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

•The report of our independent registered public accounting firm for the year ended December 31, 20242025 contains a statement with respect to substantial doubt as to our ability to continue as a going concern as a result of recurring losses from operations and negative cash flows.flows from operations.

To date, we have financed our operations primarily through an initial investment from our founder and the issuance and sale of Common Stock, our convertible preferred stock and convertible debt notes, to outside investors in private and public equity financings. In July 2023, we also received the proceeds from our initial public offering (“IPO”). From our inception through December 31, 2024, we raised an aggregate of $57.4 million in cash received from the net proceeds from such transactions. As of December 31, 2024,2025, our cash and cash equivalents were $2.6$11.9 million. We have incurred net losses in each year since our inception, and we had an accumulated deficit of $66.8$78.4 million as of December 31, 2024.2025. For the years ended December 31, 20242025 and 2023,2024, we reported net losses attributable to stockholders of $16.3$11.6 million and $11.9$16.3 million, respectively.

We expect to continue to incur significant expenses and operating losses over the next several years and for the foreseeable future. Substantially all of our operating losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect our research and development expenses to significantly increase in connection with the commencement and continuation of clinical trials of our product candidates. In addition, if we obtain marketing approval for our product candidates, we will incur significant sales, marketing and manufacturing expenses. As we are a public company, we will incur additional costs associated with operating as a public company. As a result, we expect to continue to incur significant and increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developing biotechnology products, we are unable to predict the extent of any future losses or when we will become profitable, if at all. Even if we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.

The report of our independent registered public accounting firm for the year ended December 31, 20242025 included herein contains an explanatory paragraph concurring with management’s assessment indicating that there is substantial doubt as to our ability to continue as a going concern as a result of recurring losses from operations and negative cash flows.flows from operations. We do not have a history of earnings and, as a result, substantial doubt exists about our ability to continue as a going concern. Further, based on the cash and cash equivalents as of December 31, 2024,2025, we only have sufficient cash to continue with our business plan throughinto the endsecond quarter of the first quarter in 2025.2027.

We have initiated a global phasePhase 3 trial in sarcoma, and have received authorizations from several regulatory authorities to conduct the study, we have never completed a phase 3 registration study. There are inherent risks involved in the conduct of a global phasePhase 3 trial that can be beyond our control. We also have initiated a randomized controlled phasePhase 2 study in presurgical triple negative breast cancer. It may take several years to complete the testing of our product candidates and technology for the indications for which we wish to obtain approval. Over 210 patients have been enrolled in our clinical trials through March 1, 2025. Failure or delay can occur at any stage of development, for many reasons, including:

Future legislative and regulatory proposals may materially impact the ability of the FDA and other regulatory agencies to operate as they have historically operated. We cannot be sure whether additional legislative changes or executive orders will be enacted, or whether any of the FDA’s regulations, guidancesguidance or interpretations will be changed, or what the impact of such changes on the agency and its scientific review staff, if any, may be. For example, the FDA has experienced significant and rapid fluctuations in leadership and scientific review personnel, which may be key contributing factors in multiple reported delays in agency decision making on marketing applications and agency requests for additional data that are inconsistent with prior regulatory feedback. Additionally, the next FDA user fee reauthorization package entered stakeholder negotiations in mid-2025, and any agreement is expected to enter stakeholder negotiations beginning in mid-2025, with any agreementbe sent to Congress in early 2027 for purposes of initiating the legislative process. Reauthorization of the prescription drug user fee program would need tomust be finalized by Congress by the end of September 2027 in order to avoid a disruption in FDA’s review goals for BLAsNDAs and other activities supported by user fees assessed against industry.

In addition, disruptions at the FDA and other agencies may slow the time necessary for new products to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, political disputes in Congress may result in a shutdown of the U.S. government, and in such cases certain regulatory agencies, such as the FDA and the SEC, would have to furlough critical employees and stop critical activities. Government shutdowns or slowdowns can increase the time needed for an agency to complete its review or make final approvals or other administrative decisions.

The development and approval process in the United States may take many years, require substantial resources, and may never lead to the approval of any of our product candidates by the FDA for use in the United States. To obtain the requisite regulatory approvals to commercialize any product candidates, we must demonstrate through extensive preclinical studies and clinical trials that our product candidates are safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. In particular, the general approach for FDA approval of a new drug is dispositive data from one or two adequate and well-controlled, Phase 3well-controlled clinical trials of the relevant drug in the relevant patient population. PhaseIn 3certain clinicalcases, trialsthe typicallyagency involvemay hundredsdetermine ofthat patients,confirmatory havepost-market significantevidence costsis needed to establish effectiveness and takesupport yearsfull toapproval complete.for the target indication. A product candidate can fail at any stage of testing, even after observing promising signals of activity in earlier preclinical studies or clinical trials. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. In addition, initial success in clinical trials may not be indicative of results obtained when such trials are completed. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. A number of companies in the biotechnology and biopharmaceutical industries have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that commence clinical trials are never approved as therapeutic products, and there can be no assurance that any of our future clinical trials will ultimately be successful or support further clinical development of INT230-6 or any of our other product candidates. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including:

We will likely need to obtain separate regulatory approvals for each product that uses our technology with single or multiple therapeutic agents that we intend to market. All the manufacturing facilities used to manufacture components or assemble our product candidates must be inspected and meet legal requirements. Securing regulatory approval requires the submission of extensive pre-clinicalpreclinical and clinical data and other supporting information for each proposed therapeutic indication to establish to the FDA’s satisfaction that the manufacturing facilities and processes are sufficient to assure the product’s safety, efficacy, identity, strength, quality, and purity for each intended use. The pre-clinicalpreclinical testing and clinical trials of any products using our technology with any therapeutic agent or compound we use must comply with applicable regulations of the FDA and other federal, state, and local government authorities in the United States. Clinical development is a long, expensive, and uncertain process and is subject to delays. We may encounter delays or rejections for various reasons, including our inability to enroll enough patients to complete our clinical trials. Moreover, approval policies or regulations may change. If we do not obtain and maintain regulatory approval for our system and our use of therapeutic agents, our results of operations will be harmed.

During its development, our product candidates and technology will be subject to extensive and rigorous government regulation by the FDA and possibly other foreign regulatory agencies. The FDA regulates the research, development, pre-clinicalpreclinical and clinical testing, manufacture, safety, effectiveness, record keeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution, import, and export of pharmaceutical and medical device products. Failure to comply with FDA and other applicable regulatory requirements, either before or after product approval, may subject us to administrative or judicially imposed sanctions.

The regulatory review and approval process is lengthy, expensive, and inherently uncertain. As part of the Prescription Drug User Fee Act,PDUFA, the FDA has a goal to review and act on most submissions in a given time frame. The general review goal for a drug application is ten10 to twelve12 months for a standard application and six months for a priority review application. The FDA’s review goals are subject to change and it is unknown whether the review of an NDA filing for any of our product candidates will be completed within the FDA’s review goals or will be delayed. Moreover, the duration of the FDA’s review may depend on the number and types of other NDAs that are submitted to the FDA around the same time. The development and approval process may take many years, require substantial resources, and may never lead to the approval of a product. Failure to obtain or delays in obtaining regulatory approvals may:

Congress also amended the FDCA to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug to support marketing authorization, to design and submit a diversity action plan for such clinical trial. The action plan must describe appropriate diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them. Although none of our product candidates has reached Phase 3 of clinical development, we must submit a diversity action plan to the FDA by the time we submit a Phase 3 trial, or pivotal study, protocol to the agency for review, unless we are able to obtain a waiver for some or all of the requirements for a diversity action plan. It is unknown at this time how the diversity action plan may affect the planning and timing of any future Phase 3 trial for our product candidates, but initiationInitiation of such trials may be delayed if the FDA objects to our proposed diversity action plans for any future Phase 3 trial for our product candidates. We may also experience difficulties recruiting a diverse population of patients in attempting to fulfill the requirements of any approved diversity action plan.

We and our contracted service providers are required to comply with applicable GLP regulations for nonclinical studies and GCP regulations for clinical trials. GLP and GCP requirements applicable to any of our product candidates that are in preclinical and clinical development in the United States are set forth in FDA regulations and guidelines. Similar requirements are described in guidelines produced by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) and are applicable and enforced in certain jurisdictions, such as the EU, and many other countries and jurisdictions have established similar requirements applicable to preclinical studies and clinical trials. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and clinical trial sites. Although we rely on our contracted CROs, investigators, laboratory facilities, and trial sites to conduct preclinical studies or clinical trials in compliance with applicable regulations, we remain responsible for ensuring that each of our preclinical studies and clinical trials is conducted in accordance with its investigational plan and protocol and applicable laws and regulations. If we or our contracted service providers fail to comply with applicable regulations, the data generated in our preclinical studies or clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. Accordingly, if our contracted service providers fail to comply with these regulations or fail to recruit a sufficient number of subjects, we may be required to repeat clinical trials, which would delay the regulatory approval process Our reliance on third parties to conduct clinical trials will result in less direct control over the management of data developed through clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with CROs and other third parties can be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Such parties may:

There may be significant delays in obtaining coverage for newly-approvednewly approved drugs, and coverage may be more limited than the indications for which the drug is approved by the FDA or comparable foreign regulatory authorities. Patients who are prescribed medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party payors to pay all or part of the costs associated with their prescription drugs. Patients are unlikely to use our products unless coverage is provided and payment is adequate to cover all or a significant portion of the cost of our products. Therefore, coverage and adequate payment isare critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Moreover, eligibility for coverage does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim payments for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement may be based on payments allowed for lower-cost drugs that are already reimbursed, may be incorporated into existing payments for other services and may reflect budgetary constraints or imperfections in Medicare data. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates. However, no uniform policy requirement for coverage and reimbursement for drug products exists among third-party payors in the United States. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for new drugs that we develop and for which we obtain regulatory approval could adversely affect our operating results, our ability to raise capital needed to commercialize products, and our overall financial condition.

Further, there have been, and may continue to be, legislative and regulatory proposals at the U.S. federal and state levels and in foreign jurisdictions directed at broadening the availability and containing or lowering the cost of healthcare. The continuing efforts of the government, insurance companies, managed care organizations and other third-party payors to contain or reduce costs of healthcare may adversely affect our ability to set prices for our products that would allow us to achieve or sustain profitability. In addition, governments may impose price controls on any of our products that obtain marketing approval, which may adversely affect our future profitability. Recent U.S. federal actions include initiatives incorporating “most favored nation” (international reference pricing) concepts for certain prescription drugs, as well as agency testing of new payment models that could tie Medicare reimbursement or manufacturer rebates to prices in specified reference countries.

In addition, the Inflation Reduction Act of 2022 (the “IRA”) became law in August 2022 and includes multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. For example, a manufacturer of drugs or biological products covered by Medicare Parts B or D must pay a rebate to the federal government if their drug product’s price increases faster than the rate of inflation, a calculation that is based on the specific product and is dependent on the volume of the product that is paid for by Medicare Parts B or D. In accordance with the IRA, CMS has begun negotiating drug prices, starting for payment year 2026,prices for a select number of single source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease. Additional state and federal healthcare reform measures are expected to be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for certain biopharmaceutical products or additional pricing pressures.

Our product candidate is comprised of three key ingredients, the excipient (referred to as “SHAO”) and two active, commercially available pharmaceutical ingredients cisplatin and vinblastine sulphate.sulfate. Currently each of the three ingredients and our product candidate are single sourced. While we are aware of other suppliers for the two active ingredients, those suppliers have not been qualified as yet. We also have identified other producers of both the SHAO excipient and the finished product candidate. We manufacture SHAO using Curia in Albany, New York and the INT230-6 drug product at Curia in Glasgow, Scotland. We have only qualified Curia to produce SHAO and INT230-6 at this time. We control the manufacturing processes for SHAO and INT230-6, and we have all information on the production of the molecule and product candidate; however, it would take several months to qualify a new supplier or suppliers. We purchase the cisplatin from Veranova in West Deptford, New Jersey. Veranova is the developer of cisplatin and one of the world’s largest producers of cisplatin. We have only qualified Veranova as a supplier of cisplatin for our product candidate. We purchase vinblastine sulfate from Minakem located in Mont-Saint-Guibert, Belgium. We have only qualified Minakem as a supplier of our vinblastine sulfate for our product candidate. It would take several months to qualityqualify new vendors for cisplatin and vinblastine sulfate.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient support, charitable organizations and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws regulate the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell, and distribute our product candidates for which we obtain marketing approval. Such laws include, among others: hethe federal Anti-Kickback Statute, the federal false claims laws, including the False Claims Act, HIPAA, as amended by HITECH, and their implementing regulations, the federal Physician Payments Sunshine Act, federal consumer protection and unfair competition laws and analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business practices. For additional information regarding the regulatory regime under which we operate, see “Business — Government Regulation.”

All aspects of our business, including research and development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject to extensive legislation and regulation. Changes in applicable U.S. federal and state laws and agency regulation, as well as foreign laws and regulations, could have a materially negative impact on our business. In the United States and in some other jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates or any potential future product candidates of ours, restrict or regulate post-approval activities, or affect our ability to profitably sell any product candidates for which we obtain marketing approval. Increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements. Congress also must reauthorize the FDA’s user fee programs every five years and often makes changes to those programs in addition to policy or procedural changes that may be negotiated between the FDA and industry stakeholders as part of this periodic reauthorization process. Congress most recently reauthorized the user fee programs in September 2022 without any substantive policy changes.changes, and the next reauthorization must occur by the end of September 2027.

At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, in recent years, several states have formed prescription drug affordability boards (“PDABs”). Much like the IRA’s drug price negotiation program, these PDABs have attempted to implement upper payment limits (“UPLs”) on drugs sold in their respective states in both public and commercial health plans. For example, in August 2023, Colorado’s PDAB announced a list of five prescription drugs that would undergo an affordability review. The effects of these efforts remain uncertain pending the outcomes of several federal lawsuits challenging state authority to regulate prescription drug payment limits. In December 2020, the U.S. Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers (“PBMs”) and other members of the healthcare and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area. In mid-2022, the Federal Trade Commission also launched sweeping investigations into the practices of the PBM industryindustry, and published interim reports with its findings in mid-2024 and Januray 2025, that couldalso leadappear to be contributing to additional federal and state legislative orand regulatory proposalsproposals, as well as enforcement action and private litigation, targeting such entities’PBM operations, pharmacy networks, orand financial arrangements. In February 2026, several PBM regulatory reforms became law as part of a federal budget package, including but not limited to requirements for PBMs to pass back 100% of rebates and fees to commercial health plan sponsors; to provide extensive informational disclosures related to patients’ coverage and benefits; and to accept only bona fide service fees from drug companies when providing services under Medicare Part D. The DOL also issued a proposed rule in January 2026 that would mandate specific PBM fee disclosures to self-insured plan fiduciaries under ERISA and would allow plan fiduciaries to audit those PBM disclosures to confirm accuracy. Significant efforts to change the PBM industry as it currently exists in the United States may affect the entire pharmaceutical supply chain and the business of other stakeholders, including biopharmaceutical developers like us.

We have threefour U.S. patents and one pending U.S. patent application. We have 15 foreign patents, including one European patent,patent validated in 2827 countries. We have registered trademarks and know-how. While we have patents and filed patent applications covering composition of matter, use and methods, only 1819 patents have issued. Due to the uncertainty of the patent prosecution process, there are no guarantees that our pending patent applications or any future applications will result in the issuance of a patent. Even if we are successful in obtaining more U.S. patents and new patents in other countries, there is no assurance that our patents will be upheld if later challenged or will provide significant protection or commercial advantage. For example, given the uncertain situation in Eastern Europe, we cannot assure that our Russian patent will not be lost, given that payments necessary to maintain the patent may be unavailable in future years without the risk of international sanctions. Because of the length of time and expense associated with bringing new medical drugs and devices to the market, the healthcare industry has traditionally placed considerable emphasis on patent and trade secret protection for significant new technologies. Other parties may challenge our patents, patent claims or patent applications licensed or issued to us or may design around technologies we have patented, licensed or developed.

As a result of this volatility, you may not be able to sell your Common Stock at or above the your purchase price.

The results of our operations could be adversely affected by general conditions in the global economy, the global financial markets and the global political conditions. The U.S. and global economies are facing growing inflation, higher interest rates and a potential recession. Furthermore, a severe or prolonged economic downturn, including a recession or depression resulting from public health crises such as a pandemic or ongoing political disruption such as the war between Ukraine and Russia and the conflictongoing involvingconflicts Israelin andthe HamasMiddle East could result in a variety of risks to our business, including weakened demand for our programs and development candidates, if approved, relationships with any vendors or business partners located in affected geographies and our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy or political disruption, including any international trade disputes, could also strain our manufacturers or suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our potential products. Any of the foregoing could seriously harm our business, and we cannot anticipate all of the ways in which the political or economic climate and financial market conditions could seriously harm our business.

If the equity and credit markets deteriorate, it may make any necessary equity or debt financing more difficult to secure, more costly or more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could harm our growth strategy, financial performance and stock price and could require us to delay or abandon plans with respect to our business, including clinical development plans. Further, recent developments in the banking industry could adversely affect our business. If the financial institutions with which we do business enter receivership or become insolvent in the future, there is no guarantee that the Department of the Treasury, the Federal Reserve and the Federal Deposit Insurance Corporation (“FDIC”), will intercede to provide us and other depositors with access to balances in excess of the $250,000 FDIC insurance limit, that we would be able to access our existing cash and cash equivalents, that we would be able to maintain any required letters of credit or other credit support arrangements, or that we would be able to adequately fund our business for a prolonged period of time or at all, any of which could have a material adverse effect on our business, financial condition and results of operations. We cannot predict the impact that the high market volatility and instability of the banking sector more broadly could have on economic activity and our business in particular. In addition, there is a risk that one or more of our current service providers, manufacturers or other third parties with which we conduct business may not survive difficult economic times, including the ongoing conflict between Russia and Ukraine, the warongoing betweenconflicts Israelin andthe Hamas,Middle East, the instability of the banking sector, and the uncertainty associated with current worldwide economic conditions, which could directly affect our ability to attain our operating goals on schedule and on budget.

IT treatment, or treatment designed to contain a drug inside a tumor without spreading to the rest of the body, has been an objective of clinicians since discovery of chemotherapeutic agents. The challenge with IT treatment approaches is that a tumor’s lipophilic, high fat, dense and pressurized microenvironment is incompatible with and does not absorb water-based products. We believe that this drug delivery challenge limits the effectiveness of prior and current IT treatments, which involve injecting aqueous drugs into a tumor without sufficient consideration of the tumor environment (regardless of the drug’s mechanism or approach, i.e. the stimulation of an inflammatory response or efforts to attract immune cells into a hostile live tumor). Accordingly, there remains a continued unmet need for the development of direct IT therapies for solid tumors that provide high local killing efficacy coupled with nontoxic systemic anti-cancer effects. We believe we have created a product candidatecandidate, using our non-covalent conjugation chemistry, with the necessary chemistryphysical properties to overcome this local delivery challenge. Evidence shows the mechanism of tumor killing achieved by our drug candidate also leads to systemic immune activation and T-cell repertoire expansion in certain cancers.

In 2017, we initiated the IT-01 StudyStudy, a Phase 1/2 dose escalation study using INT230-6 in the United States under an IND authorized by the FDA and in Canada under a CTA approved by Health Canada. The IT-01 Studystudy tested the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers, and enrolled 110 patients in three arms: (i) INT230-6 used as a monotherapy, (ii) INT230-6 in combination with Merck’s Keytruda® (pembrolizumab), and (iii) INT230-6 in combination with BMSBMS’s Yervoy® (ipilimumab). We completed enrollment of the IT-01 Study in June 2022, locked the IT-01 Study database in February 2023 and finalized the clinical study report in September 2023. We delivered the combination-specific reports and other information to our partners in the fourth quarter of 2023.

In 2021, we initiated the INVINCIBLEINVINCIBLE-2 Study, a Phase 2 Study.randomized study that tested INT230-6 as a monotherapy treatment in early-stage breast cancer for patients not suitable for presurgical chemotherapy. The study enrolled 91 subjects and the database was locked in November 2023. The key endpoint was whether INT230-6 could reduce a patient’s cancer compared to no treatmenttreatment, (which is the current SOC) for the majority of patients with early-stage breast cancer, or a saline injection. Substantial reduction of cancer presurgically in aggressive forms of cancer has been shown to correlate with delaying disease recurrence. OtherThe key endpoints of the INVINCIBLE 2 Study were to understand the percentage of necrosis that can be achieved in tumors of varying sizes for a given dose, especially for tumors larger than 2 centimeters in longest diameter,diameter. andWe also sought to determine whether either a local or whole bodywhole-body anti-cancer immune response could be induced. The INVINCIBLE 2INVINCIBLE-2 Study demonstrated a high order of necrosis in presurgical breast cancer tumors in the period from diagnosis to surgery, with some patients experiencing greater than 95% necrosis of the tumor. Data from the INVINCIBLE 2INVINCIBLE-2 Study demonstrated that INT230-6 had a favorable safety profile. AnThere was also an increase of certain types of immune cells (CD4+ and NK T-cells) in the tumor and bloodblood. Additionally, there was also shown. There was also an increase in the T-cells repertoire relative to control.

