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May 30, 2013
Celsion Announces ThermoDox® HEAT Study Findings to be presented at the 2013 European Conference on Interventional Oncology (ECIO) in Budapest, Hungary on June 19 and 20, 2013

LAWRENCEVILLE, N.J., May 30, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) announced today that Professor Riccardo Lencioni, MD, FSIR, EBIR, the Director of the Division of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Italy, ECIO President and Lead European Principal Investigator for Celsion's Phase III HEAT Study will, in conjunction with two separate scientific presentations, review the clinical trial results including new emerging findings from the HEAT Study post hoc analysis at the 4th European Conference on Interventional Oncology, which is being held June 19-22, 2013 in Budapest, Hungary. Dr. Lencioni will make two presentations on hepatocellular carcinoma (HCC) and related advances in interventional management.

Dr. Lencioni's first presentation, titled "New Interventional Oncology Approaches in HCC; An Update on Clinical Trials" will be held Wednesday, June 19, 2013 at 2:30 p.m. (local time) in Plenary Session: Open Issues in the Management of Liver Cancer. This presentation is part of a joint symposium of the ECIO and the International Liver Cancer Association (ILCA). This special event will be chaired by Dr. Lencioni (ECIO President) and Dr. Joseph Llovet (ILCA President).
His second presentation, titled "Thermally Sensitive Doxorubicin Carriers" will be held Thursday, June 20, 2013 at 10:30 a.m. (local time) in Plenary Session: New Horizons in Interventional Oncology.

"I am pleased to present this post-hoc analysis of a large subgroup of patients from the Phase III HEAT Study to the European and international interventional oncology community which may be indicating a meaningful clinical benefit in both progression free survival (PFS) and overall survival (OS) in patients who received an optimized RFA procedure," said Professor Lencioni. "It is important to note that the duration of heat from the RFA procedure is a key factor in a successful clinical outcome when combined with ThermoDox® as suggested by this analysis. These findings are very encouraging and consistent with our understanding of how RFA plus ThermoDox® can potentially offer an important new treatment for this underserved patient population."

Celsion has conducted a comprehensive analysis of the data from the Phase III HEAT Study of ThermoDox® in HCC, also known as primary liver cancer, with key principal investigators, data experts and liver cancer experts including Professor Lencioni. Emerging data from the HEAT Study post hoc analysis demonstrates that ThermoDox® markedly improves PFS and overall survival in patients if their lesions undergo RFA for 45 minutes or more. These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of approximately 300 patients.
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Source: press release, 5/30/13. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=768083

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Celsion Corporation Provides Business Update
HEAT Study Analysis Shows ThermoDox® Improves Progression Free Survival (PFS) and Overall Survival (OS) when Heating is Optimized
Cash Conservation Program Facilitates the Company's Strategic Options
Engagement of Financial Advisor Assists in Evaluation of Acquisition Opportunities

LAWRENCEVILLE, N.J., April 23, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today is providing a business update, including the latest findings from its analysis of clinical trial results for ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin. Celsion is evaluating ThermoDox® in a Phase III clinical trial for primary liver cancer (the HEAT Study), a Phase II clinical trial for colorectal liver metastasis and a Phase II clinical trial for recurrent chest wall breast cancer.

Phase III HEAT Study Data Analysis

The Company has conducted a comprehensive analysis of the data from the Phase III HEAT Study with key principal investigators, data experts and liver cancer experts. This follows the announcement on January 31, 2013, that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the study's primary endpoint. Emerging data from the HEAT Study post analysis demonstrates that ThermoDox® markedly improves progression free survival (PFS) and overall survival (OS) in patients who had optimal RFA. The analysis indicates that if patients' lesions undergo RFA for 45 minutes or more, they clearly benefitted from ThermoDox®. These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of patients. This data is subject to further verification and review by the HEAT Study Steering Committee.

"We have completed a thorough review of the HEAT Study and there is clear evidence that ThermoDox® can benefit patients when RFA is optimized," said Dr. Nicholas Borys, Celsion's Vice President and Chief Medical Officer. "These data are very exciting and consistent with the mechanism of ThermoDox® activity."

