10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

Quarterly Report Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

For the Quarterly Period Ended September 30, 2022

Commission File Number: 001-27072

AIM IMMUNOTECH INC.

(Exact name of registrant as specified in its charter)

Delaware	52-0845822
(State or other jurisdiction of	(I.R.S. Employer
incorporation or organization)	Identification No.)

2117 SW Highway 484, Ocala FL 34473

(Address of principal executive offices) (Zip Code)

(352) 448-7797

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.001 per share	AIM	NYSE American

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files).

☒ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

☐ Large accelerated filer	☐ Accelerated filer
☒ Non-accelerated filer	☒ Smaller reporting company
	☐ Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

48,082,275 shares of common stock were outstanding, and 713 shares of series B preferred stock were outstanding as November 9, 2022.

PART I- FINANCIAL INFORMATION

ITEM 1: Financial Statements

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Balance Sheets

(in thousands, except for share and per share data)

(Unaudited)

	September 30, 2022			December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents	$	29,759		$	32,093
Marketable securities		6,986			16,175
Funds receivable from New Jersey net operating loss		—			1,641
Prepaid expenses and other current assets		805			304
Assets held for sale		3,600			—
Total current assets		41,150			50,213
Property and equipment, net		118			4,047
Right of use asset, net		866			149
Patent and trademark rights, net		2,013			1,974
Other assets		2,138			1,316
Total assets	$	46,285		$	57,699
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	957		$	198
Accrued expenses		1,767			438
Current portion of operating lease liability		171			37
Total current liabilities		2,895			673
Long-term liabilities:
Operating lease liability		695			112
Redeemable warrants		—			35
Commitments and contingencies (Notes 12, 13, and 14)
Stockholders’ equity:
Series B Convertible Preferred Stock, stated value $1,000 per share, 713 and 715 issued and outstanding, respectively		713			715
Common Stock, par value $0.001 per share, authorized 350,000,000 shares: 48,082,275, and 47,994,672, issued and outstanding, respectively		48			48
Additional paid-in capital		418,091			417,217
Accumulated deficit		(376,157	)		(361,101	)
Total stockholders’ equity		42,695			56,879
Total liabilities and stockholders’ equity	$	46,285		$	57,699

See accompanying notes to consolidated financial statements.

2

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statement of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)

	Three months ended September 30,						Nine months ended September 30,
	2022			2021			2022			2021
Revenues:
Clinical treatment programs - US	$	21		$	33		$	85		$	85
Costs and Expenses:
Production costs		—			157			—			674
Research and development		1,372			2,006			4,883			4,749
General and administrative		5,170			1,799			9,569			6,055
Total Costs and Expenses		6,542			3,962			14,452			11,478
Operating loss		(6,521	)		(3,929	)		(14,367	)		(11,393	)
Loss on investments		(365	)		—			(1,769	)		—
Interest and other income, net		172			(20	)		296			100
Interest expense and other finance costs		—			—			—			(67	)
Extinguishment of financing obligation and note payable		—			—			—			(2,701	)
Gain on sale of fixed assets		—			—			—			216
Redeemable warrants valuation adjustment		1			51			35			22
Gain from sale of income tax operating losses		328			72			749			542
Net Loss		(6,385	)		(3,826	)		(15,056	)		(13,281	)
Other comprehensive (loss), net of tax
Reclassification adjustment for realized investment loss		—			101			—			126
Change in unrealized loss on marketable securities available for sale		—			(104	)		—			(329	)
Comprehensive loss	$	(6,385	)	$	(3,829	)	$	(15,056	)	$	(13,484	)
Basic and diluted loss per share	$	(0.13	)	$	(0.08	)	$	(0.31	)	$	(0.28	)
Weighted average shares outstanding basic and diluted		48,079,210			47,846,074			48,036,559			47,156,158

See accompanying notes to consolidated financial statements.

3

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statement of Changes in Stockholders’ Equity

For the Nine Months Ended September 30, 2022

(in thousands except share data)

(Unaudited)

	Series B Preferred			Common Stock Shares		Common Stock .001 Par Value		Additional Paid-in Capital		Accumulated other Comprehensive Income (Loss)		Accumulated Deficit			Total Stockholders’ Equity
Balance December 31, 2021	$	715			47,994,672	$	48	$	417,217	$	—	$	(361,101	)	$	56,879
Equity-based compensation		—			—		—		242		—		—			242
Net comprehensive loss		—			—		—		—		—		(3,820	)		(3,820	)
Balance March 31, 2022	$	715			47,994,672	$	48	$	417,459	$	—	$	(364,921	)	$	53,301
Common stock issuance, net of costs		—			54,150		—		55		—		—			55
Equity-based compensation		—			—		—		275		—		—			275
Series B preferred shares converted to common shares		(2	)		—		—		2		—		—			—
Net comprehensive loss		—			—		—		—		—		(4,851	)		(4,851	)
Balance June 30, 2022	$	713			48,048,822	$	48	$	417,791	$	—	$	(369,772	)	$	48,780
Common stock issuance, net of costs		—			32,895		—		25		—		—			25
Equity-based compensation		—			—		—		275		—		—			275
Cashless Warrant Conversion		—			558		—		—		—		—			—
Net comprehensive loss		—			—		—		—		—		(6,385	)		(6,385	)
Balance September 30, 2022		713			48,082,275		48		418,091		—		(376,157	)		42,695

See accompanying notes to consolidated financial statements.

4

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statement of Changes in Stockholders’ Equity

For the Nine Months Ended September 30, 2021

(in thousands except share data)

(Unaudited)

	Series B Preferred			Common Stock Shares		Common Stock Par Value		Additional Paid-in Capital		Accumulated other Comprehensive Income (Loss)			Accumulated Deficit			Total Stockholders’ Equity
Balance December 31, 2020	$	732			42,154,371	$	42	$	402,541	$	(47	)	$	(341,974	)	$	61,294
Common stock issuances, net of costs		—			5,678,626		6		12,881		—			—			12,887
Equity-based compensation		—			—		—		526		—			—			526
Series B preferred shares converted to common shares		(7	)		—		—		7		—			—			—
Comprehensive loss		—			—		—		—		(163	)		(3,579	)		(3,742	)
Balance March 31, 2021	$	725			47,832,997	$	48	$	415,955	$	(210	)	$	(345,553	)	$	70,965
Equity-based compensation		—			—		—		480		—			—			480
Comprehensive loss		—			—		—		—		(37	)		(5,876	)		(5,913	)
Balance June 30, 2021	$	725			47,832,997	$	48	$	416,435	$	(247	)	$	(351,429	)	$	65,532
Common stock issuances, net of costs		—			15,625		—		30		—			—			30
Equity-based compensation		—			—		—		314		—			—			314
Comprehensive loss		—			—		—		—		(3	)		(3,826	)		(3,829	)
Balance September 30, 2021	$	725			47,848,622	$	48	$	416,779	$	(250	)	$	(355,255	)	$	62,047

See accompanying notes to consolidated financial statements.

5

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

For the Nine Months Ended September 30, 2022 and 2021

(in thousands)

(Unaudited)

	2022			2021
Cash flows from operating activities:
Net loss	$	(15,056	)	$	(13,281	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment		29			484
Redeemable warrants valuation adjustment		(35	)		(22	)
Extinguishment of financing obligation and note payable		—			2,701
Amortization of patent, trademark rights		57			97
Changes in ROU assets		(717	)		35
Gain on sale of property and equipment		—			(216	)
Gain from sale of income tax operating losses		(749	)		(542	)
Equity-based compensation		792			1,320
Gain (Loss) on sale of marketable securities		1,768			126
Amortization of finance and debt issuance costs		—			47
Change in assets and liabilities:
Accounts receivable		—			6
Funds Receivable from New Jersey net operating loss		1,641			1,090
Prepaid expenses and other current assets and other non-current assets		(500	)		64
Lease liability		717			(35	)
Other Assets		(73	)		—
Accounts payable		758			(14	)
Accrued expenses		1,329			(80	)
Net cash used in operating activities		(10,039	)		(8,220	)
Cash flows from investing activities:
Proceeds from sale of marketable securities		9,082			849
Purchase of marketable securities		(1,661	)		(1,611	)
Purchase of property and equipment		—			(34	)
Proceeds from sale of property and equipment		300			245
Purchase of patent and trademark rights		(96	)		(444	)
Net cash provided by (used in) investing activities		7,625			(995	)
Cash flows from financing activities:
Payment of financing obligation		—			(4,732	)
Financing obligation payments		—			(122	)
Proceeds from sale of stock, net of issuance costs		80			12,917
Net cash provided by financing activities		80			8,063
Net decrease in cash and cash equivalents		(2,334	)		(1,152	)
Cash and cash equivalents at beginning of period		32,093			38,501
Cash and cash equivalents at end of period	$	29,759		$	37,349
Supplemental disclosures of non-cash investing and financing cash flow information:
Operating lease-Right of Use Assets	$	717		$	—
Unrealized loss on marketable securities	$	(1,170	)	$	(329	)
Conversion of Series B preferred	$	2		$	7

See accompanying notes to consolidated financial statements.

6

AIM IMMUNOTECH INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1: Business and Basis of Presentation

AIM ImmunoTech Inc. and its subsidiaries (collectively, “AIM”, “the Company”,) are an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and immune-deficiency disorders. The Company has established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

Our flagship products are Ampligen® (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon alfa-n3). Ampligen has not been approved by the U.S. Food and Drug Administration (“FDA”) or marketed in the United States. Ampligen is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).

Our primary present business focus involves Ampligen. Ampligen represents a double-stranded RNA being developed for globally important cancers, viral diseases and disorders of the immune system.

The Company is currently proceeding primarily in four areas:

● A randomized controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced pancreatic cancer patients.

● Evaluate Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses to check point inhibitors and other immuno oncology therapies.

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

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

The Company is prioritizing activities in an order related to the stage of development, with those clinical activities in oncology, ME/CFS and Post-COVID conditions having priority over antiviral experimentation. The Company intends that priority clinical work be conducted in trials authorized by the FDA or European Medicines Agency (“EMA”), which trials support commercial development. However, AIM’s antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection. Accordingly, AIM will conduct antiviral programs in those venues most readily available including foreign venues and able to generate valid proof-of-concept data,.

In May 2021, AIM exercised the option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale and lease-back agreement. The Company thereafter sold certain equipment and machinery that it determined to be obsolete and no longer needed for current or future manufacturing. On March 3, 2022, AIM entered into an Agreement of Sale and Purchase with Acellories, Inc. to purchase the property for an estimated $3.9 million, with AIM’s intention to keep some space specifically for its Alferon activity. The sale closed on November 1, 2022 for $3.7 million net of normal closing cost.

AIM’s business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen API. This includes utilizing Polysciences Inc. (“Polysciences”) for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods. While AIM believes it has sufficient Ampligen API to meet current needs, it is also continually exploring new efficiencies so as to maximize its ability to fulfill future obligations.

In the opinion of management, all adjustments necessary for a fair presentation of the consolidated financial statements have been included. Such adjustments consist of normal recurring items. Interim results are not necessarily indicative of results for a full year.

7

The interim consolidated financial statements and notes thereto are presented as permitted by the Securities and Exchange Commission (“SEC”), and do not contain certain information which will be included in the Company’s annual consolidated financial statements and notes thereto.

These consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years ended December 31, 2021 and 2020, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 31, 2022.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”) of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates, and those differences may be material. Accounts requiring the use of significant estimates include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent and trademark valuations, stock-based compensation calculations, building valuation, fair value of warrants, and contingency accruals.

Note 2: Net Loss Per Share

Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Equivalent common shares, consisting of stock options and warrants which amounted to 2,445,805 and 1,617,145, are excluded from the calculation of diluted net loss per share for the nine months ended September 30, 2022, and 2021, respectively, since their effect is antidilutive due to the net loss.

Note 3: Equity-Based Compensation

The fair value of each option and equity warrant award is estimated on the date of grant using a Black-Scholes-Merton option pricing valuation model. Expected volatility is based on the historical volatility of the price of the Company’s stock. The risk-free interest rate is based on U.S. Treasury issues with a term equal to the expected life of the option and equity warrant. The Company uses historical data to estimate expected dividend yield, expected life and forfeiture rates. There were 300,000 options granted in the nine months ended September 30, 2022, and no options granted in the nine months ended September 30, 2021.

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

Stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2021		1,498,798		$	4.22		9.11	$	—
Granted		150,000			0.70		9.17		—
Forfeited		(1,684	)		117.6		—		—
Expired		—			—		—		—
Outstanding September 30, 2022		1,647,114		$	3.78		8.43	$	—
Vested and expected to vest September 30, 2022		1,647,114		$	3.78		8.43	$	—
Exercisable September 30, 2022		1,542,949		$	2.43		6.66	$	—

8

Unvested stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2022		412,500		$	4.15		5.85	$	—
Granted		150,000			0.70		9.17		—
Expired		(1,684	)		117.6		—		—
Vested		(456,651	)		1.43		—		—
Unvested September 30, 2022		104,165		$	6.52		3.14	$	—

Stock option activity for non-employees:

	Number of Options		Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2022		279,723	$	6.12		7.93	$	—
Granted		150,000		0.70		9.42		—
Forfeited		—		—		—		—
Expired		—		—		—		—
Outstanding September 30, 2022		429,723	$	4.10		7.96	$	—
Vested and expected to vest September 30, 2022		429,723	$	4.10		7.96	$	—
Exercisable September 30, 2022		354,526	$	4.21		8.32	$	—

Unvested stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2022		97,831		$	3.89		7.82	$	—
Granted		150,000			0.70		9.42		—
Expired		—			—		—		—
Vested		(172,634	)		1.16		—		—
Unvested September 30, 2022		75,197		$	3.79		8.24	$	—

Stock-based compensation expense was approximately $792,000 and $1,320,000 for the nine months ended September 30, 2022, and 2021, resulting in an increase in general and administrative expenses, respectively.

As of September 30, 2022, and 2021, respectively, there was approximately $179,000 and $279,000 of unrecognized equity-based compensation cost related to options granted under the Equity Incentive Plan.

9

Note 4: Marketable Securities

Marketable securities consist of mutual funds. As of September 30, 2022, and December 31, 2021, it was determined that none of the marketable securities had an other-than-temporary impairment. As of September 30, 2022, and December 31, 2021, all securities were measured as Level 1 instruments under the fair value measurements standard (See Note 11: Fair Value). As of September 30, 2022, and December 31, 2021, the Company held approximately $6,986,000 and $16,175,000 in mutual funds.

Mutual Funds classified as available for sale consisted of:

September 30, 2022

(in thousands)

Securities	Fair Value		Short-Term Investments
Mutual Funds	$	6,986	$	6,986
Totals	$	6,986	$	6,986

September 30, 2022

(in thousands)

Securities
Net losses recognized during the period on equity securities	$	(1,769	)
Less: Net gains and losses recognized during the period on equity securities sold during the period		(598	)
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date	$	(1,171	)

Mutual Funds classified as available for sale consisted of:

December 31, 2021

(in thousands)

Securities	Fair Value		Short-Term Investments
Mutual Funds	$	16,175	$	16,175
Totals	$	16,175	$	16,175

10

December 31, 2021

(in thousands)

Securities
Net losses recognized during the period on equity securities	$	(88	)
Less: Net gains and losses recognized during the period on equity securities sold during the period		—
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date	$	(88	)

Note 5: Accrued Expenses

Accrued expenses consist of the following:

	(in thousands)
	September 30, 2022		December 31, 2021
Compensation	$	33	$	1
Professional fees		1,535		169
Clinical trial expenses		—		61
Other expenses		199		207
	$	1,767	$	438

Note 6: Property and Equipment, net

	(in thousands)
	September 30, 2022			December 31, 2021
Land, buildings and improvements	$	—		$	3,900
Furniture, fixtures, and equipment		2,353			2,353
Total property and equipment		2,353			6,253
Less: accumulated depreciation		(2,235	)		(2,206	)
Property and equipment, net	$	118		$	4,047

Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, ranging from three to thirty-nine years. Depreciation expense for the nine months ending September 30, 2022 and September 30, 2021 was $29,000 and $484,000.

The Company made a strategic shift on in-house manufacturing and recorded an impairment of the facility in the amount of $1,800,000 during the year ended December 31, 2021. During the period ending September 30, 2022, the Company reported assets held for sale related to the pending sale of the manufacturing facility located at 783 Jersey Avenue. On November 1, 2022, AIM completed the sale of its facility at 783 Jersey Avenue, New Brunswick, N.J., for $3.7 million net of normal closing cost. (See Note 11 Fair Value).

Note 7: Patents

(in thousands)
December 31, 2020	$	1,498
Acquisitions		592
Amortization		(116	)
December 31, 2021	$	1,974
Acquisitions		96
Amortization		(57	)
September 30, 2022	$	2,013

11

Patents and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method of the estimated useful life of 17 years.

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

Period Ending December 31,
(in thousands)
2022	$	23
2023		154
2024		178
2025		199
2026		235
Thereafter		1,224
Total	$	2,013

Note 8: Stockholders’ Equity

(a) Preferred Stock

The Company is authorized to issue 5,000,000 shares of $0.01 par value preferred stock with such designations, rights and preferences as may be determined by the Board of Directors. Of our authorized preferred stock, 250,000 shares have been designated as Series A Junior Participating Preferred Stock and 8,000 shares have been designated as Series B Convertible Preferred Stock. The Series B Convertible Preferred Stock has a stated value $1,000 per share.

The Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $1,000 per share. As of September 30, 2022, and December 31, 2021, the Company had 713 and 715 shares of Series B Convertible Preferred Stock outstanding, respectively. Holders shall be entitled to receive, and the Company shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock basis) to and in the same form as dividend actually paid on shares of Common Stock when as and if such dividends are paid on shares of the Common Stock. Each such Preferred Share is convertible into 114 shares of common stock. Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, the Holders shall be entitled to receive out of the assets, whether capital or surplus of the Company the same amount that a holder of Common Stock would receive if the Preferred Stock was fully converted. The Series B Convertible Preferred Stock shall have no voting Rights.

Pursuant to a registration statement relating to a rights offering declared effective by the SEC on February 14, 2019, AIM distributed to its holders of common stock and to holders of certain options and warrants as of February 14, 2019, at no charge, one non-transferable subscription right for each share of common stock held or deemed held on the record date. Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into common stock at an assumed conversion price of $8.80) and 114 warrants with an assumed exercise price of $8.80. The warrants are exercisable for five years after the date of issuance. The net proceeds realized from the rights offering were approximately $4,700,000. During the nine months ending September 30, 2022 and September 30, 2021, 2 and 7 shares, respectively, of Series B Convertible Preferred Stock were converted into common stock.

12

(b) Common Stock

The 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 authorized shares.

On July 7, 2020, the board of directors approved a plan pursuant to which all directors, officers, and employees could purchase from the Company up to an aggregate of $500,000 worth of shares at the market price. Pursuant to NYSE American rules, this plan was effective for a sixty-day period commencing upon the date that the NYSE American approved the Company’s Supplemental Listing Application. When this plan expired, the board of directors approves subsequent similar $500,000 plans for all directors, officers and employees to buy Company shares from the Company at the market price. Subsequent plans were approved by the board of directors upon the expiration of prior plans. The latest plan was approved by the board of directors on March 2, 2022.

During the nine months ended September 30, 2022, the Company issued a total of 87,045 shares of its common stock at prices ranging from $0.76 to $1.02 for a total of $80,000 as part of the employee stock purchase plan, not from the 2018 Equity Incentive Plan.

During the twelve months ended December 31, 2021, the Company issued a total of 132,238 shares of its common stock at prices ranging from $1.16 to $2.35 for a total of $205,000.

On September 27, 2019, the Company closed a 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. As of September 30, 2022, there are 15,000 Warrants outstanding.

On July 19, 2019, the Company entered into a new Equity Distribution Agreement (the “2019 EDA”) with Maxim Group LLC (“Maxim”), pursuant to which it could sell, from time to time, shares of its Common Stock through Maxim, as agent. The 2019 EDA replaced a prior EDA with Maxim. For the year ended December 31, 2020, the Company sold 20,444,807 shares under the 2019 EDA for total gross proceeds of $53,936,615, which includes a 3.5% fee to Maxim of $1,888,727. During the period ended December 31, 2021, the Company sold 5,665,731 shares under the 2019 EDA for total gross proceeds of $13,301,526, which includes a 3.5% fee to Maxim of $465,533. The 2019 EDA was terminated in early February 2021.

The 2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards, (vii) Performance Cash Awards, and (viii) Other Stock Awards. Initially, a maximum of 7,000,000 shares of Common Stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. Unless sooner terminated, the 2018 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date. During first quarter of 2022, 300,000 options were issued to employees with an exercise price of $.70 for a period of ten years with a vesting period of one year. During fourth quarter of 2021, 613,512 options were issued to employees with an exercise price range of $1.11 to $1.71 for a period of ten years with a vesting period of one year.

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

Note 9: Cash and Cash Equivalents

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

Note 10: Recent Accounting Pronouncements

During the third quarter of 2022 accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on the Company’s present or future financial statements.

Note 11: Fair Value

The Company is required under U.S. GAAP to disclose information about the fair value of all the Company’s financial instruments, whether or not these instruments are measured at fair value on the Company’s consolidated balance sheets.

The Company estimates that the fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate their carrying values due to the short-term maturities of these items. The Company also has certain warrants with a cash settlement feature in the occurrence of a Fundamental Transaction. The fair value of the redeemable warrants (“Warrants”) related to the Company’s April 2018, and March 2019 common stock and warrant issuance, are calculated using a Monte Carlo Simulation. While the Monte Carlo Simulation is one of a number of possible pricing models, the Company has determined it to be industry accepted and fairly presented the fair value of the Warrants. As an additional factor to determine the fair value of the Put’s liability, the occurrence probability of a Fundamental Transaction event was factored into the valuation.

The Company recomputes the fair value of the Warrants at the issuance date and the end of each quarterly reporting period. Such value computation includes subjective input assumptions that are consistently applied each period. If the Company were to alter its assumptions or the numbers input based on such assumptions, the resulting fair value could be materially different.

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

	September 30, 2022			December 31, 2021
Underlying price per share	$	0.58		$	0.92
Exercise price per share	$	17.16		$	17.16
Risk-free interest rate		4.06	%		0.67	%
Expected holding period		1.07			1.81
Expected volatility		70	%		120	%
Expected dividend yield		—			—

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

	September 30, 2022			December 31, 2021
Underlying price per share	$	0.58		$	0.92
Exercise price per share	$	8.80		$	8.80
Risk-free interest rate		4.12	%		0.78	%
Expected holding period		1.44			2.19
Expected volatility		65	%		125	%
Expected dividend yield		—			—

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

(i)	Risk-Free Interest Rate. The risk-free interest rates for the Warrants are based on U.S. Treasury constant maturities for periods commensurate with the remaining expected holding periods of the warrants.
(ii)	Expected Holding Period. The expected holding period represents the period of time that the Warrants are expected to be outstanding until they are exercised. The Company utilizes the remaining contractual term of the Warrants at each valuation date as the expected holding period.
(iii)	Expected Volatility. Expected stock volatility is based on daily observations of the Company’s historical stock values for a period commensurate with the remaining expected holding period on the last day of the period for which the computation is made.
(iv)	Expected Dividend Yield. Expected dividend yield is based on the Company’s anticipated dividend payments over the remaining expected holding period. As the Company has never issued dividends, the expected dividend yield is $0.00 and this assumption will be continued in future calculations unless the Company changes its dividend policy.
(v)	Expected Probability of a Fundamental Transaction. The possibility of the occurrence of a Fundamental Transaction triggering a Put right is extremely remote. As discussed above, a Put right would only arise if a Fundamental Transaction (1) is an all cash transaction; (2) results in the Company going private; or (3) is a transaction involving a person or entity not traded on a national securities exchange. The Company believes such an occurrence is highly unlikely because:

a.	The Company only has one product that is FDA approved but which will not be available for commercial sales for 18 months at the earliest;
b.	The Company flagship product is approved only in Argentina for Severely Debilitated Chronic Fatigue Syndrome patients;
c.	The Company may have to perform additional clinical trials for FDA approval of its flagship product;
d.	Industry and global market conditions continue to include uncertainty, adding risk to any transaction;
e.	Available capital for a potential buyer in a cash transaction continues to be limited;
f.	The nature of a life science company is heavily dependent on future funding and high costs, including research & development;
g.	The Company has minimal revenue streams which could be insufficient to meet the funding needs for the cost of operations or construction at their manufacturing facility; and
h.	The Company’s Rights Agreement and Executive Agreements make it less attractive to a potential buyer.

With the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities related to a Put right being triggered as:

Range of Probability	Probability
Low		0.5	%
Medium		1.0	%
High		5.0	%

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

(vi) Expected Timing of Announcement of a Fundamental Transaction. As the Company has no specific expectation of a Fundamental Transaction, for reasons stated above, the Company used a discrete uniform probability distribution over the Expected Holding Period to model the potential announcement of a Fundamental Transaction occurring during the Expected Holding Period.

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(vii)	Expected 100 Day Volatility at Announcement of a Fundamental Transaction. An estimate of future volatility is necessary as there is no mechanism for directly measuring future stock price movements. Daily observations of the Company’s historical stock values for the 100 days immediately prior to the Warrants’ grant dates, with a floor of 100%, were utilized as a proxy for the future volatility.
(viii)	Expected Risk-Free Interest Rate at Announcement of a Fundamental Transaction. The Company utilized a risk-free interest rate corresponding to the forward U.S. Treasury rate for the period equal to the time between the date forecast for the public announcement of a Fundamental Transaction and the Warrant expiration date for each simulation.
(ix)	Expected Time Between Announcement and Consummation of a Fundamental Transaction. The expected time between the announcement and the consummation of a Fundamental Transaction is based on the Company’s experience with the due diligence process performed by acquirers and is estimated to be six months. The Monte Carlo Simulation approach incorporates this additional period to reflect the delay Warrant Holders would experience in receiving the proceeds of the Put.

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

The Company applies FASB ASC 820 that defines fair value, establishes a framework for measuring fair value in U.S. GAAP, and expands disclosures about fair value measurements. The guidance does not impose any new requirements around which assets and liabilities are to be measured at fair value, and instead applies to asset and liability balances required or permitted to be measured at fair value under existing accounting pronouncements. The Company measures its warrant liability for those warrants with a cash settlement feature at fair value.

FASB ASC 820-10-35-37 establishes a valuation hierarchy based on the transparency of inputs used in the valuation of an asset or liability. Classification is based on the lowest level of inputs that is significant to the fair value measurement. The valuation hierarchy contains three levels:

● Level 1 – Quoted prices are available in active markets for identical assets or liabilities at the reporting date. Generally, this includes certain U.S. and government agency debt and equity securities that are traded in an active market.

● Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Generally, this includes debt and equity securities that are not traded in an active market.

● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or other valuation techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. As of September 30, 2022, the Company has classified the warrants with cash settlement features as Level 3. Management evaluates a variety of inputs and then estimates fair value based on those inputs. As discussed above, the Company utilized the Monte Carlo Simulation Model in valuing these warrants.

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

	(in thousands) As of September 30, 2022
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	6,986	$	6,986	$	—	$	—
Liabilities:
Redeemable warrants	$	—		—		—	$	—

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	(in thousands) As of December 31, 2021
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	16,175	$	16,175	$	—	$	—
Liabilities:
Redeemable warrants	$	35		—		—	$	35

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

Redeemable warrants:
Balance at December 31, 2021	$	35
Fair value adjustment		(35	)
Balance at September 30, 2022	$	—

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

	(in thousands) As of December 31, 2021
	Total		Level 1		Level 2		Level 3		Total Gains (Losses)
Assets:
Long lived assets held and used(a)	$	3,900	$	—	$	—	$	3,900	$	(1,800	)

(a) In accordance with Subtopic 360-10, long-lived assets held and used with a carrying amount of $5,700,000 were written down to their fair value of $3,900,000 resulting in an impairment charge of $1,800,000, which was included in earnings for the period ending December 31, 2021. A $300,000 deposit was received in the third quarter 2022 related to the asset.

Note 12: Financing Obligation Arising from Sale Leaseback Transaction

On March 16, 2018, the Company sold land and a building for $4,080,000 and concurrently entered into an agreement to lease the property back for ten years at $408,000 per year for two years through March 31, 2020. The lease payments would increase 2.5% per year for the next three years through March 31, 2023, and the lease payments would increase 3% for the remaining five years through March 31, 2028. As part of the sale of this building, warrants were provided to the buyer for the purchase of up to 73,314 shares of Company common stock for a period of five years at an exercise price of $17.05 per share, 125% of the closing price of the common stock on the NYSE American on the date of execution of the letter of intent for the purchase. The sale of the property included an option to repurchase the property based on a contractual formula which does not permanently transfer all the risks and rewards of ownership to the buyer. Because the sale of the property included the option to repurchase the property and included the above attributes, the transaction was accounted for as a financing transaction whereby the Company recorded the cash received and a financing obligation. The warrants cannot be exercised to the extent that any exercise would result in the purchaser owning in excess of 4.99% of our issued and outstanding shares of common stock.

On May 13, 2021, the Company completed its repurchase of the property for cash of $4,732,637. The repurchase resulted in the related liability recorded upon sale being extinguished on the date of the repurchase. A loss on the extinguishment was recorded based on the difference between the carrying value of the financing obligation including unamortized debt discount and the amount exchanged to extinguish the debt.

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Interest expense relating to this financing agreement was $0 for the period ended September 30, 2022 and $67,000 for the nine months ended September 30, 2021.

Note 13: Leases

The Company leases office and storage space, and other equipment under non-cancellable operating leases with initial terms typically ranging from 1 to 5 years. At contract inception, the Company reviews the facts and circumstances of the arrangement to determine if the contract is or contains a lease. The Company follows the guidance in Topic 842 “Leases” to evaluate whether the contract has an identified asset; if the Company has the right to obtain substantially all economic benefits from the asset; and if the Company has the right to direct the use of the underlying asset. When determining if a contract has an identified asset, the Company considers both explicit and implicit assets, and whether the supplier has the right to substitute the asset. When determining if the Company has the right to direct the use of an underlying asset, the Company considers if it has the right to direct how and for what purpose the asset is used throughout the period of use and if it controls the decision-making rights over the asset.

The Company’s lease terms may include options to extend or terminate the lease. The Company exercises judgment to determine the term of those leases when extension or termination options are present and include such options in the calculation of the lease term when it is reasonably certain that it will exercise those options.

The Company has elected to include both lease and non-lease components in the determination of lease payments. Payments made to a lessor for items such as taxes, insurance, common area maintenance, or other costs commonly referred to as executory costs, are also included in lease payments if they are fixed. The fixed portion of these payments are included in the calculation of the lease liability, while any variable portion would be recognized as variable lease expenses, when incurred. Variable payments made to third parties for these, or similar costs, such as utilities, are not included in the calculation of lease payments.

At lease commencement, lease-related assets and liabilities are measured at the present value of future lease payments over the lease term. As most of the Company’s leases do not provide an implicit rate, the Company exercises judgment in determining the incremental borrowing rate based on the information available when the lease commences to measure the present value of future payments.

Operating leases are included in other assets, current operating lease obligations, and operating lease obligations (less current portion) on the Company’s consolidated balance sheet. Short term leases with an initial term of 12 months or less are not presented on the balance sheet with expense recognized as incurred.

The Company entered into a Lease Agreement for a term of five years commencing on September 14, 2020 pursuant to which the Company agreed to lease two Sharp copiers. The base of $1,415 per month.

On June 13, 2018, the Company entered into a Lease Agreement for a term of six years commencing on July 1, 2018 pursuant to which the Company agreed to lease approximately 3,000 rentable square feet. The base rent increases by 3% each year, and ranges from $2,100 per month for the first year to $2,785 per month for the sixth year.

On May 1, 2019, the Company entered into a Lease Agreement for a term of three years commencing on May 1, 2019, pursuant to which the Company agreed to lease approximately 3,000 rentable square feet. The base rent is $2,500 per month for the term of the lease. On October 4, 2021, the Company executed a request to renew the lease for a one-year term as defined in the Lease Agreement. The request was accepted, and the one-year term commenced on April 30, 2022. On October 5, 2022, the Company executed a request to renew the lease for an additional one-year term at a monthly cost of $2,850. The request was accepted and the one-year term commences on May 1, 2023.

On February 17, 2022, the Company entered into a Lease Agreement for a term of two years commencing on March 1, 2022, pursuant to which the Company agreed to lease a Canon copier. The base rent is $322 per month for the term of the lease.

On June 16, 2022, the Company entered into a Lease Agreement for a term of five years commencing on July 1, 2022 pursuant to which the Company agreed to lease approximately 5,210 rentable square feet. The base rent increases by 3% each year, and ranges from $15,630 per month for the first year to $18,118 per month for the fifth year.

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The expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it is reasonably certain that the Company would exercise such options. The Company’s leases have remaining lease terms between 11 months and 5 years. As of September 30, 2022, and December 31, 2021, the weighted-average remaining term is 2.67 and 2.72 years, respectively.

The Company has determined that the incremental borrowing rate is 10% as of September 30, 2022, and December 31, 2021, respectively, based upon the recently completed financing transaction in December 2019.

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

Period December 31,
(in thousands)
2022	$	46
2023		187
2024		183
2025		180
2026		185
Thereafter		171
Less imputed interest		(86	)
Total	$	866

As of September 30, 2022, and December 31, 2021, the balance of the right of use assets was $866,000 and $149,000, respectively, and the corresponding lease liability balance was $866,000 and $149,000, respectively. Total rent expense for the nine months ended September 30, 2022, and September 30, 2021, amounted to approximately $75,000 and $39,000, respectively. Total rent expense for short term leases for the nine months ended September 30, 2022, and September 30, 2021, amounted to approximately $8,000 for both periods.

Note 14: Research, Consulting and Supply Agreements

In January 2021, the Company entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1 clinical study to assess the safety, tolerability, and biological activity of Ampligen as a potential intranasal therapy. The Company has paid CHDR approximately $1,066,000.

In April 2021, the Company approved a proposal from Polysciences for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors to the drug Ampligen. The Company is working with Polysciences to negotiate and finalize both a Service Agreement and a Quality Agreement. For the year ended December 31, 2021, the Company has incurred an expense and paid Polysciences approximately $250,000. For the nine months ended September 30, 2022, the Company paid Polysciences $103,000.

In April 2022, AIM executed a work order with Amarex Clinical Research LLC (“Amarex”), our contract research organization, pursuant to which Amarex will manage a Phase 2 clinical trial in advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM anticipates that the study will cost approximately $8.2 million, which includes pass through costs of approximately $1.0 million and excludes certain third-party costs and escalations. AIM anticipates that the study will take approximately 4.6 years to complete.

On June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex will manage a Phase 2 trial in patients with Post-COVID Conditions. It is planned that the study will be conducted at up to 10 sites in the United States. AIM is sponsoring the study. AIM anticipates that the study will cost approximately $4.4 million, which includes pass through costs of approximately $125,470, investigator costs estimated at about $2.4 million and excludes certain other third-party costs and escalations.

In December 2020, AIM added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance its capacity to produce Ampligen. This addition amplifies AIM’s manufacturing capability by providing redundancy and cost savings. The contracts augment our active and in-process fill and finish capacity. For the period ended December 31, 2021, the Company has incurred an expense and paid Pii approximately $89,000. For the nine months ended September 30, 2022, the Company incurred an expense and paid Pii approximately $259,000.

Note 15: Subsequent Events

On October 5, 2022, the Delaware Court of Chancery held a hearing regarding a motion to require the AIM Board of Directors to accept the Jorgl Group’s director nominations and include the group’s nominees on a universal proxy card for the 2022 Annual Meeting of Stockholders. On October 28, 2022, the court denied Jorgl’s motion. The Jorgl Group announced on November 2, 2022, that it did not intend to appeal the decision.

On October 12, 2022, the Company announced that its Investigational New Drug (IND) application filed with the FDA was granted clearance to proceed and therefore the Company could initiate a Phase 2 study evaluating Ampligen as a therapeutic for patients with post-COVID conditions (“AMP-518”).

On November 1, 2022, AIM completed the sale of its facility at 783 Jersey Avenue, New Brunswick, N.J., for $3.7 million net of normal closing cost.

In November 2022, AIM received notice that the FDA had granted Orphan Drug Designation to Ampligen for the treatment of Ebola virus disease.

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ITEM 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations

Special Note Regarding Forward-Looking Statements

Certain statements in this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act. These statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements may be found, among other places, in this Report in Part I, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations”; Part II, Item 1. “Legal Proceedings”; and Part II, Item 1A. “Risk Factors”, as well as the following sections of our Annual Report on Form 10-K for the year ended December 31, 2021: Item 1. “Business”, Part I; Item 1A. “Risk Factors”, Part I; Item 3. “Legal Proceedings”, Part I and Part II; Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.

All statements, other than statements of historical fact, included or incorporated herein regarding our strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “think,” “may,” “could,” “will,” “would,” “should,” “continue,” “potential,” “likely,” “opportunity” and similar expressions or variations of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements and their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties.

Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties inherent in our business including, without limitation: our ability to adequately fund our projects as we will need additional funding to proceed with our objectives; the potential therapeutic effect of our products; the possibility of obtaining regulatory approval; our ability to find senior co-development partners with the capital and expertise needed to commercialize our products and to enter into arrangements with them on commercially reasonable terms; our ability to manufacture and sell any products; our ability to enter into arrangements with third party vendors; market acceptance of our products; our ability to earn a profit from sales or licenses of any drugs; our ability to discover new drugs in the future, changing market conditions, changes in laws and regulations affecting our industry; and future matters related to our New Jersey facility, which by definition we cannot define at this time.

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We are in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders. We discuss in this Report our current and anticipated future activities, all of which are subject to change for a number of reasons. Significant testing and trials will be required to determine whether Ampligen will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. We cannot assure that the clinical studies will be successful or yield any useful data or require additional funding.

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 have been focused on the potential role that Ampligen could play in the treatment of SARS-CoV-2 — from a protective prophylaxis/early-onset therapeutic to a treatment for post-COVID conditions. Our beliefs rely on a number of studies. No assurance can be given that future studies will not result in findings that are different from those reported in the studies we refer to. 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, clearly, like all businesses, we are unable to gauge how bad this pandemic will affect our operations in the future. We reached out to numerous foreign governments related to COVID-19 and, if successful, may be working in these countries. 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.

In February 2013, we received a Complete Response Letter (CRL) from the Food and Drug Administration, or FDA, for our Ampligen New Drug Application, or NDA, for the treatment of CFS. The FDA communicated that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. Accordingly, the remaining steps to potentially gain FDA approval of the Ampligen NDA, the final results of these and other ongoing activities could vary materially from our expectations and could adversely affect the chances for approval of the Ampligen NDA. These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) the FDA may ask for additional data, information or studies to be completed or provided; and (ii) the FDA may require additional work related to the commercial manufacturing process to be completed or may, in the course of the inspection of manufacturing facilities, identify issues to be resolved. A proposed confirmatory trial and responses to the CRL are being worked on now by our R&D team and consultants.

In August 2016, we received approval of our NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”), for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe CFS. The product will be marketed by GP Pharm, our commercial partner in Latin America. We believe, but cannot assure, that this approval provides a platform for potential sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of licensed drugs. In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, should add further validation for the product as the Early Access Program, or EAP, as discussed below and underway in Europe in pancreatic cancer. ANMAT approval is only an initial, but important, step in the overall successful commercialization of our product. There are a number of actions that must occur before we could be able to commence commercial sales in Argentina. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. We are currently working with GP Pharma on the commercial launch of Ampligen in Argentina. Commercialization in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch and ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. This testing and approval process is currently delayed due to the COVID-19 pandemic and ANMAT’s internal processes. 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.

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In May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management of an EAP in Europe and Turkey related to CFS. Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in this territory, is performing EAP activities. In January 2017, the EAP was extended to pancreatic cancer patients beginning in the Netherlands. In February 2018, we signed an amendment to extend the territory to cover Canada to treat pancreatic cancer patients, pending government approval. In March 2018, we signed an amendment to which myTomorrows will be our exclusive service provider for special access activities in Canada for the supply of Ampligen for the treatment of CFS. MyTomorrows provides services related to the supply and distribution of Ampligen to patients in Early Access Programs (EAPs) which are initiated through a physician’s request; there have been no physician requests that have led to government approval, therefore no patients have been treated under an EAP for either pancreatic cancer or CFS in Canada. No assurance can be given that we can sufficiently supply product should we experience an unexpected demand for Ampligen in our clinical studies, the commercial launch in Argentina or pursuant to the EAPs. No assurance can be given that Ampligen will prove effective in the treatment of pancreatic cancer. The agreement was automatically extended for a period of 12 months on May 20, 2021, and again for an additional period of 12 months on May 20, 2022.

Multiple Ampligen clinical trials are underway, in various phases of development and activity, with a number of subjects enrolled at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint blockade. One site of clinical trials is Roswell Park and the other is the University of Pittsburgh Medical Center. (See: “Research and Development; Immuno-oncology”). No assurance can be given as to the results of these underway trials. No assurance can be given as to whether some or all of the planned additional oncology clinical trials will occur and they are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the sponsoring universities or cancer centers. Even if these additional clinical trials are initiated, as we are not the sponsor, we cannot assure that these clinical studies or the studies underway will be successful or yield any useful data. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding.

Our overall objectives include plans to continue seeking approval for commercialization of Ampligen in the United States and abroad as well as seeking to broaden commercial therapeutic indications for Alferon N Injection presently approved in the United States and Argentina. We continue to pursue senior co-development partners with the capital and expertise needed to commercialize our products and to enter into arrangements with them on commercially reasonable terms. Our ability to commercialize our products, widen commercial therapeutic indications of Alferon N Injection and/or capitalize on our collaborations with research laboratories to examine our products are subject to a number of significant risks and uncertainties including, but not limited to our, ability to enter into more definitive agreements with some of the research laboratories and others that we are collaborating with, to fund and conduct additional testing and studies, whether or not such testing is successful or requires additional testing and meets the requirements of the FDA and comparable foreign regulatory agencies. We do not know when, if ever, our products will be generally available for commercial sale for any indication.

We strived to maximize the outsourcing of certain components of our manufacturing, quality control, marketing and distribution while maintaining control over the entire process through our quality assurance and regulatory groups. We cannot provide any guarantee that the facility or our contract manufacturers will pass an FDA pre-approval inspection for Alferon N Injection manufacturing.

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In May 2021, we exercised our option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale and lease-back agreement. We thereafter sold certain equipment and machinery that we determined to be obsolete and no longer needed for current or future manufacturing. On March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc. to purchase the property for an estimated $3.9 million, with AIM’s intention to keep some space specifically for its Alferon activity. The sale was finalized on November 1, 2022 for $3.7 million net of normal closing cost.

In June 2022 we entered into a lease agreement with the New Jersey Economic Development Authority for a 5,210 square-foot, state-of-the-art R&D facility at the New Jersey Bioscience Center (“NJBC”), primarily consisting of two separate laboratory suites. The facility is AIM’s operations, research and development center.

The production of new Alferon N Injection Active Pharmaceutical Ingredient, or API, is currently on hold. The New Brunswick facility is approved by the FDA under the Biological License Application, or BLA, for Alferon N Injection. While we are selling the New Brunswick facility, we intend to maintain a certain amount of space at that facility for Alferon activities, the sale of the facility will move up the timeline for contracting with a CMO, or CMOs, capable of producing Alferon, and receiving FDA approval to do so, prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon N Injection API, it will need FDA approval as to the quality and stability of the final product before commercial sales can resume. We may need additional funds to finance the validation process. If we are unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon N Injection inventory, our operations most likely will be materially and/or adversely affected. In light of these contingencies, there can be no assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if at all, or that if and when it is again made commercially available, it will return to prior sales levels.

In December 2020, we added Pii as a “Fill & Finish” provider to enhance our capacity to produce Ampligen. This addition amplifies our manufacturing capability by providing redundancy and cost savings. The contracts augment our active and in-process fill and finish capacity.

Due to continuing delays and other obstacles related to importing Ampligen to China, on August 10, 2022, we ended our contract with Shenzhen Smoore Technology for the development of an Ampligen delivery device for the treatment of SARS-CoV-2.

We believe, and are investigating, Ampligen’s potential role in enhancing the activity of influenza vaccines. While certain studies involving rodents, non-human primates (monkeys) and healthy human subjects indicate that Ampligen may enhance the activity of influenza vaccines by conferring increased cross-reactivity or cross-protection, further studies will be required and no assurance can be given that Ampligen will assist in the development of a universal vaccine for influenza or other viruses.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

This Report also refers to estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.

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Overview

General

AIM ImmunoTech Inc. and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

Our flagship products are Ampligen® (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon alfa-n3). Ampligen has not been approved by the FDA or marketed in the United States. Ampligen is approved for commercial sale in the Argentine Republic for the treatment of severe CFS.

Our primary present business focus involves Ampligen. Ampligen represents a dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system.

We currently are proceeding primarily in four areas:

● A randomized controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced pancreatic cancer patients.

● Evaluate Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses to check point inhibitors.

● Exploring Ampligen’s antiviral activities and potential use as a prophylactic or treatment for existing viruses, new viruses and mutated viruses thereof.

● Ampligen as a treatment for ME/CFS and fatigue and/or Post-COVID conditions of fatigue.

We are prioritizing our activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer, ME/CFS and Post-COVID conditions having priority over antiviral experimentation. We intend that priority clinical work be conducted in FDA- or EMA-authorized trials which could support a potential future NDA. However, our antiviral experimentation is designed to accumulate additional preliminary data supporting our hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection. Accordingly, we will conduct our antiviral programs in those venues most readily available and able to generate valid proof-of-concept data, including foreign venues.

Immuno-Oncology.

We are focused on pancreatic cancer because testing results, to date, primarily conducted in the Netherlands, have been very promising. The Netherlands study generated statistically significant data indicating that Ampligen extended survival well beyond the Standard of Care (“SOC”), when compared to well-matched historical controls. These data support the proposition that Ampligen, when administered to either patients with locally advanced or metastatic pancreatic cancer after systemic chemotherapy showed a statistically significant increase in survival rate. In October 2021, we and our Contract Research Organization, Amarex, submitted an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. In August 2022, we received Institutional Review Board (“IRB”) approval of the trial protocol and so announced the trial’s commencement. Assuming this trial and subsequent planned clinical trials confirm the existing data, our goal is to then submit an NDA for use of Ampligen in pancreatic cancer patients.

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Because of the differences in the scale of necessary trials, our initial primary focus when it comes to pancreatic cancer will be cases that are locally advanced, rather than metastatic. The number of different approaches to treating metastatic pancreatic cancer — approaches which would be determined by treating physicians — would require a much larger, far more expensive trial than would a trial for locally advanced pancreatic cancer. Therefore, we are focusing on patients who have completed FOLFIRINOX and have stable disease. Ampligen has also demonstrated in the clinic the potential for standalone efficacy in a number of other 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. In fact, in March 2022 we announced interim data from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial to evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP Ampligen (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab for patients with recurrent platinum-sensitive ovarian cancer. We believe that data from the study, which is being conducted by the University of Pittsburgh Medical Center and funded by a Merck grant, demonstrated that when combining three drugs – Ampligen and pembrolizumab, which are both immune therapies, with cisplatin, a chemotherapy – evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function has been seen. Importantly, increases of these biomarkers in the tumor microenvironment have been correlated with favorable tumor responses. These successes in the field of immuno-oncology have guided our efforts toward the potential use of Ampligen as a combinational therapy for the treatment of a variety of solid tumor types. The first of our patent applications in this space was granted by the Netherlands on March 15, 2021.

Please see “Immuno-Oncology” below.

Ampligen as an Antiviral.

We have a research and pre-clinical history that indicates broad-spectrum antiviral capability of Ampligen in animals. We hope to demonstrate that it has the same effect in humans. To do this, among other things, we need a population infected with a virus. That is why we have spent significant resources on COVID-19 (the disease caused by SARS-CoV-2) which is active and still infecting many subjects. While much would need to be done to get Ampligen to market as a broad-spectrum antiviral, we believe that it is important to focus our efforts first and foremost on thoroughly proving the concept, especially while there is still a large COVID-19-infected population. Previously, animal studies were conducted that yielded positive results utilizing Ampligen to treat numerous viruses, such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. We have conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2.

The FDA has requested that we provide additional data to assist the agency in evaluating the potential risks and benefits of administering Ampligen to asymptomatic and mild COVID-19 individuals. However, as discussed in more detail below, where the threat to the patient from COVID-19 is high, the FDA has already authorized Ampligen in a clinical trial of patients with COVID-19 who have a pre-existing cancer. That Phase 1/2a study utilizing Ampligen is underway. We have also elected to explore studies (initially with healthy volunteers) outside the United States and have already conducted an intranasal safety study in the Netherlands.

In this regard, CHDR, a foundation located in Leiden in the Netherlands, managed a Phase 1 randomized, double-blind study for us to evaluate the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. All patients had completed treatment by June 2021 and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage level.

Today, over two years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics. Our quest to prove the antiviral activities of Ampligen continues. If Ampligen has the broad-spectrum antiviral properties that we believe that it has, it could be a very valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the future. Unlike most developing therapeutics which attack the virus, Ampligen works differently. We believe that it activates antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well.

In October 2022, our IND application filed with the FDA had cleared the approval process and we are proceeding with a Phase 2 study evaluating Ampligen as a therapeutic for patients with post-COVID conditions (“AMP-518”).

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Please see “Ampligen as a Potential Antiviral” below.

Ampligen as a treatment for ME/CFS and Post-COVID Conditions

We have long been focused on seeking the FDA’s approval for the use of Ampligen to treat ME/CFS. In fact, in February 2013, we received a Complete Response letter (“CRL”) from the FDA for our Ampligen NDA for ME/CFS, stating that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

While developing a comprehensive response to the FDA and a plan for a confirmatory trial for the FDA NDA, we proceeded independently in Argentina and, in August 2016, we received approval of an NDA from ANMAT for commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. This testing and approval process is currently delayed due to the COVID-19 pandemic and ANMAT’s internal processes. The ongoing impact of COVID-19 in Argentina is taxing the nation’s health care system and is, understandably, the main priority of its regulators. Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in Argentina.

The FDA authorized an open-label treatment protocol (“AMP-511”) allowing patient access to Ampligen for treatment in a study under which severely debilitated CFS patients have the opportunity to be on Ampligen to treat this very serious and chronic condition. The data collected from the AMP-511 protocol through a consortium group of clinical sites provide safety information regarding the use of Ampligen in patients with CFS. The AMP-511 protocol is ongoing. In October 2020, we received IRB approval for the expansion of the AMP-511 protocol to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms that we refer to as Post-COVID conditions. As of September 30, 2022, there were 11 patients enrolled in this open-label expanded access treatment protocol (including two patients with Post-COVID-19 Conditions). To date, there have been five such Post-COVID patients treated. In July 2022, AIM reported positive preliminary results based on data from the first four Post-COVID Condition patients enrolled in the study. The data show that, by week 12, compared to baseline, there was what the investigators considered a clinically significant decrease in fatigue-related measures.

We plan on a comprehensive follow through with the FDA regarding the use of Ampligen as a treatment for ME/CFS. We have learned a great deal since the FDA’s CRL and plan to adjust our approach to concentrate on specific ME/CFS symptoms. Responses to the CRL and a proposed confirmatory trial are being worked on now by our R&D team and consultants.

Please see “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)” below.

OUR PRODUCTS

Our primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded (ds) RNA (ribonucleic acid) molecules, and our FDA-approved natural alpha-interferon product, Alferon N Injection.

Ampligen®

Ampligen is approved for sale in Argentina (to 2026) for severe CFS and is an experimental drug in the United States currently undergoing clinical development for the treatment of certain cancers and ME/CFS. Over its developmental history, Ampligen has received various designations, including Orphan Drug Product Designation (FDA and EMA), Treatment protocol (e.g., “Expanded Access” or “Compassionate” use authorization) with Cost Recovery Authorization (FDA) and “promising” clinical outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research and Quality). Based on the results of published, peer-reviewed pre-clinical studies and clinical trials, we believe that Ampligen may have broad-spectrum antiviral and anti-cancer properties.

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We believe that nucleic acid compounds represent a potential new class of pharmaceutical products designed to act at the molecular level for treatment of many human diseases. Ampligen represents the first drug in the class of large (macromolecular) dsRNA molecules to apply for NDA review. There are two forms of nucleic acids: deoxyribonucleic acid (“DNA”) and ribonucleic acid (“RNA”). DNA is a group of naturally occurring molecules found in chromosomes, the cell’s genetic machinery. RNA is a group of naturally occurring informational molecules which orchestrate a cell’s behavior which, in turn, regulates the action of groups of cells, including the cells which comprise the body’s immune system. RNA directs the production of proteins and regulates certain cell activities including the activation of an otherwise dormant cellular defense against viruses and tumors. Our drug technology utilizes specifically configured RNA and is a selective Toll-like Receptor 3 (“TLR3”) agonist that can be administered intravenously, intranasally and intraperitoneally. Ampligen has been assigned the generic name rintatolimod by the United States Adopted Names Council (“USANC”) and has the chemical designation poly(I):poly(C₁₂U).

Expanded Access Program/Early Access Programs/clinical trials of Ampligen that have been conducted or that are ongoing include studies of the potential treatment of patients with pancreatic cancer, renal cell carcinoma, malignant melanoma, non-small cell lung cancer, ovarian cancer, breast cancer, colorectal cancer, prostate cancer, ME/CFS, Hepatitis B, HIV, COVID-19 and Post-COVID conditions.

We have received approval of our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. The product will be marketed by GP Pharm, our commercial partner in Latin America. Shipment of the drug product to Argentina was initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. We are currently working with GP Pharm on the commercial launch of Ampligen in Argentina. Commercialization in Argentina will require, among other things, GP Pharm to establish disease awareness, medical education, creation of an appropriate reimbursement level, design of marketing strategies and completion of manufacturing preparations for launch and 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. This testing and approval process is currently delayed due to the COVID-19 pandemic and ANMAT’s internal processes. The ongoing impact of COVID-19 in Argentina is taxing the nation’s health care system and is, understandably, the main priority of its regulators. Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in Argentina. We continue to pursue our Ampligen NDA, for the treatment of CFS with the FDA.

The FDA has authorized an open-label expanded access treatment protocol (AMP-511) allowing patient access to Ampligen in a study under which severely debilitated CFS patients have the opportunity to be on Ampligen to treat this very serious and chronic condition. The AMP-511 protocol started in the 1990s and is ongoing. The data collected from the AMP-511 protocol through clinical sites provide safety information regarding the use of Ampligen in patients with CFS. We are establishing an enlarged database of clinical safety information which we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen treatment. We believe that continued efforts to understand existing data, and to advance the development of new data and information, will ultimately support our future filings for Ampligen and/or the design of future clinical studies that the FDA requested in a CRL. The FDA approved an increased reimbursement level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs; which was re-authorized in 2021 and again in 2022. At this time, we do not plan on passing this adjustment along to the patients in this program. In October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms that we refer to as Post-COVID conditions. As of September 30, 2022, there are 11 patients enrolled in this open-label expanded access treatment protocol (including two Post-COVID-19 patients). To date, there have been five such Post-COVID patients treated. In July 2022, AIM reported positive preliminary results based on data from the first four Post-COVID Condition patients enrolled in the study. The data show that, by week 12, compared to baseline, there was what the investigators considered a clinically significant decrease in fatigue-related measures.

In May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management of an Early Access Program (“EAP”) in Europe and Turkey related to ME/CFS. Pursuant to the agreement, as amended, myTomorrows also is managing all Early Access Programs and Special Access Programs in Europe, Canada and Turkey to treat pancreatic cancer and ME/CFS patients. The agreement was automatically extended for a period of 12 months on May 20, 2021, and again for an additional period of 12 months on May 20, 2022.

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In June 2018, Ampligen was cited as outperforming two other TLR3 agonists — poly IC and natural double stranded RNA — in creating an enhanced tumor microenvironment for checkpoint blockade therapy in the journal of Cancer Research (http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985).In a head-to-head study in explant culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer T cells but, unlike the other two TLR3 agonists, it did so without causing regulatory T cell (Treg) attraction. These findings were considered important because they indicate that Ampligen selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation (attracting killer T cells), without amplifying immune-suppressive elements such as regulatory T cells. 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”).

In 2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill & Finish” at Jubilant HollisterStier, the Contract Manufacturing Organization. These lots passed all required testing for regulatory release for human use and are being used for multiple programs, including: the treatment of ME/CFS; the pancreatic cancer EAP in the Netherlands; and will continue to be used for ongoing and future clinical studies in oncology. Additionally, two lots of Ampligen were manufactured in December 2019 and January 2020 at Jubilant HollisterStier. The current manufactured lots of Ampligen have been fully tested and released for commercial product launch in Argentina and for clinical trials. Additionally, in December 2020, we added Pii as a “Fill & Finish” provider to enhance our capacity to produce Ampligen. This addition amplifies our manufacturing capability by providing redundancy and cost savings. The contracts augment our active and in-process fill and finish capacity.

Immuno-Oncology

The potential of Ampligen as an immuno-oncology therapeutic has been a major focus of AIM since our current leadership took over in 2016. We have been working with the University of Pittsburgh’s chemokine modulation research initiative, which includes the use of Ampligen as a potential adjuvant to modify the tumor microenvironment (“TME”) with the goal of increasing anti-tumor responses to check point inhibitors (“CPI”). As part of this collaboration, we have supplied Ampligen to the University. The study, under the leadership of Robert P. 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 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.

Multiple Ampligen clinical trials are underway or recently completed at major university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors. The underway trials include:

● Pancreatic Cancer Trial - The Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. The AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the U.S. and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites. In March 2022, the FDA granted clearance to proceed with the study. In April 2022, we executed a work order with Amarex to manage the clinical trial. In August 2022, we received IRB approval of the trial protocol and so announced the trial’s commencement. For the year ended December 31, 2021, we incurred expense of approximately $195,000. For the nine months ended September 30, 2022, we paid approximately $1,756,000.

See “Immuno-Oncology; Additional Progress and Analysis Related to Pancreatic Cancer” for more analysis.

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● Advanced Recurrent Ovarian Cancer

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Results of the Phase 1 portion of a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer were published in the American Association for Cancer Research publication, Clinical Cancer Research (Clin Cancer Res January 19, 2022 DOI: 10.1158/1078-0432.CCR-21-3659). The study results represent an important extension of prior studies using human tumor explants that showed Ampligen’s potentially important role as a TLR3 agonist acting synergistically with high-dose IFNα and celecoxib to selectively enhance Teff cell-attractants while suppressing Treg-attractants in the tumor microenvironment with a concomitant increase in the Teff/Treg ratio. The importance of boosting the Teff/Treg ratio in the tumor microenvironment is that it is associated with the conversion of ‘cold’ tumors into ‘hot’ tumors, which have an increased sensitivity to chemo-immunotherapy and an improved chance of showing tumor regression. The Phase 1 portion was designed to establish intraperitoneal safety. The Phase 2 portion of the study is planned to be conducted in the future. https://clinicaltrials.gov/ct2/show/NCT02432378

○

A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; enrollment has commenced, and numerous patients have commenced treatment. We announced interim data from the study demonstrating that evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function was seen when combining Ampligen, pembrolizumab and cisplatin. Increases of these biomarkers in the tumor microenvironment have been correlated with favorable tumor responses. Interim results announced March 2022 detailed an observed clinical response rate of 61% includes two complete and three partial tumor responses, plus three patients with stable disease among the 13 evaluable patients. An important priority will be to confirm these findings through continuing to enroll patients onto this study. https://clinicaltrials.gov/ct2/show/NCT03734692

In March 2021, we were granted a patent by the Netherlands Patent Office with granted patent claims that include, but are not limited to, the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors (e.g. pembrolizumab, nivolumab). Interim data from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial demonstrated that evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function was seen when combining Ampligen, pembrolizumab and cisplatin. It is critical to note that increases of these biomarkers in the tumor microenvironment have been correlated with favorable tumor responses. All told, the study has seen an Objective Response Rate (ORR) 38.5%; a study of pembrolizumab alone in the treatment of advanced recurrent ovarian cancer found ORR of 8.1% and 9.9% across two cohorts. The positive data makes this patent have heightened potential. Similar patents are pending in other countries.

● Stage 4 Metastatic Triple Negative Breast Cancer - Phase 1 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. Eight patients were enrolled and 6 patients were evaluable. https://www.clinicaltrials.gov/ct2/show/NCT03599453. The key findings announced April 2022 included:

○	The pre-determined primary endpoint of efficacy was met (increase in CD8 in TME).
○	Uniform increase of immune markers upon treatment was observed: CD8 mRNA (6.1-fold; p-0.034), GZMB mRNA (3.5-fold; p=0.058), ratios of CD8 /FOXP3 and GZMB/FOXP3 (5.7-fold; p=0.036, and 7.6-fold; p=0.024 respectively), thus successfully meeting the pre-determined primary endpoint in the study (increase in CD8 in TME).
○	In addition, an increase in CTL attractants CXCL10 (2.6-fold; p=0.104) and CCL5 (3.3-fold; p=0.019) was observed. In contrast, Treg marker FOXP3 or Treg attractants CCL22 or CXCL12 were not enhanced.
○	Three patients had stable disease lasting 2.4, 2.5 and 3.8 months, as of data cut off September 1, 2021.
○	An additional patient (non-evaluable) had a partial response (breast tumor autoamputation) with massive tumor necrosis in the post-CKM biopsy.

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● Stage 4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen as a component of chemokine modulatory regimen on colorectal cancer metastatic to liver; recruitment has been completed; 19 patients were enrolled and 12 patients were evaluable for the primary endpoint https://clinicaltrials.gov/ct2/show/NCT03403634. The key findings announced April 2022 included:

○	The study’s primary endpoint was met, evidenced by increased CD8a expression post-treatment (p=0.046).
○	Saw increase in the CD8a/CD4 (p=0.03), CD8a/FOXP3 (p<0.01) and GZMB/FOXP3 (p<0.01) ratios.
○	The expression of CTL-attracting chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and CXCL10 (p=0.06) were increased, while expression of the Treg/MDSC attractant CXCL12 (p=0.07) was decreased post-treatment.
○	Median OS was 10.5 (90% CI 2.2-15.2) months, and the median PFS was 1.5 (90% CI 1.4, 1.8) months.
○	No tumor responses were seen. The treatment was well tolerated. Of all enrolled patients (N=19), adverse events were noted in 74% of patients, with the most common being fatigue (58%). Grade 3 or higher adverse events were rare (5%).

● Early-Stage Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. https://clinicaltrials.gov/ct2/show/NCT03899987

● Early-Stage Triple Negative Breast Cancer - Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization; the objective of this study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy; the goal of this approach is to increase survival. Interim results announced in March 2022 detailed data gathered from evaluating paclitaxel’s impact on chemokine production in the human breast tumor microenvironment (TME) and the ability of a chemokine modulatory regimen (CKM) of Ampligen and Interferon-α to mitigate potentially undesirable aspects of taxane chemotherapy. Based on the results, we believe that the combination chemokine modulatory regimen including Ampligen has the potential to mitigate undesirable aspects of taxane chemotherapy. Investigators are currently analyzing data. https://clinicaltrials.gov/ct2/show/NCT04081389

● Refractory Melanoma — Roswell Park Comprehensive Cancer Center (“Roswell Park”), in a clinical trial fully funded by the National Cancer Institute (NCI), has commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant melanoma. The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination with tumor-selective chemokine modulation (“CKM”) comprised of Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib. Up to 24 patients to be (See: https://www.clinicaltrials.gov/show/NCT04093323).

Additional Progress and Analysis Related to Pancreatic Cancer

In January 2017, the EAP established under our agreement with myTomorrows to enable access of Ampligen to ME/CFS patients was extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider in Europe and 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.

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A total of 42 pancreatic cancer patients initially received treatment with Ampligen immuno-oncology therapy under the EAP program at Erasmus MC in the Netherlands; that initial program has since continued to expand and proceed with additional patients to be treated with Ampligen Supervised by Prof. C.H.J. van Eijck, MD. The team at Erasmus MC in September 2020 reported data which demonstrated a statistically significant positive survival benefit when using Ampligen in patients with locally advanced or metastatic pancreatic cancer after systemic chemotherapy, compared with historical control patients. We are working with our Contract Research Organization, Amarex Clinical Research LLC, to seek FDA “fast-track.” We have applied for fast-track status; have received denials to date; and are currently working through the FDA process to provide all the materials and information required to achieve fast-track status. The IND authorization to proceed with the Phase 2 pancreatic cancer clinical trial has been received with potential sites in the Netherlands at Erasmus MC under Prof. C.H.J. van Eijck, and also at major cancer research centers in the United States such as The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC).

Additionally:

● In December 2020, the FDA granted Ampligen Orphan Drug Designation status for the treatment of pancreatic cancer. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the act. The status helps incentivize the treatment of therapies to treat unmet medical needs by providing a company with seven years of exclusivity rights once a drug reaches market.

● In February 2021, our subsidiary, NV Hemispherx Biopharma Europe, received formal notification from the European Commission (“EC”) granting Orphan Medicinal Product Designation for Ampligen as a treatment for pancreatic cancer. Orphan products, once commercially approved in the European Union (“EU”), receive benefits including up to ten years of protection from market competition from similar medicines with similar active component and indication for use that are not shown to be clinically superior.

In June 2021, Ampligen was featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers as a potential treatment option for cancer patients who are infected with SARS-CoV-2. The study’s authors stated that Ampligen has the potential to reduce the severity of the deadly respiratory disease COVID-19. According to laboratory data presented in the publication, “Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells”, including:

● Stimulation of interferon regulatory factors and activation of the interferon signaling pathway,

● Production of immunomodulatory activity and

● Induction of the expression of MHC class I and II histocompatibility

The full journal article is titled: “Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients?” Cancers is a peer-reviewed, open access journal of oncology published semimonthly online by MDPI. The study’s authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator at Erasmus Medical Center in the Netherlands.

In October 2021, we and Amarex submitted an IND application with the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. In December 2021, the FDA responded with a Clinical Hold on the proposed study. We submitted our response to the FDA in February 2022. In March 2022, we received notification from the FDA that the Clinical Hold was released and cleared, meaning that we are now able to proceed with the study. In August 2022, we received IRB approval of the trial protocol and so announced the trial’s commencement.

In March 2022, we announced the publication of positive data in a manuscript titled, “Rintatolimod (Ampligen®) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program,” in Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer. In the single-center, named-patient program, patients with locally advanced pancreatic cancer (LAPC) or metastatic disease were treated with Ampligen for 6 weeks, at 2 doses per week with 400 mg per infusion. The study found that Ampligen improved the median survival of these patients. The study’s primary endpoints were the Systemic Immune-Inflammation Index (SIII), the Neutrophils to Lymphocyte Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells as measured by flow cytometry. Secondary endpoints were progression-free survival (PFS) and overall survival (OS). The median overall survival in the Ampligen group was 19 months, compared to a historical control group and subgroup (7.5 and 12.5, respectively) that did not receive Ampligen.

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Also in March 2022, we announced that study data evaluating the direct effects of Ampligen on human pancreatic ductal adenocarcinoma (PDAC) cells was accepted for presentation at the 15th Annual International Hepato-Pancreato-Biliary Association World Congress in New York, NY. For the study, three PDAC cell lines (CFPAC-1, MIAPaCa-2, and PANC-1) were treated with various concentrations of Ampligen and their corresponding vehicle control. The proliferation and migration effects were examined using in-vitro assays and the molecular effect was examined by targeted gene expression profiling. Additionally human PDAC samples were used to validate the expression of toll-like receptor 3 (TLR3) by immunohistochemistry. Results from the study demonstrated Ampligen decreased the proliferation and migration ability of CFPAC-1 cells. In addition, it decreased the proliferation of MIAPaCa-2 cells and the migration of PANC-1 cells. However, it did not have a dual effect in MIAPaCa-2 and PANC-1 cells. Interestingly, TLR3 was highly expressed in CFPAC-1 cells, low expressed in MIAPaCa-2 and not expressed in PANC-1. Gene expression analysis revealed the upregulation of interferon-related genes, chemokines, interleukins and cell cycle regulatory genes. The heterogeneity of TLR3 expression was confirmed in human PDAC samples. Based on these results, treating pancreatic cancer with Ampligen may have a direct anti-tumor effect in pancreatic cancer cells expressing TLR-3.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), also known as Chronic Fatigue Immune Dysfunction Syndrome (“CFIDS”) and Chronic Fatigue Syndrome (CFS), is a serious and debilitating chronic illness and a major public health problem. ME/CFS is recognized by both the government and private sector as a significant unmet medical need, including the U.S. National Institutes of Health (“NIH”), FDA and the CDC. The CDC states on its website at https://www.cdc.gov/me-cfs/ that “Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious, long-term illness that affects many body systems. People with ME/CFS are often not able to do their usual activities. At times, ME/CFS may confine them to bed. People with ME/CFS have severe fatigue and sleep problems. ME/CFS may get worse after people with the illness try to do as much as they want or need to do. This symptom is called post-exertional malaise (PEM). Other symptoms can include problems with thinking and concentrating, pain, and dizziness.”

Many severe ME/CFS patients become completely disabled or totally bedridden and are afflicted with severe pain and mental confusion even at rest. ME/CFS is characterized by incapacitating fatigue with profound exhaustion and extremely poor stamina, sleep difficulties and problems with concentration and short-term memory. It is also accompanied by flu-like symptoms, pain in the joints and muscles, tender lymph nodes, sore throat and new headaches. A distinctive characteristic of the illness is a worsening of symptoms following physical or mental exertion, which do not subside with rest.

The high number of younger people being hospitalized for COVID-19 suggests considerable numbers of people in the prime of their lives may have a COVID-induced ME/CFS-like illness in their future. According to a 2016 journal article, the estimated annual cost of lost productivity related to ME/CFS was $9-37 billion in the United States, and for direct medical costs it was $9-14 billion.

In June of 2020, we 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.

Many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report chronic fatigue, difficulty sleeping and shortness of breath months after recovering from the acute illness. “After one year, 17% of patients had not returned to work and 9% more had not returned to their pre-SARS work levels,” according to 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.”

In October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms. For more information on our AMP-511 Expanded Access Program, please see “OUR PRODUCTS: Ampligen” above.

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In November 2020, we 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.

As noted above in Overview; General; Ampligen as a treatment for ME/CFS and Post-COVID Conditions, we have long been focused on seeking the FDA’s approval for the use of Ampligen to treat ME/CFS. In fact, in February 2013, we received a CRL from the FDA for our Ampligen NDA for ME/CFS, stating that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

While developing a comprehensive response to the FDA and a plan for a confirmatory trial for the FDA NDA, we proceeded independently in Argentina and, in August 2016, we received approval of an NDA from ANMAT for commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. This testing and approval process is currently delayed due to the COVID-19 pandemic and ANMAT’s internal processes. The ongoing impact of COVID-19 in Argentina is taxing the nation’s health care system and is, understandably, the main priority of its regulators. Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in Argentina.

We plan on a comprehensive follow through with the FDA regarding the use of Ampligen as a treatment for ME/CFS. We have learned a great deal since the FDA’s CRL and plan to adjust our approach to concentrate on specific ME/CFS symptoms. Responses to the CRL and a proposed confirmatory trial are being worked on now by our R&D team and consultants.

Ampligen as a Potential Antiviral

Following the SARS-CoV-1 outbreak in 2002-03, Ampligen exhibited excellent antiviral properties and protective survival effect in NIH-contracted studies of SARS-CoV-1-infected mice, which is very similar to SARS-CoV-2, the novel virus that causes COVID-19.

● The Barnard 2006 study (https://journals.sagepub.com/doi/abs/10.1177/095632020601700505) found that Ampligen reduced virus lung levels to below detectable limits.

● The Day 2009 study (https://www.sciencedirect.com/science/article/pii/S0042682209005832) found that, instead of 100% mortality, there was 100% protective survival using Ampligen.

We 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. The SARS-CoV-2 virus – which causes COVID-19 – shares important genomic and pathogenic similarities with SARS-CoV-1 (hence its name). 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, and as discussed below, recently, Ampligen has demonstrated ex vivo 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.

Since the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment for this virus or could be part of a vaccine. We believe that Ampligen has the potential to be both an early-onset treatment for and prophylaxis against SARS-CoV-2. We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the new virus.

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In 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 (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; 3) a high-volume manufacturing process for Ampligen. Under the Patent Cooperation Treaty of 1970, which provides international protections for patents, these three provisional patent applications were converted in to two international patent applications based on the date of their filings.

In April 2020, we entered into a Material Transfer and Research Agreement (“MTA”) with Shenzhen Smoore Technology to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. The MTA was extended for two years in May 2021. Due to continuing delays and other obstacles related to importing Ampligen to China, we ended our contract with Smoore on August 10, 2022.

In August 2020, we contracted Amarex to act as our Clinical Research Organization and provide regulatory support with regard to a possible clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via intranasal delivery.

Beginning in April 2020, we entered into confidentiality and non-disclosure agreements with numerous companies for the potential outsourcing of the production of polymer, enzyme, placebo as well as Ampligen, and one Contract Research Organization, Amarex, which will provide regulatory and monitoring support related to a clinical trial testing Ampligen’s intranasal safety and potential as a COVID-19 prophylaxis via intranasal delivery.

In May 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 COVID-19 infections. This clinical trial, sponsored by Roswell Park in collaboration with us, will test the safety of this combination regimen in patients with cancer and COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. Several subjects have been treated and recruitment continues. 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 alpha-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 alpha but will receive best available care. We are a financial sponsor of the study and will provide Ampligen at no charge for this study.

In July 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 alpha, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus. We and the National Cancer Institute are supporting this trial. We reported in September 2020 that recruitment in the trial had begun (See clinicaltrials.gov/NCT04379518). In November 2020, the first patient in the study had been enrolled and treated. This study was amended to add 20 patients, with 10 randomized to receive a single dose of Ampligen and 10 patients to receive current best therapies.

We also entered into a specialized services agreement with Utah State University and have 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.

In October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with our flagship pipeline drug Ampligen. In January 2021, we commenced with the treatment of the first previously diagnosed COVID-19 patient with long-COVID symptoms (i.e., Long Hauler) also known as Post-COVID Conditions in the AMP-511 study. Enrollment of post-COVID patients continues in the study.

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In November 2020, we entered into a Material Transfer and Research Agreement with Leyden Laboratories, B.V., (“Leyden Lab”) to facilitate two proposed studies/research projects:

● An assessment of protective potential of intranasal administration of Ampligen in SARS-CoV-2 Syrian hamster challenge model; and

● An assessment of protective potential of intranasal Ampligen in lethal influenza mouse challenge model.

In January 2021, we entered into a Sponsor Agreement with CHDR to manage a Phase 1 randomized, double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen. AIM funded and sponsored the study. This study was designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. All patients had completed treatment by June 2021 and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage level. We believe that the trial is a critical step in our ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases. Amarex provided us with monitoring support during the trial.

Additionally, we filed two COVID-19-related provisional patent applications in the third quarter of 2021. In August, we filed an application for Ampligen as both an intranasal and an intravenous therapy for what we describe as Post-COVID conditions. The people suffering from Post-COVID conditions, including some young adults, can be afflicted with severe difficulties in concentrating; serious memory problems; and the inability to live an active lifestyle, to work and even to perform everyday tasks. Early data has demonstrated that patients with symptoms of Post-COVID conditions being treated with Ampligen in the ongoing AMP-511 Expanded Access Program have reported improvements in fatigue symptoms. Similarly, in ME/CFS, data supports the claim that Ampligen improves fatigue symptoms. Then in September, we filed a patent application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses and SARS-CoV-2.

In addition to securing these two provisional patent applications, we also moved forward with proposed studies in these areas and with Pre-Investigational New Drug Applications in September 2021. One pre-IND was for a Phase 2, two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Ampligen in patients experiencing Post-COVID conditions (originally referred to as Post-COVID Cognitive Dysfunction (PCCD) and being revised to Post-COVID conditions).

In October 2022, our IND application cleared the approval process and we are proceeding with the clinical trial (AMP-518). We are working to get the study up and running as quickly and efficiently as possible. We expect to commence enrollment in early 2023.

In September 2021, we submitted another pre-IND meeting request for two separate Phase 2 clinical studies to study the potential of Ampligen as both an infusion and an intranasal therapy for early-onset COVID-19. The two clinical trials would be Phase 2, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of Ampligen as an:

● Intravenous therapy – 200 mg of Ampligen or placebo, with five doses over a treatment period of 17 days; and an

● Intranasal therapy – 1,250 μg spray (625 μg per nostril), with seven doses over a treatment period of 15 days.

The FDA responded that it was premature and denied our meeting request, noting the primary reason that we first needed to address its comments on two prior similar pre-IND submissions related to the potential risks of administering Ampligen to patients with asymptomatic or mildly symptomatic COVID-19 were justified by potential benefits. We plan to respond to the FDA regarding the early onset COVID-19 submission. The FDA has already authorized Ampligen for a clinical trial in cancer patients, and subjects have been and will be treated in the investigator-sponsored Phase 2 trial at the Roswell Park Comprehensive Cancer Center. Our plans to study Ampligen in asymptomatic and mild COVID-19 cases await further consideration of the different risks and benefits associated with those trials.

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In June 2022, we announced that the Netherlands Patent Office (Octrooicentrum Nederland) had issued Patent No. 2027383 – a utility patent – covering Ampligen® (rintatolimod) and other AIM developed dsRNA products for use in the prevention or treatment of COVID-19, with a base patent term extending until 2041.

Other Diseases

In Europe, the EMA has approved the Orphan Medicinal Products Designation for Ampligen as a potential treatment of Ebola virus disease and for Alferon N Injection as a potential treatment of MERS.

We concluded our series of collaborations designed to determine the potential effectiveness of Ampligen and Alferon N Injection as potential preventive and/or therapeutic treatments for Ebola-related disorders. Although we believe that the threat of both MERS and Ebola globally may reemerge in the future, it appears that the spread of these disorders has diminished.

In April 2021, we entered into an MTA with the University of Cagliari Dipartimento di Scienze della Vita e dell’Ambiente (“UNICA”), an educational institution, under the laws of Italy, located in Monserrato (Cagliari), Italy. The MTA relates to the research and development of the effects of Ampligen and its ability to induce interferon production in several cell lines, and also on the ability of the Ebola virus protein VP35 to bind to viral dsRNA and impede interferon’s upregulation and activity, and on Ampligen’s ability to reverse VP35 inhibition of interferon production in biological systems. The research is active and ongoing.

In May 2021, we filed a U.S. Provisional Patent Application for Ampligen as a potential therapeutic to possibly slow, halt, or reverse the progression of Alzheimer’s disease.

In November 2022, we received notice that the FDA had granted Orphan Drug Designation to Ampligen for the treatment of Ebola virus disease.

Alferon N Injection®

Alferon N Injection is the registered trademark for our injectable formulation of natural alpha interferon. Alferon N Injection is the only natural-source, multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Alferon N Injection is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferons. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”). According to the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million Americans — most in their late teens and early 20s — infected with HPV. In fact, the CDC states that “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives.” Although they do not usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial health care costs.

Interferons are a group of proteins produced and secreted by cells to combat diseases. Researchers have identified four major classes of human interferon: alpha, beta, gamma and omega. Alferon N Injection contains a multi-species form of alpha interferon. The worldwide market for injectable alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products are approved for many major medical uses worldwide. Alpha interferons are manufactured commercially in three ways: by genetic engineering, by cell culture, and from human white blood cells. All three of these types of alpha interferon are or were approved for commercial sale in the United States. Our natural alpha interferon is produced from human white blood cells. The potential advantages of natural alpha interferon over recombinant (i.e., synthetic) interferon produced and marketed by other pharmaceutical firms may be based upon their respective molecular compositions. Natural alpha interferon is composed of a family of proteins containing many molecular species of interferon. In contrast, commercial recombinant alpha interferon products each contain only a single species. Researchers have reported that the various species of interferons may have differing antiviral activity depending upon the type of virus. Natural alpha interferon presents a broad complement of species, which we believe may account for its higher activity in laboratory studies. Natural alpha interferon is also glycosylated (i.e., partially covered with sugar molecules). Such glycosylation is not present on the currently U.S.-marketed recombinant alpha interferons. We believe that the absence of glycosylation may be in part responsible for the production of interferon-neutralizing antibodies seen in patients treated with recombinant alpha interferon. Although cell culture-derived interferon is also composed of multiple glycosylated alpha interferon species, the types and relative quantity of these species are different from our natural alpha interferon.

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Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product. There are essentially no neutralizing antibodies observed against Alferon N Injection to date and the product has a relatively low side-effect profile. The recombinant DNA derived alpha interferon formulations have been reported to have decreased effectiveness after one year of treatment, probably due to neutralizing antibody formation (See “Manufacturing” and “Marketing/Distribution” sections below for more details on the manufacture and marketing/distribution of Alferon N Injection).

MANUFACTURING

ANMAT in Argentina approved Ampligen for commercial distribution for the treatment of CFS in 2016. Shipment of the drug product to Argentina was initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution. In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. We are currently working with GP Pharm on the commercial launch of Ampligen in Argentina (See “Our Products; Ampligen” above).

Following our approval in Argentina, in 2017 we engaged Jubilant HollisterStier (“Jubilant”) to be our authorized CMO for Ampligen. Two lots of Ampligen consisting of more than 16,000 units were manufactured and released in 2018; these lots have been designated for human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials. The production of additional polymer (Ampligen intermediates) took place in 2019 at our New Brunswick facility. Additionally, Jubilant manufactured two more lots of Ampligen in December 2019 and January 2020. The current manufactured lots of Ampligen have been fully tested and released for commercial product launch in Argentina and for clinical trials. In addition, we have supplied GP Pharm with the Ampligen required for testing and ANMAT release. Once final approval by ANMAT is obtained, we anticipate that GP Pharm will begin distributing Ampligen in Argentina.

In December 2020, we added Pii as a “Fill & Finish” provider to enhance our capacity to produce Ampligen. This addition amplifies our manufacturing capability by providing redundancy and cost savings. The contracts augment our existing fill and finish capacity. We are prepared to initiate the production of additional Ampligen when and if needed.

In May 2021, we exercised our option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale and lease-back agreement. We thereafter sold certain equipment and machinery that we determined to be obsolete and no longer needed for current or future manufacturing. On March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc. as purchaser pursuant to which we would sell our property for $3.9 million; we have kept some space specifically for Alferon activity. The sale was completed on November 1, 2022 for $3.7 million net of normal closing cost.

In June 2022 we entered into a lease agreement with the New Jersey Economic Development Authority for a 5,210 square-foot, state-of-the-art R&D facility at the New Jersey Bioscience Center (NJBC), primarily consisting of two separate laboratory suites. The lease commenced on July 1, 2022, and runs through August 31, 2027, but can be extended for an additional five-year period. The facility is AIM’s operations, research and development center.

Our business plan calls for the utilization of one or more CMOs to produce Ampligen API. While we believe we have sufficient Ampligen API to meet our current needs, we are also continually exploring new efficiencies so as to maximize our ability to fulfill future obligations. In this regard, in April 2021, we approved a proposal from Polysciences for the manufacture of our Poly I and Poly C₁₂U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors to the drug Ampligen. We are utilizing Polysciences’s expertise to refine our approach to polymer production. Additionally, we continue to be open to the possibility of agreements with other CMOs, so as to create redundancy and to meet the potential need for larger quantities of API.

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Our second product, Alferon N Injection, is approved by the FDA for commercial sales in the United States for the treatment of genital warts. It is also approved by ANMAT in Argentina for commercial sales for the treatment of genital warts and in patients who are refractory to treatment with recombinant interferons. Commercial sales of Alferon N Injection in the United States will not resume until new batches of commercial filled and finished product are produced and released by the FDA. While our New Brunswick facility has FDA approval under the Biologics License Application (“BLA”) for Alferon N Injection, and we intend to maintain a certain amount of space at the to-be-sold facility, we will need the FDA’s approval to release commercial product once we have identified our new manufacturing approach and submitted satisfactory stability and quality release data; the FDA has conducted any required inspections; and the FDA has approved our new manufacturing process. Currently, we are not manufacturing Alferon N Injection and there is no definitive timetable to resume production.

LICENSING/COLLABORATIONS/JOINT VENTURES

To enable potential availability of Ampligen to patients on a worldwide basis, we have embarked on a strategy to license the product and/or to collaborate and/or create a joint venture with companies that have the demonstrated capabilities and commitment to successfully gain approval and commercialize Ampligen in their respective global territories of the world. Ideal partners would have the following characteristics: well-established global and regional experience and coverage; robust commercial infrastructure; a strong track record of successful development and registration of in-licensed products; and a therapeutic area fit (ME/CFS, immuno-oncology, e.g.).

MARKETING/DISTRIBUTION

In May 2016, we entered into a five-year exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with GP Pharm. Under this Agreement, GP Pharm was responsible for gaining regulatory approval in Argentina for Ampligen to treat severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina. We granted GP Pharm the right to expand rights to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones. We also granted GP Pharm an option to market Alferon N Injection in Argentina and other Latin America countries (See “Our Products; Ampligen” above). The GP Pharm contract was extended in May 2021, and will now end on May 24, 2024. In August 2021, the ANMAT granted a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina. This extends the approval until 2026.

In May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V. (“myTomorrows”), a Netherlands-based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related to ME/CFS. Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing EAP activities. These activities will be directed to (a) the education of physicians and patients regarding the possibility of early access to innovative medical treatments not yet the subject of a Marketing Authorization (regulatory approval) through named-patient use, compassionate use, expanded access and hospital exemption, (b) patient and physician outreach related to a patient-physician platform, (c) the securing of Early Access Approvals (exemptions and/or waivers required by regulatory authorities for medical treatments prior to Marketing Authorization) for the use of such treatments, (d) the distribution and sale of such treatments pursuant to such Early Access Approvals, (e) pharmacovigilance (drug safety) activities and/or (f) the collection of data such as patient-reported outcomes, doctor-reported experiences and registry data. We are supporting these efforts and supplying Ampligen to myTomorrows at a predetermined transfer price. In the event that we receive Marketing Authorization in any country in the Territory, we will pay myTomorrows a royalty on products sold. Pursuant to the Impatients Agreement, the royalty would be a percentage of Net Sales (as defined in the Impatients Agreement) of Ampligen sold in the Territory where Marketing Authorization was obtained. The formula to determine the percentage of Net Sales will be based on the number of patients that are entered into the EAP. We believe that disclosure of the exact maximum royalty rate and royalty termination date could cause competitive harm. However, to assist the public in gauging these terms, the actual maximum royalty rate is somewhere between 2% and 10% and the royalty termination date is somewhere between five and fifteen years from the First Commercial Sale of a product within a specific country. The parties established a Joint Steering Committee comprised of representatives of both parties to oversee the EAP. No assurance can be given that activities under the EAP will result in Marketing Authorization or the sale of substantial amounts of Ampligen in the Territory. The agreement was automatically extended for a period of 12 months on May 20, 2021, and again for an additional 12 months on May 20, 2022.

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In January 2017, the ANMAT granted a five-year extension to a previous approval to sell and distribute Alferon N Injection (under the brand name “Naturaferon”) in Argentina. This extends the approval until 2022. A request to extend the approval beyond 2022 has been filed and is still under review. In February 2013, we received the ANMAT approval for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon, with Naturaferon in Argentina.

In January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen to ME/CFS patients was extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider in the Territory and will manage all EAP activities relating to the pancreatic cancer extension of the program.

In August 2017, we extended our agreement with Asembia LLC, formerly Armada Healthcare, LLC, to undertake the marketing, education and sales of Alferon N Injection throughout the United States. This agreement has expired. We are in discussions with Asembia about the possibility of continuing the relationship, while also exploring the possibility of working with other, similar companies. However, we do not foresee an immediate need for this service and so may push this search further out in our expected timeline.

In February 2018, we signed an amendment to the EAP with myTomorrows. This amendment extended the Territory to cover Canada to treat pancreatic cancer patients, pending government approval. In March 2018, we signed an amendment to the EAP with myTomorrows, pursuant to which myTomorrows will be our exclusive service provider for special access activities in Canada for the supply of Ampligen for the treatment of ME/CFS.

In December 2020, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to 16 pancreatic cancer patients. In November 2021, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to an additional 5 pancreatic cancer patients. In March 2022, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to an additional 10 pancreatic cancer patients.

401(k) Plan

We have a defined contribution plan, entitled the AIM ImmunoTech Employees 401(k) Plan and Trust Agreement (the “401(k) Plan”). Our full-time employees are eligible to participate in the 401(k) Plan following 61 days of employment. Subject to certain limitations imposed by federal tax laws, participants are eligible to contribute up to 15% of their salary (including bonuses and/or commissions) per annum. Participants’ contributions to the 401(k) Plan may be matched by us at a rate determined annually by the Board of Directors.

Each participant immediately vests in his or her deferred salary contributions, while our contributions will vest over one year. A 6% matching contribution by us was reinstated effective January 1, 2021. For the nine months ending September 30, 2022 we made $107,000 in contributions and for the year ending December 31, 2021 $139,000 contributions were made.

New Accounting Pronouncements

See “Note 10: Recent Accounting Pronouncements”.

Disclosure About Off-Balance Sheet Arrangements

None.

Critical Accounting Policies

There have been no material changes in our critical accounting policies and estimates from those disclosed in Part II; Item 7: “Management’s Discussion and Analysis of Financial Condition and Results of Operations; Critical Accounting Policies” contained in our Annual Report on Form 10-K for the year ended December 31, 2021.

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RESULTS OF OPERATIONS

Three months ended September 30, 2022, versus three months ended September 30, 2021

Net Loss

Our net loss was approximately $6,385,000 and $3,826,000 for the three months ended September 30, 2022, and 2021, respectively, representing an increase in loss of approximately $2,559,000 or 67%. This increase in loss was primarily due to the following:

● an increase in loss on investments, net of $365,000;

● an increase in interest and other income of $192,000;

● an increase in general and administrative expenses of $3,370,000; offset by

● an increase in gain from sale of Income tax operating of $256,000;

● a decrease of the quarterly revaluation of certain redeemable warrants of $50,000;

● a decrease in production costs of $157,000;

● a decrease in research and development expenses of $634,000.

Net loss per share was $(0.13) and $(0.08) for the three months ended September 30, 2022, and 2021, respectively. The weighted average number of shares of our common stock outstanding as of September 30, 2022, was 48,079,210 as compared to 47,846,074 as of September 30, 2021.

Revenues

Revenues from our Ampligen® Cost Recovery Program were $21,000 and $33,000 for the three months ended September 30, 2022, and 2021, respectively. The change was due primarily to the timing of orders.

Production Costs

Production costs were approximately $0 and $157,000 respectively, for the three months ended September 30, 2022, and 2021, representing a decrease of $157,000 in production costs in the current period. The decrease was due primarily to the sale of the facility and no production for the quarter ended September 30, 2022.

Research and Development Costs

Overall Research and Development (“R&D”) costs for the three months ended September 30, 2022, were approximately $1,372,000 as compared to $2,006,000 for the same period a year ago, reflecting a decrease of approximately $634,000. The primary reason for the decrease in research and development costs was largely due to the timing and decrease in clinical trials expense of $919,000 net with an increase in salaries and facility costs of $222,000.

General and Administrative Expenses

General and Administrative (“G&A”) expenses for the three months ended September 30, 2022, and 2021, were approximately $5,170,000 and $1,799,000, respectively, reflecting an increase of approximately $3,370,000. The increase in G&A expenses during the current period was mainly due to an increase in legal fees of $3,017,000. Legal fees increased due to litigation detailed in “Part II, Item 1 – Legal Proceedings.”

Loss on Investments, net

Loss on investments for the three months ended September 30, 2022, and 2021 was approximately $365,000 and $0 respectively. This loss for the three months ended September 30, 2022 was due to the change in fair value of equity investments.

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Interest and Other Income

Interest and other income for the three months ended September 30, 2022, and 2021 was approximately $172,000 and $(20,000), respectively. This represents a net increase of approximately $192,000. This is primarily due to the change of investments into higher interest-bearing securities.

Redeemable Warrants

The quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted to a gain of $1,000 for the three months ended September 30, 2022, compared to a gain of approximately $51,000 for the three months ended September 30, 2021 (see “Financial Statements: Note 11: Fair Value” for the various factors considered in the valuation of redeemable warrants).

Gain from sale of income tax operating losses

The quarterly income tax benefit for the three months ended September 30, 2022 amounted to a gain of approximately $328,000 compared to a gain of $72,000 for the three months ended September 30, 2021 due primarily to a change in the deferred tax asset recorded for the New Jersey NOL to be sold.

Nine months ended September 30, 2022 versus nine months ended September 30, 2021

Net Loss

Our net loss was approximately $15,056,000 and $13,281,000 for the nine months ended September 30, 2022, and 2021, respectively, representing an increase in loss of approximately $1,795,000 or 14%. This increase in loss was primarily due to the following:

● an increase in loss on investments, net of $1,769,000;

● an increase of the quarterly revaluation of certain redeemable warrants of $13,000;

● an increase in interest and other income of $196,000;

● an increase in research and development expenses of $134,000;

● an increase in general and administrative expenses of $3,514,000; offset by

● an increase in gain from sale of Income tax operating of $207,000;

● a decrease in interest expense and finance cost of $2,768,000;

● a decrease in production costs of $674,000.

Net loss per share was $(0.31) and $(0.28) for the nine months ended September 30, 2022, and 2021, respectively. The weighted average number of shares of our common stock outstanding as of September 30, 2022, was 48,036,559 as compared to 47,156,158 as of September 30, 2021.

Revenues

Revenues from our Ampligen® Cost Recovery Program were $85,000 for each of the nine months ended September 30, 2022 and 2021, respectively

Production Costs

Production costs were approximately $0 and $674,000, respectively, for the nine months ended September 30, 2022, and 2021, representing a decrease of $674,000 in production costs in the current period. The decrease was due primarily to the sale of the facility and no production for the quarter ended September 30, 2022.

Research and Development Costs

Overall R&D costs for the nine months ended September 30, 2022, were approximately $4,883,000 as compared to $4,749,000 for the same period a year ago, reflecting an increase of approximately $134,000. The primary reason for the increase in research and development costs was largely due to an increase in clinical trials expense of $415,000 net with decreases in Ampligen costs of $393,000 and manufacturing costs of $178,000.

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General and Administrative Expenses

G&A expenses for the nine months ended September 30, 2022, and 2021, were approximately $9,569,000 and $6,055,000, respectively, reflecting an increase of approximately $3,515,000. The increase in G&A expenses during the current period was mainly due to a decrease in stock compensation of $527,000, offset by an increase in legal fees of $3,500,000. Legal fees increased due to litigation detailed in “Part II, Item 1 – Legal Proceedings.”

Loss on Investments, net

Loss on investments for the nine months ended September 30, 2022, and 2021 was approximately $1,769,000 and $0 respectively. This loss for the nine months ended September 30, 2022 was due to the change in fair value of equity investments.

Interest and Other Income

Interest and other income for the nine months ended September 30, 2022, and 2021 was approximately $296,000 and $100,000, respectively. This represents a net increase of approximately $196,000. This is primarily due to the change of investments into higher interest-bearing securities.

Interest Expense and Other Finance Costs

Interest and other finance costs decreased $2,768,000 primarily due to the extinguishment of debt and notes payable of $2,701,000 in the nine months ended September 30, 2021. We had no debt in the nine months ended September 30, 2022.

Redeemable Warrants

The quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted to a gain of $35,000 for the nine months ended September 30, 2022, compared to a gain of approximately $22,000 for the nine months ended September 30, 2021 (see “Financial Statements: Note 11: Fair Value” for the various factors considered in the valuation of redeemable warrants).

Gain from sale of income tax operating losses

The quarterly income tax benefit for the nine months ended September 30, 2022 amounted to a gain of approximately $749,000 compared to a gain of $542,000 for the nine months ended September 30, 2021 due primarily to a change in the deferred tax asset recorded for the New Jersey NOL to be sold.

Liquidity and Capital Resources

Cash used in operating activities for the nine months ended September 30, 2022, was approximately $10,039,000 compared to approximately $8,220,000 for the same period in 2021, representing a change of $1,819,000. The primary reasons for this change in cash used in operations in 2022 was related to non-cash charges which primarily consisted of $792,000 in stock compensation, $1,768,000 of loss on investments, net, and $749,000 of gain from sale of income tax operating losses. The main changes in working capital were an increase in accounts payable, lease liability, prepaid expenses and accrued expense. The increase in accrued expenses was due to litigation detailed in “Part II, Item 1 – Legal Proceedings.”

Cash provided by investing activities for the nine months ended September 30, 2022, was approximately $7,625,000 compared to cash used for the same period in 2021 of approximately $995,000 representing a change of $8,620,000. The primary reason for the change for the periods ended September 30, 2022 and September 30, 2021 is the sale of marketable securities of $9,082,000 and $849,000, respectively, net with the purchase of marketable securities for the same time period of $1,661,000 and $1,611,000, respectively.

Cash provided by financing activities for the nine months ended September 30, 2022, was approximately $80,000 compared to approximately $8,063,000 for the same period in 2021, a decrease of $7,983,000. The primary reason for this decrease was our receipt of $12,917,000 in net proceeds from the sale of shares in the first three months of 2021, offset with a payment for notes payable of $4,732,000 for the same period in 2021.

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As of September 30, 2022, AIM had approximately $41,150,000 in cash, cash equivalents and marketable securities, inclusive of approximately $6,986,000 in Marketable Securities, representing a decrease of approximately $9,063,000 from December 31, 2021.

We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.

The development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market. We believe, based on our current financial condition, that we have adequate funds to meet our anticipated operational cash needs and fund current clinical trials over approximately the next twenty-four months. In addition, in February 2022, the SEC declared our new S-3 shelf Registration Statement effective which will allow us to raise additional capital in the future. At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future. We may need to obtain additional funding in the future for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies. If we are unable to commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and liquidity may be adversely impacted, and additional financing may be required. There can be no assurances that, if needed, we will be able to raise adequate funds or enter into licensing, partnering or other arrangements to advance our business goals. We may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. We are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible into or exercisable for our common stock. Any additional funding may result in significant dilution and could involve the issuance of securities with rights, which are senior to those of existing stockholders. See Part I, Item 1A - “Risk Factors; We may require additional financing which may not be available” in our Annual Report on Form 10-K for the year ended December 31, 2021.

ITEM 3: Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and are not required to provide the information required under this item.

ITEM 4: Controls and Procedures

Our Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”) performed an evaluation of the effectiveness of our disclosure controls and procedures, which have been designed to permit us to effectively identify and timely disclose important information. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on that evaluation, our CEO and CFO concluded that the controls and procedures were effective as of September 30, 2022, to ensure that material information was accumulated and communicated to our management, including our CEO and CFO, is appropriate to allow timely decisions regarding required disclosure.

During the three months ended September 30, 2022, we made no change in our internal controls over financial reporting that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

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Part II – OTHER INFORMATION

ITEM 1: Legal Proceedings

Refer to Note 15 - Subsequent Events, included in Part I, Item 1 of this Form 10-Q, for a description of pending material legal proceedings.

We commenced an action against BioLife in December of 2017 for Breach of Contract. The amount of damages we are seeking in this matter have yet to be determined. Damages are not covered by insurance. BioLife, the defendant, has filed its Answer, Affirmative Defenses and a Counterclaim in the amount of $96,676 representing the invoices withheld after BioLife indicated that they were not intending to fulfill the balance of the contract. We have denied the allegations of the counterclaim. We have conducted two mediation sessions, but have been unable to resolve the matter. The parties are currently engaged in discovery, which we believe will lead to a trial date in the later part of 2022. The scheduled dates for these events to transpire were extended several times as they were dependent on the safe and full reopening of the Courts. Although it cannot be reasonably determined at this time, we believe the likelihood of an unfavorable outcome on the defendant’s counterclaim is remote.

On July 8, 2022, we received a notice from Jonathan Jorgl (the “Jorgl Notice”), an AIM stockholder who first purchased 1,000 AIM shares on June 27, 2022, seeking to nominate a control slate of two individuals for election to the three-member AIM Board of Directors (the “Board”) at the 2022 Annual Meeting of Stockholders. The Board unanimously determined the Jorgl Notice to be invalid due to numerous deficiencies, including failure to comply with the Company’s bylaws. The rejection of the Jorgl Notice was announced on July 18, 2022.

Also on July 18, 2022, we filed a complaint in the U.S. District Court for the Middle District of Florida, Ocala Division, against individuals we believe failed to register as a group pursuant to U.S. securities laws and committed other unlawful actions in the context of their attempt to effectuate a takeover of the Company’s Board. On October 11, 2022, the court dismissed the complaint without prejudice. Permission to file an amended complaint was granted and an amended complaint was filed.

On August 12, 2022, a hearing was held in the Delaware Court of Chancery concerning a motion for a temporary restraining order sought by Jorgl to require the AIM Board of Directors to accept his director nominations and include his nominees on a universal proxy card for the upcoming Annual Meeting of Stockholders. The court denied the motion several days later and scheduled a hearing on Jorgl’s motion for a preliminary injunction to be held on October 5, 2022. Extensive discovery was conducted in advance of the hearing, which was then held as scheduled.

On October 5, 2022, the Delaware Court of Chancery held a hearing regarding a motion to require the AIM Board of Directors to accept the Jorgl Group’s director nominations and include the group’s nominees on a universal proxy card for the 2022 Annual Meeting of Stockholders. On October 28, 2022, the court denied Jorgl’s motion. The Jorgl Group announced on November 2, 2022, that it did not intend to appeal the decision.

On October 28, 2022, the Delaware Court of Chancery denied Jorgl’s motion. The Jorgl Group announced on November 2, 2022, that it did not intend to appeal the decision.

ITEM 1A: Risk Factors

Please carefully consider the factors discussed below and the factors identified in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022, and our subsequent filings with the SEC, that could materially affect our business and financial condition and could cause results to differ materially from those expressed in forward-looking statements contained in this Report or other reports filed with the SEC. The risks described below and in the above reports are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and operating results. Please also see “Special Note Regarding Forward-Looking Statements” above.

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Our business, financial condition and operating results could be negatively affected as a result of actions by activist investors.

An activist stockholder (the “Activist”) submitted a notice to our Board, purporting to nominate two nominees to our three-member Board at the 2022 Annual Meeting of Stockholders. We informed the Activist that our Board determined its purported notice of nomination was invalid, as it did not comply with our Amended and Restated Bylaws. We initiated a lawsuit against the Activist, the Activist’s two nominees, and four additional individuals–all of whom we believe to be acting as a group to attempt to effectuate a takeover of our Board without registering as a group pursuant to U.S. securities laws and some of whom we believe have committed other unlawful actions. The Activist subsequently sued AIM and each of our board members in the Court of Chancery of the State of Delaware, seeking a declaratory judgment that the purported notice of nominations was valid and certain injunctive relief. The Delaware Chancery Court denied the Activist’s motion on October 28, 2022, and the Activist announced on November 2, 2022, that it did not intend to appeal the decision. Had the Activist prevailed in its lawsuit, we most likely would have been involved in a proxy contest for control of our Board, despite the deficiencies in the Activist’s purported notice of nominations. Even though we prevailed in the Delaware litigation, the litigation and the campaign by the Activist and those with whom the Activist is acting in concert against us has, and will have, likely diverted the time and energies of management and required us to incur substantial expense, possibly causing a decrease in stockholder value.

A proxy contest and related litigation, along the lines discussed above, could have a material adverse effect on us for the following reasons:

● Activist investors may attempt to effect changes in our governance and strategic direction or to acquire control over the Board or AIM. In particular, if the Activist is successful in its litigation and subsequent proxy contest, it may gain control of the Board.

● While we welcome the opinions of all stockholders, responding to proxy contests and related litigation by activist investors is likely to be costly and time-consuming, disrupt our operations, and potentially divert the attention of our Board, management team and other employees away from their regular duties and the pursuit of business opportunities to enhance stockholder value.

● Perceived uncertainties as to our future direction as a result of potential changes to the composition of the Board may lead to the perception of a change in the strategic direction of the business, instability or lack of continuity, which may cause concern to our existing or potential strategic partners, customers, employees and stockholders; may be exploited by our competitors; may result in the loss of potential business opportunities or limit our ability to timely initiate or advance clinical trials; and may make it more difficult to attract and retain qualified personnel and business partners.

 ● Proxy contests and related litigation by activist investors could cause significant fluctuations in our stock price based on temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business.

ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds

None

ITEM 3: Defaults upon Senior Securities

None.

ITEM 4: Mine Safety Disclosures

Not Applicable.

ITEM 5: Other Information

On November 9, 2022, we executed a short amendment to our November 14, 2017 Rights Plan with American Stock Transfer & Trust Company as Rights Agent (the “Rights Plan”), extending the termination date by three months. Our Board determined that it is advisable and in the best interests of the Company and its stockholders to amend the Rights Plan to extend the Final Expiration Date by three months (such that the Final Expiration Date shall be the close of business on February 14, 2023), during which time the Board will evaluate whether and for what duration and on what terms to further extend the Rights Plan.

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ITEM 6: Exhibits

(i) Exhibits - See exhibit index below.

Exhibit No.	Description
4.1	Amendment to the November 14, 2017 Second Amended and Restated Rights Agreement as of November 9, 2022, by and between AIM ImmunoTech Inc. (f/k/a Hemispherx Biopharma, Inc.) and American Stock Transfer & Trust Company, LLC. *
10.1	June 27, 2022 First Amendment to Agreement of Sale and Purchase with Acellories, Inc. (incorporated by reference to exhibit 10.86 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended June 30, 2022).
10.2	August 2, 2022 Second Amendment to Agreement of Sale and Purchase with Acellories, Inc.(incorporated by reference to exhibit 10.87 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended June 30, 2022).
10.3	August 10, 2022 Termination agreement with Shenzhen Smoore Technology Limited (incorporated by reference to exhibit 10.88 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended June 30, 2022).
10.4	October 5, 2022 Lease extension for Riverton office *
10.5	October 11, 2022 Material Transfer and Research Agreement with University of Pittsburgh (portions of this agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) *

10.6	October 21, 2022 Material Transfer and Research Agreement with University of Pittsburgh (portions of this agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) *
10.7	October 21, 2022 Fourth Amendment to Agreement of Sale and Purchase with Acellories, Inc *
31.1	Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer. *
31.2	Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer. *
32.1	Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer. *
32.2	Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer. *
101.INS * **	Inline XBRL Instance Document
101.SCH * **	Inline XBRL Taxonomy Schema
101.CAL * **	Inline XBRL Taxonomy Calculation Linkbase
101.DEF * **	Inline XBRL Taxonomy Definition Linkbase
101.LAB * **	Inline XBRL Taxonomy Label Linkbase
101.PRE * **	Inline XBRL Taxonomy Presentation Linkbase
104	Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit)

* Filed herewith.

** Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities and Exchange Act of 1934, as amended and otherwise are not subject to liability under those sections.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	AIM IMMUNOTECH INC.
	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer & President
	/s/ Robert Dickey IV
	Robert Dickey IV
	Chief Financial Officer
Date: November 14, 2022

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EX-4.1

Exhibit 4.1

AMENDMENT

TO THE

SECOND AMENDED AND RESTATED RIGHTS AGREEMENT

OF

AIM IMMUNOTECH INC.

This Amendment to the Second Amended and Restated Rights Agreement (this “Amendment”) is made this 9^th day of November, 2022, by and between AIM ImmunoTech Inc., f/k/a Hemispherx Biopharma, Inc., a Delaware corporation (the “Company’), and American Stock Transfer & Trust Company, LLC, a New York limited liability trust company (the “Rights Agent”).

WHEREAS, on November 19, 2002, the Company entered into the original Rights Agreement (the “Original Agreement”) with Continental Stock Transfer & Trust Company (“CST”) as the rights agent;

WHEREAS, the Company and CST amended and restated the Original Agreement on November 2, 2012 (the “2012 Agreement”);

WHEREAS, on April 26, 2017, the Company terminated CST as the rights agent under the Amended Agreement and appointed AST as the Rights Agent and AST accepted the appointment;

WHEREAS, the Company and the Rights Agent further amended and restated the 2012 Agreement on November 14, 2017 (as so amended and restated, the “Rights Agreement”);

WHEREAS, the Board of Directors of the Company (the “Board”) has determined that it is advisable and in the best interests of the Company and its stockholders to amend the Rights Agreement in accordance with Section 27 thereof; and

WHEREAS, pursuant to its authority under Section 27 of the Rights Agreement, the Board has approved, and directed that the Rights Agent approve, this Amendment.

NOW, THEREFORE, in consideration of the premises and mutual covenants contained in this Amendment, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Rights Agent hereby agree as follows:

1. Definitions. Capitalized terms used but not defined in this Amendment shall have the meanings given to them in the Rights Agreement.

2. Amendment. Section 7(a) of the Rights Agreement is hereby amended and restated in its entirety to read as follows:

(a) Subject to Section 7(e) hereof, at any time after the Distribution Date the registered holder of any Rights Certificate may exercise the Rights evidenced thereby (except as otherwise provided herein, including, without limitation, the restrictions on exercisability set forth in Section 9(c), Section 11(a)(iii) and Section 23(a) hereof) in whole or in part upon surrender of the Rights Certificate, with the form of election to purchase and the certificate on the reverse side thereof duly executed, to the Rights Agent at the principal office or offices of the Rights Agent designated for such purpose, together with payment of the aggregate Purchase Price with respect to the total number of one one-hundredths of a share (or other securities, cash or other assets, as the case may be) as to which such surrendered Rights are then exercisable, at or prior to the earlier of (i) 5:00 P.M., New York City time, on February 14, 2023 (or such later date as may be established by the Board of Directors prior to the expiration of the Rights) (such date the “Final Expiration Date”), or (ii) the time at which the Rights are redeemed or exchanged as provided in Section 23 and Section 24 hereof (the earlier of (i) and (ii) being herein referred to as the “Expiration Date”).

3. Other Terms. Except as set forth in this Amendment, (i) all provisions of the Rights Agreement shall remain unmodified and in full force and effect and (ii) nothing contained in this Amendment shall amend, modify or otherwise affect the Rights Agreement or any party’s rights or obligations contained therein.

4. Counterparts. This Amendment may be executed in any one or more counterparts, each of which shall be deemed an original and all of which shall together constitute the same instrument.

[Signature page follows.]

IN WITNESS WHEREOF, the parties have executed and delivered this Amendment as of the date first above written.

AIM IMMUNOTECH INC.
By:	/s/ Thomas K. Equels
Name:	Thomas K. Equels
Title:	Chief Executive Officer
American Stock Transfer & Trust Company, LLC
By:	/s/ Joseph Dooley
Name:	Joseph Dooley
Title:	Senior Vice President

EX-10.4

Exhibit 10.4

AIM ImmunoTech Inc

604 Main Street

Riverton, NJ 08077

DATE: October 3, 2022

604 Associates LLC

701 Bank Avenue

Riverton, NJ 08077

Attn: Lawrence R Antonucci

Re: Lease Renewal

Dear Larry,

This letter is in response to your email dated September 30, 2022. We accept the $350 increase in base rent and would like to renew the lease on the property at the above address for another one-year (12 month) term as defined in Section 1(b) of the current lease Our current lease extension expires on April 30, 2023. As of May 1, 2023 through April 30, 2024 our monthly rent will be $2,850.

If you agree, please sign below.

Sincerely,

/s/Peter W Rodino

Peter W. Rodino, III

COO & General Counsel

/s/Lawrence R. Antonucci 10/5/2022

Lawrence R. Antonucci

Corporate Headquarters
2117 SW Highway 484, Ocala FL 34473		t: 352-448-7797	f: 352-480-4620
Human Resources and Administration
604 Main Street, Riverton NJ 08077		t: 352-448-7797	f: 352-480-4620
Operations, Research and Development
671A US-1 South, North Brunswick, NJ 08902	www.aimimmuno.com	t: 732-249-3250	f: 732-249-6895

EX-10.5

Exhibit 10.5

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

MATERIAL TRANSFER AND RESEARCH AGREEMENT

This Agreement is made as of the date of last signature (“Effective Date”) by and between AIM ImmunoTech Inc. (“AIM”), a corporation incorporated under the laws of Delaware, and UNIVERSITY OF PITTSBURGH – Of the Commonwealth System of Higher Education (“University”), having an Office of Sponsored Programs at [***] on behalf of Dr. Robert Edwards, an employee of University. AIM and University shall be referred to individually as a “party” and together as the “parties.”

WHEREAS, University wishes to receive Confidential Information pertaining to AIM’s inventions and knowhow and also receive Ampligen^®, solely for purposes of conducting the clinical trial in Exhibit A, and

WHEREAS, AIM is willing to provide Confidential Information and Ampligen^®, at AIM’s expense, to University solely for purposes of conducting scientific research on the following terms and conditions,

NOW THEREFORE, in consideration of the premises and the mutual agreements and undertakings herein set forth, University and AIM hereby agree as follows:

1. DEFINITIONS. Whenever used in this Agreement, the following terms will have the following meanings:

1.1

“Confidential Information” means any confidential or proprietary information, knowledge, intellectual property, pre-clinical and clinical information or data, technical and/or non-technical material or property, relating to RNA pharmaceutical products and technologies, including but not limited to double-stranded RNA compounds and in particular the double-stranded RNA compound trademarked Ampligen® provided under this Agreement. A party disclosing Confidential Information shall be a “disclosing party” and a party receiving same shall be a “receiving party.”

1.2

“Clinical Study” shall mean the clinical study described in Exhibit A to be conducted by University utilizing Confidential Information and Ampligen®, work which is being funded by the National Institutes of Health.

2. PROVIDING OF MATERIAL, CONFIDENTIAL INFORMATION, AND PERFORMANCE OF THE CLINICAL STUDY.

2.1

AIM shall provide to University such Ampligen® as may be reasonably requested by University for purposes of the Clinical Study, and shall be used by University solely for the purpose of conducting the Clinical Study. AIM represents to University that it shall provide Ampligen® that has been manufactured, packaged and labeled according to all applicable laws and FDA standards. AIM is not obligated to provide any additional Ampligen® if the Clinical Study is modified without AIM’s consent to require additional Ampligen®. University shall not transfer the Ampligen® to any third party without written approval from AIM. Any unused Ampligen® left at the end of this Study or at the termination of this agreement is to be returned to AIM at University’s expense or if requested by AIM, be destroyed with documentation to be provided to AIM.

2.2

In no event shall University use Ampligen® to attempt to (i) reverse engineer or determine in any way the chemical or biological structure of Ampligen®; (ii) determine the size distribution, size, sequence, structure (including the primary structure, the secondary structure or the tertiary structure) of Ampligen®; or (iii) conduct research on Ampligen® which is not directly related to the clinical trial in Exhibit A.

1

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

2.3	The Parties acknowledge that the Ampligen® is being provided “as is,” without any warranties or representations of any sort, express or implied, including without limitation warranties of merchantability and fitness for a particular use. AIM makes no representation and provides no warranty that the use of the Ampligen® in the Study will not infringe any patent or other proprietary right of third parties.
2.4	The parties shall provide to each other such Confidential Information as is necessary for purposes of the Clinical Study.
2.5	The parties will utilize the Confidential Information exchanged solely for the purposes of conducting the Clinical Study.
2.6	University will promptly and diligently pursue the Clinical Study in a scientific manner, documenting in reproducible form the work performed and results achieved in pursuing the Clinical Study.

3. INTELLECTUAL PROPERTY.

3.1	All information or material and intellectual property rights relating thereto, including at least patents, patent applications, provisional patent applications, trademarks, trademark applications, and trade secrets owned by or licensed to a Party prior to the effective date of this Agreement or developed or obtained independently from this Study (“Background”) shall be and remain the sole property of that Party. AIM’s Background includes, at least, specific knowledge about and all rights related to Ampligen® that do not arise from this clinical trial in Exhibit A. AIM’s Background shall remain the sole property of AIM. Nothing in this Agreement shall be deemed to constitute or imply the granting of any license, immunity or other right under the Background of one Party to the other Party provided. However, AIM grants to University a free, non-exclusive, license under the Background of AIM for the sole purpose to execute the clinical trial in Exhibit A until the earlier of: (a) completion of the clinical trial; or (b) termination in accordance with Article 6.1 of this Agreement.
3.2	Ownership of and title to all trademarks, patents and other intellectual property rights in all inventions, discoveries, and other intellectual property (all herein “Intellectual Property”) which are made, conceived, or conceived and reduced to practice, or generated in the performance of the Clinical Study under this Agreement shall follow inventorship under U.S. patent law. Inventions made solely by University shall be owned solely by the University. Inventions made solely by AIM shall be owned solely by AIM. Inventions made using Ampligen® in this Clinical Trial shall be owned jointly.
3.3	University hereby grants to AIM a non-exclusive, fully paid up right to use University inventions that rely on or incorporate AMPLIGEN® or that, if patented, would infringe any patent claims held by AIM (“AIM Inventions”) for internal research purposes. Additionally, the University shall grant a time-limited right for a period of ninety (90) days from the data the invention is disclosed to AIM to negotiate a commercial, royalty-bearing license to AIM Inventions under terms to be negotiated in good faith.

4. CONFIDENTIALITY.

4.1 The parties will employ the same degree of care to keep all Confidential Information confidential as they employ with respect to their own information of like importance, which shall not constitute less than a reasonable standard of care, and will not use any Confidential Information except for the express purposes of this Agreement and will not disclose any Confidential Information received from the other party to any third party, except to consultants (employees are not third parties as this is a University agreement) who are entitled to know such Confidential Information for the purposes of carrying out the object of this Agreement, and who are obligated to abide by all of the provisions of this Agreement. Nothing in this paragraph shall prevent a disclosing party from disclosing or using its own Confidential Information as it wishes.

2

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

4.2

All Confidential Information shall remain the property of the disclosing party. Upon the written request of a disclosing party or upon termination or expiration of this Agreement, all tangible Confidential Information received from the disclosing party (including all copies thereof and samples) shall be promptly returned to the disclosing party; provided that the receiving party may retain one (1) copy of such tangible Confidential Information in a secure location for purposes of identifying its obligations under this Agreement.

4.3

The obligations of confidentiality and non-use set forth in this Article 4 of this Agreement shall not apply to any portion of the Confidential Information that:

(a)	is or becomes public or available to the general public without being wrongfully obtained or through breach of Agreement or is developed independently of Confidential Information received from the disclosing party; or
(b)	was known to and evidenced by the receiving party’s written records prepared prior to the date of this Agreement; or
(c)	is properly obtained by the receiving party from a third party with a valid legal right to disclose such Confidential Information and such third party is not under a confidentiality obligation to the disclosing party; or
(d)	is released by the disclosing party to a third party without restriction.

4.4	In the event that a receiving party is requested or required (by deposition, interrogatories, request for information or documents in legal proceedings, subpoena, civil investigative demand or other similar process) to disclose any of the Confidential Information, the receiving party shall provide the disclosing party with prompt written notice of any such request or requirement so the disclosing party may seek a protective order or other appropriate remedy and/or waive compliance with the provisions of this Confidentiality Agreement. If, in the absence of a protective order or other remedy or the receipt of a signed written waiver, the receiving party or its representatives are nonetheless, in the written opinion of their counsel, legally compelled to disclose Confidential Information to any governmental or regulatory body or else stand liable for contempt or suffer such other censure or penalty, receiving party may, without liability hereunder, disclose to such body only that portion of the Confidential Information which such counsel advises the receiving party is legally required to be disclosed, provided that the receiving party exercised efforts to allow the disclosing party to use its reasonable efforts to preserve the confidentiality of the Confidential Information.
4.5	Nothing in this Agreement shall be construed as giving a receiving party any right, title, interest in or ownership of the Confidential Information.
4.6	The provisions of this Article 4 shall survive any termination or expiry of this Agreement for a period of five (5) years.

3

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

5. DISCLOSURE TO AIM.

5.1 University shall, on a semi-annual basis provide information in writing to AIM regarding the progress, status and safety and efficacy results of the Clinical Study. University shall provide copies of all reported Safety Reports and Serious Adverse Events (SAE) Reports at time of reporting or submission to the FDA and IRB at time of submission to FDA and IRB. Such results are provided without warranty of any type and University shall not be liable to AIM in any way for use of such results. If requested by AIM, University Principal Investigator will confirm within a reasonable period of time any oral progress reports with follow-up summary written reports. University Principal Investigator will provide AIM with a final written report within 6 months after the conclusion of the clinical trial listed in Exhibit A describing the methods used and results obtained together with any other pertinent findings from the Project.

6. TERMINATION.

6.1 This Agreement shall terminate upon the earlier of (a) the completion of the Clinical Study, or (b) the written agreement signed by authorized representatives of the parties.

7. INDEMNIFICATION

7.1 AIM agrees to indemnify, defend and hold harmless the University, its trustees, officers, employees and agents, for all liability relating to any expense, claim, loss, damage or cost (including attorneys’ fees) arising out of or in any way connected with the use of the Clinical Study’s research data or results that arises from the use of AMPLIGEN^®.

8. MISCELLANEOUS.

8.1 Notices. All notices required or permitted to be given under this Agreement will be given in writing and will be effective when either personally delivered (including delivery by Fedex or other courier), or when sent by facsimile, addressed as follows:

To University:	Office of Sponsored Programs
	[***]
	Attn: Clinical and Corporate
To AIM:	AIM ImmunoTech Inc.
	2117 SW Highway 484
	Ocala, Florida 34473
	Attn: David Strayer, MD

Or such other address as either party may hereinafter specify by written notice to the other under this Section 8.1. Such notices and communications will be deemed effective on the date of personal delivery or upon confirmed answer back by facsimile.

8.2

Entire Agreement; Amendment and Waivers. This Agreement is the entire agreement between University and AIM with respect to the specific subject matter hereof. This Agreement may not be modified, amended or terminated, nor may any term hereof be waived, except by an instrument in writing, signed by authorized representatives of both University and AIM.

8.3

Severability; Enforcement. If any provision of this Agreement, or the application thereof to any person, place, or circumstance, is held by a court of competent jurisdiction to be invalid, unenforceable, or void, as written, in whole or in part, such provision will be deemed to be amended to the extent necessary to be enforceable and applied by such court in the broadest possible manner, consistent with enforceability, and the remainder of this Agreement and such provisions as applied to other persons, places, and circumstances will remain in full force and effect.

4

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

8.4	Assignment; Binding Effect. This Agreement may not be assigned, nor may any of the rights or obligations be delegated, without the prior approval of both parties.
8.5	Remedies. The parties agree that in the event of any breach or threatened breach of any of the covenants herein, the damage or imminent damage to the value and the goodwill of a party may be irreparable and extremely difficult to estimate, making any remedy extremely difficult to estimate, and/or making any remedy at law or in damages inadequate. Accordingly, the parties agree that they will be entitled to seek injunctive relief against the other party in the event of any breach of any such terms of this Agreement, in addition to any other relief (including damages) available under this Agreement or under law.
8.6	Governing Law. The validity, interpretation, enforceability, and performance of this Agreement will be governed by and construed in accordance with the laws of Florida, U.S.A. without regard to the application of conflict laws.

IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date.

AIM IMMUNOTECH, INC.		UNIVERSITY
By:	/s/ Peter W. Rodino	By:	/s/Shane Riley
	Peter W. Rodino, III:		Shane Riley
	COO and General Counsel		Associate Director, Office of Sponsored Programs
Date:	10/11/2022	Date:	10/7/2022

5

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Exhibit A

[***]

1

EX-10.6

Exhibit 10.6

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

MATERIAL TRANSFER AGREEMENT

THIS MATERIAL TRANSFER AGREEMENT (the “Agreement”) is made and entered into as of October 21, 2022 (the “Effective Date”), by and between the University of Pittsburgh – Of the Commonwealth System of Higher Education, a non-profit Pennsylvania corporation, having an office at [***] (“RECIPIENT”) and AIM ImmunoTech Inc., having an address at 2117 SW Highway 484, Ocala, FL 34473 (the “PROVIDER”).

In response to the RECIPIENT’s request for the transfer of Ampligen® (“Materials”), PROVIDER is willing to provide such Materials, subject to the following terms and conditions:

1.	Upon request for a specific quantity of Materials by RECIPIENT, such Materials shall be provided by PROVIDER to RECIPIENT, subject to availability of such Materials. The availability of such Materials shall be determined solely by PROVIDER.
2.	The Materials, and all unmodified derivatives or progeny of the Materials, remain the property of the PROVIDER. The Materials shall be used by RECIPIENT solely for pre-clinical research (Research Project) evaluating the effects of Ampligen on innate immune responses in the skin and in non-melanoma skin cancers as described in Exhibit A. The Materials, and any unmodified derivatives of the Materials, shall not be used: (a) in any product, (b) for the purpose of producing any product, or (c) for providing any service in which a product or service is sold or otherwise made commercially available. No other right or license, patent or otherwise, is granted to RECIPIENT for the use of the Materials as a result of PROVIDER’s transmission of them to RECIPIENT.
3.	The Materials shall not be sold, distributed or otherwise made available to any other party for any other purpose.
4.	The Materials shall be used with prudence and appropriate caution in any experimental work since not all of their characteristics are known. THEY ARE PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. PROVIDER MAKES NO WARRANTY OR CLAIM THAT THE MATERIALS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER PROPRIETARY RIGHTS. Except to the extent prohibited by law, RECIPIENT agrees to release the PROVIDER, its trustees, appointees, employees and agents from any liability in connection with use of the Materials by RECIPIENT. Except to the extent prohibited by law, RECIPIENT shall be liable for its acquisition, use, storage or disposal of the Materials by RECIPIENT.
5.	The Materials will be used in compliance with all applicable statutes and regulations, including NIH guidelines on the use of animals or recombinant DNA. The Materials [***].
6.	The parties shall provide to each other such Confidential Information as is reasonably necessary for purposes of the Research Project (Exhibit A).

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

7.	The parties will utilize the Confidential Information exchanged solely for the purposes of conducting the Research Project (Exhibit A).
8.	Pre-existing Property. RECIPIENT understands and acknowledges that Ampligen® (rintatolimod) is the property of PROVIDER and/or that it may be subject to certain intellectual property rights owned by or licensed to PROVIDER. All rights to Ampligen® (rintatolimod) belong to PROVIDER. This Agreement shall not be deemed or construed to convey, transfer, or license any of such intellectual property rights to RECIPIENT, other than the limited rights necessary to permit RECIPIENT to conduct the Research Project during the term of this Agreement. Further, all intellectual property belonging to either party prior to the execution of this Agreement (“Pre-existing Property) shall remain the separate property of that party and nothing contained in this Agreement shall be deemed to grant either directly or by implication, estoppel or otherwise any license under any patents, patent applications or other proprietary interests to Pre-existing Property of the other party.
9.	New Inventions. Ownership and rights to any new and patentable or unpatentable discovery, technology, know-how or other intellectual property arising from the performance of the Research Project (hereinafter “Inventions”) shall be governed by the following provisions: Other Inventions made solely by the Principal Investigator or employees of RECIPIENT shall be the property of RECIPIENT (hereinafter “RECIPIENT Inventions”); Other Inventions made jointly by employees or agents of PROVIDER and RECIPIENT shall be the joint property of PROVIDER and RECIPIENT (hereinafter “Joint Inventions”). Inventorship of Inventions conceived or reduced to practice in the course of performing the Research Project shall be determined by the application of U.S. patent laws.
10	This Agreement shall terminate upon completion of the Research Project or five (5) years from the Effective Date of this Agreement, whichever occurs first, unless terminated or extended through prior written agreement signed by authorized representatives of the parties. Either party may terminate this Agreement prior to the expiration of the designated term by giving sixty (60) days written notice to the other. The obligations of RECIPIENT hereunder shall survive termination. Upon termination, the Materials shall be either returned to PROVIDER or destroyed at the request of the PROVIDER.
11.	No Party will be liable to the other for any failure or delay in the performance of its obligations to the extent such failure or delay is caused by fire, flood, earthquakes, other elements of nature, acts of war, terrorism, riots, civil disorders, rebellions or revolutions, disease, epidemics, quarantines, pandemics, acts of government, a state of emergency, delays in visas, changes in laws and governmental policies, or other conditions beyond its reasonable control following execution of this Agreement. If the performance by either party of any of its obligations under this Agreement (including making a payment) is prevented by any such circumstances, then such party shall communicate the situation to the other as soon as possible, and the parties shall endeavor to limit the impact to the project. Nothing herein shall limit the rights of either party to terminate this Agreement.
12.	RESERVED

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

13.	[***].
14.	Notwithstanding anything to the contrary, this Agreement shall not be interpreted to prevent or delay publication of the Research Project results. RECIPIENT agrees to notify PROVIDER within a reasonable period, not less than thirty (30) days, prior to the submission for publication of the Research Project results or other disclosure of the results. PROVIDER is entitled to review such proposed publication or disclosure. RECIPIENT agrees to delete from any such proposed publication or disclosure any Confidential Information disclosed by PROVIDER to RECIPIENT, upon the reasonable request of PROVIDER. PROVIDER may request the reasonable delay of any such proposed publication or disclosure for an additional thirty (30) day period in order to file or have filed any patent applications on any inventions disclosed therein. RECIPIENT agrees to provide appropriate acknowledgement of the source of the material received under this Agreement in all publications.
15.	Governing Law. (a) The validity, interpretation, enforceability, and performance of this Agreement will be governed by and construed in accordance with the laws of Pennsylvania without regard to the application of conflict laws.
(b)	Any legal action or proceeding with respect to this Agreement may be brought in the courts of Pennsylvania, and by execution and delivery of this Agreement, the parties agree to the jurisdiction of those courts.

UNIVERSITY OF PITTSBURGH – OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
By	/s/ Heide J. Eash	Date: October 21, 2022
Name:	Heide J. Eash
Title:	Associate Director of Fed. Contracts
PROVIDER
By	/s/ Peter W. Rodino	Date: October 24, 2022
	Authorized Individual for the Provider
	Printed Name: Peter W. Rodino, III
Title:	Chief Operating Officer

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Exhibit A

Delivery of Ampligen [***]

[***]

EX-10.7

Exhibit 10.7

FOURTH AMENDMENT TO AGREEMENT OF SALE AND PURCHASE

THIS FOURTH AMENDMENT TO AGREEMENT OF SALE AND PURCHASE (this “Fourth Amendment”) is made as of October 21, 2022, by and between AIM IMMUNOTECH INC., a Delaware corporation (“Seller”), ACELLORIES, INC., a New York corporation (“Original Buyer”), and BH 783 JERSEY AVE, LLC, a New Jersey limited liability company (“New Buyer”).

WHEREAS, Seller and Original Buyer have executed that certain Agreement of Sale and Purchase dated March 3, 2022, as amended by a First Amendment to Agreement of Sale and Purchase dated June 27, 2022, a Second Amendment to Agreement of Sale and Purchase dated August 2, 2022 and a Third Amendment to Agreement of Sale and Purchase dated August 31, 2022 (collectively, the “Purchase Agreement”) for the purchase of certain Property, as defined in the Purchase Agreement, situate in the City of Brunswick, Middlesex County, New Jersey and commonly known as 783 Jersey Avenue (“Property”); and

WHEREAS, Seller, Original Buyer and New Buyer now desire to make certain amendments to the Purchase Agreement, upon and subject to the terms and conditions of this Fourth Amendment.

NOW THEREFORE, the parties hereto, in consideration of the mutual promises hereinafter set forth, and intending to be legally bound, hereby agree as follows:

1. New Buyer is hereby substituted for Original Buyer under the Purchase Agreement in all respects, and all references to “Buyer” in the Purchase Agreement shall mean and refer to New Buyer.

2. New Buyer acknowledges and reaffirms that it is purchasing the Property on a strictly “AS IS” basis as set forth in Section 11 of the Purchase Agreement.

3. All capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Purchase Agreement. This Fourth Amendment may be signed in counterpart(s). For purposes of this Fourth Amendment, facsimile or electronic signatures shall constitute original signatures. The transmission of a signed counterpart of this Fourth Amendment by electronic signature, facsimile or by portable document file shall have the same force and effect as delivery of an original signed counterpart of this Fourth Amendment, and shall constitute valid and effective delivery for all purposes. Except as expressly modified hereby, and in all respects, the remainder of the Purchase Agreement is hereby ratified and shall continue in full force and effect without modification.

[Signatures on Following Page]

IN WITNESS WHEREOF, the parties hereto have caused this Fourth Amendment to be duly executed as of the day and year first above written.

Seller:
AIM IMMUNOTECH INC.
By:	/s/ Peter W. Rodino
Name:	Peter W. Rodino
Title:	C.O.O.
Original Buyer:
ACELLORIES, INC.
By:	/s/ Albert Lalou
Name:	Albert Lalou
Title:	V.P.
New Buyer:
BH 783 JERSEY AVE, LLC
By:	/s/ Albert Lalou
Name:	Albert Lalou
Title:	Managing Member

-2-

EX-31.1

EXHIBIT 31.1

CERTIFICATIONS PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002

I, Thomas K. Equels, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of AIM ImmunoTech Inc. (the “Registrant”);
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4.	The Registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

a.	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.	Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.	Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

5. The Registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

a.	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
b.	Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

Date: November 14, 2022
	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer & President

EX-31.2

EXHIBIT 31.2

CERTIFICATIONS PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002

I, Robert Dickey IV, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of AIM ImmunoTech Inc. (the “Registrant”);
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4.	The Registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

a.	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.	Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.	Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

5. The Registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

a.	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
b.	Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

Date: November 14, 2022
	/s/ Robert Dickey IV
	Robert Dickey IV
	Chief Financial Officer

EX-32.1

EXHIBIT 32.1

CERTIFICATION PURSUANT TO

SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of AIM ImmunoTech Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended September 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Thomas K. Equels, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:

(1)	The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

Date: November 14, 2022
	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer & President

EX-32.2

EXHIBIT 32.2

CERTIFICATION PURSUANT TO

SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of AIM ImmunoTech Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended September 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Robert Dickey IV, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:

(1)	The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

Date: November 14, 2022
	/s/ Robert Dickey IV
	Robert Dickey IV
	Chief Financial Officer

XML

Cover - shares	9 Months Ended
	Sep. 30, 2022	Nov. 09, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2022
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2022
Current Fiscal Year End Date	--12-31
Entity File Number	001-27072
Entity Registrant Name	AIM IMMUNOTECH INC.
Entity Central Index Key	0000946644
Entity Tax Identification Number	52-0845822
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	2117 SW Highway 484
Entity Address, City or Town	Ocala
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34473
City Area Code	(352)
Local Phone Number	448-7797
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	AIM
Security Exchange Name	NYSE
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		48,082,275

XML

Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 29,759	$ 32,093
Marketable securities	6,986	16,175
Funds receivable from New Jersey net operating loss		1,641
Prepaid expenses and other current assets	805	304
Assets held for sale	3,600
Total current assets	41,150	50,213
Property and equipment, net	118	4,047
Right of use asset, net	866	149
Patent and trademark rights, net	2,013	1,974
Other assets	2,138	1,316
Total assets	46,285	57,699
Current liabilities:
Accounts payable	957	198
Accrued expenses	1,767	438
Current portion of operating lease liability	171	37
Total current liabilities	2,895	673
Long-term liabilities:
Operating lease liability	695	112
Redeemable warrants		35
Commitments and contingencies (Notes 12, 13, and 14)
Stockholders’ equity:
Series B Convertible Preferred Stock, stated value $1,000 per share, 713 and 715 issued and outstanding, respectively	713	715
Common Stock, par value $0.001 per share, authorized 350,000,000 shares: 48,082,275, and 47,994,672, issued and outstanding, respectively	48	48
Additional paid-in capital	418,091	417,217
Accumulated deficit	(376,157)	(361,101)
Total stockholders’ equity	42,695	56,879
Total liabilities and stockholders’ equity	$ 46,285	$ 57,699

XML

Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Preferred stock, par value	$ 0.01
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	350,000,000	350,000,000
Common stock, shares issued	48,082,275	47,994,672
Common stock, shares outstanding	48,082,275	47,994,672
Series B Convertible Preferred Stock [Member]
Preferred stock, par value	$ 1,000	$ 1,000
Preferred stock, shares, issued	713	715
Preferred stock, shares, outstanding	713	715

XML

Consolidated Statement of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenues:
Clinical treatment programs - US	$ 21	$ 33	$ 85	$ 85
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	AIM:ClinicalTreatmentProgramsUSMember	AIM:ClinicalTreatmentProgramsUSMember	AIM:ClinicalTreatmentProgramsUSMember	AIM:ClinicalTreatmentProgramsUSMember
Costs and Expenses:
Production costs		$ 157		$ 674
Research and development	1,372	2,006	4,883	4,749
General and administrative	5,170	1,799	9,569	6,055
Total Costs and Expenses	6,542	3,962	14,452	11,478
Operating loss	(6,521)	(3,929)	(14,367)	(11,393)
Loss on investments	(365)		(1,769)
Interest and other income, net	172	(20)	296	100
Interest expense and other finance costs				(67)
Extinguishment of financing obligation and note payable				(2,701)
Gain on sale of fixed assets				216
Redeemable warrants valuation adjustment	1	51	35	22
Gain from sale of income tax operating losses	328	72	749	542
Net Loss	(6,385)	(3,826)	(15,056)	(13,281)
Other comprehensive (loss), net of tax
Reclassification adjustment for realized investment loss		101		126
Change in unrealized loss on marketable securities available for sale		(104)		(329)
Comprehensive loss	$ (6,385)	$ (3,829)	$ (15,056)	$ (13,484)
Basic and diluted loss per share	$ (0.13)	$ (0.08)	$ (0.31)	$ (0.28)
Weighted average shares outstanding basic and diluted	48,079,210	47,846,074	48,036,559	47,156,158

XML

Consolidated Statement of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands	Preferred Stock [Member] Series B Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	AOCI Attributable to Parent [Member]	Retained Earnings [Member]	Total
Beginning balance, value at Dec. 31, 2020	$ 732	$ 42	$ 402,541	$ (47)	$ (341,974)	$ 61,294
Beginning balance, shares at Dec. 31, 2020		42,154,371
Equity-based compensation			526			526
Net Comprehensive loss				(163)	(3,579)	(3,742)
Common stock issuances, net of costs		$ 6	12,881			12,887
Common stock issuance, net of costs, shares		5,678,626
Series B preferred shares converted to common shares	(7)		7
Ending balance, value at Mar. 31, 2021	725	$ 48	415,955	(210)	(345,553)	70,965
Ending balance. shares at Mar. 31, 2021		47,832,997
Beginning balance, value at Dec. 31, 2020	732	$ 42	402,541	(47)	(341,974)	61,294
Beginning balance, shares at Dec. 31, 2020		42,154,371
Net Comprehensive loss						(13,484)
Ending balance, value at Sep. 30, 2021	725	$ 48	416,779	(250)	(355,255)	62,047
Ending balance. shares at Sep. 30, 2021		47,848,622
Beginning balance, value at Dec. 31, 2020	732	$ 42	402,541	(47)	(341,974)	61,294
Beginning balance, shares at Dec. 31, 2020		42,154,371
Ending balance, value at Dec. 31, 2021	715	$ 48	417,217		(361,101)	56,879
Ending balance. shares at Dec. 31, 2021		47,994,672
Beginning balance, value at Mar. 31, 2021	725	$ 48	415,955	(210)	(345,553)	70,965
Beginning balance, shares at Mar. 31, 2021		47,832,997
Equity-based compensation			480			480
Net Comprehensive loss				(37)	(5,876)	(5,913)
Ending balance, value at Jun. 30, 2021	725	$ 48	416,435	(247)	(351,429)	65,532
Ending balance. shares at Jun. 30, 2021		47,832,997
Equity-based compensation			314			314
Net Comprehensive loss				(3)	(3,826)	(3,829)
Common stock issuances, net of costs			30			30
Common stock issuance, net of costs, shares		15,625
Ending balance, value at Sep. 30, 2021	725	$ 48	416,779	(250)	(355,255)	62,047
Ending balance. shares at Sep. 30, 2021		47,848,622
Beginning balance, value at Dec. 31, 2021	715	$ 48	417,217		(361,101)	56,879
Beginning balance, shares at Dec. 31, 2021		47,994,672
Equity-based compensation			242			242
Net Comprehensive loss					(3,820)	(3,820)
Ending balance, value at Mar. 31, 2022	715	$ 48	417,459		(364,921)	53,301
Ending balance. shares at Mar. 31, 2022		47,994,672
Beginning balance, value at Dec. 31, 2021	715	$ 48	417,217		(361,101)	56,879
Beginning balance, shares at Dec. 31, 2021		47,994,672
Net Comprehensive loss						(15,056)
Ending balance, value at Sep. 30, 2022	713	$ 48	418,091		(376,157)	42,695
Ending balance. shares at Sep. 30, 2022		48,082,275
Beginning balance, value at Mar. 31, 2022	715	$ 48	417,459		(364,921)	53,301
Beginning balance, shares at Mar. 31, 2022		47,994,672
Equity-based compensation			275			275
Net Comprehensive loss					(4,851)	(4,851)
Common stock issuances, net of costs			55			55
Common stock issuance, net of costs, shares		54,150
Series B preferred shares converted to common shares	(2)		2
Ending balance, value at Jun. 30, 2022	713	$ 48	417,791		(369,772)	48,780
Ending balance. shares at Jun. 30, 2022		48,048,822
Equity-based compensation			275			275
Net Comprehensive loss					(6,385)	(6,385)
Common stock issuances, net of costs			25			25
Common stock issuance, net of costs, shares		32,895
Cashless Warrant Conversion
Cashless Warrant share Conversion, shares		558
Ending balance, value at Sep. 30, 2022	$ 713	$ 48	$ 418,091		$ (376,157)	$ 42,695
Ending balance. shares at Sep. 30, 2022		48,082,275

XML

Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Cash flows from operating activities:
Net loss	$ (6,385)	$ (3,826)	$ (15,056)	$ (13,281)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment			29	484
Redeemable warrants valuation adjustment			(35)	(22)
Extinguishment of financing obligation and note payable				2,701
Amortization of patent, trademark rights			57	97	$ 116
Changes in ROU assets			(717)	35
Gain on sale of property and equipment				(216)
Gain from sale of income tax operating losses			(749)	(542)
Equity-based compensation			792	1,320
Gain (Loss) on sale of marketable securities			1,768	126
Amortization of finance and debt issuance costs				47
Change in assets and liabilities:
Accounts receivable				6
Funds Receivable from New Jersey net operating loss			1,641	1,090
Prepaid expenses and other current assets and other non-current assets			(500)	64
Lease liability			717	(35)
Other Assets			(73)
Accounts payable			758	(14)
Accrued expenses			1,329	(80)
Net cash used in operating activities			(10,039)	(8,220)
Cash flows from investing activities:
Proceeds from sale of marketable securities			9,082	849
Purchase of marketable securities			(1,661)	(1,611)
Purchase of property and equipment				(34)
Proceeds from sale of property and equipment			300	245
Purchase of patent and trademark rights			(96)	(444)
Net cash provided by (used in) investing activities			7,625	(995)
Cash flows from financing activities:
Payment of financing obligation				(4,732)
Financing obligation payments				(122)
Proceeds from sale of stock, net of issuance costs			80	12,917
Net cash provided by financing activities			80	8,063
Net decrease in cash and cash equivalents			(2,334)	(1,152)
Cash and cash equivalents at beginning of period			32,093	38,501	38,501
Cash and cash equivalents at end of period	$ 29,759	$ 37,349	29,759	37,349	$ 32,093
Supplemental disclosures of non-cash investing and financing cash flow information:
Operating lease-Right of Use Assets			717
Unrealized loss on marketable securities			(1,170)	(329)
Conversion of Series B preferred			$ 2	$ 7

XML

Business and Basis of Presentation

9 Months Ended

Sep. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Business and Basis of Presentation

Note 1: Business and Basis of Presentation

AIM ImmunoTech Inc. and its subsidiaries (collectively, “AIM”, “the Company”,) are an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and immune-deficiency disorders. The Company has established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

Our flagship products are Ampligen® (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon alfa-n3). Ampligen has not been approved by the U.S. Food and Drug Administration (“FDA”) or marketed in the United States. Ampligen is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).

Our primary present business focus involves Ampligen. Ampligen represents a double-stranded RNA being developed for globally important cancers, viral diseases and disorders of the immune system.

The Company is currently proceeding primarily in four areas:

● A randomized controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced pancreatic cancer patients.

● Evaluate Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses to check point inhibitors and other immuno oncology therapies.

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

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

The Company is prioritizing activities in an order related to the stage of development, with those clinical activities in oncology, ME/CFS and Post-COVID conditions having priority over antiviral experimentation. The Company intends that priority clinical work be conducted in trials authorized by the FDA or European Medicines Agency (“EMA”), which trials support commercial development. However, AIM’s antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection. Accordingly, AIM will conduct antiviral programs in those venues most readily available including foreign venues and able to generate valid proof-of-concept data,.

In May 2021, AIM exercised the option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale and lease-back agreement. The Company thereafter sold certain equipment and machinery that it determined to be obsolete and no longer needed for current or future manufacturing. On March 3, 2022, AIM entered into an Agreement of Sale and Purchase with Acellories, Inc. to purchase the property for an estimated $3.9 million, with AIM’s intention to keep some space specifically for its Alferon activity. The sale closed on November 1, 2022 for $3.7 million net of normal closing cost.

AIM’s business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen API. This includes utilizing Polysciences Inc. (“Polysciences”) for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods. While AIM believes it has sufficient Ampligen API to meet current needs, it is also continually exploring new efficiencies so as to maximize its ability to fulfill future obligations.

In the opinion of management, all adjustments necessary for a fair presentation of the consolidated financial statements have been included. Such adjustments consist of normal recurring items. Interim results are not necessarily indicative of results for a full year.

The interim consolidated financial statements and notes thereto are presented as permitted by the Securities and Exchange Commission (“SEC”), and do not contain certain information which will be included in the Company’s annual consolidated financial statements and notes thereto.

These consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years ended December 31, 2021 and 2020, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 31, 2022.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”) of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates, and those differences may be material. Accounts requiring the use of significant estimates include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent and trademark valuations, stock-based compensation calculations, building valuation, fair value of warrants, and contingency accruals.

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Net Loss Per Share

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Net Loss Per Share

Note 2: Net Loss Per Share

Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Equivalent common shares, consisting of stock options and warrants which amounted to 2,445,805 and 1,617,145, are excluded from the calculation of diluted net loss per share for the nine months ended September 30, 2022, and 2021, respectively, since their effect is antidilutive due to the net loss.

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Equity-Based Compensation

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement [Abstract]

Equity-Based Compensation

Note 3: Equity-Based Compensation

The fair value of each option and equity warrant award is estimated on the date of grant using a Black-Scholes-Merton option pricing valuation model. Expected volatility is based on the historical volatility of the price of the Company’s stock. The risk-free interest rate is based on U.S. Treasury issues with a term equal to the expected life of the option and equity warrant. The Company uses historical data to estimate expected dividend yield, expected life and forfeiture rates. There were 300,000 options granted in the nine months ended September 30, 2022, and no options granted in the nine months ended September 30, 2021.

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

Stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2021		1,498,798		$	4.22		9.11	$	—
Granted		150,000			0.70		9.17		—
Forfeited		(1,684	)		117.6		—		—
Expired		—			—		—		—
Outstanding September 30, 2022		1,647,114		$	3.78		8.43	$	—
Vested and expected to vest September 30, 2022		1,647,114		$	3.78		8.43	$	—
Exercisable September 30, 2022		1,542,949		$	2.43		6.66	$	—

Unvested stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2022		412,500		$	4.15		5.85	$	—
Granted		150,000			0.70		9.17		—
Expired		(1,684	)		117.6		—		—
Vested		(456,651	)		1.43		—		—
Unvested September 30, 2022		104,165		$	6.52		3.14	$	—

Stock option activity for non-employees:

	Number of Options		Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2022		279,723	$	6.12		7.93	$	—
Granted		150,000		0.70		9.42		—
Forfeited		—		—		—		—
Expired		—		—		—		—
Outstanding September 30, 2022		429,723	$	4.10		7.96	$	—
Vested and expected to vest September 30, 2022		429,723	$	4.10		7.96	$	—
Exercisable September 30, 2022		354,526	$	4.21		8.32	$	—

Unvested stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2022		97,831		$	3.89		7.82	$	—
Granted		150,000			0.70		9.42		—
Expired		—			—		—		—
Vested		(172,634	)		1.16		—		—
Unvested September 30, 2022		75,197		$	3.79		8.24	$	—

Stock-based compensation expense was approximately $792,000 and $1,320,000 for the nine months ended September 30, 2022, and 2021, resulting in an increase in general and administrative expenses, respectively.

As of September 30, 2022, and 2021, respectively, there was approximately $179,000 and $279,000 of unrecognized equity-based compensation cost related to options granted under the Equity Incentive Plan.

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Marketable Securities

9 Months Ended

Sep. 30, 2022

Investments, Debt and Equity Securities [Abstract]

Marketable Securities

Note 4: Marketable Securities

Marketable securities consist of mutual funds. As of September 30, 2022, and December 31, 2021, it was determined that none of the marketable securities had an other-than-temporary impairment. As of September 30, 2022, and December 31, 2021, all securities were measured as Level 1 instruments under the fair value measurements standard (See Note 11: Fair Value). As of September 30, 2022, and December 31, 2021, the Company held approximately $6,986,000 and $16,175,000 in mutual funds.

Mutual Funds classified as available for sale consisted of:

September 30, 2022

(in thousands)

Securities	Fair Value		Short-Term Investments
Mutual Funds	$	6,986	$	6,986
Totals	$	6,986	$	6,986

September 30, 2022

(in thousands)

Securities
Net losses recognized during the period on equity securities	$	(1,769	)
Less: Net gains and losses recognized during the period on equity securities sold during the period		(598	)
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date	$	(1,171	)

Mutual Funds classified as available for sale consisted of:

December 31, 2021

(in thousands)

Securities	Fair Value		Short-Term Investments
Mutual Funds	$	16,175	$	16,175
Totals	$	16,175	$	16,175

December 31, 2021

(in thousands)

Securities
Net losses recognized during the period on equity securities	$	(88	)
Less: Net gains and losses recognized during the period on equity securities sold during the period		—
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date	$	(88	)

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Accrued Expenses

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Accrued Expenses

Note 5: Accrued Expenses

Accrued expenses consist of the following:

	(in thousands)
	September 30, 2022		December 31, 2021
Compensation	$	33	$	1
Professional fees		1,535		169
Clinical trial expenses		—		61
Other expenses		199		207
	$	1,767	$	438

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Property and Equipment, net

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment, net

Note 6: Property and Equipment, net

	(in thousands)
	September 30, 2022			December 31, 2021
Land, buildings and improvements	$	—		$	3,900
Furniture, fixtures, and equipment		2,353			2,353
Total property and equipment		2,353			6,253
Less: accumulated depreciation		(2,235	)		(2,206	)
Property and equipment, net	$	118		$	4,047

Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, ranging from three to thirty-nine years. Depreciation expense for the nine months ending September 30, 2022 and September 30, 2021 was $29,000 and $484,000.

The Company made a strategic shift on in-house manufacturing and recorded an impairment of the facility in the amount of $1,800,000 during the year ended December 31, 2021. During the period ending September 30, 2022, the Company reported assets held for sale related to the pending sale of the manufacturing facility located at 783 Jersey Avenue. On November 1, 2022, AIM completed the sale of its facility at 783 Jersey Avenue, New Brunswick, N.J., for $3.7 million net of normal closing cost. (See Note 11 Fair Value).

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Patents

9 Months Ended

Sep. 30, 2022

Goodwill and Intangible Assets Disclosure [Abstract]

Patents

Note 7: Patents

(in thousands)
December 31, 2020	$	1,498
Acquisitions		592
Amortization		(116	)
December 31, 2021	$	1,974
Acquisitions		96
Amortization		(57	)
September 30, 2022	$	2,013

Patents and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method of the estimated useful life of 17 years.

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

Period Ending December 31,
(in thousands)
2022	$	23
2023		154
2024		178
2025		199
2026		235
Thereafter		1,224
Total	$	2,013

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Stockholders’ Equity

9 Months Ended

Sep. 30, 2022

Equity [Abstract]

Stockholders’ Equity

Note 8: Stockholders’ Equity

(a) Preferred Stock

The Company is authorized to issue 5,000,000 shares of $0.01 par value preferred stock with such designations, rights and preferences as may be determined by the Board of Directors. Of our authorized preferred stock, 250,000 shares have been designated as Series A Junior Participating Preferred Stock and 8,000 shares have been designated as Series B Convertible Preferred Stock. The Series B Convertible Preferred Stock has a stated value $1,000 per share.

The Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $1,000 per share. As of September 30, 2022, and December 31, 2021, the Company had 713 and 715 shares of Series B Convertible Preferred Stock outstanding, respectively. Holders shall be entitled to receive, and the Company shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock basis) to and in the same form as dividend actually paid on shares of Common Stock when as and if such dividends are paid on shares of the Common Stock. Each such Preferred Share is convertible into 114 shares of common stock. Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, the Holders shall be entitled to receive out of the assets, whether capital or surplus of the Company the same amount that a holder of Common Stock would receive if the Preferred Stock was fully converted. The Series B Convertible Preferred Stock shall have no voting Rights.

Pursuant to a registration statement relating to a rights offering declared effective by the SEC on February 14, 2019, AIM distributed to its holders of common stock and to holders of certain options and warrants as of February 14, 2019, at no charge, one non-transferable subscription right for each share of common stock held or deemed held on the record date. Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into common stock at an assumed conversion price of $8.80) and 114 warrants with an assumed exercise price of $8.80. The warrants are exercisable for five years after the date of issuance. The net proceeds realized from the rights offering were approximately $4,700,000. During the nine months ending September 30, 2022 and September 30, 2021, 2 and 7 shares, respectively, of Series B Convertible Preferred Stock were converted into common stock.

(b) Common Stock

The 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 authorized shares.

On July 7, 2020, the board of directors approved a plan pursuant to which all directors, officers, and employees could purchase from the Company up to an aggregate of $500,000 worth of shares at the market price. Pursuant to NYSE American rules, this plan was effective for a sixty-day period commencing upon the date that the NYSE American approved the Company’s Supplemental Listing Application. When this plan expired, the board of directors approves subsequent similar $500,000 plans for all directors, officers and employees to buy Company shares from the Company at the market price. Subsequent plans were approved by the board of directors upon the expiration of prior plans. The latest plan was approved by the board of directors on March 2, 2022.

During the nine months ended September 30, 2022, the Company issued a total of 87,045 shares of its common stock at prices ranging from $0.76 to $1.02 for a total of $80,000 as part of the employee stock purchase plan, not from the 2018 Equity Incentive Plan.

During the twelve months ended December 31, 2021, the Company issued a total of 132,238 shares of its common stock at prices ranging from $1.16 to $2.35 for a total of $205,000.

On September 27, 2019, the Company closed a 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. As of September 30, 2022, there are 15,000 Warrants outstanding.

On July 19, 2019, the Company entered into a new Equity Distribution Agreement (the “2019 EDA”) with Maxim Group LLC (“Maxim”), pursuant to which it could sell, from time to time, shares of its Common Stock through Maxim, as agent. The 2019 EDA replaced a prior EDA with Maxim. For the year ended December 31, 2020, the Company sold 20,444,807 shares under the 2019 EDA for total gross proceeds of $53,936,615, which includes a 3.5% fee to Maxim of $1,888,727. During the period ended December 31, 2021, the Company sold 5,665,731 shares under the 2019 EDA for total gross proceeds of $13,301,526, which includes a 3.5% fee to Maxim of $465,533. The 2019 EDA was terminated in early February 2021.

The 2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards, (vii) Performance Cash Awards, and (viii) Other Stock Awards. Initially, a maximum of 7,000,000 shares of Common Stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. Unless sooner terminated, the 2018 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date. During first quarter of 2022, 300,000 options were issued to employees with an exercise price of $.70 for a period of ten years with a vesting period of one year. During fourth quarter of 2021, 613,512 options were issued to employees with an exercise price range of $1.11 to $1.71 for a period of ten years with a vesting period of one year.

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

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Cash and Cash Equivalents

9 Months Ended

Sep. 30, 2022

Cash and Cash Equivalents [Abstract]

Cash and Cash Equivalents

Note 9: Cash and Cash Equivalents

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

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Recent Accounting Pronouncements

9 Months Ended

Sep. 30, 2022

Recent Accounting Pronouncements

Recent Accounting Pronouncements

Note 10: Recent Accounting Pronouncements

During the third quarter of 2022 accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on the Company’s present or future financial statements.

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Fair Value

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Fair Value

Note 11: Fair Value

The Company is required under U.S. GAAP to disclose information about the fair value of all the Company’s financial instruments, whether or not these instruments are measured at fair value on the Company’s consolidated balance sheets.

The Company estimates that the fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate their carrying values due to the short-term maturities of these items. The Company also has certain warrants with a cash settlement feature in the occurrence of a Fundamental Transaction. The fair value of the redeemable warrants (“Warrants”) related to the Company’s April 2018, and March 2019 common stock and warrant issuance, are calculated using a Monte Carlo Simulation. While the Monte Carlo Simulation is one of a number of possible pricing models, the Company has determined it to be industry accepted and fairly presented the fair value of the Warrants. As an additional factor to determine the fair value of the Put’s liability, the occurrence probability of a Fundamental Transaction event was factored into the valuation.

The Company recomputes the fair value of the Warrants at the issuance date and the end of each quarterly reporting period. Such value computation includes subjective input assumptions that are consistently applied each period. If the Company were to alter its assumptions or the numbers input based on such assumptions, the resulting fair value could be materially different.

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

	September 30, 2022			December 31, 2021
Underlying price per share	$	0.58		$	0.92
Exercise price per share	$	17.16		$	17.16
Risk-free interest rate		4.06	%		0.67	%
Expected holding period		1.07			1.81
Expected volatility		70	%		120	%
Expected dividend yield		—			—

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

	September 30, 2022			December 31, 2021
Underlying price per share	$	0.58		$	0.92
Exercise price per share	$	8.80		$	8.80
Risk-free interest rate		4.12	%		0.78	%
Expected holding period		1.44			2.19
Expected volatility		65	%		125	%
Expected dividend yield		—			—

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

(i)	Risk-Free Interest Rate. The risk-free interest rates for the Warrants are based on U.S. Treasury constant maturities for periods commensurate with the remaining expected holding periods of the warrants.
(ii)	Expected Holding Period. The expected holding period represents the period of time that the Warrants are expected to be outstanding until they are exercised. The Company utilizes the remaining contractual term of the Warrants at each valuation date as the expected holding period.
(iii)	Expected Volatility. Expected stock volatility is based on daily observations of the Company’s historical stock values for a period commensurate with the remaining expected holding period on the last day of the period for which the computation is made.
(iv)	Expected Dividend Yield. Expected dividend yield is based on the Company’s anticipated dividend payments over the remaining expected holding period. As the Company has never issued dividends, the expected dividend yield is $0.00 and this assumption will be continued in future calculations unless the Company changes its dividend policy.
(v)	Expected Probability of a Fundamental Transaction. The possibility of the occurrence of a Fundamental Transaction triggering a Put right is extremely remote. As discussed above, a Put right would only arise if a Fundamental Transaction (1) is an all cash transaction; (2) results in the Company going private; or (3) is a transaction involving a person or entity not traded on a national securities exchange. The Company believes such an occurrence is highly unlikely because:

a.	The Company only has one product that is FDA approved but which will not be available for commercial sales for 18 months at the earliest;
b.	The Company flagship product is approved only in Argentina for Severely Debilitated Chronic Fatigue Syndrome patients;
c.	The Company may have to perform additional clinical trials for FDA approval of its flagship product;
d.	Industry and global market conditions continue to include uncertainty, adding risk to any transaction;
e.	Available capital for a potential buyer in a cash transaction continues to be limited;
f.	The nature of a life science company is heavily dependent on future funding and high costs, including research & development;
g.	The Company has minimal revenue streams which could be insufficient to meet the funding needs for the cost of operations or construction at their manufacturing facility; and
h.	The Company’s Rights Agreement and Executive Agreements make it less attractive to a potential buyer.

With the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities related to a Put right being triggered as:

Range of Probability	Probability
Low		0.5	%
Medium		1.0	%
High		5.0	%

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

(vi) Expected Timing of Announcement of a Fundamental Transaction. As the Company has no specific expectation of a Fundamental Transaction, for reasons stated above, the Company used a discrete uniform probability distribution over the Expected Holding Period to model the potential announcement of a Fundamental Transaction occurring during the Expected Holding Period.

(vii)	Expected 100 Day Volatility at Announcement of a Fundamental Transaction. An estimate of future volatility is necessary as there is no mechanism for directly measuring future stock price movements. Daily observations of the Company’s historical stock values for the 100 days immediately prior to the Warrants’ grant dates, with a floor of 100%, were utilized as a proxy for the future volatility.
(viii)	Expected Risk-Free Interest Rate at Announcement of a Fundamental Transaction. The Company utilized a risk-free interest rate corresponding to the forward U.S. Treasury rate for the period equal to the time between the date forecast for the public announcement of a Fundamental Transaction and the Warrant expiration date for each simulation.
(ix)	Expected Time Between Announcement and Consummation of a Fundamental Transaction. The expected time between the announcement and the consummation of a Fundamental Transaction is based on the Company’s experience with the due diligence process performed by acquirers and is estimated to be six months. The Monte Carlo Simulation approach incorporates this additional period to reflect the delay Warrant Holders would experience in receiving the proceeds of the Put.

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

The Company applies FASB ASC 820 that defines fair value, establishes a framework for measuring fair value in U.S. GAAP, and expands disclosures about fair value measurements. The guidance does not impose any new requirements around which assets and liabilities are to be measured at fair value, and instead applies to asset and liability balances required or permitted to be measured at fair value under existing accounting pronouncements. The Company measures its warrant liability for those warrants with a cash settlement feature at fair value.

FASB ASC 820-10-35-37 establishes a valuation hierarchy based on the transparency of inputs used in the valuation of an asset or liability. Classification is based on the lowest level of inputs that is significant to the fair value measurement. The valuation hierarchy contains three levels:

● Level 1 – Quoted prices are available in active markets for identical assets or liabilities at the reporting date. Generally, this includes certain U.S. and government agency debt and equity securities that are traded in an active market.

● Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Generally, this includes debt and equity securities that are not traded in an active market.

● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or other valuation techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. As of September 30, 2022, the Company has classified the warrants with cash settlement features as Level 3. Management evaluates a variety of inputs and then estimates fair value based on those inputs. As discussed above, the Company utilized the Monte Carlo Simulation Model in valuing these warrants.

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

	(in thousands) As of September 30, 2022
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	6,986	$	6,986	$	—	$	—
Liabilities:
Redeemable warrants	$	—		—		—	$	—

	(in thousands) As of December 31, 2021
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	16,175	$	16,175	$	—	$	—
Liabilities:
Redeemable warrants	$	35		—		—	$	35

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

Redeemable warrants:
Balance at December 31, 2021	$	35
Fair value adjustment		(35	)
Balance at September 30, 2022	$	—

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

	(in thousands) As of December 31, 2021
	Total		Level 1		Level 2		Level 3		Total Gains (Losses)
Assets:
Long lived assets held and used(a)	$	3,900	$	—	$	—	$	3,900	$	(1,800	)

(a) In accordance with Subtopic 360-10, long-lived assets held and used with a carrying amount of $5,700,000 were written down to their fair value of $3,900,000 resulting in an impairment charge of $1,800,000, which was included in earnings for the period ending December 31, 2021. A $300,000 deposit was received in the third quarter 2022 related to the asset.

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Financing Obligation Arising from Sale Leaseback Transaction

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Financing Obligation Arising from Sale Leaseback Transaction

Note 12: Financing Obligation Arising from Sale Leaseback Transaction

On March 16, 2018, the Company sold land and a building for $4,080,000 and concurrently entered into an agreement to lease the property back for ten years at $408,000 per year for two years through March 31, 2020. The lease payments would increase 2.5% per year for the next three years through March 31, 2023, and the lease payments would increase 3% for the remaining five years through March 31, 2028. As part of the sale of this building, warrants were provided to the buyer for the purchase of up to 73,314 shares of Company common stock for a period of five years at an exercise price of $17.05 per share, 125% of the closing price of the common stock on the NYSE American on the date of execution of the letter of intent for the purchase. The sale of the property included an option to repurchase the property based on a contractual formula which does not permanently transfer all the risks and rewards of ownership to the buyer. Because the sale of the property included the option to repurchase the property and included the above attributes, the transaction was accounted for as a financing transaction whereby the Company recorded the cash received and a financing obligation. The warrants cannot be exercised to the extent that any exercise would result in the purchaser owning in excess of 4.99% of our issued and outstanding shares of common stock.

On May 13, 2021, the Company completed its repurchase of the property for cash of $4,732,637. The repurchase resulted in the related liability recorded upon sale being extinguished on the date of the repurchase. A loss on the extinguishment was recorded based on the difference between the carrying value of the financing obligation including unamortized debt discount and the amount exchanged to extinguish the debt.

Interest expense relating to this financing agreement was $0 for the period ended September 30, 2022 and $67,000 for the nine months ended September 30, 2021.

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Leases

9 Months Ended

Sep. 30, 2022

Leases

Leases

Note 13: Leases

The Company leases office and storage space, and other equipment under non-cancellable operating leases with initial terms typically ranging from 1 to 5 years. At contract inception, the Company reviews the facts and circumstances of the arrangement to determine if the contract is or contains a lease. The Company follows the guidance in Topic 842 “Leases” to evaluate whether the contract has an identified asset; if the Company has the right to obtain substantially all economic benefits from the asset; and if the Company has the right to direct the use of the underlying asset. When determining if a contract has an identified asset, the Company considers both explicit and implicit assets, and whether the supplier has the right to substitute the asset. When determining if the Company has the right to direct the use of an underlying asset, the Company considers if it has the right to direct how and for what purpose the asset is used throughout the period of use and if it controls the decision-making rights over the asset.

The Company’s lease terms may include options to extend or terminate the lease. The Company exercises judgment to determine the term of those leases when extension or termination options are present and include such options in the calculation of the lease term when it is reasonably certain that it will exercise those options.

The Company has elected to include both lease and non-lease components in the determination of lease payments. Payments made to a lessor for items such as taxes, insurance, common area maintenance, or other costs commonly referred to as executory costs, are also included in lease payments if they are fixed. The fixed portion of these payments are included in the calculation of the lease liability, while any variable portion would be recognized as variable lease expenses, when incurred. Variable payments made to third parties for these, or similar costs, such as utilities, are not included in the calculation of lease payments.

At lease commencement, lease-related assets and liabilities are measured at the present value of future lease payments over the lease term. As most of the Company’s leases do not provide an implicit rate, the Company exercises judgment in determining the incremental borrowing rate based on the information available when the lease commences to measure the present value of future payments.

Operating leases are included in other assets, current operating lease obligations, and operating lease obligations (less current portion) on the Company’s consolidated balance sheet. Short term leases with an initial term of 12 months or less are not presented on the balance sheet with expense recognized as incurred.

The Company entered into a Lease Agreement for a term of five years commencing on September 14, 2020 pursuant to which the Company agreed to lease two Sharp copiers. The base of $1,415 per month.

On June 13, 2018, the Company entered into a Lease Agreement for a term of six years commencing on July 1, 2018 pursuant to which the Company agreed to lease approximately 3,000 rentable square feet. The base rent increases by 3% each year, and ranges from $2,100 per month for the first year to $2,785 per month for the sixth year.

On May 1, 2019, the Company entered into a Lease Agreement for a term of three years commencing on May 1, 2019, pursuant to which the Company agreed to lease approximately 3,000 rentable square feet. The base rent is $2,500 per month for the term of the lease. On October 4, 2021, the Company executed a request to renew the lease for a one-year term as defined in the Lease Agreement. The request was accepted, and the one-year term commenced on April 30, 2022. On October 5, 2022, the Company executed a request to renew the lease for an additional one-year term at a monthly cost of $2,850. The request was accepted and the one-year term commences on May 1, 2023.

On February 17, 2022, the Company entered into a Lease Agreement for a term of two years commencing on March 1, 2022, pursuant to which the Company agreed to lease a Canon copier. The base rent is $322 per month for the term of the lease.

On June 16, 2022, the Company entered into a Lease Agreement for a term of five years commencing on July 1, 2022 pursuant to which the Company agreed to lease approximately 5,210 rentable square feet. The base rent increases by 3% each year, and ranges from $15,630 per month for the first year to $18,118 per month for the fifth year.

The expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it is reasonably certain that the Company would exercise such options. The Company’s leases have remaining lease terms between 11 months and 5 years. As of September 30, 2022, and December 31, 2021, the weighted-average remaining term is 2.67 and 2.72 years, respectively.

The Company has determined that the incremental borrowing rate is 10% as of September 30, 2022, and December 31, 2021, respectively, based upon the recently completed financing transaction in December 2019.

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

Period December 31,
(in thousands)
2022	$	46
2023		187
2024		183
2025		180
2026		185
Thereafter		171
Less imputed interest		(86	)
Total	$	866

As of September 30, 2022, and December 31, 2021, the balance of the right of use assets was $866,000 and $149,000, respectively, and the corresponding lease liability balance was $866,000 and $149,000, respectively. Total rent expense for the nine months ended September 30, 2022, and September 30, 2021, amounted to approximately $75,000 and $39,000, respectively. Total rent expense for short term leases for the nine months ended September 30, 2022, and September 30, 2021, amounted to approximately $8,000 for both periods.

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Research, Consulting and Supply Agreements

9 Months Ended

Sep. 30, 2022

Research Consulting And Supply Agreements

Research, Consulting and Supply Agreements

Note 14: Research, Consulting and Supply Agreements

In January 2021, the Company entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1 clinical study to assess the safety, tolerability, and biological activity of Ampligen as a potential intranasal therapy. The Company has paid CHDR approximately $1,066,000.

In April 2021, the Company approved a proposal from Polysciences for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors to the drug Ampligen. The Company is working with Polysciences to negotiate and finalize both a Service Agreement and a Quality Agreement. For the year ended December 31, 2021, the Company has incurred an expense and paid Polysciences approximately $250,000. For the nine months ended September 30, 2022, the Company paid Polysciences $103,000.

In April 2022, AIM executed a work order with Amarex Clinical Research LLC (“Amarex”), our contract research organization, pursuant to which Amarex will manage a Phase 2 clinical trial in advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM anticipates that the study will cost approximately $8.2 million, which includes pass through costs of approximately $1.0 million and excludes certain third-party costs and escalations. AIM anticipates that the study will take approximately 4.6 years to complete.

On June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex will manage a Phase 2 trial in patients with Post-COVID Conditions. It is planned that the study will be conducted at up to 10 sites in the United States. AIM is sponsoring the study. AIM anticipates that the study will cost approximately $4.4 million, which includes pass through costs of approximately $125,470, investigator costs estimated at about $2.4 million and excludes certain other third-party costs and escalations.

In December 2020, AIM added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance its capacity to produce Ampligen. This addition amplifies AIM’s manufacturing capability by providing redundancy and cost savings. The contracts augment our active and in-process fill and finish capacity. For the period ended December 31, 2021, the Company has incurred an expense and paid Pii approximately $89,000. For the nine months ended September 30, 2022, the Company incurred an expense and paid Pii approximately $259,000.

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Subsequent Events

9 Months Ended

Sep. 30, 2022

Subsequent Events [Abstract]

Subsequent Events

Note 15: Subsequent Events

On October 5, 2022, the Delaware Court of Chancery held a hearing regarding a motion to require the AIM Board of Directors to accept the Jorgl Group’s director nominations and include the group’s nominees on a universal proxy card for the 2022 Annual Meeting of Stockholders. On October 28, 2022, the court denied Jorgl’s motion. The Jorgl Group announced on November 2, 2022, that it did not intend to appeal the decision.

On October 12, 2022, the Company announced that its Investigational New Drug (IND) application filed with the FDA was granted clearance to proceed and therefore the Company could initiate a Phase 2 study evaluating Ampligen as a therapeutic for patients with post-COVID conditions (“AMP-518”).

On November 1, 2022, AIM completed the sale of its facility at 783 Jersey Avenue, New Brunswick, N.J., for $3.7 million net of normal closing cost.

In November 2022, AIM received notice that the FDA had granted Orphan Drug Designation to Ampligen for the treatment of Ebola virus disease.

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Equity-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Share-Based Payment Arrangement, Employee [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Schedule of Stock Option Activity

Stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2021		1,498,798		$	4.22		9.11	$	—
Granted		150,000			0.70		9.17		—
Forfeited		(1,684	)		117.6		—		—
Expired		—			—		—		—
Outstanding September 30, 2022		1,647,114		$	3.78		8.43	$	—
Vested and expected to vest September 30, 2022		1,647,114		$	3.78		8.43	$	—
Exercisable September 30, 2022		1,542,949		$	2.43		6.66	$	—

Schedule of Unvested Stock Option Activity

Unvested stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2022		412,500		$	4.15		5.85	$	—
Granted		150,000			0.70		9.17		—
Expired		(1,684	)		117.6		—		—
Vested		(456,651	)		1.43		—		—
Unvested September 30, 2022		104,165		$	6.52		3.14	$	—

Share-Based Payment Arrangement, Nonemployee [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Schedule of Stock Option Activity

Stock option activity for non-employees:

	Number of Options		Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2022		279,723	$	6.12		7.93	$	—
Granted		150,000		0.70		9.42		—
Forfeited		—		—		—		—
Expired		—		—		—		—
Outstanding September 30, 2022		429,723	$	4.10		7.96	$	—
Vested and expected to vest September 30, 2022		429,723	$	4.10		7.96	$	—
Exercisable September 30, 2022		354,526	$	4.21		8.32	$	—

Schedule of Unvested Stock Option Activity

Unvested stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2022		97,831		$	3.89		7.82	$	—
Granted		150,000			0.70		9.42		—
Expired		—			—		—		—
Vested		(172,634	)		1.16		—		—
Unvested September 30, 2022		75,197		$	3.79		8.24	$	—

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Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2022

Investments, Debt and Equity Securities [Abstract]

Schedule of Available for Sale

Mutual Funds classified as available for sale consisted of:

September 30, 2022

(in thousands)

Securities	Fair Value		Short-Term Investments
Mutual Funds	$	6,986	$	6,986
Totals	$	6,986	$	6,986

Mutual Funds classified as available for sale consisted of:

December 31, 2021

(in thousands)

Securities	Fair Value		Short-Term Investments
Mutual Funds	$	16,175	$	16,175
Totals	$	16,175	$	16,175

Schedule of Equity Securities

September 30, 2022

(in thousands)

Securities
Net losses recognized during the period on equity securities	$	(1,769	)
Less: Net gains and losses recognized during the period on equity securities sold during the period		(598	)
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date	$	(1,171	)

December 31, 2021

(in thousands)

Securities
Net losses recognized during the period on equity securities	$	(88	)
Less: Net gains and losses recognized during the period on equity securities sold during the period		—
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date	$	(88	)

 

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Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2022

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses consist of the following:

	(in thousands)
	September 30, 2022		December 31, 2021
Compensation	$	33	$	1
Professional fees		1,535		169
Clinical trial expenses		—		61
Other expenses		199		207
	$	1,767	$	438

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Property and Equipment, net (Tables)

9 Months Ended

Sep. 30, 2022

Property, Plant and Equipment [Abstract]

Schedule of Property and Equipment

	(in thousands)
	September 30, 2022			December 31, 2021
Land, buildings and improvements	$	—		$	3,900
Furniture, fixtures, and equipment		2,353			2,353
Total property and equipment		2,353			6,253
Less: accumulated depreciation		(2,235	)		(2,206	)
Property and equipment, net	$	118		$	4,047

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Patents (Tables)

9 Months Ended

Sep. 30, 2022

Goodwill and Intangible Assets Disclosure [Abstract]

Schedule of Patents, Trademark Rights

(in thousands)
December 31, 2020	$	1,498
Acquisitions		592
Amortization		(116	)
December 31, 2021	$	1,974
Acquisitions		96
Amortization		(57	)
September 30, 2022	$	2,013

Schedule of Amortization of Patents and Trademarks

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

Period Ending December 31,
(in thousands)
2022	$	23
2023		154
2024		178
2025		199
2026		235
Thereafter		1,224
Total	$	2,013

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Fair Value (Tables)

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Schedule of Assumptions to Estimate Fair Value of Warrants

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

	September 30, 2022			December 31, 2021
Underlying price per share	$	0.58		$	0.92
Exercise price per share	$	17.16		$	17.16
Risk-free interest rate		4.06	%		0.67	%
Expected holding period		1.07			1.81
Expected volatility		70	%		120	%
Expected dividend yield		—			—

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

	September 30, 2022			December 31, 2021
Underlying price per share	$	0.58		$	0.92
Exercise price per share	$	8.80		$	8.80
Risk-free interest rate		4.12	%		0.78	%
Expected holding period		1.44			2.19
Expected volatility		65	%		125	%
Expected dividend yield		—			—

Schedule of Range of Probabilities

Range of Probability	Probability
Low		0.5	%
Medium		1.0	%
High		5.0	%

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

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

	(in thousands) As of September 30, 2022
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	6,986	$	6,986	$	—	$	—
Liabilities:
Redeemable warrants	$	—		—		—	$	—

	(in thousands) As of December 31, 2021
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	16,175	$	16,175	$	—	$	—
Liabilities:
Redeemable warrants	$	35		—		—	$	35

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

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

Redeemable warrants:
Balance at December 31, 2021	$	35
Fair value adjustment		(35	)
Balance at September 30, 2022	$	—

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

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

	(in thousands) As of December 31, 2021
	Total		Level 1		Level 2		Level 3		Total Gains (Losses)
Assets:
Long lived assets held and used(a)	$	3,900	$	—	$	—	$	3,900	$	(1,800	)

(a) In accordance with Subtopic 360-10, long-lived assets held and used with a carrying amount of $5,700,000 were written down to their fair value of $3,900,000 resulting in an impairment charge of $1,800,000, which was included in earnings for the period ending December 31, 2021. A $300,000 deposit was received in the third quarter 2022 related to the asset.

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Leases (Tables)

9 Months Ended

Sep. 30, 2022

Leases

Schedule of Operating lease Future Payments

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

Period December 31,
(in thousands)
2022	$	46
2023		187
2024		183
2025		180
2026		185
Thereafter		171
Less imputed interest		(86	)
Total	$	866

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Business and Basis of Presentation (Details Narrative) - USD ($) $ in Thousands			9 Months Ended
	Nov. 01, 2022	Mar. 03, 2021	Sep. 30, 2022	Sep. 30, 2021
Purchase of property				$ 34
Proceeds from sale of property			$ 300	$ 245
Subsequent Event [Member]
Proceeds from sale of property	$ 3,700
Acellories Inc [Member]
Purchase of property		$ 3,900

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Net Loss Per Share (Details Narrative) - shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Equity Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from earnings per share	2,445,805	1,617,145

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Schedule of Stock Option Activity (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Share-Based Payment Arrangement, Employee [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of options outstanding, Beginning	1,498,798
Weighted average exercise price, Beginning	$ 4.22
Weighted Average Remaining Contracted Term (years) Outstanding	8 years 5 months 4 days	9 years 1 month 9 days
Aggregate Intrinsic Value, Beginning
Number of options outstanding, Granted	150,000
Weighted average exercise price, Granted	$ 0.70
Weighted Average Remaining Contractual Term (Years), Granted	9 years 2 months 1 day
Number of Options, Forfeited	(1,684)
Weighted Average Exercise Price, Forfeited	$ 117.6
Number of Options, Expired
Weighted Average Exercise Price, Expired
Number of options outstanding, Ending	1,647,114	1,498,798
Weighted Average Exercise Price Outstanding, End of Period	$ 3.78	$ 4.22
Aggregate Intrinsic Value, Ending
Number of options outstanding, Vested and expected	1,647,114
Vested and expected to vest, Weighted average exercise price	$ 3.78
Weighted Average Remaining Contractual Term (Years), Vested and expected	8 years 5 months 4 days
Aggregate Intrinsic Value, Vested and expected
Number of options outstanding, Exercisable	1,542,949
Exercisable, Weighted average exercise price	$ 2.43
Weighted Average Remaining Contractual Term (Years), Exercisable	6 years 7 months 28 days
Aggregate Intrinsic Value, Exercisable
Number of Options, Forfeited	1,684
Number of Options, Expired
Share-Based Payment Arrangement, Nonemployee [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of options outstanding, Beginning	279,723
Weighted average exercise price, Beginning	$ 6.12
Weighted Average Remaining Contracted Term (years) Outstanding	7 years 11 months 15 days	7 years 11 months 4 days
Aggregate Intrinsic Value, Beginning
Number of options outstanding, Granted	150,000
Weighted average exercise price, Granted	$ 0.70
Weighted Average Remaining Contractual Term (Years), Granted	9 years 5 months 1 day
Number of Options, Forfeited
Weighted Average Exercise Price, Forfeited
Number of Options, Expired
Weighted Average Exercise Price, Expired
Number of options outstanding, Ending	429,723	279,723
Weighted Average Exercise Price Outstanding, End of Period	$ 4.10	$ 6.12
Aggregate Intrinsic Value, Ending
Number of options outstanding, Vested and expected	429,723
Vested and expected to vest, Weighted average exercise price	$ 4.10
Weighted Average Remaining Contractual Term (Years), Vested and expected	7 years 11 months 15 days
Aggregate Intrinsic Value, Vested and expected
Number of options outstanding, Exercisable	354,526
Exercisable, Weighted average exercise price	$ 4.21
Weighted Average Remaining Contractual Term (Years), Exercisable	8 years 3 months 25 days
Aggregate Intrinsic Value, Exercisable
Number of Options, Forfeited
Number of Options, Expired

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Schedule of Unvested Stock Option Activity (Details) - USD ($)	9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Options, Granted	300,000	0
Share-Based Payment Arrangement, Employee [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Options, Beginning	412,500
Weighted Average Exercise Price, Beginning	$ 4.15
Weighted Average Remaining Contractual Term (Years), Ending	5 years 10 months 6 days
Aggregate Intrinsic Value, Beginning
Number of Options, Granted	150,000
Weighted Average Exercise Price, Granted	$ 0.70
Weighted Average Remaining Contractual Term (Years), Granted	9 years 2 months 1 day
Number of Options, Expired	(1,684)
Weighted Average Exercise Price, Expired	$ 117.6
Number of Options, Vested	(456,651)
Weighted Average Exercise Price, Vested	$ 1.43
Number of Options, Ending	104,165		412,500
Weighted Average Exercise Price, Ending	$ 6.52		$ 4.15
Weighted Average Remaining Contractual Term (years) Unvested, Ending of Period	3 years 1 month 20 days
Aggregate Intrinsic Value, Ending
Number of Options, Expired	1,684
Share-Based Payment Arrangement, Nonemployee [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Options, Beginning	97,831
Weighted Average Exercise Price, Beginning	$ 3.89
Weighted Average Remaining Contractual Term (Years), Ending	8 years 2 months 26 days		7 years 9 months 25 days
Aggregate Intrinsic Value, Beginning
Number of Options, Granted	150,000
Weighted Average Exercise Price, Granted	$ 0.70
Weighted Average Remaining Contractual Term (Years), Granted	9 years 5 months 1 day
Number of Options, Expired
Weighted Average Exercise Price, Expired
Number of Options, Vested	(172,634)
Weighted Average Exercise Price, Vested	$ 1.16
Number of Options, Ending	75,197		97,831
Weighted Average Exercise Price, Ending	$ 3.79		$ 3.89
Aggregate Intrinsic Value, Ending
Number of Options, Expired

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Equity-Based Compensation (Details Narrative) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Share-Based Payment Arrangement [Abstract]
Options, granted	300,000	0
Share based compensation expense	$ 792	$ 1,320
Unrecognized stock-based compensation cost	$ 179	$ 279

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Schedule of Available for Sale (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Marketable Securities [Line Items]
Fair Value	$ 6,986	$ 16,175
Short-Term Investments	6,986	16,175
Mutual Funds [Member]
Marketable Securities [Line Items]
Fair Value	6,986	16,175
Short-Term Investments	$ 6,986	$ 16,175

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Schedule of Equity Securities (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Investments, Debt and Equity Securities [Abstract]
Net losses recognized during the period on equity securities	$ (1,769)	$ (88)
Less: Net gains and losses recognized during the period on equity securities sold during the period	(598)
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date	$ (1,171)	$ (88)

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Marketable Securities (Details Narrative) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Investments, Debt and Equity Securities [Abstract]
Marketable securities	$ 6,986	$ 16,175

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Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Compensation	$ 33	$ 1
Professional fees	1,535	169
Clinical trial expenses		61
Other expenses	199	207
Accrued expenses	$ 1,767	$ 438

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Schedule of Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 2,353	$ 6,253
Less: accumulated depreciation	(2,235)	(2,206)
Property and equipment, net	118	4,047
Land, Buildings and Improvements [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment		3,900
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 2,353	$ 2,353

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Property and Equipment, net (Details Narrative) - USD ($) $ in Thousands		9 Months Ended		12 Months Ended
	Nov. 01, 2022	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Subsequent Event [Line Items]
Depreciation		$ 29	$ 484
Asset Impairment Charges				$ 1,800
Proceeds from Sale of Property, Plant, and Equipment		$ 300	$ 245
Subsequent Event [Member]
Subsequent Event [Line Items]
Proceeds from Sale of Property, Plant, and Equipment	$ 3,700

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Schedule of Patents, Trademark Rights (Details) - USD ($) $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Goodwill and Intangible Assets Disclosure [Abstract]
Beginning balance	$ 1,974	$ 1,498	$ 1,498
Acquisitions	96		592
Amortization	(57)	$ (97)	(116)
Ending balance	$ 2,013		$ 1,974

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Schedule of Amortization of Patents and Trademarks (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021	Dec. 31, 2020
Goodwill and Intangible Assets Disclosure [Abstract]
2022	$ 23
2023	154
2024	178
2025	199
2026	235
Thereafter	1,224
Total	$ 2,013	$ 1,974	$ 1,498

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Patents (Details Narrative)	9 Months Ended
	Sep. 30, 2022
Patents and Trademarks [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Asset, Useful Life	17 years

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Stockholders’ Equity (Details Narrative) - USD ($)				3 Months Ended						9 Months Ended		12 Months Ended
	Jul. 07, 2020	Sep. 27, 2019	Sep. 12, 2018	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021	Sep. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021	Dec. 31, 2020	Mar. 16, 2018
Class of Stock [Line Items]
Preferred stock, shares authorized				5,000,000						5,000,000
Preferred stock stated value				$ 0.01						$ 0.01
Warrant exercise price														$ 17.05
Warrants and rights outstanding term														5 years
Common stock, shares authorized				350,000,000			350,000,000			350,000,000		350,000,000
Common stock specific limitations and restrictions on usage				8,000,000						8,000,000
Common stock shares issued, value				$ 25,000	$ 55,000			$ 30,000	$ 12,887,000
Warrants issued														73,314
Proceeds from Issuance or Sale of Equity										$ 80,000	$ 12,917,000
Warrant outstanding				15,000						15,000
Number of options granted										300,000	0
Common stock, shares outstanding				48,082,275			47,994,672			48,082,275		47,994,672
Director [Member]
Class of Stock [Line Items]
Option vested years			10 years
2018 Equity Incentive Plan [Member]
Class of Stock [Line Items]
Number of stock is reserved for potential issuance			7,000,000
2018 Equity Incentive Plan [Member] | Employees [Member]
Class of Stock [Line Items]
Number of options granted						300,000	613,512
Option exercise price per share						$ 0.70
Expiration period						10 years	10 years
Pre-Funded Warrants [Member]
Class of Stock [Line Items]
Shares issued price per share		$ 0.899
Percentage of outstanding stock		4.99%
Warrant [Member]
Class of Stock [Line Items]
Warrant exercise price		$ 0.99
Alliance Global Partners, LLC [Member]
Class of Stock [Line Items]
Number of shares issued upon transaction		1,740,550
Warrants issued		7,148,310
Proceeds from Issuance or Sale of Equity		$ 7,200,000
Alliance Global Partners, LLC [Member] | Warrants [Member]
Class of Stock [Line Items]
Number of warrant to purchase shares of common stock		8,888,860
Alliance Global Partners, LLC [Member] | Pre-Funded Warrants [Member]
Class of Stock [Line Items]
Shares issued price per share		$ 0.90
Maxim Group LLC [Member] | Equity Distribution Agreement [Member]
Class of Stock [Line Items]
Proceeds from Issuance or Sale of Equity												$ 13,301,526	$ 53,936,615
Sale of stock, Number of shares issued												5,665,731	20,444,807
Shares sales fee percentage							3.50%					3.50%	3.50%
Underwriting fee amount.												$ 465,533	$ 1,888,727
Minimum [Member] | 2018 Equity Incentive Plan [Member] | Employees [Member]
Class of Stock [Line Items]
Option exercise price per share							$ 1.11
Maximum [Member] | 2018 Equity Incentive Plan [Member] | Employees [Member]
Class of Stock [Line Items]
Option exercise price per share							1.71
Maximum [Member] | Alliance Global Partners, LLC [Member] | Representative Warrants [Member]
Class of Stock [Line Items]
Number of warrant to purchase shares of common stock		266,665
Directors, Officers and Employees [Member]
Class of Stock [Line Items]
Common stock shares issued, value	$ 500,000
Rights [Member]
Class of Stock [Line Items]
Warrant exercise price				$ 1,000						$ 1,000
Proceeds from warrants										$ 4,700,000
Warrant [Member]
Class of Stock [Line Items]
Warrant exercise price				$ 8.80						$ 8.80
Warrants and rights outstanding term				5 years						5 years
Series A Junior Participating Preferred Stock [Member]
Class of Stock [Line Items]
Preferred stock, shares authorized				250,000						250,000
Series B Convertible Preferred Stock [Member]
Class of Stock [Line Items]
Preferred stock, shares authorized				8,000						8,000
Preferred stock stated value				$ 1,000			$ 1,000			$ 1,000		$ 1,000
Preferred Stock, no par value				$ 0						$ 0
Preferred Stock, Shares Outstanding				713			715			713		715
Conversion of common stock										2	7
Series B Convertible Preferred Stock [Member] | Rights [Member]
Class of Stock [Line Items]
Preferred stock face value				$ 1,000						$ 1,000
Preferred Stock [Member]
Class of Stock [Line Items]
Number of shares to be issued on conversion				114						114
Common Stock [Member]
Class of Stock [Line Items]
Common stock shares issued, value										$ 80,000		$ 205,000
Number of shares issued upon transaction										87,045		132,238
Common Stock [Member] | Minimum [Member]
Class of Stock [Line Items]
Shares issued price per share				$ 0.76			$ 1.16			$ 0.76		$ 1.16
Common Stock [Member] | Maximum [Member]
Class of Stock [Line Items]
Shares issued price per share				$ 1.02			$ 2.35			$ 1.02		$ 2.35

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Schedule of Assumptions to Estimate Fair Value of Warrants (Details)	Sep. 30, 2022 $ / shares	Dec. 31, 2021 $ / shares	Mar. 16, 2018
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant term			5 years
April 2018 Warrants [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Underlying price per share	$ 0.58	$ 0.92
April 2018 Warrants [Member] | Measurement Input, Exercise Price [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	17.16	17.16
April 2018 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	4.06	0.67
April 2018 Warrants [Member] | Measurement Input, Expected Term [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant term	1 year 25 days	1 year 9 months 21 days
April 2018 Warrants [Member] | Measurement Input, Price Volatility [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	70	120
April 2018 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input
March 2019 Warrants [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Underlying price per share	$ 0.58	$ 0.92
March 2019 Warrants [Member] | Measurement Input, Exercise Price [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	8.80	8.80
March 2019 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	4.12	0.78
March 2019 Warrants [Member] | Measurement Input, Expected Term [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Warrant term	1 year 5 months 8 days	2 years 2 months 8 days
March 2019 Warrants [Member] | Measurement Input, Price Volatility [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input	65	125
March 2019 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Measurement input

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Schedule of Range of Probabilities (Details)	9 Months Ended
	Sep. 30, 2022
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Percentage of probability	5.00%
Minimum [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Percentage of probability	0.50%
Weighted Average [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Percentage of probability	1.00%
Maximum [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Percentage of probability	5.00%

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Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	$ 6,986	$ 16,175
Redeemable warrants		35
Fair Value, Inputs, Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities	6,986	16,175
Redeemable warrants
Fair Value, Inputs, Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities
Redeemable warrants
Fair Value, Inputs, Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable securities
Redeemable warrants		$ 35

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Schedule of Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis (Details) - Redeemable Warrants [Member] $ in Thousands	9 Months Ended
	Sep. 30, 2022 USD ($)
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items]
Balance at beginning	$ 35
Fair value adjustments	(35)
Balance at ending

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Schedule of Assets and Liabilities Measured at Fair Value on a Nonrecurring Basis (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($)	[1]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Property plant and equipment	$ 3,900
Total Gains (Losses)	(1,800)
Fair Value, Inputs, Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Property plant and equipment
Fair Value, Inputs, Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Property plant and equipment
Fair Value, Inputs, Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Property plant and equipment	$ 3,900

[1] In accordance with Subtopic 360-10, long-lived assets held and used with a carrying amount of $5,700,000 were written down to their fair value of $3,900,000 resulting in an impairment charge of $1,800,000, which was included in earnings for the period ending December 31, 2021. A $300,000 deposit was received in the third quarter 2022 related to the asset.

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Schedule of Assets and Liabilities Measured at Fair Value on a NonRecurring Basis (Details) (Parenthetical) - USD ($)	3 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Property plant and equipment collections		$ 3,900,000
Impairment charges		1,800,000
Deposit received	$ 300,000
Land, Buildings and Improvements [Member]
Property, Plant and Equipment [Line Items]
Long lived assets held for sale carrying amount		$ 5,700,000

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Fair Value (Details Narrative)	9 Months Ended
	Sep. 30, 2022 $ / shares
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Percentage of probability	5.00%
Floor rate used as proxy for future volatility percentage	100.00%
Measurement Input, Expected Dividend Rate [Member]
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Fair value measurement, per share	$ 0.00

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Financing Obligation Arising from Sale Leaseback Transaction (Details Narrative) - USD ($)			9 Months Ended
	May 13, 2021	Mar. 16, 2018	Sep. 30, 2022	Sep. 30, 2021
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sale of buildings		$ 4,080,000
Lease and property agreement description		lease the property back for ten years at $408,000 per year for two years through March 31, 2020. The lease payments would increase 2.5% per year for the next three years through March 31, 2023, and the lease payments would increase 3% for the remaining five years through March 31, 2028
Warrants term		5 years
Warrant to purchase of common stock		73,314
Warrant exercise price per share		$ 17.05
Warrant closing price, percentage		125.00%
Repurchase of property	$ 4,732,637
Financing Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Interest expense			$ 0	$ 67,000

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Schedule of Operating lease Future Payments (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Leases
2022	$ 46,000
2023	187,000
2024	183,000
2025	180,000
2026	185,000
Thereafter	171,000
Less imputed interest	(86,000)
Total	$ 866,000	$ 149,000

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Leases (Details Narrative)							9 Months Ended		12 Months Ended
	Oct. 05, 2022 USD ($)	Jun. 16, 2022 USD ($) ft²	Feb. 17, 2022 USD ($)	Sep. 14, 2020 USD ($)	May 01, 2019 USD ($) ft²	Jun. 13, 2018 USD ($) ft²	Sep. 30, 2022 USD ($)	Sep. 30, 2021 USD ($)	Dec. 31, 2021 USD ($)
Rent expenses							$ 75,000	$ 39,000
Weighted average remaining term							2 years 8 months 1 day		2 years 8 months 19 days
Incremental borrowing rate							0.10		0.10
Right of use asset							$ 866,000		$ 149,000
Operating lease liability							866,000		$ 149,000
Short term lease rent expense							$ 8,000	$ 8,000
Lease Agreement [Member]
Lease agreement term	1 year	5 years			3 years
Lease commenced date	May 01, 2023	Jul. 01, 2022			May 01, 2019
Base rent per month					$ 2,500
Rentable area | ft²		5,210			3,000
Percentage of base rent		3.00%
Rent expenses	$ 2,850
Lease Agreement [Member] | First Year [Member]
Base rent per month		$ 15,630
Lease Agreement [Member] | Fifth Year [Member]
Base rent per month		$ 18,118
Lease Agreement [Member] | Fraser Advanced Information Systems [Member]
Lease agreement term				5 years
Lease commenced date				Sep. 14, 2020
Base rent per month				$ 1,415
Lease Agreement [Member] | SML FL Holdings LLC [Member]
Lease agreement term						6 years
Lease commenced date						Jul. 01, 2018
Rentable area | ft²						3,000
Percentage of base rent						3.00%
Lease Agreement [Member] | SML FL Holdings LLC [Member] | First Year [Member]
Base rent per month						$ 2,100
Lease Agreement [Member] | SML FL Holdings LLC [Member] | Sixth Year [Member]
Base rent per month						$ 2,785
Lease Agreement [Member] | Canon Copier [Member]
Lease agreement term			2 years
Lease commenced date			Mar. 01, 2022
Base rent per month			$ 322
Minimum [Member]
Operating lease term							1 year
Operating lease, remaining lease term							11 months
Maximum [Member]
Operating lease term							5 years
Operating lease, remaining lease term							5 years

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Research, Consulting and Supply Agreements (Details Narrative) - USD ($)		1 Months Ended	3 Months Ended		9 Months Ended		12 Months Ended
	Jun. 13, 2022	Apr. 30, 2022	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Research and development expense			$ 1,372,000	$ 2,006,000	$ 4,883,000	$ 4,749,000
Centre for Human Drug Research [Member]
Research and consulting					1,066,000
Polysciences Inc [Member]
Research and consulting					103,000		$ 250,000
Amarex Clinical Research LLC [Member]
Research and development expense		$ 8,200,000
Research and development expense	$ 4,400,000	$ 1,000,000.0
Estimated lives		4 years 7 months 6 days
Development cost	125,470
Invigilators cost	$ 2,400,000
Pharmaceutics International, Inc [Member]
Research and development expense					$ 259,000		$ 89,000

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Subsequent Events (Details Narrative) - USD ($) $ in Thousands		9 Months Ended
	Nov. 01, 2022	Sep. 30, 2022	Sep. 30, 2021
Subsequent Event [Line Items]
Proceeds from Sale of Property, Plant, and Equipment		$ 300	$ 245
Subsequent Event [Member]
Subsequent Event [Line Items]
Proceeds from Sale of Property, Plant, and Equipment	$ 3,700