Form 8-K
8-K — Imunon, Inc.
Accession: 0001493152-26-022401
Filed: 2026-05-12
Period: 2026-05-12
CIK: 0000749647
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
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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): May 12, 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
May 12, 2026, Imunon, Inc. issued a press release reporting its financial results for the quarter ended March 31, 2026. A copy of the
press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On
May 5, 2026, Imunon, Inc. announced it would hold a conference call on May 12, 2026 to discuss its financial results for the quarter
ended March 31, 2026 and provide a business update. The conference call will also be broadcast live on the internet at https://edge.media-server.com/mmc/p/9n9b48gb/.
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 May 12, 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: May 12, 2026
By:
/s/
Jeffrey Church
Jeffrey Church
Chief Financial Officer
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 2
Exhibit
99.1
IMUNON
Reports First Quarter 2026 Financial Results
and
Provides Business Update
IMNN-001
is the First and Only 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 Q1 2029, supported by remarkable Phase 2 data showing significant
overall survival improvement
FDA
has reviewed and is aligned with Phase 3 protocol, confirms path to BLA Filing
Company
to hold conference call today at 11:00 a.m. ET
LAWRENCEVILLE,
N.J., May 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 ended March 31, 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.
“Enrollment
in our pivotal Phase 3 OVATION 3 trial continues ahead of plan, reflecting patient interest and strong conviction among principal investigators
and the broader medical community in IMNN-001’s therapeutic potential,” said Stacy Lindborg, Ph.D., President and Chief Executive
Officer of IMUNON. “Coupled with the unprecedented overall survival benefit observed in our Phase 2 (OVATION 2) study and an aligned
path to BLA filing, IMNN-001 is well positioned to potentially transform the standard of care in advanced ovarian cancer.”
RECENT
DEVELOPMENTS
Final
Phase 2 OVATION 2 Study Data Show Continued Overall Survival Improvement with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian
Cancer – On March 25, 2026, the Company announced final data from the completed Phase 2 OVATION 2 clinical trial evaluating
IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT) in 112 women with newly diagnosed advanced
ovarian cancer. IMUNON previously reported a median 11.1-month increase in overall survival (40.5 vs. 29.4 months) in the IMNN-001 treatment
arm compared to SoC chemotherapy alone. Following the most recent and final data assessment, the Company reported a median 14.7-month
increase in overall survival (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous
improvement in overall survival (3.6 months delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC
chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in overall survival
of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone. Importantly, with these new efficacy results, IMNN-001 continues
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.
IMUNON
Sharpens Focus on its Promising Pivotal Phase 3 Ovarian Cancer Study – On February 5, 2026, the Company announced a strategic
reorganization, the goal of which was to reduce operating expenses while supporting the Company’s focused strategy to rapidly advance
the pivotal Phase 3 OVATION 3 clinical trial.
FIRST
QUARTER 2026 FINANCIAL RESULTS
Net
loss for the first quarter of 2026 was $4.3 million, or $0.84 per share, compared with a net loss of $4.1 million, or $3.15 per share,
for the first quarter of 2025. Operating expenses were $4.3 million for the first quarter of 2026, compared to $4.1 million for the first
quarter of 2025.
Research
and development expenses increased to $2.3 million in the first quarter of 2026 from $2.2 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 remained unchanged at $2.0 million in each of the first quarters of 2026 and 2025.
Net
cash used for operating activities was $4.0 million for the first quarter of 2026, compared with $2.8 million for the same period last
year. This increase was primarily due to trial-related expenses associated with the OVATION 3 trial.
As
of March 31, 2026, cash and cash equivalents were $4.8 million.
Conference
Call and Webcast
The
Company will be hosting a conference call to review first quarter 2026 financial results and provide a business update today, May 12,
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 First Quarter 2026 Financial Results Call (Conference ID 8083343). 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), 609-800-9909
(U.S./Toll) or 647-362-9199 (Canada/Toll) using replay access code 8083343#.
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 dosing in 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 expected reduction of operating expenses related to the strategic reorganization, 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.
Contacts:
Media
Investors
CG
Life
ICR
Healthcare
Jenna
Urban
Peter
Vozzo
212-253-8881
443-213-0505
jurban@cglife.com
peter.vozzo@icrhealthcare.com
(Tables
to Follow)
IMUNON,
Inc.
Condensed
Consolidated Statements of Operations
(in
thousands except per share amounts)
Three Months Ended March 31,
2026
2025
Operating expenses:
Research and development
$ 2,337
$ 2,165
General and administrative
1,970
1,980
Total operating expenses
4,307
4,145
Loss from operations
(4,307 )
(4,145 )
Other income (expense):
Investment and other income
58
43
Net loss
$ (4,249 )
$ (4,102 )
Net loss per common share
Basic and diluted
$ (0.84 )
$ (3.15 )
Weighted average shares outstanding
Basic and diluted
5,029
1.301
IMUNON,
Inc.
Selected
Balance Sheet Information
(in
thousands)
March 31, 2026
December 31, 2025
ASSETS
Current assets
Cash and cash equivalents
$ 4,794
$ 8,781
Advances, deposits on clinical programs and other current assets
1,827
1,943
Total current assets
6,621
10,724
Property and equipment
460
530
Other assets
Operating lease right-of-use assets
888
984
Deposits and other assets
50
50
Total other assets
938
1,034
Total assets
$ 8,019
$ 12,288
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued liabilities
$ 3,747
$ 4,218
Operating lease liability – current portion
419
406
Total current liabilities
4,166
4,624
Operating lease liability – noncurrent portion
493
602
Total liabilities
4,659
5,226
Stockholders’ equity
Common stock
39
34
Additional paid-in capital
428,953
428,411
Accumulated deficit
(425,547 )
(421,298 )
3,445
7,147
Less: Treasury stock
(85 )
(85 )
Total stockholders’ equity
3,360
7,062
Total liabilities and stockholders’ equity
$ 8,019
$ 12,288
#
# #
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