AIM ImmunoTech Inc.
For the period ended Sep 30, 2025. Filed Nov 17, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 17, 2025
AIM$0.16+1.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001493152-25-011986
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-17.
0001493152-25-023894
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 214 previous paragraphs and 230 current paragraphs.
141 unchanged; 50 reworded; 35 added; 19 removed; 4 previous and 4 current paragraphs rearranged.
Tables are not compared: 17 previous and 13 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (35)
Current report
Please see “Immuno-Oncology” below.
Current report
Ampligen as a Treatment for Post-COVID Conditions
Current report
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, but who still demonstrate chronic fatigue-like symptoms. Eight Long-COVID patients have been treated with Ampligen in AMP-511 since January 2021. One patient is still receiving treatment.
Current report
These improvements were offset by:
Current report
Interest and Other Income
Current report
Interest and other income for the three months ended September 30, 2025, and 2024 was approximately $3,052,000 and $718,000, respectively, reflecting an increase of approximately $2,334,000. The increase was primarily due to an agreement reached with a vendor surrounding legal fees. The agreement provided that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000.
Current report
Production costs were approximately $68,000 and $8,000, respectively, for the three months ended September 30, 2025, and 2024, representing an increase of $60,000. This related to increased production activities for the three months ended 2025 when compared to the quarter ended September 30, 2024.
Current report
Research and Development (“R&D”) costs for the three months ended September 30, 2025 were approximately $607,000, as compared to $1,437,000 for the same period a year ago, reflecting a decrease of approximately $830,000. The decrease in R&D costs was a combination of decreased clinical expenses of $273,000, decreased manufacturing costs of $249,000, decreased quality control costs of $177,000 and decreased regulatory costs of $131,000.
Current report
General and Administrative (“G&A”) expenses for the three months ended September 30, 2025, and 2024, were approximately $1,798,000 and $3,079,000, respectively, reflecting a decrease of approximately $1,281,000. The decrease in G&A expenses for the three months ended September 30, 2025 was the result of ongoing cost cutting measures by the Company in an effort to improve efficiencies and reduce costs with the largest reductions relating to legal fees.
Current report
Interest expenses for the three months ended September 30, 2025 was approximately $148,000 compared with $202,000 for the three months ended September 30, 2024. Interest expense was lower due to principal reductions over the period.
Current report
Warrant issuances
Current report
On July 31, 2025, we announced the closing of the above 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 will have 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.
Current report
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 September 30, 2025.
Current report
Nine months ended September 30, 2025 versus nine months ended September 30, 2024
Current report
These improvements were offset by:
Current report
Interest and Other Income
Current report
Interest and other income for the nine months ended September 30, 2025, and 2024 was approximately $3,073,000 and $3,379,000, respectively, reflecting a decrease of approximately $306,000. During the third quarter of 2025, we reached an agreement with a vendor surrounding legal fees. The agreement provided that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000.
Current report
Gain (loss) on Investments, net
Current report
Overall Research and Development (“R&D”) costs for the nine months ended September 30, 2025, were approximately $2,861,000, as compared to $4,533,000 for September 30, 2024, reflecting a decrease of approximately $1,672,000. The components of the decrease consisted of decreases in clinical costs of $244,000, manufacturing cost decreases of $501,000, quality control cost decreases of $547,000 and regulatory decreases of $380,000.
Current report
General and Administrative (“G&A”) expenses for the nine months ended September 30, 2025, and 2024, were approximately $5,830,000 and $9,485,000, respectively, reflecting a decrease of approximately $3,655,000. The decrease in G&A expenses for the three months ended September 30, 2025 was the result of ongoing cost cutting measures by us in an effort to improve efficiencies and reduce costs with the largest reductions relating to legal fees.
Current report
Interest expense for the nine months ended September 30, 2025 was approximately $421,000 compared with $453,000 for the nine months ended September 30, 2024. Interest expense was lower due to principal reductions over the period.
Current report
Warrant issuances
Current report
On July 31, 2025, we announced the closing of the above 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 will have 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.
Current report
Based on review of the agreement, 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 our balance sheet at September 30, 2025 as the warrants might require us 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 or assets by us. Any warrant exercises would result in additional cash and equity to us because we have a sufficient number of authorized and unissued shares available to satisfy the warrant exercises in shares.
Current report
Cash provided by financing activities for the nine months ended September 30, 2025, was approximately $7,669,000 compared to approximately $5,407,000 for the same period in 2024, an increase of $2,262,000. The increase primarily resulted from the issuance of warrants which generated approximately $8,000,000 of positive cash flow for us.
Current report
During the third quarter of 2025, an agreement was reached with a vendor surrounding legal fees. The agreement provided that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000. The reduction was included as “other income” and accounts payable was reduced.
Current report
Potential Delisting from the Exchange.
Current report
May 2024 Securities Purchase Agreement
Current report
September 2024 Securities Purchase Agreement
Current report
Public Offering on a Registration Statement on Form S-1
Current report
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 will have 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.
Current report
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 September 30, 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.
