What changed in this filing

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Item 1A. Risk Factors

2026-03-09 compared with 2025-03-31 · 290 added, 198 removed, 953 unchanged (34% of the section changed)

11 unchanged sentences

• Our limited operating history makes future forecasting difficult.

• Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements.

• The successful development of pharmaceutical products is highly uncertain.

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• If we encounter difficulties enrolling patients in clinical trials, clinical trials of our product candidates may be delayed or otherwise adversely affected.

our product candidates, limit their commercialization, increase costs or necessitate the abandonment or limitation of the development of some of our product candidates.

• Our preclinical studies and clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent, delay or limit the scope of regulatory approval of our product candidates, limit their commercialization, increase costs or necessitate the abandonment or limitation of the development of some of our product candidates.

• Our business is highly dependent on the success of our product candidates.

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• Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize any product candidates we or our collaborators develop and may adversely affect the prices for such product candidates.

• Even if we obtain regulatory approval for a product candidates, our products will remain subject to regulatory scrutiny.

• Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

• Even if we obtain regulatory approval for our product candidates, our products will remain subject to regulatory scrutiny.

• A prolonged U.S.

federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.

• Unfavorable global economic conditions and government regulations could adversely affect our business, financial condition or results of operations.

• We must attract and retain highly skilled personnel and strategic partners, and we may be unable to effectively manage our growth with our limited resources.

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• If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

• Tariffs could adversely affect our business and financial results.

• Our success depends on our ability to maintain the proprietary nature of our technology.

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

• Patent applications may be denied or issued patents covering our products and product candidates could be found invalid or unenforceable.

• We may not be able to protect our intellectual property rights throughout the world.

• We may be unable to protect the confidentiality of our trade secrets and know-how.

• We rely heavily on trade secrets and proprietary know-how to protect our technology, and if our employees, consultants, or collaborators disclose such information or if our Tc Bovine, HAC or proprietary cell lines are misappropriated, competitors could replicate our platform.

government may have march-in rights with respect to certain of our intellectual property, which could limit our ability to exclusively commercialize products developed with government funding.

• If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.

• The regulatory pathway for approval of biosimilars or interchangeable biologics to our products is uncertain, which may create competitive risks

• If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

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and foreign taxation of international business activities or the adoption of other tax reform policies, as well as the application of such laws, could adversely impact our financial position and operating results.

• Tariffs could adversely affect our business and financial results.

• Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.

Risks Related to Our Business and Operations

We are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception.

We realized net losses in the fiscal year ended December 31, 2024 and 2023, we expect to continue to incur net losses for the foreseeable future, and we may never achieve or maintain profitability in the future.

We expect to continue to incur net losses for the foreseeable future, and we may never achieve or maintain profitability in the future.

We are a clinical-stage biopharmaceutical company.

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Our expenses could increase beyond expectations for a variety of reasons, including due to our growth strategy and the increase in the scope and complexity of our operations.

In executing our strategy and plans to invest in enhancing and scaling

our business, we will need to generate significant additional revenue to achieve and maintain future profitability.

In executing our strategy and plans to invest in enhancing and scaling our business, we will need to generate significant additional revenue to achieve and maintain future profitability.

We may not be able to generate sufficient revenue to achieve profitability and our recent and historical growth should not be considered indicative of future performance.

Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements.

The report of our independent registered public accounting firm on our financial statements as of and for the years ended December 31, 2024 and 2023 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern.

Going forward, we may seek additional funding through a combination of equity or debt financings, or other third-party financing, collaborative or other funding arrangements.

In the future, reports from our independent registered public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern.

If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms, if at all.

Our limited operating history makes future forecasting difficult.

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Even if we are successful in obtaining marketing approval, commercial success of any approved products will also depend in large part on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid programs and managed care organizations in the United States or country specific governmental organizations in foreign countries, which may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare.

Third-party payors could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert our

If government and other healthcare payors were not to provide coverage and adequate reimbursement for our products once approved, market acceptance and commercial success would be reduced.

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We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all.

The clinical development of our initial and potential additional product candidates is susceptible to the risk of failure inherent at any stage of development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence of adverse events that are severe or medically or commercially unacceptable, failure to comply with protocols or applicable regulatory requirements and determination by the FDA or any comparable foreign regulatory authority that a product candidate may not continue development or is not approvable.

It is possible that even if any of our product candidates have a beneficial effect, that effect will not be detected during clinical evaluation as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical trials.

Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of such product candidate that is greater than the actual positive effect, if any.

Similarly, in our clinical trials we may fail to detect toxicity of, or intolerability caused by, such product candidate, or mistakenly believe that our product candidates are toxic or not well tolerated when that is not in fact the case.

Serious adverse events or other adverse events, as well as tolerability issues, could hinder or prevent market acceptance of the product candidate at issue.

The FDA and foreign regulatory authorities also have substantial discretion in the drug approval process.

The number and types of preclinical studies and clinical trials that the FDA will require to establish substantial evidence of safety and effectiveness for regulatory approval varies depending on the product candidate, the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular product candidate.

Approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among countries and regulatory authorities, and there may be varying interpretations of data obtained from preclinical studies or clinical trials, either of which may cause delays or limitations in the approval or the decision not to approve an application.

Regulatory agencies can delay, limit or deny approval of a product candidate for many reasons, including:

Clinical development is susceptible to failure at any stage, including failure to demonstrate efficacy, occurrence of unacceptable adverse events, failure to comply with protocols or regulatory requirements, or determination by regulators that a product candidate is not approvable.

Clinical trials may fail to detect beneficial effects or toxicity, or may indicate effects that differ from actual results.

Serious adverse events or tolerability issues could hinder or prevent market acceptance of the product candidate.

The FDA and foreign regulatory authorities have substantial discretion in the drug approval process.

The number and types of preclinical studies and clinical trials required for approval varies depending on the product candidate and target disease.

Approval policies, regulations, and data requirements may change during development and vary among regulatory authorities.

Regulatory agencies can delay, limit, or deny approval for many reasons, including:

• the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

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This lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm our business, results of operations and prospects.

The FDA or a comparable foreign regulatory authority may require more information, including additional preclinical or clinical data to support approval, which may delay or prevent approval and our commercialization plans, or which we may lead us to decide to abandon the development program.

The FDA or a comparable foreign regulatory authority may require more information, including additional preclinical or clinical data to support approval, which may delay or prevent approval and our commercialization plans, or which may lead us to decide to abandon the development program.

In addition, even if we were to obtain marketing approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request (including failing to approve the most commercially promising indications), may require a REMS that restricts prescribing or distribution of our therapeutic biological product candidates, may grant approval contingent on the performance of costly post-marketing clinical studies, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

Regulatory approval for the genetic modification of animals, including those from which antibodies are isolated for injection into human patients, requires the approval of a New Animal Drug Application, which can be a lengthy and expensive process with uncertain outcomes, delays to which could substantially harm our business.

We cannot commercialize our therapeutic biological product candidates in the United States without first obtaining a regulatory approval for our animal drug candidates, i.e., the genomic modifications to our Tc Bovine, in the form of a NADA.

The requirements governing development and approval of a new animal drug are largely analogous to those for new human drugs, requiring a demonstration of the safety and efficacy of the drug for the target indication, a demonstration that the manufacturing facilities, processes and controls are adequate with respect to such product candidate to assure safety, purity and potency, and a review of potential environmental impacts from the altered genomic DNA and the transgenic animals pursuant to the requirements of the NEPA.

The time required to obtain approval for a NADA by the FDA and comparable foreign regulatory authorities is unpredictable.

Approval policies, regulations, or the type and amount of data necessary to gain approval is dependent on the specific product candidate and may change during the course of the product candidate’s preclinical and clinical development.

Furthermore, we have not obtained regulatory approval for an animal drug, and it is possible that none of our existing animal drug candidates, or any future animal drug candidates, will ever obtain regulatory approval.

