What changed in this filing

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Item 1A. Risk Factors

2026-03-27 compared with 2025-03-13 · 127 added, 75 removed, 834 unchanged (19% of the section changed)

8 unchanged sentences

Any of the factors set forth in the section entitled “Risk Factors” may limit our ability to successfully execute our business strategy.

You should carefully consider all of the information set forth in this report and, in particular, you should evaluate the specific factors set forth in the section entitled “Risk Factors” in deciding whether to invest in our securities.

You should carefully consider all of the information set

forth in this report and, in particular, you should evaluate the specific factors set forth in the section entitled “Risk Factors” in deciding whether to invest in our securities.

Some of the principal risks we face include:

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• Since our inception, we have incurred, and for the foreseeable future anticipate that we will continue to incur, significant operating losses.

• The report of our independent registered public accounting firm for the year ended December 31, 2024 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.

• The report of our independent registered public accounting firm for the year ended December 31, 2025 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 from operations.

• If we fail to establish and maintain an effective system of internal control, we may not be able to report our financial results accurately or to prevent fraud, and could harm our reputation and adversely impact the future trading price of our securities.

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• We may be the subject of product liability claims or product recalls.

• Sales of our common stock under our at-the-market offering sales agreement may result in significant dilution to our existing stockholders.

• We may not satisfy the Nasdaq Capital Market’s requirements for continued listing of our common stock.

If we cannot satisfy these requirements, the Nasdaq Capital Market could delist our common stock.

Risks Related to Our Business, Financial, and Investment Conditions

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We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future.

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 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.

public equity financings.

As of December 31, 2025, our cash and cash equivalents were $11.9 million.

We have incurred net losses in each year since our inception, and we had an accumulated deficit of $78.4 million as of December 31, 2025.

For the years ended December 31, 2024 and 2023, we reported net losses attributable to stockholders of $16.3 million and $11.9 million, respectively.

For the years ended December 31, 2025 and 2024, we reported net losses of $11.6 million and $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.

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The report by our auditors includes a paragraph that states that substantial doubt exists about the Company’s ability to continue as a going concern.

The report of our independent registered public accounting firm for the year ended December 31, 2024 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.

The report of our independent registered public accounting firm for the year ended December 31, 2025 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 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, we only have sufficient cash to continue with our business plan through the end of the first quarter in 2025.

Further, based on the cash and cash equivalents as of December 31, 2025, we only have sufficient cash to continue with our business plan into the second quarter of 2027.

Our continued operations are dependent on our ability to complete equity or debt financings or generate profitable operations.

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However, because of our limited resources, there are limited controls over information processing.

As of December 31, 2023, we identified material weaknesses due to (i) a lack of segregation of duties due to limited administrative staff, (ii) limited reconciliation and review procedures over clinical contract accruals as we have rapidly expanded into new, late-stage clinical studies, and (iii) information technology matters regarding user access that aggregate to a material weakness.

These material weaknesses were remediated as of December 31, 2024.

Our small size and internal control deficiencies may adversely affect our financial condition, results of operation and access to capital.

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We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.

Moreover, the terms of any financing may adversely affect the holdings or the rights of our

stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline.

Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline.

The sale of additional equity or convertible securities would dilute all of our stockholders.

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There are inherent risks involved in the conduct of a global Phase 3 trial that can be beyond our control.

We also have initiated a randomized controlled phase 2 study in presurgical breast cancer.

We also have initiated a randomized controlled Phase 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.

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This product is being evaluated in a Phase ½, open label, multicenter, dose escalation and expansion, first-in-human clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors.

The IGNYTE Study, which started in 2017, includes a dose escalation Phase for single agent RP1, an expansion Phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy.

The IGNYTE Study, which started in 2017, includes a dose escalation Phase for single agent RP1, an expansion Phase with a combination of RP1 and nivolumab and a Phase 2 portion

in specified tumor types for the combination therapy.

Dose escalation of RP1 by intratumoral injection in superficial tumors and in visceral tumors.

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Furthermore, the CREATES Act established a private cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish necessary samples of an RLD on “commercially reasonable, market-based terms.” If generic developers request samples of any product candidates for which we receive marketing approval in order to conduct comparative testing to support one or more ANDAs for a generic version of our products, and we refuse any such request, we may be subject to litigation under the CREATES Act.

Although lawsuits have been filed under the

CREATES Act since its enactment, those lawsuits have settled privately;

Although lawsuits have been filed under the CREATES Act since its enactment, those lawsuits have settled privately;

therefore, to date, no federal court has reviewed or opined on the statutory language and there continues to be uncertainty regarding the scope and application of the law.

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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, guidances 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 next FDA user fee reauthorization package is expected to enter stakeholder negotiations beginning in mid-2025, with any agreement sent to Congress in early 2027 for purposes of initiating the legislative process.

Reauthorization of the prescription drug user fee program would need to be finalized by Congress by the end of September 2027 in order to avoid a disruption in FDA’s review goals for BLAs and other activities supported by user fees assessed against industry.

We cannot be sure whether additional legislative changes or executive orders will be enacted, or whether any of the FDA’s regulations, guidance 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 be sent to Congress in early 2027 for purposes of initiating the legislative process.

Reauthorization of the prescription drug user fee program must be finalized by Congress by the end of September 2027 in order to avoid a disruption in FDA’s review goals for NDAs 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.

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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.

If a prolonged government shutdown occurs, or if legislative or regulatory developments or global health concerns hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it 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.

Further, future government shutdowns could

impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Changes to U.S.

tariff and import/export regulations may have an adverse effect on our business, financial condition and results of operations.

There have been significant changes and continue to be ongoing discussion and commentary regarding potential significant changes to U.S.

trade policies, treaties and tariffs, creating significant uncertainty about the future relationship between the United States and other countries with respect to trade policies, treaties and tariffs.

These developments, or the perception that any of them could occur, may have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global trade and, in particular, trade between the impacted nations and the United States.

Any of these factors could depress economic activity and have a material adverse effect on our business, financial condition, results of operations, and the market price of our common stock.

Risks Related to FDA and Foreign Regulatory Approval

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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 3 clinical trials of the relevant drug in the relevant patient population.

Phase 3 clinical trials typically involve hundreds of patients, have significant costs and take years to complete.

In particular, the general approach for FDA approval of a new drug is dispositive data from adequate and well-controlled clinical trials of the relevant drug in the relevant patient population.

In certain cases, the agency may determine that confirmatory post-market evidence is needed to establish effectiveness and support full approval 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.

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Although we are initially focusing our efforts on development of small-molecule drug products, we may in the future pursue development of biological products, which could make us subject to additional regulatory requirements.

analysis we perform of data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval.

Any analysis we perform of data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval.

We may also encounter unexpected delays or increased costs due to new government regulations.

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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-clinical 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-clinical 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.

Securing regulatory approval requires the submission of extensive preclinical 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 preclinical 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.

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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-clinical 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.

The FDA regulates the research, development, preclinical 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.

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An IND application is the first step in the regulatory process.

Under an IND, a Company develops a drug through

clinical trials in human subjects in the hopes of gathering sufficient evidence of safety and effectiveness to support the submission to the FDA of an NDA to permit marketing of the drug.

Under an IND, a Company develops a drug through clinical trials in human subjects in the hopes of gathering sufficient evidence of safety and effectiveness to support the submission to the FDA of an NDA to permit marketing of the drug.

An NDA must be supported by extensive clinical and preclinical data, as well as extensive information regarding CMC to demonstrate the safety and effectiveness of the applicable product candidate.

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The regulatory review and approval process is lengthy, expensive, and inherently uncertain.

As part of the Prescription Drug User Fee Act, 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 ten to twelve months for a standard application and six months for a priority review application.

As part of 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 10 to 12 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.

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:

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In any event, the receipt of a breakthrough therapy designation for a product candidate may not result in a faster development process, review or approval compared to products considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA.

In addition, even if one or more of

our product candidates qualify as breakthrough therapies, the FDA may later decide that the products no longer meet the conditions for qualification and rescind the breakthrough designation.

In addition, even if one or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that the products no longer meet the conditions for qualification and rescind the breakthrough designation.

If a product is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs for this condition, the product sponsor may apply for fast track designation.

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The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

Even though the FDA granted INT230-6 orphan drug designation in June 2022, and even if we are granted orphan drug designations in the United States for any of our product candidates, there can be no guarantee that we will maintain orphan status for these product candidates or receive approval for any product candidate with an orphan drug designation.

Subject to receiving approval from the FDA of an NDA or Biologics License Application, products granted orphan drug designation are provided with seven years of orphan marketing exclusivity in the United States, meaning the FDA generally will not approve applications for other product candidates for the same orphan indication that contain the same active ingredient.

We are not guaranteed to maintain or receive orphan designation for our current or future product candidates, and if our product candidates that were granted orphan designation were to lose their status as an orphan drug or the orphan marketing exclusivity provided to it in the United States, our business and results of operations could be materially adversely affected.

While orphan status for any of our products, if granted or maintained, would provide market exclusivity in the United States for the time periods specified above, we would not be able to exclude other companies from manufacturing and/or selling products using the same active ingredient for the same indication beyond the exclusivity period applicable to our product on the sole basis of orphan drug status.

In addition, orphan exclusivity does not block the approval of a different drug or biologic for the same rare disease or condition, nor does it block the approval of the same

drug or biologic for different conditions.

Even if we are the first to obtain approval of an orphan product candidate and are granted exclusivity in the United States, there are circumstances under which a later competitor product may be approved for the same indication during the period of marketing exclusivity, such as if the later product is shown to be clinically superior to our product or if we are not able to provide a sufficient quantity of the orphan drug.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

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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 initiation 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.

Initiation 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.

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We expect to control only certain aspects of our CROs’ activities.

Nevertheless, we will be responsible for ensuring that each

of our preclinical studies and clinical trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities.

Nevertheless, we will be responsible for ensuring that each of our preclinical studies and clinical trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities.

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.

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.

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For example, we may be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate.

In addition, if the FDA approves one or more of our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, and recordkeeping for such products will be subject to extensive and ongoing regulatory requirements.

In addition, if the FDA approves one or

more of our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, and recordkeeping for such products will be subject to extensive and ongoing regulatory requirements.

These requirements include submissions of safety and other post-marketing information and reports, registration, and continued compliance with the FDA’s cGMP regulations, GCP regulations for clinical trials (including post-marketing trials), and GLP regulations with respect to nonclinical studies.

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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 is critical to new product acceptance.

Therefore, coverage and adequate payment are 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.

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In addition, governments may impose price controls on any of our products that obtain marketing approval, which may adversely affect our future profitability.

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.

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”) 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, for a select number of single source Part D drugs without generic or biosimilar competition.

In accordance with the IRA, CMS has begun negotiating drug 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.

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Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.

Reference pricing used by various EU member states

and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices.

Reference pricing used by various EU member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices.

In some countries, we may be required to conduct additional clinical trials that compare the cost-effectiveness of our drug candidates to other available therapies in order to obtain reimbursement or pricing approval.

Publication of discounts by third-party payors or authorities may lead to further pressure on prices or reimbursement levels within the country of publication and other countries.

Publication of discounts by

third-party payors or authorities may lead to further pressure on prices or reimbursement levels within the country of publication and other countries.

If reimbursement of our products is unavailable or limited in scope or amount in a particular country, or if pricing is set at unsatisfactory levels, we may be unable to successfully commercialize and achieve or sustain profitability for sales of any of our drug candidates that are approved for marketing in that country and our business could be adversely affected.

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We purchase components for our product candidates from third parties, some of which may be sole-source suppliers.

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.

Currently each of the three ingredients and our product candidate are single sourced.

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We have only qualified Minakem as a supplier of our vinblastine sulfate for our product candidate.

It would take several months to quality new vendors for cisplatin and vinblastine sulfate.

It would take several months to qualify new vendors for cisplatin and vinblastine sulfate.

We rely and expect to continue to rely completely on third parties to manufacture key components of our preclinical, clinical trial and commercial product candidate supplies.

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If we are unable to obtain adequate supplies of components from our existing suppliers or need to switch to an alternate supplier and obtain FDA or other regulatory agency approval of that supplier, commercialization of our product candidates may be delayed.

future suppliers of each component do not comply with applicable regulations for the manufacturing and production of drugs, our business, financial condition, and results of operations may be materially harmed.

If we are unable to obtain sufficient compounds and labeling services on acceptable terms, or if we should encounter delays or difficulties in our relationships with our current and future suppliers or if our current and future suppliers of each component do not comply with applicable regulations for the manufacturing and production of drugs, our business, financial condition, and results of operations may be materially harmed.

If we cannot successfully purchase or produce the drugs used in the manufacture of our product candidates, our ability to develop and commercialize products using our technology would be impaired.

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Such laws include, among others:

he 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.

the 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.”

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We cannot eliminate the risk of contamination or injury from these materials, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products.

guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials.

Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials.

In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations.

Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent.

environmental laws and regulations are complex, change frequently and have tended to become more stringent.

We cannot predict the impact of such changes and cannot be certain of our future compliance.

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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.

Congress most recently reauthorized the user fee programs in September 2022 without any substantive policy changes, and the next reauthorization must occur by the end of September 2027.

Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.

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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 industry that could lead to additional federal and state legislative or regulatory proposals targeting such entities’ operations, pharmacy networks, or financial arrangements.

In mid-2022, the Federal Trade Commission also launched sweeping investigations into the practices of the PBM industry, and published interim reports with its findings in mid-2024 and Januray 2025, that also appear to be contributing to additional federal and state legislative and regulatory proposals, as well as enforcement action and private litigation, targeting PBM operations, pharmacy networks, and 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.

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We plan to participate in the Medicaid Drug Rebate Program (“MDRP”).

Under the MDRP, we will be required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having our drugs eligible for coverage under Medicaid and Medicare Part B.

Under the MDRP, we will be required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries

and paid for by a state Medicaid program as a condition of having our drugs eligible for coverage under Medicaid and Medicare Part B.

Those rebates will be based on pricing data that will be reported by us on a monthly and quarterly basis to CMS.

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Pursuant to the IRA, certain figures we report under the MDRP will also be used to compute rebates under Medicare Part D triggered by price increases that outpace inflation.

we fail to provide required information in a timely manner or are found to have knowingly submitted false information to CMS, we may be subject to civil monetary penalties and other sanctions, including termination from the MDRP.

If we fail to provide required information in a timely manner or are found to have knowingly submitted false information to CMS, we may be subject to civil monetary penalties and other sanctions, including termination from the MDRP.

Federal law requires that any company participating in the MDRP must also participate in the Public Health Service Act’s 340B drug pricing discount program (the “340B Program”).

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The calculations are complex and will often be subject to interpretation by us, governmental or regulatory agencies and the courts.

Once the pricing and rebate calculation and reporting requirements apply to us and our products, if approved, we may be liable for errors associated with our submission of pricing data.

Once the pricing and rebate calculation

and reporting requirements apply to us and our products, if approved, we may be liable for errors associated with our submission of pricing data.

If we are found to have knowingly submitted false pricing data to the Medicaid program or the FSS pricing program, or if we fail to submit pricing data on a timely basis, we may be subject to significant civil monetary penalties.

Such failure also could be grounds for CMS to terminate our National Drug Rebate Agreement, which is the agreement under which we would participate in the MDRP.

If CMS were to terminate any such rebate agreement we may have in the future, our products covered under such agreement may no longer be eligible for coverage under Medicaid or

Medicare Part B.