Current report
NYSE American Continued Listing Requirements
Current report
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.
Current report
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.
Removed paragraphs (19)
Previous report
While there are approved therapies for COVID-19, we believe that, if Ampligen has the broad-spectrum antiviral properties that we believe that it has, it could be a very valuable tool as a therapeutic or treatment for 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.
Previous report
CFS treatment requires patients to take more than 200 vials in the course of a year. Unfortunately for patients in Argentina, hyper-inflation and devaluation of the Argentine peso to the U.S. dollar has had an adverse impact and rendered the treatment costs for CFS prohibitive in the country. In addition, our partner Filaxis Farmacéutica (“Filaxis”) **(**formerly GP Pharm LATAM) has shifted its concentration from CFS to efforts in oncology. This is an area which fits well with our primary focus on pancreatic cancer, which we have determined offers the most effective path forward to successful regulatory approval for a financially viable market. We are in discussions with Filaxis and are exploring the potential approval of oncology indications in Argentina (in addition to obtaining final approval and commercialization for CFS).
Previous report
In August 2020, we contracted Amarex to act as our Clinical Research Organization and provide regulatory support with regard to a possible clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via intranasal delivery.
Previous report
Beginning in April 2020, we entered into confidentiality and non-disclosure agreements with numerous companies for the potential outsourcing of the production of polymer, enzyme, placebo as well as Ampligen.
Previous report
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, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with our flagship pipeline drug Ampligen. In January 2021, we commenced with the treatment of the first previously diagnosed COVID-19 patient with long-COVID symptoms (i.e., Long Hauler) also known as Post-COVID Conditions in the AMP-511 study. Enrollment of post-COVID patients continues in the study.
Previous report
Loss on Investments, net
Previous report
Overall Research and Development (“R&D”) costs for the three months ended June 30, 2025, were approximately $1,174,000, as compared to $1,145,000 for the same period a year ago, reflecting an increase of approximately $29,000. The primary reason for the increase in R&D costs was an increase in patent and trademark expense of $274,000, and an increase in consulting expenses of $87,000, offset by a decrease in salaries of $238,000, and outside contractors of $74,000.
Previous report
General and Administrative (“G&A”) expenses for the three months ended June 30, 2025, and 2024, were approximately $1,487,000 and $2,591,000, respectively, reflecting a decrease of approximately $1,104,000. The decrease in G&A expenses during the current period was due primarily to a decrease in professional fees of $599,000, a decrease in salaries of $238,000, a decrease in fees paid to investment bankers of $234,000, a decrease in stock compensation of $80,000, a decrease in office supplies and expenses of $24,000, a decrease in travel expenses of $21,000, and a decrease in taxes and licenses of $17,000. offset by an increase in stock market fees of $105,000.
Previous report
Interest expenses for the three months ended June 30, 2025 and 2024 were approximately $149,000 and $179,000, respectively, reflecting a decrease of approximately $30,000. The increase in interest expense in the current period was due to the interest expense incurred related to the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.
Previous report
Six Months ended June 30, 2025 versus Six Months ended June 30, 2024
Previous report
Production costs were approximately $20,000 and $16,000, respectively, for the six months ended June 30, 2025, and 2024, representing an increase of $4,000 in production costs in the current period.
Previous report
Overall Research and Development (“R&D”) costs for the six months ended June 30, 2025, were approximately $2,254,000, as compared to $3,096,000 for the same period a year ago, reflecting a decrease of approximately $842,000. The primary reason for the decrease in R&D costs was a decrease in clinical expenses of $626,000, a decrease in salaries of $426,000, a decrease in outside contractors of $276,000, a decrease in office supplies and expenses of $39,000, a decrease in Ampligen manufacturing of $34,000, and a decrease in consulting expenses of $30,000, offset by an increase in patent and trademark expenses of $605,000, and an increase in rent expense of $35,000.
Previous report
General and Administrative (“G&A”) expenses for the six months ended June 30, 2025, and 2024, were approximately $4,032,000 and $6,406,000, respectively, reflecting a decrease of approximately $2,374,000. The decrease in G&A expenses for the six months ended June 30, 2025 was due primarily to a decrease in professional fees of approximately $1,708,000, a decrease in salaries of $377,000, a decrease in fees paid to investment bankers of $364,000, and a decrease in stock compensation expenses of $160,000, offset by an increase in stock market expenses of $189,000, and an increase in public relations expenses of $81,000.
Previous report
Interest expenses for the six months ended June 30, 2025 was approximately $273,000 and $251,000 for the six months ended June 30, 2024. The increase in interest expense for the six months ended June 30, 2025 was due to the interest expense incurred related to the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.
Previous report
Cash provided by financing activities for the six months ended June 30, 2025, was approximately $1,015,000 compared to approximately $5,270,000 for the same period in 2024, representing a decrease of $4,255,000. The primary reason for this decrease was the decrease of net proceeds of $2,117,000 from the notes payable, and a decrease of proceeds from issuance of warrants of $2,047,000 net of issuance cost, offset by a decrease of $91,000 in the sale of shares in the current period.
