Full Press Release Details
Corporation Reports 2020 Financial Results and Provides Business Update
2021 with a Focus on Cancer Immunotherapy and
Infectious Vaccines and a Strong Balance Sheet
Call Begins at 11:00 a.m. Eastern Time Today
N.J. (March 19, 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 year ended December 31, 2020 and provided an update on clinical development programs with GEN-1,
a DNA-based immunotherapy in Phase I/II development for the localized treatment of ovarian cancer,
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
infectious vaccines.
entered 2021 with a renewed focus and prioritization on DNA-based immunotherapies for ovarian cancer and an initiative for next-generation
vaccines for preventing or treating infections from a broad range of infectious agents, including coronaviruses, using our PLACCINE
DNA vaccine technology platform. All of our work is supported by a strong balance sheet and a three-year cash operating
runway," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer.
Phase I/II OVATION 2 Study is over one-third enrolled. With 25 clinical sites to be activated by the end of the first quarter
of 2021, encouraging trial data to date and the strong commitment of our clinical investigators, we expect to complete enrollment
well before the end of 2021. Initial data at the 100 mg/m² dose cohort appear to be consistent with the directionally impressive
results reported from our Phase Ib dose-escalating trial (the OVATION I Study) in ovarian cancer. Of 28 patients who completed
interval debulking surgery, 81% of those treated with GEN-1 had an R0 resection, compared with 58% of control patients, a 41%
Tardugno added, "During the first quarter of 2021, we announced an initiative to focus our considerable
DNA plasmid experience and competencies on DNA vaccine development, an approach we believe may represent an advance in nucleic
acid immunotherapy. Leveraging our clinical-stage TheraPlas platform, we envision a vaccine characterized by a single-plasmid
DNA with multiple coding regions. Celsion's plasmid vectors that are currently in development are designed to promote multiple
antigens that are expressed by a single pathogen in combination with a potent immune modifier such as IL-12. IL-12 is the active
ingredient currently used in our product candidate GEN-1. We are well positioned with a capital structure sufficient to
support our planned R&D and clinical programs through transformative milestones. In doing so, we look to create significant
value for our shareholders, patients and the medical community."
Encouraging Interim Clinical Update on Phase I/II OVATION 2 Study with GEN-1 in Patients with Advanced Ovarian Cancer.
On February 25, 2021, the Company provided an update on its Phase I/II OVATION 2 Study with GEN-1 in patients with advanced
ovarian cancer. The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed
with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after
three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three adjuvant cycles of
chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall
survival. To date, the Company has enrolled approximately one-third of the anticipated 110 patients to be enrolled into the OVATION
2 Study. Currently, 28 patients have had their interval debulking surgery with the following results:
| 13 of 16, or 81%, of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed; | ||
| Seven of 12 patients, or 58%, of patients in the control arm had an R0 resection; and, | ||
| These interim data represent a 41% improvement in R0 resection rates for GEN-1- patients compared with control arm patients and is consistent with the reported improvement in resection scores noted in the encouraging Phase I OVATION I Study, the manuscript of which has been submitted for peer-review publication. |
FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer. On March 22, 2021, the Company announced receipt of Fast
Track designation from the U.S. Food and Drug Administration (FDA) for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy
currently in Phase II development for the treatment of advanced ovarian cancer. Fast Track designation is intended to facilitate
the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need. According
to the FDA, a Fast-Track Drug must show some advantage over available therapy, including:
| Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes | ||
| Avoiding serious side effects of an available therapy | ||
| Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment |
Provisional U.S. Patent Application for a Broad Range of Next-Generation DNA Vaccines. On January 28, 2021, the Company
announced the filing of a provisional U.S. patent
application for a novel DNA-based, investigational vaccine for preventing or treating infections from a broad range of infectious
agents, including coronaviruses, using its PLACCINE DNA vaccine technology platform. The provisional patent covers a family of
novel composition of multi-cistronic vectors and polymeric nanoparticles that comprise the PLACCINE DNA vaccine platform technology
for preventing or treating infectious agents that have the potential for global pandemics, including the SARS-CoV-2 virus and
its variants, using the Company's platform technology. Celsion's vaccine approach is designed to optimize the quality
of the immune response dictating the efficiency of pathogen clearance and patient recovery. Celsion has taken a multivalent approach
in an effort to generate an even more robust immune response that not only results in a strong neutralizing antibody response,
but also a more robust and durable T-cell response. Delivered with Celsion's synthetic polymeric system, the proprietary
DNA plasmid is protected from degradation and its cellular uptake is facilitated.
