CTXR - Citius Pharmaceuticals

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  1. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Citius Pharmaceuticals Announces $76.5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules
    February 17, 2021
    CRANFORD, N.J., Feb. 17, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has entered into definitive agreements with certain healthcare-focused and institutional investors for the purchase of an aggregate of 50,830,566 shares of its common stock and accompanying warrants to purchase up to an aggregate of 25,415,283 shares of its common stock, at a purchase price of $1.505 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to take place on or about February 19, 2021, subject to the satisfaction of customary closing conditions.

    https://ir.citiuspharma.com/press-r...maceuticals-announces-76-5-million-registered
     
  2. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Now above $2 :thumbsup:

    Crazy high volume. Citius will do very well imo leading up to their Phase 3 Mino-Lok product decision early April to possibly end the the trial early because the results are so powerful...
     
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  3. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    https://dawsonjames.com/wp-content/uploads/2021/02/CTXR.2.18.21.pdf

    February 18, 2021

    BUY: Funded All the Way Through Commercialization
    Citius raises “big cash” –an additional $75 million, which follows a previous raise of $20 million in January. We had anticipated dilution in our model, but with this raise,we now see the company as funded all the way through the commercialization of Mino-Lok. Given the strength of the balance sheet, we actually see lower corporate risk. Adding in the new shares, removing our projected future raises, and adjusting our risk from 30% to 15% but leaving our probability of success for Mino-Lok at 70%, and adjusting the commercial timing out to 2022 (from 2021) culminates in our price target actually adjusting higher from $6.00 to $8.00.
     
  4. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    CTXR: A Blockbuster Pharma Still Under The Radar
    Feb. 20, 2021 11:31 AM ET|About: Citius Pharmaceuticals, Inc. (CTXR)
    Summary
    Recent offerings provide enough funding through commercialization.

    Mino-Lok will have no competetion.

    IDMC changes interim data review from 75% to 65%.

    Phase 3 data "very soon"

    Price Target $8.

    https://seekingalpha.com/instablog/...969-ctxr-blockbuster-pharma-still-under-radar

    Investment Thesis
    Citius Pharmaceuticals (Ticker: $CTXR) is only a couple months away from anticipated positive Phase 3 results for its lead product Mino-Lok. However, with its $2 share price, it has a modest ~$250M market cap. If the results are positive, this small biotech share price will quickly rise to $8, or higher, as the market starts to realize its potential.
     
  5. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Citius Pharma Makes Calculated Market Moves with Phase 3 Results Looming for Potential Blockbuster Product - GeneOnline News
    2021-02-21

    Among the three products that Citius is developing, Mino-Lok has achieved the most milestones and is currently undergoing Phase 3 evaluations. It has already received the Qualified Infectious Disease Product (“QIDP”) designation providing fast track status, priority review, and additional market exclusivity. If approved, Citius believes that Mino-Lok could enter a $1.5 billion worth market and prove to be a blockbuster without any immediate competition.

    It is currently being evaluated in a Phase 3 trial to evaluate the safety and efficacy in combination with systemic antibiotics in the treatment of CRBSIs. In a letter to shareholders, Citius said that it expects to receive an interim analysis of the pivotal trial and review by the Data Monitoring Committee (DMC) in the second quarter of this year. Once positive results are confirmed, Citius is expected to quickly push for FDA clearance and manufacturing.

    https://geneonline.news/en/citius-p...ts-looming-for-potential-blockbuster-product/
     
  6. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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  7. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    From today's presentation...

    Mino-Lok (Phase 3):
    • Superior efficacy review in Q2, likely early May…
    • We are still fighting an uphill battle against Covid, we had 31 institutions, sites which were contributing patients. We are now down to 15 but we were as low as six, but we are still muddling through and adding patients.
    • This is what is relevant what is going on with Cormedix… They ran into a manufacturing challenge. We’ve been very sensitized for that and we already have our three registration batches made, they are stable and we are well prepared for the review that may be coming in some of our manufacturing sites.
    Citius Pharmaceuticals to Feature Product Candidates Including Stem-Cell Therapy for COVID-19-Related Acute Respiratory Conditions at H.C. Wainwright Global Life Sciences Conference March 9-10
    Webcast: https://journey.ct.events/view/262c140c-bae9-4791-bee8-7a03b2d8449a
     
  8. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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  9. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Benzinga Biotech Small Cap Conference | Immunology and Unmet Medical Needs | March 25
    05:28:19 Citius Pharmaceuticals

    Mino-Lok:
    Review Committee meeting still expected in Q2.

    Stem-Cell Therapy for COVID-19-Related Acute Respiratory Conditions:
    "Results of sheep study will be released shortly"

     
  10. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Nice overview...

    FN Summary: Lead product (Mino-Lok) has QIDP, Fast Track & Priority Review designation with no competition and patent protection until 2036. Phase 2 results had a 100% response rate – Phase 3 now in progress. All-star management has 1) invested side-by-side with the investors, and 2) a long history of biotech product successes.

    https://frugalnorwegian.com/ctxr/

    Table of Contents
     
  11. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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  12. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Only a few more days until the DNC meeting beginning of May. This could be a possible major share price catalyst...

    "the DNC told us they think they have good news for us at 69 events"

    [​IMG]

     
  13. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Citius Pharmaceuticals Reports Strong Clinical Community Engagement During Mino-Lok® Phase 3 Trial-Related Webinar
    April 29, 2021
    Citius Pharmaceuticals leads discussion of Mino-Lok's potential to address biofilm and CLABSI challenges
    Third webinar was the most well-attended in the Mino-Lok Series, drawing strong attendee interest from investigators, clinical trial staff and referring physicians


    https://ir.citiuspharma.com/press-r...maceuticals-reports-strong-clinical-community
     
  14. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Interesting read. The below is from an email update today from this newsletter. The pump is on, let's hope for good mino-Lok results and we are off to the races...

    https://tradersnewssource.com/citius-pharma-ctxr-provides-current-information/

    Citius Pharma (CTXR) Has a Potential Upcoming Catalyst for Its Mino-Lok Product

    Good day everyone,

    We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products.

    Current price $2.20 per share

    Our coverage of CTXR at the end of last week yielded a potential gain for our members of 11% after closing at $2.20 on Friday. We still believe the company’s shares are oversold and the analysts seem to agree with price targets at $6.00 and $8.00/share.

    You probably know by now that CTXR is advancing four products through clinical studies, Halo Lido for hemorrhoid treatment, Mino-Lok to treat infected Central Venous Catheters, Novecite-iMSCs to treat Acute Respiratory Distress Syndrome, and Mino-Wrap to treat infections associated with Breast Reconstruction.

    Today we want to talk about Mino-Lok as it will likely be the first commercial product for the company and is nearing the end of a Phase III clinical trial.

    The data forthcoming from the Interim Efficacy Analysis from the Phase III Mino-Lok may be a significant catalyst for the company shares and we believe the release of that data is coming near-term.

    Consider:
    • The company announced previously the data would be available in Q2 and here we are in May.
    • The Data Monitoring Committee and the company BOTH agreed to release the efficacy data at 65% enrollment instead of the 75% stated in the protocol. Ponder the implications of that decision.
    • The Mino-Lok Phase 2b clinical trial resulted in 100% efficacy.

    All indications are that physicians are champing at the bit in anticipation of the Mino-Lok treatment becoming available. Mino-Lok will save lives, the current standard of remove and replace has too high a mortality rate, and it would also save hospitals considerable time and expense.

    The question we should consider is how high could the value of the company increase given positive efficacy results for Mino-Lok? Estimates place the market at $750M in the USA and $1.8B worldwide.

    There is no competition for Mino-Lok. No one else has a product at the clinical level to treat infected CVCs. The market belongs to CTXR.

    Together we're strong,
    The Traders News Group
     
  15. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Let’s see if we hear something new tomorrow concerning the DMC meeting on Mino-Lok® Phase 3 Trial. There is a chance that the trial will be halted early due to superior efficacy…

    Citius Pharmaceuticals to Present Mino-Lok® and COVID-related Respiratory Treatment Update at Benzinga Global Small Cap Conference on Thursday, May 13
    May 04, 2021
    https://ir.citiuspharma.com/press-releases/detail/142/citius-pharmaceuticals-to-present-mino-lok-and

    Citius Pharmaceuticals to Participate in Fireside Chat at the Gabelli Funds Virtual Microcap Symposium on Tuesday, May 18
    May 11, 2021
    https://ir.citiuspharma.com/press-r...aceuticals-to-participate-in-fireside-chat-at
     
  16. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    Trial Profile
    Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection

    https://adisinsight.springer.com/trials/700276235

    Most Recent Events

    29 Apr 2021 According to a Citius Pharmaceuticals media release, the company announce that the updated data from this study was presented in a Webinar.

    06 Apr 2021 Planned End Date changed from 1 Feb 2021 to 1 Dec 2021.

    06 Apr 2021 Planned primary completion date changed from 1 Dec 2020 to 1 Jun 2021.
     
  17. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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    "Walrus" says Citius has a good chance of being included into the Russel Index. If yes, according to the video, this should have a positiv impact on the share price in the month of June.

    Anyway, the month of June is highly likely going to be the month when the DMC meeting concering Mino-Lok will take place. There is a chance that the phase 3 trial will be halted early because of excellent results so far...

    15:43 Russell Index Rebalance: $CTXR Inclusion?

    Weekly News, $AMC Moon, $CLF, $PLTR, & $CTXR Updates, $BBW ER, $SCWX & $NX Options, Webull, & More!
    May 30, 2021

     
  18. Dan Thunderbolt

    Dan Thunderbolt Well-Known Member

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  19. Dan Thunderbolt

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  20. Dan Thunderbolt

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