Celsion Corporation Reports Third Quarter 2019 Financial Results and Provides Business Update Independent Data Monitoring Committee (iDMC) Unanimously Recommends Continuation of Phase III OPTIMA Study at First Pre-Planne

Corporation Reports Third Quarter 2019 Financial Results and Provides Business Update

N.J. (November 14, 2019) - Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced

financial results for the three-month and nine-month periods ended September 30, 2019 and provided an update on its development

programs for ThermoDox and GEN-1.

Company's lead program is ThermoDox , a proprietary heat-activated liposomal encapsulation of doxorubicin

currently in Phase III development (the OPTIMA Study) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer.

The Company's immunotherapy candidate, GEN-1, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that

enables cell transfection followed by persistent, local secretion of the IL-12 protein. GEN-1 is currently in Phase I/II development

(the OVATION 2 Study) for the localized treatment of newly diagnosed Stage III and IV ovarian cancer.

weeks have been particularly gratifying for the team at Celsion, with encouraging news on two clinical development programs, along

with maintaining a strong balance sheet and ready access to cash at our discretion," said Michael H. Tardugno, Celsion's

chairman, president and chief executive officer.

focus on shareholder value remains uncompromised as Celsion continues to deliver results from our ongoing clinical development

programs for ThermoDox and GEN-1. Our smart use of venture debt to leverage the holdings of our equity investors,

along with our strategy to avoid punitive financing deals has worked well for us and our shareholders. We enter the fourth quarter

with sound fundamentals and a strong balance sheet that is expected to fund our clinical programs through transformative milestones

over the next 16 months," added Mr. Tardugno. "With the first of two preplanned interim efficacy analyses for the

OPTIMA Study successfully behind us, we look forward to the promise and potential for success at the 2nd preplanned

analysis, now expected to occur in the second quarter of 2020. The OPTIMA Study, a global, pivotal study completed patient enrollment

in August 2018 at more than 65 clinical sites in 14 countries, including all the major markets for primary liver cancer and represents

the first and only first line treatment for newly diagnosed primary liver cancer patients. For this indication alone, ThermoDox

represents a billion-dollar annual revenue opportunity."

week, our second product candidate, GEN-1, received the go-ahead from its DSMB to proceed with patient enrollment in the Phase

I portion of the OVATION 2 study. With the first cohort of patients in the dose-escalation portion of our OVATION 2 Study in newly

diagnosed ovarian cancer enrolled and evaluated by the DSMB, we look forward to finalizing the dose for the balance of the 130-patient

randomized study by year-end. We expect that surgical results and tumor response data will be available shortly thereafter. Meanwhile,

we continue to work through the activation of up to 25 clinical sites in the U.S. and Canada by the end of January 2020. This

promising clinical development program in immunotherapy has generated impressive results in previous trials," Mr. Tardugno

Unanimously Recommends Continuation of Celsion's Phase III OPTIMA Study for ThermoDox in Primary Liver Cancer.

On November 4, 2019 the Company announced that the iDMC unanimously recommended the OPTIMA Study continue according to protocol.

The recommendation was based on a review of blinded safety and data integrity from 556 patients enrolled in the Company's

multinational, double-blind, placebo-controlled pivotal Phase III study with ThermoDox plus RFA in patients with

iDMC's pre-planned interim efficacy review followed 128 patient events, or deaths, which occurred in August 2019. Data presented

demonstrated that progression-free survival (PFS) and overall survival (OS) data appear to be tracking with patient data observed

at a similar point in the Company's 285 patient, well-balanced subgroup of patients followed prospectively in the earlier

Phase III study (the "Prospective Subgroup") upon which the OPTIMA Study is based. This Prospective Subgroup demonstrated

a 2-year overall survival advantage and a median time to death of more than 7 ½ years.

the data review, the Company believes that the OPTIMA Study is well positioned for success at the next pre-planned interim efficacy

analysis, which is intended after a minimum of 158 patient deaths and is projected to occur during the second quarter of 2020.

The hazard ratio for success at 158 events is 0.70. This is below the hazard ratio of 0.65 observed for the 285 patients in the

HEAT Study Prospective Subgroup treated with RFA > 45 minutes.

data review demonstrated the following:

Co-sponsored Hepatocellular Carcinoma Symposium at the International Liver Cancer Association (ILCA) Annual Conference. On

September 23, 2019, the Company announced it co-sponsored a symposium focused on HCC at the 13th Annual Conference

of the International Liver Cancer Association. Other sponsors of the symposium included Bayer Healthcare Pharmaceuticals, Inc.

and Exelixis, Inc., both of whom provide therapeutics for the treatment of advanced HCC. The program, titled "Master Class

& Tumor Board: Composing Personalized HCC Treatment Strategies, Insights on Harmonizing Patient Care with a Multidisciplinary

Ensemble," featured four speakers. The program was chaired by Ghassan Abou-Alfa, MD, MBA, Memorial Sloan Kettering Cancer

Center and Professor, Weill Medical College at Cornell University, both in New York City. The other participants were: Prof. Riccardo

Lencioni, MD, FSIR, EBIR, Department of Radiology, University of Pisa, Italy, Hon. Res. Prof. Interventional Oncology, Miami Cancer

Institute; Amit Singal, MD, MS, Medical Director of Liver Tumor Program, Associate Professor of Medicine, UT Southwestern Medical

Center, Dallas; and Robin K. (Katie) Kelley, MD, Associate Professor of Clinical Medicine, Helen Diller Family Comprehensive Cancer

Center, Division of Hematology/Oncology, University of California, San Francisco.