Michael Tardugno, Celsion's Chief Executive Officer, added, "Based on the strength of these findings, the Company will request a meeting with regulatory authorities for guidance on moving forward with our HCC development program. We plan to disclose the details of the HEAT Study data at upcoming medical meetings and in a peer-reviewed publication. We will provide updates on these activities when appropriate."
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Source: press release, 4/23/13. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=758390

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January 31, 2013
Celsion Announces Results of Phase III HEAT Study of ThermoDox® in Primary Liver Cancer
Company to Host Conference Call at 8:00 AM EST Today

LAWRENCEVILLE, N.J., Jan. 31, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer.

Specifically, Celsion has determined, after conferring with its independent Data Monitoring Committee (DMC) that the HEAT Study did not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval in the population chosen for study. The HEAT Study was designed to show a 33% improvement in PFS with 80% power and a p-value = 0.05. In the trial, ThermoDox® was well-tolerated with no unexpected serious adverse events. The HEAT Study was conducted under a Special Protocol Assessment agreed to with the U.S. Food and Drug Administration (FDA).

"We are disappointed that the HEAT Study did not provide sufficient evidence of clinical effectiveness of ThermoDox® as measured by the trial's primary endpoint," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We will consider following the patients currently enrolled in the HEAT Study to the secondary endpoint, Overall Survival (OS), and are conducting additional analyses of the data from the trial in order to assess the future strategic value of ThermoDox. We expect that the results will be presented in the future at appropriate medical meetings. We wish to acknowledge and thank the patients and investigators who participated in the trial."

Celsion ended 2012 with a strong balance sheet that provides the Company the opportunity to evaluate its future development plans. The Company projects its unaudited cash and investment balance to be approximately $23 million as of December 31, 2012 and approximately $27 million as of January 31, 2013.
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Source: press release, 1/31/13. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=737033

Compound/DeviceSpecialtyIndicationCompound ClassTarget
ThermoDox Liver cancerOncologyHepatocelluar carcinomaAnthracycline (thermosensitive)DNA

Mechanism of action: ThermoDox (lyso-thermosensitive liposomal doxorubicin) is a temperature-sensitive liposomal formulation of the anthracycline antibiotic doxorubicin with potential antineoplastic activity. Upon intravenous administration, circulating thermosensitive liposomes are activated locally by increasing the tumor temperature to 40-41 degrees Celsius using an external heat source. The elevated temperature causes compositional changes in the liposomes, creating openings that allow for the release of encapsulated doxorubicin. Compared to non-thermosensitive liposomes, lyso-thermosensitive liposomes deliver higher concentrations of a cytotoxic agent to a heat-treated tumor site while sparing normal tissues unexposed to heat treatment.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2013-06-19 - 2013-06-20

Results:

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Celsion Corporation Announces Presentation of Results from Independent NIH Analysis of ThermoDox® plus Optimized RFA for the Treatment of Primary Liver Cancer at the 2016 RSNA Annual Meeting
NIH Analysis of Data from Celsion's HEAT Study Reaffirms Correlation Between Increased RFA Burn
Time per Tumor Volume and Significant Improvements in Overall Survival
Prior Subgroup Analysis of HEAT Study by Celsion Demonstrated a Two-Year Overall Survival Benefit
for Patients Treated with ThermoDox® Plus Optimized RFA Compared with Optimized RFA Alone
LAWRENCEVILLE, N.J., Nov. 29, 2016 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced the presentation of results from an independent retrospective analysis conducted by the National Institutes of Health (NIH) on the intent-to-treat population of the Company's HEAT Study, a 701-patient study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). The findings of the NIH study were presented during The Interventional Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma at the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) on Monday, November 28, 2016 from 1:00 pm to 6:00 pm CT and was moderated by Professor Riccardo Lencioni, lead European Investigator on Celsion's HEAT Study. Celsion is currently studying the use of RFA as a heat source both for tumor ablation and to activate ThermoDox® as a means of affecting the area surrounding the tumor, where later recurrence most often takes place.
The NIH analysis was conducted under the direction of Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional Radiology. The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome, concluded that increased burn time per tumor volume significantly improved overall survival (OS) in patients with solitary lesions treated with RFA + ThermoDox® compared to patients treated with RFA alone. More specifically, the analysis showed that a one unit increase in RFA duration per tumor volume improved OS by 20% in patients treated with optimized RFA + ThermoDox® compared to RFA alone.
This novel way of assessing the impact of the drug takes into account both the size of the tumor and the time of ablation, both of which appear to be important factors. The NIH analysis included 437 patients with a single lesion from the Company's HEAT Study, the same patient population being treated in the Company's ongoing Phase III OPTIMA Study. These findings are consistent with Celsion's own analysis of the HEAT Study data, which demonstrated that over a 3.5 year period, there was a statistically significant two (2) year survival benefit for patients treated with ThermoDox® plus optimized RFA over the optimized RFA only group.
"There is clear evidence that the duration of the RFA regimen used in combination with ThermoDox® is critical, as was demonstrated in the NIH's independent analysis," said Riccardo Lencioni, MD, FSIR, EBIR, Professor of Interventional Radiology, Vice Chair, Clinical and Translational Research, Department of Interventional Radiology, University of Miami School of Medicine. "Findings from this analysis provide additional confirmation that increased RFA burn time improves OS in patients administered ThermoDox®. For patients with intermediate HCC who are not optimal candidates for surgery, there exists a dire unmet need, and being able to offer these patients optimized RFA + ThermoDox® has the potential to be a meaningful paradigm shift in the current management of this deadly disease."
"It is an honor to have confirmatory support from the NIH that the use of RFA for more than 45 minutes in patients treated with ThermoDox® can have a correlative impact on reductions in tumor size and OS in patients with primary liver cancer," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "This analysis provides further validation for our ongoing global Phase III OPTIMA Study. In addition, learnings from a computational modeling study, an experimental animal study and the HEAT Study post hoc subgroup analysis, all of which are consistent with each other and which -- when examined together -- suggest a clearer understanding of a key ThermoDox heat-based mechanism of action: the longer the target tissue is heated, the greater the doxorubicin tissue concentration."
Presentation Details
Abstract Number: 16013790
Title: RFA Plus Lyso Thermosensitive Liposomal Doxorubicin Improves Survival Using Metric of RFA Duration per Tumor Volume: Retrospective Analysis of Prospective Randomized Controlled Trial
Session: Interventional Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma (VSI021)
Date and Time: Monday, November 28, 2016, 1:00 pm to 6:00 pm CT
The NIH presentation will be available on Celsion's website under "News & Investors - Scientific Presentations."
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Source: press release, 11/29/16. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=1001241

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Celsion Corporation Announces Final Overall Survival Data from HEAT Study of ThermoDox® in Primary Liver Cancer
Subgroup Data Continue to Show a Statistically Significant Improvement in Overall Survival, Consistent With a Two Year Median Survival Benefit Following Treatment with ThermoDox® plus Optimized RFA

Data from the Chinese Cohort of Patients Show Clinically Meaningful Benefit

LAWRENCEVILLE, N.J., Aug. 15, 2016 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced updated results from its final retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). The overall survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n= 285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox® and optimized RFA provided an average 54% risk improvement in OS compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 - 0.94) with a p-value of 0.02. Median overall survival for the ThermoDox® group has been reached which translates into a two year survival benefit over the optimized RFA only group (projected to be greater than 80 months for the ThermoDox® plus optimized RFA group compared to less than 60 months projection for the optimized RFA only group).

Additional findings from this most recent analysis specific to the Chinese patient cohort of 223 patients are summarized below:

In the population of 154 patients with single lesions (70% of the HEAT Study Chinese patient cohort) who received optimized RFA treatment for 45 minutes or more showed a 53% risk improvement in OS (HR = 0.66) when treated with ThermoDox® plus optimized RFA.
These data continue to support and further strengthen ThermoDox®'s potential to significantly improve OS compared to an RFA control in patients with lesions that undergo optimized RFA treatment for 45 minutes or more. The clinical benefit seen in the ITT Chinese patient cohort further confirms the importance of RFA heating time as 72% of patients in this large patient cohort in China received an optimized RFA treatment.
"Data from the HEAT Study have consistently been a foundation and provides additional evidence for our thesis that ThermoDox®, when combined with RFA standardized to a minimum of 45 minutes for intermediate size lesions has the potential to significantly improve survival in primary liver cancer, where the current overall survival rate is far too short," stated Nicholas Borys, M.D., Celsion's senior vice president and chief medical officer. "These findings, if borne out in our ongoing OPTIMA trial, will position ThermoDox® as a potentially curative treatment in primary liver cancer."

"We are delighted to present our investors and the medical community with the findings from the final data sweep from the HEAT Study which reinforces the substantial and mounting support for our ongoing global Phase III OPTIMA Study," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "Particularly, with the growing incidence of primary liver cancer in China representing approximately 50% of the 850,000 cases diagnosed annually, the data generated from the Chinese subgroup underscore the importance of ThermoDox® and the role that it will play as a first line therapy for this, the largest unmet medical need in oncology. Along with our China focused manufacturing strategy, the results from the HEAT Study will support our regulatory and long-term commercialization strategy for ThermoDox® in this important region."

The OPTIMA Study is a pivotal, double-blind, placebo-controlled Phase III clinical trial, and is expected to enroll up to 550 patients at up to 75 sites in the North America, Europe, China and Asia Pacific. As of July 31, 2016, the study has been successfully enrolling patients at more than 57 clinical sites in 13 different countries. In December 2015, Celsion announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the OPTIMA Study at up to 15 additional clinical sites in China, the country where approximately 50% of the 850,000 new cases of primary liver cancer are diagnosed each year and where the Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.
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Source: press release, 8/15/16. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=984305

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Celsion Corporation Announces Updated Overall Survival Data from HEAT Study of ThermoDox® in Primary Liver Cancer
Data Continue to Show a Statistically Significant Improvement in Overall Survival, Translating to a Greater Than Two-Year Survival Benefit Following Treatment with ThermoDox® Plus Optimized RFA
LAWRENCEVILLE, N.J., Aug. 6, 2015 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced updated results from its retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). As of July 15, 2015, the latest overall survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox® and optimized RFA provided an average 58% improvement in OS compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.63 (95% CI 0.43 - 0.93) with a p-value of 0.0198. Median overall survival for the ThermoDox® group has been reached which translates into a 25.4 month (2.1 year) survival benefit over the optimized RFA group (79 months for the ThermoDox® plus optimized RFA group versus 53.6 months for the optimized RFA only group).

In the most recent post-hoc analysis of the HEAT Study, data continued to support and further strengthen ThermoDox®'s potential to significantly improve OS compared to an RFA control in patients with lesions that undergo optimized RFA treatment for 45 minutes or more. Findings from this analysis apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm), representing a subgroup of 285 patients. Additional findings from this most recent analysis specific to the Chinese cohort of patients with single lesions (74% of the HEAT Study Chinese patient population) showed a 75% improvement (HR = 0.57 with a p-value of 0.08) in OS for the ThermoDox® plus optimized RFA group compared to optimized RFA only group. Patients in the Chinese cohort with single lesions between 3-5 cm showed a doubling of improvement (HR = 0.50 with a p-value of 0.06) in OS when treated with ThermoDox® plus optimized RFA.

"These results from the HEAT study reinforce the potential for ThermoDox® in combination with an optimized RFA regimen to serve as an effective treatment option that could significantly improve overall survival in primary liver cancer patients," stated Dr. Nicholas Borys, Celsion's senior vice president and chief medical officer. "The data from our study suggests a greater than two year median survival advantage for the ThermoDox® plus optimized RFA group, a meaningful finding given that few treatments are effective in prolonging survival in HCC. We look forward to continued analyses from the maturing HEAT Study data in China and learning more about how this regimen can prolong survival in this deadly cancer.

"The continuing strength of the HEAT Study data reinforces our confidence in ThermoDox® as the first and only front line therapy for newly diagnosed HCC patients and further improves the risk profile of our Phase III OPTIMA Study, currently enrolling patients in 12 countries globally," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "Equally important is the maturing data and the remarkable clinical benefit seen in the Chinese patient cohort. This large 221 patient subgroup represents a country with over 50% of the world's incidence (over 400,000 new cases) of HCC every year. These specific findings, along with the 25.4 months improvement in time to death seen in the global population, strengthen our options for discussions with the CFDA to identify a faster path to commercialization."

The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 75 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox® in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analysis of data from the Company's 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox®. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).
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Source: press release, 8/06/15. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=926288

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July 28, 2014

Celsion Announces Updated Overall Survival Data from HEAT Study of ThermoDox® in Primary Liver Cancer

Latest Data Sweep from a 285 Patient Subgroup Shows An Impressive 57% Improvement in Overall Survival

Data Continues to Validate Phase III OPTIMA Study Design

LAWRENCEVILLE, N.J., July 28, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today announced updated results from its retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). As of June 30, 2014, the latest quarterly Overall Survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox® and optimized RFA provided a 57% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.639 (95% CI 0.419 - 0.974) with a p-value of 0.037.

"As the data from the HEAT Study matures, it increasingly underscores the significant potential of ThermoDox® plus optimized RFA to markedly improve Overall Survival in primary liver cancer patients," stated Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Diagnostic Imaging and Intervention at the Pisa University School of Medicine in Italy. "There is a pressing need for new treatment options to address HCC, which is a highly prevalent and deadly cancer. The consistency and strength of the HEAT Study data over each of the last five quarterly data analyses provide a strong rationale and clear roadmap for further development of ThermoDox® in this indication."

As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox® may significantly improve OS compared to a RFA control in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in OS, a Hazard Ratio of 0.639 (95% CI 0.419 - 0.974), and a p-value of 0.037.

"The post-hoc HEAT Study data is striking in that it has consistently shown a marked OS benefit for ThermoDox® plus optimized RFA versus RFA alone in each of the quarterly data sweeps, with this 5th, and final data set demonstrating that this survival benefit is statistically significant," stated Michael Tardugno, Celsion's President and Chief Executive Officer. "This impressive clinical data set, together with prospective supportive preclinical study results and multivariate Cox Regression Analyses, reinforces our confidence in the protocol for our Phase III OPTIMA Study in primary liver cancer, which is evaluating ThermoDox® in combination with a standardized RFA protocol in primary liver cancer."

The HEAT Study and prior post-hoc analyses were presented at multiple medical conferences over the past year, including: the 2014 American Society of Clinical Oncology 50th Annual Meeting in June 2014; the 5th European Conference on Interventional Oncology in April 2014; the International Liver Cancer Association Annual Conference in September 2013; the European Conference on Interventional Oncology in June 2013; and the World Conference on Interventional Oncology in May 2013. Presentations were made by some of the most highly recognized liver cancer researchers and key HEAT Study investigators. Quarterly overall survival data analyses have been conducted with the full support of these researchers and clinical investigators.

The Company notes that, while the data and supporting analysis from the HEAT Study warrant additional clinical development, the information should be viewed with caution since it is based upon a retrospective analysis and this subgroup of the HEAT Study has not reached its median point for OS analysis.
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Source: press release, 7/28/14. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=862248

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April 24, 2014

Celsion Corporation Announces Updated Overall Survival Results from the HEAT Study of ThermoDox® in Primary Liver Cancer Presented at ECIO 2014
Latest Data Sweep from Large Subgroup of Patients Shows a Strong 50% Improvement in Overall Survival for ThermoDox®

Pisa University's Professor Riccardo Lencioni Highlights HEAT Study Post-Hoc Analysis, Rationale for the Phase III OPTIMA Study

LAWRENCEVILLE, N.J., April 24, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today announced that updated results from the 701 patient HEAT Study post-hoc analysis, as well as a review of the final study design of the Phase III OPTIMA Study, which both explore ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer, were presented at the 5th European Conference on Interventional Oncology (ECIO) on April 24, 2014 in Berlin, Germany. Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Diagnostic Imaging and Intervention at the Pisa University School of Medicine in Italy, former ECIO President, current Chairman of the World Conference on Interventional Oncology (WCIO) and Lead European Principal Investigator for Celsion's clinical studies of ThermoDox® plus RFA, presented the results and review as part of his Honorary Lecture presentation. The slide presentation will be on the Events and Presentations page on the Celsion website when available.

Data from the latest HEAT Study post-hoc analysis as of March 31, 2014 suggest that ThermoDox® may markedly improve overall survival, compared to RFA control, in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients (41% of the patients in the HEAT Study). For this subgroup, clinical results indicate a 50% improvement in overall survival, a Hazard Ratio of 0.666 (95% CI 0.434 - 1.022), and a p-Value of 0.06. It is important to note that the median overall survival for this subgroup has not yet been reached.

"Results from the HEAT Study, among the largest clinical trials conducted in primary liver cancer, highlight the important potential of ThermoDox® in this indication and underscore the need to optimize RFA to achieve a meaningful clinical benefit in overall survival," said Professor Lencioni. "The duration of heat from the RFA procedure appears to be a key factor in successful clinical outcomes when combined with ThermoDox®, as suggested by this large subgroup analysis. To that end, my colleagues in the oncology community and I look forward to exploring an optimized RFA procedure with ThermoDox® in the Phase III OPTIMA Study, with the goal of bringing new treatment options to a rapidly progressing disease whose worldwide incidence is growing at an alarming rate."

