What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-05-14 compared with 2024-11-19 · 313 added, 533 removed, 225 unchanged (79% of the section changed)

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as the Management’s Discussion and Analysis of Financial Condition and Results of Operations and other disclosures, included in

our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “Annual Report”), and in Exhibits 99.1 and

99.2 to our Current Report on Form 8-K/A dated April 29, 2024 (the “Form 8-K”).

our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “Annual Report”).

Forward-Looking

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in this Report include, without limitation, statements regarding:

development of, potential benefits of, and patient access to our product candidates for the

treatment of infectious diseases and cancer, including TVGN 489 for the treatment of COVID-19

and Long COVID;

ability to develop additional product candidates, including through the use of our ExacTcell TM

development of, potential benefits of, and patient access to our product candidates for the treatment of infectious diseases, cancer,

and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID;

ability to develop additional product candidates, including through the use of our ExacTcell TM technology;

anticipated benefits of ExacTcell;

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ability to generate revenue in the future;

ability to manage, grow, and diversify our business and execute our business initiatives

and strategy;

● expectations

ability to manage, grow, and diversify our business and execute our business initiatives and strategy;

regarding the healthcare and biopharmaceutical industries;

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from the results anticipated by these forward-looking statements, including without limitation risks and uncertainties related to:

effect of the recent Business Combination (as defined below) of Semper Paratus Acquisition

Corporation (n/k/a Tevogen Bio Holdings Inc.) and Tevogen Bio Inc (n/k/a Tevogen Bio Inc.)

(“Tevogen Bio”) on our business relationships, operating results, and business

outcome of any legal proceedings that may be instituted against us related to the Business

in the markets in which we compete, including with respect to its competitive landscape,

technology evolution, or regulatory changes;

outcome of any legal proceedings that may be instituted against us related to the Business Combination;

in the markets in which we compete, including with respect to its competitive landscape, technology evolution, or regulatory changes;

in domestic and global general economic conditions;

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ability to develop and maintain effective internal controls;

related to the Business Combination and our ability to realize anticipated benefits of the

Business Combination;

may fail to achieve our commercialization and development plans and identify and realize

additional opportunities, which may be affected by, among other things, competition and our

ability to grow and manage growth economically and hire and retain key employees;

may fail to achieve our commercialization and development plans and identify and realize additional opportunities, which may be affected

by, among other things, competition and our ability to grow and manage growth economically and hire and retain key employees;

related to our ability to develop, license, or acquire new therapeutics;

ability to raise capital, which may not be available on acceptable terms, as needed to fully

execute our business plan and meet our obligations on a timely basis;

ability to raise capital, which may not be available on acceptable terms, as needed to fully achieve our business plan and meet our

obligations on a timely basis;

risk of regulatory lawsuits or proceedings relating to our business;

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associated with intellectual property protection;

use of AI could lead to liability, violation of data security and privacy laws, or reputational damage;

systems may fail or suffer security breaches;

limited operating history.

ability to maintain compliance with the continued listing requirements of The Nasdaq Stock

Market LLC (“Nasdaq”);

failure to timely file certain periodic reports with the Securities and Exchange Commission

(“SEC”) and our ability to timely file such reports in the future.

Forward-looking

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

T lymphocytes (“CD8+ CTLs”), to develop off-the-shelf, precision T cell therapeutics for the treatment of infectious diseases

and cancers 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 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.

therapies are based on carefully selected, naturally occurring CTLs that recognize targets of interest from the body’s native T

cell receptor pool, unlike genetically engineered T cell therapies.

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 that can render existing treatments 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,

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

Through our Tevogen.AI artificial intelligence

T lymphocytes (“CD8+ 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 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 , has the potential to mainstream cell therapy with a new

class of off-the-shelf 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.

We are focused on using ExacTcell to develop therapeutics that are intended to be infused in patients

other than the original donor.

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.

In addition, 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, such as through our recently

announced enrollment in the Microsoft for Startups program.

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

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 active against multiple precise, well defined, and well characterized targets 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 who participated in the trial 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 submitted for peer-review and were published

in Blood Advances in June 2024.

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 .

launch a pivotal trial of TVGN 489 in COVID-19 patients with B cell malignancies, with studies of other highly vulnerable populations

TVGN 489 is also in pre-clinical development for treatment and prevention of Long COVID, and we have other product candidates

in our pipeline for other indications.

commercial success depends in part on our ability to obtain and maintain patents and other protection of our proprietary intellectual

property to safeguard developed products and scientific methods, preserve the confidentiality of our trade secrets, operate without infringing,

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

or otherwise violating our proprietary rights.

Our ability to stop third parties from improperly making, using, selling, offering to

sell, or importing 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.

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

patent applications.

Our patent estate includes patents and patent applications with claims relating to our product candidates,

methods of use, and methods of preparing the product candidates.

We have completed a 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 of the trial.

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.

patients who participated in the trial reported progression of infection, reinfection, or the development of Long COVID during the six-month

follow-up period.

addition, through our Tevogen.AI artificial intelligence initiative, we are focused on harnessing the potential of AI to expedite drug

development, optimize laboratory processes and clinical trials, unravel complex biological data, improve patient outcomes, and pass on

related savings to patients.

April 17, 2025, we entered into a Master Services and Facilities Agreement (the “MSFA”) with CD 8 Technology Services LLC

The MSFA establishes the general terms and conditions under which CD8 would provide us with access to specialized

manufacturing facilities, including clean rooms and laboratories, as well as related operational services, to support the production

of our cell therapy products.

The MSFA provides that the specific details of these facilities and services, including scope of work,

costs, and timelines, will be set out in one or more individual project work orders.

CD8 is associated with Dr.

Manmohan Patel, who beneficially

owns more than 5% of our common stock, par value $0.0001 per share (the “Common Stock”).

commercial success depends in part on our ability to obtain and maintain patent and other protection for our products and methods, preserve

the confidentiality of our trade secrets, operate without infringing, misappropriating, or otherwise violating the valid, enforceable

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

rely on a combination of patents, patent applications, trademarks, 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, trademarks or trade secrets that cover

these activities.

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

Our patent estate includes patents and patent applications with claims relating to our product candidates, methods of use, and methods

of preparing the product candidates.

To date, our U.S.

intellectual property portfolio includes three

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, five relating to the treatment of other viruses or cancer, and two related to

artificial intelligence-driven T cell target identification and receptor engagement.

Our portfolio also includes eleven ex-U.S.

patent applications, including applications in Australia, Canada, Europe, Japan, Qatar, and the 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,

the United States, our three issued utility patents, all of which expire on December 9, 2040, are 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 T cell target identification

and receptor engagement, as well as thirteen ex-U.S.

patent applications, including applications in Australia, Canada, Europe, Japan,

Qatar, the United Arab Emirates, and the Patent Cooperation Treaty 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

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

11,191,827 covering

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of December 9, 2041.

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

as “ExacTcell” and “Tevogen AI” with the United States Patent and Trademark Office.

determine strategy for patents’ claims scope for our applications on a case-by-case basis, taking into account advice of counsel

and our business model.

We file patents containing claims for protection of useful applications of our proprietary technologies and any

product candidates, including new applications or uses we discover for existing technologies and product candidates, based on our assessment

of their strategic value.

We continuously reassess the number and type of patent applications, as well as our pending and issued patent

claims, to ensure maximum coverage and value are obtained for our processes and compositions, given existing patent office rules and

the aforementioned patents were developed internally, historical expenditures related to their development were all expensed as incurred

generally accepted accounting principles (“GAAP”).

We believe these patents have significant value as the basis

of our product pipeline.

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

for registered trademark protection for “ExacTcell” and “Tevogen AI” with the United States Patent and Trademark

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

business model and needs.

We file patents containing claims for protection of useful applications of our proprietary technologies and

any product candidates, including new applications or uses we discover for existing technologies and product candidates, based on our

assessment of their strategic value.

We continuously reassess the number and type of patent applications, as well as our pending and

issued patent claims, to ensure maximum coverage and value are obtained for our processes and compositions, given existing patent office

rules and regulations.

our patents were developed internally, historical expenditures related to their development were all expensed as incurred per U.S.

accepted accounting principles (“GAAP”).

We believe these patents have significant value as the basis of our product pipeline.

Our continued investment in our pipeline highlights our belief in future commercial viability of these products.

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Agreement”) by and among Semper Paratus, Semper Merger Sub, Inc., a wholly owned subsidiary of Semper Paratus (“Merger Sub”),

SSVK Associates, LLC, Tevogen Bio, and Dr.

Ryan Saadi, in his capacity as seller representative, 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”) and Semper Paratus was renamed

Tevogen Bio Holdings Inc.

SSVK Associates, LLC, Tevogen Bio Inc (n/k/a Tevogen Bio Inc.) (“Tevogen Bio”), and Dr.

Ryan Saadi, in his capacity as seller

representative, 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”), and Semper Paratus was renamed Tevogen Bio Holdings Inc.

(the “Closing”).

See Note 4 to our unaudited consolidated financial statements in this quarterly

Report 10-Q for additional information regarding the net assets acquired through the Merger.

The Merger was accounted for as a reverse

recapitalization under GAAP because the Company was determined to be the accounting acquirer.

See Note 4 to our unaudited

consolidated financial statements in this Report for additional information regarding the net assets acquired through the Merger.

Merger was accounted for as a reverse recapitalization under GAAP because the Company was determined to be the accounting acquirer.

commencing operations in June 2020, we have devoted substantially all our efforts and financial resources to establishing corporate governance,

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date, we have not generated any revenue.

Our net loss for the three months ended September 30, 2024 and 2023 was $5.9 million and $3.9

million, respectively.

Net loss for the three months ended September 30, 2024 was primarily attributable to a $6.1 million loss from

Our net loss for the nine months ended September 30, 2024 and 2023 was $4.3 million and $56.8 million, respectively.

loss for the nine months ended September 30, 2024 was primarily attributable to a loss from operations of $44.2 million that primarily

resulted from non-cash, stock-based compensation expense recognized with the liquidity event condition contained in certain stock awards

was satisfied upon the closing of the Business Combination as well as $7.5 million in transaction costs in connection with the Business

Combination, partially offset by the change in fair value of convertible promissory notes of $48.5 million.

As of September 30, 2024,

we had cash of $2.3 million.

Our net loss and income, respectively, for the three months ended March 31, 2025 and 2024 was

$10.4 million and $11.3 million.

Net loss for the three months ended March 31, 2025 was primarily attributable to a $10.4 million loss

from operations as a result of non-cash stock-based compensation expense.

31, 2025, we had an accumulated deficit of $123.8 million and cash of $2.0 million.

February 14, 2024, we entered into a securities purchase agreement with The Patel Family, LLP (the “Patel Family”) pursuant

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restated the original agreement and the Patel Family agreed to purchase 600 shares of our Series A-1 Preferred Stock for an aggregate

purchase price of $6.0 million, of which $3.0 million has been received through November 19, 2024.

On August 21, 2024, we entered into

a securities purchase agreement with the Patel Family, pursuant to which the investor purchased 600 shares of our Series C Preferred

Stock for an aggregate purchase price of $6.0 million.

described in more detail in “ Liquidity and Capital Resources - Funding Requirements ” below, on June 6, 2024, we entered

into a Loan Agreement (the “Loan Agreement”) with the Patel Family providing for (i) an unsecured line of credit facility

(the “Facility”), pursuant to which the Patel Family agreed to lend us up to an initial amount of $36.0 million (the “Maximum

Loan Amount”) of term loans in $1.0 million increments on a monthly basis, over a draw period of thirty-six months, and (ii) a

contingent option for the Patel Family to purchase at least $14.0 million of our common stock, par value $0.0001 per share (the “Common

Stock”), in a future private placement (the “Optional PIPE”).

The Loan Agreement also contains a contingent option

for the Patel Family to purchase at least $14.0 million of our Common Stock plus up to the then-remaining available amount under the

Facility, in a future private placement if the ten-day trailing volume weighted average price per share of the Common Stock (the “Trailing

VWAP”) reaches $10.00 per share.

Pursuant to the terms of the Loan Agreement, the Company also issued to the Patel Family 1,000,000

shares of Common Stock as a commitment fee (the “Commitment Shares”), subject to forfeiture by the Patel Family of the Commitment

Shares or an equal number of shares of Common Stock in the event the Patel Family fails to (i) make a deposit under the Facility when

due or (ii) pay the purchase price for the Optional PIPE within 30 days after the Threshold Price Notice Date (as defined in the Loan

Agreement) in the event the Company has satisfied all applicable closing conditions.

on cash on hand as of the date of this Report, the $2.0 million received from the sale of Series C Preferred Stock in October 2024, as

well as our Loan Agreement, we have concluded that we have sufficient cash to fund our operations for at least the next 12 months from

the issuance date of our unaudited consolidated financial statements.

purchase price of $6.0 million, of which $3.0 million has been received through May 14, 2025.

described in more detail in “ —Liquidity and Capital Resources—Funding Requirements ” below, on June 6,

2024, we entered into a Loan Agreement (the “Loan Agreement”) with the Patel Family providing for (i) an unsecured line of

credit facility (the “Facility”), pursuant to which the Patel Family agreed to lend us up to an initial amount of $36.0 million

(the “Maximum Loan Amount”) of term loans in $1.0 million increments on a monthly basis, over a draw period of thirty-six

months, and (ii) a contingent option for the Patel Family to purchase at least $14.0 million of our Common Stock in a future private

placement (the “Optional PIPE”).