If CMS were to terminate any such rebate agreement we may have in the future, our products covered under such agreement may no longer be eligible for coverage under Medicaid or Medicare Part B.

There can be no assurance that any future submissions we may make under such programs will not be found to be incomplete or incorrect.

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Our success depends in part on our ability to obtain patents, maintain trade secret protection, operate without infringing on the proprietary rights of third parties, and commercialize our technology prior to the expiration of our patent protection.

We have three U.S.

patents and one pending U.S.

patent application.

We have 15 foreign patents, including one European patent, validated in 28 countries.

We have four U.S.

patents and 15 foreign patents, including one European patent validated in 27 countries.

We have registered trademarks and know-how.

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If some investors find our securities less attractive as a result, there may be a less active trading market for our securities, and the price of our securities may be more volatile and may decline.

Substantial influence will remain with our management and major stockholder, which could delay or prevent a change of control or cause us to take actions in conflict with the intent of our stockholders.

The existing holdings of our executive officers, directors, principal stockholders and their affiliates represent beneficial ownership, in the aggregate, of up to approximately 42.1% of our outstanding Common Stock.

Our President and CEO beneficially owns approximately 16.3% of our outstanding Common Stock.

These stockholders, if they act together, will be able to influence our management and affairs and the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially all of our assets.

These stockholders may have interests with respect to their Common Stock that are different from other investors.

The concentration of voting power among these stockholders may have an adverse effect on the price of our Common Stock.

The price of our Common Stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our Common Stock.

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• changes in general market and economic conditions.

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

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

Global, market and economic conditions may negatively impact our business, financial condition and share price.

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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 conflict involving Israel and Hamas 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.

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 ongoing conflicts in the Middle 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.

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Even if these interventions lower inflation, they may also reduce economic growth rates, create a recession, and have other similar effects.

Changes in U.S.

federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations.

For example, during the prior Trump administration, increased tariffs were implemented on goods imported into the United States.

On April 2, 2025, a universal 10% tariff on all United States imports was announced, with higher tariffs ranging from 11% to 50% on imports from 57 countries, effective August 7, 2025.

Tariff rates have since fluctuated as a result of bilateral negotiations and legal challenges, and product-specific tariffs have also been implemented.

On February 20, 2026, the U.S.

Supreme Court ruled against the Trump administration’s use of tariffs under the International Emergency Economic Powers Act (the “IEEPA”), and U.S.

Customs and Border Protection halted collections of IEEPA tariffs on February 24, 2026.

However, the decision creates uncertainty related to various aspects of the tariffs previously collected under the IEEPA, including whether, and if so, how, companies may be able to recover any portion of IEEPA tariffs previously paid.

Additionally, in response to the U.S.

Supreme Court ruling, the Trump administration imposed a new worldwide tariff effective for 150 days from February 24, 2026.

These ongoing measures have led to retaliatory tariffs from affected countries and have contributed to increased trade tensions and economic uncertainty.

Political tensions as a result of such trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets.

Any changes in political, trade, regulatory, and economic conditions, including U.S.

trade policies, could have a material adverse effect on our financial condition or results of operations.

debt ceiling and budget deficit concerns have increased the possibility of credit-rating downgrades and economic slowdowns, or a recession in the U.S.

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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 war between Israel and Hamas, 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.

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 ongoing conflicts in the 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.

Sales of our common stock under our at-the-market offering sales agreement may result in significant dilution to our existing stockholders.

We have entered into an at-the-market offering sales agreement with H.C.

Wainwright & Co., LLC pursuant to which we may offer and sell shares of our common stock from time to time through an “at-the-market” equity offering program.

Sales of shares under this program may be made at prevailing market prices or at negotiated prices and will be made in amounts and at times determined by us.

The issuance and sale of shares under the ATM program will result in dilution to our existing stockholders.

To the extent that we sell additional shares of our common stock under the sales agreement, the ownership interest of our existing stockholders will be diluted, and the per-share value of our common stock may decline.

