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.
Highlights 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
“Our 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.
“In 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.
“We 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.
“With 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.
RECENT
DEVELOPMENTS
PLACCINE:
Developing
the Prophylactic
Vaccines of the
Future
Presentation 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 website here.
Dr. 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
In addition, the PLACCINE modality had important
distinguishing advantages for a commercial vaccine, including a
shelf-life at 4⁰C for greater than nine months, and the ability for
simple, rapid and scalable manufacturing.
IMNN-001
Immunotherapy
Phase 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.
This 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 study.
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.
Presentation
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.
Researchers 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 is warranted.
Partnerships.
Collaborations and
Corporate Developments
Collaborative 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.
Received $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.
FIRST QUARTER FINANCIAL
RESULTS
IMUNON 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.
Net 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.
Cash 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.
Research 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.
General 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 legal fees to defend various
lawsuits filed after the announcement in July 2020 of the OPTIMA
Phase 3 study results, higher compensation expenses related to the
CEO succession plan announced in July 2022 and higher staffing
costs.
Other non-operating income was $93,085 for the
first quarter of 2023, compared with other non-operating expenses
of $4.6 million for the prior-year period. In the first quarter of
2022, the Company incurred a one-time payment of $4.5 million in
interest and offering expenses resulting from the sale and
subsequent redemption of $30.0 million of convertible redeemable
preferred stock. The Company incurred higher interest expense on
its loan facility with Silicon Valley Bank in the first quarter of
2023 due to rising interest rates. This loan facility has since
been assumed by First Citizen Bank under the same terms. Investment
income from the Company’s short-term investments increased by $0.3
million for the first quarter of 2023 compared with the prior-year
period due to higher returns on these investments.
Conference Call and
Webcast
The Company is hosting a conference call to
provide a business update, discuss first quarter 2023 financial
results and answer questions at 11:00 a.m. EDT 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 First Quarter 2023 Earnings Call. A live webcast of the call
will be available here.
The call will be archived for replay
until May 25, 2023. 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 6902750. A
webcast of the call will be available here for 90 days.
About IMUNON
IMUNON is a fully integrated, 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 has two platform technologies: the
TheraPlas modality for the development of immunotherapies and other
anti-cancer nucleic acid-based therapies, and the PLACCINE modality
for the development of nucleic acid vaccines for infectious
diseases and cancer. 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
conducting preclinical proof-of-concept studies on a nucleic acid
vaccine candidate targeting the SARS-CoV-2 virus to validate its
PLACCINE platform. IMUNON’s platform technologies are based on the
delivery of nucleic acids with novel synthetic delivery systems
that are independent of viral vectors or devices. IMUNON will
continue to leverage these platforms and to advance the
technological frontier of nucleic acid-based products 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 periodic reports
and prospectuses filed 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)
|
|
Quarter Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Licensing revenue |
|
$ |
- |
|
|
$ |
125 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
2,620 |
|
|
|
3,095 |
|
General and administrative |
|
|
3,064 |
|
|
|
2,872 |
|
Total operating expenses |
|
|
5,684 |
|
|
|
5,967 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(5,684 |
) |
|
|
(5,842 |
) |
|
|
|
|
|
|
|
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
Interest expense on loan facility |
|
|
(160 |
) |
|
|
(94 |
) |
Investment and other income (expense) |
|
|
253 |
|
|
|
14 |
|
Interest expense on preferred stock |
|
|
- |
|
|
|
(4,552 |
) |
Total other expense |
|
|
93 |
|
|
|
(4,632 |
) |
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(5,591 |
) |
|
$ |
(10,474 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
(0.68 |
) |
|
$ |
(1.82 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
8,281 |
|
|
|
5,770 |
|
|
|
|
|
|
|
|
|
|
IMUNON, Inc.Selected
Balance Sheet Information(in
thousands)
ASSETS |
|
March 31, 2023 |
|
|
December 31, 2022 |
|
Current
assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
10,401 |
|
|
$ |
11,493 |
|
Investment securities and interest receivable |
|
|
20,892 |
|
|
|
21,384 |
|
Money market investments, restricted cash |
|
|
2,250 |
|
|
|
1,500 |
|
Advances, deposits and other current assets |
|
|
2,789 |
|
|
|
2,778 |
|
Total current assets |
|
|
36,332 |
|
|
|
37,155 |
|
|
|
|
|
|
|
|
|
|
Property and equipment |
|
|
556 |
|
|
|
548 |
|
|
|
|
|
|
|
|
|
|
Other
assets |
|
|
|
|
|
|
|
|
Restricted cash invested in money market account |
|
|
3,750 |
|
|
|
4,500 |
|
Deferred tax asset |
|
|
- |
|
|
|
1,567 |
|
Operating lease right-of-use assets, deposits, and other
assets |
|
|
1,468 |
|
|
|
206 |
|
Total other assets |
|
|
5,218 |
|
|
|
6,273 |
|
Total assets |
|
$ |
42,106 |
|
|
$ |
43,976 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
7,887 |
|
|
$ |
8,381 |
|
Note payable – current portion |
|
|
2,181 |
|
|
|
1,425 |
|
Operating lease liability – current portion |
|
|
350 |
|
|
|
231 |
|
Total current liabilities |
|
|
10,418 |
|
|
|
10,037 |
|
|
|
|
|
|
|
|
|
|
Notes payable – noncurrent portion |
|
|
3,899 |
|
|
|
4,611 |
|
Operating lease liability – noncurrent portion |
|
|
1,142 |
|
|
|
- |
|
Total liabilities |
|
|
15,459 |
|
|
|
14,648 |
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Common stock |
|
|
91 |
|
|
|
74 |
|
Additional paid-in capital |
|
|
400,776 |
|
|
|
397,980 |
|
Accumulated other comprehensive gain (loss) |
|
|
124 |
|
|
|
27 |
|
Accumulated deficit |
|
|
(374,259 |
) |
|
|
(368,668 |
) |
|
|
|
26,732 |
|
|
|
29,413 |
|
Less: Treasury stock |
|
|
(85 |
) |
|
|
(85 |
) |
Total stockholders' equity |
|
|
26,647 |
|
|
|
29,328 |
|
Total liabilities and stockholders' equity |
|
$ |
42,106 |
|
|
$ |
43,976 |
|
# # #
Imunon (NASDAQ:IMNN)
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Imunon (NASDAQ:IMNN)
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