05/CTXR_May2020ShareholderLetter_final.pdf
     
  2. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    Besides their recently submitted pre-IND to the FDA under the Coronavirus Treatment, in particular the late stage lead asset of CTXR is very promising. It is called Mino-Lok and is mid-way through Phase 3 and has favorable review received with a huge market potential.

    Mino-Lok
    • Mid-way through Phase 3; Favorable review received from Futility Analysis by Independent Review Board
    • Mino-Lok is the first –and only –therapy under investigation that can be used to sterilize and salvage the infected CVC avoiding the complications, discomfort and costs of removal and replacement.
    • Large Market Need: Market estimated to be >$1.8 B worldwide; current SOC is dangerous and costly
    • Competitive Landscape: There are no products being developed for treatmentof infected central venous lines.
    CTXR Presentation - Summer 2020
    May 12, 2020
    https://ir.citiuspharma.com/presentations
     
  3. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    The offering was closed today.

    Citius Announces Closing of $7.5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules
    May 18, 2020
    CRANFORD, N.J., May 18, 2020 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced the closing of the previously announced registered direct offering priced at-the-market under Nasdaq rules. In the offering, Citius sold 7,058,824 shares of its common stock, at a purchase price per share of $1.0625. Additionally, Citius issued to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock.

    https://ir.citiuspharma.com/press-r...nces-closing-of-7-5-million-registered-direct
     
  4. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    This stock definitely has lots of potential imo.

    Citius Pharmaceuticals Issues May 2020 Shareholder Letter
    May 12, 2020
    https://www.citiuspharma.com/wp-content/uploads/2020/05/CTXR_May2020ShareholderLetter_final.pdf

    Looking Forward
    The remainder of 2020 should be an exciting time for all Citius shareholders given the numerous milestones ahead across our full pipeline of products:
     For Mino-Lok, results from the interim efficacy analysis are expected to be available in the second half of 2020. We also expect the trial to be completed during the first half of 2021. The antibiotic lock solution market is estimated to be a $750 million opportunity in the U.S. and is expected to grow to $1.84 billion worldwide by 2028
     We have a six-month option to license the novel stem-cell therapy (NC-MSC) for ARDS associated with COVID-19 from Novellus. Working with Novellus, we have already filed a pre-IND submission under the FDA’s emergency CTAP program. The human toll COVID-19 has caused calls for new therapies to be developed, and we think Novellus’s stem-cell technology is quite compelling
     We expect to have a PIND meeting with the FDA for Mino-Wrap by the end of 2020 and hope to initiate a Phase 2 trial by the end of 2021. We estimate the U.S. market to prevent infections associated with breast implant procedures to be a $400 million market opportunity
     For Halo-Lido, we plan to start a Phase 2b study for symptomatic relief of hemorrhoids in the second half of 2020. Halo-Lido has the potential to be the first FDA-approved prescription product on the $2 billion hemorrhoidal market
     
  5. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    Citius Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy
    June 02, 2020
    - 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 $1.84 billion by 2028

    https://ir.citiuspharma.com/press-r...s-positive-fda-feedback-on-its-submitted-plan
     
  6. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    This stock definitely has some potential in the coming weeks ahead...

    Next generation mesenchymal stem cell therapy (MSCs) for ARDS
    •ARDS caused by COVID-19
    •ARDS by all other causes

    Slide 14 of company presentation May 2020


    [​IMG]
     
  7. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    Convincing interview with the CEO
    25 June 2020
    https://www.lifesciencesinvestorforum.com/

    FDA response concerning stem-cell therapy to treat ARDS associated with COVID-19 received according to presentation. No details provided. Timeline will be adjusted accordingly. Feedback encouraging and very precise what to do. News likely on Monday...
     
  8. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    Up today again with high volume...
     
  9. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    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
    June 26, 2020
    - FDA provides very specific guidelines to study iPSC-derived MSCs" data-reactid="12">- FDA provides very specific guidelines to study iPSC-derived MSCs

    - Company intends to submit an IND application for its iMSC therapy for patients with ARDS associated with COVID-19" data-reactid="13">- Company intends to submit an IND application for its iMSC therapy for patients with ARDS associated with COVID-19

    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." data-reactid="14">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."" data-reactid="16">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."
     
  10. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    I had sold this one for a nice double end of June. Friday I again bought shares. In September Interim Data of the Phase 3 study for Mini-Lok is expected. There is a low-percentage chance that the trial will be closed early due to surperior efficacy. Regardless, overall the results will be good for sure. Mini-Lok is a great product with no competition.

    In addition the stock also has Covid-19 treatment potential.

    Imo management knows what they are doing.
     
    #10 Dan Thunderbolt, Aug 16, 2020
    Last edited: Aug 17, 2020
  11. Onepoint272

    Onepoint272 2019 Stockaholics Contest Winner

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    Appears like demand has proven itself and the 90-cent to $1 area should hold, which would be a logical price for the Last Point of Support (LPS) before mark-up. Assuming it is now ready to mark up, a P&F count shows a price projection to $5.40, which would bring it exactly into a retest of a previous high.

    10-cent-box by 3-box reversal point and figure:
    upload_2020-8-16_19-26-44.png
     
    #11 Onepoint272, Aug 16, 2020
    Last edited: Aug 16, 2020
    T0rm3nted likes this.
  12. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    Here is the relevant part from the shareholder letter concerning the lead product Mini-Lok with link. September should be interesting...

    "The next trial milestone will be an interim analysis of safety and superior efficacy. We expect to collect the relevant databy the end of June and hold our next DMCmeeting in the third quarter. If the trial were to meet the interim superiority threshold, it could be halted earlier than anticipated. However, we expect that the trial will continue as planned until it is fully enrolled, which we anticipateto be in thefirst half of 2021."

    A letter to our Shareholders, May 2020
    https://www.citiuspharma.com/wp-content/uploads/2020/05/CTXR_May2020ShareholderLetter_final.pdf

    Mino-Lok
    • Mid-way through Phase 3; Favorable review received from Futility Analysis by Independent Review Board
    • Mino-Lok is the first –and only –therapy under investigation that can be used to sterilize and salvage the infected CVC avoiding the complications, discomfort and costs of removal and replacement.
    • Large Market Need: Market estimated to be >$1.8 B worldwide; current SOC is dangerous and costly
    • Competitive Landscape: There are no products being developed for treatmentof infected central venous lines.
     
  13. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    Bought some more shares recently. According to a recent interview/presentation with the CEO the Interim Data of the Phase 3 study for Mini-Lok is expected for late September. This is only one month away. I have a good feeling on this one...
     
  14. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    This one is doing pretty well recently considering the overall market. End of September is almost there. This is from a newsletter which is covering CTXR:

    An Independent Review Board is scheduled to release a phase 3 superior efficacy analysis for Mino-Lok at the end of September. This analysis could be a MAJOR catalyst for the company shares. Remember, the efficacy analysis through the 2b trial was virtually 100%.
     
  15. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    I hope I am right with this one. Positive news on Mini-Lok superior efficacy analysis expected late September will hopefully boost the share price significantly higher. Current market cap is ~ $60 million. Market for Mini-Lok is estimated to be >$1.8 B worldwide, no known competition. According to the company presentation "With modest penetration at conservative pricing, we believe that >$500M peak year U.S. sales is achievable."

    Citius Pharmaceuticals Achieves Chemical Manufacturing and Control Milestones for Mino-Lok®
    September 22, 2020
    - Milestones include manufacturing of 3 registration lots for Mino-Lok

    https://ir.citiuspharma.com/press-r...ceuticals-achieves-chemical-manufacturing-and

    "It's important to know that we expect to be prepared to immediately move to validation/commercial manufacturing upon the completion of our Phase 3 clinical trial and receiving the required FDA clearance."
     
  16. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    This is the week, end of September is here. As mentioned previously Mini-Lok superior efficacy analysis is expected late September. I expect positive news that will likely boost the share price. We'll see...
     
  17. Dan Thunderbolt

    Dan Thunderbolt Active Member

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  18. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    Interesting article concerning today's news release. Though I do not know if all the assumptions made are correct...

    https://seekingalpha.com/instablog/...86-ctxr-ad-hoc-meeting-points-towards-success

    CTXR: Ad Hoc Meeting Points Towards Success
    Sep. 29, 2020

    The trial was not stopped for safety or futility.

    As noted, the study could NOT be stopped at this meeting for early benefit reasons.

    Early stoppage has to be through an pre-planned meeting (in the SAP) or an Ad Hoc meeting that modifies the SAP. The IDMC recommended an Ad Hoc meeting in the "near future".

    Ad Hoc meetings are requested by IDMCs for urgent safety reasons or to propose study amendments that significantly alter the SAP. This will prompt an Ad Hoc meeting of the IDMC for review prior to implementation of changes. They already said that the safety looks good and it's not futile. So what's this meeting for?

    The IDMC sees the data and knows that it can be halted for efficacy if there are some SAP mods. There is almost no other reason for them to request an Ad Hoc at this point for this trial other than to nail down the SAP for an early efficacy halt.
     
  19. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    Citius Pharmaceuticals Signs an Exclusive Worldwide Licensing Agreement with Novellus Therapeutics for Unique iMSC-Therapy for Acute Inflammatory Respiratory Conditions including COVID-19 Related Acute Respiratory Distress Syndrome (ARDS)
    October 07, 2020
    -- NoveCite, a newly formed subsidiary of Citius Pharmaceuticals, Inc., plans to develop, manufacture and commercialize a unique induced mesenchymal stem cells (NC-iMSCs)
    -- Novellus, a Cambridge, Mass-based cell engineering company, has developed patented, non-immunogenic mRNA-based induced mesenchymal stem cell (iMSC) platform
    -- NC-iMSCs demonstrate higher potency, uniformity and consistency - significant advantages over donor derived MSCs


    https://ir.citiuspharma.com/press-r...-pharmaceuticals-signs-an-exclusive-worldwide

    "NoveCite iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of the high potency seen in Novellus' pre-clinical studies, and because iMSCs are iPSC-derived, and therefore overcome the manufacturing challenges associated with donor derived cells," said Myron Holubiak, Chief Executive Officer of Citius.
     
  20. Dan Thunderbolt

    Dan Thunderbolt Active Member

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    CTXR is due for a major upwards share price movement soon imo...

    Citius Pharmaceuticals: Phase 3 Catalyst Countdown And Ready For Take Off
    Oct. 16, 2020

    Long Only, micro-cap
    Summary
    • Citius Pharmaceuticals is nearing the completion of its Phase 3 trial with top-line data due Dec 2020 (or sooner).
    • Mino-Lok fills an unmet medical need in the CRBSI space for Central Venous Catheters with potential annual US sales of $500M.
    • The Chairman of the Board has extensive experience in creating strong brands and a history of selling successful products & companies.
    • At $55M market capitalization, the Company is significantly undervalued.
    https://seekingalpha.com/article/43...e-3-catalyst-countdown-and-ready-for-take-off
     

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