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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): August 11, 2026
Imunon,
Inc.
(Exact
name of registrant as specified in its Charter)
| Delaware |
|
001-15911 |
|
52-1256615 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
| 997
Lenox Drive, Suite 100, Lawrenceville, NJ |
|
08648-2311 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
(609)
896-9100
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
| |
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
|
| |
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
|
| |
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
|
| |
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act
| Title
of each class |
|
Trading
symbol(s) |
|
Name
of each exchange on which registered |
| Common
stock, par value $0.01 per share |
|
IMNN |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
2.02 Results of Operations and Financial Condition.
On
August 11, 2026, Imunon, Inc. issued a press release reporting its financial results for the quarter ended June 30, 2026. A copy of the
press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On
August 4, 2026, Imunon, Inc. announced it would hold a conference call on August 11, 2026 to discuss its financial results for the quarter
ended June 30, 2026 and provide a business update. A live webcast of the call will also be available
here.
The
information in this report, including the exhibit hereto, is being furnished and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections
11 and 12(a)(2) of the Securities Act of 1933, as amended. Such information shall not be incorporated by reference into any filing with
the Securities and Exchange Commission made by Imunon, Inc., whether made before or after the date hereof, regardless of any general
incorporation language in such filing.
The
press release contains forward-looking statements which involve certain risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. Please refer to the cautionary note in the press release regarding these
forward-looking statements.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
No. |
|
Description |
| |
|
|
| 99.1 |
|
Press Release dated August 11, 2026 |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
IMUNON
INC. |
| |
|
|
| Dated:
August 11, 2026 |
By: |
/s/
Josh Blacher |
| |
|
Josh
Blacher |
| |
|
Interim
Chief Financial Officer |
Exhibit
99.1

IMUNON
Reports Second 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 half of 2029, supported by strong Phase 2 clinical
data showing significant overall survival benefit
Company
to hold conference call today at 11:00 a.m. EDT
LAWRENCEVILLE,
N.J., August 11, 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 six months ended June 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.
“The
second quarter brought continued momentum for IMNN-001,” said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON.
“Enrollment in our pivotal Phase 3 OVATION 3 study continues to exceed our planning assumptions, reflecting the compelling survival
data generated in OVATION 2, our highly favorable safety profile, and growing confidence among investigators in IMNN-001’s potential
to improve outcomes for women with newly diagnosed advanced ovarian cancer.”
“We
were also encouraged by new preliminary data from our ongoing Phase 2 minimal residual disease (MRD) study, which showed a deeper
antitumor response in patients treated with IMNN-001, including higher rates of circulating tumor DNA clearance and no evidence of disease
following frontline therapy. We believe these findings provide further independent evidence of IMNN-001’s biological activity and
reinforce the mechanism underlying the survival benefit observed in the OVATION 2 study, while we remain fully focused
on our highest priority of efficiently advancing OVATION 3. Based on the data generated to date, we believe IMNN-001 has the potential
to become the first frontline immunotherapy to meaningfully improve overall survival in advanced ovarian cancer and establish a new standard
of care for women facing this disease.”
RECENT
DEVELOPMENTS
IMNN-001
| ● | On
March 25, 2026, the Company announced final data from the completed Phase 2 OVATION 2 clinical
trial with a median 14.7-month increase in overall survival (45.1 vs. 30.4 months) in the
IMNN-001 treatment arm compared to SoC chemotherapy alone. Importantly, with these new efficacy
results, IMNN-001 continued to show a highly favorable safety and tolerability profile across
all clinical trials, further reinforcing the potential of this IL-12 immunotherapy to represent
a landmark advance in treatment of this disease. |
| ● | On
June 23, 2026, the Company announced that the independent Data Monitoring Committee recommended
continuation of the pivotal Phase 3 OVATION 3 clinical trial evaluating IMNN-001 in combination
with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT). |
| ● | On
July 21, 2026, the Company announced new positive preliminary data from its ongoing Phase
2 minimal residual disease (MRD) clinical trial. Nine patients in each of the control and
experimental arms have reached second-look laparoscopy (SLL), the study’s primary assessment
point for surgical MRD. Compared to control, preliminary results show a deeper antitumor
response, as demonstrated by a lower MRD-positive rate, in patients treated with IMNN-001
(44% vs. 67%), a higher rate of circulating tumor DNA (ctDNA) clearance (87.5% vs. 62.5%),
and a numerically higher rate of patients achieving no evidence of disease (NED) following
frontline therapy (100% vs. 56%). |
| ● | On
July 30, 2026, the Company provided a progress update on its pivotal Phase 3 OVATION 3 trial.
Since initiating the trial, the Company has observed rapid site activation and an enrollment
rate that is exceeding its forecast. The trial advanced from protocol submission to site
activation in approximately 6 months and from protocol approval to first patient randomized
in approximately 2 months, a third of the time of the external industry benchmark. |
Corporate
Development:
| ● | On
June 4, 2026, the Company entered into definitive agreements with aggregate
gross proceeds to the Company in the amount of $10 million. The transaction includes 250
shares of non-redeemable, non-convertible preferred stock for $2.5 million and two secured
promissory notes in the principal amounts of $2.72 million and $5.0 million. The promissory
notes accumulate interest at a rate of 8% and 5%, respectively, per annum and mature 18 months
after the issuance date. Interest will be partially offset with interest earned via bank
deposit. |
Upcoming
Events:
| ● | The
Company will host an R&D Day on September 23, 2026, in New York, featuring presentations
from leading clinical investigators on IMNN-001 and the Company’s DNA-mediated immunotherapy
platform. Additional details, including the full agenda and registration information, will
be provided in a subsequent announcement. |
FINANCIAL
RESULTS FOR THE SECOND QUARTER 2026
Net
loss for the second quarter of 2026 was $2.8 million, or $0.54 per share, compared with a net loss of $2.7 million, or $2.15 per share,
for the second quarter of 2025. Operating expenses were $2.8 million for each of the second quarters of 2026 and 2025.
Research
and development expenses increased to $1.5 million in the second quarter of 2026 compared to $1.2 million in the same period of 2025.
During 2025, the Company initiated enrollment in the OVATION 3 Study and in 2026 closed out the OVATION 2 Study.
General
and administrative expenses decreased to $1.3 million in the second quarter of 2026 compared to $1.5 million in the same period of 2025.
FINANCIAL
RESULTS FOR THE SIX MONTHS ENDED JUNE 30, 2026
Net
loss for the first half of 2026 was $7.1 million, or $1.38 per share, compared with a net loss of $6.8 million, or $6.08 per share, for
the same period of 2025. Operating expenses were $7.1 million for the first half of 2026 compared to $6.9 million for the same period
of 2025.
Research
and development expenses increased to $3.8 million in the first half of 2026 compared to $3.4 million in the same period of 2025. During
2025, the Company initiated enrollment in the OVATION 3 Study and in 2026 closed out the OVATION 2 Study.
General
and administrative expenses decreased to $3.3 million in the first half of 2026 compared to $3.5 million in the same period of 2025.
Net
cash used for operating activities was $7.0 million for the first half of 2026, compared with $5.8 million for the same period last year.
This increase was primarily due to trial-related expenses associated with the OVATION 3 trial. As of June 30, 2026, cash
and cash equivalents were $6.9 million.
Conference
Call and Webcast
The
Company will be hosting a conference call to review second quarter 2026 financial results and provide a business update today, August
11, 2026, at 11:00 a.m. EDT. 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 Second Quarter 2026 Financial Results Call (Conference ID 8021948). 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 8021948#.
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 gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological
approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit
a strong immunological response.
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 conducting a Phase 3 clinical
trial (OVATION 3). The first patient was dosed in the Company’s Phase 3 pivotal study in the third quarter of 2025. 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 has completed a first-in-human study of its COVID-19 booster vaccine (IMNN-101).
The Company will continue to leverage these 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 the timing of 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), and include statements
regarding our planned stock split. Readers are cautioned that such forward-looking statements involve risks and uncertainties including,
without limitation, risks and uncertainties related 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 June
30, | | |
Six
Months Ended June
30, | |
| | |
2025 | | |
2025 | | |
2026 | | |
2025 | |
| | |
| | |
| | |
| | |
| |
| Operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
$ | 1,465 | | |
$ | 1,227 | | |
$ | 3,802 | | |
$ | 3,392 | |
| General and administrative | |
| 1,327 | | |
| 1,541 | | |
| 3,296 | | |
| 3,521 | |
| Total operating expenses | |
| 2,792 | | |
| 2,768 | | |
| 7,098 | | |
| 6,913 | |
| | |
| | | |
| | | |
| | | |
| | |
| Loss from operations | |
| (2,792 | ) | |
| (2,768 | ) | |
| (7,098 | ) | |
| (6,913 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other (expense) income: | |
| | | |
| | | |
| | | |
| | |
| Other income(loss), net | |
| (22 | ) | |
| 27 | | |
| 35 | | |
| 70 | |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
$ | (2,814 | ) | |
$ | (2,741 | ) | |
$ | (7,063 | ) | |
$ | (6,843 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss per common share | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted | |
$ | (0.54 | ) | |
$ | (2.15 | ) | |
$ | (1.38 | ) | |
$ | (6.08 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average shares outstanding | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted | |
| 5,233 | | |
| 1,277 | | |
| 5,134 | | |
| 1,124 | |
IMUNON, Inc.
Selected Balance Sheet Information
(in
thousands)
| | |
June 30, 2026 | | |
December 31, 2025 | |
| ASSETS | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 6,864 | | |
$ | 8,781 | |
| Advances, deposits on clinical programs and other current assets | |
| 1,827 | | |
| 1,943 | |
| Total current assets | |
| 8,691 | | |
| 10,724 | |
| | |
| | | |
| | |
| Property and equipment | |
| 459 | | |
| 530 | |
| | |
| | | |
| | |
| Other assets | |
| | | |
| | |
| Restricted Cash | |
| 5,000 | | |
| - | |
| Operating lease right-of-use assets | |
| 789 | | |
| 984 | |
| Deposits and other assets | |
| 50 | | |
| 50 | |
| Total other assets | |
| 5,839 | | |
| 1,034 | |
| Total assets | |
$ | 14,989 | | |
$ | 12,288 | |
LIABILITIES
AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable and accrued liabilities | |
$ | 2,847 | | |
$ | 4,218 | |
| Note payable – current portion Note A | |
| 1,500 | | |
| - | |
| Operating lease liability – current portion | |
| 432 | | |
| 406 | |
| Total current liabilities | |
| 4,779 | | |
| 4,624 | |
| | |
| | | |
| | |
| Note Payable – Note A | |
| 673 | | |
| - | |
| Note Payable – Note B | |
| 4,861 | | |
| - | |
| Operating lease liability – noncurrent portion | |
| 379 | | |
| 602 | |
| Derivative liability | |
| 108 | | |
| - | |
| Total liabilities | |
| 10,800 | | |
| 5,226 | |
| Stockholders’ equity | |
| | | |
| | |
| Preferred stock, including additional paid-in capital | |
| 2,252 | | |
| - | |
| Common stock | |
| 47 | | |
| 34 | |
| Additional paid-in capital | |
| 430,336 | | |
| 428,411 | |
| Accumulated deficit | |
| (428,631 | ) | |
| (421,298 | ) |
| | |
| 4,274 | | |
| 7,147 | |
| Less: Treasury stock | |
| (85 | ) | |
| (85 | ) |
| Total stockholders’ equity | |
| 4,189 | | |
| 7,062 | |
| Total liabilities and stockholders’ equity | |
$ | 14,989 | | |
$ | 12,288 | |
#
# #