Full Press Release Details
Corporation Reports Second Quarter 2022 Financial Results and Provides Business Update
Mediated Immunotherapy and Next-Generation Vaccine Programs Supported with a Strong Balance Sheet
Conference Call Begins Today at 11:00 a.m. EDT
N.J. (August 15, 2022) - Celsion Corporation (NASDAQ: CLSN), a clinical-stage
drug-development company focused on DNA-mediated immunotherapy and next-generation vaccines, today announced financial results
for the three and six months ended June 30, 2022, and provided an update on its clinical development program of GEN-1,
a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development
for the treatment of advanced-stage ovarian cancer, and its preclinical studies of PLACCINE,
a proprietary, multivalent DNA plasmid technology utilizing synthetic, non-viral delivery vectors, being evaluated in proof of concept
studies for superiority over current mRNA vaccines.
we approach the second half of the year, I am pleased to report that Celsion is in a strong financial position, making important progress
with our innovative development platforms in oncology and infectious disease. Our OVATION 2 Phase II study of GEN-1 in advanced ovarian
cancer continues to advance, with complete enrollment anticipated in the third quarter. Our PLACCINE platform, which was highlighted
at the recent World Vaccine Forum, continues to show promise for the potential to address a range of infection diseases as we evaluate
its capability in a head to head comparison with commercial covid-19 vaccines," said
Dr. Corinne Le Goff, Celsion's president and chief executive officer. "Moreover, given the uncertainty of the capital markets,
it's clear that the steps that we have taken over the past 18 months to ensure a cash balance that provides a runway into 2025
was a smart strategy. We expect to report several value creating developments during this time frame."
Safety Monitoring Board Unanimously Recommends Continued Dosing Patients in the OVATION 2 Study. In June 2022, the Company announced
that following a pre-planned interim safety review of 87 as treated patients (46 patients in the experimental arm and 41 patients in
the control arm) randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring
Board (DSMB) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB
also determined that safety was satisfactory with an acceptable risk/benefit, and that weekly doses of GEN-1 were well tolerated during
a course of treatment that is given over six months in combination with standard neoadjuvant chemotherapy. No dose-limiting toxicities
Company also announced that more than 87% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data
from patients who have undergone interval debulking surgery showed that the GEN-1 treatment arm is showing improvement in R0 surgical
resection rates and CRS 3 chemotherapy response scores over the control arm. A complete tumor resection (R0) is a microscopically margin-negative
resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score 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.
February 2021, the Company announced that GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. Celsion plans to request
FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data.
from the Use of a Synthetic Control Arm to Estimate Treatment Effect in Phase Ib dose-escalating OVATION I Study presented at 2022 AACR
Annual Meeting. In April 2022, Celsion demonstrated its commitment to innovation in clinical research. The Company and the premier
global data management CRO, Medidata, announced findings on the use of a Synthetic Control Arm (SCA) in a completed
Phase Ib dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer at the Annual Meeting
of the American Association for Cancer Research (AACR). In a poster presentation entitled "Phase IB trial efficacy estimates via
a clinical trial synthetic control arm," which took place on Monday April 11, 2022, the research team's findings demonstrated
how comparing patients from a single-arm trial can help enhance understanding of treatment effects in advance of randomized trials, inform
drug development and trial design, and increase the scientific value of early phase trials.
Synthetic Control Arm is a type of external control and is formed by carefully matching patients treated with a new investigational therapy
to anonymized clinical trial patients from Medidata's extensive repository of historical clinical trials using baseline demographic
and disease characteristics. Using this advanced statistical methodology, Celsion
and Medidata found that progression-free survival
was prolonged for the patients treated with the investigational therapy GEN-1 along with standard of care chemotherapy in the OVATION
1 Study compared to well-balanced historic control patients treated with the same standard of care chemotherapy alone (Hazard
Ratio=0.53, 95% Confidence Interval (0.16, 1.73). This larger than expected effect size led to
a decrease in the number of planned patients for Celsion's subsequent Phase II trial and was used in support of Fast Track Designation
from the U.S. Food and Drug Administration (FDA) received in February 2021.
Vaccine Platform Technology Highlighted During Oral Presentation at the World Vaccine Congress. In April 2022, the Company presented
its PLACCINE platform technology at the World Vaccine Congress which took place in Washington D.C. In an oral presentation during a Session
on Cancer and Immunotherapy, Dr. Khursheed Anwer, Celsion's Chief Science Officer, highlighted the Company's technology platform
in his presentation entitled: "Novel DNA Approaches for Cancer Immunotherapies and Multivalent Infectious Disease Vaccines."
PLACCINE is one of three platform technologies Celsion has for a range of therapeutics in oncology and immunotherapy. A copy of Dr. Anwer's
presentation is available on the investor portion of the Celsion website under Scientific Presentations.
is demonstrating the potential to be a platform for a range of infectious disease that provides for rapid design capability for targeting
two or more different variants of a single virus in one vaccine. There is a clear public health need for vaccines today that address
more than one strain of viruses, like COVID-19, which have fast evolving variant capability. Murine model data has thus far been encouraging
and suggests that the Company's approach provides not only flexibility, but also the potential for efficacy comparable to benchmark
COVID-19 commercial vaccines with durability to protect expected to be greater than 6 months.
the murine model, our multivalent PLACCINE vaccine targeted against two different variants showed to be immunogenic as determined by
the levels of IgG, neutralizing antibodies, and T-cell responses. Additionally, our multivalent vaccine was equally effective against
two different variants of the COVID-19 virus while the commercial mRNA vaccine appeared to have lost some activity against the newer
variant. The Company continues to evaluate our technology and look forward to the results from our ongoing proof-of-concept non-human
primate study evaluating our PLACCINE vaccine against the challenge from live SARS-CoV-2 virus in the second quarter, with durability
results available in the second half of this year.
Corinne Le Goff Appointed as President and Chief Executive Officer; Michael H. Tardugno Appointed Executive Chairman of the Board.
In July 2022, the Company announced that the Company's Board of Directors appointed biopharmaceutical leader Corinne Le Goff, Pharm
D, MBA, as President and Chief Executive Officer and Director, effective July 18, 2022. Michael H. Tardugno will continue to serve as
Executive Chairman of Celsion's Board of Directors.
Le Goff brings decades of global healthcare leadership experience to the Company across a range of therapeutic areas including oncology,
vaccines, immunology, CNS and cardio-metabolism. She brings a wealth of experience in developing and launching successful drugs from
her tenure at both large pharmaceutical companies and small, innovative biotech companies.
to her Celsion appointment, Dr. Le Goff most recently served as the Chief Commercial Officer of Moderna, responsible for developing the
global presence and capabilities necessary to ensure the global distribution of Moderna's COVID-19 vaccine. She also led the development
of the Moderna's mRNA platform long-term commercial strategy. Dr. Le Goff joined Moderna from Amgen, where she served as President
of the U.S. Business, driving the growth strategy with increased contributions from Repatha and Aimovig .
During her 6-year tenure at Amgen, she also served as Senior Vice President of Global Product Strategy & Commercial Innovation and
as President of the Europe Region overseeing 48 markets. Dr. Le Goff was actively engaged with the policy community and advocates for
innovative, high-quality, and affordable healthcare. She represented Amgen as a member of the Healthcare Leadership Council. Prior to
joining Amgen, Dr. Le Goff held a number of senior international roles at Roche, including President of Roche France, a major affiliate
of the Roche Group, and Global Product Strategy Head of Neuroscience & Rare Diseases. Early in her career, Dr. Le Goff spent 11 years
in various leadership roles at Sanofi and Pfizer in the United States.
Le Goff earned a PhD in pharmaceutical sciences from Rene Descartes University in Paris and an MBA from Sorbonne University and INSEAD.
She also holds qualifications from Northwestern University and the Hong Kong University of Science and Technology. She received the distinction
of being named a Chevalier de la L gion d'Honneur in 2014. She holds a U.S. patent and was recently recognized by Forbes
Magazine as one of the women over the age of 50 who are changing the world.
Balance Sheet Through Registered Direct Offering of Common Shares totaling $7.0 Million in Gross Proceeds Priced At-The-Market under
NASDAQ Rules. On April 8, 2022, the Company announced the closing of a registered direct offering of 1,328,274 shares of common
stock at a purchase price of $5.27 per share, resulting in gross proceeds of $7.0 million, before deducting placement agents' fees
and expenses. Celsion intends to use the net proceeds for general corporate purposes, including research and development activities,
capital expenditures and working capital.
Quarter Financial Results
reported a net loss for the second quarter of 2022 of $6.0 million ($0.87 per share) compared with a net loss of $5.4 million ($0.95
per share) in 2021. Operating expenses were $6.1 million for the second quarter in 2022, which represented a $0.9 million (17%) increase
from $5.2 million for the second quarter of 2021.
Company ended the second quarter of 2022 with $48.1
million in cash, investments, restricted cash, and accrued interest receivable. Coupled with future
planned sales of the Company's State of New Jersey net operating losses, the Company believes it has sufficient capital resources
to fund its operations into 2025.