Full Press Release Details
Corporation Reports Third Quarter 2021 Financial Results and Provides Business Update
Sheet Supports Focus on Immuno-Oncology and Next-Generation Vaccine Initiative
Call Begins Today at 11:00 a.m. Eastern Time
N.J. (November 15, 2021) - Celsion Corporation (NASDAQ: CLSN), a clinical-stage
drug-development company focused on DNA-based immunotherapy and next-generation vaccines, today announced financial results for
the three and nine months ended September 30, 2021, and provided an update on clinical development programs with GEN-1,
a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development
for the treatment of advanced-stage ovarian cancer (Stage III/IV), and ThermoDox ,
a proprietary heat-activated liposomal encapsulation of doxorubicin under investigator-sponsored development for several cancer indications.
In addition, Celsion has two feasibility-stage platform technologies for the development
of novel nucleic acid-based immunotherapies and next-generation vaccines for infectious diseases.
continues to show momentum as patient enrollment nears 70% with full enrollment targeted by the first half of 2022. We are encouraged
with surgical resection results at the 100 mg/m² dose cohort in the Phase II OVATION 2 Study. From the first 36 patients with interval
debulking surgery, 80% treated with GEN-1 at a dose of 100 mg/m² plus neoadjuvant chemotherapy (NACT) had a complete tumor resection
(R0), which indicates a microscopically margin-negative resection with no gross or microscopic tumor remaining in the tumor bed; this
compares with 56% of patients in the control arm having R0 resections. These results are reasonably consistent with those reported from
our earlier Phase I trials in advanced-stage ovarian cancer," said Michael H. Tardugno,
Celsion's chairman, president and chief executive officer.
the International Vaccines Congress in October, Celsion announced
results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell response specific to the spike
antigen of SARS-CoV-2 when immunizing BALB/c mice with our next-generation PLACCINE DNA vaccine," added
Mr. Tardugno. "Our goal over the next several quarters is to demonstrate the superiority of Celsion's multicistronic DNA
vaccine over current mRNA vaccines with respect to the quality of immune response (higher affinity of neutralizing antibodies, IgG titers
and T-cell response) against multiple SARS-CoV-2 variants, longer duration of immune response and a stable product at lower temperatures."
Data Reported on the OVATION 2 Study. Interim clinical data from the first 36 patients who have undergone interval debulking
surgery are as follows:
| 20 patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT, with 16 out of 20 patients (80%) having R0 resections. | ||
| 16 patients were treated with NACT only, with 9 out of 16 patients (56%) having R0 resections. | ||
| When combining these results with the surgical resection rates observed in the Company's prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to NACT. |
| % Patients with R0 Resections | ||
| 0, 36, 47 mg/m² of GEN-1 plus NACT | n=22 | 50 % |
| 61, 79, 100 mg/m² of GEN-1 plus NACT | n=28 | 82 % |
of OVATION 1 Study in the Journal of Clinical Cancer Research. In July 2021, the Company announced the publication of data
from its Phase 1b OVATION 1 Study with GEN-1 in combination with NACT in patients with advanced ovarian cancer in Clinical Cancer
Research, a journal of the American Association for Cancer Research. The study, authored by Premel H. Thaker, M.D. et al.
and titled "GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I
Dose-Escalation Study," is available here. Dr. Thaker, Professor of Gynecologic Oncology and Director of Gynecologic Oncology Clinical
Research at the Washington University School of Medicine in St. Louis, is the study chair for the OVATION program.
OVATION 1 Study enrolled 18 patients with newly diagnosed stage IIIC and IV epithelial ovarian cancer in a standard 3+3 dose-escalation
design testing four GEN-1 doses (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) in combination
with NACT (carboplatin-paclitaxel). There were 15 patients evaluable for safety, and 14 underwent interval debulking and were evaluable
previously reported, there were no dose-limiting toxicities. As shown in the chart below, in the two highest doses of GEN-1 the objective
response rate was 100% and the R0 resection rate was 88%. Newly published data show the CRS, which was analyzed in this paper for the
first time, was 50% in the two highest doses of GEN-1, compared with 28% from a major publication evaluating CRS scoring.
