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.
“Potential 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.
“We 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.
“Our 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.”
Stacy Lindborg, PhD appointed President
and Chief Executive Officer
With 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.
“We 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.”
Dr. 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.
RECENT DEVELOPMENTS
IMNN-001 Immunotherapy
Reported 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.
The 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.
- Interim data from the
intent-to-treat population showed efficacy trends in PFS,
demonstrating a delay in disease progression in the treatment arm
of approximately three months 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.
- Non-prespecified subgroup analyses,
commissioned as a result of the evolving standard of care for this
population, suggest that patients treated with a PARPi as
maintenance therapy had longer PFS and OS if they were also treated
with IMNN-001, compared with patients treated with NACT only.
- The median PFS in the PARPi + NACT
group and the PARPi + NACT + IMNN-001 group was 15.7 months and
23.7 months, respectively.
- The median OS in the PARPi + NACT
group was 45.6 months and has not yet been reached in the PARPi +
NACT + IMNN-001 group.
Began 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.
PlaCCine: Developing the Prophylactic
Vaccines of the Future
IND 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.
IMNN-101 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 data.
As 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.
Preclinical 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.
The article is available
at https://authors.elsevier.com/sd/article/S0264-410X(24)00077-X.
The 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:
- IMUNON’s proprietary formulation of
functionalized polymer protected DNA from degradation and enhanced
protein expression, while the combination with an adjuvant led to
an increase in immunogenicity.
- PlaCCine vaccines are stable for up
to one year at 4°C and at least one month at 37°C.
- Vaccination with PlaCCine resulted
in the induction of spike-specific neutralizing antibodies and
cytotoxic T cells.
- In the in vivo challenge
model, the vaccine-induced immune response was capable of
suppressing viral replication.
- Multiple inserts can be cloned into
the PlaCCine backbone (a plug-and-play strategy), therefore
allowing for an immune response with broader protection.
Corporate Developments
Received $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.
FINANCIAL RESULTS FOR THE THREE MONTHS
ENDED MARCH 31, 2024
IMUNON 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.
Research 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.
General 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).
Other 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.
Net 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.
The 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.
Conference Call and Webcast
The Company is hosting a conference call at
11:00 a.m. Eastern time today to provide a business update, discuss
first quarter 2024 financial results and answer questions. To
participate in the call, please dial 833-816-1132 (Toll-Free/North
America) or 412-317-0711 (International/Toll) and ask for the
IMUNON First Quarter 2024 Earnings Call. A live webcast of the call
will be available here.
The call will be archived for replay
until May 27, 2024. The replay can be accessed at 877-344-7529
(U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088
(International Toll), using the replay access code 9343581. A
webcast of the call will be available here for 90 days.
About IMUNON
IMUNON is a clinical-stage biotechnology company
focused on advancing a portfolio of innovative treatments that
harness the body’s natural mechanisms to generate safe, effective
and durable responses across a broad array of human diseases,
constituting a differentiating approach from conventional
therapies. IMUNON is developing its non-viral DNA technology across
its modalities. The first modality, TheraPlas®, is developed for
the coding of proteins and cytokines in the treatment of solid
tumors where an immunological approach is deemed promising. The
second modality, PlaCCine®, is developed for the coding of viral
antigens that can elicit a strong immunological response. This
technology may represent a promising platform for the development
of vaccines in infectious diseases.
