What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-03-31 compared with 2025-04-15 · 270 added, 255 removed, 1299 unchanged (29% of the section changed)

10 unchanged sentences

of Risk Factors

We have paused clinical development of our lead product candidate, MAT2203,

and are devoting significant time and resources to identifying and evaluating strategic alternatives, which may not be successful.

have paused clinical development of our lead product candidate, MAT2203, and are devoting significant time and resources to identifying

and evaluating strategic alternatives, which may not be successful.

have incurred significant losses since our inception.

18 unchanged sentences

may not be able to maintain orphan drug designation or exclusivity for our anti-infective product candidates.

Track designation or priority review status by the FDA may not speed up development, review, or approval, nor guarantee approval and

our current or future product candidates may also treat indications that do not qualify for priority review vouchers.

Track designation or priority review status by the FDA may not speed up development, review, or approval, nor guarantee approval

and our current or future product candidates may also treat indications that do not qualify for priority review vouchers.

breakthrough therapy designation granted by the FDA for our product candidates may not lead to a faster development or regulatory

review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.

of our current or future product candidates as qualified infectious disease products is not assured and, in any event, even if

granted, may not actually lead to a faster development or regulatory review, and would not assure FDA approval of our product

of our current or future product candidates as qualified infectious disease products is not assured and, in any event, even if granted,

may not actually lead to a faster development or regulatory review, and would not assure FDA approval of our product candidates.

may not obtain or maintain orphan drug, Fast Track, qualified infection disease, or breakthrough therapy designations for our product

4 unchanged sentences

candidates, even with regulatory approval.

we cannot file for MAT2203 approval under Section 505(b)(2) of the FDCA or need additional safety and efficacy data, we may miss

our development and commercialization timelines.

we cannot file for MAT2203 approval under Section 505(b)(2) of the FDCA or need additional safety and efficacy data, development

and commercialization timelines may be delayed.

face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete

8 unchanged sentences

laws, we may be subject to civil or criminal penalties.

Reductions in staffing and funding at FDA and other federal agencies could

cause delays in the development and approval of our current or future product candidates.

in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our current or future

product candidates.

have been and expect to be significantly dependent on our collaborative agreements for the development of MAT2203, which exposes

2 unchanged sentences

reliance on the performance of third parties.

will be completely dependent on third parties to manufacture MAT2203 and any future product candidates, and our commercialization efforts

could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable

foreign regulatory authorities, fail to provide us with sufficient quantities of any product candidate or fail to do so at acceptable

quality levels or prices.

will be completely dependent on third parties to manufacture MAT2203 and any future product candidates, and our commercialization

efforts could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA

or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of any product candidate or fail to do

so at acceptable quality levels or prices.

pricing regulations, third-party reimbursement practices or healthcare reform initiatives could harm our business.

20 unchanged sentences

share price has been and could remain volatile.

issuance of shares of our common stock upon conversion of the shares of Preferred Stock will cause dilution to our then existing

stockholders and may depress the market price of our common stock.

securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding

our stock adversely, our stock price and trading volume could decline.

If we are unable to maintain an effective system of internal control over financial reporting, the reliability of

our financial reporting, investor confidence in us and the value of our common stock could be adversely affected.

could be delisted from the NYSE American, which could seriously harm the liquidity of our stock and our ability to raise capital.

we are unable to maintain an effective system of internal control over financial reporting, the reliability of our financial reporting,

investor confidence in us and the value of our common stock could be adversely affected.

could be delisted from the NYSE American, which could seriously harm the trading price of our common stock, the liquidity of our

stock and our ability to raise capital.

dissolution of our Company, you may not recoup all or any portion of your investment.

9 unchanged sentences

Related to Our Financial Position and Need for Additional Capital

business to date has been significantly dependent on the success of MAT2203, and we have decided to pause further development of

MAT2203 and devote significant time and resources to identifying and evaluating strategic alternatives, which may not be successful.

date, we have invested significant efforts and financial resources in the research and development of MAT2203, which was our lead

product candidate in clinical trials.

In October 2024, we announced that negotiations under a previously disclosed non-binding term

sheet regarding global rights to MAT2203 have been terminated following notification from the prospective partner.

As a result, we

implemented an 80% workforce reduction effective as of October 31, 2024 and ceased all product development activities to conserve

We may retain an advisor to assist us with a potential transaction involving MAT2203, and will evaluate other strategic

alternatives.

There can be no assurance that efforts to

identify and evaluate a potential buyer or partner for MAT2203 will result in any definitive offer to consummate a strategic

transaction, or if made what the terms thereof will be or that any transaction will be approved or consummated.

If any definitive

offer to consummate a sale is received, there can be no assurance that a definitive agreement will be executed or that, if a

definitive agreement is executed, the transaction will be consummated.