In July 2024, we initiated and dosed our first patient in the INVINCIBLE-3 StudyStudy, a Phase 3 open-label, randomized study testing INT230-6 as a monotherapy compared to the SOC drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes. This 333-patient study with an endpoint of overall survival has been authorized by the FDA, Health Canada, the European Medicines Authority, and Australia's TherapeuticsTherapeutic Goods Administration. TheIn March 2025, we paused new site activations and patient enrollments due to funding constraints. Prior to this pause, the trial ishad enrollingenrolled and21 beingpatients. conductedWe will continue to treat all patients enrolled in eightthis countries:study thein US,cooperation Australia,with Canada,our France,third-party Germany,contract Italy,research Poland, and Spain. Uporganizations to 60reduce sarcoma-focusedongoing hospitalscosts andduring otherthis centerspause. areOnce expectedsufficient tofunding participateis fromobtained, these countries. Wewe plan to enrollrestart 333site patientsactivations and expect to completepatient enrollment in the firstINVINCIBLE-3 half of 2026, with an endpoint of overall survival.Study.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the issuancessale of equity, debt financing, or other capital sources, which may include collaborations with other companies or other strategic transactions. We may not be able to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we would have to significantly delay, reduce, or eliminate the development and commercialization of one or more of our product candidates.

•Salaries and Benefits Related Costs include employee-related expenses such as salariessalaries, bonuses and related benefits for employees engaged in fund raising, management, and corporate administration functions.

Research and development expenses increaseddecreased $5.7$3.7 million or 119%,35%, and were primarily due to the following:

•Contract manufacturing decreasedcosts declined by $0.3$0.6 million in 2024,million, as there were fewerno new manufacturing batches of INT230-6 batchesin manufactured compared to 2023.2025.

•Stock-based compensation increaseddecreased due to newlower optionfair awardsvalue grantedper ourshare new chief financial officer, and additionalof option awards granted to employees in 2024, compared to minimal option awards granted in 2023.2025.

Our financial statements have been prepared assuming we will continue as a going concern. We have incurred losses from operations and negative cash flows from operations that raise substantial doubt about our ability to continue as a going concern.

We have financed our operations primarily through an initial investment from our founder, the issuance and sale of convertible debt notes, and private and public equity financings. Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates. We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials for our product candidates, developing our manufacturing capabilities and building and qualifying our manufacturing facility to support clinical trials and commercialization and providing general and administrative support for our operations, including the cost associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings, collaborations, licensing arrangements or other sources. The sale of equity and convertible debt securities may result in dilution to our stockholders. Additional capital may not be available on reasonable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, scale back or discontinue the development of our product candidates.

On NovemberOctober 21,30, 2024,2025, wethe Company entered into a Securities Purchase Agreement with a single healthcare focusedan institutional investor (the “Investor”),investor, pursuant to which wethe agreedCompany to issueissued and sell,sold in a registered direct offering by the Company directly to the Investor,investor 1,237,113200,000 shares of Commoncommon Stock to the Investor,stock at a price of $2.425$20.00 per share, for aggregate gross proceeds of approximately $3.0$4.0 million before deducting the placement agents’agent’s fees and related offering expenses. In a concurrent private placement, we agreed to issue to the Investor Common Stock warrants to purchase up to 1,237,113 shares (the “Common Warrants”) at an exercise price of $2.95 per share. Each Common Warrant will be exercisable six months from the issuance date and will expire five and one-half years from the issuance date.

We have financed our operations primarily through an initial investment from our founder, the issuance and sale of convertible debt notes, private equity financings, and the IPO, after which shares of our Common Stock began trading on Nasdaq under the symbol “INTS” on June 30, 2023. As of December 31, 2024,2025, our cash and cash equivalents were approximately $2.6$11.9 million. Based on our balances in cash and cash equivalents, we project to have sufficient cash to fund our current operating plan throughinto the end of the firstsecond quarter of 2025.2027. Accordingly, we will need to obtain substantial additional funding to continue our operations. We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.

Our cash used in operating activities for the year ended December 31, 20242025 was $15.2$9.2 million, comprising of (i) our net loss of $16.3$11.6 million, as adjusted for $3.1$2.0 million in non-cash expenses (includingprimarily $3.1$2.0 million for non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $2.1$0.3 million.

Our cash used in operating activities for the year ended December 31, 20232024 was $7.2$15.2 million, comprising of (i) our net loss of $10.5$16.3 million, as adjusted for $4.0$3.1 million in non-cash expenses (includingprimarily $2.3 million for the conversion of convertible notes into shares of Common Stock, and $1.4$3.1 million non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $0.6$2.1 million.

Our cash provided inby investing activities during the year ended December 31, 2024 totaled approximately $6.4 million and was primarily due to net redemptions of marketable debt securities (net of purchases of marketable debt securities).

Our cash provided by financing activities during the year ended December 31, 20242025 was $2.9$18.6 million, primarily comprising of net(i) proceeds of $2.4$1.9 million from our registered direct offering in 2023, net proceeds of $0.2 millionreceived from issuancesthe issuance of Commoncommon Stock from our ATM,stock and $0.3warrants in the April 2025 Offering, (ii) $1.8 million in net proceeds received from exercisesthe issuance of optionscommon stock in the June 2025 Offering, (iii) $3.6 million in net proceeds received from the issuance of common stock in the October 2025 Offering, and warrants.(iv) $11.2 million in net proceeds received from the issuance of common stock under the ATM Sales Agreement.

Our cash provided by financing activities during the year ended December 31, 20232024 was $20.5$2.9 million, primarily comprising of net proceeds of $20.2$2.4 million from our IPOregistered indirect 2023,offering, andnet proceeds of $0.2 million from the saleissuances of convertibleCommon notesStock priorfrom toour theATM, IPO.and $0.3 million in proceeds from exercises of options and warrants.

Intensity Therapeutics, Inc. is a late-stage clinical biotechnology company passionately committed to applying scientific leadership in the field of localized cancer reduction leading to anti-cancer immune activation. Our new approach involves the direct injection into tumors of a unique product created from our DfuseRxSM discovery platform. Our technology makes use of non-covalent conjugation between transporter molecules and potent drug payloads.

Intratumoral (“IT”) treatment, or treatment designed to contain a drug inside a tumor without spreading toharming the rest of the body, has been an objective of clinicians since discovery of chemotherapeutic agents. The challenge with IT treatment approaches is that a tumor’s lipophilic, high fat, dense and pressurized microenvironment is incompatible with and does not absorb water-based products. We believe that this drug delivery challenge limits the effectiveness of prior and current IT treatments, which involve injecting aqueous drugs into a tumor without sufficient consideration of the tumor environmentenvironment, (regardless of the drug’s mechanism or approach, i.e. the stimulation of an inflammatory response or efforts to attract immune cells into a hostile live tumor).approach. Accordingly, there remains a continued unmet need for the development of direct IT therapies for solid tumors that provide high local killing efficacy coupled with nontoxic systemic anti-cancer effects. We believe we have created a product candidate, using our non-covalent conjugation chemistry, with the necessary physical properties to overcome this local delivery challenge. Evidence shows the mechanism of tumor killing achieved by our drug candidate also leads to systemic immune activation and T-cell repertoire expansion in certain cancers.

Our lead product candidate, INT230-6, is primarily comprised of three components: (i) cisplatin, a proven anti-cancer cytotoxic agent, (ii) vinblastine sulfate, also a proven anti-cancer cytotoxic agent, and (iii) an amphiphilic molecule (“SHAO”) which enables the two cytotoxic agents to disperse through a tumor and diffuse into cancer cells following a direct intratumoral injection. These three components are mixed and combined into one vial at a fixed ratio. Cisplatin and vinblastine sulfate are both generic and available to purchase in bulk supply commercially. The United States Food & Drug Administration (“FDA”) has approved both drugs as intravenous agents for several types of cancers. Cisplatin was first approved in 1978 for testicular cancer, and is also approved in ovarian and bladder cancer. The drug is also used widely in several other cancers including pancreatic and bile duct cancer. Vinblastine sulfate was first approved in 1965, and is also approved in generalized Hodgkin’s disease, lymphocytic lymphoma, advanced carcinoma of the testis, and certain types of sarcomas. The drug is also used in breast and lung cancer treatments.

In 2017, we initiated a Phase 1/2 dose escalation study (“IT-01 Study”) using INT230-6 in the United States under an investigational new drug application authorized by the FDA and in Canada under a preclinical trial application approved by Health Canada. The study tested the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers, and enrolled 110 patients in three arms: (i) INT230-6 used as a monotherapy, (ii) INT230-6 in combination with Merck’s Keytruda® (pembrolizumab), and (iii) INT230-6 in combination with Bristol Myers Squibb’s Yervoy® (ipilimumab). We completed enrollment of the IT-01 Study in June 2022, locked the IT-01 Study database in February 2023 and finalized the clinical study report in September 2023. We delivered the combination-specific reports and other information to our partners in the fourth quarter of 2023.

In 2021, we initiated a Phase 2 randomized study that tested INT230-6 as a monotherapy treatment in early-stage breast cancer for patients not suitable for presurgical chemotherapy (the “INVINCIBLE-2 Study”). The study enrolled 91 subjects and the database was locked in November 2023. The key endpoint was whether INT230-6 could reduce a patient’s cancer compared to no treatment, which is the current standard of care (“SOC”) for the majority of patients with early-stage breast cancer,treatment or a saline injection.injections. Substantial reduction of cancer presurgically in aggressive forms of cancer has been shown to correlate with delaying disease recurrence. The key endpoints of the INVINCIBLE 2INVINCIBLE-2 Study were to understand the percentage of necrosis that can be achieved in tumors of varying sizes for a given dose, especially for tumors larger than 2 centimeters in longest diameter. We also sought to determine whether a local or whole-body anti-cancer immune response could be induced. The INVINCIBLE-2 Study demonstrated a high order of necrosis in presurgical breast cancer tumors in the period from diagnosis to surgery, with some patients experiencing greater than 95% necrosis of the tumor. Data from the INVINCIBLE-2 Study demonstrated that INT230-6 had a favorable safety profile. There was also an increase of certain types of immune cells (CD4+ and NK T-cells) in the tumor and blood. Additionally, there was an increase in the T-cells repertoire relative to control.

In July 2024, we initiated and dosed our first patient in a Phase 3 open-label, randomized study (the “INVINCIBLE-3 Study”) testing INT230-6 as a monotherapy compared to the standard of care (“SOC”) drugs in second-andsecond- and third-line treatment for certain soft tissue sarcoma subtypes. This 333-patient study with an endpoint of overall survival has been authorized by the FDA, Health Canada, the European Medicines Authority, and Australia's TherapeuticsTherapeutic Goods Administration. In March 2025, we paused new site activations and patient enrollments due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. We have continued to treat all patients enrolled in this study in cooperation with our third-party contract research organizations (“CRO”) to reduce ongoing costs during this pause. In April 2026, we decidedinitiated activities to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites byin the INVINCIBLE-3 Study using an FDA-reviewed amended protocol based on important learnings from patients enrolled prior to the pause. Patient enrollment will likely begin in the third quarter of 2026,2026. Increased site activation and we have prioritized commencing full patient enrollment andrates siteare activationsexpected onceas sufficient incremental funding is obtained.

In October 2024, in collaboration with the Swiss Cancer Institute, formerly the Swiss Cancer Group for Clinical Cancer Research (SAKK), we initiated and dosed our first patient in a Phase 2 study (the “INVINCIBLE-4 Study”) to treat patients with localized triple-negative breast cancer. The endpoint is the change in the pathological complete response (“pCR”) rate for the combination compared to the SOC alone. In September 2025, we paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in Cohort A due to some patients in Cohort A experiencing localized skin irritation near the tumor site. In March 2026, we reported preliminaryPreliminary data from the first 14 patients showing(seven in each cohort) showed a 71% pCR in patients receiving INT230-6 in Cohort A and a 33%42% pCR in patients receiving the SOC alone.alone (Cohort B). There was also a 44% reduction in grade 3 adverse events in Cohort A compared to Cohort B.B and fewer immune-related adverse events when our INT230-6 was added prior to the immunochemotherapy. In March 2026, a protocol amendment was submittedapproved toby the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6.INT230-6, Fulland approval to resumepatient enrollment was granted on March 26, 2026, and we plan to resume enrollmentresumed in the second quarter of 2026. WeIn areJuly 2026, the Company restarted patient treatment and is currently targeting to complete enrollment by the end of 20272027, and will likely add resources to help sites enroll new patients. In theAugust event we are unable to obtain sufficient additional funding, we may have to delay2026, the completionCompany opened its first site in France for accrual following EU submission of the INVINCIBLE-4modified Study until such funding is obtained.protocol.

Since our inception in 2012, our operations have included business planning, hiring personnel, raising capital, building our intellectual property portfolio, and performing both research and development on our product candidates. Our research has been selected for oral presentations at major oncology conferences including the American Society of Clinical Oncology (“ASCO”), the Society for Immunotherapy of Cancer (“SITC”), the Connective Tissue Oncology Society (“CTOS”) and the San Antonio Breast Cancer Society (“SABCS”). Our research has undergone peer review and been published in high-impact journals such as OncoImmunology (a paper written jointly with the NCI) and The Lancet’s journal eBioMedicine. We have incurred net losses since inception and expect to incur net losses in the future as we continue our research and development activities. To date, we have funded our operations primarily through net proceeds received from issuances of our common stock, preferred stock and convertible notes. As of MarchJune 31,30, 2026, we had approximately $10.2$9.5 million of cash and cash equivalents. Subsequent to June 30, 2026, we raised an additional $1.3 million in net proceeds under the Sales Agreement. Since our inception, we have incurred significant operating losses. We incurred net losses of $2.4$5.4 million and $3.3$5.9 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $80.8$83.8 million.

•Salaries and Benefits Related Costs include employee-related expenses such as salariessalaries, bonuses and related benefits for employees engaged in research and development functions.

•Clinical Trial Expenses includesinclude payments to third parties in connection with the clinical development of our product candidates, including CROs, and costs due to clinical trials for patient care.

◦Manufacture and labellinglabeling of GMP product candidate;

•Audit Fees consist of fees billed for professional services rendered for the audit of our annual financial statements, review of our interim financial statements, and comfort and consent letters.

•Consulting services provided by non-employees for general and administrative tasks, includesinclude accounting, tax, human resources, finance, investor relations, board compensation, and internet support.

•Insurance includes directors and officers’ insurance, workersworkers’ compensation insurance, product liability insurance, business insurance, employee and cyber liability insurance.

We earned interest income on our cash balances and investments in U.S. Treasury bills.balances.

The following tables summarize our results of operations for the three and six months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Three Months Ended MarchJune 31,30, 2026 Compared to Three Months Ended MarchJune 31,30, 2025

Research and development expenses during the three months ended MarchJune 31,30, 2026 decreasedincreased $1.0$0.3 million or 45%,19%, compared to the three months ended MarchJune 31,30, 2025, and waswere primarily due to the following:

•INVINCIBLE-3 Study costs decreasedincreased $1.1$0.3 million. In March 2025, we paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. We have continued to treat all patients enrolled in this study in cooperation with our third-party CROs during this pause. WeIn planApril 2026, we initiated plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and we have prioritized commencing full patient enrollment and site activations once sufficient incremental funding is obtained.

•Salaries and benefits related costs decreasedincreased due to lower headcount in 2026, which was entirely offset by an estimated bonus accrual during the three months ended MarchJune 31,30, 2026 compared to no estimated accrual during the three months ended MarchJune 31,30, 2025.

•SalariesStock-based andcompensation benefits related costs increased due to an estimated bonus accrualdecreased during the three months ended MarchJune 31,30, 2026 compared to no estimated accrual during the three months ended MarchJune 31,30, 2025,2025 whichas no stock-based compensation awards were partiallygranted offsetduring bythe lowerfirst stock-basedhalf compensation.of 2026.

Interest income in 2026 and 2025 related to interest earned on cash and investment balances.cash.

On March 23, 2026, we filed a prospectus supplement to adjust the maximum that we may sell and issue under the Sales Agreement to $60.0 million of our shares of common stock, not including the shares previously sold under the Sales Agreement. Since inception through MarchJune 31,30, 2026, we have issued 1,297,6551,659,087 shares of common stock under the Sales Agreement for net proceeds of $11.5$13.1 million. As of June 30, 2026, we may issue and sell up to $58.4 million of Shares remaining under the Sales Agreement. Subsequent to MarchJune 31,30, 2026, we have issued an additional 124,553319,327 shares of common stock under the Sales Agreement for net proceeds of $0.6$1.3 million.

On October 30, 2025, the Companywe entered into a Securities Purchase Agreement with an institutional investor, pursuant to which the Companywe agreed to issue and sell, in a registered direct offering by the Companyus directly to the investor 200,000 shares of common stock at a price of $20.00 per share, for aggregate gross proceeds of $4.0 million before deducting the placement agent’s fees and related offering expenses.

On April 24, 2025, we commenced a best efforts public offering (the “April 2025 Offering”) of an aggregate of (i) 125,333 shares (the “Shares”) of the our common stock, (ii) 125,333 Series B-1 Common Warrants (the “Series B-1 Common Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-1 Common Warrant Shares”), (iii) 125,333 Series B-2 Common Warrants (the “Series B-2 Common Warrants” and together with the Series B-1 Common Warrants, the “Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-2 Common Warrant Shares” and together with the Series B-1 Common Warrant Shares, the “Warrant Shares”). In connection with the April 2025 Offering, we entered into a Securities Purchase Agreement on April 24, 2025 with certain institutional investors participating in the April 2025 Offering. The April 2025 Offering closed on April 28, 2025. Each Share was sold together with one Series B-1 Common Warrant to purchase one share of common stock and one Series B-2 Common Warrant to purchase one share of common stock. The combined offering price for each Share and accompanying Warrants was $18.75. Each Warrant has an exercise price of $21.25 and was immediately exercisable upon issuance. The Series B-1 Common Warrants will expire on the five-year anniversary of the date of issuance, and the Series B-2 Common Warrants will expire on the eighteen-month anniversary of the date of issuance. We raised an aggregate of $2.35 million in the April 2025 Offering, and net proceeds of the April 2025 Offering, after deducting the fees and expenses were approximately $1.9 million.

As of MarchJune 31,30, 2026, our cash and cash equivalents were approximately $10.2$9.5 million. Based on our balances in cash and cash equivalents, our ability to continue our operations is dependent on obtaining additional capital, which is not within our control. As a result, we believe there is substantial doubt about our ability to continue as a going concern.

Our cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 was $1.8$4.2 million, comprising of (i) our net loss of $2.4$5.4 million, as adjusted for $0.4$0.8 million in non-cash expenses (primarily for non-cash stock based compensation of $0.4$0.8 million), and (ii) net changes in operating assets and liabilities of $0.2$0.5 million.

Our cash used in operating activities for the threesix months ended MarchJune 31,30, 2025 was $2.0$4.4 million, comprising of (i) our net loss of $3.3$5.9 million, as adjusted for $0.4$1.1 million in non-cash expenses (primarily for non-cash stock based compensation of $0.4$1.1 million), and (ii) net changes in operating assets and liabilities of $0.9$0.3 million.

There were no investing activities during the threesix months ended MarchJune 31,30, 2026 or MarchJune 31,30, 2025.

Our cash provided by financing activities during the threesix months ended MarchJune 31,30, 2026 was $0.2$1.8 million, comprised entirelyprimarily from net proceeds received from the issuance of common stock under the Sales Agreement.

Our cash provided by financing activities during the threesix months ended MarchJune 31,30, 2025 was $0.3$4.1 million, comprisedprimarily entirelycomprising of (i) $1.9 million in net proceeds received from the issuance of common stock and warrants in the April 2025 Offering, (ii) $1.8 million in net proceeds received from the issuance of common stock in the June 2025 Offering, and (iii) $0.3 million in net proceeds received from the issuance of common stock under the Sales Agreement.

We did not have any off-balance sheet arrangements as of MarchJune 31,30, 2026.

Critical accounting estimates are those policies which are both important to the presentation of a company’s financial condition and results and require management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For a further discussion of our critical accounting estimates, see our 2025 Annual Report. No significant changes to our accounting policies took place during the threesix months ended MarchJune 31,30, 2026.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We have irrevocably elected not to availuse ourselvesthe ofextended thistransition exemptionperiod fromfor new or revised accounting standards and, therefore, will be subject toduring the sameperiod in which we remain an emerging growth company; however, we may adopt certain new or revised accounting standards as other public companies that are not emerging growth companies.early.