Full Press Release Details
Corporation Reports 2021 Financial Results and Provides Business Update
on Cancer Immunotherapy and Next-Generation Vaccines and a Strong Balance Sheet
Call Begins Today at 11:00 a.m. Eastern Time
N.J. (March 31, 2022) - 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, 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 and
preclinical studies with PLACCINE, a proprietary,
multivalent DNA plasmid technology utilizing synthetic, non-viral vaccine delivery vectors, being evaluated for superiority over the
current generation of nucleic acid vaccines.
continues to show momentum as patient enrollment in OVATION 2, our randomized Phase II study of advanced ovarian cancer patients, is
now over 80%. Full enrollment is expected by the third quarter of 2022. We remain encouraged by surgical resection scores among patients
being treated at the 100 mg/m² dose cohort in the Phase II OVATION 2 Study. Early reports from the first 39 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
various vaccine conferences, we 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 is to demonstrate the superiority of Celsion's DNA vaccine over current mRNA vaccines 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 temperatures.
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. We
expect first inoculation of NHP subjects to occur during the last week of March with the goal of generating important data to inform
human clinical studies."
Presented at Cytokine-Based Cancer Immunotherapies Summit. In
November 2021, the Company announced that Khursheed Anwer, Ph.D., executive vice president and chief science officer, made a presentation
on the Company's GEN-1 interleukin 12 (IL-12) immunotherapy program at the Cytokine-Based Cancer Immunotherapies Summit held in
Boston on November 30 to December 2, 2021. Dr. Anwer's presentation, was titled "A Non-Viral Gene Therapy Approach to IL-12
Delivery for The Treatment of Cancer." The Company was invited to submit a poster presentation which aligned with Dr. Anwer's
oral presentation on the GEN-1 IL-12 program.
his presentation, Dr. Anwer discussed how local delivery of IL-12 without significant systemic toxicity is feasible with a non-viral
gene therapy approach that involves administration of an IL-12 plasmid with a synthetic DNA delivery system. Dr. Anwer also discussed
how weekly intraperitoneal administration of GEN-1 yields durable increases in IL-12 and IFN-y, and why repeated weekly administration
of GEN-1 in combination with standard chemotherapy remodels the tumor immune environment to favor immune stimulation over immune suppression.
Anwer also participated in two panel discussions titled "What Do We Know & Where Do We Want to Go?" and "Side Effects
- Mitigating Against Hypotension + Fever with Immune-Stimulating Agents (NK Cell Engagers, PD-1s, Cytokines, T-Cell Engagers) =
Cytokine Release Syndrome (CRS)?"
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 81 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.
Company also announced that over 75% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from
the first 39 patients who have undergone interval debulking surgery showed that the GEN-1 treatment arm is showing a 27% improvement
in R0 surgical resection rate 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.
Presentation on Celsion's Ongoing Work with DNA-based Vaccines at International Vaccines Congress. In October 2021, the
Company announced that Dr. Anwer presented at the International Vaccines Congress. His presentation was titled "Immunogenicity
of DNA Vaccines based on Multicistronic Vectors and Synthetic DNA Delivery Systems" and can
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.
Key Resources to the Company's Vaccine Development Initiative. In October 2021, the Company announced the
strengthening of its management team with a new hire and a promotion in its vaccine development program as follows:
| Carlo Iavarone, Ph.D. joined as Senior Director, Non-Clinical Research | ||
| Subeena Sood, Ph.D. promoted to Senior Manager, Biology and Preclinical Studies |
Iavarone is project leader for the PLACCINE vaccine initiative. He brings to Celsion more than 15 years of experience investigating and
leading the development of vaccines, including molecular target identification and characterization of RNA vaccines. Most recently, from
2019 until 2021 he was a science advisor for both Guidepoint and Clora, providing input for a viral target and RNA vaccine delivery system.
Dr. Iavarone joined GlaxoSmithKline in 2015 as a senior scientist studying small molecules and RNA vaccines in animal and human cell
lines. From 2007 until 2015 he held positions of increasing responsibility at Novartis, including as a principal scientist for a melanoma
Sood is responsible for assay development and in vivo experiments for the PLACCINE DNA vaccine and gene therapy program. She has
experience with several pharmaceutical companies in experiment design, pharmacological and biochemical assays, manufacturing process
design and development, and optimization and implementation of Quality by Design. Dr. Sood joined Celsion as manager of animal research
in 2019, where she has designed and conducted all preclinical research. Prior to Celsion, since 2017 she was a Formulation Scientist
at Novocol Healthcare. From 2016 to 2017, Dr. Sood was a Research Associate at Nektar Therapeutics, and from 2015 to 2016 she was a Quality
Control Chemist at Par Pharmaceuticals. She also worked in regenerative medicine as a Research Fellow at Medstar Heart Institute, Washington
Hospital Center in Washington, D.C. from 2010 to 2013.
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 mouse data
and will evaluate the Company's lead vaccine formulations for safety, immunogenicity and protection against SARS-CoV-2.
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.
a $30 Million Registered Direct Offering of Convertible Redeemable Preferred Stock. In January 2022, the Company announced that
it has entered into a securities purchase agreement with certain institutional investors to purchase 50,000 shares of Series A convertible
redeemable preferred stock and 50,000 shares of Series B convertible redeemable preferred stock. Each share of Series A and Series B
preferred stock has a purchase price of $285, representing an original issue discount of 5% of the $300 stated value of each share. Each
share of Series A preferred stock is convertible into shares of Celsion's common stock at an initial conversion price of $0.91
per share. Each share of Series B preferred stock is convertible into shares of Celsion's common stock at an initial conversion
price of $1.00 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time
following the Company's receipt of stockholder approval for a reverse stock split of the Company's common stock. Celsion
will be permitted to compel conversion of the Series A and Series B preferred stock after the fulfillment of certain conditions and subject
to certain limitations. Total net proceeds from the offerings, before deducting the placement agent's fees and other estimated
offering expenses, is approximately $28.5 million.
Series A and Series B preferred stock permit 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 to
be held on February 24, 2022. The Series A preferred stock permits the holder to vote on such proposal on an as converted to common stock
basis. The Series B preferred stock permits the holder to cast 45,000 votes per share of Series B preferred stock on such proposal. The