In addition, there can be no assurance that any transaction,

involving our company and/or assets, that is consummated would enhance shareholder value.

There also can be no assurance that we

will conduct further drug research or development activities in the future.

business to date has been significantly dependent on the success of MAT2203, and we have decided to pause further development of MAT2203

and devote significant time and resources to identifying and evaluating strategic alternatives, which may not be successful.

date, we have invested significant efforts and financial resources in the research and development of MAT2203, which was our lead product

candidate in clinical trials.

In October 2024, we announced that negotiations under a previously disclosed non-binding term sheet regarding

global rights to MAT2203 have been terminated following notification from the prospective partner.

As a result, we implemented an 80%

workforce reduction effective as of October 31, 2024 and ceased all clinical development activities to conserve cash.

We are also evaluating

other strategic alternatives.

There can be no assurance that efforts to identify and evaluate a potential buyer or partner for MAT2203

will result in any definitive offer to consummate a strategic transaction, or if made what the terms thereof will be or that any transaction

will be approved or consummated.

If any definitive offer to consummate a sale is received, there can be no assurance that a definitive

agreement will be executed or that, if a definitive agreement is executed, the transaction will be consummated.

In addition, there can

be no assurance that any transaction, involving our company and/or assets, that is consummated would enhance shareholder value.

also can be no assurance that we will conduct further drug research or development activities in the future.

such strategic transaction may require us to incur non-recurring or other charges, may increase our near-and long-term expenditures and

may pose significant integration challenges or disrupt our management or business, which could adversely affect our business.

we do not successfully consummate a transaction involving MAT2203, our board of directors may decide to pursue a winddown or dissolution

of our company.

In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing

of such dissolution as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

we do not successfully consummate a transaction involving MAT2203, our Board may decide to pursue a winddown or dissolution of our company.

In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such dissolution

as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

can be no assurance that a transaction involving MAT2203 will be consummated, and previous efforts to do so have not been successful.

If no transaction is completed, our board of directors may decide to pursue a winddown or dissolution.

In such an event, the amount of

cash available for distribution to our stockholders will depend heavily on the timing of such a decision and, ultimately, such liquidation,

since the amount of cash available for distribution continues to decrease as we fund our limited operations while we evaluate our options.

In addition, if our board of directors were to approve and recommend, and our stockholders were to approve, a winddown or dissolution

of our company, we would be required under Delaware corporate law to pay our outstanding obligations, as well as to make reasonable provision

for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders.

Our commitments and contingent

liabilities may include (i) obligations under our employment and related agreements with certain employees that provide for severance

and other payments following a termination of employment occurring for various reasons, including a change in control of our company;

(ii) potential litigation against us, and other various claims and legal actions arising in the ordinary course of business; and

(iii) non-cancelable facility lease obligations.

As a result of this requirement, a portion of our assets may need to be reserved pending

the resolution of such obligations.

In addition, we may be subject to litigation or other claims related to a winddown or dissolution

of our company.

If a winddown or dissolution were pursued, our board of directors, in consultation with its advisors, would need to evaluate

these matters and make a determination about a reasonable amount to reserve.

Accordingly, holders of our common stock could lose all

or a significant portion of their investment in the event of a winddown or dissolution of our company.

If no transaction is completed, the Board may decide to pursue a winddown or dissolution.

In such an event, the amount of cash available

for distribution to our stockholders will depend heavily on the timing of such a decision and, ultimately, such liquidation, since the

amount of cash available for distribution continues to decrease as we fund our limited operations while we evaluate our options.

if our Board were to approve and recommend, and our stockholders were to approve, a winddown or dissolution of our company, we would

be required under Delaware corporate law to pay our outstanding obligations, as well as to make reasonable provision for contingent and

unknown obligations, prior to making any distributions in liquidation to our stockholders.

Our commitments and contingent liabilities

may include (i) obligations under our employment and related agreements with certain employees that provide for severance and other payments

following a termination of employment occurring for various reasons, including a change in control of our company; (ii) potential

litigation against us, and other various claims and legal actions arising in the ordinary course of business; and (iii) non-cancelable

facility lease obligations.

As a result of this requirement, a portion of our assets may need to be reserved pending the resolution of

such obligations.

In addition, we may be subject to litigation or other claims related to a winddown or dissolution of our company.

a winddown or dissolution were pursued, our Board, in consultation with its advisors, would need to evaluate these matters and make a

determination about a reasonable amount to reserve.

Accordingly, holders of our common stock could lose all or a significant portion

of their investment in the event of a winddown or dissolution of our company.

have expressed substantial doubt about our ability to continue as a going concern and we have incurred significant losses since our inception.

1 unchanged sentence

discussed in Note 2 to the consolidated financial statements for the fiscal year ended December 31, 2025, our consolidated financial

statement for the fiscal year ended December 31, 2024 include an explanatory paragraph that such financial statements were prepared assuming

that we will continue as a going concern.

A going concern basis assumes that we will continue our operations for the foreseeable future

and contemplates the realization of assets and the settlement of liabilities in the normal course of business.

statements for the fiscal year ended December 31, 2025 were prepared assuming that we will continue as a going concern.

A going concern

basis assumes that we will continue our operations for the foreseeable future and contemplates the realization of assets and the settlement

of liabilities in the normal course of business.

Consequently,

4 unchanged sentences

However, our ability to raise capital could be affected by various risks and uncertainties.

We may not be able to raise sufficient additional capital and there can be no assurance

that these initiatives will be successful.

We may not be able to raise sufficient additional capital and there can be no assurance that these initiatives will be successful.

financial statements do not give any effect to any adjustments in the amounts and classification of assets and liabilities that may be

40 unchanged sentences

revenues that are significant enough to achieve profitability.

of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the

timing or amount of increased expenses or when, or if, we will be able to achieve profitability.

If we resume development activities

and are required by the U.S.

Food and Drug Administration, or the FDA, or comparable non-U.S.

regulatory authorities to perform

studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of

any of our product candidates, our expenses could increase.

of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing

or amount of increased expenses or when, or if, we will be able to achieve profitability.

If we resume development activities and are

required by the FDA or comparable non-U.S.

regulatory authorities to perform studies in addition to those currently expected, or if there

are any delays in completing our clinical trials or the development of any of our product candidates, our expenses could increase.

if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

6 unchanged sentences

our product development programs or commercialization efforts.

expect our expenses to be lower during 2025 compared to 2024 until we secure additional funding, but generally we expect our

expenses to increase over time if we resume the development of MAT2203.

Our expenses could further increase if we initiate new

research and preclinical development efforts for other product candidates.

In addition, if we obtain regulatory approval for any of

our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing,

sales, and distribution.

Furthermore, we expect to incur significant additional costs associated with operating as a public company.

Accordingly, we will need to obtain substantial additional funding in connection with continued operations.

If we are unable to

raise capital when needed or on attractive terms, we could be forced to delay, reduce, or eliminate our research and development

programs or any future commercialization efforts.

do not believe that our existing cash and cash equivalents, excluding restricted cash, of $7,284

thousand as of December 31, 2024 will enable us to fund our operating expenses beyond the next twelve months from the filing date of this Annual Report.

have based this estimate on assumptions that may prove to be wrong in the future, and we could use our capital resources sooner than

we currently expect.

Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and

we may need to spend more money than currently expected because of circumstances beyond our control.

Our future capital

requirements, both short-term and long-term, will depend on many factors, including, in the event we resume development activities:

expect our expenses to be lower during 2026 compared to 2025 until we secure additional funding, but generally we expect our expenses

to increase over time if we resume the development of MAT2203.

Our expenses could further increase if we initiate new research and preclinical

development efforts for other product candidates.

In addition, if we obtain regulatory approval for any of our product candidates, we

expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution.

we expect to incur significant additional costs associated with operating as a public company.

Accordingly, we will need to obtain substantial

additional funding in connection with continued operations.

If we are unable to raise capital when needed or on attractive terms, it

could have a material adverse effect on our business and our ability to continue as a going concern.

addition, based on the aggregate market value of our common stock held by non-affiliates (“public float”) as of the date

of the filing of this Annual Report, and for so long as our public float is less than $75 million, the amount we can raise through primary

public offerings of securities in any twelve-month period using Form S-3 is limited to an aggregate of one-third of our public float.

If our public float meets or exceeds $75 million at any time, we will no longer be subject to the restrictions set forth in General Instruction

I.B.6 of Form S-3.

Unless and until our public float meets or exceeds $75 million, our ability to raise capital using a shelf registration

statement will be constrained by General Instruction I.B.6 of Form S-3, which may affect the timing of and amounts we can raise.

do not believe that our existing cash and cash equivalents, excluding restricted cash, of $3,999 thousand as of December 31, 2025 will

enable us to fund our operating expenses beyond the next twelve months from the filing date of this Annual Report.

We have based this

estimate on assumptions that may prove to be wrong in the future, and we could use our capital resources sooner than we currently expect.

Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend

more money than currently expected because of circumstances beyond our control.

Our future capital requirements, both short-term and

long-term, will depend on many factors, including, in the event we resume development activities:

progress, timing, costs, and results of our clinical trials of our current and future product candidates, if any;

32 unchanged sentences

arrangements.

To the extent that

we raise additional capital through the sale of common stock, convertible securities or other equity securities, your ownership interest

may be materially diluted, and the terms of these securities may include liquidation or other preferences and anti-dilution protections

that could adversely affect your rights as a common stockholder.

