What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2026-03-31 compared with 2025-04-02 · 533 added, 466 removed, 113 unchanged (90% of the section changed)

7 unchanged sentences

following discussion and analysis.

References to the “Company,”

“we,” “us,” and “our” in this section generally refer to Tevogen Bio Inc before the Business Combination

and to Tevogen Bio Holdings Inc.

and its subsidiary collectively from and after the Business Combination, unless the context otherwise

We are a clinical-stage specialty

immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ CTLs, to develop off-the-shelf, precision

T cell therapies for the treatment of infectious diseases, cancers, and other disorders, with the aim of addressing the significant unmet

needs of large patient populations.

We believe the full potential of T cell therapies remains largely untapped, and aspire to be the first

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

We believe our allogeneic, precision

T cell technology, ExacTcell TM , has the potential to mainstream cell therapy with a new class of off-the-shelf T cell therapies

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

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

and expand single human HLA restricted CTL therapies with proactively selected, precisely defined targets.

We are focused on using ExacTcell

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

ExacTcell is designed to maximize

the immunologic specificity of our products in order to eliminate malignant and virally infected cells while allowing healthy cells to

remain intact.

In addition, through our Tevogen.AI artificial intelligence initiative, we are exploring ways to deploy artificial intelligence-powered

target detection to further accelerate our product development pace.

The first clinical product of

ExacTcell, TVGN 489, is initially being developed to fill a critical gap in COVID-19 therapeutics for the immunocompromised and the high-risk

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

We have completed a Phase 1 proof-of-concept clinical

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

No dose-limiting toxicities or significant treatment-related

adverse events were observed in the treatment arm of the trial.

Secondary endpoints showing a rapid reduction of viral load and that infusion

of TVGN 489 did not prevent development of the patients’ own T cell-related (cellular) or antibody-related (humoral) anti-COVID-19

immunity were also met.

None of the patients who participated in the trial reported progression of infection, reinfection, or the development

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

Our commercial success depends

in part on our ability to obtain and maintain patent and other protection for our products and methods, preserve the confidentiality of

our trade secrets, operate without infringing, misappropriating, or otherwise violating the valid, enforceable proprietary rights of others,

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

We rely on a combination of patents,

patent applications, trademarks, and trade secrets to establish and protect our intellectual property rights.

Our ability to stop third

parties from making, using, selling, offering to sell, or importing our products without the right to do so may depend on the extent to

which we have rights under valid and enforceable patents, trademarks or trade secrets that cover these activities.

As our patents were developed

internally, historical expenditures related to their development were all expensed as incurred per 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.

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.

to the “Company,” “we,” “us,” and “our” in this section generally refer to Tevogen Bio

Inc before the Business Combination and to Tevogen Bio Holdings Inc.

and its subsidiary collectively from and after the Business Combination,

unless the context otherwise requires.

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

to develop off-the-shelf, precision T cell therapies for the treatment of infectious diseases, cancers, and other disorders, with the

aim of addressing the significant unmet needs of large patient populations.

We believe the full potential of T cell therapies remains

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

personalized T cell therapies.

believe our allogeneic, precision T cell technology, ExacTcell TM , has the potential to mainstream cell therapy with a new

class of off-the-shelf T cell therapies with diverse applications across virology, oncology, and other areas.

ExacTcell is a set of processes

and methodologies to develop, enrich, and expand single human HLA restricted CTL therapies with proactively selected, precisely defined

We are focused on using ExacTcell to develop therapeutics that are intended to be infused in patients other than the original

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

cells while allowing healthy cells to remain intact.

In addition, through our Tevogen.AI artificial intelligence initiative, we are exploring

ways to deploy artificial intelligence-powered target detection to further accelerate our product development pace.

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

and the high-risk elderly, with potential applications in both treatment and prevention of Long COVID.

We have completed a Phase 1 proof-of-concept

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

No dose-limiting toxicities or significant

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

Secondary endpoints showing a rapid reduction of viral

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

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

None of the patients who participated in the trial reported progression of infection,

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

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

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

related savings to patients.

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

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

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

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

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

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

these activities.

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 U.S.

patents relating

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

patent applications, including two patent applications relating to the treatment

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

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

patent applications, including applications in Australia, Canada,

Europe, Japan, Qatar, the United Arab Emirates, and the Patent Cooperation Treaty directed at viral specific T cells, methods of treating

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

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

December 16, 2044.

the United States, our three issued utility patents, all of which will 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 own a registered trademark protection for “Tevogen Bio” (and design), and have applied

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

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

business model and needs.

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

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

assessment of their strategic value.

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

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

rules and regulations.

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

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

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 consolidated financial statements in this Annual Report for additional information

regarding the net assets acquired through the Merger.

The Merger was accounted for as a reverse recapitalization under GAAP because the

Company was determined to be the accounting acquirer.

Since commencing operations

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

staff, establishing research and development capability including securing laboratory space and equipment, conducting scientific research,

securing intellectual property rights to our inventions related to our product candidates and ExacTcell, carrying out drug discovery including

pre-clinical studies and our Phase 1 clinical trial of TVGN 489, raising capital, and pursuing the Business Combination.

To date, we have not

generated any revenue.

Our net loss for the years ended December 31, 2024 and 2023 was $13.7 million and $60.5 million, respectively.

Net loss for the year ended December 31, 2024 was primarily attributable to a $53.6 million loss from operations 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 December 31, 2024, we had cash of

$1.3 million.

On 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.

On March 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 the date of this Annual Report.

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

See Note 4 to our consolidated financial statements in this Annual Report for

additional information regarding the net assets acquired through the Merger.

The Merger was accounted for as a reverse recapitalization

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

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

recruiting essential staff, establishing research and development capability including securing laboratory space and equipment, conducting

scientific research, securing intellectual property rights to our inventions related to our product candidates and ExacTcell, carrying

out drug discovery including pre-clinical studies and our Phase 1 clinical trial of TVGN 489, raising capital, and pursuing the Business

date, we have not generated any revenue.

Our net loss for the years ended December 31, 2025 and 2024 was $26.3 million and $13.7 million,

respectively.

Net loss for the year ended December 31, 2025 was primarily attributable to non-cash, stock-based compensation expense,

salaries and outside services.

As of December 31, 2025, we had cash of $0.6 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 the date of this Annual Report.

As of the date of this

Annual Report, a payment date for the remaining $3.0 million has not been set.

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.

As described in more

detail in “— Liquidity and Capital Resources—Funding Requirements ” below, on June 6, 2024, we entered into

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

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

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

option for the Patel Family to purchase at least $14.0 million of our Common Stock in a future private placement (the “Optional

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

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

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

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

contingent option for the Patel Family to purchase at least $14.0 million of our Common Stock in a future private placement (the “Optional

The Loan Agreement also contains a contingent option for the Patel Family to purchase at least $14.0 million of our Common

2 unchanged sentences

Pursuant to the terms

of the Loan Agreement, we also issued to the Patel Family 1,000,000 shares of Common Stock as a commitment fee (the “Commitment

Shares”), subject to forfeiture by the Patel Family of the Commitment Shares or an equal number of shares of Common Stock in the

event the Patel Family fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional PIPE within

30 days after the Threshold Price Notice Date (as defined in the Loan Agreement) in the event we have satisfied all applicable closing

In addition, in January

2025, we received a grant of $2.0 million from KRHP to further our development

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

KRHP is affiliated with

the Patel Family.

Based on cash

on hand as of the date of this Annual Report of approximately $1.3 million, the amounts available under our Loan Agreement, and the

$8.0 million of additional committed grant funding from KRHP, we have concluded that we have sufficient cash to fund our operations

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

We 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.

Components of our Results of Operations

To 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 or other

authorization for and commercialize TVGN 489 or another product candidate.

Operating Expenses

Research and Development Expenses

Research 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:

of the Loan Agreement, we also issued to the Patel Family 20,000 shares of Common Stock as a commitment fee (the “Commitment Shares”),

subject to forfeiture by the Patel Family of the Commitment Shares or an equal number of shares of Common Stock in the event the Patel

Family fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional PIPE within 30 days after

the Threshold Price Notice Date (as defined in the Loan Agreement) in the event we have satisfied all applicable closing conditions.

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

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

2025, we received a grant of $1.0 million from KRHP to advance Tevogen.AI.

KRHP is affiliated with the Patel Family.

KRHP also committed

to provide an additional $7.0 million of grant funding to us to be used towards our ongoing operational expenses.

In addition, in June

2025, we received a capital contribution of $500,000 from Ryan Saadi, our Chairman and Chief Executive Officer.

July 3, 2025, we entered into a Sales Agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (the “Agent”),

pursuant to which we may issue and sell from time to time up to $50,000,000 of Common Stock through the Agent as the Company’s

Sales of the Company’s Common Stock through the Agent, if any, will be made by any method that is deemed to be an

“at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, pursuant

to the Company’s effective shelf registration statement on Form S-3 (File No.

333-288218) filed on June 20, 2025 with the Securities

and Exchange Commission and declared effective on June 26, 2025, the base prospectus filed as part of such registration statement, and

the prospectus supplement dated July 3, 2025.

March 3, 2026, we filed a Certificate of Amendment to our Certificate of Incorporation (the “Certificate of Amendment”) with

the Secretary of State of the State of Delaware to effect a 1-for-50 reverse stock split of our Common Stock (the “Reverse Stock

Split”), which was effective as of March 6, 2026 (the “Effective Date”).

The Common Stock began trading on Nasdaq on

a post-split basis at the open of business on the Effective Date.

on cash on hand as of the date of this Annual Report of approximately $0.6 million, net proceeds of $0.9 million received from sales

of Common Stock under the Sales Agreement subsequent to December 31, 2025, combined with the amounts available under our Loan

Agreement, and the $7.0 million of additional committed grant funding from KRHP, we have concluded that we have sufficient cash to

fund our operations for at least the next 12 months from the issuance date of our 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.

