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Item 1A. Risk Factors

2025-04-02 compared with 2024-04-29 · 447 added, 450 removed, 1750 unchanged (34% of the section changed)

in our Common Stock or Warrants involves a high degree of risk.

Before making an investment, you should carefully consider the following

risks and uncertainties, as well as general economic and business risks, and the other information contained in this Annual Report.

risk factors are not exhaustive, and investors are encouraged to perform their own investigation with respect to our business, financial

condition and prospects.

Our business, financial condition, results of operations, or prospects could be materially and adversely affected

if any of these risks occurs, and as a result, the market price of our Common Stock and Warrants could decline and you could lose all

or part of your investment.

Risk Factors.

in our shares of Common Stock or Warrants involves a high degree of risk.

Before making an investment, you should carefully consider

the following risks and uncertainties, as well as general economic and business risks, and the other information contained in this Annual

These risk factors are not exhaustive, and investors are encouraged to perform their own investigation with respect to our business,

financial condition and prospects.

Our business, financial condition, results of operations, or prospects could be materially and adversely

affected if any of these risks occurs, and as a result, the market price of our Common Stock and Warrants could decline and you could

lose all or part of your investment.

Related to Our Financial Position and Need for Additional Capital

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all of our efforts and financial resources to organizing and staffing our Company, conducting discovery, research, and development activities,

securing intellectual property rights related to our product candidates and ExacTcell platform, raising capital, and the Business Combination.

securing intellectual property rights related to our product candidates and ExacTcell technology, raising capital, and the business combination.

expect that it could be years, if ever, before we have a commercialized product.

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

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

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 cGMP manufacturing capacity, including to provide drug supply for future clinical

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;

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

authorization of INDs for future product

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

● identifying

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A decline in the value of our Company could also cause you to lose all or part of your investment.

Our management has concluded that due to cash

on hand as of the date of this report, there is substantial doubt about our ability to continue as a going concern.

As a result of our cash balance

as of the date of this report, as well as our history of operating losses and negative cash flows from operation 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, our management has concluded

that under applicable accounting requirements and disclosure rules there is substantial doubt about our ability to continue as a going

While transactions entered into

in connection with the Business Combination provided some capital and reduced our liabilities, $6.0 million in expected proceeds from

those transactions have not yet been received, and 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.

Furthermore, the disclosure regarding the ability

to continue as a going concern could have an impact on our ability to raise additional funds through the issuance of new debt or equity

securities or otherwise and on our relationships with third party contractual parties, notwithstanding our expectation that we will raise

funds as and when required.

If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less

than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or a part

of their investment.

We are relying on forthcoming

proceeds from the sale of our Series A-1 Preferred Stock to meet our liquidity needs.

Our primary sources of

funds to meet our near-term liquidity and capital requirements include cash on hand, including the funding we have received from the

sale of our Series A Preferred Stock, and the funding we expect to receive from the sale of our Series A-1 Preferred Stock.

February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which an investor agreed to purchase

shares of our Series A Preferred Stock for an aggregate purchase price of $8.0 million.

On March 27, 2024, we entered into an

agreement pursuant to which that amount was reduced to $2.0 million and the investor agreed to purchase shares of our Series A-1

Preferred Stock for an aggregate purchase price of $6.0 million.

As of the date of this Annual Report, we have received

only $1.2 million of the $6.0 million aggregate purchase price for the shares of Series A-1 Preferred Stock.

We are relying on the

proceeds from the sale of our Series A-1 Preferred Stock to 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.

are relying in part on an additional $8.0 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.

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

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scope, progress, timing, results, and costs of researching and developing TVGN 489 and our

other product candidates, including product candidates developed with our ExacTcell platform,

other product candidates, including product candidates developed with our ExacTcell technology,

and of conducting preclinical studies and clinical trials;

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Additionally,

the terms of our outstanding preferred stock (the “Preferred Stock”) 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 and due to the other terms of our Preferred Stock, or may

negatively affect our ability to obtain favorable or acceptable terms in connection with any such financing.

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.

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

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other operating restrictions that could adversely impact our ability to conduct our business.

debt financing or other financing of securities senior to our common stock will likely include financial and other covenants that will

restrict our flexibility.

future debt financing or other financing of securities senior to our Common Stock will likely include financial and other covenants that

will restrict our flexibility.

Any failure to comply with these covenants may cause an event of default and acceleration of the obligation

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willingness of patients to participate in clinical trials, or if approved by FDA, of physicians to subscribe to the novel treatment mechanics.

FDA may ask for specific post-market requirements, such as establishment of REMS, and additional information informing benefits or risks

of our products may emerge at any time prior to or after regulatory approval.

FDA may ask for specific post-market requirements, such as establishment of a REMS, and additional information informing benefits or

risks of our products may emerge at any time prior to or after regulatory approval.

policies may change and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of any

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may have obtained.

In addition, the regulatory landscape applicable to artificial intelligence is immature and changes to existing regulations

or new regulations could impede our use of artificial intelligence, which could impair our ability to achieve our goals for our artificial

intelligence initiative and result in an adverse effect on our business, results of operations and financial condition.

In addition, the regulatory landscape applicable to AI is immature and changes to existing regulations or new regulations

could impede our use of AI, which could impair our ability to achieve our goals for our AI initiative and result in an adverse effect

on our business, results of operations and financial condition.

For example, FDA’s Center for Biologics Evaluation and Research,

in coordination with others in FDA, has recently developed a regulatory framework for the safe and responsible use of AI throughout the

biological product lifecycle, which is outlined in a draft guidance document issued by FDA.

If and when finalized, this and other guidance

documents, as well as other new FDA regulations and requirements, could present substantial and increasing costs for our compliance.

an organization, we have limited experience designing and implementing preclinical and clinical trials, which is a complex, expensive,

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approval on the basis of the trial results, as well as lead to increased or unexpected costs and in delayed timelines.

have limited experience designing and implementing preclinical and clinical trials, which is a complex,

expensive, and time-consuming process and involves uncertain outcomes.

