What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-14 compared with 2025-05-15 · 321 added, 260 removed, 1135 unchanged (34% of the section changed)

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as an intranasal vaccine for influenza, including avian influenza.

are prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer,

ME/CFS and Post-COVID conditions having priority over antiviral experimentation.

are prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer having priority over other experimentation.

We intend that priority clinical work be conducted in

trials authorized by the FDA or European Medicines Agency (“EMA”), which trials support a potential future NDA.

AIM’s antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis that Ampligen

is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection.

AIM will conduct antiviral programs in those venues most readily available and able to generate valid proof-of-concept data, including

foreign venues.

have engaged Amarex Clinical Research (“Amarex”), our Clinical Research Organization, with the application and eventual management

of a follow-up Investigational New Drug (“IND”) application for the study of a potential avian influenza combination therapy

of our Ampligen and AstraZeneca’s FluMist, a nasal spray vaccine that helps prevent seasonal influenza.

We are seeking collaborative

grants from government and industry to defray the cost of the study.

In addition, the Erasmus Medical Center Safety Committee granted

approval to proceed with a Phase 2 Study of Ampligen and Imfinzi as a potential combination therapy for late-stage pancreatic cancer.

Immuno-Oncology .

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that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

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

On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into

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 ongoing due to ANMAT’s internal

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

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.

final approval by ANMAT is obtained, Ampligen can be distributed in Argentina for the treatment of CFS.

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

FDA authorized an open-label treatment protocol, AMP-511, allowing patient access to Ampligen for treatment in a study under which severely

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that we refer to as Post-COVID conditions.

As of March 31, 2025, there were 6 patients enrolled in this open-label expanded access

treatment protocol (including two patients 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.

plan on a comprehensive follow-up with the FDA regarding the use of Ampligen as a treatment for ME/CFS.

We have learned a great deal

since the FDA’s CRL and plan to adjust our approach to concentrate on specific ME/CFS symptoms.

Responses to the CRL and a proposed

confirmatory trial are being worked on now by our R&D team and consultants.

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

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.

January 2025, we announced that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov.

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our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this

would be the likely subject population for AIM’s planned follow-up clinical trial.

would be the likely subject population for any follow-up clinical trial.

see “Ampligen as a Treatment for ME/CFS and Post-COVID Conditions” below.

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have received approval of our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of

The product would be marketed by GP Pharm, 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 GP Pharm continues for commercial launch of Ampligen in Argentina.

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.

We started work with GP

Pharma in 2016 to address these key issues.

We will be looking for additional

and or alternative partners to expedite the work, gain final ANMAT approval and begin distribution.

Argentina has experienced significant

hyper-inflation.

Contracts in Argentina are U.S.

dollar contracts and 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 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.

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 GP Pharm, now Filaxis, continues for commercial launch of Ampligen in Argentina.

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.

We started work with Filaxis (then GP

Pharm) in 2016 to address these key issues.

The economic landscape in Argentina

has changed dramatically since then, with the country experiencing significant hyper-inflation.

As contracts in Argentina are U.S.

contracts, the parties must evaluate the impact of the devaluation on the relationship and the ability to go forward on a U.S.-dollar

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.

FDA has authorized an open-label expanded access treatment protocol (AMP-511) allowing patient access to Ampligen in a study under which

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level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs;

which was re-authorized in 2021, 2022, 2023 and

which was re-authorized in 2021, 2022, 2023,

2024 and 2025.

At this time, we do not plan on passing this adjustment along to the patients 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

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 that we refer to as Post-COVID

As of March 31, 2025, there were 6 patients enrolled in this open-label expanded access treatment protocol.

As of June 30, 2025, there were 4 patients enrolled in this open-label expanded access treatment protocol.

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 what they considered a clinically significant decrease

in fatigue-related measures.

data show that, by week 12, compared to baseline, the investigators observed what they considered a clinically significant decrease in

fatigue-related measures.

To date, there have been eight such Post-COVID patients treated in this study.

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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.

Additionally, in December 2020, we added Pharmaceutics International Inc.

(“Pii”) as a “Fill

& Finish” provider to enhance our capacity to produce Ampligen.

This addition amplifies our manufacturing capability by providing

redundancy and cost savings.

The contracts augment our active and in-process fill and finish capacity.

Lots of Ampligen were manufactured in December 2019, January 2020 and December 2023.

to the production of additional Ampligen when and if needed, the validation of the polymer production process with Sterling Pharma Solutions

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trial to move forward with Phase 2.

Up to 25 patients are expected to be enrolled in the

Phase 2 portion of DURIPANC.

In July 2025, we announced a positive mid-year safety

and efficacy update that included treatment of 14 subjects.

There has been no significant

toxicity reported.

Three of the 14 subjects (~21%) have progression free survival (PFS) >6

months with an additional 3 subjects (21%) not yet progressed.

Overall survival (OS) of >6

months in majority of eligible subjects (64%).

Up to 25 patients are expected to be enrolled

in the Phase 2 portion of DURIPANC.

Enrollment and dosing is ongoing in Phase 2.

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The Phase 1 portion was designed to establish intraperitoneal

The Phase 2 portion of the study is recruiting subjects.

The Phase 2 portion of the study has been terminated due to lack of funding.

https://clinicaltrials.gov/ct2/show/NCT02432378

Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen;

Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab,

plus Ampligen;

up to 45 patients to be enrolled;

enrollment has commenced, and numerous patients have commenced

In April 2024, researchers released topline data that saw an Objective Response

Rate (“ORR”) of 45% in platinum-sensitive subjects with recurrent ovarian cancer.

enrollment has commenced, and numerous patients

have commenced treatment.

In April 2024, researchers released topline data that saw an Objective

Response Rate (“ORR”) of 45% in platinum-sensitive subjects with recurrent ovarian

ORR includes complete response (“CR”) and partial response (“PR”)

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Progression-Free Survival (“PFS”) of 7.8 months.

Based on these results and other

research suggesting a similar effect in other solid tumor types, AIM sees an Ampligen combination

therapy as having potential across multiple types of cancers.

Additional clinical studies

are underway and planned in many of these types of tumors to further confirm these effects.”

https://clinicaltrials.gov/ct2/show/NCT03734692.

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.

In July 2024, results posted

online ( Study Results | Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy

in Recurrent Ovarian Cancer | ClinicalTrials.gov ) indicated 24 patients treated in the

study saw an ORR of 50% and no patients had a dose-limiting toxicity reported.

Based on these

results and other research suggesting a similar effect in other solid tumor types, AIM sees

an Ampligen combination therapy as having potential across multiple types of cancers.

clinical studies are underway and planned in many of these types of tumors to further confirm

these effects.” https://clinicaltrials.gov/ct2/show/NCT03734692.

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).

We believe that

the above positive data makes this patent have heightened potential.

Similar patents are pending in other countries.

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

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.

4 Metastatic Triple Negative Breast Cancer - Phase 1 study of metastatic triple-negative breast cancer using chemokine modulation

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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.

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.

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Up to 24 patients are to be enrolled.

study was temporarily suspended due to the Merck discontinuation of Intron-A production but has since resumed recruitment (See:

study was temporarily suspended due to the Merck discontinuation of Intron-A production but has since resumed recruitment.

2025, the study was terminated with 1 patient enrolled, funding completed.

https://www.clinicaltrials.gov/show/NCT04093323).

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or that cannot be removed by surgery (unresectable).

The study is active, but not recruiting because enrollment is completed.

In June 2025, the study was terminated with 5 patients enrolled, funding ended.

https://clinicaltrials.gov/study/NCT05756166).

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suspend the study.

data was published in March 2022 in a manuscript titled, “Rintatolimod (Ampligen®) enhances numbers of peripheral B cells and

is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX:

data was published in March 2022 in a manuscript titled, “Rintatolimod (Ampligen®) enhances numbers of peripheral B cells

and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with

a single-center named patient program,” in Cancers Special Issue:

Combination and Innovative Therapies for Pancreatic Cancer.

the single-center, named-patient program, patients with locally advanced pancreatic cancer (LAPC) or metastatic disease were treated

with Ampligen for 6 weeks, at 2 doses per week with 400 mg per infusion.

