What changed in this filing

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Item 1A. Risk Factors

2025-11-14 compared with 2025-08-14 · 120 added, 78 removed, 2 unchanged (99% of the section changed)

Risk Factors.

investment in our Common Stock involves a high degree of risk.

You should carefully consider the risks set forth in the “Risk Factors”

section of our Annual Report, other information set forth in this Report, and the additional information in the other reports we file

with the SEC.

If any of the risks contained in those reports occur, our business, results of operation, financial condition, and liquidity

could be harmed, the value of our securities could decline, and you could lose all or part of your investment.

as described below, there have been no material changes in the risk factors set forth in the “Risk Factors” section of our

Annual Report.

will require substantial additional financing to pursue our business objectives and to fund our operations, which may not be available

on acceptable terms, or at all.

A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate

our product development, commercialization efforts or other operations and affect our future viability as an ongoing business.

expect to spend substantial amounts of cash to continue the preclinical and clinical development of our current and future immunotherapy

programs, to fund our Tevogen.AI artificial intelligence initiative, and to pursue other potential business objectives.

If we receive

marketing approval for any product candidates, including TVGN 489, we will require significant additional amounts of cash in order to

launch and commercialize such product candidates.

An investment in our Common Stock involves

a high degree of risk.

You should carefully consider the risks set forth in the “Risk Factors” section of our Annual Report,

other information set forth in this Report, and the additional information in the other reports we file with the SEC.

If any of the risks

contained in those reports occur, our business, results of operation, financial condition, and liquidity could be harmed, the value of

our securities could decline, and you could lose all or part of your investment.

Except as described below, there have been no

material changes in the risk factors set forth in the “Risk Factors” section of our Annual Report.

We will require substantial additional financing

to pursue our business objectives and to fund our operations, which may not be available on acceptable terms, or at all.

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

efforts or other operations and affect our future viability as an ongoing business.

We expect to spend substantial amounts of cash

to continue the preclinical and clinical development of our current and future immunotherapy programs, to fund our Tevogen.AI artificial

intelligence initiative, and to pursue other potential business objectives.

If we receive marketing approval for any product candidates,

including TVGN 489, we will require significant additional amounts of cash in order to launch and commercialize such product candidates.

In addition, other unanticipated costs may arise.

Because the designs and outcomes

of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully

complete the development of and commercialize any product candidate we develop.

future capital requirements depend on many factors, including:

scope, progress, timing, results, and costs of researching and developing TVGN 489 and our

other product candidates, including product candidates developed with our ExacTcell technology,

and of conducting preclinical studies and clinical trials;

timing of, and the costs involved in, obtaining marketing approval for TVGN 489 and any future

product candidates we develop, if clinical trials are successful;

costs of manufacturing TVGN 489 and any future product candidates for preclinical studies

and clinical trials and in preparation for marketing approval and commercialization;

costs of commercialization activities, including marketing, sales, and distribution costs,

for TVGN 489 and any future product candidates we develop if any of these product candidates

are approved for sale;

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

on favorable terms, if at all;

costs involved in preparing, filing, prosecuting, maintaining, expanding, defending, and

enforcing patent claims, including litigation costs and the outcome of any such litigation;

timing, receipt, and amount of sales of, or royalties on, our future products, if any;

emergence of competing therapies and other developments in the markets we intend to address.

we can generate sufficient product and royalty revenue to finance our cash requirements, which we may never do, we expect to finance

our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances,

and licensing arrangements.

a result of our cash balance, as well as our history of operating losses and negative cash flows from operation combined with our anticipated

use of cash to, among other things, fund the preclinical and clinical development of our products, identify and develop new product candidates,

and seek approval for TVGN 489 and our other product candidates and any other product candidates we develop, we will require substantial

additional financing to pursue our business objectives and fund our operations.

Our future viability as an ongoing business is dependent

on our ability to generate cash from operating activities or to raise additional capital to finance our operations.

reflected in our balance sheets, we have significant accounts payable, accrued expenses and other liabilities.

Proceeds from any capital

raising transactions may be used to reduce our accounts payable accrued expenses and other liabilities.

However, there can be no assurance

that we will raise sufficient funds to eliminate such amounts.

