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Item 1A. Risk Factors

2026-03-04 compared with 2025-03-20 · 258 added, 249 removed, 817 unchanged (38% of the section changed)

Investment in our Common Stock involves a high degree of risk.

You should carefully consider the risks that are summarized below and discussed in greater detail in the following pages before making an investment decision.

If any of the following risks and uncertainties actually occur, our business, financial condition, and results of operations could be negatively impacted, and you could lose all or part of your investment.

Summary of Risk Factors

● Preclinical testing and clinical trials of our product candidates may not be successful.

If our NDA for the combination of avutometinib and defactinib is not approved by the FDA, we are unable to obtain marketing approval for or successfully commercialize avutometinib and defactinib, or any of our other product candidates, or if we experience significant delays in doing so, our business will be materially harmed.

● Even if avutometinib and defactinib, or any of our other product candidates, receives marketing approval, such product candidates may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

● The market opportunities for our product candidates, if approved, may be smaller than we estimate, and the FDA and other comparable foreign regulatory authorities may approve our product candidates for a more limited patient population than we anticipate.

● The approval of our product candidates as single agents or part of a combination therapy for the treatment of certain cancers may be more costly than our prior clinical trials, may take longer to achieve regulatory approval, may be associated with new, more severe or serious and unanticipated adverse events, and may have a smaller market opportunity.

● If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize such candidates, and our ability to generate revenue will be materially impaired.

● If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

● If serious adverse or unexpected side effects are identified during the development of our product candidates, we may need to abandon or limit our development of some of our product candidates.

● If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

● We have incurred significant losses since our inception.

We may incur losses for the foreseeable future and may never achieve or maintain profitability.

● We will need additional funding.

If we are unable to raise capital if needed, we would be forced to delay, reduce, or eliminate our product development programs or commercialization efforts, including for avutometinib and defactinib.

● Raising additional capital or entering into certain licensing arrangements may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.

● We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.

● We rely in part on third parties to conduct our clinical trials and preclinical testing, and if they do not properly and successfully perform their obligations to us, we may not be able to obtain regulatory approvals for and commercialize any of our other product candidates.

● We contract with third parties for the manufacture of our product candidates and for compound formulation research, and these third parties may not perform satisfactorily.

● If we are unable to obtain and maintain patent protection for our products, or if our licensors are unable to obtain and maintain patent protection for the products that we license from them, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and

commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected.

● We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.

● Issued patents covering our products could be found invalid or unenforceable if challenged in court or the U.S.

Patent and Trademark Office (“USPTO”)

● We depend on Secura for the achievement and payment of the contingent consideration under the asset purchase agreement between us and Secura pursuant to which we sold the COPIKTRA assets to Secura.

If Secura is unsuccessful in developing and commercializing COPIKTRA, we may not receive such payments or otherwise capitalize on the market potential of COPIKTRA.

● We depend on GenFleet to fully perform under the GenFleet Agreement inclusive of our supply agreement with GenFleet

Careful consideration should be given to the following material risk factors, in addition to the other information set forth in this Annual Report on Form 10-K and in other documents that we file with the U.S.

Securities and Exchange Commission (“SEC”) in evaluating us and our business.

Investing in our common stock involves a high degree of risk.

If any of the following risks and uncertainties actually occurs, our business, prospects, financial condition and results of operations could be materially and adversely affected.

The risks described below are not intended to be exhaustive and are not the only risks we face.

New risk factors can emerge from time to time, and it is not possible to predict the impact that any factor or combination of factors may have on our business, prospects, financial condition and results of operations.

Risks Related to the Development of Our Product Candidates and Commercialization of our Product Candidates

Ø We are highly dependent on the commercial success of AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules;

defactinib tablets) in the U.S for the foreseeable future.

In May 2025, we received accelerated approval for AVMAPKI FAKZYNJA CO-PACK in the U.S.

for treatment of adults with KRAS-mutated, recurrent LGSOC who have received prior systemic therapy.

The commercial success of AVMAPKI FAKZYNJA CO-PACK depends on a number of factors, including:

● the effectiveness of AVMAPKI FAKZYNJA CO-PACK as a treatment for adult patients with KRAS-mutated, recurrent LGSOC who have received prior systemic therapy;

● the size of the treatable patient population;

● the effectiveness of our sales and marketing efforts;

● the coverage and reimbursement levels set by governmental authorities, private health insurers, and other third-party payors;

● the adoption of AVMAPKI FAKZYNJA CO-PACK by physicians, which depends on whether physicians view it as a safe and effective treatment for adults with KRAS-mutated, recurrent LGSOC who have received prior systemic therapy;

● the occurrence of any side effects, adverse reactions, misuse or any unfavorable publicity in these or other areas associated with avutometinib and defactinib;

● the development and commercialization of products or therapies that compete with AVMAPKI FAKZYNJA CO-PACK.

Ø Preclinical testing and clinical trials of our product candidates may not be successful.

We have invested a significant portion of our efforts and financial resources in the research and development of our product candidates, including avutometinib and defactinib, for which the FDA has accepted for review our NDA under the accelerated approval pathway for the treatment of adult patients with recurrent LGSOC, who received at least one prior systemic therapy and have a KRAS mutation.

If we are unable to expand the approved indication for the c ombination product, obtain marketing approval for or successfully commercialize any of our product candidates, or if we experience significant delays in doing so, our business will be materially harmed.

We have invested a significant portion of our efforts and financial resources in the research and development of our product candidates.

Our ability to generate product revenues will depend heavily on the successful commercialization and development of our product candidates.

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If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would materially harm our business.

Even if avutometinib and defactinib, or any of our other product candidates, receives marketing approval, such product candidates may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

If avutometinib and defactinib, or any of our other product candidates, receives marketing approval, such product candidates may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community.

If avutometinib and defactinib does not achieve an adequate level of acceptance, or if we are unable to increase market acceptance of avutometinib and defactinib as compared to existing or competitive products, we may not generate significant product revenues and we may not become profitable.

The degree of market acceptance of avutometinib and defactinib, or any of our other product candidates, if approved for commercial sale, will depend on a number of factors, including:

Ø Even though AVMAPKI FAKZYNJA CO-PACK has received accelerated approval in the U.S., and even if we receive marketing approval for an expanded indication for our combination product or any of our other product candidates receives marketing approval, such product candidates may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

Even though AVMAPKI FAKZYNJA CO-PACK has received accelerated approval in the U.S., and even if we receive marketing approval for an expanded indication for our combination product or any of our other product candidates receives marketing approval, our products and product candidates may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community.

If AVMAPKI FAKZYNJA CO-PACK does not achieve an adequate level of acceptance, or if we are unable to increase market acceptance of AVMAPKI FAKZYNJA CO-PACK as compared to existing or competitive products, we may not generate significant product revenues and we may not become profitable.

The degree of market acceptance of AVMAPKI FAKZYNJA CO-PACK, or any of our other product candidates, if approved for commercial sale, will depend on a number of factors, including:

● efficacy and potential advantages compared to alternative treatments;

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● have the product removed from the market after obtaining marketing approval.

The FDA and foreign regulatory authorities may determine that the results from our ongoing and future trials do not support regulatory approval and may require us to conduct an additional clinical trial or trials.

The FDA and foreign regulatory authorities may determine that the results from our ongoing and futunew drure trials do not support regulatory approval and may require us to conduct an additional clinical trial or trials.

If these agencies take such a position, the costs of development of our product candidates could increase materially and their potential market introduction could be delayed or abandoned.

The regulatory agencies could also require that we conduct additional clinical, nonclinical or manufacturing validation studies and submit that data before it will consider an NDA.

The regulatory agencies could also require that we conduct additional clinical, nonclinical or manufacturing validation studies and submit that data before it will consider a new drug application.

Our product development costs will also increase if we experience delays in clinical testing or marketing approvals.

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For example, these differences may include changes to inclusion and exclusion criteria, efficacy endpoints and statistical design.

Many companies in the pharmaceutical and biotechnology industries, including us, have suffered significant setbacks in late stage clinical trials after achieving positive results in an earlier stage of development.

If we fail to

produce positive results in our planned clinical trials of any of our product candidates, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, would be materially adversely affected.

Many companies in the biotechnology and pharmaceutical industries, including us, have suffered significant setbacks in late stage clinical trials after achieving positive results in an earlier stage of development.

If we fail to produce positive results in our planned clinical trials of any of our product candidates, the development timeline and regulatory approval and commercialization prospects for our product candidates, and, correspondingly, our business and financial prospects, would be materially adversely affected.

Ø Our approach to the treatment of cancer through cell death, inhibition of tumor growth, and disruption of the tumor microenvironment is relatively unproven, and we do not know whether we will be able to develop any products of significant commercial value.

We are developing product candidates to treat cancer by using targeted agents to cause cell death, inhibition of tumor growth, and disruption of the tumor microenvironment, and thereby thwart the growth and proliferation of cancer cells.

Research on the use of small molecules to cause cell death, inhibition of tumor growth, and disruption of the tumor microenvironment is an emerging field and, consequently, there is still uncertainty about whether defactinib and avutometinib are effective in improving outcomes for patients with cancer.

Research on the use of small molecules to cause cell death, inhibition of tumor growth, and disruption of the tumor microenvironment is an emerging field and, consequently, there is still uncertainty about whether defactinib, avutometinib and VS-7375 are effective in improving outcomes for patients with cancer.

Any products that we develop may not effectively cause cell death, inhibition of tumor growth, and disruption of the tumor microenvironment.

While we are currently conducting clinical trials for product candidates that we believe will cause cell death, inhibition of tumor growth, and disruption of the tumor microenvironment, we may not ultimately be successful in demonstrating their efficacy, alone or in combination with other treatments.

The market opportunities for our product candidates, if approved, may be smaller than we estimate, and the FDA and other comparable foreign regulatory authorities may approve our product candidates for a more limited patient population than we anticipate.

Ø The market opportunities for AVMAPKI FAKZYNJA CO-PACK and our other product candidates, if approved, may be smaller than we estimate, and the FDA and other comparable foreign regulatory authorities may approve our product candidates for a more limited patient population than we anticipate.

The potential market opportunity for our product candidates is difficult to estimate precisely.

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These estimates may be inaccurate or based on imprecise data.

If approved by the FDA, the market opportunity of our product candidates will depend on, among other things, acceptance by the medical community, patient access, drug pricing and reimbursement.

The market opportunity of AVMAPKI FAKZYNJA CO-PACK and our product candidates, if approved, will depend on, among other things, acceptance by the medical community, patient access, drug pricing and reimbursement.

The number of patients in the addressable market may turn out to be lower than we estimate, patients may not be otherwise amenable to treatment with our drugs, or new patients may become increasingly difficult to identify or gain access to, all of which may significantly harm our business, financial condition, results of operations, and prospects.

In addition, even if we obtain approval for any of our product candidates, such approvals may be for more limited patient populations than we had anticipated, the potential market for our product candidates will be smaller than our current estimates.

In addition, even if we obtain approval for any of our product candidates, such approvals may be for more limited patient populations than we had anticipated and the potential market for our product candidates will be smaller than our current estimates.

Obtaining approval for only a smaller patient population of our target indications for which we anticipate seeking approval would have a materially adverse effect on our ability to achieve commercialization and generate revenues.

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Additionally, the adverse side effects of our product candidates may be enhanced when combined with other products.

If such adverse side effects are experienced, we could be required to conduct additional pre-clinical and clinical studies, and if such adverse side effects are severe, we may not be able to continue the clinical trials of the combination therapy because the risks may outweigh the therapeutic benefit of the combination.

If such adverse side effects are experienced, we could be required to conduct additional preclinical and clinical studies, and if such adverse side effects are severe, we may not be able to continue the clinical trials of the combination therapy because the risks may outweigh the therapeutic benefit of the combination.

Ø We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do.

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We face competition with respect to our current product candidates and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which we are developing our product candidates, including Novartis AG, Pfizer, Genentech, Inc., AstraZeneca PLC, BMS, Amgen, Revolution Medicines, Inc., BeiGene Ltd., Quanta Therapeutics, Inc., Erasca, Inc., Roche Holding AG, Incyte Corporation and Eli Lilly and Company and others.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for which we are developing our product candidates, including Abbvie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb Company, Chugai, D3 Bio, Eli Lilly, Erasca, Genentech, GenFleet, Incyte Corporation, Jacobio, Jiangsu Hengrui Pharmaceuticals

Company Ltd, Novartis AG, Pfizer, Quanta Therapeutics, Ranok Therapeutics, Revolution Medicine, Tyligand Bioscience and others.

Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to our approach, and others are based on entirely different approaches.

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Many of our competitors have significantly greater financial resources and expertise than we do in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.

Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements

with large and established companies.

Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors.

Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

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In addition, to the extent that products or product candidates of our competitors demonstrate serious adverse side effects or are determined to be ineffective in clinical trials, the commercialization and the development of our product candidates could be negatively impacted.

If we fail to obtain regulatory approval in jurisdictions outside the United States, we will not be able to market our products in those jurisdictions.

We intend to seek regulatory approval for our product candidates in countries outside of the United States and expect that these countries will be important markets for our products, if approved.

Ø If we fail to obtain regulatory approval in jurisdictions outside the U.S., we will not be able to market our products in those jurisdictions.

We intend to seek regulatory approval for our product candidates in countries outside of the U.S.

and expect that these countries will be important markets for our products, if approved.

Marketing our products in these countries will require separate regulatory approvals in each market and compliance with numerous and varying regulatory requirements.

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Moreover, the time required to obtain approval may differ from that required to obtain FDA approval.

In addition, in many countries outside the United States, a drug must be approved for reimbursement before it can be approved for sale in that country.

In addition, in many countries outside the U.S., a drug must be approved for reimbursement before it can be approved for sale in that country.

Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA.

Failure to obtain regulatory approval in one country may have a negative effect on the regulatory approval process in others.

Further, we and our collaboration partners are currently conducting clinical trials, and may in the future conduct additional clinical trials, outside the United States, including the Phase 1/2 clinical trial evaluating VS-7375 by GenFleet in China.

Further, we and our collaboration partners are currently conducting clinical trials, and may in the future conduct additional clinical trials, outside the U.S., including the Phase 1/2 clinical trial evaluating VS-7375 by GenFleet in China.

Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of these data is subject to conditions imposed by the FDA.

For example, the FDA will generally not approve the application unless the data are applicable to the United States population and United States medical practice and the FDA is able to validate the data through an on-site inspection or other appropriate means.

The FDA or any comparable foreign regulatory authority may not accept data from trials conducted outside of the United States or the applicable jurisdiction, which may result in the need for additional trials that could be costly and time consuming and could result in the product candidate not receiving approval for commercialization in the applicable jurisdiction.

For example, the FDA will generally not approve the application unless the data are applicable to the U.S.

population and U.S.

medical practice and the FDA is able to validate the data through an on-site inspection or other appropriate means.

The FDA or any comparable foreign regulatory authority may not accept data from trials conducted outside of the U.S.

or the applicable jurisdiction, which may result in the need for additional trials that could be costly and time consuming and could result in the product candidate not receiving approval for commercialization in the applicable jurisdiction.

The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.

We may not obtain foreign regulatory approvals on a timely basis, if at all.

We may not obtain foreign regulatory approvals on a timely

basis, if at all.

We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any foreign market.

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Serious adverse events generally refer to adverse events, that result in death, are life threatening, require hospitalization or prolonging of hospitalization, or cause a significant and permanent disruption of normal life functions, congenital anomalies or birth defects, or require intervention to prevent such outcomes.

Avutometinib and defactinib are being administered and studied in our Phase 1, Phase 2, and Phase 3 clinical trials, and the development program continues to progress.

For both avutometinib and defactinib, the toxicities reported to date have been predictable and appear to be manageable.

Avutometinib and defactinib are being administered and studied in our Phase 1, Phase 2, and Phase 3 clinical trials, and VS-7375 is being administered and studied in our Phase 1 and Phase 2 clinical trials and the development program continues to progress.

For avutometinib, defactinib, and VS-7375 the toxicities reported to date have been predictable and appear to be manageable.

As a result of adverse events observed to date, or further safety or toxicity issues that we may experience in our clinical trials in the future, we may not receive approval to market any product candidates, which could prevent us from ever generating revenue from the sale of products or achieving profitability.

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Outside the United States, some countries require approval of the sale price of a drug before the product can be marketed.

In many such countries, the pricing review period begins after marketing or product licensing approval is granted.

In many such countries, the pricing review period begins after marketing or product licensing

approval is granted.

In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted.

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Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products.

Increasingly, third-party payors are requiring that drug companies provide them with discounts from list prices and are challenging the prices charged for medical products.

We cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement.

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We currently hold $10.0 million in product liability insurance coverage in the aggregate, with a per incident limit of $10.0 million, which may not be adequate to cover all liabilities that we may incur.

We may need to increase our insurance coverage as we commercialize any future product candidates or if we initiate additional clinical trials in the United States and around the world.

We have in the past and may in the future need to increase our insurance coverage as we commercialize future product candidates or if we initiate additional clinical trials in the United States and around the world.

Insurance coverage is increasingly expensive.

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● Shortages of personnel at clinical trial sites and delay in startup activities.

Clinics and hospitals in Europe and United States continue to cause delays in startup and on-going activities due to the ongoing staff shortages since the onset of the COVID-19 pandemic.

Clinics and hospitals in Europe and United States continue to cause delays in startup and on-going activities due to the ongoing shortages of both site coordinators and staff within the industry.

Frequent high turnover of existing site staff and slower contracting, budget negotiations, and operational bottlenecks contribute to the delays.

● Work-from-home limitations.

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The aforementioned clinical trial also found that COPIKTRA was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood.

In September 2022, the FDA’s ODAC voted eight to four against COPIKTRA’s use in patients with relapsed or refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma after at least two prior therapies citing an unfavorable risk/benefit profile.

In September 2022, the FDA’s ODAC voted eight to four against COPIKTRA’s use in patients with relapsed or refractory chronic lymphocytic

leukemia/ small lymphocytic lymphoma after at least two prior therapies citing an unfavorable risk/benefit profile.

The FDA drug safety communication warning, the FDA’s ODAC vote, future actions by the FDA, and any safety concerns associated with COPIKTRA, perceived or real, may materially and adversely affect Secura’s development and commercialization success of COPIKTRA and, consequently, our ability to receive future contingent consideration from our sale of our right, title, and interest in COPIKTRA to Secura.

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GenFleet is currently conducting a Phase 1/2 trial in China evaluating VS-7375 in patients with KRAS G12D-mutated advanced solid tumors.

In January 2025, we exercised early the GenFleet Option for the lead compound VS-7375 and expect to initiate a Phase 1/2a study in middle of 2025 in the United States.

Pursuant to the GenFleet Agreement, we are reliant on GenFleet to fulfil their responsibilities including ongoing discovery and lead optimization for the second and third programs and execution of the Phase 1 clinical trials for the second and third programs.

In January 2025, we exercised early the GenFleet Option for the lead compound VS-7375 and initiated a Phase 1/2a study in middle of 2025 in the U.S.

Pursuant to the GenFleet Agreement, we are reliant on GenFleet to fulfill their responsibilities including ongoing discovery and lead optimization for the second and third programs and execution of the Phase 1 clinical trials for the second and third programs.

Accordingly, our ability to realize the anticipated benefits and success of the GenFleet Agreement is dependent upon GenFleet fulfilling their obligations.

Furthermore, we have entered into a supply agreement with GenFleet pursuant to which we expect to obtain VS-7375 finished product from GenFleet for use in our planned clinical trial in the United States.

If GenFleet does not perform under the supply agreement, our ability to obtain VS-7375 and consequently our planned clinical trial in the United States investigating VS-7375 will be materially adversely impacted.

If GenFleet does not perform under the supply agreement, our ability to obtain VS-7375 and consequently our current and planned clinical trial in the United States investigating VS-7375 will be materially adversely impacted.

If GenFleet does not successfully carry out their responsibilities, the benefits of the GenFleet Agreement and our collaboration with GenFleet may not be realized.

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Since inception, we have incurred significant operating losses.

As of December 31, 2024, we had an accumulated deficit of $955.5 million.

To date, we have generated minimal product revenues and have financed our operations primarily through public and private offerings of our common stock, preferred stock, warrants and pre-funded warrants, offerings of convertible notes, sales of our common stock pursuant to our at-the-market equity offering programs, our Note Purchase Agreement (the “Note Purchase Agreement”) with RGCM SA LLC, as purchaser agent, Oberland Capital Management LLC (“Oberland”) and certain funds managed by Oberland, as purchasers, (together with the other purchasers party thereto referred to as the “Note Purchase Agreement Purchasers”) our former loan and security agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford”), our loan and security agreement, as amended, with Hercules Capital Inc.

(“Hercules”), upfront payments under our license and collaboration agreements with Yakult, CSPC, and Sanofi, and the upfront payment and milestone payments under the Secura APA.

As of December 31, 2025, we had an accumulated deficit of $1.165 billion To date, we have generated minimal product revenues and have financed our operations primarily through public and private offerings of our common stock, preferred stock, warrants and pre-funded warrants, offerings of convertible notes, sales of our common stock pursuant to our at-the-market equity offering programs, our Note Purchase Agreement (the “Note Purchase Agreement”) with RGCM SA LLC, as purchaser agent, Oberland Capital Management LLC (“Oberland”) and certain funds managed by Oberland, as purchasers, (together with the other purchasers party thereto referred to as the “Note Purchase Agreement Purchasers”), former loan agreements, upfront payments under our license and collaboration agreements with Yakult, Honsha Co., Ltd.

(“Yakult”), CSPC Pharmaceutical Group Limited (“CSPC”), and Sanofi, and the upfront payment and milestone payments under the Secura APA.

We have devoted substantially all of our efforts to research and development.

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We anticipate that our expenses will increase substantially if and as we:

● prepare for the anticipated commercialization of avutometinib and defactinib;

● continue our ongoing clinical trials with our product candidates, including with defactinib and avutometinib;

● continue commercialization activities of AVMAPKI FAKZYNJA CO-PACK

● continue our ongoing clinical trials with our product candidates, including with avutometinib and defactinib for wild type LGSOC, avutometinib and defactinib for other non-LGSOC cancers;

● initiate additional clinical trials for our product candidates;

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Ø We will need additional funding.

We expect our expenses to increase in connection with our ongoing activities, particularly in connection with our planned commercialization of avutometinib and defactinib and the continued clinical development of our product candidates.

We expect our cash, cash equivalents and investments at December 31, 2024 will not be sufficient to fund our current operating plan and capital expenditure requirements for the next 12 months from the issuance of these financial statements.

We expect our expenses to increase in connection with our ongoing activities, particularly in connection with our commercialization of AVMAPKI FAKZYNJA CO-PACK and the continued clinical development of our other product candidates.

We expect our cash and cash equivalents at December 31, 2025, combined with the proceeds from exercise of warrants in January 2026 along with revenue we expect to generate from sales of AVMAPKI FAKZYNJA, will be sufficient to fund our current operating plan and capital expenditure requirements for the next 12 months from the issuance of these financial statements.

We may need to obtain additional funding in connection with our continuing operations, including for our clinical development programs.

Our future capital requirements will depend on many factors, including:

● the costs and timing of activities in anticipation of potential commercialization for avutometinib and defactinib and product candidates for which we expect to receive marketing approval;

● the costs and timing of activities of commercialization for AVMAPKI FAKZYNJA CO-PACK and product candidates for which we expect to receive marketing approval;

● the scope, progress, and results of our ongoing and potential future clinical trials;

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● the costs, timing, and outcome of regulatory review of our product candidates (including our efforts to seek approval and fund the preparation and filing of regulatory submissions);

● revenue, if any, received from commercial sales of our product candidates, including avutometinib and defactinib, should any of our product candidates receive marketing approval;

● revenue received from commercial sales of AVMAPKI FAKZYNJA CO-PACK and our product candidates, should any of our product candidates also receive marketing approval;

● the costs of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights, and defending intellectual property related claims;

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Conducting clinical trials is a time consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval of any of our product candidates.

Although the FDA has accepted for review our NDA under the accelerated approval pathway for avutometinib in combination with defactinib for the treatment of adult patients with recurrent LGSOC who received at least one prior systemic therapy and have a KRAS mutation, the NDA may not be approved by the FDA and, even if approved, avutometinib and defactinib may not achieve commercial success.

We expect that our commercial revenues will be derived from sales of products.

Even if our product candidates gain approval, it may take several years to achieve a significant level of sales, and as a result we may need to continue to rely on additional financing to further our clinical development objectives.

Even though the FDA has approved AVMAPKI FAKZYNJA CO-PACK it may not achieve commercial success.

Our commercial revenues are derived from sales of products.

Accordingly, even though we received regulatory approval for AVMAPKI FAKZYNJA CO-PACK, it may take several years to achieve a significant level of sales, and as a result we may need to continue to rely on additional financing to further our clinical development objectives.

Adequate additional financing may not be available to us on acceptable terms, or at all.

We will require additional financing to execute our operating plan and continue to operate as a going concern.

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), we have the responsibility to evaluate whether conditions and/or events raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date the consolidated financial statements are issued.

The Company believes that it may have sufficient funds to meet its obligations within the next 12 months from the issuance of these financial statements.

However, this belief relies on the achievement of certain mitigation efforts.

The analysis under ASC 205-40, initially cannot take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued.

Accordingly, these uncertainties and risk factors meet the ASC 205-40 standard for raising substantial doubt about our ability to continue as a going concern within one year of the issuance date of our consolidated financial statements.

Lack of necessary funds may require us, among other things, to delay, scale back, or eliminate some or all of our planned clinical trials.

Because we continue to experience net operating losses (“NOL”), our ability to continue as a going concern is subject to our ability to obtain necessary capital from outside sources, including obtaining additional capital from the sale of our securities or assets, achieving milestones for additional drawdowns under our Loan Agreement or obtain loans from financial institutions, or entering into additional partnership arrangements.

There can be no assurances that we will be able to obtain such capital on

favorable terms or at all.

If we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate our research and development activities for our product candidates, or ultimately not be able to continue as a going concern.

Ø Unfavorable economic conditions could have a material adverse effect on our business, financial condition, results of operations, or cash flows.

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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, on March 4, 2025, the U.S.

imposed a 25% tariff on imports from Canada and Mexico that do not satisfy the U.S.-Mexico-Canada Agreement rules of origin with certain exemptions and a 20% additional tariff on imports from China.

For example, the current presidential administration has imposed or is considering imposing tariffs on a large number of countries, reciprocal tariffs with certain countries and particularized tariffs on certain types of foreign goods, including pharmaceutical products and components manufactured outside of the U.S.

Historically, tariffs have led to increased trade and political tensions.

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Tightening of the equity markets makes it more difficult to raise capital at a reasonable valuation or at all.

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.

Tariffs, economic sanctions, and other changes in U.S.

trade policy have in the past and could in the future negatively affect our business, financial condition, and results of operations.

In addition, the U.S.

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Sections 382 and 383 of the Internal Revenue Code (“IRC”) and similar provisions under state law limits the annual use of NOL carry-forwards and tax credit carryforwards, respectively, following an ownership change pursuant to section 382 of the IRC and similar state provisions.

In general, an ownership change occurs for purposes of Section 382 if there are certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%.

In general, an ownership change occurs for purposes of Section 382 if there are certain cumulative changes in the ownership interest of significant stockholders over a three year period in excess of-year period in excess of 50%.

During 2024, we believe we triggered ownership changes under Section 382 of the IRC and similar provisions under state law.

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Ø Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations.

On January 13, 2025 (the “Note Purchase Agreement Closing Date”), we entered into the Note Purchase Agreement pursuant to which we may sell to the Note Purchase Agreement Purchasers, and the Note Purchase Agreement Purchasers may buy from us notes (the “Notes”) in an aggregate principal amount not to exceed $150.0 million, consisting of the following:

● an initial sale of $75.0 million principal amount of Notes;

● at our option, a second sale (the “Second Sale”) of $25.0 million principal amount of Notes, at any time prior to December 31, 2025, upon the FDA approval sufficient for the promotion and sale of avutometinib and defactinib for the treatment of LGSOC and subject to certain other customary conditions precedent;

● at our option, a third sale (the “Third Sale”) of up to $50.0 million principal amount of Notes, at any time prior to December 31, 2026, provided that trailing six-month worldwide net sales of avutometinib and defactinib are at least $55.0 million and subject to certain other customary conditions precedent.

We completed an initial sale of $75.0 million principal amount of Notes on the Note Purchase Agreement Closing Date.

In addition, the we may issue and sell additional Notes with aggregate principal amount of up to $75.0 million as follows:

at our option, the a second purchase (the “Second Purchase”) of $25.0 million principal amount of Notes, at any time prior to December 31, 2025, upon the FDA’s approval sufficient for the promotion and sale of avutometinib and defactinib for the treatment of LGSOC and subject to certain other customary conditions precedent.

In March 2026, we amended the Note Purchase Agreement to extend the date by which we may draw down the Second Purchase from December 31, 2025 to June 30, 2026;

at our option, the, a third purchase of up to $50.0 million principal amount of Notes, at any time prior to December 31, 2026, provided that trailing six-month worldwide net sales of avutometinib and defactinib are at least $55.0 million and subject to certain other customary conditions precedent.

The outstanding principal amount of the Notes bear interest at a rate per annum equal to the sum of (i) the greater of the Term SOFR (as defined in the Note Purchase Agreement) and 4.29%, and (ii) 3.71%, subject to adjustment in certain circumstances set forth in the Note Purchase Agreement and an overall cap of 9.75%, payable quarterly in arrears until the seventh anniversary of the Note Purchase Agreement Closing Date or the date on which all amounts owing to the Note Purchase Agreement Purchasers under the Note Purchase Agreement have been paid in full (the “Note Purchase Agreement Maturity Date”).

For the first eight (8) quarters following the Note Purchase Agreement Closing Date, at our option, up to 50% of the interest due may be paid-in-kind and added to the then-outstanding principal balance of the Notes.

Through December 31, 2025, we have not elected to defer any interest through the paid-in-kind option.

Upon the occurrence and during the continuance of an Event of Default (as defined in the Note Purchase Agreement) under the Note Purchase Agreement, the then-applicable interest rate on all outstanding obligations may be increased by an additional 5.00%.

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“Included Products” is defined in the Note Purchase Agreement to include (a) avutometinib and defactinib, including any product that contains either one of the foregoing in combination with any other active ingredient(s), and (b) all other compounds, chemical entities or pharmaceutical products being designed, developed, licensed, manufactured or commercialized by us or our subsidiaries from time to time.

The Revenue Participation Percentage will increase pro rata immediately upon the occurrence of the Second Sale and the Third Sale, such that the Revenue Participation Percentage shall increase to a maximum of 2.00% in the event that $150.0 million in aggregate principal amount of Notes has been purchased pursuant to the Note Purchase Agreement following the Third Sale.

The Revenue Participation Percentage will increase pro rata immediately upon the occurrence of the Option Sale, such that the Revenue Participation Percentage shall increase to a maximum of 2.00% in the event that $150.0 million in aggregate principal amount of Notes has been purchased pursuant to the Note Purchase Agreement following the Option Sale.

The outstanding principal amount of the Notes, interest accrued thereon and any other amounts owing to the Note Purchase Agreement Purchasers under the Note Purchase Agreement will be due in two equal installments on (a) the sixth anniversary of the Note Purchase Agreement Closing Date, and (b) the Note Purchase Agreement Maturity Date.

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Our obligations under the Note Purchase Agreement are secured by a security interest on substantially all of our and our subsidiaries’ assets, including our intellectual property related to avutometinib and defactinib, and a negative pledge on intellectual property related to the Company’s collaboration and option agreement with GenFleet, subject to certain exceptions relating to our development of our intellectual property.

This indebtedness may create additional financing risk for us, particularly if our business or prevailing financial market conditions are not conducive to paying off or refinancing our outstanding debt obligations at

This indebtedness could also have other important negative consequences, including we will need to repay our indebtedness by making payments of interest and principal, which will reduce the amount of money available to finance our operations, our research and development efforts and other general corporate activities.

Further, our agreement to pay Oberland the Revenue Participation Percentage with respect to potential future sales of certain of our product candidates may limit future revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval, as well as our ability to generate revenues that are significant or large enough to achieve profitability.

In addition, we may be delayed in satisfying the criteria required under the Note Purchase Agreement to exercise the Second Sale and Third Sale, or may never satisfy such criteria, which may require us to find other sources of funding to finance our operations.

In addition, we may be delayed in satisfying the criteria required under the Note Purchase Agreement to exercise the Option Sale, or may never satisfy such criteria, which may require us to find other sources of funding to finance our operations.

To the extent additional debt is added to our current debt levels, the risks described above could increase.

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Failure to satisfy our current and future debt obligations under the Note Purchase Agreement or breaching any covenants under the Note Purchase Agreement, subject to specified cure periods with respect to certain breaches, could result in an event of default and, as a result, could accelerate all of the amounts due.

In the event of an acceleration of amounts due under the Note Purchase Agreement, we may not have enough available cash or be able to raise additional funds through equity or debt financings to repay such indebtedness at the time of such acceleration.

of an acceleration of amounts due under the Note Purchase Agreement, we may not have enough available cash or be able to raise additional funds through equity or debt financings to repay such indebtedness at the time of such acceleration.

In that case, we may be required to delay, limit, reduce or terminate our product candidate development or grant to others the rights to develop and market our product candidates that we would otherwise prefer to develop and market internally.

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For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial.

Moreover, the FDA and other regulatory agencies require us to comply with standards, commonly referred to as Good Clinical Practices (“GCP”) for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.

Moreover, the FDA and other regulatory agencies require us to comply with GCP for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected.

Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators, and trial sites.

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regulatory authorities may require us to obtain and submit additional preclinical, manufacturing, or clinical data before we may initiate our planned trials and/or may not accept such additional data as adequate to initiate our planned trials.

We contract with third parties for the manufacture of our product candidates and for compound formulation research, and these third parties may not perform satisfactorily.

Ø We contract with third parties for the manufacture of our products and product candidates and for compound formulation research, and these third parties may not perform satisfactorily.

We do not have any manufacturing facilities or personnel.

We currently obtain all of our supply of our product candidates for clinical development and commercial requirements from third-party manufacturers or third-party collaborators, and we expect to continue to rely on third parties for the manufacture of clinical and commercial quantities of our product candidates.

We currently obtain all of our AVMAPKI FAKZYNJA CO-PACK commercial supply and supply of our product candidates for clinical development and commercial requirements from third-party manufacturers or third-party collaborators, and we expect to continue to rely on third parties for the manufacture of clinical and commercial quantities of our product candidates.

In addition, we currently rely on third parties for the development of various formulations of our product candidates.

This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost or quality, which could delay, prevent, or impair our development or commercialization efforts.

We do not currently have arrangements in place for redundant supply or a second source throughout our supply chain.

We do not currently have arrangements in place for redundant supply for every commercial and clinical product candidate throughout our supply chain.

Even though we have supply agreements in place with our third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

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There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

Any interruption of the development or operation of the manufacturing facilities due to, among other reasons, events such as order delays for equipment or materials, equipment malfunction, quality control, and quality assurance issues, regulatory delays and possible negative effects of such delays on supply chains and expected timelines for product availability, production yield issues, shortages of qualified personnel, discontinuation of a facility or business, failure, or damage to a facility by natural disasters or public health crises, such as the COVID-19 pandemic, could result in the cancellation of shipments, loss of product in the manufacturing process, or a shortfall in available product candidates or materials.

effects of such delays on supply chains and expected timelines for product availability, production yield issues, shortages of qualified personnel, discontinuation of a facility or business, failure, or damage to a facility by natural disasters or public health crises, such as the COVID-19 pandemic, could result in the cancellation of shipments, loss of product in the manufacturing process, or a shortfall in available product candidates or materials.

If our current contract manufacturers cannot perform as agreed or these parties cease to provide quality manufacturing and related services to us, we may be required to replace that manufacturer.

If we are not able to engage appropriate replacements in a timely manner, our ability to manufacture our product candidates in sufficient quality and quantity required for planned pre-clinical testing, clinical trials and potential commercial use of our product candidates would be adversely affected.

If we are not able to engage appropriate replacements in a timely manner, our ability to manufacture our product candidates in sufficient quality and quantity required for planned preclinical testing, clinical trials and potential commercial use of our product candidates would be adversely affected.

Although we believe that there are several potential alternative manufacturers who could manufacture our product candidates, we may incur added costs and delays in identifying and qualifying any such replacement, as well as producing the drug product and obtaining regulatory approvals for the new manufacturer.

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Our drug development programs and the potential commercialization of our product candidates will require additional cash to fund expenses.

For some of our product candidates, we may decide to collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of those product candidates.

For some of our product candidates, we may decide to collaborate with biotechnology and pharmaceutical companies for the development and potential commercialization of those product candidates.

We face significant competition in seeking appropriate collaborators.

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We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all.

If we are unable to do so, we may have to curtail the development of certain product candidates, reduce or delay our development programs, delay potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

If we are unable to do so, we may have to curtail the development of certain product candidates, reduce or delay our

development programs, delay potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all.

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Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements.

For example, we have engaged in a strategic collaboration with IQVIA, pursuant to which we intend to leverage IQVIA’s expertise and resources for the commercialization and launch of the investigational combination of avutometinib plus defactinib for the treatment of recurrent KRAS mutant LGSOC.

Accordingly, we will depend on IQVIA and their performance under the strategic collaboration arrangements for the successful commercialization and launch of avutometinib and defactinib for the treatment of recurrent KRAS mutant LGSOC.

If IQVIA does not successfully carry out their responsibilities under the collaboration agreements or does not perform to the standard or level we anticipate, the benefits of the strategic collaboration with IQVIA may not be realized and our commercialization efforts will be harmed.

For example, we have engaged in a strategic collaboration with IQVIA, pursuant to which we are leveraging IQVIA’s expertise and resources for the commercialization of the AVMAPKI FAKZYNJA CO-PACK for the treatment of KRAS mutated recurrent LGSOC, particularly marketing and commercial analytics support for AVMAPKI FAKZYNJA CO-PACK.

Accordingly, we depend on IQVIA and their performance of these services under the strategic collaboration arrangements for the successful commercialization of AVMAPKI FAKZYNJA CO-PACK for the treatment of KRAS mutated recurrent LGSOC.

If IQVIA does not successfully carry out their responsibilities under the collaboration agreements or does not perform the specific services we have engaged them to perform to the standard or level we anticipate, the benefits of the strategic collaboration with IQVIA may not be realized and our commercialization efforts will be harmed.

Collaborations involving our product candidates are subject to numerous risks, which may include that:

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● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

collaborators could independently develop, or

develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

● agreements with collaborators may not provide exclusive rights to use their intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and product candidates in the future;

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Ø Our operations in foreign jurisdictions, and those of third parties for which we rely on, may be impacted by economic, political and social conditions in such jurisdictions.

Our business could be adversely affected by conditions the adverse geopolitical and macroeconomic developments, including the military conflict between Ukraine and Russia, the ongoing military conflict in the Middle East, and any related sanctions.

While we do not currently have clinical trials in Ukraine, Russia, or the Middle East, we have clinical trial sites in Europe.

foreign policy in Latin America, and any related sanctions.

While we do not currently have clinical trials in Ukraine, Russia, Latin America or the Middle East, we have clinical trial sites in Europe.

We also source clinical supply for our product candidates from third-party contract manufacturing organizations in Europe.

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or Chinese governments, political unrest or unstable economic conditions including sanctions on China or any of our China-based counterparties.

Furthermore, the conflicts between Ukraine and Russia, the ongoing military conflict in the Middle East, and the associated measures taken or that may be taken by the United States, North Atlantic Treaty Organization (“NATO”) and others create global security concerns, including the possibility of expanded regional or global conflict, and are likely to have short-term and likely longer-term negative impacts on regional and global economies, any or all of which could disrupt our supply chain, and adversely affect our ability to conduct ongoing and future clinical trials of our product candidates.

Furthermore, the conflicts between Ukraine and Russia, the ongoing military conflict in the Middle East, and the associated measures taken or that may be taken by the U.S., North Atlantic Treaty Organization (“NATO”) and others create global security concerns, including the possibility of expanded regional or global conflict, and are likely to have short-term and likely longer-term negative impacts on regional and global economies, any or all of which could disrupt our supply chain, and adversely affect our ability to conduct ongoing and future clinical trials of our product candidates.

Risks Related to Our Intellectual Property

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For example, under our license agreements with Pfizer and Chugai, we are required to use diligent or commercially reasonable efforts to develop and commercialize licensed products under the agreement and to satisfy other specified obligations.

licenses, which could materially adversely affect the value of the product candidate being developed under these license agreements.

If we fail to comply with our obligations under these licenses, our licensors may have the right to terminate these license agreements, in which event we might not be able to market any product that is covered by these agreements, or to convert the exclusive licenses to non-exclusive licenses, which could materially adversely affect the value of the product candidate being developed under these license agreements.

Termination of these license agreements or reduction or elimination of our licensed rights may result in our having to negotiate new or reinstated licenses with less favorable terms, which may not be possible.

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We have limited control over these activities or any other intellectual property that may be related to our in-licensed intellectual property.

For example, we cannot be certain that such activities by these licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights.

and other intellectual property rights.

We have limited control over the manner in which our licensors initiate an infringement proceeding against a third-party infringer of the intellectual property rights or defend certain of the intellectual property that is licensed to us.

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Ø If we are unable to obtain and maintain patent protection for our products, or if our licensors are unable to obtain and maintain patent protection for the products that we license from them, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be adversely affected.

Our success depends in large part on our and our licensors’ ability to obtain and maintain patent protection in the United States and other countries with respect to our products, their respective components, formulations, combination therapies, methods used to manufacture them and methods of treatment and development that are important to our business.

Our success depends in large part on our and our licensors’ ability to obtain and maintain patent protection in the U.S.

and other countries with respect to our products, their respective components, formulations, combination therapies, methods used to manufacture them and methods of treatment and development that are important to our business.

If we or our licensors do not adequately protect our or our licensors’ intellectual property rights, competitors may be able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability.

We and our licensors seek to protect our proprietary position by filing patent applications in the United States and abroad related to our products that are important to our business.

We and our licensors seek to protect our proprietary position by filing patent applications in the U.S.

and abroad related to our products that are important to our business.

We may in the future also license or purchase patent applications filed by others.

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In addition, to the extent that we license intellectual property, we cannot make assurances that those licenses will remain in force.

In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.

In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the U.S.

Furthermore, patents have a limited lifespan.

In the United States, the natural expiration of a patent is generally 20 years after it is filed (21 years if first filed as a provisional application).

In the U.S., the natural expiration of a patent is generally 20 years after it is filed (21 years if first filed as a provisional application).

Various extensions may be available;

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Our and our licensors’ pending and future patent applications may not result in patents being issued which protect our products or which effectively prevent others from commercializing competitive products.

Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the our ability to protect our inventions, maintain and enforce our intellectual property rights, or narrow the scope of our patent protection, or affect the value of our intellectual property.

The laws of foreign countries may not protect our rights to the same extent as the laws of the United States.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases, at all.

Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish our ability to protect our inventions, maintain and enforce our intellectual property rights, or narrow the scope of our patent protection, or affect the value of our intellectual property.

The laws of foreign countries may not protect our rights to the same extent as the laws of the U.S.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the U.S.

and other jurisdictions are typically not published until 18 months after filing, or in some cases, at all.

Therefore, we cannot be certain that we or our licensors were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions.

Assuming the other requirements for patentability are met, in the United States, for patents that have an effective filing date prior to March 15, 2013, the first to make the claimed invention is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent.

In March 2013, the United States transitioned to a first inventor to file system in which, assuming the other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent.

Assuming the other requirements for patentability are met, in the U.S., for patents that have an effective filing date prior to March 15, 2013, the first to make the claimed invention is entitled to the patent, while outside the U.S., the first to file a patent application is entitled to the patent.

In March 2013, the U.S.

transitioned to a first inventor to file system in which, assuming the other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent.

We may be subject to a third-party pre-issuance submission of prior art to the U.S.

Patent and Trademark Office, or become involved in opposition, derivation, reexamination, inter parties review or interference proceedings challenging our patent rights or the patent rights of others.

Patent and Trademark Office (“USPTO”), or become involved in opposition, derivation, reexamination, inter parties review or interference proceedings challenging our patent rights or the patent rights of others.

An adverse determination in any such submission, proceeding, or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.

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There also may be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim.

We may in the future, become subject to a third-party pre-issuance submission of prior art or opposition, derivation, revocation, re-

examination, post-grant and inter partes review, or interference proceeding and other similar proceedings challenging our patent rights or the patent rights of others in the USPTO or other foreign patent office.

We may in the future, become subject to a third-party pre-issuance submission of prior art or opposition, derivation, revocation, re-examination, post-grant and inter partes review, or interference proceeding and other similar proceedings challenging our patent rights or the patent rights of others in the USPTO or other foreign patent office.

Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated, or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical products, or limit the duration of the patent protection of our products.

In addition, given the amount of time required for the development, testing, and regulatory review of new products, patents protecting such products might expire before or shortly after such products are commercialized.

commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

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Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

We anticipate additional patent applications will be filed both in the United States and in other countries, as appropriate.

We anticipate additional patent applications will be filed both in the U.S.

and in other countries, as appropriate.

However, we cannot predict:

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● whether we will need to initiate or defend litigation or administrative proceedings which may be costly regardless of whether we win or lose.

Additionally, we cannot be certain that the claims in our pending patent applications covering our products and their methods of use will be considered patentable by the USPTO, or by patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid or patentable by courts in the United States or foreign countries.

that the claims in any of our issued patents will be considered valid or patentable by courts in the U.S.

or foreign countries.

Method of use patents protect the use of a product for the specified method.

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The licensing and acquisition of third-party intellectual property rights is a competitive area, and companies, which may be more established, or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our products.

More established companies may have a competitive advantage over us due to their

size, cash resources and greater clinical development and commercialization capabilities.

More established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts.

We also may be unable to license or acquire the relevant compound or product candidate on terms that would allow us to make an appropriate return on our investment.

Any product candidate that we acquire may require additional development efforts prior to commercial sale, including manufacturing, pre-clinical testing, extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities.

Any product candidate that we acquire may require additional development efforts prior to commercial sale, including manufacturing, preclinical testing, extensive clinical testing and approval by the FDA and applicable

foreign regulatory authorities.

All product candidates are prone to risks of failure typical of pharmaceutical product development.

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Ø Issued patents covering our products could be found invalid or unenforceable if challenged in court or the USPTO.

If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering our products, the defendant could counterclaim that the patent covering our products, as applicable, is

invalid and/or unenforceable.

In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are various grounds upon which a third party can assert invalidity or unenforceability of a patent.

Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.

In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are various grounds upon which a third party can assert invalidity or unenforceability of a patent.

Third parties may also raise similar claims before administrative bodies in the U.S.

or abroad, even outside the context of litigation.

Such mechanisms include re-examination, inter partes review, post grant review and equivalent proceedings in foreign jurisdictions (such as opposition proceedings).

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Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize or license our technology and products.

Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

Ø Changes to patent law in the U.S.

and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other drug and biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

Obtaining and enforcing patents in the drug and biopharmaceutical industry involves both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain.

In addition, the United States has passed wide-ranging patent reform legislation under the America Invents Act.

In addition, the U.S.

has passed wide-ranging patent reform legislation under the America Invents Act.

Moreover, recent U.S.

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Ø We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

We may not be able to pursue patent coverage of our products in certain countries outside of the United States.

Filing, prosecuting and defending patents on products in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States may be less extensive than those in the United States.

In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.

The breadth and strength of our patents issued in foreign jurisdictions or regions may not be the same as the corresponding patents issued in the United States.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.

Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to certain territories where we have patent protection, but enforcement is not as strong as that in the United States.

We may not be able to pursue patent coverage of our products in certain countries outside of the U.S.

Filing, prosecuting and defending patents on products in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S.

may be less extensive than those in the U.S.

In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the U.S.

The breadth and strength of our patents issued in foreign jurisdictions or regions may not be the same as the corresponding patents issued in the U.S.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S.

or other jurisdictions.

These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

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This difficulty with enforcing patents could make it difficult for us to stop the infringement of our patents or marketing of competing products otherwise generally in violation of our proprietary rights.

invalidated or interpreted narrowly, put our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, put our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Accordingly, our efforts to

enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Ø If we do not obtain patent term extension and data exclusivity for any of our current products, our business may be materially harmed.

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We have yet to conduct comprehensive freedom to operate searches to determine whether our use of certain of the patent rights owned by or licensed to us would infringe patents issued to third parties.

We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products, including interference proceedings before the U.S.

Patent and Trademark Office.

Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.

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A finding of infringement could prevent us from commercializing our products or force us to cease some of our business operations, which could materially harm our business.

Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

Claims that we have misappropriated confidential information or trade secrets of third parties could have a similar negative impact on our business.

If a third party alleges that we infringe its intellectual property rights, we may face a number of issues, including, but not limited to:

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Third parties may assert that we are employing their proprietary technology without authorization.

Patents issued in the United States by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof.

Patents issued in the U.S.

by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightened standard of proof.

There may be issued third-party patents of which we are currently unaware with claims to compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our products.

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Moreover, we may fail to identify relevant patents or incorrectly conclude that a patent is invalid, not enforceable, exhausted, or not infringed by our activities.

If any third-party patents, held now or obtained in the future by a third party, were found by a court of competent jurisdiction to cover the manufacturing process of our products, constructs or molecules used in or formed during the manufacturing process, or any final product or methods use of

the product, the holders of any such patents may be able to block our ability to commercialize the product unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable.

If any third-party patents, held now or obtained in the

future by a third party, were found by a court of competent jurisdiction to cover the manufacturing process of our products, constructs or molecules used in or formed during the manufacturing process, or any final product or methods use of the product, the holders of any such patents may be able to block our ability to commercialize the product unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable.

Similarly, if any third-party patent were held by a court of competent jurisdiction to cover any aspect of our formulations, any combination therapies or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the product unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable.

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Ø Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their

normal responsibilities.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.

In addition, there could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

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These lawsuits may consume our time and other resources even if we are successful.

In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets.

As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad.

In addition, some courts inside and outside the U.S.

are less willing or unwilling to protect trade secrets.

As a result, we may encounter significant problems in protecting and defending our intellectual property both in the U.S.

If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them from using that technology or information to compete with us.

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Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings.

If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected.

If we are unable to establish name

recognition based on our trademarks and trade names, we may not be able to compete effectively, and our business may be adversely affected.

Ø European patents and patent applications could be challenged in the recently created Unified Patent Court for the European Union.

Our owned or our licensors’ European patents and patent applications could be challenged in the recently created Unified Patent Court (“UPC”) for the European Union.

We may decide to opt out our European patents and

patent applications from the UPC.

We may decide to opt out our European patents and patent applications from the UPC.

However, if certain formalities and requirements are not met, our European patents and patent applications could be challenged for non-compliance and brought under the jurisdiction of the UPC.

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Ø If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize such candidates, and our ability to generate revenue will be materially impaired.

O btaining approval of an NDA can be a lengthy, expensive, and uncertain process, and the FDA has substantial discretion in the review and approval process and may decide that our data is insufficient for approval and require additional preclinical, clinical, or other studies.

While we have engaged in discussions with the FDA with respect to the scope and nature of our NDA submission for avutometinib in combination with defactinib , the FDA may, for example, require additional data under the RAMP 301 study before approving the NDA for the scope we request, or at all.

There can be no assurance regarding the timing and outcome of the FDA review and approval of our NDA submission.

The activities associated with a product candidate’s development and commercialization, including its design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, and distribution are subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries.

Obtaining approval of an NDA can be a lengthy, expensive, and uncertain process, and the FDA has substantial discretion in the review and approval process and may decide that our data is insufficient for approval and require additional preclinical, clinical, or other studies.

There can be no assurance regarding the timing and outcome of the FDA review and approval of an NDA submission.

and by comparable authorities in other countries.

Failure to obtain marketing approval for product candidates will prevent us from commercializing such product candidates.

We have not received approval to market any of our current product candidates from regulatory authorities in any jurisdiction in the United States.

We have not received approval to market any of our current product candidates from regulatory authorities in any jurisdiction in the U.S.

We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and have relied on and expect to rely on third-party contract research organizations to assist us in this process.

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A product candidate may not be effective, may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

The process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the product candidates involved.

The process of obtaining marketing approvals, both in the U.S.

and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty of the product candidates involved.

Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application.

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Ø We have received orphan drug designation for certain of our product candidates, but there can be no assurance that we will be able to prevent third parties from developing and commercializing products that are competitive to these product candidates.

In March 2024, the FDA granted orphan drug designation to avutometinib, alone or in combination with defactinib for the treatment of patients with recurrent LGSOC.

In March 2024, the FDA granted orphan drug designation to avutometinib in combination with defactinib for the treatment of patients with recurrent LGSOC.

In July 2024, the FDA granted orphan drug designation to avutometinib in combination with defactinib for the treatment of pancreatic cancer.

Defactinib has received orphan drug designation in the United States, the European Union, and Australia for the treatment of patients with ovarian cancer.

Orphan drug exclusivity grants seven years of marketing exclusivity under the FDCA, up to ten years of marketing exclusivity in Europe, and five years of marketing exclusivity in Australia.

Defactinib has received orphan drug designation in the U.S., the European Union, and Australia for the treatment of patients with ovarian cancer.

Orphan drug exclusivity grants seven years of marketing exclusivity under the FDCA, up to ten years of marketing exclusivity in the European Union, and five years of marketing exclusivity in Australia.

Other companies have received orphan drug designations for compounds other than defactinib for the same indications for which we may have received orphan drug designation in corresponding territories.

While orphan drug exclusivity for defactinib provides market exclusivity against the same active ingredient for the same indication, we would not be able to exclude other companies from manufacturing and/or selling drugs using the same active ingredient for the same indication beyond that timeframe on the basis of orphan drug exclusivity.

Furthermore, the marketing exclusivity in Europe can be reduced from ten years to six years if the orphan designation criteria are no longer met or if the drug is sufficiently profitable so that market exclusivity is no longer justified.

Furthermore, the marketing exclusivity in the European Union can be reduced from ten years to six years if the orphan designation criteria are no longer met or if the drug is sufficiently profitable so that market exclusivity is no longer justified.

Even if we are the first to obtain marketing authorization for an orphan drug indication, there are circumstances under which the FDA may approve a competing product for the same indication during the seven-year period of marketing exclusivity, such as if the later product is the same compound as our product but is shown to be clinically superior to our product, or if the later product is a different drug than our product candidate.

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Court of Appeals for the Eleventh Circuit in Catalyst Pharmaceuticals, Inc.

Becerra regarding interpretation of the Orphan Drug Act’s exclusivity provisions as applied to drugs and biologics approved for orphan indications narrower than the product’s orphan designation has the potential to significantly broaden the scope of orphan exclusivity for such products.

Becerra (“ Catalyst ”) regarding interpretation of the Orphan Drug Act’s exclusivity provisions as applied to drugs and biologics approved for orphan indications narrower than the product’s orphan designation has the potential to significantly broaden the scope of orphan exclusivity for such products.

FDA announced on January 24, 2023, that despite the Catalyst decision, it will continue to apply its longstanding regulations, which tie the scope of orphan exclusivity to the uses or indications for which the drug is approved, rather than to the designation.

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Ø We have sought and obtained fast track designation from the FDA for one of our product candidates, and may seek such fast track designation for one more additional product candidates, but we might not receive such additional designation, and such designation may not actually lead to a faster development or regulatory review or approval process nor does it ensure that we will receive marketing approval.

Any sponsor may seek fast track designation for a drug if it is intended for the treatment of a serious condition and nonclinical or clinical data demonstrate the potential to address unmet medical need for this condition, a drug sponsor may apply for FDA fast track designation.

In January 2024, the FDA granted fast track designation for combination of avutometinib and LUMAKRAS for the treatment of patients with KRAS G12C-mutant metastatic NSCLC who have received at least one prior systematic therapy and have not been previously treated with a KRAS G12C inhibitor.

In April 2024, the FDA granted fast track designation for avutometinib, in combination with defactinib plus LUMAKRAS, for the treatment of patients with KRAS G12C-mutated metastatic NSCLC who received at least one prior systematic therapy.

Additionally, in July 2025, the FDA granted fast track designation to VS-7375, for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy.

We may also seek fast track designation for additional product candidates, which we may not receive from the FDA.

However, fast track designation does not ensure that we will receive marketing approval or that approval will be granted within any particular timeframe.

We may not experience a faster development or regulatory review or approval process with fast track designation compared to conventional FDA procedures.

We may not experience a faster development or regulatory review or approval process with fast

track designation compared to conventional FDA procedures.

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

Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures.

We have completed an NDA submission under the FDA’s accelerated approval pathway for one of our product candidates, and we may seek accelerated approval for one more additional product candidates.

Ø We have obtained approval in the U.S.

for the combination of avutometinib and defactinib under the FDA’s accelerated approval pathway, and we may seek accelerated approval for one more additional product candidates.

The FDA has substantial discretion regarding approvals under the accelerated approval pathway, and we may not be able to obtain accelerated approval for any of our product candidates.

The FDA has accepted for review our NDA under the accelerated approval pathway for avutometinib in combination with defactinib for the treatment of adult patients with recurrent LGSOC, who received at least one prior systemic therapy, and have a KRAS mutation.

In May 2025, the FDA approved our NDA under the accelerated approval pathway for avutometinib in combination with defactinib for the treatment of adult patients with recurrent LGSOC, who received at least one prior systemic therapy, and have a KRAS mutation.

We may explore regulatory strategies for our other product candidates that involve use of the FDA’s accelerated approval pathway.

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As a condition of approval, the FDA requires that a sponsor of a drug receiving accelerated approval perform a post-marketing confirmatory clinical trial or trials.

FDA has broad discretion with regard to approval under the accelerated approval program, and FDA’s interpretation of the criteria for accelerated approval, such as what it considers to be available therapies, is subject to change.

The FDA has broad discretion with regard to approval under the accelerated approval program, and the FDA’s interpretation of the criteria for accelerated approval, such as what it considers to be available therapies, is subject to change.

No assurance can be given that other therapeutics will not receive full approval prior to our potential receipt of accelerated approval.

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Even if we receive approval for any of our product candidates through the accelerated approval program, we will be subject to rigorous post-marketing requirements, including the completion of one or more post-market confirmatory studies, to verify the clinical benefit of our product candidate, and submission to the FDA of all promotional materials prior to their dissemination.

The FDA could seek to withdraw the approval, if received, for multiple reasons, including if we fail to conduct any required post-market confirmatory trial with due diligence, our post-market confirmatory trial does not confirm the predicted clinical benefit, other evidence shows that our product candidate is not safe or effective under the conditions for use, or we disseminate promotional materials that are found by FDA to be false or misleading.

Any delay in obtaining, or inability to obtain, approval through the accelerated approval pathway, or any issues in maintaining any such approvals that we receive, would delay or prevent commercialization of our product candidates, and would materially adversely affect our business, financial condition, results of operations, and cash flows.

Any product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

Any product candidate for which we obtain marketing approval, along with the manufacturing processes, post approval clinical data, labeling, advertising, and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities.

Ø Although we have received accelerated approval for the combination of AVMAPKI FAKZYNJA CO-PACK, it or any product candidate for which we obtain marketing approval are subject to ongoing regulatory obligations and could be subject to restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

AVMAPKI FAKZYNJA CO-PACK and any other product candidate for which we obtain marketing approval, along with the manufacturing processes, post approval clinical data, labeling, advertising, and promotional activities for such product, is subject to continual requirements of and review by the FDA and other regulatory authorities.

These requirements include submissions of safety and other post marketing information and reports, registration and listing requirements, cGMP requirements relating to quality control, quality assurance, and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping.

Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post marketing testing and surveillance to monitor the safety or efficacy of the product, including the imposition of a REMS.

The FDA closely regulates the post approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling.

The FDA imposes stringent restrictions on manufacturers’ communications regarding off label use, and if we do not market our products for their approved indications, we may be subject to enforcement action for off label marketing.

Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of

approval or contain requirements for costly post marketing testing and surveillance to monitor the safety or efficacy of the product, including the imposition of a REMS.

The development of our marketing and sales capabilities will require significant financial and management resources.

Our sales and marketing efforts may not be successful or may be limited by future government policies or initiatives.

For example, the FDA stated in September 2025 that it intends to more aggressively enforce requirements related to direct-to-consumer drug advertising and sent a significant number of warning or untitled letters to pharmaceutical companies alleging deceptive prescription drug advertising, which represents a dramatic increase in FDA actions compared to prior years.

The current administration’s focus on pharmaceutical advertising heightens the risk that we may, in the future, receive a warning or enforcement action related to our advertising and marketing practices, which could adversely affect our business.

In addition, later discovery of previously unknown problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

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If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may fail to obtain any marketing approvals, lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

Our business operations, including our relationships with healthcare providers, third-party payors, and patients, are or will be subject to a broad range of healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings if our activities are challenged as non-compliant.

Ø Our business operations, including our relationships with healthcare providers, third-party payors, and patients, are subject to a broad range of healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings if our activities are challenged as non-compliant.

Pharmaceutical manufacturers and their products are subject to extensive federal and state regulation, including laws intended to prevent fraud and abuse in the healthcare industry.

These laws may constrain the business or financial arrangements and relationships through which we conduct business, including how we conduct research regarding, market, sell, and distribute our products.

In the United States, these laws include, but are not limited to the following, some of which are likely to apply only if or when we obtain marketing approval for a product candidate:

In the U.S., these laws include, but are not limited to the following, some of which are likely to apply only if or when we obtain marketing approval for a product candidate:

● the federal healthcare anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid.

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● the federal anti-kickback prohibition known as Eliminating Kickbacks in Recovery Act, or EKRA, which prohibits certain payments related to referrals of patients to certain providers (recovery homes, clinical treatment facilities, and laboratories) and applies to services reimbursed by private health plans as well as government health care programs;

● the FDCA, which, among other things, strictly regulates drug product and medical device marketing, prohibits manufacturers from marketing such products for off-label use and regulates the distribution of samples;

● the FDCA, which, among other things, strictly regulates drug product marketing, prohibits manufacturers from marketing such products for off-label use and regulates the distribution of samples;

● federal laws that require pharmaceutical manufacturers to calculate, report and certify certain complex product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under governmental healthcare programs, which data may be used in the calculation of reimbursement and/or discounts on approved products;

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For example, the General Data Protection Regulation (“GDPR”), impose obligations with respect to operations in the European Economic Area (“EEA”), and increasing the scrutiny applied to transfers of personal data from the EEA (including health data from our clinical sites in the EEA) to countries that are considered by the European Commission to lack an adequate level of data protection, such as the United States.

The compliance obligations imposed by the GDPR have required us to revise our operations and increased our cost of doing business.

The compliance obligations imposed by the GDPR

have required us to revise our operations and increased our cost of doing business.

In addition, the GDPR provides for substantial fines for breaches of data protection requirements, and it confers a private right of action on data subjects for breaches of data protection requirements.

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states have adopted comprehensive data privacy laws that may increase the costs of compliance, inhibit the sharing of personal data across national boundaries, and impact operations.

The number and complexity of both federal and state laws continues to increase;

The number and complexity of both federal and state laws continue to increase;

the laws contain ambiguous requirements or require administrative guidance for implementation;

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and additional governmental resources are being used to enforce these laws and to prosecute companies and individuals who are believed to be violating them.

Efforts to ensure that our business

arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations involves substantial costs.

Governmental authorities may potentially conclude that our business practices, including arrangements we may have with physicians and other healthcare providers, or patient assistance programs, may not comply with applicable laws.

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If any of the physicians or other providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil, or administrative sanctions, including exclusions from government funded healthcare programs.

Further, we are exposed to the risk that our employees, independent contractors, principal investigators, CROs, consultants and vendors may engage in fraud or other misconduct, including actions resulting non-compliance with regulatory standards and requirements such as those described above.

Further, we are exposed to the risk that our employees, independent contractors, principal investigators, CROs, consultants and vendors may engage in fraud or other misconduct, including actions resulting in non-compliance with legal requirements such as those described above and, if so, we could incur liability for their actions.

It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws, standards, or regulations.

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Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

The FDA and other comparable regulatory authorities could require clearance or approval of an in vitro diagnostic or companion diagnostic device as a condition of approval for any product candidates that require or would commercially benefit from such tests, including the combination of avutometinib and defactinib.

Ø The FDA and other comparable regulatory authorities could require clearance or approval of an in vitro diagnostic or companion diagnostic device as a condition of approval for any product candidates that require or would commercially benefit from such tests.

If we are unable to successfully validate, develop and obtain regulatory approval for companion diagnostic tests for our product candidates that require or would commercially benefit from such tests, or experience significant delays in doing so, we may not realize the full commercial potential of these product candidates, and our drug development strategy and operational results may be harmed.

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The development programs for some of our product candidates contemplate working with developers or obtaining access to marketed companion diagnostic tests, which are assays or tests to identify an appropriate patient population.

For example, in connection with our NDA for the treatment of adult patients with recurrent LGSOC, who received at least one prior systemic therapy and have a KRAS mutation, we may be required to obtain FDA approval or clearance of a companion diagnostic.

If safe and effective use of any of our product candidates we may develop depends on a companion diagnostic, we may not receive marketing approval, or marketing approval may be delayed, if we are unable to or are delayed in developing, identifying, or obtaining regulatory approval or clearance for the companion diagnostic product for use with our product candidate.

For example, in connection with our NDA for the treatment of adult patients with recurrent LGSOC, who received at least one prior systemic therapy and have a KRAS mutation, we must satisfy a post-marketing commitment to conduct analytical and clinical validation to support development of a diagnostic device that is essential to the safe and effective use of the combination of avutometinib and defactinib in KRAS-mutated, recurrent low grade serous ovarian cancer.

delayed in developing, identifying, or obtaining regulatory approval or clearance for the companion diagnostic product for use with our product candidate.

In addition, the process of obtaining or creating such companion diagnostics is time consuming and costly and we, and/or future collaborators, may encounter difficulties in developing and obtaining regulatory clearance or approval for the companion diagnostics.

Ø Current and future health care reforms may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.

In the United States and some foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, prevent or delay marketing approval of our product candidates, restrict or regulate post approval activities, and affect our ability to profitably sell any of our product candidates for which we obtain marketing approval.

and some foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, prevent or delay marketing approval of our product candidates, restrict or regulate post approval activities, and affect our ability to profitably sell any of our product candidates for which we obtain marketing approval.

healthcare industry generally and U.S.

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government and individual states have been aggressively pursuing healthcare reform.

For example, the ACA, enacted in March 2010, was intended to broaden access to health insurance through a Medicaid expansion and the implementation of the individual mandate for health insurance coverage, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry, and impose additional health policy reforms.

For example, the ACA, enacted in 2010, was intended to broaden access to health insurance through a Medicaid expansion and the implementation of the individual mandate for health insurance coverage, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry, and impose additional health policy reforms.

The law, for example, increased drug rebates under state Medicaid programs for brand name prescription drugs and extended those rebates to Medicaid managed care and assessed a fee on manufacturers and importers of brand name prescription drugs reimbursed under certain government programs, including Medicare and Medicaid.

Beyond the ACA, there are ongoing and widespread health care reform efforts, a number of which have focused on regulation of prices or payment for drug products.

Beyond the ACA, there are ongoing and widespread healthcare reform efforts, a number of which have focused on regulation of prices or payment for drug products.

Drug pricing and payment reform has been an ongoing focus.

For example, federal legislation eliminated a statutory cap on Medicaid drug rebate program rebates effective January 1, 2024.

As another example, the Inflation Reduction Act (“IRA”) of 2022 includes a number of changes intended to address rising prescription drug prices in Medicare Parts B and D, with varying implementation dates.

These changes include caps on Medicare Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer discount drug program (replacing the ACA Medicare Part D coverage gap discount program) and a drug price negotiation program for certain high spend Medicare Part B and D drugs.

The IRA is anticipated to have a significant impact on the pharmaceutical industry.

Subsequent to the enactment of the IRA, in 2024, the Biden Administration announced its commitment to expanding certain IRA reforms.

There have been significant and wide-ranging reforms to federal policy and the federal government under the new Trump Administration.

The focus on drug pricing and payment reform is likely to continue under the new Trump Administration.

Other potential healthcare reform efforts under the Trump Administration could affect access to healthcare coverage or the funding of health care benefits.

There is significant uncertainty regarding the nature or impact of any such reform implemented by the Trump Administration through executive action or by Congress.

Healthcare reform efforts have been and may continue to be subject to scrutiny and legal challenge.

For example, with respect to the ACA, tax reform legislation was enacted that eliminated the tax penalty established for individuals who do not maintain mandated health insurance coverage beginning in 2019 and, in 2021, the U.S.

Supreme Court dismissed the latest judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

As another example, revisions to regulations under the federal anti-kickback statute would remove protection for traditional Medicare Part D discounts offered by pharmaceutical manufacturers to pharmacy benefit managers and health plans.

Pursuant to court order, the removal was delayed and recent legislation imposed a moratorium on implementation of the rule until January 1 2032.

As a further example, the IRA drug price negotiation program has been challenged in litigation filed by various pharmaceutical manufacturers and industry groups.

Recently, there has been considerable public and government scrutiny of pharmaceutical pricing and proposals to address the perceived high cost of pharmaceuticals.

There have also been efforts at the federal level to implement measures to regulate drug pricing or payment for pharmaceutical products, including legislation on drug importation.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price constraints, restrictions on copayment assistance by pharmaceutical manufacturers, marketing cost disclosure and transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.

We expect continued scrutiny on drug pricing and government price reporting from Congress, agencies, and other bodies.

In addition, other broader legislative changes have been adopted that could have an adverse effect upon, and could prevent, our products’ commercial success.

For example, the Budget Control Act of 2011, as amended, resulted in the imposition of reductions in Medicare (but not Medicaid) payments to providers in 2013 and remains in effect through 2032 unless additional Congressional action is taken.

For example, the Inflation Reduction Act (“IRA”) of 2022 includes several changes intended to address rising prescription drug prices in Medicare Parts B and D, with varying implementation dates.

These changes include caps on Medicare Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer discount drug program (replacing the prior Medicare Part D coverage gap discount program) and a drug price negotiation program for certain high spend Medicare Part B and D drugs (with the first set of negotiated Medicare maximum fair prices going into effect in 2026).

The IRA has had a significant impact on the pharmaceutical industry and that impact is anticipated to continue.

Beyond the IRA, changes to Medicaid effective in 2024 eliminated the Medicaid rebate cap and changes to certain Medicare price reporting requirements for drugs beginning in 2026 will likely increase the administrative and compliance burden for manufacturers.

In addition, recent legislation expanded the orphan drug exclusion in the IRA Medicare drug price negotiation program.

Under the current presidential administration there has been significant reform activity focused on drug pricing and reimbursement.

For example, President Trump issued an Executive Order in April 2025 with multiple directives aimed at lowering drug prices, including refining the Medicare drug price negotiation program established by the IRA, accelerating competition for high-cost prescription drugs by accelerating approval of generics and biosimilars and facilitating the process for re-classifying prescription drugs as over-the-counter drugs, and increasing drug importation.

In May 2025, President Trump issued another Executive Order that directed government agencies and officials to identify most-favored nation pricing targets for prescription drugs (and looked to pharmaceutical manufacturers to make significant progress towards delivering target prices to patients), prevent foreign countries from disproportionately shifting the cost of global pharmaceutical research and development to the U.S., and facilitate direct-to-consumer purchasing programs for pharmaceutical manufacturers to sell their products to patients at the most-favored-nation price.

In the wake of the Executive Orders and related executive initiatives, a number of pharmaceutical manufacturers have announced direct-to-consumer offerings with discounted prices and/or reached agreement with the federal government regarding pricing for drugs, including prices for Medicaid drugs and newly launched products.

A website sponsored by the federal government that offers pharmaceutical direct-to-consumer channels has been launched as of February 2026.

Federal agencies are developing new drug pricing pilot programs, such as a Medicaid model

which would authorize the federal government to negotiate Medicaid supplemental rebates with participating manufacturers on behalf of state Medicaid programs, in exchange for standardized coverage criteria for participating manufacturer drugs, and proposed Medicare Part B and Part D pilot models that, if finalized as proposed, would replace existing inflation-based Medicare rebates with rebates determined on the basis of international prices, for drugs and patients subject to the model.

Other healthcare reform efforts or actions may affect access to healthcare coverage or the funding of health care benefits, although the full impact of such efforts or actions cannot be predicted.

For example, the Congressional Budget Office has estimated that Medicaid provisions in the 2025 budget reconciliation legislation, including restrictions in eligibility and funding for Medicaid, as well as changes to the healthcare marketplace such as the elimination of certain subsidies, will increase the number of uninsured patients.

Individual states in the U.S.

have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price and reimbursement constraints, restrictions on copayment assistance by pharmaceutical manufacturers, value-based pricing, marketing cost disclosure and other transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.

Healthcare reform efforts have been and may continue to be subject to scrutiny, legal challenge and subsequent amendment, creating further uncertainty.

Other government actions could have an adverse effect upon, and could prevent, our products’ commercial success.

For example, the Trump Administration’s announced tariff on branded or patented drugs may increase the cost of drug products that are imported from abroad or manufactured using products or materials imported from abroad.

The timeline for implementation of this tariff has not yet been finalized.

As another example, the Budget Control Act of 2011, as amended, resulted in the imposition of reductions in Medicare (but not Medicaid) payments to providers in 2013 and remains in effect through 2032 unless additional Congressional action is taken.

Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented and/or any significant taxes or fees that may be imposed on us could have an adverse impact on our results of operations.

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Additionally, the Loper decision may result in increased regulatory uncertainty, inconsistent judicial interpretations, and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action or as a result of legal challenges, either in the United States or abroad.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action or as a result of legal challenges, either in the U.S.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, our business could be materially harmed.

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Healthcare reform measures that may be adopted in the future could have a material adverse effect on our industry generally and on our ability to successfully commercialize any product candidates, if and when approved.

Ø If we fail to comply with our obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to penalties and sanctions, which could have a material adverse effect on our business, financial condition, results of operations, and future prospects.

We participate in the Medicaid Drug Rebate program, the Public Health Service's 340B program, the VA FSS program, and particular other federal and state government pricing programs.

Such programs often require us to report pricing and other data to the government and, in turn, provide discounts and/or pay rebates to certain government payors and/or private purchasers that may be based on the reported data.

Pricing and rebate calculations vary across programs, are complex, and are often subject to evolving interpretation by the governmental agencies, the courts, and us.

Any price recalculations we determine are needed could result in a reassessment of liability for prior quarters.

Any determination by governmental agencies that we have failed to comply with our reporting and payment obligations could subject us to civil monetary and other penalties and sanctions, including possible termination of our program participation agreements, which could have a material adverse effect on our business, financial condition, results of operations, and future prospects.

Ø Disruptions at the FDA and other government agencies caused by funding shortages could prevent our product candidates from being developed, approved, or commercialized in a timely manner, or at all, which could negatively impact our business.

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If a prolonged government shutdown occurs, preventing 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 or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Due to the recent change in presidential administration, we face uncertainty regarding potential regulatory developments that may adversely affect our business.

We face uncertainty regarding the potential for changes in the regulatory environment following the change in presidential administration in January 2025.

While many of the Trump administration’s proposed policies appear to be focused on deregulation, the new administration and federal government could adopt legislation, regulation, or policy that adversely affects our business or creates a more challenging and costly environment to pursue the development and commercialization of our current or future product candidates.

Ø We face uncertainty regarding potential regulatory developments that may adversely affect our business.

We face uncertainty regarding the potential for changes in the regulatory environment.

While many of the current administration’s proposed policies appear to be focused on deregulation, a new administration and federal government could adopt legislation, regulation, or policy that adversely affects our business or creates a more challenging and costly environment to pursue the development and commercialization of our current or future product candidates.

For example, the federal government, including the FDA, may implement legislative, regulatory, or policy changes regarding the standards for approving drugs that we may be unable to satisfy or regarding the marketing of approved drugs that may limit or prohibit the advertising and promotion of our current or future product candidates, if approved.

Additionally, because one objective of the current Trump administration appears to be to decrease spending in the federal government, the FDA could face staff reductions, which could impact the FDA’s ability to engage in routine regulatory and oversight activities and result in delays or limitations on our ability to proceed with clinical development programs and obtain regulatory approvals.

It is difficult to predict how executive actions that may be

taken under the current Trump administration may affect the FDA’s ability to exercise its regulatory authority.

It is difficult to predict how executive actions that may be taken under the current Trump administration may affect the FDA’s ability to exercise its regulatory authority.

If such executive actions impose constraints on the FDA’s ability to engage in routine oversight and product review activities in the normal course, our business may be negatively impacted.

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Ø Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on the efforts and abilities of the principal members of our senior management and other key personnel, including Daniel Paterson, our President and Chief Executive Officer, Daniel Calkins, our Chief Financial Officer, and Matthew Ros, our Chief Operating Officer.

Although we have formal employment agreements with Daniel Paterson, Daniel Calkins, Matthew Ros and other members of our senior management and key personnel, these agreements do not prevent them from terminating their employment with us at any time.

Although we have formal employment agreements with Daniel Paterson, Daniel Calkins, Michael Kauffman and other members of our senior management and key personnel, these agreements do not prevent them from terminating their employment with us at any time.

We do not maintain “key person” insurance for any of our executives or other employees.

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Recruiting and retaining qualified scientific, clinical, manufacturing, and sales and marketing personnel will also be critical to our success.

We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies, universities, and research institutions for similar personnel.

We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous biotechnology and pharmaceutical companies, universities, and research institutions for similar personnel.

Although we have implemented a retention plan for certain key employees, our retention plan may not be successful in incentivizing these employees to continue their employment with us.

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The SEC and other regulatory bodies are increasingly focusing on cybersecurity enforcement, and the costs of complying with these regulatory initiatives may be significant.

If a security incident or data breach were to occur and cause interruptions in our operations, it could result in a material disruption of our key business processes and clinical development programs.

If a security incident or data breach were to occur and cause interruptions in our operations, it could result in a material disruption of our key business processes and clinical

development programs.

For example, the loss of clinical trial data from ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

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These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock.

In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors.

In addition, because our board of directors are responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors.

Among other things, these provisions:

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● actual or anticipated changes in estimates as to financial results, development timelines, or recommendations by securities analysts;

● developments regarding the commercialization of our product candidates, including avutometinib and defactinib;

● developments regarding the commercialization of AVMAPKI FAKZYNJA CO-PACK;

● variations in our financial results or those of companies that are perceived to be similar to us;

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Ø We can issue and have issued shares of preferred stock, which may adversely affect the rights of holders of our common stock.

We have in the past issued, and we may at any time in the future issue, shares of preferred stock, and as of December 31, 2024 we have 1,000,000 shares of our Series A convertible preferred stock, par value $0.0001 per share (the “Series A Convertible Preferred Stock”) and 0 shares of our Series B convertible preferred stock, par value $0.0001 per share (the “Series B Convertible Preferred Stock” and together with the Series A Convertible Preferred Stock, the “Preferred Stock”) issued and outstanding.

We have in the past issued, and we may at any time in the future issue, shares of preferred stock.

Our amended and restated certificate of incorporation authorizes us to issue up to 5,000,000 shares of preferred stock with designations, rights and preferences determined from time-to-time by our board of directors.

Accordingly, our board of directors is empowered, without stockholder approval, to issue preferred stock with dividend, liquidation, conversion, voting or

other rights superior to those of holders of our common stock.

For example, our Series B Convertible Preferred Stock ranks senior to our common stock, and the holders of our Series B Convertible Preferred Stock are entitled to a liquidation preference of $1.00 per share of Series B Convertible Preferred Stock in the event of our liquidation, dissolution or winding up, which could limit or eliminate any payments that the holders of our common stock could expect to receive upon our liquidation.

Additionally, holders of our Preferred Stock are entitled to receive, on an as converted basis, dividends and consideration in the event of certain transactions equivalent to the dividends and consideration received by the holders of our common stock, which would make paying dividends and engaging in certain transactions more expensive.

We also may not make any changes to our amended and restated certificate of incorporation that would limit the rights of the holders of our either series of our preferred stock without the affirmative vote of a majority of such series of preferred stock, which may make it more difficult to take certain corporate actions in the future.

Accordingly, our board of directors is empowered, without stockholder approval, to issue preferred stock with dividend, liquidation, conversion, voting or other rights superior to those of holders of our common stock.

Should we issue preferred stock the terms thereof could make it more difficult to take certain corporate actions or make paying dividends and engaging in certain transactions more expensive or challenging.

Ø Our stockholders will experience substantial dilution if outstanding warrants or pre-funded warrants are exercised for shares common stock.

As of December 31, 2024, there were pre-funded warrants to purchase up to 5,000,000 shares of our common stock and warrants to purchase up to 18,083,334 shares of our common stock outstanding.

The pre-funded warrants have an exercise price equal to $0.001 per underlying share of common stock and do not expire.

Each warrant has an exercise price equal to $3.50 and is exercisable for one shares of our common stock (or, in certain limited circumstances in lieu of a share of common stock, a pre-funded warrant for one share of our common stock at the warrant exercise price less the exercise price of the pre-funded warrant purchased) .

The warrants expire on January 25, 2026.

The conversion of the outstanding pre-funded warrants and warrants into shares of common stock would be substantially dilutive to existing stockholders.

As of December 31, 2025, there were outstanding pre-funded warrants to purchase up to 13,656,048 shares of our common stock issued as part of the July 2024 Offering, 2025 Private Placement, and November 2025 Public Offering.

The pre-funded warrants have an exercise price equal to either $0.001 or $0.0001 per underlying share of common stock and do not expire.

Additionally, as part of the July 2024 Offering, warrants to purchase up to 8,429,166 shares of our common stock were outstanding as of December 31, 2025, of which 8,391,666 Warrants were exercised in January 2026 and the remaining 37,500 Warrants expired.

The conversion of the

outstanding pre-funded warrants into shares of common stock would be substantially dilutive to existing stockholders.

Any dilution or potential dilution may cause our stockholders to sell their shares, which may contribute to a downward movement in the stock price of our common stock.

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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