Celsion Terminates Share Sale Agreement with LPC and Sees Big Gains

This week shares of Celsion Corp. were soaring over 80% and racing to a new six month high.

The reason for the big move came after Wall Street learned that the cancer drug development company disclosed that it terminated the share purchase agreement with Lincoln Park Capital (LPC).

With trading volume at 18.9 million shares, the stock was the second-most active ahead of the open on Thursday morning.

The stock purchase agreement, which was originally announced in September 2020, called for Celsion to sell to LPC up to $26 million worth of shares over 36 months. Since that agreement was announced, Celsion had sold $2.2 million worth of its common stock to LPC.

It was this past November that Celsion reported financial results for the three and nine months ended September 30, 2020. At the time the compay also provided an update on clinical development programs with GEN-1, its DNA-mediated IL-12 immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer, and ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin currently in Phase III development for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer.

“The OVATION 2 Study with our GEN-1 immunotherapy continues recruitment into the 100 mg/m² dose cohort,” said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer.

“This study is based on encouraging results from our Phase Ib OVATION 1 Study in advanced ovarian cancer. In June 2020, the Data Safety Monitoring Board (DSMB) for the OVATION 2 Study recommended that the Phase II portion proceed with the dose of 100 mg/m2, and in July 2020, we announced the randomization of the first two patients in this portion of the Study. This milestone was achieved approximately five months ahead of our previously announced schedule. We have a very aggressive recruitment program in place and anticipate completing enrollment of approximately 110 patients in the second or third quarter of 2021. Importantly, as an open-label study, clinical updates will be provided throughout the course of treatment, including response rates and surgical resection scores,” Mr. Tardugno added.

Mr. Tardugno noted, “Since the DMC’s finding that the OPTIMA Study crossed the futility boundary, albeit with substantial uncertainty, and leaving the decision to terminate the Study up to the Company, we have determined to continue following patients for overall survival (OS) until such time as futility is either confirmed or dispelled.”

Mr. Tardugno added, “As promised, Celsion has engaged a global biometrics contract research organization (CRO), with forensic statistical analysis capability that specializes in data management, statistical consulting, statistical analysis and data sciences. They have particular expertise in evaluating unusual data from clinical trials, and experience with associated regulatory issues. The primary objective of the CRO’s work is to determine the basis and reasoning behind continuing to follow patients for OS. Also as promised, and in parallel, the Company has submitted all OPTIMA Study clinical trial data to the National Institutes of Health (NIH) for an independent evaluation using a Cox Regression Analysis for minimum burn time per tumor volume. This evaluation is similar to the hypothesis generated from the NIH paper published in the Journal of Vascular and Interventional Radiology.”

In conclusion, Mr. Tardugno stated, “Celsion feels strongly that we owe it to patients, physicians and our investors to continue examining the data from the OPTIMA Study, particularly given how surprising the recommendation was to Celsion from the DMC. While the trial outcome as predicted by the second interim analysis may not change, and as unlikely as it may be, in the event we see substantial clinical benefit from the CRO and NIH analyses, we will carefully review our options with the 14 regulatory agencies under which the OPTIMA Study is being conducted. We expect to report findings from these independent analyses before the end of the year, either or both of which will guide our decision to continue to follow patients to the final analysis at 197 or more deaths, a milestone we expect to be reached in mid-2021.”

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.