The Loan Agreement also contains a contingent option for the Patel Family to purchase at

least $14.0 million of our Common Stock, plus up to the then-remaining available amount under the Facility, in a future private placement

if the ten-day trailing volume weighted average price per share of the Common Stock (the “Trailing VWAP”) reaches $10.00

Pursuant to the terms of the Loan Agreement, we also issued to the Patel Family 1,000,000 shares of Common Stock as a commitment

fee (the “Commitment Shares”), subject to forfeiture by the Patel Family of the Commitment Shares or an equal number of shares

of Common Stock in the event the Patel Family fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price

for the Optional PIPE within 30 days after the Threshold Price Notice Date (as defined in the Loan Agreement) in the event we have satisfied

all applicable closing conditions.

addition, in January 2025, we received a grant of $2.0 million from KRHP LLC, a New Jersey limited liability company (“KRHP”),

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

KRHP is affiliated with the Patel Family.

KRHP also committed to provide an additional $8.0 million of grant funding to the Company to

be used towards the Company’s ongoing operational expenses.

on cash on hand as of the date of this Report of approximately $2.0 million, the amounts available under our Loan Agreement, and $8.0

million of additional committed grant funding from KRHP, we have concluded that we have sufficient cash to fund our operations for at

least the next 12 months from the issuance date of our unaudited consolidated financial statements.

do not expect to generate product revenue unless and until we obtain marketing approval or other authorization for and successfully commercialize

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marketing, managed market, and distribution functions, and training and deploying a specialty medical science liaison team.

Minimum Bid Price Compliance

June 14, 2024, we received a letter from Nasdaq’s Listing Qualifications Department (the “Staff”) notifying us that

we no longer met the $1.00 per share minimum bid price requirement for continued listing on Nasdaq (the “Minimum Bid Price Requirement”)

based on the closing bid price for our Common Stock for the previous 35 consecutive business days.

The letter had no immediate effect

on the listing of our Common Stock and outstanding public warrants to purchase Common Stock, and we were provided an initial compliance

period of 180 calendar days from receipt of the letter, or until December 11, 2024, to regain compliance with the Minimum Bid Price Requirement.

On October 28, 2024, we received a letter from the Staff notifying us that we had regained compliance with the Minimum Bid Price Requirement.

The letter confirmed that, from October 14, 2024 through October 25, 2024, the closing bid price of our Common Stock had been $1.00 per

share or higher and, accordingly, we had regained compliance with the Minimum Bid Price Requirement and that the matter was closed.

of our Results of Operations

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studies, and clinical development of TVGN 489, and pre-clinical studies of other product candidates, and include:

● acquisition

of supplies and equipment and leasing lab spaces;

incurred to conduct the necessary pre-clinical studies required by the U.S.

Food and Drug

Administration to obtain the regulatory approval necessary to conduct our TVGN 489 clinical

Food and Drug Administration to obtain the regulatory

approval necessary to conduct our TVGN 489 clinical trial;

benefits, and other related costs for personnel engaged in research and development functions;

of funding research performed by third parties, including pursuant to agreements with contract

research organizations (“CROs”), and investigative site costs to conduct our

pre-clinical studies and clinical trials;

of funding research performed by third parties, including pursuant to agreements with contract research organizations (“CROs”),

and investigative site costs to conduct our pre-clinical studies and clinical trials;

manufacturing

costs, including expenses incurred under agreements with contract manufacturing organizations

(“CMOs”), including manufacturing scale-up expenses, and the cost of acquiring

and manufacturing pre-clinical study and clinical trial materials;

of outside consultants, including their fees, stock-based compensation, and related travel

of laboratory supplies and acquiring materials for pre-clinical studies and clinical trials;

costs, including expenses incurred under agreements with contract manufacturing organizations (“CMOs”), including manufacturing

scale-up expenses, and the cost of acquiring and manufacturing pre-clinical study and clinical trial materials;

of outside consultants, including their fees, stock-based compensation, and related travel expenses;

of laboratory supplies and acquiring materials for pre-clinical studies and clinical trials; and

facility-related

expenses, which include direct depreciation costs of equipment and expenses for rent and

maintenance of facilities and other operating costs.

expenses, which include direct depreciation costs of equipment and expenses for rent and maintenance of facilities and other operating

and development activities are central to the biotechnology business model.

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respect to products other than TVGN 489, successfully completing pre-clinical studies;

● successfully

initiating future clinical trials;

● successfully

enrolling patients in and completing clinical trials;

for and receiving marketing approvals from applicable regulatory authorities;

and maintaining intellectual property protection and regulatory exclusivity for TVGN 489

and any other product candidates we are developing or may develop in the future and enforcing,

defending, and protecting these rights;

arrangements with third-party manufacturers, or establishing adequate commercial manufacturing

capabilities;

● establishing

sales, marketing, and distribution capabilities and launching sales of our products, if and

when approved, whether alone or in collaboration with others;

adoption of TVGN 489 and any other product candidates, if and when approved, by patients

and the medical community;

and maintaining intellectual property protection and regulatory exclusivity for TVGN 489 and any other product candidates we are

developing or may develop in the future and enforcing, defending, and protecting these rights;

arrangements with third-party manufacturers, or establishing adequate commercial manufacturing capabilities;

sales, marketing, and distribution capabilities and launching sales of our products, if and when approved, whether alone or in collaboration

adoption of TVGN 489 and any other product candidates, if and when approved, by patients and the medical community;

effectively with potential therapeutic alternatives in our target disease areas;

reimbursement by private and public payors including health technology appraisal entities

reimbursement by private and public payors including health technology appraisal entities in non-U.S.

change in the outcome of any of these variables concerning the development, manufacturing, or commercialization activities of a product

candidate could result in a change in the costs and timing associated with the development of that product candidate.

For example, if

we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate,

if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials

or tests are not positive or are only modestly positive, if there are safety concerns or if we determine that the observed safety or

efficacy profile would not be competitive in the marketplace, we could be required to expend significant additional financial resources

and time on the completion of clinical development.

We anticipate that product commercialization may take several years, and we expect

to spend a significant amount in development costs.

candidate could result in a significant change in the costs and timing associated with the development of that product candidate.

example, if we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently

contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of

these trials or tests are not positive or are only modestly positive, if there are safety concerns, or if we determine that the observed

safety or efficacy profile would not be competitive in the marketplace, we could be required to expend significant additional financial

resources and time on the completion of clinical development.

We anticipate that product commercialization may take several years, and

we expect to spend a significant amount in development costs.

and Administrative Expenses

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Increased costs associated with being a public company will also include expenses related to services associated with

maintaining compliance with SEC and Nasdaq Stock Market requirements, insurance, and investor relations costs.

If any of our current

or future product candidates obtains marketing approval, we expect that we would incur significantly increased expenses associated with

sales and marketing efforts.

expense, net consists primarily of interest on our convertible promissory notes and loan agreement, partially offset by interest earned

on bank deposits.

(See “— Sources of Liquidity ” below).

maintaining compliance with SEC and Nasdaq requirements, insurance, and investor relations costs.

If any of our current or future product

candidates obtains marketing approval, we expect that we would incur significantly increased expenses associated with sales and marketing

expense, net consists primarily of interest on our former convertible promissory notes and Loan Agreement, partially offset by interest

earned on bank deposits.

(See “— Liquidity and Capital Resources — Sources of Liquidity ” below.)

Transaction Costs

costs we incurred in relation to the Merger were initially capitalized as deferred transaction costs up through the Closing Date, at

which time such costs were charged to expense in our statements of operations less the amount of cash received in the Merger.

costs we incurred in relation to the Business Combination were initially capitalized as deferred transaction costs up through the Closing

Date, at which time such costs were charged to expense in our statements of operations less the amount of cash received in the Business

in Fair Value of Convertible Promissory Notes

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the Closing, at which time the convertible promissory notes were converted into our Common Stock.

in Fair Value of Written Call Option Derivative Liabilities

Equity-linked

purchase options issued in connection with our debt agreements are assessed to determine whether they are freestanding or embedded with

the host instrument under ASC 815.

Our embedded and freestanding purchase options were determined to be liability-classified derivative

instruments and are measured at fair value both on the date of issuance and at each subsequent balance sheet date, with changes in fair

value recorded to “Change in fair value of written call option derivative liabilities” within the consolidated statements

of operations and consolidated statements of cash flows.

on Issuance of Commitment Shares

other expenses consist of losses on the issuance of the Commitment Shares during the nine months ended September 30, 2024 associated

with the Loan Agreement.

Since we intend to elect the fair value option for future draws under the Loan Agreement, we expense all issuance

costs associated with the Loan Agreement, which are comprised of the fair value of the Commitment Shares as well as the issuance date

fair value of the $14 million Purchase Option and Additional Amount Purchase Option.

For more information about the Loan Agreement, see

“— Liquidity and Capital Resources—Funding Requirements ” below.

other expenses consist of losses on the issuance of the Commitment Shares for the period ended March 31, 2025 associated with the Loan

Since we intend to elect the fair value option for future draws under the Loan Agreement, we expense all issuance costs associated

with the Loan Agreement, which are comprised of the fair value of the Commitment Shares as well as the issuance date fair value of the

$14 million Purchase Option and Additional Amount Purchase Option.

For more information about the Loan Agreement, see “— Liquidity

and Capital Resources—Funding Requirements ” below.

Tax Provision

inception, we have incurred significant net losses.

As of March 31, 2025, we had net operating loss carryforwards (“NOLs”)

for federal and state income tax purposes of $25.6 million and $27.8 million, respectively.

We have provided a valuation allowance against

the full amount of our net deferred tax assets since, in the opinion of our management, based upon our historical and anticipated future

losses, it is more likely than not that the benefits will not be realized.

utilization of our NOLs may be subject to a substantial annual limitation in the event of certain cumulative changes in the ownership

interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal

Revenue Code of 1986, as amended, respectively, as well as similar state provisions.

of Operations

of the three months ended September 30, 2024 and 2023

following table summarizes our results of operations for the three months ended September 30, 2024 and 2023:

months ended September 30,

Operating expenses:

and administrative

Total operating expenses

Loss from operations

Interest expense, net

Change in fair value of

convertible promissory notes

Change in fair value of

written call option derivative liabilities

on issuance of commitment shares

and Development Expenses

do not track our internal research and development costs on a program-by-program basis.

The following table summarizes our research and

development expenses for the three months ended September 30, 2024 and 2023:

months ended September 30,

Personnel costs

Stock-based compensation

Other clinical and pre-clinical development

Facilities and other expenses

research and development expenses

and development expenses for the three months ended September 30, 2024 were $3.3 million, compared to $1.1 million for the three months

ended September 30, 2023.

The increase was primarily attributable to an increase in stock-based compensation due to stock compensation

expense related to the RSUs granted to Dr.

and Administrative Expenses

following table summarizes our general and administrative expenses for the three months ended September 30, 2024 and 2023:

months ended September 30,

Personnel costs

Stock-based compensation

Legal and professional fees

Facilities and other expenses

general and administrative expenses

and administrative expenses for the three months ended September 30, 2024 were $2.8 million compared to $1.2 million for the three

months ended September 30, 2023.

The $0.5 million increase in legal and professional fees was primarily attributable to additional

services incurred as a result of the Merger.

The $1.1 million in stock-based compensation was due to stock compensation

expense related to the RSUs granted to Dr.

recognized $0.0 million and $0.3 million in interest expense for the three months ended September 30, 2024 and 2023, respectively.

expense for the three months ended September 30, 2023 was attributable primarily to the outstanding principal balance associated with

our convertible promissory notes which converted into Common Stock in connection with the Closing.

in Fair Value of Convertible Promissory Notes

recognized a non-cash charge of $1.3 million for the change in fair value of the convertible promissory notes for the three months ended

September 30, 2023.

The change in fair value of the convertible promissory notes was primarily a result of the increase in the underlying

estimated fair value of our Common Stock during the three months ended September 30, 2023.

The convertible promissory notes were converted

into shares of Common Stock in connection with the Closing.

in Fair Value of Written Call Option Derivative Liabilities

recognized a non-cash charge of $0.2 million for the fair value of our written call option derivative liabilities associated with our

Loan Agreement for the three months ended September 30, 2024.

of the nine months ended September 30, 2024 and 2023

following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:

months ended September 30,

of the three months ended March 31, 2025 and 2024

Three months ended March 31,

Operating expenses:

and administrative

Research and development

General and administrative

Total operating expenses

1 unchanged sentence

(10,356,347 )

(29,516,724 )

Interest expense, net

Merger transaction costs

Change in fair value of

convertible promissory notes

(49,122,865 )

Change in fair value of

written call option derivative liabilities

on issuance of commitment shares

$ (4,282,828 )

Change in fair value of warrants

Change in fair value of convertible promissory notes

$ (10,367,061 )

2 unchanged sentences

The following table summarizes our research and

development expenses for the nine months ended September 30, 2024 and 2023:

months ended September 30,

development expenses for the periods ended March 31, 2025 and 2024:

Period ended March 31,

Personnel costs

Stock-based compensation

Other clinical and pre-clinical development

Other clinical and pre-clinical development expenses

Facilities and other expenses

Total research and development

and development expenses for the nine months ended September 30, 2024 were $28.2 million, compared to $3.5 million for the nine months

ended September 30, 2023.

The increase was primarily attributable to an increase in stock-based compensation due to a non-cash stock-based

compensation expense of $20.5 million recognized from certain stock-based awards that continue to vest through satisfaction of service

conditions subsequent to the satisfaction of the liquidity condition upon the Closing.

Total research and development expenses

and development expenses for the period ended March 31, 2025 were $3.2 million, as compared to $20.8 million for the period ended March

The decrease was primarily attributable to stock-based compensation expense recognized as part of

and Administrative Expenses

following table summarizes our general and administrative expenses for the nine months ended September 30, 2024 and 2023:

months ended September 30,

following table summarizes our general and administrative expenses for the three months ended March 31, 2025 and 2024:

Three months ended March 31,

Personnel costs

2 unchanged sentences

Facilities and other expenses

general and administrative expenses

and administrative expenses for the nine months ended September 30, 2024 were $16.0 million compared to $3.3 million for the nine months

ended September 30, 2023.

The increase was primarily attributable to stock-based compensation expense of $8.9 million, of which $6.7

million was recognized as a non-cash stock-based compensation expense from certain stock-based awards that continue to vest through satisfaction

of service conditions subsequent to the satisfaction of the liquidity condition upon the Closing, and $2.2 million was recognized as

restricted stock compensation expense related to the RSUs granted.

The increase of $1.2 million in personnel costs was primarily attributable

to an increase in headcount and an increase in premium for the Company’s director and officer insurance policy, and $0.8 million

was recognized as a loss from the issuance of Series A Preferred Stock.

The increase of $2.7 million in legal and professional fees was

primarily attributable to the additional services incurred as a result of the Merger.

recognized $0.2 million and $0.9 million in interest expense for the nine months ended September 30, 2024 and 2023, respectively, which

was attributable primarily to the outstanding principal balance associated with our convertible promissory notes that converted into

Common Stock in connection with the Closing.

Total general and administrative expenses

and administrative expenses for the period ended March 31, 2025 were $7.2 million, as compared to $8.7 million for the period ended March

The decrease was primarily attributable to decreases in stock-based compensation and personnel costs, partially offset by increases

in legal and professional fees.

recognized $24,577 and $159,305 in interest expense for the three months ended March 31, 2025 and 2024, respectively, which was attributable

primarily to the outstanding balance on our Line of Credit facility and the outstanding principal balance associated with our convertible

promissory notes that converted into Common Stock in connection with the Closing.

Transaction Costs

transaction costs in excess of cash received from the Merger of $7.5 million were recognized as period expenses for the nine months ended

September 30, 2024.

transaction costs in excess of cash received from the Business Combination of $7.5 million were recognized as period expenses for the

three months ended March 31, 2024.

in Fair Value of Convertible Promissory Notes

recognized a non-cash gain of $48.5 million and a non-cash loss of $49.1 million for the change in fair value of the convertible promissory

notes for the nine months ended September 30, 2024 and 2023, respectively.

The change was primarily a result of the increase in the underlying

estimated fair value of our Common Stock during the nine months ended September 30, 2023 compared to a decrease in the underlying estimated

fair value of our Common Stock from January 1, 2024 to the settlement of the convertible promissory notes upon the Closing.

was no non-cash gain or loss recognized in the three months ended March 31, 2025 in relation to our convertible promissory notes.

recognized a non-cash gain of $48.5 million for the change in fair value of the convertible promissory notes for the three months ended

March 31, 2024.

on Issuance of Commitment Shares

incurred losses on the issuance of Commitment Shares during the nine months ended September 30, 2024, associated with the Loan Agreement.

incurred losses on the issuance of Commitment Shares during the three months ended March 31, 2024, associated with the Loan Agreement.

and Capital Resources

of September 30, 2024, we had $2.3 million in cash, as compared to $1.1 million in cash as of December 31, 2023.

To date, we have not

yet commercialized any products or generated any revenue from product sales and have financed our operations primarily with proceeds

from the sale of convertible promissory notes and preferred stock, funds drawn on the Loan Agreement, and research tax credits.

January 2021, we have raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes, $2.0 million from

the sale of our Series A Preferred Stock, $3.0 million from deposits related to the future sale of our Series A-1 Preferred Stock, and

$6.0 million from the sale of our Series C Preferred Stock.

In June 2024, we entered into the Loan Agreement, which provided up to $36.0

million of term loans that can be drawn in $1.0 million increments each month over thirty-six months, as described below.

As of September

30, 2024, we have drawn an aggregate of $1.0 million under the Loan Agreement.

following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023:

For the nine months ended

September 30,

of March 31, 2025 we had $2.0 million in cash, as compared to $1.3 million in cash as of December 31, 2024.

To date, we have not yet

commercialized any products or generated any revenue from product sales and have financed our operations primarily with proceeds from

the sale of convertible promissory notes and preferred stock, funds drawn on the Loan Agreement, and grant funding.

Since January 2021,

we have raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes, $2.0 million from the sale of

our Series A Preferred Stock, $3.0 million from deposits related to the future sale of our Series A-1 Preferred Stock, and $6.0 million

from the sale of our Series C Preferred Stock.

In June 2024, we entered into the Loan Agreement, which provided up to $36.0 million of

term loans that can be drawn in $1.0 million increments each month over thirty-six months, as described below.

As of March 31, 2025,

we had drawn $3.0 million with a remaining $27.0 million available for future financing over the remaining 27 months of

the draw period, and we drew an additional $0.5 million under the Loan Agreement in April 2025.

In addition, in January 2025, we received

a grant of $2.0 million and a commitment of a grant of $8.0 million from KRHP.

We expect to receive the additional $8.0 million KRHP

grant in cash during the second quarter of 2025.

following table summarizes our cash flows for the three months ended March 31, 2025 and 2024:

the three months ended

Cash provided by (used in)

3 unchanged sentences

Investing activities

Financing activities

Net change in cash

$ (2,877,646 )

Flows from Operating Activities

the nine months ended September 30, 2024, we used $9.0 million of net cash in operating activities.

Cash used in operating activities

reflected $9.7 million of net loss, non-cash charges related to the change in the fair value of the convertible promissory notes, stock-based

compensation expense, Merger transaction costs, loss on the issuance of Series A Preferred Stock, loss on issuance of the Commitment

Shares, depreciation expense, reductions in the operating right of use (“ROU”) assets, and non-cash interest on the convertible

promissory notes, partially offset by a $0.7 million net change in our operating assets and liabilities attributable to the timing of

our payments to our vendors for research and development activities.

the nine months ended September 30, 2023, we used $6.2 million of net cash in operating activities.

Cash used in operating activities

reflected our net loss of $56.9 million offset by $49.1 million of non-cash charges related to the change in the fair value of the convertible

promissory notes, depreciation expense, and reductions in the operating ROU assets, offset by a $0.4 million net change in our operating

assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.

During the three months ended March 31, 2025, we used $3.3 million of net

cash in operating activities.

Cash used in operating activities reflected our net loss of $10.4 million offset by $7.3 million in non-cash

stock-based compensation expense, depreciation expense, and the net change in our operating assets and liabilities attributable to the

timing of our payments to our vendors for research and development activities.

the three months ended March 31, 2024, we used $2.2 million of net cash in operating activities.

Cash used in operating activities reflected

our net income of $11.3 million offset by $13.9 million of non-cash charges related to the change in the fair value of the convertible

promissory notes, stock-based compensation expense, depreciation expense, reductions in the operating ROU assets, and non-cash interest

on the convertible promissory notes, offset by a $0.5 million net change in our operating assets and liabilities attributable to the

timing of our payments to our vendors for research and development activities.

Flows from Investing Activities

the nine months ended September 30, 2023, we purchased $0.1 million of property and equipment.

There was no investing activities during

the nine months ended September 30, 2024.

the three months ended March 31, 2025 and 2024, we did not have any cash flows from investing activities.

Flows from Financing Activities

the nine months ended September 30, 2024, we received $10.2 million of net cash from financing activities attributable to $2.0 million

in proceeds from the sale of Series A Preferred Stock, $4.0 million in proceeds from the sale of Series C Preferred Stock, $3.0 million

of non-refundable prepaid proceeds towards the anticipated issuance of Series A-1 Preferred Stock, $1.0 million drawn under the Loan

Agreement, and $0.2 million of cash in connection with the Merger.

the nine months ended September 30, 2023, we received $3.7 million of net cash from financing activities attributable to the proceeds

from the convertible promissory notes, partially offset by $0.2 million in payment of deferred transaction costs.

During the three months ended March 31, 2025, we received $2.0 million

of net cash from financing activities attributable to a draw on the Loan Agreement and $2.0 million attributable to the KRHP grant.

the three months ended March 31, 2024, we received $2.4 million of net cash from financing activities attributable to $2.0 million of

proceeds from the issuance of the Series A Preferred Stock, $0.2 million of non-refundable prepaid proceeds towards the anticipated issuance

of Series A-1 Preferred Stock, and $0.2 million of cash in connection with the Merger.

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

received from the sale of our Series A and Series C Preferred Stock and the funding we expect to receive from the sale of our Series

A-1 Preferred Stock, and our access to an unsecured line of credit (limited to a $1.0 million monthly draw) under the Loan Agreement

described below.

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

A-1 Preferred Stock, our access to an unsecured line of credit (limited to a $1.0 million monthly draw) under the Loan Agreement described

below, and the $8.0 million of grant funding that KRHP has committed to provide to be used towards the Company’s ongoing operational

On February 14, 2024, we entered into a securities purchase agreement with the Patel Family pursuant to which the Patel Family

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

On March 27, 2024, we entered

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

into an agreement pursuant to which that amount was reduced to $2.0 million and the Patel Family agreed to purchase shares of our Series

A-1 Preferred Stock for an aggregate purchase price of $6.0 million.

3 unchanged sentences

our business, operating, and development plans.

On August 21, 2024, we entered into a securities purchase agreement with an investor

pursuant to which the investor agreed to purchase shares of our Series C Preferred Stock for an aggregate purchase price of $6.0 million.

June 6, 2024, we entered into the Loan Agreement, pursuant to which the Lender agreed to provide to the Company up to the Maximum Loan

Amount of $36.0 million under the Facility.

The Lender is also the investor in our Series A, Series A-1, and Series C Preferred Stock.

The Facility permits us to borrow up to $1.0 million monthly in a single monthly draw over a period of up to three years.

accrue interest at a fixed annual rate of the lower of (i) the daily secured overnight financing rate, measured on the date we receive

the draw (the “Deposit Date”), plus 2.00% and (ii) 7.00%, accruing quarterly beginning on the Deposit Date and payable quarterly

beginning on the three-month anniversary of the Deposit Date.

Interest will be payable in shares of Common Stock with an effective purchase

price of $1.50 per share, and each draw will mature 48 months after the Deposit Date.

Prepayment will be permitted without penalty.

Company may repay or prepay any amount of outstanding principal balance under the Facility at the Company’s election in cash or

in shares of Common Stock with an effective purchase price of the greater of $1.50 per share and the 10-day trailing volume weighted

On August 21, 2024, we entered into a securities purchase agreement with the Patel Family

pursuant to which the Patel Family agreed to purchase shares of our Series C Preferred Stock for an aggregate purchase price of $6.0

June 6, 2024, we entered into the Loan Agreement, pursuant to which the Patel Family agreed to provide to us up to the Maximum Loan Amount

of $36.0 million under the Facility.

The Facility permits us to borrow up to $1.0 million monthly in a single monthly draw over a period

of up to three years.

Draws accrue interest at a fixed annual rate of the lower of (i) the daily secured overnight financing rate, measured

on the date we receive the draw (the “Deposit Date”), plus 2.00% and (ii) 7.00%, accruing quarterly beginning on the Deposit

Date and payable quarterly beginning on the three-month anniversary of the Deposit Date.

Interest will be payable in shares of Common

Stock with an effective purchase price of $1.50 per share, and each draw will mature 48 months after the Deposit Date.

Prepayment will

be permitted without penalty.

We may repay or prepay any amount of outstanding principal balance under the Facility at our election in

cash or in shares of Common Stock with an effective purchase price of the greater of $1.50 per share and the 10-day trailing volume weighted

average price of the Common Stock (the “Trailing VWAP”) as of the trading day prior to payment, subject to certain requirements

related to resale registration.

Pursuant to the Loan Agreement, we also agreed to provide the Lender an option to purchase $14.0 million

of shares of our Common Stock plus an additional amount up to the total then-remaining available and undrawn portion of the Maximum Loan

Amount (which amount would thereafter no longer be available under the Facility).

Pursuant to the Loan Agreement, we also agreed to provide the Patel Family an option to purchase $14.0

million of shares of our Common Stock plus an additional amount up to the total then-remaining available and undrawn portion of the Maximum

Loan Amount (which amount would thereafter no longer be available under the Facility).

The Optional PIPE would be priced at a 30% discount

to the Trailing VWAP on the date such price first reaches at least $10.00 per share (the “Threshold Price Date”) and will

be exercisable by the Lender by written notice within three business days after the Company has notified the Lender of the Threshold

be exercisable by the Patel Family by written notice within three business days after we have notified the Patel Family of the Threshold

Price Date (the date of such notice, the “Threshold Price Notice Date”).

Pursuant to the terms of the Loan Agreement, we

issued to the Lender the Commitment Shares, subject to forfeiture by the Lender of the Commitment Shares or an equal number of shares

of Common Stock in the event the Lender fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the

Optional PIPE within 30 days after the Threshold Price Notice Date in the event the Company has satisfied all applicable closing conditions.

issued to the Patel Family the Commitment Shares, subject to forfeiture by the Patel Family of the Commitment Shares or an equal number

of shares of Common Stock in the event the Patel Family fails to (i) make a deposit under the Facility when due or (ii) pay the purchase

price for the Optional PIPE within 30 days after the Threshold Price Notice Date in the event we have satisfied all applicable closing

There is no assurance as to the amount of proceeds we will ultimately receive under the Loan Agreement.

As of September 30, 2024, we

have drawn an aggregate of $1.0 million under the Loan Agreement

As of March 31, 2025,

we have drawn an aggregate of $3.0 million under the Loan Agreement, and we drew an additional $0.5 million under the Loan Agreement

in April 2025.

expect to devote considerable financial resources to our ongoing and planned activities, particularly as we conduct our planned clinical

11 unchanged sentences

future capital requirements will depend on many factors, including:

progress, costs, and results of our planned clinical trials of TVGN 489 and other planned

and future clinical trials;

scope, progress, costs and results of our pre-clinical testing and clinical trials of TVGN

489 for additional combinations, targets, and indications;

number of and development requirements for additional indications for TVGN 489 or for any

other product candidates;

ability to scale up our manufacturing processes and capabilities to support clinical trials

of TVGN 489 and other product candidates we are developing and may develop in the future;

costs, timing, and outcome of regulatory review of TVGN 489 and other product candidates

progress, costs, and results of our planned clinical trials of TVGN 489 and other planned and future clinical trials;

scope, progress, costs, and results of our pre-clinical testing and clinical trials of TVGN 489 for additional combinations, targets,

and indications;

number of and development requirements for additional indications for TVGN 489 or for any other product candidates;

ability to scale up our manufacturing processes and capabilities to support clinical trials of TVGN 489 and other product candidates

we are developing and may develop in the future;

costs, timing, and outcome of regulatory review of TVGN 489 and other product candidates we are developing and may develop in the

changes in the regulatory environment and enforcement rules;

ability to establish and maintain strategic collaborations, licensing or other arrangements

and the financial terms of such arrangements;

costs and timing of future commercialization activities, including product manufacturing,

sales, marketing, and distribution, for TVGN 489 and other product candidates we are developing

and may develop in the future for which we may receive marketing approval;

ability to obtain and maintain acceptance of any approved products by patients, the medical

community, and third-party payors;

amount and timing of revenue, if any, received from commercial sales of TVGN 489 and any

other product candidates we are developing or develop in the future for which we receive

marketing approval;

ability to establish and maintain strategic collaboration, licensing, or other arrangements and the financial terms of such arrangements;

costs and timing of future commercialization activities, including product manufacturing, sales, marketing, and distribution, for

TVGN 489 and other product candidates we are developing and may develop in the future for which we may receive marketing approval;

ability to obtain and maintain acceptance of any approved products by patients, the medical community, and third-party payors;

amount and timing of revenue, if any, received from commercial sales of TVGN 489 and any other product candidates we are developing

or develop in the future for which we receive marketing approval;

changes in pharmaceutical pricing and reimbursement infrastructure;

availability of raw materials for use in production of our product candidates; and

costs and timing of preparing, filing and prosecuting patent applications, maintaining and

enforcing our intellectual property and proprietary rights, and defending any intellectual

property-related claims.

of September 30, 2024, we had cash of $2.3 million.

Our cash balance, the $2.0 million received from the sale of Series C Preferred Shares,

and the Loan Agreement, which allows us to draw down term loans of $1.0 million per month over thirty-six months, will allow us to have

adequate cash and financial resources, to operate for at least the next 12 months from the date of issuance of our unaudited consolidated

financial statements included in this Report.

costs and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property and

proprietary rights, and defending any intellectual property-related claims.

of March 31, 2025, we had cash of $2.0 million.

We believe that our cash balance and amounts available under the Loan Agreement, which

allows us to draw down term loans of $1.0 million per month over the remaining 27 months of the draw period, will allow us to have adequate

cash and financial resources, to operate for at least the next 12 months from the date of issuance of our unaudited consolidated financial

statements included in this Report.

In addition, KRHP has committed to provide an additional $8.0 million of grant funding to the Company

to be used towards the Company’s ongoing operational expenses.

The grant funding will be used to satisfy the Company’s obligations

as they come due through March 31, 2026.

The Company does not plan to initiate a clinical trial until additional funding is received.

regularly evaluate different strategies to obtain funding for operations for subsequent periods.

9 unchanged sentences

Obligations and Commitments

following table summarizes our contractual obligations and commitments as of September 30, 2024:

following table summarizes our contractual obligations and commitments as of March 31, 2025:

Less than 1 Year

More than 3 Years

Contractual obligations:

lease commitments (1)

of Credit repayment (2)(3)

Agreement repayment (3)

Total contractual obligations

obligations pursuant to our office and laboratory leases in Philadelphia, Pennsylvania and

Warren, New Jersey.

obligations to settle outstanding balances on our Line of Credit, if paid in cash at time

of settlement.

(3) Reflects balance of loans drawn on line of credit and accrued interest.

obligations pursuant to our office and laboratory leases in Philadelphia, Pennsylvania and Warren, New Jersey.

notes payable obligations assumed as part of the Merger.

obligations to settle outstanding balances on our Loan Agreement, if paid in cash at time of settlement, as well as accrued interest.

commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant

5 unchanged sentences

Payments due upon cancellation consisting only of payments for services provided or expenses incurred,

including non-cancelable obligations of our service providers, up to the date of cancellation are not included in the table above as

the amount and timing of such payments are not known.

including noncancelable obligations of our service providers, up to the date of cancellation are not included in the table above as the

amount and timing of such payments are not known.

Accounting Policies and Estimates

discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared

in accordance with GAAP.

The preparation of the financial statements requires us to make estimates and judgments that affect the reported

amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements.

an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, the fair value of our Common

Stock, the fair value of our convertible promissory notes, and stock-based compensation.

We base our estimates on historical experience,

known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form

the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Actual results may differ from these estimates under different assumptions or conditions, including those factors set out in the “ Risk

Factors ” section of our Annual Report.

See also the section entitled “– Forward-Looking Statements ”

our significant accounting policies are described in more detail in Note 3 to our financial statements contained in this Report and Note

3 to the audited financial statements included as Exhibit 99.1 to the Form 8-K, we believe the following accounting policies are the

most critical to the judgments and estimates used in the preparation of our financial statements or involve a significant level of estimation

uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operation.

and Development Expenses

and development activities are expensed as incurred.

As part of the process of preparing our financial statements, we are required to

estimate our accrued research and development expenses, including those related to clinical trials and product candidate manufacturing.

This process involves reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services

that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the services

when we have not yet been invoiced or otherwise notified of actual costs.

Our service providers invoice us in arrears or require prepayments

for services performed, as well as on a pre-determined schedule or when contractual milestones are met.

We make estimates of our accrued

expenses as of each balance sheet date in the financial statements based on facts and circumstances known to us at that time.

We periodically

confirm the accuracy of the estimates with the service providers and make adjustments if necessary.

Examples of estimated accrued research

and development expenses include fees paid to:

in connection with pre-clinical and clinical development activities;

in connection with clinical trials;

in connection with the process development and scale-up activities and the production of

pre-clinical and clinical trial materials.

for clinical trials and manufacturing activities are recognized based on an evaluation of our vendors’ progress towards completion

of specific tasks, using data such as participant enrollment, clinical site activations, or information provided to us by our vendors

regarding their actual costs incurred.

Payments for these activities are based on the terms of individual contracts and payment timing

may differ significantly from the period in which the services were performed.

We determine accrual estimates through reports from and

discussions with applicable personnel and outside service providers as to the progress or state of completion of studies, or the services

Our estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time.

Costs that are paid in advance of performance are deferred as a prepaid expense and amortized over the service period as the services

are provided.

we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing

of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that

are too high or too low in any particular period.

To date, there have not been any material adjustments to our prior estimates of accrued

research and development expenses.

However, due to the nature of estimates, we cannot assure that we will not make changes to our estimates

in the future as we become aware of additional information about the status or conduct of our clinical trials and other research activities.

under our compensation plans are accounted for in accordance with ASC 718.

Compensation cost is measured at the grant date fair value

of the award and is recognized over the vesting period of the award.

We use the straight-line method to record compensation expense of

awards with service-based vesting conditions.

We account for forfeitures of stock-based awards as they occur.

We recognize share-based

compensation expense for awards with performance conditions when it is probable that the condition will be met, and the award will vest.

Prior to the Merger, we estimated the fair value of our Common Stock in accordance with the guidance outlined in the American Institute

of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued

as Compensation .

the fair value of Common Stock

to the Closing, we were required to estimate the fair value of shares of our Common Stock underlying our stock-based awards and in connection

with valuing our convertible promissory notes.

Because our Common Stock was not publicly traded prior to February 15, 2024, the fair

value of our Common Stock prior to such date had been estimated on each grant date by our board of directors, with input from our management,

considering third-party valuations of our Common Stock.

board of directors considered various objective and subjective factors to estimate the estimated fair value of our Common Stock, including:

estimated value of all classes of securities outstanding;

anticipated capital structure that will directly impact the value of the currently outstanding

results of operations and financial position;

status of our research and development efforts;

composition of, and changes to, our management team and board of directors;

lack of liquidity of our Common Stock as a private company;

stage of development and business strategy and the material risks related to our business

and industry;

market conditions affecting the life sciences and biotechnology industry sectors;

likelihood of achieving a liquidity event for the holders of our Common Stock, such as an

initial public offering, or a sale of the company, given the prevailing market conditions;

market value and volatility of comparable companies.

Value Measurements

recurring fair value measurements primarily consist of the convertible promissory notes prior to the Merger, for which we elected the

fair value option, the freestanding $14 million purchase option under the Loan Agreement, and the bifurcated purchase option that is

embedded within the loan commitment under the Loan Agreement.

used the Probability Weighted Expected Return Method (“PWERM”) valuation methodology to determine the fair value of the convertible

promissory notes prior to the Merger for all the periods presented.

The PWERM is a scenario-based methodology that estimates the fair

value based upon an analysis of future values for the company, assuming various outcomes.

The value is based on the probability-weighted

present value of expected future investment returns considering each of the possible outcomes available.

The future value under each

outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at

an indication of value.

Significant assumptions used in determining the fair value of convertible promissory notes include volatility,

discount rate, and probability of a future liquidity event.

In February 2024, concurrent with the Merger, we converted our outstanding

convertible promissory notes into 10,337,419 shares of Common Stock.

used a Monte Carlo Simulation (“MCS”) valuation methodology to determine the fair value of the freestanding $14 million purchase

option and embedded purchase option associated with the Loan Agreement at inception and as of September 30, 2024.

The MCS methodology

simulates the Company’s future stock price to estimate if and when the Trailing VWAP will reach $10.00 per share, and discounts

the resulting payoff back to each valuation date using a present value factor.

Significant assumptions used in determining the fair value

of these options include volatility and discount rate.

discussion and analysis of our financial condition and results of operations is based on our unaudited consolidated financial statements,

which have been prepared in accordance with GAAP.

The preparation of the unaudited consolidated financial statements requires us to make

estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets

and liabilities in our unaudited consolidated financial statements.

On an ongoing basis, we evaluate our estimates and judgments, including

those related to accrued expenses, the fair value of our Common Stock, the fair value of our convertible promissory notes, and stock-based

compensation.

We base our estimates on historical experience, known trends and events, and various other factors that are believed to

be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and

liabilities that are not readily apparent from other sources.

Actual results may differ from these estimates under different assumptions

or conditions, including those factors set out in the “ Risk Factors ” section of our Annual Report.

What changed 10-Q

Item 2. Management’s Discussion and Analysis