AI Earnings Predictions for Imunon Inc. (IMNN)

EX-99.1

2 ex99-1.htm

EX-99.1

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/To

EX-99.1

2 ex99-1.htm

EX-99.1

Exhibit 99.1

IMUNON

Reports 2025 Financial Results and Provides Business Update

Highlighting Significant Progress with Pivotal Phase 3 Study

IMNN-001

is the first frontline immunotherapy to demonstrate the potential for a clinically meaningful overall survival benefit in women newly diagnosed with advanced ovarian cancer

Final Phase 2 clinical data show continued median overall survival improvement with IMNN-001

Enrollment in the OVATION 3 Study, IMUNON’s Phase 3 pivotal trial for IMNN-001, remains ahead of plan supported by continued strong interest from principal investigators and the medical community

Company to hold conference call today at 11:00 a.m. EDT

LAWRENCEVILLE,

N.J., March 31, 2026 (GLOBE NEWSWIRE) – IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the year ended December 31, 2025, 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 advancing IMNN-001, a potential breakthrough for women with newly diagnosed advanced ovarian cancer,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “A final data assessment of the Phase 2 OVATION 2 Study indicates that treatment with IMNN-001 was associated with an overall survival benefit of more than a year in patients treated with IMNN-001 plus chemotherapy and more than two years in women also receiving PARP inhibitors as part of maintenance therapy.”

“Unprecedented survival data results from the Phase 2 OVATION 2 Study, coupled with compelling interim results from our MRD study and a clear regulatory path in Phase 3, position IMNN-001 with the potential to deliver transformative impact on ovarian cancer treatment. These new results showing continued improvements in overall survival are especially exciting given that there have been virtually no advances in frontline standard of care for women newly diagnosed with ovarian cancer in the last 35 years,” Dr. Lindborg continued.

RECENT

DEVELOPMENTS

IMNN-001

Immunotherapy

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 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 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 continued to show a highly favorable safety and tolerability profile, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment of this disease.

R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer – On November 10, 2025, the Company hosted an R&D Day, providing updates on new IMNN-001 data and discussing progress with the Phase 3 OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer. Highlights from the R&D Day are summarized below.

Data from the Phase 2 OVATION 2 clinical trial:

○ Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from “cold” to “hot” by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.

○ Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.

○ The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.

Safety, tolerability and translational insights from the Phase 2 minimal residual disease (MRD) study of IMNN-001:

○ Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.

○ New translational data that show IMNN-001 prefere

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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): November 13, 2025

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 November 13, 2025, Imunon, Inc. issued a press release reporting its financial results for the quarter ended September 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

On November 6, 2025, Imunon, Inc. announced it would hold a conference call on November 13, 2025 to discuss its financial results for the quarter ended September 30, 2025 and provide a business update. The conference call will also be broadcast live on the internet at http://www.imunon.com.

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 November 13, 2025

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: November 13, 2025 By: /s/ Kimberly Graper

Kimberly Graper

Chief Financial Officer