All of our product candidates are in preclinical or clinical development

and their risk of failure is high.

The clinical trials and manufacturing of our product candidates are, and the manufacturing and marketing

of our products, if approved, will be, subject to extensive and rigorous review and regulation by numerous government authorities in

the United States and in other countries where we intend to test and market our product candidates.

Before obtaining regulatory approvals

for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex, and expensive preclinical studies

and clinical trials that our product candidates are both safe and effective for use in each target indication.

In particular, because

our product candidates are subject to regulation as biological products, we will need to demonstrate that they are safe, pure, and potent

for use in their target indications.

Each product candidate must demonstrate an adequate risk versus benefit profile in its intended

patient population and for its intended use.

We cannot be certain of the timely completion or outcome of our preclinical studies and

clinical trials and cannot predict if FDA will accept our proposed clinical programs or if the outcome of our preclinical studies and

clinical trials will ultimately support the further development of our current or future product candidates.

As a result, we cannot be

sure that we will be able to submit INDs or similar applications for our preclinical programs on the timelines we expect, if at all,

and we cannot be sure that such submission will result in FDA allowing clinical trials to begin.

have limited experience designing and implementing preclinical and clinical trials, which is a complex, expensive, and time-consuming

process and involves uncertain outcomes.

All of our product candidates are in preclinical or clinical development and their risk of failure

The clinical trials and manufacturing of our product candidates are, and the manufacturing and marketing of our products, if

approved, will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and

in other countries where we intend to test and market our product candidates.

Before obtaining regulatory approvals for the commercial

sale of any of our product candidates, we must demonstrate through lengthy, complex, and expensive preclinical studies and clinical trials

that our product candidates are both safe and effective for use in each target indication.

In particular, because our product candidates

are subject to regulation as biological products, we will need to demonstrate that they are safe, pure, and potent for use in their target

Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for

its intended use.

We cannot be certain of the timely completion or outcome of our preclinical studies and clinical trials and cannot

predict if FDA will accept our proposed clinical programs or if the outcome of our preclinical studies and clinical trials will ultimately

support the further development of our current or future product candidates.

As a result, we cannot be sure that we will be able to submit

INDs or similar applications for our preclinical programs on the timelines we expect, if at all, and we cannot be sure that such submission

will result in FDA allowing clinical trials to begin.

we may not successfully or cost-effectively design and implement preclinical and clinical trials that achieve our desired clinical endpoints

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

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

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.

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

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may vary significantly among different CROs and trial sites;

or independent institutional review boards (“IRBs”) may not authorize us or our

investigators to commence a clinical trial or conduct a clinical trial at a prospective trial

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;

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

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clinical trial may also be suspended or terminated by us, the IRB for the institutions in which such trials are being conducted, the

DSMB for such trial, or by FDA due to a number of factors.

Those factors could include 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 FDA, resulting in

the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product

candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

In addition, FDA may order the temporary or permanent discontinuation of our clinical trials at any time if it believes that the clinical

trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk

to the patients enrolled in our clinical trials, or that the applicable INDs do not contain sufficient information to assess the risks

to patients in the proposed trials.

For example, in November 2020, FDA placed a clinical hold on our IND for TVGN 489 for the treatment

of patients with COVID-19 infection, requested certain information regarding the manufacture of TVGN 489, and asked us to revise our

sterility testing approach so that such testing is performed on the final drug product, as opposed to testing before harvesting the cells

for cryopreservation.

In May 2021, FDA found that we sufficiently addressed all of these issues and lifted the clinical hold, permitting

us to initiate our Phase 1 trial, which we completed in January 2023.

data and safety monitoring board (“DSMB”) for such trial, or by FDA due to a number of factors.

Those factors could include

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 FDA, resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects,

failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack

of adequate funding to continue the clinical trial.

In addition, FDA may order the temporary or permanent discontinuation of our clinical

trials at any time if it believes that the clinical trials are not being conducted in accordance with applicable regulatory requirements

or that they present an unacceptable safety risk to the patients enrolled in our clinical trials, or that the applicable INDs do not

contain sufficient information to assess the risks to patients in the proposed trials.

For example, in November 2020, FDA placed a clinical

hold on our IND for TVGN 489 for the treatment of patients with COVID-19 infection, requested certain information regarding the manufacture

of TVGN 489, and asked us to revise our sterility testing approach so that such testing is performed on the final drug product, as opposed

to testing before harvesting the cells for cryopreservation.

In May 2021, FDA found that we sufficiently addressed all of these issues

and lifted the clinical hold, permitting us to initiate our Phase 1 trial, which we completed in January 2023.

may experience regulatory delays or rejections as a result of many reasons.

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any marketing authorizations we may have obtained.

may never receive RMAT designation for TVGN 489 or any other product candidate, and receiving this designation may not lead to a faster

development or regulatory review or approval process, and will not increase the likelihood that such product candidates will receive

marketing approval.

may never receive regenerative medicine advanced therapy (“RMAT”) designation for TVGN 489 or any other product candidate,

and receiving this designation may not lead to a faster development or regulatory review or approval process, and will not increase the

likelihood that such product candidates will receive marketing approval.

may seek RMAT designation from FDA for TVGN 489 for the treatment of COVID-19, or for our other product candidates.

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our ability to commence sales and generate revenue.

approach to the discovery and development of product candidates using our ExacTcell platform is unproven and may not result in marketable

approach to the discovery and development of product candidates using our ExacTcell technology is unproven and may not result in marketable

success of our business depends in part upon our ability to develop and commercialize cell therapies based on our proprietary ExacTcell

We have only conducted one Phase 1 trial based on a product developed using ExacTcell.