The study found that Ampligen improved the median survival of

these patients.

The study’s primary endpoints were the Systemic Immune-Inflammation Index (SIII), the Neutrophils to Lymphocyte

Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells as measured by flow cytometry.

Secondary endpoints

were progression-free survival (PFS) and overall survival (OS).

The median overall survival in the Ampligen group was 19 months, compared

to a historical control group and subgroup (7.5 and 12.5, respectively) that did not receive Ampligen.

Combination and Innovative Therapies for

Pancreatic Cancer.

In the single-center, named-patient program, patients with locally advanced pancreatic cancer (LAPC) or

metastatic disease were treated with Ampligen for 6 weeks, at 2 doses per week with 400 mg per infusion.

The study found that

Ampligen improved the median survival of these patients.

The study’s primary endpoints were the Systemic Immune-Inflammation

Index (SIII), the Neutrophils to Lymphocyte Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells

as measured by flow cytometry.

Secondary endpoints were progression-free survival (PFS) and overall survival (OS).

overall survival in the Ampligen group was 19 months, compared to a historical control group and subgroup (7.5 and 12.5,

respectively) that did not receive Ampligen.

in March 2022, we announced that study data evaluating the direct effects of Ampligen on human pancreatic ductal adenocarcinoma (PDAC)

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uterus grows outside the uterus, causing severe pelvic pain and making it difficult or impossible to become pregnant.

method involves the administration of a therapeutically effective amount of a pharmaceutical composition containing our proprietary

double-stranded RNA products.

The patented method

involves the administration of a therapeutically effective amount of a pharmaceutical composition containing our proprietary double-stranded

RNA products.

The versatile administration options offer flexibility for patient-specific needs and care.

also covers treatments targeting recurrent endometriosis and includes options for co-administration with interferons, including

well-known types such as alpha and beta interferons.

The patent also covers treatments

targeting recurrent endometriosis and includes options for co-administration with interferons, including well-known types such as alpha

and beta interferons.

announced in February 2025 our intention to pursue a study of a potential avian influenza combination therapy of Ampligen and AstraZeneca’s

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We are currently collaborating with GP

Pharm on the commercial launch of Ampligen in Argentina (See “Our Products;

Pharm, now Filaxis, on the commercial launch of Ampligen in Argentina (See “Our Products;

Ampligen” above).

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of Ampligen in December 2019, January 2020 and December 2023.

In addition, we have supplied GP Pharm with the Ampligen required for testing

and ANMAT release under the agreement that GP Pharm would be the eventual distributor in Argentina.

December 2020, we added Pii as a “Fill & Finish” provider to enhance our capacity to produce Ampligen.

This addition

amplifies our manufacturing capability by providing redundancy and cost savings.

The contracts augment our existing fill and finish capacity.

We are prepared to initiate the production of additional Ampligen when and if needed.

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.

June 2022 we entered into a lease agreement with the New Jersey Economic Development Authority for a 5,210 square-foot, state-of-the-art

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the validation of the polymer production process with Sterling is ongoing.

In March 2023,

we submitted a purchase order for a total of $1,432,257 to manufacture additional lots of Ampligen at Jubilant.

An additional lot was

manufactured by Jubilant in December 2023.

second product, Alferon N Injection, is approved by the FDA for commercial sales in the United States for the treatment of genital warts.

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and a therapeutic area fit (e.g., ME/CFS, immuno-oncology).

has now turned its focus to oncology, we are exploring the potential for the use of Ampligen in Argentina for the treatment

of pancreatic cancer as either a monotherapy or in combination with immunotherapies.

MARKETING/DISTRIBUTION

May 2016, we entered into a five-year, exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”)

with GP Pharm.

with GP Pharm, now Filaxis.

Under this Agreement, GP Pharm was responsible for gaining regulatory approval in Argentina for Ampligen to treat severe

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sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones.

also granted GP Pharm an option to market Alferon N Injection in Argentina and other Latin America countries (See “Our Products;

Ampligen” above).

The GP Pharm contract was extended in May 2021 with an end date of May 24, 2024.

also granted GP Pharm an option to market Alferon N Injection in Argentina and other Latin America countries.