Debt financing and preferred equity financing, if available, would result

in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take

specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends, that could adversely impact

our ability to conduct our business.

Securing additional financing could require a substantial amount of time and attention from our

management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our

management’s ability to oversee the development of our product candidates.

To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity

securities, your ownership interest may be materially diluted, and the terms of these securities may include liquidation or other preferences

and anti-dilution protections that could adversely affect your rights as a common stockholder.

Debt financing and preferred equity financing,

if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting

our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends, that could

adversely impact our ability to conduct our business.

Securing additional financing could require a substantial amount of time and attention

from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely

affect our management’s ability to oversee the development of our product candidates.

we raise additional funds through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third

6 unchanged sentences

of December 31, 2025, we had outstanding options to purchase an aggregate of 457,219 shares of our common stock at a weighted average

exercise price of $46.70 per share and outstanding warrants to purchase an aggregate of 666,667 shares of our common stock at an exercise price of $17.50.

On February 13, 2025, we issued warrants to purchase an aggregate of 5,631,404 shares of our common stock at an exercise price of $0.6446

per share, and we expect to issue warrants to purchase an additional 5,631,404 at an exercise price of $0.6446 per share in the near future.

The exercise of such outstanding options and warrants will result in dilution of the value of our shares.

exercise price of $34.76 per share and outstanding warrants to purchase an aggregate of 10,516,543 shares of our common stock at a weighted

average exercise price of $0.97 The exercise of such outstanding options and warrants will result in dilution of the value of our shares.

operating history to date may make it difficult to evaluate the success of our business and to assess our future viability.

39 unchanged sentences

Any delay in the approval process will harm our business.

expect to invest most of our capital in maintaining the regulatory status of MAT2203 and prosecuting associated

intellectual property while we look for a partner to continue clinical development of MAT2203.

Our ability to generate revenue related to product sales,

which we do not expect will occur for at least the next several years, if ever, will depend on the successful development and regulatory

approval of one or more of our product candidates.

expect to invest most of our capital in maintaining the regulatory status of MAT2203 and prosecuting associated intellectual property

while we look for a partner to continue clinical development of MAT2203.

Our ability to generate revenue related to product sales, which

we do not expect will occur for at least the next several years, if ever, will depend on the successful development and regulatory approval

of one or more of our product candidates.

All our product candidates require regulatory review and approval prior to commercialization.

60 unchanged sentences

MAT2203 product candidates.

We have entered into an agreement with Patheon, a wholly owned subsidiary of ThermoFisher, to prepare for

the commercial manufacture of MAT2203.

If we do not develop a long-term manufacturing capability for our LNC platform product candidates

sufficient to produce product for continued development and, if regulatory approval is obtained, then commercialization of these products,

we will be dependent on a small number of third-party manufacturers for the manufacture of our product candidates.

We may not have long-term

agreements with any of these third parties, and if they are unable or unwilling to perform for any reason, we may not be able to locate

alternative acceptable manufacturers or formulators or enter into favorable agreements with them.

Any inability to acquire enough of

our products in a timely manner from these third parties could delay clinical trials and prevent us from developing our products in a

cost-effective manner or on a timely basis.

In addition, manufacturers of our product candidates are subject to cGMP and similar foreign

standards, and we would not have control over compliance with these regulations by our manufacturers.

If one of our contract manufacturers

fails to maintain compliance, the production of our products could be interrupted, resulting in delays and additional costs.

if the facilities of such manufacturers do not pass a pre-approval or post-approval plant inspection, the FDA will not grant approval

and may institute restrictions on the marketing or sale of our products.

We previously entered into an agreement with Patheon, a wholly owned subsidiary of ThermoFisher, to prepare

for the commercial manufacture of MAT2203, but this agreement ended with the reduction in force implemented in 2024.

If we, or a partner,

do not develop a long-term manufacturing capability for our LNC Platform product candidates sufficient to produce product for continued

development and, if regulatory approval is obtained, then commercialization of these products, we will be dependent on a small number

of third-party manufacturers for the manufacture of our product candidates.

We may not have long-term agreements with any of these third

parties, and if they are unable or unwilling to perform for any reason, we may not be able to locate alternative acceptable manufacturers

or formulators or enter into favorable agreements with them.

Any inability to acquire enough of our products in a timely manner from

these third parties could delay clinical trials and prevent us from developing our products in a cost-effective manner or on a timely

In addition, manufacturers of our product candidates are subject to cGMP and similar foreign standards, and we would not have

control over compliance with these regulations by our manufacturers.

If one of our contract manufacturers fails to maintain compliance,

the production of our products could be interrupted, resulting in delays and additional costs.

In addition, if the facilities of such

manufacturers do not pass a pre-approval or post-approval plant inspection, the FDA will not grant approval and may institute restrictions

on the marketing or sale of our products.

may be reliant on third party manufactures and suppliers to meet the demands of our clinical supplies.

5 unchanged sentences

factors, may have an adverse impact on our ability to manufacture our product candidates.

we are unable to successfully commercialize our current or future product candidates our ability to generate revenue will be

we are unable to successfully commercialize our current or future product candidates our ability to generate revenue will be limited.

if we obtain regulatory approval for our product candidates, our long-term viability and growth depend on the successful commercialization

61 unchanged sentences

ability to commercialize our products or product candidates.

we cannot enroll enough patients to complete our clinical trials, our business, financial condition, and results of operations may be

adversely affected.

we cannot enroll enough patients to complete our upcoming clinical trials, our business, financial condition, and results of

operations may be adversely affected.

completion rate of clinical studies of our products is dependent on, among other factors, the patient enrollment rate.

9 unchanged sentences

to obtain comparator drug/device.

believe our procedures for enrolling patients have been appropriate;

however, delays in patient enrollment would increase costs and delay

ultimate commercialization and sales, if any, of our products.

Such delays could materially adversely affect our business, financial

condition, and results of operations.

in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our current and

future product candidates.

believe that historically our procedures for enrolling patients have been appropriate;

however, delays in patient enrollment would increase

costs and delay ultimate commercialization and sales, if any, of our products.

Such delays could materially adversely affect our business,

financial condition, and results of operations.

in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our current and future

product candidates.

the FDCA, our products cannot be investigated in humans or marketed without approval from FDA.

102 unchanged sentences

we are unsuccessful in identifying and developing additional product candidates, our potential for growth may be impaired.

if we receive regulatory approval for MAT2203 or any other future product candidates we may develop, we still may not be able to

successfully commercialize such products and the revenue that we generate from its sales, if any, may be limited.

if we receive regulatory approval for MAT2203 or any other future product candidates we may develop, we still may not be able to successfully

commercialize such products and the revenue that we generate from its sales, if any, may be limited.

approved for marketing, the commercial success of MAT2203 or any other product candidates we may develop will depend upon its acceptance

73 unchanged sentences

to safety and efficacy to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated development and commercialization

current plans for filing the NDAs for MAT2203 include efforts to minimize the data we will be required to generate to obtain marketing

Current plans for filing the NDA for MAT2203 include efforts to minimize the data we will be required to generate to obtain marketing

approval for this product candidate and therefore reduce the development time.

203 unchanged sentences

and other risks and uncertainties.

future profitability will depend, in part, on our ability to commercialize our product candidates in foreign markets for which we intend

future profitability may depend, in part, on our ability to commercialize our product candidates in foreign markets for which we intend

to rely on collaborations with third parties.

10 unchanged sentences

protection of intellectual property rights in some foreign countries;

the impact of tariffs and the cost of doing business in foreign markets;

impact of tariffs and the cost of doing business in foreign markets;

currency exchange rate fluctuations;

69 unchanged sentences

on the performance of third parties.

expect to enter into agreements with third-party CROs, or governmental entities like the NIH, to conduct and manage our clinical programs.

We rely heavily on these parties for execution of clinical studies for MAT2203 and our other product candidates and can control only

certain and very limited aspects of their activities.

Nevertheless, we would be responsible for ensuring that each of our studies is

conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance on the NIH or CROs

would not relieve us of our regulatory responsibilities.

We, the NIH and our CROs would be required to comply with cGCPs, which are regulations

and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area and comparable foreign

regulatory authorities for any products in clinical development.

The FDA enforces these cGCP regulations through periodic inspections

of trial sponsors, principal investigators, and trial sites.

If we or the NIH or our CROs fail to comply with applicable cGCPs, the clinical

data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us

to perform additional clinical trials before approving our marketing applications.

We cannot assure you that, upon inspection, the FDA

will determine that any of our clinical trials comply with cGCPs.

In addition, our clinical trials must be conducted with products produced

under cGMP regulations and will require many test subjects.

Our failure or the failure of the NIH or our CROs to comply with these regulations

may require us to repeat clinical trials, which would delay the regulatory approval process and could also subject us to enforcement

action up to and including civil and criminal penalties.

expect to enter into agreements with third-party CROs, or governmental entities like the NIH, to conduct and manage our clinical

We rely heavily on these parties for execution of clinical studies for MAT2203 and our other product candidates and can

control only certain and very limited aspects of their activities.

Nevertheless, we would be responsible for ensuring that each of

our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance

on the NIH or CROs would not relieve us of our regulatory responsibilities.