The degree of dilution will depend on the number of shares sold, the sales price per share, and the net proceeds we receive.

Because shares may be sold at various times and prices, investors purchasing shares in the ATM offering may experience dilution, and existing stockholders may experience further dilution if and when additional shares are issued.

In addition, the actual number of shares that we may issue under the ATM program is uncertain and could be substantial, subject to the terms of the agreement and applicable regulatory limitations.

The sale of a substantial number of shares, or the perception that such sales may occur, could adversely affect the market price of our common stock.

Sales of a substantial number of shares of our Common Stock by our existing stockholders in the public market could cause our stock price to fall.

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If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our Common Stock in the public market, the trading price of our Common Stock could decline.

We may not satisfy the Nasdaq Capital Market’s requirements for continued listing of our common stock.

If we cannot satisfy these requirements, the Nasdaq Capital Market could delist our common stock.

Our common stock is listed on the Nasdaq Capital Market under the symbol “INTS.” To continue to be listed on the Nasdaq Capital Market, we are required to satisfy a number of conditions.

As previously disclosed, on May 19, 2025, we received notice from the staff of the Nasdaq Stock Market that we were not in compliance with the minimum stockholders’ equity requirement for continued listing as set forth in Nasdaq Listing Rule 5550(b)(1), and on June 6, 2025, we received a separate notice that we were not in compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2).

On August 8, 2025, we received a letter from Nasdaq stating that based on our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, the Staff had determined that we complied with the minimum stockholders’ equity requirement.

With respect to compliance with the $1.00 minimum bid price requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had a grace period of 180 calendar days, or until December 3, 2025, to regain compliance with Nasdaq Listing Rule 5550(a)(2).

On December 4, 2025, we received a second letter from Nasdaq stating that we were eligible for an additional 180 calendar days, or until June 1, 2026, to regain compliance with the minimum bid price requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A).

On March 5, 2026, Nasdaq confirmed that we had regained compliance with the minimum bid price requirement.

We cannot assure you that we will be able to satisfy the Nasdaq Capital Market listing requirements in the future.

Our failure to regain compliance with any Nasdaq Listing Rules could result in delisting.

If we are delisted from the Nasdaq Capital Market, trading in our shares of common stock may be conducted, if available, on the OTC Market or, if available, via another market.

In the event of such delisting, an investor would likely find it significantly more difficult to dispose of, or to obtain accurate quotations as to the value of the shares of our common stock, and our ability to raise future capital through the sale of the shares of our common stock or other securities convertible into or exercisable for our common stock could be severely limited.

This could have a long-term impact on our ability to raise future capital through the sale of our common stock.

Our management will have broad discretion in using the cash and cash equivalents and may not use these proceeds effectively, which could affect our results of operations and cause our stock price to decline.

We will have considerable discretion in the application of our cash and cash equivalents.

We intend to use our cash and cash equivalents to fund discovery and clinical development efforts as well as to further expand our manufacturing platform and capabilities, to grow our infrastructure to support our pipeline, and to fund new and ongoing research activities, working capital and other general corporate purposes, which may include funding for the hiring of additional personnel, capital expenditures and the costs of operating as a public company.

activities, working capital and other general corporate purposes, which may include funding for the hiring of additional personnel, capital expenditures and the costs of operating as a public company.

As a result, investors will be relying upon management’s judgment with only limited information about our specific intentions for the use of the balance of the net proceeds of our cash and cash equivalents.

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In addition, unless we consent in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause or causes of action arising under the Securities Act, including all causes of action asserted against any defendant to such complaint.

For the avoidance of doubt, this provision is intended to benefit and may be enforced by us, our officers and directors, the underwriters to any offering giving rise to such complaint, and any other professional entity whose profession gives authority to a statement made by that person or entity and who has prepared or certified any part of the documents underlying the offering.

gives authority to a statement made by that person or entity and who has prepared or certified any part of the documents underlying the offering.

However, these choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors