What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-03-27 compared with 2025-03-27 · 151 added, 130 removed, 721 unchanged (28% of the section changed)

25 unchanged sentences

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.

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, 2025, 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

(deficit) was approximately ($9,783,000).

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

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

listed on the Exchange.

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

95 unchanged sentences

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;

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.

37 unchanged sentences

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

are a smaller reporting company, and the reduced disclosure requirements applicable to smaller reporting companies may make our common

stock less attractive to investors.

are a “smaller reporting company” as defined in the Exchange Act.

We may take advantage of certain of the scaled disclosures

available to smaller reporting companies until the fiscal year following the determination that our voting and non-voting common stock

held by non-affiliates is $250 million or more measured on the last business day of our second fiscal quarter, or our annual revenues

are less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates

is $700 million or more measured on the last business day of our second fiscal quarter.

is possible that some investors will find our common stock less attractive as a result of the foregoing, which may result in a less active

trading market for our common stock and higher volatility in our stock price.

Associated with Our Business

3 unchanged sentences

As of December 31, 2025, we had approximately $3,047,000

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.

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

4 unchanged sentences

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

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.

of December 31, 2025, our accumulated deficit was approximately $440,786,000.

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.

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

37 unchanged sentences

However, there are a number of additional actions that must occur before we would be able to commence commercial sales in Argentina.

For example, Ampligen is still in the process of release testing the product that has already been sent.

FDA’s regulatory review and approval process is extensive, lengthy, expensive and inherently uncertain.

To receive approval for

a product candidate, we must, among other things, demonstrate to the FDA’s satisfaction with substantial evidence from well-controlled

pre-clinical and clinical trials that the product candidate is both safe and effective for each indication for which approval is sought.

Before we can sell Ampligen for any use or promote Alferon N Injection for any use other than as Alferon N Injection for treatment of

refractory or recurring genital warts, we will need to file the appropriate NDA with the FDA in the U.S.

and the appropriate regulatory

agency outside of the U.S.

To receive approval

for a product candidate, we must, among other things, demonstrate to the FDA’s satisfaction with substantial evidence from

well-controlled pre-clinical and clinical trials that the product candidate is both safe and effective for each indication for which

approval is sought.

Before we can sell Ampligen for any use or promote Alferon N Injection for any use other than as Alferon N

Injection for treatment of refractory or recurring genital warts, we will need to file the appropriate NDA with the FDA in the U.S.

and the appropriate regulatory agency outside of the U.S.

where we intend to market and sell such products.

At present the only NDA we have filed with the FDA is the

NDA for the use of Ampligen to treat CFS.

The FDA issued a Complete Response Letter (“CRL”) in February 2013 for this NDA

and provided recommendations to address certain outstanding issues before they could approve Ampligen for Commercial Sales.

stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the treatment of CFS and that the data

do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database

and multiple discrepancies within the submitted data.

The FDA indicated that we needed to conduct additional work.

Therefore, ultimate

FDA approval, if any, may be delayed indefinitely and may require us to expend more resources than we have available.

It is also possible

that additional studies, if performed and completed, may not be successful or considered sufficient by the FDA for approval or even to

make our applications approvable.

If any of these outcomes occur, we may be forced to abandon one or more of our future applications

for approval, which might significantly harm our business and prospects.

As a result, we cannot predict if or when we might receive regulatory

approval for the use of Ampligen to treat CFS or for the use of any other products.

Even if regulatory approval from the FDA is received

for the use of Ampligen to treat CFS or eventually, for the use of any other product, any approvals that we obtain could contain significant

limitations in the form of narrow indications, patient populations, warnings, precautions or contra-indications or other conditions of

use, or the requirement that we implement a risk evaluation and mitigation strategy.

In such an event, our ability to generate revenues

from such products could be greatly reduced and our business could be harmed.

We have filed an NDA

with the FDA for the use of Ampligen to treat CFS.

The FDA issued a Complete Response Letter (“CRL”) in

February 2013 for this NDA and provided recommendations to address certain outstanding issues before they could approve Ampligen for

Commercial Sales.

The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for the

treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due

to the limited size of the safety database and multiple discrepancies within the submitted data.

The FDA indicated that we needed to

conduct additional work.

Therefore, ultimate FDA approval, if any, may be delayed indefinitely and may require us to expend more

resources than we have available.

It is also possible that additional studies, if performed and completed, may not be successful or

considered sufficient by the FDA for approval or even to make our applications approvable.

If any of these outcomes occur, we may be

forced to abandon one or more of our future applications for approval, which might significantly harm our business and prospects.

a result, we cannot predict if or when we might receive regulatory approval for the use of Ampligen to treat CFS or for any other

uses, or for the use of any other products.

Even if regulatory approval from the FDA is received for the use of Ampligen to treat

CFS or for any other uses, or, eventually, for the use of any other product, any approvals that we obtain could contain significant

limitations in the form of narrow indications, patient populations, warnings, precautions or contra-indications or other conditions

of use, or the requirement that we implement a risk evaluation and mitigation strategy.

In such an event, our ability to generate

revenues from such products could be greatly reduced and our business could be harmed.

we are unable to gain necessary FDA approvals related to Ampligen and Alferon N Injection on a timely basis, or we are unable to generate

7 unchanged sentences

clinical trials and other studies, a product candidate could fail to receive regulatory approval for many reasons, including the following:

be able to demonstrate to the satisfaction of the FDA that our product candidate is safe and effective for any indication;

be able to demonstrate to the satisfaction of the FDA that our product candidate is safe

and effective for any indication;

FDA may disagree with the design or implementation of our clinical trials or other studies;

results of the clinical trials or other studies may not demonstrate that a product candidate’s clinical and other benefits

outweigh its safety risks;

results of the clinical trials or other studies may not demonstrate that a product candidate’s

clinical and other benefits outweigh its safety risks;

FDA may disagree with our interpretation of data from clinical trials or other studies;

data collected from clinical trials and other studies of a product candidate may not be sufficient to support the submission of an

approval policies or regulations of the FDA may significantly change in a manner rendering our clinical and other study data insufficient

for approval;

data collected from clinical trials and other studies of a product candidate may not be sufficient

to support the submission of an NDA;

approval policies or regulations of the FDA may significantly change in a manner rendering

our clinical and other study data insufficient for approval;

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

18 unchanged sentences

organizations.

Significant uncertainty exists as to the reimbursement status of newly approved health care products, and from time to

time legislation is proposed, which, if adopted, could further restrict the prices charged by and/or amounts reimbursable to manufacturers

Significant uncertainty exists as to the reimbursement status of newly approved health care products, and from time-to-time

legislation is proposed, which, if adopted, could further restrict the prices charged by and/or amounts reimbursable to manufacturers

of pharmaceutical products.

26 unchanged sentences

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

Please see Item

Cybersecurity in Part I.

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 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.

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

17 unchanged sentences

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

Deposit Insurance Corporation (“FDIC”), and the loss of such assets would have a severe negative affect on our operations

Deposit Insurance Corporation (“FDIC”), and the loss of such assets would have a severe negative effect on our operations

and liquidity.

147 unchanged sentences

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

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

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

may be required by the FDA.

7 unchanged sentences

Associated with Our Manufacturing

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, or if we are unable to identify a CMO or CMOs that meet our requirements, then our operations

would most likely be materially and/or adversely affected.

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.

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

24 unchanged sentences

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

we produced limited quantities of API for our products in our prior 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.

21 unchanged sentences

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

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, or if we are unable to identify a CMO or CMOs that meet our requirements, then our operations

would most likely be materially and/or adversely affected.

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 prior

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.

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

and packing sets for Alferon N Injection and Ampligen.

are a limited number of organizations in the United States available to provide the final steps in the manufacturing for Alferon N Injection

and Ampligen.

To formulate, fill, finish and package our products (“fill and finish”), we require an FDA-approved third party

and packing sets for Ampligen and Alferon N Injection.

are a limited number of organizations in the United States available to provide the final steps in the manufacturing for Ampligen and

Alferon N Injection.

To formulate, fill, finish and package our products (“fill and finish”), we require an FDA-approved

third party CMO.

January 2017, we approved a quote and provided a purchase order with Jubilant HollisterStier LLC pursuant to which Jubilant manufactured

11 unchanged sentences

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.

The costs and availability of products and materials we

need for the production of Ampligen and the commercial production of Alferon N Injection and other products which we may commercially

produce are subject to fluctuation depending on a variety of factors beyond our control, including competitive factors, changes in technology,

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

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

The costs and availability of products and materials we need for

the production of Ampligen and the commercial production of Alferon N Injection and other products which we may commercially produce

are subject to fluctuation depending on a variety of factors beyond our control, including competitive factors, changes in technology,

and FDA and other governmental regulations and there can be no assurance that we will be able to obtain such products and materials on

45 unchanged sentences

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

Ampligen) in the Argentine Republic

for the treatment of severe CFS.

The product will be marketed by GP Pharm, our commercial partner in Latin America.

In September 2019,

we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales.

We are currently working

with GP Pharma on the commercial launch of Ampligen in Argentina.

Commercialization in Argentina will require, among other things, GP

Pharm to establish disease awareness, medical education, creation of an appropriate reimbursement level, design of marketing strategies

and completion of manufacturing preparations for launch.

Ampligen) in the Argentine

Republic for the treatment of severe CFS.

The product will be marketed by GP Pharm, now renamed Filaxis, our commercial partner in

Latin America.

In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and

subsequent sales.

We are currently working with Filaxis on the commercial launch of Ampligen in Argentina.

Commercialization in

Argentina will require, among other things, Filaxis to establish disease awareness, medical education, creation of an appropriate

reimbursement level, design of marketing strategies and completion of manufacturing preparations for launch.

next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting

1 unchanged sentence

This testing and approval process is currently delayed due ANMAT’s internal processes.

Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in Argentina.

Once final approval by ANMAT is obtained, Filaxis will begin distributing Ampligen in Argentina.

We continue to pursue our Ampligen

36 unchanged sentences

products may be subject to substantial competition.

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.

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 (“Post-COVID conditions”), as well as multiple types of cancers.

With regard to COVID-19,

11 unchanged sentences

and human clinical trials of pharmaceutical products and in obtaining FDA, The Health Protection Branch of the Canada Department of National

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

Health and Welfare (“HPB”), European Medicines Agency (EMA) and other regulatory approvals of products.

Accordingly, our competitors may succeed in obtaining

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

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

There are no drugs approved for U.S.

72 unchanged sentences

has ranged from $1.21 to $24.25 per share.

For the two months ended February 28, 2026, the trading price of our common stock has ranged

from $0.79 to $1.30 per share.

We expect the price of our common stock to remain volatile.

The average daily trading volume

of our common stock varies significantly.

The average daily trading volume of our common

stock varies significantly.

of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress

4 unchanged sentences

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

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.

We cannot predict the effect that

future sales of our common stock or the market perception that we are permitted to sell a significant number of our securities would

have on the market price of our common stock.

Please see Item 7- “Management’s Discussion and Analysis of Financial Condition

and Result of Operations;

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.

We cannot predict the effect that future sales of our common stock or the market perception that we are permitted

to sell a significant number of our securities would have on the market price of our common stock.

Please see Item 7- “Management’s

Discussion and Analysis of Financial Condition and Result of Operations;

Liquidity and Capital Resources” in PART II.

19 unchanged sentences

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

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:

investors may attempt to effect changes in our governance and strategic direction or to acquire control over the Board or AIM.

particular, if the Activist is successful in its litigation and subsequent proxy contest, it may gain control of the Board.

we welcome the opinions of all stockholders, responding to proxy contests and related litigation by activist investors is likely

to be costly and time-consuming, disrupt our operations, and potentially divert the attention of our Board, management team and other

employees away from their regular duties and the pursuit of business opportunities to enhance stockholder value.

uncertainties as to our future direction as a result of potential changes to the composition of the Board may lead to the perception

of a change in the strategic direction of the business, instability or lack of continuity, which may cause concern to our existing

or potential strategic partners, customers, employees and stockholders;

proxy contest and related litigation could have a material adverse effect on us for the following reasons:

investors may attempt to effect changes in our governance and strategic direction or to acquire

control over the Board or AIM.

In particular, if the Activist is successful in its litigation

and subsequent proxy contest, it may gain control of the Board.

we welcome the opinions of all stockholders, responding to proxy contests and related litigation

by activist investors is likely to be costly and time-consuming, disrupt our operations,

and potentially divert the attention of our Board, management team and other employees away

from their regular duties and the pursuit of business opportunities to enhance stockholder

uncertainties as to our future direction as a result of potential changes to the composition

of the Board may lead to the perception of a change in the strategic direction of the business,

instability or lack of continuity, which may cause concern to our existing or potential strategic

partners, customers, employees and stockholders;

may be exploited by our competitors;

may result in the loss

of potential business opportunities or limit our ability to timely initiate or advance clinical trials;

and may make it more difficult

to attract and retain qualified personnel and business partners.

contests and related litigation by activist investors could cause significant fluctuations in our stock price based on temporary

or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our

result in the loss of potential business opportunities or limit our ability to timely initiate

or advance clinical trials;

and may make it more difficult to attract and retain qualified

personnel and business partners.

contests and related litigation by activist investors could cause significant fluctuations

in our stock price based on temporary or speculative market perceptions or other factors

that do not necessarily reflect the underlying fundamentals and prospects of our business.

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