What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-14 compared with 2024-05-28 · 347 added, 240 removed, 343 unchanged (63% of the section changed)

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of our results of operations and our liquidity and capital resources should be read together with our unaudited consolidated financial

statements and the related notes appearing elsewhere this Report and the audited financial information and related notes, as well 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

statements and the related notes appearing elsewhere in this Report and the audited financial information and related notes, as well

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”).

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that convey future events, conditions, circumstances, or outcomes to identify these forward-looking statements.

Forward-looking statements

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, cancer,

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

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

Forward-looking

statements 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, 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

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;

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

and strategy;

● expectations

regarding the healthcare and biopharmaceutical industries;

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from the results anticipated by these forward-looking statements, including the following risks and uncertainties, among others:

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 generally;

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;

the 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 generally;

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;

in domestic and global general economic conditions;

may not be able to execute our growth strategies or may experience difficulties in managing our growth and expanding operations;

may not be able to effectively remediate our material weakness and develop and maintain effective internal controls;

related to the Business Combination and the failure 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 keep pace with rapid technological developments to provide new and innovative products and services or make substantial

investments in unsuccessful new products and services;

may not be able to execute our growth strategies or may experience difficulties in managing

our growth and expanding operations;

may not be able to develop and maintain effective internal controls;

related to the Business Combination and the failure 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 keep pace with rapid technological developments to provide new and innovative

products and services or make substantial investments in unsuccessful new products and services;

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

will need to raise additional capital, which may not be available on acceptable terms or at all, in order to execute our business

will need to raise additional capital, which may not be available on acceptable terms or

at all, in order to execute our business plan;

risk of regulatory lawsuits or proceedings relating to our business;

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ability to continue as a going concern;

success and continuation of business operations are dependent on raising additional capital sufficient to meet our obligations on

a timely basis.

success and continuation of business operations are dependent on raising additional capital

sufficient to meet our obligations on a timely basis;

related to the failure to satisfy continued listing requirements of The Nasdaq Stock Market

LLC (“Nasdaq”), including maintaining a minimum closing bid price of $1.00 per

share pursuant to Nasdaq Listing Rule 5550(a)(2);

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

statements should be considered in light of these factors and the factors described elsewhere in this Report, including in the “Risk

Factors” section, in the “Risk Factors” section of our Annual Report, and in our various filings with the Securities

and Exchange Commission (the “SEC”).

It is important that you read these factors and the other cautionary statements made

in this Report as being applicable to all related forward-looking statements wherever they appear in this Report.

If any of these factors

materialize, or if any underlying assumptions prove incorrect, our actual results, performance, or achievements may differ materially

from any future results, performance or achievements expressed or implied by these forward-looking statements.

You should also read the

more detailed description of our business in our Annual Report when considering forward-looking statements.

We caution readers not to

place undue reliance on any forward-looking statements herein, which speak only as of the date of this Report.

We undertake no obligation

to publicly update any forward-looking statements, except as required by law.

Factors” section, in the “Risk Factors” section of our Annual Report, and in our various filings with the SEC.

important that you read these factors and the other cautionary statements made in this Report as being applicable to all related forward-looking

statements wherever they appear in this Report.

If any of these factors materialize, or if any underlying assumptions prove incorrect,

our actual results, performance, or achievements may differ materially from any future results, performance or achievements expressed

or implied by these forward-looking statements.

You should also read the more detailed description of our business in our Annual Report

when considering forward-looking statements.

We caution readers not to place undue reliance on any forward-looking statements herein,

which speak only as of the date of this Report.

We undertake no obligation to publicly update any forward-looking statements, except

as required by law.

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

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

We 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 platform, ExacTcell TM , represents a significant scientific breakthrough

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

applications spanning virology, oncology, and neurology.

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

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

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.

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 platform, ExacTcellTM, 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

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

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

We plan to launch 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.

On February 14, 2024 (the “Closing Date”), pursuant to the agreement and plan of merger dated June 28,

2023 (the “Merger 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.

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 preclinical development for treatment and prevention of Long COVID.

February 14, 2024 (the “Closing Date”), pursuant to the agreement and plan of merger dated June 28, 2023 (the “Merger

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.

(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 U.S.

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

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 U.S.

generally accepted accounting principles (“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 income for the three months ended March 31, 2024, was $11.3 million and our net loss for the three months ended

March 31, 2023, was $30.8 million.

Net income for the three months ended March 31, 2024, was primarily attributable to a $48.5 million decrease in fair value in the three months ended March 31, 2024 due to the decrease in the fair value of our common stock prior to

the Business Combination, partially offset by $7.5 million in transaction costs

in connection with the Business Combination and a $29.5 million loss from operations that primarily resulted from non-cash,

stock-based compensation expense recognized when the liquidity event condition contained in certain stock-based awards was satisfied

upon the Closing.

As of March 31, 2024, we had an accumulated deficit of $88.4 million and cash of

$1.3 million.

February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor purchased 500

shares of our Series A Preferred Stock for an aggregate purchase price of $2.0 million.

On March 27, 2024, we entered into an

Amended and Restated Securities Purchase Agreement with the investor pursuant to which we amended and restated the original

agreement and the investor agreed to purchase 600 shares of our Series A-1 Preferred Stock for an aggregate purchase price of $6.0

million, of which $0.2 million was received during the three months ended March 31, 2024, and $2.0 million has been received

subsequent to March 31, 2024.

The remainder is expected to be received in the second quarter of 2024.

The shares of Series A

Preferred Stock are convertible into a total of 500,000 shares of our common stock at the election of the holder, and the shares of

Series A-1 Preferred Stock will be convertible into a total of 600,000 shares of the Company’s common stock.

Preferred Stock is and the Series A-1 Preferred Stock will be subject to a call right providing us the right to call the stock if

the volume weighted average price of the common stock for the 20 days prior to delivery of the call notice is greater than $5.00 per

share and there is an effective resale registration statement on file covering the underlying common stock.

The Series A Preferred

Stock is and the Series A-1 Preferred Stock will be non-voting, has or will have no mandatory redemption, and carries or will carry

an annual 5% cumulative dividend, increasing by 2% each year, and the dividend on the Series A-1 Preferred Stock is capped at 15%

As described in more detail in “Liquidity and Capital Resources – Funding Requirements” below,

on May 10, 2024, we entered into a binding term sheet with a lender for a unsecured line of credit for up to $36.0 million, as well as

for a contingent option for the lender to purchase at least $14.0 million of shares of our common stock in a future private placement

(the “Optional PIPE”).

We anticipate that this transaction will close during the quarter ending June 30, 2024, but we have

not yet entered into a definitive agreement and there is no assurance as to the timing of the closing or the amount of proceeds we will

ultimately receive.

on cash on hand as of the date of this Report, as well as our history of operating losses and negative cash flows from operation combined

with our anticipated use of cash, we have concluded that we do not have sufficient cash to fund our operations for 12 months from the

issuance date of our unaudited consolidated financial statements, and as a result, under the applicable accounting standards and disclosure

rules, there is substantial doubt about our ability to continue as a going concern.

In making this determination, applicable accounting

standards prohibited us from considering the potential mitigating effect of plans that have not been fully implemented as of the date

of our unaudited consolidated financial statements, including without limitation plans to raise additional capital.

Our net loss for the three months ended June 30, 2024 and 2023 was $9.7 million and $22.2 million,

respectively.

Net loss for the three months ended June 30, 2024 was primarily attributable to a $8.6

million loss from operations.

Our net income (loss) for the six months ended June 30, 2024 and

2023 was $1.6 million and $(52.9) million, respectively.

Net income for the six months ended June 30, 2024 was primarily attributable

to a decrease in fair value in the six months ended June 30, 2024 due to the decrease in the fair value of our common stock, $0.0001

par value per share (the “Common Stock”), prior to the Business Combination, partially offset by $7.5 million in transaction

costs in connection with the Business Combination and a $38.1 million loss from operations that primarily resulted from non-cash, stock-based

compensation expense recognized when the liquidity event condition contained in certain stock-based awards was satisfied upon the Closing.

As of June 30, 2024, we had an accumulated deficit of $98.1 million and cash of $1.1 million.

February 14, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor purchased 500 shares

of our Series A Preferred Stock for an aggregate purchase price of $2.0 million.

On March 27, 2024, we entered into an Amended and Restated

Securities Purchase Agreement with the investor pursuant to which we amended and restated the original agreement and the investor 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 June 30, 2024.

The remainder is

expected to be received in the third quarter of 2024.

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

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

facility (the “Facility”), pursuant to which the Lender agreed to lend us up to $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 Lender to purchase at least $14.0 million of Common Stock in a future private placement (the “Optional PIPE”).

Agreement also contains a contingent option for the lender 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 Lender 1,000,000 shares of Common Stock as a commitment fee (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

(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, 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.

do not expect to generate product revenue unless and until we obtain marketing approval for and successfully commercialize TVGN 489 or

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sales and marketing efforts.

expense, net consists primarily of interest on our convertible promissory notes, partially offset by interest earned on bank deposits.

Income (Expense), Net

income (expense), net consists primarily of interest on our convertible promissory notes, partially offset by interest earned on bank

(See “— Sources of Liquidity ” below).

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our statements of operations at each balance sheet date through the settlement of the convertible promissory notes in connection with

the Closing, at which time the convertible promissory notes were converted into our common stock.

Tax Provision

inception, we have generally incurred significant net losses.

As of December 31, 2023, we had net operating loss carryforwards,

(“NOLs”) for federal and state income tax purposes of $13.9 million and $16.4 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.

the Closing, at which time the convertible promissory notes were converted into our common stock and consolidated statements of cash flows.

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.

of the three months ended March 31, 2024 and 2023

following table summarizes our results of operations for the three months ended March 31, 2024 and 2023:

Three months ended March 31,

on Issuance of Commitment Shares

other expenses consist of losses on the issuance of the Commitment Shares during the three months ended June 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 $14.0 million Purchase Option and Additional Amount Purchase Option.

For more information about the Loan Agreement, see

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

of Operations

of the three months ended June 30, 2024 and 2023

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

Three months ended June 30,

Operating expenses:

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Loss from operations

Interest income (expense), net

Change in fair value of warrants

Change in fair value of convertible promissory notes

(19,700,000 )

Interest expense, net

Change in fair value of written call option derivative liabilities

Loss on issuance of commitment shares

(22,184,353 )

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 June 30, 2024 and 2023:

Three months ended June 30,

Personnel costs

Stock-based compensation

Other clinical and pre-clinical development expenses

Facilities and other expenses

Total research and development expenses

and development expenses for the three months ended June 30, 2024 were $4.1 million, compared to $1.0 million for the three months ended

June 30, 2023.

The increase was primarily attributable to restricted stock compensation expense of $1.5 million related to the RSUs granted

Saadi and a non-cash stock-based compensation expense of $1.5 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.

and Administrative Expenses

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

Three months ended June 30,

Personnel costs

Stock-based compensation

Legal and professional fees

Facilities and other expenses

Total general and administrative expenses

and administrative expenses for the three months ended June 30, 2024 were $4.5 million compared to $1.2 million for the three months

ended June 30, 2023.

The increase was primarily attributable to increased legal and professional fees of $2.0 million, primarily

attributable to additional services incurred as a result of with the Merger, restricted stock compensation expense of $0.7 million

related to the RSUs granted to Dr.

Saadi, and a non-cash stock-based compensation expense of

$0.4 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.

Income (Expense), Net

recognized $0.3 million in interest expense for the three months ended June 30, 2023.

Interest expense for the three months ended June 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 $19.7 million for the change in fair value of the convertible promissory notes for the three months ended

June 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 June 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 June 30, 2024.

on Issuance of Commitment Shares

incurred losses on the issuance of Commitment Shares pursuant to the Loan Agreement during the three months ended June 30, 2024.

of the six months ended June 30, 2024 and 2023

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

Six months ended June 30,

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

(38,115,751 )

Interest income (expense), net

Merger transaction costs

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(47,842,865 )

Change in fair value of written call option derivative liabilities

Loss on issuance of commitment shares

Net income (loss)

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The following table summarizes our research and

development expenses for the three months ended March 31, 2024 and 2023:

Three months ended March 31,

development expenses for the six months ended June 30, 2024 and 2023:

Six months ended June 30,

Personnel costs

Stock-based compensation from satisfaction of liquidity condition upon the Closing

Stock-based compensation

Other clinical and pre-clinical development expenses

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Total research and development expenses

and development expenses for the three months ended March 31, 2024 were $20.8 million, compared to $1.3 million for the three months

ended March 31, 2023.

and development expenses for the six months ended June 30, 2024 were $24.9 million, compared to $2.4 million for the six months

ended June 30, 2023.

The increase was primarily attributable to a non-cash stock-based compensation expense of $20.5 million

recognized when the liquidity event condition contained in certain stock-based awards (the “Liquidity Condition”) was

satisfied upon the Closing.

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 and restricted

stock compensation expense of $2.3 million related to the RSUs granted to Dr.

and Administrative Expenses

following table summarizes our general and administrative expenses for the three months ended March 31, 2024 and 2023:

Three months ended March 31,

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

Six months ended June 30,

Personnel costs

Stock-based compensation from satisfaction of liquidity condition upon

Stock-based compensation

Legal and professional fees

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Total general and administrative expenses

and administrative expenses for the three months ended March 31, 2024 were $8.7 million compared to $1.0 million for the three

months ended March 31, 2023.

The increase was primarily attributable to a non-cash stock-based compensation expense of $6.3 million

recognized when the liquidity event condition contained in certain stock-based awards (the “Liquidity Condition”) was satisfied upon

recognized $0.2 million and $0.3 million in interest expense for the three months ended March 31, 2024 and 2023, respectively, which

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

common stock in connection with the Closing.

and administrative expenses for the six months ended June 30, 2024 were $13.2 million compared to $2.1 million for the six months ended

June 30, 2023.

The increase was primarily attributable to stock-based compensation expense of $7.7 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 $1.0 million was recognized as restricted stock compensation expense related to the RSUs granted to Dr.

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 $2.2 million in legal and professional fees was primarily attributable to the

additional services incurred as a result of the Merger.

Interest Expense, Net

recognized $0.2 million and $0.6 million in interest expense for the six months ended June 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.

Transaction Costs

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

for the three months ended March 31, 2024.

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

June 30, 2024.

in Fair Value of Convertible Promissory Notes

recognized a non-cash gain of $48.5 million and a non-cash loss of $28.1 million for the change in fair value of the convertible promissory notes for the

three months ended March 31, 2024 and 2023, respectively.

recognized a non-cash gain of $48.5 million and a non-cash loss of $47.8 million for the change in fair value of the convertible promissory

notes for the six months ended June 30, 2024 and 2023, respectively.

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

estimated fair value of the Company’s common stock during the three months ended March 31, 2023 compared to a decrease in the underlying estimated fair value of the Company’s common stock from January 1, 2024 to the settlement of the convertible promissory notes upon the

estimated fair value of our common stock during the six months ended June 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.

in Fair Value of Written Call Option Derivative Liabilities

recognized a non-cash loss 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 June 30, 2024.

on issuance of commitment shares

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

and Capital Resources

of March 31, 2024, we had $1.3 million in cash and an accumulated deficit of $88.4 million compared to $1.1 million in cash and an accumulated

of June 30, 2024, we had $1.1 million in cash and an accumulated deficit of $98.1 million compared to $1.1 million in cash and an accumulated

deficit of $99.7 million as of December 31, 2023.

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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, and $1.2 million from the sale of our Series A-1 Preferred Stock.

following table summarizes our cash flows for the three months ended March 31, 2024 and 2023:

Three months ended March 31,

$2.0 million from the sale of our Series A Preferred Stock, an d $3.0 million from de posits

related to the future sale of our Series A-1 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.

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

For the six months ended June 30,

Cash provided by (used in)

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Net change in cash

$ (2,027,654 )

Flows from Operating Activities

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

the six months ended June 30, 2024, we used $5.1 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 right of use (“ROU”)

assets, 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.

the three months ended March 31, 2023, we used $2.2 million of net cash in operating activities.

our net income of $1.6 million and $1.9 million net change in our operating assets and liabilities attributable to the timing of our

payments to our vendors for research and development activities, offset by $8.6 million of 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.

the six months ended June 30, 2023, we used $4.4 million of net cash in operating activities.

Cash used in operating activities reflected

our net loss of $52.9 million offset by $48.6 million of non-cash charges related to the change in the fair value of the convertible

promissory notes, depreciation expense, reductions in the operating ROU assets, and a $0.1 million net change in our operating assets

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

promissory notes, depreciation expense, and reductions in the operating ROU assets, offset by a $0.1 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 three months ended March 31, 2023, the Company purchased $0.1 million of property and equipment.

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

There was no investing activities during the

six months ended June 30, 2024.

Flows from Financing Activities

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

the six months ended June 30, 2024, we received $5.2 million of net cash from financing activities attributable to proceeds from the

issuance of $2.0 million Series A Preferred Stock, $3.0 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.

the three months ended March 31, 2023, we received $2.5 million of net cash from financing activities attributable to the proceeds from

the six months ended June 30, 2023, we received $2.5 million of net cash from financing activities attributable to the proceeds from

the convertible promissory notes.

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

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

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

On March 27, 2024, we entered into an

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

Stock for an aggregate purchase price of $6.0 million.

We have not yet received $4.8 million of the $6.0 million purchase price for the

Series A-1 Preferred Stock.

Even if we receive such proceeds, we will still need additional capital to fully implement our business,

operating, and development plans.

On May 10, 2024, we entered into a

binding term sheet (the “Financing Term Sheet”) with a lender pursuant to which the lender agreed to provide to the

Company up to $36.0 million (the “Maximum Loan Amount”) under an unsecured line of credit (the “Facility”).

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 an investor agreed to purchase

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

27, 2024, we entered into an agreement pursuant to which that amount was reduced to $2.0 million and the investor agreed to purchase

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

We have not yet received $3.0 million

of the $6.0 million purchase price for the Series A-1 Preferred Stock.

Even if we receive

such proceeds, we will still need additional capital to fully implement our business, operating, and development plans.

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 and Series A-1 Preferred Stock.

The Facility would permit us to borrow up to $1.0

million monthly in a single monthly draw over a period of up to three years.

Draws would accrue interest at a fixed annual rate of

the lower of (i) daily SOFR plus 2.00%, measured on the date we receive the draw (the “Deposit Date”), and (ii) 7.00%,

payable quarterly.

Interest would be payable in shares of our common stock priced at $1.50 per share, and each draw would mature 48

months after the Deposit Date.

Prepayment would be permitted without penalty, and we would be permitted to repay or prepay any

amount of outstanding principal balance at our election in cash or in shares of common stock priced at the greater of $1.50 per

share and the closing price of the common stock on the day immediately preceding such payment, provided that there is an effective

resale registration statement with respect to such shares.

Pursuant to the Financing Term Sheet, we would also agree 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 cease to be available under the Facility).

PIPE would be priced at a 30% discount to the 10-day trailing volume weighted average price of our common stock on the date such

volume weighted average price first reaches at least $10.00 per share.

We anticipate that we will enter into a definitive agreement

for the financing provided by the Financing Term Sheet during the quarter ending June 30, 2024, but we have not yet entered into

such an agreement and there is no assurance as to the timing of closing or the amount of proceeds we will ultimately receive.

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.

The 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 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).

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 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.

There is no assurance as to the amount

of proceeds we will ultimately receive under the Loan Agreement.

Subsequent to June 30, 2024, the Company drew $1.0 million from the

Facility, and $33.5 million remains available to borrow under the Facility for future draws.

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

30 unchanged sentences

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

of March 31, 2024, we had cash of $1.3 million.

Based on our cash balance, as well as our history of operating losses and negative cash

flows from operation combined with our anticipated use of cash to, among other things, fund the preclinical and clinical development

of our products, identify and develop new product candidates, and seek approval for TVGN 489 and our other product candidates and any

other product candidates we may develop, management has concluded that we do not have sufficient cash to fund our operations for 12 months

from the date of our unaudited consolidated financial statements included in this Report without additional financing, and as a result,

there is substantial doubt about our ability to continue as a going concern.

In making this determination, applicable accounting standards

prohibited us from considering the potential mitigating effect of plans that have not been fully implemented as of the date of our unaudited

consolidated financial statements, including raising additional capital.

Our financial information has been prepared on a basis that

assumes that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and

commitments in the normal course of business.

This financial information and our unaudited consolidated financial statements do not include

any adjustments that may result from an unfavorable outcome of this uncertainty.

such time, if ever, as we can generate substantial revenues from product sales, we expect to finance our cash needs through a combination

of public and private equity offerings and debt financings, strategic alliances, collaborations, and marketing, distribution, or licensing

arrangements.

However, adequate additional financing may not be available to us on acceptable terms, or at all, and may be impacted by

the economic climate and market conditions.

See the risk factor in our Annual Report captioned “We will require substantial

additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all.

A failure to obtain

this necessary capital when needed could force us to delay, limit, reduce or terminate our product development, commercialization efforts

or other operations.”

of June 30, 2024, we had cash of $1.1 million.

Our cash balance 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.

We do not plan to initiate a clinical trial until additional

funding is received.

We are currently evaluating different

strategies to obtain the additional funding for future operations for subsequent periods.

These strategies may include but are not limited

to private placements of equity and/or debt, licensing and/or marketing arrangements, and public offerings of equity and/or debt securities.

We may not be able to obtain financing on acceptable terms, or at all, and may not be able to enter into strategic alliances or other

arrangements on favorable terms, or at all.

The terms of any financing may adversely affect the holdings or the rights of our stockholders.

If we are unable to obtain funding, we could be required to delay, reduce or eliminate research and development programs, product portfolio

expansion, or future commercialization efforts, which could adversely affect our business prospects.

Obligations and Commitments

following table summarizes our contractual obligations and commitments as of March 31, 2024:

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

Less than 1 Year

14 unchanged sentences

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

in accordance with U.S.

generally accepted accounting principles (“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.

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