What changed in this filing

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Item 1A. Risk Factors

2025-04-15 compared with 2024-03-27 · 231 added, 170 removed, 1323 unchanged (23% of the section changed)

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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 incurred significant losses since our inception.

We expect to incur losses over the next several years and may never achieve

We expect to incur losses for the foreseeable future and may never achieve

or maintain profitability.

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or product candidates.

stockholders may be subject to substantial dilution by exercises of outstanding options and warrants.

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

are early in our development efforts, which may not be successful.

cannot be certain that our product candidates will receive regulatory approval, without which we will not be able to market any of

our product candidates.

Any delay in the approval process will harm our business.

depend in part on technology owned or licensed to us by third parties, the loss of which would terminate or delay the further development

of our product candidates, injure our reputation, or force us to pay higher royalties.

drug development involves a lengthy and expensive process and uncertain as to outcome.

in any aspect of our clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval

for our product candidates.

cannot market our product candidates without regulatory approval, and any delay in this process will harm our business

depend in part on third-party technology, the loss of which could harm our business.

may not have or be able to obtain sufficient quantities of our products to meet our supply and clinical studies obligations and our

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we are unable to successfully commercialize our products our ability to generate revenue will be limited.

our preclinical and clinical studies do not produce positive results, if our clinical trials are delayed or if serious side effects

are identified during such studies or trials, we may experience delays, incur additional costs and ultimately be unable to commercialize

our product candidates.

our studies or trials produce negative results, are delayed, or identify serious side effects, we may face delays, additional costs,

and be unable to commercialize our product candidates.

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

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

Fast Track designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory

review or approval process, nor will it assure FDA approval of our product candidates.

Additionally, our product candidates may 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 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 be able to obtain or maintain orphan drug designation, Fast Track designation, qualified infection disease designation or

breakthrough therapy designation for any of our product candidates, and even if granted, such designations may not actually lead

to a faster development or regulatory review and would not assure FDA approval of any of our product candidates.

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

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

candidates and, even if granted, these designations may not speed up development or review and do not guarantee FDA approval.

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

currently have no sales and marketing organization.

If we are unable to establish satisfactory sales and marketing capabilities,

we may not successfully commercialize any of our product candidates, even if regulatory approval is obtained.

we are unable to file for approval of MAT2203 under Section 505(b)(2) of the FDCA or if we are required to generate additional data

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

and commercialization timelines.

lack a sales and marketing organization.

Without establishing these capabilities, we may not successfully commercialize our product

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.

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

if we obtain marketing approval for any product candidate, we will be subject to ongoing obligations and continued regulatory review,

which may result in significant additional expense.

Additionally, our product candidates could be subject to labeling and other restrictions

and withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience

unanticipated problems with our future products.

with marketing approval, we will face ongoing regulatory obligations and reviews, potentially incurring significant expenses.

product candidates could face labeling restrictions, market withdrawal, and penalties for non-compliance or unforeseen issues.

legislation, and/or regulations and policies adopted by the FDA may increase the time and cost required for us to conduct and complete

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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.

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

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reliance on the performance of third parties.

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

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

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

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

In addition, the loss of the services of certain key employees would adversely impact our business prospects.

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

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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.

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Related to Our Financial Position and Need for Additional Capital

have incurred significant losses since our inception.

We expect to incur losses over the next several years and may never achieve or

maintain profitability.

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.

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.

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.

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

We expect to incur losses over the next several years and may never achieve or maintain profitability.

discussed in Note 2 to the consolidated financial statements for the fiscal year ended December 31, 2024, 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.

Consequently,

management is pursuing various financing alternatives to fund our operations so we can continue as a going concern.

Management plans

to secure the necessary financing through the issue of new equity or through a potential licensing partnership of MAT2203 and/or the

entering into alternative strategic arrangements.

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.

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

necessary should we be unable to continue as a going concern.

Some adjustments could be material.

have incurred significant operating losses in every year since inception and expect to incur net operating losses for the foreseeable

Our net loss was $22,942 thousand and $20,997 thousand for the years ended December 31, 2023 and 2022, respectively.

Our net loss was $24.3 million and $22.9 million for the years ended December 31, 2024 and 2023, respectively.

As of December

31, 2023, we had an accumulated deficit of $175,573 thousand.

31, 2024, we had an accumulated deficit of $199.8 million.

We do not know whether or when we will become profitable.

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All our product candidates are in the development stage, and we have not completed development of any product candidate.

We expect to continue to incur significant expenses and operating losses over the next several years.

We expect to continue to incur significant expenses and operating losses for the foreseeable future.

Our net losses may fluctuate significantly

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our stockholders’ deficit and working capital.

We anticipate that our expenses will increase substantially if and as we:

If we resume the development of MAT2203 or any other product candidates, we anticipate

that our expenses will increase substantially as we:

further clinical and preclinical studies of MAT2203, our lead LNC product candidate;

the conduct of further clinical studies of MAT2203, even if such studies are partially financed with non-dilutive funding from the

the conduct of further clinical studies of MAT2203, even if such studies are partially financed with non-dilutive funding;

to discover and develop additional product candidates;

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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 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

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.

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

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our product development programs or commercialization efforts.

expect our expenses to increase in connection with our ongoing activities, particularly as we conduct additional clinical studies of

our product candidates, including the potential Phase 3 clinical trials of MAT2203, and conduct additional preclinical and clinical trials

to further validate and expand our LNC Platform, continue research and development, initiate clinical trials and, if development succeeds,

seek regulatory approval of our product candidates.

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 our continuing 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.

believe that our existing cash, cash equivalents and marketable debt securities, excluding restricted cash, of $13,756 thousand as of

December 31, 2023 will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2024,

but not beyond.

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:

progress, timing, costs, and results of our ongoing and planned clinical trials of our product candidates;

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:

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

scope, progress, timing, costs, and results of clinical trials of, and research and preclinical development efforts for, other product

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revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

headcount growth and associated costs as we expand our research and development and establish a commercial infrastructure;

headcount growth and associated costs if we expand our research and development and establish a commercial infrastructure;

costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights

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arrangements.

We do not have any committed external source of funds other than limited grant funding from the NIH.

To the extent that

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rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

stockholders may be subject to substantial dilution by exercises of outstanding options.

stockholders may be subject to substantial dilution by exercises of outstanding options and warrants.

of December 31, 2024, we had outstanding options to purchase an aggregate of 685,405 shares of our common stock at a weighted average

exercise price of $0.83 per share.

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

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.

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

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Any delay in the approval process will harm our business.

expect to invest most of our capital in the development of our LNC Platform.

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,

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

we are unable to successfully commercialize our products our ability to generate revenue will be limited.

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

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

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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.

In addition, companies developing new

therapies routinely seek and receive guidance from FDA regarding their methods and plans for developing their products.

We and companies

like us may also benefit from FDA-administered programs like orphan drug designation and expedited development pathways, e.g., breakthrough

Any material reductions in the ability of FDA to perform these and other functions may delay development and approval of

our product candidates.

Recent actions by the United States federal government have caused concern in the industry that this may occur.

For example, beginning on February 13, 2025, the Department of Health and Human Services began firing a large number of its probationary

employees, a category that includes new federal employees and employees recently promoted or transferred to new positions or agencies.

Larger layoffs may follow, according to a memorandum issued by the Office of Personnel Management on February 26, 2025.

These terminations,

if they withstand legal challenges, may significantly delay and impede our interactions with FDA.

Similar results may stem from the recent

confirmed resignations of some senior FDA employees with responsibility for regulation of drugs and biologics, as well as possible future

layoffs and resignations.

There are also reports that the United States federal government intends to request Congress to reduce FDA

funding in upcoming budgets.

Such funding cuts may also delay the development and approval of our products.

