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

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