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Item 1. Business

2025-04-02 compared with 2024-04-29 · 801 added, 640 removed, 864 unchanged (63% of the section changed)

are a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic

T lymphocytes (“CD8+ CTLs” or “CTLs”), to develop off-the-shelf, precision T cell therapies for the treatment

of infectious diseases, cancers, and neurological disorders, with the aim of addressing the significant unmet needs of large patient

We believe that sustainability and commercial success in the forthcoming era of medicine will rely on ensuring patient accessibility

through advanced science, innovative business models and engagement across the development lifecycle and healthcare system.

to be the first biotechnology company offering commercially attractive, economically viable, and cost-effective personalized T cell therapies.

believe our allogeneic, precision T cell technology platform, ExacTcell TM , represents a significant scientific breakthrough

that has the potential to produce a new class of off-the-shelf – manufactured and stored for immediate use – drugs with diverse applications

spanning virology, oncology, and neurology.

ExacTcell is a set of processes and methodologies to develop, enrich, and expand single human

leukocyte antigen (“HLA”) restricted CTL therapies with proactively selected, precisely defined targets.

HLA molecules are

proteins that play an important role in the immune system’s ability to recognize “self” versus “foreign.”

There are numerous HLA types that vary from person to person.

CD8+ CTLs, also known as killer T cells, are white blood cells that are

part of the immune system and destroy infected, malignant, or otherwise damaged cells.

We are focused on using ExacTcell to develop allogeneic

therapeutics, meaning therapeutics that are intended to be infused in patients other than the original donor.

T lymphocytes (“CTLs”), to develop off-the-shelf, precision T cell therapies for the treatment of infectious diseases, cancers,

and other disorders, with the aim of addressing the significant unmet needs of large patient populations.

We believe that sustainability

and commercial success in the forthcoming era of medicine will rely on ensuring patient accessibility through advanced science, innovative

business models and engagement across the development lifecycle and healthcare system.

We believe the full potential of T cell therapies

remains largely untapped and aspire to be the first biotechnology company offering commercially attractive, economically viable, and

cost-effective personalized T cell therapies.

believe our allogeneic, precision T cell technology, ExacTcell TM , represents a significant scientific breakthrough with the

potential to mainstream cell therapy with a new class of off-the-shelf – manufactured and stored for immediate use – T cell

therapies with diverse applications across virology, oncology, and other areas.

ExacTcell is a set of processes and methodologies to

develop, enrich, and expand single human leukocyte antigen (“HLA”) restricted CTL therapies with proactively selected, precisely

defined targets.

HLA molecules are proteins that play an important role in the immune system’s ability to recognize “self”

versus “foreign.” There are numerous HLA types that vary from person to person.

CD8+ CTLs, also known as killer T cells,

are white blood cells that are part of the immune system and destroy infected, malignant, or otherwise damaged cells.

We are focused

on using ExacTcell to develop allogeneic therapeutics, meaning therapeutics that are intended to be infused in patients other than the

original donor.

therapies are based on carefully selected, naturally occurring CTLs that are designed to recognize targets of interest from the body’s

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distinct antigens, with the aim to circumvent the impact of mutations in viruses and cancer cells, which can render existing treatments

ExacTcell is designed to maximize the immunologic specificity of our products in order to eliminate malignant and virally

infected cells while allowing healthy cells to remain intact.

We believe this high degree of specificity has the potential to significantly

reduce the chances of cross-reactivity or adverse impact on healthy cells.

Our confidence in ExacTcell is reflected in our development

pipeline, which has been carefully tailored to address the unmet needs of large patient populations grappling with life-threatening viral

diseases, both viral and non-viral induced cancers, and neurological disorders such as multiple sclerosis.

first clinical product of ExacTcell, TVGN 489, is being developed to fill a critical gap in COVID-19 therapeutics for the immunocompromised

and the high-risk elderly, with potential applications in both treatment and prevention of chronic lingering

symptoms of the disease (“Long COVID”).

Viruses, including COVID-19, hijack cellular machinery to transform infected cells

into virus production plants.

focused on a single target ineffective.

ExacTcell is designed to maximize the immunologic specificity of our products in order to eliminate

malignant and virally infected cells while allowing healthy cells to remain intact.

We believe this high degree of specificity has the

potential to significantly reduce the chances of cross-reactivity or adverse impact on healthy cells.

Our confidence in ExacTcell is

reflected in our development pipeline, which has been carefully tailored to address the unmet needs of large patient populations grappling

with life-threatening viral diseases, cancers, and other disorders.

first clinical product of ExacTcell, TVGN 489, is initially being developed to fill a critical gap in COVID-19 therapeutics for the immunocompromised

and the high-risk elderly, with potential applications in both treatment and prevention of chronic, lingering symptoms of the disease

(“Long COVID”).

Viruses, including COVID-19, hijack cellular machinery to transform infected cells into virus production

Elimination of infected cells is necessary to allow them to be replaced by healthy, uninfected counterparts.

TVGN 489 consists of CTLs that are designed to be active against multiple precise, well defined, and well characterized targets spread

across the SARS-CoV-2 genome.

The product progressed from pre-discovery to the clinic in less than 18 months, and in January 2023, we

completed the Phase 1 proof-of-concept clinical trial of TVGN 489 for the treatment of ambulatory, high-risk adult COVID-19 patients.

No dose-limiting toxicities or significant treatment-related adverse events were observed in the treatment arm.

Secondary endpoints showing

a rapid reduction of viral load and that infusion of TVGN 489 did not prevent development of the patients’ own T cell-related (cellular)

or antibody-related (humoral) anti-COVID-19 immunity were also met.

None of the patients reported progression of infection, reinfection,

or the development of Long COVID during the six-month follow-up period.

These clinical observations were mirrored by laboratory evidence

of the persistence of TVGN 489 cells for at least six months after treatment.

We hope to launch a pivotal trial of TVGN 489 in COVID-19

patients with B cell malignancies as soon as late 2024, with studies of other highly vulnerable populations thereafter.

TVGN 489 is also

in preclinical development for treatment and prevention of Long COVID.

to February 14, 2024, Semper Paratus Acquisition Corporation (“Semper Paratus”) was a special purpose acquisition

company formed for the purpose of effecting a merger, stock purchase, reorganization or similar acquisition or business combination

with one or more businesses.

On February 14, 2024 (the “Closing Date”), Semper Paratus completed the previously

announced business combination pursuant to that certain Agreement and Plan of Merger by and among Semper Paratus, Semper Merger Sub,

Inc., a Delaware corporation and a wholly owned subsidiary of Semper Paratus (“Merger Sub”), SSVK Associates, LLC,

Semper Paratus’s sponsor (the “Sponsor”), in its capacity as purchaser representative, Tevogen Bio Inc, a Delaware

corporation (“Tevogen Bio”), and Dr.

Ryan Saadi, in his capacity as seller representative (the “Merger

contemplated by the Merger Agreement, on the Closing Date, Merger Sub merged with and into Tevogen Bio, with Tevogen Bio being the surviving

company and a wholly owned subsidiary of Semper Paratus (the “Merger,” and together with the other transactions contemplated

by the Merger Agreement, the “Business Combination”).

In connection with the closing of the Business Combination, we changed

our name from “Semper Paratus Acquisition Corporation” to “Tevogen Bio Holdings Inc.” As of the open of trading

on February 15, 2024, our common stock and public warrants began trading on The Nasdaq Stock Market LLC (“Nasdaq”) as “TVGN”

and “TVGNW,” respectively.

are leveraging our understanding of immunotherapy and our ExacTcell platform to discover, validate, and build a proprietary pipeline

of T cell therapies with diverse targets in infectious disease, cancer, and neurological disorders.

The figure below details our pipeline

of product candidates and their targets:

1 clinical trials are designed in part to generate proof of concept data and safety-related data on tolerability and side effects.

pivotal trial is a trial designed to generate data sufficient to support the filing of an application for regulatory approval.

pivotal trial may not necessarily be denoted as a Phase 3 clinical trial, and instead may be a Phase 2 or Phase 2/3 clinical trial.

We believe that Phase 2, Phase 2/3, or Phase 3 clinical trials may serve as pivotal trials for TVGN 489.

completed Phase 1 clinical trial of TVGN 489 was specifically conducted in ambulatory, high-risk adult patients with acute cases

believe that the data from our completed Phase 1 clinical trial should be sufficient to serve as the basis for one or more later

stage, potentially pivotal trials in acute COVID-19 patients with B-cell cancer immune suppression, other B cell immune suppressed

acute COVID-19 patients without a B cell cancer indication, and for Long COVID prevention and treatment.

We cannot be certain whether

we will be permitted to move from a Phase 1 trial directly to a pivotal trial covering any specific target population until FDA reviews

and concurs with or rejects our proposed plans, and FDA may require us to conduct further trials to generate additional safety and

efficacy data prior to approval.

collected in the completed Phase 1 trial of TVGN 489 includes and in all future trials of TVGN 489 is expected to include information

regarding the incidence of Long COVID in patients treated with TVGN 489 versus untreated patients or those treated with alternate

TVGN 489 consists

of CTLs designed to be active against multiple precise, well defined, and well characterized targets spread across the SARS-CoV-2 genome.

The product progressed from pre-discovery to the clinic in less than 18 months, and in January 2023, we completed the Phase 1 proof-of-concept

clinical trial of TVGN 489 for the treatment of ambulatory, high-risk adult COVID-19 patients.

No dose-limiting toxicities or significant

treatment-related adverse events were observed in the treatment arm.

Secondary endpoints showed a rapid reduction of viral load and that

infusion of TVGN 489 did not prevent the development of the patients’ own T cell-related (cellular) or antibody-related (humoral)

anti-COVID-19 immunity.

None of the patients reported progression of infection, reinfection, or the development of Long COVID during

the six-month follow-up period.

These clinical observations were mirrored by laboratory evidence of the persistence of TVGN 489 cells

for at least six months after treatment.

The results of the trial were published in Blood Advances in June 2024 following

We believe these findings validate our initiative to develop off-the-shelf T cell therapies for outpatient administration,

targeting diseases that affect large patient populations – for the very first time.

We are planning a pivotal trial of TVGN 489

in COVID-19 patients with B cell malignancies, with studies of other highly vulnerable populations thereafter.

TVGN 489 is also in preclinical

development for treatment and prevention of Long COVID based on evidence of a persistent viral reservoir in Long COVID patients.

February 14, 2024, Tevogen Bio Inc (n/k/a Tevogen Bio Inc.) (“Tevogen Bio”) completed the previously announced business combination

with Semper Paratus Acquisition Corporation (“Semper Paratus”), a special purpose acquisition company formed for the purpose

of effecting a merger, stock purchase, reorganization or similar acquisition or business combination with one or more businesses, pursuant

to which Tevogen Bio became a wholly owned subsidiary of Semper Paratus.

In connection with the closing of that business combination,

Semper Paratus changed its name from “Semper Paratus Acquisition Corporation” to “Tevogen Bio Holdings Inc.”

are leveraging our understanding of immunotherapy and our ExacTcell technology to discover, validate, and build a proprietary pipeline

of T cell therapies with diverse targets in infectious disease, cancer, and other disorders.

The figure below details our pipeline of

product candidates and their targets:

Phase 1 clinical trials are designed

in part to generate proof of concept data and safety-related data on tolerability and side effects.

A pivotal trial is a trial designed to generate data

sufficient to support the filing of an application for regulatory approval.

A pivotal trial may not necessarily be denoted as a Phase

3 clinical trial and instead may be a Phase 2 or Phase 2/3 clinical trial.

We believe that Phase 2, Phase 2/3, or Phase 3 clinical

trials may serve as pivotal trials for TVGN 489.

We believe that the safety data from our completed

Phase 1 clinical trial should be sufficient to serve as the basis for one or more later stage, potentially pivotal trials in acute

SARS-CoV-2 patients with B-cell cancer immune suppression, other B cell immune suppressed acute SARS-CoV-2 patients with a B cell

cancer indication, and for Long COVID prevention and treatment.

We cannot be certain whether we will be permitted to move from a

Phase 1 trial directly to a pivotal trial covering any specific target population until FDA reviews and concurs with or rejects our

proposed plans, and FDA may require us to conduct further trials to generate additional safety and efficacy data prior to approval.

goal is to have a positive impact on patients’ health and treatment equity by developing and commercializing personalized cell

therapies to treat infectious disease, cancer, and neurological disease.

Key elements of our strategy to advance toward this goal include

the following:

therapies to treat infectious disease, cancer, and other diseases.

Our strategy is to target large patient populations for each pipeline

Key elements of our strategy to advance toward this goal include the following:

the clinical development of TVGN 489 for the treatment of COVID-19 and Long COVID .

We completed a Phase 1 proof-of-concept

trial of TVGN 489 for the treatment of high-risk ambulatory adult COVID-19 patients in January 2023 and hope to launch a pivotal

trial in COVID-19 patients with B cell malignancies as soon as late 2024.

TVGN 489 is also in development for other highly vulnerable

COVID-19 patients and sufferers of Long COVID.

We will undertake a Long COVID genetic predisposition trial early in the second quarter

of 2024 in part to generate information needed to expeditiously conduct a Long Covid treatment trial that we expect to be launched

in approximately the first quarter of 2025.

our ExacTcell platform to develop therapies for additional indications .

In addition to TVGN 489, we are leveraging our ExacTcell

platform to advance product candidates in virology, oncology, and neurology.

Preclinical investigation is underway with product candidates

for the treatment of Epstein-Barr virus-associated lymphomas, multiple sclerosis, and several other viral and cancer targets.

manufacturing capabilities, including through acquisitions .

We will need to develop manufacturing capabilities for clinical

and, if approved, commercial supply of our cell therapy products.

Our efforts to develop manufacturing capability are currently focused

on acquiring existing manufacturing facilities or constructing one or more new manufacturing facilities, including through collaboration

with a potential facility development partner, and we have identified a potential clinical manufacturing facility for use.

strategic alliances and collaborating with partners to augment our capabilities .

We may pursue strategic alliances with other

biopharmaceutical companies with well-established presences in the specialties we aim to target for our indications.

This may include

co-marketing, co-promotion, and co-development relationships, or a partnership with a diagnostics company to help improve availability

of rapid HLA testing.

We also intend to explore options to work with partners to augment the study and treatment of patients and

the impact of our product candidates, including medical professionals, healthcare professional networks, pharmacy benefit managers,

insurance companies, and artificial intelligence companies.

ExacTcell Platform

ExacTcell platform and our therapies harness one of nature’s own approaches to eradicating cancer and other diseases:

trial of TVGN 489 for the treatment of high-risk ambulatory adult COVID-19 patients in January 2023 and plan to launch a pivotal

trial in COVID-19 patients with B cell malignancies.

TVGN 489 is also in development for other highly vulnerable COVID-19 patients

and sufferers of Long COVID.

A Phase 2 treatment trial examining the safety and efficacy of TVGN 489 in individuals with Long COVID

is currently under development.

Leveraging our ExacTcell

technology to develop therapies for additional indications .

In addition to TVGN 489, we are leveraging our ExacTcell technology

to advance product candidates in virology, oncology, and other conditions.

For example, early work is underway that leverages our

expertise in the selection of viral peptide targets to be used preventatively in the form of a T cell vaccination.

Developing manufacturing

capabilities, including through acquisitions .

We will need to develop manufacturing capabilities for clinical and, if approved,

commercial supply of our cell therapy products.

Our efforts to develop manufacturing capability are currently focused on acquiring

a manufacturing and research and development facility, including through collaboration with a potential facility development partner.

Forming strategic

alliances and collaborating with partners to augment our capabilities .

We may pursue strategic alliances with other biopharmaceutical

companies with well-established presences in the specialties we aim to target for our indications.

This may include co-marketing,

co-promotion, and co-development relationships, or a partnership with a diagnostics company to help improve availability of HLA testing

(rapid testing in acute illnesses and prompt testing in more chronic conditions).

We also intend to explore options to work with

partners to augment the study and treatment of patients and the impact of our product candidates, including medical professionals,

healthcare professional networks, pharmacy benefit managers, insurance companies, and artificial intelligence companies.

believe that positive data from studies and clinical trials can help pave the way for positive regulatory discussions, strategic partnerships,

and future label expansions, furthering our ability to meet our goal.

ExacTcell Technology

ExacTcell technology and our therapies harness one of nature’s own approaches to eradicating cancer and other diseases:

the cytotoxic

or killer T cell.

We believe that our patented ExacTcell precision allogeneic T cell development platform has the potential to be a broadly

applicable approach for developing convenient and reasonably priced cellular immunotherapies for the treatment of acute viral infections,

long-term consequences of viral infections such as Long COVID, viral- and non-viral-induced cancers, and certain neurological disorders.

We believe that our patented ExacTcell precision allogeneic T cell development technology has the potential to be a

broadly applicable approach for developing convenient and reasonably priced cellular immunotherapies for the treatment of acute viral

infections, long-term consequences of viral infections such as Long COVID, viral- and non-viral-induced cancers, and other disorders.

Although our initial product development has been in the area of infectious disease, we believe our technology also holds promise for

applications in cancers and autoimmune diseases, which would increase our total addressable market.

We also believe that ExacTcell can

enable us to deliver products faster, at a greater scale, and at lower cost than future competing cell therapies, if any.

focuses on the selection and expansion of naturally occurring, genetically unmodified CD8+ CTLs to target multiple, distinct, preselected

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T cells are white blood cells that play a vital role in the immune system’s defense against diseases, including viruses and cancer.

Most CTLs, including those developed with ExacTcell, express T cell receptors (“TCRs”), which are surface proteins that provide

CTLs, including those developed with ExacTcell, express T cell receptors (“TCRs”), which are surface proteins that provide

each T cell with its unique immune specificity to recognize and react against specific foreign antigenic peptides of infected or malignant

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By stimulating with only carefully

defined smaller peptides that are selected to bind to a single HLA-class I molecule, our approach elicits a high degree of target-specific

CD8+ responses, which we believe may result in improved outcomes as compared to these other approaches.

Knowing the specific peptide

targets also allows rapid identification of the impact of mutations on our CTL products.

selected smaller peptides that are known to bind to a single HLA-class I molecule and to be recognized by CTLs, our approach elicits

a high degree of target-specific CD8+ responses, which we believe may result in improved outcomes as compared to these other approaches.

Knowing the specific peptide targets also allows rapid identification of the impact of mutations on our CTL products.

Having multiple

targets within a product also blunts the impact of any one mutation.

to the targeted nature of the cells ExacTcell can produce, we also believe we may be able to avoid some of the unwanted corollary effects

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autologous and allogeneic CAR-T platforms.

Autologous cell therapies are derived from a donor’s own cells, as contrasted with allogenic

therapies such as ours, where cells are from third party donors.

order to select candidate peptides for ExacTcell products, we rely on a combination of computer-facilitated prediction of the ability

of specific peptide candidates to bind to specific HLA molecules and published scientific research.

Once candidates are selected, we

use tetramer staining to assess whether T cells recognize the target peptides and assess cytotoxicity against individual peptide-pulsed

and non-pulsed targets.

This allows us to rapidly and proactively select multiple, precise, candidate T cell targets and then quickly

experimentally confirm them for use.

Through our Tevogen.ai artificial intelligence initiative, we are exploring ways to deploy artificial

intelligence-powered target detection to further accelerate our product development pace, either internally or in collaboration with

leading entities in the field of artificial intelligence.

Data from our Phase 1 trial strongly supports this belief.

Autologous cell therapies are derived

from a donor’s own cells, as contrasted with allogenic therapies such as ours, where cells are from third party donors.

order to select candidate peptides for ExacTcell products, we rely on computer-facilitated prediction of the ability of specific peptide

candidates to bind to specific HLA molecules.

Once candidates are selected and used to stimulate T cells in the laboratory, we use tetramer

staining to assess whether T cells recognize the target peptides and assess cytotoxicity against individual peptide-pulsed and non-pulsed

This allows us to rapidly and proactively select multiple, precise, candidate T cell targets and then quickly experimentally

confirm their effectiveness.

Through our Tevogen.AI artificial intelligence initiative,

we are exploring ways to deploy artificial intelligence-powered target detection to accelerate our product development pace, either internally

or in collaboration with leading entities in the field of artificial intelligence, such as through our enrollment in the Microsoft for

Startups program and use of Microsoft Azure.

illustrated in the figure below, we begin the ExacTcell process by collecting cells from a healthy donor.

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infections due to eradication of normal parts of the immune system along with the cancer.

recently, in November of 2023, FDA announced that it had “received reports of T-cell malignancies, including chimeric antigen receptor

positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.” These

secondary malignancies resulted in hospitalization and death in a small subset of patients.

On January 19, 2024, FDA required a class-wide

black box warning be added to the label of these CAR T products regarding this risk.

FDA also underscored that the benefits of CAR-T

therapies continue to outweigh their risks but recommended lifelong monitoring of this potential side effect.

Currently approved autologous

CAR-T platforms utilize the patient’s own T cells to manufacture their products.

These cells have previously been exposed to cancer

therapy and are genetically altered and subsequently expanded.

contrast, CTLs generated using the ExacTcell platform come from a healthy donor with a normal immune system.

ExacTcell CTLs are not genetically

altered in the manufacturing process and although they expand during manufacture, this is the expected response of a T-lymphocyte when

encountering its target antigen.

The genetic modifications necessary to make CAR-T cells, which may be associated with the recent reports

of T-cell malignancies, are not utilized in the manufacture of our products made on the ExacTcell platform.

Moreover, secondary malignancies

have not been described in the unmodified T cell products given to hundreds of post-transplant patients.

Although our ExacTcell products

are not designed to be genetically modified, they are still in the early stages of testing, and only limited human and laboratory study

data are available regarding the risk profiles of our products.

Allogeneic CAR-T approaches are in early-stage development, but concerns

exist regarding side effects similar to autologous CAR-T, and additionally, the development of graft versus host disease with allogeneic

CAR-T products, both of which we believe will be of lower risk with our platform.

November 2023, FDA announced that it had “received reports of T-cell malignancies” in patients who received certain autologous

CAR T cell immunotherapies.

In January 2024, FDA required a class-wide black box warning be added to the label of these CAR T products

regarding this risk.

Currently approved autologous CAR-T platforms utilize the patient’s own T cells to manufacture their products.

These cells have previously been exposed to cancer therapy and are genetically altered and subsequently expanded.

contrast, CTLs generated using the ExacTcell technology come from a healthy donor with a normal immune system.

ExacTcell CTLs are not

genetically altered in the manufacturing process and although they expand during manufacture, this is the expected response of a T-lymphocyte

when encountering its target antigen.

The genetic modifications necessary to make CAR-T cells, which may be associated with the recent

reports of T cell malignancies, are not utilized in the manufacture of our products made on the ExacTcell technology.

Moreover, secondary

malignancies have not been described in the unmodified T cell products given to hundreds of post-transplant patients.

Although products

from our ExacTcell technology are not designed to be genetically modified, they are still in the early stages of testing, and only limited

human and laboratory study data are available regarding the risk profiles of our products.

Allogeneic CAR-T approaches are in early-stage

development, but concerns exist regarding side effects similar to autologous CAR-T, and additionally, the development of graft versus

host disease with allogeneic CAR-T products, both of which we believe will be of lower risk with our technology.

of doses per donor can be obtained using the ExacTcell approach, which is expected to facilitate off-the-shelf use and the ability to

administer doses within hours of diagnosis in the case of treatments against viruses where rapid therapeutic intervention is crucial.

Use of TVGN 489, for example, is expected to begin with a confirmatory COVID-19 test and rapid HLA typing for which results would be

available in six to eight hours, allowing selection of the proper product based on HLA type.

After confirmation of HLA type, thawing

takes minutes, and cells are infused within ten minutes of thawing.

convenience of “off-the-shelf” – manufactured and stored for immediate use – therapy has the potential to offer timely and

cost-efficient therapeutics by potentially eliminating the need for specialized medical facilities, unlike existing platforms.

products in which the active CD8+ T cell components are present at high concentrations, we believe relatively small volumes will be required,

allowing our therapies to be easily and promptly delivered in the ambulatory setting as a very brief intravenous administration such

as in a physician’s office.

are working to further advance ExacTcell with a new, proprietary T cell receptor-engineered process (“TCR-T”), which we believe

may substantially increase the number of doses that can be produced from a single donor.

Available technology can be used to allow us

to interrogate over a thousand individual T cells to determine which one kills peptide-pulsed targets fastest or kills the most in a

given timeframe.

This highest performing T cell can then be isolated, and its T cell receptor sequenced, allowing us to make an artificial

TCR gene that can be introduced into CD8+ T cells collected from healthy donors.

We believe this could allow at least a several-fold

increase in the number of desired CTLs as compared to our current approach.

We expect efforts to produce second generation products based

on this process may begin shortly after and if initial regulatory approval of the first-generation product is obtained.

administer doses within hours of diagnosis when rapid therapeutic intervention is crucial.

Use of TVGN 489, for example, is expected

to begin with a confirmatory COVID-19 test and rapid HLA typing for which results would be available in six to eight hours, allowing

selection of the proper product based on HLA type.

After confirmation of HLA type, thawing takes minutes, and cells are infused within

ten minutes of thawing.

convenience of “off-the-shelf” – manufactured and stored for immediate use – therapy has the potential to offer

timely and cost-efficient therapeutics by potentially eliminating the need for specialized medical facilities, unlike existing platforms.

By producing products in which the active CD8+ T cell components are present at high concentrations, we believe relatively small volumes

will be required, allowing our therapies to be easily and promptly delivered in the ambulatory setting as a very brief intravenous administration

such as in a physician’s office.

are working to further advance ExacTcell with a new, proprietary T cell receptor-engineered process, which we believe may substantially

increase the number of doses that can be produced from a single donor.

Available technology can be used to allow us to interrogate over

a thousand individual T cells to determine which one kills peptide-pulsed targets fastest or kills the most in a given timeframe.

highest performing T cell can then be isolated, and its T cell receptor sequenced, allowing us to make an artificial TCR gene that can

be introduced into CD8+ T cells collected from healthy donors.

We believe this could allow at least a several-fold increase in the number

of desired CTLs as compared to our current approach.