The reasons our animal drug candidates could fail to receive regulatory approvals are generally the same as the reasons that human drug product candidates may fail to obtain approval.

Our failure to obtain a regulatory approval for our animal drug candidates could significantly harm our business, the results of our operations and our prospects.

Requests for additional information from a regulatory authority could delay or prevent approval or result in our decision to abandon the development program entirely.

If we do receive regulatory approval of our animal drug candidates, then we will have ongoing responsibilities including registration, recordkeeping, filing supplements, and periodic reporting, which could reveal additional complications and threaten the ongoing approval of our animal drug candidates.

Further, as our polyclonal antibody product candidates are regulated as biological products, such product candidates will also require the submission and approval of a BLA prior to marketing.

In general, to commercialize any of our product candidates, we must obtain marketing authorization for both the therapeutic antibody product and the altered animal genomic DNA that enables production of the polyclonal antibodies.

In addition, the new 2025 U.S.

presidential administration has implemented or threatened reductions in force and work stoppages across several U.S.

federal agencies.

Any such reductions or stoppages at the FDA or other federal agencies could delay the approval or review processes for any of our products and product candidates, which could negatively impact our business and results of operations.

In addition, the new presidential administration may institute policies, communications or programs that could negatively impact the biotechnology industry, vaccine products and our ability to raise additional financing.

Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price.

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Even if we do receive regulatory approval to market a product candidate, any such approval may be subject to limitations on the indicated uses for which we may market the product.

It is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain the appropriate regulatory approvals necessary for us to commence product sales.

It is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain the appropriate regulatory approvals necessary for

us to commence product sales.

Any delay in obtaining, or an inability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates, generating revenue and achieving and sustaining profitability.

The time required to obtain approval for a NADA by the FDA and comparable foreign regulatory authorities is unpredictable.

The reasons our animal drug candidates could fail to receive regulatory approvals are generally the same as the reasons that human drug product candidates may fail to obtain approval.

Our failure to obtain a regulatory approval for our animal drug candidates could significantly harm our business, the results of our operations and our prospects.

Requests for additional information from a regulatory authority could delay or prevent approval or result in our decision to abandon the development program entirely.

Further, as our polyclonal antibody product candidates are regulated as biological products, such product candidates will also require the submission and approval of a BLA prior to marketing.

If we encounter difficulties enrolling patients in clinical trials, clinical trials of our product candidates may be delayed or otherwise adversely affected.

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Although we have previously claimed a refundable research and development tax credit there is a possibility that we may not be able to claim such credit, or we might qualify for a lesser credit.

financial statements, or if the Australian government significantly reduces or eliminates the tax credit, our business and results of operation may be adversely affected.

If we lose our ability to operate SAB Australia, or if in the future we are ineligible or unable to receive the research and development tax credit or are required to refund any research and development tax credit previously received or have to reserve for such credit in our financial statements, or if the Australian government significantly reduces or eliminates the tax credit, our business and results of operation may be adversely affected.

The regulatory approval processes of the FDA are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

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In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.

To date, we have not submitted a NADA or BLA to the FDA or similar drug or biological product approval submissions to comparable foreign regulatory authorities for any product candidate.

To date, we have not submitted a NADA or BLA to the FDA or

similar drug or biological product approval submissions to comparable foreign regulatory authorities for any product candidate.

We may never obtain FDA approval for any product candidates in the United States, and even if we do, we may never obtain approval for or commercialize any product candidates in any other jurisdiction, which would limit our ability to realize their full market potential.

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• the potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.

Regulators or IRBs of the institutions in which clinical trials are being conducted may suspend, limit or terminate a clinical trial, or data monitoring committees may recommend that we suspend or terminate a clinical trial, due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a benefit from using an investigational product, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, safety issues or adverse side effects, failure to demonstrate a benefit from using an investigational product, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

Negative or inconclusive results from our clinical trials or preclinical studies could mandate repeated or additional clinical trials and, to the extent we choose to conduct clinical trials in other indications, could result in changes to or delays in clinical trials of our product candidates in such other indications.

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In addition, these side effects may not be appropriately recognized or managed by the treating medical staff.

We may need to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates.

We may need to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of

our product candidates.

Inadequate training in recognizing or managing the potential side effects of our product candidates could result in harm to patients that are administered our product candidates.

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Our technology platforms may fail to discover and to generate additional product candidates that are suitable for further development.

All product candidates are prone to risks of failure typical of pharmaceutical product development, including the possibility that a product candidate may not be suitable for clinical development as a result of its harmful side effects, limited efficacy or other characteristics that indicate that it is unlikely to be a product that will receive approval by the FDA and other comparable foreign regulatory authorities and achieve market acceptance.

If we do not successfully develop and commercialize product candidates based upon its technological approach, we may not be able to obtain product or collaboration revenues in future periods, which would adversely affect our business, prospects, financial condition and results of operations.

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Healthcare providers, physicians and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval.

Our future arrangements with third party payors, distributors, retailers, marketers and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute, the federal False Claims Act, and similar state or foreign laws which may constrain the business or financial arrangements and relationships through which we sell, market and distribute any product candidates for which we obtain marketing

In addition, we may be subject to transparency laws and patient privacy regulation by U.S.

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In the United States and certain non-U.S.

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 or our collaborators’ ability to profitably sell any product candidates that obtain marketing approval.

prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our or our collaborators’ ability to profitably sell any product candidates that obtain marketing approval.

For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively the Affordable Care Act, was enacted in the United States.

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Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.

We cannot predict the likelihood, nature or extent of

government regulation that may arise from future legislation or administrative action, 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, either in the United States or abroad.

If we or our collaborators are slow or unable to adapt to new requirements or policies, or if we or our collaborators are not able to maintain regulatory compliance, any of our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability, which would adversely affect our business.

Even if we obtain regulatory approval for a product candidates, our products will remain subject to regulatory scrutiny.

Even if we obtain regulatory approval for our product candidates, our products will remain subject to regulatory scrutiny.

Even if we obtain regulatory approval in a jurisdiction for our product candidates, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, recordkeeping, and submission of safety and other post-market information.

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In addition, product manufacturers are subject to payment of program fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with GMP requirements and adherence to commitments made in the BLA or foreign marketing application.

If we or a regulatory agency discovers previously unknown problems with a product such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or with the integrity or sufficiency of data, records, or documentation, or disagrees with the promotion, marketing or labeling of that product, a regulatory agency may impose restrictions relative to that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

marketing or labeling of that product, a regulatory agency may impose restrictions relative to that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If we or a regulatory agency later discovers previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or if we fail to comply with applicable regulatory requirements following approval of any of our product candidates, a regulatory agency may:

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Congress and the public.

Additionally, advertising and promotion of any product candidate that obtains approval outside of

the United States will be heavily scrutinized by comparable foreign entities and stakeholders.

Additionally, advertising and promotion of any product candidate that obtains approval outside of the United States will be heavily scrutinized by comparable foreign entities and stakeholders.

Violations, including actual or alleged promotion of our products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions by the FDA, other U.S.

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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 lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions.

Average review times at the FDA have fluctuated in recent years as a result.

In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new biologics or modifications to approved biologics to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Since that time, there have been several threatened “shutdowns” of the U.S.

federal government, including as recently as March 2025.

If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

A prolonged U.S.

federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.

On October 1, 2025, the federal government of the United States began a shutdown at 12:01 a.m.

EDT as a result of congressional failure to pass appropriations legislation for the 2026 fiscal year, which began that day, and lasted for 43 days.

Subsequent partial federal government shutdowns occurred in January and February of 2026.

A continued and prolonged shutdown could materially and adversely affect our business, operations, financial condition, and legal matters.

A federal government shutdown may result in the furlough of federal employees, reduced availability of government services, and suspension or delay of activities by key agencies that regulate, fund, or interact with our business, including the SEC, the FDA, the HHS, and the U.S.

Patent and Trademark Office.

During such periods, review and approval of our filings, applications, and submissions could be delayed, and we may be unable to access or rely upon certain government data or

In addition, the Administrative Office of the U.S.

Courts and federal judiciary operations rely on appropriated funds and fee-based reserves that may be exhausted in the event of an extended shutdown.

If federal court funding lapses or is limited to “essential” functions only, civil litigation, bankruptcy proceedings, and regulatory enforcement actions involving us or our affiliates could be postponed or suspended.

Any such delay could impede our ability to resolve disputes, enforce contractual rights, or obtain timely judicial relief, which may have a material adverse effect on our financial position or prospects.

Such conditions could negatively impact our access to financing, timing of capital-raising transactions, and the liquidity or trading volume of our securities.

Accordingly, the federal government shutdown, or uncertainty regarding the continuity of government operations could have a material adverse effect on our business, results of operations, and stock price.

Unfavorable global economic conditions and government regulations could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.

Factors such as geopolitical events (including the ongoing wars in Iran, Ukraine and Israel and the risk of increased tensions between China and Taiwan), inflationary pressures, public health crises, and U.S.

election cycles, and changes in government administration and policies have caused extreme volatility and disruptions in the capital and credit markets in recent years.

Uncertainty or unfavorable global economic conditions could result in a variety of impacts to our business, including weakening demand for our products, and adversely impacting our ability to raise additional capital when needed on acceptable terms, if at all.

A weak or declining economy has strained in the past and may in the future strain our manufacturers or suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our services.

Further, the Trump administration has proposed or enacted tariffs and substantial changes to trade policies, which could adversely affect our business.

For example, the Trump administration has imposed tariffs on certain foreign products, including from Canada, Mexico and China, that in the past have resulted in and may result in future retaliatory tariffs on U.S.

goods and products.

Additionally, on September 25, 2025, the current U.S.

administration announced a 100% tariff on brand-name or patented drugs unless pharmaceutical companies expand their manufacturing operations in the U.S., and may impose more restrictions on goods.

Although the pharmaceutical tariff is currently on hold, this could have a material adverse effect on our supply chain and business prospects as well as the larger biopharmaceutical industry.

While certain tariffs have subsequently been suspended, modified or temporarily reduced, we cannot predict the results of the U.S.

government’s trade negotiations or the outcome of ongoing legal challenges to specific tariff policies.

We cannot predict whether these policies will continue, or if new policies will be enacted, or the impact, if any, that any policy changes could have on our business.

Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the economic climate and financial market conditions could adversely affect our business.

There is also uncertainty surrounding potential changes to the healthcare regulatory environment in the United States, and it is not possible to predict how these changes may be implemented, and the ultimate effects of such changes on our business.

In addition, the U.S.

federal government and other governments may reduce funding for health care or other programs or make changes that adversely affect the number of persons eligible for certain programs, the services provided to enrollees in such programs and premiums we can charge.

The levels of U.S.

federal government spending are difficult to predict and are subject to significant risk.

Considerable uncertainty exists regarding how future budget and program decisions will unfold, including the spending priorities of the new presidential administration and Congress, and what challenges budget reductions, if any, will present for our business and our industry generally.

For example, on January 20, 2025, President Trump established by executive order the U.S.

DOGE Service Temporary Organization ("DOGE") to reform federal government processes and reduce expenditures, and on February 5, 2025, the Centers for Medicare & Medicaid Services, or CMS, announced that it is collaborating with DOGE to determine where there may be opportunities for more effective and efficient use of resources.

Further, there are reports that the administration is exploring and implementing policies which may put limits on, or freeze, credit card spending by government employees on behalf of government agencies.

Additionally, the Trump administration took several Executive Actions, including the issuance of a number of Executive Orders, that imposed significant burdens on, or otherwise materially delayed, the FDA’s ability to engage in routine oversight activities, such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.

It is difficult to predict whether additional orders will be implemented, or how these orders will be rescinded and replaced under the current or future administrations.

We must attract and retain highly skilled personnel and strategic partners, and we may be unable to effectively manage our growth with our limited resources.

We have limited human resources and our future success depends and will depend in part on our ability to attract, train, retain and motivate highly skilled executive level management, research and development, and sales personnel and to establish and maintain effective strategic alliances with key companies in our industry.

Competition is intense for many of these types of personnel from other companies, consulting firms and more established organizations, many of which have significantly larger operations and greater financial, marketing, human, and other resources.

Competition is intense for many of these types of

personnel from other companies, consulting firms and more established organizations, many of which have significantly larger operations and greater financial, marketing, human, and other resources.

We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms or at all.

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Failure to fully integrate new employees into our operations could have a material adverse effect on our business, prospects, financial condition and results of operations.

We depend on our senior management and senior scientific staff, and their loss or unavailability could put us at a competitive disadvantage.

Our success depends largely on the skills, experience and reputation of certain key management and personnel, in particular our directors, executive officers and senior scientific staff.

The loss or unavailability of any of these individuals for any

significant period of time could have a material adverse effect on our business, prospects, financial condition and results of operations.

Our employees and independent contractors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could negatively impact our business, prospects, financial condition and operating results.

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Whether or not we are successful in defending against any such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations, which could harm our business, financial condition and results of operations.

We rely on third parties to perform some of our research and preclinical studies, and we plan to rely on third parties to conduct our clinical trials.

If these third parties do not satisfactorily carry out their contractual duties or fail to meet expected deadlines, our development programs may be delayed or subject to increased costs, each of which may have an adverse effect on our business and prospects.

We do not have the ability to conduct all aspects of our preclinical studies or future clinical trials ourselves.

As a result, we are, and expect to remain, dependent on third parties to perform some of our research and preclinical studies and any future clinical trials of our product candidates, including but not limited to governmental agencies and university laboratories, contract manufacturers, contract research organizations (CROs), distribution and supply (logistics) services organizations, contract testing organizations (CTOs), consultants or consultant organization with specialized knowledge based expertise.

The timing of the initiation and completion of our current and planned preclinical studies and clinical trials will therefore be partially controlled by such third parties and may result in delays to our development programs.

Specifically, we expect CROs, clinical investigators, and consultants to play a significant role in the conduct of future clinical trials and the subsequent collection and analysis of data.

However, we will not be able to control all aspects of their activities.

Nevertheless, as the sponsor of the INADs, INDs and clinical protocols governing our future clinical trials, we will be responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs, CTOs, and other third parties does not relieve us of our regulatory responsibilities.

We, our CROs, CTOs, and clinical sites will be required to comply with GLP requirements for preclinical studies, as well as GCP requirements for clinical trials involving human subjects, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area, and comparable foreign regulatory authorities, for all of our current product candidates and any future product candidates in clinical development.

Regulatory authorities enforce these GLP and GCP requirements through periodic inspections of trial sponsors, testing laboratories, clinical trial investigators, and clinical trial sites.

If we or any of our CROs, CTOs, or clinical trial sites fail to adhere to our clinical trial protocols or to comply with applicable GLP or GCP requirements, as applicable, the data

generated in our future preclinical studies or clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional preclinical studies or clinical trials before accepting for review or approving our marketing applications.

In addition, our clinical trials must be conducted with product candidates produced under GMP regulations.

Our failure to comply with these regulations may require us to stop and/or repeat clinical trials, which would delay the marketing approval process.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.

Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities.

The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the trial results or data.

The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized.

This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of our product candidates.

There is no guarantee that any such CROs, CTOs, clinical trial investigators or other third parties on which we plan to rely will devote adequate time and resources to our development activities or perform as contractually required.

Further, the performance of our third parties on which we rely may be interrupted by future pandemics similar to the COVID-19 pandemic, including due to travel or quarantine policies, heightened exposure of CRO staff who are healthcare providers to such pandemics or prioritization of resources toward the pandemic (similar public health emergencies that may arise in the future).

If any of these third parties fails to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, otherwise performs in a substandard manner, or terminates its engagement with us, the timelines for our development programs may be extended or delayed or our development activities may be suspended or terminated.

If any of our future clinical trial sites terminates for any reason, we may experience the loss of follow-up information on subjects enrolled in such clinical trials unless we are able to transfer those subjects to another qualified clinical trial site, which may be difficult or impossible.

We are limited in our ability to manufacture pharmaceutical products.

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There can be no assurance that such products can be manufactured by us or any other party at a cost or in quantities which are commercially viable.

We depend on our senior management and senior scientific staff, and their loss or unavailability could put us at a competitive disadvantage.

Our success depends largely on the skills, experience and reputation of certain key management and personnel, in particular our directors, executive officers and senior scientific staff.

The loss or unavailability of any of these individuals for any significant period of time could have a material adverse effect on our business, prospects, financial condition and results of operations.

We rely on third parties to perform some of our research and preclinical studies, and we plan to rely on third parties to conduct our clinical trials.

We do not have the ability to conduct all aspects of our preclinical studies or clinical trials ourselves.

We depend on third parties, including contract research organizations (CROs), contract testing organizations (CTOs), contract manufacturers, and clinical investigators to perform research, preclinical studies, and clinical trials.

The timing of our development programs will therefore be partially controlled by such third parties and may result in delays.

As the sponsor of the INADs, INDs, and clinical protocols governing our trials, we remain responsible for ensuring compliance with applicable protocols and regulatory standards.

We and our third-party contractors must comply with Good Laboratory Practice (GLP) requirements for preclinical studies and Good Clinical Practice (GCP) requirements for clinical trials, which are enforced by the FDA and comparable foreign regulatory authorities through periodic inspections.

If we or our contractors fail to comply with these requirements, the data generated may be deemed unreliable, and regulators may require us to repeat studies or trials, which would delay the approval process.

Principal investigators for our clinical trials may serve as scientific advisors or consultants and receive compensation for such services.

The FDA or comparable foreign regulatory authorities may conclude that such financial relationships create conflicts of interest that affect interpretation of trial data.

This could result in regulators questioning data integrity, leading to delays or rejection of our marketing applications.

There is no guarantee that CROs, CTOs, clinical investigators, or other third parties will devote adequate time and resources to our development activities or perform as contractually required.

Third-party performance may also be interrupted by public health emergencies.

If any third party fails to meet deadlines, adhere to protocols, or meet regulatory requirements, our development timelines may be extended or suspended.

If clinical trial sites terminate, we may lose follow-up information on enrolled subjects unless we can transfer them to another qualified site.

We intend to rely on third parties to produce commercial supplies of our product candidates.

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For continued noncompliance, the USDA may impose fines, suspend, or revoke animal research licenses or confiscate research animals.

There can be no assurance that we will not encounter difficulties in scaling up our manufacturing processes.

Significant scale-up of manufacturing may result in unanticipated technical challenges and may require additional inspections, permits, or other authorizations by the FDA, the USDA, or corresponding state agencies.

We may encounter difficulties in scaling up production, including problems involving raw material suppliers, production yields, technical difficulties, scaled-up product characteristics, quality control and assurance, shortage of qualified personnel, capacity constraints, compliance with FDA and foreign regulations, environmental compliance, production costs and development of advanced manufacturing techniques and process controls.

The actual cost to manufacture and process our product candidates could also be greater than we expect and could materially and adversely affect the commercial viability of any product candidates that we develop.

difficulties, if they occur and are not resolved to the satisfaction of the FDA or other regulatory agency, could lead to significant delays and possibly the termination of the future development or commercial program for such product candidate.

These risks become more acute as we scale-up for commercial quantities, where a reliable source of product becomes critical to commercial success.

The commercial viability of any of our product candidates, if approved, will depend on our ability to produce our product candidates at a large scale.

Failure to achieve this level of supply could jeopardize the successful commercialization of our therapeutic product candidates, should any be approved for marketing.

The manufacture of polyclonal antibodies from transgenic animals is complex and requires significant expertise, including the development of advanced manufacturing techniques and process controls.

Manufacturers of polyclonal antibody products often encounter difficulties in production, particularly in scaling out up and validating initial production and ensuring the absence of contamination.

These problems include difficulties with production costs and yields, quality control, including stability of the product candidate, quality assurance testing, operator error, shortages of qualified personnel, shortages of raw materials, as well as compliance with strictly enforced federal, state and foreign regulations.

Furthermore, if contaminants are discovered in our animal production facility, it may need to be closed for an extended period of time to investigate and remedy the contamination.

We cannot ensure provide assurance that any stability or other issues relating to the manufacture of our product candidates will not occur in the future.

Our manufacturing capabilities could be affected by cost-overruns, resource constraints, unexpected delays, equipment failures, labor shortages or disputes, natural disasters, power failures and numerous other factors that could prevent us from realizing the intended benefits of our manufacturing strategy, jeopardize our ability to produce our product candidates, and have a material adverse effect on our business, financial condition, results of operations and prospects.

We may encounter difficulties in scaling up our manufacturing processes, which may result in unanticipated technical challenges and require additional regulatory inspections or authorizations.

Scaling difficulties could include problems with raw material suppliers, production yields, quality control, personnel shortages, capacity constraints, regulatory compliance, and production costs.

Manufacturing costs could be greater than expected and materially affect the commercial viability of our product candidates.

Failure to scale production to commercial quantities could jeopardize successful commercialization of any approved products.

The manufacture of polyclonal antibodies from transgenic animals is complex and requires significant expertise.

Manufacturers often encounter difficulties in scaling up, validating production, and ensuring the absence of contamination.

These problems include difficulties with production costs and yields, quality control, operator error, personnel and raw material shortages, and regulatory compliance.

If contaminants are discovered in our animal production facility, it may need to be closed for an extended period.

We cannot provide assurance that stability or other manufacturing issues will not occur in the future.

realizing the intended benefits of our manufacturing strategy, jeopardize our ability to produce our product candidates, and have a material adverse effect on our business, financial condition, results of operations and prospects.

Our product candidates are uniquely manufactured, and we may encounter difficulties in production, particularly with respect to scaling our manufacturing capabilities.

The manufacturing process used to produce Tc Bovine is novel and has not been validated for commercial production.

There is a risk that of we may experience manufacturing issues associated with the differences in donor starting materials, interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, and variability in product characteristics.

There is a risk that we may experience manufacturing issues associated with the differences in donor starting materials, interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, and variability in product characteristics.

Even minor deviations from our normal manufacturing processes could result in reduced production yields, lot failures, product defects, product delays, product recalls, product liability claims and other supply disruptions.

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Our inability to do so could have a material adverse effect on our business, financial condition, prospects and results of operations.

In addition, we could incur higher manufacturing costs if manufacturing processes or standards change

and we could need to replace, modify, design or build and install equipment, all of which would require additional capital expenditures.

We have not entered into long term manufacturing and supply agreements with any producers.

On October 26, 2022, we entered into a Manufacturing Option Agreement (the “Emergent Manufacturing Agreement”) and Right of First Refusal Agreement (the “Emergent RoFR Agreement,” and together with the Emergent Manufacturing Agreement, the “Emergent Agreements”) with Emergent BioSolutions Canada, Inc., a wholly-owned subsidiary of Emergent BioSolutions Inc.

(“Emergent”).

The Emergent Agreements contemplate that we will enter into one or more binding Master Manufacturing Services Agreements, whereby Emergent will provide contract development and manufacturing services to produce our fully-human polyclonal antibody products.

Under the Emergent Manufacturing Agreement, we granted Emergent an exclusive option for the exclusive commercial manufacture of commercial stage product utilizing our humanized polyclonal antibodies.

Pursuant to the terms of our arrangement, we will notify Emergent in advance of our first commercial manufacturing needs for any product and each additional product, and Emergent may then exercise the exclusive manufacturing option with respect to such product.