Abou-Alfa and Prof. Lencioni have been involved in the development of Celsion's lead product ThermoDox for

the treatment of HCC. A review of the data supporting Celsion's Phase III trial with ThermoDox plus radiofrequency

ablation in newly diagnosed HCC patients (the OPTIMA Study) was presented by Prof. Lencioni.

from Single-Site Study in China of ThermoDox Plus RFA Published in the Journal of Cancer Research and

Therapeutics. On August 27, 2019, the Company announced that a study from a single site in China titled "Thermosensitive

liposomal doxorubicin plus radiofrequency ablation increased tumor destruction and improved survival in patients with medium and

large hepatocellular carcinoma: A randomized, double-blinded, dummy-controlled clinical trial in a single center" was published

in the Journal of Cancer Research and Therapeutics. These data were generated as part of the Phase III HEAT Study sponsored

by Celsion Corporation. The data from this single site at the Peking University Cancer Hospital and Institute in Beijing show

an OS improvement of 22.5 months in patients with 3-7 cm unresectable hepatocellular carcinoma tumors receiving ThermoDox

plus RFA, compared with RFA alone.

this study, patients received 50 mg/m2 of ThermoDox or placebo, plus RFA for 45 minutes or longer.

Patients were followed for 11 to 80 months (average: 49.1 24.8 months), with 18 of 22 patients completing the study.

The mean OS for the ThermoDox plus RFA group was 68.5 7.2 months, which was significantly greater than

the placebo plus RFA group (46.0 10.6 months, p=0.045). At the end of the follow-up period, the percentage of patients

alive after 1, 3 and 5 years were as follows:

publication can be found in the Journal of Cancer Research and Therapeutics | Year: 2019 | Volume: 15 | Issue: 4 | Page

773 - 783. The authors are Yang W, Lee JC, Chen MH, Zhang ZY, Bai XM, Yin SS, et al. from the Departments of Ultrasound

and Radiology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital

and Institute in Beijing. Prof. Min-Hua Chen was a principal investigator in Celsion's Phase III HEAT Study, from which

these data are derived, and is also a principal investigator in the Company's Phase III OPTIMA Study.

of the National Institutes of Health Analysis of ThermoDox Published in the Journal of Vascular and Interventional

Radiology. On August 13, 2019, the Company announced that results from an independent analysis of the Company's

ThermoDox HEAT Study conducted by the National Institutes of Health (NIH) were published in the peer-reviewed

publication Journal of Vascular and Interventional Radiology. The analysis was conducted by the intramural research program

of the NIH and the NIH Center for Interventional Oncology, with the full data set from the Company's HEAT Study. The analysis

evaluated the full data set to determine if there was a correlation between baseline tumor volume and RFA heating time (minutes/tumor

volume in milliliters), with or without ThermoDox treatment, for patients with HCC. The NIH analysis was conducted

under the direction of Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional

article, titled "RFA Duration Per Tumor Volume May Correlate with Overall Survival in Solitary Hepatocellular Carcinoma

Patients Treated with RFA Plus Lyso-thermosensitive Liposomal Doxorubicin," discussed the NIH analysis of results from 437

patients in the HEAT Study (all patients with a single lesion representing 62.4% of the study population). The key finding was

that increased RFA heating time per tumor volume significantly improved OS in patients with single-lesion HCC who were treated

with ThermoDox plus RFA, compared to patients treated with RFA alone. A one-unit increase in RFA duration per

tumor volume was shown to result in about a 20% improvement in OS for patients administered ThermoDox , compared

to RFA alone. The authors conclude that increasing RFA heating time in combination with ThermoDox significantly

improves OS and establishes an improvement of over 2 years versus the control arm when the heating time per milliliter of tumor

is greater than 2.5 minutes. This finding is consistent with the Company's own results, which defined the optimized RFA

procedure as a 45-minute treatment for tumors with a diameter of 3 centimeters. Thus, the NIH analysis lends support to the hypothesis

underpinning the OPTIMA Study.

DSMB Review of Phase I Portion of OVATION 2 Study in Ovarian Cancer. On November 5, 2019, the Company announced that the DSMB

has completed its safety review of data from the first eight patients enrolled in the ongoing Phase I/II OVATION 2 Study. Based

on the DSMB's recommendation, the study will continue as planned and the Company will proceed with completing enrollment

in the Phase I portion of the trial. The OVATION 2 Study is a Phase I/II study designed with a single dose escalation phase to