The Company’s lead clinical program, IMNN-001,
is a DNA-based immunotherapy for the localized treatment of
advanced ovarian cancer currently in Phase 2 development. IMNN-001
works by instructing the body to produce safe and durable levels of
powerful cancer-fighting molecules, such as interleukin-12 and
interferon gamma, at the tumor site. Additionally, the Company is
entering a first-in-human study of its COVID-19 booster vaccine
(IMNN-101). We will continue to leverage these modalities and to
advance the technological frontier of plasmid DNA to better serve
patients with difficult-to-treat conditions. For more information
on IMUNON, visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that
forward-looking statements in this news release are made pursuant
to the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995. Readers are cautioned that such
forward-looking statements involve risks and uncertainties
including, without limitation, unforeseen changes in the course of
research and development activities and in clinical trials; the
uncertainties of and difficulties in analyzing interim clinical
data; the significant expense, time and risk of failure of
conducting clinical trials; the need for IMUNON to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses; possible actions by
customers, suppliers, competitors or regulatory authorities; and
other risks detailed from time to time in IMUNON’s filings with the
Securities and Exchange Commission. IMUNON assumes no obligation to
update or supplement forward-looking statements that become untrue
because of subsequent events, new information or otherwise.
Contacts:
IMUNON |
LHA Investor Relations |
Jeffrey W. Church |
Kim Sutton Golodetz |
Executive Vice President, CFO |
212-838-3777 |
and Corporate Secretary |
Kgolodetz@lhai.com |
609-482-2455 |
|
jchurch@imunon.com |
|
(Tables to Follow)
IMUNON, Inc.Condensed
Consolidated Statements of Operations(in thousands
except per share amounts)
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Licensing revenue |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
3,294 |
|
|
|
2,620 |
|
General and administrative |
|
|
1,717 |
|
|
|
3,064 |
|
Total operating expenses |
|
|
5,011 |
|
|
|
5,684 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(5,011 |
) |
|
|
(5,684 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense on loan facility |
|
|
- |
|
|
|
(160 |
) |
Investment and other income |
|
|
82 |
|
|
|
253 |
|
Total other income (expense), net |
|
|
82 |
|
|
|
93 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,929 |
) |
|
$ |
(5,591 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.68 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
9,400 |
|
|
|
8,281 |
|
|
|
|
|
|
|
|
|
|
IMUNON,
Inc. |
Selected Balance
Sheet Information |
(in
thousands) |
|
|
|
|
|
|
|
|
|
March 31,2024 |
|
|
December 31,2023 |
|
ASSETS |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,347 |
|
|
$ |
5,839 |
|
Investment securities and interest receivable on investment
securities |
|
|
7,462 |
|
|
|
9,857 |
|
Advances, deposits on clinical programs and other current
assets |
|
|
2,285 |
|
|
|
2,545 |
|
Total current assets |
|
|
12,094 |
|
|
|
18,241 |
|
|
|
|
|
|
|
|
|
|
Property and equipment |
|
|
694 |
|
|
|
752 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
|
|
Deferred tax asset |
|
|
- |
|
|
|
1,280 |
|
Operating lease right-of-use assets, deposits, and other
assets |
|
|
1,537 |
|
|
|
1,645 |
|
Total other assets |
|
|
1,537 |
|
|
|
2,925 |
|
Total assets |
|
$ |
14,325 |
|
|
$ |
21,918 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
4,316 |
|
|
$ |
6,906 |
|
Operating lease liability – current portion |
|
|
501 |
|
|
|
485 |
|
Total current liabilities |
|
|
4,817 |
|
|
|
7,391 |
|
|
|
|
|
|
|
|
|
|
Operating lease liability – noncurrent portion |
|
|
1,008 |
|
|
|
1,139 |
|
Total liabilities |
|
|
5,825 |
|
|
|
8,530 |
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Common stock |
|
|
94 |
|
|
|
94 |
|
Additional paid-in capital |
|
|
401,470 |
|
|
|
401,501 |
|
Accumulated other comprehensive gain (loss) |
|
|
133 |
|
|
|
61 |
|
Accumulated deficit |
|
|
(393,112 |
) |
|
|
(388,183 |
) |
|
|
|
8,585 |
|
|
|
13,473 |
|
Less: Treasury stock |
|
|
(85 |
) |
|
|
(85 |
) |
Total stockholders' equity |
|
|
8,500 |
|
|
|
13,388 |
|
Total liabilities and stockholders' equity |
|
$ |
14,325 |
|
|
$ |
21,918 |
|
# # #
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