Our approach to the development of cell

therapies using ExacTcell is novel.

Our approach to the development of

cell therapies using ExacTcell is novel.

We may not continue to have access to effective HLA-typing diagnostics and may have difficulties

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side effects or adverse events, which could vary in severity from minor reactions to death and in frequency from infrequent to prevalent.

In addition, if one or more of our product candidates or our T cell platform technology proves to be unsafe it would also materially

harm our business.

In addition, if one or more of our product candidates or our T cell technology proves to be unsafe it would also materially harm our

addition to side effects caused by the product candidate, the administration process or related procedures also can cause adverse side

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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, including as a result of the

COVID-19 pandemic or similar occurrences.

Conversely, a decrease in cases may reduce the number of eligible candidates for trials testing

COVID-19 therapeutics, such as TVGN 489.

Additionally, as time passes, treating COVID-19 may become a less critical issue in the eyes

of the public, further limiting the potential patient population for COVID-19 therapeutics.

Moreover, TVGN 489 may represent a departure

from more commonly used methods for COVID-19 treatment, and potential patients and their doctors may be inclined to use more conventional

therapies for the treatment of COVID-19 rather than enroll in any future clinical trial.

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

A decrease in cases may reduce

the number of eligible candidates for trials testing COVID-19 therapeutics, such as TVGN 489.

Additionally, as time passes, treating

COVID-19 is becoming a less critical issue in the eyes of the public, further limiting the potential patient population for COVID-19

therapeutics.

Moreover, TVGN 489 may represent a departure from more commonly used methods for COVID-19 treatment, and potential patients

and their doctors may be inclined to use more conventional therapies for the treatment of COVID-19 rather than enroll in any future clinical

timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient

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fluctuated in recent years as a result.

In addition, government funding of FDA and other government agencies on which our operations

may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid

and unpredictable.

at FDA and other agencies may also slow the time necessary for biological products, or biologics, or modifications to approved biologics

to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

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.

Disruptions at FDA and other agencies may also increase the time necessary to meet with and provide

feedback to entities developing drug products, review and/or approve our submissions, conduct inspections, issue regulatory guidance,

or otherwise authorize our actions requiring regulatory approval, which would adversely affect our business.

In addition, government

funding of FDA and other government agencies on which our operations may rely, including those that fund research and development activities,

is subject to the political process, which is inherently fluid and unpredictable.

For example, the Trump Administration recently established

the Department of Government Efficiency, which implemented a federal government hiring freeze and large scale layoffs of current federal

employees, and also announced additional efforts to reduce federal government employee headcount and the size of the federal government.

The Trump Administration has also, for example, rescinded a previous executive order tasking the Center for Medicare and Medicaid Innovation

to consider new payment and healthcare models to limit drug spending and eliminated a previous executive order that directed HHS to establish

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.

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

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to obtain approval of or market any such product candidate.

use artificial intelligence in our business may require us to spend material resources and presents risks that could adversely impact

our business, including by posing security and other risks to our confidential and/or proprietary information.

intend to use AI in and integrate AI into our business processes, and this innovation presents risks and challenges that could affect

its adoption, and therefore our business.

If we enable or offer solutions that draw controversy due to perceived or actual negative societal

impact, we may experience brand or reputational harm, competitive harm or legal liability.

The use of certain AI technology can give

rise to intellectual property risks, including compromises to proprietary intellectual property and intellectual property infringement.

Additionally, we expect to see increasing government and supranational regulation related to AI use and ethics, which may also significantly

increase the burden and cost of research, development and compliance in this area.

For example, the new Artificial Intelligence Act (the

“AI Act”) in the EU imposes significant obligations on providers and deployers of high-risk AI systems and encourages such

providers and deployers to account for specified ethical principles in the development and use of these systems.

If we develop or use

AI systems that are governed by the AI Act or similar regulations, it may necessitate ensuring higher standards of data quality, transparency,

and human oversight, as well as adhering to specific and potentially burdensome and costly ethical, accountability, and administrative

requirements.

The rapid evolution of AI will require the application of significant resources to design, develop, test and maintain our

products and services to help ensure that AI is implemented in accordance with applicable law and regulation and in a socially responsible

manner and to minimize any real or perceived unintended harmful impacts.

Our vendors may also incorporate AI tools into their offerings,

and may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security.

Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities

involving the theft and misuse of personal information, confidential information and intellectual property.

Any of these effects could

damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and

adversely impact our business.

Related to Business Development and Commercialization

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

and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by FDA, the U.S.

Trade Commission, the Department of Justice, the Office of Inspector General of the Department of Health and Human Services, state attorneys

general, members of the U.S.

and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by FDA, the FTC, the Department

of Justice, the Office of Inspector General of the Department of Health and Human Services, state attorneys general, members of the U.S.

Congress and the public.

Violations, including actual or alleged promotion of our products for unapproved

or off-label uses, are subject to enforcement letters, inquiries and investigations, and potential civil and criminal sanctions by FDA.

Any actual or alleged failure to comply with labeling and promotion requirements may result in fines, warning letters, mandates to corrective

information to healthcare practitioners, injunctions, or civil or criminal penalties.

Violations, including actual or alleged promotion of our products for unapproved or off-label uses, are subject

to enforcement letters, inquiries and investigations, and potential civil and criminal sanctions by FDA.

Any actual or alleged failure

to comply with labeling and promotion requirements may result in fines, warning letters, mandates to corrective information to healthcare

practitioners, injunctions, or civil or criminal penalties.

we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product

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in these laws could materially and adversely harm our business.

are subject to federal and state data privacy and security laws and regulations and expectations relating to privacy continue to evolve.

Changes in these laws may limit our data access, use, and disclosure, and may require increased expenditures.

In addition, data protection,

privacy and similar laws protect more than patient information and, although they vary by jurisdiction, these laws can extend to employee

information, business contact information, provider information, and other information relating to identifiable individuals.

the California Consumer Privacy Act (“CCPA”) requires covered businesses to, among other things, provide disclosures to California

consumers regarding the collection, use and disclosure of such consumers’ personal information and afford such consumers new rights

with respect to their personal information, including the right to opt out of certain sales of personal information.

Comprehensive and

sensitive data laws in a number of states have gone into or will go into effect during the next few years.

We believe that further increased

regulation in additional jurisdictions is likely in the area of data privacy.

Any of the foregoing may have a material adverse effect

on our ability to provide services to patients and, in turn, our results of operations.

protection, privacy and similar laws protect more than patient information and, although they vary by jurisdiction, these laws can extend

to employee information, business contact information, provider information, and other information relating to identifiable individuals.

Failure to comply with these laws may result in, among other things, civil and criminal liability, negative publicity, damage to our

reputation, and liability under contractual provisions.

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.

are subject to federal and state data privacy and security laws and regulations, state data breach notification laws, state health information

and/or genetic privacy laws, and federal and state consumer protection and consumer privacy laws (such as Section 5 of the FTC Act, the

FTC Health Breach Notification Rule, and the CCPA)).

Laws and expectations relating to privacy continue to evolve.

Changes in these laws

may limit our data access, use, and disclosure, and may require increased expenditures.

In addition, data protection, privacy and similar

laws protect more than patient information and, although they vary by jurisdiction, these laws can extend to employee information, business

contact information, provider information, and other information relating to identifiable individuals.

For example, the CCPA requires

covered businesses to, among other things, provide disclosures to California consumers regarding the collection, use and disclosure of

such consumers’ personal information and afford such consumers new rights with respect to their personal information, including

the right to opt out of certain sales of personal information.

Comprehensive and sensitive data laws in a number of states have gone

into or will go into effect during the next few years.

We believe that further increased regulation in additional jurisdictions is likely

in the area of data privacy.

Any of the foregoing may have a material adverse effect on our ability to provide services to patients and,

in turn, our results of operations.

to comply with these laws may result in, among other things, civil and criminal liability, negative publicity, damage to our reputation,

and liability under contractual provisions.

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.

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

solutions, including generative AI, are increasingly being used in the biopharmaceutical industry.

There is a global trend towards more

regulation (e.g., the AI Act and AI laws passed in certain states) to ensure the ethical use, privacy, and security of AI and the data

that it processes.

AI solutions that we may employ and rely upon may lead to the impermissible use or disclosure of confidential information

(including personal data and proprietary information) in contravention of our internal policies, data protection laws, other applicable

laws, or contractual requirements.

The misuse of AI solutions may give rise to liability, lead to the loss of trade secrets or other

intellectual property, result in reputational harm, or lead to outcomes with unintended biases or other consequences.

The misuse of AI

solutions could also result in unauthorized access and use of personal data of our employees, clinical trial participants, collaborators,

or other third parties.

Any of these events could have a material adverse effect on our business, prospects, operating results, and financial

condition and could adversely affect the price of our Common Stock.

internal computer systems, or those used by our contractors or consultants, may fail, or suffer security breaches.

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significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or security breach were to result

in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could

incur liability and the further development and commercialization of our product candidates could be delayed.

Despite our efforts and given the ever-changing threat landscape,

the possibility of these events occurring cannot be eliminated entirely and there can be no assurance that any measures we take will

prevent cyber-attacks or unauthorized access that could adversely affect our business.

To the extent that any disruption or security

breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary

information, we could incur liability and the further development and commercialization of our product candidates could be delayed.

and reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult

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the treatment or procedure in which our product is used.

Further, at least annually, the Centers for Medicare and Medicaid Services (“CMS”)

revise the reimbursement systems used to reimburse health care providers, which may result in reduced Medicare payments.

In some cases,

private third-party payers rely on all or portions of Medicare payment systems to determine payment rates.

Changes to government healthcare

programs that reduce payments under these programs may negatively impact payments from private third-party payers and reduce the willingness

of physicians and providers to use our product candidates.

Further, at least annually, CMS revises the reimbursement systems used to reimburse

health care providers, which may result in reduced Medicare payments.

In some cases, private third-party payers rely on all or portions

of Medicare payment systems to determine payment rates.

Changes to government healthcare programs that reduce payments under these programs

may negatively impact payments from private third-party payers and reduce the willingness of physicians and providers to use our product

the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors.

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compare the cost-effectiveness of a particular product candidate to currently available therapies.

Other European Union member states

allow companies to fix their own prices for medicines but monitor and control company profits.

In addition, in some countries, cross-border

imports from low-priced markets exert a commercial pressure on pricing within a country.

Other EU member states allow companies

to fix their own prices for medicines but monitor and control company profits.

In addition, in some countries, cross-border imports from

low-priced markets exert a commercial pressure on pricing within a country.

marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if government and other

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and transparency measures, and designed to encourage importation from other countries and bulk purchasing.

Legally mandated price controls

on payment amounts by third-party payors or other restrictions could harm our business, financial condition, results of operations and

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine

what drug products and which suppliers will be included in their prescription drug and other healthcare programs.

The continuing efforts

of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs

of healthcare and/or impose price controls may adversely affect our business, financial condition, results of operations and prospects.

Additionally, some individual

states have begun establishing Prescription Drug Affordability Boards to review high-cost drugs and, in some cases, set upper payment

Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, financial

condition, results of operations and prospects.

In addition, regional healthcare authorities and individual hospitals are increasingly

using bidding procedures to determine what drug products and which suppliers will be included in their prescription drug and other healthcare

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services

to contain or reduce costs of healthcare and/or impose price controls may adversely affect our business, financial condition, results

of operations and prospects.

may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and health information

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We may be unable to find a sufficient alternative supply channel in a reasonable time or on commercially reasonable terms.

Any performance

failure on the part of our suppliers could delay the development and potential commercialization of our product candidates, including

limiting supplies necessary for clinical trials and regulatory approvals, which would have a material adverse effect on our business.

changes in global economic conditions, and an increase in the costs of goods and services, including as a result of tariffs, could negatively

impact testing volumes, the demand for biopharma laboratory services, cash collections, profitability, and the availability and cost

Any performance failure on the part of our suppliers could delay the development and potential commercialization of our product

candidates, including limiting supplies necessary for clinical trials and regulatory approvals, which would have a material adverse effect

on our business.

the third parties we rely on to help conduct our preclinical studies and clinical trials do not successfully carry out their contractual

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Furthermore, if third parties have

filed such patent applications, we may challenge their ownership, for example in a derivation proceeding before the USPTO to determine

who has the right to the claimed subject matter in the applications.

Similarly, if our patent applications are challenged in a derivation

proceeding, the USPTO may hold that a third party is entitled to certain patent ownership rights instead of us.

We may then be forced

to seek a license from the third party that may not be available on commercially favorable terms, or at all.

filed such patent applications, we may challenge their ownership, for example in a derivation proceeding before the U.S.

Patent and Trademark

Office (the “USPTO”) to determine who has the right to the claimed subject matter in the applications.

Similarly, if our

patent applications are challenged in a derivation proceeding, the USPTO may hold that a third party is entitled to certain patent ownership

rights instead of us.

We may then be forced to seek a license from the third party that may not be available on commercially favorable

terms, or at all.

patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce, or

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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

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 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.

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.

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.

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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of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not

covered by patents, including portions of our ExacTcell platform.

covered by patents, including portions of our ExacTcell technology.

However, trade secrets can be difficult to protect, and some courts

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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 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 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.

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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biotechnology companies, governmental agencies, academic institutions, public and private research institutions, technology companies

active in the artificial intelligence space, and others.

Our commercial opportunities will be significantly impacted if our competitors

develop and commercialize products that are safer, more effective, have fewer side effects, are less expensive or obtain more significant

acceptance in the market than any product candidates that we develop.

Additionally, our commercial opportunities will be significantly

impacted if novel upstream products or changes in treatment protocols reduce the overall incidence or prevalence of diseases in our current

or future target population.

Competition could result in reduced sales and pricing pressure on our product candidates, if approved by

In addition, significant delays in the development of our product candidates could allow our competitors to bring products to market

before us and impair any ability to commercialize our product candidates.

active in the AI space, and others.

Our commercial opportunities will be significantly impacted if our competitors develop and commercialize

products that are safer, more effective, have fewer side effects, are less expensive or obtain more significant acceptance in the market

than any product candidates that we develop.

Additionally, our commercial opportunities will be significantly impacted if novel upstream

products or changes in treatment protocols reduce the overall incidence or prevalence of diseases in our current or future target population.

Competition could result in reduced sales and pricing pressure on our product candidates, if approved by FDA.

In addition, significant

delays in the development of our product candidates could allow our competitors to bring products to market before us and impair any

ability to commercialize our product candidates.

of the approved or commonly used drugs and therapies for certain of our target diseases are well established and are widely accepted

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as in acquiring technologies and technology licenses complementary to our programs or advantageous to our business.

also face substantial competition for our artificial intelligence initiatives and our computational approaches to drug discovery.

competitors may have significantly greater experience and expertise in using artificial intelligence, algorithmic tool development, predictive

analytics, and data science to expedite drug development, optimize laboratory processes and clinical trials, unravel complex biological

data, and improve patient outcomes than we do, and significantly greater financial and other resources with which to do so.

intelligence technologies are changing rapidly and we must adapt and develop these technologies in a timely and effective manner at an

acceptable cost in order to compete.

There can be no assurance that we will be able to develop, acquire, or integrate artificial intelligence

technologies, tools, and processes successfully or as quickly or cost-effectively as our competitors, or that these technologies, tools,

and processes will meet our needs or achieve our goals.

In addition, if the technologies, tools, or processes that we develop are incorrectly

designed, do not operate properly, or are otherwise deficient, or if we do not have the rights to use the data on which they rely, we

may not achieve our goals for this initiative, our performance and reputation could suffer or we could incur liability through the violation

of laws, privacy rights, or contracts.

Even with the successful use of artificial intelligence, we may fail to allocate resources efficiently,

which could adversely impact our pipeline and ability to compete effectively.

also face substantial competition for our AI initiatives and our computational approaches to drug discovery.

Our competitors may have

significantly greater experience and expertise in using AI, algorithmic tool development, predictive analytics, and data science to expedite

drug development, optimize laboratory processes and clinical trials, unravel complex biological data, and improve patient outcomes than

we do, and significantly greater financial and other resources with which to do so.

AI technologies are changing rapidly and we must

adapt and develop these technologies in a timely and effective manner at an acceptable cost in order to compete.

There can be no assurance

that we will be able to develop, acquire, or integrate AI technologies, tools, and processes successfully or as quickly or cost-effectively

as our competitors, or that these technologies, tools, and processes will meet our needs or achieve our goals.

In addition, if the technologies,

tools, or processes that we develop are incorrectly designed, do not operate properly, or are otherwise deficient, or if we do not have

the rights to use the data on which they rely, we may not achieve our goals for this initiative, our performance and reputation could

suffer or we could incur liability through the violation of laws, privacy rights, or contracts.

Even with the successful use of AI, we

may fail to allocate resources efficiently, which could adversely impact our pipeline and ability to compete effectively.

ability to attract and retain highly skilled personnel is critical to our operations and expansion.

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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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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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inability to commercialize any product candidates that we may develop.

we currently hold trial liability insurance coverage consistent with industry standards, the amount of coverage may not adequately cover

all liabilities that we may incur.

We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to

satisfy any liability that may arise.

We intend to expand our insurance coverage for products to include the sale of commercial products

if we obtain marketing approval for our product candidates, but we may be unable to obtain commercially reasonable product liability

A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance

coverage, could decrease our cash and adversely affect our business and financial condition.

we currently hold liability insurance coverage consistent with industry standards, the amount of coverage may not adequately cover all

liabilities that we may incur.

We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy

any liability that may arise.

We intend to expand our insurance coverage for products to include the sale of commercial products if we

obtain marketing approval for our product candidates, but we may be unable to obtain commercially reasonable product liability insurance.

A successful product liability claim or series of claims brought against us, particularly if judgments exceed our insurance coverage,

could decrease our cash and adversely affect our business and financial condition.

ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations.

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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;

failure to utilize AI technologies in the development of our product candidates;

success of competitive products or technologies;

● 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

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

or inability to do so at acceptable cost;

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;

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

● fluctuations

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

● inconsistent

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

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.

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

Potential future delays in the filing of our reports with

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

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

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

result in the delisting of our Common Stock and Warrants from the Nasdaq Stock Market LLC (“Nasdaq”), regulatory sanctions

from the SEC, or breach of covenants in any future credit facilities or of any preferred equity or debt securities that we may issue

in the future, any of which could have a material adverse impact on our operations, your investment in our Common Stock and Warrants,

and our ability to register with the SEC public offerings of our securities for our benefit or the benefit of our security holders.

Additionally,

any potential failure to timely file future periodic reports could result in investors not receiving access to current or timely information

regarding our business and operations with which to make investment decisions.

may not have the funds necessary to satisfy our future obligations under the terms of our Preferred Stock and uncertainties with respect

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our business.

Our Series A Preferred Stock, which has an aggregate face value of $2.0 million, and our Series A-1 Preferred Stock,

for which we expect to receive aggregate gross proceeds of $6.0 million, carry an annual 5% cumulative dividend, increasing by 2% each year, in the case

of the Series A-1 Preferred Stock in no event to more than 15% per year.

Our Series B Preferred Stock, which has an aggregate face

value of $3.6 million, pays a 3.25% quarterly dividend beginning 35 days after issuance, increasing by 0.25% each month that the

Series B Preferred Stock remains outstanding after the first 30 days after its issuance, but in no event to more than 7.5% per

The Series A Preferred Stock and the Series A-1 Preferred Stock is callable if the volume weighted average price of the

common stock for the 20 days prior to delivery of the call notice is greater than $5.00 per share and there is an effective resale

registration statement on file covering the underlying common stock.

The Series B Preferred Stock is callable at any

Our Series A Preferred Stock, which has an aggregate face value of $2.0 million, carries an annual 5% cumulative dividend,

increasing by 2% each year.

The Series A Preferred Stock is callable if the volume weighted average price of the Common Stock for the

20 days prior to delivery of the call notice is greater than $5.00 per share and there is an effective resale registration statement

on file covering the underlying Common Stock.

Our Series C Preferred Stock, which has an aggregate face value of $6.0 million, carries

an annual 7.5% cumulative dividend, compounded annually, payable in shares of Series C Preferred Stock, or at our election, in cash.

The Series C Preferred Stock is callable at any time after the fifth anniversary of the issuance date.

may not have sufficient funds or be able to obtain financing from third parties to pay the dividends applicable to our Preferred Stock

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to operate our business and execute our business strategy, and the trading volatility and price of our securities.

failure to meet the continued listing requirements of Nasdaq could result in a delisting of our Common Stock and our Warrants.

we fail to satisfy the continued listing requirements of Nasdaq, 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.

In the event 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.

incur increased costs as a result of operating as a public company, and our management devotes substantial time to compliance initiatives

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

the 2024 Plan, without stockholder approval, in a number of circumstances.

Investors purchasing shares or other securities in the future

could have rights superior to existing shareholders.

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.

the Tevogen Bio Holdings Inc.

2024 Omnibus Incentive Plan, without stockholder approval, in a number of circumstances.

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.

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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and (ii) the date on which we have issued more than $1.00 billion in non-convertible debt securities during the prior three-year period.

In addition, the JOBS Act also provides that an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply

to private companies.

We have elected not to opt out of such extended transition period and, therefore, we may not be subject to the

same new or revised accounting standards as other public companies that are not emerging growth companies.

This may make comparison of

our financial statements with the financial statements of other companies who comply with public company adoption dates difficult or

impossible because of the potential differences in accounting standards used.

Investors may find our Common Stock less attractive because

it will rely on these exemptions, which may result in a less active trading market for our Common Stock and its price may be more volatile.

In addition, the JOBS Act also provides that an emerging growth company can delay the adoption of certain accounting standards until

those standards would otherwise apply to private companies.

We have elected not to opt out of such extended transition period and, therefore,

we may not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

This may make comparison of our financial statements with the financial statements of other companies who comply with public company

adoption dates difficult or impossible because of the potential differences in accounting standards used.

Investors may find our Common

Stock less attractive because it will rely on these exemptions, which may result in a less active trading market for our Common Stock

and its price may be more volatile.

Additionally,

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differ from our actual results, our share price and trading volume could decline.

trading market for our Common Stock is influenced by the research and reports that industry or securities analysts publish about us or

our business.

trading market for our Common Stock may be influenced by research and reports that industry or securities analysts may publish about

us or our business.

We do not have any control over these analysts.

Securities and industry analysts do not currently, and may never, publish

research on us.

no securities or industry analysts commence coverage of us, the trading price of our Common Stock would likely be negatively impacted.

In the event securities or industry analysts initiate coverage, and one or more of these analysts cease coverage of us or fail to publish

We have limited analyst coverage and we may continue to have limited

analyst coverage in the future.

securities or industry analysts fail to commence coverage of us, the trading price of our Common Stock may be negatively impacted.

the event securities or industry analysts initiate coverage, and one or more of these analysts cease coverage of us or fail to publish

reports on us regularly, we could lose visibility in the financial markets, which in turn could cause the price of our Common Stock or

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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 if it becomes 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 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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could result in substantial costs and divert management’s and Board’s attention and resources from our business.

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

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

Also, we may be

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

its stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties

of any securities litigation and stockholder activism.

Additionally,

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

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

Also, we may be required to

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

Further, its stock

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

litigation and stockholder activism.

may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative

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all of your investment.

cannot assure you that the due diligence conducted by Semper Paratus prior to the consummation of the Business Combination identified

all material issues or risks associated with Tevogen, our business or the industry in which we compete.

As a result of these factors,

we may be forced to write-down or write-off assets, restructure our operations, or incur impairment or other charges that could result

in our reporting losses.

Even if Semper Paratus’s due diligence has identified certain risks, unexpected risks may arise and previously

known risks may materialize in a manner not consistent with Semper Paratus’s risk analysis.

If any of these risks materialize,

this could have a material adverse effect on our financial condition and results of operations and could contribute to negative market

perceptions about our securities.

have identified material weaknesses in our internal control over financial reporting as of December 31, 2023.

unable to develop and maintain proper and effective internal control over financial reporting, our ability to produce accurate and

timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our

common stock may decline.

management concluded that we identified material weaknesses in our internal controls over financial reporting as of

December 31, 2023, related to our accounting for complex financial instruments and internal controls over collectability over

amounts due from related parties.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over

financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial

statements will not be prevented or detected and corrected on a timely basis.

addition, Tevogen Bio’s management identified material weaknesses in its internal control over financial reporting relating to

not maintaining a sufficient complement of personnel commensurate with its accounting and reporting requirements resulting in

inadequate segregation of duties over the preparation, review and posting of manual journal entries to the general ledger, and

resulting in not having a sufficient risk assessment process to identify and analyze risks of misstatement due to error and/or

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 and costly.

If we identify any new material weaknesses in the future, any such newly

identified material weakness could limit our ability to prevent or detect a misstatement of our accounts or disclosures that could result

in a material misstatement of our annual or interim financial statements.

In such case, we may be unable to maintain compliance with securities

law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors

may lose confidence in our financial reporting and our stock price may decline as a result.

We cannot assure you that the measures we

have taken to date, or any measures we may take in the future, will be sufficient to avoid potential future material weaknesses.

may be forced to write-down or write-off assets, restructure our operations, or incur impairment or other charges that could result in

our reporting losses.

In addition, unexpected risks may arise and previously known risks may materialize in a manner not consistent with

prior risk analysis.

If any of these risks materialize, this could have a material adverse effect on our financial condition and results

of operations and could contribute to negative market perceptions about our securities.

have identified material weaknesses in our internal control over financial reporting.

If we are unable to develop and maintain proper

and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired,

investors may lose confidence in our financial reporting and the trading price of our Common Stock may decline.

management has previously concluded that we had material weaknesses in our internal controls over financial reporting related to our

not maintaining a sufficient complement of personnel commensurate with its accounting and reporting requirements resulting in inadequate

segregation of duties over the preparation, review, and posting of manual journal entries to the general ledger and in not having a sufficient

risk assessment process to identify and analyze risks of misstatement due to error and/or fraud.

A material weakness is a deficiency,

or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material

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

or detect a misstatement of our accounts or disclosures that could result in a material misstatement of our annual or interim financial

In such case, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic

reports in addition to applicable stock exchange listing requirements, investors may lose confidence in our financial reporting and our

stock price may decline as a result.

We cannot assure you that the measures we have taken to date, or any measures we may take in the

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

GAAP and U.S.

Securities and Exchange Commission (“SEC”) regulations in order to better align with segregation of duties and perform appropriate risk assessment procedures

to evaluate risks of material misstatement.

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.

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

12 unchanged sentences

restrict our future access to the capital markets.

significant portion of our total outstanding shares are restricted from immediate resale but may be sold into the market in the near

This could cause the market price of our Common Stock to drop significantly, even if our business is doing well.

significant portion of our total outstanding shares may be sold into the market in the near future.

This could cause the market price

of our Common Stock to drop significantly, even if our business is doing well.

of a substantial number of shares of our Common Stock in the public market could occur at any time.

In addition, we have a substantial

number of restricted stock units and we expect that tax obligations with respect to vesting and settlement of many of these restricted

stock units will be satisfied through sell-to-cover arrangements.

These sales, or the perception in the market that the holders of a

large number of shares intend to sell shares, could reduce the market price of our Common Stock.

certain of our stockholders are subject to certain restrictions regarding the transfer of our Common Stock, these shares may be sold

after the expiration or early termination of the respective applicable lock-ups under the Letter Agreement, dated November 3, 2021, by

and among Semper Paratus, its officers, its directors and the Initial Shareholders (the “Letter Agreement”) and the Lock-Up

Agreement, dated February 14, 2024 (the “Lock-Up Agreement”), by and among the Company, the Sponsor, and Dr.

Saadi (the “Significant

Company Holder” and, together with the Sponsor, the “Locked-Up Parties”) with respect to certain of our securities

held by the Locked-Up Parties, respectively.

We intend to file one or more registration statements to provide for the resale of certain

of such shares from time to time.

As restrictions on resale end and any registration statements we file for the resale of such shares

are available for use, the market price of our Common Stock could decline if the holders of currently restricted shares sell them or

are perceived by the market as intending to sell them.

