Full Press Release Details
Reports Third Quarter 2022 Financial Results
Provides Business Update
Conference Call Today at 11:00 a.m. ET
N.J. (November 14, 2022) - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development
company focused on developing DNA-mediated immunotherapy and next-generation vaccines, today announced financial results for the
three-month and nine-month periods ended September 30, 2022. Highlights of the quarter and recent weeks include:
| Compelling results from ongoing NHP study confirms PLACCINE as a viable modality for the development of the next generation of prophylactic vaccines | |
| Agreement with Acuitas Therapeutics to evaluate IMUNON's plasmid DNA with Acuitas lipid nanoparticle delivery system | |
| Enrollment of Phase I/II OVATION 2 study with GEN-1 in advanced ovarian cancer fully completed | |
| Cash runway expected into 2025 |
Company also provided an update on its preclinical studies of PLACCINE, a proprietary DNA-based
plasmid technology powered by synthetic, non-viral delivery systems, being evaluated in proof-of-concept studies in COVID-19; its clinical
development 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,
recent partnership agreements aiming at strengthening the development of our DNA plasmid platform.
am pleased to report that IMUNON is making excellent progress with our innovative development modalities in infectious diseases and immuno-oncology,
while maintaining a strong financial position," said Dr. Corinne Le Goff, IMUNON's President and Chief Executive
Officer. "Our PLACCINE modality continues to advance with very promising data from a non-human primate proof-of-concept study comparing
our vaccine with commercial mRNA vaccines. Furthermore, I am looking forward to productive collaborations
to continue developing our next generation DNA plasmid platform. Enrollment in our 110-patient OVATION 2 Study of GEN-1 in advanced
ovarian cancer was completed during the third quarter." She added: "With the continuing volatility of the public markets,
our decision to raise additional capital earlier this year to strengthen our balance sheet and extend our operating roadway into 2025
was well timed. We expect to report several value-creating developments during this period."
Development of the prophylactic vaccines of the future
Results from Ongoing Non-Human Primate Study Support PLACCINE as Viable Prophylactic Vaccine Development Modality. In October
2022, the Company reported partial results from an ongoing non-human primate study designed to examine the immunogenicity of its proprietary
DNA-based vaccine in support of PLACCINE as a viable alternative to commercial mRNA vaccines. The study examined a single plasmid DNA
vector containing the SARS-CoV-2 Alpha variant spike antigen formulated with a synthetic DNA delivery system and administered by intramuscular
the study, Cynomolgus monkeys were vaccinated with the PLACCINE vaccine or a commercial mRNA vaccine on Day 1, 28 and 84. Analysis of
blood samples for IgG and neutralizing antibodies showed evidence of immunogenicity both in PLACCINE and mRNA vaccinated subjects. Analysis
of bronchoalveolar lavage for viral load by quantitative PCR showed viral clearance by more than 90% of the non-vaccinated controls.
Viral clearance from nasal swab followed a similar pattern in a majority of vaccinated animals and a similar clearance profile was observed
when viral load was analyzed by the tissue culture infectious dose method.
a head-to-head comparison, the protection efficiency as measured by viral clearance following challenge with the SARS-CoV-2 virus was
similar between PLACCINE and a commercial mRNA vaccine. In an ongoing stability study, the physio-chemical properties and immunogenicity
of the Company's PLACCINE vaccine did not change during storage at 4 C for up to three months.
DNA-based Vaccine Demonstrated Robust Response in Murine Model. In September 2022, the Company provided an update on the development
of a DNA-based vaccine using its PLACCINE platform technology.
data from its completed proof-of-concept mouse challenge study confirmed that a PLACCINE DNA-based vaccine can produce robust levels
of IgG, neutralizing antibodies and T-cell responses. The data demonstrated the ability of the PLACCINE vaccine to protect a SARS-CoV-2
mouse model in a live viral challenge. In the study, mice were vaccinated with a PLACCINE vaccine expressing the SARS-CoV-2 spike antigen
from the D614G variant, the Delta variant or a combination vaccine expressing both the D614G and Delta spike variants. The vaccinations
were administered by intramuscular injection on Day 0 and Day 14, followed by challenge with live SARS-CoV-2 virus on Day 42. All three
vaccines, including the single and dual antigen vaccines, were found to be safe and elicited IgG responses and inhibited the viral load
by 90-95%. The dual-antigen vaccine was equally effective against both variants of the SARS CoV-2 virus. The murine model data suggest
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 exceed six months.
Enrollment Reached in Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer. In September 2022, the Company announced
its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer completed enrollment with 110 patients. GEN-1 is the Company's
IL-12 gene-mediated immunotherapy. Topline results are expected in the first half of 2024.
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 tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following
NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. IL-12
is a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle
comprises a DNA plasmid encoding IL-12 and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by
persistent, local secretion of the IL-12 protein at therapeutic levels.
October 2022, following a pre-planned interim safety review, 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. No dose-limiting toxicities were reported. The Company also announced that interim clinical data from
87 patients who underwent interval debulking surgery showed that those in the GEN-1 treatment arm had improvement in R0 surgical resection
rates and CRS 3 chemotherapy response scores versus 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 examination of the omentum. However, with only 50% of the PFS events so far, the data are still very immature.
2021 the Company announced GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. The Company plans to request FDA Breakthrough
Therapy Designation for GEN-1 based on the encouraging clinical data.
entered into an agreement with Acuitas Therapeutics to evaluate PLACCINE Plasmid DNA with Acuitas' lipid nanoparticle
delivery system. Under this agreement, Acuitas will evaluate the administration of IMUNON's vector constructs formulated
in various LNP formulations for gene expression and immunogenicity in murine models.
the third quarter of 2022, Company management presented at two healthcare conferences. They are:
| Chardan's 6 th Annual Genetic Medicines Conference held October 3-4, 2022. | ||
| H.C. Wainwright 24 th Annual Global Investment Conference held September 12-14, 2022. |
Le Goff presented a corporate overview and members of senior management participated in the conferences.
E. Dentzer, CEO of Curis, appointed to IMUNON's Board of Directors. In October 2022, the Company announced
the appointment of James E. Dentzer to its Board of Directors. Mr. Dentzer is the chief executive officer of Curis, Inc., a biotechnology
company focused on the development of innovative therapeutics for the treatment of cancer and brings to IMUNON more than 20 years of
leadership in the global pharmaceutical industry.
Dentzer has been President and Chief Executive Officer and a member of the Board of Directors of Curis, Inc. since September 2018. From
March 2018 to September 2018, Mr. Dentzer served as Curis' Chief Operating Officer and Chief Financial Officer. From
March 2016 to March 2018, Mr. Dentzer served as Curis' Chief Administrative Officer and Chief Financial Officer.
Prior to joining Curis, Mr. Dentzer served as Chief Financial Officer of Dicerna Pharmaceuticals, Inc. from December 2013 to December
2015, and of Valeritas and Amicus Therapeutics, Inc. from October 2006 to October 2009. In prior positions, he spent six years as Corporate
Controller of Biogen Inc. and six years in various senior financial roles at E.I. du Pont de Nemours and Company in the U.S. and Asia.
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 its Board of Directors appointed biopharmaceutical executive Corinne Le Goff, Pharm. D., MBA
as President, Chief Executive Officer and Director, effective July 18, 2022. Michael H. Tardugno continues to serve as Executive Chairman
of IMUNON's Board of Directors. Dr. 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 large pharmaceutical companies and small, innovative biotech companies.
to IMUNON, Dr. Le Goff most recently served as 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 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 .
Le Goff was recently recognized by Forbes magazine as one of the women over the age of 50 who are changing the world.
Quarter Financial Results
reported a net loss for the third quarter of 2022 of $6.1 million ($0.87 per share), compared with a net loss of $5.4 million ($0.94
per share) for the third quarter of 2021. Operating expenses were $6.3 million for the third quarter in 2022, an increase of $1.1 million
(21%) from $5.2 million for the comparable prior-year period.
and development expenses were $2.4 million for the third quarter of 2022, a decrease of $0.1 million (2%) from $2.5 million for the comparable
period in 2021. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE
DNA vaccine technology platform increased to $1.5 million for the third quarter of 2022, compared with $1.3 million for the same period
of 2021. Costs associated with the OPTIMA Phase III study were $0.1 million for the third quarter of 2022, which represented expenses
associated with closing out this previously discontinued study. Other clinical, CMC and regulatory costs were $0.8 million for the third
quarter of 2022, compared with $1.0 million for the comparable period of 2021.