We, the NIH and our CROs would be required to comply

with cGCPs, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European

Economic Area and comparable foreign regulatory authorities for any products in clinical development.

The FDA enforces these cGCP

regulations through periodic inspections of trial sponsors, principal investigators, and trial sites.

If we or the NIH or our CROs

fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or

comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing

applications.

We cannot assure you that, upon inspection, the FDA will determine that any of our clinical trials comply with cGCPs.

In addition, our clinical trials must be conducted with products produced under cGMP regulations and will require many test

Our failure or the failure of the NIH or our CROs to comply with these regulations may require us to repeat clinical

trials, which would delay the regulatory approval process and could also subject us to enforcement action up to and including civil

and criminal penalties.

a result, many important aspects of our drug development programs would be outside of our direct control.

225 unchanged sentences

will need to increase the size of our organization to grow our business, and we may experience difficulties in managing this growth.

have 3 employees as of March 31, 2025.

If our development and commercialization plans and strategies develop, we may need to expand the

size of our employee base for managerial, development, operational, sales, marketing, financial and other resources.

Future growth would

impose significant added responsibilities on members of management, including the need to identify, recruit, maintain, motivate, and

integrate additional employees.

In addition, our management may have to divert a disproportionate amount of its attention away from our

day-to-day activities and devote a substantial amount of time to managing these growth activities.

Our future financial performance and

our ability to commercialize our product candidates and our ability to compete effectively will depend, in part, on our ability to effectively

manage any future growth.

have two full time employees and retained the services of two independent contractors/consultants as of March 16, 2026.

If our development

and commercialization plans and strategies develop, we may need to expand the size of our employee base for managerial, development,

operational, sales, marketing, financial and other resources.

Future growth would impose significant added responsibilities on members

of management, including the need to identify, recruit, maintain, motivate, and integrate additional employees.

In addition, our management

may have to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of

time to managing these growth activities.

Our future financial performance and our ability to commercialize our product candidates and

our ability to compete effectively will depend, in part, on our ability to effectively manage any future growth.

we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business

3 unchanged sentences

Jabbour, our Chairman, Chief Executive

Officer and President.

Officer and President could adversely affect our business prospects.

ability to compete in the highly competitive pharmaceutical industry depends in large part upon our ability to attract highly qualified

10 unchanged sentences

to attract and retain high-quality personnel, the rate and success at which we can develop and commercialize product candidates would

our 2013 Equity Compensation expired in May 2024.

While we expect to seek shareholder approval for a new equity compensation plan at

our next annual meeting of shareholders, there can be no assurance that we will obtain shareholder approval for a new plan.

unable to grant equity awards to new and existing officers, employees and directors, our ability to attract and retain qualified individuals

to run our Company may be inhibited, which could materially impair our business.

product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization

69 unchanged sentences

to the terms of our Series A Preferred Stock, we may be obligated to pay significant royalties.

to the terms of the Certificate of Designations of Preferences, Rights and Limitations (the “Certificate of Designations”)

to the terms of the Certificate of Designations of Preferences, Rights and Limitations (the “Series A Certificate of Designations”)

for our Series A Preferred Stock, we are required to pay royalties of up to $35 million per year.

2 unchanged sentences

from the licensing or other disposition of MAT2203, we are required to pay to certain former holders of our Series A Preferred Stock,

in aggregate, a royalty equal to (i) 4.5% of Net Sales (as defined in the Certificate of Designations), subject in all cases to a cap

of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as defined in the Certificate of Designations), subject in all

cases to a cap of $10 million per calendar year.

The Royalty Payment Rights will expire when the patents covering the applicable product

expire, which is currently expected to be in 2033.

rights of the holders of common stock may be impaired by the potential issuance of preferred stock.

articles of incorporation give our board of directors the ability to designate and issue preferred stock in one or more series.

result, the board of directors may, without stockholder approval, issue new series of preferred stock with voting, dividend, conversion,

liquidation, or other rights which could adversely affect the relative voting power and equity interest of the holders of common stock.

Additional issuances of preferred stock, which could be issued with the right to more than one vote per share, could have the effect

of discouraging, delaying, or preventing a change of control of us.

The possible impact on takeover attempts could adversely affect the

price of our common stock.

Although we have no present intention to designate any new series, or issue any shares, of preferred stock,

we may do so in the future.

in aggregate, a royalty equal to (i) 4.5% of Net Sales (as defined in the Series A Certificate of Designations), subject in all cases

to a cap of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as defined in the Series A Certificate of Designations),

subject in all cases to a cap of $10 million per calendar year.

