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IMUNON Reports First Quarter 2023 Financial Results and Provides Business Update Non-Viral DNA-Mediated Immunotherapy and Next-Generation Vaccine Programs with Multiple Near-Term Milestones Supported by a Strong Balance

Key Takeaway: Reports First Quarter 2023 Financial Results and Provides Business Update DNA-Mediated Immunotherapy and Next-Generation Vaccine Programs with Multiple Near-Term Milestones Supported by a Strong Balance Sheet Call Begins Today at 11:00 a.m. EDT N.J. (May 11, 2023) - IMUNON, In

Full Press Release Details

Reports First Quarter 2023 Financial Results and Provides Business Update
DNA-Mediated Immunotherapy and Next-Generation Vaccine Programs with Multiple Near-Term Milestones Supported by a Strong Balance Sheet
Call Begins Today at 11:00 a.m. EDT
N.J. (May 11, 2023) - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development
company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, today announced financial results
for the three months ended March 31, 2023, 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 PLACCINE, a proprietary, multivalent DNA plasmid technology utilizing synthetic, non-viral vaccine delivery vectors being evaluated
in preclinical studies for superiority over the current generation of nucleic acid vaccines.
of the first quarter of 2023 and recent weeks include:
Opened enrollment in a Phase 1/2 clinical study of IMNN-001 in combination with Avastin in advanced ovarian cancer
Announced compelling results from a non-human primate study confirming PLACCINE as a viable modality for the development of the next generation of prophylactic vaccines; PLACCINE is a non-viral, non-device plasmid DNA-based vaccine modality targeting multiple antigens from a single vector
Reported data suggesting PLACCINE vaccines elicit robust and more durable T-cell responses than commercial mRNA vaccines, signaling that these vaccines may provide greater protection against reinfection, hospitalization or death
Signed new research collaborations with The Wistar Institute to develop new vaccine formulations utilizing PLACCINE for infectious diseases
Reported cash and cash equivalents of $37.3 million as of March 31, 2023, which is expected to fund operations into 2025
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 coupled with final data from non-human primate studies showing excellent
immunological response and viral clearance. We also 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 more than 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," said Dr. Corinne Le Goff, IMUNON's
President and Chief Executive Officer.
March we applied for a pre-IND consultation with the U.S. Food and Drug Administration (FDA) to receive guidance on our proposed program
for our seasonal COVID-19 booster vaccine prior to submitting an Investigational New Drug (IND) application with the FDA in the fourth
quarter of 2023. Our objective is to confirm in a Phase 1 clinical study the safety of our PLACCINE modality. We will also select our
next pathogen target for our PLACCINE modality. We likely will choose a pathogen from 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 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," she added.
have now developed an in-house pilot manufacturing capability for DNA plasmids and nanoparticle delivery systems. Our scientists can
select any protein from the human or pathogen proteomes to be engineered. Our existing labs also have the ability to conduct testing
and to run experiments in a variety of animal disease models. These internal capabilities will allow us to control both the costs and
the development timelines in support of our goal to attract corporate partners.
the continued volatility of the public equity markets, our decision to raise significant capital in 2021 and early 2022 to extend our
cash runway into 2025 was well timed. We expect to report several value-creating developments over the next six to 18 months, among them
reporting additional interim data on IMNN-001 from our OVATION 2 Study and the combination study with bevacizumab in advanced ovarian
cancer, reporting topline data from the OVATION 2 Study, filing the IND for our SARS-CoV-2 vaccine and announcing proof-of-concept vaccine
data for our next pathogen," 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., IMUNON's Executive Vice President and Chief Science Officer,
presented data on the Company's PLACCINE platform at the Vaccine Technology Summit 2023. 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
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.
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.
new Phase 1/2 study 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. A third party will partially fund the
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.
at American Association for Cancer Research (AACR) Describes Findings from Mouse Model of Peritoneally Disseminated Ovarian Cancer Suggest
Biweekly Dosing Regimen for Further Evaluation in Human Clinical Studies. In April 2023 Jean Boyer,
Ph.D., IMUNON's vice president of preclinical research, presented a poster titled
"Efficacy of IMNN-001, an Interleukin-12 Immune Gene Therapy, at Different Dose Frequencies" at AACR. The poster can be found
on the company's website here.
concluded that IMNN-001 demonstrated stimulation of the immune response in the ID8 ovarian tumor model. Of the three dosing regimens
tested, the once every 2-week regimen demonstrated comparability to the weekly regimen while showing superiority to the once every 3-week
regimen, particularly with respect to mortality and tumor burden. Thus, exploring once every 2-week dosing of IMNN-001 in human studies
Collaborations and Corporate Developments
Research Agreement Signed with The Wistar Institute's Vaccine & Immunotherapy Center. 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.
$1.6 Million in Non-Dilutive Funding from the Sale of New Jersey Net Operating Losses. In January 2023, the Company announced it
received $1.6 million in net cash proceeds from the sale of approximately $1.7 million of its unused New Jersey net operating losses
(NOLs). The NOL sales cover the tax year 2021 and are administered through the New Jersey Economic Development Authority's (NJEDA)
Technology Business Tax Certificate Transfer (NOL) program. This non-dilutive funding further strengthened the Company's balance
sheet. The Company plans to sell an additional $1.9 million of unused New Jersey NOLs available to the Company under the program in 2023.
quarter Financial Results
reported a net loss for the first quarter of 2023 of $5.6 million, or $0.68 per share, compared with a net loss of $10.5 million, or
$1.82 per share, for the first quarter of 2022. Operating expenses were $5.7 million for the first quarter of 2023, a decrease of $0.3
million or 5% from $6.0 million for the first quarter of 2022.
cash used for operating activities was $4.1 million for the first quarter of 2023, compared with $8.0 million for the comparable prior-year
period. This decrease was primarily due to the one-time payment of $4.5 million in interest expense resulting from the sale and subsequent
redemption of $30.0 million of convertible, redeemable preferred stock during the first quarter of 2022.
provided by financing activities of $2.5 million during the first quarter of 2023 resulted from equity sales under the Company's
At-the-Market Equity Facility. The Company had $37.3 million in
cash, investments and restricted cash as of March 31, 2023. Combined with $1.9 million in
planned future sales of the Company's State of New Jersey NOLs, the Company believes it has sufficient capital resources to fund
its operations into 2025.
and development (R&D) expenses were $2.6 million for the first quarter of 2023, a decrease of $0.5 million from $3.1 million for
the comparable period in 2022. R&D costs associated with the development of IMNN-001 to support the OVATION 2 Study as well as development
of the PLACCINE DNA vaccine technology platform increased to $1.7 million for the first quarter of 2023, compared with $1.9 million for
the same period of 2022. Other clinical and regulatory costs were $0.3 million for the first quarter of 2023, compared with $0.8 million
for the first quarter of 2022. CMC costs increased to $0.7 million for the first quarter of 2023, compared with $0.3 million for the
first quarter of 2022 due to higher costs related to the development of in-house pilot manufacturing capabilities for DNA plasmids and
nanoparticle delivery systems.
and administrative expenses were $3.1 million for the first quarter of 2023, compared with $2.9 million for the comparable prior-year
period. This increase was primarily attributable to lower non-cash stock compensation expense offset by higher professional fees, including
Last updated: May 11, 2023