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

Furthermore, because ourOur product candidates are drug-device combination products comprising an electroporation device for delivery of a biologic, and additional time may be required to obtain regulatory approval for our product candidates because of the complexity involved with developing and manufacturing a drug-device combination product. In addition, ifIf the FDA and similarcomparable regulatory authorities in foreign jurisdictions do not provide marketing authorization for our CELLECTRA delivery devices, then we will not be able to bring to market our DNA medicines that rely on delivery by such a device. Such delays or failure to obtain marketing authorization for our devices would result in significant harm to our business.devices.

We planare to pursuepursuing accelerated approval for ourINO-3107 productfor candidatethe INO-3107treatment of RRP and may in the future decide to pursue accelerated approval for one or more of our other product candidates. Under the FDA’s accelerated approval program, the FDA may approve a drug or biologic for a serious or life-threatening disease or condition that provides a meaningful advantage over available therapies based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. For drugs or biologics granted accelerated approval, post-marketing confirmatory trials are required to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. These confirmatory trials must be completed with due diligence, and the FDA may require that the trial be designed, initiated, and/or fully enrolled prior to approval.

IfOur wepursuit pursueof accelerated approval for INO-3107 forand the treatment or RRP, or aany future product candidate for another disease or condition, wecandidates would do sobe on the basis that there is no available therapy for thata particular disease or condition or that our product candidate provides a benefit over available therapy. If standard of care were to evolve or if any of our competitors were to receive full approval on the basis of a confirmatory trial for a drug or biologic for a disease or condition for which we are seeking accelerated approval before we receive accelerated approval, the disease or condition would no longer qualify as one for which there is no available therapy, and accelerated approval of our product candidate would not occur without a showing of benefit over available therapy. For example, in light of the FDA’s approval of PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of RRP in adults, we anticipate that the FDA will not approve our BLA for INO-3107 under the accelerated approval pathway unless we demonstrate that INO-3107 provides a clinically meaningful benefit over existing therapies, including PAPZIMEOS. The treatment landscape can change quickly as the FDA converts accelerated approvals to full approvals on the basis of successful confirmatory trials.

Moreover, even if the accelerated approval is granted the FDA may withdraw approval of INO-3107 or any future product candidate approved under the accelerated approval pathway if, for example:

•global unrest, including geopolitical risks emanating from countries such as Russia and China,conflicts, global pathogen outbreaks or pandemics, terrorist activities, the conflict between Israel and Hamas, bank failures and other economic and other external factors beyond our control.

With respect to clinical trials of product candidates for rare diseases, such as our planned confirmatory trial of INO-3107 for the treatment of recurrent respiratory papillomatosis, or RRP, we may encounter difficulties in recruiting a sufficient number of patients to enroll in the trial due to the small number of patients with the disease. Because RRP is caused by specific HPV types, 6 and 11, and there is currently no standard protocol for diagnostic/screening of RRP patients unless there are symptoms of dysphonia, respiratory distress or other symptoms related to the presence of papillomas, it may be difficult to identify and diagnose patients for whom INO-3107 may be a potential treatment.

Our DNA medicines programs are in various stages of research and development, and currently include DNA medicine candidates in discovery, preclinical studies and Phase 1, 2 and 3 clinical trials.development. There are limited data regarding the efficacy of DNA medicine candidates compared with conventional therapies, including vaccines, and we must conduct a substantial amount of additional research and development before the FDA or any comparable foreign regulatory authority will approve any of our DNA medicine candidates. The success of our efforts to develop and commercialize our DNA medicine candidates could be delayed or fail for a number of reasons. For example, we could experience delays in product development and clinical trials. Our DNA medicine candidates could be found to be ineffective or unsafe, or otherwise fail to receive necessary regulatory clearances to proceed with further clinical development or to be approved for marketing. Our products, even if they are deemed to be safe and effective by regulatory authorities, could be difficult to manufacture on a large scale, particularly given the complexity concerning the manufacturing of combination products, or uneconomical to market, or our competitors could develop superior products more quickly and efficiently or more effectively market their competing products.

DNA medicines are a novel approach to treating and preventing disease, and our CELLECTRA delivery devices are a novel approach to administering medicines. NegativeAdverse perceptionevents or negative perceptions of the efficacy, safety, or tolerability of any investigational medicines we develop or our devices could adversely affect our ability to conduct our business, advance our investigational medicines, or obtain regulatory approvals.

No DNA medicines have been granted EUA or have been approved to date by the FDA. Adverse events in clinical trials of our investigational medicines or in clinical trials of others developing similar products and the resulting publicity, as well as any other adverse events in the field of DNA medicine, or other products that are perceived to be similar to DNA medicines, such as those related to other nucleic acid based vaccines such as mRNA vaccines, gene therapy or gene editing, could result in a decrease in the perceived benefit of one or more of our programs, increased regulatory scrutiny, decreased confidence by patients and clinical trial collaborators in our investigational medicines, and less demand for any product that we may develop. Our pipeline of DNA medicine candidates could result in a greater quantity of reportable adverse events, including suspected unexpected serious adverse reactions, other reportable negative clinical outcomes, manufacturing reportable events or material clinical events that could lead to clinical delay or hold by the FDA or applicable regulatory authority or other clinical delays, any of which could negatively impact the perception of one or more of our programs, as well as our business as a whole. In addition, responses by U.S., state, or foreign governments to negative public perception may result in new legislation or regulations that could limit our ability to develop any investigational medicines or commercialize any approved products, obtain or maintain regulatory approval, or otherwise achieve profitability. More restrictive statutory regimes, government regulations, or negative public opinion would have an adverse effect on our business, financial condition, results of operations, and prospects and may delay or impair the development of our investigational medicines and commercialization of any approved products or demand for any products we may develop.

If we or our manufacturers were to encounter any of these difficulties or our manufacturers otherwise fail to comply with their obligations to us, our ability to provide our proprietary device to our partners and to supply DNA medicine candidates for clinical trials or to commercially launch a product would be jeopardized. For example, as part of the testing process required for BLA submission for INO-3107, we identified a manufacturing issue in the single use administration component of our CELLECTRA 5PSP device that we are working to resolve. However, the timeline ondevice, which wedelayed expectour to be ableability to commence our confirmatory trial and submit our BLA for INO-3107INO-3107. hasWhile beenwe delayedbelieve asthat awe result.have Thererectified the issue, there can be no assurance we will be able to rectify this manufacturing issue on the timeline we expect or at all or that we will not identify additional issues with our device that could further delay our planned regulatory submission or impair our ability to receive regulatory approval.approval in the future. In addition, we will have to update our existing IND with the 5PSP device in conjunction with submitting our confirmatory trial protocol for INO-3107, which will be subject to further FDA review.

FDA and comparable foreign regulatory authorities’ policies may also change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. For example, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper Bright decision could result in additional legal challenges to regulations and decisions issued by federal agencies, including the FDA, on which we rely. Any such legal challenges, if successful, could have a material impact on our business. Additionally, the Loper Bright decision may result in increased regulatory uncertainty, inconsistent judicial interpretations, and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. Certain policies of any administration may impact our business and industry. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

There are no pharmacologic therapies approved to treat the underlying causes of many diseases that we currently attempt to address or may address in the future. There has been limited clinical trial experience for the development of pharmaceuticals to treat these rare diseases in general, and we are not aware of a registrational trial that led to approval of a drug to treat these diseases. There have been some historical trials with other agents which may have utilized clinical endpoints that are less applicable to our efforts that address the underlying defect. As a result, the design and conduct of clinical trials of investigational medicines for the treatment of these disorders and other disorders may take longer, be more costly, or be less effective as part of the novelty of development in these diseases. For example, our product candidate INO-3107 is being developed for RRP, a rare condition for which there are no approved non-surgical treatments.

We have obtained Orphan Drug Designation for one of our DNA medicine candidates. As part of our business strategy, we may continue to seek Orphan Drug Designation for additionalour DNA medicine candidates, and we may be unsuccessful in obtaining new designations or may be unable to obtain or maintain the benefits associated with Orphan Drug Designation, including the potential for orphan drug exclusivity.

If any of our current or future collaborators breaches or terminates our agreements, or fails to conduct our collaborative activities in a timely manner, our commercialization of products could be diminished or blocked completely. We may not receive any event-based payments, milestone payments or royalty payments under our collaborative agreements if our collaborative partners fail to develop products in a timely manner or at all. It is possible that collaborators will change their strategic focus, pursue alternative technologies or develop alternative products, either on their own or in collaboration with others. Further, we may be forced to fund programs that were previously funded by our collaborators, and we may not have, or be able to access, the necessary funding. The effectiveness of our partners, if any, in marketing our products will also affect our revenues and earnings.

We have entered into agreements with government agencies, such as the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIH NIAID), Defense Advanced Research Projects Agency (DARPA), Medical CBRN Defense Consortium (MCDC) and the Department of Defense (DoD) Joint Program Executive Office (JPEO) for Chemical, Biological, Radiological and Nuclear Defense (CBRN), and we intend to continue entering into these types of agreements with government agencies in the future. Our business is partially dependent on the continued performance by these government agencies of their responsibilities under these agreements, including adequate continued funding of the agencies and their programs. We have no control over the resources and funding that government agencies may devote to these agreements, which may be subject to annual renewal and which generally may be terminated by the government agencies at any time. For example, in 2021 the DoD discontinued funding for the planned Phase 3 trial of our COVID-19 product candidate, which resulted in increased expenditures by us.

We currently have only a small marketing organization and no sales organization. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, if approved, we may not be able to generate product revenues.

We currently have only a small commercial organization to support pre-commercial activities for our proprietary device and DNA medicine candidates, if approved, and we do not currently have a sales organization.approved. In order to successfully commercialize INO-3107 or any other products that may receive regulatory approval, we must build our marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. We contemplate establishing our own sales force or seeking third-party partners to sell our products. The establishment and development of a sales force, either on our own or in conjunction with third parties, will be expensive and time-consuming and could delay any product launch, and we may not be able to successfully develop or acquire this capability. We will also have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel. To the extent we rely on third parties to commercialize our approved products, if any, we will receive lower revenues than if we commercialized these products ourselves. In the event we are unable to successfully develop our own marketing and sales force or collaborate with a third-party marketing and sales organization, we would not be able to commercialize our DNA medicine candidates which would negatively impact our ability to generate product revenues.

For example, FDA approved PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of RRP in adults, and if approved, INO-3107 will have to compete with this product. If our proprietary device and DNA medicine candidates are approved but do not achieve an adequate level of acceptance by physicians, healthcare payors and patients, we may not generate sufficient revenue from these products, and we may not become or remain profitable. In addition, our efforts to educate the medical community and third-party payors on the benefits of our DNA medicine candidates may require significant resources and may never be successful.

A significant trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular products and services. Third-party payors are increasingly challenging the effectiveness of and prices charged for medical products and services. Moreover, the U.S. government, state legislatures and foreign governmental entities have shown significant interest in implementing cost containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and coverage and requirements for substitution of generic products for branded prescription drugs. For example, the U.S. Department of Health and Human Services, or HHS, imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. HHS has also been empowered to negotiate the price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. We may not be able to obtain third-party payor coverage or reimbursement for our products in whole or in part. Further, coverage policies and third-party payor reimbursement rates may change at any time. Therefore, even if favorable coverage and reimbursement status is attained for one or more products, less favorable coverage policies and reimbursement rates may be implemented in the future.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. IfIn a2025, widespread reductions in force among federal agencies occurred and may adversely impact the ability of FDA to timely review applications, including our planned BLA. The prolonged government shutdown occurs,and itreduction of personnel and funding levels could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

If our information technology systemssystems, or those of third parties uponwith whichwhom we relywork, or our data, are or were to be compromised, we could experience material adverse consequences resulting from such compromise, including but not limited to, regulatory investigations and actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue and profits; and other adverse consequences.compromise.

We rely to a large extent upon sophisticated information technology systems to operate our businesses, some of which are managed, hosted provided and/or used for third-parties or their vendors. We collect, store and transmit large amounts of confidential, proprietary or otherwise sensitive information (including personal information and pseudonymized information), and we deploy and operate an array of technical and procedural controls designed to maintain the confidentiality, availability and integrity of such information as appropriate. A significant breakdown, invasion, corruption, destruction, interruption, unavailability or unavailabilityother compromise of critical information technology systems or infrastructure, by our workforce, others with authorized access to our systems or unauthorized persons could negatively impact operations. Hardware, software, or applications we develop or obtain from third parties may contain defects in design or manufacture or other supply chain problems that could unexpectedly compromise our information and network security.

The ever-increasing use and evolution of technology, including cloud-based computing, creates opportunities for the compromise of information storedprocessed inby ourus or our third-party providers' systems, portable media or storage devices.providers. Cyber-attacks, malicious internet-based activity, online and offline fraud and other similar activities threaten our information and information technology systems and those of third parties uponwith whichwhom we rely.work. Such threats are prevalent and continue to rise, are increasingly difficult to detect and come from a variety of sources such as traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through error or malfeasance), sophisticated national states and nation-state support actors (for example, in conjunction with military conflicts). During times of war and other major conflicts, we and the third parties with whom we work may be vulnerable to a heightened risk of these attacks. We and the third parties upon which we relythey are subject to a variety of evolving threats, including but not limited to: business interruption, loss of information, theft of information or reputational damage from industrial espionage attacks, malware or other cyber-attacks (including ransomware), social-engineering attacks (including through deep fakes which may be increasingly more difficult to identify as fake and phishing attacks), malicious code (such as viruses and worms), denial-of-service attacks, credential stuffing attacks, credential harvesting, personnel misconduct or error, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, telecommunications failures, natural disasters, attacks enhanced or facilitated by artificial intelligence, or AI, and other similar threats, any of which may compromise our system infrastructure or lead to data compromise. In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations, loss of data, reputational harm andharm, diversion of funds.funds and the potential loss of income. Extortion payments may alleviate some of the negative impact of a ransomware attack but we may be unwilling or unable to make such payments. Remote work has also become more common andposes increased risks to our information technology systems and data. Future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities as our systems could be negatively affected by vulnerabilities resent in acquired or integrated entities’ systems and technologies. Furthermore, we may discover security issues that were not found during diligence of such acquired or integrated entities and it may be difficult to integrate such entities into our information technology environment and security programs.

We rely on servicethird providers and third-party technologiesparties to operate critical business systems or to process sensitive information in a variety of contexts, including without limitation, cloud-based infrastructure, personnel email, data hosting, and other functions. Our ability to monitor these third parties’ information security practices is limited and these service providersthey may not have adequate information security measures in place. If ourthey servicewere providersto experience a security incident or other interruption, we could also experience adverse consequences. While we may be entitled to damages if ourthose servicethird providersparties fail to satisfy their privacy or security-related obligations to us, any aware may be insufficient or we may be unable to recover such award.

While we have implemented measures designed to protect our data and information technology systems, there can be no assurance that our efforts will be effective (including, without limitation prevent service interruptions or security incidents). We take steps designed to detect, mitigate and remediate vulnerabilities in our information systemssystems, (such as our hardware and software, including that of the third parties uponwith whichwhom we rely).work. We may not, however, detect and remediate all such vulnerabilities on a timely or effective basis. Vulnerabilities could be exploited and result in a security incident. Any such interruption or breach of our systems could adversely affect our business operations and/or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business and reputational harm to us. In addition, as the regulatory environment related to information security, data collection and use, and privacy becomes increasingly rigorous, with new and constantly changing requirements applicable to our business, compliance with those requirements could also result in additional costs. We may expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against security incidents. Certain data privacy and security obligations may require us to implement and maintain specific or reasonable security measures.

In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position. Additionally, sensitive information of ours could be leaked, disclosed, or revealed as a result of or in connection with our personnel’s or vendors’ use of artificial intelligence (AI) technologies, including generative AI, and machine learning (ML) technologies (collectively, AI/ML technologies).AI. Any sensitive information (including confidential, competitive, proprietary, or personal data) that we input into a third-party generative AI/ML platform could be leaked or disclosed to others, including if sensitive information is used to train the third parties’ AI/ML model.technology. Additionally, where an AI/ML modeltechnology ingests personal data and makes connections using such data, those technologies may reveal other personal or sensitive information generated by the model.

•Clinical response was not dependent upon HPV viral loads, molecular subtype or other elements of the papilloma microenvironment Other products in our development pipeline include INO-3112, a DNA immunotherapy candidate targeting HPV-16/-18 combined with a DNA plasmid encoding for human IL-12 as an immune activator, for the treatment of oropharyngeal squamous cell carcinoma, or OPSCC, a type of head and neck cancer commonly known as throat cancer. We have entered into a clinical collaboration and supply agreement with Coherus BioSciences, Inc. to evaluate the combination of INO-3112 and LOQTORZI (toripalimab-tpzi) in a clinical trial for patients with locoregionally advanced, high-risk, HPV16HPV-16/18-18 positive OPSCC. Under the terms of the supply agreement, Coherus will provide LOQTORZI for a planned Phase 3 clinical trial. We have also gained alignment with FDA on the design of the planned Phase 3 trial in the United States and received initial feedback from European regulatory authorities on the proposed design of the trial in Europe.

InOther addition to our development efforts with the productpipeline candidates describedinclude above,those we are actively developing or planning to develop DNA medicines for other indications, includingtargeting HPV-related anal dysplasia; cancers in people with certain gene mutations; and a potential vaccine booster to protect against the Ebola virus. We are also working to identify partnership opportunities for our DNA-Encoded Protein (DPROT) and DNA-Encoded Monoclonal Antibody (DMAb) preclinical stage candidates and technology. We were previously conducting clinical trials of a DNA medicineimmunotherapy candidate for the treatment of HPV-related cervical high-grade squamous intraepithelial lesions, or HSIL, but announced in 2023 that we were ceasing development for this indication in the United States. However, our collaborator ApolloBio Corporation continues to conduct a Phase 3 clinical trial of this candidate in China and plans to seek regulatory approval for and potentially commercialize the candidate in that jurisdiction.

Our partners and collaborators includeduring Advaccine2025 Biopharmaceuticals Suzhou Co,included ApolloBio Corporation, AstraZeneca, Coherus Biosciences, Defense Advanced Research Projects Agency (DARPA), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, National Cancer Institute (NCI), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Plumbline Life Sciences, Regeneron Pharmaceuticals, Richter BioLogics, the University of Pennsylvania, the Walter Reed Army Institute of Research,Pennsylvania and The Wistar Institute.

All of our DNA medicine candidates are in the research and development phase. We have not generated any revenues from the sale of any products, and we do not expect to generate any material revenues unless and until we obtain marketing approval for and successfully commercialize INO-3107 and our other product candidates. We earn revenue from license fees and milestone revenue and collaborative research and development agreements and contracts. Our DNA medicine candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All DNA medicine candidates that we advance to clinical testing will require regulatory approval prior to commercial use, and will require significant costsfunding for commercialization. We may not be successful in our research and development efforts, and we may never generate sufficient product revenue to be profitable.

RevenueAll revenue was primarily derived under the collaborative arrangements and other contracts, including arrangementsarrangement with affiliated entity,ApolloBio for the years ended December 31, 20242025 and 2023. We derived 100% and 29%, respectively, of our revenue from a single collaborator, ApolloBio, in those years.2024.

(a) NetIncludes DMAb, DPROT and other research and development programs, net of contributions received from grant agreements and recorded as contra-research and development expense.

•$1.9$13.2 million in lower immunologydrug andmanufacturing, clinical study and other expenses related to INO-3107;

•$10.6$3.3 million in higherlower drugcontract manufacturing related to INO-3107labor;

•$4.6$2.8 million of higherlower expensed inventory.inventory;

Contributions received from current grant agreements and recorded as contra-research and development expense were $2.1 million$913,000 and $6.8$2.1 million for the years ended December 31, 20242025 and 2023,2024, respectively. The decrease was primarily due to decreasesfunding received from the close-out of $3.6the millionCEPI and $553,000, respectively,grants in reimbursements2024; fromoffset Advaccineby andthe increase in expenses earned under the sub-grants through Wistar.

General and administrative expenses, which include business development expenses and patent expenses, were $37.0$32.7 million for the year ended December 31, 20242025 as compared to $47.6$37.0 million in 2023.2024. The $10.6$4.3 million overall decrease was primarily the result ofincluded:

•$5.4$2.3 million in lower employee and consultant compensation, including employee and consultant stock-based compensation, primarily as a result of lower headcount anda lower weighted average grant date fair value forof the equity awards grantedexpensed during 2024the year; and

The $1.0 million$178,000 decrease in interest expense for the year ended December 31, 20242025 as compared to 20232024 was primarily due to our senior convertible promissory notes that were repaid in full on March 1, 2024.

Change in Fair Value of Common Stock Warrant LiabilityLiabilities

WeThe recognized a gain of $2.8 million from a decreasechange in the fair value of our common stock warrant liabilityliabilities of $493,000 and $2.8 million for the yearyears ended December 31, 2024.2025 Thisand change2024, wasrespectively, is related to the revaluation of the liability associated with the December 2024 Warrants and July 2025 Warrants, as defined below, we issued in December 2024 and was primarily the result of a decrease in our stock price during the period between the issuance date and December 31, 2024.below. We will continue to estimaterecord the fair value of these December 2024 Warrants and July 2025 Warrants at each balance sheet date and will record gain or loss on the consolidated statement of operations for changes in fair value between balance sheet dates.

Gain (Loss) Gain on Investment in Affiliated Entity

The gain (loss) gain on investment in affiliated entity resulted from the change in the fair market value of our investment in PLS of $490,000 and $(1.2) million and $773,000 for the years ended December 31, 20242025 and 2023,2024, respectively. We record our investment in PLS at its market value based on the closing price of the shares on the Korea New Exchange Market at each balance sheet date, with changes in fair value reflected in the consolidated statementsstatement of operations.

Other expense, net, of $2.6 million for the year ended December 31, 2025 was primarily due to financing costs incurred in connection with the issuance of the July 2025 Warrants, as well as the realized loss on short-term investments sold during the year. Other expense, net, of $3.2 million for the year ended December 31, 2024 was primarily due to athe realized loss on our short-term investments sold during the year, as well as the financing costs we incurred in connection with the issuance of the Warrants, as defined below, in December 2024.2024 Other expense, net, of $4.7 million for the year ended December 31, 2023 was primarily the result of realized losses on short-term investments sold during the year.Warrants.

Since inception, we have incurred operating losses and accordingly have not recorded a provision for U.S. income taxes for any of the periods presented. Utilization of net operating losses and tax credits are subject to a substantial annual limitation due to ownership change limitations provided by the Internal Revenue Code of 1986, as amended, or IRC. As of December 31, 2024,2025, we had net operating loss carry forwards for U.S. federal, California and Pennsylvaniaother state income tax purposes of $1.1$1.2 billion, $259.9$444.5 million and $88.6$86.0 million, respectively, net of the net operating losses that will expire due to IRC Section 382 limitations. We also had U.S. federal and state research and development tax credits of $46.1$48.8 million and $7.9$9.2 million, respectively, net of the federal research and development credits that will expire due to IRC Section 383 limitations. The net operating losses and credits began to expire during 2025.2026.

OurHistorically, our primary uses of cash arehave been to finance research and development activities, including clinical trial activities for the advancement of our DNA medicine candidates. WeSince inception, we have satisfied our cash requirements principally from proceeds from the sale of equity and debt securities, indebtedness and grants and government contracts.

As of December 31, 2024,2025, we had cash, cash equivalents and short-term investments of $94.1$58.5 million and working capital of $62.5$17.5 million, as compared to $145.3$94.1 million and $110.5$62.5 million as of December 31, 2023,2024, respectively.

Net cash provided by financing activities was $51.5$53.1 million and $5.0$51.5 million for the years ended December 31, 20242025 and 2023,2024, respectively. The variance was primarily due to the aggregate net proceeds of $49.0 million from the July 2025 Offering and November 2025 Offering (defined below), $1.3 million received from the exercise of warrants and $1.1 million received from the sale of common stock under the 2024 Sales Agreement (defined below) in 2025, compared to the aggregate net proceeds of $60.8 million from the April 2024 Offering and December 2024 Offering (described below) and net proceeds of $6.1 million from the sale of common stock under at-the-marketthe sales2024 agreements,Sales Agreement (defined below) and 2021 Sales Agreement in 2024, offset by the repayment of our convertible senior notes of $16.4 million in March 2024.

Offering of Common Stock and Warrants

On DecemberNovember 16,12, 2024,2025, we closed an underwritten public offering, or the DecemberNovember 20242025 Offering, relating to the issuance and sale of 10,000,00015,131,700 shares of theour common stock, and accompanying warrants to purchase 10,000,000 shares of common stock, or the Warrants,stock at an offering price of $3.00$1.90 per share and accompanying Warrant.share. The net proceeds from the DecemberNovember 20242025 Offering were $27.6$26.6 million, after deducting the underwriting discounts and commissions and offering expenses paid by us.

Our historical financial statements have been prepared under the assumption that we will continue as a going concern. As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.8 billion and had cash, cash equivalents and short-term investments of $37.7$36.7 million. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued. Based on our current plans and forecasted expenses, we expect that our cash, cash equivalents and short-term investments as of the filing date, MayAugust 13, 2026, together with the net proceeds of $16.0 million from the April 2026 Offering, which closed on April 6,12, 2026, will enable us to fund our planned operating expenses and capital expenditure requirements through a potential launch of INO-3107, if approved, and into thelate first quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than expected. Until we can generate sufficient revenue, if ever, to fund our operations, we will need to finance future cash needs through strategic alliance and licensing arrangements, grant agreements and/or future public or private debt or equity financings including At-the-Market Equity Offering Sales Agreements.

We have experienced significant operating losses over the last several years. As of MarchJune 31,30, 2026 our accumulated deficit was $1.8 billion. We have generated limited revenues, primarily consisting of license revenue, grant funding and interest income. We expect to continue to incur substantial additional operating losses for at least the next several years as we advance our clinical trials and research and development activities and seek to commercialize INO-3107, which, if approved, would be our first marketed product. We may never successfully commercialize INO-3107 or our other DNA medicine candidates or proprietary device technology and thus may never have any significant future revenues or achieve and sustain profitability.

Our certificate of incorporation authorizes us to issue up to 600,000,000 shares of common stock and up to 10,000,000 shares of preferred stock with such rights and preferences as may be determined by our board of directors. Subject to compliance with applicable rules and regulations, we may issue our shares of common stock or securities convertible into our common stock from time to time in connection with a financing, acquisition, investment, our stock incentive plans or otherwise. For example, in the July 2026 Offering, we issued 21,052,632 shares of our common stock and accompanying warrants to purchase up to 42,105,264 shares of our common stock (or Pre-Funded Warrants in lieu thereof), which amount increased to up to 48,421,052 shares upon the Underwriter's exercise of its option to purchase additional warrants. In addition, we have several other series of warrants outstanding that may be exercised at any time. Any such issuance of additional common stock, including on the exercise of warrants, could result in substantial dilution to our existing stockholders and cause the trading price of our common stock to decline.

In January 2026, a new position statement was published in The Laryngoscope (S. R.Best, A. D.Friedman, C. A.Rosen, et al.,“Recurrent Respiratory Papillomatosis Foundation Position Statement on the Management of Adults With RRP,” The Laryngoscope (2026): 1–11, https://doi.org/10.1002/lary.70379) outlining a contemporary, evidence-based approach to the management of adults with RRP and highlighting the benefits of HPV-specific immunotherapy to address the underlying disease that causes RRP. The paper was sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF), a patient advocacy organization, and authored by 16 leading physicians in the field of RRP. The paper recommends HPV-specific immunotherapy as the preferred first-line treatment for adults with RRP, including PAPZIMEOS™, a competitor’s product that was approved by the U.S. Food and Drug Administration, or FDA, in August 2025, as well as INO-3107, should it be approved. PAPZIMEOS, a gorilla adenoviral vector-based immunotherapy, was approved for the treatment of adults with RRP. PAPZIMEOS is administered as adjuvant treatment following surgical debulking. Unlike INO-3107, PAPZIMEOS requires additional surgery prior to its third and fourth doses if visible papilloma are present to maintain a state of minimal residual disease as part of its treatment regimen. In a single-arm, open-label Phase 1/2 study of PAPZIMEOS in patients with RRP requiring three or more surgical procedures per year, 24-month complete response rate was only 43%. Because of this difference and other advantages, we believe INO-3107 has the potential to become the preferred treatment of both patients and their healthcare providers based on clinical results and tolerability data to date, and the simplicity of its patient-centric treatment regimen, should it receive approval from the FDA.

In December 2025, the FDA accepted our BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP and set the Prescription Drug User Fee Act (PDUFA) target date for October 30, 2026. We are now focused on advancing INO-3107 through the regulatory process, which will involve continuing to interact with the FDA as they complete their review of our BLA. That includes addressing the preliminary potential review issue they noted in their file acceptance letter regarding eligibility for the accelerated approval program. In January 2026, we requested a meeting with the FDA to discuss maintaining eligibility for review under the accelerated approval program. The FDA agreed to meet and requested that INOVIO complete an assessment aid, which we submitted in February 2026. InBy Aprilearly 2026August 2026, the FDA had completed its mid-cyclemid- and late-cycle review ofmeetings for the BLA,BLA whereand noall newscheduled significantpre-licensure issuesinspections. wereIn raised.July As a part of the mid-cycle review communications,2026, the FDA reiterated their intention to scheduleconducted the previously agreed to informal meetingmeeting, during which we presented the totality of data supporting INO-3107's safety and efficacy, its highly differentiated approach to treating RRP, and the rationale for accelerated approval eligibility. We also discussed the current standard of care and the ongoing need for additional therapeutic options. During the informal meeting, the FDA did not discuss theirits preliminary commentary on eligibility for review underin the file acceptance letter regarding accelerated approval program.eligibility. WeThe areFDA waitingstated tothat receivefeedback a meeting date. As previously disclosed, we are not currently planning to seek approval for our BLA for INO-3107 underon the traditionalconfirmatory pathway, which we anticipate could potentially require us to conduct a Phase 3 trial, thetrial design of which would need to be agreed with the FDA and would be atforthcoming. aWe substantial cost. INOVIO continuescontinue to believe that INO-3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments, however the FDA may not agree with INOVIO’sour position and may decide INO-3107 is not eligible for review under the accelerated approval program.

InWe 2025 wehave presented key data regarding the development of INO-3107 at several scientific conferences. Highlights from the data include:

•By the end of Year 2, 91% (21/23) of evaluable patients continued to experience a reduction of one or more surgeries. In Year 2, 86% (24/28) saw a 50-100% reduction in surgeries. Only two patients had not yet responded to treatment with INO-3107INO-3107.

Other pipeline candidates include those targeting HPV-related anal dysplasia; cancers in peopleassociated with certain gene mutations; and a potential vaccine booster to protect against the Ebola virus. We are also working to identify partnership opportunities to advance our DNA-Encoded Protein (DPROT) and DNA-Encoded Monoclonal Antibody (DMAb) technology, whichwith a focus on developing additional DPROT indications in the rare disease space, including Fabry Disease and Hypophosphatasia (HPP). This technology has shown great potential across multiple disease targets through the production of monoclonal antibodies or missing defective proteins within the body.

We were previously conductingconducted clinical trials of a DNA immunotherapy candidate for the treatment of HPV-related cervical high-grade squamous intraepithelial lesions, or HSIL, but announced in 2023 that we were ceasing development for this indication in the United States. However, in May 2026, our collaborator ApolloBio Corporation continuesannounced topositive conducttopline aresults from their ongoing Phase 3 clinical trial of this candidate in ChinaChina. ApolloBio continues to advance the program and plans to use these results to seek regulatory approval for the product candidate and if approved, potentially commercialize the candidateit in that jurisdiction.

As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.8 billion. We expect to continue to incur substantial operating losses in the future due to our commitment to our research and development programs, the funding of preclinical studies, clinical trials and regulatory activities and the costs of general and administrative activities.

Revenue. Total revenue was $0 for both the three and six months ended June 30, 2026, as compared to $0 and $65,000 for the three and six months ended MarchJune 31, 2026 and30, 2025, respectively, all of which was derived under the collaborative arrangement with ApolloBio.

The following table summarizes our research and development expense by product candidate for the three and six months ended MarchJune 31,30, 2026 and 2025:

•$953,000$1.5 million in lower employee and consultant compensation, including stock-based compensation;

•$571,000$1.4 million in lower engineering professional and outside services related to our device development; and

•$544,000$556,000 of lower expensed inventory;inventory.

Contributions received from current grant agreements and recorded as contra-research and development expense were $51,000$171,000 and $286,000$222,000 for the three and six months ended MarchJune 31,30, 20262026, respectively, as compared to $315,000 and $601,000 for the three and six months ended June 30, 2025, respectively. The decrease was primarily due to a decrease in expenses earned under the sub-grants through Wistar.

General and administrative expenses. General and administrative expenses, which include commercial, business development expenses and patent expenses, were $7.9$7.8 million and $9.0$15.7 million for the three and six months ended MarchJune 31,30, 20262026, respectively, as compared to $8.6 million and $17.6 million for the three and six months ended June 30, 2025, respectively. Decreases for the three-month period year over year included:

•$424,000$386,000 in lower employee and consultant compensation, including stock-based compensation.compensation; offset by

Stock-based compensation. Employee stock-based compensation expense is measured at the grant date, based on the fair value of the award, and is recognized as expense over the requisite vesting period. Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended MarchJune 31,30, 2026 and 2025 was $687,000$753,000 and $1.4 million, respectively, of which $275,000$299,000 and $547,000,$574,000, respectively, was included in research and development expenses, and $412,000$454,000 and $821,000,$866,000, respectively, was included in general and administrative expenses. Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2025 was $819,000 and $2.2 million, respectively, of which $319,000 and $866,000, respectively, was included in research and development expenses, and $500,000 and $1.3 million, respectively, was included in general and administrative expenses. The decrease was primarily due to a lower weighted average grant date fair value of equity awards, affecting both current and prior period awards.

Interest income. Interest income for the three and six months ended MarchJune 31,30, 2026 and 2025 was $440,000$364,000 and $808,000,$803,000, respectively, as compared to $611,000 and $1.4 million for the three and six months ended June 30, 2025, respectively. The decrease for the three-monththree periodand six-month periods year over year was primarily due to a lower short-term investment balance.

Change in Fair Value of Common Stock Warrant Liabilities. The change in fair value of our common stock warrant liabilities of $4.1$13.9 million and $3.7$18.0 million for the three and six months ended MarchJune 31,30, 20262026, respectively, as compared to $(1.9) million and $1.8 million for the three and six months ended June 30, 2025, respectively, is related to the revaluation of the liability associated with the December 2024 Warrants, July 2025 Warrants and JulyApril 20252026 Warrants, as defined below. We record the fair value of these December 2024 Warrants, July 2025 Warrants and JulyApril 20252026 Warrants at each balance sheet date and will record gain or loss on the consolidated statement of operations for changes in fair value between balance sheet dates. During the three months ended March 31, 2026, the July 2025 Series A Warrants expired unexercised, and the remaining warrant liability was recognized as a gain in the condensed consolidated statement of operations, with no subsequent fair value remeasurement.

(Loss) gain on investment in affiliated entity. The (loss) gain reflects the change in the fair value of our investment in Plumbline Life Sciences, Inc. (PLS), which was of $0 and $(2.1) million for the three and $695,000six months ended June 30, 2026, respectively, as compared to $776,000 and $1.5 million for the three and six months ended MarchJune 31, 2026 and30, 2025, respectively. As of December 31, 2025, we measured our investment in PLS based on the quoted market price of its common stock on the Korea New Exchange Market. During the three months ended March 31, 2026, trading of PLS’s common stock was suspended, and we determined that the market for the security was not active. Accordingly, we reclassified the investment from Level 1 to Level 3 within the fair value hierarchy and estimated fair value using unobservable inputs. Based on our evaluation of PLS’s financial condition and the absence of observable market transactions, we determined that the fair value of our investment in PLS was $0 as of MarchJune 31,30, 2026.

Net unrealized gain on available-for-sale equity securities. The net unrealized gain on available-for-sale equity securities for the three and six months ended MarchJune 31,30, 2026 and 2025 of $79,000$94,000 and $140,000,$173,000, respectively, as compared to $759,000 and $900,000 for the three and six months ended June 30, 2025, respectively, resulted from a change in the fair market value of the investments.

Other expense, net. Other expense, net, for the three and six months ended MarchJune 31,30, 2026 and 2025 of $285,000$1.7 million and $500,$2.0 million, respectively, as compared to $703,000 and $704,000 for the three and six months ended June 30, 2025, respectively, related primarily to financing costs incurred in connection with the issuance of the Common Stock Warrants in April 2026, as well as the realized loss on short-term investments sold during the respective periods.

As of MarchJune 31,30, 2026, we had cash, cash equivalents and short-term investments of $37.7$36.7 million and working capital deficit of $1.5 million,$(2,000), as compared to $58.5 million and $17.5 million, respectively, as of December 31, 2025.

Net cash used in operating activities was $21.6$39.6 million and $26.9$47.7 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. The variance was primarily due to the timing and changes in working capital balances, offset by decreased operating expenses.

Net cash provided by (used in) investing activities was $2.6$8.8 million and $(52,000)$5.2 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. The variance was primarily the result of timing differences in short-term investment purchases, sales and maturities.

Net cash provided by financing activities was $1.0$18.1 million and $1.0 million$993,000 for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, both of which were primarily related to net proceeds received from the April 2026 Offering (defined below) and the sale of common stock under the Sales Agreements (defined below) during the respective periods.

On AprilJuly 6,31, 2026, we closed an underwritten public offeringoffering, (or the “AprilJuly 2026 Offering”)Offering, relating to the issuance and sale by the Company of 12,500,00021,052,632 shares of our common stock, par value $0.001 per share, and accompanying Serieswarrants, Aor warrantsthe July 2026 Warrants, to purchase up to 12,500,00042,105,264 shares of ourits common stock (or pre-funded warrants, each representing the right to purchase one share of common stock at an exercise price of $0.001 (the “Pre-Funded Warrants”)warrants in lieu thereofthereof, or the Pre-Funded Warrants) at an exercise price of $1.40$1.10 per share of common stock (or $1.3991.099 per Pre-Funded Warrant) (the “2026 Series A Warrants”) and Series B warrants to purchase up to 12,500,000 shares of our common stock (or Pre-Funded Warrants in lieu thereof) at an exercise price of $1.40 per share of common stock (or $1.399 per Pre-Funded Warrant) (the “2026 Series B Warrants” and, together with the Series A Warrants, the “2026 Warrants”), at a combined public offering price of $1.40$0.95 per share of common stock and accompanying 2026 Warrants. The net proceeds to us from the AprilJuly 2026 Offering were $16.0 million, after deducting the underwriting discounts and commissions and offering expenses paid by us.Warrant.

During the threesix months ended MarchJune 31,30, 2026, we sold 667,074 shares of common stock under the 2024 Sales Agreement. The sales were made at a weighted average price of $1.65 per share, resulting in aggregate net proceeds of $1.1 million. During the threesix months ended MarchJune 31,30, 2025, we sold 518,670 shares of common stock under the 2024 Sales Agreement. The sales were made at a weighted average price of $2.16 per share, resulting in aggregate net proceeds of $1.1 million. As of MarchJune 31,30, 2026, there was $56.8 million of remaining capacity under the 2024 Sales Agreement. On April 1, 2026 the Company notified the Sales Agent that it was suspending and terminating the prospectus, dated August 13, 20242024, (or the “ATM Prospectus”),Prospectus, related to the Sales Agreement. The Company will not make any sales of its Common Stock pursuant to the Sales Agreement unless and until a new prospectus is filed. The Sales Agreement remains in full force and effect.

During the threesix months ended MarchJune 31,30, 2026 and 2025, no warrants or stock options were exercised and tax payments of $130,000$186,000 and $74,000,$109,000, respectively, were made related to net share settlement of RSU awards.

As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.8 billion, and we expect to continue to operate at a loss for the near term. The amount of our accumulated deficit will continue to increase, as it will be expensive to continue research and development efforts. Our current cash resources will not be sufficient to complete the clinical development of our product candidates beyond INO-3107, and we anticipate that additional financing will be required in order to complete the development of and to commercialize and generate revenues from the sale of INO-3107 or any other product candidates that may receive regulatory approval. If these activities are successful and if we receive approval from the FDA to market our DNA medicine candidates, then we will need to raise additional funding to market and sell the approved products and equipment. In addition to the potential issuance of equity or debt securities in order to raise capital, we are also evaluating potential collaborations as an additional way to fund our operations. We have focused our resources on advancing INO-3107 toward potential U.S. approval and commercialization, while extending our cash runway. As part of this effort, we prioritized programs, spending, and resource allocation, including eliminating roles that do not directly support this objective. We expect our cash runwayrunway, including the net proceeds from the July 2026 Offering, to extend into thelate first quarter of 2027, without giving effect to any further capital raising activities that we may undertake.

Our ability to continue operations is dependent upon our ability to obtain additional capital in the future and achieve profitable operations. We expect to continue to rely on outside sources of financing to meet our capital needs and we may never achieve positive cash flow. In light of these factors, management believes that there is substantial doubt about our ability to continue as a going concern beyond the late fourthfirst quarter of 2026.2027. The condensed consolidated financial statements as of and for the three and six months ended MarchJune 31,30, 2026 do not include any adjustments that might result from the outcome of this uncertainty.

We have existing supply agreements with contract manufacturers to manufacture drug substance, including for INO-3107. At MarchJune 31,30, 2026, we had approximately $2.1$1.3 million in minimum purchase obligations in connection with these agreements. We expect to satisfy these obligations from existing cash over the next twelve months.

During the threesix months ended MarchJune 31,30, 2026, there have been no significant changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2025 Annual Report.