Previous report
We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.
Previous report
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.
Previous report
If we are unable to commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and liquidity may be adversely impacted, and additional financing may be required. There can be no assurances that, if needed, we will be able to raise adequate funds or enter into licensing, partnering or other arrangements to advance our business goals. We may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. We are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible into or exercisable for our common stock. Any additional funding may result in significant dilution and could involve the issuance of securities with rights, which are senior to those of existing stockholders.
Previous report
Subsequent to June 30, 2025, we closed a financing pursuant to a Registration Statement on Form S-1 (SEC File No. 333-284443) on July 30, 2025 in which we raised $8,000,000 in gross proceeds.
Reworded paragraphs (50)
Previous wording
Certain statements in this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements, other than statements of historical fact, included or incorporated herein regarding our strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “think,” “may,” “could,” “will,” “would,” “should,” “continue,” “potential,” “likely,” “opportunity” and similar expressions or variations of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements and their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties. These statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements may be found, among other places, in the following sections of our Annual Report on Form 10-K for the year ended December 31, 2024: Part I; Item 1. “Business”, Part I; Item 1A. “Risk Factors”, Part I; Item 3. “Legal Proceedings”, and Part I; Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this Report speak only as of the date hereof. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the Report sets forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical tr…
Excerpt shortened here; the source contains the full paragraph.
Current wording
Certain statements in this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements, other than statements of historical fact, included or incorporated herein regarding our strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “think,” “may,” “could,” “will,” “would,” “should,” “continue,” “potential,” “likely,” “opportunity” and similar expressions or variations of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements and their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties. These statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements may be found, among other places, below in this Item 2: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in Part II: Other information: Item 1A: “Risk Factors” of this report, and the following sections of our Annual Report on Form 10-K for the year ended December 31, 2024: Part I; Item 1. “Business”, Part I; Item 1A. “Risk Factors”, Part I; Item 3. “Legal Proceedings”, and Part I; Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Report. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successfu…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
We have a research and pre-clinical history that indicates broad-spectrum antiviral capability of Ampligen in animals. We hope to demonstrate that it has the same effect in humans. To do this, among other things, we need a population infected with a virus. That is why we have spent significant resources on COVID-19 (the disease caused by SARS-CoV-2) which is active and still infecting many subjects. While much would need to be done to get Ampligen to market as a broad-spectrum antiviral, we believe that it is important to focus our efforts first and foremost on thoroughly proving the concept, especially while there is still a large COVID-19-infected population. Previously, animal studies were conducted that yielded positive results utilizing Ampligen to treat numerous viruses, such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. We have conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2.
Current wording
We have a research and pre-clinical history that indicates broad-spectrum antiviral capability of Ampligen in animals. We hope to demonstrate that it has the same effect in humans. To do this, among other things, we need a population infected with a virus. That is why our most recent antiviral focus has been on COVID-19 (the disease caused by SARS-CoV-2) and Long COVID. Previous animal studies yielded positive results utilizing Ampligen to treat numerous viruses, such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. We have conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2.
Previous wording
Please see “Ampligen as a Treatment for ME/CFS and Post-COVID Conditions” below.
Current wording
Please see “Ampligen as a Treatment for Post-COVID Conditions” below.
Previous wording
The FDA authorized an open-label treatment protocol, AMP-511, allowing patient access to Ampligen for treatment in a study under which severely debilitated CFS patients have the opportunity to be on Ampligen to treat this very serious and chronic condition. The data collected from the AMP-511 protocol through a consortium group of clinical sites provide safety information regarding the use of Ampligen in patients with CFS. The AMP-511 protocol is ongoing. In October 2020, we received IRB approval for the expansion of the AMP-511 protocol to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms that we refer to as Post-COVID conditions. As of June 30, 2025, there were 4 patients enrolled in this open-label expanded access treatment protocol (including one patient with Post-COVID Conditions). To date, there have been eight such Post-COVID patients treated in the study. AIM previously 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, there was what the investigators considered a clinically significant decrease in fatigue-related measures and improvement in cognition.
Current wording
As of September 30, 2025, there were 4 patients enrolled in this open-label expanded access treatment protocol (including one patient with Post-COVID Conditions). AIM previously 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, there was what the investigators considered a clinically significant decrease in fatigue-related measures and improvement in cognition. Eight such patients have been treated in the study to date.
Previous wording
In 2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill & Finish” at Jubilant HollisterStier, the Contract Manufacturing Organization. These lots passed all required testing for regulatory release for human use and are being used for multiple programs, including: the treatment of ME/CFS; the pancreatic cancer EAP in the Netherlands; and will continue to be used for ongoing and future clinical studies in oncology. Lots of Ampligen were manufactured in December 2019, January 2020 and December 2023.
