Full Press Release Details
Corporation Reports Second Quarter 2018 Financial Results
Provides Business Update
Balance Sheet With Cash Sufficient to Fund Operations Into the First Half of 2020
and Year-to-Date Cash Expenses Consistent With Prior Guidance
to Hold Conference Call on Tuesday, August 14, 2018 at 11:00 a.m. EDT
N.J., August 14, 2018 - Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced
financial results for the quarter and six-month period ended June 30, 2018 and provided an update on its development programs
for ThermoDox , its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA
plasmid vector encased in a nanoparticle delivery system, designed to enable cell transfection followed by persistent, local secretion
of the IL-12 protein. The Company's lead program is ThermoDox , which is currently in Phase III development
for the treatment of primary liver cancer, and its immunotherapy candidate, GEN-1, is currently in Phase I/II development for
the localized treatment of ovarian cancer.
continues to make significant progress with our two ongoing clinical development programs for ThermoDox and GEN-1.
We expect to complete enrollment in our 550-patient global, pivotal Phase III OPTIMA Study in primary liver cancer and initiate
patient enrollment in our 130-patient Phase I/II randomized OVATION II Study in newly diagnosed patients with ovarian cancer during
the third quarter," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "We
have a strong balance sheet and are well positioned financially to continue to advance these key programs, with several important
announcements for both of our clinical programs expected over the next six to 12 months, including the final progression-free
survival data from our OVATION I Phase IB clinical trial of GEN-1 and the first pre-planned interim analysis of the ThermoDox
Phase III OPTIMA Study."
Phase I Clinical Study Results Published in The Lancet Oncology. On July 10, 2018, the Company announced that results
from a Phase I trial of ThermoDox were published in the peer-reviewed journal, The Lancet Oncology.
Conducted by a multi-disciplinary team of biomedical engineers, oncologists, radiologists and anesthetists at the University of
Oxford, United Kingdom, the trial evaluated the safety and efficacy of ThermoDox with focused ultrasound
for the treatment of liver cancer.
to as the TARDOX Study, the trial demonstrated that the ThermoDox plus focused ultrasound technique increased
doxorubicin delivery to tumors between two- and ten-fold in the majority of patients in this 10-patient trial. A lysolipid thermally
sensitive liposome encapsulating the chemotherapy agent, doxorubicin, ThermoDox is designed to release
targeted levels of doxorubicin into and around liver tumors with heat activation. In this Phase I study, and consistent with the
ThermoDox heat-activated design, the amount of drug passively reaching the tumor was low and estimated
to be below therapeutic levels before ultrasound exposure. Following focused ultrasound application with ThermoDox ,
chemotherapy concentrations within the liver tumor were between two and ten times higher in seven out of 10 patients, with an
average increase of 3.7 times across all patients.
Phase I trial evaluated patients with inoperable primary or secondary liver tumors and who had previously received chemotherapy.
The procedure was carried out under general anesthesia, and patients received a single intravenous dose of 50 mg/m2
of ThermoDox . The target tumor was selectively heated to over 39.5o C using an approved ultrasound-guided
focused ultrasound device at the Churchill Hospital in Oxford. In six patients, the temperature at the target tumor was monitored
using a temporarily implanted probe, while in the remaining four patients, ultrasonic heating was carried out non-invasively.
Side effects were monitored for 30 days after the procedure, and apart from the existing side effects caused by general anesthetic
and chemotherapy, no additional side effects were observed.
TARDOX Study, supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, was carried out
as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering, the Oncology
Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust.
Monitoring Committee Unanimously Recommended Continuation of the OPTIMA Study in Primary Liver Cancer Following its Planned Safety
and Data Review from 411 Patients. On April 9, 2018, the Company announced that the independent Data Monitoring Committee
(DMC) for the Company's 550-patient, pivotal Phase III clinical study of ThermoDox in combination with radiofrequency
ablation (RFA) for primary liver cancer (the OPTIMA Study), unanimously recommended that the study continue according to protocol
to its data readout. The DMC's recommendation was based on the Committee's assessment of safety and data integrity
of the first 75% of patients randomized in the trial as of February 5, 2018 and concluded that the integrity of the study was
intact and that ThermoDox was safe for continued enrollment of newly diagnosed, intermediate-stage patients. An
analysis of blinded data from the intent-to-treat population, consolidated for both arms, indicated that median progression free
survival (PFS) was 20.8 months. This compared favorably to the HEAT Study subgroup (285 patients treated with RFA greater than
45 minutes) median PFS of 19.7 months and was consistent with the hypothesis-generating estimates from the HEAT Study manuscript
published in the October 2017 issue of the peer-reviewed medical journal, Clinical Cancer Research.' The OPTIMA
Study's design and statistical plan incorporates two pre-planned interim efficacy analyses by the DMC with the intent of
evaluating safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability
of treatment success to continue, modify or terminate the study.
