Celsion Corporation Introduces a Wholly-Owned Subsidiary to Develop ThermoDox

Celsion GmbH oversees ongoing and future cancer research with ThermoDox®.

FREMONT, CA: Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, declares that its newly formed wholly-owned subsidiary, Celsion GmbH, will oversee all ongoing and future investigator-sponsored development of ThermoDox®, the Company's proprietary heat-activated liposomal encapsulation of doxorubicin. Andreas Voss, M.D., a renowned oncologist, joins Managing Director of Celsion GmbH. Later this year, he will resign from Celsion's board of directors to lead the subsidiary based in Zug, Switzerland.

Celsion's management now focuses exclusively on GEN-1, DNA-mediated IL-12 immunotherapy in Phase I/II development for the treatment of advanced ovarian cancer, and PLACCINE", its nucleic acid vaccine platform. Celsions' ongoing investment in ThermoDox® will be limited to clinical drug supply and modest financial support.

ThermoDox® is currently being developed on an investigator-sponsored basis for a variety of cancer indications, including:

A Phase I study led by the University Medical Center Utrecht in the Netherlands to determine the safety, tolerability, and feasibility of ThermoDox® in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound hyperthermia and cyclophosphamide therapy for the local treatment of metastatic breast cancer's primary tumor.

A Phase I study led by Oxford University in the United Kingdom will evaluate the intravenous administration of ThermoDox® in combination with High Intensity Focused Ultrasound in patients with pancreatic cancer.

The National Institutes of Health is conducting a clinical trial to evaluate ThermoDox® in combination with the chemotherapy drug mitomycin in patients with bladder cancer.

Commenting on his new role in leading Celsion GmbH, Dr. Voss says, “I am excited to spearhead this effort and to work with investigators around the world who are interested in pursuing further clinical development of ThermoDox®. Building upon encouraging preclinical results in several cancer indications, we have been fielding numerous requests from investigators to conduct their own studies. We know that doxorubicin is one of the most active cytotoxic drugs with no known specific resistance mechanism. Furthermore, the ability of ThermoDox® to deliver high doses into tumor tissue is proven and its mechanism of action is well understood. Celsion GmbHs long-term objective is to seek partnerships that will maximize the potential of ThermoDox®, ultimately providing value to the parent company.”

Michael H. Tardugno, Celsions chairman, president, and chief executive officer, says, “Despite the bitter disappointment and surprise with our Phase III OPTIMA study of ThermoDox® in primary liver cancer, many investigators are undaunted by various anomalies related to that data and see value in the drugs continued study. We owe patients and the scientific community the opportunity to investigate ThermoDox® while removing the financial obligation from our stockholders. Celsion is now solely focused on the significant opportunity we face with GEN-1 and PLACCINE in advanced ovarian cancer and SARS-CoV-2 vaccines, respectively. I am delighted that Celsion GmbH is in the experienced hands of Dr. Voss, who will pursue other collaborations and partnerships with the intent to monetize this asset.”