"The combination of ThermoDox® and an optimized RFA treatment continues to demonstrate a consistent and impressive improvement in overall survival in HCC patients, as suggested by this and previous data sweeps," stated Dr. Nicholas Borys, Celsion's Chief Medical Officer. "The most recent data, along with supporting multi-variate analyses, point to the importance of optimized RFA as the leading factor in patients with improved overall survival. We look forward to working with the many leading researchers participating in the OPTIMA Study to efficiently enroll the study, and to the potential of providing new treatment options to this underserved patient population."

In addition to the U.S., Celsion is planning to conduct the OPTIMA Study in up to 100 centers in 14 countries in Asia, Europe and North America, and anticipates patient enrollment in this multicenter global trial to begin in mid-2014. The Company maintains a strong cash position supporting the OPTIMA Study, last reported at $57 million.

The Company also notes that, while the data and supporting analysis from the HEAT Study warrant additional clinical development, they should be viewed with caution since they are based on a retrospective analysis and the HEAT Study has not reached its median point for overall survival analysis.
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Source: press release, 4/24/14. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=842191

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January 27, 2014

Celsion Corporation Announces Updated Overall Survival Results from Phase III HEAT Study of ThermoDox® in Primary Liver Cancer
Latest Data from Large Subgroup of Patients Shows that the Combination of ThermoDox® and Optimized RFA Provides a Statistically Significant Survival Improvement of Over 50%

Provides Basis for Further Development of ThermoDox® in HCC Patients

LAWRENCEVILLE, N.J., Jan. 27, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today announced that the latest overall survival data from its post-hoc analysis of results from the Company's Phase III HEAT Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radio frequency ablation (RFA), supports the continued clinical development of ThermoDox® in a prospective pivotal Phase III Study, subject to regulatory review and agreement. This analysis followed the announcement on January 31, 2013, that the HEAT Study did not meet its primary endpoint, progression-free survival (PFS). As provided for in the HEAT Study's Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the Company continues to follow patients for overall survival, the secondary endpoint of the Study. Data from four quarterly reviews of overall survival have been evaluated since the announcement of top line PFS data.

Data from the updated HEAT Study analysis suggests that ThermoDox® may significantly improve overall survival, compared to control, in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients (41% of the patients in the HEAT Study). Updated OS data from this subgroup of patients is summarized below:

In the patient subgroup treated in the ThermoDox® arm, whose RFA procedure lasted longer than 45 minutes (285 patients or 63% of single lesion patients) clinical results indicate a 55% improvement in overall survival, a Hazard Ratio of 0.64 (95% CI 0.41 - 1.00) and a P-value = 0.0495. Median overall survival for this subgroup has not yet been reached.
In contrast, the patient subgroup treated with ThermoDox® whose RFA procedure lasted less than 45 minutes in duration (167 patients or 37% of single lesion patients) indicated a Hazard Ratio of 1.12 (95% CI 0.68 - 1.86) and a P-value = 0.66. Median overall survival for this subgroup has not yet been reached.
The Hazard Ratios reported above warrants additional clinical development and should be viewed with caution since they are based on a retrospective analysis and the HEAT Study has not reached its median point for overall survival analysis. Celsion will continue to follow patients in the HEAT Study to the secondary endpoint, overall survival, and will update the subgroup analysis based on RFA heating duration.
"The HEAT Study post-hoc data is compelling. The combination of ThermoDox® and an optimized RFA treatment appears to have a significant improvement in overall survival in HCC patients," stated Dr. Nicholas Borys, Celsion's Chief Medical Officer. "While this conclusion is reached based on a post-hoc evaluation, it is nonetheless supported by the consistency of the data seen over a one year follow-up period, and by what is now a statistically significant outcome for overall survival. Our investigators are convinced that RFA can and should be optimized in future trials."

The HEAT Study and prior post-hoc analyses were presented at three medical conferences in 2013, including the World Conference on Interventional Oncology in May; the European Conference on Interventional Oncology in June and the International Liver Cancer Association Annual Conference in September. Presentations were made by some of the most highly recognized liver cancer researchers and key HEAT Study investigators. Quarterly overall survival data analyses have been conducted with the full support of these researchers and clinical investigators.

