UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________ to ____________

Commission file number: 001-15911

Imunon, Inc.

(Exact name of Registrant as specified in its charter)

Delaware

52-1256615

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification Number)

997 Lenox Drive, Suite 100,

Lawrenceville, NJ 08648

(Address of principal executive offices)

(609) 896-9100

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by checkmark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act (Check One):

	Large accelerated filer ☐	Accelerated filer ☐
	Non-accelerated filer ☒	Smaller reporting company ☒
	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. ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 10, 2025, the Registrant had 3,070,354 shares of common stock, $0.01 par value per share, outstanding.

IMUNON, INC.

QUARTERLY REPORT ON

FORM 10-Q

TABLE OF CONTENTS

		Page(s)
PART I: FINANCIAL INFORMATION

Item 1.	Financial Statements
	Condensed Consolidated Balance Sheets as of September 30, 2025 (Unaudited) and December 31, 2024	1
	Condensed Consolidated Statements of Operations (Unaudited) for the Three and Nine Months Ended September 30, 2025 and 2024	3
	Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2025 and 2024	4
	Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) for the Three Months Ended September 30, 2025 and 2024	6
	Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) for the Nine Months Ended September 30, 2025 and 2024	7
	Notes to the Condensed Consolidated Financial Statements (Unaudited)	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17

Item 3.	Quantitative and Qualitative Disclosures about Market Risk	32

Item 4.	Controls and Procedures	32

PART II: OTHER INFORMATION		33

Item 1.	Legal Proceedings	33

Item 1A.	Risk Factors	33

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	34

Item 3.	Defaults Upon Senior Securities	34

Item 4.	Mine Safety Disclosures	34

Item 5.	Other Information	34

Item 6.	Exhibits	34

SIGNATURES		35

Cautionary Note Regarding Forward-Looking Statements

This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical fact are “forward-looking statements” for purposes of this Quarterly Report on Form 10-Q, including, without limitation, any projections of earnings, revenue or other financial items, the Company’s ability to regain compliance with Nasdaq’s continued listing requirements, any statements of the plans and objectives of management for future operations (including, but not limited to, pre-clinical development, clinical trials, manufacturing and commercialization), uncertainties and assumptions regarding any continuing impact of the COVID-19 pandemic on our business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, any statements concerning proposed drug candidates, potential therapeutic benefits, or other new products or services, any statements regarding future economic conditions or performance, any changes in the course of research and development activities and in clinical trials, any possible changes in cost and timing of development and testing, capital structure, financial condition, working capital needs and other financial items, and any statements of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified using terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential” or “continue,” or the negative thereof or other comparable terminology. Although we believe that our expectations are based on reasonable assumptions within the bounds of our knowledge of our industry, business, and operations, we cannot guarantee that actual results will not differ materially from our expectations.

Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including, but not limited to, the inherent uncertainty in the drug development process, our ability to raise additional capital to fund our planned future operations, our ability to obtain or maintain U.S. Food and Drug Administration (“FDA”) and foreign regulatory approvals for our drug candidates, our ability to enroll patients in our clinical trials, risks relating to third parties’ conduct of our clinical trials, risks relating to government, private health insurers and other third-party payers coverage or reimbursement, risks relating to commercial potential of a drug candidate in development, changes in technologies for the treatment of cancer, impact of development of competitive drug candidates by others, risks relating to intellectual property, volatility in the market price of our common stock, potential inability to maintain compliance with The Nasdaq Marketplace Rules and the impact of adverse capital and credit market conditions. These and other risks and assumptions are described in Item 1A. Risk Factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in other documents that we file or furnish with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. All forward-looking statements speak only as of the date they are made, and we do not intend to update or revise any forward-looking statements even if new information becomes available in the future, except as required by law or applicable regulations. We operate in a highly competitive, highly regulated, and rapidly changing environment and our business is in a state of evolution. Therefore, it is likely that new risks will emerge, and that the nature and elements of existing risks will change, over time. It is not possible for management to predict all such risk factors or changes therein, or to assess either the impact of all such risk factors on our business or the extent to which any individual risk factor, combination of factors, or new or altered factors, may cause results to differ materially from those contained in any forward-looking statement.

Except where the context otherwise requires, in this Quarterly Report on Form 10-Q, the “Company,” “Imunon,” “we,” “us,” and “our” refer to Imunon, Inc., a Delaware corporation and its wholly owned subsidiaries.

Trademarks

The Company’s brand and product names contained in this document are trademarks, registered trademarks, or service marks of Imunon, Inc. or its subsidiary in the United States (“U.S.”) and certain other countries. This document also contains references to trademarks and service marks of other companies that are the property of their respective owners.

PART I: FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

IMUNON, INC.

CONDENSED CONSOLIDATED

BALANCE SHEETS

	September 30, 2025		December 31, 2024
		(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	5,250,929	$	5,872,767
Advances and deposits on clinical programs and other current assets		2,006,756		2,136,192
Total current assets		7,257,685		8,008,959

Property and equipment (at cost, less accumulated depreciation and amortization)		601,425		541,272

Other assets:
Operating lease right-of-use assets, net		1,078,623		1,117,133
Deposits and other assets		50,000		50,000
Total other assets		1,128,623		1,167,133

Total assets	$	8,987,733	$	9,717,364

See accompanying notes to the unaudited condensed consolidated financial statements.

IMUNON, INC.

CONDENSED CONSOLIDATED

BALANCE SHEETS

(Continued)

	September 30, 2025			December 31, 2024
	(Unaudited)
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable – trade	$	1,126,826		$	1,300,026
Other accrued liabilities		2,676,951			3,033,747
Operating lease liabilities - current portion		394,135			452,358
Total current liabilities		4,197,912			4,786,131

Operating lease liabilities - non-current portion		708,097			686,935
Total liabilities		4,906,009			5,473,066

Commitments and contingencies		-			–

Stockholders’ equity:

Preferred stock - $0.01 par value (100,000 shares authorized and no shares issued or outstanding at September 30, 2025 and December 31, 2024)		-			–

Common stock - $0.01 par value (350,000,000 and 112,500,000 shares authorized at September 30, 2025 and December 31, 2024, respectively); 2,896,275 and 966,714 shares issued at September 30, 2025 and December 31, 2024, respectively; and 2,896,273 and 966,712 shares outstanding at September 30, 2025 and December 31, 2024, respectively)		28,963			9,667
Additional paid-in capital		421,213,171			411,122,863
Accumulated deficit		(417,075,222	)		(406,803,044	)
Total stockholders’ equity before treasury stock		4,166,912			4,329,486

Treasury stock, at cost (2 shares at September 30, 2025 and December 31, 2024)		(85,188	)		(85,188	)
Total stockholders’ equity		4,081,724			4,244,298

Total liabilities and stockholders’ equity	$	8,987,733		$	9,717,364

See accompanying notes to the unaudited condensed consolidated financial statements.

IMUNON, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF OPERATIONS

(Unaudited)

	2025			2024			2025			2024
	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2025			2024			2025			2024

Operating expenses:
Research and development	$	1,899,251		$	3,293,209		$	5,291,297		$	9,406,715
General and administrative		1,576,577			1,668,258			5,097,694			5,579,549
Total operating expenses		3,475,828			4,961,467			10,388,991			14,986,264

Loss from operations		(3,475,828	)		(4,961,467	)		(10,388,991	)		(14,986,264	)

Other income:
Investment income, net		46,704			115,992			116,813			423,247
Total other income, net		46,704			115,992			116,813			423,247

Net loss	$	(3,429,124	)	$	(4,845,475	)	$	(10,272,178	)	$	(14,563,017	)

Net loss per common share
Basic and diluted	$	(1.16	)	$	(3.76	)	$	(5.53	)	$	(14.13	)

Weighted average shares outstanding
Basic and diluted		2,943,655			1,289,823			1,855,922			1,030,622

See accompanying notes to the unaudited condensed consolidated financial statements.

IMUNON, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS

(Unaudited)

.	2025			2024
	For the Nine Months Ended September 30,
	2025			2024
Cash flows from operating activities:

Net loss	$	(10,272,178	)	$	(14,563,017	)

Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		216,830			202,938
Amortization of right-of-use assets		312,805			349,892
Realized losses, net, on investment securities		-			(61,983	)
Stock-based compensation		115,895			364,177
Shares issued in exchange for services		99,040			-
Realization of deferred income tax asset		-			1,280,385
Net changes in:
Advances, deposits, and other current assets		129,436			324,580
Accounts payable and accrued liabilities		(841,351	)		(2,330,958	)
Net cash used in operating activities		(10,239,523	)		(14,433,986	)

Cash flows from investing activities:
Purchases of investment securities		-			(57,174	)
Proceeds from sale and maturity of investment securities		-			9,915,448
Purchases of property and equipment		(276,983	)		(14,634	)
Net cash (used in) provided by investing activities		(276,983	)		9,843,640

Cash flows from financing activities:
Proceeds from sale of common stock equity, net of issuance costs		6,437,251			9,063,715
Proceeds from issuance of common stock upon exercise of warrants		3,467,694			-
Issuance costs for stock dividend		(10,277	)		-
Net cash provided by financing activities		9,894,668			9,063,715

Net change in cash and cash equivalents		(621,838	)		4,473,369
Cash and cash equivalents at beginning of period		5,872,767			5,838,566
Cash and cash equivalent at end of period	$	5,250,929		$	10,311,935

See accompanying notes to the unaudited condensed consolidated financial statements.

IMUNON, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS (Continued)

(Unaudited)

	For the Nine Months Ended September 30,
	2025		2024
Supplemental disclosures of cash flow information:

Non-cash investing and financing activities:
Recognition of operating lease right-of-use asset and liability	$	274,295	$	-

See accompanying notes to the unaudited condensed consolidated financial statements.

IMUNON, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited)

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024

	Shares		Amount		Capital			Shares		Amount				Deficit			Equity
	Common Stock Outstanding				Additional Paid-in			Treasury Stock						Accumulated			Total Stockholders’
	Shares		Amount		Capital			Shares		Amount				Deficit			Equity

Balance at July 1, 2025 (unaudited)		1,717,502	$	17,175	$	416,373,961			2	$	(85,188	)	-	$	(413,646,098	)	$	2,659,850

Net loss		-		-		-			-		-		-		(3,429,124	)		(3,429,124	)
Effect of reverse stock split		70,448		704		-			-		-				-			704
Sale of equity through equity financing facilities, net of costs		543,265		5,433		3,467,387			-		-				-			3,472,820
Issuance of common stock upon exercise of common stock warrants		222,227		2,223		1,497,777			-		-				-			1,500,000
Stock dividend, net of offering costs		330,397		3,304		(13,581	)		-		-				-			(10,277	)
Shares issued to satisfy certain obligations		10,767		108		98,932			-		-				-			99,040
Issuance of common stock upon exercise of restricted options		1,667		16		-			-		-				-			16
Stock-based compensation expense		-		-		(211,305	)		-		-				-			(211,305	)
Balance at September 30, 2025 (unaudited)		2,896,273	$	28,963	$	421,213,171			2	$	(85,188	)	-	$	(417,075,222	)	$	4,081,724

	Shares		Amount		Capital		Shares		Amount			Income		Deficit			Equity
	Common Stock Outstanding				Additional Paid-in		Treasury Stock					Accumulated Other Comprehensive		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Shares		Amount			Income		Deficit			Equity

Balance at July 1, 2024 (unaudited)		626,727	$	6,267	$	401,720,499		2	$	(85,188	)	$	-	$	(397,900,344	)	$	3,741,234
Net loss		-		-		-		-		-			-		(4,845,475	)		(4,845,475	)
Realized and unrealized gains, net, on investments securities		339,254		3,393		9,060,322		-		-			-		-			9,063,715
Issuance of common stock upon exercise of restricted stock		734		7		103		-		-			-		-			110
Stock-based compensation expense		-		-		232,137		-		-			-		-			232,137
Balance at September 30, 2024 (unaudited)		966,715	$	9,667	$	411,013,061		2	$	(85,188	)	$	-	$	(402,745,819	)	$	8,191,721

See accompanying notes to the unaudited condensed consolidated financial statements.

IMUNON, INC.

CONDENSED CONSOLIDATED

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited)

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024

	Shares		Amount		Capital			Shares		Amount				Deficit			Equity
	Common Stock Outstanding				Additional Paid-in			Treasury Stock						Accumulated			Total Stockholders’
	Shares		Amount		Capital			Shares		Amount				Deficit			Equity

Balance at January 1, 2025		966,712	$	9,667	$	411,122,863			2	$	(85,188	)	-	$	(406,803,044	)	$	4,244,298

Net loss		-		-		-			-		-		-		(10,272,178	)		(10,272,178	)
Effect of reverse stock split		70,448		704		-			-		-				-			704
Sale of equity through equity financing facilities, net of costs		1,032,752		10,328		6,426,219			-		-				-			6,436,547
Issuance of common stock upon exercise of common stock warrants		482,550		4,826		3,462,869			-		-				-			3,467,695
Stock dividend, net of offering costs		330,397		3,304		(13,581	)		-		-				-			(10,277	)
Shares issued to satisfy certain obligations		10,767		108		98,932			-		-				-			99,040
Issuance of common stock upon exercise of restricted options		2,647		26		-			-		-				-			26
Stock-based compensation expense		-		-		115,869			-		-				-			115,869
Balance at September 30, 2025 (unaudited)		2,896,273	$	28,963	$	421,213,171			2	$	(85,188	)	-	$	(417,075,222	)	$	4,081,724

	Shares		Amount		Capital		Shares		Amount			Income			Deficit			Equity
	Common Stock Outstanding				Additional Paid-in		Treasury Stock					Accumulated Other Comprehensive			Accumulated			Total Stockholders’
	Shares		Amount		Capital		Shares		Amount			Income			Deficit			Equity

Balance at January 1, 2024		626,654	$	6,266	$	401,588,570		2	$	(85,188	)	$	60,796		$	(388,182,802	)	$	13,387,642
Balance		626,654	$	6,266	$	401,588,570		2	$	(85,188	)	$	60,796		$	(388,182,802	)	$	13,387,642

Net loss		-		-		-		-		-			-			(14,563,017	)		(14,563,017	)
Sale of equity through equity financing facilities, net of issuance costs		339,254		3,393		9,060,322		-		-			-			-			9,063,715
Issuance of common stock upon exercise of restricted options		807		8		113		-		-			-			-			121
Realized and unrealized losses, net, on investments securities		-		-		-		-		-			(60,796	)		-			(60,796	)
Stock-based compensation expense		-		-		364,056		-		-			-			-			364,056
Balance at September 30, 2024 (unaudited)		966,715	$	9,667	$	411,013,061		2	$	(85,188	)	$	-		$	(402,745,819	)	$	8,191,721
Balance		966,715	$	9,667	$	411,013,061		2	$	(85,188	)	$	-		$	(402,745,819	)	$	8,191,721

See accompanying notes to the unaudited condensed consolidated financial statements.

IMUNON, INC.

NOTES TO THE CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

(UNAUDITED)

SEPTEMBER 30, 2025

Note 1. Business Description

Imunon, Inc. (“Imunon” or the “Company”) is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms with the aim 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 coding of proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the coding of viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases.

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 II clinical trial (OVATION 2) and is currently conducting 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. 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.

Note 2. Basis of Presentation

The accompanying unaudited condensed consolidated financial statements, which include the accounts of the Company and its wholly owned subsidiaries, have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. All significant intercompany balances and transactions have been eliminated in consolidation. During the quarter and nine-month period ended September 30, 2025, there were no changes to the Company’s accounting policies. Certain information and disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations.

In the opinion of management, all adjustments, consisting only of normal recurring accruals considered necessary for a fair presentation, have been included in the accompanying unaudited condensed consolidated financial statements. Operating results for the nine months ended September 30, 2025 and 2024 are not necessarily indicative of the results that may be expected for any other interim period(s) or for any full year. For further information, refer to the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on February 27, 2025.

The preparation of financial statements in conformity with GAAP requires management to make judgments, estimates, and assumptions that affect the amounts reported in the Company’s condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. Events and conditions arising subsequent to the most recent balance sheet date have been evaluated for their possible impact on the unaudited condensed consolidated financial statements and accompanying notes.

Going Concern Uncertainty

Since inception, the Company has incurred substantial operating losses, principally from expenses associated with the Company’s research and development programs, clinical trials conducted in connection with the Company’s drug candidates, and applications and submissions to the U.S. Food and Drug Administration (“FDA”). The Company has not generated significant revenue and has incurred significant net losses in each year since inception. For the nine months ended September 30, 2025, the Company had a net loss of $10.3 million and used $10.2 million to fund operations. As of September 30, 2025, the Company has incurred approximately $419 million of cumulative net losses. As of September 30, 2025, the Company had $5.3 million in cash and cash equivalents to fund its operations.

The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the U.S. and worldwide resulting from the recent tariff announcement by the U.S. federal government, the Russian invasion of Ukraine and the unrest in the Middle East. The Company continues to monitor its operating activities in light of these events, and it is possible that these events could result in a variety of risks to the business. The specific impact, if any, is not readily determinable as of the date of these unaudited condensed consolidated financial statements.

The Company has based its estimates on assumptions that may prove to be wrong. The Company may need to obtain additional funds sooner or in greater amounts than it currently anticipates. Potential sources of financing include strategic relationships, public or private sales of the Company’s shares or debt and other sources. If the Company raises funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interest of existing stockholders may be diluted.

The actual amount of funds the Company will need to operate is subject to many factors, some of which are beyond the Company’s control. These factors include the progress of research activities; the number and scope of research programs; the progress of preclinical and clinical development activities; the progress of the development efforts of parties with whom the Company has entered into research and development agreements; the costs associated with additional clinical trials of drug candidates; the ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements; the ability to achieve milestones under licensing arrangements; the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and the costs and timing of regulatory approvals.

A fundamental component of the ability to continue as a going concern is the Company’s ability to raise capital as required, as to which no assurances can be provided. To address the additional funding requirements of the Company, management has undertaken the following initiatives:

	●	it has assessed its current expenditures and will reduce spending where necessary;

	●	it will pursue additional capital funding in the public and private markets through equity sales and/or debt facilities;

	●	it will pursue possible partnerships and collaborations; and

	●	it will pursue potential out licensing for its drug candidates.

The Company’s ability to continue as a going concern will depend on its ability to raise additional capital, attain further operating efficiencies, reduce expenditures, and, ultimately, to generate revenue. There are no assurances that these future funding and operating efforts will be successful. If management is unsuccessful in these efforts, the Company’s current capital is not expected to be sufficient to fund operations for the next twelve months.

Such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Based on the above, management has determined there is substantial doubt regarding our ability to continue as a going concern. The report of our independent registered public accounting firm for the year ended December 31, 2024, includes an explanatory paragraph which expresses substantial doubt about our ability to continue as a going concern.

Management’s plan includes private or public equity financings, collaborations, or other strategic transactions such as raising funds from outside investors via its ATM program and other potential funding sources. The Company may not be able to obtain funding on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. The Company’s ability to raise additional funds will depend, among other factors, on financial, economic and market conditions, many of which are outside of its control, and it may be unable to raise financing when needed, or on terms favorable to the Company. If the Company is unable to obtain sufficient capital to fund its operations it may be required to evaluate alternatives. The Company’s condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets, carrying amounts or the amount and classification of liabilities that may be required should the Company be unable to continue as a going concern.

Note 3. New Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued accounting pronouncements will not have a material impact on the Company’s condensed consolidated financial position, results of operations, and cash flows, or do not apply to its operations.

In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, “Improvements to Income Tax Disclosures”, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. Early adoption is permitted. The Company is currently evaluating the impact of the ASU on the income tax disclosures within the unaudited condensed consolidated financial statements; the Company expects changes to the Company’s income tax disclosure.

In November 2024, the FASB issued ASU No. 2024-03, “Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures: Disaggregation of Income Statement Expenses” (“ASU 2024-03”). ASU 2024-03 will require more detailed information about the types of expenses in commonly presented income statement captions such as “Cost of sales” and “Selling, general and administrative expenses”. The new guidance is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027 with early adoption permitted. The Company is currently evaluating the impact that this change will have on the Company’s disclosures.

Note 4. Net Loss per Common Share

Basic and diluted net loss per common share was computed by dividing net loss for the year by the weighted average number of shares of common stock outstanding, both basic and diluted, during each period. The impact of common stock equivalents has been excluded from the computation of diluted weighted average common shares outstanding in periods where there is a net loss, as their effect is anti-dilutive.

The total number of shares of common stock issuable upon exercise of warrants, stock option grants and equity awards was 990,233 and 447,499 shares for the nine months ended September 30, 2025 and 2024, respectively. For the nine-month periods ended September 30, 2025 and 2024, diluted loss per common share was the same as basic loss per common share as the other warrants, and equity awards that were convertible into shares of the Company’s common stock were excluded from the calculation of diluted loss per common share as their effect would have been anti-dilutive.

The Company declared a 15% stock dividend that was distributed on August 21, 2025 to stockholders of record as of August 7, 2025. In accordance with Accounting Standards Codification (“ASC”) 260, basic and diluted earnings per share amounts and weighted-average shares outstanding have been restated for all periods presented to reflect the effect of this stock dividend. The Company did not pay any dividends during the first nine months of 2024.

Note 5. Segment Performance Measures and Expenses

The Company operates in one segment for the research and development of product candidates. The Company’s chief operating decision maker (“CODM”) has been identified as the Chief Executive Officer and President, who reviews operating results to make decisions about allocating resources and assessing performance for the entire Company based on condensed consolidated financial information. Consequently, the Company views the entire organization as one reportable segment and the strategic purpose of all operating activities (including general and administrative expenses) is to support that one segment. As a pre-revenue research and development company, the CODM evaluates company-wide performance and allocates resources based on non-financial research and development milestones achieved, and to a lesser extent, financial measures of performance such as clinical development (research and development expenses) and general and administrative expenses incurred. The CODM does not generally evaluate the Company’s performance using asset or historical cash flow information.

The table below provides a summary of the significant expense categories and consolidated net loss details provided to the CODM (in thousands):

	2025			2024
	For the nine months ended September 30,
	(In thousands)						Change Increase (Decrease)
	2025			2024
Operating Expenses:
Clinical Research
OVATION 2 and MRD Trials	$	212		$	1,139		$	(927	)	(81.4	)%
OVATION 3 Trial		695			-			695		-	%
PlaCCine Vaccine Phase 1 Trial		42			1,412			(1,370	)	(97.0	)%
Other Clinical and Regulatory		1,387			1,900			(513	)	(27.0	)%
Subtotal		2,336			4,451			(2,115	)	(47.5	)%
Non-Clinical R&D and CMC
OVATION Program		2,209			851			1,358		159.6	%
PlaCCine Vaccine Program		-			2,554			(2,554	)	-	%
Manufacturing (CMC)		746			1,551			(805	)	(51.9	)%
Subtotal		2,955			4,956			(2,001	)	(40.4	)%
Research and development expenses		5,291			9,407			(4,116	)	(43.8	)%
General and administrative expenses		5,098			5,580			(482	)	(8.6	)%
Total operating expenses		10,389			14,987			(4,598	)	(30.7	)%
Loss from operations	$	(10,389	)	$	(14,987	)	$	(4,598	)	(30.7	)%

Note 6. Other Accrued Liabilities

Other accrued liabilities at September 30, 2025 and December 31, 2024 include the following:

Schedule of Other Accrued Liabilities

	September 30, 2025		December 31, 2024
Amounts due to contract research organizations and other contractual agreements	$	910,501	$	1,048,036
Accrued payroll and related benefits		1,687,690		1,945,111
Accrued professional fees and other		78,760		40,600
Total	$	2,676,951	$	3,033,747

Note 7. Stockholders’ Equity

On May 15, 2024, the Company filed with the U.S. Securities and Exchange Commission (“SEC”) a shelf registration statement on Form S-3 (the “2024 Registration Statement”) for the offer and sale of up to $75 million of its securities. The 2024 Registration Statement was declared effective on May 22, 2024. The 2024 Registration Statement is intended to provide the Company with flexibility to raise capital in the future for general corporate purposes. As noted in the prospectus supplement that the Company filed on July 22, 2025, the aggregate market value of outstanding Common Stock held by non-affiliates was approximately $79,075,969, based on 2,121,895 shares of Common Stock outstanding as of July 22, 2025, of which 2,100,291 shares were held by non-affiliates, and a price of $37.65 per share, which was the last reported sale price of Common Stock on The Nasdaq Stock Market LLC (“Nasdaq”) on June 2, 2025. As a result, the Company’s public float increased above $75.0 million, and the Company is no longer subject to the limitations contained in General Instruction I.B.6 of Form S-3.

Reverse Stock Split

On July 25, 2025, the Company effected a 15-for-1 reverse stock split of its common stock which was made effective for trading purposes as of 12:01 a.m. ET on July 25, 2025. As of that date, each 15 shares of issued and outstanding common stock and equivalents were consolidated into one share of common stock. All shares have been restated to reflect the effects of the 15-for-1 reverse stock split. In addition, at the market open on July 25, 2025, the Company’s common stock started trading under a new CUSIP number 15117N701 although the Company’s ticker symbol, IMNN, remained unchanged.

The reverse stock split was previously approved by the Company’s stockholders at the 2025 Annual Meeting held on July 11, 2025, and the Company subsequently filed a Certificate of Amendment to its Certificate of Incorporation to effect the stock consolidation. The primary reasons for the reverse stock split and the amendment are:

	●	To provide the Company with the ability to support its future anticipated growth and would provide greater flexibility to consider and respond to future business opportunities and needs as they arise, including equity financings and stock-based acquisitions of new technology and product development candidates. The availability of additional shares of Common Stock would permit the Company to undertake certain of the foregoing actions without delay and expense associated with holding a Special Meeting of Stockholders to obtain stockholder approval each time such an opportunity arises that would require the issuance of shares of Common Stock; and

	●	To continue listing on The NASDAQ Capital Market, which requires that the Company comply with the applicable listing requirements under NASDAQ Marketplace Rules, which requirements include, among others, a minimum bid price of at least $1.00 per share.

Immediately prior to the reverse stock split, the Company had 31,828,447 shares of common stock outstanding which consolidated into 2,121,942 shares of the Company’s common stock. No fractional shares were issued in connection with the reverse stock split. All fractional shares were rounded up to the nearest whole share. The reverse stock split did not impact the total authorized number of shares of common or preferred stock or the par value thereof. The number of outstanding options, stock awards and warrants were adjusted accordingly, with outstanding options and stock awards being reduced from approximately 1.9 million to approximately 0.1 million and outstanding warrants being reduced from approximately 12.7 million to approximately 0.8 million.

Increase to Authorized Shares

At the 2025 Annual Meeting of Stockholders (the “Annual Meeting”) of the Company held on July 11, 2025, upon the recommendation of the Company’s board of directors, the Company’s stockholders voted on and approved an amendment to the Company’s Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 112,500,000 shares to 350,000,000 shares, and to make a corresponding change to the number of authorized shares of capital stock. Such amendment became effective on July 11, 2025 upon filing with the Secretary of State of the State of Delaware.

Stock Dividend

On July 28, 2025, the Company announced that the Company’s Board of Directors approved a 15% stock dividend, 0.15 shares of common stock (the “Stock Dividend”) per share of the Company’s issued and outstanding shares of common stock and per each common stock equivalent with dividend rights.

The Board of Directors fixed August 7, 2025 as the record date (the “Record Date”) for the Stock Dividend, and the Stock Dividend was issued on August 21, 2025 to stockholders of record as of the Record Date.

The number of outstanding warrants were adjusted accordingly, with outstanding warrants increasing from approximately 0.8 million to approximately 1.0 million.

At the Market Offering Agreement

On May 15, 2024, the Company amended the At the Market Offering Agreement, dated as of May 25, 2022 (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) as sales agent. Pursuant to the terms of the amended ATM Agreement, the Company may offer and sell, from time to time, through Wainwright, shares of the Company’s common stock having an aggregate offering price of up to $5,500,000. The Company intends to use the net proceeds from any offering under the amended ATM Agreement for general corporate purposes, including research and development activities, capital expenditures and working capital.

On July 30, 2024, the Company notified Wainwright that it was suspending its use of and terminating the “at the market offering” sales agreement prospectus (the “ATM Prospectus”), related to the potential issuance from time to time of the Company’s common stock pursuant to the ATM Agreement, by and between the Company and Wainwright. Notwithstanding the termination of the ATM Prospectus, the ATM Agreement remains in full force and effect.

On September 3, 2024, the Company filed a new prospectus supplement to the 2024 Registration Statement with the SEC for an aggregate offering price of up to $5,500,000 related to the potential issuance from time to time of the Company’s common stock pursuant to the ATM Agreement with Wainwright as sales agent.

On July 22, 2025, the Company filed a prospectus supplement (the “Prospectus Supplement”) to register an additional $4,500,000 of shares of the Company’s common stock, par value $0.01 per share issuable pursuant to the At the Market Offering Agreement, dated as of May 25, 2022, as amended by Amendment No. 1 to At the Market Offering Agreement, dated as of May 15, 2024 (as amended, the “Sales Agreement”), by and between the Company and H.C. Wainwright & Co., LLC, as sales agent or principal (the “Sales Agent”). The Company previously registered the offer and sale of up to $5,500,000 of shares of Common Stock through the Sales Agent under the Sales Agreement. Prior to the date hereof, the Company has sold an aggregate of $1,815,267 shares of Common Stock through the Sales Agent under the Sales Agreement. Accordingly, the Prospectus Supplement covers an aggregate of $8,184,733 of Shares, consisting of $3,684,733 remaining of the amount originally registered and the additional $4,500,000 increase under the Prospectus Supplement.

The Company sold 5,932 shares of common stock under the ATM Agreement for net proceeds of $99,506 during 2024. During 2025, the Company sold 551,265 shares of common stock under the ATM Agreement for net proceeds of $3,638,767 through September 30, 2025. The Company sold 174,081 shares of common stock under the ATM Agreement for net proceeds of $816,030 subsequent to September 30, 2025.

July 2024 Offering

On July 30, 2024, the Company entered into the July 2024 Purchase Agreement with the Purchasers, pursuant to which the Company issued, in a registered direct offering, an aggregate of 333,334 shares of the Company’s common stock at an offering price of $30.00 per share for gross proceeds of $10.0 million before the deduction of placement agent fees and offering expenses. In a concurrent private placement and also pursuant to the July 2024 Purchase Agreement, the Company issued to the Purchasers the Warrants to purchase an aggregate of 333,334 shares of its common stock at an exercise price of $30.00 per share.

The Warrants became exercisable immediately after issuance for a term of five and one-half years following the date of issuance. The closing of the July 2024 Offering occurred on August 1, 2024.

On May 12, 2025, the Company entered into an exchange agreement (the “Agreement”) with the holders (the “Warrant Holders”) of certain warrants of the Company issued on August 1, 2024, which are exercisable for an aggregate of 333,334 shares of the Company’s common stock, par value $0.01 per share. Pursuant to the terms of the Agreement, the Company will issue to the Warrant Holders an aggregate of 194,734 shares of Common Stock (the “Warrant Exchange Shares”), on a one-for-one basis, in exchange for shares issuable under the Warrants (the “Warrant Exchange”), in reliance on an exemption from registration provided by Section 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”). Pursuant to the Agreement, the Warrant Holders also agreed to waive the Company’s compliance with the provisions of Section 4.12(b) of the Securities Purchase Agreement, dated July 30, 2024, with respect to any Company Variable Rate Transaction (as defined in the Purchase Agreement) for a period of forty-five (45) days from the date of the Agreement and agreed to a lock up period on the Warrant Exchange Shares ending on the opening of trading on May 14, 2025. The Warrant Exchange closed on May 13, 2025. The number of Warrant Exchange Shares that will be issued pursuant to the Agreement will represent 19.98% of the shares of Common Stock outstanding as of the date of the Agreement.

May 2025 Offering

On May 23, 2025, the Company entered into a Securities Purchase Agreement with certain institutional and accredited investors, for the issuance and sale in a private placement of (i) 185,186 shares of the Company’s common stock, (ii) 296,297 of pre-funded warrants at an exercise price of $0.0001 per share and (iii) 962,964 warrants at an exercise price of $6.75 per share for gross proceeds of approximately $3.3 million before the deduction of placement agent fees and offering expenses.

The Prefunded Warrants became exercisable immediately after issuance for a term of two and one-half years following the date of issuance. The Warrants will be exercisable upon receipt of such approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market (or any successor entity) from the stockholders of the Company with respect to issuance of all of the Warrants and the shares of Common Stock upon the exercise thereof (“Stockholder Approval,” and such date, the “Stockholder Approval Date”) and have a term of three years. The prefunded warrants were exercised in full on June 16, 2025 and June 18, 2025.

In addition, the Company issued to H.C. Wainwright & Co., LLC warrants (the “Placement Agent Warrants”) to purchase up to an aggregate of 24,075 shares of common stock at an exercise price equal to $8.44 per share. The Placement Agent Warrants have substantially the same terms as the Warrants. The closing of the May 2025 Offering occurred on May 28, 2025. On July 11, 2025, the Company’s stockholders approved the issuance of the Warrants.

Note 8. Stock-Based Compensation

The Company has long-term compensation plans that permit the granting of equity-based awards in the form of stock options, restricted stock, restricted stock units, stock appreciation rights, other stock awards, and performance awards.

In 2018, stockholders approved the Imunon, Inc. 2018 Stock Incentive Plan (the “2018 Plan”). The 2018 Plan, as amended, permits the granting of 131,334 shares of Imunon common stock as equity awards in the form of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, other stock awards, performance awards, or in any combination of the foregoing.

As of September 30, 2025, there were a total of 264,667 shares of Imunon common stock reserved for issuance under the 2018 Plan, which were comprised of 24,986 shares of Imunon common stock subject to equity awards previously granted under the 2018 Plan and 235,509 shares of Imunon common stock available for future issuance under the 2018 Plan. At the 2025 Annual Stockholders Meeting of the Company held on July 11, 2025, stockholders approved an amendment to the 2018 Plan, as previously amended, whereby the Company increased the number of shares of common stock available by 133,333 to a total of 264,667 under the 2018 Plan, as amended.

Total compensation cost related to stock options and restricted stock awards was approximately $0.1 million and $0.4 million of expense for the nine months ended September 30, 2025 and 2024, respectively. Of these amounts, approximately $29,000 for the nine months ended September 30, 2025 and $0.2 million expense for the same period ended September 30, 2024 were charged to research and development expenses and $0.1 million of expense for the nine months ended September 30, 2025 and $0.2 million of expense for the nine months ended September 30, 2024 were charged to general and administrative expenses.

A summary of stock option awards and restricted stock grants, inclusive of awards granted under the 2018 Stock Plan and Inducement Option Grants for the nine months ended September 30, 2025 is presented below:

	Stock Options					Restricted Stock Awards				Weighted Average
	Options Outstanding			Weighted Average Exercise Price		Non-vested Restricted Stock Outstanding		Weighted Average Grant Date Fair Value		Contractual Terms of Equity Awards (in years)
Equity awards outstanding at January 1, 2025		107,865		$	28.97		2,647	$	14.85

Equity awards granted		35,693		$	11.44		-	$	-

Equity awards issued		-			-		2,647	$	14.85

Equity awards terminated or forfeited		(118,572	)	$	25.56		-	$	-

Equity awards outstanding at September 30, 2025		24,986		$	20.12		-	$	-		8.8

Equity awards exercisable at September 30, 2025		17,292		$	24.85						8.4

Aggregate intrinsic value of equity awards exercisable at September 30, 2025	$	-

As of September 30, 2025, there was $58,000 of total unrecognized compensation cost related to non-vested stock-based compensation arrangements. That cost is expected to be recognized over a period of three 3 to four years. The weighted average grant date fair value of the stock options granted was $11.44 during the nine months ended September 30, 2025.

The fair values of stock options granted were estimated at the date of grant using the Black-Scholes option pricing model. The Black-Scholes model was originally developed for use in estimating the fair value of traded options, which have different characteristics from the Company’s stock options. The model is also sensitive to changes in assumptions, which can materially affect the fair value estimate. The Company used the following assumptions for determining the fair value of options granted under the Black-Scholes option pricing model:

	For the Nine Months Ended September 30,
	2025			2024
Risk-free interest rate	4.22 to 4.55		%	3.72 to 4.31		%
Expected volatility	110.74 to 123.22		%	101.74 to 115.81		%
Expected life (in years)	9.0 to 10.0			9.0 to 10.0
Expected dividend yield		0.0	%		0.0	%

Expected volatilities utilized in the model are based on historical volatility of the Company’s stock price. The risk-free interest rate is derived from values assigned to U.S. Treasury bonds with terms that approximate the expected option lives in effect at the time of grant.

Note 9. Warrants

The following is a summary of all warrant activity for the nine-month period ended September 30, 2025:

Schedule of Warrant Activity

Warrants	Number of Warrants Issued			Weighted Average Exercise Price

Warrants outstanding at January 1, 2025		395,224		$	32.74

Warrants issued		1,475,838			4.54

Warrants exercised – cashless		(223,946	)		-

Warrants exercised		(671,732	)		5.16

Warrants expired		(10,137	)		242.61

Warrants outstanding at September 30, 2025		965,247		$	8.18

Aggregate intrinsic value of outstanding warrants at September 30, 2025	$	-

Weighted average remaining contractual terms at September 30, 2025		2.8 years

Note 10. Leases

Lawrenceville, New Jersey Lease

In August 2023, the Company renewed its Lawrenceville office lease for a 24-month agreement for 9,850 square feet with monthly rent payments of approximately $22,983 to $23,394. In April 2025, the Company renewed its Lawrenceville office lease until November 30, 2028 for 4,359 square feet (to be reduced to 4,011 following April 1, 2026) with monthly rent payments of approximately $10,361 to $10,863.

Huntsville, Alabama Lease

In January 2023, the Company renewed its Huntsville facility lease for a 60-month lease agreement for 11,420 square feet with monthly rent payments of approximately $28,550 to $30,903.

The following is a table of the lease payments and maturity of the Company’s operating lease liabilities as of September 30, 2025:


2025	$	120,196
2026		488,821
2027		498,086
2028		149,896
Subtotal future lease payments		1,256,999
Less imputed interest		(154,767	)
Total lease liabilities	$	1,102,232

Weighted average remaining life		2.6

Weighted average discount rate		9.98	%

For the nine-month period ended September 30, 2025, operating lease expense was $402,384 and cash paid for operating leases included in operating cash flows was $400,936. For the nine-month period ended September 30, 2024, operating lease expense was $479,401 and cash paid for operating leases included in operating cash flows was $488,047.

Note 11. Commitments and Contingencies

The Company is not currently a party to any material legal proceedings.

Note 12. Subsequent Events

The Company has evaluated its subsequent events from September 30, 2025, through the date these condensed consolidated financial statements were issued.

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion and analysis of our financial condition and results of operations. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those discussed in forward-looking statements. Factors that might cause a difference include, but are not limited to, those discussed above under “Cautionary Note Regarding Forward-Looking Statements,” and in Item 1A. Risk factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Overview

Imunon is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms with the aim 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 coding of proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the coding of viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases.

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 II clinical trial (OVATION 2) and is currently conducting 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. Additionally, the Company has entered into a first-in-human study of its COVID-19 booster vaccine (IMNN-101). We will continue to leverage these modalities and to advance the technological frontier of plasmid DNA based treatments to better serve patients with difficult-to-treat conditions.

Technology Platform

Imunon’s technology platform is optimized for the delivery of DNA and mRNA therapeutics via synthetic non-viral carriers and is capable of providing cell transfection for double-stranded DNA plasmids and large therapeutic RNA segments such as mRNA. There are two components to the system, a backbone with plasmid DNA or mRNA payload encoding therapeutic proteins, or pathogen antigens or tumor associated antigens or cancer neoantigens and a delivery system. The delivery system is designed to protect the DNA or mRNA from degradation and promote trafficking into cells and through intracellular compartments. We designed the delivery system by chemically modifying the low molecular weight polymer to improve its gene transfer activity without increasing toxicity. We believe that our non-viral DNA technology may be a viable alternative to current approaches to gene delivery due to several distinguishing characteristics, including enhanced molecular versatility that allows for complex modifications to potentially improve activity and safety.

The biocompatibility of these polymers reduces the risk of adverse immune response, thus allowing for repeated administration. Compared to naked DNA or cationic lipids, we believe that our delivery systems are generally more efficient, cost effective and have a more favorable safety profile. We believe that these advantages place Imunon in a position to capitalize on this technology platform.

THERAPLAS MODALITY: IMNN-001 DEVELOPMENT PROGRAM

Ovarian Cancer Overview

Ovarian cancer is the most lethal of gynecological malignancies among women with more than 60% of women dying within five years of diagnosis. This poor outcome is due in part to the lack of effective prevention and early detection strategies. There were approximately 20,000 new cases of ovarian cancer in the U.S. in 2021 with an estimated 13,000 deaths. Mortality rates for ovarian cancer declined very little in the last 40 years due to the unavailability of detection tests and improved treatments. Most women with ovarian cancer are not diagnosed until Stages III or IV, when the disease has spread outside the pelvis to the abdomen and areas beyond, causing swelling and pain. With the five-year survival rates for Stages III and IV at 41% and 20%, respectively, there remains a need for a therapy that not only reduces the recurrence rate but also meaningfully improves overall survival. Patients whose cancer recurs or progresses after initially responding to surgery and first-line chemotherapy have been divided into one of the two groups based on the time from completion of platinum therapy to disease recurrence or progression. This time period is referred to as platinum-free interval. The platinum-sensitive group has a platinum-free interval of longer than nine months. This group generally responds to additional treatment with platinum-based therapies. The platinum resistant group has a platinum-free interval of shorter than nine months and is resistant to additional platinum-based treatments. Pegylated liposomal doxorubicin, topotecan, and bevacizumab are the only approved second-line therapies for platinum-resistant ovarian cancer. The overall response rate for these therapies is 10% to 20% with median overall survival (“OS”) of 11 to 12 months. Additionally, 10% to 15% of ovarian cancer cases nationwide are a result of germline or somatic BRCA mutations. With cognizance of tumor genetics, practice has shifted to include targeted agents in ovarian cancer treatment.

Poly (ADP-ribose) polymerase (“PARP”) enzymes are responsible for detecting and repairing single-stranded and double-stranded DNA breaks during cell replication. BRCA1/2 mutations hinder the homologous recombination repair pathway, and tumor cells utilize PARP enzymes to repair DNA. For this reason, these tumors are particularly sensitive to the mechanism of PARP inhibitors. PARP inhibitors have expanded treatment options in ovarian cancer in maintenance following front-line treatment, but few treatment options are left for women who are not eligible to receive PARP inhibitors and no product has ever demonstrated an OS improvement in the front-line treatment of newly diagnosed patients with ovarian cancer.

Immunotherapy is an attractive, novel approach for the treatment of ovarian cancer particularly since ovarian cancers are considered immunogenic tumors. Interleukin-12 (“IL-12”) is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The precedence for the therapeutic role of IL-12 in ovarian cancer is based on epidemiologic and clinical and preclinical data.

IMNN-001 Immunotherapy

IMNN-001 is a DNA-based immunotherapeutic drug candidate for the localized treatment of ovarian cancer by intraperitoneally administration of an IL-12 encoded DNA plasmid formulated with our proprietary TheraPlas delivery system. In the clinical development program, the immunotherapy treatment schedule follows frontline standard of care and is combined with a standard chemotherapy drug, which can potentially achieve better clinical outcomes than with chemotherapy alone. We believe that increases in IL-12 concentrations at tumor sites for several days after a single administration could create a potent immune environment against tumor activity and that a direct killing of the tumor with concomitant use of cytotoxic chemotherapy could result in a more robust and durable antitumor response than chemotherapy alone. We believe the rationale for local therapy with IMNN-001 is based on the following:

	●	Loco-regional production of the potent cytokine IL-12 avoids toxicities and poor pharmacokinetics associated with systemic delivery of recombinant IL-12;

	●	Persistent local delivery of IL-12 lasts up to one week and dosing can be repeated; and

	●	Local therapy is ideal for long-term maintenance therapy.

OVATION 1 Study. In February 2015, we announced that the FDA accepted the Phase I dose-escalation clinical trial of IMNN-001 in combination with the standard of care in neoadjuvant ovarian cancer (the “OVATION 1 Study”). The OVATION 1 Study was designed to:

	●	identify a tolerable and therapeutically active dose of IMNN-001 within certain safety parameters by recruiting and maximizing an immune response;

	●	enroll three to six patients per dose level and evaluate safety and efficacy; and

SEC Form 10-Q filed by Imunon Inc.