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 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:

of supplies and equipment and leasing lab spaces;

incurred to conduct the necessary pre-clinical studies required by FDA to obtain the regulatory approval necessary to conduct

TVGN 489 clinical trials;

incurred to conduct the necessary pre-clinical studies required by FDA to obtain the regulatory approval necessary to conduct TVGN

489 clinical trials;

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

8 unchanged sentences

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

Research and development activities

are central to the biotechnology business model.

Product candidates in later stages of clinical development generally have higher development

costs than those in earlier stages, primarily due to the increased study sizes, which also leads generally 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, incur increased 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.

The successful development of

our current or future product candidates is highly uncertain.

At this time, we cannot reasonably estimate or know the nature, timing,

and costs of the efforts that will be necessary to complete the development of any product candidates.

The success of TVGN 489 and our

other product candidates will depend on several factors, including the following:

and development activities are central to the biotechnology business model.

Product candidates in later stages of clinical development

generally have higher development costs than those in earlier stages, primarily due to the increased study sizes, which also leads generally

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, incur

increased 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.

At this time, we cannot reasonably estimate or

know the nature, timing, and costs of the efforts that will be necessary to complete the development of any product candidates.

of TVGN 489 and our other product candidates will depend on several factors, including the following:

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

9 unchanged sentences

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

A 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.

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.

General and Administrative Expenses

General and administrative expenses

primarily consist of personnel expenses, which include salaries, benefits, and stock-based long term incentive compensation for employees.

These expenses also encompass corporate facility costs such as rent, utilities, depreciation, and maintenance, as well as costs not classified

under research and development expenses.

Legal fees pertaining to intellectual property and corporate matters, as well as fees for accounting

and consulting services, are also included in general and administrative expenses.

We expect that our general and

administrative expenses will increase in the future to support our continued research and development activities, potential commercialization

efforts, and increased costs of operating as a public company.

These increases will likely include increased costs related to the hiring

of additional personnel and fees to outside consultants, lawyers, accountants, and recruitment firms, among other expenses.

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

SEC and Nasdaq requirements, insurance, and investor relations costs.

If any of our current or future product candidates obtains marketing

approval, we expect that we would incur significantly increased expenses associated with sales and marketing efforts.

Interest Expense, Net

Interest expense, net consists

primarily of interest on our former convertible promissory notes and Loan Agreement, partially offset by interest earned on bank deposits.

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.

We anticipate that product commercialization may take several years, and

we expect to spend a significant amount in development costs.

and Administrative Expenses

and administrative expenses primarily consist of personnel expenses, which include salaries, benefits, and stock-based long term incentive

compensation for employees.

These expenses also encompass corporate facility costs such as rent, utilities, depreciation, and maintenance,

as well as costs not classified under research and development expenses.

Legal fees pertaining to intellectual property and corporate

matters, as well as fees for accounting and consulting services, are also included in general and administrative expenses.

expect that our general and administrative expenses will increase in the future to support our continued research and development activities,

potential commercialization efforts, and increased costs of operating as a public company.

These increases will likely include increased

costs related to the hiring of additional personnel and fees to outside consultants, lawyers, accountants, and recruitment firms, among

other expenses.

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

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

If any of our current or future product candidates

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

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

earned on bank deposits.

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

Merger Transaction Costs

Transaction costs we incurred in relation

to the Business Combination were initially capitalized as deferred transaction costs up through the Closing Date, at which time such costs

were charged to expense in our statements of operations less the amount of cash received in the Business Combination.

Change in Fair Value of Convertible Promissory Notes

accounting standards provide

entities with an option to measure many financial instruments and certain other items at fair value.

As a result of us electing this option,

we recorded all convertible promissory notes at fair value with changes in fair value reported in 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.

Loss on Issuance of Commitment Shares

Our other expenses consist

of losses on the issuance of the Commitment Shares for the year ended December 31, 2024 associated with the Loan Agreement.

Since we intend

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

which are comprised of the fair value of the Commitment Shares as well as the issuance date fair value of the $14 million Purchase Option

and Additional Amount Purchase Option.

For more information about the Loan Agreement, see “— Liquidity and Capital Resources—Funding

Requirements ” below.

Income Tax Provision

Since inception, we have incurred

significant net losses.

As of December 31, 2024, we had net operating loss carryforwards (“NOLs”) for federal and state income

tax purposes of $25.6 million and $27.8 million, respectively.

We have provided a valuation allowance against the full amount of our net

deferred tax assets since, in the opinion of our management, based upon our historical and anticipated future losses, it is more likely

than not that the benefits will not be realized.

Our 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.

Results of Operations

Comparison of the years ended December 31, 2024

The following table summarizes

our results of operations for the years ended December 31, 2024 and 2023:

Transaction Costs

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

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

in Fair Value of Convertible Promissory Notes

accounting standards provide entities with an option to measure many financial instruments and certain other items at fair value.

a result of us electing this option, we recorded all convertible promissory notes at fair value with changes in fair value reported in

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.

in Fair Value of Warrants

the result of the Merger, the Company accounts for its warrants originally sold as part of Semper Paratus’s initial public offering

(the “IPO”) in accordance with ASC 815, Derivatives and Hedging Contracts in Entity’s Own Equity (“ASC

815”) and ASC 480, Distinguishing Liabilities from Equity (“ASC 480”).