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

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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 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

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protection of intellectual property rights in some foreign countries;

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

currency exchange rate fluctuations;

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with universities, governmental agencies, and not-for-profit organizations for both strategic and financial resources.

Key among these

agreements is our collaboration agreements with the NIH for the development of MAT2203.

The loss of, or failure to perform by us or our

partners under any applicable agreements or arrangements, or our failure to secure additional agreements for our product candidates,

would substantially disrupt or delay our research and development activities, including our in-process and anticipated clinical trials.

Any such loss would likely increase our expenses and materially harm our business, financial condition, and results of operation.

The loss of, or

failure to perform by us or our partners under any applicable agreements or arrangements, or our failure to secure additional agreements

for our product candidates, would substantially disrupt or delay our research and development activities, including our in-process and

anticipated clinical trials.

Any such loss would likely increase our expenses and materially harm our business, financial condition,

and results of operation.

expect that we will rely on third parties to conduct clinical trials for our product candidates, which exposes us to the risk of reliance

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have 3 employees as of March 31, 2025.

As our development and commercialization plans and strategies develop, we will 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.

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

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In addition, the loss of the services of certain key employees, including Jerome D.

Jabbour, our Chief Executive Officer and

President, Theresa Matkovits, our Chief Development Officer, and Dr.

Hui Liu, our Chief Technology Officer, would adversely impact our

business prospects.

Jabbour, our Chairman, Chief Executive

Officer and President.

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

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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

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face a potential risk of product liability because of the clinical testing of MAT2203 or any future product candidates and will face

an even greater risk if we commercializeMAT2203 or any other future product.

an even greater risk if we commercialize MAT2203 or any other future product.

For example, we may be sued if any product we develop or

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If and when we obtain FDA or EMA approval

of MAT2203 and/or MAT2501, which we do not expect to occur before 2027, if ever, and/or if we generate sales of such products, or we

receive any proceeds from the licensing or other disposition of MAT2203 or MAT2501, 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.

of MAT2203, which we do not expect to occur before 2029, if ever, and/or if we generate sales of such products, or we receive any proceeds

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.

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turn could cause our stock price or trading volume to decline.

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.

have identified a material weakness in our internal control over financial reporting.

If we are not able to remediate this material weakness

and otherwise 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.

a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such

internal controls.

Section 404 of SOX, or Section 404, requires that we evaluate and determine the effectiveness of our internal controls

over financial reporting and provide a management report on internal control over financial reporting.

A material weakness is a deficiency,

or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material

misstatement of annual or interim financial statements will not be prevented or detected and corrected on a timely basis.

assessed the effectiveness of our internal control over financial reporting based on criteria established in “Internal Control—Integrated

Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

Based on this assessment,

management has concluded as of December 31, 2024, our internal control over financial reporting was not effective, as management identified

a deficiency in internal control over financial reporting that was determined to be a material weakness.

did not maintain an effective internal control environment to ensure the processing of and reporting of non-routine transactions are

complete, accurate and timely.

Specifically, we did not have the accounting resources necessary to ensure the timely preparation and

review of the Company’s annual indefinite lived assets impairment assessment.

our steps are insufficient to successfully remediate the material weakness and otherwise establish and 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 materially and adversely affected.

Effective internal control over financial reporting is necessary for us to provide

reliable and timely financial reports and, together with adequate disclosure controls and procedures, are designed to reasonably detect

and prevent fraud.

Any failure to implement required new or improved controls, or difficulties encountered in their implementation could

cause us to fail to meet our reporting obligations.

Undetected material weaknesses in our internal control over financial reporting could

lead to financial statement restatements and require us to incur the expense of remediation.

we do not expect that disclosure controls or internal control over financial reporting will prevent all errors and all fraud.

system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s

objectives will be met.

Further, the design of a control system must reflect the fact that there are resource constraints and the benefits

of controls must be considered relative to their costs.

Because of the inherent limitations in all control systems, no evaluation of

controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

Failure of our control

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.

