AIM 10-K & 10-Q changes, risk factors and insider trading
AIM ImmunoTech Inc. · NYSE · Biological Products, (No Diagnostic Substances) · CIK 946644 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “We are a smaller reporting company, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.”
Largest changes
“We are a smaller reporting company, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.”see in full comparison
“We 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 …”see in full comparison
“Since 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.”see in full comparison
“We are exploring engaging a Contract Manufacturing Organization (“CMO”) to produce Alferon active pharmaceutical ingredients (“API”). 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.”see in full comparison
“We are exploring engaging a Contract Manufacturing Organization (“CMO”) to produce Alferon active pharmaceutical ingredients (“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 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.”see in full comparison
“It 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.”see in full comparison
Full comparison: every changed paragraph (29)
We
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 not
able to regain compliance by June 11, 2026, our common stock may be delisted from the Exchange. As of December 31, 2024,2025, our stockholders’
(deficit) was $1.3approximately million.($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
standards. We
intend to take all reasonable measures available to regain compliance under the Exchange’s listing rules and remain
listed on the
Exchange.
We are a smaller reporting company, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
We 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.
It 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.
The
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, 2024,2025, we had approximately $4.0$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.
As
of December 31, 2024,2025, our accumulated deficit was approximately $426.8 million.$440,786,000. As with many biotechnology companies, we have not yet generated
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.
While
we received approval of our Argentinian NDA from ANMAT for commercial sale of rintatolimod (U.S. tradename: Ampligen) in the Argentine
Republic for the treatment of severe ME/CFS, ANMAT approval is only an initial, but important, step in the overall successful commercialization
of our product. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent
sales. 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.
The
FDA’s regulatory review and approval process is extensive, lengthy, expensive and inherently uncertain. To receive approval
for for
a product candidate, we must, among other things, demonstrate to the FDA’s satisfaction with substantial evidence from
well-controlled 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 weWe have filed an NDA
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. 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. As
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 of
use, or the requirement that we implement a risk evaluation and mitigation strategy. In such an event, our ability to generate
revenues revenues
from such products could be greatly reduced and our business could be harmed.
Our
ability to successfully commercialize our products will depend, in part, on the extent to which reimbursement for the cost of such products
and related treatment will be available from government health administration authorities, private health coverage insurers and other
organizations. Significant uncertainty exists as to the reimbursement status of newly approved health care products, and from time totime-to-time
time legislation is proposed, which, if adopted, could further restrict the prices charged by and/or amounts reimbursable to manufacturers
of pharmaceutical products. We cannot predict what, if any, legislation will ultimately be adopted or the impact of such legislation
on us. There can be no assurance that third partythird-party insurance companies will allow us to charge and receive payments for products sufficient
to realize an appropriate return on our investment in product development.
We utilize various software applications and other information technology that are critically important to our business operations. We rely 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. Please see Item 1C. Cybersecurity in Part I.
Our
success is dependent on the continued efforts of our staff, especially certain doctors and researchers. The loss of the services of personnel
personnel key to our operationsoperations, 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.
We
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 affecteffect on our operations
and liquidity.
The
FDAFDA, in its February 1, 2013 CRL 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 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.
If
approved, one or more of the potential side effects of the drug might deter usage of Ampligen in certain clinical situations and therefore,therefore
could adversely affect potential revenues and physician/patient acceptability of our product.
To
date, no consistent policy has emerged regarding the breadth of protection afforded by pharmaceutical and biotechnology patents. There
can be no assurance that new patent applications relating to our products, process or technology will result in patents being issued
or that, if issued, such patents will afford meaningful protection against competitors with similar technology. It is generally anticipated
that there may be significant litigation in the industry regarding patent and intellectual property rights. Such litigation could require
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 filedfiled, 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.
We
cannot predict what additional studies and/or additional testingtesting, or information may be required by the FDA. Accordingly, we are unable
to estimate the nature, timing, costs and necessary efforts to complete these projects nor the anticipated completion dates. In addition,
we have no basis for estimating when material net cash inflows may commence. We have yet to generate significant revenues from the sale
of these developmental products.
Due
to the inherent uncertainty involved in the design and conduct of clinical trials and the applicable regulatory requirements, including
the factors discussed belowabove in “Business” we cannot predict what additional studies and/or additional testingtesting, or information
may be required by the FDA. In addition, most of our studies to date have involved only a small group of participants and positive results
in such a small group does not mean that such results will prove true in studies with a much larger group of participants. Accordingly,
we are unable to estimate the nature, timing, costs and necessary efforts to complete these projects nor the anticipated completion dates.
In addition, we have no basis for estimating when material net cash inflows may commence. We have yet to generate significant revenues
from the sale of these developmental products. Please see “We will require additional financing which may not be available”
above.
We
are exploring engaging a Contract Manufacturing Organization (“CMO”) to produce Alferon active pharmaceutical ingredients
(“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 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.
While
we produced limited quantities of API for our products in our oldprior 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
needs. 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. 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.below.
We are exploring engaging a Contract Manufacturing Organization (“CMO”) to produce Alferon active pharmaceutical ingredients (“API”). 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.
There
are limited number of organizations in the United States available to provide the final manufacturing steps of formulation, fill, finish
and packing sets for Ampligen and Alferon N Injection and Ampligen.Injection.
There
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
and Ampligen.Injection. To formulate, fill, finish and package our products (“fill and finish”), we require an FDA-approved
third party
CMO.
Should
there be an unanticipated delay in producing or receiving new product,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 inmanufacturing the manufacturingprocess,
process, we may be unable to manufacture Alferon N InjectionAmpligen and/or Ampligen.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
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
terms acceptable to us or at all.
We
have received approval of our NDA from ANMAT for commercial sale of rintatolimod (U.S. tradename: Ampligen) in the Argentine
Republic 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 GP PharmaFilaxis on the commercial launch of Ampligen in Argentina. Commercialization in
Argentina will require, among other things, GP
PharmFilaxis to establish disease awareness, medical education, creation of an appropriate
reimbursement level, design of marketing strategies
and completion of manufacturing preparations for launch.
The
next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting
final approval to begin commercial sales. This testing and approval process is currently delayed due ANMAT’s internal processes.
Once final approval by ANMAT is obtained, GP PharmFilaxis will begin distributing Ampligen in Argentina. We continue to pursue our Ampligen
NDA, for the treatment of CFS with the FDA.
Ampligen.
Our flagship product, Ampligen, is being evaluated as a potential treatment for COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome
syndrome (ME/CFS) and COVID-induced CFS symptoms (“LongPost-COVID Haulersconditions”), as well as multiple types of cancers. With regard to COVID-19,
multiple global companies are actively working to develop therapies for COVID-19, including several companies which have successfully
developed vaccines and treatments. It is possible that these or other companies may be developing therapies that are similar to that
which we are attempting to develop,develop and could therefore develop them first. Some of these potential products may have an entirely different
approach or means of accomplishing similar therapeutic effects to products being developed by us. These competing products may be more
effective and less costly than our products. In addition, conventional drug therapy, surgery and other more familiar treatments may offer
competition to our products. Furthermore, many of our competitors have significantly greater experience than we do in preclinical testing
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”), European Medicines Agency (EMA) and other regulatory approvals of products. Accordingly, our competitors may succeed in obtaining
FDA, HPBHPB, EMA or other regulatory product approvals more rapidly than us. There are no drugs approved for U.S. commercial sale for the treatment
of CFS; 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.
Our
common stock is listed for quotation on the NYSE American. For the year ended December 31, 2024,2025, the trading price of our common stock
has ranged from $0.18$1.21 to $0.61$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.