We expect efforts to produce second generation products based on this process may

begin shortly after and if initial regulatory approval of the first-generation product is obtained.

First Product Candidate

first product candidate, TVGN 489, is an off-the-shelf, allogeneic cytotoxic CD8+ T cell therapy designed to fill a critical gap in COVID-19

therapeutic solutions for the immunocompromised and the high-risk elderly, with potential applications in both treatment and prevention

of Long COVID.

Treatment for these groups represents an area of unmet or incompletely met need which we believe TVGN 489 can significantly

We rapidly progressed TVGN 489 from pre-discovery to the clinic in only 18 months.

TVGN 489 cells are derived from healthy donors

who recovered from a prior COVID-19 infection, and TVGN 489 is active against multiple, precise targets spread across the SARS-CoV-2

first product candidate, TVGN 489, is an off-the-shelf, allogeneic cytotoxic CD8+ T cell therapy designed to fill a critical remaining

gap in COVID-19 therapeutic solutions for the immunocompromised and the high-risk elderly, who remain at substantial risk for poor outcomes,

with potential applications in both treatment and prevention of Long COVID.

Treatment for these groups represents an area of unmet or

incompletely met need which we believe TVGN 489 can significantly address.

We rapidly progressed TVGN 489 from pre-discovery to the clinic

in only 18 months.

TVGN 489 cells are derived from healthy donors who recovered from a prior COVID-19 infection, and TVGN 489 is active

against multiple, precise targets spread across the SARS-CoV-2 genome.

January 2023, we completed a Phase 1 proof-of-concept trial of TVGN 489 for the treatment of ambulatory high-risk adult COVID-19 patients.

No dose-limiting toxicities or significant TVGN 489-related adverse events were observed in this trial at any of the four dosing levels

Secondary endpoints showing a rapid reduction of COVID-19 viral load and to show that infusion of TVGN 489 did not prevent development

of the patient’s own T cell-related (cellular) and antibody-related (humoral) anti-COVID-19 immunity were also met.

Secondary endpoint analysis showed a rapid reduction in COVID-19 viral load and that the infusion of TVGN 489 did not prevent

the development of the patient’s own T cell-related (cellular) and antibody-related (humoral) anti-COVID-19 immunity.

none of the patients in the treatment arm reported progression of infection, reinfection, or the development of Long COVID during the

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HLA type in the population.

believe TVGN 489 has the potential to be less susceptible to viral mutation than monoclonal antibodies, less susceptible to drug resistance

than antivirals, and to rapidly be able to overcome any increased immune evasion of current and emerging SARS-CoV-2 variants.

believe ExacTcell can enable us to deliver products faster, at a greater scale, and at lower cost than future competing cell therapies,

Despite selection of T cell targets in 2020, the HLA-A*02:01 TVGN 489 product has maintained a high degree of activity through

the full range of studied delta and subsequent omicron variants.

In contrast, most monoclonal antibodies were withdrawn from the market

for lack of efficacy related to the emergence of new variants, providing what we believe to be evidence of decreased susceptibility of

TVGN 489 to viral mutation.

In addition, knowing the precise peptide targets of our therapy helps allow rapid assessment regarding their

preservation or loss as soon as new variants are sequenced.

We check emerging COVID-19 variants against TVGN 489 targets on an ongoing

believe that TVGN 489 targets are less susceptible to viral mutations due to their small size than monoclonal antibody targets and less

susceptible to drug resistance than antivirals.

As evidence of this, despite selection of T cell targets in 2020, more than 95% of the

targets for the HLA-A*02:01 TVGN 489 product targets have remained intact through the first quarter of 2025.

In contrast, most monoclonal

antibodies were withdrawn from the market for lack of efficacy related to the lack of recognition of new variants, providing what we

believe to be evidence of decreased susceptibility of TVGN 489 to viral mutation.

In addition, knowing the precise peptide targets of

our therapy helps allow rapid assessment regarding their preservation or loss as soon as new variants are sequenced.

We check emerging

COVID-19 variants against TVGN 489 targets on an ongoing basis.

caused by the SARS-CoV-2 virus, has killed millions and infected hundreds of millions since its emergence in late 2019.

Groups currently

most at risk for poor outcomes due to COVID-19 are immunocompromised individuals unable to mount an adequate immune response, such as

those with immune system cancers, immunodeficiency disorders, transplant recipients, patients with immune-mediated disorders requiring

immunosuppressive therapy, or high doses of corticosteroids, the elderly and the unvaccinated.

For example, recent data shows that the

majority of COVID-19 deaths occur in people over the age of 65.

The risk of severe illness from COVID-19 for an individual tends to escalate

with an increase in their number of underlying medical conditions.

In addition to the acute impacts of infection, a significant portion

of those who have been infected by COVID-19 in the past develop more chronic and potentially debilitating symptoms afterwards, a condition

termed Long COVID.

Of US adults, 17.6% had experienced symptoms of Long COVID, according to the Centers for Disease Control and Prevention’s

(“CDC’s”) household pulse survey taken from January 9 through February 5, 2024.

As of October 2023, 5% of all adults

were still experiencing symptoms of Long COVID, according to a USA FACTS review of U.S.

Census Bureau data.

Despite the availability

of vaccines and emergence of initial therapeutics, significant gaps and shortcomings in treatment remain both for vulnerable patients

experiencing an acute infection and for Long Covid sufferers for whom there are no treatment options approved for the indication or its

underlying causes.

Groups most at

risk for poor outcomes due to COVID-19 are immunocompromised individuals unable to mount an adequate immune response, such as those with

immune system cancers, immunodeficiency disorders, transplant recipients, patients with immune-mediated disorders requiring immunosuppressive

therapy, or high doses of corticosteroids, the elderly and the unvaccinated.

Data shows that the majority of COVID-19 deaths occur in

people over the age of 65.

The risk of severe illness from COVID-19 for an individual tends to escalate with an increase in their number

of underlying medical conditions.

In addition to the acute impacts of infection, a significant portion of those who have been infected

by COVID-19 in the past develop more chronic and potentially debilitating symptoms afterwards, a condition termed Long COVID.

the availability of vaccines and emergence of initial therapeutics, significant gaps and shortcomings in treatment remain both for vulnerable

patients experiencing an acute infection and for Long Covid sufferers for whom there are no treatment options approved for the indication

or its underlying causes.

other viruses that have RNA as their genetic material, SARS-CoV-2 is constantly evolving through random mutations.

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so as to evade the immune system.

of May 2023, about 103 million cumulative confirmed COVID-19 cases were reported in the United States alone.

While there has been a decrease

in the number of confirmed and reported cases, this is a multifactorial issue due in part to a decrease in testing by younger or healthier

individuals, reliance on home tests, the results of which are often not reported, expiration of federal funding for testing, and the

CDC’s discontinuation of collection of testing data.

However, a large number of Americans remain highly vulnerable to COVID-19

infection, including immunocompromised and elderly patients.

For example, the rate of hospitalization in cancer patients with COVID-19

infection remains high, specifically for those under active chemotherapy or immunosuppression.

There is therefore a high unmet need to

have an effective treatment available for these populations.

Classic herd immunity leading to eradication of COVID-19 is unlikely, much

as is the case for influenza, respiratory syncytial virus (RSV), and other endemic respiratory viruses.

This contrasts with smallpox,

for example, where both natural infection and vaccination eliminated virus transmission.

SARS-CoV-2 infection and vaccination produce

a steadily waning natural and vaccine-induced immunity, respectively, but do not eliminate transmission.

Although the number of daily

reported cases and deaths has declined, the emergence of more transmissible variants has led to spikes in cases and mortality, and variants

are expected to continue to evolve over time.

The potential rise of immune-evasive variants in immunocompromised patients provides a public health

rationale for the treatment of immunocompromised patients in order to more rapidly and aggressively eliminate the virus and avoid generation

of new variants.

large number of Americans remain highly vulnerable to COVID-19 infection, including immunocompromised and elderly patients.

the rate of hospitalization in cancer patients with COVID-19 infection remains high, specifically for those under active chemotherapy

or immunosuppression.

There is therefore a high unmet need to have an effective treatment available for these populations.

immunity leading to eradication of COVID-19 is unlikely, much as is the case for influenza, respiratory syncytial virus (RSV), and other

endemic respiratory viruses.

This contrasts with smallpox, for example, where both natural infection and vaccination eliminated virus

transmission.

SARS-CoV-2 infection and vaccination produce a steadily waning natural and vaccine-induced immunity, respectively, but

do not eliminate transmission.

Although the number of daily reported cases and deaths has declined, the emergence of more transmissible

variants has led to spikes in cases and mortality, and variants are expected to continue to evolve over time.

current COVID-19 landscape is also characterized by continued vaccine hesitancy among a significant portion of the population, unequal

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and treatment could lead to higher pricing for diagnostics and therapeutics.

two anti-viral agents, Nirmatrelvir/Ritonavir (Paxlovid) and Remdesivir, have been FDA-approved for the treatment of COVID-19.

Paxlovid is indicated for treatment in individuals at high risk for viral progression, neither drug has been specifically authorized

two anti-viral agents, Nirmatrelvir with Ritonavir (Paxlovid) and Veklury (remdesivir), have been FDA-approved for the treatment of COVID-19.

While Paxlovid is indicated for treatment in individuals at high risk for viral progression, neither drug has been specifically authorized

for use in immunocompromised patients, creating a need for the development of novel therapies in this area.

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introduced early in the pandemic for treatment of COVID-19 but typically have been rendered ineffective over time as the virus continues

No therapies have been approved to treat the underlying causes of the symptoms of Long COVID, and significant research is

ongoing to determine why some patients fully recover while others develop long-term complications.

One prophylactic monoclonal antibody for COVID-19 prevention, Pemgarda (Pemivibart), has received emergency use authorization

for moderate to severely immune compromised patients.

Whether this monoclonal antibody will remain more durable than other monoclonal

antibody remains to be seen, although resistance to the drug has already been observed in some variants.

No therapies have been approved

to treat the underlying causes of the symptoms of Long COVID, and significant research is ongoing to determine why some patients fully

recover while others develop long-term complications.

Advantages of TVGN 489

the ongoing spread of COVID-19 and its effects and continued gaps in treatment, there is a clear need for alternatives to current therapeutic

options for COVID-19.

We believe TVGN 489 has been shown to be less susceptible to viral mutations than monoclonal antibodies and thus

able to overcome the increased immune evasion of current and emerging COVID-19 variants.

We also believe TVGN 489 has the potential to

be less susceptible to drug resistance than antivirals.

As contrasted with existing therapies, TVGN 489 is designed to recognize multiple

specific target peptides from distinct COVID-19 proteins, versus one or two targets typically derived only from the spike protein.

other viral therapies buy time for natural immunity to emerge and definitively control the virus, TVGN 489 provides natural immunity

directly and immediately to patients.

options for COVID-19 We have shown that TVGN 489 is less susceptible to viral mutations than monoclonal antibodies and thus able to overcome

the increased immune evasion of current and emerging COVID-19 variants.

We also believe TVGN 489 has the potential to be less susceptible

to drug resistance than antivirals.

As contrasted with existing therapies, TVGN 489 is designed to recognize multiple specific target

peptides from distinct COVID-19 proteins, versus one or two targets typically derived only from the spike protein.

Whereas other viral

therapies buy time for natural immunity to emerge and definitively control the virus, TVGN 489 provides natural immunity directly and

immediately to patients.

489’s targets have also persisted in studied COVID-19 variants.

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studied to date.

This is in significant contrast with the target loss of anti-spike monoclonal antibody therapies, which led to the withdrawal

of emergency use authorizations (“EUAs”) that had been granted during the now-expired COVID-19 National Public Health Emergency.

For example, the EUA for AbCellera Biologics’ and Eli Lilly’s bamlanivimab administered alone, which was granted in November

2020, was revoked in April 2021 due to a sustained increase in viral variants that were not sensitive to this product.

This is in significant contrast with the target loss of anti-spike monoclonal antibody therapies, which has led to the

withdrawal of emergency use authorizations (“EUAs”) that had been granted during the now-expired COVID-19 National Public

Health Emergency.

variants have demonstrated how this virus is able to escape our immune system through mutation.

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which is shorter than the average noted by patients in the observational arm, and 83% of patients in the interventional arm had negative

nasal swab polymerase chain reaction tests within 14 days.

The consistency of the resolution was suggestive of a treatment effect and

the observed period is in contrast to a range of up to 90 days in the general population.

This observed consistency and rapidity of nasal

swab COVID-19 resolution was in a population where five individuals were on active immunosuppression for cancer and one for lupus at

the time of COVID-19 infection.

Two patients on the trial went on to stem cell transplantation, an immunosuppressive procedure, within

a month of treatment.

Neither experienced COVID-19 reactivation, which we believe further attests to the rapid acting nature of this

When immunocompromised patients get sick from COVID-19, their current treatment regimens for existing conditions are often stopped.

For oncology patients, this can be especially disruptive or even harmful.

Given TVGN 489’s design and these results, we believe

TVGN 489 may allow immunocompromised patients to recover and be able to return to their pre-COVID-19 treatment regimen with minimal delays.

nasal swab polymerase chain reaction tests and there was a 99% viral load reduction in all patients within 14 days.

The consistency of

the resolution was suggestive of a treatment effect and the rapidity of nasal swab COVID-19 resolution was shown in a population where

five individuals were on active immunosuppression for cancer (three with hematological malignancy, two with solid tumors) and one for

lupus at the time of COVID-19 infection.

Moreover, a more recent study showed that the median time to SARS-CoV-2 nasal swab PCR negativity

was 72 days for patients with a hematologic malignancy highlighting the rapidity of response in the Tevogen phase I study.

on the trial went on to stem cell transplantation, an immunosuppressive procedure, within a month of treatment.

Neither experienced COVID-19

reactivation, which we believe further attests to the rapid acting nature of this product.

When immunocompromised patients get sick from

COVID-19, their current treatment regimens for existing conditions are often stopped.

For oncology patients, this can be especially disruptive

or even harmful to the curative potential of their treatment.

Given TVGN 489’s design and these results, we believe TVGN 489 may

allow immunocompromised patients to recover and be able to return to their pre-COVID-19 treatment regimen with minimal delays.

of TVGN 489 and Mechanism of Action

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individual peptide-pulsed and non-pulsed targets, and selected final peptides for use in TVGN 489 on that basis.

conducted multiple in-vitro studies of TVGN 489 in preparation for filing the investigational new drug application (“IND”)

with FDA and observed strong antiviral activity against SARS-CoV-2 in these laboratory studies.

In preclinical studies, we observed that

TVGN 489 cells kill target cells that are exposed to SARS-CoV-2 peptides, but not cells that are not exposed to those peptides.

is illustrated in the figure below, which shows the percentage of cells killed over a four-hour period when targets were pulsed with

the peptides and when they were not, with the x-axis showing the lysis rates based on the ratio of CTLs to target cells.

conducted multiple in-vitro studies of TVGN 489 in preparation for filing the IND with FDA and observed strong antiviral activity against

SARS-CoV-2 in these laboratory studies.

In preclinical studies, we observed that TVGN 489 cells kill target cells that are exposed to

SARS-CoV-2 peptides, but not cells that are not exposed to those peptides.

This is illustrated in the figure below, which shows the percentage

of cells killed over a four-hour period when targets were pulsed with the peptides and when they were not, with the x-axis showing the

lysis rates based on the ratio of CTLs to target cells.

Identification

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confident that between 90% and 95% of the COVID-19 infected population could be treated based on our research.

We believe generating

these CTLs can provide treatment for SARS-CoV-2 or, with the appropriate targets, for other viral infections.

Immunizing an individual

to these specific targets should form the basis of helping to prevent a subsequent infection through a T cell vaccine.

Target identification

thus has the potential to assist with prevention as well as treatment.

Development for COVID-19 Patients

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COVID-19 and were deemed to be at high risk for complications due to the presence of one or more underlying medical conditions defined

as high risk by the CDC, including among others cancer, hypertension, obesity, diabetes, cardiovascular disease, and old age.

which was conducted at Thomas Jefferson University Hospital in Philadelphia, was completed in January 2023.

as high risk by the Centers for Disease Control and Prevention, including among others cancer, hypertension, obesity, diabetes, cardiovascular

disease, and old age.

The trial, which was conducted at Thomas Jefferson University Hospital in Philadelphia, was completed in January

trial included two arms, with 12 patients in the treatment, or interventional, arm and 18 patients in the observational arm.

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or 3 x 10 6 /kg.

These dose levels were chosen based on

data regarding antiviral T cell therapy in hematopoietic transplant patients involving the administration of similar cell numbers.

patients were enrolled at each dosing level with the option to enroll three more if a significant side effect was observed.

level concluded with three patients rather than six and the treatment arm concluded with a total of 12 patients rather than 24, primarily

due to the absence of appreciable toxicities across all dose levels.

The comparative arm, which was designed to end enrollment when treatment

arm enrollment was completed, concluded with 18 patients, appreciably less than what would have occurred if the treatment group required

additional enrollment.

Observational arm patients received standard of care treatment, including monoclonal antibodies.

Interventional

arm patients were monitored in the hospital for four days before being discharged and then were observed daily at home for ten additional

days and again at the one, two, three, and six-month anniversary of the initial infusion.

Observational arm patients were monitored at

home over the same interval.

Patients treated on the first dosing level

had the high-risk delta variant of COVID-19.

These dose levels were chosen based on data regarding antiviral T cell therapy in hematopoietic

transplant patients involving the administration of similar cell numbers.

Three patients were enrolled at each dosing level with the

option to enroll three more if a significant side effect was observed.

Each dose level concluded with three patients rather than six

and the treatment arm concluded with a total of 12 patients rather than 24, due to the absence of appreciable toxicities across all dose

The comparative arm, which was designed to end enrollment when treatment arm enrollment was completed, concluded with 18 patients,

appreciably less than what would have occurred if the treatment group required additional enrollment.

Observational arm patients received

standard of care treatment, including monoclonal antibodies.

Interventional arm patients were monitored in the hospital for four days

before being discharged and then were observed daily at home for ten additional days and again at the one, two, three, and six-month

anniversary of the initial infusion.

Observational arm patients were monitored at home over the same interval.

primary endpoints of the trial, which were safety-related, were met.

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None of the patients who participated in the trial reported progression of their

COVID-19 infection and none developed COVID-19 or Long COVID during the six-month follow-up period.

These clinical observations were

mirrored by laboratory evidence of the persistence of infused TVGN 489 cells for at least six months after treatment.

COVID-19 infection and none developed recurrent COVID-19 or Long COVID during the six-month follow-up period.

These clinical observations

were mirrored by laboratory evidence of the persistence of infused TVGN 489 cells for at least six months after treatment.

of infused therapeutic cells remains a significant issue in the T cell therapy space, leading to challenges in controlling viral infections,

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However, the evidence of their prolonged persistence provides us with encouragement for future

applications of the ExacTcell platform, particularly in oncology.

applications of the ExacTcell technology, particularly in oncology.

believe based on precedential industry examples, including in areas with high unmet needs or strong early phase clinical trial results,

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Although the clinical

trial process usually includes three phases, a pivotal trial may not necessarily be denoted as a Phase 3 clinical trial, and instead

may be a Phase 2 or Phase 2/3 clinical trial.

As soon as late 2024, we hope to begin a pivotal trial of TVGN 489 for the treatment of

COVID-19 in select vulnerable populations with humoral immune suppression due to B cell malignancy or the treatment thereof.

with hematological malignancies continue to experience higher rates of hospitalization and death as compared to the general population

and those with solid tumors.

Increased mortality, hospitalization, and incidence of Long COVID are higher in patients with B cell malignancies

due to inadequate vaccination response and the immunosuppressive consequences of treatment received for B cell cancers.

While the major

acute outcomes of patients with hematological malignancies and COVID-19 have improved with increasing experience, delays in cancer treatment

due to the infection are increasingly recognized as a long-term impact of COVID-19 in this population.

Whereas treatment arm patients

in our Phase 1 proof-of-concept clinical trial all had a single HLA type, we expect to treat patients in this pivotal trial who have

any of the six most common HLA types, which we believe would represent between 60% and 65% of the population.

The primary endpoint of

this trial is planned to be reduced risk of hospitalization, with secondary endpoints relating to pace of viral load reduction, duration

of hospitalization, intensive care unit admissions, hours on supplemental oxygen, mortality, COVID-19 recurrence, Long COVID diagnosis,

and interruption in cancer treatment associated with COVID-19.

At this stage, however, we cannot be certain whether we will be permitted

to move from a Phase 1 trial directly to a pivotal trial until FDA reviews and concurs with or rejects our proposed plans, and FDA may

require us to conduct further trials to generate additional safety and efficacy data.

development of TVGN 489 continues, we may also seek FDA’s regenerative medicine advanced therapy (“RMAT”) designation

for TVGN 489, which as explained in “Regulatory Environment – Expedited Development and Review Programs” below, is intended

to facilitate efficient development and expedited review.

trial process usually includes three phases, a pivotal trial may not necessarily be denoted as a Phase 3 clinical trial and instead may

be a Phase 2 or Phase 2/3 clinical trial.

We hope to begin a pivotal trial of TVGN 489 for the treatment of COVID-19 in select vulnerable

populations with humoral immune suppression due to B cell malignancy or the treatment thereof.

Patients with hematological malignancies

continue to experience higher rates of hospitalization and death as compared to the general population and those with solid tumors.

mortality, hospitalization, and incidence of Long COVID are higher in patients with B cell malignancies due to inadequate vaccination

response and the immunosuppressive consequences of treatment received for B cell cancers.

While the major acute outcomes of patients

with hematological malignancies and COVID-19 have improved with increasing experience, for cancer patients who contract COVID-19, uninterrupted

treatment is critical, as delays can impact long-term outcomes.

Whereas treatment arm patients in our Phase 1 proof-of-concept clinical

trial all had a single HLA type, we expect to treat patients in this pivotal trial who have any of the six most common HLA types, which

we believe would represent between 60% and 65% of the population.

The primary endpoint of this trial is planned to be reduction in SARS-CoV-2

viral load and reduction in the delays of cancer treatment.

Secondary endpoints include the incidence and duration of hospitalization,

intensive care unit admissions, hours on supplemental oxygen, mortality, COVID-19 recurrence, and Long COVID diagnosis.

At this stage,

however, we cannot be certain whether we will be permitted to move from a Phase 1 trial directly to a pivotal trial until FDA reviews

and concurs with or rejects our proposed plans, and FDA may require us to conduct further trials to generate additional safety and efficacy

development of TVGN 489 continues, we may also seek FDA’s RMAT designation for TVGN 489, which as explained in “Regulatory

Environment – Expedited Development and Review Programs” below, is intended to facilitate efficient development and expedited

Target Patient Populations and Indications for TVGN 489

target patient populations for TVGN 489 that we are prioritizing include the treatment of COVID-19 in B cell immune suppressed acute

COVID-19 patients without a B cell cancer indication, elderly and infirm acute COVID-19 patients, and Long COVID sufferers.

above, these patients are among those with the greatest need for effective treatment.

We believe that the safety and the clinical benefit

data from our completed Phase 1 clinical trial in ambulatory, high-risk adult patients should be sufficient to serve as the basis for

later-stage and potentially pivotal trials in these patient groups as well as for the prevention of Long COVID.

However, whether such

trials may serve as pivotal trials, the phase of these trials, and the dose level to be selected in each trial remains subject to discussions

with and agreement by FDA.

also intend to develop TVGN 489 for the treatment of acute COVID-19 in patients on T cell suppressing drugs, including solid organ transplant

The suppression of these patients’ immune systems may make them more susceptible to developing graft versus host disease.

Based on data analyzed from hundreds of bone marrow transplant patients receiving T cell therapies showing almost no incidence of graft

versus host disease, we believe it unlikely that patients on T cell suppressing drugs would develop graft versus host disease as a result

of treatment with TVGN 489.

However, we believe the possibility nonetheless merits an additional safety study in this target population

prior to moving forward with later stage clinical development.

In addition, higher doses may also be required for efficacy in these patients

as compared to other patients, as T cell suppressing drugs may reduce the impact of TVGN 489, requiring more cells to produce comparable

the majority of younger and healthier adults with COVID-19 avoid poor outcomes after infection without treatment, there remain subsets

of the population (such as humorally suppressed patients with B cell malignancies, as described above) who are vulnerable to significant

complications from COVID-19 because of a weak immune system or suboptimal responses to vaccines.

Treatment of these individuals is an

area of unmet need that we believe TVGN 489 therapy has the opportunity to fill.

These target populations also include COVID-19 patients

with a non-B-cell cancer indication, elderly and infirm acute COVID-19 patients, and those with immune suppression due solid organ or

hematopoietic transplantation or autoimmunity or its treatment.

Regardless of age or comorbidity, individuals with Long COVID represent

another critical area of unmet need.

As noted above, these patients are among those with the greatest need for effective treatment.

believe that the safety and the clinical benefit data from our completed Phase 1 clinical trial in ambulatory, high-risk adult patients

should be sufficient to serve as the basis for later-stage and potentially pivotal trials in these patient groups as well as for the

prevention of Long COVID.

However, whether such trials may serve as pivotal trials, the phase of these trials, and the dose level to

be selected in each trial remains subject to discussions with and agreement by FDA.

studies have detected persistent viral spike and nucleocapsid proteins in some Long COVID patients, suggesting a persistent viral reservoir

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whether FDA will require us to conduct a separate prevention trial until FDA reviews and concurs with or rejects our proposed plans.

is also beginning to identify Long COVID biomarkers in preparation for Long COVID treatment trials.

We believe that certain individuals

may be genetically predisposed to Long COVID, in that the HLA types of Long COVID patients may be skewed toward some HLA types and away

However, very limited Long COVID-related HLA typing information has been published to date.

We therefore plan to launch

a non-therapeutic blood draw study in the second quarter of 2024 to assess whether the Long COVID population generally reflects

or is skewed towards or away from certain HLA types and to determine the optimal HLA types to target in a therapeutic trial of TVGN 489

for the treatment of Long COVID.

This will allow us to develop CTLs for the HLA types most commonly found in Long COVID.