They have since decided to discontinue this effort with Alferon but we continue to search for other partners in Argentina

to continue this project.

The contract was extended in May 2021 with an end date of May 24, 2024.

While we are in discussions

with GP Pharm to extend the agreement, we are also open to the possibility of looking for a new partner.

In August 2021, ANMAT granted

a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina.

This extends the approval

with Filaxis to extend the agreement, we are also open to the possibility of looking for a new partner.

In August 2021, ANMAT

granted a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina.

This extends the

approval until 2026.

May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V.

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experiences and registry data.

We are supporting these efforts and supplying Ampligen to myTomorrows at a predetermined transfer price.

In the event that we receive Marketing Authorization in any country in the Territory, we will pay myTomorrows a royalty on products sold.

Pursuant to the Impatients Agreement, the royalty would be a percentage of Net Sales (as defined in the Impatients Agreement) of Ampligen

sold in the Territory where Marketing Authorization was obtained.

The formula to determine the percentage of Net Sales will be based

on the number of patients that are entered into the EAP.

We believe that disclosure of the exact maximum royalty rate and royalty termination

date could cause competitive harm.

However, to assist the public in gauging these terms, the actual maximum royalty rate is somewhere

between 2% and 10% and the royalty termination date is somewhere between five and fifteen years from the First Commercial Sale of a product

within a specific country.

The parties established a Joint Steering Committee comprised of representatives of both parties to oversee

No assurance can be given that activities under the EAP will result in Marketing Authorization or the sale of substantial amounts

of Ampligen in the Territory.

We are supporting these efforts and have supplied Ampligen to myTomorrows at a predetermined transfer

In the event that we receive Marketing Authorization in any country in the Territory, we will pay myTomorrows a royalty on products

Pursuant to the Impatients Agreement, the royalty would be a percentage of Net Sales (as defined in the Impatients Agreement) of

Ampligen sold in the Territory where Marketing Authorization was obtained.

The formula to determine the percentage of Net Sales will

be based on the number of patients that are entered into the EAP.

We believe that disclosure of the exact maximum royalty rate and royalty

termination date could cause competitive harm.

However, to assist the public in gauging these terms, the actual maximum royalty rate

is somewhere between 2% and 10% and the royalty termination date is somewhere between five and fifteen years from the First Commercial

Sale of a product within a specific country.

The parties established a Joint Steering Committee comprised of representatives of both

parties to oversee the EAP.

No assurance can be given that activities under the EAP will result in Marketing Authorization or the sale

of substantial amounts of Ampligen in the Territory.

The agreement was automatically extended for a period of 12 months on May 20, 2021;

has been automatically

extended for 12 months on each subsequent May 20;

and will continue to be automatically extended for periods of 12 months every May 20

until terminated or the terms of the agreement are met.

has been automatically extended for 12 months on each subsequent May 20;

and will continue to be automatically extended for periods of

12 months every May 20 until terminated or the terms of the agreement are met.

January 2017, ANMAT granted a five-year extension to a previous approval to sell and distribute Alferon N Injection (under the brand

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been filed and is still under review.

In February 2013, we received ANMAT approval for the treatment of refractory patients that failed

or were intolerant to treatment with recombinant interferon.

We are in continued negotiations with GP Pharm as to how and whether to

move forward with “Naturaferon” in Argentina.

In February 2013, we received ANMAT approval for the treatment of refractory patients that

failed or were intolerant to treatment with recombinant interferon.

GP Pharm now renamed Filaxis has decided not to move forward with this project and has sent us a notice of termination for this project.

However, as there are numerous companies in Argentina now providing patients treatment with recombinant interferon, we believe these companies

and their patients would benefit greatly from having the opportunity to treat those refractory patients with Naturaferon.

We are continuing

to seek out potential partners to move this project forward in the near future.

January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen to ME/CFS patients was extended to

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6% safe harbor matching contribution by us was reinstated effective January 1, 2021;

For the three months ending March 31, 2025 we made

approximately $38,000 in contributions, and for the year ending December 31, 2024 approximately $167,000 in contributions were made.

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.