DMC analysis in April 2018 was the last planned interim analysis prior to enrollment completion, which is currently expected in
the third quarter of 2018, with results from the first interim efficacy analysis expected in the first half of 2019.
$10 Million From A Strategic Loan Facility with Horizon Technology Finance Corporation. On
June 28, 2018, the Company announced it entered into a $10 million loan agreement with Horizon Technology Finance Corporation
which it drew down upon closing. The Company will use the funding provided under the agreement for working capital and advancement
of its product pipeline, including ThermoDox and GEN-1, as well as other strategic initiatives designed to broaden
its product pipeline. The funding is in the form of secured indebtedness bearing interest at a calculated LIBOR-based variable
rate. Payments under the loan agreement are interest only for the first twenty-four (24) months after loan closing, followed by
a 24-month amortization period of principal and interest through the scheduled maturity date.
Added to the Russell Microcap Index. On June 25, 2018, the Company was
added to the Russell Microcap Index as part of the Russell indexes annual reconstitution, effective after the
U.S. market opens today. Membership in the Russell Microcap Index, which remains in place for one year, means
automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell U.S.
Indexes primarily by objective, market-capitalization rankings and style attributes.
the quarter ended June 30, 2018, Celsion reported a net loss attributable to common shareholders of $8.2 million, or a loss of
$0.46 per share, compared to $4.9 million, or a loss of $0.79 per share, in the same period of 2017. Operating expenses were $8.1
million in the second quarter of 2018 compared to $4.7 million in the same period of 2017. During the second quarter of 2018,
the Company incurred $3.2 million in non-cash stock option expense compared to $0.7 million in the same comparable period of 2017.
the six-month period ended June 30, 2018, the Company reported a net loss attributable to common shareholders of $12.7 million,
or a loss of $0.73 per share, compared to $10.4 million, or a loss of $1.75 per share, in the same six-month period of 2017. Operating
expenses were $12.5 million during the first six months of 2018 compared to $9.6 million in the same period of 2017. During the
first half of 2018, the Company incurred $3.4 million in non-cash stock option expense compared to $0.8 million in the same comparable
six-month period of 2017.
cash used for operating activities was $8.8 million in the first six months of 2018, compared to $7.3 million in the same period
in 2017. This was in line with our projected cash utilization for 2018 of approximately $16 million, averaging approximately $4
million per quarter. The Company ended the second quarter of 2018 with $26.3 million of total cash, cash equivalents, investment
securities and interest receivable, which included the $10 million in gross proceeds from the Company's new venture debt
facility completed on June 27, 2018 with Horizon Technology Finance Corporation. The Company believes it has sufficient capital
resources to fund its operations into the first half of 2020.
and development costs increased $1.6 million, from $3.0 million in the second quarter of 2017 to $4.6 million in the second quarter
of 2018. Clinical development costs for the Phase III OPTIMA Study increased to $2.0 million in the second quarter of 2018, compared
to $1.5 million in the second quarter of 2017. This $0.5 million increase was attributable to higher patient enrollment in this
pivotal Phase III trial during the first half of 2018. Costs associated with the startup of the OVATION II Study were $0.1 million
in the second quarter of 2018. Other costs related to clinical supplies and regulatory support for the ThermoDox
and GEN-1 clinical development programs increased by $0.2 million in the second quarter of 2018 when compared to the same prior-year
period. In the second quarter of 2018, the Company also incurred an increase of $0.7 million in non-cash stock compensation expense
compared to the same period of 2017.
and development costs increased $0.8 million, from $6.5 million in the first six months of 2017 to $7.3 million in the first half
of 2018. Clinical development costs for the Phase III OPTIMA Study increased to $3.3 million in the first half of 2018, compared
to $3.0 million in the first half of 2017. This $0.3 million increase was attributable to higher patient enrollment in the pivotal
Phase III trial during 2018. Costs associated with the startup of the OVATION II Study were $0.2 million in the first half of
2018. Other costs related to for clinical supplies and regulatory support for the ThermoDox and GEN-1 clinical
development programs increased by $0.2 million in the first half of 2018 when compared to the same prior-year period. In the first