Exhibit 99.1
IMUNON
Reports Third Quarter 2026 Financial Results and Provides Business Update
IMNN-001
is the first frontline treatment candidate to demonstrate the potential for a clinically meaningful overall survival benefit in women
newly diagnosed with ovarian cancer
Enrollment
in the Phase 3 OVATION 3 Study of IMNN-001 is expected to be completed by the first quarter of 2029, supported by strong Phase 2 clinical
data showing significant overall survival benefit
Conference
call to be held today at 11:00 a.m. EST
LAWRENCEVILLE,
N.J., November 12, 2026 – IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in late-stage development with
its DNA-mediated immunotherapy, today reported financial results for the three months and nine months ended September 30, 2026, and highlighted
recent business updates including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed
advanced ovarian cancer.
“IMUNON
continues to make significant progress in the clinical development of IMNN-001 for advanced ovarian cancer,” said Stacy R. Lindborg,
Ph.D., President and Chief Executive Officer of IMUNON. “The data generated to date, our collaboration with the National Cancer
Institute, and the favorable safety profile observed across studies support the ongoing advancement of the program and its potential
to provide a transformative treatment for women with this difficult disease. We believe the OVATION 3 study is well positioned, with
a broad patient population, two planned interim analyses, and a development strategy designed to support efficient execution and evaluation
of the treatment’s potential benefit.”
“We
have also taken steps to continue to sharpen our strategic focus and strengthen IMUNON’s financial position. Through our agreement
to transition ThermoDox® to a dedicated development partner and our recent debt-for-equity exchange, we are demonstrating
the disciplined approach to capital allocation that we believe is essential to advancing our most significant clinical opportunity while
preserving opportunities for future value creation. As we look ahead, our priorities remain clear: execute OVATION 3, build on the growing
body of evidence supporting IMNN-001 and advance a potentially transformative new treatment option for women who urgently need better
outcomes.”
RECENT
DEVELOPMENTS
IMNN-001:
On
July 23, 2026, the Company announced that translational and clinical data on IMNN-001 were presented at the inaugural AACR Conference
on Drug Discovery and Development (AACR D3), held July 21–24, 2026, in Boston. The presentation included findings from the randomized
Phase 2 OVATION 2 study demonstrating that IMNN-001 was safe and well-tolerated, achieved local delivery of IL-12, and induced anti-tumoral
immune responses, with no cytokine release syndrome or higher incidence of immune-related events observed in the experimental arm compared
with control. Translational analyses indicated that IMNN-001 enhanced favorable ratios of CD8+ T cells to regulatory T cells and CD8+
to CD4+ cells in tumors and the tumor microenvironment, consistent with previously reported associations with improved outcomes. These
findings support the ongoing pivotal Phase 3 OVATION 3 trial, which is designed to confirm the safety and survival benefit of IMNN-001
in frontline advanced ovarian cancer.
On
September 10, 2026, the Company announced it had entered into a Cooperative Research and Development Agreement (CRADA) with
the National Cancer Institute (NCI), part of the National Institutes of Health. Under the CRADA, the NCI’s Cancer
Therapy Evaluation Program (CTEP), which will assume regulatory sponsorship, will support further clinical and non-clinical development
of IMNN-001 under the NCI Experimental Therapeutics (NExT) Program. IMNN-001 is the first gene-based immunotherapy selected by NCI/CTEP
for partnered clinical development under a CRADA.
On
September 22, 2026, the Company announced that the Independent Data Monitoring Committee (IDMC) overseeing its ongoing Phase 2 minimal
residual disease (MRD) translational study of IMNN-001 recommended that the study continue without modification, identifying no new safety
signals and confirming comparable safety across both treatment arms.
On
September 23, 2026, the Company hosted its 2026 R&D Day in New York, featuring presentations from the lead clinical investigators
on the completed Phase 2 OVATION 2 study, the pivotal Phase 3 OVATION 3 study and the Phase 2 MRD study, together with translational
data on how IMNN-001 remodels the tumor immune microenvironment. A replay is available on the Scientific Presentations page of the Company’s
website, accessible through this webcast link.
On
November 6, 2026, the Company announced new translational data from its randomized Phase 2 OVATION 2 study of IMNN-001 in newly diagnosed
advanced ovarian cancer. The data are being presented in a poster at the Society for Immunotherapy of Cancer (SITC) 41st Annual Meeting
(SITC 2026), being held November 4–8, 2026, at the Phoenix Convention Center in Phoenix, Arizona.
Corporate
Development:
On
September 29, 2026, the Company entered into an Exchange Agreement, under which $1.2 million of outstanding debt, together with accrued
and unpaid interest, was exchanged for shares of the Company’s newly designated, non-convertible Series B Preferred Stock. The
transaction reduces the outstanding balance of the Company’s A-1 Note by approximately 43% and increases stockholders’ equity
while preserving financial flexibility, with no issuance of common stock or warrants.
On
October 21, 2026, the Company announced that it had entered into an agreement to sell its rights to ThermoDox®, a heat-activated
liposomal formulation of doxorubicin, to VoxelDox Therapeutics, Inc. (“VoxelDox”). Under the agreement, closing of which
is contingent on VoxelDox raising $2.5 million in funding, VoxelDox intends to advance the development of ThermoDox for the treatment
of glioblastoma multiforme. In exchange, IMUNON will receive an equity ownership stake in VoxelDox, payments of up to $16.5 million contingent
upon meeting development milestones and significant royalties on future net sales of ThermoDox product following commercial approval.
On
October 27, 2026, the Company filed a registration statement on Form S-1 with the Securities and Exchange Commission relating to a proposed
offering of its securities. The registration statement has not yet become effective. These securities may not be sold, nor may offers
to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer
to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which
such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state
or jurisdiction.
FINANCIAL
RESULTS FOR THE THIRD QUARTER 2026
Net
loss available to common shareholders for the third quarter of 2026 was $3.8 million, or $0.64 per share, compared with a net loss of
$3.4 million, or $1.16 per share, for the third quarter of 2025. Operating expenses were $3.4 million for the third quarter of 2026,
largely unchanged from $3.5 million for the third quarter of 2025.
Research
and development expenses were $1.8 million in the third quarter of 2026, compared with $1.9 million in the same period of 2025. Clinical
costs associated with the OVATION studies were $0.4 million, compared with $0.5 million in the corresponding period in 2025. As enrollment
in the OVATION 3 Study advanced, these costs were offset by lower manufacturing and clinical supply costs and lower other clinical and
regulatory costs.
General
and administrative expenses increased to $1.7 million in the third quarter of 2026, compared with $1.6 million in the same period of
2025, primarily reflecting higher outside professional fees.
FINANCIAL
RESULTS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026
Net
loss available to common shareholders for the nine months ended September 30, 2026 was $10.9 million, or $2.01 per share, compared with
a net loss of $10.3 million, or $5.53 per share, for the same period of 2025. Operating expenses were $10.5 million for the nine months
ended September 30, 2026, compared with $10.4 million for the same period of 2025.
Research
and development expenses increased to $5.6 million for the nine months ended September 30, 2026, compared with $5.3 million in the same
period of 2025. Clinical costs associated with the OVATION studies of $0.8 million were flat with the comparable period in 2025, and
manufacturing and clinical supply costs supporting the OVATION and MRD programs increased to $3.3 million from $3.0 million, partially
offset by lower costs associated with the MRD Study and the closeout of the OVATION 2 Study.
General
and administrative expenses were $5.0 million for the nine months ended September 30, 2026, largely unchanged from $5.1 million for the
same period of 2025.
Net
cash used in operating activities was $10.2 million for the nine months ended September 30, 2026, unchanged from the same period last
year. At September 30, 2026, cash and cash equivalents were $4.0 million, and the Company held an additional $5.0 million of restricted
cash.
Conference
Call and Webcast
The
Company will host a conference call to review third quarter 2026 financial results and provide a business update today, November 12,
2026, at 11:00 a.m. EST. To participate in the call, please dial (800) 715-9871 (U.S. and Canada/Toll Free) or (646) 307-1963 (U.S./Toll)
and ask for the IMUNON Third Quarter 2026 Financial Results Call (Conference ID 4174261). A live webcast of the call will also be available
here.
An
audio replay of the call will be available for 90 days and can be accessed at (800) 770-2030 (U.S. and Canada/Toll Free) or (609) 800-9909
(U.S./Toll) using replay access code 4174261#.
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 lead modality, TheraPlas®,
is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological
approach is deemed promising.
The
Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer
that has completed multiple clinical trials, including one Phase 2 clinical trial (OVATION 2), and is currently being studied in a Phase
3 clinical trial (OVATION 3). 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. The Company will continue to leverage its modalities and to advance,
either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions.
For more information, please 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. All statements, other than statements of historical fact, including, but not
limited to, statements regarding expectations regarding the timing and enrollment of the Company’s clinical trials, the potential
of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved,
the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its
development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words
such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,”
“intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances).
Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties
relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim
results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the
significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans;
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, except to the extent required by law, to update or
supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
Investor
Contact:
Valter
Pinto
KCSA
Strategic Communications
212-896-1254
imunon@kcsa.com
(Tables
to Follow)
IMUNON,
Inc.
Condensed
Consolidated Statements of Operations
(in
thousands except per share amounts)
| | |
Three Months Ended September
30, | | |
Nine Months Ended September
30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| | |
| | |
| | |
| | |
| |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 1,793 | | |
$ | 1,899 | | |
$ | 5,595 | | |
$ | 5,291 | |
| General and administrative | |
| 1,655 | | |
| 1,577 | | |
| 4,951 | | |
| 5,098 | |
| Total operating expenses | |
| 3,448 | | |
| 3,476 | | |
| 10,546 | | |
| 10,389 | |
| | |
| | | |
| | | |
| | | |
| | |
| Loss from operations | |
| (3,448 | ) | |
| (3,476 | ) | |
| (10,546 | ) | |
| (10,389 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other (expense) income | |
| (302 | ) | |
| 47 | | |
| (267 | ) | |
| 117 | |
| | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
$ | (3,750 | ) | |
$ | (3,429 | ) | |
$ | (10,813 | ) | |
$ | (10,272 | ) |
| | |
| | | |
| | | |
| | | |
| | |
Deemed
dividend – preferred stock | |
| (63 | ) | |
| - | | |
| (82 | ) | |
| - | |
| | |
| | | |
| | | |
| | | |
| | |
Net
loss available to common shareholders | |
$ | (3,813 | ) | |
$ | (3,429 | ) | |
$ | (10,895 | ) | |
$ | (10,272 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per common share | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted | |
$ | (0.64 | ) | |
$ | (1.16 | ) | |
$ | (2.01 | ) | |
$ | (5.53 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average shares outstanding | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted | |
| 5,947 | | |
| 2,944 | | |
| 5,408 | | |
| 1,856 | |
IMUNON,
Inc.
Selected
Balance Sheet Information
(in
thousands)
| | |
September
30, 2026 | | |
December
31, 2025 | |
| ASSETS | |
| | |
| |
| Current
assets | |
| | | |
| | |
| Cash and cash
equivalents | |
$ | 4,039 | | |
$ | 8,781 | |
| Advances, deposits on clinical
programs and other current assets | |
| 1,799 | | |
| 1,943 | |
| Total current
assets | |
| 5,838 | | |
| 10,724 | |
| | |
| | | |
| | |
| Property
and equipment | |
| 394 | | |
| 530 | |
| | |
| | | |
| | |
| Other
assets | |
| | | |
| | |
| Restricted
cash | |
| 5,039 | | |
| - | |
| Operating
lease right-of-use assets | |
| 687 | | |
| 984 | |
| Deposits
and other assets | |
| 51 | | |
| 50 | |
| Total other
assets | |
| 5,777 | | |
| 1,034 | |
| Total assets | |
$ | 12,009 | | |
$ | 12,288 | |
LIABILITIES
AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| Current
liabilities | |
| | | |
| | |
| Accounts payable and accrued
liabilities | |
$ | 2,414 | | |
$ | 4,217 | |
| Note payable – current
portion Note A | |
| 1,380 | | |
| - | |
| Operating lease liability
– current portion | |
| 445 | | |
| 407 | |
| Total current
liabilities | |
| 4,239 | | |
| 4,624 | |
| | |
| | | |
| | |
| Note Payable – Note
B | |
| 4,884 | | |
| - | |
| Operating lease liability
– noncurrent portion | |
| 263 | | |
| 602 | |
| Total
liabilities | |
| 9,386 | | |
| 5,226 | |
| Stockholders’
equity | |
| | | |
| | |
| Preferred stock, including
additional paid-in capital | |
| 3,384 | | |
| - | |
| Common stock | |
| 62 | | |
| 34 | |
| Additional
paid-in capital | |
| 431,373 | | |
| 428,411 | |
| Accumulated deficit | |
| (432,111 | ) | |
| (421,298 | ) |
| | |
| 2,708 | | |
| 7,147 | |
| Less: Treasury stock | |
| (86 | ) | |
| (85 | ) |
| Total
stockholders’ equity | |
| 2,622 | | |
| 7,062 | |
| Total
liabilities and stockholders’ equity | |
$ | 12,009 | | |
$ | 12,288 | |
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