Full Press Release Details
Celsion Corporation Reports First Quarter 2022 Financial
Results and Provides Business Update
DNA Mediated Immunotherapy and Next-Generation Vaccine
Programs Supported with a Strong Balance Sheet
Conference Call Begins Today at 11:00 a.m. EDT
LAWRENCEVILLE, N.J. (May 16, 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 quarter ended March 31, 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 the current
generation of nucleic acid vaccines.
in OVATION 2, our randomized Phase II study of advanced ovarian cancer patients, continues to show momentum with 85% of patients enrolled
as of May 15, 2022, and full enrollment expected to be completed by the third quarter of 2022. We remain encouraged by surrogate endpoints
like surgical resection scores among patients being treated at the 100 mg/m² dose cohort in the study. Early reports from the first
thirty-nine patients who have undergone interval debulking surgery showed a 27% improvement in the surgical resection (R0) rate in the
GEN-1 treatment arm over the control arm. A complete R0 is a microscopically margin-negative resection in which no gross or microscopic
tumor remains in the tumor bed," said Michael H. Tardugno, Celsion's chairman,
president and chief executive officer.
"We have presented results from preclinical
studies which showed our next-generation PLACCINE DNA vaccine can target two different viral variants, demonstrating immunogenicity as
determined by the levels of IgG, neutralizing antibodies, and T-cell responses. Our research shows that our multivalent PLACCINE vaccine
was equally effective against two different variants of the COVID-19 virus while the commercial mRNA comparison vaccine appeared to have
lost some activity against the newer variant," added Mr. Tardugno. "Our goal is to demonstrate PLACCINE's superiority
with respect to the quality of immune response against SARS-CoV-2 variants, including a longer duration of immune response and a stable
product at commercially favorable storage temperatures when compared to commercially available mRNA vaccines. To that end, we have engaged
BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study of our first
of many vaccine candidates as protection against SARS-CoV-2. The first inoculation of NHP subjects
occurred the last week of March with the goal of generating important data to inform human clinical studies by mid-June 2022."
Data Safety Monitoring
Board's Unanimous Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced
Ovarian Cancer. In February 2022, the Company announced that following a pre-planned interim safety review of eighty-one as treated
patients 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 is satisfactory with an acceptable risk/benefit, and that patients tolerate GEN-1 during a course of treatment
that lasts up to six months. No dose-limiting toxicities were reported.
Findings 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 from 9 AM through 12:00 PM EST, 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.
of Concept Vaccine Candidate Advanced to Non-Human Primate Challenge Study Against SARS-CoV-2. In January 2022, the Company announced
it had engaged BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study
with Celsion's DNA-based approach for a SARS-CoV-2 vaccine. The NHP pilot study follows the generation of encouraging murine data
and will evaluate the Company's vaccine formulations for safety, immunogenicity and protection against SARS-CoV-2.
In completed preclinical studies, Celsion demonstrated
safe and efficient immune responses including IgG response, neutralizing antibodies and T-cell responses that parallel the activity of
commercial vaccines following intramuscular (IM) administration of novel vaccine compositions expressing a single viral antigen. In addition,
vector development has shown promise of neutralizing activity against a range of SARS-CoV-2 variants. Celsion's novel DNA-based
vaccines are based on a simple intramuscular injection that does not require viral encapsulation or special equipment for administration.
Ongoing directional and technical guidance from our Vaccine Advisory Board,
which is comprised of leaders in commercial vaccine development, virology, vector engineering and drug development, has been invaluable
as we approach this critical advancement in our platform development program. We expect NHP studies to begin during the second quarter
of 2022 with the goal of generating important data to inform human clinical studies.
PLACCINE 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.
PLACCINE 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.
In 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.
Issuance and Redemption of Convertible Redeemable
Preferred Stock. In January 2022, the Company announced that it had entered into a securities purchase agreement with
certain institutional investors to purchase Series A and B convertible redeemable preferred stock for approximately $28.5 million in
gross proceeds. The Series A and Series B preferred stock permitted the holders thereof to vote together with the holders of the Company's
common stock on a proposal to effectuate a reverse stock split of the Company's common stock at a special meeting of Company stockholders
held on February 24, 2022. The Series A and Series B preferred stock were not permitted to vote on any other matters.
The holders of the Series A and Series B preferred
stock had the right to redeem their shares of preferred stock for cash at 105% of the stated value after the Company's stockholders'
approval of the reverse stock split. On March 3, 2022, the Company redeemed for cash at a price equal to 105% of the $300 stated value
per share all of its Preferred Stock. As a result, all shares of the Preferred Stock have been retired
and are no longer outstanding and Celsion's only class of outstanding stock is its common stock, par value $0.01 per share. Each
share of common stock entitles the holder to one vote.
Received $1.4 Million