Imunon, Inc 10-Q, filed Nov 12, 2026
Imunon, Inc. (IMNN)
About this 10-Q
Imunon, Inc filed this 10-Q on November 12, 2026, covering the quarter ended September 30, 2026.
Headline figures
Quarter ended September 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $3.75M
- compared with a net loss of $3.43M a year earlier
- Diluted EPS
- -$0.64
- compared with -$1.16 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____________ to _______________
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(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act
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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
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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):
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As of November 12, 2026, the Registrant had shares of common stock, $ par value per share, outstanding.
IMUNON, INC.
QUARTERLY REPORT ON
FORM 10-Q
TABLE OF CONTENTS
| 2 |
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, 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), 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, 2025, 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 subsidiaries 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.
| 3 |
PART I: FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
IMUNON, INC.
CONDENSED CONSOLIDATED
BALANCE SHEETS
| September 30, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Advances and deposits on clinical programs and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment (at cost, less accumulated depreciation and amortization) | ||||||||
| Other assets: | ||||||||
| Restricted cash | ||||||||
| Operating lease right-of-use assets, net | ||||||||
| Deposits and other assets | ||||||||
| Total other assets | ||||||||
| Total assets | $ | $ | ||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 4 |
IMUNON, INC.
CONDENSED CONSOLIDATED
BALANCE SHEETS
(Continued)
| September 30, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable - trade | $ | $ | ||||||
| Other accrued liabilities | ||||||||
| Note payable - Note A-1 - current portion | ||||||||
| Operating lease liability - current portion | ||||||||
| Derivative liability associated with redemption feature of Note A-1 | ||||||||
| Total current liabilities | ||||||||
| Note payable - Note B | ||||||||
| Operating lease liability - non-current portion | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Series A Preferred stock - $ par value ( shares authorized; shares issued and outstanding at September 30, 2026, and shares issued or outstanding at December 31, 2025) | ||||||||
| Series A Additional paid-in capital - preferred stock | ||||||||
| Series B Preferred stock - $ par value ( shares authorized; shares issued and outstanding at September 30, 2026, and shares issued or outstanding at December 31, 2025) | ||||||||
| Preferred stock, value | ||||||||
| Series B Additional paid-in capital - preferred stock | ||||||||
| Additional paid-in capital - preferred stock | ||||||||
| Common stock - $ par value ( shares authorized; and shares issued at September 30, 2026 and December 31, 2025, respectively; and and shares outstanding at September 30, 2026 and December 31, 2025, respectively) | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity before treasury stock | ||||||||
| Treasury stock, at cost ( shares at September 30, 2026 and December 31, 2025) | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 5 |
IMUNON, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Investment income, net | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ||||||||||||
| Loss on extinguishment of Note A-1 | ( | ) | ( | ) | ||||||||||||
| Change in fair value of derivative liability | ||||||||||||||||
| Total other (expense) income, net | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Deemed Dividend - Series A Preferred Stock | ( | ) | ( | ) | ||||||||||||
| Deemed Dividend - Series B Preferred Stock | ( | ) | ( | ) | ||||||||||||
| Net loss available to common shareholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per common share available to common shareholders | ||||||||||||||||
| Basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average shares outstanding | ||||||||||||||||
| Basic and diluted | ||||||||||||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 6 |
IMUNON, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
| 2026 | 2025 | |||||||
| For the Nine Months Ended September 30, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | ||||||||
| Amortization of right-of-use assets | ||||||||
| Stock-based compensation | ||||||||
| Common stock issued in exchange for compensation and services | ||||||||
| Loss on Extinguishment of Note A-1 | ||||||||
| Change in fair value of derivative liability | ( | ) | ||||||
| Paid in kind interest accretion – Note A-1 | ||||||||
| Amortization of Note A-1 and Note B discount and issuance costs | ||||||||
| Net changes in: | ||||||||
| Advances, deposits, and other current assets | ||||||||
| Accounts payable and accrued liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of property and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from sale of common stock, net of issuance costs | ||||||||
| Proceeds from sale of preferred stock, net of issuance costs* | ||||||||
| Proceeds from issuance of notes payable, net of issuance costs | ||||||||
| Issuance costs for stock dividend | ( | ) | ||||||
| Proceeds from issuance of common stock upon exercise of warrants | ||||||||
| Net cash (used in) provided by financing activities | ||||||||
| Net change in cash, cash equivalents and restricted cash | ( | ) | ||||||
| Cash, cash equivalents and restricted cash at beginning of period | ||||||||
| Cash, cash equivalents and restricted cash at end of period | $ | $ | ||||||
| 2026 | 2025 | |||||||
For the Nine Months Ended September 30, | ||||||||
| 2026 | 2025 | |||||||
| Supplemental disclosures of cash flow information: | ||||||||
| Non-cash investing and financing activities: | ||||||||
| Exchange of Note A-1 payable with Series B preferred stock* | $ | $ | ||||||
| Recognition of operating lease right-of-use asset and liability | ||||||||
| * |
See accompanying notes to the unaudited condensed consolidated financial statements.
| 7 |
IMUNON, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2026 AND 2025
| Series A Preferred Stock Outstanding | Series B Preferred Stock Outstanding | Common
Stock Outstanding | Treasury Stock | |||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Additional Paid-in Capital | Shares | Amount | Additional Paid-in Capital | Shares | Amount | Additional Paid-in Capital | Shares | Amount | Accumulated Deficit | Total Equity | ||||||||||||||||||||||||||||||||||||||||
| Balance at July 1, 2026 (unaudited) | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Issuance of preferred stock, net of costs and discount | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Sale of equity through equity financing facilities, net of costs | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of common stock warrants | - | - | ( | ) | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Equity issued for payment of compensation and fees in lieu of cash | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2026 (unaudited) | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||
| 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) | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Effect of reverse stock split | - | |||||||||||||||||||||||||||
| Sale of equity through equity financing facilities, net of costs | - | |||||||||||||||||||||||||||
| Issuance of common stock upon exercise of common stock warrants | - | |||||||||||||||||||||||||||
| Stock dividend, net of offering costs | ( | ) | - | ( | ) | |||||||||||||||||||||||
| Shares issued to satisfy certain obligations | - | |||||||||||||||||||||||||||
| Issuance of common stock upon exercise of restricted options | - | |||||||||||||||||||||||||||
| Stock-based compensation expense | - | ( | ) | - | ( | ) | ||||||||||||||||||||||
| Balance at September 30, 2025 (unaudited) | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
See accompanying notes to the unaudited condensed consolidated financial statements
| 8 |
IMUNON, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026 AND 2025
Series A Preferred Stock Outstanding | Series B Preferred Stock Outstanding | Common Stock Outstanding | Treasury Stock | |||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Additional Paid-in Capital | Shares | Amount | Additional Paid-in Capital | Shares | Amount | Additional Paid-in Capital | Shares | Amount | Accumulated Deficit | Total Stockholders’ Equity | ||||||||||||||||||||||||||||||||||||||||
| Balance at January 1, 2026 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||
| Issuance of preferred stock, net of costs and discount | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Sale of equity through equity financing facilities, net of costs | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of common stock warrants | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||
| Equity issued for payment of compensation and fees in lieu of cash | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2026 (unaudited) | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||
| 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 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Balance | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Effect of reverse stock split | - | |||||||||||||||||||||||||||
| Sale of equity through equity financing facilities, net of costs | - | |||||||||||||||||||||||||||
| Issuance of common stock upon exercise of common stock warrants | - | |||||||||||||||||||||||||||
| Stock dividend, net of offering costs | ( | ) | - | ( | ) | |||||||||||||||||||||||
| Shares issued to satisfy certain obligations | - | |||||||||||||||||||||||||||
| Issuance of common stock upon exercise of restricted options | - | |||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | ||||||||||||||||||||||||||
| Balance at September 30, 2025 (unaudited) | $ | $ | $ | ( | )- | $ | ( | ) | $ | |||||||||||||||||||
| Balance | $ | $ | $ | ( | )- | $ | ( | ) | $ | |||||||||||||||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 9 |
IMUNON, INC.
NOTES TO THE CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
(UNAUDITED)
SEPTEMBER 30, 2026
Note 1. Business Description
Imunon, Inc. (“Imunon,” the “Company,” “we,” “our,” or “us”) is a clinical-stage biotechnology company focused on developing its non-viral DNA technology to advance 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. The lead modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising.
The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials, including one Phase 2 clinical trial (OVATION 2), and is currently being studied in a Phase 3 clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site.
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 (“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. 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 three months and nine months ended September 30, 2026, and 2025 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, 2025, filed with the Securities and Exchange Commission on March 31, 2026.
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 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 financial statements and accompanying notes.
Significant Accounting Policies
Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 31, 2026. See Note 3 to the Condensed Consolidated Financial Statements contained in this Quarterly Report on Form 10-Q.
Restricted cash
Restricted cash is defined as cash held for a specific purpose and not available for immediate general business use. It is classified as a current or non-current asset based on the expected timing of release. All restricted cash is included in the unaudited condensed consolidated statement of cash flows as part of total cash and cash equivalents. Liquidity ratios exclude restricted cash to reflect actual liquidity. Restrictions are documented and reviewed quarterly. Restricted cash consists of funds held in escrow accounts and cash collateral required under certain loan agreements as more detailed in Note 7.
Classification of Preferred Stock
The Company applies the guidance of ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”), when determining the classification and measurement of its preferred stock. Preferred stock subject to mandatory redemption (if any) are classified as liability instruments and are measured at fair value. The Company classifies contingently redeemable preferred stock (if any), which includes preferred stock that features redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control, as temporary equity. At all other times, the Company classifies its preferred stock in stockholders’ equity.
| 10 |
Embedded Derivatives
The Company reviews the terms of convertible loan notes and other hybrid financing arrangements to determine whether there are embedded derivative instruments, including conversion options that are required to be bifurcated and accounted for separately either as a derivative financial instrument or an equity instrument. Derivatives are accounted for under ASC 815, Derivatives and Hedging. Derivative financial instruments are initially measured at fair value, and then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations as a component of net income.
The discount from face value of the liability component remaining from allocating some or all of the proceeds of the hybrid instrument to the derivative, together with the stated rate of interest on the instrument, is amortized over the life of the instrument through periodic charges to consolidated statements of operations, using the effective interest method. Embedded derivatives that are bifurcated and recognized as liability instruments.
The Note A-1 contains a limited redemption feature to redeem Note A-1 principal on any trading day on which the Company’s common stock trades at or above 115% of the Nasdaq Minimum Price, in an amount up to 5% of the cumulative daily dollar trading volume in aggregate across the outstanding Notes. The Company determined that this feature is not clearly and closely related to the promissory notes host and meets the definition of a derivative. The feature has been bifurcated and is recorded as a derivative liability measured at fair value. (For further details, see “Note 7. Preferred Stock and Notes Payable”)
Debt Issuance Costs and Discount
Debt issuance costs include incremental and direct costs incurred in relation to debt, such as legal fees, accounting fees, and other direct costs of the financing. Amounts paid to the lender are a reduction in the proceeds received by the Company and are generally considered a component of issuance discount, unless it is paid to compensate the lender for the services rendered or as a reimbursement of direct costs incurred by them in relation to the debt, in which case it would be akin to a debt issuance cost.
Debt issuance costs related to a recognized promissory note liability are presented in the consolidated balance sheets as a direct deduction from the carrying amount of the debt liability rather than as an asset, consistent with the presentation of debt discounts, and are amortized to interest expense over the term of the related debt using the effective interest method.
Preferred Stock Issuance Costs
Preferred stock issuance costs consist of specific incremental costs directly attributable to the issuance of preferred stock. These include placement agent and broker fees, legal and accounting fees (including comfort letter fees), and other direct costs of the offering. In accordance with SEC Staff Accounting Bulletin (“SAB”) Topic 5.A, Expenses of Offering, these costs are charged against the gross proceeds of the offering. When preferred stock is issued together with other financial instruments in a single transaction, issuance costs are allocated among the instruments issued based on their relative values. The portion allocated to debt instruments is accounted for as described under “Debt Issuance Costs and Discount.”
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 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, 2026, the Company had a net loss of $
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 tariffs announcement by the U.S. federal government, the Russian invasion of Ukraine and the unrest in the Middle East and in Europe. 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 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 continues to address its current expenditures and will reduce spending where necessary; |
| ● | it continues to pursue additional capital funding in the public and private markets through equity sales and/or debt facilities; |
| ● | it continues to pursue partnerships and collaborations; and |
| ● | it continues to pursue out licensing for its drug candidates and/or platform technology. |
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, 2025, 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 and debt financings, collaborations, and/or partnerships, or other strategic transactions such as raising funds from investors through its ATM program and the proposed public offering filed on Form S-1, as further described in Note 13. 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 unaudited 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.
| 11 |
Note 3. New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the 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 consolidated financial position, results of operations, and cash flows, or does not apply to its operations.
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, if any, this change will have on the Company’s disclosures.
In December 2025, the FASB issued ASU 2025-11, “Narrow Scope Improvements” (“ASU 2025-11”) which is intended to improve the navigability of the guidance in Interim Reporting (Topic 270) and clarify when it applies. Under the amendments, an entity is subject to ASC 270 if it provides “interim financial statements and notes in accordance with GAAP.” ASU 2025-11 also addresses the form and content of such financial statements, adds lists to ASC 270 of the interim disclosures required by all other codification topics, and establishes a principle under which an entity must “disclose events since the end of the last annual reporting period that have a material impact on the entity.” As the FASB stated in the proposed guidance and reiterates in 2025-11, the amendments are not intended to “change the fundamental nature of interim reporting or expand or reduce current interim disclosure requirements”. ASU 2025-11 is effective for interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company does not believe ASU 2025-11 will have a material effect on its unaudited condensed consolidated financial statements.
Other than the items noted above, there have been no new accounting pronouncements not yet effective or adopted in the current year that the Company believes have a material impact, or potential material impact, to its unaudited condensed consolidated financial statements.
Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted average number of shares of common stock outstanding during the period. Net loss available to common shareholders is net loss less the preferred return accumulated during the period on the Series A Preferred Stock and Series B Preferred Stock, whether or not declared, in accordance with ASC 260-10-45-11. See Note 7 for the terms of the Series A Preferred Stock and Series B Preferred Stock.
Diluted net loss per common share is computed by dividing net loss available to common shareholders by the weighted average number of shares of common stock outstanding during the period, plus the dilutive effect, if any, of potential common shares. Potential common shares consist of shares issuable upon the exercise of outstanding common stock warrants and stock options, determined using the treasury stock method. The Company reported a net loss available to common shareholders for all periods presented. Including potential common shares would therefore have been anti-dilutive, so diluted net loss per common share is the same as basic net loss per common share for all periods presented.
As
more fully described in Note 8 of unaudited condensed consolidated financial statements, on December 31, 2025, the Company completed
the sale of a security offering that included prefunded warrants to purchase up to
The Series A Preferred Stock and Series B Preferred Stock are not convertible into common stock and therefore do not represent potential common shares.
As
more fully described in Note 8 of these unaudited condensed consolidated financial statements, the Company declared a
Schedule of Computation of Basic and Diluted Net Loss per Common Share
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| For
the Three Months Ended September 30, | For
the Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Net loss available to common share available to common shareholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per common share available to common shareholders | ||||||||||||||||
| Basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average shares outstanding | ||||||||||||||||
| Basic and diluted | ||||||||||||||||
| 12 |
Schedule of Computation of Diluted Net Loss per Common Share Anti-dilutive Securities
| 2026 | 2025 | |||||||
| September 30, | ||||||||
| 2026 | 2025 | |||||||
| Common stock warrants | ||||||||
| Stock options | ||||||||
| Total | ||||||||
Note 5. Segment Performance Measures and Expenses
The
Company operates in
The table below provides a summary of the significant expense categories and consolidated net loss details provided to the CODM (in thousands):
Schedule of Significant Expense Categories and Consolidated Net Loss
| 2026 | 2025 | |||||||||||||||
| For the Nine Months Ended September 30, | ||||||||||||||||
| (Thousands) | Change Increase (Decrease) | |||||||||||||||
| 2026 | 2025 | |||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Clinical Research | ||||||||||||||||
| OVATION Trials (Phase 2 & 3) | $ | $ | $ | ( | ) | - | % | |||||||||
| MRD Study | % | |||||||||||||||
| PlaCCine Vaccine Phase 1 Trial | ( | ) | - | % | ||||||||||||
| Other Clinical and Regulatory | ( | ) | - | % | ||||||||||||
| Subtotal | ( | ) | - | % | ||||||||||||
| Non-Clinical R&D and CMC | ||||||||||||||||
| Manufacturing & Clinical Supply | % | |||||||||||||||
| Subtotal | % | |||||||||||||||
| Research and development expenses | % | |||||||||||||||
| General and administrative expenses | ( | ) | - | % | ||||||||||||
| Total operating expenses | % | |||||||||||||||
| Loss from operations | $ | $ | $ | % | ||||||||||||
Note 6. Other Accrued Liabilities
Other accrued liabilities at September 30, 2026 and December 31, 2025 include the following:
Schedule of Other Accrued Liabilities
| September 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Amounts due to contract research organizations and other contractual agreements | $ | $ | ||||||
| Accrued payroll and related benefits | ||||||||
| Accrued professional fees, interest expense, franchise taxes and other | ||||||||
| Total | $ | $ | ||||||
| 13 |
Note 7. Preferred Stock and Notes Payable
Debt consists of following as of September 30, 2026:
Schedule of Debt
| Amount | ||||
| Note A-1 | $ | |||
| Note B | ||||
| Total Debt | ||||
| Less: current portion | ( | ) | ||
| Less: unamortized debt discount and issuance costs | ( | ) | ||
| Debt, net of discount and issuance costs | $ | |||
On
June 2, 2026, the Company entered into a Securities Purchase Agreement (the “June 2026 Securities Purchase Agreement”) with
Streeterville Capital, LLC (the “Investor”), providing for the issuance and sale by the Company, and the purchase by the
Investor, of (i) shares (the “Preferred Shares”) of the Company’s Series A Preferred Stock, par value $ per
share (the “Series A Preferred Stock”), at an issued value of $ per share and a stated value of $ per share,
for aggregate gross proceeds of $
The
Note B will bear interest at
Broker
fees totaling $
| 14 |
Interest expense consistent of following for nine months ended September 30:
Schedule of Interest Expense
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Interest expense on Note A-1 | $ | $ | $ | $ | ||||||||||||
| Interest expense on Note B | ||||||||||||||||
| Amortization of debt discount and issuance costs on Note A-1 | ||||||||||||||||
| Amortization of debt issuance costs - Note B | ||||||||||||||||
| Total | $ | $ | ||||||||||||||
Permanent Equity Classification
The Company classified the shares of Series A Preferred Stock as permanent stockholders’ equity as of the Closing Date. Under ASC 480-10-S99-3A, an equity instrument must be classified outside of permanent equity if it is redeemable upon the occurrence of an event not solely within the control of the issuer. On July 29, 2026, the Company and the Investor executed an Irrevocable Waiver and Covenant Not to Exercise Redemption Rights (the “Waiver”), effective as of June 2, 2026, under which the Investor irrevocably waived the default redemption right under Section 12(b)(i) of the Certificate of Designation with respect to all events of default. The Waiver is a Type 1 recognized subsequent event under ASC 855-10-25-1 that provides evidence of conditions existing at the June 3, 2026 closing date and confirms the permanent-equity classification applied as of that date. Accordingly, because the Series A Preferred Stock is not redeemable upon an event outside the Company’s control, it is classified as permanent stockholders’ equity in accordance with ASC 480-10-S99-3A.
The Series A Preferred Stock accrues a preferred
return at a rate of
In the event of a voluntary or involuntary liquidation, dissolution or winding up of the Company, each outstanding share of Series A Preferred Stock is entitled to receive, before any distribution to holders of common stock, an amount equal to its stated value plus any accrued and unpaid preferred return. After payment of this liquidation preference, the holders of Series A Preferred Stock do not participate in any remaining distributions.
Restricted Cash
At
September 30, 2026, approximately $
Note B Amendment
On July 14, 2026, effective as of June 2, 2026, the Company and the Investor amended the Note B to remove its limited redemption feature - the feature permitting the Investor to redeem principal based on the trading volume of the Company’s common stock on days the stock trades at or above 115% of the Nasdaq Minimum Price. As a result, that feature applies only to the Note A-1, and no derivative liability was recorded in connection with the Note B.
Embedded Derivative Liability Note A-1 Limited Redemption
The
fair value of the bifurcated derivative was $
| 15 |
The following table reconciles the derivative liability for the redemption feature of the A-1 Note, which is measured at fair value on a recurring basis using significant unobservable inputs (Level 3):
Schedule of Fair Value on Recurring Basis Using Significant Unobservable Inputs
| September 30, | ||||
| 2026 | ||||
| (Unaudited) | ||||
| Balance at beginning of period | $ | |||
| Initial recognition upon issuance of A-1 Note (June 3, 2026) | ||||
| Change in fair value recognized in earnings ⁽¹⁾ | ( | ) | ||
| Derecognition upon partial extinguishment of A-1 Note | ( | ) | ||
| Balance at end of period | $ | |||
Conversion of a Portion of the A-1 Secured Promissory Note into Series B Preferred Stock
On
September 28, 2026, the Company entered into an exchange agreement with Streeterville Capital, LLC pursuant to which the Company exchanged
$
The
Series B Preferred Stock provides for an annual preferred return of
Holders of the Series B Preferred Stock do not have the right to require redemption of their shares. The Company may redeem the shares, solely at the discretion of its Board of Directors, at 110% of the applicable liquidation amount, plus any accrued and unpaid preferred return. The occurrence of an event of default may increase the stated value of the Series B Preferred Stock but does not provide the holder with a right to require cash redemption. Based on these terms, the Company determined that the Series B Preferred Stock is not mandatorily redeemable and is not redeemable upon an event outside the Company’s control. Accordingly, the Series B Preferred Stock is classified within permanent stockholders’ equity under ASC 480-10-S99-3A.
The
exchange was accounted for as a partial extinguishment of the Note A-1 under ASC 470-50. The Company measured the Series B Preferred
Stock issued at its estimated fair value of $
The following table summarizes the amounts recognized in connection with the exchange:
Schedule of Amounts Recognized in Connection with the Exchange
| Amount | ||||
| Fair value of Series B Preferred Stock issued | $ | |||
| Net carrying amount of Note A-1 extinguished | ( | ) | ||
| Portion of embedded derivative liability derecognized | ( | ) | ||
| Loss on extinguishment of Note A-1 | $ | |||
The
net carrying amount of the Note A-1 extinguished included $
Immediately
before the exchange, the Company remeasured the embedded derivative associated with the Note A-1’s limited redemption feature to
its September 28, 2026 fair value of approximately $
| 16 |
The
Company recorded approximately $
The preferred return on the Series B Preferred Stock does not affect net loss until declared or otherwise settled. However, the preferred return accumulated during each reporting period, whether or not declared, is deducted from net loss in determining net loss available to common stockholders and basic and diluted net loss per common share. Any preferred return paid through the issuance of additional Series B Preferred Stock will be reflected as a noncash financing activity.
As
of September 30, 2026, shares of Series B Preferred Stock were issued and outstanding, with an aggregate stated value of $
Note 8. Stockholders’ Equity
On
May 15, 2024, the Company filed with the U.S. SEC a shelf registration statement on Form S-3 (the “2024 Registration Statement”)
for the offer and sale of up to $
Reverse Stock Split
On
July 25, 2025, the Company effected a
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 affect 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 anticipated future 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 $ per share. |
Immediately
prior to the reverse stock split, the Company had shares of common stock outstanding which consolidated into 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 million to approximately million and outstanding warrants
being reduced from approximately
| 17 |
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 shares to 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
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
At the Market Offering Agreement
| ● | On
March 23, 2026, the Company filed a prospectus supplement registering an additional $ |
During
the first nine months of 2026, the Company sold shares of common stock under the ATM Agreement for net proceeds of $
As
of September 30, 2026, $
May 2025 Warrant Exchange
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
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) shares of the Company’s common stock, (ii)
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 warrants (the “Placement Agent Warrants”) to H.C. Wainwright & Co., LLC to purchase up to
an aggregate of
| 18 |
December 2025 Offering
On
December 29, 2025, the Company entered into a Securities Purchase Agreement (the “December 2025 Purchase Agreement”) with
a single healthcare-focused institutional investor (the “Purchaser”) for a registered direct offering (“the December
2025 Offering”) of (i) shares of the Company’s common stock, (ii) pre-funded warrants (the “December 2025 Pre-funded
Warrants”) in lieu of shares of the Company’s common stock, to the extent the Purchaser so chooses, to purchase up to
The
December 2025 Pre-funded Warrants and Warrants are being sold at a combined offering price of $ per December 2025 Pre-funded Warrant
and December 2025 Warrant. The December 2025 Pre-funded Warrants have an exercise price of $
The
Company received gross proceeds of approximately $
The shares, pre-funded warrants, and warrants issued and sold to the Purchaser under the December 2025 Purchase Agreement were offered and sold by the Company pursuant to an effective registration statement on Form S-3 (Registration No. 333-279425), as previously filed with and declared effective by the SEC and a related prospectus supplement.
Series A Preferred Stock
See Note 7 for a description of the Series A Preferred Stock issued in connection with the June 2026 Securities Purchase Agreement.
Series B Preferred Stock
See Note 7 for a description of the Series B Preferred Stock issued in connection with the Exchange Agreement.
Issuance of Unregistered Common Stock
During
the nine-month period ended September 30, 2026, the Company issued shares of common stock to certain officers and directors of
the Company in lieu of approximately $
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.
At the 2018 Annual Stockholders Meeting of the Company (“ASHM”) held on May 15, 2018, stockholders approved the Imunon, Inc. 2018 Stock Incentive Plan (the “2018 Plan”). The 2018 Plan, as originally adopted, permitted the granting of 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.
| 19 |
Stockholders have since approved amendments to the 2018 Plan at the 2019 ASHM held on May 14, 2019, the 2020 ASHM held on June 15, 2020, the 2021 ASHM held on June 10, 2021, the 2023 ASHM held on June 14, 2023, the 2025 ASHM held on July 11, 2025 and at the 2026 ASHM held on June 16, 2026. As of September 30, 2026, a total of awards have been approved by the Company’s shareholders for issuance under the 2018 Plan, as amended. Following is a schedule of the stock awards approved to the 2018 Plan, as amended:
Schedule of 2018 ASHM Plan Amendments
Shareholder Approval Event | 2018 Plan (as adopted and amended) | Number of Awards Approved | Cumulative Awards Approved | |||||||
| 2018 ASHM | 2018 Plan Adoption | |||||||||
| 2019 ASHM | Amendment #1 | |||||||||
| 2020 ASHM | Amendment #2 | |||||||||
| 2021 ASHM | Amendment #3 | |||||||||
| 2023 ASHM | Amendment #4 | |||||||||
| 2025 ASHM | Amendment #5 | |||||||||
| 2026 ASHM | Amendment #6 | |||||||||
The
Company has issued stock awards to employees, officers and directors in the form of stock options, restricted stock and common stock.
Stock option and restricted stock awards vest upon terms determined by the Compensation Committee of the Board of Directors and are subject to accelerated vesting in the event of a change of control or certain terminations of employment. The Company issues new shares to satisfy its obligations from the exercise of options or the grant of restricted stock awards.
Total compensation cost related to stock options and restricted stock awards was approximately $ million and $ million of expense for the nine months ended September 30, 2026 and 2025, respectively. Of these amounts, approximately $ million and $ million for the nine months ended September 30, 2026 were charged to research and development expenses and general and administrative expenses, respectively, compared to $ and $ million for the same periods of 2025 charged to research and development expenses and administrative expenses, respectively.
During
the nine-month period ended September 30, 2026, the Company also issued shares of common stock to employees in payment for $
Schedule of Stock Options Awards and Restricted Stock Grants
| Stock Options | Weighted | |||||||||||
Options Outstanding | Weighted Average Exercise Price |
Average Contractual Terms of Equity Awards (in years) | ||||||||||
| Stock options outstanding at January 1, 2026 | $ | |||||||||||
| Stock options granted | $ | |||||||||||
| Stock options terminated | ( | ) | $ | |||||||||
| Stock options outstanding at September 30, 2026 | $ | |||||||||||
| Stock options exercisable at September 30, 2026 | $ | |||||||||||
| Aggregate intrinsic value of stock options exercisable at September 30, 2026 | $ | |||||||||||
As of September 30, 2026, there were approximately shares remaining for issuance under the 2018 Plan, as amended. As of September 30, 2026, there was a total of $ million unrecognized compensation cost related to non-vested stock-based compensation arrangements. That cost is expected to be recognized over a period of years. The weighted average grant date fair values of the stock options granted were $during the nine-month period ended September 30, 2026
| 20 |
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, | ||||||||
| 2026 | 2025 | |||||||
| Risk-free interest rate | % | % to | % | |||||
| Expected volatility | % | to | % | |||||
| Expected life (in years) | to | |||||||
| Expected dividend yield | % | % | ||||||
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 10. Warrants
Following is a summary of all warrant activity for the nine-month period ended September 30, 2026:
Summary of Warrant Activity
| Warrants | Number of Warrants Issued | Weighted Average Exercise Price | ||||||
| Warrants outstanding at December 31, 2025 | $ | |||||||
| Pre-funded warrants exercised during the nine months ended September 30, 2026 | ( | ) | ||||||
| Warrants outstanding at September 30, 2026 | $ | |||||||
| Weighted average remaining contractual terms at September 30, 2026 | years | |||||||
Note 11. Leases
Lawrenceville,
New Jersey Lease - In August 2023, the Company renewed its Lawrenceville office lease for a
Huntsville,
Alabama Lease - In January 2023, the Company renewed its Huntsville facility lease for a
The following is a table of the lease payments and maturity of the Company’s operating lease liabilities as of September 30, 2026:
Schedule of Lease Payments and Maturity of Operating Lease Liabilities
| Remainder of 2026 | $ | |||
| 2027 | ||||
| 2028 | ||||
| 2029 and thereafter | ||||
| Subtotal future lease payments | ||||
| Less imputed interest | ( | ) | ||
| Total lease liabilities | $ | |||
| Weighted average remaining life | ||||
| Weighted average discount rate | % |
| 21 |
For
the nine-month period ended September 30, 2026, operating lease expense was $
Note 12. Commitments and Contingencies
We are not currently a party to any material legal proceedings.
Note 13. Subsequent Events
The Company has evaluated its subsequent events from September 30, 2026 and through the date these unaudited condensed consolidated financial statements were issued, determining all subsequent events have been disclosed.
Sale of ThermoDox
On
October 20, 2026, Imunon entered into an Asset Purchase Agreement with VoxelDox Therapeutics, Inc. (“VoxelDox”), pursuant
to which the Company agreed to sell to VoxelDox the Company’s assets relating to ThermoDox®, a heat-activated liposomal formulation
of doxorubicin (the “Purchased Assets”), including related trademarks, regulatory filings, clinical and preclinical data,
manufacturing know-how and existing drug product vials. VoxelDox intends to develop ThermoDox for glioblastoma and other high-grade gliomas.
The transaction is contingent on VoxelDox raising at least $
If
the transaction closes, VoxelDox will issue to the Company shares of VoxelDox common stock equal to
Until VoxelDox completes a qualified equity financing, the Company may appoint one of VoxelDox’s five directors and one non-voting observer. The Purchase Agreement contains customary representations, warranties, covenants and indemnification provisions.
Subject
to VoxelDox board approval and separate consulting agreements, VoxelDox will grant Michael H. Tardugno, the Company’s Executive
Chairman, and Frederick J. Fritz, a member of the Company’s Board of Directors, shares of VoxelDox common stock each equal to
2026 Financing
On
October 27, 2026, the Company filed a registration statement on Form S-1 (File No. 333-299647) with the SEC, as amended on October 28,
2026, for a proposed best-efforts public offering. The offering covers up to shares of common stock, or pre-funded warrants
in lieu thereof, together with common warrants to purchase up to
| 22 |
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 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, 2025.
Overview
Imunon, Inc. (“Imunon,” the “Company,” “we,” “our,” or “us”) is a clinical-stage biotechnology company focused on developing its non-viral DNA technology to advance 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. The lead modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising.
The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials, including one Phase 2 clinical trial (OVATION 2), and is currently being studied in a Phase 3 clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site.
Technology Platform
Imunon’s technology platform is optimized for the delivery of DNA and mRNA therapeutics via synthetic non-viral carriers and facilitates 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 one of 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. with an estimated 13,000 deaths. There are approximately 300,000 new cases of ovarian cancer worldwide. Mortality rates for ovarian cancer have declined very little in the last 40 years due to the lack of early 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 major need for a therapy that not only reduces the recurrence rate but also meaningfully improves overall survival.
With an increased understanding of tumor genetics, practice has shifted to include targeted agents in ovarian cancer treatment. Ten to 15% of ovarian cancer cases nationwide are a result of germline or somatic BRCA mutations, and up to 40-50% of ovarian cancers have BRCA mutations, or other mutations which also inhibit DNA repair.
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 maintenance options in ovarian cancer, but no new frontline maintenance treatment options which improve survival are available for women who are not eligible to receive PARP inhibitors.
Immunotherapy is an attractive, novel approach for the treatment of ovarian cancer particularly since ovarian cancers are considered potentially 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 a therapeutic role of IL-12 in ovarian cancer is based on epidemiologic and clinical and preclinical data.
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IMNN-001 Immunotherapy
IMNN-001 is a DNA-based immunotherapeutic drug candidate for the localized treatment of ovarian cancer by intraperitoneally administering an IL-12 plasmid formulated with our proprietary TheraPlas delivery system. In this DNA-based approach, the immunotherapy 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, and our demonstrated ability to safely deliver repeated doses could create a potent anti-tumor immune environment that is synergistic with concomitant use of cytotoxic chemotherapy, resulting 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 safely repeated weekly; and |
| ● | Local therapy is ideal for long-term 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 |
| ● | attempt to define an optimal dose for a follow-on Phase I/II study. |
In addition, the OVATION 1 Study established a unique opportunity to assess how cytokine-based compounds such as IMNN-001 directly affect ovarian cancer cells and the tumor microenvironment in newly diagnosed ovarian cancer patients. The study was designed to characterize the nature of the immune response triggered by IMNN-001 at various levels of the patients’ immune system, including:
| ● | Infiltration of cancer fighting T-cell lymphocytes into primary tumor and tumor microenvironment including peritoneal cavity, which is the primary site of metastasis of ovarian cancer; |
| ● | Changes in local and systemic levels of immuno-stimulatory and immune-suppressive cytokines associated with tumor suppression and growth, respectively; and |
| ● | Expression profile of a comprehensive panel of immune related genes in pre-treatment and IMNN-000 treated tumor tissue. |
During 2016 and 2017, we announced data from the first 14 patients in the OVATION 1 Study. On October 3, 2017, we announced final translational research and clinical data from the OVATION 1 Study.
Key translational research findings from all evaluable patients are summarized below:
| ● | The intraperitoneal treatment of IMNN-001 in conjunction with standard-of-care neoadjuvant chemotherapy (“NACT”) resulted in dose-dependent increases in IL-12 and Interferon-gamma (IFNγ) levels that were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic circulation. These and other post-treatment changes including decreases in VEGF levels in peritoneal fluid were consistent with an IL-12 based immune mechanism; |
| ● | Consistent with the previous partial reports, the effects observed in the Immunohistochemistry analysis were pronounced decreases in the density of immunosuppressive T-cell signals (Foxp3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment; |
| ● | The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients, suggesting an overall shift in the tumor microenvironment from immunosuppressive to pro-immune stimulatory following treatment with IMNN-001. An increase in CD8+ to immunosuppressive T-cell populations was a leading indicator and believed to be a good predictor of improved OS; and |
| ● | Analysis of peritoneal fluid by cell sorting, not reported before, showed a treatment-related decrease in the percentage of immunosuppressive T-cell (Foxp3+), which was consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift in tumor naïve CD8+ cell population to more efficient tumor killing memory effector CD8+ cells. |
The Company reported encouraging clinical data from the first 14 patients who completed treatment in the OVATION 1 Study. IMNN-001 plus standard chemotherapy produced no dose-limiting toxicities and positive dose dependent efficacy signals which correlate well with positive surgical outcomes as summarized below:
| ● | Of the 14 patients treated in the entire study, two patients demonstrated a complete response, 10 patients demonstrated a partial response, and two patients demonstrated stable disease, as measured by Response Evaluation Criteria in Solid Tumors (“RECIST”) criteria. This translated to a 100% disease control rate and an 86% objective response rate (“ORR”). Of the five patients treated in the highest dose cohort, there was a 100% ORR with one complete response and four partial responses; |
| ● | 14 patients had successful resections of their tumors, with nine patients (64%) having a complete tumor resection (“R0”), which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Seven out of eight (88%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0 surgical resection; and |
| ● | All patients experienced a clinically significant decrease in their CA-125 protein levels. CA-125 was used to monitor certain cancers during and after treatment. CA-125 was present in greater concentrations in ovarian cancer cells than in other cells. |
On March 26, 2020, the Company announced with Medidata Solutions, a subsidiary of Dassault Systèmes, that examining matched patient data provided by Medidata in a synthetic control arm (“SCA”) with results from the Company’s Phase I dose-escalating OVATION 1 Study showed positive results in progression-free survival (“PFS”). The hazard ratio (“HR”) was 0.53 in the intent-to-treat (“ITT”) group, showing strong signals of efficacy. In its March 2019 discussion with the Company, the FDA noted that preliminary findings from the Phase I OVATION 1 Study were exciting but lacked a control group to evaluate IMNN-001’s independent impact on impressive tumor response, surgical results and PFS. The FDA encouraged the Company to continue its IMNN-001 development program and consult with FDA with new findings that may have a bearing on designations such as Fast Track and Breakthrough Therapy.
On July 29, 2021, the Company announced final PFS results from the OVATION 1 Study published in the Journal of Clinical Cancer Research. Median PFS in patients treated per protocol (n=14) was 21 months and was 18.4 months for the ITT population (n=18) for all dose cohorts, including three patients who dropped out of the study after 13 days or less, and two patients who did not receive full NACT and IMNN-001 cycles. Under the current standard of care, in women with Stage III/IV ovarian cancer undergoing NACT, their disease progresses within about 12 months on average. The results from the OVATION 1 Study supported continued evaluation of IMNN-001 based on promising tumor response, as reported in the PFS data, and the ability for surgeons to completely remove visible tumors at the time of interval debulking surgery. IMNN-001 was well tolerated, and no dose-limiting toxicities were detected in the OVATION 1 Study. Intraperitoneal administration of IMNN-001 was feasible with broad patient and physician acceptance.
OVATION 2 Study. The Company held an Advisory Board Meeting on September 27, 2017 with clinical investigators and scientific experts including those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and finalize clinical, translational research and safety data from the OVATION 1 Study to determine the next steps forward for our IMNN-001 immunotherapy program. On November 13, 2017, the Company filed its Phase I/II clinical trial protocol with the FDA for IMNN-001 for the localized treatment of ovarian cancer. The protocol was designed with a single dose escalation phase to 100 mg/m² to identify a tolerable dose of IMNN-001 within certain safety parameters while maximizing an immune response. The Phase I portion of the study would be followed by a continuation at the selected dose in approximately 110 patients randomized Phase II study.
In the OVATION 2 Study, patients in the IMNN-001 treatment arm would receive IMNN-001 plus chemotherapy pre- and post-interval debulking surgery (“IDS”). The OVATION 2 Study was designed to include up to 110 patients with Stage III/IV ovarian cancer, with 15 patients in the Phase I portion and up to 95 patients in Phase II. The sample size is consistent with a Phase II trial designed to inform the design of a Phase III trial comparing IMNN-001 with neoadjuvant + adjuvant chemotherapy versus neoadjuvant + adjuvant chemotherapy alone. As a Phase II study, the OVATION 2 Study was not powered for statistical significance. The primary endpoint is PFS and the primary analysis would be conducted after at least 80 events had been observed or after all patients had been followed for at least 16 months, whichever was later. Additional endpoints included objective response rate, overall survival, chemotherapy response score, and surgical response.
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In March 2020, the Company announced encouraging initial clinical data from the first 15 patients enrolled in the Phase I portion of the OVATION 2 Study for patients newly diagnosed with Stage III and IV ovarian cancer. The OVATION 2 Study was designed to combine IMNN-001, the Company’s IL-12 gene-mediated immunotherapy, with standard-of-care NACT. Following NACT, patients undergo IDS, followed by three additional cycles of chemotherapy.
IMNN-001 plus standard-of-care NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlate well with successful surgical outcomes as summarized below:
| ● | Of the 15 patients treated in the Phase I portion of the OVATION 2 Study, nine patients were treated with IMNN-001 at a dose of 100 mg/m² plus NACT and six patients were treated with NACT only. All 15 patients had successful resections of their tumors, with eight out of nine patients (88%) in the IMNN-001 treatment arm having an R0 resection. Only three out of six patients (50%) in the NACT only treatment arm had a R0 resection. |
| ● | When combining these results with the surgical resection rates observed in the Company’s OVATION 1 Study, a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflected the strong dose-dependent efficacy of adding IMNN-001 to the current standard of care NACT: |
% of Patients R0 Resections | ||||||||
| 0, 36, 47 mg/m² of IMNN-001 plus NACT | N =12 | 42 | % | |||||
| 61, 79, 100 mg/m² of IMNN-001 plus NACT | N = 17 | 82 | % | |||||
| ● | The ORR as measured by RECIST criteria for the 0, 36, 47 mg/m² dose IMNN-001 patients were comparable, as expected, to the higher (61, 79, 100 mg/m²) dose IMNN-001 patients, with both groups demonstrating an approximate 80% ORR. |
On March 23, 2020, the Company announced that the European Medicines Agency (the “EMA”) Committee for Orphan Medicinal Products (“COMP”) had recommended that IMNN-001 be designated as an orphan medicinal product for the treatment of ovarian cancer. IMNN-001 previously received orphan designation from the FDA.
In February 2021, the Company announced that it had received Fast Track designation from the FDA for IMNN-001 and also provided an update on the OVATION 2 Study. The Company reported that approximately one-third, or 34 patients, of the anticipated 110 patients had been enrolled into the OVATION 2 Study, of which 20 were in the treatment arm and 14 were in the control. Of the 34 patients enrolled in the trial, 27 patients have had their IDS with the following results:
| ● | 80% of patients treated with IMNN-001 had a R0 resection. |
| ● | 58% of patients in the control arm had an R0 resection. |
| ● | These interim data represented a 38% improvement in R0 resection rates for IMNN-001 patients compared with control arm patients and was consistent with the reported improvement in resection scores noted in our Phase I OVATION 1 Study, the manuscript of which was submitted for peer review publication. |
In June 2022, the Company announced that following a pre-planned interim safety review of 87 as treated patients (46 patients in the experimental arm and 41 patients in the control arm) randomized in the OVATION 2 Study, the Data Safety Monitoring Board (“DSMB”) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety was satisfactory, with an acceptable risk/benefit, and that patients tolerated IMNN-001 during a course of treatment that would last up to six months. No dose-limiting toxicities were reported at this point in the OVATION 2 Study. Interim clinical data from patients who had undergone IDS showed that the IMNN-001 treatment arm was continuing to show improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores over the control arm. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental examination.
In September 2022, the Company announced that its Phase I/II OVATION 2 Study with IMNN-001 in advanced ovarian cancer had completed enrollment with 113 patients. In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its Phase I/II OVATION 2 Study. Interim clinical data from the ITT population showed efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm, with the hazard ratio nearing the required value. Preliminary OS data followed a similar trend, showing an approximate 9-month improvement in the treatment arm over the control arm.
Subgroup analyses showed patients treated with a PARP inhibitor (“PARPi”) as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001 compared with patients treated with NACT only. The PARPi subgroup was not specified prior to the trial because they were approved after the OVATION 2 Study was initiated. However, this subgroup, and others, were pre-specified prior to Database lock and formal analysis.
| ● | The median PFS in the PARPi + NACT group and the PARPi + NACT + IMNN-001 group was 15.7 months and 23.7 months, respectively. |
| ● | The median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group. |
Imunon also continues to see benefits in other secondary endpoints including an approximately 20% higher R0 tumor resection score and a doubling of the CRS 3 chemotherapy response score to approximately 30% in the treatment arm versus 14% in the control arm. Chemotherapy response score is considered a good prognostic indicator in ovarian cancer. The DSMB determined that safety analyses continue to show good tolerability of IMNN-001 in this setting.
In June 2024, the Company announced database lock for the OVATION 2 Study. At that time, median OS and PFS had been reached, and all patients in the open-label study had achieved treatment observation duration of 16 months, as required by protocol to evaluate efficacy. On July 11, 2024, a scientific advisory board with DSMB members, principal investigators, and scientific experts was held to review efficacy and safety data from the OVATION 2 study.
On July 30, 2024, the Company announced positive topline results from the Phase I/II OVATION 2 Study. Highlights from patients treated with IMNN-001 plus standard-of-care in a first-line treatment setting include:
| ● | An 11.1 month increase in median OS compared with standard-of-care alone in the ITT population. |
| ● | A hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival. |
| ● | Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival. |
| ● | For nearly 40% of trial participants treated with a PARP inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm. |
The PFS results, the trial’s primary endpoint, support the OS results with:
| ● | A three-month improvement in PFS compared with standard-of-care alone. |
| ● | A hazard ratio in the intent-to-treat population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm. |
These initial results from the OVATION 2 Study were presented in a late-breaking session at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting in November 2024.
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On September 11, 2024, a scientific advisory board was held with DSMB members, principal investigators, and scientific experts to discuss and seek input on the protocol synopsis for the Phase III trial. A protocol synopsis was submitted along with a briefing document for review and input at the End-of-Phase II (“EOP2”) meeting with the U.S. Food and Drug Administration focused on the Phase III study. The EOP2 meeting was conducted in the fourth quarter of 2024.
| ● | The positive outcome of the EOP2 in-person meeting with the U.S. Food and Drug Administration (FDA), supported the advancement of IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3 pivotal study. The interaction with the FDA included an extensive review of data generated to date, including positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer. Treatment was also generally well tolerated, with no reports of cytokine release syndrome or any other serious immune-related adverse events. |
| ● | The Company also held a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding production of IMNN-001 for the treatment of women with newly diagnosed advanced ovarian cancer. The goal of the meeting was to seek alignment and agreement with the FDA on key CMC topics to support IMNN-001 production for the planned Phase 3 pivotal trial and a potential future new biologic license application (BLA) submission. The meeting with the FDA included a review of the Company’s current good manufacturing practice (cGMP) clinical-scale and commercial manufacturing process for IMNN-001, conducted at the Company’s manufacturing facility based in Huntsville, Alabama. The Agency agreed that the Company’s potency assay which measures interferon-gamma (IFN-γ) is acceptable for the Phase 3 clinical study and for use in a commercial setting for release of drug product. The FDA also agreed with the Company’s strategy to establish comparability of the core components of IMNN-001 produced by the Company with product previously produced through an external contract development and manufacturing organization. |
In December 2024, the Company announced additional clinical data from ongoing analyses of results from the Phase 2 OVATION 2 Study. The updated results (including a post announcement, immaterial statistical correction), based on an additional seven months of patient monitoring, showed the following:
| ● | The hazard ratio (HR) decreased from 0.74 to 0.70 in the ITT population, with an increase in median overall survival (OS) from 11.1 to 13 months following treatment with IMNN-001 plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (NACT) versus SoC alone. |
| ● | More than one-third of patients in the trial survived more than 36 months from the point of study enrollment, with 62% of those surviving patients from the IMNN-001 treatment arm and 38% from the SoC arm. Over 10% of trial participants have reached 48 months or beyond. |
In June 2025, the Company announced positive data from the Company’s Phase 2 OVATION 2 Study showing that treatment with IMNN-001 in women with newly diagnosed advanced ovarian cancer resulted in consistent, clinically meaningful improvements in several key endpoints across treatment groups, including overall survival (OS), progression-free survival (PFS), chemotherapy response score and surgical response. Treatment with IMNN-001 also showed a favorable safety profile, with no reports of serious immune-related adverse events. The full results were presented in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, and simultaneously published in the peer-reviewed journal Gynecologic Oncology. The data presented highlighted the following results achieved across all treatment groups:
| ● | Median 13-month increase in OS and median 3-month increase in PFS in IMNN-001 treatment arm compared to standard of care alone. |
| ● | Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect. |
| ● | Use of poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in IMNN-001 treatment arm after >5 years compared to 37 months on standard of care. |
| ● | Chemotherapy response score highlights double the response rate of a complete or near complete histopathological response following treatment with 26.1% in the IMNN-001 treatment arm compared to 13.0% in the control arm. |
| ● | Surgical response rate of no macroscopic residual tumor left after surgery 64.6% in the IMNN-001 treatment arm compared to 52.1% in the control arm. |
| ● | Hazard ratio of 0.78 in study participants who are homologous recombination proficient (HRP) and hazard ratio of 0.42 in women positive for homologous recombination deficiency (HRD+), including BRCA1 or BRCA2 mutations, suggesting increased therapeutic activity. |
| ● | IMNN-001 was generally safe and well tolerated, with no reports of cytokine release syndrome, systemic toxicity or serious immune-related adverse events. |
On June 18, 2025, the Company presented positive translational data from the OVATION 2 Study of IMNN-001 at the ESMO Gynecological Cancers Congress 2025, that took place on June 19-21, 2025, in Vienna, Austria. Results presented at the ESMO Congress showed that treatment with IMNN-001 induced substantial increases in IL-12 and interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Increases in IL-12, IFN-γ and TNF-α levels in the peritoneal cavity were approximately 27-, 62- and 36-fold following treatment, respectively, demonstrating the tumor-localized effect of IMNN-001 in women with advanced ovarian cancer. IMNN-001 continues to show a favorable safety profile.
In September 2025, the Company presented additional positive translational data from the OVATION 2 Study at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Advances in Ovarian Cancer Research reinforcing the favorable safety profile and efficacy benefits of IMNN-001 observed in the clinic, including increases in key anti-cancer immune cytokines and modulation of relevant anti-tumor immune cell populations, such as CD8+ T cells and myeloid dendritic cells, in the tumor and tumor microenvironment in study participants post-treatment. Results presented at the AACR Special Conference demonstrated:
| ● | Positive shift in the local TME to favorable immune stimulatory T cell ratios in the majority of participants treated with IMNN-001, including favorable ratios of CD8+/T regulatory (Treg) cells, CD8+/IDO+ cells, and CD8+/CD4+ cells. |
| ● | TME shift in favor of decreased immunosuppression cells (IDO+, PDL1+, Treg, CD4+) and increased immunostimulatory cells (CD8+, CD8+ effector, myeloid dendritic cells) in the majority of participants post-treatment. |
| ● | IMNN-001 treatment creates a “hot” anti-TME by increasing the recruitment of anti-tumor CD8+ and myeloid dendritic cells in 50-80% of the paired samples and decreasing immunosuppressive markers (IDO, PDL1, Treg cells) in 65-80% of the samples. |
| ● | IMNN-001 continues to show a favorable safety profile. |
Results from the study continue to validate our TheraPlas® technology and the broad impact of IMNN-001 on important cancer-fighting cytokines, effectively turning the tumor microenvironment from “cold” to ‘hot’ by activating both innate and adaptive immune systems, with limited to no systemic toxicities.
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On November 10, 2025, the Company held a R&D Day which showcased recent progress with its IMNN-001 development program for the treatment of newly diagnosed advanced ovarian cancer, including a review of positive data from the Company’s Phase 2 OVATION 2 Study and the minimal residual disease (MRD) study conducted in partnership with Break Through Cancer.
R&D Day Featured Speakers and Program Highlights:
| ● | Premal H. Thaker, M.D., Washington University School of Medicine, discussed the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She highlighted the data from the Phase 2 OVATION 2 clinical trial, with results including: |
| ○ | 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 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. |
| ● | Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, discussed safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including: |
| ○ | 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 clearly showed IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling. | |
| ○ | New data further supporting the highly favorable benefit-risk and tolerability profile of IMNN-001. | |
| o | The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab and in the maintenance setting. |
| ● | Giorgio Paulon, Ph.D., Berry Consultants, LLC, reviewed the Phase 2 and ongoing Phase 3 trial designs and the strength of evidence for IMNN-001 from a statistical perspective. He highlighted the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on interim analyses of overall survival. |
| ● | Douglas V. Faller, M.D., Ph.D., Imunon’s Chief Medical Officer, presented new data further demonstrating that IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He shared the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward. |
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. Imunon initially 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. Per protocol, overall survival (OS) was followed for up to 3 years from last patient in (LPI). Following the 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 delta) with increasing follow-up time. In addition, the final 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 final 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 an important advance in the treatment of ovarian cancer.
On July 23, 2026, the Company announced that translational and clinical data on IMNN-001 would be presented in a poster at the inaugural AACR Conference on Drug Discovery and Development (AACR D3), held July 21–24, 2026, in Boston. The presentation included findings from the randomized Phase 2 OVATION-2 study demonstrating that IMNN-001 was safe and well-tolerated, achieved local delivery of IL-12, and induced anti-tumoral immune responses, with no cytokine release syndrome or higher incidence of immune-related events observed in the experimental arm compared with control. Translational analyses indicated that IMNN-001 enhanced favorable ratios of CD8+ T cells to regulatory T cells and CD8+ to CD4+ cells in tumors and the tumor microenvironment, consistent with previously reported associations with improved outcomes. These findings support the ongoing pivotal Phase 3 OVATION-3 trial, which is designed to confirm the safety and survival benefit of IMNN-001 in frontline advanced ovarian cancer.
In September 2026, the Company entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health. Under the CRADA, the Company and the NCI’s Cancer Therapy Evaluation Program (CTEP), which will assume regulatory sponsorship, will support further clinical and non-clinical development of IMNN-001 under the NCI Experimental Therapeutics (NExT) Program managed by CTEP. IMNN-001 is the first gene-based immunotherapy selected by NCI/CTEP for partnered clinical development under a CRADA. The Company believes the selection of IMNN-001 for this collaboration provides external validation of the potential of IMNN-001 and the Company’s proprietary TheraPlas® DNA-mediated immunotherapy platform.
Under the agreement, NCI investigators will evaluate IMNN-001 in new solid tumor indications and combination regimens, building on clinical data from the Company’s ovarian cancer program. The Company will retain ownership of its background intellectual property and will retain ownership of new intellectual property solely generated by the Company under the collaboration, including the right to use data generated under the collaboration for the research and development of IMNN-001. The collaboration provides an opportunity to leverage NCI resources, including the expertise of CTEP and the National Clinical Trials Network (NCTN), to generate additional clinical data for IMNN-001 in new indications while the Company’s internal resources remain focused on the pivotal Phase 3 OVATION 3 trial in frontline advanced ovarian cancer.
On September 23, 2026, the Company held an R&D Day and made a frontline case for Phase 3 IMNN-001 Study: 14.7-Month OS signal, Historical IL-12 Safety Barriers Overcome. Clinical investigators and Management presented an update on the IMNN-001 program in newly diagnosed advanced ovarian cancer. The presentations reviewed final overall survival results from the randomized Phase 2 OVATION 2 study, preliminary clinical and translational findings from the Phase 2 minimal residual disease (MRD) study conducted in partnership with Break Through Cancer and investigators at MD Anderson Cancer Center, and enrollment and operational progress in the ongoing pivotal Phase 3 OVATION 3 trial.
Key conclusions included:
| ● | Consistency of clinical evidence favoring IMNN-001 across all OVATION 2 study endpoints: PFS, OS, Objective Response Rate (ORR), R0 Surgical response and Chemotherapy Response of 3. In the intent-to-treat population of the 112-patient OVATION 2 study, a 14.7-month OS benefit was observed with IMNN-001 plus neoadjuvant and adjuvant chemotherapy versus standard of care alone. In women treated with PARP inhibitors a 24.2-month OS benefit was observed with the IMNN-001 treatment arm. | |
| ● | The OVATION 2 safety profile was consistent with local intraperitoneal administration and did not include cytokine release syndrome or the serious systemic immune-related adverse events that limited earlier systemic IL-12 programs. Independent data monitoring committees recommended continuation of both OVATION 3 and the MRD study without modification. | |
| ● | Translational data from OVATION 1 and OVATION 2, as well as preliminary findings from the MRD study, supported the intended mechanism of local IL-12 production via the TheraPlas nanoparticle platform, with preferential macrophage uptake, recruitment of CD8+ T cells and other immune effectors, decreases in immunosuppressive markers, and remodeling of the tumor microenvironment. Preliminary MRD observations among patients who had reached second-look laparoscopy provided independent trial data that is supportive of OVATION-2 results, including lower MRD-positive rates, higher circulating tumor DNA clearance, and higher rates of no evidence of disease in the IMNN-001 arm. | |
| ● | OVATION 3 is a randomized, approximately 500-patient Phase 3 trial with overall survival as the primary endpoint and two pre-planned event-driven interim analyses designed to support a potential earlier submission for full approval if the survival signal crosses pre-specified thresholds. Enrollment is proceeding consistent with internal planning assumptions. |
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OVATION 3 Study. The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard of care (SoC) NACT alone. Study participants are being randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3c or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population. Participants who are HRD positive will receive poly (ADP-ribose) polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.
In March 2025, the Company announced that the FDA is aligned with the protocol for the Phase 3 OVATION 3 pivotal trial of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer.
In May 2025, the first site was activated and in July 2025, the Company announced that the first patient was randomized and treated.
On June 23, 2026, the independent Data Monitoring Committee (iDMC) recommended continuation of the pivotal Phase 3 OVATION 3 clinical trial. IMNN-001 has continued to demonstrate a highly favorable safety and tolerability profile, with no observed episodes of cytokine release syndrome, systemic toxicities or serious immune-related adverse events that have historically blocked the use of IL-12 to effectively treat cancer patients. Safety profiles have been comparable between the two arms of the study (IMNN-001 plus neoadjuvant and adjuvant chemotherapy {N/ACT} versus N/ACT alone), consistent with observations from the Company’s ongoing Phase 2 Minimal Residual Disease (MRD) study (see below). The iDMC has recommended continuation of the OVATION 3 clinical trial without modification, representing another important validation of the efficacy and safety data previously reported and brings new levels of momentum to the Company’s efforts to advance this trial as rapidly as possible.
As of September 30, 2026, nine sites are open to recruitment. As reported on July 30, 2026, since initiating the trial, the Company has observed rapid site activation and an enrollment rate that is tracking with the internal forecast. The currently observed study-level enrollment rate is above 0.4 patients per site per month which exceeds the assumed rate of 0.3 patients per site per month used in the trial plan. The Company anticipates that additional sites will open on pace with projection to complete enrollment by the first quarter of 2029.
IMNN-001 in Combination with Bevacizumab. In February 2023, the Company and Break Through Cancer, a public foundation dedicated to supporting translational research in the most difficult-to-treat cancers that partners with top cancer research centers, announced the commencement of patient enrollment in a collaboration to evaluate IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer in the frontline, neoadjuvant clinical setting.
This Phase I/II study, titled “Targeting Ovarian Cancer Minimal Residual Disease (MRD) Using Immune and DNA Repair Directed Therapies,” is expected to enroll 30 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir Jazaeri, M.D., Vice Chair for Clinical Research and Director of the Gynecologic Cancer Immunotherapy Program in the Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson. Dana-Farber Cancer Institute, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and Memorial Sloan Kettering Cancer Center will also be participating in the trial. In addition, The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology (MIT) will provide artificial intelligence services including biomarker and genomic analysis.
Patients are randomized 1:1 in a two-arm trial. In October 2023, the first patient began treatment at University of Texas MD Anderson Cancer Center in the Phase I/II Clinical Trial Evaluating IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer. The trial’s primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL), and the secondary endpoint is PFS. SLL data are expected within one year following the completion of enrollment and final PFS data are expected approximately three years following the completion of enrollment. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.
On July 21, 2026, the Company announced new positive preliminary data from its ongoing Phase 2 MRD clinical trial. Nine patients in each of the control and experimental arms (total target accrual of 30 patients, 15 in each arm) 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%).
A review of the MRD study accomplishments was conducted in the third quarter of 2025, and it was determined that study goals contributing to the IMNN-001 development plan and Break Through Cancer study objectives can be accomplished in a trial of 30 patients. A decision was made in November 2025 to complete enrollment of the trial once the ITT population has reached 30 patients.
In August 2026, the Stephenson Cancer Center at University of Oklahoma was added as an additional clinical site and was open to recruitment.
As of September 30, 2026, the ITT population was twenty-seven (27) patients randomized and treated in the study at the University of Texas MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center and the University of Oklahoma.
PLACCINE DNA VACCINE MODALITY: IMNN-101
The Company previously developed PLACCINE, a novel DNA vaccine platform enabling durable antigen expression, flexible manufacturing, and rapid development. PlaCCine cassettes encoding tumor-associated antigens or neoantigens drove antigen-specific immune responses, delayed tumor growth, and improved survival in mouse cancer models. The company completed a Phase 1 proof-of concept clinical trial of IMNN-101 in 24 healthy subjects and confirmed safety and immunogenicity, validating clinical feasibility for cancer and infectious disease vaccines. In Q1 2026, the Company discontinued development of PLACCINE and IMNN-101 and abandoned the related patents and patent applications to focus its resources on the development of IMNN-001, including the OVATION 3 trial. The Company does not expect to incur material additional costs related to PLACCINE or IMNN-101.
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Business Plan and Going Concern Risk
We have not generated and do not expect to generate any revenue from product sales in the next several years, if at all. An element of our business strategy has been to pursue, as resources permit, the research and development of a range of drug candidates for a variety of indications. We may also evaluate licensing products from third parties to expand our current product pipeline. This is intended to allow us to diversify the risks associated with our research and development expenditures. To the extent we are unable to maintain a broad range of drug candidates, our dependence on the success of one or a few drug candidates would increase and would have a more significant impact on our financial prospects, financial condition, and market value. We may also consider and evaluate strategic alternatives, including investment in, or acquisition of, complementary businesses, technologies, or products. Drug research and development is an inherently uncertain process and there is a high risk of failure at every stage prior to approval. The timing and the outcome of clinical results are extremely difficult to predict. The success or failure of any preclinical development and clinical trial can have a disproportionately positive or negative impact on our results of operations, financial condition, prospects, and market value.
Our current business strategy includes the possibility of entering into collaborative arrangements with third parties to complete the development and commercialization of our drug candidates. In the event that third parties are contracted to manage the clinical trial process for one or more of our drug candidates, the estimated completion date would largely be under the control of that third party rather than us. We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our development plan or capital requirements. We may also apply for subsidies, grants or government or agency-sponsored studies that could reduce our development costs. However, we cannot forecast with any degree of certainty whether we will be selected to receive any subsidy, grant or governmental funding.
As of September 30, 2026, the Company had $4.0 million in cash and cash equivalents to fund its operations. The Company’s primary sources of cash have been proceeds from the issuance and sale of its common stock, including via its at-the-market (“ATM”) program and other funding transactions including preferred stock and debt financings. There can be no assurance that the Company will be able to do so in the future on a timely basis on terms acceptable to the Company, or at all. The Company has not yet commercialized any of its product candidates. Even if the Company commercializes one or more of its product candidates, it may not become profitable in the near term. The Company’s ability to achieve profitability depends on several factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership.
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, 2025, includes an explanatory paragraph which expresses substantial doubt about our ability to continue as a going concern. See also Note 2 to the Condensed Consolidated Financial Statements contained in this Quarterly Report on Form 10-Q.
Management’s plan includes raising funds from outside investors through the issuance and sale of its common stock, including the use of its ATM program and other potential funding transactions. However, as mentioned above, there can be no assurance such funding will be available to the Company or that it will be obtained on terms favorable to the Company or will provide the Company with sufficient funds to meet its objectives. The Company’s 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.
As a result of the risks and uncertainties discussed in the 2025 Annual Report filed on March 31, 2026 with the SEC, among others, we are unable to estimate the duration and completion costs of our research and development projects or when, if ever, and to what extent we will receive cash inflows from the commercialization and sale of a product if one of our drug candidates receives regulatory approval for marketing, if at all. Our inability to complete any of our research and development activities, preclinical studies or clinical trials in a timely manner or our failure to enter into collaborative agreements when appropriate could significantly increase our capital requirements and could adversely impact our liquidity. While our estimated future capital requirements are uncertain and could increase or decrease as a result of many factors, including the extent to which we choose to advance our research and development activities, preclinical studies and clinical trials, or whether we are in a position to pursue manufacturing or commercialization activities, we will need significant additional capital to progress our drug candidates through development and clinical trials, obtain regulatory approvals and manufacture and commercialize approved products, if any. We do not know whether we will be able to access additional capital when needed or on terms favorable to us or our stockholders. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.
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Financing Overview
Equity, Debt and Other Forms of Financing
During the nine months ended September 30, 2026, we issued a total of 2.8 million shares of common stock for approximately $2.3 million in gross proceeds. Subsequent to September 30, 2026 and through the date of this Quarterly Report on Form 10-Q, no share of common stock was issued under the at-the-market (“ATM”).
On May 15, 2024, the Company filed with the 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. Upon the filing of Form 10-K on March 31, 2026, the Company’s public float was less than $75 million, and as a result, the Company is currently subject to the limitations contained in General Instruction I.B.6 of Form S-3.
Preferred Stock and Notes Payable
On June 2, 2026, the Company entered into a Securities Purchase Agreement (the “June 2026 Securities Purchase Agreement”) with Streeterville Capital, LLC (the “Investor”), providing for the issuance and sale by the Company, and the purchase by the Investor, of (i) 250 shares (the “Preferred Shares”) of the Company’s Series A Preferred Stock, par value $0.01 per share (the “Series A Preferred Stock”), at an issued value of $10,000 per share and a stated value of $12,000 per share, for aggregate gross proceeds of $2,500,000; (ii) a Secured Promissory Note A-1 in an original principal amount of $2,720,000 (the “Note A-1”); and (iii) a Secured Promissory Note B in an original principal amount of $5,000,000 (the “Note B” and together with the Note A-1, the “Notes”). The transactions contemplated by the Securities Purchase Agreement (collectively, the “Transaction”) closed on June 3, 2026 (the “Closing Date”). At closing, the Company received $10,000,000 from the Investor, $5,000,000 of which was deposited into a bank account owned by a wholly owned subsidiary of the Company as cash collateral for the Notes (the “Cash Collateral Account”). The $5,000,000 amount is classified as restricted cash on the balance sheet. The obligations under the Notes are secured by substantially all of the assets of the Company, other than its intellectual property assets, and are guaranteed by certain of the Company’s subsidiaries. The Company intends to utilize the $5,000,000 of proceeds from the closing of the Transaction, along with any proceeds later released from the Cash Collateral Account, for general corporate purposes, including research and development activities, capital expenditures and working capital. The Company agreed to pay the placement agents for financing a fee of 7.0% of the gross proceeds received by the Company in connection with the Transaction.
If the aggregate outstanding balance of the Note A-1 or the aggregate number of outstanding Preferred Shares is reduced by $2,000,000 (or, if less than $2,000,000, the entire remaining outstanding balance of the Note A-1), the Company will have the right to exchange up to $1,000,000, plus interest (or, if less than $1,000,000, the entire remaining amount of the Note B, or such other amount as the parties mutually agree), of the Note B for a new secured note in the same form and having the same terms as the Note A-1 (each, a “Note Exchange”). Upon the completion of each Note Exchange, an amount of cash equal to the amount of the Note B exchanged in such Note Exchange will be released from the Cash Collateral Account to the Company. The Note A-1 will bear interest at 8% per annum and will mature 18 months following the Closing Date.
The Note B will bear interest at 5% per annum and will mature 18 months following the Closing Date. The Notes can be prepaid by the Company in whole or in part at any time, subject to a 10% prepayment premium on any principal amounts prepaid. Beginning six months after the Closing Date, the Investor may redeem up to $250,000 of the principal amount of the Note A-1 each calendar month. In addition, on any trading day when the Company’s common stock trades at a price that is at least 15% greater than the “Minimum Price” as defined under Nasdaq Stock Market LLC Rule 5635(d), the Investor may redeem an additional principal amount of the Notes equal to 5% of the trading volume of the Company’s common stock on such trading day. The Company will be subject to customary covenants while the Notes remain outstanding. The Notes also contain customary events of default, the occurrence of which would permit the Investor to accelerate the obligations under the Notes and exercise remedies against any collateral (including amounts on deposit in the Cash Collateral Account) or guarantees in respect of the Note. In addition, following the occurrence of an event of default, the interest rate of each Note would increase to the lesser of 15% per year or the maximum rate permitted by applicable law.
Broker fees totaling $350,000 were allocated between the preferred stock and Note A-1 based on their values. Issuance costs, which primarily include legal fees totaling $292,310, were allocated between the preferred stock and Note A-1 and Note B based on the face value of each financial instrument and will be amortized over the life of the instruments. The original issuance discount associated with Note A-1 was recorded as a contra-liability to be amortized over the life of the note. The Company concluded the preferred stock was permanent equity and included it in Stockholder’s Equity for as of September 30, 2026.
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On September 28, 2026, the Company entered into an exchange agreement with Streeterville Capital, LLC pursuant to which the Company exchanged $1.2 million of the outstanding principal amount of its Secured Promissory Note A-1 (the “Note A-1”) for 120 newly issued shares of Series B Preferred Stock, par value $0.01 per share (the “Series B Preferred Stock”). The Series B Preferred Stock was issued at a conversion price of $10,000 per share and has a stated value of $12,000 per share. The transaction was undertaken, in part, to increase the Company’s stockholders’ equity in support of compliance with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1).
The Series B Preferred Stock provides for an annual preferred return of 8% of stated value, compounded daily and payable quarterly, at the Company’s election, in cash or additional shares of Series B Preferred Stock issued at $10,000 per share. The Series B Preferred Stock does not have voting rights, except with respect to amendments that materially and adversely affect the rights or preferences of the Series B Preferred Stock and is not convertible into common stock. Upon a liquidation, dissolution or winding up of the Company, the Series B Preferred Stock ranks pari passu with the Company’s Series A Preferred Stock and senior to the Company’s common stock.
Holders of the Series B Preferred Stock do not have the right to require redemption of their shares. The Company may redeem the shares, solely at the discretion of its Board of Directors, at 110% of the applicable liquidation amount, plus any accrued and unpaid preferred return. The occurrence of an event of default may increase the stated value of the Series B Preferred Stock but does not provide the holder with a right to require cash redemption. Based on these terms, the Company determined that the Series B Preferred Stock is not mandatorily redeemable and is not redeemable upon an event outside the Company’s control. Accordingly, the Series B Preferred Stock is classified within permanent stockholders’ equity under ASC 480-10-S99-3A.
Significant Accounting Policies
Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements included in our 2025 Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 31, 2026. See Note 3 to the Condensed Consolidated Financial Statements contained in this Quarterly Report on Form 10-Q.
As a clinical-stage biopharmaceutical company, our business, and our ability to execute our strategy to achieve our corporate goals are subject to numerous risks and uncertainties. Material risks and uncertainties relating to our business and our industry are described in “Item 1A. Risk Factors” under “Part II: Other Information” included herein.
FINANCIAL REVIEW FOR THE THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2026 AND 2025
Results of Operations
Our net loss was $3.8 million and $10.8 million for the three months and nine months ended September 30, 2026, respectively, compared to a net loss of $3.4 million and $10.3 million, respectively for the same periods of 2025.
With $4.0 million in cash and cash equivalents at September 30, 2026, 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.
Management’s plan includes raising funds from the issuance and sale of its common stock via its ATM program and other funding transactions as more fully described in Note 13. However, as mentioned above, there is no assurance such funding will be available to the Company or that it will be obtained on terms favorable to the Company or will provide the Company with sufficient funds to meet its objectives. The Company’s 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.
The Company operates in one segment for the research and development of our 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 consolidated financial information. Consequently, we view the entire organization as one reportable segment and the strategic purpose of all operating activities (including general & 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. Our CODM does not generally evaluate our performance using asset or historical cash flow information.
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| For the three months ended September 30, | ||||||||||||||||
| (in thousands) | Change Increase (Decrease) | |||||||||||||||
| 2026 | 2025 | |||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Clinical Research | ||||||||||||||||
| OVATION Trials (Phase 2 & 3) | $ | 427 | $ | 524 | $ | (97 | ) | -19 | % | |||||||
| MRD Study | 73 | - | 73 | -100 | % | |||||||||||
| PlaCCine Vaccine Phase 1 Trial | - | 9 | (9 | ) | -100 | % | ||||||||||
| Other Clinical and Regulatory | 452 | 436 | 16 | 4 | % | |||||||||||
| Subtotal | 952 | 969 | (17 | ) | -2 | % | ||||||||||
| Non-Clinical R&D and CMC | ||||||||||||||||
| Manufacturing & Clinical Supply | 841 | 930 | (89 | ) | -10 | % | ||||||||||
| Subtotal | 841 | 930 | (89 | ) | -10 | % | ||||||||||
| Research and development expenses | 1,793 | 1,899 | (106 | ) | -6 | % | ||||||||||
| General and administrative expenses | 1,655 | 1,577 | 78 | 5 | % | |||||||||||
| Total operating expenses | 3,448 | 3,476 | (28 | ) | -1 | % | ||||||||||
| Loss from operations | $ | 3,448 | $ | 3,476 | $ | (28 | ) | -1 | % | |||||||
Research and Development Expenses
Research and development (“R&D”) expenses were $1.8 million in the third quarter of 2026 compared to $1.9 million in the same period of 2025. Clinical costs associated with the OVATION studies were $0.4 million in the third quarter of 2026 compared to $0.5 million for the same period of 2025. During 2025, the Company initiated enrollment in the OVATION 3 Study and closed out the OVATION 2 study. In connection with the closeout of the OVATION 2 study, approximately $0.6 million of expenses previously accrued by the Company had been written down. Other clinical and regulatory costs were $0.5 million the third quarter of 2026 compared to $0.4 million in the same period of 2025. Manufacturing and clinical supply costs associated with the development and testing of IMNN-001 to support the OVATION and MRD programs were $0.8 million in the third quarter of 2026 compared to $0.9 million in same period of 2025, with the major contribution to this decrease relating to the efficiency in advancement of OVATION-3.
General and Administrative Expenses
General and administrative expenses increased to $1.7 million in the third quarter of 2026 compared to $1.6 million in the same period of 2025. This increase is related to an increase in outside professional fees during the third quarter of 2026.
Other income/expense was $0.3 million in the third quarter of 2026 compared to $(0.1) million in the same period of 2025. The increase in other expense includes the loss on extinguishment of debt and interest expense on notes payable.
| For the nine months ended September 30, | ||||||||||||||||
| (Thousands) | Change Increase (Decrease) | |||||||||||||||
| 2026 | 2025 | |||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Clinical Research | ||||||||||||||||
| OVATION Trials (Phase 2 & 3) | $ | 774 | $ | 800 | $ | (26 | ) | -3 | % | |||||||
| MRD Study | 169 | 106 | 63 | 59 | % | |||||||||||
| PlaCCine Vaccine Phase 1 Trial | - | 42 | (42 | ) | -100 | % | ||||||||||
| Other Clinical and Regulatory | 1,379 | 1,387 | (8 | ) | -1 | % | ||||||||||
| Subtotal | 2,322 | 2,335 | (13 | ) | -1 | % | ||||||||||
| Non-Clinical R&D and CMC | ||||||||||||||||
| Manufacturing & Clinical Supply | 3,272 | 2,955 | 317 | 11 | % | |||||||||||
| Subtotal | 3,272 | 2,955 | 317 | 11 | % | |||||||||||
| Research and development expenses | 5,594 | 5,290 | 304 | 6 | % | |||||||||||
| General and administrative expenses | 4,951 | 5,098 | (147 | ) | -3 | % | ||||||||||
| Total operating expenses | 10,545 | 10,388 | 157 | 2 | % | |||||||||||
| Loss from operations | $ | 10,545 | $ | 10,388 | $ | 157 | 2 | % | ||||||||
Research and Development Expenses
Research and development (“R&D”) expenses were $5.6 million in the first nine months of 2026 compared to $5.3 million in the same period of 2025. Clinical costs associated with the OVATION studies were $0.8 million in the first nine months of 2026 compared to $0.8 million in the same period of 2025. During 2025, the Company initiated enrollment in the OVATION 3 Study and closed out the OVATION 2 study. In connection with the closeout of the OVATION 2 study, approximately $0.6 million of expenses previously accrued by the Company had been written down. Other clinical and regulatory costs were $1.4 million in the first nine months of 2026 compared to $1.4 million in the same period of 2025. Manufacturing and clinical supply costs associated with the development and testing of IMNN-001 to support the OVATION and MRD programs were $3.3 million in the first nine months of 2026 compared to $3.0 million in same period of 2025. The increase in 2026 includes severance costs.
General and Administrative Expenses
General and administrative expenses were $4.9 million in the first nine months of 2026 compared to $5.0 million in the same period of 2025.
Other income/expense was $0.3 million in the first nine months of 2026 compared to $(0.1) million in the same period of 2025. The increase in other expense includes the loss on extinguishment of debt and interest expense on notes payable.
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FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES
Since inception, we have incurred significant losses and negative cash flows from operations. We have financed our operations primarily through the net proceeds from the sales of equity, credit facilities and amounts received under product licensing agreements. The process of developing IMNN-001 and other drug candidates and technologies requires significant research and development work and clinical trial studies, as well as significant manufacturing and process development efforts. We expect these activities, together with our general and administrative expenses, to result in significant operating losses for the foreseeable future. Our expenses have significantly and regularly exceeded our income, and we had an accumulated deficit of $432 million at September 30, 2026.
At September 30, 2026, we had total current assets of $5.8 million and current liabilities of $4.2 million, resulting in net working capital of $1.6 million. At September 30, 2026, we had cash and cash equivalents of $4.0 million and $5.0 million in restricted cash. At December 31, 2025, we had total current assets of $10.7 million and current liabilities of $4.6 million, resulting in net working capital of $6.1 million. We have substantial future capital requirements to continue our research and development activities and advance our drug candidates through various development stages. The Company believes these expenditures are essential for the commercialization of its technologies.
Net cash used in operating activities for the first nine months of 2026 was $10.2 million. Net cash associated with investing activities was insignificant during the first nine months of 2026.
The following table provides a summary of cash flow data for each applicable period:
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2026 | 2025 | |||||||
| Net cash used in operating activities | $ | (10,213,701 | ) | $ | (10,239,523 | ) | ||
| Net cash used in investing activities | (70,872 | ) | (276,983 | ) | ||||
| Net cash (used in) provided by financing activities | 10,582,280 | 9,894,668 | ||||||
| Net change in cash, cash equivalents and restricted cash | 297,707 | (621,838 | ) | |||||
| Cash, cash equivalents and restricted cash at beginning of period | 8,781,059 | 5,872,767 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 9,078,766 | $ | 5,250,929 | ||||
Operating Activities
Net cash used in operating activities was $10.2 million for the nine months ended September 30, 2026, compared with $10.2 million for the same period in 2025. Cash used in operating activities primarily reflects operating expenses of $10.5 million, consisting of research and development expenses and general and administrative expenses.
Investing Activities
Net cash used in investing activities was $0.1 million for the nine months ended September 30, 2026, compared with $0.3 million for the same period in 2025, and consisted solely of purchases of property and equipment.
Financing Activities
Net cash provided by financing activities was $10.6 million for the nine months ended September 30, 2026, compared with $9.9 million for the same period in 2025. Financing activities in 2026 consisted primarily of net proceeds of $7.1 million from the issuance of Note A-1 and Note B and net proceeds of $2.2 million from the issuance of preferred stock. They also included net proceeds of $1.3 million from the sale of common stock under the ATM Agreement.
As described in Note 13, subsequent to September 30, 2026, on October 27, 2026, the Company filed a registration statement on Form S-1 (File No. 333-299647) with the SEC, as amended on October 28, 2026, for a proposed best-efforts public offering. As of October 29, 2026, the proposed offering had not been completed, no proceeds had been received, and there was no minimum offering requirement. The Company will continue to seek additional capital through additional public or private equity offerings, debt financing, additional strategic alliance and licensing arrangements, collaborative arrangements, or some combination of these financing alternatives. If we raise additional funds through the issuance of equity securities, the percentage ownership of our stockholders could be significantly diluted, and the newly issued equity securities may have rights, preferences, or privileges senior to those of the holders of our common stock. If we raise funds through the issuance of debt securities, those securities may have rights, preferences, and privileges senior to those of our common stock. If we seek strategic alliances, licenses, or other alternative arrangements, such as arrangements with collaborative partners or others, we may need to relinquish rights to certain of our existing or future technologies, drug candidates, or products we would otherwise seek to develop or commercialize on our own, or to license the rights to our technologies, drug candidates, or products on terms that are not favorable to us. The overall status of the economic climate could also result in the terms of any equity offering, debt financing, or alliance, license, or other arrangement being even less favorable to us and our stockholders than if the overall economic climate were stronger. We also will continue to look for government sponsored research collaborations and grants to help offset future anticipated losses from operations and, to a lesser extent, interest income.
If adequate funds are not available through either the capital markets, strategic alliances, or collaborators, we may be required to delay or, reduce the scope of, or terminate our research, development, clinical programs, manufacturing, or commercialization efforts, or effect additional changes to our facilities or personnel, or obtain funds through other arrangements that may require us to relinquish some of our assets or rights to certain of our existing or future technologies, drug candidates, or products on terms not favorable to us.
Such conditions raise substantial doubts about the Company’s ability to continue as a going concern. Management’s plan includes raising funds from the issuance and sale of its common stock via its ATM program and other funding transactions. However, as mentioned above, there is no assurance such funding will be available to the Company or that it will be obtained on terms favorable to the Company or will provide the Company with sufficient funds to meet its objectives. The Company’s 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.
Off-Balance Sheet Arrangements and Contractual Obligations
Material Cash Requirements and Contractual Obligations
Our material cash requirements consist primarily of funding the Phase 3 OVATION 3 trial and the manufacturing of IMNN-001, general and administrative expenses, and obligations under our secured notes and operating leases. At September 30, 2026, $1.5 million of principal was outstanding under the A-1 Note (8%, paid in kind) and $5.0 million under the B Note (5%, paid in cash), both maturing in December 2027. Beginning in December 2026, the holder may redeem up to $250,000 of A-1 Note principal monthly, plus additional amounts based on trading volume. The notes carry a 10% prepayment premium and customary covenants. The B Note is collateralized by $5.0 million of restricted cash that is not available for operations. Undiscounted operating lease payments total approximately $770,000 through 2028. Our $4.0 million of unrestricted cash is not expected to fund operations and debt service for the next twelve months. We plan to fund these requirements through our ATM program, the proposed offering on Form S-1 and other financings, although there can be no assurance such funding will be available. See “Going Concern” above.
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Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements, as defined in Item 303 of Regulation S-K, during the periods presented.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. CONTROLS AND PROCEDURES
We have carried out an evaluation, under the supervision and with the participation of management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as that term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our principal executive officer and principal financial officer have concluded that, as of September 30, 2026, which is the end of the period covered by this report, our disclosure controls and procedures are effective at the reasonable assurance level in alerting them in a timely manner to material information required to be included in our periodic reports with the SEC.
There were no changes in our internal control over financial reporting identified in connection with the evaluation that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Our management, including our chief executive officer and chief financial officer, do not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple errors or mistakes. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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PART II: OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently a party to any material legal proceedings.
Item 1A. Risk Factors
Except as set forth below, there have been no material changes to the risk factors in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. The following risk factors supplement, and to the extent inconsistent supersede, those risk factors.
Our secured notes are secured by substantially all of our non-intellectual property assets, and a default could result in acceleration and loss of our cash collateral.
Our notes issued to Streeterville Capital, LLC mature in December 2027 and are secured by substantially all of our assets other than intellectual property. $5.0 million of the proceeds is held in a restricted collateral account. Beginning in December 2026, the holder may redeem up to $250,000 of Note A-1 principal monthly, plus additional amounts based on trading volume, reducing cash available for operations. Upon a default, the holder may accelerate the notes and foreclose on the collateral, including the cash account, and the interest rate would rise to up to 15%.
We are dependent entirely on the success of IMNN-001.
We have discontinued PLACCINE and IMNN-101, abandoned the related patents and agreed to sell our ThermoDox assets. IMNN-001 is now our only product candidate, and any setback in the IMNN-001 program would materially harm our business, and we have no other candidates to offset it. This risk factor replaces the risk factor in our Annual Report titled “Our success will depend in part on our ability to grow and diversify, which in turn will require that we manage and control our growth effectively.”
We manufacture IMNN-001 at a single facility.
We manufacture IMNN-001 at our Huntsville, Alabama facility and have no alternative facility. The facility must comply with cGMP requirements and is subject to FDA inspection. A compliance failure, damage to the facility, loss of the facility or loss of key personnel could interrupt clinical supply. Moving manufacturing to a third party would be costly and slow and would require demonstrating comparability to the FDA. We also rely on third parties for materials and certain testing. This risk factor replaces the risk factor in our Annual Report titled “Because we rely on third-party manufacturing and supply partners, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.”
The ThermoDox sale may not close, and we may receive little or no value from it.
Closing of the October 2026 sale of our ThermoDox assets to VoxelDox Therapeutics, Inc. requires VoxelDox to raise at least $2.5 million. If the sale closes, our consideration is illiquid private company stock and up to $16.5 million in milestones plus royalties that depend on VoxelDox’s future success. Milestones and royalties are cut by 50% if the transferred vials are not usable. Our Executive Chairman and one director are expected to receive VoxelDox equity for consulting services, which may create conflicts of interest.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
During the quarter ended September 30, 2026, the Company issued an aggregate of 107,953 shares of common stock to certain officers and directors pursuant to compensatory arrangements. The shares were issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering. No underwriting discounts or commissions were paid in connection with these issuances.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
In
the third quarter of 2026 through September 30, 2026, no directors or executive officers
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Item 6. Exhibits.
| 10.1 | Exchange Agreement dated September 28, 2026, by and between Company and Streeterville Capital, LLC. incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed on September 28, 2026. | |
| 31.1+ | Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 31.2+ | Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| 32.1* | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| 101** |
The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 formatted in XBRL (Extensible Business Reporting Language): (i) the unaudited Consolidated Balance Sheets, (ii) the unaudited Consolidated Statements of Operations, (iii) the unaudited Consolidated Statements of Comprehensive Loss, (iv) the unaudited Consolidated Statements of Cash Flows, (v) the unaudited Consolidated Statements of Change in Stockholders’ Equity (Deficit), and (vi) Notes to Consolidated Financial Statements.
| |
| + | Filed herewith. | |
| * | Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Securities Exchange Act, except as otherwise stated in such filing. | |
| ** | XBRL information is filed herewith. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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 thereunto duly authorized.
| November 12, 2026 | IMUNON, INC. | |
| Registrant | ||
| By: | /s/ Stacy R. Lindborg Ph.D. | |
| Stacy R. Lindborg, Ph.D. | ||
| Chief Executive Officer | ||
| By: | /s/ Josh Blacher | |
| Josh Blacher | ||
| Interim Chief Financial Officer |
| 37 |
Exhibit 31.1
IMUNON, INC.
CERTIFICATION
I, Stacy R. Lindborg Ph.D., certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Imunon, Inc.; | ||
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | ||
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | ||
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15 (f)), for the registrant and have: | ||
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. | |
| Imunon, Inc. | ||
| November 12, 2026 | By: | /s/ Stacy R. Lindborg Ph.D. |
| Stacy R. Lindborg Ph.D. | ||
| Chief Executive Officer | ||
Exhibit 31.2
IMUNON, INC.
CERTIFICATION
I, Josh Blacher, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Imunon, Inc.; | ||
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | ||
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | ||
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15 (f)), for the registrant and have: | ||
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and | |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): | ||
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. | |
| Imunon, Inc. | ||
| November 12, 2026 | By: | /s/ Josh Blacher |
| Josh Blacher | ||
| Interim Chief Financial Officer | ||
Exhibit 32.1
IMUNON, INC.
SECTION 1350 CERTIFICATIONS*
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), each of the undersigned hereby certifies that, to the best of his knowledge, (i) the Quarterly Report on Form 10-Q for the period ended September 30, 2026 of Imunon, Inc. (the “Company”) filed with the Securities and Exchange Commission on the date hereof fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act and (ii) the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| November 12, 2026 | By: | /s/ Stacy R. Lindborg Ph. D. |
| Stacy R. Lindborg Ph.D. | ||
| Chief Executive Officer | ||
| November 12, 2026 | By: | /s/ Josh Blacher |
| Josh Blacher | ||
| Interim Chief Financial Officer |
* This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.