What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-19 compared with 2024-08-14 · 402 added, 334 removed, 356 unchanged (67% of the section changed)

17 unchanged sentences

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:

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;

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

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A number of important factors could cause actual results to differ materially

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

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;

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

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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 develop and maintain effective internal controls;

related to the Business Combination and the failure to realize anticipated benefits of the

ability to execute our growth strategies or manage growth and expanding operations;

ability to develop and maintain effective internal controls;

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

Business Combination;

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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 plan;

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;

risk of regulatory lawsuits or proceedings relating to our business;

● uncertainties

inherent in the execution, cost, and completion of preclinical studies and clinical trials;

inherent in the execution, cost, and completion of pre-clinical studies and clinical trials;

related to regulatory review and approval and commercial development;

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limited operating history;

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;

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);

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

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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 therapies for the treatment of infectious diseases,

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

We believe that

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

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

We believe the full potential

of T cell therapies remains largely untapped, and aspire to be the first biotechnology company offering commercially attractive, economically

viable, and cost-effective personalized T cell therapies.

believe our allogeneic, precision T cell technology 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.

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

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

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

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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.

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.

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.

11,191,827 covering

methods of treating COVID-19 infection using COVID-19 peptide specific CTLs;

11,207,401 covering COVID-19 peptide-specific

11,219,684 covering methods of manufacturing COVID-19 peptide specific CTLs.

A pending utility patent application

in the United States directed at viral specific T cells and methods of treating and preventing viral infections has an anticipated expiration

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.

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

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

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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.

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 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

another product candidate, and we cannot assure you that we will ever generate significant revenue or profits.

We expect to incur significant

expenses related to expanding our research and development capability, building our manufacturing infrastructure including through acquisitions,

and developing our commercialization organization, including reimbursement, marketing, managed market, and distribution functions, and

training and deploying a specialty medical science liaison team.

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.

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

to which the Patel Family purchased 500 shares of our Series A Preferred Stock for an aggregate purchase price of $2.0 million.

27, 2024, we entered into an Amended and Restated Securities Purchase Agreement with the Patel Family pursuant to which we amended and

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.

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

TVGN 489 or another product candidate.

We expect to incur expenses related to expanding our research and development capability, building

our manufacturing infrastructure including through acquisitions, and developing our commercialization organization, including reimbursement,

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

date, we have not generated any revenue, and we do not expect to generate any revenue from the sale of products unless and until we obtain

marketing approval for and commercialize TVGN 489 or another product candidate.

marketing approval or other authorization for and commercialize TVGN 489 or another product candidate.

and Development Expenses

and development expenses consist primarily of costs incurred for our research activities, including staffing, discovery efforts, preclinical

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

and development expenses consist primarily of costs incurred for our research activities, including staffing, discovery efforts, pre-clinical

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 trial;

Food and Drug

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

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 expenses;

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

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;

● facility-related

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

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

maintenance of facilities and other operating costs.

and development activities are central to the biotechnology business model.

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to longer patient enrollment times in later-stage clinical trials.

We expect our research and development expenses to increase significantly

over the next several years as we increase manufacturing, shipping, and storage of clinical batches required for clinical trials, personnel

costs, including stock-based compensation, conduct planned clinical trials for TVGN 489 and other clinical and pre-clinical activities

for other product candidates, and prepare regulatory filings for any of our product candidates.

We expect our research and development expenses to increase over the

next several years as we increase manufacturing, shipping, and storage of clinical batches required for clinical trials, personnel costs,

including stock-based compensation, conduct planned clinical trials for TVGN 489 and other clinical and pre-clinical activities for other

product candidates, and prepare regulatory filings for any of our product candidates.

successful development of our current or future product candidates is highly uncertain.

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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;

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;

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;

effectively with potential therapeutic alternatives in our target disease areas;

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

reimbursement by private and public payors including health technology appraisal entities

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

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.

Product commercialization will take several years, and we expect to spend

a significant amount in development costs.

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.

and Administrative Expenses

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sales and marketing efforts.

Income (Expense), Net

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

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).

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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 and consolidated statements of cash flows.

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

in Fair Value of Written Call Option Derivative Liabilities

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

of operations.

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 three months ended June 30, 2024 associated with

the Loan Agreement.

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

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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,

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:

Research and development

General and administrative

and administrative

Total operating expenses

Loss from operations

Interest income (expense), net

Change in fair value of warrants

Change in fair value of convertible promissory notes

(19,700,000 )

Change in fair value of written call option derivative liabilities

Loss on issuance of commitment shares

(22,184,353 )

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

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The following table summarizes our research and

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

Three months ended June 30,

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 expenses

Other clinical and pre-clinical development

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.

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 June 30, 2024 and 2023:

Three months ended June 30,

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

months ended September 30,

Personnel costs

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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.

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

June 30, 2023.

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 June 30, 2023.

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

The convertible promissory notes were converted

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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,

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,

Operating expenses:

Research and development

General and administrative

and administrative

Total operating expenses

1 unchanged sentence

(44,201,278 )

Interest income (expense), net

Interest expense, net

Merger transaction costs

Change in fair value of warrants

Change in fair value of convertible promissory notes

Change in fair value of

convertible promissory notes

(49,122,865 )

Change in fair value of written call option derivative liabilities

Loss on issuance of commitment shares

Net income (loss)

Change in fair value of

written call option derivative liabilities

on issuance of commitment shares

$ (4,282,828 )

$ (56,845,448 )

and Development Expenses

1 unchanged sentence

The following table summarizes our research and

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

Six months ended June 30,

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

months ended September 30,

Personnel costs

Stock-based compensation

Other clinical and pre-clinical development expenses

Other clinical and pre-clinical development

Facilities and other expenses

Total research and development expenses

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 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.

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.

and Administrative Expenses

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

Six months ended June 30,

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

months ended September 30,

Personnel costs

2 unchanged sentences

Facilities and other expenses

Total general and administrative expenses

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.

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.

Transaction Costs

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.

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.

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 six months ended June 30, 2024 and 2023, respectively.

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 six months ended June 30, 2023 compared to a decrease in the underlying estimated

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.

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.

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

and Capital Resources

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.

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 research tax

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, an d $3.0 million from de posits

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

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.

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

For the six months ended June 30,

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,

Cash provided by (used in)

3 unchanged sentences

Investing activities

Financing activities

Net change in cash

1 unchanged sentence

Flows from 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 $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

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

1 unchanged sentence

Flows from Investing Activities

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.

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.

Flows from Financing Activities

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 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.

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.

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

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

Stock, 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.

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

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

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 $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.

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

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.

As of September 30, 2024, we

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

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

trials of TVGN 489 and other product candidates.

3 unchanged sentences

In addition, our product candidates, if approved, may not achieve commercial success.

expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance our pre-clinical

studies and clinical trials.

In addition, if we obtain marketing approval for TVGN 489 in any indication or for any other product candidate

we are developing or develop in the future, we expect to incur significant commercialization expenses related to product manufacturing,

sales, marketing, and distribution.

Furthermore, we expect to continue to incur increased costs associated with operating as a public

Accordingly, we will need to obtain substantial additional funding.

expect our expenses to increase in connection with our ongoing activities, particularly as we advance our pre-clinical studies and clinical

In addition, if we obtain marketing approval for TVGN 489 in any indication or for any other product candidate we are developing

or develop in the future, we expect to incur commercialization expenses related to product manufacturing, sales, marketing, and distribution.

Furthermore, we expect to continue to incur increased costs associated with operating as a public company.

Accordingly, we will need

additional funding to fully implement our business plans.

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

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 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 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;

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 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.

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.

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

These strategies may include but are

not limited to private placements of securities, licensing and/or marketing arrangements, partnerships with other pharmaceutical or biotechnology

companies, and public offerings of securities.

We may not be able to obtain financing on acceptable terms and may not be able to enter

into strategic alliances or other arrangements on favorable terms.

The terms of any financing may adversely affect the holdings or the

rights of our stockholders.

If we are unable to obtain sufficient 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

Obligations and Commitments

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

Less than 1 Year

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

Contractual obligations:

Operating lease commitments (1)

lease commitments (1)

of Credit repayment (2)(3)

Total contractual obligations

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

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.

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 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.

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.

Accounting Policies and Estimates

30 unchanged sentences

and development expenses include fees paid to:

in connection with preclinical and clinical development activities;

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 preclinical and clinical trial materials.

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

34 unchanged sentences

estimated value of all classes of securities outstanding;

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

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

results of operations and financial position;

2 unchanged sentences

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;

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; and

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.

1 unchanged sentence

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 $36 million purchase option

that is embedded within the loan commitment under the Loan Agreement.

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

11 unchanged sentences

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

used a Monte Carlo simulation to determine the fair value of the freestanding $14 million purchase

option and embedded $36 million purchase option associated with the Loan Agreement at inception and as of June 30, 2024.

The Monte Carlo simulation methodology

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

8 unchanged sentences

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis