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 year ended
December 31, 2023. 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 the treatment of first-line, locally advanced-stage
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 in preclinical
studies for the development of next-generation vaccines.
Highlights of 2023 and recent weeks include the
following:
- Reported interim progression-free
survival (PFS) and overall survival (OS) data with IMNN-001 in the
Phase 2 OVATION 2 Study in patients with advanced ovarian cancer.
Interim data from the intent-to-treat (ITT) population showed an
approximate 30% delay in disease progression or death in the
treatment arm compared with the control arm, and preliminary OS
data showed an approximate nine-month improvement in the treatment
arm over the control arm.
- Enrolled four patients in a Phase
1/2 clinical trial evaluating IMNN-001 in combination with
bevacizumab in patients with advanced ovarian cancer at the
University of Texas MD Anderson Cancer Center, and recently added
Memorial Sloan Kettering Cancer Center as a clinical site for this
study.
- Announced results from a non-human
primate study confirming PlaCCine as a viable modality for the
development of the next generation of prophylactic vaccines.
- Reported pre-clinical data
demonstrating PlaCCine vaccines elicit robust and more durable T
cell responses than commercial mRNA vaccines in animal models,
signaling that PlaCCine vaccines may provide greater protection
against reinfection, hospitalization or death.
- Submitted an Investigational New
Drug (IND) application with the U.S. Food and Drug Administration
(FDA) in the first quarter of 2024 for a Phase 1/2 proof-of-concept
clinical trial with a seasonal COVID-19 booster vaccine.
- Launched a new current Good
Manufacturing Practices production facility to efficiently
support R&D with significantly
lower costs for infectious disease vaccines,
and DNA-based immuno-oncology therapies.
“IMUNON has a dedicated management team to
advance our two platform technologies and execute our strategic
plan,” said Mr. Michael Tardugno, IMUNON’S Executive Chairman. “We
remain on track to report topline results mid-year from the OVATION
2 Study with IMNN-001 in advanced ovarian cancer. If the interim
data are confirmed in the final readout, the observed PFS benefit
would represent a clinically meaningful outcome. We also remain on
track to begin a Phase 1 proof-of-concept clinical study in the
second quarter of 2024 with a seasonal COVID-19 booster vaccine,
following FDA clearance of our IND application. Our objective is to
confirm the safety and immunogenicity of our clinical vaccine in
humans. Based on these results, we will advance discussions with
potential partners to continue development of the platform.”
“IMUNON made significant progress during 2023,
in particular with advancing our clinical programs in
immuno-oncology with IMNN-001, our gene-mediated IL-12
immunotherapy. In September we reported interim PFS and OS data in
our OVATION 2 Study suggesting a delay in disease progression or
death in the treatment arm of approximately 30% 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
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 PlaCCine modality continues to advance with
very encouraging data. We demonstrated the validity of this
proprietary technology in prophylactic vaccines, with impressive
preclinical proof-of-concept data not only in COVID-19, but also in
a multiple of other pathogenic viruses. We also completed the
evaluation of our vaccines in non-human primates. The final data
from these studies show excellent immunological response and viral
clearance. In a recent mouse study, we demonstrated 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 have also demonstrated continued drug stability at
standard refrigerated temperature of 4C for more than 12 months,
representing a significant commercial advantage over commercial
mRNA-based vaccines.
Given the high costs and long lead times of
third party CMOs, we have strategically invested in, and completed
development of in-house pilot manufacturing capabilities for DNA
plasmids and synthetic delivery systems. Our scientists can now
select any protein from the human or pathogen proteomes to be
engineered. Our labs also can conduct testing and run experiments
in a variety of animal disease models independently supporting
bench-to-bedside development of our novel therapies and vaccines.
These capabilities are expected to allow us to realize our goal of
attracting strategic partners while minimizing dependence on
vendors so that we control both the costs and the development
timelines.
“We are excited about the key value-creating
milestones we face in 2024. The potential for advances in treating
late-stage ovarian cancer may be within reach, while a better
vaccine platform technology holds tremendous commercial promise. We
look forward to continuing to create value for our stockholders and
for patients,” Mr. Tardugno concluded.
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 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 interval debulking surgery,
followed by three additional cycles of chemotherapy to treat any
residual tumor.
The open-label study is directional and designed
with an 80% confidence interval to show an approximate 33%
improvement in PFS, when comparing the treatment arm (NACT +
IMNN-001) with the control arm (NACT only). The secondary endpoints
include OS, objective response rate, pathological response,
surgical response and serologic response. The final readout of this
study is expected in mid-2024. A positive readout would inform next
development steps.
- Interim data from the ITT
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
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.
Continued benefits were seen in other secondary
endpoints including an approximately 25% higher R0 tumor resection
score and a doubling of the CRS 3 chemotherapy response score to
approximately 30% in the treatment arm, versus 14% in 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. Chemotherapy response score is considered
a good prognostic indicator in ovarian cancer. Safety analyses
continue to show good tolerability of IMNN-001 in this setting.
