Celsion Corporation

Period: 11/02/2015 to 07/10/2020
Lead Plaintiff Deadline: 12/28/2020

SUMMARY OF CASE:

A securities class action has been filed against Celsion Corporation (CLSN) on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Celsion securities between November 2, 2015 through July 10, 2020.  This case has been filed in the USDC – NJ.

Celsion was founded in 1982 and is headquartered in Lawrenceville, New Jersey.  Celsion is an integrated development clinical stage oncology drug company that focuses on the development and commercialization of directed  chemotherapies, DNA-mediated immunotherapy, and RNA-based therapies for the treatment of cancer.

Celsion’s lead product candidate is ThermoDox, a heat-activated liposomal encapsulation of doxorubicin that is in Phase III clinical development for treating primary liver cancer.

In February 2014, Celsion announced that the U.S. Food and Drug Administration (“FDA”) had reviewed and provided clearance for the Company’s planned pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox in combination with radio frequency ablation (“RFA”) in primary liver cancer, also known as hepatocellular carcinoma (“HCC”), called the “OPTIMA Study.”  The trial design was purportedly based on a comprehensive analysis of data from the Company’s Phase III HEAT Study, which purportedly  demonstrated that treatment with ThermoDox resulted in a 55% improvement in overall survival (“OS”) in a substantial number of HCC patients that received an optimized RFA treatment.

The OPTIMA Study was expected to enroll 550 patients globally, with up to 100 sites in the U.S., Europe, China and Asia Pacific, to evaluate ThermoDox in combination with RFA. The primary endpoint for the trial was OS, and the statistical plan called for two interim efficacy analyses by an independent Data Monitoring Committee (“DMC”).

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading   statements   regarding   the   Company’s   business,   operational   and compliance policies.   Specifically,  Defendants  made false  and/or misleading statements and/or failed to disclose that: (i) Defendants had significantly overstated the efficacy of ThermoDox; (ii) the foregoing significantly diminished the approval and  commercialization  prospects  for  ThermoDox;  and  (iii)  as  a  result,  the Company’s public statements were materially false and misleading at all relevant times.

On July 13, 2020, Celsion announced  that “it  ha[d] received a recommendation from the independent [DMC] to consider stopping the global Phase III OPTIMA Study of ThermoDox® in combination with [RFA] for the treatment of [HCC],   or   primary   liver   cancer.” According   to   the   Company, “[t]he recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020,” which “found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903.”

On this news, Celsion’s stock price fell $2.29 per share, or 63.97%, to close at $1.29 per share on July 13, 2020.