Under the Emergent RoFR Agreement, we granted Emergent an exclusive right of first refusal to license and develop our products, developed using humanized polyclonal antibodies based on our platform to treat (i) botulism anti-toxin, (ii) pandemic influenza, or (iii) anti-fungal diseases.

Any definitive manufacturing arrangement will be determined at the time any Master Manufacturing Services Agreement is entered into with Emergent, and there is no guarantee we will do so.

We intend to pursue agreements with contract manufacturers to produce the components and drug products that we will use in the future for the commercialization of products that make using of our technology, as well as for labeling and finishing services.

We may not be able to enter into such arrangements on acceptable terms or at all.

Components of our product candidates are currently manufactured for us in small quantities for use in our preclinical and clinical studies.

We will require significantly greater quantities to commercialize any given product.

We may not be able to find alternate sources of comparable components.

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

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

In addition, we could incur higher manufacturing costs if manufacturing processes or standards change and we could need to replace, modify, design or build and install equipment, all of which would require additional capital expenditures.

We are subject to manufacturing risks that could substantially increase the costs and limit supply of product candidates or prevent us from achieving a commercially viable production process.

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We are subject to inspections by regulatory authorities to confirm compliance with applicable regulatory requirements.

Any failure to follow cGMP or other regulatory requirements or delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or storage of our product candidates as a result of a failure of our facilities or the facilities or operations of third parties to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and commercialize our product candidates, leading to significant delays in the availability of therapeutic product for clinical studies or the termination or hold on a clinical study, or the delay or prevention of a filing or approval of marketing applications for our product candidates.

therapeutic product for clinical studies or the termination or hold on a clinical study, or the delay or prevention of a filing or approval of marketing applications for our product candidates.

Significant noncompliance could also result in the imposition of sanctions, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approvals for our product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could damage our reputation.

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Our product candidates are based on materials produced by genetically engineered bovines.

As of March 17, 2025, we maintain a herd of approximately 157 genetically engineered production animals at a single location in South Dakota and a larger herd of recipient animals at other locations.

As of February 18, 2026, we maintain a herd of approximately 153 genetically engineered production animals at a single location in South Dakota and a larger herd of recipient animals at other locations.

Our ability to produce product candidates is dependent on the continued health and productivity of these animals.

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Any of these factors could have an adverse effect on our financial condition and ability to operate.

We have not entered into long term manufacturing and supply agreements with any producers.

(“Emergent”).

Under the Emergent Manufacturing Agreement, we granted Emergent an exclusive option for the exclusive commercial manufacture of commercial stage product utilizing our humanized polyclonal antibodies.

Any definitive manufacturing arrangement will be determined at the time any Master Manufacturing Services Agreement is entered into with Emergent, and there is no guarantee we will do so.

We may not be able to enter into such arrangements on acceptable terms or at all.

Components of our product

candidates are currently manufactured for us in small quantities for use in our preclinical and clinical studies.

We will require significantly greater quantities to commercialize any given product.

We may not be able to find alternate sources of comparable components.

Cyber-attacks or other failures in our telecommunications or information technology systems, or those of our collaborators, CROs, third-party logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations.

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In addition, we may suffer reputational harm or face litigation or adverse regulatory action as a result of cyber-attacks or other data security breaches and may incur significant additional expense to implement further data protection measures.

“Cybersecurity”, of this Annual Report on Annual Report for more information.

“Cybersecurity”, of this Annual Report for more information.

Collaborations with third parties may be important to our business.

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• collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

• collaborators may decide not to continue the development of collaboration products and 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;

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;

• a collaborator with marketing, distribution and commercialization rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of any such product candidate;

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There can be no assurance that our competitors will not succeed in developing technologies and products that are more effective than any being developed by us or that would render our technology and products obsolete or noncompetitive.

There can be no

assurance that these and other efforts by potential competitors will not be successful, or that other methods will not be developed to compete with our technology.

There can be no assurance that these and other efforts by potential competitors will not be successful, or that other methods will not be developed to compete with our technology.

There are specific products and technologies that compete with our current product pipeline and that may outperform or be more competitive than our products.

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

We cannot predict the impact of

such changes and cannot be certain of our future compliance.

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

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.

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We do not carry specific biological waste or hazardous waste insurance coverage, workers compensation or property and casualty and general liability insurance policies that include coverage for damages and fines arising from biological or hazardous waste exposure or contamination.

Tariffs could adversely affect our business financial results.

Tariffs could adversely affect our business and financial results.

We purchase components of our product candidates, including consumable supplies and raw materials, from U.S.

domestic sources, as well as various global sources including but not limited to those located in China and the European Union.

The current U.S.

presidential administration has proposed the implementation of a number of tariffs, including tariffs on products and materials from these jurisdictions, which could increase our production costs.

If tariffs make purchases of materials from certain jurisdictions untenable, we may also need to obtain materials from other sources, when possible, which could also increase our costs and delay our planned clinical trials and manufacture of our products and product candidates.

Any of these factors may adversely affect our financial condition or results of operations.

Our ability to continue to operate as a going concern depends on our ability to obtain adequate financing in the future.

Our ability to continue as a going concern is dependent, among other things, on our ability to raise additional capital resources.

We plan to seek additional funding through a combination of equity or debt financings, or other third-party financing, collaborative or other funding arrangements.

Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all.

If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate our assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.

Management believes there is substantial doubt about our ability to continue as a going concern for the one-year period following the date that the consolidated financial statements for December 31, 2024 were issued.

The consolidated financial statements for December 31, 2024 have been prepared on the basis that the Company will continue as a going concern, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability for the Company to continue as a going concern.

government has made and continues to make significant additional changes in U.S.

trade policy and may continue to take future actions that could negatively impact U.S.

For example, the United States has announced tariffs on many goods imported from specified nations.

In addition, there are currently discussions concerning potential increased tariffs for pharmaceutical and medical device products, which may impact our supply chain and create uncertainty in the broader pharmaceutical industry.

While certain tariffs have been suspended, modified or temporarily reduced, we cannot predict the results of the U.S.

government’s trade negotiations or the outcome of ongoing legal challenges to specific tariff policies.

Changes in U.S.

trade policy, including recently announced tariffs, related to countries where we or our suppliers operate could result in increased costs for raw materials, components, or finished goods for us, or challenges for our third-party contract manufacturers, distributors and suppliers to continue to meet demands for our products at current prices.

These cost increases may reduce our margins, require us to raise prices, or make our products less competitive in the marketplace.

Additionally, retaliatory tariffs imposed by other countries on U.S.

exports could adversely impact demand for our products in international markets or increase the costs of conducting business.

If we are unable to mitigate these risks through supply chain adjustments, pricing strategies, or other measures, our financial performance and growth prospects could be negatively affected.

Risks Related to Our Intellectual Property

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Our success in large part depends on our ability to maintain the proprietary nature of our technology and other trade secrets.

To do so, we must prosecute and maintain existing patents, obtain new patents and pursue trade secret and other intellectual property protection.

To do so, we must prosecute and maintain existing patents, obtain new patents, protect trade secrets and pursue other intellectual property protection.

We also must operate without infringing the proprietary rights of third-parties or allowing third-parties to infringe our rights.

Patent issues relating to pharmaceuticals and biologics involve complex legal, scientific and factual questions.

To date, no consistent policy has emerged regarding the breadth of biotechnology patent claims that are granted by the U.S.

Patent and Trademark Office (“USPTO”) or enforced by the federal courts.

To date, no consistent policy has emerged regarding the breadth of biotechnology patent claims that are granted by the US PTO or enforced by the federal courts.

Therefore, we do not know whether any particular patent applications will result in the issuance of patents, or that any patents issued to us will provide us with any competitive advantage.

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Furthermore, there is a risk that others will independently develop or duplicate similar technology or products or circumvent the patents issued to us.

While we rely on a combination of patents, trademarks and trade secret protection, as well as other contractual agreements to protect the intellectual property related to product candidates and proprietary technologies, our strategy and future prospects are based, in particular, on our patent portfolio and regulatory exclusivity.

The uncertainties with respect to the legal system in the US, Europe and other countries, including uncertainties regarding the enforcement of laws, and sudden or unexpected changes in laws and regulations with little advance notice, or policies and practices that weaken the intellectual property framework (such as laws or regulations that promote or provide broad discretion to issue a compulsory license) could adversely affect us and limit the legal protections available to us.

We will best be able to protect our technologies, and product candidates and their uses from unauthorized use by third parties to the extent that valid and enforceable patents, effectively protected trade secrets, or other regulatory exclusivities, cover them.

However, the process of obtaining patent protection is expensive and time-consuming, and we may not be able to prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

The patent position and other intellectual property rights of biopharmaceutical companies involve complex legal, administrative and factual questions, and the issuance, scope, validity and enforceability of patents cannot be predicted with certainty.

Also, intellectual property rights have limitations and do not necessarily address all potential threats to our competitive advantage.

Our ability to obtain patent protection for our technologies and product candidates is uncertain, and the degree of future protection afforded by such intellectual property rights is uncertain due to a number of factors, including, but not limited to:

• we may not have been the first to make or file patent applications for the inventions covered by pending patent applications or issued patents;

• others may independently develop identical, similar or alternative technologies, products or compositions and uses thereof;

• any or all of our pending, or any future patent applications may not result in issued patents;

• any patents issued to us may not provide a basis for commercially viable products, or may not provide any competitive advantages in countries of significant business opportunity;

• third parties may initiate interference, re-examination, post-grant review, inter partes review, or derivation actions in the US Patent and Trademark Office (“ USPTO ”), or oppositions in the European Patent Office (“ EPO ”), or observations or protests, or any similar actions in other patent administrative or court proceedings worldwide that challenge the validity, enforceability or scope of such patents, which may result in our patent claims being narrowed or invalidated which could limit our ability to prevent competitors from developing and marketing similar products;

• our technologies, compositions and methods may not be patentable;

• others may design around our patent claims to produce competitive products or uses which fall outside of the scope of our patents;

• third parties may have blocking patents that could prevent us from marketing our products or practicing our own patented technology;

• patent terms may be inadequate to protect our competitive position on our technologies, and product candidates for an adequate amount of time;

• the Supreme Court of the US, other US federal courts, Congress, the USPTO or similar foreign authorities may change the standards of patentability and any such changes could narrow or invalidate, or change the scope of, or change the patent lifetime of, our patents;

• the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process.

In addition, periodic maintenance fees on issued patents often must be paid to the USPTO and foreign patent agencies over the lifetime of the patent.

While an unintentional lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

Third parties may claim we infringe their intellectual property rights.

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cease selling or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue;

obtain a license from the holder of the intellectual property right alleged to have been infringed, which license may not be available on reasonable terms, if at all;

obtain a license from the holder of the intellectual property right alleged

to have been infringed, which license may not be available on reasonable terms, if at all;

and redesign our products to avoid infringing the intellectual property rights of third-parties, which may be time-consuming or impossible to do.

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We have third party collaborators that might claim rights in or to our technology and/or assets.

We have extensive experience collaborating with multiple parties in Government and industry, and has agreements and collaborations that allow potential claims and actual rights, such as shared publication rights, shared inventions, access to assets, potential claims of co-inventorship, limited rights to data, general purpose rights to data, and other claims that may affect our business operations, intellectual property portfolio, interruption of operating assets or our ability to protect our own rights.

We have extensive experience collaborating with multiple parties in Government and industry, and have agreements and collaborations that allow potential claims and actual rights, such as shared publication rights, shared inventions, access to assets, potential claims of co-inventorship, limited rights to data, general purpose rights to data, and other claims that may affect our business operations, intellectual property portfolio, interruption of operating assets or our ability to protect our own rights.

There can be no assurance that our competitors, suppliers, service providers, collaborators or other parties will not succeed in asserting rights that are or become contrary to our interests.

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

Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity,

and is therefore costly, time-consuming and inherently uncertain.

In addition, the United States has recently enacted and is currently implementing and proposing wide-ranging patent reform legislation.

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

In addition, the United States enacted wide-ranging patent reform legislation.

Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations.

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Depending on decisions by the U.S.

Congress, the federal courts and the USPTO, the laws and regulations governing patents, particularly those directed to pharmaceutical and biopharmaceutical products and uses could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

Congress, the federal courts and the US PTO, the laws and regulations governing patents, particularly those directed to pharmaceutical and biopharmaceutical products and uses could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

We cannot predict how these decisions or any future decisions by the U.S.

Congress, the federal courts or the USPTO may impact the value of our patents.

Congress, the federal courts or the US PTO may impact the value of our patents.

Similarly, any adverse changes in the patent laws of other jurisdictions could have a material adverse effect on our business and financial condition.

Patent applications may be denied or issued patents covering our products and product candidates could be found invalid or unenforceable.

Even if patents do successfully issue and even if such patents cover our technologies, products, product candidates, compositions and methods of use, third parties may initiate interference, re-examination, post-grant review, inter partes review, or derivation actions in the USPTO, third-party oppositions at the EPO or observations or protests, or similar actions challenging the validity, enforceability or scope of such patents in other patent administrative proceedings worldwide, which may result in our patent claims being narrowed or invalidated.

Such proceedings could result in revocation or amendment of such patents in such a way that they no longer cover our technologies, product candidates or competitive products.

Further, if we initiate legal proceedings against a third-party to enforce a patent covering our product, product candidate or technology, the defendant could counterclaim that the patent covering our product, product candidate or technology is invalid or unenforceable.

In patent litigation in the US, certain European and other countries worldwide, it is commonplace for defendants to make counterclaims alleging invalidity and unenforceability in the same proceeding, or to commence parallel defensive proceedings such as patent nullity actions to challenge validity and enforceability of asserted patent claims.

Such proceedings could result in revocation or amendment of such patents in such a way that they no longer cover our technologies, product candidates or competitive products.

We may not be able to protect our intellectual property rights throughout the world.

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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.

We may be unable to protect the confidentiality of our trade secrets and know-how.

In addition to seeking patent protection for our products and product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position.

We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, collaboration partners, consultants, advisors, vendors, university and/or institutional researchers and other third parties.

We also have entered or seek to enter into confidentiality and invention or patent assignment agreements with our employees, advisors and consultants.

Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and once disclosed we may lose trade secret protection.

Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective.

In addition, we may not be able to obtain adequate remedies for such breaches.

Our trade secrets may also be obtained by third parties by other means, such as breaches of our physical or computer security systems.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time consuming, and the outcome is unpredictable and may be inadequate.

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

Moreover, 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, or those to whom they communicate, from using that technology or information to compete with us.

If any of our trade secrets were to be disclosed to, or independently developed by, a competitor, our competitive position would be harmed.

Additionally, because our manufacturing platform is embodied in living biological assets, such as our Tc bovine (our transchromosomic cattle) that embody our engineered human artificial chromosome (HAC)—we face unique risks of physical misappropriation.

Unlike traditional pharmaceutical manufacturing equipment or cell lines that can be secured in controlled laboratory environments, our cattle must be maintained in agricultural facilities where they may be more vulnerable to theft or unauthorized access.

If one or more of our transchromosomic cattle, particularly breeding animals, were stolen or otherwise misappropriated, a competitor could potentially use such animals to establish a competing herd capable of producing human polyclonal antibodies.

The self-replicating nature of these biological assets means that even a small number of misappropriated animals could, over time, be bred into a substantial competing platform.

While we maintain security measures and contractual protections, there can be no assurance that these measures will be sufficient to prevent such misappropriation, and our legal remedies in the event of theft may be inadequate to prevent a competitor from exploiting misappropriated genetic material, particularly in jurisdictions with weaker intellectual property enforcement.

Any such misappropriation could materially and adversely affect our competitive position, business, financial condition, and results of operations.

We rely heavily on trade secrets and proprietary know-how to protect our technology, and if our employees, consultants, or collaborators disclose such information or if our Tc Bovine, HAC or proprietary cell linesare misappropriated, competitors could replicate our platform.

Our competitive advantage depends significantly on trade secrets and proprietary know-how related to our DiversitAb platform, including specialized knowledge concerning the genetic engineering, breeding, husbandry, immunization protocols, and antibody harvesting processes for our Tc bovine cattle with fully humanized immune systems.

We seek to protect this information through confidentiality agreements, invention assignment agreements, and other contractual protections with our employees, consultants, scientific advisors, contractors, and collaborators.

However, these agreements may be breached, and we may not have adequate remedies for any such breach.

In addition, our trade secrets and proprietary know-how may otherwise become known to or be independently discovered by competitors.

We face particular risks that current or former employees, consultants, or collaborators who have knowledge of our proprietary methods and techniques could join competitors or form competing enterprises and use that knowledge to replicate

aspects of our platform.

While we typically require such individuals to sign non-disclosure and, where enforceable, non-compete agreements, these protections may be difficult to enforce, may be subject to legal limitations on enforceability in various jurisdictions, and may not prevent the use of general knowledge, skills, and experience acquired during their tenure with us.

The highly specialized nature of our platform means that a relatively small number of individuals possess critical expertise regarding our Tc bovine, our proprietary HAC and cell lines and associated manufacturing and production processes, making the departure of any such individual to a competitor a significant risk.

government may have march-in rights with respect to certain of our intellectual property, which could limit our ability to exclusively commercialize products developed with government funding.

Certain of our technologies and product candidates have been developed with funding from the U.S.

government, including through contracts with government agencies.

As a result, the government may have certain rights to our intellectual property under the Bayh-Dole Act of 1980 and related regulations.

Under the Bayh-Dole Act, the U.S.

government retains a non-exclusive, royalty-free license to practice any government-funded invention for governmental purposes.

More significantly, the government has "march-in" rights, which allow it to require us or our licensees to grant licenses to third parties, or to grant such licenses itself, if the government determines that:

(i) we have not taken, or are not expected to take within a reasonable time, effective steps to achieve practical application of the invention;

(ii) action is necessary to alleviate health or safety needs which are not reasonably satisfied by us;

(iii) action is necessary to meet requirements for public use specified by federal regulations and such requirements are not reasonably satisfied by us;

or (iv) we have failed to comply with the agreement regarding the preference for U.S.

If the government exercises march-in rights or otherwise requires us to grant licenses to third parties, we may be unable to exclusively commercialize products covered by the applicable intellectual property, which could materially and adversely affect our business, financial condition and results of operations.

If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.

Depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our U.S.

patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments.

patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Amendments.

The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process.

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If we are unable to obtain patent term extension or the term of any such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and prospects could be materially harmed.

The regulatory pathway for approval of biosimilars or interchangeable biologics to our products is uncertain, which may create competitive risks.

Our product candidates, including human polyclonal antibodies derived from our proprietary DiversitAb platform utilizing genetically modified cattle with humanized immune systems, are regulated as biologics by the FDA.

The Biologics Price Competition and Innovation Act ("BPCIA") established an abbreviated pathway for the approval of biosimilar and interchangeable biological products.

However, given the novel and highly complex nature of our technology platform—which produces human polyclonal antibodies through immunization of genetically engineered transchromosomic cattle rather than through traditional cell culture or recombinant methods—there is significant uncertainty regarding how the FDA and other regulatory authorities will apply biosimilar standards to products derived from our platform.

Unlike traditional monoclonal antibodies or recombinant biologics, human polyclonal antibodies produced through our platform represent a heterogeneous mixture of antibodies that may be difficult to characterize or replicate using conventional biosimilar development approaches.

Regulatory authorities may struggle to define appropriate standards for demonstrating biosimilarity or interchangeability for such products, which could result in unpredictable outcomes.

On the one hand, this complexity may provide some protection against biosimilar competition because of the inherent difficulty in replicating our manufacturing process and the resulting product profile.

On the other hand, regulatory uncertainty could lead to the approval of products that are purportedly "biosimilar" to ours under standards that do not adequately account for the unique characteristics of our products, potentially exposing us to competition from products that may not truly be equivalent.

Additionally, we cannot predict how pricing and reimbursement frameworks for biosimilars will evolve or how such frameworks will apply to our

Changes in the regulatory landscape, including any guidance issued by the FDA regarding biosimilarity standards for novel biologics platforms such as ours, could materially affect our competitive position and ability to maintain exclusivity for our products, which could have a material adverse effect on our business, financial condition and results of operations.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

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Risks Related to Being a Public Company

We incur increased costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could adversely affect our business, financial condition, and results of operations.

As a public company, we are and will continue to be subject to the reporting requirements of the Exchange Act, the listing standards of Nasdaq and other applicable securities rules and regulations.

We expect that the requirements of these rules and regulations will continue to increase our legal, accounting, and financial compliance costs, make some activities more difficult, time-consuming and costly, and place significant strain on our personnel, systems, and resources.

For example, the Exchange Act requires, among other things, that we file annual, quarterly, and current reports with respect to our business and results of operations.

As a result of the complexity involved in complying with the rules and regulations applicable to public companies, our management’s attention may be diverted from other business concerns, which could harm our business, financial condition, and results of operations, although we have already hired additional employees to assist us in complying with these requirements, we may need to hire more employees in the future or engage outside consultants, which will increase our operating expenses.

In addition, changing laws, regulations, and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs, and making some activities more time-consuming.

These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

We intend to invest substantial resources to comply with evolving laws, regulations, and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from business operations to compliance activities.

If our efforts to comply with new laws, regulations, and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us, and our business may be harmed.

We also expect that being a public company and these new rules and regulations will make it increasingly expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.

These factors could also make it more difficult for us to attract and retain qualified members of our board of directors (the “Board”), particularly to serve on our Audit Committee of the Board (the “Audit Committee”) and compensation committee of the Board (the “Compensation Committee”), and qualified executive officers.

As a result of disclosure of information in filings required of a public company, our business and financial condition are more visible, which may result in an increased risk of threatened or actual litigation, including by competitors and other third parties.

If such claims are successful, our business, financial condition, and results of operations could be harmed, and even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and harm our business, financial condition, and results of operations.

We are an “emerging growth company,” and our election to comply with the reduced disclosure requirements as a public company may make our common stock less attractive to investors.

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

As a public company, we are and will continue to be subject to the reporting requirements of the Exchange Act, the listing standards of Nasdaq and other applicable securities rules and regulations.

For example, the Exchange Act requires, among other things, that we file annual, quarterly, and current reports with respect to our business and results of operations.

complying with these requirements, we may need to hire more employees in the future or engage outside consultants, which will increase our operating expenses.

This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired.

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In addition, if we are unable to continue to meet these requirements, we may not be able to remain listed on Nasdaq.

We are not currently required to comply with the SEC rules that implement Section 404 of the Sarbanes-Oxley Act and are therefore not required to make a formal assessment of the effectiveness of our internal control over financial reporting for that purpose.

As a public company, we are required to provide an annual management report on the effectiveness of our internal control over financial reporting.

Our independent registered public accounting firm is not required to formally attest to the effectiveness of our internal control over financial reporting until after we are no longer an “emerging growth company” as defined in the JOBS Act.

time, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control over financial reporting is documented, designed or operating.

At such time, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control over financial reporting is documented, designed or operating.

Any failure to maintain effective disclosure controls and internal control over financial reporting could have an adverse effect on our business and results of operations and could cause a decline in the price of our common stock.

If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud, we previously identified a material weakness in our internal control over financial reporting, which has been remediated during the year ended December 31, 2024.

In the future, we may identify additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, which may result in material errors in our financial statements or cause us to fail to meet our period reporting obligations, and adversely affect the trading price of our common stock.

We previously identified a material weakness in our internal control over financial reporting, which was subsequently remediated during the year ended December 31, 2024.

We have remediated past material weaknesses and we pursue ongoing efforts to strengthen our internal controls.

Maintaining a consistently strong control environment requires the ability to attract and retain sufficient qualified personnel and/or consultants and other factors.

We may not be able to attract or retain sufficient numbers of qualified personnel.

In connection with the preparation of our financial statements for the year ended December 31, 2023, our management identified a material weakness, which involved insufficient documentation of the formalized processes and procedures that are critical to the accomplishment of financial reporting objectives, as described more fully in “Item 9A.

Controls and Procedures” of Part I of this Annual Report.

If we are unable to provide reliable and timely financial reports in the future, our business and reputation may be further harmed.

Failures in internal controls may negatively affect investor confidence in our management and the accuracy of our financial statements and disclosures or result in adverse publicity and concerns from investors and commercial customers, any of which could have a negative effect on the price of our shares, subject us to regulatory investigations and penalties and/or shareholder litigation, and materially adversely impact our business and financial condition.

Our warrants are accounted for as liabilities and changes in value of the warrants could have a material effect on our financial results.

In October 2021, the Company consummated the business combination contemplated by the agreement and plan of merger, dated as of June 21, 2021, as amended on August 12, 2021, made by and among Big Cypress Acquisition Corp., a Delaware corporation (“BCYP”), Big Cypress Merger Sub Inc., a Delaware corporation (“Merger Sub”), the Company, and Shareholder Representative Services LLC, a Colorado limited liability company, solely in its capacity as the representative, agent and attorney-in-fact of the SAB Stockholders (the “Business Combination”).

Prior to the Business Combination, on April 12, 2021, the staff of the SEC issued a Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies (“SPACs”) (the “SEC Staff Statement”).

The SEC Staff Statement focused on certain accounting and reporting considerations related to warrants of a kind similar to warrants that we issued prior to the Business Combination at the time of our initial public offering and the exercises by the underwriters of their over-allotment options in January 2021.

In response to the SEC Staff Statement, we determined to classify these warrants (the “public warrants”) as derivative liabilities measured at fair value, with the initial valuation occurring on October 22, 2021, the “Closing Date” of the Business Combination, with changes in fair value each period reported in earnings.

On September 29, 2023, the Company entered into a securities purchase agreement with certain accredited investors (the “September 2023 Purchase Agreement”), pursuant to which the Company agreed to issue and sell shares of preferred stock and warrants, in a private placement.

See Note 12, Warrants for further information about the private placement offering.

On April 12, 2021, the staff of the SEC issued a Staff Statement on Accounting and Reporting Considerations for Warrants Issued by Special Purpose Acquisition Companies (“SPACs”) (the “SEC Staff Statement”).

The SEC Staff Statement focused on certain accounting and reporting considerations related to warrants of a kind similar to warrants that were issued by BCYP prior to the Business Combination at the time of the BCYP initial public offering and the exercises by the underwriters of their over-allotment options in January 2021.

In response to the SEC Staff Statement, we determined to classify these warrants (the “public warrants”) as derivative liabilities measured at fair value, with the initial valuation occurring on October 22, 2021, the closing date of the Business Combination, with changes in fair value each period reported in earnings (the “Business Combination Closing Date”).

On September 29, 2023, we entered into a securities purchase agreement with certain accredited investors (the “September 2023 Purchase Agreement”), pursuant to which we agreed to issue and sell shares of preferred stock and warrants, in a private placement.

See Note 12, Warrants for further information about the September 2023 Purchase Agreement.

On July 21, 2025, we entered into a securities purchase agreement with certain accredited investors (the “Series B Offering”), pursuant to which we agreed to issue and sell shares of newly-designated Series B convertible preferred stock and warrants, in a private placement.

See Note 12, Warrants , for further information about the Series B Offering.

As a result, included on our balance sheet are derivative liabilities related to embedded features contained within the warrants.

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changes in our effective tax rate;

our ability to make accurate accounting estimates and appropriately recognize revenue for our solutions for which there are no relevant comparable products;

our ability to make accurate

accounting estimates and appropriately recognize revenue for our solutions for which there are no relevant comparable products;

changes in accounting standards, policies, guidance, interpretations, or principles;

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• a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

• requirement that a meeting of stockholders may only be called by members of our Board and the ability of our stockholders to call a special meeting is specifically denied, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors.

force consideration of a proposal or to take action, including the removal of directors.

These provisions, alone or together, could delay hostile takeovers and changes in control or changes in our Board and management.

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In addition, we may not be able to obtain additional financing on terms favorable to us, if at all.

If we are unable to obtain adequate financing or financing on terms satisfactory to

us, when we require it, our ability to continue to support our business growth and to respond to business challenges could be significantly limited.

On January 26, 2024, we entered into a Controlled Equity Offering℠ Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.

If we are unable to obtain adequate financing or financing on terms satisfactory to us, when we require it, our ability to continue to support our business growth and to respond to business challenges could be significantly limited.

On January 26, 2024, we entered into a Controlled Equity Offering℠ Sales Agreement (the “Cantor Sales Agreement”) with Cantor Fitzgerald & Co.

(“Cantor”), relating to shares of our common stock.

In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $20,000,000 from time to time through Cantor, acting as our sales agent.

As of the date hereof, we have not offered or sold any shares of common stock pursuant to the Sales Agreement.

In accordance with the terms of the Cantor Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $20,000,000 from time to time through Cantor, acting as our sales agent.

Effective December 17, 2025, we terminated the Cantor Sales Agreement.

No sales had been made under the Cantor Sales Agreement at the time it was terminated.

On December 29, 2025, we entered into a sales agreement (the “UBS Sales Agreement”) with UBS Securities LLC (“UBS”), relating to shares of our common stock.

In accordance with the terms of the UBS Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $75,000,000 from time to time through UBS, acting as our sales agent.

As of the date hereof, no sales have been made under the UBS Sales Agreement.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

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On November 28, 2023, we registered up to 344,626,967 shares of our common stock (34,462,696 shares following the Reverse Stock Split), in connection with a private placement of securities consummated in October 2023.

The shares of common stock offered for resale by these selling stockholders represented approximately 658.7% of our total common stock outstanding as of October 30, 2023, and represents approximately 371% of our total common stock outstanding as of March 21, 2025.

The shares of common stock offered for resale by these selling stockholders represents approximately 68% of our total common stock outstanding as of March 2, 2026.

Although each stockholder for whom the shares of common stock registered for resale is not permitted to convert their Preferred Stock into shares of common stock to the extent that after giving effect to such conversion, such holder would (together with such holder’s affiliates and related parties) beneficially own in excess of 4.99% (or 9.99% at the election of the holder) of the shares of common stock outstanding immediately after giving effect to such conversion, the market price of our common stock could decline if the holders of such shares sell them over time or are perceived by the market as intending to sell them.

On September 30, 2025, we registered up to 250,000,000 shares of our common stock, in connection with a private placement of securities consummated in July 2025.

The shares of common stock offered for resale by these selling stockholders represents approximately 491% of our total common stock outstanding as of March 2, 2026.

Although each stockholder for whom the shares of Common Stock registered for resale hereunder is not permitted to convert their Series B Shares into shares of Common Stock to the extent that after giving effect to such conversion, such holder would (together with such holder’s affiliates and related parties) beneficially own in excess of 4.99% (or 9.99% at the election of the holder) of the shares of Common Stock outstanding immediately after giving effect to such conversion, the market price of our Common Stock could decline if the holders of such shares sell them over time or are perceived by the market as intending to sell them

Risks Related to Capital Markets

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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