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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Celsion Corporation    CLSN

CELSION CORPORATION

(CLSN)
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CELSION CORP : Other Events, Financial Statements and Exhibits (form 8-K)

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07/13/2020 | 09:03am EDT

Item 8.01 Other Events

On July 13, 2020, Celsion Corporation (the "Company") issued a press release announcing that it had received a recommendation from the independent Data Monitoring Committee (the "DMC") to consider stopping the Phase III OPTIMA Study of ThermoDox® in combination with radiofrequency ablation for the treatment of hepatocellular carcinoma, or primary liver cancer (the "Study"). As further described below and in the press release, this recommendation is based on the July 9, 2020 pre-planned interim safety and efficacy analysis conducted by the DMC.

The recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020. The DMC analysis found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903. However, the 2-sided p-value of 0.524 for this analysis provides uncertainty, subsequently, the DMC has left the final decision of whether to stop the OPTIMA Study to Celsion. There were no safety concerns noted during the interim analysis. A copy of the press release is attached hereto as Exhibit 99.1, and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.




(d) Exhibits.



Exhibit
  No.     Description

 99.1       Press Release, dated July 13, 2020, announcing the DMC
          recommendation

© Edgar Online, source Glimpses

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Financials (USD)
Sales 2020 0,51 M - -
Net income 2020 -18,1 M - -
Net Debt 2020 - - -
P/E ratio 2020 -1,77x
Yield 2020 -
Capitalization 35,9 M 35,9 M -
Capi. / Sales 2020 71,1x
Capi. / Sales 2021 144x
Nbr of Employees 29
Free-Float 98,5%
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Mean consensus OUTPERFORM
Number of Analysts 2
Average target price 4,00 $
Last Close Price 1,08 $
Spread / Highest target 270%
Spread / Average Target 270%
Spread / Lowest Target 270%
EPS Revisions
Managers
NameTitle
Michael H. Tardugno Chairman, President & Chief Executive Officer
Jeffrey Wayne Church CFO, Secretary & SVP-Investor Relations
Nicholas Borys Chief Medical Officer & Senior Vice President
Khursheed Anwer Chief Scientific Officer & Executive VP
Pok Yu Chow Independent Director
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