What changed in this filing

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Item 1A. Risk Factors

2025-03-27 compared with 2024-04-01 · 342 added, 244 removed, 509 unchanged (54% of the section changed)

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Risk Factors” above.

Related to Ownership of Our Securities

have a history of losses, expect to continue to incur losses in the near term and may not achieve or sustain profitability in the future,

and as a result, there is a substantial doubt about our ability to continue as a going concern.

attached financial statements have been prepared assuming we will continue as a going concern.

Our management must evaluate whether there

are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern

for one year from the date these financial statements are issued.

This evaluation does not take into consideration the potential mitigating

effect of management’s plans that have not been fully implemented or are not within our control as of the date the financial statements

When substantial doubt about our ability to continue as a going concern exists, management evaluates whether the mitigating

effect of its plans sufficiently alleviates the substantial doubt.

If we are unable to implement sufficient mitigation efforts, we may

be forced to limit our business activities or be unable to continue as a going concern, which would have a material adverse effect on

our results of operations and financial condition.

are currently not in compliance with the Exchange continued listing requirements.

If we are unable to regain compliance with the Exchange’s

listing requirements, our securities could be delisted, which could affect our common stock market price and liquidity and reduce our

ability to raise capital.

are not currently in compliance with the Exchange’s stockholders’ equity rule because our stockholders’ equity is less

than the required minimum of $6,000,000.

Pursuant to the letter from the Exchange informing us of this non-compliance, we submitted a

Plan to the Exchange illustrating how we can regain compliance by June 11, 2026.

The Exchange did accept our plan, however if, we are not

able to regain compliance by June 11, 2026, our common stock may be delisted from the Exchange.

As of December 31, 2024, our stockholders’

(deficit) was $1.3 million.

We must increase our stockholders’ equity to be at least $6 million to regain compliance with this rule.

If we are not able to raise sufficient capital, we may be unable to regain compliance with the Exchange’s listing standards.

intend to take all reasonable measures available to regain compliance under the Exchange’s listing rules and remain listed on the

cannot assure you that we will be able to regain compliance with the Exchange listing standards.

Our failure to continue to meet these

requirements would result in our common stock being delisted from the Exchange.

We and holders of our securities could be materially

adversely impacted if our securities are delisted from the Exchange.

In particular:

may be unable to raise equity capital on acceptable terms or at all;

price of our common stock will likely decrease as a result of the loss of market efficiencies associated with the Exchange and the

loss of federal preemption of state securities laws;

may be unable to sell or purchase our securities when they wish to do so;

may become subject to stockholder litigation;

may lose the interest of institutional investors in our common stock;

may lose media and analyst coverage;

common stock could be considered a “penny stock,” which would likely limit the level of trading activity in the secondary

market for our common stock;

would likely lose any active trading market for our common stock, as it may only be traded on one of the over-the-counter markets,

we are not able to comply with the applicable continued listing requirements or standards of the NYSE American, our common stock could

be delisted from the Exchange.

common stock is listed on the Exchange.

In order to maintain this listing, we must maintain a certain share price, financial and share

distribution targets, including maintaining a minimum amount of stockholders’ equity and a minimum number of public stockholders.

In addition to these objective standards, the Exchange may delist the securities of any issuer (i) if, in its opinion, the issuer’s

financial condition and/or operating results appear unsatisfactory;

(ii) if it appears that the extent of public distribution or the

aggregate market value of the security has become so reduced as to make continued listing on the Exchange inadvisable;

(iii) if the issuer

sells or disposes of principal operating assets or ceases to be an operating company;

(iv) if an issuer fails to comply with the Exchange’s

listing requirements;

(v) if an issuer’s securities sell at what the Exchange considers a “low selling price” which

the exchange generally considers $0.10 per share, the Exchange may suspend trading of the common stock, until the issuer corrects this

via a reverse split of shares after notification by the Exchange;

or (vi) if any other event occurs or any condition exists which makes

continued listing on the Exchange, in its opinion, inadvisable.

There are no assurances how the market price of the common stock will

be impacted in future periods as a result of the general uncertainties in the capital markets and any specific impact on our Company

as a result of the recent volatility in the capital markets.

the event that our common stock is delisted from the Exchange and is not eligible for quotation on another market or exchange, trading

of our common stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities,

such as the Pink Sheets or the OTC Markets.

In such event, investors may face material adverse consequences, including, but not limited

to, a lack of trading market for the common stock, reduced liquidity and market price of the common stock, decreased analyst coverage

of the common stock, and an inability for us to obtain any additional financing to fund our operations that we may need.

the common stock is delisted, the common stock may be subject to the so-called “penny stock” rules.

The SEC has adopted regulations

that define a penny stock to be any equity security that has a market price per share of less than $5.00, subject to certain exceptions,

such as any securities listed on a national securities exchange.

For any transaction involving a penny stock, unless exempt, the rules

impose additional sales practice requirements and burdens on broker-dealers (subject to certain exceptions) and could discourage broker-dealers

from effecting transactions in our stock, further limiting the liquidity of our shares, and an investor may find it more difficult to

acquire or dispose of the common stock on the secondary market.

factors could have a material adverse effect on the trading price, liquidity, value and marketability of the common stock.

may seek to raise additional funds or develop strategic relationships by issuing securities that would dilute your ownership.

on the terms available to us, if these activities result in significant dilution, it may negatively impact the trading price of our common

additional financing that we secure may require the granting of rights, preferences or privileges senior to, or pari passu with,

those of our common stock.

Any issuances by us of equity securities may be at or below the prevailing market price of our common stock

and in any event may have a dilutive impact on your ownership interest, which could cause the market price of our common stock to decline.

We may also raise additional funds through the incurrence of debt or the issuance or sale of other securities or instruments senior to

our shares of common stock, which may be highly dilutive.

The holders of any securities or instruments we may issue may have rights superior

to the rights of our common stock.

If we experience dilution from the issuance of additional securities and we grant superior rights

to new securities over holders of our common stock, it may negatively impact the trading price of our common stock and you may lose all

or part of your investment.

active, liquid and orderly trading market for our common stock may not develop, the price of our stock may be volatile, and you could

lose all or part of your investment.

though our common stock is currently listed on the Exchange, we cannot predict the extent to which investor interest in our company will

lead to the development of an active trading market in our securities or how liquid that market might become.

If such a market does not

develop or is not sustained, it may be difficult for you to sell your shares of common stock at the time you wish to sell them, at a

price that is attractive to you, or at all.

There could be extreme fluctuations in the price of our common stock if there are a limited

number of shares in our public float.

trading price of our common stock may be highly volatile and could be subject to wide fluctuations in response to various factors, some

of which are beyond our control.

Our stock price could be subject to wide fluctuations in response to a variety of factors, which include:

announcements

of the results of clinical trials by us or our competitors;

announcements

of legal actions against us and/or settlements or verdicts adverse to us;

reactions to products;

approvals, delays in expected governmental approvals or withdrawals of any prior governmental approvals or public or regulatory agency

comments regarding the safety or effectiveness of our products, or the adequacy of the procedures, facilities or controls employed

in the manufacture of our products;

or foreign regulatory policy during the period of product development;

in patent or other proprietary rights, including any third-party challenges of our intellectual property rights;

announcements

of technological innovations by us or our competitors;

announcements

of new products or new contracts by us or our competitors;

or anticipated variations in our operating results due to the level of development expenses and other factors;

in financial estimates by securities analysts and whether our earnings meet or exceed the estimates;

and trends in the pharmaceutical and other industries;

accounting standards;

investment market fluctuation;

of prior financial results;

notice of NYSE American non-compliance, the NYSE American rejection of our plan to regain compliance or our inability to effect

efforts pursuant to the Plan to regain compliance, if accepted;

of any of the risks described in these risk factors and the risk factors incorporated by reference herein.

addition, broad market and industry factors may seriously affect the market price of companies’ stock, including ours, regardless

of actual operating performance.

In addition, in the past, following periods of volatility in the overall market and the market price

of a particular company’s securities, securities class action litigation has often been instituted against these companies.

litigation, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.

our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.

SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks.

Penny stocks are generally

equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized

for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions

in such securities is provided by the exchange or system.

If we do not retain a listing on the Exchange and if the price of our common

stock is less than $5.00, our common stock will be deemed a penny stock.

The penny stock rules require a broker-dealer, before a transaction

in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information.

In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules,

a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive

(i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement;

(ii) a written agreement to transactions

involving penny stocks;

and (iii) a signed and dated copy of a written suitability statement.

These disclosure requirements may have

the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty

selling their shares.

we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments.

we were to dissolve as a corporation, as part of ceasing to do business or otherwise, we will be required to pay all amounts owed to

any creditors before distributing any assets to holders of our capital stock.

There is a risk that in the event of such a dissolution,

there will be insufficient funds to repay amounts owed to holders of any of our indebtedness and insufficient assets to distribute to

our capital stockholders, in which case investors could lose their entire investment.

securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they

change their recommendations regarding our securities adversely, our stock price and trading volume could decline.

trading market for our common stock is influenced by the research and reports that industry or securities analysts may publish about

us, our business, our market or our competitors.

If any of the analysts who may cover us change their recommendation regarding our common

stock adversely, or provide more favorable relative recommendations about our competitors, our stock price would likely decline.

analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in

the financial markets, which in turn could cause our stock price or trading volume to decline.

Associated with Our Business

may require additional financing which may not be available.

development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical

development, and clinical trials that are necessary to bring pharmaceutical products to market.

As of December 31, 2023, we had

approximately $13,070,000 in cash and cash equivalents.

At present we do not generate any material revenue from our operations, and

we do not anticipate doing so in the near future.

We may need to obtain additional funding in the future for new studies and/or if

current studies do not yield positive results, require unanticipated changes and/or additional studies.

In February 2022, the SEC

declared our universal shelf registration statement on Form S-3 effective.

Pursuant to that registration statement, we can sell up

to $100 million of our securities and raise additional capital as needed in the future.

Subsequent to the end of 2023, we raised

$2,500,000 in net proceeds from the sale of an unsecured Note and we have entered into an equity line agreement (see, Part II;

Management’s Discussion and Analysis

of Financial Condition and Results of Operations and Part I;

Atlas Equity Line of Credit ).

No assurance can be given as to the amount of funds that could be

raised pursuant to this registration statement or the potential dilution to current stockholders.

will need to allocate capital to eventually commercialize and sell Ampligen and/or recommence sales of Alferon N Injection.

believe, based on our current financial condition, that we have adequate funds to meet our anticipated operational cash needs and fund

current clinical trials over approximately the next twenty-four months.

If our funds are not adequate, and we are subsequently unable

to obtain additional funding, through joint venturing, sales of securities and/or otherwise, our ability to develop our products, commercially

produce inventory or continue our operations may be materially adversely affected.

will require additional financing which may not be available.

development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical development,

and clinical trials that are necessary to bring pharmaceutical products to market.

As of December 31, 2024, we had approximately $4.0

million in cash, cash equivalents and marketable securities.

At present we do not generate any material revenue from our operations,

and we do not anticipate doing so in the near future.

We will need to obtain additional funding in the future for new studies and/or

if current studies do not yield positive results, require unanticipated changes and/or additional studies.

believe, based on our current financial condition, that we do not have adequate funds to meet our anticipated operational cash needs

and fund current clinical trials.

If our funds are not adequate, and we are subsequently unable to obtain additional funding, through

joint venturing, sales of securities and/or otherwise, our ability to develop our products, commercially produce inventory or continue

our operations may be materially adversely affected.

may continue to incur substantial losses and our future profitability is uncertain.

of December 31, 2023, our accumulated deficit was approximately $409,508,000.

As with many biotechnology companies, we have not yet generated

significant revenues from our products and may incur substantial and increased losses in the future.

We cannot assure that we will ever

achieve significant revenues from product sales or become profitable.

We require, and will continue to require, the commitment of substantial

resources to develop our products.

We cannot assure that our product development efforts will be successfully completed or that required

regulatory approvals will be obtained or that any products will be manufactured and marketed successfully or be profitable.

of December 31, 2024, our accumulated deficit was approximately $426.8 million.

As with many biotechnology companies, we have not yet

generated significant revenues from our products and may incur substantial and increased losses in the future.

We cannot assure that

we will ever achieve significant revenues from product sales or become profitable.

We require, and will continue to require, the commitment

of substantial resources to develop our products.

We cannot assure that our product development efforts will be successfully completed

or that required regulatory approvals will be obtained or that any products will be manufactured and marketed successfully or be profitable.

drug and related technologies are investigational and subject to regulatory approval.

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including, but not limited to, the U.S.

FDA, the Health Protection Branch (“HPB”) of Canada, the Agency for the European

Medicines Agency (“EMA”) in Europe;

and the Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”)

in Argentina.

Obtaining regulatory approvals is a rigorous and lengthy process and requires the expenditure of substantial resources.

In order to obtain final regulatory approval of a new drug, we must demonstrate to the satisfaction of the regulatory agency that the

product is safe and effective for its intended uses and that we are capable of manufacturing the product to the applicable regulatory

We require regulatory approval in order to market Ampligen or any other proposed product and receive product revenues or royalties.

We cannot assure you that Ampligen will ultimately be demonstrated to be safe and efficacious.

While Ampligen is authorized for use in

clinical trials in the U.S., we cannot assure you that additional clinical trial approvals will be authorized in the United States or

in other countries, in a timely fashion or at all, or that we will complete these clinical trials.

In addition, although Ampligen has

been authorized by the FDA for treatment use under certain conditions, including provision for cost recovery, there can be no assurance

that such authorization will continue in effect.

FDA, the Health Protection Branch (“HPB”) of Canada, the Agency for the EMA in Europe;

and the Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”) in Argentina.

Obtaining regulatory

approvals is a rigorous and lengthy process and requires the expenditure of substantial resources.

In order to obtain final regulatory

approval of a new drug, we must demonstrate to the satisfaction of the regulatory agency that the product is safe and effective for its

intended uses and that we are capable of manufacturing the product to the applicable regulatory standards.

We require regulatory approval

in order to market Ampligen or any other proposed product and receive product revenues or royalties.

We cannot assure you that Ampligen

will ultimately be demonstrated to be safe and efficacious.

While Ampligen is authorized for use in clinical trials in the U.S., we cannot

assure you that additional clinical trial approvals will be authorized in the United States or in other countries, in a timely fashion

or at all, or that we will complete these clinical trials.

In addition, although Ampligen has been authorized by the FDA for treatment

use under certain conditions, including provision for cost recovery, there can be no assurance that such authorization will continue

we received approval of our Argentinian NDA from ANMAT for commercial sale of rintatolimod (U.S.

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FDA may not approve the proposed manufacturing processes and facilities for a product candidate.

COVID-19 coronavirus or other global pandemics could adversely impact our business, including our clinical trials.

We cannot predict

the ultimate effects of the COVID-19 virus on our business.

COVID-19 pandemic had and to a certain extent continues to have a major disruptive effect in the US and worldwide, including in countries

in which there are planned or active clinical trial sites studying Ampligen.

The COVID-19 pandemic or a future major pandemic could severely

impact our business and clinical trials, including:

or difficulties in enrolling patients in our clinical trials;

or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial

sites and hospital staff supporting the conduct of our clinical trials;

of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by

federal or state governments, employers and others;

in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees

or their families or the desire of employees to avoid contact with large groups of people;

in issuing reports, results and publishing papers;

in receiving approval from local regulatory authorities to initiate our planned clinical trials;

in clinical sites receiving the supplies and materials needed to conduct our clinical trials;

in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in our clinical

in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which

our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations

in employee resources or forced furlough of government employees;

of the FDA to accept data from clinical trials in affected geographies outside the United States.

noted elsewhere in this Report, progress of our commercial launch in Argentina has been delayed due to pandemic factors.

impact of COVID-19 in Argentina is taxing the nation’s health care system and is, understandably, a main priority of its regulators.

we are not able to estimate the effects of the COVID-19 outbreak or future pandemics, they may have a material adverse effect on our

results of future operations, financial position, and liquidity.

may be subject to product liability claims from the use of Ampligen, Alferon N Injection, or other of our products which could negatively

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to attempt to take appropriate precautions, we cannot assure that we will avoid significant product liability exposure.

of health care reimbursement for our products.

of health care reimbursement for our products exists.

ability to successfully commercialize our products will depend, in part, on the extent to which reimbursement for the cost of such products

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obtained insurance coverage to mitigate any potential significant loss in this area.

rely upon information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity

incidents, could harm our ability to operate our business effectively.

operations could be disrupted if our information systems fail, if we are unsuccessful in implementing necessary upgrades or if we are

subject to cyber-attacks.

Our business depends on the efficient and uninterrupted operation of our computer and communications systems

and networks, hardware and software systems and our other information technology.

We collect and maintain information, which includes

confidential and proprietary information, as well as personal information regarding our customers and employees, in digital form.

maintained in digital form is subject to risk of cyber-attacks, which are increasing in frequency and sophistication.

Cyber-attacks could

include the deployment of harmful malware, viruses, worms, and other means to affect service reliability and threaten data confidentiality,

integrity and availability.

Despite our efforts to monitor and safeguard our systems to prevent data compromise, the possibility of a

future data compromise cannot be eliminated entirely, and risks associated with intrusion, tampering, and theft remain.

we do not have insurance coverage with respect to system failures or cyber- attacks.

A failure of our systems, or an inability to successfully

expand the capacity of these systems, or an inability to successfully integrate new technologies into our existing systems could have

a material adverse effect on our business, results of operations, financial condition, and cash flows.

and our vendors’ sophisticated information technology operations are spread across multiple, sometimes inconsistent, platforms,

which pose difficulties in maintaining data integrity across systems.

The ever-increasing use and evolution of technology, including

cloud-based computing, creates opportunities for the unintentional or improper dissemination or destruction of confidential information

stored in our systems.

breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse

of trade secrets, proprietary information or other confidential information, whether as a result of theft, hacking, fraud, trickery or

other forms of deception, or for any other cause, could enable others to produce competing products, use our proprietary technology or

information and/or adversely affect our business position.

Further, any such interruption, security breach, loss or disclosure of confidential

information could result in financial, legal, business and reputational harm to our company and could have a material adverse effect

on our business, financial condition, results of operations, cash flows and stock price.

Please see Part I;

Item 1C “Cybersecurity”

of our information technology infrastructure could have a material adverse effect on operations.

utilize various software applications and other information technology that are critically important to our business operations.

on information technology networks and systems, including the Internet, to process, transmit, and store electronic and financial information,

to manage a variety of business processes and activities.

We depend on our information technology infrastructure to communicate internally

and externally with employees, consultants and others.

We also use information technology networks and systems to comply with regulatory,

legal, and tax requirements.

These information technology systems, some of which are managed by third parties, may be susceptible to

damage, disruptions, or shutdowns due to failures during the process of upgrading or replacing software, databases or components thereof,

power outages, hardware failures, computer viruses, attacks by computer hackers or other cybersecurity risks, telecommunication failures,

user errors, natural disasters, terrorist attacks, or other catastrophic events.