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 has joined MD Anderson
Cancer Center in enrolling patients in this clinical trial. A total
of four patients have been enrolled in the study to date.
PlaCCine: Developing the Prophylactic
Vaccines of the Future
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.
IMUNON’s Vice President
of R&D Presented at the Vaccines Summit-2023.
In November 2023, Jean Boyer, Ph.D. delivered a presentation titled
“Robust Immunogenicity and Protection with PlaCCine: A Novel DNA
Vaccine Delivered with a Functionalized Polymeric Delivery System”
during the “New Vaccine Development” session at the Vaccines
Summit-2023 in Boston. The presentation included updated data
related to IMUNON’s PlaCCine SARS-CoV-2 DNA vaccine, including
studies showing PlaCCine expresses spike proteins in mice and
primates demonstrating induction of spike-specific neutralizing
antibody responses and CD8 and CD4 spike-specific cellular
responses. The induced immune responses in vaccinated mice were
maintained for up to 14 months after vaccination. The presentation
also showed that in both primates and mice, the induced immune
responses reduced lung viral loads by more than 90%. In mouse
studies, robust immune responses were observed following a single
intramuscular injection of either PlaCCine SARS-CoV-2 DNA vaccine
or a novel PlaCCine Lassa Virus DNA vaccine.
IMUNON’s Chief Science Officer Presented
at the 3rd International Vaccines
Congress. In October 2023, Khursheed Anwer, Ph.D.
delivered a presentation titled “A DNA-based Vaccine Technology
Independent of Virus or Device” at the 3rd International Vaccines
Congress in Boston. The presentation described the multiple
advantages of the PlaCCine modality over current commercial vaccine
platforms. The presentation also described the versatility of the
PlaCCine modality, demonstrating activity against Marburg and
influenza viruses in collaboration with the Wistar Institute, and
activity against Lassa virus being evaluated at the NIH/NIAID.
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 Year Ended
December 31, 2023
IMUNON reported a net loss for 2023 of $19.5
million, or $2.16 per share, compared with a net loss for 2022 of
$35.9 million, or $5.03 per share. Operating expenses were $21.0
million for 2023, a decrease of $4.4 million or 17% from $25.4
million for 2022. The Company recognized tax benefits from the sale
of its New Jersey NOLs of $1.3 million and $1.6 million in 2023 and
2022, respectively.
Research and development (R&D) expenses were
$11.3 million for 2023, a decrease of $0.4 million from $11.7
million for 2022. Costs associated with the OVATION 2 Study were
$1.2 million and $1.5 million for 2023 and 2022, respectively.
Costs associated with the Phase 3 OPTIMA Study were de minimis for
2023 compared with $1.0 million for 2022. Other clinical and
regulatory costs were $1.8 million for 2023 compared with $1.9
million for 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, were $6.0 million for
2023 compared with $6.1 million for 2022. CMC costs increased to
$2.3 million for 2023 compared with $1.2 million for 2022 due to
the development of in-house pilot manufacturing capabilities for
DNA plasmids and nanoparticle delivery systems in 2023.
General and administrative expenses were $9.7
million for 2023 compared with $13.7 million for 2022. This
decrease was primarily attributable to lower non-cash stock
compensation expense ($1.3 million), lower employee-related costs
($0.8 million), lower legal costs ($1.0 million), lower insurance
costs ($0.6 million) and lower public company expenses ($0.2
million), offset by higher consulting fees ($0.2 million).
Other non-operating income was $0.2 million for
2023 compared with other non-operating expenses of $12.5 million
for 2022. This increase was attributable to the following:
- Investment income from the
Company’s short-term investments was $1.2 million for 2023 and $0.5
million for 2022.
- In June 2021, the Company entered
into a $10.0 million loan facility with Silicon Valley Bank (SVB).
The Company immediately used $6.0 million from this facility to
retire all outstanding indebtedness with Horizon Technology Finance
Corporation. In connection with the loan facility, the Company
incurred $0.2 million in interest expense in 2023 compared with
$0.5 million in 2022. In the second quarter of 2023, the Company
terminated the SVB Loan Facility, paid early termination and
end-of-term charges and recognized $0.3 million as a loss on debt
extinguishment.
- In 2022, the Company recognized (i)
an impairment charge of $13.4 million due to the write off of
In-Process Research & Development (IPR&D) assets and (ii) a
non-cash gain of $5.4 million due to the write-off of the earnout
milestone liability because of the requirements not being
achieved.
- In 2022, the Company incurred
additional interest expense attributable to the one-time payment of
$4.5 million in interest and offering expenses resulting from the
sale and subsequent redemption of $28.5 million of Series A & B
convertible redeemable preferred stock.