Current wording
In 2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill & Finish” at Jubilant HollisterStier, the Contract Manufacturing Organization. These lots passed all required testing for regulatory release for human use and are being used for multiple programs, including the treatment of ME/CFS in the United States and the treatment of pancreatic cancer in the Netherlands. These lots will be used for ongoing and future clinical studies in oncology. Additional lots of Ampligen were manufactured in December 2019, January 2020 and December 2023.
Previous wording
We hold multiple patents related to the use of Ampligen in the treatment of cancer. In March 2021, we were granted a patent by the Netherlands Patent Office with granted patent claims that include, but are not limited to, the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors (e.g. pembrolizumab, nivolumab). In November 2023, we received a new patent involving the administration of a unique combination of two compounds to patients suffering from pancreatic cancer, renal cell carcinoma, colorectal cancer and/or melanoma. The first compound is an anti-PD-L1 antibody and the second compound is Ampligen; The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment. Additionally, in June 2025 we received a patent 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, and provides patent protection for manufacturing until 2041.
Current wording
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 pending 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.
Previous wording
Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. The study was temporarily suspended due to the Merck discontinuation of Intron-A production. Roswell Park has had a Type-C meeting with the FDA and has performed the necessary experiments to replace Intron-A with a generic alpha-interferon. This trial resumed recruiting in April 2025. https://clinicaltrials.gov/ct2/show/NCT03899987.
Current wording
Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment was initiated in this study designed for up to 45 patients. The study was temporarily suspended due to the Merck discontinuation of Intron-A production. Roswell Park has had a Type-C meeting with the FDA and has performed the necessary experiments to replace Intron-A with a generic alpha-interferon. As of August 2025,the study is no longer recruiting patients. A total of 12 patients were enrolled. https://clinicaltrials.gov/ct2/show/NCT03899987.
Previous wording
A Type D meeting package seeking the FDA guidance on expansion of inclusion criteria and treatment arms to be included was submitted to the FDA. We subsequently amended the study protocol. AIM recently made a business decision to place screening/enrollment on hold and suspend the study.
Current wording
A Type D meeting package seeking the FDA guidance on expansion of inclusion criteria and treatment arms to be included was submitted to the FDA. We subsequently amended the study protocol. In February 2025, we made a business decision to place screening/enrollment on hold and suspend the study.
Previous wording
Since the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment for this virus or could be part of a vaccine. We believe that Ampligen has the potential to be both an early-onset treatment for and prophylaxis against SARS-CoV-2. We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the new virus.
Current wording
Since the late 2019 outbreak of SARS-CoV-2, we have worked to determine whether Ampligen could be an effective treatment for this virus or could be part of a vaccine. We believe that Ampligen has the potential to be both an early-onset treatment for and prophylaxis against SARS-CoV-2. We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the new virus.
Previous wording
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, sponsored by Roswell Park in collaboration with us, will test the safety of this combination regimen in patients with cancer and COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. Several subjects have been treated. It is planned that the phase 1/2a study will enroll up to 44 patients in two stages. Phase 1 will see 12-24 patients receiving both Ampligen and interferon alpha-2b at escalating doses. Once that initial phase is complete, further study participants will be randomized to two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alpha but will receive best available care. We are a financial sponsor of the study and will provide Ampligen at no charge for this study. In November 2020, the first patient in the study had been enrolled and treated. This study was amended to add 20 patients, with 10 randomized to receive a single dose of Ampligen and 10 patients to receive current best therapies. (See clinicaltrials.gov/NCT04379518). Due to a shortage of qualifying subjects with COVID-19 and cancer as a result of the positive impact of vaccinations and treatments for COVID-19, Roswell is seeking approval to expand the qualifying subject criteria to include other diseases lethal to immuno-compromised cancer patients, such as influenza. Accordingly, the study is temporarily suspended while seeking said approvals.
Current wording
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, sponsored by Roswell Park in collaboration with us, will test the safety of this combination regimen in patients with cancer and COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. Several subjects have been treated. It is planned that the phase 1/2a study will enroll up to 44 patients in two stages. Phase 1 will see 12-24 patients receiving both Ampligen and interferon alpha-2b at escalating doses. Once that initial phase is complete, further study participants will be randomized to two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alpha but will receive best available care. We are a financial sponsor of the study and will provide Ampligen at no charge for this study. In November 2020, the first patient in the study had been enrolled and treated. This study was amended to add 20 patients, with 10 randomized to receive a single dose of Ampligen and 10 patients to receive current best therapies. (See clinicaltrials.gov/NCT04379518). Roswell reported partial results from the study.
Previous wording
In January 2021, we entered into a Sponsor Agreement with CHDR to manage a Phase 1 randomized, double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen. AIM funded and sponsored the study. This study was designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study was completed, and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage level. We believe that the trial is a critical step in our ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases. Amarex provided us with monitoring support during the trial.
Current wording
In January 2021, we entered into a Sponsor Agreement with CHDR to manage a Phase 1 randomized, double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen. AIM funded and sponsored the study. This study was designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study was completed, and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage level. We believe that the trial is a critical step in our efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases. Amarex provided us with monitoring support during the trial.
