Full Press Release Details
Corporation Reports Second Quarter 2019 Financial Results and Provides Business Update
Pre-Planned Efficacy Analysis of the Phase III OPTIMA Study Planned for Mid-October
Balance Sheet Plus the Non-Dilutive Sale of $4 Million of New Jersey State Net Operating Losses Will Fund Operations Into 2021
Manuscript Provides Support for ThermoDox's Potential in the OPTIMA Study
to Hold Conference Call on Thursday, August 15, 2019 at 11:00 a.m. EDT
N.J. (August 14, 2019) - Celsion Corporation (NASDAQ: CLSN), an oncology
drug development company, today announced financial results for the three and six months ended June 30, 2019 and provided an update
on its development programs for ThermoDox and GEN-1. The 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/IV
a clear focus on shareholder value, Celsion continues to execute its business plan for our ongoing clinical development programs
with ThermoDox and GEN-1. We are exceptionally well positioned on the fundamentals with a strong balance sheet that is expected
to fund our clinical programs through transformative milestones over the next 18 months," said Michael H. Tardugno, Celsion's
chairman, president and chief executive officer. "We look forward to the first of two preplanned interim efficacy analyses
for the OPTIMA Study expected in October 2019. At the current event rate, the second interim analysis, if needed, is expected
to occur in early 2020. This 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."
first cohort of patients in the dose-escalation portion of our OVATION 2 Study in newly diagnosed ovarian cancer has been enrolled.
We continue to work through the activation of up to 30 clinical sites in the U.S. and Canada by the end of this year. Importantly,
enrollment of patients in the Phase I portion of the study is expected to be completed and initial data reported by the end of
2019. This promising clinical development program in immunotherapy has generated impressive results in previous trials,"
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 (CIO), 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 radiofrequency
ablation (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 Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology
and Chief, NIH Clinical Center Interventional Radiology.
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 overall survival (OS) in patients with single-lesion
HCC who were treated with RFA plus ThermoDox , 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 two 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.
Lock for First Prespecified Interim Analysis in OPTIMA Phase III Study of ThermoDox in Primary Liver Cancer. On
August 5, 2019, the Company announced the prescribed number of events has been reached for the first prespecified interim analysis
of the OPTIMA Phase III Study with ThermoDox plus radiofrequency ablation (RFA) in patients with HCC. Following preparation
of the data, the first interim analysis will be conducted by the Independent Data Monitoring Committee (iDMC). The iDMC meeting
is expected to occur by mid-October. This timeline is consistent with the Company's stated expectations and is necessary
to provide a full and comprehensive data set that may represent the potential for a successful trial outcome. The iDMC recommendations
will be announced as soon as possible after the meeting.
accordance with the statistical plan, this initial interim analysis has a target of at least 118 events, or 60% of the total number
required for the final analysis. At the time of the data cutoff, the Company received reports of 128 events. The hazard ratio
for success at 128 events is approximately 0.63, which represents a 37% reduction in the risk of death compared with RFA alone,
and is consistent with the 0.65 hazard ratio that was observed in the prospective HEAT Study subgroup, which demonstrated a two-year
overall survival advantage and a median time to death of more than seven and a half years.
OPTIMA Study was fully enrolled in August 2018 with 556 subjects from 65 clinical sites in 14 countries. The design of the OPTIMA
Study is based on the Company's HEAT Study, in which a subgroup analysis of 285 subjects with a single lesion of 3-7 cm
in size received a single ThermoDox administration in combination with a 45-minute or longer RFA procedure. Followed prospectively
for over 2.5 years, patients treated with ThermoDox demonstrated a median survival of more than 7.5 years and a survival
benefit of more than two years over the control group. These data were published in the October 2017 issue of the peer-reviewed
journal Clinical Cancer Research, and are available here.
Approval to Begin a Clinical Study of ThermoDox Plus High Intensity Focused Ultrasound in Breast Cancer Patients
at University Medical Center Utrecht in the Netherlands. On June 20, 2019, the Company announced that the University Medical
Center Utrecht in the Netherlands received Institutional Review Board (IRB) approval to begin a Phase I study to determine the
safety, tolerability and feasibility of ThermoDox in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound
(MR-HIFU) hyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer (mBC).
The secondary objective of this study is to assess radiological objective response of distant metastases and of the primary breast
single-site, investigator-sponsored study - image-guided targeted doxorubicin delivery with hyperthermia to optimize loco-regional
control in breast cancer; the i-GO Feasibility Study - will enroll up to 12 newly diagnosed mBC patients. Study subjects
will receive up to six cycles of the following regimen at three-week intervals:
study further reinforces the broad potential of ThermoDox to treat a range of solid tumors with multiple localized heating
of New U.S. Patent for ThermoDox . On April 17, 2019, the Company announced that the United States Patent and Trademark
Office granted U.S. Patent No. 10,251,901 B2 - Thermosensitive Nanoparticle Formulations and Method of Making the Same
- which is directly applicable to the method of treating cancer using a new ThermoDox formulation. The
claim covers a method for preparing (as well as the composition of) a doxorubicin sulfate temperature-sensitive liposome and extends
protection for the ThermoDox patent portfolio to 2033. This new patent broadens the ThermoDox intellectual
property portfolio and provides for lifecycle management well into the future.
Participated in Two Investor Conferences. During May 2019, the Company attended the
ThinkEquity Conference in New York City and the Deutsche Bank 44th Annual Health Care Conference in Boston. A webcast
of Celsion's presentation at the ThinkEquity Conference may be accessed by visiting the "News & Investors"
section of Celsion's corporate website. The format of the Deutsche Bank Health Care Conference was comprised of one-on-one
and small group meetings with leading institutional investors.
Quarter Financial Results
the quarter ended June 30, 2019, Celsion reported a net loss of $5.9 million ($0.29 per share), compared with $8.2 million ($0.46
per share) in the same period of 2018. Operating expenses were $5.7 million in the second quarter of 2019, which represented a
$2.4 million (30%) decrease from $8.1 million in the same period of 2018. During the second quarter of 2019, the Company incurred
$0.6 million in non-cash stock option expense, compared with $3.2 million in the comparable prior-year period.
and development expenses decreased $1.0 million to $3.6 million in the second quarter of 2019, compared with $4.6 million in the
second quarter of 2018. Clinical development costs for the Phase III OPTIMA Study decreased $0.8 million to $1.2 million in the
second quarter of 2019, compared with $2.0 million in the second quarter of 2018, due to the completion of enrollment in this
556-patient trial in August 2018. Costs associated with the startup of the OVATION 2 Study were $0.1 million in the second quarter
of 2019. Other costs related to clinical supplies and regulatory support for the ThermoDox and GEN-1 clinical development
programs increased by $0.3 million in the second quarter of 2019 compared with the prior-year period. In the second quarter of
2019, non-cash stock compensation expense decreased $2.6 million compared with the same period of 2018.
and administrative expenses were $2.1 million in the second quarter of 2019, compared with $3.5 million in the same period of
2018. The decrease was primarily attributable to a $1.8 million decrease in non-cash stock compensation expense, offset by a $0.2
million increase in professional fees primarily related to recruiting fees for several new positions to support the anticipated
regulatory and commercialization efforts for ThermoDox .
Company realized $0.1 million of interest income from its short-term investments during the second quarters of 2019 and 2018.
In connection with the Company's venture debt facility with Horizon entered in late June 2018, the Company incurred interest