What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2020-11-12 compared with 2020-08-14 · 583 added, 515 removed, 1449 unchanged (43% of the section changed)

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thousands, except for share and per share data)

September 30, 2020

December 31, 2019

Current assets:

and cash equivalents

Marketable securities,

Funds receivable

from sale of New Jersey net operating loss

Accounts receivable,

expenses and other current assets

Cash and cash equivalents

Marketable securities, short term

Funds receivable from sale of New Jersey net operating loss

Accounts receivable, net

Prepaid expenses and other current assets

Total current assets

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Accrued expenses

Current portion

of operating lease liabilities

portion of financing obligation

current liabilities

Current portion of operating lease liabilities

Current portion of financing obligation

Total current liabilities

Long-term liabilities:

Operating lease

Operating lease obligation

Notes payable, net

Financing obligation

arising from sale leaseback transaction (Note 14)

Financing obligation arising from sale leaseback transaction (Note 14)

Redeemable warrants

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Stockholders’

Series B Convertible

Preferred Stock, stated value $1,000 per share, 8,000 shares designated, 737 and 778 shares issues 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, 8,000 shares designated, 733 and 778 shares issues and outstanding, respectively

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

issued and outstanding 40,685,282 and 10,386,754 respectively

Additional paid-in

Accumulated other

comprehensive income

stockholders’

liabilities and stockholders’

Additional paid-in capital

Accumulated other comprehensive income

Accumulated deficit

Total stockholders’

Total liabilities and stockholders’

accompanying notes to consolidated financial statements.

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thousands, except share and per share data)

treatment programs –United States

treatment programs - Europe

Three months ended

September 30,

Nine months ended

September 30,

Clinical treatment programs –

United States

Clinical treatment programs - Europe

Total revenues

Costs and expenses:

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Research and development

and administrative

costs and expenses

General and administrative

Total costs and expenses

Operating loss

Interest and other

Interest expense

and other finance costs

Extinguishment

of notes payable

Convertible note

valuation adjustment

Interest and other income

Interest expense and other finance costs

Extinguishment of notes payable

Convertible note valuation adjustment

Settlement of litigation

warrants valuation adjustment

Other comprehensive

income (loss):

loss on marketable securities

comprehensive loss

and diluted loss per share

Weighted average

shares outstanding, basic and diluted

Redeemable warrants valuation adjustment

Other comprehensive income (loss):

Unrealized loss on marketable securities

Net comprehensive loss

Basic and diluted loss per share

Weighted average shares outstanding, basic and diluted

accompanying notes to consolidated financial statements.

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Statement of Changes in Stockholders’

the Six Months Ended June 30, 2020 and 2019

the Nine Months Ended September 30, 2020 and 2019

thousands except share data)

Comprehensive

Income (Loss)

Stockholders’

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Shares issued to pay accounts payable

Series B preferred shares converted

to common shares

Net comprehensive

Balance June 30, 2020

Series B preferred shares converted to common shares

Net comprehensive loss

Balance September 30, 2020

Series B Preferred

Accumulated other

Comprehensive

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Shares issued for:

Common stock issuance,

Convertible note

origination shares

Common stock issuance, net of costs

Convertible note origination shares

Deemed dividends

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Shares issued to pay accounts payable

Series B preferred shares issued, net

of offering costs

Series B preferred shares converted

to common shares

Net comprehensive

Balance June 30, 2019

Series B preferred shares issued, net of offering costs

Series B preferred shares converted to common shares

Net comprehensive loss

Balance September 30, 2019

accompanying notes to consolidated financial statements.

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Statements of Cash Flows

the Six Months Ended June 30, 2020 and 2019

the Nine Months Ended September 30, 2020 and 2019

Cash flows from operating activities:

Adjustments to reconcile net loss to

net cash used in operating activities:

Depreciation of

property and equipment

Redeemable warrants

valuation adjustment

Fair value of convertible

note adjustment

Change in convertible

Extinguishment of

notes payable

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation of property and equipment

Redeemable warrants valuation adjustment

Fair value of convertible note adjustment

Change in convertible debt –

Extinguishment of notes payable

Warrant modification

Amortization of

patent, trademark rights

Amortization of patent, trademark rights

Changes in ROU assets

Equity-based compensation

Realized (loss)

gain on sale of marketable securities

Amortization of

finance and debt issuance costs

Realized (loss) gain on sale of marketable securities

Amortization of finance and debt issuance costs

Change in assets and liabilities:

Accounts and other

Prepaid expenses

and other current assets

Accounts receivable and other receivables

Prepaid expenses and other current assets

Lease liability

Accounts payable

Accrued interest

Net cash used

in operating activities

Accrued interest expense

Accrued expenses

Net cash used in operating activities

Cash flows from investing activities:

Proceeds from sale

of marketable securities

Purchase of marketable

Purchase of property

and equipment

of patent and trademark rights

Net cash provided

by (used in) investing activities

Proceeds from sale of marketable securities

Purchase of marketable securities

Purchase of property and equipment

Purchase of patent and trademark rights

Net cash used in investing activities

Cash flows from financing activities:

Payment of note

Financing obligation

from sale of stock, net of issuance costs

Net cash provided

by financing activities

Payment of note payable

Financing obligation payments

Proceeds from note payable, net of issuance costs

Proceeds from sale of stock, net of issuance costs

Net cash provided by financing activities

Net increase in cash and cash equivalents

Cash and cash

equivalents at beginning of period

Cash and cash

equivalents at end of period

Supplemental disclosures of non-cash

investing and financing cash flow information:

loss on marketable securities

of series B preferred

of note payable into shares

issued to settle accounts payable

Lease –

Cash and cash equivalents at beginning of period

Cash and cash equivalents at end of period

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

Unrealized loss on marketable securities

Conversion of Series B preferred

Conversion of note payable into shares

Stock issued to settle accounts payable

Operating lease –

right of use assets

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Under the Patent Cooperation Treaty of 1970, which provides international protections for patents, the three

provisional patent applications can convert to international patent applications based on the date of their filings.

provisional patent applications can be converted to international patent applications based on the date of their filings.

early April 2020, the Company entered into a Material Transfer Agreement with Shenzhen Smoore Technologies located in Shenzhen

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biologically active Ampligen deep into the lung airways of humans.

The Company is currently awaiting study details from Smoore.

The Ampligen is scheduled to be shipped to Smoore for testing, pending resolution of various China inbound import regulatory

requirements.

Ampligen is scheduled to be shipped to Smoore for testing,

pending resolution of various China inbound import regulatory requirements.

AIM and Smoore are working to identify and navigate

any and all regulatory obligations.

The Company will provide additional updates as they become available.

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The relationship with ChinaGoAbroad is ongoing.

May 11, 2020, the FDA authorized an IND for Roswell Park Cancer Institute to conduct a Phase 1/2a study of a regimen of Ampligen

and interferon alpha in cancer patients with mild or moderate COVID-19 infections.

This new clinical trial, sponsored by the Roswell

Park in collaboration with the Company, will test the safety of this combination regimen in patients with cancer and mild to moderate

COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway.

It is planned

that the phase 1/2a study will enroll up to 80 patients in two stages.

Phase 1 will see 12-24 patients receiving both Ampligen

and interferon alfa-2b at escalating doses.

Once that initial phase is complete, further study participants will be randomized

one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alfa but will

receive best available care.

The Company intends to be a financial sponsor of the study and will provide Ampligen at no charge

for this study.

May 11, 2020, the FDA authorized an IND for Roswell Park Comprehensive Cancer Institute (“Roswell Park”) to conduct

a Phase 1/2a study of a regimen of Ampligen and interferon alpha in cancer patients with mild or moderate COVID-19 infections.

This new clinical trial, sponsored by the Roswell Park in collaboration with the Company, will test the safety of this combination

regimen in patients with cancer and mild to moderate COVID-19, and the extent to which this therapy will promote clearance of

the SARS-CoV-2 virus from the upper airway.

It is planned that the phase 1/2a study will enroll up to 44 patients in two stages.

Phase 1 will see 12-24 patients receiving both Ampligen and interferon alfa-2b at escalating doses.

Once that initial phase is

complete, further study participants will be randomized to two arms:

one receiving the two-drug combination and a control group

who will not receive Ampligen or interferon alfa but will receive best available care.

The Company intends to be a financial sponsor

of the study and will provide Ampligen at no charge for this study.

March 2020, the Japanese National Institute of Infectious Diseases (“NIID”) initiated preliminary laboratory testing

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to provide Ampligen samples for various research projects.

Per this agreement, the details of all preclinical and

clinical results will remain confidential until released by NIID and Shionogi.

July 6, 2020, we entered into a clinical trial agreement with Roswell Park Comprehensive Cancer Center pursuant to which Roswell

Park will conduct a Phase 1/2 trial of Ampligen (rintatolimod) in combination with Interon-A (interferon alfa-2b),

in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus .

Per this agreement, the details of all preclinical and clinical results

will remain confidential until released by NIID and Shionogi.

July 6, 2020, we entered into a clinical trial agreement with Roswell Park pursuant to which Roswell Park will conduct a Phase

1/2a trial of Ampligen (rintatolimod) in combination with Intron-A (interferon alfa-2b), in cancer patients with COVID-19, the

disease caused by the SARS-CoV-2 coronavirus.

the Company also entered into a material transfer agreement with the University of Rochester which is planning a series of in

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The Company also entered into a specialized services agreement with Utah State University that has supplied Ampligen

to support the University’s Institute for Viral Research in its research into SARS-CoV-2 and testing is underway.

June of 2020, AIM filed a provisional patent application for, among other discoveries, the use of Ampligen®

as a potential

early-onset therapy for the treatment of COVID-19 induced chronic fatigue.

to support the University’s Institute for Viral Research in its research into SARS-CoV-2.

The Utah State results show that

Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

June 2020, AIM filed a provisional patent application for, among other discoveries, the use of Ampligen®

as a potential early-onset

therapy for the treatment of COVID-19 induced chronic fatigue.

survivors of the first SARS-CoV-1 epidemic in 2003 continued to report chronic fatigue, difficulty sleeping and shortness of breath

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is increasing evidence that patients with COVID-19 can develop a similar, ME/CFS-like illness.

AIM plans to investigate the possible

activity of Ampligen in the “Long Hauler”

population, including a plan to modify our AMP-511 program to include Long

In October 2020, AIM received Institutional

Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program (EAP) clinical trial for Myalgic Encephalomyelitis/Chronic

Fatigue Syndrome (ME/CFS) to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like

November 2, 2020, AIM announced the publication of statistically significant data detailing how Ampligen could have a considerable

positive impact on people living with ME/CFS when administered in the early stages of the disease.

The data were published in

PLOS ONE , a peer-reviewed open access scientific journal published by the Public Library of Science.

AIM researchers found

that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients.

The findings potentially

carry special importance for COVID-19 “Long Haulers,”

who are uniquely situated to potentially benefit from Ampligen

as an early onset therapy for subjects who have recovered from acute COVID-19, but then experience chronic fatigue-like symptoms.

COVID-19 pandemic has significantly impacted the economic conditions in the U.S., accelerating during the first half of March.

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Equivalent common shares, consisting of stock options and warrants which amounted to 8,017 and 5,893,040 and 534,283 and

are excluded from the calculation of diluted net loss per share for the three months and six months ended June 30, 2020 and 2019,

respectively, since their effect is antidilutive due to the net loss.

6,733,420 are excluded from the calculation of diluted net loss per share for the three months and nine months ended September

30, 2020 and 2019, respectively, since their effect is antidilutive due to the net loss.

Equity-Based Compensation

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

Options granted in the six months

ended June 30, 2020 and 2019 were 0 and 39,267, respectively.

Options granted in the nine months

ended September 30, 2020 and 2019 were 400,000 and 39,267, respectively.

option for employees’

activity during the six months ended June 30, 2020 is as follows:

activity during the nine months ended September 30, 2020 is as follows:

option activity for employees:

Outstanding January 1, 2020

Outstanding June 30, 2020

Vested and expected

to vest June 30, 2020

Exercisable June 30, 2020

Outstanding September 30, 2020

Vested and expected to vest September 30, 2020

Exercisable September 30, 2020

stock option activity for employees:

Unvested January 1, 2020

Unvested June 30, 2020

Unvested September 30, 2020

option activity for non-employees:

Outstanding January 1, 2020

Outstanding June 30, 2020

Vested and expected

to vest June 30, 2020

Exercisable June 30, 2020

Outstanding September 30, 2020

Vested and expected to vest September 30, 2020

Exercisable September 30, 2020

stock option activity for non-employees:

Unvested January 1, 2020

Unvested June 30, 2020

compensation expense was approximately $346,000 and $426,000 for the six months ended June 30, 2020 and 2019 resulting in an increase

in general and administrative expenses, respectively.

of June 30, 2020, and 2019, respectively, there was approximately $442,000 and $1,101,000 of unrecognized equity-based compensation

Unvested September 30, 2020

compensation expense was approximately $596,000 and $649,000 for the nine months ended September 30, 2020 and 2019 resulting in

an increase in general and administrative expenses, respectively.

of September 30, 2020, and 2019, respectively, there was approximately $1,080,000 and $877,000 of unrecognized equity-based compensation

cost related to options granted under the Equity Incentive Plan.

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Due to the Company extending the timeline of Alferon production to in excess of one year, the Company reclassified Alferon work

in process inventory of $1,095,000 to other assets within our balance sheet as of June 30, 2020 and December 31, 2019 and due

to the high cost estimates to bring the facility back online.

in process inventory of $1,095,000 to other assets within our balance sheet as of September 30, 2020 and December 31, 2019 and

due to the high cost estimates to bring the facility back online.

Prior to completing validation, the Company plans on modernizing

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securities consist of mutual funds and debt securities.

As of June 30, 2020, and December 31, 2019, it was determined that none

of the marketable securities had an other-than-temporary impairment.

At June 30, 2020 and December 31, 2019, all securities were

measured as Level 1 instruments of the fair value measurements standard (see Note 13:

As of June 30, 2020, and December

31, 2019 the Company held $6,401,000 and $7,308,000 in debt and equity securities, respectively.

As of September 30, 2020, and December 31, 2019, it was determined that

none of the marketable securities had an other-than-temporary impairment.

At September 30, 2020 and December 31, 2019, all securities

were measured as Level 1 instruments of the fair value measurements standard (see Note 13:

As of September 30, 2020,

and December 31, 2019 the Company held $15,980,000 and $7,308,000 in debt and equity securities, respectively.

securities classified as available for sale consisted of:

(in thousands)

Gains /(Losses)

Marketable Securities

Treasury notes

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(in thousands)

than 12 Months

Less than 12 Months

12 Months or More

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expenses consist of the following:

(in thousands)

September 30, 2020

December 31, 2019

Professional fees

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Property and Equipment

(in thousands)

September 30, 2020

December 31, 2019

Land, buildings and improvements

Furniture, fixtures,

and equipment

Furniture, fixtures, and equipment

Total property and equipment

equipment, net

accumulated depreciation

Property and equipment, net

and equipment are recorded at cost.

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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.

June 30, 2020, and December 31, 2019, the Company had 737 and 778 shares of Series B Convertible Preferred Stock outstanding,

September 30, 2020, and December 31, 2019, the Company had 733 and 783 shares of Series B Convertible Preferred Stock outstanding,

respectively.

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from the rights offering were approximately $4,700,000.

During the six months ending June 30, 2020, 41 shares of Series B Convertible

Preferred Stock were converted into common stock.

During the nine months ending September 30, 2020, 45 shares of Series

B Convertible Preferred Stock were converted into common stock.

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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from the Company at the market price.

As of June 30, 2019, the Company has issued 67,767 shares of its common stock at prices

As of September 30, 2019, the Company has issued 67,767 shares of its common stock at prices

between $4.03 and $4.37 for a total of $274,000.

This plan expired August 19, 2019.

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

of (i) 1,740,550 shares of Common Stock;

(ii) pre-funded warrants exercisable for 7,148,310 shares of Common Stock (the “Pre-funded

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 $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 six months ended June 30, 2020, 1,870,000 of the Pre-funded Warrants

were exercised and 8,873,860 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.

On September 27, 2019, the Company closed

an public offering underwritten by A.G.P./Alliance Global Partners, LLC (the “Offering”) of (i) 1,740,550 shares of

Common Stock;

(ii) pre-funded warrants exercisable for 7,148,310 shares of Common Stock (the “Pre-funded 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 $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 nine months ended September

30, 2020, 1,870,000 of the Pre-funded Warrants were exercised and 8,873,860 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.

May 2, 2019, the Company entered into a modification agreement with certain redeemable warrant holders of the August 23, 2017

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On March 3, 2020, the Company filed a new prospectus supplement

with SEC increasing the aggregate offering price of shares of common stock it could sell under the 2019 EDA $10,867,245.

10, 2020, the Company filed another prospectus supplement with SEC increasing the aggregate offering price under the 2019 EDA

to $18,833,739.

During the six months ended June 30, 2020, the Company sold 12,580,926 shares under the 2019 EDA for total gross

proceeds of $32,878,403, which includes a 3.5% fee to Maxim of $1,150,744.

On June 15, 2020, the Company filed another prospectus

supplement with SEC increasing the aggregate offering price under the 2019 EDA to $19,406,552.

During the quarter ended June 30,

2020, the Company sold 5,964,197 shares under the 2019 EDA for total gross proceeds of $15,560,537, which includes a 3.5% fee

to Maxim of $544,619.The actual number of shares, that the Company can sell, and the proceeds to be received therefrom under the

2019 EDA are dependent upon the market price of its Common Stock.

with SEC increasing the aggregate offering price of shares of common stock it could sell under the 2019 EDA to $10,867,245.

March 10, 2020, the Company filed another prospectus supplement with SEC increasing the aggregate offering price under the 2019

EDA to $18,833,739.

During the nine months ended September 30, 2020, the Company sold 18,990,367 shares under the 2019 EDA for

total gross proceeds of $50,692,287, which includes a 3.5% fee to Maxim of $1,774,230.

On June 15, 2020, the Company filed another

prospectus supplement with SEC increasing the aggregate offering price under the 2019 EDA to $19,406,552.

On August 18, 2020,

the Company filed another prospectus supplement with SEC increasing the aggregate offering price under the 2019 EDA to $19,004,095.

During the quarter ended September 30, 2020, the Company sold 6,409,441 shares under the 2019 EDA for total gross proceeds of

$17,813,884, which includes a 3.5% fee to Maxim of $623,486.

The actual number of shares, that the Company can sell, and the proceeds

to be received therefrom under the 2019 EDA are dependent upon the market price of its Common Stock.

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

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of $9.68 for a period of ten years with a vesting period of one year.

of June 30, 2020, and December 31, 2019, there were 34,250,615 and 10,386,754 shares outstanding, respectively.

In August, 2020, 400,000 options were issued to each of

these officers with a exercise price range of of $2.77 to $3.07 for a period of ten years with a vesting period of one year.

of September 30, 2020, and December 31, 2019, there were 40,685,282 and 10,386,754 shares outstanding, respectively.

Cash and Cash Equivalents

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Long Term Debt.

expense associated with the IR Note was $0 for June 30, 2020 and $50,000 for the six months ended June 30, 2019.

expense associated with the IR Note was $0 for September 30, 2020 and $94,000 for the nine months ended September 30, 2019.

Long-Term Debt

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repayment of the Convertible Note is secured by substantially all of our assets other than its intellectual property.

the three months ending June 30, 2020, the Holder made redemptions of $650,000 reducing the principal to $1,985,000.

May 29, 2020, the Company paid off the outstanding CV note consisted of principal of $1,985,000, and accrued interest payable

The net payment of $1,795,000, less the write off of the origination discount of $369,000 and

issuance costs of $6,000, resulted in a gain on extinguishment of $66,000.

the quarter ending June 30, 2020, the Holder made redemptions of $650,000 reducing the principal to $1,985,000.

29, 2020, the Company paid off the outstanding CV note consisted of principal of $1,985,000, and accrued interest payable of $220,000.

The net payment of $1,795,000, less the write off of the origination discount of $369,000 and issuance costs of $6,000, resulted

in a gain on extinguishment of $66,000.

December 5, 2019, the Company issued a secured Promissory Note (the “AS Note”) to Atlas Sciences L.P.

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conjunction with the financing, the Company used the proceeds to pay the outstanding IR Note.

Convertible Note

expense associated with the CV Note and AS Note for the period ended June 30, 2020 was approximately $116,000 and $106,000, respectively.

Convertible Note Payable.

expense associated with the CV Note and AS Note for the period ended September 30, 2020 was approximately $116,000 and $106,000,

respectively.

Company is required under U.S.

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Company utilized the following assumptions to estimate the fair value of the August 2016 Warrants:

September 30, 2020

December 31, 2019

Underlying price per share

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Company utilized the following assumptions to estimate the fair value of the February 2017 Warrants:

September 30, 2020

December 31, 2019

Underlying price per share

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$ 30.25 –

$ 30.25-33.00

Risk-free interest rate

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Company utilized the following assumptions to estimate the fair value of the June 2017 Warrants:

September 30, 2020

December 31, 2019

Underlying price per share

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Company utilized the following assumptions to estimate the fair value of the August 2017 Warrants:

September 30, 2020

December 31, 2019

Underlying price per share

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Company utilized the following assumptions to estimate the fair value of the April 2018 Warrants:

September 30, 2020

December 31, 2019

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, 2020

December 31, 2019

Underlying price per share

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of probabilities related to a Put right being triggered as:

of Probability

Range of Probability

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

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of fair value requires significant management judgment or estimation.

As of June 30, 2020, the Company has classified the

warrants with cash settlement features as Level 3.

As of September 30, 2020, the Company has classified

the warrants with cash settlement features as Level 3.

Management evaluates a variety of inputs and then estimates fair value

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

As of June 30, 2020

(in thousands)

As of September 30, 2020

Treasury notes

mortgage backed Securities

Government mortgage backed Securities

Corporate bonds

Marketable Securities

Redeemable warrants

(in thousands)

As of December 31, 2019

Redeemable warrants

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

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Fair value adjustment

Balance at June 30, 2020

Balance at September 30, 2020

Financing Obligation Arising from Sale Leaseback Transaction

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would be the excess of the liability (current fair value of the property) over its carrying amount.

If the option is exercised,

the cash payment by the seller-lessee is to pay off the financing obligation.

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 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.

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 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.

Property and Equipment in Note 7 above are the property and equipment involved in this transaction.

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will continue until a sale has been recognized.

minimum payments required under the Financing Obligation and the balance of the Finance Obligation as of June 30, 2020 are as

minimum payments required under the Financing Obligation and the balance of the Finance Obligation as of September 30, 2020 are

(in thousands)

Total of payments

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Less discount on debt instrument

Less imputed interest

Total balance

expense relating to this financing agreement was $31,000 for the six months ended June 30, 2020 and $35,000 for the six months

ended June 30, 2019.

Less current portion

Long term portion

expense relating to this financing agreement was $46,000 for the nine months ended September 30, 2020 and $51,000 for the nine

months ended September 30, 2019.

February 2016, the FASB established Topic 842, Leases, by issuing ASU No.

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new disclosures about our leasing activities.

Company entered into a Lease Agreement for a term of five years commencing on June 1, 2015 with Fraser Advanced Information Systems,

pursuant to which the Company agreed to lease two Sharp copiers.

The base rent increases by 5% each year, and ranges from approximately

$1,049 per month for the first year to $1,335 per month on the fifth year.

Company entered into a Lease Agreement for a term of five years commencing on September 14, 2020 with Fraser Advanced Information

Systems, pursuant to which the Company agreed to lease two Sharp copiers.

The base of $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 with SML FL Holdings

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The Company’s leases have remaining lease terms between 6 months and

As of June 30, 2020, the weighted-average remaining term is 2.17 years.

As of September 30, 2020, the weighted-average remaining term is 2.17 years.

The Company has determined that the incremental

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are the lease commitments for the next 5 years and thereafter.

Year-Ending June 30,

Year-Ending September 30,

(in thousands)

Less Imputed Interest

of June, 30, 2020, the balance of the right of use assets was $130,000 and the corresponding lease liability balance was $130,000.

Total rent expense was $30,000 for the six months ended June 30, 2020 and $28,000 for the six months end June 30, 2019.

of September, 30, 2020, the balance of the right of use assets was $188,000 and the corresponding lease liability balance was

Total rent expense was $41,000 for the nine months ended September 30, 2020 and $44,000 for the nine months end September

Subsequent Events

August 6, 2020, AIM contracted Amarex Clinical Research LLC (“Amarex”) to act as the Company’s Clinical Research

Organization and provide regulatory support with regard to a clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis

via intranasal delivery.

For Phase I the Company anticipates providing approximately $514,000 to Amarex.

For the subsequent Phase

II the Company anticipates providing approximately an additional $650,000.

Additional costs expected to be incurred by us for

the clinical trial are estimated at $4.5 million.

It is anticipated that Phase I will consist of 24 test subjects and that Phase

II will consist of 150 test subjects, subject to obtaining IND authorization from the FDA.

August 12, 2020, the Company granted to Thomas K.

Equels, Chief Executive Officer, consistent with his employment agreement, 300,000

ten-year options to purchase common stock with an exercise price of $3.07 per share which vest in one year.

The Company also granted

William Mitchell and Stewart Appelrouth, as compensation for their services as members of committees of the board of directors,

each 50,000 ten-year options to purchase common stock with an exercise price of $2.77 per share which vest in one year.

On November 10,

2020, the Company entered into a five year employment agreement with Thomas K.

Equels, President, CEO and Executive Vice

Chairman of the Board.

Compensation is divided into both short- and long-term compensation.

Short term (cash)

compensation will consist of a base salary of $850,000 and a year-end target bonus of $350,000 based on performance and goals

established by the Compensation Committee.

Long term compensation will be provided by 300,000 non-qualified yearly stock

options with one-year vesting on November 30,2021, and each anniversary date thereafter.

On November 11, 2020, the Company

issued to Mr.

Equels 10 year options to purchase 300,000 shares of the Company’s common stock.

The exercise price of

these options is $1.96 per share, the closing price of the common stock on the NYSE American on the trading date immediately

preceding the date of issuance.

The options will vest one year after their issuance.

These options were issued pursuant to

the terms of Mr.

Equels’

employment agreement.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

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in laws and regulations affecting our industry, and issues related to our New Brunswick, New Jersey facility.

With the outbreak of the

COVID-19 coronavirus and our prior research into Ampligen’s antiviral activity against Severe Acute Respiratory Syndrome,

or SARS, we are now expanding our clinical/business focus to include the potential of Ampligen to serve as a protective prophylaxis

and an early-onset therapeutic for the virus SARS-CoV-2, the cause of COVID-19 and as part of a vaccine.

Significant testing

and trials will be required to determine whether Ampligen will be effective in the treatment of the COVID-19 coronavirus in humans

and no assurance can be given that it will be the case.

Our beliefs rely on a number of previous studies related to SARS-CoV-1.

No assurance can be given that future studies will not result in findings that are different from those reported in the studies

to which we refer.

the outbreak of the COVID-19 coronavirus and our prior research into Ampligen’s antiviral activity against Severe Acute

Respiratory Syndrome, or SARS, we are now expanding our clinical/business focus to include the potential of Ampligen to serve

as a protective prophylaxis and an early-onset therapeutic for the virus SARS-CoV-2, the cause of COVID-19 and as part of a vaccine.

Significant testing and trials will be required to determine whether Ampligen will be effective in the treatment of the COVID-19

coronavirus in humans and no assurance can be given that it will be the case.

Our beliefs rely on a number of previous studies

related to SARS-CoV-1.

No assurance can be given that future studies will not result in findings that are different from those

reported in the studies to which we refer.

Results obtained in animal models do not necessarily predict results in humans.

Some of the world’s largest

pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19.

Even if Ampligen proves effective

in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another

treatment that eventually proves capable will not negate our current and future efforts.

The pandemic is disrupting world health

and world economies and most likely will continue to do so for a long time.

While we are able to continue to operate, we –like

all businesses —

are unable to gauge exactly how this pandemic will affect our operations in the future.

We are reaching

out, directly and indirectly, to the U.S.

government, numerous foreign governments and entities related to the COVID-19

coronavirus and, if successful, will be working in these countries.

of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19.

if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given

first priority or that another treatment that eventually proves capable will not negate our current and future efforts.

is disrupting world health and world economies and most likely will continue to do so for a long time.

While we are able to continue

to operate, we –like all businesses —

are unable to gauge exactly how this pandemic will affect our operations in

We are reaching out, directly and indirectly, to the U.S.

government, numerous foreign governments and entities related

to the COVID-19 coronavirus and, if successful, will be working in these countries.

this regard, we are working with Japan’s National Institute of Infectious Diseases (“NIID”) to test Ampligen

as a potential treatment for COVID-19 coronavirus.

In March 2020, the NIID initiated preliminary laboratory testing of

Ampligen as a potential treatment for COVID-19.

In March 2020, the NIID initiated preliminary laboratory testing of Ampligen

as a potential treatment for COVID-19.

On July 1, 2020, we entered into a trilateral material transfer and research agreement

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provide Ampligen samples for various research projects.

Per the agreement, the details of all preclinical and clinical

results will remain confidential until released by NIID and Shionogi.

Per the agreement, the details of all preclinical and clinical results

will remain confidential until released by NIID and Shionogi.

addition, Shenzhen Smoore Technology Limited has agreed to run preliminary tests in China to the efficacy of Smoore’s inhalation

delivery device using Ampligen.

Assuming Ampligen proves an effective COVID-19 treatment, significant testing will be required

to determine whether the Smoore device will be able to safely deliver Ampligen in an appropriate dose without diminishing its

efficacy against COVID-19.

Operating in foreign countries carries with it a number of risks, including potential difficulties

in enforcing intellectual property rights.

We cannot assure that our potential operations in foreign countries will not be adversely

affected by these risks.

We have filed provisional patent applications related to the COVID-19 coronavirus.

However, these filings

do not assure that patents will ultimately be granted.

We recently contracted Amarex Clinical Research LLC (“Amarex”)

to act as our Clinical Research Organization and provide regulatory support with regard to a clinical trial testing Ampligen’s

potential as a COVID-19 prophylaxis via intranasal delivery.

Ampligen is scheduled to be shipped to Smoore for testing, pending resolution of various China

inbound import regulatory requirements.

AIM and Smoore are working to identify and navigate any and all regulatory obligations.

Assuming Ampligen proves an effective COVID-19 treatment, significant testing will be required to determine whether the Smoore

device will be able to safely deliver Ampligen in an appropriate dose without diminishing its efficacy against COVID-19.

in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights.

We cannot assure that our potential operations in foreign countries will not be adversely affected by these risks.

We have filed

provisional patent applications related to the COVID-19 coronavirus.

However, these filings do not assure that patents will ultimately

We recently contracted Amarex Clinical Research LLC (“Amarex”) to act as our Clinical Research Organization

and provide regulatory support with regard to a clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via

intranasal delivery.

Testing is subject to obtaining IND authorization from the FDA.

assurance can be given that the IND will be obtained or that the testing will be successful.

Should it prove promising, additional

testing will be required.

July 6, 2020, the Company entered into a clinical trial agreement (CTA) with Roswell Park Comprehensive Cancer Center to support

Roswell Park’s Phase 1/2a trial of Ampligen in combination with interferon alfa-2b, in cancer patients with mild to moderate

COVID-19, the disease caused by the SARS-CoV-2 coronavirus.

Funding for the clinical trial is provided, in part, through grants

from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.

It is planned that the phase 1/2b

study will enroll up to 80 patients in two stages.

Phase 1 will see 12-24 patients receiving both Ampligen and interferon alfa-2b

at escalating doses.

No assurance can be given that the IND will

be obtained or that the testing will be successful.

Should it prove promising, additional testing will be required.

July 6, 2020, the Company entered into a clinical trial agreement (CTA) with Roswell Park to support Roswell Park’s Phase

1/2a trial of Ampligen in combination with interferon alfa-2b, in cancer patients with mild to moderate COVID-19, the disease

caused by the SARS-CoV-2 coronavirus.

Funding for the clinical trial is provided, in part, through grants from the National Cancer

Institute and AIM, as well as institutional support from Roswell Park.

It is planned that the phase 1/2a study will enroll up

to 44 patients in two stages.

Phase 1 will see 12-24 patients receiving both Ampligen and interferon alfa-2b at escalating doses.

Once that initial phase is complete, further study participants will be randomized to two arms:

one receiving

the two-drug combination and a control group who will not receive Ampligen or interferon alfa but will receive best available

We are a financial sponsor of the study and will provide Ampligen at no charge for this study.

Additional information on

the clinical trial is available at clinicaltrials.gov.

one receiving the two-drug combination

and a control group who will not receive Ampligen or interferon alfa but will receive best available care.

We are a financial

sponsor of the study and will provide Ampligen at no charge for this study.

Additional information on the clinical trial, which

is recruiting patients, is available at clinicaltrials.gov .

the Company also entered into a material transfer agreement with the University of Rochester which is planning a series of in

vitro experiments in which it will be testing the direct antiviral activity of Ampligen on SARS-CoV-2, as well as the mechanism

The Company also entered into a specialized services agreement with Utah State University and has supplied Ampligen

to support the university’s Institute for Viral Research in its research into SARS-CoV-2 and testing underway.

The Company also entered into a specialized services agreement with Utah State University and supplied Ampligen to

support the University’s Institute for Viral Research in its research into SARS-CoV-2.

The Utah State results show that

Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

February 2013, we received a Complete Response Letter from the Food and Drug Administration, or FDA, for our Ampligen New Drug

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Additionally, AIM has shipped Ampligen to Argentina for ANMAT’s release.

Approval of rintatolimod for severe CFS in the Argentine Republic does not in any way suggest that the Ampligen NDA in the United

States or any comparable application filed in the European Union or elsewhere will obtain commercial approval.

Approval of rintatolimod

for severe CFS in the Argentine Republic does not in any way suggest that the Ampligen NDA in the United States or any comparable

application filed in the European Union or elsewhere will obtain commercial approval.

May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management

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tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint blockade.

Four are at Roswell Park Comprehensive Cancer Center (“RPCCC”) and the other two are at the University of Pittsburgh

Four are at Roswell Park and the other two (one temporarily suspended with plans to be reactivated) are at the University of Pittsburgh

Medical Center.

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Ampligen®

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

represents an RNA being developed for globally important cancers, viral diseases and disorders of the immune system.

Ampligen®

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

We have also seen success in increasing

survival rates and efficacy in the treatment of animal tumors when Ampligen®

is used in combination with checkpoint blockade

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

We have also seen success in

increasing survival rates and efficacy in the treatment of animal tumors when Ampligen®

is used in combination with checkpoint

blockade therapies.

This success in the field of immuno-oncology has guided our focus toward the potential use of Ampligen®

as a combinational

therapy for the treatment of a variety of solid tumor types.

as a combinational therapy for the treatment of a variety of solid tumor types.

There are currently multiple Ampligen®

clinical trials testing

Ampligen in humans —

trials testing Ampligen in humans —

both underway and planned —

at major cancer research centers around the country.

was used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate

of Healthcare in the Netherlands at Erasmus Medical Center.

We currently are awaiting a report on the Netherland’s EAP.

Ampligen ®

is also being evaluated

for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

AIM is currently sponsoring an expanded access

program for ME/CFS patients in the U.S.

In August 2016, we received approval of our NDA from Administracion Nacional de Medicamentos,

Alimentos y Tecnologia Medica (ANMAT) for commercial sale of Ampligen®

in the Argentine Republic for the treatment of severe

was used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the

Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

In September, AIM reported receipt of statistically significantly

results of positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after

systemic chemotherapy.

AIM will work with its Contract Research Organization, Amarex Clinical Research LLC, to seek FDA “fast-track”

and possibly even FDA “breakthrough”

designations and to obtain authorization to conduct a follow-up pancreatic cancer

Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof.

van Eijck, and also at major cancer research

centers in the United States.

Ampligen®

is also being evaluated for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

AIM is currently sponsoring

an expanded access program for ME/CFS patients in the U.S.

In August 2016, we received approval of our NDA from Administracion

Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of Ampligen®

in the Argentine Republic

for the treatment of severe CFS.

With regulatory approval in Argentina, Ampligen®

is the world’s only approved therapeutic for ME/CFS.

2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen®

is the world’s only approved therapeutic

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

Ampligen®

to Argentina.

The next steps in the commercial launch of Ampligen®

include ANMAT conducting a final inspection of the product and release

tests before granting final approval to begin commercial sales.

AIM has supplied GP Pharm with the Ampligen required for

testing and ANMAT release.

include ANMAT conducting a final inspection

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

AIM has supplied GP Pharm with the

Ampligen required for testing and ANMAT release.

Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen®

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ANMAT for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon in Argentina.

Funding is now available to commence modernization of a manufacturing process to potentially obtain FDA manufacturing approval

of a low-cost, higher-volume process.

operate a 30,000 sq.

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to the patients in this program.

As of June 30, 2020, there are 10 patients enrolled in this open-label expanded access treatment

As of September 30, 2020, there are 10 patients enrolled in this open-label expanded access treatment

In October 2020, AIM received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access

Program (EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed

with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms.

May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management

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as regulatory T cells.

The study was conducted at the University of Pittsburgh and Roswell Park Comprehensive Cancer Center (“RPCCC”),

as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of Research Excellence (SPORE).

Based upon these

findings AIM and RPCCC expanded their existing scientific collaboration to advance the clinical development of Ampligen®

has shown promise in preclinical studies when combined with checkpoint inhibitors (CPIs).

The parties executed a Memorandum of

Understanding (“MOU”) designed to further assess the clinical potential of Ampligen®

The study was conducted at the University of Pittsburgh and Roswell Park as a part of the NIH-funded P01

CA132714 and Ovarian Cancer Specialized Program of Research Excellence (SPORE).

Based upon these findings AIM and Roswell Park

expanded their existing scientific collaboration to advance the clinical development of Ampligen®

which has shown promise

in preclinical studies when combined with checkpoint inhibitors (CPIs).

The parties executed a Memorandum of Understanding (“MOU”)

designed to further assess the clinical potential of Ampligen®

in treating certain cancers.

This phase I/II study will evaluate the potential of Ampligen®

to enhance the immune mediated effects of CPIs in patients

with advanced solid tumors including bladder, melanoma and renal cell carcinoma.

This phase I/II study will evaluate

the potential of Ampligen®

to enhance the immune mediated effects of CPIs in patients with advanced solid tumors including

bladder, melanoma and renal cell carcinoma.

2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen®, following its “Fill

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the SARS-CoV-1 outbreak in 2002-03, Ampligen exhibited excellent antiviral properties and protective survival effect in NIH-contracted

studies of SARS-infected mice, which is almost identical to SARS-CoV-2, the novel virus that causes COVID-19.

studies of SARS-infected mice, which is very similar to SARS-CoV-2, the novel virus that causes COVID-19.

Barnard 2006 study ( https://journals.sagepub.com/doi/abs/10.1177/095632020601700505 ) found that Ampligen reduced virus

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was 100% protective survival.

compared key transcription regulatory sequences of SARS-CoV-1 to SARS-CoV-2 and found significant and compelling similarities,

suggesting highly probable extension of the antiviral effects of Ampligen in the earlier NIH-contracted SARS experiments to COVID-19.

compared key transcription regulatory sequences of SARS-CoV-1 to SARS-CoV-2 and found significant similarities, suggesting highly

probable extension of the antiviral effects of Ampligen in the earlier NIH-contracted SARS experiments to COVID-19.

SARS-CoV-2 virus –

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shares important genomic and pathogenic similarities with SARS-CoV-1 (hence

Since Ampligen has shown antiviral activity against more distantly related coronaviruses, there is a reasonable probability

that the antiviral effects of Ampligen against SARS-CoV-1 will likely extend to SARS-CoV-2.

This creates a compelling case for

clinical trials to evaluate Ampligen as a potential tool in the fight against COVID-19.

Since Ampligen has shown antiviral activity against more distantly related coronaviruses, there was a reasonable probability

that the antiviral effects of Ampligen against SARS-CoV-1 will likely extend to SARS-CoV-2, as discussed below, recently, Ampligen

has demonstrated in vitro antiviral activity against SARS-CoV-2.

We believe that this creates a compelling case for clinical trials

to evaluate Ampligen as a potential tool in the fight against COVID-19.

the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment

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February 2020, we filed three provisional patent applications related to Ampligen in our efforts toward joining the global health

community in the fight against the deadly coronavirus.

community in the fight against the deadly coronavirus (See:

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

Our three provisional patent applications include:

1) Ampligen as a therapy

for the coronavirus;

2) Ampligen as part of a proposed intranasal universal coronavirus vaccine that combines Ampligen with inactivated

coronavirus, conveying immunity and cross-protection and;

1) Ampligen as a therapy for the coronavirus;

2) Ampligen as part of a proposed

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

3) a high-volume manufacturing process for Ampligen.

Under the Patent

Cooperation Treaty of 1970, which provides international protections for patents, the three provisional patent applications can

convert to international patent applications based on the date of their filings.

Under the Patent Cooperation Treaty of 1970, which provides international

protections for patents, the three provisional patent applications can convert to international patent applications based on the

date of their filings.

early April 2020, we entered into a Material Transfer Agreement with Shenzhen Smoore Technologies located in Shenzhen China, the

world’s largest manufacturer of inhalation devices.

Pursuant to this agreement, we are providing Smoore with Ampligen and

Smoore will be conducting in vitro tests using its porous ceramic atomizer technology.

Pursuant to this agreement, Smoore has agreed to run preliminary tests

in China to the efficacy of Smoore’s inhalation delivery device using Ampligen.

Initial testing will include evaluation

of Ampligen with regard to safety and characterization of the inhaler vapor properties.

of Ampligen with regards to safety and characterization of the inhaler vapor properties.

Additional testing will study the particle

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deep into the lung airways of humans.

The Company is currently awaiting additional proposed study details from Smoore.

provide additional updates as they become available.

The Ampligen is scheduled to be shipped to Smoore for testing, pending resolution of various

China inbound import regulatory requirements.

AIM and Smoore are working to identify and navigate any and all regulatory obligations.

August 6, 2020, we contracted Amarex Clinical Research LLC (“Amarex”) to act as our Clinical Research Organization

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We expect that Phase I will consist of 24 test subjects and that Phase II will consist of 150 test subjects.

subject to obtaining IND authorization from the FDA.

in April 2020, we entered into confidentiality and non-disclosure agreements with numerous companies for the potential outsourcing

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The relationship with ChinaGoAbroad is ongoing.

May 11, 2020, the FDA authorized an IND for Roswell Park Cancer Institute to conduct a Phase 1/2a study of a regimen of Ampligen

and interferon alpha in cancer patients with mild or moderate COVID-19 infections.

This new clinical trial, sponsored by the Roswell

Park in collaboration with us, will test the safety of this combination regimen in patients with cancer and mild to moderate COVID-19,

May 11, 2020, the FDA authorized an IND for Roswell Park to conduct a Phase 1/2a study of a regimen of Ampligen and interferon

alpha in cancer patients with mild or moderate COVID-19 infections.

This new clinical trial, sponsored by the Roswell Park in

collaboration with us, will test the safety of this combination regimen in patients with cancer and mild to moderate COVID-19,

and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway.

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We intend to be a financial sponsor of the study and will provide Ampligen at no charge for this

July 6, 2020, we entered into a clinical trial agreement with Roswell Park Comprehensive Cancer Center pursuant to which Roswell

Park will conduct a Phase 1/2 trial of Ampligen (rintatolimod) in combination with interferon alfa, in cancer patients with COVID-19,

the disease caused by the SARS-CoV-2 coronavirus.

July 6, 2020, we entered into a clinical trial agreement with Roswell Park pursuant to which Roswell Park will conduct a Phase

1/2a trial of Ampligen (rintatolimod) in combination with interferon alfa, in cancer patients with COVID-19, the disease caused

by the SARS-CoV-2 coronavirus.

The National Cancer Institute and AIM are supporting this trial.

AIM reported in September that

recruitment in the trial had begun.

clinicaltrials.gov/NCT04379518.

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entered into a specialized services agreement with Utah State University and has supplied Ampligen to support the University’s

Institute for Viral Research in its research into SARS-CoV-2 and testing is underway.

Institute for Viral Research in its research into SARS-CoV-2.

The Utah State results show that Ampligen was able to decrease SARS-CoV-2

infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

have been working with the University of Pittsburgh’s chemokine modulation research initiative which includes the use of

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Edwards, MD, chair of gynecologic services at Magee-Women’s Hospital of the

University of Pittsburgh School of Medicine, and Professor of Surgery Pawel Kalinski, M.D., Ph.D., at RPCCC, Buffalo, N.Y., involved

the chemokine modulatory regimen developed by Dr.

Kalinski’s group and successfully completed the Phase 1 dose escalation

in patients with resectable colorectal cancer.

University of Pittsburgh School of Medicine, and Professor of Surgery Pawel Kalinski, M.D., Ph.D., at Roswell Park, Buffalo, N.Y.,

involved the chemokine modulatory regimen developed by Dr.

Kalinski’s group and successfully completed the Phase 1 dose

escalation in patients with resectable colorectal cancer.

In the 1st quarter of 2017, Dr.

Kalinski relocated to RPCCC in Buffalo, NY and

has established a cancer program which will continue to require a supply of Ampligen®.

October 2018, we signed a clinical trial agreement with RPCCC to evaluate Ampligen®

in combination with checkpoint inhibitors

The Phase IIa clinical trial will evaluate the immune-mediated effects of cytokine modulation in combination with CPIs

in patients with primary resistance to CPI therapy.

Kalinski relocated to Roswell Park in

Buffalo, NY and has established a cancer program which will continue to require a supply of Ampligen®.

October 2018, we signed a clinical trial agreement with Roswell Park to evaluate Ampligen®

in combination with checkpoint

inhibitors (CPIs).

The Phase IIa clinical trial will evaluate the immune-mediated effects of cytokine modulation in combination

with CPIs in patients with primary resistance to CPI therapy.

The protocol will seek to evaluate the combination of Ampligen®

in patients with advanced urothelial carcinoma, renal cell carcinoma and melanoma.

and CPIs in patients with advanced urothelial carcinoma, renal cell carcinoma and melanoma.

Ampligen®

is our investigational immune-enhancing

TLR3 agonist that has demonstrated a robust anti-cancer effect in preclinical models when combined with CPIs.

This new agreement

expands the extensive prior clinical and preclinical work into the clinical checkpoint blockade arena and offers the opportunity

to begin evaluation of this combination therapy in patients with a variety of solid tumors where large numbers of patients do

not respond or progress following treatment with standard CPI-based therapy.

is our investigational

immune-enhancing TLR3 agonist that has demonstrated a robust anti-cancer effect in preclinical models when combined with CPIs.

This new agreement expands the extensive prior clinical and preclinical work into the clinical checkpoint blockade arena and offers

the opportunity to begin evaluation of this combination therapy in patients with a variety of solid tumors where large numbers

of patients do not respond or progress following treatment with standard CPI-based therapy.

six Ampligen®

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

addition, six Ampligen clinical trials are planned for initiation in 2020/21, subject to funding:

Ampligen clinical trials are planned for initiation in 2020/21:

Brain-Metastatic

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approaches, including Ampligen.

RPCCC and Moffitt Cancer Center have both received “Breakthrough Awards”

Department of Defense.

Roswell Park and Moffitt Cancer Center have both received “Breakthrough Awards”

from the U.S.

Department of Defense (DOD).

Together, these separate but parallel proposed clinical trials are receiving approximately

$15 million in DOD funding to study Ampligen.

RPCCC is currently working on its draft of the IND, which its study and Moffitt’s

study require before next steps can be taken.

Roswell Park is currently working on its draft of the IND, which its study and

Moffitt’s study require before next steps can be taken.

4 Refractory Metastatic Colorectal Carcinoma —

Phase 2 study that will evaluate Ampligen in combination with pembrolizumab

in refractory metastatic colorectal carcinoma at RPCCC.

Fountzilas, PI.

in refractory metastatic colorectal carcinoma at Roswell Park.

Up to 25 patients to be enrolled.

This is expected

to be funded by grants, testing Ampligen and pembrolizumab.

This is expected to be funded

by grants, testing Ampligen and pembrolizumab.

https://www.clinicaltrials.gov/show/NCT04119830

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Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib

for the treatment of HLA-A2+ refractory melanoma at RPCCC.

for the treatment of HLA-A2+ refractory melanoma at Roswell Park.

Up to 24 patients to be enrolled.

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cell carcinoma, resistant to checkpoint blockade, that will evaluate Ampligen in combination with a checkpoint blockade therapy

Opyrchal, PI.

at Roswell Park.

Protocol design and funding currently being finalized.

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However, we now anticipate an extended delay, as other studies with funding have moved ahead of the Ampligen project.

RPCCC is exploring a pilot study to establish proof of concept.

Roswell Park is exploring a pilot study to establish proof of concept.

Pancreatic Cancer —

Phase 2 study in advanced pancreatic cancer using checkpoint blockade plus Ampligen at University

of Nebraska Medical Center.

of Nebraska Medical Center and Erasmus University.

Protocol and budget being developed.

This proposed study may be based on data

from our Dutch EAP (see below) and UNMC animal experiments showing synergy between Ampligen and checkpoint therapy.

confirmatory animal trial has been completed;

This proposed study may be based on

data from our Dutch EAP (see below) and UNMC animal experiments showing synergy between Ampligen and checkpoint therapy.

second confirmatory animal trial has been completed;

while it did not replicate the previous survival results, it did demonstrate

a significant anti-tumor effect.

addition, the National Cancer Institute awarded $14.5 million to Roswell Park to study Ampligen as part of five Roswell Park-led

chemokine modulation clinical trials in melanoma, colorectal and ovarian cancers

January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen®

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Turkey and will manage all EAP activities relating to the pancreatic cancer extension of the program.

In February 2018,

the agreement with myTomorrows was extended to cover Canada to treat pancreatic cancer patients, pending government approval.

There have been no physician requests to date that would cause the program to move forward with the approval process.

In February 2018, the agreement

with myTomorrows was extended to cover Canada to treat pancreatic cancer patients, pending government approval.

There have been

no physician requests to date that would cause the program to move forward with the approval process.

of December 31, 2019, 42 pancreatic cancer patients have received treatment with Ampligen®

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was part of a larger original report covering a variety of medical topics, which can be found at https://www.pancreasclub.com/wp-content/uploads/2018/06/Poster-Abstracts.pdf .

patients have completed treatment and we expect a comprehensive report from the Erasmus team on the immunological response in

relation to survival (while again recognizing the SARS-CoV-2 pandemic could very well re-direct the focus of clinicians and the

health care community).

AIM hopes to work with Dr.

Van Eijck, Dr.

Latifi, and Erasmus M.C.

to initiate a combination therapy program

to extend the results seen thus far in the Netherlands by combining Ampligen with checkpoint blockade therapy.

September, AIM reported receipt of statistically significant results of positive survival benefit when using Ampligen in patients

with locally advanced/metastatic pancreatic cancer after systemic chemotherapy versus matched historical controls.

AIM will work

with its Contract Research Organization, Amarex Clinical Research LLC, to seek FDA “fast-track”

and possibly even

FDA “breakthrough”

designations and to obtain IND authorizations to conduct a follow-up pancreatic cancer Phase 2/3

clinical trial with sites in the Netherlands at Erasmus MC under Prof.

van Eijck, and also at major cancer research centers in

the United States.

Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”)

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( Simmaron Research ).

Now there is increasing evidence that patients with COVID-19

can develop a similar, ME/CFS-like illness.

These patients are commonly referred to as “Long

Haulers.”

Now there is increasing evidence that patients with

COVID-19 can develop a similar, ME/CFS-like illness.

These patients are commonly referred to as “Long Haulers.”

http://simmaronresearch.com/2020/04/will-covid-19-leave-an-explosion-of-me-cfs-cases-in-its-wake/

plans to investigate the possible activity of Ampligen in the “Long Hauler”

population, including a plan to modify

our AMP-511 program to include Long Haulers.

October 2020, AIM received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program

(EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed

with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms.

November 2, 2020, AIM announced the publication of statistically significant data detailing how Ampligen could have a considerable

positive impact on people living with ME/CFS when administered in the early stages of the disease.

The data were published in

PLOS ONE , a peer-reviewed open access scientific journal published by the Public Library of Science.

AIM researchers found

that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients.

Europe, the EMA has approved the Orphan Medicinal Products Designation for rintatolimod (Ampligen®) as a potential treatment

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clinical trials.

is approved by the FDA for commercial sales in the US for the treatment of genital warts.

is approved by the FDA for commercial sales in the U.S.

for the treatment of genital warts.

It is also approved by ANMAT in Argentina

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

Funding is now available to commence modernization of a manufacturing

process to potentially obtain FDA manufacturing approval of a low-cost, higher-volume process.

Licensing/Collaborations/Joint

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The 6% Company matching contribution was terminated effective January 1, 2016.

For the six months ended June 30, 2020, the Company

did not make any contributions towards the 401(k) Plan.

For the nine months ended September 30, 2020, the

Company did not make any contributions towards the 401(k) Plan.

Accounting Pronouncements

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OF OPERATIONS

months ended June 30, 2020 versus three months ended June 30, 2019

net loss was approximately $3,370,000 and $2,036,000 for the three months ended June 30, 2020 and 2019, respectively, representing

months ended September 30, 2020 versus three months ended September 30, 2019

net loss was approximately $3,306,000 and $2,948,000 for the three months ended September 30, 2020 and 2019, respectively, representing

an increase in loss of approximately $358,000 or 12% when compared to the same period in 2019.

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three months was primarily due to the following:

loss of $1,054,000 from the quarterly reevaluation of certain redeemable warrants in 2020;

decrease in general and administrative (G&A) expense of $225,000 or 12%;

increase in research and development expenses of

$367,000, mostly due to completion of Ampligen manufacturing of $454,000, offset by a decrease of $97,000 in clinical

gain on extinguishment of notes payable of $142,000.

loss per share was $(0.11) and $(1.07) for the three months ended June 30, 2020 and 2019, respectively.

The weighted average number

of shares of our common stock outstanding as of June 30, 2020 was 29,970,197 as compared to 1,898,703 as of June 30, 2019.

increase in general and administrative (G&A) expense of $239,000 or 13%;

increase in interest income of $61,000;

decrease of $415,000 from the 2019 quarterly reevaluation of certain redeemable warrants in;

decrease in production costs of $26,000;

decrease in research and development expenses of $88,000;

decrease interest expense and other finance cost of $142,000

loss per share was $(0.08) and $(1.13) for the three months ended September 30, 2020 and 2019, respectively.

The weighted average

number of shares of our common stock outstanding as of September 30, 2020 was 38,907,546 as compared to 2,603,854 as of September

from our Ampligen®

Cost Recovery Program were $40,000 and $29,000 for the quarters ended June 30, 2020 and 2019, respectively.

There was an increase in revenues of $11,000.

The revenue was generated from the EAP and our FDA approved open-label treatment

protocol, (“AMP 511”), that allows patient access to Ampligen®

Cost Recovery Program were $36,000 and $61,000 for the quarters ended September 30, 2020 and 2019, respectively.

There was a decrease in revenues of $25,000.

The change in revenue is related to timing of orders and shipments in the three months

ending September 30, 2020.

The revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP

511”), that allows patient access to Ampligen®

for treatment in an open-label safety study.

costs were approximately $200,000 and $215,000, respectively, for the three months ended June 30, 2020 and 2019, representing

costs were approximately $204,000 and $230,000, respectively, for the three months ended September 30, 2020 and 2019, representing

a decrease of $26,000 in production costs in the current period.

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and Development Costs

and Development (“R&D”) costs for the quarter ended June 30, 2020 were approximately $1,463,000 as compared to

$1,096,000 for the quarter ended June 30, 2019 reflecting an increase of approximately $367,000.

The reason for the increase in

research and development costs was due to an increase in Ampligen polymer production cost of $230,000, and increase in Ampligen

compliance and stability of $224,000 and an increases in cost recovery of $10,000 offset by decreases in clinical research of

$97,000 and maintenance and engineering cost of $27,000.

and Development (“R&D”) costs for the quarter ended September 30, 2020 were approximately $1,102,000 as compared

to $1,190,000 for the quarter ended September 30, 2019 reflecting a decrease of approximately $88,000.

The reason for the decrease

in research and development costs was due to decreases in Ampligen polymer production cost of $350,000, Ampligen compliance and

stability of $64,000 and maintenance and engineering of $35,000 offset by and an increate in cost recovery of $25,000 and an increase

in clinical research of $268,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the quarters ended June 30, 2020 and 2019 were approximately $1,717,000

and $1,942,000, respectively, reflecting a decrease of approximately $225,000 or 12%.

The decrease in G&A expenses during

the current period was mainly due to a decrease in public relations of $132,000, salaries & benefits, including bonuses of

$200,000 offset by an increase in professional and legal fees of $130,000.

and Administrative (“G&A”) expenses for the quarters ended September 30, 2020 and 2019 were approximately $2,085,000

and $1,846,000, respectively, reflecting an increase of approximately $239,000 or 13%.

The increase in G&A expenses during

the current period was mainly due to an increase in professional fees of $236,000 and public relations of $34,000.

Income-Expenses

and other finance costs increased $150,000 in the three months ended June 30, 2020 mostly due to the costs associated with

the long-term debt which were not in effect in the three months ended June 30, 2019.

and other finance costs decreased $142,000 in the three months ended September 30, 2020 mostly due to the costs associated with

the long-term debt which were not in effect in the three months ended September 30, 2020.

The long-term debt was extinguished

in the second quarter of 2020.

on extinguishment of notes payable

the quarter ended June 30, 2020 there was a gain of $142,000 related to the prepayment of the notes payable.

Interest income increased $61,000 in the three months ended September 30, 2020 from the investments

from the proceeds from stock sales and exercised warrants.

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

the three months ended June 30, 2020 which amounted to a gain of approximately $31,000 compared to a gain of $1,085,000 for June

30, 2019 (see Note 13:

the three months ended September 30, 2020 which amounted to a gain of approximately $31,000 compared to a gain of $446,000 for

September 30, 2019 (see Note 13:

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

months ended June 30, 2020 versus six months ended June 30, 2019

net loss was approximately $7,160,000 and $5,393,000 for the six months ended June 30, 2020 and 2019, respectively, representing

months ended September 30, 2020 versus nine months ended September 30, 2019

net loss was approximately $10,466,000 and $8,341,000 for the nine months ended September 30, 2020 and 2019, respectively, representing

an increase in loss of approximately $2,125,000 or 25% when compared to the same period in 2019.

This increase in loss for these

six months was primarily due to the following:

nine months was primarily due to the following:

increase in G&A expense of $515,000 or 9%;

increase in interest and finance costs of $227,000 related to long term debt;

loss of $150,000 from the quarterly reevaluation of certain redeemable warrants in 2020 compared to a gain of $1,039,000

increase in research and development expenses of $319,000, mostly due to a general increase of Ampligen manufacturing cost

increase in research and development expenses of $231,000;

increase of $392,000 from the extinguishment of notes payable;

change of $120,000 for the quarterly revaluation of certain redeemable warrants in 2020 compared to a credit of $1,485,000

decrease in an insurance settlement of $260,000 in 2019;

loss per share was $(0.19) and $(3.53) for the six months ended June 30, 2020 and 2019, respectively.

The weighted average number

of shares of our common stock outstanding as of June 30, 2020 was 37,073,765 as compared to 1,529,848 as of June 30, 2019.

increase in interest and finance costs of $80,000 related to long term debt;

increase in interest income of $87,000;

decrease in production costs of $68,000.

loss per share was $(0.36) and $(4.41) for the nine months ended September 30, 2020 and 2019, respectively.

The weighted average

number of shares of our common stock outstanding as of September 30, 2020 was 28,826,283 as compared to 1,891,782 as of September

from our Ampligen®

Cost Recovery Program were $85,000 and $29,000 for the six month ended June 30, 2020 and 2019, respectively.

Cost Recovery Program were $121,000 and $90,000 for the nine months ended September 30, 2020 and 2019,

respectively.

There was an increase in revenues of $31,000.

The change in revenue is related to timing of orders and shipments

in the nine months ending September 30, 2020.

The revenue was generated from the EAP and our FDA approved open-label treatment

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for treatment in an open-label safety study.

costs were approximately $404,000 and $446,000, respectively, for the six months ended June 30, 2020 and 2019, representing an

increase of $42,000 in production costs in the current period.

costs were approximately $608,000 and $676,000, respectively, for the nine months ended September 30, 2020 and 2019, representing

a decrease of $68,000 in production costs in the current period.

These costs primarily represent production expenses related to

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and Development Costs

and Development (“R&D”) costs for the six months ended June 30, 2020 were approximately $2,343,000 as compared

to $2,024,000 for the six months ended June 30, 2019 reflecting an increase of approximately $319,000.

and Development (“R&D”) costs for the nine months ended September 30, 2020 were approximately $3,445,000 as compared

to $3,214,000 for the nine months ended September 30, 2019 reflecting an increase of approximately $231,000.

The primary reasons

for the increase in research and development costs was due to an increase in production cost of $114,000, an increase in stability

and compliance expense of $325,000, offset by a decreases in clinical research of $91,000 and maintenance and engineering of $56,000.

for the increase in research and development costs was due to an increase in abandoned patents of $129,000, a general increase

in Ampligen compliance cost of $235,000 and outside lab fees of $110,000 and offset by a decrease in outside contractors of $239,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the six months ended June 30, 2020 and 2019 were approximately $3,986,000

and Administrative (“G&A”) expenses for the nine months ended September 30, 2020 and 2019 were approximately $6,070,000

and $5,555,000, respectively, reflecting an increase of approximately $515,000 or 9%.

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Income-Expenses

and finance costs increased $227,000 in the six months ended June 30, 2020 mostly due to the costs associated with the long-term

debt which were not in effect in the six months ended June 30, 2019.

was gain on extinguishment of notes payable of $142,000 in the six months ended June 30, 2020, in the same six months ending

June 30, 2019 there was a loss on extinguished debt of $250,000.

June 2019 the was a gain from settlement proceeds of $260,000

which did not occur in 2020.

and finance costs increased $80,000 in the nine months ended September 30, 2020 mostly due to the costs associated with the long-term

debt which were not in effect in the nine months ended September 30, 2019.

Interest income increased $87,000 in the nine months

ended September 30, 2020 from the proceeds from stock sales and exercised warrants.

There was gain on extinguishment of notes

payable of $142,000 in the nine months ended September 30, 2020, in the same nine months ending September 30, 2019 there was a

loss on extinguished debt of $250,000.

June 2019 the was a gain from settlement proceeds of $260,000 which did not occur in 2020.

quarterly revaluations of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability for

the six months ended June 30, 2020 which amounted to a loss of approximately $150,000 compared to a gain of $1,039,000

for June 30, 2019 (see Note 13:

the nine months ended September 30, 2020 which amounted to a loss of approximately $120,000 compared to a gain of $1,485,000 for

September 30, 2019 (see Note 13:

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

and Capital Resources

of June 30, 2020, we had approximately $33,908,000 in cash and cash equivalents As of December 31, 2019, we had

approximately $1,470,000 in cash and cash equivalents.

Cash used in operating activities for the six months ended

June 30, 2020 was $4,525,000 compared to $4,324,000.

The primary reasons for the increase was the decrease in accounts

receivable and other receivables which included the sale of New Jersey NOL in the period ended June 30, 2020.

provided from investing activities for the six months ended June 30, 2020 was approximately $601,000 compared to cash used

in investing activities of approximately $626,000 for the same period in 2019, representing an increase

of $1,227,000.

The primary reason for the decrease during the current period is the purchase of marketable securities of

$7,590,000 offset by the sale of marketable securities of $8,497,000.

provided by financing activities for the six months ended June 30, 2020 was approximately $36,362,000 compared to approximately

of September 30, 2020, we had approximately $38,496,000 in cash and cash equivalents.

As of December 31, 2019, we had approximately

$1,470,000 in cash and cash equivalents.

Cash used in operating activities for the nine months ended September 30, 2020 was $7,514,000

compared to $6,778,000.

The primary reasons for the increase was the decrease in accounts receivable and other receivables which

included the sale of New Jersey NOL in the period ended September 30, 2020.

used in investing activities for the nine months ended September 30, 2020 was approximately $8,982,000 compared to $858,000 for

the same period in 2019, representing an increase of $8,124,000.

The primary reason for the increase during the current period

is the purchase of marketable securities of $17,169,000 offset by the sale of marketable securities of $8,497,000.

provided by financing activities for the nine months ended September 30, 2020 was approximately $53,522,000 compared to approximately

$16,953,000 for the same period in 2019, an increase of $36,571,000.

The primary reason for the increase in the six

months ended June 30, 2020 is our receipt of net proceeds of approximately $32,878,000 from the sale common stock pursuant to

our 2019 EDA with Maxim Group and the exercise of warrants (see Note 8:

The primary reason for the increase in the nine months ended

September 30, 2020 is our receipt of net proceeds of approximately $58,066,000 from the sale common stock pursuant to our 2019

EDA with Maxim Group and the exercise of warrants (see Note 8:

Stockholders’

Equity) compared to $15,307,000 for the same

period in 2019.

August 6, 2020, we contracted Amarex to act as our Clinical Research Organization and provide regulatory support with regard to

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In Phase II we anticipate providing approximately an additional $650,000.

costs expected to be incurred by us for the clinical trial are estimated at $4.5 million.

costs expected to be incurred by us for the clinical trial are estimated at $4,500,000.

(see “Covid-19”

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

What changed 10-Q

Item 1. Financial Statements