What changed in this filing

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Item 1A. Risk Factors

2026-03-31 compared with 2025-04-02 · 354 added, 349 removed, 1848 unchanged (28% of the section changed)

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to advance the development of TVGN 489 and our preclinical product candidates;

our ExacTcell technology to advance additional product candidates into preclinical and clinical

regulatory approvals for any product candidates that successfully complete clinical trials

and potential commercialization;

and expand our current cGMP manufacturing capacity, including to provide drug supply for

future clinical trials;

our ExacTcell technology to advance additional product candidates into preclinical and clinical development;

regulatory approvals for any product candidates that successfully complete clinical trials and potential commercialization;

and expand our current cGMP manufacturing capacity, including to provide drug supply for future clinical trials;

our AI technologies;

additional clinical, quality control, regulatory, scientific, and administrative personnel;

our operational, financial, and management systems and increase personnel, including to support

our clinical development, manufacturing, and commercialization efforts and our operations

as a public company;

our operational, financial, and management systems and increase personnel, including to support our clinical development, manufacturing,

and commercialization efforts and our operations as a public company;

expand, and protect our intellectual property portfolio;

a marketing, sales, distribution, and medical affairs infrastructure to commercialize any

products for which we may obtain marketing approval and commercialize, whether on our own

or jointly with a partner;

a marketing, sales, distribution, and medical affairs infrastructure to commercialize any products for which we may obtain marketing

approval and commercialize, whether on our own or jointly with a partner;

or in-license other technologies or engage in strategic partnerships;

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preclinical studies and clinical trials of our product candidates;

and obtaining marketing approvals for any product candidates that we or our collaborators

and obtaining marketing approvals for any product candidates that we or our collaborators develop;

authorization of investigational new drug applications INDs for future product candidates;

● identifying

and developing new product candidates;

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cGMP supply of our product candidates for clinical trials and, if approved, commercial sales;

and commercializing products for which we obtain marketing approval by establishing a marketing,

sales, distribution, and medical affairs infrastructure or, alternatively, collaborating

with a commercialization partner;

coverage and adequate reimbursement by hospitals and third-party payors, including governmental

authorities, such as Medicare and Medicaid, private insurers, and managed care organizations,

for product candidates, if approved, that we or our collaborators develop;

market acceptance of product candidates, if approved, that we develop as viable treatment

and commercializing products for which we obtain marketing approval by establishing a marketing, sales, distribution, and medical

affairs infrastructure or, alternatively, collaborating with a commercialization partner;

coverage and adequate reimbursement by hospitals and third-party payors, including governmental authorities, such as Medicare and

Medicaid, private insurers, and managed care organizations, for product candidates, if approved, that we or our collaborators develop;

market acceptance of product candidates, if approved, that we develop as viable treatment options;

any competing technological and market developments;

● negotiating

favorable terms in any collaboration, licensing, or other arrangements into which we may

enter and performing our obligations under such arrangements;

● maintaining,

protecting, and expanding our portfolio of intellectual property rights, including patents,

trade secrets and know-how;

favorable terms in any collaboration, licensing, or other arrangements into which we may enter and performing our obligations under

such arrangements;

protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how;

against third-party interference or infringement claims, if any;

● attracting,

hiring, and retaining qualified personnel.

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are relying in part on an additional $7.0 million of grant funding that we have not yet received to meet our liquidity needs.

primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, amounts available under the

Loan Agreement, and an additional $8.0 million of grant funding we expect to receive in the second quarter of 2025 from KRHP LLC, a

New Jersey limited liability company (“KRHP”).

In January 2025, we received a grant of $2.0 million from KRHP to further

our development of off-the-shelf, genetically unmodified precision T cell therapeutics to treat infectious diseases and cancers.

KRHP also committed to provide an additional $8.0 million of grant funding to the Company to be used towards the Company’s

ongoing operational expenses.

primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, amounts available under the Loan

Agreement (as defined below), proceeds from sales of Common Stock under our Sales Agreement with A.G.P./Alliance Global Partners (the

“Sales Agreement”), and an additional $7.0 million of grant funding we expect to receive in 2026 from

KRHP LLC, a New Jersey limited liability company (“KRHP”).

In January 2025, we received a grant of $2.0 million from KRHP

to further our development of off-the-shelf, genetically unmodified precision T cell therapeutics to treat infectious diseases and cancers.

In August 2025, we received a grant of $1.0 million from KRHP to advance Tevogen.AI.

KRHP also committed to provide an additional $7.0

million of grant funding to the Company to be used towards the Company’s ongoing operational expenses.

are relying in part on the additional grant funding to help meet our liquidity needs.

Even if we receive all of such proceeds, we will

still need additional capital to fully implement our business, operating, and development plans.

At this time, we have not secured any

additional financing.

There can be no assurance that additional capital will be available to us, or that, if available, it will be on

terms satisfactory to us.

If we do not obtain additional capital on terms satisfactory to us, or at all, it may cause us to delay, curtail,

scale back or forgo some or all of our research and development or business operations, which could have a material adverse effect on

our business and financial results.

will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at

A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development,

commercialization efforts or other operations.

expect to spend substantial amounts of cash to continue the preclinical and clinical development of our current and future programs.

If we receive marketing approval for any product candidates, including TVGN 489, we will require significant additional amounts of cash

in order to launch and commercialize such product candidates.

still need more capital to fully implement our business, operating, and development plans, in addition to proceeds from sales of Common

Stock under our Sales Agreement.

At this time, we have not secured any additional financing.

There can be no assurance that additional

capital will be available to us, or that, if available, it will be on terms satisfactory to us.

If we do not obtain additional capital

on terms satisfactory to us, or at all, it may cause us to delay, curtail, scale back or forgo some or all of our research and development

or business operations, which could have a material adverse effect on our business and financial results.

will require substantial additional financing to pursue our business objectives and to fund our operations, which may not be available

on acceptable terms, or at all.

A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate

our product development, commercialization efforts or other operations and affect our future viability as an ongoing business.

expect to spend substantial amounts of cash to continue the preclinical and clinical development of our current and future immunotherapy

programs, to fund our Tevogen.AI artificial intelligence initiative, and to pursue other potential business objectives.

If we receive

marketing approval for any product candidates, including TVGN 489, we will require significant additional amounts of cash in order to

launch and commercialize such product candidates.

In addition, other unanticipated costs may arise.

Because the designs and

outcomes of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary

to successfully complete the development of and commercialize any product candidate we develop.

Because the designs and outcomes

of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully

complete the development of and commercialize any product candidate we develop.

future capital requirements depend on many factors, including:

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and licensing arrangements.

a result of our cash balance, as well as our history of operating losses and negative cash flows from operations combined with our anticipated

use of cash to, among other things, fund the preclinical and clinical development of our products, identify and develop new product candidates,

and seek approval for TVGN 489 and our other product candidates and any other product candidates we develop, we will require substantial

additional financing to pursue our business objectives and fund our operations.

Our future viability as an ongoing business is dependent

on our ability to generate cash from operating activities or to raise additional capital to finance our operations.

reflected in our balance sheets, we have significant accounts payable, accrued expenses and other liabilities.

Proceeds from any capital-raising

transactions may be used to reduce our accounts payable accrued expenses and other liabilities.

However, there can be no assurance that

we will raise sufficient funds to eliminate such amounts.

Additionally,

the terms of the Preferred Stock and our Loan Agreement may negatively impact our ability to raise additional capital through equity

or debt financings, due to the potential substantial dilution to our stockholders that could occur as a result of the conversion of our

convertible Preferred Stock or our issuance of shares under the Loan Agreement and due to the other terms of our Preferred Stock and

the Loan Agreement, or may negatively affect our ability to obtain favorable or acceptable terms in connection with any such financing.

the terms of our Preferred Stock, our Loan Agreement, and our Sales Agreement may negatively impact our ability to raise additional capital

through equity or debt financings, due to the potential substantial dilution to our stockholders that could occur as a result of the

conversion of our convertible Preferred Stock or our issuance of shares under the Loan Agreement or Sales Agreement and due to the other

terms of our Preferred Stock and such agreements, or may negatively affect our ability to obtain favorable or acceptable terms in connection

with any such financing.

if we raise additional capital through marketing, sales, and distribution arrangements or other collaborations, strategic alliances,

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cells in order to produce T cell immunity, developing and commercializing our product candidates subjects us to a number of challenges,

regulatory approval from FDA, which has relatively limited experience with regulating the

development and commercialization of T cell immunotherapies;

and deploying consistent and reliable processes for procuring blood from consenting third-party

donors, isolating T cells from the blood of such donors, activating the isolated T cells

against specific antigens, characterizing and storing the resulting activated T cells for

future therapeutic use, selecting and delivering a sufficient supply and breadth of appropriate

human leukocyte antigen-matched (“HLA-matched”) cells from among the available

T cell lines, and finally infusing these activated T cells into patients to eliminate virus-infected

cells in the patient and induce anti-disease benefit;

on healthcare provider site availability and accessibility to patients for receipt of T cell

these product candidates in combination with other therapies currently used to treat patients

in our target population, which may increase the risk of adverse side effects;

medical personnel regarding the potential side effect profile of each of our product candidates,

particularly those that may be unique to our allogeneic T cell therapy product candidates;

regulatory approval from FDA, which has relatively limited experience with regulating the development and commercialization of T

cell immunotherapies;

and deploying consistent and reliable processes for procuring blood from consenting third-party donors, isolating T cells from the

blood of such donors, activating the isolated T cells against specific antigens, characterizing and storing the resulting activated

T cells for future therapeutic use, selecting and delivering a sufficient supply and breadth of appropriate human leukocyte antigen-matched

(“HLA-matched”) cells from among the available T cell lines, and finally infusing these activated T cells into patients

to eliminate virus-infected cells in the patient and induce anti-disease benefit;

on healthcare provider site availability and accessibility to patients for receipt of T cell infusions;

these product candidates in combination with other therapies currently used to treat patients in our target population, which may

increase the risk of adverse side effects;

medical personnel regarding the potential side effect profile of each of our product candidates, particularly those that may be unique

to our allogeneic T cell therapy product candidates;

understanding

and addressing variability in the quality of a donor’s T cells, which could ultimately

affect our ability to manufacture product in a reliable and consistent manner;

processes for the safe administration of these products, including long-term follow-up and

registries, as applicable, for all patients who receive these product candidates;

and addressing variability in the quality of a donor’s T cells, which could ultimately affect our ability to manufacture product

in a reliable and consistent manner;

processes for the safe administration of these products, including long-term follow-up and registries, as applicable, for all patients

who receive these product candidates;

manufacturing

our product candidates to our specifications and in a timely manner to support our clinical

trials and, if approved, commercialization;

clinical and, if approved by FDA, commercial supplies for the materials used to manufacture

and process these product candidates that are free from viruses and other pathogens that

may increase the risk of adverse side effects;

a manufacturing process and distribution network that can provide a stable supply with a

cost of goods that allows for an attractive return on investment;

● establishing

sales and marketing capabilities ahead of and after obtaining any regulatory approval to

gain market acceptance, and obtaining adequate coverage, reimbursement and pricing by third-party

payors and government authorities;

our product candidates to our specifications and in a timely manner to support our clinical trials and, if approved, commercialization;

clinical and, if approved by FDA, commercial supplies for the materials used to manufacture and process these product candidates

that are free from viruses and other pathogens that may increase the risk of adverse side effects;

a manufacturing process and distribution network that can provide a stable supply with a cost of goods that allows for an attractive

return on investment;

sales and marketing capabilities ahead of and after obtaining any regulatory approval to gain market acceptance, and obtaining adequate

coverage, reimbursement and pricing by third-party payors and government authorities;

therapies for types of diseases beyond those initially addressed by our current product candidates.

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We also expect to continue to rely on third parties to conduct our pivotal clinical trials.

Related to Reliance on Manufacturing and Third Parties .” If these third parties do not successfully carry out their contractual

duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize

TVGN 489 any future product candidates we develop, and our business could be materially harmed.

