CorMedix-- Lohn sich noch ein Einstieg?

http://www.cormedix.com/

https://www.accesswire.com/539070/...lit-And-Provides-Business-Update

 

RS : become effective before trading opens on March 26, 2019,

es a result of the reverse stock split, the number of shares of common stock issued and outstanding will be reduced from approximately 119.0 million to approximately 23.8 million shares. There will be no change to the number of authorized shares.

Recent Corporate and Clinical Highlights:

--Announced statistically significant topline results of the interim analysis and full data set of its Phase 3 LOCK-IT-100 Study in Neutrolin.

The full data set showed a 71% reduction in the risk of occurrence of CRBSIs compared with the active control of heparin, which is well in excess of the study's assumed treatment effect size of a 55% reduction and statistically significant with a p-value of 0.0006.

-- Cash at December 31, 2018 amounted to $17.6 million

Now that our cash position has been strengthened and we anticipate that existing cash can fund us into the second quarter of 2020, we believe we are well positioned to make significant progress during 2019

Fourth Quarter 2018 Financial Highlights

For the fourth quarter 2018, CorMedix recorded a net income of $2.2 million, or $0.02 per share, compared with a net loss of $10.3 million, or $0.15 per share in the fourth quarter 2017, an increase of $12.5 million. The significant improvement in the fourth quarter 2018 was primarily driven by the reversal of clinical trial expenses as a result of the confidential settlement agreement with our CRO signed in November 2018.

Operating expenses in the fourth quarter 2018 recorded a gain of $2.1 million, compared to an expense of $10.4 million in the fourth quarter of 2017, a decrease of approximately 120%. This decrease was due primarily to a $12.8 million, or 151% decrease, in R&D expense, while SG&A expenses remained unchanged.

Full-Year 2018 Financial Highlights

For the full-year 2018, CorMedix recorded a net loss of $26.8 million, or $0.30 per share, compared with a net loss of $32.9 million, or $0.60 per share for the full-year 2017. The decrease in the loss in 2018 was primarily driven by decreased costs related to the LOCK-IT-100 clinical study.

Operating expenses for the full-year 2018 were $26.9 million, compared to $33.1 million for the full-year 2017, a decrease of approximately 19%. This decrease was due primarily to a $5.7 million, or 23% decrease, in R&D expense, while SG&A expenses remained unchanged.

 

  The number of outstanding shares of the registrant’s common stock was 119,014,093 as of March 12, 2019.

Da stehen noch über 40 Mio Aktien, fast alle im Geld! Das werden mit Sicherheit noch mehr, wenn die sich untereinander verdünnen.

BIN DANN MAL WEG!!!!!!!!!

As of December 31, 2018, we had outstanding the following securities that are convertible into or exercisable for shares of our common stock:
 
●
options to purchase an aggregate of 120,000 shares of our common stock issued to our officers, directors, employees and non-employee consultants under our Amended and Restated 2006 Stock Incentive Plan, or the 2006 Stock Plan, with a weighted average exercise price of $1.44 per share;
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options to purchase an aggregate of 4,936,326 shares of our common stock issued to our officers, directors and non-employee consultants under our 2013 Stock Plan, with a weighted average exercise price of $1.87 per share;
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warrants for 500,000 shares of common stock issued in May 2013 with an exercise price of $0.001 per share that expire on May 30, 2019;
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warrants for 750,000 shares of common stock with an exercise price of $0.001 that expire on October 22, 2019;
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warrants for 725,000 shares of common stock with an exercise price of $0.90 that expire on January 8, 2020;
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Series C-2 Preferred Stock convertible into 1,500,000 shares of common;
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Series C-3 Preferred Stock convertible into 1,040,000 shares of common stock;
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Series D Preferred Stock convertible into 1,479,240 shares of common stock;
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Series E Preferred Stock convertible into 1,959,759 shares of common stock;
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Series F Preferred Stock convertible into 12,345,679 shares of common stock, subject to adjustment;
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warrants for 682,500 shares of common stock issued in March 2014 with an exercise price of $2.50 per share that expire on September 10, 2019;
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warrants for 200,000 shares of common stock with an exercise price of $7.00 that expire on March 3, 2020;
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warrants for 83,400 shares of common stock with an exercise price of $7.00 that expire on March 25, 2020;
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Series B warrants for 11,974,839 shares of common stock with an exercise price of $1.05 that expire on August 10, 2022;
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underwriter warrants for 664,419 shares of common stock with an exercise price of $0.9375 that expire on August 10, 2022;
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warrants for 564,858 shares of common stock with an exercise price of $0.001 that expire on November 16, 2020;
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warrants for 450,000 shares of common stock with an exercise price of $1.50 that expire on December 31, 2023;
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Senior convertible note convertible into 5,000,000 shares of common stock; and
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restricted stock units for 29,087 shares of common stock with an average grant date fair value of $2.08 per share.

 

Der Einszieg hätte sich geringfügig gelohnt! ;-))) Heul!!!  

Doch alles richtig gemacht.  

das der Kurs so explodiert?

Zahlen habe ich keine gefunden....  

Alle warten auf NDA, danach Fast Track (bedeutet ca. 6 Monate) bis zum möglichen FDA Approval  

Upcoming Events

CorMedix Inc. to Report First Quarter 2019 Financial Results and Provide a Corporate Update
May 13 – 4:30pm ET, 2019
Click Here for Webcast  

kurze Frage. Würdet ihr bei positiven NDA verkaufen (sell the news) oder halten und auf FDA Approval spekulieren ? Oder vielleicht Teilverkauf bei NDA ? Danke  

Kommt immer drauf an, wann und zu welchem Preis man gekauft hatte, aber man sollte schon versuchen alle Katalysatoren "zu spielen".  Heute hat CRMD das Nasdaq Listing erhalten und am 28.02.21 steht eine FDA Entscheidung zu Defencath an.

"Defencath soll als Katheterverschlusslösung bei Hämodialysepatienten zur Vorbeugung von katheterbedingten Blutkreislaufinfektionen eingesetzt werden. Das Unternehmen sagte, wenn es genehmigt wird, wird Defencath möglicherweise die erste antibakterielle und antimykotische Katheterverriegelungslösung in den USA sein, die katheterbedingte Infektionen bei Hämodialysepatienten verhindert."

 

Das Nasdaq Listing erhöht die Aufmerksamkeit für institutionelle Anleger. Oder es spekulieren einige auf den Katalysator, Ende des Monats.  

https://seekingalpha.com/news/...in-a-month-cormedix-takes-a-breather  

CRL für Defencath

"Die FDA stellte nach Überprüfung der Aufzeichnungen Bedenken in der Produktionsstätte eines Drittanbieters fest, obwohl die Agentur die Probleme nicht spezifizierte. CorMedix wird ein Treffen mit der FDA beantragen, das voraussichtlich Mitte April stattfinden wird."

https://www.benzinga.com/general/biotech/21/03/...fencath-application

 

Auch bei CRMD fruchtet die 3-Tage-Regel nicht sofort nach dem Sell-Off einzusteigen. MK 238 Mio. $  

MK 220 Mio. $, denke so langsam könnte sich CRMD stabilisieren.  

Zahlen für Q1/21

• kein Umsatz
  
• Verlust 7 Mio. $
  
• Cash 76 Mio. $
  

CorMedix strengthened its balance sheet via equity financing activity during the first quarter, raising net proceeds of approximately $41.5 million.

http://irdirect.net/filings/viewer/index/1410098/000121390021026169/

 

• MK 215 Mio. $,
  

"CRMD benötigt eine zusätzliche Prozessqualifizierung mit anschließender Validierung, um die von der FDA in der NDA für DefenCath als Behandlungsoption für katheterbedingte Blutkreislaufinfektionen bei Hämodialysepatienten festgestellten Mängel zu beheben. Infolgedessen wird erwartet, dass die NDA im vierten Quartal 2021 erneut eingereicht wird."

 

Insider-Kauf

• 15.000 Aktien zu 6,03$
  

http://irdirect.net/filings/viewer/index/1410098/000121390021027991/

 

"CorMedix Inc. [...] hat heute ein Update zum Zeitplan für die erneute Einreichung vorgelegt für den DefenCath New Drug Application („NDA“). CorMedix hat bei seinem Drittauftragshersteller („CMO“) Verzögerungen festgestellt. Das Unternehmen wurde vom CMO darüber informiert, dass es Probleme gibt, die nichts mit den Herstellungsaktivitäten von DefenCath zu tun haben. Der Zeitplan für CorMedix und den CMO zur Behebung von Mängeln in der Einrichtung, die für die erneute Einreichung der DefenCath NDA erforderlich sind, ist derzeit ungewiss. Wir werden ein Update bereitstellen, sobald weitere Informationen verfügbar sind."

https://www.sec.gov/Archives/edgar/data/1410098/...-1_cormedixinc.htm

 

CorMedix gibt die erneute Einreichung der NDA für DefenCath bekannt

https://www.cormedix.com/...on-of-new-drug-application-for-defencath/

 

FDA verweigert erneut die Zulassung für DefenCath

https://seekingalpha.com/news/...d-candidate-defencath-shares-sink-60

 

NDA für DefenCath erneut eingereicht

https://cormedix.com/...sion-of-new-drug-application-for-defencath-2/