If any of our significant information technology systems

suffer severe damage, disruption or shutdown, and our disaster recovery and business continuity plans do not effectively resolve the

issues in a timely manner, our financial condition and results of operations may be materially and adversely affected.

loss of services of key personnel could hurt our chances for success.

success is dependent on the continued efforts of our staff, especially certain doctors and researchers.

The loss of the services of personnel

key to our operations could have a material adverse effect on our operations and chances for success.

The loss of key personnel or the

failure to recruit additional personnel as needed could have a materially adverse effect on our ability to achieve our objectives.

requires estimates, judgements and assumptions which inherently contain uncertainties.

The loss of the services of

personnel key to our operations or the failure to recruit additional personnel as needed, could have a materially adverse effect on

our operations and on our overall ability to achieve our objectives.

accounting principles generally accepted in the United States of America (“GAAP”) requires estimates, judgements and assumptions

which inherently contain uncertainties.

are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance

Any future changes in estimates, judgments and assumptions used or necessary revisions to prior estimates, judgments or assumptions

could lead to a restatement of our results.

financial statements included in this Annual Report on Form 10-K are prepared in accordance with GAAP.

This involves making estimates,

judgments and assumptions that affect reported amounts of assets (including intangible assets), liabilities, mezzanine equity, stockholders’

equity, operating revenues, costs of sales, operating expenses, other income, and other expenses.

Estimates, judgments, and assumptions

are inherently subject to change in the future and any necessary revisions to prior estimates, judgments or assumptions could lead to

a restatement.

Any such changes could result in corresponding changes to the amounts of assets (including goodwill and other intangible

assets), liabilities, mezzanine equity, stockholders’ equity, operating revenues, costs of sales, operating expenses, other income

and other expenses.

We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the

circumstances.

Accounting estimates involve a significant level of estimation uncertainty and have had or are reasonably likely to have

a material impact on our financial condition or results of operations.

Because of the uncertainty of factors surrounding the estimates

or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates, which may

be material to our financial statements.

financial statements included in this registration statement of which this prospectus forms a part are prepared in accordance with GAAP.

This involves making estimates, judgments and assumptions that affect reported amounts of assets (including intangible assets), liabilities,

mezzanine equity, stockholders’ equity, operating revenues, costs of sales, operating expenses, other income, and other expenses.

Estimates, judgments, and assumptions are inherently subject to change in the future and any necessary revisions to prior estimates,

judgments or assumptions could lead to a restatement.

Any such changes could result in corresponding changes to the amounts of assets

(including goodwill and other intangible assets), liabilities, mezzanine equity, stockholders’ equity, operating revenues, costs

of sales, operating expenses, other income and other expenses.

currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the Federal

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Associated with Our Products

The development of

Ampligen is subject to significant risks.

Ampligen may be found

to be ineffective or to have adverse side effects, fail to receive necessary regulatory clearances, be difficult to manufacture on a

commercial scale, be uneconomical to market or be precluded from commercialization by proprietary right of third parties.

development of Ampligen is subject to significant risks.

may be found to be ineffective or to have adverse side effects, fail to receive necessary regulatory clearances, be difficult to manufacture

on a commercial scale, be uneconomical to market or be precluded from commercialization by proprietary right of third parties.

Our investigational

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could adversely affect potential revenues and physician/patient acceptability of our product.

The development of Alferon N Injection

is subject to significant risks.

development of Alferon N Injection is subject to significant risks.

Alferon N Injection is approved for marketing in the United States for intralesional treatment of refractory or recurring external genital

warts in patients 18 years of age or older, to date it has not been approved for other indications.

Given our focus on developing Ampligen

as an oncology therapy and antiviral, alone and in combination with other drugs, at this time we are not focusing on developing Alferon

side effects from the use of Ampligen or Alferon N Injection could adversely affect potential revenues and physician/patient acceptability

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for this use or other potential uses of Alferon N Injection which could threaten or limit such product’s usefulness.

Related to our activities associated with Ampligen’s potential effectiveness as a treatment for COVID-19 of Post-COVID Conditions

It is not possible to predict the future of COVID-19, and related Post-COVID

Conditions, as a global public health threat or the development of related therapies.

No assurance can be given that Ampligen will aid

in or be applied to the treatment of this virus.

Related to Our Activities Associated with Ampligen’s Potential Effectiveness as a Treatment for COVID-19 or Post-COVID Conditions

is not possible to predict the future of COVID-19, and related Post-COVID Conditions, as a global public health threat or the development

of related therapies.

No assurance can be given that Ampligen will aid in or be applied to the treatment of this virus.

additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 or Post-COVID

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any of the cancers which we have sought to target.