Additionally, Celsion has been consulting with its clinical advisors, regulatory and expert statistician consultants and the FDA regarding the study design and statistical plan for its proposed pivotal Phase III clinical trial. The Company anticipates initiating a multicenter global trial in the first half of 2014.

"These data continue to support our strong interest in ThermoDox® and its potential as a first line treatment for a significant percentage of the world's 750,000 newly diagnosed HCC patients," noted Michael H. Tardugno, Celsion's President and Chief Executive Officer. "In addition to the FDA, the Company is pursuing regulatory approval of its new Phase III clinical trial in multiple countries, particularly those where HCC's prevalence represents an important health issue. In parallel with this effort, we are recruiting key CRO partners to initiate the Study rapidly following regulatory agency agreement. With our strong financial resources and the support of the global HCC community, we are confident in our ability to conduct a timely and cash efficient pivotal program."
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Source: press release, 1/27/14. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=821197

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October 24, 2013

Celsion Corporation Provides Clinical Update on ThermoDox® HEAT Study Findings
Updated Overall Survival in a Large Subgroup of Patients Provides a Basis for Continued Clinical Development
LAWRENCEVILLE, N.J., Oct. 24, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today announced that the latest overall survival data from its post-hoc analysis of results from the Phase III HEAT Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, supports continued clinical development through a prospective pivotal Phase III Study, subject to regulatory review and agreement. The data analysis was conducted with the support of the Company's key principal investigators, and its data and liver cancer experts. This post-hoc analysis followed the announcement on January 31, 2013, that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the Study's primary endpoint, progression-free survival (PFS). The Company continues to follow patients in the Study to the secondary endpoint, overall survival (OS). Data from three OS sweeps have been conducted since the top line PFS data was announced in January. Celsion expects to submit its proposed pivotal Phase III clinical protocol for FDA review in the fourth quarter of 2013 and anticipates initiating a multicenter global trial in the first half of 2014.

Emerging data from the HEAT Study post-hoc analysis has been presented at three scientific and medical conferences in 2013 (World Conference on Interventional Oncology in May 2013; European Conference on Interventional Oncology in June 2013 and International Liver Cancer Association Annual Conference in September 2013) by key HEAT Study investigators and leading liver cancer experts. The data from the HEAT Study post-hoc analysis suggests that ThermoDox® may markedly improve overall survival, when compared to the control group, in patients if their tumors undergo optimal RFA treatment. These findings apply to single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients (41% of the patients in the HEAT Study). Updated OS data from this subgroup of patients is summarized below:

In the patient subgroup treated in the ThermoDox® arm whose RFA procedure lasted longer than 45 minutes (285 patients or 63% of single lesion patients) clinical results indicate an improvement in overall survival with a Hazard Ratio of 0.63 (95% CI 0.393 — 1.011) and a P-value = 0.056. The median in this subgroup has not been reached.
In contrast, the patient subgroup treated with ThermoDox® whose RFA procedure lasted less than 45 minutes in duration (167 patients or 37% of single lesion patients) demonstrated a Hazard Ratio of 1.14 (95% CI 0.737 — 1.776) and a P-value = 0.547. The median in this subgroup has not been reached.
The Hazard Ratios reported above, while more than sufficient to support additional clinical development, should be viewed with caution since they are not statistically significant and the HEAT Study has not reached its median for overall survival analysis. Celsion continues to follow all patients in the HEAT Study to the secondary endpoint, overall survival, and will update the subgroup analysis based on RFA heating duration.
"An important lesson learned from the HEAT Study is that RFA can be optimized in order to improve outcomes of patients with HCC. This is true for RFA alone and particularly true of RFA plus ThermoDox®. We have learned from the HEAT Study data and from computer simulations that RFA dwell time is a key factor for success. These data were confirmed in large animal studies which now give us the confidence to move forward with a pivotal study," stated Dr. Nicolas Borys, Celsion's Chief Medical Officer. "Further, we are encouraged that investigators from the HEAT Study have expressed a strong interest in participating in a follow-on clinical trial."

"Equally important is that the data supporting our continued development program has been carefully reviewed by our HEAT Study principal investigators, international liver cancer experts, former FDA reviewers and independent statisticians," noted Michael H. Tardugno, Celsion's President and CEO. "We will present these findings in detail to the U.S Food and Drug Administration during the fourth quarter and we will work with the Agency on the best path forward in a pivotal study."
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Source: press release, 10/24/13. http://investor.celsion.com/releaseDetail.cfm?ReleaseID=799725

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June 20, 2013
Celsion's ThermoDox® HEAT Study Findings Reviewed at the 2013 European Conference on Interventional Oncology (ECIO) in Budapest, Hungary on June 19 and 20, 2013
Duration of RFA Procedure Correlates with Meaningful Clinical Benefit
LAWRENCEVILLE, N.J., June 20, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) announced today that Professor Riccardo Lencioni, MD, FSIR, EBIR, 2013 ECIO Program Co-Chairman and the Director of the Division of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Italy and Lead European Principal Investigator for the HEAT Study reviewed the clinical trial results from the Company's Phase III HEAT Study including findings from the HEAT Study post-hoc analysis at the 2013 European Conference on Interventional Oncology, which is being held June 19-22, 2013 in Budapest, Hungary. The emerging post-hoc findings suggest that the heating cycles can be optimized to markedly improve radiofrequency ablation (RFA) when used with ThermoDox®. The post-hoc data indicates that ThermoDox® may provide potential for clinically relevant improved progression free survival (PFS) and Overall Survival (OS) outcomes. Professor Lencioni made two presentations on hepatocellular carcinoma (HCC) and related advances in interventional management.

Professor Lencioni's first presentation, titled "New Interventional Oncology Approaches in HCC; An Update on Clinical Trials" was held on Wednesday, June 19, 2013 at 2:30 p.m. (local time) in Plenary Session: Open Issues in the Management of Liver Cancer. This presentation is part of a joint symposium of the ECIO and the International Liver Cancer Association (ILCA). This special event will be chaired by Professor Lencioni (2013 ECIO Program Co-Chairman) and Dr. Joseph Llovet (ILCA President)
His second presentation, titled "Thermally Sensitive Doxorubicin Carriers" was held on Thursday, June 20, 2013 at 10:30 a.m. (local time) in Plenary Session: New Horizons in Interventional Oncology
"I am pleased to present this post-hoc analysis of a large subgroup of patients from the Phase III HEAT Study to the European and international interventional oncology community which may be indicating a meaningful clinical benefit in both progression free survival (PFS) and overall survival (OS) in patients who received an optimized RFA procedure," said Professor Lencioni. "It is important to note the duration of heat from the RFA procedure is a key factor in a successful clinical outcome when combined with ThermoDox®. These findings are consistent with our understanding that increased perfusion and associated heating time are important factors for ensuring that the heat-sensitive liposomes are activated to deposit high concentrations of doxorubicin in the tumor and the surrounding liver tissue."

The data from the HEAT Study post-hoc analysis presented by Professor Lencioni demonstrate that ThermoDox® markedly improves PFS and OS in patients with a single lesion if their lesions undergo RFA for 45 minutes or more. These findings apply to HCC lesions regardless of size and represent a subgroup of approximately 300 patients or 42% of the patients in the HEAT Study.

In the patient subgroup treated in the ThermoDox® arm whose RFA procedure lasted longer than 45 minutes and was completed within 90 minutes (40% of single lesion patients) Overall Survival improved by 66% (Hazard Ratio of 0.602) when compared to the control arm of RFA treatment only.
In the patient subgroup treated in the ThermoDox® arm whose RFA procedure lasted longer than 90 minutes (23% of single lesion patients), Overall Survival almost doubled (Hazard Ratio of 0.508) when compared to the control arm of RFA treatment only.
When combined, these two subgroups show clinical results that indicated a 53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a Pvalue = 0.105.
In contrast, the patient subgroup treated with ThermoDox® whose RFA procedure lasted less than 45 minutes in duration (37% of single lesion patients) indicated that the control arm had an improved Overall Survival benefit when compared to the ThermoDox® arm.
The Hazard Ratios reported above should be viewed with caution since they are not statistically significant and the HEAT Study has not reached its median point for Overall Survival analysis. Celsion will continue following all patients enrolled in the HEAT Study to the secondary endpoint, Overall Survival, and update its subgroup analysis based on RFA heating duration.
Professor Lencioni's presentation is available on the Company's website at www.celsion.com under "News & Investor Info — Events & Presentations."
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Source: press release, 6/20/13. http://investor.celsion.com/releasedetail.cfm?ReleaseID=772645