Celsion Corporation Issues Letter to Stockholders

Discusses Broad-based DNA Vaccine Initiative, OVATION 2 Study,
and Phase III OPTIMA Study Conclusions

LAWRENCEVILLE, N.J., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced that Michael H. Tardugno, the company’s chairman, president and chief executive officer, issued a letter to stockholders providing:

• Further details on the Company’s vaccine initiative using its PLACCINE DNA vaccine platform technology for preventing or treating infectious agents that have the potential for global pandemics, including the SARS-CoV-2 virus and its variations;
• Expectations for clinical development programs with GEN-1, the company’s DNA-mediated IL-12 immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer;
• An update on the status of the Phase III OPTIMA Study with ThermoDox plus radiofrequency ablation (RFA) in patients newly diagnosed with primary liver cancer, or hepatocellular carcinoma (HCC) and the decision to stop following patients in the Study; and
• A review of the company’s strong financial condition and three-year operating runway.

The full text of the letter follows.

To My Fellow Stockholders:

Celsion enjoys a broad base of technologies and competencies. Although 2020 was a challenging year in terms of the OPTIMA Study findings and the impact of COVID-19, we are, in fact, positioned for a future of broader development and exciting prospects. My message to you today is that a single disappointing study, OPTIMA, is not going to diminish the prospects of Celsion and its potential to bring exciting medicines to market.

Let me explain why, starting with TheraPlas and its adaptation to the PLACCINE platform.

Through its first investigational product GEN-1, Celsion’s TheraPlas technology has demonstrated it can safely and effectively deliver and activate a DNA plasmid in patients. More than 90 patients have been treated in our oncology program with results demonstrating excellent safety, and with data clearly showing the activation of an immune response. We now believe that an adaption of the TheraPlas technology can do the same as a much-needed vaccine for the near future. We are calling this version of our proprietary plasmid and DNA delivery technology the PLACCINE platform. PLACCINE is the subject of our recently filed provisional patent that was announced on January 28, 2021.