The Royalty Payment Rights will expire when the patents covering the

applicable product expire, which is currently expected to be in 2033.

common stock ranks junior to the Preferred Stock in the event of a liquidation, dissolution or winding-up of the Company.

the event of any liquidation, dissolution or winding-up of the Company, a holder of shares of the Preferred Stock will be entitled to

receive an amount equal to 100% of the stated value before any distribution or payment may be made with respect to the common stock.

issuance of shares of our common stock upon conversion of the shares of Preferred Stock will cause dilution to our then existing stockholders

and may depress the market price of our common stock.

share of Preferred Stock is convertible into a number of shares of common stock calculated by dividing (i) stated value by (ii) a fixed

conversion price of $0.586.

issuance of shares of our common stock upon conversion of the Preferred Stock will result in immediate and substantial dilution to the

interests of holders of our shares of common stock and may depress the market price of our common stock.

do not intend to pay dividends on our common stock in the foreseeable future.

Board of Directors will determine, in its sole discretion, our dividend policy after considering our financial condition, results of

operations and capital requirements, as well as other factors.

We do not anticipate paying cash dividends on our common stock in the

foreseeable future and you should not invest in us with the anticipation of receiving dividend income.

Board will determine, in its sole discretion, our dividend policy after considering our financial condition, results of operations and

capital requirements, as well as other factors.

We do not anticipate paying cash dividends on our common stock in the foreseeable future

and you should not invest in us with the anticipation of receiving dividend income.

active public trading market for our common stock may not be sustained.

75 unchanged sentences

systems to prevent error or fraud could materially adversely impact us.

could be delisted from the NYSE American, which could seriously harm the liquidity of our stock and our ability to raise capital.

had in the past, and may have in the future, difficulty satisfying NYSE American listing requirements for our common stock.

unable to regain or maintain such compliance, we may cease to be eligible to trade on Nasdaq.

In such event:

may have to pursue trading on a less recognized or accepted market, such as the OTC Bulletin Board or the “pink sheets.”

of our common stock could be less liquid and marketable, thereby reducing the ability of stockholders to purchase or sell our shares

as quickly and as inexpensively as they have done historically.

If our stock is traded as a “penny stock,” transactions

in our stock would be more difficult and cumbersome.

may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive

investments with higher associated risks, such that existing or prospective institutional investors may be less interested in, or

prohibited from, investing in our common stock.

This may also cause the market price of our common stock to decline.

could be delisted from the NYSE American, which could seriously harm the trading price of our common stock, the liquidity of our stock

and our ability to raise capital.

common stock is listed on the NYSE American.

We must satisfy the continued listing requirements of the NYSE American to maintain the

listing of our common stock on the NYSE American.

had in the past, and may have in the future, difficulty satisfying NYSE American continued listing requirements for our common stock.

On September 21, 2023, we received a deficiency letter from the NYSE American indicating that the Company was not in compliance with

the NYSE American continued listing standard set forth in Section 1003(f)(v) of the NYSE American Company Guide due to its shares of

common stock selling for a substantial period of time at a low price per share, which NYSE American determined to be a 30 trading day

average price of less than $0.20 per share.

On March 22, 2024, we announced that on March 21, 2024, we received a letter from the NYSE

American indicating that the Company had regained compliance with the NYSE American continued listing standard set forth in Section 1003(f)(v)

of the NYSE American Company Guide due to its shares of common stock demonstrating sustained price improvement.

On August 27, 2024, we

received notice that trading of our shares of common stock had been halted by the NYSE American due to its low trading price.

halt remained in effect until after we consummated the communicated reverse stock split of the common stock and the market opened on

September 3, 2024.

On January 10, 2025, we announced that we received the January 2025 NYSE Notice from the NYSE American stating that

the Company failed to hold an annual meeting of stockholders during the fiscal year ended December 31, 2024, as required by Section 704

of the NYSE American Company Guide.

We received a letter from the NYSE American on June 23, 2025 that we had resolved the deficiency

set forth in the January 2025 NYSE Notice by virtue of holding our Annual Meeting for the fiscal year ended December 31, 2023 on June

As a result, the BC indicator was removed from our stock symbol.

can be no assurance that we will be able to maintain compliance with the NYSE American continued listing requirements, and if we are

unable to maintain compliance with such continued listing requirements, including any minimum trading price or market capitalization

requirements, our shares may be delisted from the NYSE American, which could reduce the liquidity of our common stock materially and

result in a corresponding material reduction in the price of our common stock.

addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all,

and may result in the potential loss of confidence by investors, employees, suppliers, customers and business development opportunities.

Such a delisting likely would impair your ability to sell or purchase our common stock when you wish to do so.

Further, if we were to

be delisted from the NYSE American, our common stock may no longer be recognized as a “covered security,” and we would be

subject to regulation in each state in which we offer our securities.

Delisting can also lead a termination that our common stock is

stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly

result in a reduced level of trading activity in the secondary trading market for our common stock.

Thus, delisting from the NYSE American

could adversely affect our ability to raise additional financing through the public or private sale of equity securities, would significantly

impact the ability of investors to trade our securities and would negatively impact the value and liquidity of our common stock.

dissolution of our company, you may not recoup all or any portion of your investment.

9 unchanged sentences

which could adversely affect the rights of the holders of our common stock.

board of directors has the authority to fix and determine the relative rights and preferences of preferred stock.

Our board of directors

has the authority to issue up to 10,000,000 additional shares of our preferred stock without further stockholder approval.

our board of directors could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to

our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and

the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock.

In addition, our board

of directors could authorize the issuance of a series of preferred stock that has greater voting power than our common stock or that

is convertible into our common stock, which could decrease the relative voting power of our common stock or result in dilution to our

existing stockholders.

Board has the authority to fix and determine the relative rights and preferences of preferred stock.

Our Board has the authority to issue

up to 10,000,000 shares of our preferred stock without further stockholder approval.

As a result, our Board could authorize the issuance

of a series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend

payments before dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with

a premium, prior to the redemption of our common stock.

In addition, our Board could authorize the issuance of a series of preferred

stock that has greater voting power than our common stock or that is convertible into our common stock, which could decrease the relative

voting power of our common stock or result in dilution to our existing stockholders.

Anti-takeover

5 unchanged sentences

Furthermore, these provisions could prevent or frustrate attempts by our stockholders to replace or remove members of

our board of directors.

These provisions also could limit the price that investors might be willing to pay in the future for our common

stock, thereby depressing the market price of our common stock.

Stockholders who wish to participate in these transactions may not have

the opportunity to do so.

These provisions also could limit the price that investors might be willing to pay in the future for our common stock, thereby

depressing the market price of our common stock.

Stockholders who wish to participate in these transactions may not have the opportunity

These provisions, among other things:

provide that special meetings of stockholders may be called only by the board of directors, President, or our Chairman of the Board

of Directors, or at the request in writing by stockholders of record owning at least fifty (50%) percent of the issued and outstanding

voting shares of common stock;

provide that special meetings of stockholders may be called only by the Board, President, or our Chairman of the Board of Directors,

or at the request in writing by stockholders of record owning at least fifty (50%) percent of the issued and outstanding voting shares

of common stock;

do not include a provision for cumulative voting in the election of directors.

2 unchanged sentences

The absence of cumulative voting may have

the effect of limiting the ability of minority stockholders to effect changes in our board of directors;

the effect of limiting the ability of minority stockholders to effect changes in our Board;

allow us to issue, without stockholder approval, up to 10,000,000 shares of preferred stock (all of which remain available for issuance)

34 unchanged sentences

ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

Our ability to utilize our U.S.

federal net operating loss, carryforwards

federal tax credits may be limited under Sections 382 of the Internal Revenue Code of 1986, as amended.

The limitations apply

if an “ownership change,” as defined by Section 382 and Section 383, occurs.

Generally, an ownership change occurs if the

percentage of the value of the stock that is owned by one or more direct or indirect “five percent shareholders” increases

by more than 50 percentage points over their lowest ownership percentage at any time during the applicable testing period (typically

three years).

In addition, future changes in our stock ownership, which may be outside of our control, may trigger an “ownership

change” and, consequently, Section 382 and Section 383 limitations.

As a result, if we earn net taxable income, our ability to

use our pre-change net operating loss carryforwards and other tax attributes to offset U.S.

federal taxable income may be subject to

limitations, which could potentially result in increased future tax liability to us.

In addition, the Tax Act, among other things, imposes

significant additional limitations on the deductibility of interest and limits net operating loss (NOL) deductions to 80% of net taxable

income for losses arising in taxable years beginning after December 31, 2017.

ability to utilize our U.S.

federal net operating loss, carryforwards and U.S.

federal tax credits may be limited under Sections 382

of the Internal Revenue Code of 1986, as amended.

The limitations apply if an “ownership change,” as defined by Section 382

and Section 383, occurs.

Generally, an ownership change occurs if the percentage of the value of the stock that is owned by one or more

direct or indirect “five percent shareholders” increases by more than 50 percentage points over their lowest ownership percentage

at any time during the applicable testing period (typically three years).

In addition, future changes in our stock ownership, which may

be outside of our control, may trigger an “ownership change” and, consequently, Section 382 and Section 383 limitations.

As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards and other tax attributes

to offset U.S.

federal taxable income may be subject to limitations, which could potentially result in increased future tax liability

In addition, the Tax Act, among other things, imposes significant additional limitations on the deductibility of interest and

limits net operating loss (NOL) deductions to 80% of net taxable income for losses arising in taxable years beginning after December

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

What changed 10-K

Item 1A. Risk Factors