The assessment considers whether the

warrants are freestanding financial instruments and meet the definition of a liability pursuant to ASC 480 and meet all of the conditions

for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own shares of Common Stock,

among other conditions.

This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance

and as of each subsequent quarterly period end date while the warrants are outstanding.

For issued or modified warrants that meet all

of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the

time of issuance.

For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required

to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter until settlement.

in the estimated fair value of the warrants are recognized as a non-cash loss on the consolidated statements of operations.

standards, the Company’s private placement warrants sold at the time of the IPO do not meet the criteria for equity classification

and must be recorded as liabilities while the public warrants sold in connection with the IPO do meet the criteria for equity classification

and must be recorded as equity.

on Issuance of Commitment Shares

other expenses consist of losses on the issuance of the Commitment Shares for the year ended December 31, 2024 associated with the Loan

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

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

$14 million Purchase Option and Additional Amount Purchase Option.

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

and Capital Resources-Funding Requirements ” below.

Tax Provision

inception, we have incurred significant net losses.

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

for federal and state income tax purposes of $43.1 million and $45.4 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.

of Operations

of the years ended December 31, 2025 and 2024

following table summarizes our results of operations for the years ended December 31, 2025 and 2024:

Year ended December 31,

5 unchanged sentences

(26,140,515 )

(53,564,488 )

Interest expense, net

2 unchanged sentences

Change in fair value of convertible promissory notes

(50,428,303 )

Loss on issuance of commitment shares

1 unchanged sentence

$ (13,727,380 )

Research and Development Expenses

We 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 years ended December 31, 2024 and 2023:

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 years ended December 31, 2025 and 2024:

Year ended December 31,

4 unchanged sentences

Total research and development expenses

Research and development expenses

for the year ended December 31, 2024 were $31.0 million, compared to $4.4 million for the year ended December 31, 2024.

The increase was

primarily attributable to an increase in stock-based compensation due to stock compensation expense related to the restricted stock units

(“RSUs”) granted to Dr.

Saadi on the Closing Date.

General and Administrative Expenses

The following table summarizes

our general and administrative expenses for the years ended December 31, 2024 and 2023:

and development expenses for the year ended December 31, 2025 were $11.1 million, compared to $31.0 million for the year ended December

The decrease was primarily attributable to lower non-cash stock-based compensation expense.

and Administrative Expenses

following table summarizes our general and administrative expenses for the years ended December 31, 2025 and 2024:

Year ended December 31,

4 unchanged sentences

Total general and administrative expenses

General and administrative expenses

for the year ended December 31, 2024 were $22.5 million compared to $4.4 million for the year ended December 31, 2023.

The increase was

primarily attributable to stock-based compensation expense of $13.8 million, of which $7.7 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 $2.3 million was recognized as restricted stock compensation expense related

to the RSUs granted.

The increase of $0.6 million in personnel costs was primarily attributable to an increase in headcount and an increase

in premium for our director and officer insurance policy.

The increase of $4.0 million in legal and professional fees was primarily attributable

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

Interest Expense, Net

We recognized $0.2 million and

$1.2 million in interest expense for the years ended December 31, 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

Merger Transaction Costs

Merger transaction costs in excess of cash

received from the Business Combination of $7.5 million were recognized as period expenses for the year ended December 31, 2024.

Change in Fair Value of Convertible Promissory

We recognized a non-cash gain

of $48.5 million and a non-cash loss of $50.4 million for the change in fair value of the convertible promissory notes for the years ended

December 31, 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 year ended December 31, 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.

Loss on Issuance of Commitment Shares

We incurred losses on the issuance

of Commitment Shares during the year ended December 31, 2024, associated with the Loan Agreement.

Liquidity and Capital Resources

Sources of Liquidity

As of December 31, 2024, we had

$1.3 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 grant funding.

Since January 2021, we have raised aggregate gross proceeds

of $24.0 million from the sale of convertible promissory notes, $2.0 million from the sale of our Series A Preferred Stock, $3.0 million

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

In June 2024, we entered into the Loan Agreement, which provided up to $36.0 million of term loans that can be drawn in $1.0 million increments

each month over thirty-six months, as described below.

As of December 31, 2024, we had drawn $1.0 million with a remaining $30.0 million available

for future financing over the remaining 30 months.

We drew an additional $1.0 million on February 10, 2025.

In addition, in

January 2025, we received a grant of $2.0 million from KRHP.

We expect to receive an additional $8.0 million grant from KRHP during the second quarter of 2025.

The following table summarizes

our cash flows for the years ended December 31, 2024 and 2023:

and administrative expenses for the year ended December 31, 2025 were $15.0 million compared to $22.5 million for the year ended December

The decrease was primarily attributable to lower legal and professional fees and non-cash stock-based compensation expense.

recognized $0.2 million in interest expense for the years ended December 31, 2025 and 2024, respectively, which was attributable primarily

to the outstanding balance on the Facility and the outstanding principal balance associated with our convertible promissory notes that

converted into Common Stock in connection with the Closing, respectively.

Transaction Costs

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

year ended December 31, 2024.

in Fair Value of Warrants

recognized a gain on change in fair value of derivative warrant liabilities of $60,701 during the year ended December 31, 2025 and a

loss of $58,180 during the year ended December 31, 2024.

The change in value during these periods was largely attributable to the changes

in the price of underlying Common Stock and risk-free rates and decreases to the time until expiration of the warrants.

in Fair Value of Convertible Promissory Notes

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

We recognized

a non-cash gain of $48.5 million for the change in fair value of the convertible promissory notes for the year ended December 31, 2024.

The non-cash gain in the year ended December 31, 2024, was primarily a result of the increase in the underlying estimated fair value

of our Common Stock during the year ended December 31, 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.

on Issuance of Commitment Shares

incurred losses on the issuance of Commitment Shares during the year ended December 31, 2024, associated with the Loan Agreement.

Presentation of Loss from Operations

inception, we have incurred substantial operating losses, primarily driven by non-cash stock-based compensation expense, which does not

directly impact our cash position or operating liquidity.

Other significant contributors to our operating losses have included legal

and professional fees, clinical and pre-clinical development expenses, other personnel expenses, and facilities expenses.

enhance investors’ understanding of our historical results, we present below adjusted loss from operations, which is a non-GAAP

measure that we define as loss from operations, calculated in accordance with GAAP, adjusted to exclude stock-based compensation expense.

We believe adjusted loss from operations provides additional insight into the underlying capital efficiency of our business and helps

investors evaluate our long-term operating performance by illustrating that a significant portion of our reported losses represents equity-based

compensation expense rather than cash expenditures.

Stock-based compensation is a key element of our employee and executive compensation

and retention strategy and will continue to impact our reported GAAP results in future periods.

non-GAAP measure should not be considered in isolation or as a substitute for GAAP financial information and may not be directly comparable

to similarly titled measures reported by other companies.

Investors are encouraged to review the reconciliations provided below together

with our GAAP results included in the unaudited consolidated financial statements and the notes thereto appearing elsewhere in this Report.

reconciliation of loss from operations to adjusted loss from operations is set forth below.

Year Ended December 31,

Loss from operations

$ (26,140,515 )

$ (53,564,488 )

Stock-based compensation

Adjusted loss from operations

$ (9,917,654 )

$ (12,800,352 )

and Capital Resources

of December 31, 2025 we had $0.6 million in cash, as compared to $1.3 million in cash as of December 31, 2024.

To date, we have not yet

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

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

of Common Stock under the Sales Agreement.

Since January 2021, we have raised aggregate gross proceeds of $24.0 million from the sale

of convertible promissory notes, $2.0 million from the sale of our Series A Preferred Stock, $3.0 million from deposits related to the

future sale of our Series A-1 Preferred Stock, and $6.0 million from the sale of our Series C Preferred Stock.

In June 2024, we entered

into the Loan Agreement, which provided up to $36.0 million of term loans that can be drawn in $1.0 million increments each month over

thirty-six months, as described below.

As of December 31, 2025, we had drawn $4.4 million with a remaining $18.0 million available for

future financing over the remaining 18 months of the draw period.

In January and August 2025, we received a grant of $2.0 million and

$1.0 million, respectively, and have a remaining commitment of a grant of $7.0 million from KRHP.

In addition, in June 2025, we received

a capital contribution of $500,000 from Dr.

Ryan Saadi, our Chairman and Chief Executive Officer.

July 3, 2025, we entered into the Sales Agreement, pursuant to which we may issue and sell from time to time up to $50,000,000 of shares

of Common Stock through the Agent as our sales agent.

Sales of our Common Stock through the Agent, if any, will be made by any method

that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933,

as amended, pursuant to our effective shelf registration statement on Form S-3 filed on June 20, 2025, and the prospectus supplement

dated July 3, 2025.

Each time we wish to issue and sell Common Stock under the Sales Agreement, we will provide a placement notice to

the Agent containing the parameters in accordance with which shares are to be sold, including, but not limited to, the number of shares

of Common Stock to be issued, the time period during which sales are requested to be made, any limitation on the number of shares of

Common Stock that may be sold in any one trading day, and any minimum price below which sales may not be made.

The Agent will use commercially

reasonable efforts consistent with its normal trading and sales practices to sell the Common Stock from time to time, based upon our

instructions, including any price, time or size limits we may impose pursuant to and subject to the terms and conditions of the Sales

We are not obligated to make any sales of Common Stock under the Sales Agreement and may terminate the Sales Agreement at

any time upon written notice.

We will pay the Agent a commission on the gross proceeds.

July 3, 2025 and December 31, 2025, the Company sold an aggregate of approximately 130,000 shares of Common Stock under the Sales Agreement

at a weighted average price per share of $37.50 on a post-Reverse Stock Split basis, resulting in gross proceeds of approximately $5.0

After deducting total expenses of approximately $140,000, including commission to the Agent of approximately $125,000, net proceeds

to the Company were approximately $4.9 million.

following table summarizes our cash flows for the years ended December 31, 2025 and 2024:

Year ended December 31,

Cash provided by (used in)

5 unchanged sentences

Net change in cash

$ (4,431,868 )

Cash Flows from Operating Activities

During the year ended December

31, 2024, we used $12.0 million of net cash in operating activities.

Cash used in operating activities reflected our net loss of $13.7

million offset by $1.7 million of non-cash charges related to the change in the fair value of the convertible promissory notes, depreciation

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

the net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development

During the year ended December

31, 2023, we used $8.2 million of net cash in operating activities.

Cash used in operating activities reflected our net loss of $60.5

million offset by $52.0 million of non-cash charges related to the change in the fair value of the convertible promissory notes, depreciation

expense, reductions in the ROU assets, non-cash interest on the convertible promissory notes, and a $0.3 million net change in our operating

Flows from Operating Activities

the year ended December 31, 2025, we used $12.3 million of net cash in operating activities.

Cash used in operating activities reflected

our net loss of $26.3 million offset by non-cash stock-based compensation expense, depreciation expense, and the net change in our operating

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

Cash Flows from Investing Activities

During the years ended December

31, 2024 and 2023, we used $0.0 million and $0.1 million respectively, for the purchase of property and equipment.

Cash Flows from Financing Activities

During the year ended December

31, 2024, we received $12.3 million of net cash from financing activities attributable to $2.0 million in proceeds from the sale of Series

A Preferred Stock, $6.0 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.

During the year ended December

31, 2023, we received $4.0 million of net cash from financing activities attributable to the proceeds from the convertible promissory

notes, less $0.1 million related to payments of deferred transaction costs.

Funding Requirements

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

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

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

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

the year ended December 31, 2024, we used $12.0 million of net cash in operating activities.

Cash used in operating activities reflected

our net loss of $13.7 million offset by $1.7 million in non-cash stock-based compensation expense, depreciation expense, and the net

change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development

Flows from Investing Activities

the year ended December 31, 2025, we used $0.1 million of net cash in investing activities attributable to $0.1 million in purchases

of property and equipment.

the year ended December 31, 2024, we did not have any cash flows from investing activities.

Flows from Financing Activities

the year ended December 31, 2025, we received $11.7 million of net cash from financing activities attributable to $3.4 million in draws

on the Loan Agreement, $3.0 million attributable to KRHP grants, $500,000 in capital contributions from Dr.

Saadi, and $4.9 million in

proceeds pursuant to the Sales Agreement, net of offering costs.

the year ended December 31, 2024, we received $12.3 million of net cash from financing activities attributable to $2.0 million in proceeds

from the sale of Series A Preferred Stock, $6.0 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.

primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, our access to an unsecured line

of credit (limited to a $1.0 million monthly draw) under the Loan Agreement described below, potential future sales of Common Stock under

the Sales Agreement, and the $7.0 million of grant funding that KRHP has committed to provide to be used towards the Company’s

ongoing operational expenses.

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

We have not yet received $3.0 million of the $6.0 million purchase price for the Series A-1 Preferred Stock.

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

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.

On June 6, 2024, we entered into

the Loan Agreement, pursuant to which the Patel Family agreed to provide to us up to the Maximum Loan Amount of $36.0 million under the Facility.

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.

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 purchased 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 Patel Family agreed to provide to us up to the Maximum Loan Amount

of $36.0 million under the Facility.

The Patel Family 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.

Draws accrue interest at a fixed annual rate of the lower

of (i) the daily secured overnight financing rate, measured on the date we receive the draw (the “Deposit Date”), plus 2.00%

and (ii) 7.00%, accruing quarterly beginning on the Deposit Date and payable quarterly beginning on the three-month anniversary of the

Deposit Date.

Interest will be payable in shares of Common Stock with an effective purchase price of $1.50 per share, and each draw will

mature 48 months after the Deposit Date.

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.

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 $75.00 per share, and each draw will mature 48 months after the Deposit Date.

Prepayment will be permitted without penalty.

We may repay or prepay any amount of outstanding

principal balance under the Facility at our election in cash or in shares of Common Stock with an effective purchase price of the greater

of $1.50 per share and the 10-day trailing volume weighted average price of the Common Stock (the “Trailing VWAP”) as of the

trading day prior to payment, subject to certain requirements related to resale registration.

Pursuant to the Loan Agreement, we also

agreed to provide the Patel Family an option to purchase $14.0 million of shares of our Common

repay or prepay any amount of outstanding principal balance under the Facility at our election in cash or in shares of Common Stock with

an effective purchase price of the greater of $75.00 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 Patel Family an option to purchase $14.0 million of shares of our Common

Stock plus an additional amount up to the total then-remaining available and undrawn portion of the Maximum Loan Amount (which amount

8 unchanged sentences

PIPE within 30 days after the Threshold Price Notice Date in the event we have satisfied all applicable closing conditions.

assurance as to the amount of proceeds we will ultimately receive under the Loan Agreement.

As of December 31, 2024, we have drawn an

aggregate of $1.0 million under the Loan Agreement.

We 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.

Identifying potential

product candidates and conducting pre-clinical testing and clinical trials is a time-consuming, expensive, and uncertain process that

takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product

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

As of December 31, 2025, we had drawn

$4.4 million with a remaining $18.0 million available for future draws over the remaining 18 months of the draw period

July 3, 2025, the Company entered into the Sales Agreement, pursuant to which the Company may issue and sell from time to time up to

$50,000,000 of shares of Common Stock through the Agent as the Company’s sales agent.

See “— Liquidity and Capital

Resources—Sources of Liquidity ” above for more information on amounts sold under the Sales 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.

potential product candidates and conducting pre-clinical testing and clinical trials is a time-consuming, expensive, and uncertain process

that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve

product sales.

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

We expect our expenses

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

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.

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.

Our future capital requirements

will depend on many factors, including:

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;

16 unchanged sentences

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

As of December 31, 2024, we had

cash of $1.3 million.

We believe that our cash balance and amounts available under the Loan Agreement, which allows us to draw down term

loans of $1.0 million per month over 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 consolidated financial statements included in this Annual Report.

In addition, KRHP has committed to provide an additional $8.0 million of

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

The grant funding will be used to satisfy

the Company’s obligations as they come due through March 31, 2026.

The Company does not plan to initiate a clinical trial until

additional funding is received.

We 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 prospects.

Contractual Obligations and Commitments

The following table summarizes

our contractual obligations and commitments as of December 31, 2024:

lease commitments (1)

Agreement repayment (3)

contractual obligations

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

notes payable obligations assumed as part of the Merger.

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

The commitment amounts in the

table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed

or minimum services to be used, fixed, minimum, or variable price provisions, and the approximate timing of the actions under the contracts.

Our contracts with CROs, CMOs, and other third parties for the manufacture of our product candidates and to support pre-clinical research

studies and clinical testing are generally cancelable by us upon prior notice and do not contain any minimum purchase commitments.

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

Critical Accounting Policies and Estimates

This discussion and analysis

of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance

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

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

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

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

We base our estimates on historical experience,

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

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

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

Factors ” section and elsewhere in this Annual Report, including the section entitled “ Special Note Regarding Forward-Looking

While our significant accounting

policies are described in more detail in Note 3 to our consolidated financial statements, we believe the following accounting policies

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

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

of operation.

Research and Development Expenses

Research and development activities

are expensed as incurred.

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

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

This process involves

reviewing open contracts and purchase orders, communicating with our applicable personnel to identify services that have been performed

on our behalf and estimating the level of service performed and the associated cost incurred for the services when we have not yet been

invoiced or otherwise notified of actual costs.

Our service providers invoice us in arrears or require prepayments for services performed,

as well as on a pre-determined schedule or when contractual milestones are met.

We make estimates of our accrued expenses as of each balance

sheet date in the consolidated financial statements based on facts and circumstances known to us at that time.

We periodically confirm

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

Examples of estimated accrued research and

development expenses include fees paid to:

of December 31, 2025, we had cash of approximately $0.6 million.

We believe that our cash balance, net proceeds of $0.9 million received

pursuant to the Sales Agreement subsequent to December 31, 2025, amounts available under the Loan Agreement, which allows us to draw

down term loans of $1.0 million per month over the remaining 18 months of the draw period, and the remaining commitment for a $7.0 million

grant from KRHP 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 consolidated financial statements included in this Annual Report.

The Company does not plan to initiate a clinical

trial until additional funding is received.

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

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

Company has material cash requirements arising from its contractual obligations, primarily consisting of operating lease commitments

and debt obligations under notes payable and its Loan Agreement.

of December 31, 2025, the Company’s short-term cash requirements (due within the next 12 months) totaled approximately $2.1 million,

consisting of:

● approximately

$1.7 million related to notes payable,

● approximately

$0.3 million of operating lease commitments, and

● approximately

$0.1 million of interest due on draws under the Company’s Loan Agreement.

Company’s long-term cash requirements (due beyond 12 months) totaled approximately $5.5 million, consisting of:

● approximately

$4.4 million related to the Loan Agreement, and

● approximately

$1.1 million of operating lease commitments.

Company expects to fund these cash requirements through a combination of cash generated from operations and available financing arrangements.

The Company continually evaluates its liquidity position and may seek to refinance or restructure certain obligations as they come due.

commitment amounts above are associated with contracts that are enforceable and legally binding and that specify all significant terms,

including fixed or minimum services to be used, fixed, minimum, or variable price provisions, and the approximate timing of the actions

under the contracts.

Our contracts with CROs, CMOs, and other third parties for the manufacture of our product candidates and to support

pre-clinical research studies and clinical testing are generally cancelable by us upon prior notice and do not contain any minimum purchase

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.

Accounting Policies and Estimates

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

have been prepared in accordance with GAAP.

The preparation of the consolidated financial statements requires us to make estimates and

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

in our consolidated financial statements.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued

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

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 and elsewhere in this Annual Report, including the section entitled

“ Special Note Regarding Forward-Looking Statements.

our significant accounting policies are described in more detail in Note 3 to our consolidated financial statements, we believe the following

accounting policies are the most critical to the judgments and estimates used in the preparation of our consolidated financial statements

or involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial

condition or results of operation.

and Development Expenses

and development activities are expensed as incurred.

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

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

manufacturing.

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

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

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

Our service providers invoice us in arrears or require

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

We make estimates

of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known

to us at that time.

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

Examples of estimated accrued research and development expenses include fees paid to:

in connection with preclinical and clinical development activities;

1 unchanged sentence

in connection with the process development and scale-up activities and the production of preclinical and clinical trial materials.

Costs for clinical trials and

manufacturing activities are recognized based on an evaluation of our vendors’ progress towards completion of specific tasks, using

data such as participant enrollment, clinical site activations, or information provided to us by our vendors regarding their actual costs

Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from

the period in which the services were performed.

We determine accrual estimates through reports from and discussions with applicable personnel

and outside service providers as to the progress or state of completion of studies, or the services completed.

Our estimates of accrued

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

Costs that are paid in advance of performance

are deferred as a prepaid expense and amortized over the service period as the services are provided.

Although we do not expect our

estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed

relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low

in any particular period.

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

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

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

Fair Value Measurements

Our recurring fair value measurements primarily

consist of the convertible promissory notes prior to the Merger, for which we elected the fair value option, the freestanding $14 million

purchase option under the Loan Agreement, and the bifurcated purchase option that is embedded within the loan commitment under the Loan

We used the Probability Weighted Expected

Return Method (“PWERM”) valuation methodology to determine the fair value of the convertible promissory notes prior to the

Merger for all the periods presented.

The PWERM is a scenario-based methodology that estimates the fair value based upon an analysis of

future values for the company, assuming various outcomes.

The value is based on the probability-weighted present value of expected future

investment returns considering each of the possible outcomes available.

The future value under each outcome is discounted back to the

valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value.

assumptions used in determining the fair value of convertible promissory notes include volatility, discount rate, and probability of a

future liquidity event.

In February 2024, concurrent with the Merger, we converted our outstanding convertible promissory notes into 10,337,419

shares of Common Stock.

We 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 December 31, 2024.

The MCS methodology simulates our future stock price to estimate if

and when the Trailing VWAP will reach $10.00 per share, and discounts the resulting payoff back to each valuation date using a present

value factor.

Significant assumptions used in determining the fair value of these options include volatility and discount rate.

Stock-Based Compensation

Awards under our compensation

plans are accounted for in accordance with Accounting Standards Codification 718, Compensation – Stock Compensation .

cost is measured at the grant date fair value of the award and is recognized over the vesting period of the award.

We use the straight-line

method to record compensation expense of awards with service-based vesting conditions.

We account for forfeitures of stock-based awards

as they occur.

We recognize share-based compensation expense for awards with performance conditions when it is probable that the condition

will be met, and the award will vest.

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

outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company

Equity Securities Issued as Compensation .

Recent Accounting Pronouncements

See Note 3 to our consolidated

financial statements found in this Annual Report for a description of recent accounting pronouncements applicable to our financial statements.

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

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

regarding their actual costs incurred.

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

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

We determine accrual estimates through reports from and

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

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

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

are provided.

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

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

are too high or too low in any particular period.

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

research and development expenses.

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

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

Value Measurements

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

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

embedded within the loan commitment under the Loan Agreement.

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

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

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

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

The value is based on the probability-weighted

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

The future value under each

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

an indication of value.

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

discount rate, and probability of a future liquidity event.

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

convertible promissory notes into 206,748 shares of Common Stock.

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

option and embedded purchase option associated with the Loan Agreement at inception and as of December 31, 2025.

The MCS methodology

simulates our future stock price to estimate if and when the Trailing VWAP will reach $500.00 per share, and discounts the resulting

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

Significant assumptions used in determining the fair value of these

options include volatility and discount rate.

under our compensation plans are accounted for in accordance with Accounting Standards Codification 718, Compensation - Stock Compensation .

Compensation cost is measured at the grant date fair value of the award and is recognized over the vesting period of the award.

the straight-line method to record compensation expense of awards with service-based vesting conditions.

We account for forfeitures of

stock-based awards as they occur.

We recognize share-based compensation expense for awards with performance conditions when it is probable

that the condition will be met, and the award will vest.

Prior to the Merger, we estimated the fair value of our Common Stock in accordance

with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation

of Privately-Held-Company Equity Securities Issued as Compensation .

Accounting Pronouncements

Note 3 to our consolidated financial statements found in this Annual Report for a description of recent accounting pronouncements applicable

to our financial statements.

Quantitative and Qualitative Disclosures About Market Risk.

5 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-K

Item 7. Management’s Discussion and Analysis