Net cash used for operating activities was $19.0
million for 2023 compared with $23.1 million for 2022. 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 $28.5 million of Series A & B convertible
redeemable preferred stock in the first quarter of 2022. Cash used
in financing activities was $3.6 million for 2023 from the pay-off
of the SVB loan ($6.4 million), offset by sales under the Company’s
At-the-Market Equity Facility ($2.8 million). This compares with
cash provided by financing activities of $6.7 million for 2022
resulting from an at-the-market equity offering ($6.2 million) and
sales under the Company’s At-the-Market Equity Facility ($0.5
million).
The Company ended 2023 with $15.7
million in cash, investments and accrued interest receivable.
Along with future planned sales of the Company’s remaining $1.3
million of New Jersey NOLs, the Company believes it has sufficient
capital resources to fund its operations into the fourth quarter of
2024.
Conference Call and Webcast
The Company is hosting a conference call to
provide a business update, discuss 2023 financial results and
answer questions at 10:00 a.m. Eastern time today. To participate
in the call, please dial 866-777-2509 (Toll-Free/North America) or
412-317-5413 (International/Toll) and ask for the IMUNON 2023
Earnings Call. A live webcast of the call will be available
here.
The call will be archived for replay
until April 11, 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
8601697. 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 |
|
IMUNON, Inc.Condensed
Consolidated Statements of Operations(in thousands
except per share amounts)
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Licensing revenue |
|
$ |
- |
|
|
$ |
500 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
11,287 |
|
|
|
11,734 |
|
General and administrative |
|
|
9.743 |
|
|
|
13,688 |
|
Total operating expenses |
|
|
21,030 |
|
|
|
25,422 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(21,030 |
) |
|
|
(24,922 |
) |
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
Gain from change in valuation of earnout milestone liability |
|
|
- |
|
|
|
5,396 |
|
Impairment of goodwill and in-process research and development |
|
|
- |
|
|
|
(13,366 |
) |
Interest expense, investment income and other income (expense),
net |
|
|
960 |
|
|
|
(4,575 |
) |
Loss on debt extinguishment |
|
|
(329 |
) |
|
|
|
|
Other (loss) income |
|
|
(396 |
) |
|
|
2 |
|
Total other income (expense), net |
|
|
235 |
|
|
|
(12,543 |
) |
|
|
|
|
|
|
|
|
|
Loss before income tax benefit |
|
|
(20,795 |
) |
|
|
(37,465 |
) |
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
|
1,280 |
|
|
|
1,567 |
|
Net loss |
|
$ |
(19,515 |
) |
|
$ |
(35,898 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(2.16 |
) |
|
$ |
(5.03 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
9,045 |
|
|
|
7,143 |
|
|
|
|
|
|
|
|
|
|
IMUNON, Inc. |
|
|
Selected Balance Sheet Information |
|
|
(in thousands) |
|
|
|
|
|
|
|
|
ASSETS |
|
December 31, 2023 |
|
December 31, 2022 |
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
5,839 |
|
$ |
11,493 |
|
|
Investment securities and interest receivable on investment
securities |
|
9,857 |
|
|
21,384 |
|
|
Money market investments, restricted cash |
|
- |
|
|
1,500 |
|
|
Advances, deposits on clinical programs and other current
assets |
|
2,545 |
|
|
2,403 |
|
|
Total current assets |
|
18,241 |
|
|
36,780 |
|
|
|
|
|
|
|
|
Property and equipment |
|
752 |
|
|
548 |
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
Deferred tax asset |
|
1,280 |
|
|
1,567 |
|
|
Restricted cash invested in money market account |
|
- |
|
|
4,500 |
|
|
Operating lease right-of-use assets, deposits, and other
assets |
|
1,645 |
|
|
581 |
|
|
Total other assets |
|
2,925 |
|
|
6,648 |
|
|
Total assets |
$ |
21,918 |
|
$ |
43,976 |
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable and accrued liabilities |
$ |
6,906 |
|
$ |
8,381 |
|
|
Note payable – current portion |
|
- |
|
|
1,425 |
|
|
Operating lease liability – current portion |
|
485 |
|
|
231 |
|
|
Total current liabilities |
|
7,391 |
|
|
10,037 |
|
|
|
|
|
|
|
|
Notes payable – noncurrent portion |
|
- |
|
|
4,611 |
|
|
Operating lease liability – noncurrent portion |
|
1,139 |
|
|
- |
|
|
Total liabilities |
|
8,530 |
|
|
14,648 |
|
|
Stockholders' equity |
|
|
|
|
|
Common stock |
|
94 |
|
|
74 |
|
|
Additional paid-in capital |
|
401,501 |
|
|
397,980 |
|
|
Accumulated other comprehensive gain (loss) |
|
61 |
|
|
27 |
|
|
Accumulated deficit |
|
(388,183 |
) |
|
(368,668 |
) |
|
|
|
13,473 |
|
|
29,413 |
|
|
Less: Treasury stock |
|
(85 |
) |
|
(85 |
) |
|
Total stockholders' equity |
|
13,388 |
|
|
29,328 |
|
|
Total liabilities and stockholders' equity |
$ |
21,918 |
|
$ |
43,976 |
|
|
# # #
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