Full Press Release Details
Reports First Quarter 2024 Financial Results and Provides Business Update
Call Begins Today at 11:00 a.m. Eastern Time
N.J. (May 13, 2024) - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development
company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results
for the three months ended March 31, 2024. The Company also provided an update on its clinical development programs with IMNN-001, a
DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for first-line treatment of locally advanced ovarian cancer,
and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression
of pathogen antigens for the development of next-generation vaccines.
key value-creating milestones are upon us. We expect that this summer will be rewarding and busy as we look to improve the treatment
paradigm in late-stage ovarian cancer and to offer an "mRNA-better" vaccine platform technology with excellent commercial
promise," said Mr. Michael H. Tardugno, IMUNON's Executive Chairman.
remain on track to report topline results from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer in mid-2024. If interim data
are confirmed, the observed progression-free survival (PFS) benefit would represent a clinically meaningful outcome. In September, we
reported interim PFS and overall survival (OS) data suggesting an approximate 30% delay in disease progression or death in the treatment
arm compared with the control arm, with the hazard ratio nearing the study objective. Preliminary OS data followed a similar trend, showing
an approximate nine month improvement in the treatment arm over the control arm. Subgroup analyses suggest patients treated with a PARP
inhibitor (PARPi) as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001, compared with patients treated
with neoadjuvant chemotherapy (NACT) only," he added.
Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for our seasonal COVID-19 booster vaccine (IMNN-101)
was accepted by the Agency. The Company has begun a Phase 1 proof-of-concept study in two investigational centers. Our goal is to confirm
the safety and immunogenicity of this DNA-based vaccine as an annual booster with long-lasting protection. The first patients are expected
to be enrolled during the current quarter, and based on the results, we intend to advance discussions with potential partners for further
development. Our optimism is based, in part, on final data from non-human primate studies that showed excellent immunological response
and viral clearance. In a recent mouse study, we demonstrated that a single dose of IMNN-101, without a booster dose, produced longer
duration of IgG responses and higher T cell activation than an mRNA vaccine. We have also demonstrated continued drug stability at standard
refrigerated temperature of 4 C for more than 12 months, representing a significant advantage over commercial mRNA-based vaccines."
Lindborg, PhD appointed President and Chief Executive Officer
great pleasure, the Company announced the appointment of Stacy R. Lindborg, Ph.D. as President and Chief Executive Officer, effective
May 13, 2024. Dr. Lindborg has served on IMUNON's board of directors since 2021 and was most recently Co-Chief Executive Officer
of BrainStorm Cell Therapeutics, where she remains a director.
are delighted that Dr. Lindborg has agreed to deepen her ties with IMUNON as President and CEO," said Mr. Tardugno. "We have
benefited significantly from her counsel as a director, where she has played an integral role in establishing our strategic priorities.
Stacy joins the Company at a particularly important time. We now look forward to benefiting from her expertise in a more meaningful way,
especially as our near-term data readouts will require important decisions with respect to advancing various programs and assets."
Lindborg, a globally recognized biostatistician, has nearly 30 years of pharmaceutical and biotech industry experience with a particular
focus on R&D, regulatory affairs, executive management and strategy development. She has worked with biologics, small molecules and
cell therapies to address a range of diseases and disorders. She has extensive experience in early-stage development, having taken molecules
from first-in-human studies into the clinic, through regulatory approval and commercial launch.
Interim PFS and OS Data in OVATION 2 Study in Advanced Ovarian Cancer. In September 2023, the Company announced
interim PFS and OS data with IMNN-001 in its OVATION 2 Study. This study is evaluating the dosing, safety, efficacy and biological activity
of intraperitoneal IMNN-001 in combination with chemotherapy prior to tumor reduction surgery (known as: NACT) in patients newly diagnosed
with advanced epithelial ovarian, fallopian tube or primary peritoneal 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 tumor debulking surgery, followed by
three additional cycles of chemotherapy to treat any remaining tumor tissue.
open-label study is directional and is designed to show an approximate 33% improvement in PFS when comparing the treatment arm with the
control arm. Key secondary endpoints include OS, and the objective response rate. The final readout of this study is expected in mid-2024.
A positive readout would inform the Phase 3 study design.
Treatment in a Phase 1/2 Clinical Trial Evaluating IMNN-001 in Combination with Bevacizumab (Avastin ) in Advanced Ovarian Cancer.
In October 2023, the first patient was enrolled in this trial at the University of Texas MD Anderson Cancer Center. This trial is
expected to enroll 50 patients with Stage III/IV ovarian cancer. Patients undergoing frontline neoadjuvant therapy will be randomized
1:1 to receive standard chemotherapy plus bevacizumab, or standard chemotherapy plus bevacizumab and IMNN-001. The trial's primary
endpoint is detection of minimal residual disease (MRD) by second-look laparoscopy and the secondary endpoint is PFS. This trial will
also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase
of ovarian cancer that is currently undetectable by imaging or tumor markers. In February 2024, the Company announced that Memorial Sloan
Kettering Cancer Center joined MD Anderson Cancer Center in enrolling patients in this clinical trial.
Developing the Prophylactic Vaccines of the Future
Application Cleared by the FDA to Begin Human Testing of IMNN-101. In April 2024, the Company announced receipt
of FDA clearance to begin a Phase 1 proof-of-concept clinical trial with IMNN-101, a seasonal COVID-19 booster vaccine. Pending resolution
of limited comments from the FDA, IMUNON expects to commence patient enrollment in the second quarter of 2024.
utilizes the company's PlaCCine platform, a proprietary mono- or multi-valent DNA plasmid that regulates the expression of key
pathogen antigens and is delivered via a unique synthetic DNA delivery system. The primary objectives of the Phase 1 study are to evaluate
safety, tolerability, neutralizing antibody response and the vaccine's durability (duration of immunogenicity) in healthy adults.
Secondary objectives include evaluating the ability of IMNN-101 to elicit binding antibodies and cellular responses and their associated
durability. Based on reported preclinical data, durability of immune protection is expected to be superior to published mRNA vaccine
currently planned, the Phase 1 study will enroll 24 subjects evaluating three escalating doses of IMNN-101 at two U.S. clinical trial
sites. For this study, IMMN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA's
Vaccines and Related Biological Products Advisory Committee's June 2023 announcement of the framework for updated COVID-19 doses.
Data for IMUNON's PlaCCine DNA-Based Vaccine in SARS-CoV-2 Published in Peer-Reviewed Journal Vaccine. In February 2024,
the Company announced that an article titled "Strong
immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functionalized polymer" was published
in the peer-reviewed journal Vaccine, by Elsevier.
article is available at https://authors.elsevier.com/sd/article/S0264-410X(24)00077-X.
study described in the article used IMUNON's proprietary formulation against the spike proteins from two SARS-CoV-2 variants, both
alone and in combination. Data from the study show:
$1.3 Million in Non-Dilutive Funding from the Sale of New Jersey Net Operating Losses. In March 2024, the Company received $1.3 million
in net cash proceeds from the sale of approximately $1.4 million of its unused New Jersey net operating losses (NOLs). The NOL sales
cover the tax year 2022 and are administered through the New Jersey Economic Development Authority's Technology Business Tax Certificate
Transfer (NOL) program. This non-dilutive funding further strengthened the Company's balance sheet.
RESULTS FOR THE THREE MONTHS ENDED MARCH 31, 2024
reported a net loss for the first quarter of 2024 of $4.9 million, or $0.52 per share, compared with a net loss of $5.6 million, or $0.68
per share, for the first quarter of 2023. Operating expenses were $5.0 million for the first quarter of 2024, a decrease of $0.7 million
or 12% from $5.7 million for the first quarter of 2023.
and development (R&D) expenses were $3.3 million for the first quarter of 2024, an increase of $0.7 million from $2.6 million for
the comparable period in 2023. Costs associated with the OVATION 2 Study were $0.3 million for both the first quarters of 2024 and 2023.
Other clinical and regulatory costs were $1.1 million for the first quarter of 2024 compared with $0.3 million for the prior-year period.
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, were $1.6 million for the first quarter of 2024, compared with $1.4 million for the same period last year.
CMC costs were $0.3 million for the first quarter of 2024, compared with $0.6 million for 2023 due to the development of in-house pilot
manufacturing capabilities for DNA plasmids and nanoparticle delivery systems.
and administrative expenses were $1.7 million for the first quarter of 2024, compared with $3.1 million for the comparable prior-year
period. This decrease was primarily attributable to lower non-cash stock compensation expense ($0.3 million), lower legal costs ($0.5
million), lower employee-related costs ($0.2 million), lower consulting fees ($0.2 million) and lower insurance costs ($0.1 million).
non-operating income was $81,921 for the first quarter of 2024, compared with $93,085 for the comparable prior-year period. Investment
income decreased $0.2 million due to lower balances of short-term investments in the current quarter. Interest expense decreased $0.2
million due to the repayment of the Company's loan facility with Silicon Valley Bank in the second quarter of 2023.
cash used for operating activities was $5.9 million for the first quarter of 2024, compared with $4.0 million for the comparable prior-year
period. This increase was primarily due to the final payment of CRO costs associated with the Phase III OPTIMA Study.
Company ended the first quarter of 2024 with $9.8 million
in cash, investments and accrued interest receivable. The Company believes it has sufficient capital
resources to fund its operations to the end of 2024.