What changed in this filing

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Item 1. Financial Statements

2023-08-14 compared with 2023-05-15 · 234 added, 208 removed, 488 unchanged (48% of the section changed)

4 unchanged sentences

thousands, except for share and per share amounts)

March 31, 2023

June 30, 2023

December 31, 2022

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Stockholders’ equity:

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

Series B Convertible Preferred Stock, stated value $ 1,000 per share, 690 and 696 issued and outstanding, respectively

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

48,419,491 and 48,084,287 , issued and outstanding, respectively

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thousands, except share and per share data)

Three months ended March 31,

Three months ended

Six months ended

Clinical treatment programs - US

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Interest and other income

Interest expense and other finance costs

(Loss) on sale of fixed assets

Redeemable warrants valuation adjustment

(Loss) on sale of assets

Gain from sale of Income tax operating losses

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Statements of Changes in Stockholders’ Equity

the Six Months Ended June 30, 2023 and 2022

thousands except share data)

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$ ( 380,546 )

Shares issued for:

Common stock issuance, net of costs

Equity-based compensation

Series B preferred shares converted to common

Series B preferred shares converted to common shares

Net comprehensive loss

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$ ( 384,207 )

Common stock issuance, net of costs

Equity-based compensation

Series B preferred shares converted to common shares

Net comprehensive loss

Balance June 30, 2023

$ ( 389,116 )

Accumulated other

Comprehensive

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$ ( 361,101 )

Shares issued for:

Common stock issuance, net of costs

Equity-based compensation

Series B preferred shares converted to common shares

Net comprehensive loss

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$ ( 364,921 )

Common stock issuance, net of costs

Equity-based compensation

Series B preferred shares converted to common shares

Net Comprehensive loss

Balance June 30, 2022

$ ( 369,772 )

accompanying notes to consolidated financial statements.

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Statements of Cash Flows

the Three Months Ended March 31, 2023 and 2022

the Six Months Ended June 30, 2023 and 2022

Cash flows from operating activities:

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Changes in ROU assets

Loss on available for sale marketable securities

Gain from sale of income tax operating losses

Equity-based compensation

Unrealized loss (gain) on marketable securities

(Loss) on sale of marketable securities

Change in assets and liabilities:

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 patent and trademark rights

Purchase of marketable securities

Proceeds from sales of property and equipment

Net cash used in investing activities

Proceeds from sale of property and equipment

Purchase of patent and trademark rights

Net cash (used in) provided by investing activities

Cash flows from financing activities:

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Net cash provided by financing activities

Net decrease in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

Cash and cash equivalents at beginning of period

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

Operating lease-Right of Use Assets

Unrealized gain (loss) on marketable securities

Conversion of Series B preferred

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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 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.

business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen and its Active Pharmaceutical

Ingredients (APIs).

This includes utilizing Jubilant HollisterStier and Sterling for the manufacture of Ampligen and our Poly I and Poly

C12U polynucleotides, respectively.

Additionally, our relationship with Polysciences Inc.

(“Polysciences”) continues and

R&D development of polymer manufacture is ongoing.

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

also continually exploring new efficiencies in order 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.

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consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years

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

on March 31, 2023.

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 on March 31, 2023.

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

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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.

and trademark valuations, stock-based compensation calculations, 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 2,595,914 and 2,447,924 , are excluded from the calculation

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

of diluted net loss per share for the six months ended June 30, 2023, and 2022, respectively, since their effect is antidilutive due

to the net losses recorded for the periods.

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

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:

During the six months ended June 30, 2023, there were no

options granted and 300,000 options granted during the six months ended June 30, 2022.

stock option activity during the three months ended June 30, 2023, was as follows:

option activity for employees:

of Vest Stock Option Activity

Outstanding January 1, 2023

Outstanding March 31, 2023

Vested and expected to vest March 31, 2023

Exercisable March 31, 2023

Outstanding June 30, 2023

Vested and expected to vest June 30, 2023

Exercisable June 30, 2023

stock option activity for employees:

of Unvested Stock Option Activity

Unvested January 1, 2023

Unvested March 31, 2023

Unvested June 30, 2023

option activity for non-employees:

of Vest Stock Option Activity

Outstanding January 1, 2023

Outstanding March 31, 2023

Vested and expected to vest March 31, 2023

Exercisable March 31, 2023

Outstanding June 30, 2023

Vested and expected to vest June 30, 2023

Exercisable June 30, 2023

stock option activity for non-employees:

of Unvested Stock Option Activity

Unvested January 1, 2023

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.

Unvested June 30, 2023

compensation expense was approximately $ 50,000 and $ 275,000 for the three months ended June 30, 2023 and 2022, respectively.

stock option activity during the six months ended June 30, 2023, was as follows:

option activity for employees:

Outstanding January 1, 2023

Outstanding June 30, 2023

Vested and expected to vest June 30, 2023

Exercisable June 30, 2023

stock option activity for employees:

Unvested January 1, 2023

Unvested June 30, 2023

option activity for non-employees:

Outstanding January 1, 2023

Outstanding June 30, 2023

Vested and expected to vest June 30, 2023

Exercisable June 30, 2023

stock option activity for non-employees:

Unvested January 1, 2023

Unvested June 30, 2023

compensation expense was approximately $ 132,000 and $ 517,000 for the six months ended June 30, 2023 and 2022, respectively.

June 30, 2023, and 2022, respectively, there was approximately $ 85,000 and $ 454,000 of unrecognized equity-based compensation cost related

to options granted under the Equity Incentive Plan.

Marketable Securities

securities consist of mutual funds.

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

As of June 30, 2023 and December 31, 2022, it was determined that none of the marketable securities

had an other-than-temporary impairment.

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

As of June 30, 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

As of June 30, 2023, and December 31, 2022 the Company held $ 7,360,000

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

Funds classified as available for sale consisted of:

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 gain recognized during the period on equity securities

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

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Accrued Expenses

March 31, 2023

June 30, 2023

December 31, 2022

(in thousands)

March 31, 2023

June 30, 2023

December 31, 2022

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of Property and Equipment

March 31, 2023

June 30, 2023

December 31, 2022

(in thousands)

March 31, 2023

June 30, 2023

December 31, 2022

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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.

Depreciation expense for the six months ending June 30, 2023 and June

30, 2022 was $ 21,000 and $ 20,000 , 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 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).

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

sale of the manufacturing facility located at 783 Jersey Avenue (See Note 11 Fair Value).

Patents, and Trademark Rights, Net

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December 31, 2021

Abandonments and expirations

December 31, 2022

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.

Abandonments and expirations

June 30, 2023

and trademarks are stated at cost.

Patents are amortized using the straight-line method over an estimated useful life of 17

years and 10 years, respectively.

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

Schedule of Amortization of Patents and Trademarks

of Amortization of Patents and Trademarks

Year Ending December 31,

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

As of March 31,

As of June 30,

2023, and December 31, 2022, the Company had 690 and 696 shares of Series B Convertible Preferred Stock outstanding, respectively.

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were approximately $ 4,700,000 .

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

During the six months ending June 30, 2023, 2 shares of Series B Convertible Preferred Stock were converted

into common stock.

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 .

Common Stock and Equity Finances

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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 total proceeds of $ 205,000 .

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

the six months ended June 30, 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 six months ended June 30, 2022, the Company issued a total of 53,922 shares

of its common stock at prices ranging from $ 1.02 for

total proceeds of $ 55,000 as part of the employee stock purchase plan, not from the 2018 Equity Incentive Plan .

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 $ 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

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 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.

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 .

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 June 30, 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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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 March 31, 2023, and December 31, 2022, there were 48,407,326 and 48,084,287 shares outstanding, respectively.

April 19, 2023, the Company 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 (the “Offering”).

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.

For the six months ended June 30, 2023, the Company 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, the Company 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 .

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”).

of June 30, 2023, and December 31, 2022, there were 48,419,491 and 48,084,287 shares outstanding, respectively.

Cash and 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.

considers all highly liquid interest-earning investments with an original maturity of three months or less at the date of purchase to

be cash equivalents.

Recent Accounting Pronouncements

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 has implemented all new accounting pronouncements that are in effect.

These pronouncements did not have any material impact

on the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting

pronouncements that have been issued that might have a material impact on its financial position or results of operations.

Accounting pronouncements issued by the FASB since filing the Annual Report on Form 10-K for the year ended December 31, 2022 did not or are not believed by management to have a material

impact on the Company’s present or future financial statements.

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

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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

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.

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.

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

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Expected dividend yield

Warrants measurement input

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

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Expected dividend yield

Warrants measurement input

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

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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.

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.

Probability of a Fundamental Transaction.

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for the relevant period input change.

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

As of June 30, 2023 and December 31, 2022 there was no carrying amount and estimated fair value

of the above Warrants.

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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.

of June 30, 2023, the Company has classified the warrants with cash settlement features as

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

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

As of March 31, 2023

As of June 30, 2023

Marketable securities

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to lease two Sharp copiers.

The base of $ 1,415 per month.

The base rent under the agreement is $ 1,415 per month.

June 13, 2018, the Company entered into a Lease Agreement for a term of six years commencing on July 1, 2018 pursuant to which the Company

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30, 2023, and December 31, 2022, the weighted-average remaining term was 46 and 52 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:

Company’s weighted average incremental borrowing rate for its leases was 10 % as of June 30, 2023, and December 31, 2022, respectively.

minimum lease payments as of June 30, 2023, are as follows:

of Operating Lease Future Payments

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Less imputed interest

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 .

of June 30, 2023, the net balance of the right of use assets was $ 781,000 and the corresponding lease liability balance was $ 803,000 .

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.

Total rent expense was $ 141,000 for the six months ended June 30, 2023, and $ 27,000 for the six months ended June 30, 2022.

Research, Consulting and Supply Agreements

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

following represent companies with which AIM has active contracts that it paid toward during the six months ended June 30, 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.

has multiple contracts with Amarex Clinical Research LLC (“Amarex”).

During the six months ended June 30, 2023, the Company

paid $ 538,000 related to these ongoing agreements:

Cancer - In April 2022, AIM executed a work order with Amarex pursuant to which Amarex is

managing a Phase 2 clinical trial in locally advanced pancreatic cancer patients designated

Per the work order, AIM anticipates that Amarex’s management of the study

will cost approximately $ 8.2 million.

This estimate includes pass-through costs of approximately

$ 1.0 million and excludes certain third-party and investigator costs and escalations necessary

for study completion.

AIM anticipates that the study will take approximately 4.6 years to

the six months ended June 30, 2023, the Company paid approximately $ 233,400 related to this

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.

is managing a Phase 2 trial in patients with Post-COVID Conditions.

It is planned that the

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and excludes certain other third-party costs and escalations.

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

the six months ended June 30, 2023, the Company paid approximately $ 304,600 related to this

Services Limited

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For the year ended December 31, 2021, the Company

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

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

In March 2022, the Company announced that

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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.

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

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.

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.

the six months ended June 30, 2023, the Company paid approximately $ 18,000 related to this

HollisterStier

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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.

entered into an agreement with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company.

2017 engagement of Jubilant, two lots of Ampligen consisting of more than 16,000 units were manufactured and released in the year 2018.

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

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

manufactured additional two lots of Ampligen in December 2019 and January 2020.

In March 2023, the Company submitted a purchase order

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

were no payments related to this agreement during the six months ended June 30, 2023.

Subsequent to June 30, 2023, the Company paid $ 1,432,257

related to this agreement.

Pharmaceutics

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

the Company’s capacity to produce the drug Ampligen.

This addition amplifies AIM’s manufacturing capability by providing

redundancy and cost savings.

the AIM’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

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.

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

the six months ended June 30, 2023, the Company paid approximately $ 55,400 related to this

April 2021, AIM 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

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

the six months ended June 30, 2023, there were no payments related to this agreement.

also utilizes Yamasa Corporation (“Yamasa”) for the production of raw materials required to create polymer precursors to

manufacture the drug Ampligen.

In March 2023, the Company submitted a work order for $ 327,730 related to the purchase of 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.

the six months ended June 30, 2023, there were no payments related to this agreement.

Pharma Solutions

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.

the six months ended June 30, 2023, the Company paid approximately $ 357,000 related to this

Subsequent Events

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.

As disclosed in a Schedule 13D/A filed with the SEC on August 7, 2023, a stockholder submitted a notice of intent to nominate individuals

for election as directors at the Company’s 2023 Annual Meeting of Stockholders.

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