What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-08-14 compared with 2023-05-15 · 256 added, 191 removed, 1058 unchanged (30% of the section changed)

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our ability to discover new drugs in the future, changing market conditions, changes in laws and regulations affecting our industry,

and future matters related to our New Jersey facility, which by definition we cannot define at this time.

are in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases,

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product and release tests before granting final approval to begin commercial sales.

This testing and approval process is currently delayed

due to the COVID-19 pandemic and ANMAT’s internal processes.

This testing and approval process has been currently

delayed due to the COVID-19 pandemic and ANMAT’s internal processes.

Approval of rintatolimod for severe CFS in the Argentine Republic

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effective in the treatment of pancreatic cancer.

The agreement was automatically extended for one year periods on May 20, 2021 and 2022,

and is anticipated to extend again on May 20, 2023.

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.

Ampligen clinical trials are underway, in various phases of development and activity, with subjects enrolled at university cancer centers

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facility is AIM’s operations, research and development center.

production of new Alferon N Injection Active Pharmaceutical Ingredient, or API, is currently on hold.

The New Brunswick facility is approved

by the FDA under the Biological License Application, or BLA, for Alferon N Injection.

While we have sold the New Brunswick facility,

we maintain a certain amount of space at that facility for Alferon activities, the sale of the facility will move up the timeline for

contracting with a CMO, or CMOs, capable of producing Alferon, and receiving FDA approval to do so, prior to commercial sale of newly

produced inventory product.

If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon N Injection

API, it will need FDA approval as to the quality and stability of the final product before commercial sales can resume.

We may need additional

funds to finance the validation process.

If we are unable to gain the necessary FDA approvals related to the manufacturing process and/or

final product of new Alferon N Injection inventory, our operations most likely will be materially and/or adversely affected.

of these contingencies, there can be no assurances that the approved Alferon N Injection product will be returned to production on a

timely basis, if at all, or that if and when it is again made commercially available, it will return to prior sales levels.

production of the new Alferon N Injection Active Pharmaceutical Ingredient, or API, is currently on hold.

The New Brunswick facility

was approved by the FDA under the Biological License Application, or BLA, for Alferon N Injection.

While we have sold the New Brunswick

facility, we maintain a certain amount of space at that facility for Alferon activities, the sale of the facility will move up the timeline

for contracting with a CMO, or CMOs, capable of producing Alferon, and receiving FDA approval to do so, prior to the commercial sale

of newly produced inventory product.

If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon

N Injection API, it will need FDA approval as to the quality and stability of the final product before commercial sales can resume.

may need additional funds to finance the validation process.

If we are unable to gain the necessary FDA approvals related to the manufacturing

process and/or final product of new Alferon N Injection inventory, our operations most likely will be materially and/or adversely affected.

In light of these contingencies, there can be no assurances that the approved Alferon N Injection product will be returned to production

on a timely basis, if at all, or that if and when it is again made commercially available, it will return to prior sales levels.

December 2020, we added Pharmaceutics International Inc.

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as a therapy for locally advanced or metastatic late-stage pancreatic cancer.

In August 2022, we received Institutional Review Board

(“IRB”) approval of the trial protocol and so announced the trial’s commencement.

Assuming this trial and subsequent

planned clinical trials confirm the existing data, our goal is to then submit an NDA for use of Ampligen in pancreatic cancer patients.

of the differences in the scale of necessary trials, our initial primary focus when it comes to pancreatic cancer will be cases that

are locally advanced, rather than metastatic.

The number of different approaches to treating metastatic pancreatic cancer — approaches

which would be determined by treating physicians — would require a much larger, far more expensive trial than would a trial for

locally advanced pancreatic cancer.

Therefore, we are focusing on patients who have completed FOLFIRINOX and have stable disease.

The number of different approaches to treating metastatic pancreatic cancer —

approaches which would be determined by treating physicians — would require a much larger, far more expensive trial than would

a trial for locally advanced pancreatic cancer.

Therefore, we are focusing on patients who have completed FOLFIRINOX and have stable

In August 2022, we received Institutional Review Board (“IRB”) approval of the trial protocol in locally

advanced pancreatic cancer and so announced the trial’s commencement.

Assuming this trial and subsequent planned clinical

trials confirm the existing data, our goal is to then submit an NDA for use of Ampligen in pancreatic cancer patients.

has also demonstrated in the clinic the potential for standalone efficacy in a number of other solid tumors.

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have been addressed in an amended protocol approved by the IRB on March 30, 2023.

As of August 14, 2023, the study had met its full planned

enrollment of 80 subjects and subjects are being dosed.

see “ Ampligen as a Potential Antiviral ” below.

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chronic fatigue-like symptoms that we refer to as Post-COVID conditions.

As of March 31, 2023, there were 12 patients enrolled in this

open-label expanded access treatment protocol (including four patients with Post-COVID-19 Conditions).

As of June 30, 2023, there were 11 patients enrolled in this

open-label expanded access treatment protocol (including five patients with Post-COVID Conditions).

To date, there have been seven

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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, 2023, there are 10 patients enrolled in this open-label expanded access treatment protocol (including

four Post-COVID-19 patients).

As of June 30, 2023, there are 11 patients enrolled in this open-label expanded access treatment protocol (including five

Post-COVID patients).

To date, there have been seven such Post-COVID patients treated.

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also is managing all Early Access Programs and Special Access Programs in Europe, Canada and Turkey to treat pancreatic cancer and ME/CFS

The agreement was automatically extended for a period of 12 months on May 20, 2021, and is anticipated to extend again on May 20, 2023.

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.

June 2018, Ampligen was cited as outperforming two other TLR3 agonists — poly IC and natural double stranded RNA — in creating

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Additionally, two lots of Ampligen were manufactured

in December 2019 and January 2020 at Jubilant HollisterStier.

The current manufactured lots of Ampligen have been fully tested and released

for commercial product launch in Argentina and for clinical trials.

Additionally, in 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.

in December 2019 and January 2020 at Jubilant HollisterStier and we recently issued a purchase order for a total of $1,432,257 to manufacture

additional lots of Ampligen at Jubilant.

The current manufactured lots of Ampligen have been fully tested and released for commercial

product launch in Argentina and for clinical trials.

Additionally, in 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 active and in-process fill and finish capacity.

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enrollment has commenced, and numerous patients have commenced

We announced interim data from the study demonstrating that evidence of increased

biomarkers associated with T cell chemotaxis and cytolytic function was seen when combining

Ampligen, pembrolizumab and cisplatin.

Increases of these biomarkers in the tumor microenvironment

have been correlated with favorable tumor responses.

Interim results announced March 2022

detailed an observed clinical response rate of 61% includes two complete and three partial

tumor responses, plus three patients with stable disease among the 13 evaluable patients.

We announced interim data from the study demonstrating that evidence of

increased biomarkers associated with T cell chemotaxis and cytolytic function was seen when

combining Ampligen, pembrolizumab and cisplatin.

Increases of these biomarkers in the tumor

microenvironment have been correlated with favorable tumor responses.

Interim results announced

March 2022 detailed an observed clinical response rate of 61% includes two complete and three

partial tumor responses, plus three patients with stable disease among the 13 evaluable patients.

An important priority will be to confirm these findings through continuing to enroll patients

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has seen an Objective Response Rate (ORR) of 38.5%;

a study of pembrolizumab alone in the treatment of advanced recurrent ovarian cancer

found ORR of 8.1% and 9.9% across two cohorts.

a study of pembrolizumab alone in the treatment of advanced recurrent ovarian

cancer found ORR of 8.1% and 9.9% across two cohorts.

We believe that the positive data makes this patent have heightened potential.

patents are pending in other countries.

Similar patents are pending in other countries.

4 Metastatic Triple Negative Breast Cancer - Phase 1 study of metastatic triple-negative

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Patient enrollment has been initiated in this study designed for up to 45

The study is temporarily suspended due to the Merck discontinuation of

Intron-A production.

Roswell Park has had a Type-C meeting with the FDA and is currently performing the necessary experiments to

replace Intron-A with a generic alpha-interferon.

We expect this trial to resume in the near future.

The study is temporarily suspended due to the Merck discontinuation of Intron-A

Roswell Park has had a Type-C meeting with the FDA and is currently performing

the necessary experiments to replace Intron-A with a generic alpha-interferon.

this trial to resume in the near future.

https://clinicaltrials.gov/ct2/show/NCT03899987

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https://clinicaltrials.gov/ct2/show/NCT04081389

Melanoma — Roswell Park Comprehensive Cancer Center (“Roswell Park”), in a clinical trial fully funded by the

National Cancer Institute (NCI), has commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant

The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination with tumor-selective

chemokine modulation (“CKM”) comprised of Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib.

Up to 24 patients

are to be enrolled.

The study is temporarily suspended due to the Merck discontinuation of Intron-A production.

has had a Type-C meeting with the FDA and is currently performing the necessary experiments to replace Intron-A with a generic

alpha-interferon.

We expect this trial to resume in the near future.

Melanoma — Roswell Park Comprehensive Cancer Center (“Roswell Park”),

in a clinical trial fully funded by the National Cancer Institute (NCI), has commenced patient

enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant melanoma.

Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination

with tumor-selective chemokine modulation (“CKM”) comprised of Interferon alpha

2b, Ampligen (rintatolimod) and Celecoxib.

Up to 24 patients are to be enrolled.

is temporarily suspended due to the Merck discontinuation of Intron-A production.

Park has had a Type-C meeting with the FDA and is currently performing the necessary experiments

to replace Intron-A with a generic alpha-interferon.

We expect this trial to resume in the

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

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compared with historical control patients.

Additional patients have since been enrolled and, we believe, the data

further confirms the original findings.

We are working with our Contract Research Organization, Amarex Clinical Research LLC, to seek

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DURIPANC Study,” in which it will use study drugs provided by both AstraZeneca and us.

In June 2023 we received the required

approvals from the Central Committee on Research Involving Human Subjects, which is the Competent Authority for the review of clinical

trials in the Netherlands, and the Medical Ethics Review Committee Erasmus MC, which is the governing ethics board.

Additionally:

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Center in the Netherlands.

October 2021, we and Amarex submitted an IND application with the FDA for a planned Phase 2 study of Ampligen as a therapy for

locally advanced or metastatic late-stage pancreatic cancer.

In December 2021, the FDA responded with a Clinical Hold on the

proposed study.

October 2021, we and Amarex submitted an IND application with the FDA for a planned Phase 2 study of Ampligen as a therapy for locally

advanced or metastatic late-stage pancreatic cancer.

In December 2021, the FDA responded with a Clinical Hold on the proposed study.

We submitted our response to the FDA in February 2022.

In March 2022, we received notification from the FDA that the

Clinical Hold was released and cleared, meaning that we are now able to proceed with the study specifically to treat locally

advanced pancreatic cancer patients.

In August 2022, we received IRB approval of the trial protocol and so announced the

trial’s commencement.

The study is recruiting patients.

In March 2022, we received notification from the FDA that the Clinical Hold was

released and cleared, meaning that we are now able to proceed with the study specifically to treat locally advanced pancreatic cancer

In August 2022, we received IRB approval of the trial protocol and so announced the trial’s commencement.

recruiting patients.

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

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Ampligen may have a direct anti-tumor effect in pancreatic cancer cells expressing TLR-3.

April 4, 2023, AIM executed an Unrestricted Grant Agreement with Erasmus University Medical Center pursuant to which Erasmus MC will

use its best efforts to diligently carry out immune monitoring in pancreatic cancer patients.

On April 5, 2023, the Company entered into

a Consulting Agreement with Casper H.J.

van Eijck, MD, PhD, pursuant to which, among other things, Dr.

van Eijck will assist the Company

in recruiting and assisting sites outside of the Netherlands to participate in clinical trials evaluating Ampligen for the treatment

of pancreatic cancer.

June 27, 2023, we announced the publication of pre-clinical

data that suggests Ampligen has the potential to act directly on tumor cells to reduce tumor cell growth in pancreatic cancer patients

with sufficient tumor levels of TLR-3, suggesting a potential biomarker to identify patients who may respond to Ampligen.

The anti-tumor

analysis was published in the peer-reviewed journal American Journal of Cancer Research in the paper “Rintatolimod:

treatment in patients with pancreatic cancer expressing Toll-like receptor 3.”

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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in the fight against the deadly coronavirus (See:

https://aimimmuno.com/press-release/aim-immunotech-files-provisional-patent-application-for-the-use-of-ampligenr-as-a-potential-therapy-for-covid-19-induced-chronic-

https://aimimmuno.com/press-release/aim-immunotech-files-provisional-patent-application-for-the-use-of-ampligenr-as-a-potential-therapy-for-covid-19-induced-chronic-fatigue/).

Our three provisional patent applications include:

1) Ampligen as a therapy for the coronavirus;

2) Ampligen as part of

a proposed intranasal universal coronavirus vaccine that combines Ampligen with inactivated coronavirus, conveying immunity and cross-protection

2) Ampligen as part of a proposed

intranasal universal coronavirus vaccine that combines Ampligen with inactivated coronavirus, conveying immunity and cross-protection

3) a high-volume manufacturing process for Ampligen.

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November 2020, we entered into a Material Transfer and Research Agreement with Leyden Laboratories B.V.

to supply Ampligen and related

expertise for two research projects involved SARS-CoV-2 and lethal influenza.

(“Leyden”) to supply

Ampligen and related expertise for two research projects involved SARS-CoV-2 and lethal influenza.

The MTA has since expired and we have

no active projects with Leyden.

January 2021, we entered into a Sponsor Agreement with CHDR to manage a Phase 1 randomized, double-blind study to evaluate the safety

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have been addressed in an amended protocol approved by the IRB on March 30, 2023.

As of August 14, 2023, the study had met its full planned enrollment of

80 subjects and subjects are being dosed.

May 9, 2023, we were granted a U.S.

Patent for a method for preventing or reducing antigenic drift or viral reassortment in a host animal

comprising determining if a host animal has been exposed to or infected by an avian influenza virus and administering to the exposed

host animal alpha-interferon.

Europe, the EMA has approved the Orphan Medicinal Products Designation for Ampligen as a potential treatment of Ebola virus disease and

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Additionally, on May 9, 2023, we were granted a U.S.

Patent for a method for

preventing or reducing antigenic drift or viral reassortment in a host animal comprising determining if a host animal has been exposed

to or infected by an avian influenza virus and administering to the exposed host animal alpha-interferon.

Patent for a method for preventing

or reducing antigenic drift or viral reassortment in a host animal comprising determining if a host animal has been exposed to or infected

by an avian influenza virus and administering to the exposed host animal alpha-interferon.

MANUFACTURING

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operations, research and development center.

December 5, 2022, we entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”)

for the manufacture of our Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’ Dudley, UK

location to produce the polymer precursors to manufacture the drug Ampligen.

business plan calls for the utilization of one or more CMOs to produce Ampligen API.

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to meet our current needs, we are also continually exploring new efficiencies so as to maximize our ability to fulfill future obligations.

In this regard, in April 2021, we approved a proposal from Polysciences for the manufacture of our Poly I and Poly C 12 U polynucleotides

and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors

to the drug Ampligen.

We are utilizing Polysciences’ expertise to refine our approach to polymer production.

Additionally, we continue

to be open to the possibility of agreements with other CMOs, so as to create redundancy and to meet the potential need for larger quantities

In this regard, on December 5, 2022, we entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions

(“Sterling”) for the manufacture of our Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’

Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen.

We are utilizing Sterling’s expertise to

refine our approach to polymer production.

In March 2023, we submitted a work order for a total of $1,432,257 to manufacture additional

lots of Ampligen at Jubilant.

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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of commercial filled and finished product are produced and released by the FDA.

While our New Brunswick facility has FDA approval under

the Biologics License Application (“BLA”) for Alferon N Injection, and we maintain a certain amount of space at this facility,

we will need the FDA’s approval to release commercial product once we have identified our new manufacturing approach and submitted

satisfactory stability and quality release data;

the FDA has conducted any required inspections;

and the FDA has approved our new manufacturing

Currently, we are not manufacturing Alferon N Injection and there is no definitive timetable to resume production.

The New Brunswick facility was approved by the FDA under

the Biological License Application, or BLA, for Alferon N Injection.

While we have sold the New Brunswick facility, we maintain a certain

amount of space at that facility for Alferon activities.

We will need the FDA’s approval to release commercial product once we

have identified our new manufacturing approach and submitted satisfactory stability and quality release data.

Currently, we are not manufacturing

Alferon N Injection and there is no definitive timetable to resume production.

LICENSING/COLLABORATIONS/JOINT

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name “Naturaferon”) in Argentina.

This extends the approval until 2022.

A request to extend the approval beyond 2022 has

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, with Naturaferon in Argentina.

This extended the approval until 2022.

extend the approval beyond 2022 has 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, with Naturaferon in Argentina.

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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all EAP activities relating to the pancreatic cancer extension of the program.

August 2017, we extended our agreement with Asembia LLC, formerly Armada Healthcare, LLC, to undertake the marketing, education and sales

of Alferon N Injection throughout the United States.

August 2017, we extended our agreement with Asembia LLC, formerly Armada Healthcare, LLC, to undertake the marketing, education and

sales of Alferon N Injection throughout the United States.

This agreement has expired.

We were in discussions with Asembia about the possibility

of continuing the relationship, while also exploring the possibility of working with other, similar companies.

However, we still do not

foresee an immediate need for this service and so have decided to push this search further out in our expected timeline.

We were in discussions with Asembia about the

possibility of continuing the relationship, while also exploring the possibility of working with other, similar companies.

we still do not foresee an immediate need for this service and continue to push this search further out in our

expected timeline.

February 2018, we signed an amendment to the EAP with myTomorrows.

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contribution by us was reinstated effective January 1, 2021.

For the three months ending March 31, 2023 we made $38,600 in contributions,

and for the year ending December 31, 2022 $122,000 contributions were made.

For the six months ended June 30, 2023, we made $77,100 in contributions,

and for the year ending December 31, 2022 $122,000 was contributed.

Accounting Pronouncements

Recent Accounting Pronouncements”.

Accounting Policies and Estimates

have been no material changes in our critical accounting policies and estimates from those disclosed in Part II;

Accounting Estimates

have been no material changes in our critical accounting estimates from those disclosed in Part II;

“Management’s

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OF OPERATIONS

months ended March 31, 2023 versus three months ended March 31, 2022

net loss was approximately $3,661,000 and $3,820,000 for the three months ended March 31, 2023, and 2022, respectively, representing

a decrease in loss of approximately $158,000 or 4%.

This decrease in loss was primarily due to the following:

decrease of the quarterly revaluation of certain redeemable warrants of $31,000;

decrease in loss on investments, net of $1,137,000;

decrease in production costs of $77,000;

increase in loss on sale of fixed assets of $23,000;

increase in gain from sale of Income tax operating of $65,000;

increase in interest and other income of 154,000;

months ended June 30, 2023 versus three months ended June 30, 2022

losses were $4,909,000 and $4,851,000 for the three months ended June 30, 2023, and 2022, respectively, representing an increase in loss

of $58,000 or 1%.

This increase in loss was primarily due to the following:

increase in research and development expenses of $478,000.

increase in general and administrative expenses of $369,000;

loss per share was $ (0.08) and $(0.08) for the three months ended March 31, 2023, and 2022, respectively.

increase in gain from sale of Income tax operating of $96,000;

increase in interest and other income of $239,000;

decrease in production costs of $69,000;

decrease in loss on investments, net of $376,000.

net loss per share was $(0.10) and $(0.10) for the three months ended June 30, 2023, and 2022, respectively.

The weighted average number

of shares of our common stock outstanding as of March 31, 2023, was 48,399,950 as compared to 47,994,672 as of March 31, 2022.

from our Ampligen® Cost Recovery Program were $49,000 and $33,000 for the quarters ended March 31, 2023, and 2022, respectively.

of shares of our common stock outstanding as of June 30, 2023, was 48,411,251 as compared to 48,034,100 as of June 30, 2022.

from our Ampligen® Cost Recovery Program were $42,000 and $30,000 for the three months ended June 30, 2023 and 2022, respectively.

The change was due primarily to the increase in drug utilization for the AMP-511 study for the two sites that are open and treating patients.

quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted

to $0 for the three months ended March 31, 2023, compared to a $31,000 for the three months March 31, 2022 (see “Financial Statements:

Fair Value” for the various factors considered in the valuation of redeemable warrants).

(loss) on Investments, net

Gain (loss) on investments

for the three months ended March 31, 2023 , and 2022 were approximately 203,000 and ($934,000), respectively, reflecting a decrease in the loss on investments of approximately

($1,137,000).

The decrease in loss was due to the change in the fair value of equity investments.

costs were approximately $0 and $77,000, respectively, for the three months ended March 31, 2023, and 2022, representing a decrease of

$77,000 in production costs in the current period.

The decrease was due primarily to the sale of the New Brunswick facility and no production

for the three months ended March 31, 2023 compared to the three months ended March 31, 2022.

from sale of income tax operating losses

quarterly income tax benefit for the three months ended March 31, 2023, amounted to a gain of approximately $255,000 compared to a gain

of $190,000 for the three months ended March 31, 2022 due primarily to a deferred tax asset recorded in 2023 for the New Jersey NOL to

be sold in 2024.

were no production costs for the three months ended June 30, 2023 and approximately $69,000 for the three months ended June 30, 2022,

representing a decrease of $69,000 in production costs in the current period.

The decrease was due primarily to the sale of the facility

and no production in 2023 compared to 2022.

and Development Costs

Research and Development (“R&D”) costs for the three months ended March 31, 2023, were approximately $2,052,000, as compared

Research and Development (“R&D”) costs for the three months ended June 30, 2023, were approximately $2,953,000, as compared

to $2,475,000 for the same period a year ago, reflecting an increase of approximately $478,000.

The primary reason for the increase

in research and development costs was largely due to an increase in clinical trials for AMP-518 of $261,200, AMP-270 of $193,000, pancreatic

cancer trial of $174,365, AMP-600 of $160,000 as well an increase in outside contractors of $198,000 and rent expense of $62,500 offset

by a decrease in computer and information services of $46,000.

The primary reason for the increase in

research and development costs was largely due to increases in manufacturing costs of $1,492,000 and regulatory costs of $77,000 net

of decreases in clinical trial costs of $1,062,000, engineering and maintenance costs of $37,000 and quality control costs of $29,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended March 31, 2023, and 2022, were approximately $2,292,000

and Administrative (“G&A”) expenses for the three months ended June 30, 2023, and 2022, were approximately $2,550,000

and $2,181,000, respectively, reflecting an increase of approximately $369,000.

The increase in G&A expenses during the current period

was mainly due to an increase in professional fees of $293,000, interest expense of $45,500 and insurance of $43,600 offset by a decrease

in stock compensation of $160,600.

was primarily due to an increase in professional fees of $766,000 offset by a decrease in stock compensation of $385,000.

on Investments, net

on Investments for the three months ended June 30, 2023, and 2022 were approximately, $94,000 and $470,000, respectively, reflecting

a decrease in loss of approximately $376,000.

This decrease in loss on investments for the three months ended June 30, 2023, was due

to the change in fair value of equity investments.

and Other Income

and other income for the three months ended June 30, 2023, and 2022 was $318,000 and $79,000, respectively.

This represents a net increase

of approximately $239,000.

from sale of income tax operating losses

quarterly income tax benefit for the three months ended June 30, 2023 resulted in a gain of approximately $328,000 compared to a gain

of $232,000 for the three months ended June 30, 2022 due primarily to a deferred tax asset recorded in 2023 for the New Jersey NOL to

be sold in 2024.

months ended June 30, 2023 versus six months ended June 30, 2022

losses were $8,570,000 and $8,671,000 for the six months ended June 30, 2023, and 2022, respectively, representing a decrease in loss

of $101,000 or 1%.

This decrease in loss was primarily due to the following:

increase in interest and other income of $393,000;

increase in gain from sale of Income tax operating of $160,000;

decrease in loss on investments, net of $1,513,000;

decrease in production costs of $147,000;

increase in research and development expenses of $1,494,000;

increase in general and administrative expenses of $588,000.

loss per share was $(0.18) and $(0.18) for the years ended June 30, 2023, and 2022, respectively.

The weighted average number of shares

of our common stock outstanding as of June 30, 2023, was 48,405,675 as compared with 48,014,713 as of June 30, 2022.

from our Ampligen® Cost Recovery Program were $91,000 and $64,000 for the six month periods ended June 30, 2023 and 2022, respectively.

The change is primarily related to the increase in drug utilization for the AMP-511 study for the two sites that are open and treating

were no production costs for the six months ended June 30, 2023, and approximately $147,000 for the six months ended June 30, 2022, representing

a decrease of $147,000 in production costs.

The decrease was due primarily to the sale of the facility and no production in 2023 compared

and Development Costs

costs for the six months ended June 30, 2023, were $5,005,000 compared with $3,511,000 for the same period a year ago, reflecting an

increase of $1,494,000.

The primary cause of the increase in research and development costs was attributable to increases in manufacturing

costs of approximately $1,804,000 and quality control costs of approximately $50,000 net of decreases in clinical trials expense of approximately

$223,000, engineering and maintenance costs of approximately $72,000 and regulatory costs of approximately $52,000.

and Administrative Expenses

expenses for the six months ended June 30, 2023, and 2022, were $4,841,000 and $4,253,000, respectively, reflecting an increase of approximately

The increase in G&A expenses was mainly due to an increase in professional fees of $766,000 and travel costs of $53,000

offset by a decrease in stock compensation of $385,000.

(Loss) on Investments, net

Gain (Loss) on Investments for

the six months ended June 30, 2023, and 2022 were approximately, $109,000 and ($1,404,000), respectively, reflecting a decrease in loss

of approximately $1,513,000.

This decrease in loss on investments for the six months ended June 30, 2023, was due to the change in fair

value of equity investments.

and Other Income

and other income for the six months ended June 30, 2023, and 2022 was $517,000 and $124,000, respectively.

This represents a net increase

of approximately $393,000.

quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability.

no change for the six months ended June 30, 2023, compared with a gain of $34,000 for the six months ended June 30, 2022 (see “Financial

Fair Value” for the various factors considered in the valuation of redeemable warrants).

from sale of income tax operating losses

quarterly income tax benefit for the six months ended June 30, 2023, was $582,000 compared with $422,000 for the six months ended June

30, 2022, due primarily to a change in the deferred tax asset recorded for the New Jersey NOL to be sold.

and Capital Resources

used in/provided by operating activities for the three months ended March 31, 2023, was approximately $3,680,000 compared to approximately

$2,758,000 for the same period in 2022, representing a change of $922,000.

The primary reasons for this change in cash used in operations

in 2023 was related to non-cash charges which primarily consisted of $1,118,000 in gain on investments.

The main changes in working capital

were an increase in accounts payable and a decrease in prepaid expenses and Equity-based compensation.

used in/provided by investing activities for the three months ended March 31, 2023, was approximately $78,000 used in compared to $346,000

used in the same period in 2022, representing a change of $268,000.

The primary reason for the change during the current period is the

sale of marketable securities for the three months ended March 31, 2023 and March 31, 2022 of $598,000 and $407,000 net with the purchase

of marketable securities for the three months ended March 31, 2023 and March 31, 2022 of $$712,000 and $720,000 as well as the sale of

fixed assets for the three months ended March 31, 2023 and March 31, 2022 of $29,000 and $0, respectively.

provided by financing activities for the three months ended March 31, 2023, was approximately $100,000 compared to approximately $0 for the

same period in 2022, an increase of $100,000.

The primary reason for this increase was our receipt of $100,000 in net proceeds from the

sale of shares in the first three months of 2023.

of March 31, 2023, AIM had approximately $30,849,000 in cash, cash equivalents and marketable securities, inclusive of approximately

$7,454,000 in Marketable Securities, representing a decrease of approximately $3,341,000 from December 31, 2022.

used in operating activities for the six months ended June 30, 2023, was $5,838,000 compared with $5,071,000 used in operating activities

during first six months of 2022, representing a change of $767,000.

The primary reasons for this change in cash used in operations in

2023 was related to non-cash charges which primarily consisted of $385,000 in stock compensation, $1,513,000 of loss on investments,

net, and $160,000 of gain from sale of income tax operating losses.

The main changes in working capital were an increase in accounts

payable and prepaid expenses and a decrease in accrued expenses.

used in investing activities for the six months ended June 30, 2023, was approximately $282,000 compared with cash provided by investing

activities for the same period in 2022 of approximately $7,375,000, representing a change of $7,657,000.

The primary reason for the change

for the periods ended June 30, 2023, and June 30, 2022, is the sale of marketable securities of $598,000 and $8,713,000, respectively,

net with the purchase of marketable securities for the same time period of $712,000 and $1,262,000, respectively.

provided by financing activities for the six months ended June 30, 2023, was approximately $105,000 compared with $55,000 provided

during the same period in 2022, an increase of $50,000.

The primary reason for this increase was our receipt of $105,000 in net

proceeds from the sale of shares in the first six months of 2023 compared with the receipt of $55,000 in net proceeds from the sale

of shares for the same period in 2022.

of June 30, 2023, we held $28,398,000 in cash, cash equivalents and marketable securities, which included $7,360,000 of Marketable Securities,

representing a decrease of approximately $5,792,000 from December 31, 2022.

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

5 unchanged sentences

twenty-four months.

present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future.

We may need to

obtain additional funding in the future for new studies and/or if current studies do not yield positive results, require unanticipated

changes and/or additional studies.

In this regard, in February 2022, the SEC declared our new S-3 shelf Registration Statement effective

which will allow us to raise additional capital in the future.

On April 19, 2023, we entered into an Equity Distribution Agreement (the

“EDA”), with Maxim Group LLC (“Maxim”), pursuant to which we may sell from time to time, shares of our common

stock having an aggregate offering price of up to $8.5 million through Maxim, as agent.

Sales under the EDA were registered under the

S-3 Shelf Registration Statement.

Under the terms of the Distribution Agreement, Maxim will be entitled to a transaction fee at a fixed

rate of 3.0% of the gross sales price of Shares sold under the EDA.

Subsequent to the end of Q1 2023, we sold 969 shares under the 2023

EDA for total gross proceeds of approximately $485, which includes a 3% fee to Maxim of approximately $15.

We hope to raise additional

funds through the EDA.

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 from the EDA or otherwise, or enter into licensing, partnering or other arrangements

In this regard, in April, 2023, we entered into an Equity Distribution Agreement (the “EDA”), with Maxim

Group LLC (“Maxim”), pursuant to which we may sell from time to time, shares of our common stock having an aggregate offering

price of up to $8.5 million through Maxim, as agent.

For the six months ended June 30, 2023, we sold 11,937 shares under the EDA for

total gross proceeds of $5,593, which includes a 3.0% fee to Maxim of $168.

Subsequent to the period ended June

30, 2023, we sold 234,386 shares under the EDA for total gross proceeds of $152,579, which includes a 3.0% fee to Maxim of $4,577.

At present we do not generate

any material revenues from operations, and we do not anticipate doing so in the near future.

We may need to obtain additional funding

in the future for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional

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 from the EDA or otherwise or enter into licensing, partnering or other arrangements

to advance our business goals.

12 unchanged sentences

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What changed 10-Q

Item 2. Management’s Discussion and Analysis