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Tevogen Bio Holdings Inc. (TVGN)

CIK: 0001860871. SIC: 2836 Biological Products, (No Diagnostic Substances). Latest 10-K as of: 2026-03-31.

SIC breadcrumb: Manufacturing > Chemicals And Allied Products > SIC 2836 Biological Products, (No Diagnostic Substances)

SEC company page: https://www.sec.gov/edgar/browse/?CIK=1860871. Latest filing source: 0001493152-26-014326.

Selected Fundamentals

MetricValueUnitFYFiled
Net income-26,275,432USD20252026-03-31
Assets4,382,994USD20252026-03-31

Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-31. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001860871.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

Flow metrics use full-year FY periods from 10-K/10-K/A filings; balance-sheet metrics use FY-end instants. Free cash flow = operating cash flow - capital expenditures. Missing metrics are omitted rather than fabricated.

Metric20212022202320242025
Net income4,408,361-60,477,680-13,727,380-26,275,432
Operating income-8,843,025-53,564,488-26,140,515
Diluted EPS-2.44-3.50-8.08
Operating cash flow-215,395-8,171,118-11,998,730-12,328,577
Capital expenditures133,00064,439
Assets352,852,166357,138,3565,505,5033,461,6754,382,994
Liabilities15,179,87515,057,70499,934,40010,135,68012,617,720
Stockholders' equity-14,227,709-33,951,217-94,428,897-6,674,005-8,234,726
Cash and cash equivalents344,581129,1860.000.000.00
Free cash flow-8,304,118-12,393,016

Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

Metric20212022202320242025
Current ratio13.330.780.020.260.22

Financial Charts

Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-15. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001860871.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

QuarterEnd DateRevenueNet IncomeDiluted EPSMethod
2023-Q22023-03-311,235,400reported discrete quarter
2023-Q32023-06-30-195,056reported discrete quarter
2023-Q42023-12-31-828,923derived Q4 = FY annual - nine-month YTD
2024-Q12024-03-3111,264,842-0.26reported discrete quarter
2024-Q22024-03-3111,264,842reported discrete quarter
2024-Q22024-06-30-0.04reported discrete quarter
2024-Q32024-06-30-9,663,447reported discrete quarter
2024-Q32024-09-30-0.03reported discrete quarter
2024-Q42024-12-31-9,444,552derived Q4 = FY annual - nine-month YTD
2025-Q12025-03-31-10,367,061-0.07reported discrete quarter
2025-Q22025-03-31-10,367,061reported discrete quarter
2025-Q22025-06-30-0.03reported discrete quarter
2025-Q32025-06-30-5,503,979reported discrete quarter
2025-Q32025-09-30-0.03reported discrete quarter
2025-Q42025-12-31-4,677,580derived Q4 = FY annual - nine-month YTD
2026-Q12026-03-31-5,446,255-1.61reported discrete quarter

Quarterly Charts

Macro Cross-References

Latest quarter (10-Q)

Latest 10-Q source: 0001493152-26-023920.

Extracted from Part I Item 2 to the first post-MD&A boundary after HTML sanitization. Confidence: high. Filing date: 2026-05-15. Report date: 2026-03-31.

Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You
should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated
financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q (this “Report”). This discussion
and other parts of this Report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans,
objectives, expectations and intentions. As a result of many factors, including those factors set forth in the “Risk Factors”
section of this Report, our actual results could differ materially from the results described in or implied by the forward-looking statements
contained in the 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 requires.

Overview

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, 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 human leukocyte antigen (HLA) restricted CTL therapies with proactively selected, precisely defined targets. We are
focused on using ExacTcell to develop therapeutics that are intended to be infused in patients other than the original donor. ExacTcell
is designed to maximize the immunologic specificity of our products in order to eliminate malignant and virally infected cells while
allowing healthy cells to remain intact. In addition, through our Tevogen.AI artificial intelligence initiative, we are exploring ways
to deploy artificial intelligence-powered target detection to further accelerate our product development pace.

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 chronic, lingering symptoms of the disease
(“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.

In
addition, through Tevogen.AI, 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.

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.

14

We
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.

In
the United States, our three issued utility patents, all of which will expire on December 9, 2040, are U.S. Patent No. 11,191,827 covering
methods of treating COVID-19 infection using COVID-19 peptide specific CTLs; U.S. Patent No. 11,207,401 covering COVID-19 peptide-specific
CTLs; and U.S. Patent No. 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 “AdapTcell,” “ExacTcell,” “PredicTcell,” and “Tevogen
AI” with the United States Patent and Trademark Office.

We
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.

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.

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 three months ended March 31, 2026 and 2025 was $5.4 million and $10.4 million,
respectively. Net loss for the three months ended March 31, 2026 was primarily attributable to non-cash, stock-based compensation expense,
salaries and outside services. As of March 31, 2026, we had cash of $0.7 million.

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. In August 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.

On
July 3, 2025, we entered into the Sales Agreement with 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 our sales agent. Sales
of our common stock through the Agent may 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 (File No. 333-288218) filed on June 20, 2025 with the Securities and Exchange Commission (the “SEC”) 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.

15

On
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 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.

Based
on cash on hand as of the date of this Report of approximately $0.7 million, net proceeds of $0.1 million received from sales of common
stock under the Sales Agreement subsequent to March 31, 2026, net proceeds of $3.0 million received from the sale of prefunded common stock
purchase warrants, 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 unaudited 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

Revenue

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

Res

[Excerpt truncated for page length; source filing is linked above.]

Latest 10-K MD&A

Extracted from Item 7 to the first post-MD&A boundary after HTML sanitization. Confidence: high. Filing date: 2026-03-31. Report date: 2025-12-31.

Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You
should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated
financial statements and related notes included elsewhere in this Annual Report. This discussion and other parts of this Annual Report
contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations and
intentions. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Annual Report,
our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the
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 requires.

Overview

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, ExacTcellTM, 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.

In
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.

82

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.

We
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.

In
the United States, our three issued utility patents, all of which will expire on December 9, 2040, are U.S. Patent No. 11,191,827 covering
methods of treating COVID-19 infection using COVID-19 peptide specific CTLs; U.S. Patent No. 11,207,401 covering COVID-19 peptide-specific
CTLs; and U.S. Patent No. 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
Office.

We
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.

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. (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, 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.

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. 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
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 $500.00 per share. Pursuant to the terms
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.

83

In
January 2025, we received a grant of $2.0 million from KRHP LLC, a New Jersey limited liability company (“KRHP”), to further
our development of off-the-shelf, genetically unmodified precision T cell therapeutics to treat infectious diseases and cancers. In August
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.

On
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 agent. 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.

On
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.

Based
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.

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

Revenue

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:

●

acquisition
of supplies and equipment and leasing lab spaces;

●

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

●

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

●

costs
of funding research performed by third parties, including pursuant to agreements with CROs, and investigative site costs to conduct
our pre-clinical studies and clinical trials;

●

manufacturing
costs, including expenses incurred under agreements with CMOs, including manufacturing scale-up expenses, and the cost of acquiring
and manufacturing pre-clinical study and clinical trial materials;

●

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

●

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

●

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

84

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:

●

with
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;

●

applying
for and receiving marketing approvals from applicable regulatory authorities;

●

obtaining
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;

●

making
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;

●

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

●

competing
effectively with potential therapeutic alternatives in our target disease areas; and

●

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

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.

85

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. 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.

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. (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

U.S.
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.

Change
in Fair Value of Warrants

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

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, 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.

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.

86

Results
of Operations

Comparison
of the years ended December 31, 2025 and 2024

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

Year ended December 31,

2025

2024

Operating expenses:

Research and development

$

11,111,586

$

31,033,276

General and administrative

15,028,929

22,531,212

Total operating expenses

26,140,515

53,564,488

Loss from operations

(26,140,515

)

(53,564,488

)

Interest expense, net

(195,618

)

(184,037

)

Merger transaction costs

-

(7,499,353

)

Change in fair value of warrants

60,701

(58,180

)

Change in fair value of convertible promissory notes

-

48,468,678

Loss on issuance of commitment shares

-

(890,000

)

Net loss

$

(26,275,432

)

$

(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, 2025 and 2024:

Year ended December 31,

2025

2024

Personnel costs

$

2,285,015

$

466,955

Stock-based compensation

7,329,355

27,012,127

Other clinical and pre-clinical development expenses

583,777

2,584,651

Facilities and other expenses

913,439

969,543

Total research and development expenses

$

11,111,586

$

31,033,276

Research
and development expenses for the year ended December 31, 2025 were $11.1 million, compared to $31.0 million for the year ended December
31, 2024. The decrease was primarily attributable to lower non-cash stock-based compensation expense.

General
and Administrative Expenses

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

Year ended December 31,

2025

2024

Personnel costs

$

1,984,144

$

1,725,326

Stock-based compensation

8,893,506

13,752,010

Legal and professional fees

3,753,997

6,636,232

Facilities and other expenses

397,282

417,644

Total general and administrative expenses

$

15,028,929

$

22,531,212

87

General
and administrative expenses for the year ended December 31, 2025 were $15.0 million compared to $22.5 million for the year ended December
31, 2024. The decrease was primarily attributable to lower legal and professional fees and non-cash stock-based compensation expense.

Interest
Expense, Net

We
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.

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 Warrants

We
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.

Change
in Fair Value of Convertible Promissory Notes

There
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.

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.

Non-GAAP
Presentation of Loss from Operations

Since
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.

To
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.

This
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.

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

Year Ended December 31,

2025

2024

Loss from operations

$

(26,140,515

)

$

(53,564,488

)

Less: Stock-based compensation

16,222,861

40,764,136

Adjusted loss from operations

$

(9,917,654

)

$

(12,800,352

)

Liquidity
and Capital Resources

Sources
of Liquidity

As
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.

On
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
Agreement. 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.

Between
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
million. 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.

88

Cash
Flows

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

Year ended December 31,

2025

2024

Cash provided by (used in)

Operating activities

$

(12,328,577

)

$

(11,998,730

)

Investing activities

(64,439

)

-

Financing activities

11,662,393

12,229,328

Net change in cash

$

(730,623

)

$

230,598

Cash
Flows from Operating Activities

During
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.

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 in non-cash stock-based compensation expense, depreciation expense, and the net
change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development
activities.

Cash
Flows from Investing Activities

During
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.

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

Cash
Flows from Financing Activities

During
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.

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.

Funding
Requirements

Our
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 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.

89

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. 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 $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 $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
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 $500.00 per share (the “Threshold Price Date”) and will be exercisable by the
Patel Family by written notice within three business days after we have notified the Patel Family of the Threshold Price Date (the date
of such notice, the “Threshold Price Notice Date”). Pursuant to the terms of the Loan Agreement, we issued to the Patel Family
the Commitment Shares, subject to forfeiture by the Patel Family of the Commitment Shares or an equal number of shares of Common Stock
in the event the Patel Family fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional
PIPE within 30 days after the Threshold Price Notice Date in the event we have satisfied all applicable closing conditions. There is
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

On
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.

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 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. 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.

Our
future capital requirements will depend on many factors, including:

●

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

●

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

●

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

90

●

our
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;

●

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

●

potential
changes in the regulatory environment and enforcement rules;

●

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

●

the
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;

●

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

●

the
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;

●

potential
changes in pharmaceutical pricing and reimbursement infrastructure;

●

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

●

the
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.

As
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.

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
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.

As
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.

The
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.

The
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.

91

The
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
commitments. 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.

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 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. We base
our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the
circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions, including
those factors set out in the “Risk Factors” section and elsewhere in this Annual Report, including the section entitled
“Special Note Regarding Forward-Looking Statements.”

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:

●

vendors
in connection with preclinical and clinical development activities;

●

CROs
in connection with clinical trials; and

●

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

92

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 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
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 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
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 Agreement.

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. 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.

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, 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.

Stock-Based
Compensation

Awards
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. 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.

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