Celsion Corporation Reports Second Quarter 2021 Financial Results and Provides Business Update Strong Balance Sheet Supports Focus in Immuno-Oncology and on Next-Generation Vaccine Initiative Conference Call Begins Today

Corporation Reports Second Quarter 2021 Financial Results and Provides Business Update

Balance Sheet Supports Focus in Immuno-Oncology and on Next-Generation Vaccine Initiative

Call Begins Today at 11:00 a.m. Eastern Time

N.J. (August 12, 2021) - Celsion Corporation (NASDAQ: CLSN), a clinical-stage

drug-development company focused on DNA-based immunotherapy and next-generation vaccines, today announced financial results for

the three and six months ended June 30, 2021, and provided an update on clinical development programs with GEN-1,

a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development

for the treatment of advanced-stage ovarian cancer (Stage III/IV), and ThermoDox ,

a proprietary heat-activated liposomal encapsulation of doxorubicin under investigator-sponsored development for several cancer indications.

In addition, Celsion has two feasibility-stage platform technologies for the development

of novel nucleic acid-based immunotherapies and next-generation vaccines for infectious diseases.

our oncology-focused immunotherapy, continues to show encouraging resection results at the 100 mg/m² dose cohort in the Phase II

OVATION 2 Study. These results are consistent with those reported from our earlier Phase I trials in advanced-stage ovarian cancer. In

July 2021, the Data Safety Monitoring Board (DSMB) unanimously recommended that the OVATION 2 Study continue treating patients with the

100 mg/m2 dose. The DSMB also determined that safety was satisfactory with an acceptable risk/benefit and no dose-limiting

toxicities," said Michael H. Tardugno, Celsion's chairman, president and chief

executive officer. "These findings were supported with positive R0 surgical resection scores from the first 36 patients with interval

debulking surgery. Of those, 80% treated with GEN-1 at a dose of 100 mg/m² plus NACT had a complete tumor resection (R0), which

indicates a microscopically margin-negative resection with no gross or microscopic tumor remaining in the tumor bed, compared with 56%

of patients in the control arm having R0 resections.

recent weeks, Celsion strengthened its capabilities in vaccine development with the expansion of our Vaccine Advisory Board," continued

Mr. Tardugno. "Drs. Dan H. Barouch and Luke D. Handke joined Drs. Britt A. Glaunsinger and Xinzhen Yang on the VAB, which was formed

during the first quarter of this year. We're delighted to assemble a group of well-known and distinguished scientists to advise

management's work in developing next-generation vaccines directed to COVID-19 and its variants, and other infectious diseases for

which there are few or no preventive options."

Tardugno concluded, "Results of the OVATION 1 Study recently published in the Journal of Clinical

Research showed complete/near complete chemotherapy response scores (CRS) of 50% in the two highest doses of GEN-1, compared with

28% from a major publication evaluating CRS scoring. CRS is a three-tier standardized scoring system

for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental

examination. While not an FDA recognized endpoint, like R0 resection rates, CRS 3 is believed to be a predictor of progression-free survival."

Recommends GEN-1 to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study in Advanced Ovarian Cancer. The

OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian

cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following

NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.

July 2021, the Company announced that following a pre-planned

interim safety review of 55 as-treated patients randomized in the Phase I/II OVATION 2 Study, the DSMB unanimously recommended that the

OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory

with an acceptable risk/benefit, and that patients can tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to

six months. No dose-limiting toxicities were reported.

than 50% of the Projected 110 Patients Have Been Enrolled in the OVATION 2 Study. Interim clinical data from the first 36 patients

who have undergone interval debulking surgery are as follows:

on Phase I/II OVATION 2 Study Presented at the Society of Gynecologic Oncology Virtual Annual Meeting on Women's Cancer.

In April 2021, the Company announced that a poster highlighting

its ongoing OVATION 2 Study was presented at the Virtual Annual Meeting on Women's Cancer, sponsored by the Society of Gynecologic

Oncology. The poster, titled "A Phase I/II Study Evaluating Intraperitoneal GEN-1 in Combination with Neoadjuvant Chemotherapy

[NACT] in Patients with Newly Diagnosed Advanced Epithelial Ovarian Cancer (EOC)," can be viewed here. The poster was presented

by Premal Thaker, M.D., Study Chair of the OVATION 2 Study and Professor of Obstetrics and Gynecology, Director of Gynecological Oncology

Clinical Research, Division of Gynecologic Oncology, Washington University School of Medicine.

poster describes the OVATION 2 Study, which is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement

in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (NACT + GEN-1) with the control

announced in the first quarter of 2021 that GEN-1 had received Fast Track designation from the U.S. Food and Drug Administration. This

designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill

an unmet medical need.

Advisory Board Expanded. In July 2021, the Company announced

the addition of Dan H. Barouch, M.D., Ph.D. and Luke D. Handke, Ph.D. to its Vaccine Advisory Board (VAB). They join Britt A. Glaunsinger,

Ph.D. and Xinzhen Yang, M.D., Ph.D. on the VAB, which was formed in February 2021.

Barouch is the principal investigator at the Barouch Laboratory, Director of the Center for Virology and Vaccine Research at Beth Israel

Deaconess Medical Center and William Bosworth Castle Professor of Medicine at Harvard Medical School. In addition, he is a key participant

in the Bill & Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery, the National Institutes of Health Martin Delaney

HIV-1 Cure Collaboratory and the Ragon Institute of MGH, MIT and Harvard. Dr. Barouch and his team were instrumental in developing the

vector, a variant of an adenovirus called Ad26, that was used to make single-dose vaccines for HIV, tuberculosis and Zika, and ultimately,

in conjunction with Johnson & Johnson researchers, SARS-CoV-2. He has authored numerous peer-reviewed articles.

Handke is a highly skilled molecular biologist and microbiologist with a decade of pharmaceutical industry experience including nine

years with Pfizer's Vaccine Research and Early Development Unit. At Pfizer he served as molecular biology lead on an early phase

viral vaccine program and was the lead reviewer of data sources and literature citations for licensure application for the Trumenba

meningococcal group B vaccine in the U.S. and in Europe. He began his career in vaccine research at Wyeth. He is co-author and

co-inventor on various patent applications for a protein-based RSV vaccine and a SARS-CoV-2 detection assay and authored 10 peer-reviewed

publications including six as first author. Dr. Handke is currently a Senior Scientist at the University of Nebraska Medical Center in

Omaha. In addition to serving on the VAB, Dr. Handke will provide consulting services to Celsion in connection with its vaccine development

program, which involves DNA-based vectors in combination with proprietary non-viral cellular delivery agents. He also will advise Celsion

as it advances this program into human clinical studies.

Established to Manage Investigator-Sponsored Development of ThermoDox . In

June 2021, the Company announced that its new wholly owned subsidiary, Celsion GmbH, will manage all current and future investigator-sponsored

development of ThermoDox . Andreas Voss, M.D., a leading oncology researcher, has been named Managing Director of Celsion

GmbH and will step down from Celsion's board of directors later this year to head the subsidiary, which is based in Zug, Switzerland.

Celsion GmbH allows Celsion's management to focus solely on GEN-1 and PLACCINE, its nucleic acid vaccine platform. In addition

to clinical and regulatory advice, Celsion's ongoing investment in ThermoDox will be limited to providing clinical

drug supply and modest financial support. ThermoDox is currently under investigator-sponsored development for several

of Enrollment in Phase 1 Study with ThermoDox and Focused Ultrasound in Pancreatic Cancer. In July 2021, Celsion

GmbH announced the commencement of enrollment in Oxford University's Phase I PanDox study with ThermoDox in conjunction

with focused ultrasound in patients with pancreatic cancer.

investigator-led study sponsored by the University of Oxford and supported by the National Institute for Health Research (NIHR) Oxford

Biomedical Research Centre has now received ethics, MHRA and institutional R&D approval to commence (ClinicalTrials.gov Identifier:

NCT04852367). PanDox is being carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical

Engineering, the Oncology Clinical Trials Office and the Oxford University Hospitals NHS Foundation Trust. Prof. Mark Middleton, M.D.,

Head of the Department of Oncology at the University of Oxford, is the chief clinical investigator and Prof. Constantin Coussios, FREng,

Ph.D., Director of the Institute of Biomedical Engineering, is the lead scientific investigator.

primary endpoint of the two-arm 18-subject PanDox study is enhanced uptake of doxorubicin in pancreatic tumors using ThermoDox

and focused ultrasound (FUS), compared with systemic delivery of free doxorubicin. ThermoDox will be administered

intravenously in 12 patients with non-resectable pancreatic ductal adenocarcinoma and locally activated by focused ultrasound-mediated

hyperthermia. This will be compared with conventional systemic delivery of doxorubicin without FUS in 6 patients. Secondary endpoints

PanDox study is expected to be completed by December 2022 and is similar in design to Oxford's 10-patient TARDOX study, which demonstrated

that ThermoDox plus focused ultrasound increased doxorubicin tumor concentrations by up to 10-fold and enhanced nuclear

drug uptake in patients with liver tumors. The findings of the TARDOX study are published in Lancet Oncology (Lyon et al., 2018) and

Radiology (Gray et al., 2019).

Balance Sheet Through Two Registered Direct Offerings of Common Shares Totaling $50 Million in Gross Proceeds. In

January 2021, the Company announced