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

A reverse-stock split

of our common stock may not have the intended consequences.

On November 1, 2023, our

shareholders approved an amendment to our Certificate of Incorporation to effect a reverse stock split at a ratio in the range of 1-for-2

to 1-for-50, to be determined at the discretion of the Board, and to reduce the total number of authorized shares of common stock from

500,000,000 to 250,000,000, which we refer to as the reverse stock split and authorized share reduction, respectively.

We believe that

the reverse stock split may result in an increase to the market price of our common stock, enhance the appeal of our common stock to the

financial community, improve the trading liquidity of our common stock, make it possible for us to “up-list” our common stock

to a higher tier stock exchange, and make us eligible for inclusion on certain biotechnology and pharmaceutical trading indices and exchange-traded

However, we cannot assure

you that the reverse stock split, if implemented, will result in any anticipated benefits, including an increase of the market price of

our common stock in proportion to the reduction in the number of shares of our common stock outstanding.

Moreover, a reverse-stock split

may have the effect of decreasing our overall market value.

There can be no assurance that the reverse stock split will result in a per

share price that will attract institutional investors or investment funds or that such share price will satisfy the investing guidelines

of institutional investors or investment funds or improve the trading liquidity of our common stock.

Moreover, the number of shares of our common stock

available for issuance following the implementation of the reverse stock split would increase to the extent the reverse stock split reduces

the number of outstanding shares of our common stock relative to the number of authorized shares.

Such available shares may be used for

future corporate purposes, including future acquisitions, investment opportunities, the establishment of collaboration or other strategic

agreements, capital raising transactions involving equity or convertible debt securities, future at the market offerings of common stock,

or issuance under current or future employee equity plans, and the issuance of equity securities in connection with such transactions

may result in potentially significant dilution of our current stockholders’ ownership interests in us.

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

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

a result of our merger with Aquarius Biotechnologies, Inc., our ability to utilize our U.S.

Our ability to utilize our U.S.

federal net operating loss, carryforwards

15 unchanged sentences

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

Cybersecurity

Risk Management and Strategy

like other companies in our industry, face several cybersecurity risks in connection with our business.

Our business strategy, results

of operations, and financial condition have not, to date, been affected by risks from cybersecurity threats.

During the reporting period,

we have not experienced any material cyber incidents, nor have we experienced a series of immaterial incidents, which would require disclosure.

the ordinary course of our business, we use, store and process data including data of our employees, trial participants, partners, clients,

We have implemented a cybersecurity risk management program that is designed to identify, assess, and mitigate risks from

cybersecurity threats to this data and our systems.

Our cybersecurity risk management program incorporates several components, including

information security program assessments, continuous monitoring of cyber risks and threats using automated tools, written incident response

and disaster recovery policies and procedures, and employee training.

Under the direction of our Chief Financial Officer, our cyber risk

management program is led by a third-party IT consultant with more than 30 years of technology engineering experience and several advanced

We also deploy endpoint detection software and device management in conjunction with other reputable cybersecurity software.

Additionally, we require multifactor authentication across all systems.

periodically engage third parties to conduct risk assessments and other vulnerability analyses.

Lastly, our program includes cybersecurity

training for all employees.

The semi-annual training focuses on cyber threat awareness, including phishing.

Related to Cybersecurity Risks

the ultimate direction of our chief executive officer (“CEO”), the Board of Directors is updated on our cybersecurity risk

management program, including any critical cybersecurity risks, ongoing cybersecurity initiatives and strategies, and applicable regulatory

requirements and industry standards, on an as-needed basis.

The CEO also notifies the Board of any cybersecurity incidents (suspected

or actual) and provides updates on the incidents as well as cybersecurity risk mitigation activities as appropriate.

administrative offices consist of approximately 8,900 square feet of office space in Bedminster, NJ that we occupy under a lease that

expires in June 2029.

We also lease laboratory space approximating 14,000 square feet in Bridgewater, NJ, that expires in July 2027.

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