For more information on Patents, please see PART I, Item 1 “Business;

cannot assure that our competitors will not seek and obtain patents regarding the use of similar products in combination with various

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Such litigation could require

substantial resources from us, and we may not have the financial resources necessary to enforce the patent rights that we hold.

can be made that our patents will provide competitive advantages for our products, process and technology or will not be successfully

challenged by competitors.

No assurance can be given that patents do not exist or could not be filed which would have a materially adverse

effect on our ability to develop or market our products or to obtain or maintain any competitive position that we may achieve with respect

to our products.

Our patents also may not prevent others from developing competitive products or processes using related technology.

can be no assurance that we will be able to obtain necessary licenses if we cannot enforce patent rights we may hold.

In addition, the

failure of third parties from whom we currently license certain proprietary information or from whom we may be required to obtain such

licenses in the future, to adequately enforce their rights to such proprietary information, could adversely affect the value of such

licenses to us.

we cannot enforce the patent rights we currently hold we may be required to obtain licenses from others to develop, manufacture or market

our products.

There can be no assurance that we would be able to obtain any such licenses on commercially reasonable terms, if at all.

We currently license certain proprietary information from third parties, some of which may have been developed with government grants

under circumstances where the government maintained certain rights with respect to the proprietary information developed.

substantial resources from us, and we may not have the financial resources necessary to enforce the patent license rights that we hold.

No assurance can be made that our patents will provide competitive advantages for our products, process and technology or will not be

successfully challenged by competitors.

No assurance can be given that patents do not exist or could not be filed which would have a

materially adverse effect on our ability to develop or market our products or to obtain or maintain any competitive position that we

may achieve with respect to our products.

Our patents also may not prevent others from developing competitive products or processes using

related technology.

can be no assurance that we will be able to obtain necessary licenses if we cannot enforce patent license rights we may hold.

the failure of third parties from whom we currently license certain proprietary information or from whom we may be required to obtain

such licenses in the future, to adequately enforce their rights to such proprietary information, could adversely affect the value of

such licenses to us.

we cannot enforce the patent license rights, we currently hold we may be required to obtain licenses from others to develop, manufacture

or market our products.

There can be no assurance that we would be able to obtain any such licenses on commercially reasonable terms,

We currently license certain proprietary information from third parties, some of which may have been developed with government

grants under circumstances where the government maintained certain rights with respect to the proprietary information developed.

No assurances

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to the inherent uncertainty involved in the design and conduct of clinical trials and the applicable regulatory requirements, including

the factors discussed above in “Our Products”, we cannot predict what additional studies and/or additional testing or information

the factors discussed below in “Business” we cannot predict what additional studies and/or additional testing or information

may be required by the FDA.

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from the sale of these developmental products.

As of December 31, 2023, we had approximately $13,070,000 in Cash, Cash Equivalents.

see “ We may require additional financing which may not be available ” above.

Please see “ We will require additional financing which may not be available ”

Associated with Our Manufacturing

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would most likely be materially and/or adversely affected.

are exploring engaging a Contract Manufacturing Organization (“CMO”) to produce Alferon API.

At present, we do not have a

supply of Alferon N Injection or the requisite API.

Additionally, although our old New Brunswick facility was FDA approval under the

BLA for Alferon N Injection, this status will need to be reapproved when a CMO or a new facility is identified for the production of

We cannot provide any guarantee that a CMO or other future facility will pass an FDA pre-approval inspection for Ampligen or

Alferon N Injection manufacture.

are exploring engaging a Contract Manufacturing Organization (“CMO”) to produce Alferon active pharmaceutical ingredients

At present, we do not have a supply of Alferon N Injection or the requisite API.

Additionally, although our old

New Brunswick facility was FDA approved under the BLA for Alferon N Injection, this status will need to be reapproved when a CMO or a

new facility is identified for the production of the drug.

We cannot provide any guarantee that a CMO or other future facility will pass

an FDA pre-approval inspection for Ampligen or Alferon N Injection manufacture.

we are unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon N Injection

inventory or contract with a CMO, our operations most likely will be materially adversely affected.

For more information on Alferon N

Injection regarding potential commercial sales, please see PART I, Item 1 - “Business;

Manufacturing”.

are no long-term agreements with suppliers of required materials and services for Ampligen and there are a limited number of raw material

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no assurance that we will be able to obtain such products and materials on terms acceptable to us or at all.

we produced limited quantities of active pharmaceutical ingredients (“API”) for our products in our old New Brunswick, NJ

facility, the sale of this facility necessitated our exploring the engagement of a CMO to produce API for both Ampligen and Alferon.

While we believe we have sufficient API to meet our current Ampligen needs, we are also continually exploring new efficiencies so as

to maximize our ability to fulfill future obligations.

Currently, the Alferon N Injection manufacturing process is on hold and there

is no definitive timetable for its restart.

Please see “ Our Alferon N.

Injection commercial sales were halted due to lack of

finished goods inventory.

If we are unable to gain the necessary FDA approvals related to Alferon N Injection, our operations most likely

will be materially and/or adversely affected ” above.

we produced limited quantities of API for our products in our old New Brunswick, NJ facility, the sale of this facility necessitated

our exploring the engagement of a CMO to produce API for both Ampligen and Alferon.

At the present, we may not have sufficient API to

make an additional batch of Ampligen utilizing our current GMP manufacturing process.

We are continually exploring new efficiencies to

maximize our ability to fulfill future obligations.

We currently have in stock sufficient supplies to meet our current projected clinical

If these needs should increase drastically beyond current expectations or should current stocks unexpectedly expire before expectations

and we are unable to successfully manufacture additional API, this would adversely affect our ability to continue clinical development.

Currently, the Alferon N Injection manufacturing process is on hold and there is no definitive timetable for its restart.

“ Our Alferon N.

Injection commercial sales were halted due to lack of finished goods inventory.

If we are unable to gain the

necessary FDA approvals related to Alferon N Injection, our operations most likely will be materially and/or adversely affected ”

validation of the polymer production process with Sterling is ongoing.

We would need to finance and complete this process to produce

additional polymer — or purchase polymer, likely in bulk, from a vendor — before we could produce additional Ampligen.

we are unable to obtain or manufacture the required materials/reagents, and/or procure services needed in the final steps in the manufacturing

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such products and materials on terms acceptable to us or at all.

For more information on Ampligen manufacturing, please see PART I, Item

1 - “Business;

Our Products;

Manufacturing” above.

are limited number of organizations in the United States available to provide the final manufacturing steps of formulation, fill, finish

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finish capacity.

there be an unanticipated delay in receiving new product or should we experience an unexpected demand for Ampligen, our ability to supply

Ampligen most likely will be adversely affected.

If we are unable to procure services needed in the final steps in the manufacturing

there be an unanticipated delay in producing or receiving new product, or should we experience an unexpected demand for Ampligen, our

ability to supply Ampligen most likely will be adversely affected.

If we are unable to procure services needed in the in the manufacturing

process, we may be unable to manufacture Alferon N Injection and/or Ampligen.

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terms acceptable to us or at all.

For more information on Ampligen and Alferon N Injection manufacturing, please see PART I, Item 1 -

Our Products;

Manufacturing” above.

is no assurance that, upon success, manufacture of a drug on a limited-scale basis for investigational use would lead to a successful

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technical personnel and capital.

While we intend to identify a CMO (or CMOs) with a state-of-the-art facility capable of meeting potential

increased demand for Ampligen, there can be no assurance that our manufacturing will be successful or that any given product will be

determined to be safe and effective, or capable of being manufactured under applicable quality standards, economically, and in commercial

quantities, or successfully marketed.

We are currently working with Sterling on the validation of a polymer production process that would

enable us to produce polymer in the necessary quantities.

Additionally,

while we intend to identify a CMO (or CMOs) with a state-of-the-art facility capable of meeting potential increased demand for Ampligen,

there can be no assurance that our manufacturing will be successful or that any given product will be determined to be safe and effective,

or capable of being manufactured under applicable quality standards, economically, and in commercial quantities, or successfully marketed.

have limited manufacturing experience for Ampligen and Alferon N Injection.

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We will need to comply with regulatory requirements for such facilities,

including those of the FDA pertaining to cGMP requirements or maintaining our BLA status.

There can be no assurance that such facilities

can be used, built, or acquired on commercially acceptable terms, or that such facilities, if used, built, or acquired, will be adequate

for the production of our proposed products for large-scale commercialization or our long-term needs.

including those of the FDA pertaining to cGMP requirements or maintaining our NDA or BLA status.

There can be no assurance that such

facilities can be used, built, or acquired on commercially acceptable terms, or that such facilities, if used, built, or acquired, will

be adequate for the production of our proposed products for large-scale commercialization or our long-term needs.

have never produced Ampligen, Alferon N Injection or any other products in large commercial quantities.

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Our flagship product, Ampligen, is being evaluated as a potential treatment for COVID-19, myalgic encephalomyelitis/chronic fatigue

syndrome (ME/CFS) and COVID-induced CFS symptoms (“Long Haulers”);

as well as multiple types of cancers.

syndrome (ME/CFS) and COVID-induced CFS symptoms (“Long Haulers”), as well as multiple types of cancers.

With regard to COVID-19,

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Health and Welfare (“HPB”) and other regulatory approvals of products.

Accordingly, our competitors may succeed in obtaining FDA, HPB or

other regulatory product approvals more rapidly than us.

Accordingly, our competitors may succeed in obtaining

FDA, HPB or other regulatory product approvals more rapidly than us.

There are no drugs approved for U.S.

commercial sale for the treatment of CFS;

commercial sale for the treatment

standard of care is to focus on symptom relief, such as addressing pain or depression.

The dominant competitors with drugs to treat disease

indications which we plan to address include Pfizer, GlaxoSmithKline, Merck & Co., Novartis and AstraZeneca.

Biotech competitors

include Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.

These potential competitors are among

the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially greater

financial resources, product development, and manufacturing and marketing capabilities than we have.

Although we believe our principal

advantage is the unique mechanism of action of Ampligen on the immune system, we cannot assure that we will be able to compete.

The dominant competitors with drugs to

treat disease indications which we plan to address include Pfizer, GlaxoSmithKline, Merck & Co., Novartis and AstraZeneca.

competitors include Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.

These potential competitors

are among the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially

greater financial resources, product development, and manufacturing and marketing capabilities than we have.

Although we believe our

principal advantage is the unique mechanism of action of Ampligen on the immune system, we cannot assure that we will be able to compete.

Our competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical

community, and have substantially greater financial resources, product development, and manufacturing and marketing capabilities than

Alferon N Injection currently competes with Merck’s injectable recombinant alpha interferon product (Intron® A) for

the treatment of genital warts.

In addition, other pharmaceutical firms offer self-administered topical cream, for the treatment of external

genital and perianal warts such as Graceway Pharmaceuticals (Aldara®), Perrigo Company (Imiquimod

Cream - Generic Equivalent to Aldara®), Watson Pharma (Condylox®) and MediGene (Veregen®).

Alferon N Injection also

competes with surgical, chemical, and other methods of treating genital warts.

We cannot assess the impact products developed by our

competitors, or advances in other methods of the treatment of genital warts, will have on the commercial viability of Alferon N Injection.

If and when we obtain additional approvals of uses of this product, we expect to compete primarily on the basis of product performance.

Our competitors have developed or may develop products (containing either alpha or beta interferon or other therapeutic compounds) or

other treatment modalities for those uses.

There can be no assurance that, if we are able to obtain regulatory approval of Alferon N

Injection for the treatment of new indications, we will be able to achieve any significant penetration into those markets.

because certain competitive products are not dependent on a source of human blood cells, such products may be able to be produced in

greater volume and at a lower cost than Alferon N Injection.

Currently, our wholesale price on a per unit basis of Alferon N Injection

is higher than that of the competitive recombinant alpha and beta interferon products.

Please see risk factor “We may not be profitable

unless we can protect our patents and/or receive approval for additional pending patents” above for additional information.

Other competitors provide recombinant alpha and beta interferon products.

Many pharmaceutical firms offer self-administered

topical cream, for the treatment of external genital and perianal warts.

Alferon N Injection also competes with surgical, chemical, and

other methods of treating genital warts.

We cannot assess the impact products developed by our competitors, or advances in other methods

of the treatment of genital warts, will have on the commercial viability of Alferon N Injection.

If and when we obtain additional approvals

of uses of this product, we expect to compete primarily on the basis of product performance.

Our competitors have developed or may develop

products (containing either alpha or beta interferon or other therapeutic compounds) or other treatment modalities for those uses.

can be no assurance that, if we are able to obtain regulatory approval of Alferon N Injection for the treatment of new indications, we

will be able to achieve any significant penetration into those markets.

In addition, because certain competitive products are not dependent

on a source of human blood cells, such products may be able to be produced in greater volume and at a lower cost than Alferon N Injection.

Currently, our wholesale price on a per unit basis of Alferon N Injection is higher than that of the competitive recombinant alpha and

beta interferon products.

Please see risk factor “ We may not be profitable unless we can protect our patents and/or receive

approval for additional pending patents ” above for additional information.

companies may succeed in developing products earlier than we do, obtaining approvals for such products from the FDA more rapidly than

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may issue shares to be used to meet our capital requirements or use shares to compensate employees, consultants and/or Directors.

have registered securities for public sale pursuant to a universal shelf registration statement which will allow us to raise additional

capital as needed in the future from the sale of our securities.

are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible into or exercisable

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Sales of a significant number of shares of our common stock in the public markets, or the perception that such

sales could occur as a result of our utilization of our shelf registration statement or otherwise could depress the market price of our

sales might occur could depress the market price of our

common stock and impair our ability to raise capital through the sale of additional equity securities.

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business, financial condition and operating results could be negatively affected as a result of actions by activist investors.

activist group (the “Activist Group”) submitted a notice (the “Notice”) to our Board, seeking to put forth three

individuals for election as directors to our four-person Board at our 2023 Annual Meeting.

The Activist Group includes many of the persons

who made a similar but failed attempt at our 2022 Annual Meeting.

The Board once again found that the Activist Group’s Notice was

invalid and rejected it.

After a full trial, the Delaware Chancery Court upheld our rejection.

2022, activist groups have attempted to replace our Board with candidates of their own at each of our last three annual meetings of stockholders

and litigation ensued.

proxy contest and related litigation, along the lines discussed above, could have a material adverse effect on us for the following reasons:

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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