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IMUNON Reports 2022 Financial Results and Provides Business Update Conference Call Begins Today at 11:00 a.m. Eastern Time LAWRENCEVILLE, N.J. (

Key Takeaway: Reports 2022 Financial Results and Provides Business Update Call Begins Today at 11:00 a.m. Eastern Time N.J. (March 30, 2023) - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines

Full Press Release Details

Reports 2022 Financial Results and Provides Business Update
Call Begins Today at 11:00 a.m. Eastern Time
N.J. (March 30, 2023) - 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
year ended December 31, 2022, and provided an update on its clinical development programs with IMNN-001 (formerly GEN-1), a DNA-based
interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of advanced-stage ovarian cancer, and with PLACCINE,
a proprietary, multivalent DNA plasmid technology utilizing synthetic, non-viral vaccine delivery vectors being evaluated in preclinical
studies for superiority over current generation of nucleic acid vaccines.
of 2022 and recent weeks include:
Completed enrollment in the Phase 1/2 OVATION 2 Study with IMNN-001 in advanced ovarian cancer.
Phase 1/2 Clinical Study of IMNN-001 in combination with Avastin in advanced ovarian cancer was opened to enrollment in the first quarter of 2023.
Reported compelling results from a non-human primate (NHP) study confirming PLACCINE as a viable modality for the development of the next generation of prophylactic vaccines. PLACCINE is IMUNON's non-viral, non-device plasmid DNA-based vaccine modality targeting multiple antigens from a single vector.
Signed new research collaborations with The Wistar Institute to develop new vaccine formulations utilizing the Company's PLACCINE modality for the development of vaccines for infectious diseases, and with Acuitas Therapeutics to evaluate IMUNON's plasmid DNA with Acuitas' lipid nanoparticle delivery system.
Made strategic investment in Transomic Technologies to strengthen IMUNON's development capabilities of the PLACCINE DNA vaccine modality.
Reported cash and cash equivalents of $38.9 million as of December 31, 2022, which is expected to fund operations into 2025.
am pleased to report that IMUNON made significant progress during 2022 in advancing our clinical programs in immuno-oncology with IMNN-001,
our IL-12 gene-mediated immunotherapy. Earlier in the year we reported data from 46 patients in the experimental arm of our OVATION 2
Phase 1/2 study who had undergone interval debulking surgery, showing an improvement in R0 surgical resection rates and CRS 3 chemotherapy
response scores over the 41 patients in the control arm. In September we reached full enrollment of 110 patients in this study and expect
to report an additional set of interim, more mature data in the second half of 2023 and topline results by mid-2024," said Dr.
Corinne Le Goff, IMUNON's President and Chief Executive Officer.
PLACCINE modality continues to advance with very promising data. We demonstrated the validity of this proprietary technology in prophylactic
vaccines, with impressive proof-of-concept data in a COVID-19 model. We also completed the evaluation of our vaccines in non-human primates.
I am pleased to report that the final data are consistent with the earlier data and show excellent immunological response and viral clearance.
We demonstrated in a recent mouse study that a single dose of our PLACCINE vaccine without a booster dose produced longer duration of
IgG responses and higher T-cell activation than an mRNA vaccine. We are now nine months into a 12-month PLACCINE stability study and
have demonstrated continued drug stability at the standard refrigerated temperature of 4 C, representing a significant commercial
advantage over mRNA-based vaccines," she added. "With the continuing volatility of the public markets, our decision to raise
capital earlier this year to strengthen our balance sheet and extend our operating runway into 2025 was well timed. We expect to report
several value-creating developments during this period."
Le Goff continued, "This year we anticipate filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration
(FDA) for our seasonal COVID-19 booster vaccine. Our objective is to confirm in a Phase 1 clinical study the safety of our PLACCINE modality.
In the first half of 2023, we intend to apply for a pre-IND consultation with the FDA to receive guidance on our proposed program prior
to submitting the IND.
also will select our next pathogen target for our PLACCINE modality. It is likely that we will choose a pathogen among the list of priority
pathogens established by the Coalition for Epidemic Preparedness Innovations. Our vaccine program objective is to establish the safety
and efficacy of our platform in a Phase 1 human study, and then seek to out-license this powerful technology to pharmaceutical companies
for the utilization of our platform and/or to establish non-dilutive partnerships to develop vaccines for pathogens of interest."
have developed in-house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems. Our scientists can select
any protein from the human or pathogen proteomes to be engineered. In combination, during recent months we made an investment in Transomic
Technologies, which offers a comprehensive array of CRISPR, RNAi and gene expression tools and services. Our existing labs also have
the ability to conduct testing and to run experiments in a variety of animal disease models. These capabilities are expected to allow
us to realize our goal of attracting corporate partners while minimizing dependence on vendors so that we control both the costs and
the development timelines. Our progress to date is evidence that IMUNON is a fully integrated clinical development company with expertise
in running global mid-stage clinical programs," Dr. Le Goff concluded.
Developing the Prophylactic Vaccines of the Future