We may require more time and incur greater

costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop.

Risks Related to Reliance on Manufacturing and Third Parties .” If these third parties do not successfully carry out their

contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for

or commercialize TVGN 489 any future product candidates we develop, and our business could be materially harmed.

We may require more

time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we

we are unable to successfully develop, receive regulatory approval for, and commercialize our product candidates, our business will be

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INDs submitted to FDA that allow commencement of our clinical trials for our product candidates;

● sufficiency

of our financial and other resources to complete the necessary preclinical studies and clinical

development of, or making arrangements with third-party manufacturers for, our commercial

manufacturing processes for our clinical trials and any of our product candidates that receive

regulatory approval at an acceptable cost and on a timely basis;

of our financial and other resources to complete the necessary preclinical studies and clinical trials;

development of, or making arrangements with third-party manufacturers for, our commercial manufacturing processes for our clinical

trials and any of our product candidates that receive regulatory approval at an acceptable cost and on a timely basis;

of timely marketing approvals from FDA;

commercial sales of products, if approved;

of the benefits and use of our products, if approved, by patients, the medical community,

and third-party payors, for their approved indications;

prevalence and severity of adverse events or other safety issues experienced with our product

availability, perceived advantages, cost, safety, and efficacy of alternative therapies for

any product candidate, and any indications for such product candidate, that we develop;

of the benefits and use of our products, if approved, by patients, the medical community, and third-party payors, for their approved

prevalence and severity of adverse events or other safety issues experienced with our product candidates;

availability, perceived advantages, cost, safety, and efficacy of alternative therapies for any product candidate, and any indications

for such product candidate, that we develop;

ability to produce any product candidates we develop on a commercial scale;

and maintaining patent, trademark and trade secret protection and regulatory exclusivity

for our product candidates and otherwise protecting our rights in our intellectual property

● maintaining

and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our product candidates and otherwise

protecting our rights in our intellectual property portfolio;

compliance with regulatory requirements, including cGMP requirements;

and maintaining coverage and adequate reimbursement by third-party payors, including government

payors, for our products, if approved by FDA;

● maintaining

a continued acceptable safety, tolerability and efficacy profile of the products following

● maintaining

and growing an organization of scientists and functional experts who can develop and commercialize

our products and technology.

and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for our products, if approved

a continued acceptable safety, tolerability and efficacy profile of the products following approval;

and growing an organization of scientists and functional experts who can develop and commercialize our products and technology.

we do not succeed with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or

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may experience delays in completing planned clinical trials for a variety of reasons, including the following:

extensive research and development required because our product candidates are based on new

technologies;

extensive research and development required because our product candidates are based on new technologies;

availability of financial resources to commence and complete the planned trials;

agreement on acceptable terms with prospective clinical research organizations (“CROs”)

and clinical trial sites, the terms of which can be subject to extensive negotiation and

may vary significantly among different CROs and trial sites;

or independent IRBs may not authorize us or our investigators to commence a clinical trial

or conduct a clinical trial at a prospective trial site;

agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites, the

terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

or independent IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective

suitable patients to participate in a trial or sufficient patients to complete a trial;

patients complete a trial or return for post-treatment follow-up;

trial sites deviating from trial protocol or dropping out of a trial, which may require that

we add new clinical trial sites or investigators;

trial sites deviating from trial protocol or dropping out of a trial, which may require that we add new clinical trial sites or investigators;

manufacturing

the necessary product for use in the clinical trials;

trials of any product candidate may fail to show safety, purity, or potency, or may produce

negative or inconclusive results, which may cause us to decide, or regulators to require

us, to conduct additional nonclinical trials or clinical trials or which may cause us to

decide to abandon product candidate development programs;

of our product candidates could cause undesirable side effects that could result in significant

negative consequences, including the inability to enter clinical development or receive regulatory

● competition

trials of any product candidate may fail to show safety, purity, or potency, or may produce negative or inconclusive results, which

may cause us to decide, or regulators to require us, to conduct additional nonclinical trials or clinical trials or which may cause

us to decide to abandon product candidate development programs;

of our product candidates could cause undesirable side effects that could result in significant negative consequences, including

the inability to enter clinical development or receive regulatory approval;

from other clinical trial programs for similar indications and clinical trial patients.

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may disagree with the design or implementation of our clinical trials;

may be unable to demonstrate to the satisfaction of FDA that a product candidate is safe,

pure, and potent for its proposed indication;

results of clinical trials may not meet the level of statistical significance required by

FDA for approval;

may be unable to demonstrate that a product candidate’s clinical and other benefits

outweigh its safety risks;

may be unable to demonstrate to the satisfaction of FDA that a product candidate is safe, pure, and potent for its proposed indication;

results of clinical trials may not meet the level of statistical significance required by FDA for approval;

may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

may disagree with our interpretation of data from clinical trials or preclinical studies;

data collected from clinical trials of our product candidates may not be sufficient to support

the submission of a BLA to FDA to obtain regulatory approval in the United States;

may find deficiencies with or fail to approve our manufacturing processes or facility or

the manufacturing processes or facilities of third-party manufacturers with which we contract

for clinical and commercial supplies.

data collected from clinical trials of our product candidates may not be sufficient to support the submission of a BLA to FDA to

obtain regulatory approval in the United States;

may find deficiencies with or fail to approve our manufacturing processes or facility or the manufacturing processes or facilities

of third-party manufacturers with which we contract for clinical and commercial supplies.

lengthy approval process as well as the unpredictability of clinical trial results may result in our failing to obtain regulatory approval

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Additionally, RMAT designation can be revoked if the criteria for eligibility cease to be met as clinical data emerges.

may also seek other accelerated approval pathways for our product candidates, which face some of the same risks as seeking RMAT designation,

and may not be successful or actually result in expedited review or approval.

One of these programs is the FDA Commissioner’s National

Priority Voucher pilot program, which additionally is new and has only seen 18 products receive vouchers and one product see FDA approval

as of December 2025, therefore presenting additional unknown risks.

business is highly dependent on our first product candidate, TVGN 489, and we must conduct clinical testing before we can obtain regulatory

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may withdraw approvals of such product;

may require additional warnings on the labels such as a “black box” warning or

a contraindication;

may be required to create a medication guide outlining the risks of such side effects for

distribution to patients or other requirements subject to a REMS;

may require additional warnings on the labels such as a “black box” warning or a contraindication;

may be required to create a medication guide outlining the risks of such side effects for distribution to patients or other requirements

subject to a REMS;

could be sued and held liable for harm caused to patients;

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may be required to recall a product or change the way such product is administered to patients;

restrictions may be imposed on the marketing of the particular product or the manufacturing

processes for the product or any component thereof;

restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component

reputation and physician or patient acceptance of our products may suffer.

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patient eligibility criteria defined in the protocol;

nature and size of the patient population required for analysis of the trial’s primary

endpoints and the process for identifying patients;

nature and size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying

number and location of participating clinical sites or patients;

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ability to recruit clinical trial investigators with the appropriate competencies and experience;

● clinicians’

and patients’ perceptions as to the potential advantages and risks of the product candidate

being studied in relation to other available therapies, including any new products that may

be approved for the indications we are investigating;

availability of competing commercially available therapies and other competing drug candidates’

clinical trials;

ability to obtain and maintain patient informed consents for participation in our clinical

and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other

available therapies, including any new products that may be approved for the indications we are investigating;

availability of competing commercially available therapies and other competing drug candidates’ clinical trials;

ability to obtain and maintain patient informed consents for participation in our clinical trials;

risk that patients enrolled in clinical trials will drop out of the trials before completion;

outside of our control, including as a result of business interruptions resulting from natural

disasters and public health emergencies, such as the coronavirus.

outside of our control, including as a result of business interruptions resulting from natural disasters and public health emergencies,

such as the coronavirus.

may experience difficulties in patient enrollment in our future clinical trials for a variety of reasons.

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IRB with respect to a particular clinical trial site, for various reasons, including:

● deficiencies

in the conduct of the clinical trials, including failure to conduct the clinical trial in

accordance with regulatory requirements or study protocols;

● deficiencies

in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements

or study protocols;

in the clinical trial operations or trial sites;

adverse side effects or the emergence of undue risks to study subjects;

● deficiencies

in the trial design necessary to demonstrate efficacy;

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an artificial intelligence task force and develop a strategic plan.

It is unclear how these executive actions or other potential

actions by the Trump Administration will impact the regulatory authorities that oversee our business.

These budgetary pressures may reduce

FDA’s ability to perform its responsibilities.

If a significant reduction in FDA’s workforce occurs, FDA’s budget is

significantly reduced, or there are other disruptions at FDA and other agencies, more time may be necessary for biological products,

or biologics, or modifications to approved biologics to be reviewed and/or approved by necessary government agencies, which could increase

our costs and would adversely affect our business.

In addition, if a prolonged government shutdown occurs, it could significantly impact

the ability of FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

For example, over the last several years, the United States government has shut down several times and certain regulatory agencies, such

as FDA, have had to furlough critical FDA employees and stop critical activities.

Additionally, Congress may introduce and ultimately

pass healthcare related legislation that could impact the drug approval process.

It is unclear how these executive actions or other potential actions

by the Trump Administration will impact the regulatory authorities that oversee our business.

These budgetary pressures may reduce FDA’s

ability to perform its responsibilities.

If a significant reduction in FDA’s workforce occurs, FDA’s budget is significantly

reduced, or there are other disruptions at FDA and other agencies, more time may be necessary for biological products, or biologics,

or modifications to approved biologics to be reviewed and/or approved by necessary government agencies, which could increase our costs

and would adversely affect our business.

In addition, if a prolonged government shutdown occurs, it could significantly impact the ability

of FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

over the last several years, the United States government has shut down several times and certain regulatory agencies, such as FDA, have

had to furlough critical FDA employees and stop critical activities.

Additionally, Congress may introduce and ultimately pass healthcare

related legislation that could impact the drug approval process.

may develop future product candidates in combination with other therapies, which exposes us to additional regulatory risks.

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by physicians and patients of the drug as a safe and effective treatment;

administrative and logistical burden of treating patients, including the availability and

accessibility of healthcare provider sites for administering infusions to patients;

administrative and logistical burden of treating patients, including the availability and accessibility of healthcare provider sites

for administering infusions to patients;

adoption of novel cellular therapies by physicians, hospitals, and third-party payors;

potential and perceived advantages of product candidates over alternative treatments;

safety of product candidates seen in a broader patient group, including its use outside the

approved indications should physicians choose to prescribe for such uses;

safety of product candidates seen in a broader patient group, including its use outside the approved indications should physicians

choose to prescribe for such uses;

restrictions on use together with other medications;

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cost of treatment in relation to alternative treatments;

availability of coverage and adequate reimbursement from, and our ability to negotiate pricing

with, third-party payors, providers, and government authorities;

availability of coverage and adequate reimbursement from, and our ability to negotiate pricing with, third-party payors, providers,

and government authorities;

convenience and ease of administration;

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warning letters or untitled letters;

modifications to promotional materials or require us to provide corrective information to

healthcare practitioners, or require other restrictions on the labeling or marketing of such

us to enter into a consent decree, which can include imposition of various fines, reimbursements

for inspection costs, required due dates for specific actions and penalties for noncompliance;

modifications to promotional materials or require us to provide corrective information to healthcare practitioners, or require other

restrictions on the labeling or marketing of such products;

us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due

dates for specific actions and penalties for noncompliance;

an injunction or impose civil or criminal penalties or monetary fines;

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or impose restrictions on operations, including costly new manufacturing requirements;

or detain products, refuse to permit the import or export of products, or require us to initiate

a product recall.

or detain products, refuse to permit the import or export of products, or require us to initiate a product recall.

occurrence of any of the foregoing may inhibit our ability to successfully commercialize our products.

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In addition, compliance with such laws may require increased costs to us or may dictate that

wet not offer certain types of services in the future.

we not offer certain types of services in the future.

use of AI could give rise to liability, breaches of data security and privacy laws, or reputational damage.

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and the states in which we conduct our business.

These laws, described in further detail in “ Regulatory Environment –

Healthcare Regulation – Other Healthcare Laws and Compliance Requirements ,” include:

federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly

and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly,

to induce, or in return for, the purchase or recommendation of an item or service reimbursable

under a federal healthcare program, such as the Medicare and Medicaid programs;

federal civil False Claims Act, which prohibits, among other things, individuals or entities

from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment

of government funds, or knowingly making, using or causing to be made or used, a false record

or statement material to an obligation to pay money to the government or knowingly concealing

or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money

to the federal government;

which created new federal criminal statutes that prohibit executing a scheme to defraud any

healthcare benefit program and making false statements relating to healthcare matters;

as amended by the Health Information Technology for Economic and Clinical Health Act, and

its implementing regulations, which imposes specified requirements relating to the privacy,

security, and transmission of individually identifiable health information;

federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices,

biologics, and medical supplies for which payment is available under Medicare, Medicaid or

the Children’s Health Insurance Program (with certain exceptions) to report annually

to the CMS information related to direct or indirect payments and other transfers of value

to physicians and teaching hospitals (and certain other practitioners), as well as ownership

and investment interests held in the Company by physicians and their immediate family members;

law equivalents of each of the above federal laws, such as anti-kickback and false claims

laws that may apply to items or services reimbursed by any third-party payor, including governmental

and private payors, laws that require manufacturers to comply with the pharmaceutical industry’s

voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal

government, or otherwise restrict payments that may be made to healthcare providers and other

potential referral sources, state laws that require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers

or marketing expenditures, and state laws governing the privacy and security of health information

in specified circumstances, many of which differ from each other in significant ways and

may not have the same scope or application, thus complicating compliance efforts.

These laws, described in further detail in “ Regulatory Environment - Healthcare

Regulation - Other Healthcare Laws and Compliance Requirements ,” include:

federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering,

or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service

reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;

federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing

to be presented, a false or fraudulent claim for payment of government funds, or knowingly making, using or causing to be made or

used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and

improperly avoiding, decreasing or concealing an obligation to pay money to the federal government;

which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making

false statements relating to healthcare matters;

as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, which imposes

specified requirements relating to the privacy, security, and transmission of individually identifiable health information;

federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics, and medical supplies for

which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to

report annually to the CMS information related to direct or indirect payments and other transfers of value to physicians and teaching

hospitals (and certain other practitioners), as well as ownership and investment interests held in the Company by physicians and

their immediate family members;

law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services

reimbursed by any third-party payor, including governmental and private payors, laws that require manufacturers to comply with the

pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government,

or otherwise restrict payments that may be made to healthcare providers and other potential referral sources, state laws that require

drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers

or marketing expenditures, and state laws governing the privacy and security of health information in specified circumstances, many

of which differ from each other in significant ways and may not have the same scope or application, thus complicating compliance

to ensure that our collaborations with third parties, and our business generally, will comply with applicable United States and healthcare

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collaborators

may have significant discretion in determining the efforts and resources that they will apply

to these collaborations;

may have significant discretion in determining the efforts and resources that they will apply to these collaborations;

collaborators

could independently develop, or develop with third parties, products that compete directly

or indirectly with our products or product candidates;

could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product

collaborators

may not properly enforce, maintain, or defend our intellectual property rights or may use

our proprietary information in a way that gives rise to actual or threatened litigation or

that could jeopardize or invalidate our intellectual property or proprietary information,

may not properly enforce, maintain, or defend our intellectual property rights or may use our proprietary information in a way that

gives rise to actual or threatened litigation or that could jeopardize or invalidate our intellectual property or proprietary information,

exposing us to potential litigation or other intellectual property proceedings;

collaborators

may infringe the intellectual property rights of third parties, which may expose us to litigation

and potential liability;

may arise between a collaborator and us that cause the delay or termination of the research,

development, or commercialization of the product candidate, or that result in costly litigation

or arbitration that diverts management attention and resources;

may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

may arise between a collaborator and us that cause the delay or termination of the research, development, or commercialization of

the product candidate, or that result in costly litigation or arbitration that diverts management attention and resources;

collaborators

with marketing and distribution rights to one or more of our product candidates that achieve

regulatory approval may not commit sufficient resources to the marketing and distribution

of such products;

a present or future collaborator were to be involved in a business combination, the continued

pursuit and emphasis on our product development or commercialization program under such collaboration

could be delayed, diminished, or terminated;

with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient

resources to the marketing and distribution of such products;

a present or future collaborator were to be involved in a business combination, the continued pursuit and emphasis on our product

development or commercialization program under such collaboration could be delayed, diminished, or terminated;

collaboration

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include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity

or ownership of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review

and derivation proceedings.

Additional changes in patent law could increase the uncertainties and costs surrounding the prosecution of

our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our

business, financial condition, results of operations and prospects.

or ownership of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation

Additional changes in patent law could increase the uncertainties and costs surrounding the prosecution of our patent applications

and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition,

results of operations and prospects.

addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly

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

Such mechanisms include re-examination, post grant review, inter partes review and equivalent proceedings in foreign

jurisdictions.

Such proceedings could result in the revocation or cancellation of or amendment to our patents in such a way that they

no longer cover our product candidates.

Such mechanisms include re-examination, post grant review, inter partes review and equivalent proceedings in foreign jurisdictions.

Such proceedings could result in the revocation or cancellation of or amendment to our patents in such a way that they no longer cover

our product candidates.

The outcome following legal assertions of invalidity and unenforceability is unpredictable.

cannot be certain that there is no invalidating prior art of which the patent examiner and we were unaware during prosecution.

If a defendant

were to prevail on a legal assertion of invalidity or unenforceability, we could lose part, and perhaps all, of the patent protection

on one or more of our product candidates.

We cannot be certain

that there is no invalidating prior art of which the patent examiner and we were unaware during prosecution.

If a defendant were to prevail

on a legal assertion of invalidity or unenforceability, we could lose part, and perhaps all, of the patent protection on one or more

of our product candidates.

Such a loss of patent protection could have a material adverse impact on our business.

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We may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual

property rights with respect to our product candidates and technology, including post grant review and inter partes review

before the USPTO.

The risks of being involved in such litigation and proceedings may also increase as our product candidates approach

commercialization and as we gain greater visibility as a public company.

Third parties may assert infringement claims against us based

on existing patents or patents that may be granted in the future, regardless of their merit.

There is a risk that third parties may choose

to engage in litigation with us to enforce or to otherwise assert their patent rights against us.

Even if we believe such claims are

without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable, and infringed, which

could materially and adversely affect our ability to commercialize any of our product candidates or technologies covered by the asserted

third-party patents.

property rights with respect to our product candidates and technology, including post grant review and inter partes review before

The risks of being involved in such litigation and proceedings may also increase as our product candidates approach commercialization

and as we gain greater visibility as a public company.

Third parties may assert infringement claims against us based on existing patents

or patents that may be granted in the future, regardless of their merit.

There is a risk that third parties may choose to engage in litigation

with us to enforce or to otherwise assert their patent rights against us.

Even if we believe such claims are without merit, a court of

competent jurisdiction could hold that these third-party patents are valid, enforceable, and infringed, which could materially and adversely

affect our ability to commercialize any of our product candidates or technologies covered by the asserted third-party patents.

we are found to infringe a third party’s valid and enforceable intellectual property rights, we could be required to obtain a license

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and may not adequately protect our business or permit us to maintain our competitive advantage.

may be able to make products that are similar to our product candidates but that are not

covered by the claims of the patents that we own or may own in the future;

or any partners or collaborators, might not have been the first to make the inventions covered

by the issued patents or pending patent applications that we own or may own in the future;

or any partners or collaborators, might not have been the first to file patent applications

covering certain of our or their inventions;

may independently develop similar or alternative technologies or duplicate any of our technologies

without infringing our owned or licensed intellectual property rights;

is possible that our pending patent applications or those that we may own in the future will

not lead to issued patents;

patents that we hold rights to may be held invalid or unenforceable, including as a result

of legal challenges by our competitors;

competitors might conduct research and development activities in countries where we do not

have patent rights and then use the information learned from such activities to develop competitive

products for sale in our major commercial markets;

may be able to make products that are similar to our product candidates but that are not covered by the claims of the patents that

we own or may own in the future;

or any partners or collaborators, might not have been the first to make the inventions covered by the issued patents or pending patent

applications that we own or may own in the future;

or any partners or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;

may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or

licensed intellectual property rights;

is possible that our pending patent applications or those that we may own in the future will not lead to issued patents;

patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

competitors might conduct research and development activities in countries where we do not have patent rights and then use the information

learned from such activities to develop competitive products for sale in our major commercial markets;

may not develop additional proprietary technologies that are patentable;

patents of others may have an adverse effect on our business;

may choose not to file a patent for certain trade secrets or know-how, and a third party

may subsequently file a patent covering such intellectual property.

may choose not to file a patent for certain trade secrets or know-how, and a third party may subsequently file a patent covering

such intellectual property.

any of these events occur, they could significantly harm our business, financial condition, results of operations and prospects.

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Future growth would impose significant added responsibilities on members of management, including:

● identifying,

recruiting, integrating, maintaining, and motivating additional employees;

our internal development efforts effectively, including the clinical and FDA review process

for TVGN 489 and any future product candidates we develop, while complying with our contractual

obligations to contractors and other third parties;

our internal development efforts effectively, including the clinical and FDA review process for TVGN 489 and any future product candidates

we develop, while complying with our contractual obligations to contractors and other third parties;

our operational, financial and management controls, reporting systems and procedures.

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candidates we develop and, accordingly, may not achieve our research, development, and commercialization goals.

may not realize the benefits of any acquisitions, strategic alliances, or similar arrangements that we enter into.

the future, we may seek and form strategic alliances, create joint ventures or collaborations, or enter into acquisitions or licensing

arrangements with third parties that we believe will complement or augment our existing technologies and product candidates, including

other pharmaceutical companies and CROs.

transactions can entail numerous operational and financial risks, including exposure to unknown liabilities, disruption of our business

and diversion of our management’s time and attention in order to manage a collaboration or develop acquired products, product candidates

or technologies, incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs,

higher than expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased

amortization expenses, difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired

business, impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management

and ownership and the inability to retain key employees of any acquired business.

As a result, if we enter into acquisition or in-license

agreements or strategic partnerships, we may not consummate the transactions on a timely basis or at all, and may not be able to realize

the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture, which

could delay our timelines or otherwise adversely affect our business.

We also cannot be certain that, following a strategic transaction

or license, we will achieve the revenue or specific net income that justifies such transaction or such other benefits that led us to

enter into the arrangement.

liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates.

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of trial participants;

● termination

of clinical trial sites or entire trial programs;

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of investigations by regulators;

● significant

time and costs to defend the related litigation;

● substantial

monetary awards to trial subjects or patients;

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factors may have a material adverse effect on the market price of our securities, including, but not limited to:

commencement, enrollment, delay, or results of our ongoing or future clinical trials, or

changes in the development status of our product candidates;

commencement, enrollment, delay, or results of our ongoing or future clinical trials, or changes in the development status of our

product candidates;

decision to initiate, not to initiate, or to terminate a clinical trial;

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serious safety concerns related to the use of our product candidates;

delay in our regulatory filings for our product candidates and any adverse or perceived adverse

development with respect to the applicable regulatory authority’s review of such filings;

actions, including failure to receive regulatory approval, with respect to our product candidates

or our competitors’ products or product candidates;

delay in our regulatory filings for our product candidates and any adverse or perceived adverse development with respect to the applicable

regulatory authority’s review of such filings;

actions, including failure to receive regulatory approval, with respect to our product candidates or our competitors’ products

or product candidates;

failure to commercialize our products;

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announcements

by us or our competitors of significant acquisitions, strategic collaborations, joint ventures,

collaborations, capital commitments, significant development milestones, or product approvals;

by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations, capital commitments,

significant development milestones, or product approvals;

failure to obtain new commercial partners;

failure to obtain adequate manufacturing capacity or product supply for any approved product

or inability to do so at acceptable cost;

failure to obtain adequate manufacturing capacity or product supply for any approved product or inability to do so at acceptable

failure to achieve expected product sales and profitability;

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level of expenses related to our product candidates or clinical development programs;

● significant

lawsuits, including without limitation patent or stockholder litigation;

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in financial estimates or recommendations by securities analysts;

● fluctuations

in the valuation or financial results of companies perceived by investors to be comparable

● inconsistent

in the valuation or financial results of companies perceived by investors to be comparable to us;

trading volume levels of our shares;

● announcement

or expectation of additional financing efforts;

of Common Stock by us, our executive officers or directors, or our stockholders;

● fluctuations

of Common Stock by us, our executive officers or directors, or our stockholders, including under our Sales Agreement;

and market conditions in the U.S.

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economic, political and social conditions;

events or factors, many of which are beyond our control, or unrelated to our operating performance

or prospects.

events or factors, many of which are beyond our control, or unrelated to our operating performance or prospects.

recent years, the stock market in general has experienced significant price and volume fluctuations that have often been unrelated or

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of our Common Stock following the business combination.

we fail to meet Nasdaq’s continued listing requirements, our Common Stock and our outstanding public warrants to purchase Common

Stock could be delisted.

Common Stock and our Warrants are listed on Nasdaq.

We are required to meet specified financial and other requirements in order to maintain

such listing, including a requirement that the closing bid price for our Common Stock remain above $1.00 and that the market value of

our Common Stock is at least $50 million and the market value of publicly held shares of our Common Stock is at least $15 million.

September 23, 2025, we received a notification letter from Nasdaq’s Listing Qualifications Staff notifying us that the closing

bid price for our Common Stock had been below $1.00 for the previous 30 consecutive business days and that we therefore are not in compliance

with the minimum bid price requirement for continued inclusion on Nasdaq under Nasdaq Listing Rule 5450(a)(1) (the “Bid Price Requirement”).

On March 20, 2026, we received written notice (the “Notification Letter”) from Nasdaq that the Company had regained

compliance with the Bid Price Requirement.

The Notification Letter was sent following the implementation of a 1-for-50 reverse stock

split of the Company’s Common Stock (the “Reverse Split”), which became effective on March 6, 2026.

is no guarantee that we will maintain compliance with the Bid Price Requirement.

If we are once again notified by Nasdaq that we are

not in compliance with the Bid Price Requirement we do not regain compliance by the compliance deadline, we may be eligible for an additional

180 calendar days, provided that we submit an online transfer application to transfer the listing of our Common Stock to the Nasdaq Capital

Market, submit an application fee, and meet the continued listing requirement for market value of publicly held shares and all other

initial listing standards for the Nasdaq Capital Market, except the bid price requirement.

In addition, we will be required to provide

written notice of our intention to cure the deficiency during the second compliance period by effecting a reverse stock split if necessary.

If it appears to Nasdaq that we will not be able to cure the deficiency during the second compliance period, or if we determine not to

submit a transfer application or make the required representation, Nasdaq will provide written notice to us that our Common Stock will

be subject to delisting.

In the event of such notification, we may appeal Nasdaq’s determination to delist its securities, but

there can be no assurance that Nasdaq would grant our request for continued listing.

can be no assurance that we will be able to maintain compliance with the minimum bid price requirement or will otherwise be in compliance

with other Nasdaq listing criteria.

we fail to maintain compliance with the requirement to maintain a minimum closing bid price of $1.00 per share or to meet other Nasdaq

continued listing requirements, Nasdaq may take steps to delist our securities.

Such a delisting would likely have a negative effect

on the price of our securities and would impair your ability to sell or purchase the securities when you wish to do so.

of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our

securities to become listed again, stabilize the market price or improve the liquidity of our securities, prevent our securities from

dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

Additionally,

if our securities are not listed on, or become delisted from, Nasdaq for any reason, and are quoted on the OTC Bulletin Board, an inter-dealer

automated quotation system for equity securities that is not a national securities exchange, the liquidity and price of our securities

may be more limited than if our securities were quoted or listed on Nasdaq or another national securities exchange.

You may be unable

to sell your securities unless a market can be established or sustained.

have previously failed to timely file certain periodic reports with the SEC.

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the SEC pose significant risks to our business, and could materially and adversely affect our financial condition and results of operations.

did not timely file our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 or our Form 10-Q for the quarterly

period ended March 31, 2024 and missed the initial deadline for the filing of our Form 10-Q for the quarterly period ended September

did not timely file our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 or our Form 10-Q for the quarterly period

ended March 31, 2024 and missed the initial deadline for the filing of our Form 10-Q for the quarterly period ended September 30, 2024

and our Form 10-K for the fiscal year ended December 31, 2024.

While we are now current in our filing of periodic reports under the Exchange Act, there is no assurance that in the

future our reporting will always be timely.

Our access to financing may be impaired by any untimely filing of our periodic reports.

For example, we will not be eligible to register the offer and sale of our securities using a short-form registration statement on

Form S-3 until we have timely filed all periodic reports required under the Exchange Act for a period of twelve calendar months

and any portion of a month immediately preceding the filing of such registration statement.

In addition, in the event the filing of

our periodic reporting is delayed in the future, we may experience a material adverse effect on our ability to grow our

While we are now current in our filing of periodic reports under the Exchange

Act, there is no assurance that in the future our reporting will always be timely.

Our access to financing may be impaired by any untimely

filing of our periodic reports.

For example, we will not be eligible to register the offer and sale of our securities using a short-form

registration statement on Form S-3 unless we have timely filed all periodic reports required under the Exchange Act for a period of twelve

calendar months and any portion of a month immediately preceding the filing of such registration statement.

In addition, in the event

the filing of our periodic reporting is delayed in the future, we may experience a material adverse effect on our ability to grow our

failures to timely file periodic reports with the SEC could subject us to enforcement action by the SEC and stockholder lawsuits, and

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by ongoing revisions to disclosure and governance practices.

may issue additional shares of our Common Stock or other equity securities without your approval, which would dilute your ownership interests

and may depress the market price of your shares.

may issue additional shares of our Common Stock or other equity securities of equal or senior rank in the future in connection with,

have issued and in the future may issue additional shares of our Common Stock or other equity securities without your approval, which

would dilute your ownership interests and may depress the market price of your shares.

have issued and sold shares of our Common Stock under our Sales Agreement and in the form of equity awards of to our officers and directors.

We may issue additional shares of our Common Stock or other equity securities of equal or senior rank in the future in connection with,

among other things, raising additional capital, future acquisitions, repayment of outstanding indebtedness, or award issuances under

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The additional

shares or other securities convertible into or exchangeable for our public shares may be offered at price that may not be the same as

the price per share in this offering.

We may sell shares or other securities in any other offering at a price per share that is less

than the price per share paid by the investors in this offering, and investors purchasing shares or other securities in the future could

have rights superior to existing stockholders.

The price per share at which the additional shares or securities convertible or exchangeable

into public shares, will be sold in future transactions may be higher or lower than the price per share paid by investors in this offering.

If any of the above should occur, our stockholders, including investors who purchased public shares in this offering, will experience

additional dilution, and any such issuances may result in downward pressure on the price of our Common Stock.

shares or other securities convertible into or exchangeable for our public shares may be offered at prices that may not be the same as

the price per share paid by other investors.

Investors purchasing shares or other securities in the future could have rights superior

to existing stockholders.

The price per share at which the additional shares or securities convertible or exchangeable into public shares,

will be sold in future transactions may be higher or lower than the price per share paid by other investors.

If any of the above should

occur, our stockholders will experience additional dilution, and any such issuances may result in downward pressure on the price of our

Common Stock.

issuance of additional shares of Common Stock or other equity securities of equal or senior rank could have the following effects:

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Our share price may decline if our actual results do not match the projections of these securities research analysts.

business and operations could be negatively affected we become subject to any securities litigation or stockholder activism, which could

cause us to incur significant expense, hinder execution of business and growth strategy and impact its stock price.

business and operations could be negatively affected if we become subject to any securities litigation or stockholder activism, which

could cause us to incur significant expense, hinder execution of business and growth strategy and impact its stock price.

the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has

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Additionally,

such securities litigation and stockholder activism could give rise to perceived uncertainties as to our future, adversely affect its

such securities litigation and stockholder activism could give rise to perceived uncertainties as to our future, adversely affect our

relationships with service providers and make it more difficult to attract and retain qualified personnel.

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incur significant legal fees and other expenses related to any securities litigation and activist stockholder matters.

Further, its stock

Further, our stock

price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities

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misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis.

we continue to evaluate steps to remediate these material weaknesses, the material weaknesses will not be considered remediated until

our plan has been fully implemented, the applicable controls are fully operational for a sufficient period of time, and we have concluded,

through testing, that the newly implemented and enhanced controls are operating effectively.

At this time, we cannot predict the success

of such efforts or the outcome of future assessments of the remediation efforts.

If the material weaknesses are not remediated, or if

we generally fail to establish and maintain effective internal controls appropriate for a public company, we may be unable to produce

timely and accurate financial statements, and we may conclude that our internal control over financial reporting is not effective, which

could adversely impact our investors’ confidence and our stock price.

In addition, these remediation measures may be time consuming

we have remediated one material weakness as of December 31, 2025 and we continue to evaluate steps to remediate the remaining

material weakness, the material weakness will not be considered remediated until our plan has been fully implemented, the

applicable controls are fully operational for a sufficient period of time, and we have concluded, through testing, that the newly

implemented and enhanced controls are operating effectively.

At this time, we cannot predict the success of such efforts or the

outcome of future assessments of the remediation efforts.

If the material weakness is not remediated, or if we generally fail to

establish and maintain effective internal controls appropriate for a public company, we may be unable to produce timely and accurate

financial statements, and we may conclude that our internal control over financial reporting is not effective, which could adversely

impact our investors’ confidence and our stock price.

In addition, these remediation measures may be time consuming and

we identify any new material weaknesses in the future, any such newly identified material weakness could limit our ability to prevent

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future, will be sufficient to avoid potential future material weaknesses.

address these material weaknesses, we intend to hire additional accounting personnel with appropriate expertise in accounting and reporting

generally accepted accounting principles (“GAAP”) and SEC regulations in order to better align with segregation

of duties and perform appropriate risk assessment procedures to evaluate risks of material misstatement.

address the material weakness, we intend to hire additional accounting personnel with appropriate expertise in accounting and reporting

generally accepted accounting principles (“GAAP”) and SEC regulations in order to perform appropriate risk assessment procedures to evaluate risks of material misstatement.

also cannot assure you that there will not be material weaknesses in our internal control over financial reporting in the future.

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directors and the requirements that our compensation and nominating and governance committees be composed entirely of independent directors.

We are not currently taking advantage of these exemptions.

However, for so long as we qualify as a “controlled company,”

we maintain the option to rely on some or all of these exemptions.

If we rely on these exemptions, we may not have a majority of independent

directors and our compensation and nominating and governance committees may not consist entirely of independent directors.

in the event we elect to rely on these exemptions in the future, our stockholders would not have the same protections afforded to stockholders

We currently take advantage of certain of these exemptions.

For so long as we qualify as a “controlled company,” we maintain

the option to rely on some or all of these exemptions.

If we rely on these exemptions, we may not have a majority of independent directors

and our compensation and nominating and governance committees may not consist entirely of independent directors.

Accordingly, in the

event we elect to rely on these exemptions in the future, our stockholders would not have the same protections afforded to stockholders

of companies that are subject to all of the corporate governance requirements of Nasdaq.

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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