What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-04-02 · 464 added, 470 removed, 1195 unchanged (44% of the section changed)

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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

business models and engagement throughout various stages of the drug development and commercialization lifecycle.

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 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 – pre-manufactured and ready-to-use – allogeneic 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.

Allogeneic therapeutics are intended to be infused

into individuals other than the original donor.

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.

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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CD8+ CTLs in ExacTcell-based products target multiple and

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

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.

distinct antigens, with the aim to circumvent the impact of mutations in viruses and virally driven as well as sporadic cancer cells,

which can render existing treatments 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.

this high degree of specificity has the potential to significantly reduce the chances of cross-reactivity or adverse impact on healthy

Our confidence in ExacTcell is reflected in our development pipeline, which has been carefully tailored to address the unmet needs

of 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

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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.

None of the treated 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

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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.”

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 development for

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

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

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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.

1 Phase 1 clinical

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

2 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.

3 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 other diseases.

Our strategy is to target large patient populations for each pipeline

Our strategy is to target large or underserved patient populations

for each pipeline product.

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

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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.

is currently under consideration.

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, our process identifies

those peptide targets to which T cells respond.

While currently focused on developing CTL products for the treatment of active disease,

these same targets could be used preventatively in the form of a T cell vaccination.

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

strategic alliances, collaborating with partners, and entering into business combinations to augment our capabilities .

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

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.

In addition, from time to time we enter into letters of intent to explore potential

acquisitions.

For example, in March 2026, we entered into a letter of intent to acquire a greater than 50% economic ownership stake

in a company with a clinical research organization (CRO).

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

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

antigens present only on virus-infected or malignant cells and to kill those cells.

We believe that by relying on CD8+ CTLs, ExacTcell

has the potential to produce an entirely new class of drugs that could present numerous benefits over existing platforms.

to other approaches, ExacTcell enables a single, specific HLA molecule to be targeted in a clinical product and the specific target peptides

to be known with certainty and precision.

HLA molecules are proteins present on the cell surface that play an important role in the immune

system’s ability to recognize “self” versus “foreign.” Specifically, HLA molecules present foreign antigens

to T cells for eradication.

antigenic peptides present only on virus-infected or malignant cells and to kill those cells.

We believe that by relying on CD8+ CTLs,

ExacTcell has the potential to produce an entirely new class of drugs that could present numerous benefits over existing platforms.

contrast to other approaches, ExacTcell enables a single, specific HLA molecule to be targeted in a clinical product and the specific

target peptides to be known with certainty and precision.

HLA molecules are proteins present on the cell surface that play an important

role in the immune system’s ability to recognize “self” versus “foreign.” Specifically, HLA molecules present

foreign antigens to T cells for eradication.

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

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in conjunction with HLA-class II molecules.

available cell-based immunotherapy approaches include genetically unmodified T cells applied to the treatment of viruses early after

transplant and genetically modified chimeric antigen receptor (“CAR”) T cells used to treat a selected subset of malignancies.

available allogeneic cell-based immunotherapy approaches include genetically unmodified T cells applied to the treatment of viruses early

after transplant and genetically modified chimeric antigen receptor (“CAR”) T cells used to treat a selected subset of malignancies.

We believe that to date, cellular therapy has not been harnessed to its full potential for clinical application.

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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.

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.

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.

November 2023, FDA announced that it had “received reports of T-cell malignancies” in patients who received certain 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, and continues to recommend long-term monitoring.

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.

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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.

Moreover, in contrast to CAR-T cell products, 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

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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.

convenience of “off-the-shelf” – pre-manufactured and ready-to-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, which we believe may substantially

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six-month follow-up period.

The TVGN 489 in the Phase 1 trial was formulated to match patients expressing HLA-A*02:01, the most common

HLA type in the population.

Two patients on this trial were admitted for autologous and allogeneic hematopoietic stem cell transplantation

within one month of treatment with TVGN 489, and neither patient developed evidence of recurrent COVID-19 despite the significant immunocompromised

state related to transplantation.

