What changed in this filing

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Item 1. Financial Statements

2023-05-15 compared with 2022-11-14 · 425 added, 461 removed, 271 unchanged (77% of the section changed)

3 unchanged sentences

Balance Sheets

thousands, except for share and per share data)

September 30, 2022

thousands, except for share and per share amounts)

March 31, 2023

December 31, 2022

4 unchanged sentences

Prepaid expenses and other current assets

Assets held for sale

Total current assets

10 unchanged sentences

Operating lease liability

Redeemable warrants

Commitments and contingencies (Notes 12 and 13)

Stockholders’ equity:

Series B Convertible Preferred Stock, stated value $ 1,000 per share, 713 and 715 issued and outstanding, respectively

Common Stock, par value $ 0.001 per share, authorized 350,000,000 shares:

Series B Convertible Preferred Stock, stated value $ 1,000

per share, 692

and 696 issued and outstanding, respectively

Common Stock, par value $ 0.001

per share, authorized 350,000,000

shares, 48,407,326

and 48,084,287 issued and outstanding, respectively

Additional paid-in capital

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AND SUBSIDIARIES

Statement of Operations and Comprehensive Loss

Statements of Comprehensive Loss

thousands, except share and per share data)

Three months ended September 30,

Nine months ended September 30,

Three months ended March 31,

Clinical treatment programs – US

Total Revenues

Costs and Expenses:

4 unchanged sentences

Operating loss

Loss on investments

Interest and other income, net

Interest expense and other finance costs

Extinguishment of financing obligation and note payable

Gain on sale of fixed assets

Gain (Loss) on investments

Interest and other income

Redeemable warrants valuation adjustment

(Loss) on sale of assets

Gain from sale of income tax operating losses

Other comprehensive (loss), net of tax

Reclassification adjustment for realized investment loss

Change in unrealized loss on marketable securities available for sale

Comprehensive loss

Basic and diluted loss per share

3 unchanged sentences

AND SUBSIDIARIES

Statement of Changes in Stockholders’ Equity

the Nine Months Ended September 30, 2022

Statements of Changes in Stockholders’ Equity

thousands except share data)

Series B Preferred

Common Stock .001 Par Value

Additional Paid-in Capital

Accumulated other Comprehensive Income (Loss)

Accumulated Deficit

Stockholders’ Equity

Comprehensive

Income (Loss)

Stockholders’

Balance December 31, 2022

$ ( 380,546 )

Equity-based compensation

Net comprehensive loss

Balance March 31, 2022

$ ( 364,921 )

Shares issued for:

Common Stock issuance, net of costs

Equity based compensation

Series B preferred shares converted to common shares

Series B preferred shares converted to common

Net comprehensive loss

Balance June 30, 2022

Balance March 31, 2023

$ ( 384,207 )

Common stock issuance, net of costs

Equity-based compensation

Cashless Warrant Conversion

Net comprehensive loss

Balance September 30, 2022

accompanying notes to consolidated financial statements.

IMMUNOTECH INC.

AND SUBSIDIARIES

Statement of Changes in Stockholders’ Equity

the Nine Months Ended September 30, 2021

thousands except share data)

Series B Preferred

Common Stock Par Value

Additional Paid-in Capital

Accumulated other Comprehensive Income (Loss)

Accumulated Deficit

Stockholders’ Equity

Comprehensive

Income (Loss)

Stockholders’

Balance December 31, 2021

$ ( 361,101 )

Common stock issuances, net of costs

Equity-based compensation

Series B preferred shares converted to common shares

Comprehensive loss

Balance March 31, 2021

$ ( 361,101 )

Equity-based compensation

Comprehensive loss

Balance June 30, 2021

$ ( 351,429 )

Common stock issuances, net of costs

Shares issued for:

Equity based compensation

Comprehensive loss

Net comprehensive loss

Balance September 30, 2021

Balance March 31, 2022

$ ( 364,921 )

accompanying notes to consolidated financial statements.

2 unchanged sentences

Statements of Cash Flows

the Nine Months Ended September 30, 2022 and 2021

the Three Months Ended March 31, 2023 and 2022

Cash flows from operating activities:

2 unchanged sentences

Redeemable warrants valuation adjustment

Extinguishment of financing obligation and note payable

Amortization of patent, trademark rights

Changes in ROU assets

Gain on sale of property and equipment

Loss on available for sale marketable securities

Gain from sale of income tax operating losses

Equity-based compensation

Gain (Loss) on sale of marketable securities

Amortization of finance and debt issuance costs

Unrealized loss (gain) on marketable securities

Change in assets and liabilities:

Accounts receivable

Funds Receivable from New Jersey net operating loss

Prepaid expenses and other current assets and other non current assets

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Proceeds from sale of marketable securities

Purchase of marketable securities

Purchase of property and equipment

Proceeds from sale of property and equipment

Purchase of patent and trademark rights

Net cash provided by (used in) investing activities

Purchase of marketable securities

Proceeds from sales of property and equipment

Net cash used in investing activities

Cash flows from financing activities:

Payment of financing obligation

Financing obligation payments

Proceeds from sale of stock, net of issuance costs

4 unchanged sentences

Supplemental disclosures of non-cash investing and financing cash flow information:

Operating lease-Right of Use Assets

Unrealized loss on marketable securities

Conversion of Series B preferred

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ImmunoTech Inc.

and its subsidiaries (collectively, “AIM”, “the Company”,) are an immuno-pharma company headquartered

in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and

immune-deficiency disorders.

The Company has established a strong foundation of laboratory, pre-clinical and clinical data with respect

to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to

aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

flagship products are Ampligen® (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and

Alferon N Injection® (Interferon alfa-n3).

Ampligen has not been approved by the U.S.

Food and Drug Administration (“FDA”)

or marketed in the United States.

Ampligen is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic

Fatigue Syndrome (“CFS”).

primary present business focus involves Ampligen.

Ampligen represents a double-stranded RNA being developed for globally important cancers,

viral diseases and disorders of the immune system.

and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are

an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple

types of cancers, viral diseases and immune-deficiency disorders.

We have established a strong foundation of laboratory, pre-clinical

and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system

of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

flagship products are Ampligen (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon

N Injection (Interferon Alfa-n3).

Ampligen has not been approved by the FDA or marketed in the United States.

Ampligen is approved for

commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).

Company’s primary present business focus involves Ampligen.

Ampligen is a double-stranded RNA (“dsRNA”) molecule being

developed for globally important cancers, viral diseases and disorders of the immune system.

Company is currently proceeding primarily in four areas:

randomized controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced pancreatic

cancer patients.

Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor

responses to check point inhibitors and other immuno oncology therapies.

Ampligen’s antiviral activities and potential use as a prophylactic or early onset treatment for existing viruses, new viruses

and mutated viruses thereof.

as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or Post-COVID conditions

Company is prioritizing activities in an order related to the stage of development, with those clinical activities in oncology,

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

The Company intends that priority clinical work be

conducted in trials authorized by the FDA or European Medicines Agency (“EMA”), which trials support commercial

However, 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.

Accordingly, AIM will conduct antiviral programs in those venues most readily available including foreign venues

and able to generate valid proof-of-concept data,.

May 2021, AIM exercised the option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018

sale and lease-back agreement.

The Company thereafter sold certain equipment and machinery that it determined to be obsolete and no

longer needed for current or future manufacturing.

On March 3, 2022, AIM entered into an Agreement of Sale and Purchase with

Acellories, Inc.

to purchase the property for an estimated $ 3.9 million,

with AIM’s intention to keep some space specifically for its Alferon activity.

The sale closed on November 1, 2022 for $ 3.7

million net of normal closing

a randomized, controlled study to evaluate efficacy and safety of Ampligen compared to a

control group to treat locally advanced pancreatic cancer patients.

Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment

with the goal of increasing anti-tumor responses to checkpoint inhibitors.

Ampligen’s antiviral activities and potential use as a prophylactic or treatment for

existing viruses, new viruses and mutated viruses thereof.

Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”)

and fatigue and/or Post-COVID conditions of fatigue.

Company is prioritizing activities in an order related to the stage of development, with those clinical activities in oncology, ME/CFS

and Post-COVID conditions having priority over antiviral experimentation.

The Company intends that priority clinical work be conducted

in trials authorized by the FDA or European Medicines Agency (“EMA”), which trials support commercial development.

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 including foreign venues and able to generate valid proof-of-concept

business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen API.

This includes utilizing

Polysciences Inc.

(“Polysciences”) for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods.

While AIM believes it has sufficient Ampligen API to meet current needs, it is also continually exploring new efficiencies so as to maximize

its ability to fulfill future obligations.

the opinion of management, all adjustments necessary for a fair presentation of the consolidated financial statements have been included.

This includes

utilizing Jubilant HollisterStier and Polysciences Inc.

(“Polysciences”) for the manufacture of our Poly I and Poly C12U

polynucleotides and associated test methods.

While AIM believes it has sufficient Ampligen API to meet current needs, it is also

continually exploring new efficiencies so as to maximize its ability to fulfill future obligations.

the opinion of management, all adjustments necessary for a fair presentation of its consolidated financial statements have been included.

Such adjustments consist of normal recurring items.

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ended December 31, 2022 and 2021, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed

with the SEC on March 31, 2022.

Use of Estimates

The preparation of

financial statements in conformity with accounting principles generally accepted in the United States of America requires management to

make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”) of contingent

assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period.

on March 31, 2023.

preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires

management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”)

of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the

reporting period.

Actual results could differ from those estimates, and those differences may be material.

Accounts requiring the use of significant estimates

include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent and trademark valuations,

stock-based compensation calculations, building valuation, fair value of warrants, and contingency accruals.

Accounts requiring the use

of significant estimates include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent

and trademark valuations, stock-based compensation calculations, building valuation, fair value of warrants, and contingency accruals.

Net Loss Per Share

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Equivalent common shares, consisting of stock options and warrants which amounted to 2,522,390 and 2,453,782 , are excluded from the calculation

of diluted net loss per share for the nine months ended September 30, 2022, and 2021, respectively, since their effect is antidilutive

due to the net loss.

of diluted net loss per share for the three months ended March 31, 2023, and 2022, respectively, since their effect is antidilutive due

to the net losses recorded for the periods.

Equity-Based Compensation

6 unchanged sentences

data to estimate expected dividend yield, expected life and forfeiture rates.

There were 300,000 options granted in the nine months ended

September 30, 2022, and no options granted in the nine months ended September 30, 2021.

option for employees’ activity during the nine months ended September 30, 2022, is as follows:

During the three months ended March 31, 2023, there were

no options granted and 150,000 options granted during the three months ended March 31, 2022.

options activity during the three months ended March 31, 2023, was as follows:

option activity for employees:

Schedule of Stock Option Activity

of Vest Stock Option Activity

Outstanding January 1, 2023

Outstanding September 30, 2022

Vested and expected to vest September 30, 2022

Exercisable September 30, 2022

Outstanding March 31, 2023

Vested and expected to vest March 31, 2023

Exercisable March 31, 2023

stock option activity for employees:

Schedule of Unvested

Stock Option Activity

of Unvested Stock Option Activity

Unvested January 1, 2023

Unvested September 30, 2022

Unvested March 31, 2023

option activity for non-employees:

of Stock Option Activity

of Vest Stock Option Activity

Outstanding January 1, 2023

Outstanding September 30, 2022

Vested and expected to vest September 30, 2022

Exercisable September 30, 2022

Outstanding March 31, 2023

Vested and expected to vest March 31, 2023

Exercisable March 31, 2023

stock option activity for non-employees:

Schedule of Unvested Stock Option Activity

of Unvested Stock Option Activity

Unvested January 1, 2023

Unvested September 30, 2022

compensation expense was approximately $ 792,000 and $ 1,320,000 for the nine months ended September 30, 2022, and 2021, resulting in an

increase in general and administrative expenses, respectively.

of September 30, 2022, and 2021, respectively, there was approximately $ 179,000 and $ 279,000 of unrecognized equity-based compensation

cost related to options granted under the Equity Incentive Plan.

Unvested March 31, 2023

compensation expense was approximately $ 82,000 and $ 242,000 for the three months ended March 31, 2023 and 2022, resulting in a decrease

in general and administrative expenses, respectively.

of March 31, 2023, and 2022, respectively, there was approximately $ 134,000

and $ 729,000

of unrecognized equity-based compensation cost related to options granted under the Equity Incentive Plan.

Marketable Securities

securities consist of mutual funds.

As of September 30, 2022, and December 31, 2021, it was determined that none of the marketable securities

As of March 31, 2023 and December 31, 2022, it was determined that none of the marketable securities

had an other-than-temporary impairment.

As of September 30, 2022, and December 31, 2021, all securities were measured as Level 1 instruments

under the fair value measurements standard (See Note 11:

As of September 30, 2022, and December 31, 2021, the Company held

approximately $ 6,986,000 and $ 16,175,000 in mutual funds.

As of March 31, 2023 and December 31, 2022, all securities were measured as Level 1 instruments

of the fair value measurements standard (See Note 11:

As of March 31, 2023, and December 31, 2022 the Company held $ 7,454,000

and $ 7,137,000 in mutual funds, respectively.

Funds classified as available for sale consisted of:

Schedule of Available for Sale

of Equity Securities

Net losses recognized during the period on equity securities

March 31, 2023

(in thousands)

of Available of Sale

March 31, 2023

(in thousands)

Schedule of Equity Securities

Net gains and losses recognized during the period on equity securities

Net gains and losses recognized during the period on equity securities sold during the period

1 unchanged sentence

Funds classified as available for sale consisted of:

December 31, 2021

(in thousands)

Net losses recognized during the period on equity securities

3 unchanged sentences

expenses consist of the following:

of Accrued Expenses

Accrued Expenses

March 31, 2023

December 31, 2022

(in thousands)

September 30, 2022

March 31, 2023

December 31, 2022

2 unchanged sentences

Other expenses

Accrued expenses

Property and Equipment, net

of Property and Equipment

March 31, 2023

December 31, 2022

(in thousands)

September 30, 2022

March 31, 2023

December 31, 2022

Land, buildings and improvements

Furniture, fixtures, and equipment

Total property and equipment

accumulated depreciation

1 unchanged sentence

and equipment are recorded at cost.

Depreciation is computed using the straight-line method over the estimated useful lives of the respective

assets, ranging from three to thirty-nine years.

Depreciation expense for the nine months ending September 30, 2022 and September 30,

2021 was $ 29,000 and $ 484,000 .

Depreciation and amortization are computed using the straight-line method over the estimated useful

lives of the respective assets, ranging from three to ten years.

Depreciation expense for the three months ending March 31, 2023 and

March 31, 2022 was $ 11,000 and $ 10,000 , respectively.

Company made a strategic shift on in-house manufacturing and recorded an impairment of the facility in the amount of $ 1,800,000 during

the year ended December 31, 2021.

During the period ending September 30, 2022, the Company reported assets held for sale related to

the pending sale of the manufacturing facility located at 783 Jersey Avenue.

On November 1, 2022, AIM completed the sale of its

facility at 783 Jersey Avenue, New Brunswick, N.J., for $ 3.7

million net of normal closing cost.

During the period ending March 31, 2022, the Company reported assets held for sale related to the pending

sale of the manufacturing facility located at 783 Jersey Avenue.

On November 1, 2022, AIM completed the sale of its facility at 783 Jersey

Avenue, New Brunswick, N.J., for $ 3.7 million net of normal closing cost.

(See Note 11 Fair Value).

Patents, and Trademark Rights, Net

of Patents, Trademark Rights

(in thousands)

December 31, 2021

December 31, 2022

September 30, 2022

and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method of the estimated useful life

of patents and trademarks for each of the next five years is as follows:

of Amortization of Patents and Trademarks

Period Ending December 31,

(in thousands)

March 31, 2023

and trademarks are stated at cost and are amortized using the straight-line method over an estimated useful life of 17 years.

of patents and trademarks for each of the next five years and thereafter is as follows:

Schedule of Amortization of Patents and Trademarks

Year Ending December 31,

Stockholders’ Equity

5 unchanged sentences

The Series B Convertible

Preferred Stock has a stated value $ 1,000 per share.

Preferred Stock has a stated value of $ 1,000 per share.

Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $ 1,000 per share.

As of September

As of March 31,

2023, and December 31, 2022, the Company had 692 and 696 shares of Series B Convertible Preferred Stock outstanding, respectively.

Holders shall be entitled to receive, and the Company shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock

shall be entitled to receive, and the Company shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock

basis) to and in the same form as dividend actually paid on shares of Common Stock when as and if such dividends are paid on shares of

5 unchanged sentences

The Series B Convertible

Preferred Stock shall have no voting Rights.

Preferred Stock does not carry voting Rights.

to a registration statement relating to a rights offering declared effective by the SEC on February 14, 2019, AIM distributed to its

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were approximately $ 4,700,000 .

During the nine months ending September 30, 2022 and September 30, 2021, 2 and 7 shares, respectively,

of Series B Convertible Preferred Stock were converted into common stock.

During the three months ending March 31, 2023, 0 shares of Series B Convertible Preferred Stock were converted

into common stock.

Common Stock and Equity Finances

Company has authorized shares of 350,000,000 with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000

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for a sixty-day period commencing upon the date that the NYSE American approved the Company’s Supplemental Listing Application.

When this plan expired, the board of directors approves subsequent similar $ 500,000 plans for all directors, officers and employees to

buy Company shares from the Company at the market price.

Subsequent plans were approved by the board of directors upon the expiration

of prior plans.

The latest plan was approved by the board of directors on March 2, 2022.

the nine months ended September 30, 2022, the Company issued a total of 87,045 shares of its common stock at prices ranging from $ 0.76

to $ 1.02 for a total of $ 80,000 as part of the employee stock purchase plan, not from the 2018 Equity Incentive Plan.

The Company created successive new plans following the expiration of the plan.

During the fiscal years ended December 31, 2021 and 2022,

the Company issued 132,238 and 86,817 shares of its common stock at prices ranging from $ 1.16 to $ 2.35 ;

and from $ 0.76 to $ 1.02 /per

share under these plans.

The latest plan was approved by the board of directors in April 2023.

the three months ended March 31, 2023, the Company issued a total of 322,583 shares of its common stock at a price of $ 0.31 for total

proceeds of $ 100,000 .

the twelve months ended December 31, 2022, the Company issued a total of 132,238 shares of its common stock at prices ranging from $ 1.16

to $ 2.35 for a total of $ 205,000 .

to $ 2.35 for total proceeds of $ 205,000 .

September 27, 2019, the Company closed a public offering underwritten by A.G.P./Alliance Global Partners, LLC (the “Offering”)

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Warrants”), and (iii) warrants to purchase up to an aggregate of 8,888,860 shares of Common Stock (the “Warrants”).

In conjunction with the Offering, a Representative’s

Warrant to purchase up to an aggregate of 266,665 shares of common stock (the “Representative’s Warrant”) .

The shares of Common Stock and Warrants were sold at a combined Offering price of $ 0.90 , less underwriting discounts and commissions.

Each Warrant sold with the shares of Common Stock represents the right to purchase one share of Common Stock at an exercise price of

In conjunction with the Offering, a Representative’s Warrant to purchase up to an aggregate of 266,665 shares of common stock (the

“Representative’s Warrant”).

The shares of Common Stock and Warrants were sold at a combined Offering price of $ 0.90 ,

less underwriting discounts and commissions.

Each Warrant sold with the shares of Common Stock represents the right to purchase one share

of Common Stock at an exercise price of $ 0.99 per share.

The Pre-Funded Warrants and Warrants were sold at a combined Offering price

of $ 0.899 , less underwriting discounts and commissions.

The Pre-Funded Warrants were sold to purchasers whose purchase of shares of Common

Stock in the Offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially

owning more than 4.99 % of the Company’s outstanding Common Stock immediately following the consummation of the Offering, in lieu

of shares of Common Stock.

Each Pre-Funded Warrant represents the right to purchase one share of Common Stock at an exercise price of

$ 0.001 per share.

The Pre-Funded Warrants and Warrants were sold at a combined Offering price of $ 0.899 , less underwriting discounts and

The Pre-Funded Warrants were sold to purchasers whose purchase of shares of Common Stock in the Offering would otherwise

result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99 % of the Company’s

outstanding Common Stock immediately following the consummation of the Offering, in lieu of shares of Common Stock.

Each Pre-Funded Warrant

represents the right to purchase one share of Common Stock at an exercise price of $0.001 per share.

The Pre-Funded Warrants are exercisable

immediately and may be exercised at any time until the Pre-Funded Warrants are exercised in full.

A registration statement on Form S-1,

relating to the Offering was filed with the SEC and was declared effective on September 25, 2019, the net proceeds were approximately

$ 7,200,000 .

As of September 30, 2022, there are 15,000 Warrants outstanding.

July 19, 2019, the Company entered into a new Equity Distribution Agreement (the “2019 EDA”) with Maxim Group LLC (“Maxim”),

pursuant to which it could sell, from time to time, shares of its Common Stock through Maxim, as agent.

The 2019 EDA replaced a prior

EDA with Maxim.

For the year ended December 31, 2020, the Company sold 20,444,807 shares under the 2019 EDA for total gross proceeds

of $ 53,936,615 , which includes a 3.5 % fee to Maxim of $ 1,888,727 .

During the period ended December 31, 2021, the Company sold 5,665,731

shares under the 2019 EDA for total gross proceeds of $ 13,301,526 , which includes a 3.5 % fee to Maxim of $ 465,533 .

The 2019 EDA was terminated

in early February 2021.

The Pre-Funded Warrants are exercisable immediately and may be exercised at any time until the Pre-Funded Warrants

are exercised in full.

A registration statement on Form S-1, relating to the Offering was filed with the SEC and was declared effective

on September 25, 2019, the net proceeds were approximately $ 7,200,000 .

During the year ending December 31, 2020, 1,870,000 of the Pre-funded

Warrants were exercised and 8,873,960 Warrants were exercised.

In addition, on March 25, 2020, the Representative’s Warrant was

amended to permit exercise of such warrant to commence on March 30, 2020.

These warrants were exercised on March 31, 2020 and an aggregate

of 266,665 shares were issued upon exercise of this warrant for gross proceeds of approximately $ 264,000 and a $ 46,000 expense for the

warrant modification.

As of March 31, 2023, there are 15,000 Warrants outstanding.

2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock

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will continue in effect for a period of 10 years from its effective date.

During first quarter of 2022, 300,000 options were issued to

employees with an exercise price of $ .70 for a period of ten years with a vesting period of one year.

During fourth quarter of 2021,

On October 17, 2018, the Board of Directors issued 26,324 options

to the officers and directors at the exercise price of $ 9.68 expiring in 10 years, and on November 14, 2018, the Board of Directors issued

23 options to each employee, officer and director at the exercise price of $ 9.68 expiring in ten years.

On January 28, 2019, 27,570 options

were issued to each of these officers with an exercise price of $ 9.68 for a period of ten years with a vesting period of one year.

August 2020, 400,000 options were issued to each of these officers with an exercise price range of $ 2.77 to $ 3.07 for a period of ten

years with a vesting period of one year.

During the fiscal year ending December 31, 2022, 850,000 options were issued to employees with

an exercise price range of $ 0.31 to $ 1.71 for a period of ten years with a vesting period of one year.

During the fourth quarter of 2021,

613,512 options were issued to employees with an exercise price range of $ 1.11 to $ 1.71 for a period of ten years with a vesting period

of September 30, 2022, and December 31, 2021, there were 48,082,275 and 47,994,672 shares outstanding, respectively.

of March 31, 2023, and December 31, 2022, there were 48,407,326 and 48,084,287 shares outstanding, respectively.

Cash and Cash Equivalents

Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.

considers all highly liquid interest-earning investments with a maturity of three months or less at the date of purchase to be cash equivalents.

Recent Accounting Pronouncements

the third quarter of 2022 accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact

the first quarter of 2023 accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact

on the Company’s present or future financial statements.

Company is required under U.S.

GAAP to disclose information about the fair value of all the Company’s financial instruments, whether

or not these instruments are measured at fair value on the Company’s consolidated balance sheets.

Company estimates that the fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate

their carrying values due to the short-term maturities of these items.

The Company also has certain warrants with a cash settlement

feature in the occurrence of a Fundamental Transaction.

The fair value of the redeemable warrants (“Warrants”) related

to the Company’s April 2018, and March 2019 common stock and warrant issuance, are calculated using a Monte Carlo Simulation.

While the Monte Carlo Simulation is one of a number of possible pricing models, the Company has determined it to be industry

accepted and fairly presented the fair value of the Warrants.

As an additional factor to determine the fair value of the Put’s

liability, the occurrence probability of a Fundamental Transaction event was factored into the valuation.

Company complies with the provisions of FASB ASC 820 “Fair Value Measurements” for its financial and non-financial assets

and liabilities.

ASC 820 defines fair value, establishes a framework for measuring fair value and expands disclosure for each major asset

and liability category measured at fair value on either a recurring or nonrecurring basis.

fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate their carrying values due

to the short-term maturities of these items and are considered a Level 1 instrument

of the fair value measurements standard .

The Company also has certain warrants with a cash settlement feature in the occurrence

of a Fundamental Transaction.

The fair value of the redeemable warrants (“Warrants”) related to the Company’s

February 2017, June 2017, April 2018, and March 2019 common stock and warrant issuance, are calculated using a Monte Carlo

Company recomputes the fair value of the Warrants at the issuance date and the end of each quarterly reporting period.

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of Assumptions to Estimate Fair Value of Warrants

September 30, 2022

December 31, 2021

Underlying price per share

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Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:

September 30, 2022

December 31, 2021

Underlying price per share

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Expected dividend yield

Measurement input

significant assumptions using the Monte Carlo Simulation approach for valuation of the Warrants are:

(i) Risk-Free

Interest Rate .

The risk-free interest rates for the Warrants are based on U.S.

Treasury constant maturities for periods commensurate

with the remaining expected holding periods of the warrants.

Expected Holding Period .

The expected holding period represents the period of time that the Warrants are expected to be outstanding until they are exercised.

The Company utilizes the remaining contractual term of the Warrants at each valuation date as the expected holding period.

Expected Volatility .

Expected stock volatility is based on daily observations of the Company’s historical stock values for a period commensurate

with the remaining expected holding period on the last day of the period for which the computation is made.

Expected Dividend Yield .

Expected dividend yield is based on the Company’s anticipated dividend payments over the remaining expected holding period.

As the Company has never issued dividends, the expected dividend yield is $ 0.00 and this assumption will be continued in future calculations

constant maturities for periods commensurate with the remaining expected holding periods

of the warrants.

(ii) Expected

Holding Period .

The expected holding period represents the period of time that the Warrants

are expected to be outstanding until they are exercised.

The Company utilizes the remaining

contractual term of the Warrants at each valuation date as the expected holding period.

(iii) Expected

Expected stock volatility is based on daily observations of the Company’s

historical stock values for a period commensurate with the remaining expected holding period

on the last day of the period for which the computation is made.

(iv) Expected

Dividend Yield .

The expected dividend yield is based on the Company’s anticipated dividend

payments over the remaining expected holding period.

As the Company has never issued dividends,

the expected dividend yield is 0% and this assumption will be continued in future calculations

unless the Company changes its dividend policy.

Expected Probability

of a Fundamental Transaction.

The possibility of the occurrence of a Fundamental Transaction triggering a Put right is extremely

As discussed above, a Put right would only arise if a Fundamental Transaction (1) is an all cash transaction;

in the Company going private;

or (3) is a transaction involving a person or entity not traded on a national securities exchange.

The Company believes such an occurrence is highly unlikely because:

only has one product that is FDA approved but which will not be available for commercial sales for 18 months at the earliest;

The Company flagship product

is approved only in Argentina for Severely Debilitated Chronic Fatigue Syndrome patients;

The Company may have to

perform additional clinical trials for FDA approval of its flagship product;

Industry and global market

conditions continue to include uncertainty, adding risk to any transaction;

Available capital for a

potential buyer in a cash transaction continues to be limited;

The nature of a life science

company is heavily dependent on future funding and high costs, including research & development;

The Company has minimal

revenue streams which could be insufficient to meet the funding needs for the cost of operations or construction at their manufacturing

The Company’s Rights

Agreement and Executive Agreements make it less attractive to a potential buyer.

Probability of a Fundamental Transaction.

Put rights arise if a Fundamental Transaction

1) is an all cash transaction;

(2) results in the Company going private;

or (3) is a transaction

involving a person or entity not traded on a national securities exchange.

The Company believes

such an occurrence is unlikely because:

Company only has one product that is FDA approved but is currently not available for commercial

Company will have to perform additional clinical trials for FDA approval of its flagship

and market conditions continue to include uncertainty, adding risk to any transaction.

nature of a life sciences company is heavily dependent on future funding and high fixed costs,

including Research & Development.

Company has minimal revenues streams which are insufficient to meet the funding needs for

the cost of operations or construction at their manufacturing facility;

Company’s Rights Agreement and Executive Agreements make it less attractive to a potential

the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities

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Monte Carlo Simulation has incorporated a 5.0 % probability of a Fundamental Transaction to date for the life of the securities.

(vi) Expected

Timing of Announcement of a Fundamental Transaction.

As the Company has no specific expectation of a Fundamental Transaction,

for reasons stated above, the Company used a discrete uniform probability distribution over the Expected Holding Period to model

the potential announcement of a Fundamental Transaction occurring during the Expected Holding Period.

As the Company has no specific expectation

of a Fundamental Transaction, for reasons elucidated above, the Company utilized a discrete

uniform probability distribution over the Expected Holding Period to model in the potential

announcement of a Fundamental Transaction occurring during the Expected Holding Period.

(vii) Expected

100 Day Volatility at Announcement of a Fundamental Transaction .

An estimate of future volatility is necessary as there is no

mechanism for directly measuring future stock price movements.

Daily observations of the Company’s historical stock values

for the 100 days immediately prior to the Warrants’ grant dates, with a floor of 100 %, were utilized as a proxy for the future

Expected Risk-Free Interest

Rate at Announcement of a Fundamental Transaction .

The Company utilized a risk-free interest rate corresponding to the forward

Treasury rate for the period equal to the time between the date forecast for the public announcement of a Fundamental Transaction

and the Warrant expiration date for each simulation.

Expected Time Between

Announcement and Consummation of a Fundamental Transaction.

The expected time between the announcement and the consummation of

a Fundamental Transaction is based on the Company’s experience with the due diligence process performed by acquirers and is

estimated to be six months.

The Monte Carlo Simulation approach incorporates this additional period to reflect the delay Warrant

Holders would experience in receiving the proceeds of the Put.

the assumptions remain consistent from period to period (e.g., using historical stock prices), the numbers input change from period to

period (e.g., the actual historical prices input for the relevant period).

Company applies FASB ASC 820 that defines fair value, establishes a framework for measuring fair value in U.S.

GAAP, and expands disclosures

about fair value measurements.

The guidance does not impose any new requirements around which assets and liabilities are to be measured

at fair value, and instead applies to asset and liability balances required or permitted to be measured at fair value under existing

accounting pronouncements.

The Company measures its warrant liability for those warrants with a cash settlement feature at fair value.

ASC 820-10-35-37 establishes a valuation hierarchy based on the transparency of inputs used in the valuation of an asset or liability.

Classification is based on the lowest level of inputs that is significant to the fair value measurement.

The valuation hierarchy contains

three levels:

Quoted prices are available in active markets for identical assets or liabilities at the reporting date.

Generally, this includes

and government agency debt and equity securities that are traded in an active market.

Level 2 – Observable

inputs other than Level 1 prices such as quoted prices for similar assets or liabilities;

An estimate of future

volatility is necessary as there is no mechanism for directly measuring future stock price

Daily observations of the Company’s historical stock values for the 100

days immediately prior to the Warrants’ grant dates, with a floor of 100 %, were utilized

as a proxy for future volatility estimates.

(viii) Expected

Risk-Free Interest Rate at Announcement of a Fundamental Transaction .

The Company utilized

a risk-free interest rate corresponding to the forward U.S.

Treasury rate for the period

equal to the time between the date forecast for the public announcement of a Fundamental

Transaction and the Warrant expiration date for each simulation.

(ix) Expected

Time Between Announcement and Consummation of a Fundamental Transaction.

time between the announcement and the consummation of a Fundamental Transaction is based

on the Company’s experience with the due diligence process performed by acquirers and

is estimated to be six months.

The Monte Carlo Simulation approach incorporates this additional

period to reflect the delay Warrant Holders would experience in receiving the proceeds of

the assumptions remain consistent from period to period (e.g., utilizing historical stock prices), the actual historical prices input

for the relevant period input change.

As of March 31, 2023 and December 31, 2022 there was no carrying amount and estimated fair value

of the above Warrants.

Company accounts for certain assets and liabilities at fair value.

The hierarchy below lists three levels of fair value based on the

extent to which inputs used in measuring fair value are observable in the market.

AIM categorizes each of its fair value measurements

in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety.

1 – Quoted prices are available in active markets for identical assets or liabilities

at the reporting date.

Generally, this includes debt and equity securities that are traded

in an active market.

2 – Observable inputs other than Level 1 prices such as quote prices for similar assets

or liabilities;

quoted prices in markets that are not active;

or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets

or other inputs that are observable

or can be corroborated by observable market data for substantially the full term of the assets

or liabilities.

Generally, this includes debt and equity securities that are not traded in an active market.

Level 3 – Unobservable

inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow

methodologies, or other valuation techniques, as well as instruments for which the determination of fair value requires significant

management judgment or estimation.

As of September 30, 2022, the Company has classified the warrants with cash settlement features

Management evaluates a variety of inputs and then estimates fair value based on those inputs.

As discussed above, the

Company utilized the Monte Carlo Simulation Model in valuing these warrants.

Generally, this includes debt and equity securities that are not traded in

an active market.

3 – Unobservable inputs that are supported by little or no market activity and that

are significant to the fair value of the assets or liabilities.

Level 3 assets and liabilities

include financial instruments whose value is determined using pricing models, discounted

cash flow methodologies, or other valuation techniques, as well as instruments for which

the determination of fair value requires significant management judgment or estimation.

of March 31, 2023, the Company has classified the warrants with cash settlement features

Management evaluates a variety of inputs and then estimates fair value based

on those inputs.

As discussed above, the Company utilized the Monte Carlo Simulation Model

in valuing the warrants.

table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy

as (in thousands):

of Assets and Liabilities Measured at Fair Value on a Recurring Basis

(in thousands)

As of September 30, 2022

As of March 31, 2023

Marketable securities

Redeemable warrants

(in thousands)

As of December 31, 2022

Marketable securities

Redeemable warrants

changes in Level 3 Liabilities measured at fair value on a recurring basis are summarized as follows (in thousands):

of Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis

Redeemable warrants:

Balance at December 31, 2021

Fair value adjustment

Balance at September 30, 2022

table below presents the balances of assets and liabilities measured at fair value on a nonrecurring basis by level within the hierarchy

of Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis

(in thousands)

As of December 31, 2021

Total Gains (Losses)

Long lived assets held and used (a)

accordance with Subtopic 360-10, long-lived assets held and used with a carrying amount of $ 5,700,000 were written down to their

fair value of $ 3,900,000 resulting in an impairment charge of $ 1,800,000 , which was included in earnings for the period ending December

A $ 300,000 deposit was received in the third quarter 2022 related

to the asset.

Financing Obligation Arising from Sale Leaseback Transaction

March 16, 2018, the Company sold land and a building for $ 4,080,000 and concurrently entered into an agreement to lease the property

back for ten years at $408,000 per year for two years through March 31, 2020.

The lease payments would increase 2.5% per year for the

next three years through March 31, 2023, and the lease payments would increase 3% for the remaining five years through March 31, 2028 .

As part of the sale of this building, warrants were provided to the buyer for the purchase of up to 73,314 shares of Company common stock

for a period of five years at an exercise price of $ 17.05 per share, 125 % of the closing price of the common stock on the NYSE American

on the date of execution of the letter of intent for the purchase.

The sale of the property included an option to repurchase the property

based on a contractual formula which does not permanently transfer all the risks and rewards of ownership to the buyer.

Because the sale

of the property included the option to repurchase the property and included the above attributes, the transaction was accounted for as

a financing transaction whereby the Company recorded the cash received and a financing obligation.

The warrants cannot be exercised to

the extent that any exercise would result in the purchaser owning in excess of 4.99% of our issued and outstanding shares of common stock.

May 13, 2021, the Company completed its repurchase of the property for cash of $ 4,732,637 .

The repurchase resulted in the related liability

recorded upon sale being extinguished on the date of the repurchase.

A loss on the extinguishment was recorded based on the difference

between the carrying value of the financing obligation including unamortized debt discount and the amount exchanged to extinguish the

expense relating to this financing agreement was $ 0 for the period ended September 30, 2022 and $ 67,000 for the nine months ended September

Redeemable warrant

Company leases office and storage space, and other equipment under non-cancellable operating leases with initial terms typically ranging

from 1 to 5 years.

At contract inception, the Company reviews the facts and circumstances of the arrangement to determine if the contract

is or contains a lease.

The Company follows the guidance in Topic 842 “ Leases ” to evaluate whether the contract has

an identified asset;

if the Company has the right to obtain substantially all economic benefits from the asset;

and if the Company has

the right to direct the use of the underlying asset.

When determining if a contract has an identified asset, the Company considers both

explicit and implicit assets, and whether the supplier has the right to substitute the asset.

When determining if the Company has the

right to direct the use of an underlying asset, the Company considers if it has the right to direct how and for what purpose the asset

is used throughout the period of use and if it controls the decision-making rights over the asset.

Company’s lease terms may include options to extend or terminate the lease.

The Company exercises judgment to determine the term

of those leases when extension or termination options are present and include such options in the calculation of the lease term when

it is reasonably certain that it will exercise those options.

contract inception, utilizing the guidance of ASC 842 “ Leases ” the Company reviews the facts and circumstances of

each contract to determine its proper treatment and classification in accordance with U.S.

Company has elected to include both lease and non-lease components in the determination of lease payments.

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The fixed portion of these payments are included in the calculation of the lease liability, while

any variable portion would be recognized as variable lease expenses, when incurred.

Variable payments made to third parties for these,

or similar costs, such as utilities, are not included in the calculation of lease payments.

lease commencement, lease-related assets and liabilities are measured at the present value of future lease payments over the lease term.

As most of the Company’s leases do not provide an implicit rate, the Company exercises judgment in determining the incremental

borrowing rate based on the information available when the lease commences to measure the present value of future payments.

leases are included in other assets, current operating lease obligations, and operating lease obligations (less current portion) on the

Company’s consolidated balance sheet.

Short term leases with an initial term of 12 months or less are not presented on the balance

sheet with expense recognized as incurred.

any variable portion is recognized as variable lease expenses as incurred.

lease inception, lease-related assets and liabilities are measured at the present value of future lease payments over the lease term.

For leases that do not provide an implicit rate, the Company utilizes an estimated incremental borrowing rate based on market observations

existing at lease inception to calculate the present value of future payments.

assets are disclosed as Right of Use assets on the Company’s consolidated balance sheet and are amortized over the expected useful

life of the lease.

Lease liabilities are separately disclosed as a current and non-current portion on the Company’s consolidated

balance sheet.

term leases with an initial term of 12 months or less are not presented on the balance sheet with expense recognized as incurred.

Company entered into a Lease Agreement for a term of five years commencing on September 14, 2020 pursuant to which the Company agreed

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May 1, 2019, the Company entered into a Lease Agreement for a term of three years commencing on May 1, 2019 , pursuant to which the Company

agreed to lease approximately 3,000 rentable square feet.

The base rent is $ 2,500 per month for the term of the lease.

On October 4,

2021, the Company executed a request to renew the lease for a one-year term as defined in the Lease Agreement.

The request was accepted,

and the one-year term commenced on April 30, 2022.

On October 5, 2022, the Company executed a request to renew the lease for an additional

one-year term at a monthly cost of $ 2,850 .

The request was accepted and the one-year term commences on May 1, 2023 .

agreed to lease approximately 3,000 rentable square feet at a base rent of $ 2,500 per month.

The Company renewed the lease for a one-year

term extending the rental period to April 2023.

On October 5, 2022, the Company renewed the lease for an additional one-year term at

a monthly cost of $ 2,850 commencing on May 1, 2023 .

February 17, 2022, the Company entered into a Lease Agreement for a term of two years commencing on March 1, 2022 , pursuant to which

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for the first year to $ 18,118 per month for the fifth year.

December 9, 2022, the Company entered into a Lease Agreement for a term of two years commencing on April 1, 2023 , pursuant to which the

Company agreed to lease approximately 470 square feet of wet laboratory space.

The base rent increases by 6 % each year and ranges from

$ 1,645 per month for the first year to $ 1,744 per month for the second year.

expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it is reasonably certain

that the Company would exercise such options.

The Company’s leases have remaining lease terms between 11 months and 5 years.

of September 30, 2022, and December 31, 2021, the weighted-average remaining term is 2.67 and 2.72 years, respectively.

Company has determined that the incremental borrowing rate is 10 % as of September 30, 2022, and December 31, 2021, respectively, based

upon the recently completed financing transaction in December 2019.

minimum payments as of September 30, 2022, are as follows:

The Company’s leases have remaining lease terms between 12 and 53 months.

31, 2023, and December 31, 2022, the weighted-average remaining term was 25 and 28 months, respectively.

Company’s weighted average incremental borrowing rate for its leases was 10 % as of March 31, 2023, and December 31, 2022, respectively.

minimum lease payments as of March 31, 2023, are as follows:

of Operating Lease Future Payments

Period December 31,

(in thousands)

Year Ending December 31,

Less imputed interest

of September 30, 2022, and December 31, 2021, the balance of the right of use assets was $ 866,000 and $ 149,000 , respectively, and the

corresponding lease liability balance was $ 866,000 and $ 149,000 , respectively.

Total rent expense for the nine months ended September

30, 2022, and September 30, 2021, amounted to approximately $ 75,000 and $ 39,000 , respectively.

Total rent expense for short term leases

for the nine months ended September 30, 2022, and September 30, 2021, amounted to approximately $ 8,000 for both periods.

of March 31, 2023, the net balance of the right of use assets was $ 792,000 and the corresponding lease liability balance was $ 815,000 .

At December 31, 2022, the balance of the right of use assets was $ 829,000 and the corresponding lease liability balance was $ 837,000 .

Total rent expense was $ 87,000 for the three months ended March 31, 2023, and $ 17,000 for the three months ended March 31, 2022.

Research, Consulting and Supply Agreements

January 2021, the Company entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1

clinical study to assess the safety, tolerability, and biological activity of Ampligen as a potential intranasal therapy.

has paid CHDR approximately $ 1,066,000 .

April 2021, the Company approved a proposal from Polysciences for the manufacture of our Poly I and Poly C12U polynucleotides and associated

test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors to the drug Ampligen.

The Company is working with Polysciences to negotiate and finalize both a Service Agreement and a Quality Agreement.

For the year ended

December 31, 2021, the Company has incurred an expense and paid Polysciences approximately $ 250,000 .

For the nine months ended September

30, 2022, the Company paid Polysciences $ 103,000 .

April 2022, AIM executed a work order with Amarex Clinical Research LLC (“Amarex”), our contract research organization, pursuant

to which Amarex will manage a Phase 2 clinical trial in advanced pancreatic cancer patients designated AMP-270.

Per the work order, AIM

anticipates that the study will cost approximately $ 8.2 million, which includes pass through costs of approximately $ 1.0 million and

excludes certain third-party costs and escalations.

AIM anticipates that the study will take approximately 4.6 years to complete.

June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex will manage a Phase 2 trial in patients with Post-COVID

It is planned that the study will be conducted at up to 10 sites in the United States.

following represent companies with which AIM has active contracts that it paid toward in Q1 2023.

Clinical Research LLC

has multiple contracts with Amarex Clinical Research LLC (“Amarex”) In the first Q1 2023, we paid $ 520,800 related

to these ongoing agreements:

Cancer - In April 2022, AIM executed a work order with Amarex pursuant to which Amarex will manage a Phase 2 clinical trial in

locally advanced pancreatic cancer patients designated AMP-270.

Per the work order, AIM anticipates that the study will cost

approximately $ 8.2

million, which includes pass through costs of approximately $ 1.0

million and excludes certain third-party and investigator costs and escalations.

AIM anticipates that the study will take

approximately 4.6

years to complete.

Q1 2023, we paid approximately $ 309,400 related to this agreement.

Conditions - On June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex

will manage a Phase 2 trial in patients with Post-COVID Conditions.

It is planned that the

study will be conducted at up to 10 sites in the United States.

AIM is sponsoring the study.

AIM anticipates

that the study will cost approximately $ 4.4 million, which includes pass through costs of approximately $ 125,470 , investigator costs

estimated at about $ 2.4 million and excludes certain other third-party costs and escalations.

AIM anticipates that the study will cost approximately $ 4.4 million, which includes pass

through costs of approximately $ 125,470 , investigator costs estimated at about $ 2.4 million

and excludes certain other third-party costs and escalations.

Q1 2023, we paid approximately $ 211,400 related to this agreement.

Services Limited

July 2021, the Company executed a Reservation and Start-Up Agreement (the “Agreement”) with hVIVO Services Limited (“hVIVO”),

and subsequently signed a clinical trial agreement (“CTA”) in September.

For the year ended December 3, 2021, the Company

had incurred an expense and paid hVIVO approximately $ 2,340,000 for services incurred in 2021.

In March 2022, the Company announced that

it had officially withdrawn its application from the Medicines and Healthcare Regulatory Agency and terminated its agreement with hVIVO

and incurred a cancelation fee of $ 60,000 which was paid in the first quarter 2022.

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

(“myTomorrows”),

a Netherlands-based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related

Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing

EAP activities.

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

automatically extended again for

an additional period of 12 months on May 20, 2022;

and will be automatically extended again on May 20, 2023.

Q1 2023, we paid $ 8,000 related to this agreement.

HollisterStier

HollisterStier (“Jubilant”) is AIM’s authorized CMO for Ampligen for the approval in Argentina.

In 2017, the Company

entered into a purchase order with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company.

the 2017 engagement of Jubilant, four lots of Ampligen consisting of more than 16,000 units have been manufactured and released in year

The first lot was designated for human use in the United States in the cost recovery CFS program and for expanded oncology clinical

The second lot has been designated for these programs in addition to commercial distribution in Argentina for the treatment of

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

Q1 2023, there were no payments related to this agreement.

Pharmaceutics

International Inc.

December 2020, AIM added Pharmaceutics International Inc.

(“Pii”) as a “Fill & Finish” provider to enhance

its capacity to produce Ampligen.

This addition amplifies AIM’s manufacturing capability by providing redundancy and cost savings.

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

For the period ended December 31, 2021, the Company has incurred

an expense and paid Pii approximately $ 89,000 .

For the nine months ended September 30, 2022, the Company incurred an expense and paid

Pii approximately $ 259,000 .

the Company’s capacity to produce the drug Ampligen.

This addition amplifies AIM’s manufacturing capability by providing

redundancy and cost savings.

The contracts augment AIM’s existing fill and finish capacity.

As agreed to in the Master Services

Agreement, the terms of each of AIM’s projects with Pii will be negotiated separately and defined in individual Service Contracts.

For the year ended December 31, 2022, the Company has incurred an expense and paid Pii approximately $ 278,000 .

Q1 2023, we paid approximately $ 9,300 related to this agreement.

April 2021, the Company approved a proposal from Polysciences Inc.

(“Polysciences”) for the manufacture of our Poly I and

Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce

the polymer precursors to the drug Ampligen.

The Company is working with Polysciences to negotiate and finalize both a Service Agreement

and a Quality Agreement.

For the year ended December 31, 2021, the Company has incurred an expense and paid Polysciences approximately

For the three months ended March 31, 2022, the Company paid Polysciences $ 103,000 .

Q1 2023, there were no payments related to this agreement.

Company has utilized Yamasa Corporation (“Yamasa”) for the production of raw materials required to create polymer precursors

to manufacture the drug Ampligen.

In March 2023, we submitted a work order for $ 327,730

related to the purchase of these raw materials

These raw materials will be used in the manufacture of polymer precursors at Sterling.

Q1 2023, there were no

related to Yamasa.

Sterling Pharma Solutions

On December 5, 2022, the Company

entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”) for the manufacture

of the Company’s 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.

Q1 2023, there were no payments related to this agreement.

Subsequent Events

October 5, 2022, the Delaware Court of Chancery held a hearing regarding a motion to require the AIM Board of Directors to accept the

Jorgl Group’s director nominations and include the group’s nominees on a universal proxy card for the 2022 Annual Meeting

of Stockholders.

On October 28, 2022, the court denied Jorgl’s motion.

The Jorgl Group announced on November 2, 2022, that it did

not intend to appeal the decision.

October 12, 2022, the Company announced that its Investigational New Drug (IND) application filed with the FDA was granted clearance

to proceed and therefore the Company could initiate a Phase 2 study evaluating Ampligen as a therapeutic for patients with post-COVID

conditions (“AMP-518”).

November 1, 2022, AIM completed the sale of its facility at 783 Jersey Avenue, New Brunswick, N.J., for $ 3.7

million net of normal closing cost .

In November 2022, AIM received notice that the FDA had granted Orphan

Drug Designation to Ampligen for the treatment of Ebola virus disease.

April 4, 2023, the “Company executed an Unrestricted Grant Agreement with Erasmus University Medical Center (“EUMC”)

pursuant to which EUMC will use its best efforts to diligently carry out immune monitoring in pancreatic cancer patients.

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.

April 19, 2023, we entered into an Equity Distribution Agreement (the “EDA”) with Maxim Group LLC (“Maxim”),

pursuant to which the Company may sell, from time to time, shares of its 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

EDA, 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.

the quarter ended March 31, 2023, the Company did not sell any shares under the EDA.

Subsequent to the end of Q1 2023, the Company sold

969 shares under the 2023 EDA for total gross proceeds of approximately $ 485 , which includes a 3 % fee to Maxim of approximately $ 15 .

On May 9, 2023, the Company was granted a U.S.

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.

On May 10, 2023, the Company filed

a Certificate of Increase in Delaware, increasing the number of preferred stock designated as Series A Junior Participating Preferred

Stock to 4,000,000 .

On May 12, 2023, the Company amended

and restated its November 14, 2017 Rights Plan with American Stock Transfer & Trust Company as Rights Agent (the “Rights Plan”).

Please see Item II, Part 5 “Other Information” for more details.

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 1. Financial Statements