Since
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.
A
proxy contest and related litigation, along the lines discussed above,litigation could have a material adverse effect on us for the following reasons:
Management's Discussion & Analysis (MD&A)
New heading “Interest and other income”
New heading “Warrant issuances”
Largest changes
“If the common stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire the common stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.”see in full comparison
“As part of the Plan, we will be holding a special meeting of stockholders solely for the purpose of authorizing a reverse split of our outstanding shares. The proxy statement for that meeting has been filed with the SEC and is available on the SEC’s website. We believe that effecting a reverse split will assist us with raising capital we need to continue our business and avoiding an automatic delisting if the stock price drops to $0.10 per share.”see in full comparison
“To maintain our listing on the NYSE American (the “Exchange”), among other things, we are required to maintain Stockholders Equity of $6,000,000 or we may receive a warning or a delisting notice.”see in full comparison
“The exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. …”see in full comparison
“Cash used in operating activities for the year ended December 31, 2025, was approximately $10,957,000 compared with approximately $14,888,000 for the same period in 2024, a decrease of $3,931,000. Net cash used in operating activities for the year ended December 31, 2025, was impacted by a net loss of approximately $13,958,000, an improvement from a net loss of approximately $17,320,000 in 2024. …”see in full comparison
“Cash provided by investing activities was $4,706,000 in 2024, a significant improvement from $(832,000) in 2023, reflecting a $5,538,000 year-over-year increase. The primary driver of this improvement was $5,623,000 in proceeds from the sale of marketable securities in 2024, compared to $1,299,000 in 2023. Additionally, purchases of marketable securities declined to $361,000 in 2024 from $1,593,000 in the prior year, further contributing to the positive cash flow impact. …”see in full comparison
Full comparison: every changed paragraph (60)
These improvements were offset by:
Interest and other income
Interest and other income was $3,183,000 and $5,192,000 for the years ended December 31, 2025, and 2024, respectively. Other income for the year ended December 31, 2025, was primarily attributable to an agreement reached with a vendor surrounding disputed legal fees. The agreement related to a liability classified as accounts payable of $4,916,000 and stipulated that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000. The forgiven fees were classified as other income in 2025. Primary components of other income for the year ended December 31, 2024, included D&O insurance proceeds of $4,250,000 and a vendor credit of $657,000. None of the above-mentioned items are considered recurring.
For
the years ended December 31, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue
was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to
Ampligen® for treatment in an open-label safety study.
For
the years ended December 31,202431,2025 and 2023,2024, production costs were approximately $31,000$128,000 and $42,000,$31,000, respectively, reflecting aan decreaseincrease
of $11,000$97,000 in the current period. This reductionincrease was primarily due to the increase in production costs incurred for of the manufacturing
of Ampligen
in the last quarter of 2023, which did not recur in 2024.Ampligen.
For
the year ended December 31, 2024,2025, research and development (“R&D”) expenses totaled approximately $6,197,000,$3,924,000, compared
to $10,939,000$6,197,000 in the prior year, representing a decrease of approximately $4,742,000.$2,273,000. This reduction was primarily driven by a $3,216,000$1,290,000
decrease in company sponsored clinical trial expenses andexpenses, a $1,622,000$1,920,000 reduction in outsidesalaries and consultant costs.fees, a $163,000 decrease in
rent and office expenses, and $18,000 net in other cost reductions. This is offset by an increase in patent and trademark expenses of
$1,053,000 together with a $65,000 increase in IT expenses.
For
the years ended December 31, 20242025, and 2023,2024, general and administrative
(“G&A”) expenses were approximately $13,714,000
$7,700,000 and $21,137,000,$13,714,000, respectively, reflecting a decrease of approximately
$7,423,000. $6,014,000. This reduction was primarily driven by
a $7,211,000$4,384,000 decrease in legal, financial and consulting fees, which were higher in
the prior year due to expenses incurred in
response to stockholder nomination litigation issuesissues. Also contributing to, the reduction was a decrease of $544,000 in 2023.stock comp
expenses, a decrease of $469,000 of investment banker fees, a $448,000 decrease in salaries, a $236,000 decrease in public relation
expenses, a $195,000 decrease in director fees, a $37,000 decrease in insurance expenses, a $27,000 decrease in office supplies and
expenses, and an $18,000 decrease in travel expenses, which is offset by an increase in rent expense of $46,000, taxes and license
fees of $160,000, an increase in SEC filing fees of $115,000, and $23,000 of increases in other expenses.
For
the years ended December 31, 2024,2025, and 2023,2024, gain (loss) on investments was approximately 17,000 and ($93,000) and $200,000,, respectively, reflecting
an increase in investment lossesgain of approximately $293,000.$110,000. This lossgain was primarily driven by changes in the fair value of equity investments.
Warrant issuances
On July 30, 2025, we announced the closing of a public offering of an aggregate of 2,000,000 shares of our common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants. The warrants were issued with an exercise price of $4.00 per share and were exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8,000,000. Maxim Group LLC acted as sole placement agent in connection with this offering.
Based on a review of the Class E and F warrants, it was determined that the warrants met the liability criteria described in Accounting Standards Codification 480. Accordingly, as the warrants might require us to issue additional stock under certain circumstances, a loss was recognized and the resulting computed value was classified as a liability on our balance sheet at December 31, 2025.
In
2024,the prior year, we recognized a ($1,604,000) impact related to the sale of our net operating losses (NOLs) under the New Jersey Technology
Business Business
Tax Certificate Transfer Program, compared to a $1,667,000 benefit in 2023.Program. This decline was primarily due to our company reaching the
program’s lifetime cap of
$20,000,000 in cumulative NOL sales. Accordingly, as of December 31, 2025, we had no remaining net operating loss carryforwards available
for future sales.
Cash used in operating activities for the year ended December 31, 2025, was approximately $10,957,000 compared with approximately $14,888,000 for the same period in 2024, a decrease of $3,931,000. Net cash used in operating activities for the year ended December 31, 2025, was impacted by a net loss of approximately $13,958,000, an improvement from a net loss of approximately $17,320,000 in 2024. This reduction was largely driven by a $4,385,000 decrease in legal, financial and consulting fees, which were higher in the prior year due to expenses incurred in response to stockholder nomination litigation issues. Non- cash operating activity adjustments were $3,879,000 for the year ended December 31, 2025, compared with $2,136,000 for the year ended December 31, 2024. In 2025, $1,138,000 of patents and trademarks expired or were abandoned compared with $48,000 in the prior year. Additionally, during the year ended December 31, 2025, the Company recognized a gain of $3,041,000 from the settlement of disputed legal fees and a loss of $4,411,000 from the issuance of class E and F warrants. During the year ended December 31, 2024, significant non-cash operating activity adjustments included $686,000 of equity based compensation, compared with $60,000 during the year ended December 31, 2025.
Changes in cash flows from operating activities related to changes in assets and liabilities were ($878,000) and $296,000 for the years ended December 31, 2025, and 2024, respectively. During the year ended December 31, 2024, the Company received $1,184,000 from the sale of New Jersey operating losses. In the prior year, we recognized proceeds from the sale of our net operating losses (NOLs) under the New Jersey Technology Business Tax Certificate Transfer Program. In 2024 the Company reached the program’s lifetime cap of $20,000,000 in cumulative NOL sales. Accordingly, as of December 31, 2025, we had no remaining net operating loss carryforwards available for future sales.
Cash provided by investing activities was $1,853,000 in 2025 and $4,706,000 in 2024, reflecting a $2,853,000 year-over-year decrease. The primary driver of this decrease was $2,322,000 in proceeds from the sale of marketable securities in 2025, compared with $5,623,000 in 2024.
Cash provided by financing activities totaled $10,388,000 in 2025, compared with $6,444,000 in 2024, reflecting a $3,944,000 year-over-year increase. This increase was primarily driven by the proceeds of $7,314,000 from the issuance of warrants compared with $3,303,000 from warrant transactions during the year ended December 31, 2024.
Cash
used in operating activities for the year ended December 31, 2024, was approximately $14,888,000 compared to approximately $21,267,000
for the same period in 2023, a decrease of $6,379,000. Net cash used in operating activities for the year ended December 31, 2024 was
impacted by a net loss of approximately $17,320,000, an improvement from approximately $28,962,000 in 2023. However, since net loss includes
significant non-cash expenses, actual cash from operations was influenced by several adjustments. Non-cash adjustments comparing 2024
to 2023 included a decrease of $2,000 in depreciation of property, plant, and equipment, an increase of $10,000 in amortization of patents
and trademarks, an increase of $301,000 in amortization of financial obligations. Other significant non-cash expenses included $17,000
in non-cash lease expenses and $443,000 in equity-based compensation. Additionally, we recognized a $293,000 loss on the sale of marketable
securities, a $458,000 loss related to the valuation of warrants, a $34,000 loss from patent abandonments. Proceeds from the sale of fixed assets were $0 in 2024, compared to $18,000 in 2023, reflecting a decrease in asset
sales and related cash inflows year-over-year. These were partially offset
by a $692,000 gain from funds received under the New Jersey NOL program and a $50,000 reduction in prepaid expenses. Changes in working
capital also impacted operating cash flows, with a $6,126,000 decrease in accounts payable, a $2,378,000 decrease in accrued expenses,
a $1,062,000 increase in other assets, and a $35,000 decrease in lease liabilities. Collectively, these factors contributed to the overall
cash flow from operating activities during the period.
Cash
provided by investing activities was $4,706,000 in 2024, a significant improvement from $(832,000) in 2023, reflecting a $5,538,000 year-over-year
increase. The primary driver of this improvement was $5,623,000 in proceeds from the sale of marketable securities in 2024, compared
to $1,299,000 in 2023. Additionally, purchases of marketable securities declined to $361,000 in 2024 from $1,593,000 in the prior year,
further contributing to the positive cash flow impact. The Company continued investing in intellectual property, with $538,000 spent
on patents and trademarks in 2024, compared to $585,000 in 2023. Capital expenditures included $18,000 in purchases of property, plant,
and equipment (PP&E) in 2024, whereas 2023 included $47,000 in proceeds from the sale of PP&E. The overall increase in net investing
cash flow was primarily attributable to higher proceeds from marketable securities and lower investment purchases, improving the company’s
liquidity position.
Cash
provided by financing activities totaled $6,444,000 in 2024, a significant increase compared to $485,000 in 2023, reflecting a
$5,959,000 year-over-year improvement. This increase was primarily driven by $892,000 in net proceeds from the sale of stock in
2024, up from $485,000 in 2023. Additionally, the company secured $2,500,000 in proceeds from the issuance of notes payable,
compared to zero in the prior year. Another key factor was a $3,303,000 non-cash warrant valuation adjustment in 2024, which had no
comparable entry in 2023. In 2024, we repaid $251,000 in debt, whereas no debt repayments were made in 2023. These financing
activities strengthened the company’s liquidity position and provided additional capital to support ongoing operations and
strategic initiatives.
InWe
addition,continued weto have sufferedreport losses from operations as of December 31, 2024,2025, and have a working capital deficit. These conditions raise substantial
substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of the issuance
of these consolidated
financial statements. See Note 1 to our audited Consolidated Financial Statements. Please
see “Risk Factors - We 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.”
The
accompanying audited consolidated financial statements have been prepared assuming that we will continue as a going concern. On December
December 31, 2024,2025, our current liabilities exceeded our current assets by $5,359,000$2,929,000 which raisedfurther raises doubt about our ability to continue
continue as a going concern. Additionally, at December 31, 2024,2025, our stockholders’ equity was below the minimum requirements
for continued
listing on the NYSE American. However, please see “Class E and Class F Warrant Reclassification” in Item 1. Business above.
At
December 31, 2024, Management
evaluated the conditions, and theirthe significance of those conditions related to our ability to meet our obligations
and andnoted a working capital deficit of $5,359,000. It was determined that
the primary cause of the working capital deficit was related
to an accounts payable balance of approximately $6,400,000. This balance
includes included approximately $4,900,000 of legal fees related to litigation.
During We2025 arewe currentlysuccessfully negotiatingnegotiated with the law firm to reduce prior
billings. These negotiations areresulted ongoingin anda could,favorable if resolved favorably to us,outcome
which partially alleviatemitigated the working capital deficit.deficit in 2025.
On March 6, 2026, we completed a rights offering (the “2026 Rights Offering”) to our stockholders and to holders of certain of our outstanding options and warrants that had the right to participate in the 2026 Rights Offering as of February 10, 2026, the record date. In the Rights Offering we issued non-transferable subscription rights to purchase 1,842 Units. Each Unit consists of one share of Series G Convertible Preferred Stock (the “G Preferred”) and 2,000 warrants to purchase common stock (the “G Warrants”). Each share of G Preferred is convertible, at the option of the holder at any time, into a number of shares of our common stock equal to the quotient of the stated value of the Preferred Stock ($1,000) divided by $1.00, the conversion price. Each G Warrant is exercisable for one share of our common stock at an exercise price of $1.00 per share from March 6, 2026, the date of issuance, through its expiration five years from the date of issuance. Although the 2026 Rights Offering closed after Fiscal year end December 31, 2025, it raised approximately $1,800,000 in gross proceeds.
On
September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature
of the remaining execution fee of $725,437. The amendment allowed that the remainder would not be exclusive to the agreement dated on
April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied
to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to
exhaust the balance, that the refund would be refunded in cash. Due to the changes brought about by the amendment, the nature of the
payment changed to deposit status. At December 31, 2024,2025, we had an outstanding deposit of $653,000approximately $205,000, which may be used to
offset future
clinical research expenditures. This deposit is listed as a non-current asset on the balance sheet but could provide working
capital capital
if the timing of expenditures are realized within the next 12 months.
We entered into an amendment to a Promissory Note with our lender on March 10, 2026. The maturity date for the Note was extended until June 30, 2026. Other than the maturity date extension, there were no other changes to the agreement.
The
closing price of our common stock on the NYSE American on March 24, 2025 was $0.14 per share. On December 11, 2024, we
received an official
notice of noncompliance with the NYSE American’s continued listing requirements. This includes the need
for us to have stockholders’
equity of $6.0 million$6,000,000 or more. The NYSE American’s review showed that we were not in
compliance with that requirement. As required,
we submitted a plan (the “Plan”) to the NYSE American illustrating how we
can regain compliance by June 11, 2026. The Plan
includes a number of ways to raise capital. The NYSE American accepted our Plan on
February 26, 2025. If we are not able to regain compliance
by June 11, 2026, our common stock may be delisted from the NYSE
American. As of December 31, 2024,2025, our stockholders’ deficit was
approximately ($1.3$9,783,000) million.. We must increase our
stockholders’ equity to be at least $6 million$6,000,000 to regain compliance with this
rule. If we are not able to raise sufficient
capital as set forth in the Plan or by other means, we may be unable to regain compliance
with the NYSE American’s listing
standards standards, and our securities could be subject to delisting. In the event that the price of our
Common Stock drops to $0.10 per
share, our Common Stock will automatically be delisted from the NYSE American. However, please see “Class
E and Class F Warrant Reclassification” in Item 1. Business above.
On April 30, 2025, the Company held a special meeting of stockholders and authorized the Company’s Board of Directors to effect a reverse split at its discretion on a basis of up to one for 100 outstanding shares of Common Stock. On May 29, 2025, the Board authorized the Reverse Split and on June 10, 2025, the Company filed an amendment to its Articles of Incorporation effecting a reverse split of its outstanding shares of Common Stock on a one for 100 basis (the “Reverse Split”). Stockholders were given cash in lieu of any fractional shares on a post-split basis.
On June 11, 2025, the Company was notified by the Exchange that the Company had regained compliance with Section 1003(f)(v) of the Exchange’s Company Guide (low selling price) and that trading in the Company’s Common Stock was reinstated on the Exchange on June 17, 2025.
As
part of the Plan, we will be holding a special meeting of stockholders solely for the purpose of authorizing a reverse split of our outstanding
shares. The proxy statement for that meeting has been filed with the SEC and is available on the SEC’s website. We believe that
effecting a reverse split will assist us with raising capital we need to continue our business and avoiding an automatic delisting if
the stock price drops to $0.10 per share.
The
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. We 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. At present we do
not generate any material revenues from operations, and we do not anticipate doing so in the near future. We will need to obtain additional
funding in the future to continue operations and for new studies and/or if current studies do not yield positive results, require unanticipated
changes and/or additional studies.
Today,
some foursix years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics. Our quest to prove
the antiviral
activities of Ampligen continues. If Ampligen has the broad-spectrum antiviral properties that we believe that it has,
it could be a
very valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the
future. Unlike
most developing therapeutics which attack the virus, Ampligen works differently. We believe that it activates antiviral
immune system
pathways that fight not just a particular virus or viral variant, but other similar viruses as well.
Atlas Equity Line of Credit (Equity Purchase Agreement)
On March 28, 2024, we entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”) with Atlas Sciences, LLC, a Utah limited liability company (“Atlas”), pursuant to which Atlas committed to purchase up to $15,000,000 of our common stock. As of February 2025, the Purchase Agreement was no longer in effect.
As of December 31, 2025, a total of 30,829 shares had been issued pursuant to the purchase agreement for a total of approximately $398,000 after clearing costs. There were no shares issued subsequent to December 31, 2025.
Securities Purchase Agreement
May 2024 Securities Purchase Agreement
On May 31, 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which, on June 3, 2024, we issued to the Purchaser, (i) in a registered direct offering, 56,410 shares of our common stock (the “Shares”), par value $0.001 per share (“common stock”) and (ii) in a concurrent private placement, we issued to the Purchaser Class A common warrants to purchase an aggregate of up to 56,410 shares of our common stock (the “A Warrants”) at an exercise price of $36.30 per share and Class B common warrants to purchase an aggregate of up to 56,410 shares of our common stock (the “B “Warrants” and, along with the A Warrants, the “Common Warrants”) at an exercise price of $36.30 per share. The A Warrants and B Warrants are not exercisable for six months after the issuance date and expire, respectively, five years and six months and twenty-four months after the issuance date. The Common Warrants and the shares of common stock are issuable upon the exercise of such warrants are offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.
The Shares were offered by us pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022.
Pursuant to the terms of the Purchase Agreement, subject to certain exceptions, we could not issue any equity securities for 60 days following the issuance date, provided that we were able to utilize our at-the-market offering program with the Placement Agent after 30 days. Additionally, we cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after the issuance date. In addition, our executive officers and each of our directors have entered into lock-up agreements with us pursuant to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise dispose of our securities, subject to certain exceptions.
The exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants. If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for us, and may exercise every right and power that we may exercise and will assume all of our obligations under the Common Warrants with the same effect as if such successor entity had been named in the warrant itself. Common Warrant Holders will have additional rights defined in the Common Warrants. The Common Warrants are exercisable on a “cashless” basis only if there is not a current registration statement permitting public resale. In this regard, we filed a registration statement to register the resale of the Common Warrant Shares providing for the resale of the Shares issued and issuable upon exercise of the Common Warrants. That registration statement was declared effective by the SEC on July 11, 2024. We have agreed to use commercially reasonable efforts to cause such registration statement to keep such registration statement effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.
Maxim Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis, in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”), by and between us and the Placement Agent. Pursuant to the Placement Agency Agreement, the Placement Agent was paid a cash fee of 8% of the aggregate gross proceeds paid to us for the securities sold in the Transactions and reimbursement of certain out-of-pocket expenses.
We evaluated the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity and determined that they were in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification and are classified as equity within the consolidated financial statements. Proceeds allocated to such warrants totaled approximately $2,500,000. For the year ended December 31, 2025, no Common Warrants were exercised, and all remain outstanding on December 31, 2025, related to this agreement.
September 2024 Securities Purchase Agreement
On September 30, 2024, we entered into a Purchase Agreement with the Selling Stockholder as Purchaser, pursuant to which we issued to the Selling Stockholder, (i) in a registered direct offering, 46,530 shares of our common stock (“Shares”) and (ii) in the concurrent Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up to 46,530 Shares (the “Common Warrant Shares”) each with an exercise price of $28.00. The Class C and Class D Warrants together, hereinafter the “Common Warrants”. The purchase price for Shares in the registered direct offering was $28.00 per Share.
We received aggregate gross proceeds from the Transactions of approximately $1,260,000, before deducting fees to the Placement Agent and other estimated offering expenses payable by us. The Shares were offered by us pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared effective on February 4, 2022. The Common Warrants and the Common Warrant Shares issued in the Private Placement were not registered under the Securities Act. Rather the Common Warrants and the Common Warrant Shares were issued pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The Class C Warrants and the Class D Warrants are not exercisable until December 3, 2024, and will expire, respectively, twenty-four months and five years and six months after that date.
We evaluated the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity and determined that they were in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification and are classified as equity within the consolidated financial statements. Proceeds allocated to such warrants totaled approximately $2,500,000. For the year ended December 31, 2025, no Common Warrants were exercised, and all remain outstanding on December 31, 2025, related to this agreement.
Public Offering on a Registration Statement on Form S-1
On July 31, 2025, we announced the closing of our public offering of an aggregate of 2,000,000 shares of our common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants. The warrants had an exercise price of $4.00 per share and were exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8,000,000. Maxim Group LLC acted as sole placement agent in connection with this offering.
As of March 25, 2026, the adjusted exercise price of the Class E and Class F warrants was $1.439 per share, and the adjusted number of outstanding and unexercised Class E and Class F warrants was to purchase 5,078,619 and 4,760,610 shares of common stock, respectively.
Based on review of the Class E and F Warrants, it was determined that the warrants met the liability criteria as described in Accounting Standards Codification 480. As such, a loss was recognized and the resulting computed value was classified as a liability on the Company’s balance sheet at December 31, 2025 as the warrants might require the Company to issue additional stock under certain circumstances. While the warrants met the technical requirements of the accounting standard, the ultimate redemption of the warrants will not require any cash expenditure or transfer of assets by the Company. Any warrant exercises would result in additional cash and equity to the Company because the Company has a sufficient number of authorized and unissued shares available to satisfy the warrant exercises in shares. Subsequent to the year ended December 31, 2025, these warrants will be re-evaluated to determine if they should be reclassified to equity from liability. Please see “Class E and Class F Warrant Reclassification in Item 1. Business above.
As discussed above, on March 6, 2026, we completed a rights offering to our stockholders and to holders of certain of our outstanding options and warrants that had the right to participate in the rights offering as of February 10, 2026, the record date. It raised approximately $1,800,000 in gross proceeds.
NYSE American Continued Listing Requirements
To maintain our listing on the NYSE American (the “Exchange”), among other things, we are required to maintain Stockholders Equity of $6,000,000 or we may receive a warning or a delisting notice.
If the common stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire the common stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.
Possible Sources of Funding
Universal Shelf Registration Statement and At-The-Market Offering with Maxim On April 1, 2025, we entered into a new sales agreement (the “Sales Agreement”) with Maxim Group LLC (“Maxim”) pursuant to which we may issue and sell up to an aggregate of $3,000,000 shares of our common stock from time to time through Maxim acting as agent. Under the terms of the Sales Agreement, in no event will we, inter alia, issue or sell through the Sales Agreement such number or dollar amount of shares of common stock that would exceed the number or dollar amount of shares of common stock permitted to be sold under Form S-3 (including General Instruction I.B.6 thereof, if applicable).
Pursuant to the Sales Agreement, we will pay Maxim in cash, upon each sale of the common stock pursuant to the sales agreement, a commission in an amount equal to 3.0% of the aggregate gross proceeds from each sale of common stock. Because there is no minimum offering amount required as a condition to this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. We have agreed, under certain circumstances, to reimburse a portion of Maxim’s expenses, including legal fees up to a maximum of $50,000, and $5,000 on a quarterly basis thereafter.
The shares under the sales agreement will only be offered after a prospectus related to such offering is filed with the SEC. If and when the shares are offered, they will be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-286319), which was declared effective on July 3, 2025.
During the year ended December 31, 2025, we sold 155,874 shares under the ATM Sales Agreement for total gross proceeds of approximately $225,362, which includes a 3.0% fee to Maxim of $6,761. Subsequent to December 31, 2025, the Company has sold 2,025,292 shares under the ATM Sales Agreement for total gross proceeds of approximately $2,063,396, which includes a 3.0% fee to Maxim of approximately $61,901.
We
grant stock options, the valuation of which requires significant judgement. To estimate their fair value, we use the Black-ScholesBlack-Scholes-Merton pricing model,
which involves assumptions about stock volatility, expected option life, and risk-free interest rates. Changes in estimated volatility
or expected option life could have a material impact on stock-based compensation expenses.
What changed in the latest 10-Q
Risk Factors
New heading “We have issued a significant number of shares and warrants, which may result in substantial dilution to existing stockholders.”
Removed heading “We 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.”
Largest changes
“We 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.”see in full comparison
“We are not currently in compliance with the NYSE American’s stockholders’ equity rule because our stockholders’ equity is less than the required minimum of $6.0 million. Pursuant to the letter from the NYSE American informing us of this non-compliance, we submitted a Plan to the Exchange illustrating how we can regain compliance by June 11, 2026. The NYSE American accepted our plan, but, if we are unable to regain compliance by June 11, 2026, our common stock may be delisted from the NYSE American. As of March 31, 2026, our stockholders’ equity was approximately $2.1 million. …”see in full comparison
“We cannot assure you that we will be able to regain compliance with the NYSE American listing standards. Our failure to continue to meet these requirements would result in our common stock being delisted from the NYSE American. We and holders of our securities could be materially adversely impacted if our securities are delisted from the NYSE American. In particular:”see in full comparison
“We have issued a significant number of shares and warrants, which may result in substantial dilution to existing stockholders.”see in full comparison
“During the six months ended June 30, 2026, we completed multiple equity transactions, including a rights offering, inducement transactions, and registered direct offerings, which raised aggregate gross proceeds of approximately $10.4 million. These transactions resulted in the issuance of a substantial number of shares of common stock, preferred stock, and warrants. As of June 30, 2026, we had approximately 48.5 million warrants outstanding with various exercise prices. If all outstanding warrants are exercised, existing stockholders would experience significant dilution. …”see in full comparison
Please carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 27, 2026, which could materially affect our business, financial condition, or future results. The risks described in the above reports are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition and operating results. Please also see “Special Note Regarding Forward-Looking Statements” above. In addition to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, stockholders should carefully consider the following updates to our risk factors:see in full comparison
Full comparison: every changed paragraph (6)
Please carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 27, 2026, which could materially affect our business, financial condition, or future results. The risks described in the above reports are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition and operating results. Please also see “Special Note Regarding Forward-Looking Statements” above. In addition to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, stockholders should carefully consider the following updates to our risk factors:
We have issued a significant number of shares and warrants, which may result in substantial dilution to existing stockholders.
During the six months ended June 30, 2026, we completed multiple equity transactions, including a rights offering, inducement transactions, and registered direct offerings, which raised aggregate gross proceeds of approximately $10.4 million. These transactions resulted in the issuance of a substantial number of shares of common stock, preferred stock, and warrants. As of June 30, 2026, we had approximately 48.5 million warrants outstanding with various exercise prices. If all outstanding warrants are exercised, existing stockholders would experience significant dilution. Additionally, the exercise of these warrants or the sale of shares issuable upon exercise could depress the market price of our common stock. We may need to raise additional capital in the future, which could result in further dilution to stockholders.
We
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.
We
are not currently in compliance with the NYSE American’s stockholders’ equity rule because our stockholders’ equity
is less than the required minimum of $6.0 million. Pursuant to the letter from the NYSE American informing us of this non-compliance,
we submitted a Plan to the Exchange illustrating how we can regain compliance by June 11, 2026. The NYSE American accepted our plan,
but, if we are unable to regain compliance by June 11, 2026, our common stock may be delisted from the NYSE American. As of March 31,
2026, our stockholders’ equity was approximately $2.1 million. We must increase our stockholders’ equity to be at least $6.0
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 NYSE American’s listing standards. We intend to take all reasonable measures available to regain compliance under the NYSE
American listing rules and remain listed on the NYSE American.
We
cannot assure you that we will be able to regain compliance with the NYSE American listing standards. Our failure to continue to meet
these requirements would result in our common stock being delisted from the NYSE American. We and holders of our securities could be
materially adversely impacted if our securities are delisted from the NYSE American. In particular:
Management's Discussion & Analysis (MD&A)
New heading “Equity transactions”
New heading “Research and development”
New heading “General and administrative”
New heading “Equity transactions”
New heading “Research and development”
New heading “General and administrative”
New heading “Equity Distribution Agreement”
Largest changes
“The accompanying unaudited consolidated financial statements have been prepared assuming that we will continue as a going concern. On March 31, 2026, our current assets exceeded our current liabilities by $69 thousand which raised doubt about our ability to continue as a going concern. Additionally, at March 31, 2026, our stockholders’ equity was below the minimum requirements for continued listing on the NYSE American. See “Potential Delisting from the NYSE American” below. …”see in full comparison
“As of June 30, 2026, we did not have any off-balance sheet arrangements, as defined in Item 303(b) of Regulation S-K, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.”see in full comparison
On December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listingsee in full comparisonrequirements.requirements specificallyThis includes the need for usrelating tohavea required stockholders’ equity of $6 million or more. The NYSE American’s review showed that we were not in compliance with that requirement.As required, weWe submitted a plan (the “Plan”) to the NYSE Americanillustratingdetailing actionshowwecanwould take to regain compliance by June 11, 2026. ThePlan includes a number of ways to raise capital. TheNYSE American accepted our Plan on February 26, 2025. If wearehadnotbeenableunable to regain compliance by June 11, 2026, our common stockmaywasbesubjectdelistedto delisting from the NYSE American. As ofMarchJune31,30, 2026, our stockholders’ equity was$2.1$7.7 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 as set forth in the Plan or by other means, we may be unable to regain compliance with the NYSE American’s listing standards, and our securities could be subject to delisting. In the event that the price of our Common Stock drops to $0.10 per share, our Common Stock will automatically be delisted from the NYSE American.
“Ongoing operating losses combined with limited current working capital raised substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of the issuance of these consolidated financial statements. See Note 1 to our Unaudited Condensed Consolidated Financial Statements.”see in full comparison
“The Company entered into a warrant exercise inducement offer letter agreement, dated May 7, 2026 with holders of (i) Class A and Class B warrants to purchase common stock, par value $0.001 per share, issued on May 31, 2024; (ii) Class C and Class D Common Stock purchase warrants issued on September 30, 2024; and (iii) Class E and Class F Common Stock purchase warrants issued on July 31, 2025. …”see in full comparison
Full comparison: every changed paragraph (98)
Ampligen
is a wide-spectrum therapeutic that has shown positive safety and efficacy in clinical trials of many different solid tumor types. However,
based specifically on clinical success as to safety and efficacy in our pancreatic cancer Early Access Program and an ongoing Phase 2
trial, AIM has made the business decision to focus its efforts on the development of Ampligen for the treatment of late-stage pancreatic
cancer, as we believe that this path will potentially lead to the most lucrative outcome. PancreaticEach year pancreatic cancer killedkills more than
100,000 100,000
people in the American and European Union markets – and more than 450,000 people worldwide – as recently as 2022.worldwide. When AIM
looks at the global health
problem of pancreatic cancer, we see a large market in an unmet medical need and with relatively little clinical
competition. This large
unmet market is enhanced by an intellectual property program with broad-combination therapy patents in the United
States, Japan and Europe,
as well as market exclusivity provided by orphan drug designations in the United States and the European Union.
Oncology
is one of the areas of biotech known for multibillion-dollar mergers and acquisitions deals – large-market Phase 3 oncology clinical
trials with positive data are alwaysa adesirable focus for acquisition. AIM strongly believes that such a Phase 3 study will be possible following
the ongoing Phase 2 clinical study evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor
Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the
“DURIPANC” study). The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected
to enroll up to 25 subjects in the Phase 2 portion. The primary objective of the study is the clinical benefit rate of the combination
therapy. The secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring
using available tissue biopsies and peripheral immune profiling; and assessing quality of life. According to the Erasmus MC Cancer Institute,
the promising progression-free survival and overall survival seen in Phase 1 of the study – which we believe supported advancement
to the ongoing Phase 2 portion of the study – continue to be seenseen. As of June 30, 2026, all subjects have been enrolled in the
study and enrollmenthave isreceived ongoing.the first dose of study medication. Erasmus MC expects that detailed data
will be published later this year.
According to Erasmus MC, there has also been no significant toxicity – an encouraging safety
profile for a post-chemo setting –
and Ampligen subjects are consistently reporting “high” quality of life during treatment.
We
have received approval of our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe
CFS. The product would be marketed by GP Pharm – now Filaxis – our commercial partner in Latin America. Shipment of the drug
product to Argentina was initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution. In September
2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020,
we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. Collaboration
with Filaxis continues for commercial launch of Ampligen in Argentina.Argentina and they are currently in the process of renewing the existing
license. To successfully bring this to market, several key steps are necessary,
including building disease awareness, providing medical
education, securing appropriate reimbursement, developing effective market strategies,
and finalizing manufacturing preparations for
launch.
The
economic landscape in Argentina has changed dramatically since then,then with the country experiencing significant hyper-inflation.
As contracts
in Argentina are U.S. dollar contracts, the parties must evaluate the impact of the devaluation on the relationship and
the ability to
go forward on a U.S.-dollar basis. The combination of the cost and frequency of treatments has rendered CFS treatments
in Argentina cost
prohibitive, at least for the time being. We will therefore focus our efforts with Filaxis on an approval in Argentina
for pancreatic
cancer.
We
consider patent exclusivity as a crucial component of our business. As of MarchJune 31,30, 2026, we had 31 patents worldwide with 21 additional
pending patent applications comprising our intellectual property.
We
hold multiple patents related to the use of Ampligen as part of a combination therapy when combined with checkpoint inhibitors for the
treatment of cancer. The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment.
AIM’s “synergistic” patents include a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as
part of a combination oncology therapy when paired with an anti-PD-L1 antibody; a patent in Japan (expires December 20, 2039) for the
use of Ampligen in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer; and a patent
in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors,
such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). Additional “synergistic” patent applications
are pendingpending, and AIM will promptly announce when any such patent is issued. Additionally, in June 2025 we received a patent (expires January
25, 2041) covering methods involving the manufacture of a range of therapeutic double-stranded RNA (dsRNA) products, of which Ampligen
is included. Combined with our multiple compositions and methods patents involving Ampligen, this manufacturing patent, along with our
other issued patents, further secures our control over the synthesis and use of the first-in-class drug.
AIM
has made the business decision to focus its efforts on the development of Ampligen for the treatment of late-stage pancreatic cancer,
as we believe that this path will potentially lead to the most lucrative outcome. PancreaticEach year, pancreatic cancer killedkills more than 100,000
people in
the American and European Union markets – and more than 450,000 people worldwide – as recently as 2022.worldwide. AIM’s intellectual
property portfolio
includes orphan drug designations for pancreatic cancer in both the United States and Europe. The company announced
in March 2026 that
it would seek similar status in Japan.
In
May 2020, the FDA authorized an IND for Roswell Park to conduct a Phase 1/2a study of a regimen of Ampligen and interferon alpha in cancer
patients with COVID-19 infections. This clinical trial (NCT04379518), sponsored in collaboration with Roswell Park, was designed
to test
the safety of the combination regimen in patients with cancer and COVID-19, and the extent to which this therapy might promote
clearance clearance
of the SARS-CoV-2 virus from the upper airway. The first patient enrolled and treated in November 2020. This study was amended
to add
20 patients but ultimately terminated afterin January 2026 due to low accrual. Roswell Park reported partial results from the study. The study was terminated in January 2026 with study,
4 patients enrolledwere due to low accrual.enrolled.
The
AMP-511 Expanded Access Program (“AMP-511”) is an open-label treatment protocol allowing Ampligen access to severely debilitated
CFS patients. The AMP-511 protocol started in the 1990s and is ongoing. The data collected from the AMP-511 protocol through clinical
sites provide safety information regarding the use of Ampligen in patients with CFS. We are establishing an enlarged database of clinical
safety information which we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen
treatment. We believe that continued efforts to understand existing data, and to advance the development of new data and information,
will ultimately support our future filings for Ampligen and/or the design of future clinical studies that the FDA requested in a CRL.
The FDA approved an increased reimbursement level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs; which
was re-authorized in 2021, 2022, 2023, 20242024, 2025 and 2025.2026. At this time, we do not plan on passing this adjustment along to the patients
in in
this program.
In
October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include
patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms
known as Post-COVID conditions. As of MarchJune 31,30, 2026, there were 4 patients enrolled in this open-label expanded access treatment protocol
protocol (including one patient with Post-COVID Conditions). In July 2022, AIM reported positive preliminary results based on data from
the first
four Post-COVID Condition patients enrolled in the study. The data show that, by week 12, compared to baseline, the investigators observed
observed what they considered a clinically significant decrease in fatigue-related measures. To date, there have been eight such Post-COVID patients
patients treated in this study.
AIM’s operations, research and development facility is housed in the New Jersey Bioscience Center and leased with the New Jersey Economic Development Authority.
AIM’s
operations, research and development facility is housed in the New Jersey Bioscience Center and leased with the New Jersey Economic Development
Authority Jubilant
HollisterStier (“Jubilant”) has been our authorized CMO for Ampligen since 2017. Multiple lots of Ampligen were produced
from 2018 to 2023. AIM currently has adequate stock of Ampligen for ongoing clinical purposes. In addition, we have supplied GP Pharm,
now Filaxis, with the Ampligen required for testing and ANMAT release under the agreement that GP Pharm, now Filaxis, would be the eventual
distributor in Argentina.
The Company’s net loss for the quarter ended June 30, 2026 was $3.8 million compared with a net loss of $2.8 million for the quarter ended June 30, 2025, an increase of $1.0 million. The increase in net loss was primarily attributable to offering related costs incurred in connection with multiple equity transactions completed during the quarter, including placement agent fees, legal fees, accounting fees, and other direct transaction costs, as discussed below.
The
Company’s net loss during the quarter ended March 31, 2026 was $3.0 million which was $682 thousand less than the $3.7 million
loss for the quarter ended March 31, 2025. Included in the March 2026 loss was a $468 thousand loss on warrant valuations recognized
prior to their reclassification from liability to equity as well as a $32 thousand loss on issuance of warrants related to the Rights
Offering. These losses are not expected to be incurred moving forward.
Total
costs and expenses declinedincreased to $2.2$3.5 million
for the quarter ended June 30, 2026, compared with $2.7 million for the quarter ended MarchJune 31, 2026, compared with $3.6 million
for the quarter ended March 31,30, 2025, aan decreaseincrease of $1.4approximately million and represents the primary driver for the overall decrease in net loss.32.5%.
Equity transactions
May 2026 Class H Inducement Transaction
On May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million. In connection with the inducement, the Company reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share. In consideration for the immediate exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date. In connection with the inducement transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc. with an exercise price of $0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9, 2026. The Class H Warrants and Class H Placement Agent Warrants are equity-classified. The Class H Warrants are not exercisable until the Company obtains stockholder approval (See Note 17: Subsequent Events) and include a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction provisions.
The Company evaluated the temporary reduction in the exercise price of the Class A through Class F Warrants as a modification of freestanding equity-classified written call options. The incremental fair value effect of the modification was approximately $8,235 based on a class-by-class analysis and was attributable to the Class A and Class C Warrants. The aggregate fair value of the new Class H Warrants issued to the exercising holders was approximately $6.6 million. Accordingly, the aggregate value transferred to the exercising warrant holders was approximately $6.6 million.
The Company also incurred approximately $561 thousand of placement-agent costs in connection with the transaction, consisting of approximately $363 thousand of cash placement-agent fees and approximately $198 thousand representing the fair value of the Class H Placement Agent Warrants. Total holder-side consideration and placement-agent costs associated with the transaction were therefore approximately $7.2 million.
The transaction generated gross exercise proceeds of approximately $3.6 million. The Company recognized equity issuance costs equal to the gross proceeds of the transaction, consisting of approximately $561 thouand of placement-agent costs and approximately $3.0 million of holder-side inducement consideration. The remaining approximately $3.6 million of value transferred to the exercising warrant holders exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend. Because the Company had an accumulated deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
The deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net loss available to common stockholders for purposes of calculating basic earnings per share. The noncash entries associated with the Class H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’ equity. After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately $3.2 million, representing the net cash proceeds received.
At June 30, 2026 447,116 Placement Agent Warrants and 14,903,840 Class H Warrants were outstanding.
May 2026 Class I Offering
On May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
The combined offering price was $0.325 per share of common stock and accompanying Class I Warrants. Although the Class I Securities Purchase Agreement permitted each Purchaser to elect Pre-Funded Warrants in lieu of common stock, no Purchaser elected to receive Pre-Funded Warrants at closing, and consequently no May 2026 Pre-Funded Warrants were issued. Gross proceeds to the Company totaled approximately $2.4 million.
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately $196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date of the Registration Statement. The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants. The Class I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July 21, 2026. (See Note 17: Subsequent Events) At June 30, 2026 there were 451,161 Placement Agent Warrants and 15,038,702 Class I Warrants outstanding.
On June 10, 2026, the Company closed a registered direct offering and concurrent private placement (the “June 2026 Class J Offering”) of 2,554,119 registered shares of common stock, 771,503 unregistered shares of common stock, Pre-Funded Warrants to purchase up to 1,782,616 shares of common stock at a nominal exercise price of $0.001 per share (fully pre-funded at closing), and Class J Common Stock Purchase Warrants to purchase up to 10,216,476 shares of common stock at an exercise price of approximately $0.52 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
The combined offering price was approximately $0.52 per share and accompanying warrant. Gross proceeds to the Company totaled approximately $2.6 million.
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately $212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement Agent Warrants exercisable at approximately $0.65 per share with a five-year term. The Class J Warrants, June 2026 Pre-Funded Warrants, and Class J Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants. The Class J Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July 21, 2026 (concurrent with the Class I and Class H Warrants). (See Note 17: Subsequent Events) For the three months ended June 30, 2026, prefunded warrants were exercised for 1,300,828 shares of common stock. At June 30, 2026 481,788 Pre-Funded Warrants, 306,494 Placement Agent Warrants and 10,216,476 Class J Warrants were outstanding.
Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the pre-funded warrants and received nominal cash proceeds from the exercise.
Research and development
Research and development costs declined to $589 thousand during the quarter ended June 30, 2026 compared with $1.2 million during the quarter ended June 30, 2025. Research costs declined as the Company completed a Phase II study in 2026 and shifted its focus toward a European Pancreatic Cancer study which is funded by a grant and in collaboration with a major pharmaceutical interest. The Company expects to begin new studies shortly and the timing and amount of clinical expenditures is dependent on recruiting patients and therefore can be difficult to project and lead to significant expense variations between periods.
General and administrative
Research
and development costs declined to $482 thousand during the quarter ended March 31, 2026 compared with $1.1 million during the quarter
ended March 31, 2025. During the first quarter of 2025, the Company decided to direct its focus and efforts on the development of Ampligen
for the treatment of late-stage pancreatic cancer, with the belief that this path will potentially lead to the most lucrative outcome.
As a result, the Company evaluated its patent portfolio and made a decision to reduce its annual maintenance fees and development of
patents not meeting its current core objective. As a result, $335 thousand was charged to clinical expenses during the first quarter
of 2025 related to prior costs of developing and maintaining patents not specific to the primary focus and was the largest component
of the variance between the quarters.
Additionally,
fewer patients were enrolled in the Company’s Phase 2 testing for pancreatic cancer during the first quarter of 2026 than during
the quarter ended March 31, 2025, which resulted in $88 thousand in reduced payments to Amarex, the principal administrator of several
of AIM’s largest clinical studies. The timing and amount of clinical expenditures is dependent on recruiting patients and therefore
can be difficult to project.
General
and administrative costs for the quarter ended March 31, 2026 were $783 thousand below the first quarter of 2025 as a result of reduced
legal fees. During the quarter ended March 31, 2025, the Company was receiving final billings related to a shareholder dispute which
was settled during the fourth quarter of 2024.
General
and administrative costs for the quarter ended June 30, 2026 were $1.5 million above those during the three months ended June 30, 2025
due to increases in issuance costs together with legal and accounting fees associated with the equity transactions Interest
expense was $304$295 thousand and $124$149 thousand for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increase in interest
expense is due to additional debt. On November 18, 2025, the Company (“Borrower”) entered into a Note Purchase Agreement
with Streeterville Capital LLC (“Streeterville” or the “Lender”). Under the terms of the agreement, Streeterville
paid the Company $2.5 million in exchange for an unsecured promissory Note with an Original Issue Discount of $781 thousand. The Company
will pay $3.3 million consisting of the principal amount of the Note, together with the original issue discount and $20 thousand of lender
transaction fees, no later than November 18, 2027. The stated interest rate of the note is 10%.
The Company’s net loss for the six months ended June 30, 2026 was $6.8 million compared with a net loss of $6.5 million for the six months ended June 30, 2025, an increase of $300 thousand. The increase in net loss was primarily attributed to offering related costs incurred in connection with multiple equity transactions completed during the period, including placement agent fees, legal fees, accounting fees, and other direct costs, as discussed below. These increased costs were partially offset by lower research and development expenses.
Total costs and expenses decreased to $5.8 million for the six months ended June 30, 2026, compared with $6.3 million for the six months ended June 30, 2025, representing a decrease of approximately 8.2%.
Equity transactions
March 2026 Rights Offering
On March 6, 2026, the Company completed a rights offering to its stockholders and to holders of certain of its outstanding options and warrants that had the right to participate in the 2026 Rights Offering, as of February 10, 2026, the record date. In the Rights Offering the Company issued non-transferable subscription rights to purchase 1,842 Units. Each Unit consists of one share of Series G Convertible Preferred Stock (the “G Preferred”) and 2,000 warrants to purchase common stock (the “G Warrants”). Each share of G Preferred is convertible, at the option of the holder at any time, into a number of shares of common stock equal to the quotient of the stated value of the Preferred Stock ($1 thousand) divided by $1.00, the conversion price. Each G Warrant is exercisable for one share of common stock at an exercise price of $1.00 per share from March 6, 2026, the date of issuance, through its expiration five years from the date of issuance. Maxim Group LLC acted as the Company’s dealer-manager. The 2026 Rights Offering raised $1.8 million in gross proceeds.
For the three months ended June 30, 2026, 149 shares of the Series G Preferred had been converted for 149,000 shares of common stock and no Class G Warrants were exercised. For the six months ended June 30, 2026, 1,313 shares of the Series G Preferred had been converted for 1,313,000 shares of common stock, and 310,000 Class G Warrants had been exercised. Subsequent to June 30, 2026, 8 shares of the G Preferred had been converted to 8,000 shares of common stock. At June 30, 2026 3,374,000 Class G Warrants and 529 Series G Preferred were outstanding.
May 2026 Class H Inducement Transaction
On May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million. In connection with the inducement, the Company reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share. In consideration for the immediate exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date. In connection with the inducement transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc. with an exercise price of $0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9, 2026. The Class H Warrants and Class H Placement Agent Warrants are equity-classified. The Class H Warrants are not exercisable until the Company obtains stockholder approval (See Note 17: Subsequent Events) and include a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction provisions.
The Company evaluated the temporary reduction in the exercise price of the Class A through Class F Warrants as a modification of freestanding equity-classified written call options. The incremental fair value effect of the modification was approximately $8,235 based on a class-by-class analysis and was attributable to the Class A and Class C Warrants. The aggregate fair value of the new Class H Warrants issued to the exercising holders was approximately $6.6 million. Accordingly, the aggregate value transferred to the exercising warrant holders was approximately $6.6 million.
The Company also incurred approximately $561 thousand of placement-agent costs in connection with the transaction, consisting of approximately $363 thousand of cash placement-agent fees and approximately $198 thousand representing the fair value of the Class H Placement Agent Warrants. Total holder-side consideration and placement-agent costs associated with the transaction were therefore approximately $7.2 million.
The transaction generated gross exercise proceeds of approximately $3.6 million. The Company recognized equity issuance costs equal to the gross proceeds of the transaction, consisting of approximately $561 thouand of placement-agent costs and approximately $3.0 million of holder-side inducement consideration. The remaining approximately $3.6 million of value transferred to the exercising warrant holders exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend. Because the Company had an accumulated deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
The deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net loss available to common stockholders for purposes of calculating basic earnings per share. The noncash entries associated with the Class H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’ equity. After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately $3.2 million, representing the net cash proceeds received At June 30, 2026 447,116 Placement Agent Warrants and 14,903,840 Class H Warrants were outstanding.
May 2026 Class I Offering
On May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
The combined offering price was $0.325 per share of common stock and accompanying Class I Warrants. Although the Class I Securities Purchase Agreement permitted each Purchaser to elect Pre-Funded Warrants in lieu of common stock, no Purchaser elected to receive Pre-Funded Warrants at closing, and consequently no May 2026 Pre-Funded Warrants were issued. Gross proceeds to the Company totaled approximately $2.4 million.
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately $196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date of the Registration Statement. The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants. The Class I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July 21, 2026. (See Note 17: Subsequent Events) At June 30, 2026 there were 451,161 Placement Agent Warrants and 15,038,702 Class I Warrants outstanding.
On June 10, 2026, the Company closed a registered direct offering and concurrent private placement (the “June 2026 Class J Offering”) of 2,554,119 registered shares of common stock, 771,503 unregistered shares of common stock, Pre-Funded Warrants to purchase up to 1,782,616 shares of common stock at a nominal exercise price of $0.001 per share (fully pre-funded at closing), and Class J Common Stock Purchase Warrants to purchase up to 10,216,476 shares of common stock at an exercise price of approximately $0.52 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
The combined offering price was approximately $0.52 per share and accompanying warrant. Gross proceeds to the Company totaled approximately $2.6 million.
Ladenburg Thalmann & Co., Inc. acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately $212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement Agent Warrants exercisable at approximately $0.65 per share with a five-year term. The Class J Warrants, June 2026 Pre-Funded Warrants, and Class J Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants. The Class J Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July 21, 2026 (concurrent with the Class I and Class H Warrants). (See Note 17: Subsequent Events) For the three months ended June 30, 2026, prefunded warrants were exercised for 1,300,828 shares of common stock. At June 30, 2026 481,788 Pre-Funded Warrants, 306,494 Placement Agent Warrants and 10,216,476 Class J Warrants were outstanding.
Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the pre-funded warrants and received nominal cash proceeds from the exercise.
Research and development
Research and development costs declined to $1.1 million during the six months ended June 30, 2026 compared with $2.3 million during the six months ended June 30, 2025. During the first quarter of 2025, the Company decided to direct its focus and efforts on the development of Ampligen for the treatment of late-stage pancreatic cancer, with the belief that this path will potentially lead to the most lucrative outcome. As a result, the Company evaluated its patent portfolio and made a decision to reduce its annual maintenance fees and development of patents not meeting its current core objective. As a result, $335 thousand was charged to clinical expenses during the first quarter of 2025 related to prior costs of developing and maintaining patents not specific to the primary focus and was a significant factor in the variance between the quarters.
AIM insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 4 Form 4 filings (1 insider, 4 trade dates, 62,900 shares, about $13.5K) and open-market sales in 0 filings. Net open-market shares: 62,900 (purchases minus sales); net value about $13.5K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-17 | Equels Thomas K |
Open-market purchase | 24,000 | $0.21 | $5.0K |
| 2026-09-16 | Equels Thomas K |
Open-market purchase | 11,000 | $0.21 | $2.3K |
| 2026-09-15 | Equels Thomas K |
Open-market purchase | 22,000 | $0.22 | $4.8K |
| 2026-09-14 | Equels Thomas K |
Open-market purchase | 5,900 | $0.22 | $1.3K |
Well-known investors holding AIM (13F)
None of the 59 investors we track reported a position in their latest 13F.