Previous wording
Since the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment for this virus or could be part of a vaccine. We believe that Ampligen has the potential to be both an early-onset treatment for and prophylaxis against SARS-CoV-2. We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the new virus.
Current wording
We believe that Ampligen has the potential to be both an early-onset treatment for, and prophylaxis against, SARS-CoV-2. We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the newer virus.
Previous wording
Alferon N Injection is the registered trademark for our injectable formulation of natural alpha interferon. Alferon N Injection is the only natural-source, multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Alferon N Injection is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferons. Argentina has experienced hyper-inflation and recently devalued its currency to the U.S. dollar by 50%. Contracts in Argentina are in U.S. dollars and the parties must evaluate the impact of the recent devaluation on its relationship. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”). According to the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million Americans — most in their late teens and early 20s — infected with HPV. In fact, the CDC states that “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives.” Although they do not usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial health care costs.
Current wording
Alferon N Injection is the registered trademark for our injectable formulation of natural alpha interferon. Alferon N Injection is the only natural-source, multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Alferon N Injection is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferons. Argentina has experienced hyper-inflation and devaluation of its currency compared to the U.S. dollar. Contracts with GP Pharm are U.S. dollar contracts and the parties must evaluate the impact of the recent devaluation on its relationship. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”). According to the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million Americans — most in their late teens and early 20s — infected with HPV. In fact, the CDC states that “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives.” Although they do not usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial health care costs.
Previous wording
Each participant immediately vests in his or her deferred salary contributions as well as the Company’s safe harbor contributions. A 6% safe harbor matching contribution by us was reinstated effective January 1, 2021; however, was discontinued effective June 1, 2025. For the six months ending June 30, 2025 we made approximately $57,000 in contributions, and for the year ending December 31, 2024 approximately $167,000 in contributions were made.
Current wording
Each participant immediately vests in his or her deferred salary contributions as well as our safe harbor contributions. A 6% safe harbor matching contribution by us was reinstated effective January 1, 2021. For the nine months ending September 30, 2025 we made approximately $87,000 in contributions, and for the year ending December 31, 2024 approximately $167,000 in contributions were made.
Previous wording
Critical Accounting Policies and Estimates
Current wording
Critical Accounting Policies and Use of Estimates
Previous wording
Our net loss was approximately $2,794,000 and $1,836,000 for the three months ended June 30, 2025, and 2024, respectively, representing a increase in loss of approximately $958,000 or 52%. This increase in loss was primarily due to the following:
Current wording
Our net loss was approximately $3,284,000 and $3,700,000 for the three months ended September 30, 2025, and 2024, respectively, representing a decreased loss of approximately $416,000 or 11%. This loss decrease was primarily due to the following:
Previous wording
Net loss per share was $(3.68) and $(3.00) for the three months ended June 30, 2025, and 2024, respectively. The weighted average number of shares of our common stock outstanding as of June 30, 2025, was 759,289 as compared to 528,374 as of June 30, 2024.
Current wording
Net loss per share was $(1.57) and $(6.00) for the three months ended September 30, 2025, and 2024, respectively. The weighted average number of shares of our common stock outstanding as of September 30, 2025, was 2,093,446 as compared to 1,195,439 as of September 30, 2024.
Previous wording
Revenues from our Ampligen® Cost Recovery Program were $25,000 and $50,000 for the three months ended June 30, 2025, and 2024, respectively, representing a decrease of $25,000 which is primarily related to the fluctuation of patient participation.
Current wording
Revenues from our Ampligen® Cost Recovery Program were $26,000 and $35,000 for the three months ended September 30, 2025, and 2024, respectively, representing a decrease of $9,000 which is primarily related to the fluctuation of patient participation.
Previous wording
The loss on investments for the three months ended June 30, 2025, and 2024 was approximately ($9,000) and ($85,000), respectively, reflecting a decrease in the loss on investments of approximately $76,000. The decrease in loss was due to the change in the fair value of equity investments.
Current wording
Gain (loss) on investments for the three months ended September 30, 2025, and 2024 was approximately ($1,000) and $273,000, respectively, reflecting decrease of approximately $274,000. The decrease was primarily due to the change in the fair value of equity investments.
Previous wording
Our net loss was approximately $6,499,000 and $7,653,000 for the six months ended June 30, 2025, and 2024, respectively, representing a decrease in loss of approximately $1,154,000 or 15%. This decrease in loss was primarily due to the following:
Current wording
Our net loss was approximately $9,783,000 and $11,353,000 for the nine months ended September 30, 2025, and 2024, respectively, representing a decrease in loss of approximately $1,570,000 or 14%. This decrease in loss was primarily due to the following:
Previous wording
Net loss per share was $ (8.88) and $(15.00) for the six months ended June 30, 2025, and 2024, respectively. The weighted average number of shares of our common stock outstanding as of June 30, 2025, was 731,650 as compared to 511,619 as of June 30, 2024.
Current wording
Net loss per share was $(8.18) and $(21.00) for the nine months ended September 30, 2025, and 2024, respectively. The weighted average number of shares of our common stock outstanding as of September 30, 2025, was 1,195,439 as compared to 533,514 as of September 30, 2024.
Previous wording
Revenues from our Ampligen® Cost Recovery Program were $41,000 and $90,000 for the six months ended June 30, 2025, and 2024, respectively, representing a decrease of $49,000 which is primarily related to the fluctuation of patient participation.
Current wording
Revenues from our Ampligen® Cost Recovery Program were $67,000 and $125,000 for the nine months ended September 30, 2025, and 2024, respectively, representing a decrease of $58,000 which is primarily related to the fluctuation of patient participation.
Previous wording
For the six months ended June 30, 2025 and 2024, 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.
Current wording
For the nine months ended September 30, 2025 and 2024, 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.
Previous wording
Gain (loss) on investments for the six months ended June 30, 2025, and 2024 was approximately $18,000 and $(177,000), respectively, reflecting an increase in the gain on investments of approximately $195,000. The increase in gain was due to the change in the fair value of equity investments.
Current wording
Gains on investments for the nine months ended September 30, 2025, and 2024 were approximately $17,000 and $95,000, respectively, reflecting a decrease in the gain on investments of approximately $79,000. The decrease primarily resulted from a change in the fair value of equity investments.
Previous wording
Production costs were approximately $10,000 and $8,000, respectively, for the three months ended June 30, 2025, and 2024, representing an increase of $2,000 in production costs in the current period.
Current wording
Production costs were approximately $88,000 and $24,000, respectively, for the nine months ended September 30, 2025, and 2024, representing an increase of $64,000.
Previous wording
Cash used in operating activities for the six months ended June 30, 2025, was approximately $3,892,000 compared to approximately $7,823,000 for the same period in 2024, a decrease of $3,931,000. The primary reasons for this decrease in cash used in operations in 2025 was a decreased in net loss of $1,154,000, an increase in other assets of $1,127,000, an increase in accounts payable of $1,902,000, an increase in accrued expenses of $1,154,000, offset by a decrease in funds receivable from New Jersey net operating loss of $1,181,000.
Current wording
Cash used in operating activities for the nine months ended September 30, 2025, was approximately $8,971,000 compared to approximately $10,933,000 for the same period in 2024, a decrease of $1,962,000. The primary reasons for this decrease in cash used in operations in 2025 was primarily due to the decreased net loss for the period.
Previous wording
Cash provided by investing activities for the six months ended June 30, 2025 was approximately $1,652,000 compared to cash used of approximately $668,000 for the same period in 2024, an increase of $984,000. The primary reason for the change during the current period is the increase in sale and purchase of marketable investments of $921,000.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2025 was approximately $1,948,000 compared to approximately $1,002,000 for the same period in 2024, an increase of $946,000. The primary reason for the change during the current period is an increase in proceeds from the sale of marketable investments of $725,000.
Previous wording
Our principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due. As of June 30, 2025, we had approximately $835,000 in cash, cash equivalents and marketable investments, inclusive of approximately $359,000 in marketable investments, representing a decrease of approximately $3,142,000 from December 31, 2024.
Current wording
Our principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due. As of September 30, 2025, we had approximately $2,409,000 in cash, cash equivalents and marketable investments, inclusive of approximately $62,000 in marketable investments, representing a decrease of approximately $1,568,000 from December 31, 2024.
Previous wording
In addition, we have incurred losses from operations as of June 30, 2025, and have a working capital deficit. These conditions raise 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.
Current wording
We have incurred losses from operations as of September 30, 2025, and have a working capital deficit. These conditions raise 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.
Previous wording
The accompanying unaudited consolidated financial statements have been prepared assuming that we will continue as a going concern. On June 30, 2025, our current liabilities exceeded our current assets by $9,368,000 which raised doubt about our ability to continue as a going concern. Additionally, at June 30, 2025, our stockholders’ equity was below the minimum requirements for continued listing on the NYSE American. See “Potential Delisting from the NYSE American” below.
Current wording
The accompanying unaudited consolidated financial statements have been prepared assuming that we will continue as a going concern. On September 30, 2025, our current liabilities exceeded our current assets by $1,468,000 which raised doubt about our ability to continue as a going concern. Additionally, at September 30, 2025, our stockholders’ equity was below the minimum requirements for continued listing on the Exchange. See “Potential Delisting from the Exchange” below.
Previous wording
Our principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due. We have suffered losses from operations and net cash used on operating activities for the year ended December 31, 2024 and for the period ended June 30, 2025, and have a working capital deficit as of December 31, 2024 and as of June 30, 2025. Additionally, our stockholders’ equity was below the minimum requirements for continued listing on the New York Stock Exchange American (“NYSE American”). These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of issuance of these unaudited condensed consolidated financial statements. Management evaluated the conditions, and the significance of these conditions related to our ability to meet our obligations. If we are unable to implement sufficient mitigation efforts, we may need to limit our business activities or be unable to continue as a going concern, which would have a material adverse effect on our results of operations and financial condition.
Current wording
These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of issuance of these unaudited condensed consolidated financial statements. Management evaluated the conditions, and the significance of these conditions related to our ability to meet our obligations. If we are unable to implement sufficient mitigation efforts, we may need to limit our business activities or be unable to continue as a going concern, which would have a material adverse effect on our results of operations and financial condition.
Previous wording
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 June 30, 2025, we had an outstanding deposit of $265,000 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 if the timing of expenditures are realized within the next 12 months.
Current wording
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 a 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 September 30, 2025, we had an outstanding deposit of $240,000 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 if the timing of expenditures are realized within the next 12 months.
Previous wording
On April 4, 2025, trading of the Company’s common stock was suspended by NYSE American. Leading up to this event, the Company and Streeterville (the “Lender”) were in regular communication, and both parties acknowledged the possibility of such an occurrence. On May 13, 2025, the Lender and the Borrower entered into a Forbearance Agreement pursuant to which, for a 1% fee and expenses, the Lender released the Borrower and its affiliates from all defaults under the Agreements through the date of the Forbearance Agreement and confirmed that, as a result, no Default Interest is due, with no effect on liquidity. The outstanding balance of the Note, following the application for the Forbearance Fee, is $2,484,000.
Current wording
On April 4, 2025, trading of our common stock was suspended by Exchange. Leading up to this event, we and Streeterville (the “Lender”) were in regular communication, and both parties acknowledged the possibility of such an occurrence. On May 13, 2025, the Lender and the Borrower entered into a Forbearance Agreement pursuant to which, for a 1% fee and expenses, the Lender released the Borrower and its affiliates from all defaults under the Agreements through the date of the Forbearance Agreement and confirmed that, as a result, no Default Interest is due, with no effect on liquidity. The outstanding balance of the Note, following the application for the Forbearance Fee, was $2,484,000.
Previous wording
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 or more, given we have had 5 years of operating losses. As required, we submitted a plan (the “Plan”) to the NYSE American illustrating our plan to regain compliance by June 11, 2026. The Plan includes a number of capital formation initiatives. The NYSE American accepted our Plan on February 26, 2025. However, if we are not able to regain compliance by June 11, 2026, our common stock may be suspended and subject to delisting from the NYSE American. As of June 30, 2025, our stockholders’ deficit was ($6.5) million. We must increase our stockholders’ equity to be at least $6 million to regain compliance with this rule. If we are unable 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 suspended and subject to delisting from the NYSE American. The price of our common stock dropped below $0.10 and on April 4, 2025, and we received a delisting letter from the NYSE American and trading in our common stock on the NYSE American was suspended. We sought a review of the delisting and were granted a hearing to be held on June 5, 2025. Since the suspension our common stock trades on the Pink Open Market under the symbol “AIMI”.
Current wording
On December 11, 2024, we received an official notice of noncompliance with the Exchange’s continued listing requirements. This includes the need for us to have stockholders’ equity of $6,000,000 or more, given we have had 5 years of operating losses. As required, we submitted a plan (the “Plan”) to the Exchange illustrating our plan to regain compliance by June 11, 2026. The Plan includes a number of capital formation initiatives. The Exchange accepted our Plan on February 26, 2025. However, if we are not able to regain compliance by June 11, 2026, our common stock may be suspended and subject to delisting from the Exchange. As of September 30, 2025, our stockholders’ deficit was approximately ($6,077,000). We must increase our stockholders’ equity to be at least $6,000,000 to regain compliance with this rule. If we are unable to raise sufficient capital as set forth in the Plan or by other means, we may be unable to regain compliance with the Exchange’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 suspended and subject to delisting from the Exchange. The price of our common stock dropped below $0.10 and on April 4, 2025, and we received a delisting letter from the Exchange and trading in our common stock on the Exchange was suspended. We sought a review of the delisting and were granted a hearing held on June 5, 2025.
Previous wording
On April 30, 2025, we held a special meeting of stockholders to approve a series of alternate amendments to our Certificate of Incorporation to effect, at the option of our Board of Directors, a reverse stock split of our outstanding common stock at a ratio in the range of up to 1-for-100, with such ratio to be determined by our Board of Directors in its sole discretion. At that meeting, stockholders approved the measure.
Current wording
On April 30, 2025, we held a special meeting of stockholders to approve a series of alternate amendments to our Certificate of Incorporation to effect, at the option of our Board of Directors, a reverse stock split of our outstanding common stock at a ratio in the range of up to 1-for-100, with such ratio to be determined by our Board of Directors in its sole discretion. At that meeting, stockholders approved the measure. On June 10, 2025, we filed an amendment to our Articles of Incorporation effecting a reverse split of our outstanding shares of common stock on a one-for-100 basis (the “Reverse Split”). This did not affect the number of authorized shares.
Previous wording
In June 2025, the Company effected a 100-to-1 reverse stock split of the outstanding shares, in order to become compliant with the NYSE regulations. This did not affect the number of authorized shares. On June 11, 2025, we were notified by the NYSE American that we had regained compliance with Section 1003(f)(v) of the NYSE American Company Guide (low selling price) and that trading on our Common Stock was reinstated on the NYSE American on June 17, 2025 under the ticker symbol “AIM”.
Current wording
On June 11, 2025, we were notified by the Exchange that we had regained compliance with Section 1003(f)(v) of the Exchange’s Company Guide (low selling price) and that trading on our Common Stock was reinstated on the Exchange on June 17, 2025 under the ticker symbol “AIM”.
Previous wording
We have entered into an Equity Distribution Agreement (the “Sales Agreement”) with Maxim Group LLC (“Maxim”), dated April 1, 2025, pursuant to which we may issue and sell up to an aggregate of $3,000,000 of shares of our common stock under the Registration Statement from time to time through Maxim acting as agent, subject to certain limitations, as set forth therein and below. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Maxim may sell shares of our common stock by any method permitted by law deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act, including sales made directly on or through the NYSE American, the existing trading market for our common stock, sales made to or through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted by law, including in privately negotiated transactions.
Current wording
We have entered into an Equity Distribution Agreement (the “Sales Agreement”) with Maxim Group LLC (“Maxim”), dated April 1, 2025, pursuant to which we may issue and sell up to an aggregate of $3,000,000 of shares of our common stock under the Registration Statement from time to time through Maxim acting as agent, subject to certain limitations, as set forth therein and below. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Maxim may sell shares of our common stock by any method permitted by law deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act, including sales made directly on or through the Exchange, the existing trading market for our common stock, sales made to or through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted by law, including in privately negotiated transactions.
Previous wording
Under the terms of the Sales Agreement, in no event will we issue or sell such number or dollar amount of shares of common stock that would (i) exceed the number or dollar amount of shares of common stock registered and available on the Registration Statement, (ii) exceed the number of authorized but unissued shares of common stock, (iii) 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), or (iv) exceed the number or dollar amount of common stock for which the Company will file a prospectus to the Registration Statement.
Current wording
Under the terms of the Sales Agreement, in no event will we issue or sell such number or dollar amount of shares of common stock that would (i) exceed the number or dollar amount of shares of common stock registered and available on the Registration Statement, (ii) exceed the number of authorized but unissued shares of common stock, (iii) 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), or (iv) exceed the number or dollar amount of common stock for which we will file a prospectus to the Registration Statement.
Previous wording
Maxim will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the NYSE American. In connection with the sale of the common stock on our behalf, Maxim will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of Maxim will be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution to Maxim against certain civil liabilities, including liabilities under the Securities Act.
Current wording
Maxim will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the Exchange. In connection with the sale of the common stock on our behalf, Maxim will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of Maxim will be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution to Maxim against certain civil liabilities, including liabilities under the Securities Act.
Previous wording
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 has committed to purchase up to $15 million of our common stock.
Current wording
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 has committed to purchase up to $15,000,000 of our common stock.
Showing the first 40 of 50 pairs. Open the source sections for the rest.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
In July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions (“AMP-518”). We announced in August 2023 that the study had met the planned enrollment of 80 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. All patients have completed the study, with topline data reported in February 2024.
Current report — wording carried from elsewhere
Please see “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)” below.
Current report — wording carried from elsewhere
During the nine months ended September 30, 2024, we recovered $2,500,000 of Director and Officer (D&O) insurance originating from legal costs related to shareholder litigation matters. Additionally, in September 2024 an amendment to an original agreement with a vendor clarifying and changing the nature of a remaining execution fee of $725,437. The amendment allowed that the remainder would not be exclusive to the original agreement, 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.
Current report — wording carried from elsewhere
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 nine months ended September 30,2025, no Common Warrants were exercised, and all remain outstanding on September 30, 2025, related to this agreement.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
In this regard, CHDR, a foundation located in Leiden in the Netherlands, managed a Phase 1 randomized, double-blind study for us to evaluate the safety, tolerability, and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study was completed, and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage level.
Previous report — wording carried elsewhere
We have long been focused on seeking the FDA’s approval for the use of Ampligen to treat ME/CFS. In fact, in February 2013, we received a CRL from the FDA for our Ampligen NDA for ME/CFS. We believe the Phase 3 results provided in the NDA were positive. The CRL indicated that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.
Previous report — wording carried elsewhere
While developing a comprehensive response to the FDA and a plan for a confirmatory trial for the FDA NDA, we proceeded independently in Argentina and, in August 2016, we received approval of an NDA from ANMAT for commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. The next steps in the commercial launch of Ampligen included ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. We engaged GP Pharm, now named Filaxis Farmaceutica, to manage ANMAT engagement and marketing Ampligen post approval. ANMAT approval process requires testing and final approval, all of which are internally managed by ANMAT. Once final approval by ANMAT is obtained, Ampligen can be distributed in Argentina for the treatment of CFS.
Previous report — wording carried elsewhere
Potential Delisting from the NYSE American.