Responses: Tumor Response, Surgical Outcome, Pathological Response and Chemotherapy Response Score with NAC/GEN-1 Escalating Doses
| Radiographic Response | Total (n) | Cohort 1 36 mg/m 2 | Cohort 2 47 mg/m 2 | Cohort 3 61 mg/m 2 | Cohort 4 79 mg/m 2 | |||||||
| CR | 2 | 1 | 0 | 0 | 1 | |||||||
| Tumor Response | PR | 10 | 0 | 3 | 3 | 4 | ||||||
| SD | 2 | 2 | 0 | 0 | 0 | |||||||
| Objective Response Rate | 67% | 100% | ||||||||||
| R0 | 9 | 2 | 0 | 2 | 5 | |||||||
| Surgical Outcome | R1 | 3 | 1 | 2 | 0 | 0 | ||||||
| R2 | 2 | 0 | 1 | 1 | 0 | |||||||
| R0 Resection Rate | 33% | 88% | ||||||||||
| cPR | 1 | 1 | 0 | 0 | 0 | |||||||
| Pathological Response | Micro | 8 | 1 | 2 | 1 | 4 | ||||||
| Macro | 5 | 1 | 1 | 2 | 1 | |||||||
| cPR/Micro Rate | 60% | 63% | ||||||||||
| CRS 3 | 5 | 1 | 0 | 2 | 2 | |||||||
| Chemotherapy Response Score | CRS 2 | 5 | 2 | 1 | 0 | 2 | ||||||
| CRS 1 | 4 | 0 | 2 | 1 | 1 | |||||||
| CRS 3 Rate | 17% | 50% |
Responses: IL-12 and IFN- Levels, Response to Immune-Suppressive Agents; Ratio of CD8+ Cells to Immune Suppressive Agents
| A dose-dependent increase in immunostimulatory cytokines IL-12 and its downstream cytokine IFN- in ascitic fluid. The anticancer effects of these cytokines are widely recognized in human malignancies. | ||
| The proportion of myeloid dendritic cells in the peritoneal fluid trended higher (3.1-fold) accompanied by a similar 3.0-fold rise in CD8+ cells. | ||
| GEN-1 appeared to reduce four immunosuppressive signals (Foxp3, IDO1, PD-1 and PD-L1) within the tumor microenvironment, a trend not seen with NAC therapy alone. | ||
| GEN-1 appeared to stimulate the body's immune system through the production of CD4 and CD8 cells. | ||
| GEN-1 gene therapy was associated with an apparent increase in the cytotoxic state of T cells within the tumor microenvironment as indicated by the increases in the ratios of CD8+/CD4+ and CD8+/Treg cells. Indeed, higher CD8+/CD4+ T cell and CD8+/Treg ratios are considered prognostic for prolonged survival. |
Advisory Board Expanded. In July 2021, the Company announced
the addition of Dan H. Barouch, M.D., Ph.D. and Luke D. Handke, Ph.D. to its Vaccine Advisory Board (VAB). They joined Britt A. Glaunsinger,
Ph.D. and Xinzhen Yang, M.D., Ph.D. on the VAB, which was formed in February 2021.
Barouch is the principal investigator at the Barouch Laboratory, Director of the Center for Virology and Vaccine Research at Beth Israel
Deaconess Medical Center and William Bosworth Castle Professor of Medicine at Harvard Medical School. In addition, he is a key participant
in the Bill & Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery, the National Institutes of Health Martin Delaney
HIV-1 Cure Collaboratory and the Ragon Institute of MGH, MIT and Harvard. Dr. Barouch and his team were instrumental in developing the
vector, a variant of an adenovirus called Ad26, that was used to make single-dose vaccines for HIV, tuberculosis and Zika, and ultimately,
in conjunction with Johnson & Johnson researchers, SARS-CoV-2. He has authored numerous peer-reviewed articles.
Handke is a highly skilled molecular biologist and microbiologist with a decade of pharmaceutical industry experience including nine
years with Pfizer's Vaccine Research and Early Development Unit. At Pfizer he served as molecular biology lead on an early phase
viral vaccine program and was the lead reviewer of data sources and literature citations for licensure application for the Trumenba
meningococcal group B vaccine in the U.S. and in Europe. He began his career in vaccine research at Wyeth. He is co-author and
co-inventor on various patent applications for a protein-based RSV vaccine and a SARS-CoV-2 detection assay and authored 10 peer-reviewed
publications including six as first author. Dr. Handke is currently a Senior Scientist at the University of Nebraska Medical Center in
Omaha. In addition to serving on the VAB, Dr. Handke will provide consulting services to Celsion in connection with its vaccine-development
program, which involves DNA-based vectors in combination with proprietary non-viral cellular delivery agents. He also will advise Celsion
as it advances this program into human clinical studies.
from In Vivo Studies with PLACCINE DNA Vaccine Platform Indicate Immune Response Against SARS-Cov-2. In September 2021,
the Company announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell response
specific to the spike antigen of SARS-CoV-2 when immunizing BALB/c mice with the Company's next-generation PLACCINE DNA vaccine
platform. Moreover, the antibodies to SARS-CoV-2 spike antigen prevented the infection of cultured cells in a viral neutralization assay.
The production of antibodies predicts the ability of PLACCINE to protect against SARS-CoV-2 exposure, and the elicitation of cytotoxic
T-cell response shows the vaccine's potential to eradicate cells infected with SARS-CoV-2. These findings demonstrate the potential
immunogenicity of Celsion's PLACCINE DNA vaccine, which is hypothesized to provide broad-spectrum protection and resistance against
variants by incorporating multiple viral antigens, to improve vaccine stability at storage temperatures of 4oC and above,
and to facilitate cheaper and easier manufacturing. Celsion reported these data at the International Vaccines Conference in October 2021.
with Hainan Poly Pharm to Manufacture Celsion's DNA-based Vaccine. In September 2021, the Company announced an amendment
to its existing contract manufacturing agreement with Hainan Poly Pharm Co. Ltd., a generics manufacturer dedicated to providing therapeutic-value
products and services to patients and customers around the world, to include development work for the Company's investigational
DNA-based COVID-19 vaccine. Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for
use, will also manufacture commercial batches for Celsion's vaccine based on its TheraPlas technology. Poly Pharm is experienced
with chemistry, manufacturing and controls (CMC), process development and good manufacturing processes (cGMP), including process optimization
and manufacturing services to help customers advance new drug development projects. Its sites and pharmaceutical compounds have been
approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), China's National Medical Products
Administration (NMPA) and the World Health Organization (WHO).
Presentation on Celsion's Ongoing Work with DNA-based Vaccines at International Vaccines Congress. In October 2021, the
Company announced that Khursheed Anwer, Ph.D., executive vice president and chief science officer, presented at the International Vaccines
Congress . Dr. Anwer's presentation was titled "Immunogenicity of DNA Vaccines based on Multicistronic Vectors and Synthetic
DNA Delivery Systems" and can be viewed here. Dr. Anwer discussed ongoing proof-of-concept
studies in SARS-CoV-2 with the Company's DNA-based vaccine approach utilizing its PLACCINE platform. PLACCINE, Celsion's
proprietary design for DNA vectors, encompasses molecular elements designed to improve the immune response by targeting multiple antigens
of a pathogen or multiple mutants of the same antigen. Dr. Anwer also reviewed the PLACCINE technology and the production of a family
of DNA vaccine vectors expressing one or more SARS-CoV-2 surface antigens as a proof-of-concept target, verified vector composition and
demonstrated expression of the encoded genes.
at Three Healthcare Investment Conferences. Celsion management made presentations at the following investment conferences in
| Chardan's 5 th Annual Genetic Medicines Conference . Michael H. Tardugno, Celsion's chairman, president and chief executive officer, and Khursheed Anwer, Ph.D., Celsion's chief scientific officer, participated in a fireside chat. | ||
| LD Micro Main Event . Jeffrey W. Church, Celsion's chief financial officer, presented virtually. | ||
| Alliance Global Partners' Virtual Healthcare Conference . Mr. Tardugno participated in an oncology focused panel discussion moderated by James Molloy, Research Analyst. |
Quarter Financial Results
the quarter ended September 30, 2021, Celsion reported a net loss of $5.4 million ($0.06 per share), compared with a net loss of $8.1
million ($0.24 per share) in the same period of 2020. Operating expenses were $5.2 million in the third quarter of 2021, which represented
a $0.9 million (21%) increase from $4.3 million in the same period of 2020.
Company ended the third quarter of 2021 with $60.6 million in cash, investment securities, restricted cash and accrued interest receivable.
Coupled with future sales of unused New Jersey NOL's, the Company believes it has sufficient capital resources to fund its operations
through the end of 2024.
and development (R&D) expenses were $2.5 million in the third quarter of 2021, consistent with $2.5 million reported in the third
quarter of 2020. Costs associated with the OVATION 2