Accounting Pronouncements

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OF OPERATIONS

months ended March 31, 2025 versus three months ended March 31, 2024

net loss was approximately $3,705,000 and $5,817,000 for the three months ended March 31, 2025, and 2024, respectively, representing

a decrease in loss of approximately $2,112,000 or 36%.

This decrease in loss was primarily due to the following:

decrease in research and development costs of $871,000;

decrease in general and administrative expenses of $1,270,000;

increase in gain on investments of $119,000;

decrease in revenue of $24,000;

months ended June 30, 2025 versus three months ended June 30, 2024

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:

decrease in interest and other income of $2,570,000;

increase of interest expense and other finance costs of $52,000

loss per share was $(0.05) and $(0.12) for the three months ended March 31, 2025, and 2024, respectively.

increase in research and development expenses of $29,000;

decrease in revenue of $25,000;

decrease in general and administrative expenses of $1,104,000;

decrease in warrant valuation loss of $458,000;

decrease in loss on investments of $76,000;

decrease in interest expense of $30,000

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 March 31, 2025, was 70,329,869 as compared to 49,458,023 as of March 31, 2024.

from our Ampligen® Cost Recovery Program were $16,000 and $40,000 for the three months ended March 31, 2025, and 2024, respectively,

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.

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.

the three months ended March 31, 2025 and 2024, we had no Alferon N Injection® Finished Good product to commercially sell and all

the three 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.

(loss) on Investments, net

(loss) on investments for the three months ended March 31, 2025, and 2024 was approximately $27,000 and $(92,000), respectively, reflecting

an increase in the gain on investments of approximately $119,000.

The increase in gain was due to the change in the fair value of equity

costs were approximately $10,000 and $8,000, respectively, for the three months ended March 31, 2025, and 2024, representing an increase

on Investments, net

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

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.

and Development Costs

Research and Development (“R&D”) costs for the three months ended March 31, 2025, were approximately $1,080,000, as compared

to $1,951,000 for the same period a year ago, reflecting a decrease of approximately $871,000.

The primary reason for the decrease in

R&D costs was a decrease in clinical expenses of $690,000, a decrease in outside contractors of $205,000, a decrease in salaries

of $188,000, and a decrease of consulting expenses of $117,000, offset by an increase of patent and trademark expenses of $331,000.

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.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended March 31, 2025, and 2024, were approximately $2,545,000

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 legal professional fees of $1,111,000, a decrease in salaries of $139,000, and a decrease in

fees paid to investment bankers of $130,000, offset by an increase in stock market fees of $83,000 and an increase in public relations

expenses of $74,000.

expenses for the three months ended March 31, 2025 and 2024 were approximately $124,000 and $72,000, respectively, reflecting an increase

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

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.

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the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.

Months ended June 30, 2025 versus Six Months ended June 30, 2024

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:

decrease in general and administrative expenses of $2,374,000;

decrease in research and development expenses of $842,000;

decrease in warrant valuation loss of $458,000;

decrease in losses on investments of $195,000;

decrease in interest and other income of $2,640,000;

decrease in revenues of $49,000

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.

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.

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.

(loss) on Investments, net

(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

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.

and Development Costs

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

and Administrative Expenses

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.

expenses for the six months ended June 30, 2025 was approximately $273,000 and $251,000 for the six months ended June 30, 2024.

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.

and Capital Resources

used in operating activities for the three months ended March 31, 2025, was approximately $2,361,000 compared to approximately $4,815,000

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 net loss during the three months of $2,112,000, an increase in accounts payable of $437,000, an increase in accrued expense

of $602,000, an increase of other assets of $367,000, and an increase in abandonment and expiration of patents and trademark rights of

$335,000, offset by a decrease in funds receivable from NJ NOL of $1,184,000, an increase in lease liability of $122,000,

and an increase in gain on sale of investments of $119,000.

provided by investing activities for the three months ended March 31, 2025 was approximately $898,000 compared to cash used of approximately

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.

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.

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in sale and purchase of marketable investments of $921,000.

provided by financing activities for the three months ended March 31, 2025, was approximately $660,000 compared to approximately $2,829,000

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 $2,500,000 from the notes payable, net of issuance cost, offset by an increase of $332,000 in the sale of shares in the current period.

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.

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 March 31, 2025, we had approximately $2,247,000 in cash, cash

equivalents and marketable investments, inclusive of approximately $1,349,000 in marketable investments, representing a decrease of approximately

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.

addition, we have suffered losses from operations as of March 31, 2025, and have a working capital deficit.

addition, we have incurred losses from operations as of June 30, 2025, and have a working capital deficit.

These conditions raise substantial

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30, 2025, our current liabilities exceeded our current assets by $9,368,000 which raised doubt about our ability to continue as a going

Additionally, at March 31, 2025, our stockholders’ equity was below the minimum requirements for continued listing on

the NYSE American.

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.

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 March 31, 2025, and have a working capital deficit as of December 31, 2024 and as of March

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.

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.

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

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.

September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature

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payment changed to deposit status.

At March 31, 2025, we had an outstanding deposit of $653,000 which may be used to offset future clinical

At June 30, 2025, we had an outstanding deposit of $265,000 which may be used to offset future clinical

research expenditures.

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of expenditures are realized within the next 12 months.

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

The outstanding balance of the Note, following the application for the Forbearance Fee, is $2,484,000.

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.

a research and development company, we are conducting research necessary to bring our product, Ampligen, to market.

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Delisting from the NYSE American .

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.

December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listing requirements.

includes the need for us to have stockholders’ equity of $6.0 million or more, given we have had 5 years of operating losses.

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 March 31, 2025,

our stockholders’ deficit was ($3.9) 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.

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”.

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”.

April 30, 2025, we held a special meeting of stockholders to approve a series of alternate amendments to our Certificate of Incorporation

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At that meeting, stockholders approved

Before the reverse split can be effected, it must be authorized by FINRA.

That process currently is underway.

June 2025, the Company effected a 100-to-1 reverse stock split of the outstanding shares, in order to become compliant with the NYSE

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”.

are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed

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securities with rights, which are senior to those of existing stockholders.

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.

Sources of Funding .

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filed covering the offering.

Neither the Universal Shelf Registration Statement nor the At-The-Market Offering with Maxim may occur unless and until certain

other events first occur, including but not limited to, the Registration Statement being declared effective by the SEC and our common

stock recommences trading on the NYSE American.

prospectus and accompanying based prospectus in the Registration Statement in electronic format may be made available on a website maintained

by Maxim and Maxim may distribute such prospectus and accompanying base prospectus electronically.

shares under the sales agreement will only be offered after a prospectus related to such offering is filed with the SEC.

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.

Equity Line of Credit (Equity Purchase Agreement)

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in the Purchase Agreement are satisfied.

The registration statement was declared effective on May 1, 2024 and the final prospectus

The registration statement was declared effective on May 1, 2024 and the final prospectus was

has no right to require us to sell any shares to Atlas, but Atlas is obligated to make purchases as we direct, subject to certain conditions.

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which were filed as exhibits 10.104 and 10.105 to our 2024 Annual Report on Form 10-K.

As of December 31, 2024, a total

of 759,685 shares have been issued pursuant to the purchase agreement for a total of approximately $128,000 after clearing costs.

March 31, 2025, a total of 3,082,961 shares have been issued pursuant to the purchase agreement for a total of approximately $398,000

of December 31, 2024, a total of 7,596 shares have been issued pursuant to the purchase agreement for a total of approximately $128,000

after clearing costs.

There were no shares issued subsequent to March 31, 2025.

As of June 30, 2025, a total of 30,829 shares have been issued pursuant to the purchase agreement for a total of

approximately $398,000 after clearing costs.

There were no shares issued subsequent to June 30, 2025.

Purchase Agreement

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of 8% of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain out-of-pocket

Company 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

$2.5 million.

For the three months ended March 31,2025, no Common Warrants were exercised, and all remain outstanding on March 31, 2025

related to this agreement.

Company 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 $2.5 million.

For the three months ended June 30, 2025, no Common Warrants were exercised, and all remain

outstanding on June 30, 2025 related to this agreement.

September 30, 2024, the Company 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, 4,653,036 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 4,653,036 Shares (the “Common

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis