IMNN 10-K & 10-Q changes, risk factors and insider trading

We are providing the following cautionary discussion of risk factors and uncertainties that we believe are relevant to our business. These are factors that, individually or in the aggregate, we think could cause our actual results to differ materially from expected or historical results and our forward-looking statements. We note these factors for investors as permitted by Section 21E of the Exchange Act and Section 27A of the Securities Act. You should understand that it is not possible to predict or identify all such factors. Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties that may impact our business. Moreover, we operate in a competitive and rapidly changing environment. New factors emerge from time to time, and it is not possible to predict the impact of all of these factors on our business, financial conditioncondition, or results of operations. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events, or otherwise.

We will need to raise additional capital to fund our planned future operations, and we may be unable to secure such capital without significant dilutive financing transactions. If we are not able to raise additional capital, we may not be able to complete the development, testingtesting, and commercialization of our drug candidates.

Despite our reliance on third parties to conduct our clinical trials, we are ultimately responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires clinical trials to be conducted in accordance with good clinical practices for conducting, recording and reporting the results of clinical trials and that the rights, integrity and confidentiality of clinical trial participants are protected. We also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicitypublicity, and civil and criminal sanctions. Our reliance on third parties parties that we do not control does not relieve us of these responsibilities and requirements. If we or a third party we rely on fails to meet these requirements, we may not be able to obtain, or may be delayed in obtaining, marketing authorizations for our drug candidates and and will not be able to, or may be delayed in our efforts to, successfully commercialize our drug candidates. This could have a material adverse effect on our business, financial condition, results of operations and prospects.

An important element of our strategy for developing, manufacturingmanufacturing, and commercializing our drug candidates is entering into strategic alliances with pharmaceutical companies, research institutionsinstitutions, or other industry participants to advance our programs and enable us to maintain our financial and operational capacity.

Healthcare providers, physiciansphysicians, and third-party payors in the U.S. and elsewhere play a primary role in the recommendation and prescription of biopharmaceutical products. Arrangements with third-party payors and customers can expose biopharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute biopharmaceutical products. In particular, the research of our drug candidates, as well as the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

We may fail to comply with evolving European and other privacy laws.and data protection laws, which could materially adversely affect our business.

We are subject to varying degrees of privacy regulation in the countries in which we operate, and the general trend is toward increasingly stringent regulation and enforcement. We are, for example, subject to costly and complex U.S. and foreign laws governing the collection, use, storage, disclosure, and cross-border transfer of informationpersonal information, about patients and other individuals and compliance with such requirements can be costly and operationally burdensome that may materially adversely affect our financial condition and business operations. SinceBecause we have conducted and may conduct clinical trials in the European Economic Area (“EEA”), we are subject to additional data protection and clinical trial laws in the European Union. The General Data Protection Regulation, (EU) 2016/679 (“GDPR”), for example, governs the processing of personal data, and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates, providing notices to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, alerting data subjects and authorities about data breaches, and taking specific measures when engaging third-party processors. The GDPR also imposes strict rules on the transfer of personal data to countries outside the EEA, including the U.S., and confers on data subjects the right to lodge complaints with supervisory authorities, and seek certain judicial review for violations of the GDPR. In addition, the GDPR includes restrictions on cross-border data transfers. Under the GDPR, competent regulatory authorities have the power to impose fines up to EUR 20 million or 4% of the global annual turnover (whichever is higher), depending on the nature of the violation (see Art. 83, GDPR). In addition to fines, we may be subject to investigations, corrective orders, suspension of data processing activities, private claims for damages, and reputational harm, any of which could materially adversely affect our business, financial condition, and results of operations. Further consequences of non-compliance could be cease and desist claims by certain organizations/competitors, damage claimsclaims, and reputational damage. Further, We are also subject to Regulation (EU) NoNo. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human useuse, which and repealing Directive 2001/20/EC governs how we conduct clinical trials in the European Union together with Good Clinical Practices. As a result of Brexit, moreover, we also have independent obligations, similar to those already imposed on us by GDPR, under the United Kingdom’s Data Protection Act, 2018. Additionally, there are other local data protection laws, industry-specific requirements, regulations, or applicable codes of conduct which may impact our operations. WeAlthough we have taken steps to implementimplemented privacy compliance programs and controls,controls but our business remains subject to potential risks of controls imposed on cross border data flows, unauthorized access, and loss of personal data through internal and external threats that could adversely impact our business operations and research activities.

The commercial success of our products, if approved, will depend upon their acceptance by the medical community and third-party payors as clinically useful, cost effective and safe. Any of our drug candidates or similar drug candidates being investigated by our competitors may prove not to be effective in trial or in practice, cause adverse events or other undesirable side effects. Our testing and clinical practice may not confirm the safety and efficacy of our drug candidates or even if further testing and clinical practice produce positive results, the medical community may view these new forms of treatment as effective and desirable or our efforts to market our new products, if approved, may fail. Market acceptance depends upon physicians and hospitals obtaining adequate reimbursement rates from third-party payors to make our products, if approved, commercially viable. Any of these factors could have an adverse effect on our business, financial conditioncondition, and results of operations.

Our business strategy contemplates growth and diversification. Our ability to manage growth effectively will require that we continue to expend funds to improve our operational, financial and management controls, reporting systems and procedures. In addition, we must effectively expand, traintrain, and manage our employees. We will be unable to manage our business effectively if we are unable to alleviate the strain on resources caused by growth in a timely and successful manner. There can be no assurance that we will be able to manage our growth and a failure to do so could have a material adverse effect on our business.

We are exposed to the risk that our employees, independent contractors, consultants, collaboratorscollaborators, and contract research organizations may may engage in fraudulent conduct or other illegal activity. Misconduct by those parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (1) FDA regulations or similar regulations of comparable non-U.S. regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities, (2) manufacturing standards, (3) federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable non-U.S. regulatory authorities, and (4) laws that require the reporting of financial information or data accurately. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self- dealing, briberybribery, and other abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programsprograms, and other business arrangements. Employee or collaborator misconduct could also involve the improper use of, including trading on, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. While we have a code of conduct and business ethics, it is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws, standards or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, imprisonment, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could have a material adverse effect on our ability to operate our business and our results of operations.

The Company is from time to time subject to legal proceedings and claims that arise in the ordinary course of business. From time to time, third parties may in the future assert intellectual property rights to technologies that are important to the Company’s business and may in the future demand that we license their technology. Litigation may result in substantial costs and may divert management’s attention and resources, which may seriously harm the Company’s business, overall financial conditioncondition, and operating results.

Our success will depend, in a substantial part, on our ability to maintain our rights under license agreements granting us rights to use patented technologies. For instance, we are party to license agreements with Duke University, under which we have exclusive rights to commercialize medical treatment products and procedures based on Duke’s thermo-sensitive liposome technology. The Duke University license agreement contains a license fee, royalty and/or research support provisions, testing and regulatory milestones, and other performance requirements that we must meet by certain deadlines. If we breach any provisions of the license and research agreements, we may lose our ability to use the subject technology, as well as compensation for our efforts in developing or exploiting the technology. Any such loss of rights and access to technology could have a material adverse effect on our business.

If any of our pending patent applications are not issued, or are deemed invalid following issuance, or if our issued patents expire without obtaining issuance of our later-filed patent applications, we may lose valuable intellectual property protection.

We have filed patent applications, and plan to file additional patent applications, covering various aspects of our technologies and our proprietary drug candidates. There can be no assurance that the patent applications for which we apply would actually issuebe issued as patents or do so with commercially relevant or broad coverage. The coverage claimed in a patent application can be significantly reduced before the patent is issued. The scope of our claim coverage can be critical to our ability to enter into licensing transactions with third parties and our right to receive royalties from our collaboration partnerships. Since publication of discoveries in scientific or patent literature often lags behind the date of such discoveries, we cannot be certain that we were the first inventor of inventions covered by our patents or patent applications. In addition, there is no guarantee that we will be the first to file a patent application directed to an invention.

Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. As of FebruaryMarch 21,30, 2025,2026, we had 14,620,7323,922,764 shares of common stock outstanding, all of which, other than shares held by our directors and and certain officers, were eligible for sale in the public market, subject in some cases to compliance with the requirements of Rule 144, 144, including the volume limitations and manner of sale requirements. In addition, all of the shares of common stock issuable upon exercise of warrants will be freely tradable without restriction or further registration upon issuance.

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, increases in inflation rates and uncertainty about economic stability. For example, the COVID-19 pandemic resulted in widespread unemployment, economic slowdownslowdown, and extreme volatility in the capital markets. Similarly, the ongoing conflict between Ukraine and Russia and the unrest in the Middle East has created extreme volatility in the global capital markets and is expected to have further global economic consequences, including with respect to global supply chain and energy concerns.

Our certificate of incorporation and bylaws may discourage, delaydelay, or prevent a merger or acquisition that a stockholder may consider favorable by authorizing the issuance of “blank check” preferred stock. This preferred stock may be issued by our Board of Directors on such terms as it determines, without further stockholder approval. Therefore, our Board of Directors may issue such preferred stock on terms unfavorable to a potential bidder in the event that our Board of Directors opposes a merger or acquisition. In addition, our staggered Board of Directors may discourage such transactions by increasing the amount of time necessary to obtain majority representation on our Board of Directors. Certain other provisions of our bylaws and of Delaware law may also discourage, delaydelay, or prevent a third party party from acquiring or merging with us, even if such action were beneficial to some, or even a majority, of our stockholders.

Imunon is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms with the aim to generate safe, effectiveeffective, and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. Imunon is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the coding of proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the coding of viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases.

The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase II clinical developmenttrial studies.(OVATION 2) and is currently conducting a Phase 2 clinical trial (MRD trial) in partnership with the Break Through Cancer Foundation and a Phase 3 clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has entered intocompleted dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The WeCompany will continue to leverage these modalities and to advance advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions.

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, grantgrant, or governmental funding.

Given our development plans, we anticipate cash resources will not be sufficient to fund our operations for the next twelve months. The Company has no committed sources of additional capital. As a result of the risks and uncertainties discussed in this Annual Report on Form 10-K, 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 willwould receive cash inflows from the commercialization and sale of a product. 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, development activities, preclinical studies and clinical trials, or if we are in a position to pursue manufacturing or commercialization activities, we will need significant additional capital to develop our drug candidates through development and clinical trials, obtain regulatory approvals and manufacture and commercialized 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.

DuringAs 2024discussed and 2023,below, we issued a combined total of 5.1approximately million shares and 1.93.5 million shares of common stock, respectively, as discussed belowstock for approximately $9.0 $24.9 million in combined gross proceeds during 2025 and approximately $2.8 million, respectively, in net proceeds.2024.

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. However,As noted in the Company’sprospectus abilitysupplement that the Company filed on July 22, 2025, the aggregate market value of our outstanding Common Stock held by non-affiliates was approximately $79,075,969, based on 2,121,895 shares of Common Stock outstanding as of July 22, 2025, of which 2,100,291 shares were held by non-affiliates, and a price of $37.65 per share, which was the last reported sale price of our Common Stock on The Nasdaq Stock Market LLC (“Nasdaq”) on June 2, 2025. As a result, our public float increased above $75.0 million, and we were no longer subject to offerthe andlimitations sell its securitiescontained in a primary offering on the 2024 Registration Statement is limited by General Instruction I.B.6 of Form S-3S-3. (the “Baby Shelf Limitation”), which limitsUpon the amountfiling thatof this Form 10-K on or about March 31, 2026, the Company’s public float will be less than $75.0 million and as a result, the Company can offer to up to one-third of its public float during any trailing 12-month period. The Company would no longerwill be subject to the Baby Shelflimitations Limitationcontained ifin itsGeneral publicInstruction floatI.B.6 exceedsof $75Form million.S-3.

The Company has an At-the-Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC. The Company sold 88,976744,646 and 5,920 shares of common stock under the ATM Agreement for net proceeds of $4,530,663 and $99,506 during 2024.2025 Duringand 2024, 2023,respectively. theThe Company sold 1,878,488did not sell any shares of common stock forunder netthe proceedsATM Agreement subsequent to December 31, 2025 and through the date of $2,750,658.filing this Form 10-K.

Please refer to Note 2 to our financial statements included in this Annual Report. Also refer to Part I, Item 1A, Risk Factors, in this Annual Report, including, but not limited to, “We will need to raise substantial additional capital to fund our planned future operations, and we may be unable to secure such capital without significant dilutive financing transactions. If we are not able to raise additional capital, we may not be able to complete the development, testingtesting, and commercialization of our drug candidates.”

As the warrants issued upon our financings in 2025 and 2024 meet the criteria for equity classification under ASC 815, those warrants were classified classified as equity as of December 31, 2025 and 2024. No warrants were issued in 2023.

For the year ended December 31, 2024,2025, our net loss was $18.6$14.5 million compared to a net loss of $19.5$18.6 million for the year ended December 31, 2023. The Company recognized $1.3 million in tax benefits from the sale of its New Jersey NOLs under the NOL Program in the fourth quarter of 2023.2024. As of December 31, 2024,2025, the Company had $5.9$8.8 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 ATM program and other funding transactions. 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 or at all. 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.

Research and development (“R&D”) expenses decreased $0.3$3.8 million to $7.8 million in 2025 from $11.6 million in 2024 from $11.3 million in 2023.2024. Costs associated with the OVATION 2 Study were $1.4$0.4 and $1.2 million in 2024 and 2023, respectively. Costs associated with the PlaCCine Vaccine Study were $1.4 million in 2024.2025 and 2024, respectively. The Company initiated the OVATION 3 Study during 2025 and incurred costs of $1.3 million during this period. Other clinical and regulatory costs were $1.9 million in 2025 compared to $2.4 million in 2024 compared to $1.8 million in 2023.2024. R&D costs associated with the development of IMNN-001 to support the OVATION 2 Studystudies were $3.0 million in 2025 compared to $1.8 million in 2024,2024. anR&D increaseand fromcosts $0.3associated millionwith in samethe periodPlaCCine ofVaccine 2023.Study Theand the development of the PLACCINE DNA vaccine technology platform decreased to $2.6 million in 2024 comparedwere to$1.4 $4.5million and $2.6 million, respectively. There were no costs associated with the PlaCCine millionstudy or PLACCINE DNA development in 2023.2025. CMC costs decreased to $1.1 million in 2025 compared to $2.0 million in 2024 compared to $2.3 million in 2023.2024.

General and administrative expenses decreased to $6.9 million in 2025 compared to $7.5 million in 2024 compared to $9.7 million in 2023.2024. This decrease is primarily attributable to the decreasedecreases in legal expenses of $1.4 million, employee related costs of $0.4$0.3 million, non-cashconsulting, stockand compensationprofessional expensesfees of $0.3 million, insuranceand costsconference and travel expenses of $0.1 million,million andoffset by an increase in franchise tax of $0.2 million offset by higher consulting fees of $0.2$0.1 million.

Since inception, we have incurred significant losses and negative cash flows from operations. WeDuring this period, we have financed our operations primarily through the net proceeds from the sales of equity, credit facilitiesfacilities, sale of our New Jersey net operating losses, and amounts received under our product licensing agreement with Yakult and our technology development agreement with Hisun.agreements. The process of developing IMNN-001 and other drug candidates and technologies requires significant 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 foreseeable future. Our expenses have significantly and regularly exceeded our income, and we had an accumulated deficit of $407$421 million at December 31, 2024.2025.

AtOn December 31, 20242025 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. On December 31, 2025, we had cash and cash equivalents of $8.8 million. On December 31, 2024, we had total current assets of $8.0 million and current liabilities of $4.8 million, resulting in net working capital of $3.2 million. On December 31, 2024, we had cash and cash equivalents of $5.9 million. On December 31, 2023, we had total current assets of $18.2 million and current liabilities of $7.4 million, resulting in net working capital of $10.8 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 20242025 was $18.9$13.9 million. Our net loss of $18.6$14.5 million for 20242025 included non-cash expense transactions transactions of $0.5$0.1 million inrelated non-cashto stock-based compensation expense. On December 31, 2024, we had cash and cash equivalents of $5.9 million. See Financing Overview.compensation.

The Company may seek additional capital through further public or private equity offerings, debt financing, additional strategic alliance and licensing arrangements, collaborative arrangements, or some combination of these financing alternatives. See Financing Overview. 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, 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.

Imunon’s technology platform is optimized for the delivery of DNA and mRNA therapeutics via synthetic non-viral carriers and isfacilitates capable of providingcell 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.

THERAPLAS MODALITY:IMNN-001 DEVELOPMENT PROGRAM

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. in 2021 with an estimated 13,000 deaths. There are approximately 300.000 new cases of ovarian cancer world-wide. Mortality rates for ovarian cancer has declined very little in the last 40 years due to the unavailabilitylack 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. Patients whose cancer recurs or progresses after initially responding to surgery and first-line chemotherapy have been divided into one of the two groups based on the time from completion of platinum therapy to disease recurrence or progression. This time period is referred to as platinum-free interval. The platinum-sensitive group has a platinum-free interval of longer than six months. This group generally responds to additional treatment with platinum-based therapies. The platinum resistant group has a platinum-free interval of shorter than six months and is resistant to additional platinum-based treatments. Pegylated liposomal doxorubicin, topotecan, and bevacizumab are the only approved second-line therapies for platinum-resistant ovarian cancer. The overall response rate for these therapies is 10% to 20% with median overall survival (“OS”) of 11 to 12 months. Additionally, 10% to 15% of ovarian cancer cases nationwide are a result of germline or somatic BRCA mutations. With cognizance of tumor genetics, practice has shifted to include targeted agents in ovarian cancer treatment.

Poly (ADP-ribose) polymerase (“PARP”) enzymes are responsible for detecting and repairing single-stranded and double-stranded DNA breaks during cell replication. BRCA1/2 mutations hinder the homologous recombination repair pathway, and tumor cells utilize PARP enzymes to repair DNA. For this reason, these tumors are particularly sensitive to the mechanism of PARP inhibitors. PARP inhibitors have expanded treatmentmaintenance options in ovarian cancer, but fewno new frontline maintenance treatment options which improve survival are left 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. tumors. Interleukin-12 (“IL-12”) is one of the most active cytokines for the induction of potent anti-cancer immunity acting through through the induction of T-lymphocyte and natural killer cell proliferation. The precedence for a therapeutic role of IL-12 in ovarian cancer cancer is based on epidemiologic and clinical and preclinical data.

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 administrationadministration, and our demonstrated ability to safely deliver repeated doses could create a potent anti-tumor immune environment against tumor activity and that ais direct killing of the tumorsynergistic with concomitant use of cytotoxic chemotherapychemotherapy, could result 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:

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.

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. ThisThe PARPi subgroup was not aspecified pre-specifiedprior subgroupto asthe PARPtrial inhibitorsbecause 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.

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. 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.

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 Study participants are being randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3 or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD) including BRCA1 or BRCA2 mutations.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.

A review of the MRD study accomplishments aswas conducted in the third quarter of September 19, 2025, was conducted and it was determined that study goals contributing to 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.

As of MarchJune 31,30, 2026, the ITT population was at twenty-twotwenty-four (2224) patients randomized and treated in the study at the University of Texas MD MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center. andThe Stephenson Cancer Center at University of Oklahoma havehas been added addedas asan additional clinical sitessite for this study and areis open to recruitment.

Imunon’s vaccine approach is designed to optimize the quality of the immune response dictating the efficiency of pathogen clearance and patient recovery. Imunon has taken a multivalent approach in an effort to generate an even more robust immune response that not only results in a strong neutralizing antibody response, but also a more robust and durable T-cell response. Delivered with Imunon’s synthetic polymeric system, the proprietary DNA plasmid is protected from degradationdegradation, and its cellular uptake is facilitated.

As of MarchJune 31,30, 2026, the Company had $4.8$6.9 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 potential funding transactions.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.

Management’s plan includes raising funds from outside investors through the issuance and sale of its common stock, including the use of its at-the-market (“ATM”) program and other potential funding transactions. However, as mentioned above, there iscan 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.

During 2025 and for the threesix months endingended MarchJune 31,30, 2026, we issued a total of 3.23.5 million shares of common stock as discussed below for approximately $15.9 $14.9 million in netgross proceeds. Subsequent to MarchJune 31,30, 2026 and through the date of this Quarterly Report on Form 10-Q, we issued another 146,354162,804 shares of common stock under the at-the-market (“ATM”) program for net proceeds of $417,447.$298,494.

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. As noted in the prospectus supplement that the Company filed on July 22, 2025, the aggregate market value of our outstanding Common Stock held by non-affiliates was approximately $79,075,969, based on 2,121,895 shares of Common Stock outstanding as of July 22, 2025, of which 2,100,291 shares were held by non-affiliates, and a price of $37.65 per share, which was the last reported sale price of our Common Stock on The Nasdaq Stock Market LLC (“Nasdaq”) on June 2, 2025. As a result, our public float increased above $75.0$75 million, and we were no longer subject to the limitations contained in General Instruction I.B.6 of Form S-3. Upon the filing of the Form 10-K on March 31, 2026, the Company’s public float was less than $75.0$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.

FINANCIAL REVIEW FOR THE THREE MONTHS AND SIX MONTHS ENDED MARCHJUNE 31,30, 2026 AND 2025

ForOur the three months ended March 31, 2026, our net loss was $4.3$2.8 million and $7.1 million for the three-months and six-months ended June 30, 2026, respectively, compared to a net loss of $4.1$2.7 million and $6.8 million, respectively for the same three-month periodperiods of 2025.

With $4.8$6.9 million in cash and cash equivalents at MarchJune 31,30, 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 a going concern.

Research and development (“R&D”) expenses increasedwere to $2.3$1.5 million in the firstsecond quarter of 2026 fromcompared $2.2to $1.2 million in the same same period of 2025. Clinical costs associated with the OVATION 3studies studywere was $0.1$0.2 million each ofin the firstsecond quartersquarter of 2026 and 2025.compared Clinical costs associated with the OVATION 2 study wasto $0.1 million each of for the firstsame quartersperiod of 2026 and 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 remained relatively unchanged at $0.6$0.3 million in each of the firstsecond quarters of 2026 and 2025. R&DManufacturing and clinical supply costs associated with the development and testing of IMNN-001 to support the OVATION and programMRD programs were $1.3$0.9 million in the firstsecond quarter of 2026 compared to $0.9$0.7 million in same period of 2025.2025, CMC costs were $0.2 million inand the firstmajor quartercontribution to this increase relates to the advancement of 2026 compared to $0.4 million in the same period of 2025.OVATION-3.

GeneralOther andincome/expense administrativeis expensesinsignificant remained relatively unchanged at $2.0 million infor each of the firstsecond quarters of 2026 and 2025.

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 $426$428 million at MarchJune 31,30, 2026.

At MarchJune 31,30, 2026, we had total current assets of $6.2$8.7 million and current liabilities of $4.2$4.8 million, resulting in net working capital of $2.0$3.9 million. At MarchJune 31,30, 2026, we had cash and cash equivalents of $4.8$6.9 million.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 threesix months of 2026 was $4.0$7.0 million. Net cash associated with investing activities was was insignificant during the first threesix months of 2026.

The Company will continue to seek additional capital through furtheradditional 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.