Following the

results of that study, we plan to begin a clinical trial in Long COVID treatment in approximately the fourth quarter of 2024.

symptoms will also be explored for an association with the viral reservoir in advance of this trial.

Additional studies in vulnerable

populations are expected to follow.

studies have indicated that there is not an HLA class I-based predisposition to Long COVID.

Therefore, it was not necessary for us to

undertake a genetic prediction study to determine optimal class I HLA types for CTL donor selection.

Instead, a Phase 2 study is in development

that will examine the effect of treatment with TVGN 489 on specific categories of Long COVID sufferers such as those with fatigue or

brain fog based on the existence of a SARS-CoV-2 reservoir which may cause these symptoms.

This protocol is in a very early stage of

Discovery Programs, Product Candidates and Indications

addition to TVGN 489, we have several product candidates under early-stage development in virology, neurology, and oncology using our

ExacTcell platform technology.

We are developing Epstein-Barr virus (“EBV”) specific CTLs for potential use in multiple sclerosis

(“MS”) and EBV-associated lymphomas.

Our TVGN 601 is being developed for MS, and our TVGN 930 is being developed for EBV-associated

EBV is a common virus that infects over 90% of the world’s adult population, according to the World Health Organization

(the “WHO”), and is mainly transmitted through saliva, but also through other body fluids such as blood and semen.

the leading cause of infectious mononucleosis, and infects B-cells, a type of immune cell.

Recent studies have suggested a potential

link between infection with EBV and later onset of inflammation that causes MS, and EBV infection can lead to a variety of cancers and

cancer-like disorders, including lymphomas, nasopharyngeal cancers, Post-Transplant Lymphoproliferative Disorder, and others.

widespread nature of EBV and the serious health problems it can cause, investigative work is underway to identify effective peptide targets

for this virus to further the development of TVGN 601 and TVGN 930.

Investigative work is also underway to develop product candidates

targeted at human papilloma virus (“HPV”)-related diseases, including TVGN 920 in cervical cancer and TVGN 960 in oropharyngeal

cancer, which is a type of mouth and throat cancer.

ExacTcell technology.

For example, investigative work is also underway to develop product candidates targeted at human papilloma virus

(“HPV”)-related diseases, including TVGN 920 in cervical cancer and TVGN 960 in oropharyngeal cancer, which is a type of

mouth and throat cancer.

Cervical cancer and oropharyngeal cancer are both commonly caused by HPV.

to the WHO, HPV is responsible for 99% of cervical cancers.

Mouth and throat cancers are more diverse, but the WHO estimates that about

70% of oropharyngeal cancers are due to HPV.

Although a vaccine for HPV exists, the National Cancer Institute estimates that as of 2021,

only 58.5% of adolescents between the ages of 13 and 15 had received the recommended doses, estimated vaccination among older populations

is lower, and the COVID pandemic has shown that significant portions of the population will avoid vaccination.

We believe that as with

other viral infections, the availability of both a preventative strategy and a treatment strategy is important to reduce incidence and

impact of disease and is investigating peptide candidates for HPV to further the development of TVGN 920 and TVGN 960.

According to the WHO, HPV is responsible

for 99% of cervical cancers.

Mouth and throat cancers are more diverse, but the WHO estimates that about 70% of oropharyngeal cancers

are due to HPV.

Although a vaccine for HPV exists, the National Cancer Institute estimates that as of 2022, only 58.6% of adolescents

between the ages of 13 and 15 had received the recommended doses, estimated vaccination among older populations is lower, and the COVID

pandemic has shown that significant portions of the population will avoid vaccination.

We believe that as with other viral infections,

the availability of both a preventative strategy and a treatment strategy is important to reduce incidence and impact of disease and

is investigating peptide candidates for HPV to further the development of TVGN 920 and TVGN 960.

We are also beginning investigative

work to develop TVGN 116, a product candidate targeted at hepatitis B.

We are also developing Epstein-Barr virus (“EBV”)

specific CTLs for potential use in multiple sclerosis (“MS”) and EBV-associated lymphomas.

Our TVGN 601 is being developed

for MS, and our TVGN 930 is being developed for EBV-associated lymphomas.

EBV is a common virus that infects over 90% of the world’s

adult population, according to the World Health Organization (the “WHO”), and is mainly transmitted through saliva, but also

through other body fluids such as blood and semen.

EBV is the leading cause of infectious mononucleosis, and infects B-cells, a type

of immune cell.

Recent studies have suggested a potential link between infection with EBV and later onset of inflammation that causes

MS, and EBV infection can lead to a variety of cancers and cancer-like disorders, including lymphomas, nasopharyngeal cancers, Post-Transplant

Lymphoproliferative Disorder, and others.

Given the widespread nature of EBV and the serious health problems it can cause, investigative

work is underway to identify effective peptide targets for this virus to further the development of TVGN 601 and TVGN 930.

believe that our ExacTcell approach also presents a novel and highly specific technique to combating cancers with T cell therapy.

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supply of our cell therapy products.

Our efforts to develop manufacturing capability are currently focused on acquiring existing manufacturing

facilities or constructing one or more new manufacturing facilities, including through collaboration with a potential facility development

Our efforts to develop manufacturing capability are currently focused on finding a manufacturing

and research and development facility, including through collaboration with a potential facility development partner.

Commercialization Plans

approved, we plan to globally commercialize TVGN 489 and our other product candidates aimed at serving a large patient population suffering

from infectious diseases, cancer, and multiple sclerosis.

Our commercial and market access team has been diligently working alongside

our research and development team and external experts to better understand market dynamics, identify segments with high unmet needs,

map the patient journey, understand the competition within each segment, and identify opportunities for our product candidates.

from infectious diseases, cancer, and other disorders.

Our commercial and market access team has been diligently working alongside our

research and development team and external experts to better understand market dynamics, identify segments with high unmet needs, map

the patient journey, understand the competition within each segment, and identify opportunities for our product candidates.

team continues to offer input in portfolio planning and target prioritization for our research pipeline.

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development of TVGN 489.

believe that the U.S.

opportunity for our key pipeline products includes:

Approximately 750,000

patients with B cell hematologic cancer, 2,175,000 addressable patients with other cancers, including lung, breast, colon, pancreatic

and liver, and 18 million addressable patients with Long COVID.

Approximately 5.5 million patients

with high-risk HPV infections, of which 200,000 are diagnosed with high grade dysplasia per year.

Approximately 92,000 patients with

the main EBV-associated lymphomas.

Approximately 110,000 patients with

HPV-related mouth and throat cancer.

Approximately 1 million patients with

EBV-related multiple sclerosis.

Approximately 500,000 to 1 million

patients with high-risk chronic Hepatitis B for prevention of liver cancer.

October 2023, we announced Tevogen.AI, a new early-stage initiative focused on harnessing the potential of artificial intelligence to

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We also intend to explore the potential use of artificial intelligence to power tools that could anticipate

potential adverse reactions and efficacy concerns for and identify patients who would be most likely to respond to an investigational

potential adverse reactions, efficacy concerns, and identify patients who would be most likely to respond to an investigational therapy.

The ability to search the human genome for specific peptide sequences might, for example, eliminate some peptide targets simplifying

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active HLA-peptide complexes and additionally to predict T cell receptor engagement tied to specific HLA-peptide complexes.

its inception, Tevogen.AI has begun investigating individual viral isolates with a keen focus on target selection of peptides for our

pipeline of products.

We continue curating a highly refined dataset across 14 isolates, with more targets planned, to train future machine

learning and predictive artificial intelligence foundational models.

Further, we are investigating the human genome to understand immunologically

active HLA-peptide complexes related to our first patent filing.

We intend to create an interface we call PredicTcell to take inputs

in the form of proteins and suggest a viable T cell receptor design to bind to the given protein.

To aid this effort, we have entered

into agreements with leading artificial intelligence and technology companies.

The collaborative nature of these agreements affords Tevogen.AI

access to experts and other resources to fulfill its mission of creating foundational algorithmic models of T cell interactions with

Tevogen.AI is also exploring how we can leverage datasets from partners and enrich them with internal insights to drive clinical

trial recruitment and monitoring to ensure efficacy of a given T cell product.

History and Team

were incorporated as a Cayman Islands exempted company in April 2021, and Tevogen Bio was established in June 2020 as a Delaware corporation.

Our senior leadership team is composed of eminent scientists and accomplished biopharmaceutical leaders.

The team brings together diverse

experience across the entire life sciences spectrum, including biotechnology, pharmaceuticals, hospitals, public and private insurance,

education, and health policy.

Additionally, our team holds substantial expertise in drug development, global product launches, and commercialization

and ensuring patient access across a range of therapeutic areas.

Bio was established in June 2020 as a Delaware corporation, and Semper Paratus was incorporated as a Cayman Islands exempted company

in April 2021.

Our senior leadership team is composed of accomplished scientists and biopharmaceutical leaders.

The team brings together

diverse experience across the entire life sciences spectrum, including biotechnology, pharmaceuticals, hospitals, public and private

insurance, education, and health policy.

Additionally, our team holds substantial expertise in drug development, global product launches,

and commercialization and ensuring patient access across a range of therapeutic areas.

biotechnology industry, and in particular the cell therapy sector, are characterized by the rapid evolution of technologies and understanding

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more successfully than we do.

489 is being developed to fill the critical gaps that exist in COVID-19 therapeutics for the immunocompromised and the high-risk elderly.

No treatments are specifically approved for immunocompromised patients as of the date of this Annual Report, and clinical trial data

of currently approved treatments in immunocompromised patients is limited.

The National Institutes of Health’s (“NIH”)

COVID-19 Treatment Guidelines Panel, a group of clinical experts that has developed guidance on COVID-19 care (the “NIH Panel Guidelines”),

currently recommends prompt treatment of COVID-19 in non-hospitalized immunocompromised patients with antiviral drugs, but acknowledges

the limitations of these drugs and related research in such patients.

489 is being developed to fill the critical gaps that exist in COVID-19 therapeutics for the immunocompromised, the high-risk elderly,

and Long COVID.

Only one product has been FDA approved to date for treatment of COVID-19 in the immunocompromised population.

This treatment

provides passive immunity in the form of high-titer COVID-19 convalescent plasma (“CCP”) treatment, available from the non-profit

blood donation center, OneBlood, serving the southeastern United States.

Blood banks nationwide can request CCP from OneBlood, but it

is unclear how long it takes to transport the therapy.

In one trial, CCP was administered to young (median age 43 years) patients with

few comorbidities other than multiple sclerosis or neuromyelitis optica, for which they were receiving anti-CD 20 therapy.

Treated patients

with persistent symptoms before therapy had resolution of fever in seven days and the majority had reduction of viremia after CCP treatment.

In another trial of immune compromised patients with mild COVID-19 within seven days of infection, CCP did not prevent the evolution

of SARS-CoV-2 mutations in either the treated or untreated groups, and only two of 117 patients studied had B cell deficiency.

the majority of patients had undergone solid organ transplantation, only one patient in the treatment group underwent allogeneic hematopoietic

stem cell transplant, and there were minimal differences in outcomes between CCP-treated and non-treated groups.

The only significant

finding was a reduced rate of hospitalization in the CCP treatment group versus the non-treated group, with zero hospitalizations out

of 59 patients versus five out of 58.

In both of these studies, CCP was dosed multiple times.

This therapy is an FDA licensed treatment

through a blood donation center and is not marketed.

We believe more data is needed regarding this therapy, especially in humorally suppressed

individuals, and that questions remain about widespread availability and effectiveness in specific subgroups.

trial data of other approved treatments in immunocompromised patients is limited.

The National Institutes of Health’s COVID-19

Treatment Guidelines Panel, a group of clinical experts that developed guidance on COVID-19 care (the “NIH Panel Guidelines”),

recommended prompt treatment of COVID-19 in non-hospitalized immunocompromised patients with antiviral drugs, but acknowledged the limitations

of these drugs and related research in such patients.

Two antivirals are currently FDA-approved for COVID-19 treatment:

Gilead Science’s Veklury ® (Remdesivir) for the treatment of mild-to-moderate COVID-19 in hospitalized or non-hospitalized

adults who are at high risk for progression to severe COVID-19, and Pfizer’s Paxlovid (Nirmatrelvir/Ritonavir tablets) for the

treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19.

The NIH Panel Guidelines highlight

the limitation of the insights that clinical trials conducted for Remdesivir and for Nirmatrelvir/Ritonavir tablets in broader populations

can provide with respect to immunocompromised patients, as each trial enrolled only limited numbers of such patients.

For example, a

retrospective study examining the use of Nirmatrelvir/Ritonavir tablets in vulnerable individuals with COVID-19 included only 13.2% highly

immunocompromised and 10.6% moderately immunocompromised patients with cancer, with cancer type and type immunosuppressive medications

not otherwise specified.

Although the NIH Panel Guidelines acknowledge observation in retrospective studies of “some potential

benefits” of the use of Paxlovid for patients with “various immunocompromising conditions,” they also note that because

the pivotal trial of Nirmatrelvir/Ritonavir tablets did not enroll many immunocompromised participants, “efficacy ...

was not established

for this population.” Based on our target product profile, therefore, we anticipate that these products may not be direct competitors

in our target patient population.