is a natural extension of the Company's synthetic, non-viral TheraPlas delivery technology currently in a Phase II trial
for the treatment of late-stage ovarian cancer with GEN-1. Celsion's proprietary multifunctional
DNA vaccine technology concept is built on the flexible PLACCINE technology platform that is amenable to rapidly responding to
the SARS-CoV-2 virus, as well as possible future mutations of SARS-CoV-2, other future pandemics, emerging bioterrorism threats
and novel infectious diseases. Celsion's extensive experience with TheraPlas suggests that the PLACCINE-based nanoparticles
are stable at storage temperatures of 4oC to 25oC,
making vaccines developed on this platform easily suitable for broad worldwide distribution.
a Vaccine Advisory Board. On February 12, 2021, the Company announced the
formation of a Vaccine Advisory Board and the appointment of its first two members:
| Britt A. Glaunsinger, Ph.D., Professor, Virology & Molecular Biology, Howard Hughes Medical Institute, University of California, Berkeley; and | ||
| Dr. Xinzhen Yang, M.D., Ph.D., Independent Professional Consultant for the Gerson Lehman Group and former Director of Viral Vaccines / Program Lead of the HCMV Vaccine Program at Pfizer Inc. |
Balance Sheet Through a $35 Million Registered Direct Offering of Common Shares Priced At-The-Market Under NASDAQ Rules. On
January 26, 2021, the Company announced the closing of a registered direct offering of 25,925,925 shares of common stock
at a purchase price of $1.35 per share, priced at-the-market under Nasdaq rules, resulting in net proceeds of $32.6 million after
deducting placement agents' fees but before expenses payable by the Company. Celsion intends to use the net proceeds for
general corporate purposes, including research and development activities, capital expenditures and working capital. This financing,
coupled with the pending sale of its New Jersey net operating losses in the first half of 2021, will extend the Company's
operating roadway through 2023, well beyond several important clinical and R&D milestones.
$2 Million Allocation Through the New Jersey Technology Business Tax Certificate Transfer (NOL) Program, with an Additional $5
Million Expected in 2021-2023. In December 2020, the Company received approval from
the New Jersey Economic Development Authority's (NJEDA) Technology Business Tax Certificate Transfer program to sell its
unused New Jersey net operating losses (NOLs) and R&D tax credits. In 2019, the
Company received approval from the NJEDA to sell $1.9 million of its unused New
Jersey NOLs and was able to transfer this credit and receive approximately $1.8 million
of net cash proceeds in the first half of 2020. The Company anticipates it will be able
to transfer this current year credit and receive net proceeds of approximately $1.85 million in
the first half of 2021. An additional $5.0 million allocation of NOL sales will be available to the Company during 2021-2023.
Letter to Stockholders with an Update on the Phase III OPTIMA Study with ThermoDox .
11, 2021, the Company issued a letter to stockholders providing an update on the status of the Phase III OPTIMA Study and the
decision to stop following patients in the Study. Since the surprising and incredibly disappointing second interim analysis
results of the Phase III OPTIMA Study in primary liver cancer announced on July 9, 2020, in which the independent Data Monitoring
Committee (DMC) found that the interim findings suggested futility, the Company continued to follow patients for overall survival
(OS). Independent analyses conducted by a global biometrics contract research organization and by the National Institutes of Health
(NIH) did not find any evidence of significance or factors that would justify continuing to follow patients for OS. Therefore,
the Company has notified all clinical sites to discontinue following patients. The OPTIMA Study database of 556 patients was frozen
at 185 patient deaths. While the analyses did identify certain patient subgroups that appear to have had a clinical benefit, the
Company concluded that it would not be in its best interest to pursue these retrospective findings as the regulatory hurdles supporting
further development will be significant.
will continue to work closely with and support investigations involving ThermoDox by others throughout the world
in breast cancer, pancreatic cancer and in solid tumors in children. Following inquiries from the NIH, the Company intends to
renew its Cooperative Research and Development Agreement (CRADA) with the Institute at a nominal cost, one goal of which is to
pursue the NIH's interest in a study of ThermoDox to treat patients with bladder cancer. Importantly, Celsion
is developing a business model to support these investigator-sponsored studies in a manner that will not interfere with the Company's
focus on its GEN-1 programs and vaccine development initiative.
Results for the Year Ended December 31, 2020
reported a net loss of $21.5 million ($0.67 per share) in 2020, compared with a net loss of $16.8 million ($0.77 per share)