at Vaccine Technology Summit 2023 Describes Compelling Preclinical Data Supporting Continued development of PLACCINE as a Differentiated,
Next-Generation Vaccine. In March 2023, Khursheed Anwer, Ph.D., the Company's Executive Vice President and Chief Science Officer,
presented data on the company's PLACCINE platform at the Vaccine Technology Summit 2023 in Boston. Dr. Anwer's presentation is titled "A Novel DNA Vaccine Platform with Potential to Create Next Generation Vaccines," and can
be found on the company's website here.
Anwer reviewed the Company's work in advancing its PLACCINE modality and the promising preclinical data generated to date. Among
topics presented was the ability of this multi-valent technology to achieve broad spectrum immunity from a single DNA plasmid with a
synthetic delivery system. This ability is independent of virus, device or liquid nanoparticle formulations. The data presented showed:
Robust immunogenicity and protection in SARS-CoV-2 models
Durable cellular or humoral responses detectable for more than 12 months
Comparable protection activity to a commercial mRNA vaccine in a booster-dose comparison
Superior immune quality versus the mRNA vaccine in a single-dose comparison
addition, the PLACCINE modality had important distinguishing advantages for a commercial vaccine, including a shelf-life at 4 C
for greater than nine months, and the ability for simple, rapid and scalable manufacturing.
at World Vaccine & Immunotherapy Congress Highlights PLACCINE Preclinical Proof of Concept and Key Competitive Advantages. In
December 2022, Khursheed Anwer, Ph.D., the Company's Chief Science Officer, presented at the World Vaccine & Immunotherapy
Congress. Dr. Anwer highlighted the PLACCINE modality and proof-of-concept rodent and non-human primate data in SARS-CoV-2. Slides from
Dr. Anwer's presentation are available here.
Results from NHP Study and Additional Preclinical Studies Support PLACCINE as a Viable Prophylactic Vaccine Development Modality.
In October 2022 the Company reported partial results from an ongoing NHP 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. In 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.
March 1, 2023, IMUNON's CEO issued a Letter to Shareholders announcing the final results from the Company's evaluation of
its vaccines in NHP. Dr. Le Goff reported that the final data are consistent with the earlier data and show excellent immunological response
and viral clearance. The Company reported results from a recent mouse study that demonstrated a single dose of PLACCINE vaccine without
a booster dose produced longer duration of IgG responses and higher T-cell activation than an mRNA vaccine as well as nine-month data
from a 12-month PLACCINE stability study that demonstrates continued drug stability at 4 C (standard refrigerated temperature),
representing a significant commercial advantage over mRNA-based vaccines.
1/2 Clinical Study of IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer was opened to enrollment. In February 2023
the Company announced a collaboration to evaluate IMNN-001 in a Phase 1/2 clinical trial in combination
with bevacizumab in ovarian cancer in the frontline, neoadjuvant setting. Working with four of the foremost comprehensive cancer centers
in the world, the goal of this project is to transform the care of women with ovarian cancer by developing unprecedented capabilities
for understanding and targeting persistent minimal residual disease (MRD), as explained here.
trial is open to enrollment at the University of Texas MD Anderson Cancer Center with expected
additional participation at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and Memorial Sloan Kettering Cancer Center.
The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology will provide artificial intelligence
services throughout the trial, including biomarker and genomic analyses, which is expected to expand the Company's knowledge of
the treatment paradigm.
new Phase 1/2 study, titled "A Phase I/II Study Evaluating the Effect of IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol
Lipopolymer) on Minimal Residual Disease (MRD) as determined by Second Look Laparoscopy when Administered in Combination with Bevacizumab
and Neoadjuvant Chemotherapy in Subjects Newly Diagnosed with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer," is
expected to enroll 50 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir Jazaeri, M.D.,
Professor of Gynecologic Oncology and Reproductive Medicine at MD Anderson. The study will be partially funded by a third party.
Research Agreement with The Wistar Institute's Vaccine & Immunotherapy Center, Acuitas Therapeutics and Transomic Technology.
In January 2023 the Company announced a collaborative research agreement with The Wistar Institute, a global leader in biomedical
research, through its Vaccine & Immunotherapy Center, to research and develop new vaccine formulations utilizing the Company's
PLACCINE modality for the development of vaccines for infectious diseases. The Wistar Institute Vaccine & Immunotherapy Center possesses
world-renowned expertise in cancer, immunology, infectious diseases and vaccine creation. They are uniquely positioned to advance new
vaccine formulations and will facilitate further expansion and development of PLACCINE with the goal of expanding vaccine targets ideally
matched for the Company's novel formulated DNA delivery platform.
the fourth quarter of 2022 the Company 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 Company also announced a strategic
investment in Transomic Technology to utilize its custom vector construction services to continue to generate plasmids that are being
developed and evaluated by IMUNON as part of the Company's DNA vaccine program. As a condition of the investment, Michael H. Tardugno,
IMUNON's executive chairman, has joined the Transomic board of directors.
$1.6 Million in Non-Dilutive Funding from the Sale of New Jersey Net Operating Losses. In January 2023, the Company announced it
Last updated: Mar 30, 2023