The TVGN 489 in the Phase 1 trial was formulated to match patients expressing HLA-A*02:01, the most

common HLA type in the population.

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

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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.

targets for the HLA-A*02:01 TVGN 489 product targets have remained intact through March 2026.

In contrast, most monoclonal

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government funding for COVID-19 testing,

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

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

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

two antiviral agents, Paxlovid (nirmatrelvir with ritonavir) and Veklury (remdesivir), have been FDA-approved for the treatment of COVID-19, with Lagevrio (molnupiravir) available under emergency use authorization (“EUA”).

While Paxlovid is indicated for treatment in individuals at high risk for viral progression, these drugs have not been specifically authorized

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

Both drugs also present challenges

for subsets of patients.

Paxlovid is associated with many drug-drug interactions, resulting in the need to temporarily stop ongoing medications

or seek alternative therapy and thereby making it difficult for some patients to take.

This is especially true for patients on multiple

medications, which is often true of high-risk patients requiring anti-COVID-19 treatment.

Paxlovid is also known to be associated with

COVID-19 rebound, which has been calculated as high as 21% in ambulatory patients, according to a study published in the Annals of Internal

Medicine in November 2023.

Although the rate of rebound in high-risk subgroups is less well-documented, we anticipate it may be as high

or higher in this group.

These therapies also present

challenges for subsets of patients.

Paxlovid is associated with many drug-drug interactions, resulting in the need to temporarily stop

ongoing medications or seek alternative therapy and thereby making it difficult for some patients to take.

This is especially true for

patients taking multiple medications, which is often true of high-risk patients requiring anti-COVID-19 treatment.

Paxlovid is also known

to be associated with COVID-19 rebound, which has been calculated as high as 21% in ambulatory patients, according to a study published

in the Annals of Internal Medicine in November 2023.

Although the rate of rebound in high-risk subgroups is less well-documented, we

anticipate it may be as high or higher in this group.

Paxlovid also must be started within five days of symptom development to be effective.

Remdesivir must be given

within seven days and is only available in intravenous form, requiring three daily infusions in a treatment center.

Remdesivir has also

been associated with liver enzyme abnormalities and gastrointestinal side effects.

Monoclonal antibodies to the viral spike protein were

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

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.

Remdesivir must be given within seven days and is only available in intravenous form, requiring three daily infusions in a treatment

Remdesivir has also been associated with liver enzyme abnormalities and gastrointestinal side effects.

Lagevrio (molnupiravir)

is an anti-viral agent that has received emergency use authorization for the treatment of COVID-19, but is rarely used due to reports

of limited efficacy.

Monoclonal antibodies to the viral spike protein were introduced early in the pandemic for treatment of COVID-19

but typically have been rendered ineffective over time as the virus continues to evolve.

One prophylactic monoclonal antibody for COVID-19

prevention, Pemgarda (Pemivibart), has received emergency use authorization for moderate to severely immune compromised patients.

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 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.

the persistence 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 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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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

withdrawal of EUAs that had been granted during the now-expired COVID-19 National Public

Health Emergency.

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All patients in the interventional arm of our Phase 1 clinical trial noted improved symptoms within two to three days,

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 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.

which is shorter than the average noted by patients in the observational arm, and there was a ≥ 99% viral load reduction in all patients

by PCR 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.

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 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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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.

We have completed final

peptide selection for six HLA restrictions (HLA-A*02:01, HLA-A*01:01, HLA-A*03:01, HLA-A*11:01, HLA-A*23:01, and HLA-A*24:02), which

we believe would cover approximately two thirds of the U.S.

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 could 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.

Over the last year, we have moved toward a more enclosed manufacturing process and increased the number of active

CTLs in our candidates.

In the proof-of-concept trial, TVGN 489 contained 68.5% SARS-CoV-2-specific CTLs.

Modifications to the ExacTcell

platform have increased the content of active CTLs to over 80% on a consistent basis.

Development for COVID-19 Patients

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Analysis of COVID-19 viral

load showed that the patients were early in their COVID-19 disease course.

Patients were treated with TVGN 489 at one of four dose levels:

load showed that the patients were early in their COVID-19 disease course at the time of treatment.

Patients were treated with TVGN 489

at one of four dose levels:

1 x 10 5 /kg;

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or 3 x 10 6 /kg.

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.

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 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.

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the HSCT patient group is thought to allow for longer than typical persistence.

our Phase 1 clinical trial for TVGN 489, following infusion, peripheral blood of five patients was collected at various timepoints throughout

the six-month follow-up period.

These samples were sent to Adaptive Biotechnologies (“Adaptive”) to evaluate the persistence

of infused TVGN 489 in the patients following treatment, and Adaptive conducted analyses by sequencing protein chains of TCRs in the

As seen in the figure below, Adaptive’s data showed persistence of T cells present in the TVGN 489 product but absent

from the recipients prior to administration of TVGN 489.

This subset of CTLs was found in all samples tested, including at the final

study assessment at six months.

The TCRs used to recognize TVGN 489’s peptides were also shown to be largely distinct from person

to person, making it highly unlikely that the cells from later timepoints derive from anything other than the product in these five different

Taken together, we believe this data shows the persistence of TVGN 489 cells six months after administration.

our Phase 1 clinical trial for TVGN 489, following infusion, peripheral blood of six patients was collected at various timepoints throughout

the follow-up period.

These samples were sent to Adaptive Biotechnologies (“Adaptive”) to evaluate the persistence of infused

TVGN 489 in the patients following treatment, and Adaptive conducted analyses by sequencing protein chains of TCRs in the samples.

of these patients had samples analyzed through the six-month end of study follow-up, and as seen in the figure below, Adaptive’s

data showed persistence of T cells present in the TVGN 489 product but absent from the recipients prior to administration of TVGN 489.

This subset of CTLs was found in all samples tested, including at the final study assessment at six months.

The TCRs used to recognize

TVGN 489’s peptides were also shown to be largely distinct from person to person, making it highly unlikely that the cells from

later timepoints derive from anything other than the product in these five different patients.

Taken together, we believe this data shows

the persistence of TVGN 489 cells six months after administration.

489 COVID-19 Reactive CD8+ T Cells Detected Throughout the Six-Month Follow Up Period

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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

mortality, hospitalization, and persistence of COVID-19 infection are higher in patients with B cell malignancies due to inadequate vaccination

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

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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

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

or potentially, the FDA Commissioner’s National Priority Voucher pilot program, which the FDA is exploring as a pathway to reduce

review times, even as compared to other priority review programs, for candidates meeting certain criteria.

Target Patient Populations and Indications for TVGN 489

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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.

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

or hematopoietic transplantation or autoimmunity or treatment of these conditions.

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

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.

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.

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.

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

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

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.

CAR-T or Bispecific T-cell Engager (BiTE) antibody approaches, which recruit a heterogeneous group of T cells to the tumor, our approach

would instead focus a highly purified population of CTLs on the tumor, which we believe may provide more potential to accomplish the

task of eradicating the cancer.

Cancer cells may not always express an ideal T cell target on their own.

However, it is possible to coat

a cancer cell with a well-recognized target peptide using monoclonal antibodies or liposomes.

We believe this would allow our target

specific CTLs to then attack the cancer cells.

We also believe that our approach has the potential to eventually bring the benefits of

cell therapies to first-line options in oncology, as well as to create products that may overcome current limitations of checkpoint inhibitors.

According to the World Health Organization

(the “WHO”), HPV is responsible for 99% of cervical cancers.

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

that in the U.S., about 60% to 70% of oropharyngeal cancers are due to HPV.

Although a vaccine for HPV exists, the National Cancer Institute

estimates that as of 2023, only 57.3% 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 we are 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 chronic hepatitis B, with

the hope of avoiding the need for liver transplant due to cirrhosis or liver cancer.

While treatments for hepatitis B exist, these are

generally not curative and require patient compliance for a lifetime.

We believe that a single treatment with hepatitis B-specific CTLs

may produce better treatment acceptance and compliance.

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 WHO, and is mainly transmitted through saliva, but also through other body fluids such as blood and semen.

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.

Testing of EBV peptides in our laboratory is currently underway.

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

Unlike CAR-T or Bispecific T-cell Engager (BiTE) antibody approaches, which recruit a heterogeneous group of T cells to the

tumor, our approach would instead focus a highly purified population of CTLs on the tumor, which we believe may provide more potential

to accomplish the task of eradicating the cancer.

Non-viral (sporadic) cancers may not always express an ideal T cell target on their

However, it is possible to coat this sort of cancer cell with a well-recognized target peptide using monoclonal antibodies or liposomes.

We believe this would allow our target specific CTLs to then attack the cancer cells.

We also believe that our approach has the potential

to eventually bring the benefits of cell therapies to first-line options in oncology, as well as to create products that may overcome

current limitations of checkpoint inhibitors.

cells can lose their ability to fight viruses and tumors in prolonged infections and cancer in a state called T cell exhaustion that

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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.

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

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

History and Team

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.

Team and History

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.

February 2024, Tevogen Bio Inc (n/k/a Tevogen Bio Inc.) (“Tevogen Bio”) completed a business combination with Semper Paratus

Acquisition Corporation (“Semper Paratus”), a special purpose acquisition company, pursuant to which Semper Paratus changed

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

a subsidiary of Tevogen Bio Holdings Inc.

Tevogen Bio was established in June 2020 as a Delaware corporation, and Semper Paratus was

incorporated as a Cayman Islands exempted company in April 2021.

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

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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.

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

This treatment provides passive immunity in the form of high-titer COVID-19 convalescent plasma (“CCP”) , 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.

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.

While 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.

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.

A randomized trial in immunocompromised

patients with mild COVID-19, the result of which were published in March 2025, showed that treatment with CCP is associated with decreased

rates of hospitalization and death.

In the U.S., CCP therapy is an FDA licensed treatment through a blood donation center and is not

Therefore, widespread availability if needed would be questionable.

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.

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.

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.

Lagevrio (molnupiravir) is

recommended as an alternative therapy for non-hospitalized adults with mild-to-moderate SARS-CoV-2 but only when preferred options

(Paxlovid or Remdesivir) are not available, feasible, or clinically appropriate.

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

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

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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.

For example, in March 2024, Invivyd, Inc.

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 press releases from Invivyd confirmed 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

and other monoclonal antibodies remain vulnerable to novel viral mutations.

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is directly within the target peptide.

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

(tabelecleucel) has received approval in Europe for treating a rare hematologic cancer caused by EBV.

broadly, known companies developing virus-specific T cell therapies include Atara Biotherapeutics, Inc.

(“Atara Bio”), whose

Ebvallo (tabelecleucel) has received approval in Europe for treating a rare hematologic cancer caused by EBV.

However, in a recent setback,

the FDA declined approval for this therapy in the U.S.

in January of 2026.

AlloVir, Inc.

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.

(“AlloVir”), which merged with Kalaris

Therapeutics, Inc.

(“Kalaris”) in March 2025, was another company developing allogeneic T cell therapies for viral diseases.

Following the merger, the company focuses on ophthalmological products.

Neither Atara Bio nor Kalaris 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 did not continue 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

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and methods of preparing the product candidates.

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

As of March 27, 2026, our U.S.

intellectual property portfolio includes three 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

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.

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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.

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

Capital Resources

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At our current size, ensuring this culture is primarily achieved through the recruitment process.

Talent recruitment at our current stage is setting the foundation for further company growth.

When attracting talent, we ensure that

every job description mentions our core values, and the importance of these values in achieving our mission.

Beyond evaluating experience,

job applicants are also evaluated based on their values and passions.

We believe it is necessary that each employee represents our four

As our employee numbers increase, we plan to create more defined programs to further enhance our company culture and retention

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.

recruitment at our current stage is setting the foundation for further company growth.

When attracting talent, we ensure that every job

description mentions our core values, and the importance of these values in achieving our mission.

Beyond evaluating experience, job applicants

are also evaluated based on their values and passions.

We believe it is necessary that each employee represents our four core values.

As our employee numbers increase, we plan to create more defined programs to further enhance our company culture and retention of personnel.

corporate headquarters are located in Warren, New Jersey, and consist of 13,242 square feet dedicated to corporate, operational, and

pre-commercial activities under a lease that expires February 28, 2033.

We also have one research and development facility located

in Philadelphia, which is a shared facility with laboratory space dedicated to us that is focused on preclinical and pharmacodynamic

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

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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”) 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 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

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 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 Investigational 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 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;

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 certain 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 Strategies (“REMS”),

to report adverse events and biological product deviations, and to complete any post-approval studies such as confirmatory trials

or pediatric studies.

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purposes of BLA approval, clinical trials are typically conducted in the following sequential phases:

The investigational product is initially introduced into a small group of healthy human

subjects or patients with the target disease or condition.

These trials are designed to test

the safety, dosage tolerance, absorption, metabolism and distribution of the investigational

The investigational product is initially introduced into a small group of healthy human subjects or patients with the target disease

or condition.

These trials are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational

product in humans and the side effects associated with increasing doses.

These trials may

also yield early evidence of effectiveness.

The investigational product is administered to a slightly larger patient population with

a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, and

dosing schedule and to identify possible adverse side effects and safety risks.

Phase 2 clinical trials may be conducted to obtain information prior to beginning larger

and more expensive Phase 3 clinical trials.

The investigational product is administered to an expanded patient population to further

evaluate dosage, to provide statistically significant evidence of clinical efficacy and to

further test for safety, generally at multiple geographically dispersed clinical trial sites.

These clinical trials are intended to generate sufficient data to statistically demonstrate

the efficacy and safety of the product, to establish the overall risk/benefit ratio of the

investigational product, and to provide an adequate basis for product approval by FDA.

These trials may also yield early evidence of effectiveness.

The investigational product is administered to a slightly larger patient population with a specified disease or condition to evaluate

the preliminary efficacy, optimal dosages, and dosing schedule and to identify possible adverse side effects and safety risks.

Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically

significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical

These clinical trials are intended to generate sufficient data to statistically demonstrate the efficacy and safety

of the product, to establish the overall risk/benefit ratio of the investigational product, and to provide an adequate basis for

product approval by FDA.

phases may overlap or be combined.

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Other potential consequences include, for example:

● restrictions

on the marketing or manufacturing of a product, complete withdrawal of the product from the

market, or product recalls;

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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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).

the coverage gap in most Medicare drug plans, commonly referred to as the donut hole (this existing coverage gap program is 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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new program will be subject to a civil monetary penalty.

In addition, the IRA establishes a Medicare Part B inflation rebate scheme effective

In addition, the IRA established 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

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inflation rebate is subject to a civil monetary penalty.

The IRA also creates a drug price negotiation program under which the prices

The IRA also created 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

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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

Securities and Exchange Commission (the “SEC”) in accordance with the Securities Exchange Act of 1934, as amended (the “Exchange

These include our Annual Reports on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.

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 FD.

Therefore, we encourage

investors to monitor the “Investors” page of our website and review the information we post on that page.

SEC maintains a website that contains reports, proxy and information statements, and other information regarding issuers that file electronically

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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

table below sets forth certain information concerning our executive officers serving as of the filing of this Annual Report:

Executive Officer, Chairperson and Director

Financial Officer

Neal Flomenberg

Scientific Officer and Global R&D Lead

Chief Commercial

Commercial Officer

Ryan Saadi has served as our Chief Executive Officer and Chairperson since February 2024, and served as Chief Executive Officer

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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 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.

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 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.

Prior to those positions,

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.

Flomenberg’s 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.

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.

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

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business