Additionally,

the terms of our Preferred Stock, our Loan Agreement, and our Sales Agreement may negatively impact our ability to raise additional capital

through equity or debt financings, due to the potential substantial dilution to our stockholders that could occur as a result of the

conversion of our convertible Preferred Stock or our issuance of shares under the Loan Agreement or Sales Agreement and due to the other

terms of our Preferred Stock and such agreements, or may negatively affect our ability to obtain favorable or acceptable terms in connection

with any such financing.

if we raise additional capital through marketing, sales, and distribution arrangements or other collaborations, strategic alliances,

or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, future revenue

streams, research programs, or technologies or grant licenses on terms that may not be favorable to us.

If we raise additional capital

through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely

affect our stockholders’ rights.

Further, to the extent that we raise additional capital through the sale of Common Stock or securities

convertible or exchangeable into Common Stock, your ownership interest will be diluted.

If we raise additional capital through debt financing,

we would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific

actions, such as incurring additional debt, making capital expenditures, engaging in acquisition, merger, or collaboration transactions,

selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments, declaring dividends, or

other operating restrictions that could adversely impact our ability to conduct our business.

future debt financing or other financing of securities senior to our Common Stock will likely include financial and other covenants that

will restrict our flexibility.

Any failure to comply with these covenants may cause an event of default and acceleration of the obligation

to pay the debt, which would have a material adverse effect on our business, prospects, financial condition, and results of operations

and we could lose our existing sources of funding and impair our ability to secure new sources of funding.

additional financing may not be available to us on acceptable terms, or at all, and may be impacted by the economic climate and market

If we are unable to obtain additional financing on favorable terms when needed, we may be required to delay, limit, reduce,

or terminate preclinical studies, clinical trials, or other research and development activities or one or more of our development programs.

Because the designs and outcomes of our planned and anticipated clinical trials are

highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development of and commercialize

any product candidate we develop.

Our future capital requirements depend on many

factors, including:

the scope, progress, timing, results, and costs of researching and developing TVGN 489 and our other product candidates, including product candidates developed with our ExacTcell technology, and of conducting preclinical studies and clinical trials;

the timing of, and the costs involved in, obtaining marketing approval for TVGN 489 and any future product candidates we develop, if clinical trials are successful;

the costs of manufacturing TVGN 489 and any future product candidates for preclinical studies and clinical trials and in preparation for marketing approval and commercialization;

the costs of commercialization activities, including marketing, sales, and distribution costs, for TVGN 489 and any future product candidates we develop if any of these product candidates are approved for sale;

our ability to establish and maintain strategic collaborations, licensing, or other arrangements on favorable terms, if at all;

the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending, and enforcing patent claims, including litigation costs and the outcome of any such litigation;

the timing, receipt, and amount of sales of, or royalties on, our future products, if any;

the emergence of competing therapies and other developments in the markets we intend to address.

Until we can generate sufficient product and royalty

revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public

or private equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements.

As a result of our cash balance, as well as our

history of operating losses and negative cash flows from operation combined with our anticipated use of cash to, among other things, fund

the preclinical and clinical development of our products, identify and develop new product candidates, and seek approval for TVGN 489

and our other product candidates and any other product candidates we develop, we will require substantial additional financing to pursue

our business objectives and fund our operations.

Our future viability as an ongoing business is dependent on our ability to generate cash

from operating activities or to raise additional capital to finance our operations.

As reflected in our balance sheets, we have significant

accounts payable, accrued expenses and other liabilities.

Proceeds from any capital raising transactions may be used to reduce our accounts

payable accrued expenses and other liabilities.

However, there can be no assurance that we will raise sufficient funds to eliminate such

Additionally, the terms of our Preferred Stock,

our Loan Agreement, and our Sales Agreement may negatively impact our ability to raise additional capital through equity or debt financings,

due to the potential substantial dilution to our stockholders that could occur as a result of the conversion of our convertible Preferred

Stock or our issuance of shares under the Loan Agreement or Sales Agreement and due to the other terms of our Preferred Stock and such

agreements, or may negatively affect our ability to obtain favorable or acceptable terms in connection with any such financing.

Furthermore, if we raise additional capital through

marketing, sales, and distribution arrangements or other collaborations, strategic alliances, or licensing arrangements with third parties,

we may have to relinquish certain valuable rights to our product candidates, future revenue streams, research programs, or technologies

or grant licenses on terms that may not be favorable to us.

If we raise additional capital through public or private equity offerings,

the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights.

to the extent that we raise additional capital through the sale of Common Stock or securities convertible or exchangeable into Common

Stock, your ownership interest will be diluted.

If we raise additional capital through debt financing, we would be subject to fixed payment

obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional

debt, making capital expenditures, engaging in acquisition, merger, or collaboration transactions, selling or licensing our assets, making

capital expenditures, redeeming our stock, making certain investments, declaring dividends, or other operating restrictions that could

adversely impact our ability to conduct our business.

Any future debt financing or other financing of

securities senior to our Common Stock will likely include financial and other covenants that will restrict our flexibility.

to comply with these covenants may cause an event of default and acceleration of the obligation to pay the debt, which would have a material

adverse effect on our business, prospects, financial condition, and results of operations and we could lose our existing sources of funding

and impair our ability to secure new sources of funding.

Adequate additional financing may not be available

to us on acceptable terms, or at all, and may be impacted by the economic climate and market conditions.

If we are unable to obtain additional

financing on favorable terms when needed, we may be required to delay, limit, reduce, or terminate preclinical studies, clinical trials,

or other research and development activities or one or more of our development programs.

If we fail to regain compliance with Nasdaq’s

$1.00 minimum closing bid price requirement or otherwise to meet Nasdaq’s continued listing requirements, our Common Stock and our

outstanding public warrants to purchase Common Stock could be delisted.

Our Common Stock and our outstanding public warrants

to purchase Common Stock (our “Warrants”) are listed on Nasdaq.

We are required to meet specified financial and other requirements

in order to maintain such listing, including a requirement that the closing bid price for our Common Stock remain above $1.00.

On September 23, 2025, we received a notification

letter from Nasdaq’s Listing Qualifications Staff notifying us that the closing bid price for our Common Stock had been below $1.00

for the previous 30 consecutive business days and that we therefore are not in compliance with the minimum bid price requirement for continued

inclusion on Nasdaq under Nasdaq Listing Rule 5450(a)(1).

The notification has no immediate effect on the listing of our Common Stock

and our Warrants on Nasdaq.

Under the Nasdaq Listing Rules, we have a period

of 180 calendar days to regain compliance.

To regain compliance, the closing bid price of our Common Stock must be at least $1.00 or higher

for a minimum of ten consecutive business days and up to generally not more than 20 consecutive business days, and in such case, Nasdaq

will provide us with written confirmation of compliance.

If we do not regain compliance by March 23, 2026, we may be eligible for an additional

180 calendar days, provided that we submit an online transfer application to transfer the listing of our Common Stock to the Nasdaq Capital

Market, submit an application fee, and meet the continued listing requirement for market value of publicly held shares and all other initial

listing standards for the Nasdaq Capital Market, except the bid price requirement.

In addition, we will be required to provide written

notice of our intention to cure the deficiency during the second compliance period by effecting a reverse stock split if necessary.

it appears to Nasdaq that we will not be able to cure the deficiency during the second compliance period, or if we determine not to submit

a transfer application or make the required representation, Nasdaq will provide written notice to us that our Common Stock will be subject

to delisting.

In the event of such notification, we may appeal Nasdaq’s determination to delist its securities, but there can be

no assurance that Nasdaq would grant our request for continued listing.

There can be no assurance that we will be able

to regain compliance with the minimum bid price requirement or will otherwise be in compliance with other Nasdaq listing criteria.

If we fail to regain compliance with the requirement

to maintain a minimum closing bid price of $1.00 per share or to meet other Nasdaq continued listing requirements, Nasdaq may take steps

to delist our securities.

Such a delisting would likely have a negative effect on the price of our securities and would impair your ability

to sell or purchase the securities when you wish to do so.

In the event of a delisting, we can provide no assurance that any action taken

by us to restore compliance with listing requirements would allow our securities to become listed again, stabilize the market price or

improve the liquidity of our securities, prevent our securities from dropping below the Nasdaq minimum bid price requirement or prevent

future non-compliance with Nasdaq’s listing requirements.

Additionally, if our securities are not listed on, or become delisted

from, Nasdaq for any reason, and are quoted on the OTC Bulletin Board, an inter-dealer automated quotation system for equity securities

that is not a national securities exchange, the liquidity and price of our securities may be more limited than if our securities were

quoted or listed on Nasdaq or another national securities exchange.

You may be unable to sell your securities unless a market can be established

or sustained.

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

What changed 10-Q

Item 1A. Risk Factors