In addition, until recently we had

a substantial number of restricted stock units.

Sales, or the perception in the market that the holders of a large number of shares intend

to sell shares, could reduce the market price of our Common Stock.

restrictions on resale end and any registration statements we file for the resale of such shares are available for use, the market price

of our Common Stock could decline if the holders of previously restricted shares sell them or are perceived by the market as intending

to sell them.

directors, executive officers, and principal stockholders, and Dr.

8 unchanged sentences

They may also have

interests that differ from yours and may vote in a way with which you disagree.

In addition, under the Nasdaq rules, a company of which

more than 50% of the voting power is held by an individual, group or another company is a “controlled company” and need not

comply with certain requirements, including the requirement that a majority of the board of directors consist of independent directors

and the requirements that the company’s compensation and nominating and governance committees be composed entirely of independent

interests that differ from our investors and may vote in a way with which our investors disagree.

In addition, under the Nasdaq rules,

a company of which more than 50% of the voting power is held by an individual, group or another company is a “controlled company”

and need not comply with certain requirements, including the requirement that a majority of the board of directors consist of independent

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.

26 unchanged sentences

warrants at a later time where the underlying share price is higher and (2) may not compensate the holders for the value of the warrants.

warrant holder may only be able to exercise its public warrants on a “cashless basis” under certain circumstances, and if

a warrant holder does so, such warrant holder will receive fewer shares of Common Stock from such exercise than if a warrant holder were

to exercise such warrants for cash.

warrant agreement provides that in the following circumstances holders of warrants who seek to exercise their warrants will not be permitted

to do for cash and will, instead, be required to do so on a cashless basis in accordance with Section 3(a)(9) of the Securities Act:

(i) if the Common Stock issuable upon exercise of the warrants is not registered under the Securities Act in accordance with the terms

of the warrant agreement;

(ii) if we have so elected and the Common Stock is at the time of any exercise of a warrant not listed on a

national securities exchange such that it satisfies the definition of “covered securities” under Section 18(b)(1) of the

Securities Act;

and (iii) if we have so elected and we call the public warrants for redemption.

If you exercise your public warrants

on a cashless basis, you would pay the warrant exercise price by surrendering all of the warrants for that number of Common Stock equal

to the quotient obtained by dividing (x) the product of the number of Common Stock underlying the warrants, multiplied by the excess

of the “fair market value” of the Common Stock (as defined in the next sentence) over the exercise price of the warrants

by (y) the fair market value.

The “fair market value” is the average reported closing price of the Common Stock for the 10

trading days ending on the third trading day prior to the date on which the notice of redemption is sent to the holders of the warrants.

As a result, you would receive fewer shares of Common Stock from such exercise than if you were to exercise such warrants for cash.

public warrants may never be in the money and they may expire worthless.

exercise price for the outstanding public warrants is $11.50 per share.

Such warrants may never be in the money prior to their expiration,

and as such, the warrants may expire worthless.

likely were a passive foreign investment company prior to the Business Combination.

likely were a passive foreign investment company (“PFIC”) prior to the Business Combination, which may have subjected U.S.

holders of our former Class A ordinary shares or warrants to adverse U.S.

federal income tax consequences in connection with the Business

Our PFIC status may depend upon whether we qualified for the PFIC start-up exception.

Depending on the particular circumstances,

the application of the start-up exception may be subject to uncertainty.

Upon written request, we will endeavor to provide to a U.S.

holder such information as the Internal Revenue Service may require, including a PFIC annual information statement, in order to enable

holder to make and maintain a “qualified electing fund” election, but there can be no assurance that we will timely

provide such required information, and such election would be unavailable with respect to our warrants in all cases.

is possible a 1% U.S.

federal excise tax will be imposed on us in connection with redemptions of our ordinary shares after or in connection

with the Business Combination.

Inflation Reduction Act of 2022 imposes a 1% excise tax on the fair market value of certain repurchases (including certain redemptions)

of stock by publicly traded domestic (i.e., United States) corporations (and certain non-U.S.

corporations treated as “surrogate

foreign corporations”).

The excise tax applies to stock repurchases occurring in 2023 and beyond.

The amount of the excise tax

is generally 1% of the fair market value of the shares of stock repurchased at the time of the repurchase, subject to certain exceptions.

For purposes of calculating the excise tax, repurchasing corporations are permitted to net the fair market value of certain new stock

issuances against the fair market value of stock repurchases during the same taxable year.

On April 9, 2024, the U.S.

Department of the

Treasury published proposed regulations on the excise tax.

Although the regulations are not final, taxpayers may generally rely upon

such proposed regulations until final regulations are issued.

As an entity that was incorporated as a Cayman Islands exempted company,

the 1% excise tax is generally not expected to apply to redemptions of our Class A ordinary shares (absent any final regulations and

other additional guidance that may be issued in the future with retroactive effect).

However, in connection with the Business Combination,

we domesticated and continued as a Delaware corporation and, because our securities are trading on Nasdaq, it is possible that we will

be subject to the excise tax with respect to subsequent redemptions, including redemptions in connection with the Business Combination,

that are treated as repurchases for this purpose (other than, pursuant to recently published proposed regulations from the U.S.

of the Treasury, redemptions in complete liquidation of the company).

In all cases, the extent of the excise tax that may be incurred

will depend on a number of factors, including the fair market value of our stock redeemed, the extent such redemptions could be treated

as dividends and not repurchases, the fair market value of shares of Common Stock issued to Tevogen Bio holders in connection with the

Business Combination (as well as other Common Stock issued during the same taxable year) and the content of any final regulations and

other additional guidance from the U.S.

Department of the Treasury that may be issued and applicable to the redemptions.

The excise tax

is imposed on the repurchasing corporation itself, not the shareholders from which stock is repurchased.

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