Moreover, we believe that TVGN 489’s anticipated single outpatient infusion may be easier to

administer than Veklury’s multiple infusions over a number of days.

Additionally, Paxlovid requires daily doses, has a significant

number of drug interaction issues, as discussed in “COVID-19 Background” and noted by the NIH Panel Guidelines, and has experienced

numerous patient reports of disease relapse or rebound, which in each case we do not anticipate for TVGN 489 based on its design and

our Phase 1 proof of concept trial results.

We do expect that these products may present direct competition in high-risk elderly patients,

but we are initially targeting immunocompromised indications.

Gilead Science’s

Veklury ® (Remdesivir) for the treatment of mild-to-moderate COVID-19 in hospitalized or non-hospitalized adults who

are at high risk for progression to severe COVID-19, and Pfizer’s Paxlovid (Nirmatrelvir/Ritonavir tablets) for the treatment of

mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19.

The NIH Panel Guidelines highlight the limitation

of the insights that clinical trials conducted for Remdesivir and for Nirmatrelvir/Ritonavir tablets in broader populations can provide

with respect to immunocompromised patients, as each trial enrolled only limited numbers of such patients.

For example, a retrospective

study examining the use of Nirmatrelvir/Ritonavir tablets in vulnerable individuals with COVID-19 included only 13.2% highly immunocompromised

and 10.6% moderately immunocompromised patients with cancer, with cancer type and type immunosuppressive medications not otherwise specified.

Although the NIH Panel Guidelines acknowledge observation in retrospective studies of “some potential benefits” of the use

of Paxlovid for patients with “various immunocompromising conditions,” they also note that because the pivotal trial of Nirmatrelvir/Ritonavir

tablets did not enroll many immunocompromised participants, “efficacy ...

was not established for this population.” Based

on our target product profile, therefore, we anticipate that these products may not be direct competitors in our target patient population.

Moreover, we believe that TVGN 489’s anticipated single outpatient infusion may be easier to administer than Veklury’s multiple

infusions over a number of days.

Additionally, Paxlovid requires daily doses, has a significant number of drug interaction issues, as

discussed in “COVID-19 Background” and noted by the NIH Panel Guidelines, and has experienced numerous patient reports of

disease relapse or rebound, which in each case we do not anticipate for TVGN 489 based on its design and our Phase 1 proof of concept

trial results.

We do expect that these products may present direct competition in high-risk elderly patients, but we are initially targeting

immunocompromised indications.

There remains no documented effective treatments for Long COVID, with a recent study showing no benefit

from the use of Paxlovid (Nirmatrelvir/Ritonavir tablets) in patients with Long COVID.

antibodies have also previously been considered promising as an effective therapeutic option for COVID-19, including in immunocompromised

patients, and several had been granted EUAs.

However, these treatments have had their EUAs revoked by FDA due to lack of efficacy stemming

Most of these treatments have had their EUAs revoked by FDA due to lack of efficacy stemming

from viral mutations.

For example, AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a monoclonal antibody pair

that previously had an EUA granted on December 8, 2021, for preventive use in immunocompromised patients, was undermined by viral mutations,

resulting in the revocation of its EUA in January 2023, only 13 months later.

Evushield had previously been associated with a reduced

risk of mortality in ancestral strains of COVID-19, but the results of a trial reported in February 2024 showed that Evushield failed

to impact patient clinical status or increase viral clearance in hospitalized COVID-19 patients.

This finding was thought to be due at

least in part to evasion of the therapy by newer COVID-19 variants, highlighting the difficulty of applying monoclonal antibody treatments

to COVID-19 therapy.

There are nonetheless ongoing efforts to develop additional anti-COVID monoclonal antibodies for treatment and prevention

of Covid-19 infection.

For example, in January 2024, Invivyd applied to FDA for EUA of its product, VYD222, a broadly neutralizing monoclonal

antibody used for COVID-19 prevention in immunocompromised individuals.

While this product has shown in vitro activity against a currently

circulating variant, JN.1, it may remain vulnerable to novel viral mutations.

There are nonetheless ongoing efforts to develop additional anti-COVID monoclonal antibodies for treatment and

prevention of COVID-19 infection.

For example, in March 2024, Invivyd received an EUA of its product, Pemgarda (pemivibart), a broadly

neutralizing monoclonal antibody used for COVID-19 prevention in immunocompromised individuals who have not either been exposed to or

developed active COVID infection.

While recent press releases from Invivyd confirm continued activity of

Pemivibart against circulating strains of SARS-CoV-2, third-party research showed that inhibitory concentrations needed for neutralization

of the JN.1 sublineages increased for Pemivibart, and that activity was substantially adversely impacted by the currently highest circulating

variant at the time of the research.

and other monoclonal antibodies remain vulnerable to novel viral mutations.

Antibodies, unlike T-cells, recognize intact molecules.

Consequently, even remote mutations, not directly where the antibodies bind, may alter how the target molecule folds and its overall

shape and therefore prevent antibody binding.

T-cells, in contrast, recognize small peptide breakdown products of proteins and are only

affected if the mutation is directly within the target peptide.

Although it is possible that the epitope targeted by VYD 222 and others

like it will remain more durable, this remains to be seen.

Consequently,

even remote mutations, not directly where the antibodies bind, may alter how the target molecule folds and its overall shape and therefore

prevent antibody binding.

T-cells, in contrast, recognize small peptide breakdown products of proteins and are only affected if the mutation

is directly within the target peptide.

broadly, known companies developing virus-specific T cell therapies include Atara Biotherapeutics (“Atara Bio”), whose Ebvallo

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AlloVir, Inc.

(“AlloVir”) is another company developing

allogeneic T cell therapies for viral diseases.

Neither Atara Bio nor AlloVir has an active development program for the treatment of

AlloVir conducted a Phase 1b trial of an allogeneic, partially HLA-matched product candidate in COVID-19 and reported results

of the trial in 2021 but has not continued clinical development.

One patient in the trial experienced a recurrence of the disease and

died four weeks after treatment.

Atara Bio announced in November 2023 that the Phase 2 trial of its T cell therapy, ATA 188, targeting

EBV-infected B cells and plasma cells in progressive forms of multiple sclerosis, failed to meet efficacy or biomarker endpoints.

initially treated with placebo in this trial later received ATA 188, which we believe may have made it more challenging to discern a

difference between the study arms.

ATA 188 targets only three latent EBV proteins, whereas our CTL peptide targets are selected from

all proteins expressed at the appropriate point in the viral life cycle, whether unique to that point in the viral life cycle or not.

is another company developing allogeneic T cell therapies for viral diseases.

Neither Atara Bio nor AlloVir has an active development

program for the treatment of COVID-19.

AlloVir conducted a Phase 1b trial of an allogeneic, partially HLA-matched product candidate in

COVID-19 and reported results of the trial in 2021 but has not continued clinical development.

One patient in the trial experienced a

recurrence of the disease and died four weeks after treatment.

Atara Bio paused development of its T cell therapy, ATA188, after announcing

in November 2023 that the Phase 2 trial of ATA188 targeting EBV-infected B cells and plasma cells in progressive forms of multiple sclerosis

failed to meet efficacy or biomarker endpoints.

ATA188 targets only three latent EBV proteins, whereas our CTL peptide targets are selected

from all proteins expressed at the appropriate point in the viral life cycle, whether unique to that point in the viral life cycle or

This approach provides far more immunologic targets and thus more opportunities for viral control.

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understanding and control of dosage.

anticipate that we may face competition as new therapies enter the market and advanced technologies become available from time to time.

We expect that any treatments which we develop and commercialize will need to compete on, among other things, efficacy, safety, convenience

of administration and delivery, and price.

Commercialization of any treatments we develop will be affected by the level of competition

from original and biosimilars products and the availability of reimbursement from government and other third-party payors.

anticipate that we will continue to face competition as new therapies enter the market and advanced technologies become available from

time to time.

We expect that any treatments which we develop and commercialize will need to compete on, among other things, efficacy,

safety, convenience of administration and delivery, and price.

Commercialization of any treatments we develop will be affected by the

level of competition from original and biosimilars products and the availability of reimbursement from government and other third-party

ability to commercialize our proprietary cell products could be significantly and adversely affected if our competitors develop and commercialize

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valid, enforceable proprietary rights of others, and prevent others from infringing, misappropriating, or otherwise violating our proprietary

We rely on a combination of patents, patent applications, and trade secrets to establish and protect our intellectual property

Our ability to stop third parties from making, using, selling, offering to sell, or importing our products without the right

to do so may depend on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.

We rely on a combination of patents, patent applications, trademarks, and trade secrets to establish and protect our intellectual

property rights.

Our ability to stop third parties from making, using, selling, offering to sell, or importing our products without the

right to do so may depend on the extent to which we have rights under valid and enforceable patents, trademarks or trade secrets that

cover these activities.

continue to build our intellectual property portfolio and seek to protect our proprietary position by, among other things, filing patent

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and methods of preparing the product candidates.

As of March 15, 2024, our U.S.

As of February 24, 2025, our U.S.

intellectual property portfolio includes three U.S.

relating to TVGN 489 for the treatment of COVID-19, nine pending U.S.

patent applications, including two patent applications relating

to the treatment of COVID-19, five relating to the treatment of other viruses or cancer, and two related to artificial intelligence-driven

T cell target identification and receptor engagement, as well as eleven ex-U.S.

patents relating to TVGN 489 for the treatment of COVID-19, nine pending U.S.

patent applications, including two patent applications

relating to the treatment of COVID-19, six relating to the treatment of other viruses or cancer, and one related to artificial intelligence-driven

T cell target identification and receptor engagement, as well as thirteen ex-U.S.

patent applications, including applications in Australia,

Canada, Europe, Japan, Qatar, and United Arab Emirates directed at viral specific T cells, methods of treating and preventing viral infections,

and methods for developing CD3+CD+ cells against multiple viral epitopes for the treatment of viral infections, which have anticipated

expiration dates through July 29, 2042.

Canada, Europe, Japan, Qatar, United Arab Emirates, and the Patent Cooperation Treaty (PCT) directed at viral specific T cells, methods

of treating and preventing viral infections, methods for developing CD3+CD+ cells against multiple viral epitopes for the treatment of

viral infections, and systems for predicting immunologically active peptides with machine learning models, which have anticipated expiration

dates through December 16, 2044.

the United States, our three issued utility patents, all of which will expire on December 9, 2040, are U.S.

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of December 9, 2041.

addition, we have applied for registered trademark protection for “Tevogen Bio” (and design) as well as “ExacTcell”

with the U.S.

Patent and Trademark Office (the “USPTO”).

determine strategy for claim scope for our patent applications on a case-by-case basis, taking into account advice of counsel and our

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rules and regulations.

addition, we own a registered trademark for “Tevogen Bio” (and design), and have applied for a registered trademark protection

for “ExacTcell” and “Tevogen.AI” (and logo) with the USPTO.

Capital Resources

success depends on our ability to attract and retain highly qualified management and personnel.

As of April 26, 2024, we had 17 full-time

As of March 21, 2025, we had 18 full-time

and no part-time employees.

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of personnel.

corporate headquarters are located in Warren, New Jersey, and consist of 6,708 square feet dedicated to corporate, operational, and pre-commercial

activities under a lease that expires February 14, 2026.

We also have two research and development facilities located in Philadelphia:

our 3,620 square foot research and development center under a lease that expires June 30, 2025;

and a shared facility with laboratory

space dedicated to us that is focused on preclinical and pharmacodynamic activities.

anticipate expansion of both our corporate office and research and development facilities and intend to facilitate both in-house clinical

and commercial manufacturing and are currently engaged in active discussions regarding such expansion.

Regulation and Product Approval

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and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.

policies may change and additional government regulations may be enacted that could prevent or delay further development or regulatory

approval of any product candidates, product or manufacturing changes, additional disease indications or label changes.

We cannot predict

the likelihood, nature or extent of government regulation that might arise from future legislative or administrative action.

policies may change and additional government regulations may be enacted that could prevent, delay, or present significant new challenges

and costs for further development or regulatory approval of any product candidates, product or manufacturing changes, additional disease

indications or label changes.

We cannot predict the likelihood, nature or extent of government regulation that might arise from future

legislative or administrative action.

and Approval for Licensing Biologics in the United States

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These actions could include the suspension or termination of clinical trials by FDA,

FDA’s refusal to approve pending applications or supplemental applications, withdrawal of an approval, issuance of warning or untitled

letters, product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions,

fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought

by FDA, the Department of Justice (“DOJ”), and other governmental entities.

FDA’s refusal to approve pending applications or supplemental applications, suspension or withdrawal of an approval, issuance of

warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, import detention,

injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties

brought by FDA, the Department of Justice (“DOJ”), and other governmental entities.

applicant seeking approval to market and distribute a biologic in the United States must typically undertake the following:

of non-clinical laboratory tests and studies performed in accordance with FDA’s good laboratory practice (“GLP”)

labeling and distribution of investigational drugs in compliance with FDA’s current good manufacturing practice (“cGMP”)

requirements;

to FDA of an IND, which must become effective before clinical trials may begin and must be updated annually and when significant

of non-clinical laboratory tests and studies performed in accordance with FDA’s Good

Laboratory Practice (“GLP”) regulations;

● manufacture,

labeling and distribution of investigational drugs in compliance with FDA’s current

Good Manufacturing Practice (“cGMP”) requirements;

to FDA of an Investigational New Drug application (“IND”), which must become

effective before clinical trials may begin and must be updated annually and when significant

changes are made;

by an independent institutional review board (“IRB”) for each clinical site before each clinical trial may be initiated;

of adequate and well-controlled human clinical trials in accordance with FDA’s Good Clinical Practices (“GCP”)

to establish the safety, purity, and potency of the proposed biological product candidate for its intended purpose;

completion of all pivotal clinical trials, preparation of and submission to FDA of a Biologics License Application (“BLA”)

requesting marketing approval, which includes providing sufficient evidence to establish the efficacy, safety, purity, and potency

of the proposed biological product for its intended use, including from results of nonclinical testing and clinical trials;

completion of an FDA advisory committee review, when appropriate, as may be requested by FDA to assist with its review;

completion of one or more FDA inspections of the manufacturing facility or facilities at which the proposed product, or certain components

thereof, are produced to assess compliance with cGMP and data integrity requirements to assure that the facilities, methods, and

controls are adequate to preserve the biological product’s identity, strength, quality, and purity and, if applicable, FDA’s

good tissue practice (“GTP”) requirements for human cellular and tissue products;

completion of FDA inspections of selected clinical investigation sites to assure compliance with GCP requirements and the integrity

of the clinical data;

completion of an FDA sponsor GCP inspection, often conducted at the applicant’s headquarters facility;

of user fees (unless there is a waiver, exemption, or reduction) under the Prescription Drug User Fee Act (“PDUFA”) for

the relevant year;

review and approval of the BLA to permit commercial marketing of the licensed biologic for particular indications for use in the

United States;

with post-approval requirements, including the potential requirements to implement a Risk Evaluation and Mitigation Strategy (“REMS”),

to report adverse events and biological product deviations, and to complete any post-approval studies;

of any post-approval clinical studies required by FDA, such as confirmatory trials or pediatric studies.

by an Investigational Review Board (“IRB”) for each clinical site before each

clinical trial may be initiated;

● performance

of adequate and well-controlled human clinical trials in accordance with FDA’s Good

Clinical Practice (“GCP”) requirements to establish the safety, purity, and potency

of the proposed biological product candidate for its intended purpose;

completion of all pivotal clinical trials, preparation of and submission to FDA of a Biologics

License Application (“BLA”) requesting marketing approval, which includes providing

sufficient evidence to establish the efficacy, safety, purity, and potency of the proposed

biological product for its intended use, including from results of nonclinical testing and

clinical trials;

● satisfactory

completion of an FDA advisory committee review, when appropriate, as may be requested by

FDA to assist with its review;

● satisfactory

completion of one or more FDA inspections of the manufacturing facility or facilities at

which the proposed product, or certain components thereof, are produced to assess compliance

with cGMP and data integrity requirements to assure that the facilities, methods, and controls

are adequate to preserve the biological product’s identity, strength, quality, and

purity and, if applicable, FDA’s Good Tissue practice (“GTP”) requirements

for certain human cellular and tissue products;

● satisfactory

completion of FDA inspections of selected clinical investigation sites to assure compliance

with GCP requirements and the integrity of the clinical data;

● satisfactory

completion of an FDA sponsor GCP inspection, often conducted at the applicant’s headquarters

of user fees (unless there is a waiver, exemption, or reduction) under the Prescription Drug

User Fee Act (“PDUFA”) for the relevant year;

review and approval of the BLA to permit commercial marketing of the licensed biologic for

particular indications for use in the United States;

with post-approval requirements, including the potential requirements to implement a Risk

Evaluation and Mitigation Strategies (“REMS”), to report adverse events and biological

product deviations, and to complete any post-approval studies such as confirmatory trials

or pediatric studies.

time to time, legislation is drafted, introduced, and passed in Congress that could significantly change the statutory provisions governing

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an unacceptable health risk or that the trial is unlikely to meet its stated objectives.

trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety

monitoring board (“DSMB”).

trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a DSMB.

DSMBs review unblinded study data at pre-specified times during the course of the study.

DSMB determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy, the DSMB

can make a recommendation to the sponsor to modify or stop the trial.

If the DSMB determines that there is an unacceptable

safety risk for subjects or other grounds, such as no demonstration of efficacy, the DSMB can make a recommendation to the sponsor to

modify or stop the trial.

grounds for a sponsor’s decision to suspend or terminate a study may be made based on evolving business objectives or competitive

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a product is approved to gain more information about the product, referred to as Phase 4 trials.

Such post-approval trials are conducted following initial approval, often to develop additional data and information relating to the

use of the product in new indications.

Such post-approval trials are conducted

following initial approval, often to develop additional data and information relating to the use of the product in new indications.

reports detailing the results of the clinical trials must be submitted at least annually to FDA.

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be produced, FDA may issue an approval letter or a Complete Response Letter (“CRL”).

An approval letter authorizes commercial marketing of the biologic with specific prescribing information for specific indications.

CRL will describe all of the deficiencies that FDA has identified in the BLA, except that where FDA determines that the data supporting

the application are inadequate to support approval, FDA may issue the CRL without first conducting required inspections, testing submitted

product lots and/or reviewing proposed labeling.

If and when the deficiencies have been addressed to FDA’s satisfaction in a resubmission

of the BLA, FDA will issue an approval letter.

In issuing the CRL, FDA may recommend actions that the applicant might take to place the

BLA in condition for approval, including requests for additional data, information, or clarification.

FDA may delay or refuse approval

of a BLA if applicable regulatory criteria are not satisfied, and may require additional testing or information and/or require new clinical

Even with submission of this additional information, FDA ultimately may decide that the application does not satisfy the regulatory

criteria for approval.

An approval letter authorizes commercial

marketing of the biologic with specific prescribing information for specific indications.

A CRL will describe all of the deficiencies

that FDA has identified in the BLA, except that where FDA determines that the data supporting the application are inadequate to support

approval, FDA may issue the CRL without first conducting required inspections, testing submitted product lots and/or reviewing proposed

If and when the deficiencies have been addressed to FDA’s satisfaction in a resubmission of the BLA, FDA will issue an

approval letter.

In issuing the CRL, FDA may recommend actions that the applicant might take to place the BLA in condition for approval,

including requests for additional data, information, or clarification.

FDA may delay or refuse approval of a BLA if applicable regulatory

criteria are not satisfied, and may require additional testing or information and/or require new clinical trials.

Even with submission

of this additional information, FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

the approval process, FDA will determine whether a REMS is necessary to help ensure the benefits outweigh the risks of the biologic.

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precautions be included in the product labeling.

FDA may also require that post-approval studies, including Phase

4 clinical trials, be conducted to further assess the drug’s safety after approval.

FDA may prevent or limit further marketing

of a product based on the results of post-market studies or surveillance programs.

FDA may also require that post-approval studies, including Phase 4 clinical trials,

be conducted to further assess the drug’s safety after approval.

FDA may prevent or limit further marketing of a product based

on the results of post-market studies or surveillance programs.

may also require testing and surveillance programs to monitor the product after commercialization.

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Other potential consequences include, for example:

on the marketing or manufacturing of a product, complete withdrawal of the product from the market, or product recalls;

● restrictions

on the marketing or manufacturing of a product, complete withdrawal of the product from the

market, or product recalls;

warning or untitled letters, or holds on post-approval clinical studies;

of FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;

of FDA to approve pending applications or supplements to approved applications, or suspension

or revocation of existing product approvals;

seizure or detention, or refusal of FDA to permit the import or export of products;

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The federal government has levied large civil, administrative, and criminal fines and penalties

against companies for alleged improper promotion, and has also requested that companies enter into Corporate

Integrity Agreements and Consent Decrees of Permanent Injunction under which specified promotional conduct is changed or curtailed.

against companies for alleged improper promotion, and has also requested that companies enter into Corporate Integrity Agreements and

Consent Decrees of Permanent Injunction under which specified promotional conduct is changed or curtailed.

distribution of prescription drugs and biologics are subject to the Drug Supply Chain Security Act (“DSCSA”), which requires

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Act of 1984, referred to as the Hatch-Waxman Act.

The allowable patent term extension is

calculated as one-half of the product’s testing phase, which is the time between the effective date of an IND and initial BLA submission,

and all of the approval phase, which is the time between BLA submission and approval, up to a maximum of five years.

The time can be

shortened if FDA determines that the applicant did not pursue approval with due diligence.

The total patent term after the extension

may not exceed 14 years from the date of FDA approval of the product.

Only one patent claiming each approved product is eligible for

restoration and the patent holder must apply for restoration within 60 days of approval, even if the product cannot be commercially marketed

at that time.

The USPTO, in consultation with FDA, reviews and approves the application for patent term restoration.

The allowable patent term extension is calculated as one-half of the product’s

testing phase, which is the time between the effective date of an IND and initial BLA submission, and all of the approval phase, which

is the time between BLA submission and approval, up to a maximum of five years.

The time can be shortened if FDA determines that the

applicant did not pursue approval with due diligence.

The total patent term after the extension may not exceed 14 years from the date

of FDA approval of the product.

Only one patent claiming each approved product is eligible for restoration and the patent holder must

apply for restoration within 60 days of approval, even if the product cannot be commercially marketed at that time.

The USPTO, in consultation

with FDA, reviews and approves the application for patent term restoration.

patents that might expire during the BLA application phase, the patent owner may request an interim patent extension.

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and Marketing Exclusivities

Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval

pathway for biological product candidates shown to be highly similar to or interchangeable with an FDA licensed biological product.

biological product on which another biological product candidate’s BLA relies to establish biosimilarity is known as a reference

Biosimilarity sufficient to reference a prior FDA-approved product requires that there be no differences in conditions of use,

route of administration, dosage form and strength, and no clinically meaningful differences between the biological product candidate

and the reference product in terms of safety, purity, and potency.

Biosimilarity must be shown through analytical trials, animal trials

and at least one clinical trial, unless the Secretary of HHS waives a required element.

A biosimilar product candidate may be deemed

interchangeable with a prior approved product if it meets the higher hurdle of demonstrating that it can be expected to produce the same

clinical results as the reference product and, for products administered multiple times, the biological product candidate and the reference

biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative

to exclusive use of the reference biologic.

Complexities associated with the larger, and often more complex, structures of biologics,

as well as the process by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval

pathway that are still being resolved by FDA.

BPCIA created an abbreviated approval pathway for biological product candidates shown to be highly similar to or interchangeable with

an FDA licensed biological product.

A biological product on which another biological product candidate’s BLA relies to establish

biosimilarity is known as a reference product.

Biosimilarity sufficient to reference a prior FDA-approved product requires that there

be no differences in conditions of use, route of administration, dosage form and strength, and no clinically meaningful differences between

the biological product candidate and the reference product in terms of safety, purity, and potency.

Biosimilarity must be shown through

analytical trials, animal trials and at least one clinical trial, unless the Secretary of HHS waives a required element.

product candidate may be deemed interchangeable with a prior approved product if it meets the higher hurdle of demonstrating that it

can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biological

product candidate and the reference biologic may be switched after one has been previously administered without increasing safety risks

or risks of diminished efficacy relative to exclusive use of the reference biologic.

Complexities associated with the larger, and often

more complex, structures of biologics, as well as the process by which such products are manufactured, pose significant hurdles to implementation

of the abbreviated approval pathway that are still being resolved by FDA.

reference biologic is granted 12 years of exclusivity from the time of first licensure of the reference product, and no application for

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Some of our pre-commercial activities are subject to some of these laws.

federal Anti-Kickback Statute makes it illegal for any person or entity, including

a prescription drug manufacturer or a party acting on its behalf to knowingly and willfully, directly or indirectly, solicit, receive,

offer, or pay any remuneration in cash or in kind that is intended to induce or reward the referral of business, including the purchase,

order, or lease of any item or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.

The term “remuneration” has been broadly interpreted to include anything of value.

The Anti-Kickback

Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, formulary

managers and beneficiaries on the other.

federal Anti-Kickback Statute makes it illegal for any person or entity, including a prescription drug manufacturer or a party acting

on its behalf to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration in cash or in kind

that is intended to induce or reward the referral of business, including the purchase, order, or lease of any item or service for which

payment may be made under a federal healthcare program, such as Medicare or Medicaid.

The term “remuneration” has been broadly

interpreted to include anything of value.

The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical

manufacturers on one hand and prescribers, purchasers, formulary managers and beneficiaries on the other.

there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions

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and circumstances.

Several courts have found that the Anti-Kickback Statute may be

violated if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare program business.

addition, liability may be established without actual knowledge of the statute or specific intent to violate it.

Violations of this law

are punishable by up to ten years in prison, and can also result in criminal fines, civil money penalties and exclusion from participation

in federal healthcare programs.

a claim including items or services resulting from a violation of the federal Anti-Kickback

Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

Several courts have found that the Anti-Kickback Statute may be violated if any one purpose of an arrangement involving

remuneration is to induce referrals of federal healthcare program business.

In addition, liability may be established without actual

knowledge of the statute or specific intent to violate it.

Violations of this law are punishable by up to ten years in prison, and can

also result in criminal fines, civil money penalties and exclusion from participation in federal healthcare programs.

a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent

claim for purposes of the federal civil False Claims Act.

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

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providing sham consulting fees, grants, free travel and other benefits to physicians to induce them to prescribe

the company’s products;

and inflating prices reported to private price publication services, which are used to set drug payment

rates under government healthcare programs.

Penalties for federal civil False Claims Act violations may include up to three times the

actual damages sustained by the government, plus mandatory civil penalties of between $13,508 and $27,018 for each separate false claim,

and the potential for exclusion from participation in federal healthcare programs.

In addition, although the federal False Claims Act

is a civil statute, False Claims Act violations may also implicate various federal criminal statutes.

our products;

and inflating prices reported to private price publication services, which are used to set drug payment rates under government

healthcare programs.

Penalties for federal civil False Claims Act violations may include up to three times the actual damages sustained

by the government, plus mandatory per claim civil penalties, and the potential for exclusion from participation in federal healthcare

In addition, although the federal False Claims Act is a civil statute, False Claims Act violations may also implicate various

federal criminal statutes.

healthcare fraud provisions of The Health Insurance Portability and Accountability Act (“HIPAA”) prohibit knowingly and willfully

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result in the imposition of significant civil and/or criminal penalties.

federal Physician Payment Sunshine Act, implemented as the Open

Payments Program, requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare,

Medicaid or the Children’s Health Insurance Program (with certain exceptions)

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

hospitals (and certain other practitioners as of 2022), as well as ownership and investment interests held in the company by physicians

and their immediate family members.

federal Physician Payment Sunshine Act, implemented as the Open Payments Program, requires manufacturers of drugs, devices, biologics,

and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain

exceptions) to report annually to the Centers for Medicare and Medicaid Services (“CMS”) information related to direct or

indirect payments and other transfers of value to physicians and teaching hospitals (and certain other practitioners as of 2022), as

well as ownership and investment interests held in the Company by physicians and their immediate family members.

we intend to commercialize products that could be reimbursed under a federal health care program and other governmental healthcare programs,

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been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

example, the Affordable Care Act (“ACA”)

substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S.

example, the Affordable Care Act (“ACA”) substantially changed the way healthcare is financed by both the government and

private insurers, and significantly impacts the U.S.

pharmaceutical industry.

The ACA contains provisions that may reduce the profitability of drug products through increased rebates for

drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain

Medicare Part D beneficiaries, and annual fees based on

pharmaceutical companies’ share of sales to federal health care programs.

The ACA made several changes to the Medicaid

Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability by raising the minimum basic Medicaid

The ACA also expanded the universe of Medicaid utilization subject to drug rebates by requiring pharmaceutical manufacturers

to pay rebates on Medicaid managed care utilization and by enlarging the population potentially eligible for Medicaid drug benefits.

The ACA contains provisions that may reduce the profitability

of drug products through increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed

care plans, mandatory discounts for certain Medicare Part D beneficiaries, and annual fees based on pharmaceutical companies’ share

of sales to federal health care programs.

The ACA made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical

manufacturers’ rebate liability by raising the minimum basic Medicaid rebate.

The ACA also expanded the universe of Medicaid utilization

subject to drug rebates by requiring pharmaceutical manufacturers to pay rebates on Medicaid managed care utilization and by enlarging

the population potentially eligible for Medicaid drug benefits.

have been judicial challenges to certain aspects of the ACA, as well as efforts by Congress to modify, and by agencies to alter the implementation

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Further, the Bipartisan Budget Act of 2018, among other things, amended the ACA to increase from 50

percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare

Part D to close the coverage gap in most Medicare drug plans, commonly referred to as the donut

hole (this existing coverage gap program will be sunset by the Inflation Reduction Act beginning in 2025 and replaced with a new manufacturer

discount program).

percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D to close

the coverage gap in most Medicare drug plans, commonly referred to as the donut hole (this existing coverage gap program will be sunset

by the Inflation Reduction Act beginning in 2025 and replaced with a new manufacturer discount program).

is possible that the ACA, as currently enacted or as may be amended in the future, as well as other healthcare reform measures, including

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For example, the Inflation Reduction Act introduces

several changes to the Medicare Part D benefit, including

a limit on annual out-of-pocket costs and a change in manufacturer liability under the program which could negatively affect the profitability

of our product candidates.

The IRA sunsets the current Part D coverage gap discount program starting

in 2025 and replaces it with a new manufacturer discount program.

Failure to pay a discount under this new program will be subject to

a civil monetary penalty.

In addition, the IRA establishes a Medicare Part

B inflation rebate scheme effective January 2023 and a Medicare Part

D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe rebates if the price of a Part

B or Part D drug increases faster than the pace of inflation.

Failure to timely pay a Part

B or D inflation rebate is subject to a civil monetary penalty.

The IRA also creates a drug price negotiation

program under which the prices for Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar

competition will be capped by reference to, among other things, a specified non-federal average manufacturer price starting in 2026.

Failure to comply with requirements under the drug price negotiation program is subject to an excise tax and/or a civil monetary penalty.

Congress continues to examine various policy proposals that may result in pressure on the prices of prescription drugs with respect to

the government health benefit programs and otherwise.

The IRA or other legislative changes could impact the market conditions for our

product candidates.

several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs and a change in manufacturer liability

under the program which could negatively affect the profitability of our product candidates.

The IRA sunsets the current Part D coverage

gap discount program starting in 2025 and replaces it with a new manufacturer discount program.

Failure to pay a discount under this

new program will be subject to a civil monetary penalty.

In addition, the IRA establishes a Medicare Part B inflation rebate scheme effective

January 2023 and a Medicare Part D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will

owe rebates if the price of a Part B or Part D drug increases faster than the pace of inflation.

Failure to timely pay a Part B or D

inflation rebate is subject to a civil monetary penalty.

The IRA also creates a drug price negotiation program under which the prices

for Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar competition will be capped by reference

to, among other things, a specified non-federal average manufacturer price starting in 2026.

Failure to comply with requirements under

the drug price negotiation program is subject to an excise tax and/or a civil monetary penalty.

Congress continues to examine various

policy proposals that may result in pressure on the prices of prescription drugs with respect to the government health benefit programs

and otherwise.

The IRA or other legislative changes could impact the market conditions for our product candidates.

general, there has been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their commercial

products, which has resulted in several Congressional inquiries and proposed and enacted

federal and state legislation designed to, among other things, bring more transparency to drug product pricing, review the relationship

between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.

state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological

product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing

cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among

other things, bring more transparency to drug product pricing, review the relationship between pricing and manufacturer patient programs,

and reform government program reimbursement methodologies for drug products.

At the state level, legislatures have increasingly passed

legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient

reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures,

and, in some cases, designed to encourage importation from other countries and bulk purchasing.

may also be subject to federal, state, national and international laws and regulations governing the privacy and security of health-related

and other personal data we collect and maintain (e.g., Section 5 of the Federal Trade Commission Act, the California

Privacy Rights Act, and the EU’s General Data Protection Regulation (the “GDPR”)).

The GDPR, for example, imposes restrictions

on the processing (e.g., collection, use, or disclosure) of personal data in the EU and also imposes strict restrictions on the transfer

of personal data out of the EU to the United States.

These laws and regulations are evolving and subject to interpretation and may impose

limitations on our activities or otherwise adversely affect our business.

In addition, state laws govern the privacy and security of

health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect,

thus complicating compliance efforts.

and other personal data we collect and maintain (e.g., Section 5 of the Federal Trade Commission Act (the “FTC Act”), the

California Consumer Privacy Act, as amended by the California Privacy Rights Act (the “CCPA”), and the European Union’s

(“EU”) General Data Protection Regulation).

These laws and regulations are evolving and subject to interpretation and may

impose limitations on our activities or otherwise adversely affect our business.

In addition, state laws govern the privacy and security

of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same

effect, thus complicating compliance efforts.

we or our third party partners fail to comply or are alleged to have failed to comply with these or other applicable data protection

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remedies that harm our business, including orders that we modify or cease existing business practices.

maintain a website at the following address:

www.tevogen.com.

The information on our website is not incorporated by reference in this

We make available on or through our website certain reports and amendments to those reports that we file with or furnish to the

Securities and Exchange Commission (the “SEC”) in accordance with the Securities Exchange Act of 1934, as amended (the

“Exchange Act”).

These include our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports

We make this information available on our website free of charge as soon as reasonably practicable after we electronically

file the information with, or furnish it to, the SEC.

In addition, we routinely post on the “Investors” page of our website

news releases, announcements and other statements about our business and results of operations.

We may use the “Investors”

page of our website as a means of disclosing material, non-public information and to comply with our disclosure obligations under Regulation

Therefore, we encourage investors to monitor the “Investors” page of our website and review the information we post on

SEC maintains a website that contains reports, proxy and information statements, and other information regarding issuers that file electronically

with the SEC at the following address:

http://www.sec.gov.

About Our Executive Officers

table below sets forth certain information concerning our executive officers serving as of the filing of this Annual

Chief Executive

Officer, Chairperson and Director

Chief Financial

Neal Flomenberg

Scientific Officer and Global R&D Lead

Chief Commercial

Ryan Saadi has served as our Chief Executive Officer and Chairperson since February 2024, and served as Chief Executive Officer

and Chairperson of Tevogen Bio beginning in June 2020.

Saadi has been a member of the Leadership Council of the Yale School of Public

Health since 2021.

Prior to founding Tevogen Bio, Dr.

Saadi was the Global Vice President of Evidence, Market Access, and Strategic Pricing

for CSL Behring, a biopharmaceutical company that manufactures plasma-derived and recombination therapeutic products, from September

2018 to October 2019.

Before CSL Behring, Dr.

Saadi served as Global Head, Market Access and Policy, Oncology for Janssen from 2012 to

September 2018 and Worldwide Vice President, Health Policy, Reimbursement, Strategic Pricing and Market Access for Johnson & Johnson’s

Cordis business from 2008 to 2012.

Saadi was Global Vice President, Health Outcomes & Pricing for Genzyme and Global

Head, Health Outcomes and Market Access for Sanofi-Aventis’ oncology, bone and arthritis product portfolio.

From 2010 through 2019,

Saadi has also served as a Voting Member of the CMS Medicare Evidence Development & Coverage Advisory Committee, which provides

independent guidance and expert advice to CMS on clinical topics.

Desai has served as our Chief Financial Officer since February 2024, and served as Chief Financial Officer of Tevogen Bio

beginning in June 2020.

Desai previously served as President of Star Accounting Services Inc., an accounting firm providing accounting

and tax services to businesses and individuals, from January 2005 to December 2021.

Desai is a certified public accountant.

also serves as the Treasurer of Shrimad Rajchandra Mission Dharampur (USA) Inc., a community outreach and development nonprofit.

Neal Flomenberg has served as our Chief Scientific Officer and Global R&D Lead since February 2024, and served as Chief

Scientific Officer and Global R&D Lead of Tevogen Bio beginning in July 2022.

Prior to joining Tevogen Bio, Dr.

Flomenberg served

as professor and Chair of the Department of Medical Oncology at Sidney Kimmel Medical College of Thomas Jefferson University from 2008

to July 2022 and Deputy Director of Thomas Jefferson University’s Sidney Kimmel Cancer Center from 2015 to July 2022.

those positions, Dr.

Flomenberg held a number of leadership roles in the academia, hospital, and research settings.

career has focused on blood cancers, particularly those requiring bone marrow or peripheral blood stem cell transplants, and he has authored

over 175 peer reviewed publications.

At Jefferson, Dr.

Flomenberg also maintained an active medical practice and was continually listed

in Philadelphia Magazine’s “Top Doctors in Philadelphia” for more than 15 years prior to joining Tevogen Bio.

Khan has served as our Chief Commercial Officer since February 2024, and served as Chief Commercial Officer of Tevogen Bio

beginning in April 2022.

Previously, Mr.

Khan held several roles at the New Jersey Institute of Technology (“NJIT”), a public

research university, and its subsidiaries from 2014 to March 2022.

Most recently, Mr.

Khan served as Senior Director and then Executive

Director of Operations & Business Planning at BioCentriq, a for-profit cell and gene therapy contract development and manufacturing

organization owned by New Jersey Innovation Institute (“NJII”), which was itself a non-profit subsidiary of NJIT, from September

2018 to March 2022.

While at BioCentriq, Mr.

Khan was part of the leadership team that prepared BioCentriq for its spin-off from NJII.

Khan held several roles at NJII from 2014 to February 2020, including Director of Business Development, Biopharma Innovation beginning

in 2018, where he worked to facilitate academic, government, and industry collaboration in the biopharmaceutical field.

March 2018, Mr.

Khan also acted as Founder and Chief Strategist for Pharmique Health LLC, where he advised corporations on strategic

commercial planning and other matters.

Previously, Mr.

Khan co-founded Tegelix Therapeutics, a now-defunct pharmaceutical company, and

held various regional and global commercialization and alliance management roles at Hoechst Marion Roussel, Aventis, and then Sanofi-Aventis.

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 1. Business