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, 2017~~March 31, 2022

Commission File Number: ~~1-13441~~001-27072

~~HEMISPHERX BIOPHARMA,~~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.)

~~860 N. Orange Avenue, Suite B, Orlando,~~ 2117 SW Highway 484, OcalaFL ~~32801~~34473

(Address of principal executive offices) (Zip Code)

~~(215) 988-0080~~(352)448-7797

(Registrant’s telephone number, including area code)

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

~~(Former name, former address and former fiscal year, if changed since last report)~~

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.

~~[X]~~ ☒ Yes ~~[ ]~~ ☐ No

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ 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).

~~[X]~~ ☒ Yes ~~[ ]~~ ☐ No

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

~~[ ]~~	☐ Large accelerated filer	~~[ ]~~	☐ Accelerated filer
~~[ ]~~	☒ Non-accelerated filer	~~[X]~~	☒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 ~~[X]~~ ☒ No

~~31,761,221shares~~

48,048,822 shares of common stock were outstanding, and 713 shares of series B preferred stock were outstanding as ~~of November 1, 2017.~~May 10, 2022.

PART ~~I -~~I- FINANCIAL INFORMATION

ITEM 1:Financial Statements

~~HEMISPHERX BIOPHARMA,~~AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Balance Sheets

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

September 30, 2017 December 31, 2016
(Unaudited) (Audited)
ASSETS
Current assets:
Cash and cash equivalents $ 503 $ 2,408
Marketable securities 1,800 3,460
Accounts receivable 42 -
Assets held for sale 764 764
Prepaid expenses and other current assets 626 309
Total current assets 3,735 6,941

Property and equipment, net 8,795 9,514
Patent and trademark rights, net 860 872
Other assets 1,335 1,546
Total assets $ 14,725 $ 18,873

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 460 $ 887
Accrued expenses
1,740
1,548
Total current liabilities
2,200
2,435

Long- term

Note payable 1,466 -

Redeemable warrants 1,018 940

Commitments and contingencies (Note 6 and Note 13)

Stockholders’ equity:
Preferred stock, par value $0.01 per share, authorized 5,000,000; issued and outstanding; none _ _
Common stock, par value $0.001 per share, authorized 350,000,000 shares; issued and outstanding 31,077,372 and 24,202,921, respectively 31 24
Additional paid-in capital
316,748
315,980
Accumulated other comprehensive income (loss) 29 (5 )
Accumulated deficit
(306,767
) (300,501 )
Total stockholders’ equity
10,041
15,498
Total liabilities and stockholders’ equity $ 14,725 $ 18,873

(Unaudited)

	March 31, 2022			December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents	$	28,989		$	32,093
Marketable securities		15,554			16,175
Funds receivable from New Jersey net operating loss		1,641			1,641
Prepaid expenses and other current assets		296			304
Assets held for sale		3,900			—
Total current assets		50,380			50,213
Property and equipment, net		137			4,047
Right of use asset, net		144			149
Patent and trademark rights, net		1,988			1,974
Other assets		1,506			1,316
Total assets	$	54,155		$	57,699
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	378		$	198
Accrued expenses		328			438
Current portion of operating lease liability		60			37
Total current liabilities		766			673
Long-term liabilities:
Operating lease liability		84			112
Redeemable warrants		4			35
Commitments and contingencies (Notes 12, 13 and 14)		-			-

Stockholders’ equity:
Series B Convertible Preferred Stock, stated value $1,000 per share, 715 issued and outstanding		715			715
Common Stock, par value $0.001 per share, authorized 350,000,000 shares; 47,994,672 issued and outstanding		48			48
Additional paid-in capital		417,459			417,217
Accumulated deficit		(364,921	)		(361,101	)
Total stockholders’ equity		53,301			56,879
Total liabilities and stockholders’ equity	$	54,155		$	57,699

See accompanying notes to consolidated financial statements.

~~-2-~~

~~HEMISPHERX BIOPHARMA,~~AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)

Three months ended
September 30, Nine months ended
September 30,
2017 2016 2017 2016
Revenues:
Clinical treatment programs - US $ 4 $ 22 $ 101 $ 76
Clinical treatment programs - Europe 86 — 286 —

Total revenues 90 22 387 76

Costs and expenses:
Production costs 399 272 887 830
Research and development 787 1,342 3,284 3,244
General and administrative 1,556 1,634 4,839 5,721

Total costs and expenses 2,742 3,248 9,010 9,795

Operating loss (2,652 ) (3,226 ) (8,623 ) (9,719 )

Interest expense and other finance costs (51 ) — (70 ) —
Interest and other income/expense 13 40 60 156
Redeemable warrants valuation adjustment 1,438 103 2,361 103
Insurance proceeds from legal settlement, net — 190 — 1,626
Gain (Loss) on sales of short term marketable securities — 31 6 (56 )
Gain from sale of income tax net operating losses
and research credits — — — 1,561

Net loss (1,252 ) (2,862 ) (6,266 ) (6,329 )

Other comprehensive income (loss):
Reclassification adjustments for loss on sales of short term marketable securities included in net loss — (31 ) (6 ) 56
Unrealized gain on marketable securities 11 15 40 112
Net comprehensive loss $ (1,241 ) $ (2,878 ) $ (6,232 ) $ (6,161 )

Basic and diluted loss per share $ (0.04 ) $ (0.13 ) $ (0.23 ) $ (0.30 )

Weighted average shares outstanding, basic and diluted 30,096,500 21,832,940 27,598,715 21,046,418


	Three months ended March 31,
	2022			2021
Revenues:
Clinical treatment programs – US	$	33		$	28
Clinical treatment programs – Europe		—			—
Total Revenues		33			28
Costs and Expenses:
Production costs		77			237
Research and development		1,036			1,424
General and administrative		2,072			2,112
Total Costs and Expenses		3,185			3,773
Operating loss		(3,152	)		(3,745	)
(Loss) on investments		(934	)		—
Interest and other income		45			72
Interest expense and other finance costs		—			(50	)
Redeemable warrants valuation adjustment		31			(37	)
Gain from sale of income tax operating losses		190			181

Net Loss		(3,820	)		(3,579	)

Other comprehensive loss
Reclassification adjustment for realized investment loss		—			2
Change in unrealized loss on marketable securities available for sale		—			(163	)
Net comprehensive loss	$	(3,820	)	$	(3,740	)
Basic and diluted loss per share	$	(0.08	)	$	(0.08	)
Weighted average shares outstanding basic and diluted		47,994,672			45,726,855

See accompanying notes to consolidated financial statements.

~~-3-~~

~~HEMISPHERX BIOPHARMA,~~AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated ~~Statement~~Statements of Changes in Stockholders’ Equity

~~For the Nine Months Ended September 30, 2017~~

(in thousands except share data)

~~(Unaudited)~~

	Series B Preferred Shares			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
Shares issued for:
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

	Series B Preferred Shares			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, 2020		732			42,154,371	$	42	$	402,541	$	(47	)	$	(341,974	)	$	61,294
Shares issued for:
Common Stock issuance, 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		—			—			—
Net comprehensive loss		—			—		—		—		(161	)		(3,579	)		(3,740	)
Balance March 31, 2021		725			47,832,997	$	48	$	415,995	$	(208	)	$	(345,553	)	$	70,967

Common Stock Shares Common Stock $0.001
Par
Value Additional Paid-In Capital Accumulated Other Compre- hensive Income (Loss) Accumulated Deficit Total
Stockholders’ Equity
Balance at December 31, 2016 24,202,921 $ 24 $ 315,980 $ (5 ) $ (300,501 ) $ 15,498
Equity-based compensation 446,753 _ 286 — — 286
Issuance of redeemable warrants — —
(2,050
) — —
(2,050
)
Deemed dividends — — (388 ) — _ (388 )
Common stock issuance, net of costs 4,646,205 5 2,175 — — 2,180
Common stock issued for accounts payable 1,781,493 2 745 — — 747
Net comprehensive income (loss) — — — 34
(6,266
)
(6,232
)

Balance at September 30, 2017 31,077,372 $ 31 $
316, 748
$ 29 $
(306,767
) $
10,041

See accompanying notes to consolidated financial statements.

~~-4-~~

~~HEMISPHERX BIOPHARMA,~~AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

For the ~~Nine~~Three Months Ended ~~September 30, 2017~~March 31, 2022 and ~~2016~~2021

(in thousands)

(Unaudited)

2017 2016
Cash flows from operating activities:
Net loss $
(6,266
) $ (6,329 )

Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment 739 854
Amortization of Debt Issuance Costs 13 -
Redeemable warrants valuation adjustment
(2,361
) (103 )
Amortization and abandonment of patent and trademark rights 48 125
Equity-based compensation 286 344
Realized gain(loss) on sale of marketable securities (6 ) 56

Change in assets and liabilities:
Accounts receivable (42 ) —
Prepaid expenses and other current assets (317 ) (224 )
Other assets 211 —
Accounts payable 174 (202 )
Accrued expenses
340
201
Net cash used in operating activities (7,181 ) (5,278 )

Cash flows from investing activities:
Sale of marketable securities 1,699 3,371
Purchase of property, equipment and construction in progress (20 ) (160 )
Lease deposit refund — 14
Additions to patent and trademark rights (36 ) (282 )
Net cash provided by investing activities 1,643 2,943

Cash flows from financing activities:
Payments on capital leases — (1 )
Debt issuance costs (90 ) —
Proceeds from note payable 1,543 —
Proceeds from sale of stock, net of issuance costs 2,180 4,694
Net cash provided by financing activities 3,633 4,693

Net increase (decrease) in cash and cash equivalents (1,905 ) 2,358
Cash and cash equivalents at beginning of period 2,408 2,115
Cash and cash equivalents at end of period $ 503 $ 4,473

Supplemental disclosures of non-cash investing and financing cash flow information:
Unrealized gain on marketable securities $ 40 $ 112
Insurance proceeds from legal settlement — $ 1,626
Stock issued for accrued expenses $ 747 $ —
Fair value of redeemable warrants granted $
2,050
$ 2,617

	2022			2021
Cash flows from operating activities:
Net loss	$	(3,820	)	$	(3,579	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment		10			162
Redeemable warrants valuation adjustment		(31	)		37
Amortization of patent, trademark rights		19			65
Changes in ROU assets		5			11
Loss on available for sale marketable securities		19			2
Gain from sale of income tax operating losses		(190	)		(181	)
Equity-based compensation		242			526
Unrealized loss on marketable securities		915			—
Amortization of finance and debt issuance costs		—			36
Change in assets and liabilities:
Prepaid expenses and other current assets and other non current assets		8			26
Lease liability		(5	)		(11	)
Accounts payable		180			(194	)
Accrued expenses		(110	)		55
Net cash used in operating activities		(2,758	)		(3,045	)
Cash flows from investing activities:
Proceeds from sale of marketable securities		407			2,039
Purchase of marketable securities		(720	)		(1,151	)
Purchase of patent and trademark rights		(33	)		(365	)
Net cash (used in) provided by investing activities		(346	)		523
Cash flows from financing activities:
Financing obligation payments		—			(93	)
Proceeds from sale of stock, net of issuance costs		—			12,887
Net cash provided by financing activities		—			12,794
Net (decrease) increase in cash and cash equivalents		(3,104	)		10,272
Cash and cash equivalents at beginning of period		32,093			38,501
Cash and cash equivalents at end of period	$	28,989		$	48,773
Supplemental disclosures of non-cash investing and financing cash flow information:
Conversion of Series B preferred	$	—			7

See accompanying notes to consolidated financial statements.

~~-5-~~

~~HEMISPHERX BIOPHARMA,~~AIM IMMUNOTECH INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1:Business and Basis of Presentation

~~The consolidated financial statements include the financial statements of Hemispherx Biopharma,~~AIM ImmunoTech Inc. and its ~~wholly-owned~~ 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 ~~two domestic subsidiaries: BioPro Corp.~~established a strong foundation of laboratory, pre-clinical and ~~BioAegean Corp.~~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), ~~both~~a first-in-class drug of ~~which are incorporated~~large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon alfa-n3). Ampligen has not been approved by the FDA or marketed in ~~Delaware~~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 dsRNA being developed for globally important cancers, viral diseases and ~~are dormant.~~ disorders of the immune system.

The Company ~~also~~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.
	●	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 myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or difficulty thinking/concentrating as the predominate Post-COVID conditions (as referenced on CDC website Sept. 16, 2021).

The Company is prioritizing 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. The Company intends that priority clinical work be conducted in FDA or EMA authorized trials which could support a potential future New Drug Application (“NDA”). 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 and able to generate valid proof-of-concept data, including foreign venues.

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 they determined to be obsolete and no longer needed for current or future manufacturing. Then, on March 3, 2022, AIM entered into an Agreement of Sale and Purchase with Acellories, Inc. as purchaser pursuant to which the Company will sell the property for $3.9 million. The buyer has a ~~foreign subsidiary, Hemispherx Biopharma Europe N.V./S.A., which was established~~mortgage contingency, with the clause expiring on June 1, 2022. Assuming that condition is met, we would anticipate closing on or before July 1, 2022.

Moving forward, AIM will require one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen API. While AIM believes they have sufficient Ampligen API to meet their current needs, they are also continually exploring new efficiencies so as to maximize their ability to fulfill future obligations. In this regard, in ~~Belgium in 1998. All significant intercompany balances~~April 2021, AIM approved a proposal from Polysciences Inc. (“Polysciences”) for the manufacture of Poly I and ~~transactions have been eliminated in consolidation.~~

Poly C₁₂U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance their capacity to produce the polymer precursors to the drug Ampligen. The Company ~~has incurred numerous years~~is utilizing Polysciences’s expertise to refine their approach to polymer production. Additionally, AIM continues to be open to the possibility of ~~substantial operating losses~~agreements with other CMOs, so as ~~it pursued its clinical~~to create redundancy and ~~pre-clinical development activities and appropriate regulatory approval processes before any such products can be sold and marketed. As~~to meet the potential need for larger quantities of September 30, 2017, our accumulated deficit was $306,767,000. The Company has not yet generated significant revenues from our products and may incur substantial losses in the future. The Company evaluated these conditions and events that may raise substantial doubt about the Company’s ability to continue as a going concern; however, the Company believes that it has alleviated the substantial doubt by implementing certain actions. The Company reexamined its fundamental priorities in terms of direction, corporate culture and its ability to fund operations. As a result, there were significant changes at the Company including the Company restructuring its executive management team, initiating the pursuit of international sales of clinical grade materials, and implementing a cost saving program which assisted the Company in gained efficiencies and eliminated redundancies within its workforce. In addition, the Company is in the process of selling an underutilized building adjacent to its New Jersey manufacturing facility site. Also, the Company is 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 approved drug Alferon N®. Lastly, the Company plans to access the public equity markets to raise further capital.API.

In the opinion of ~~Management,~~management, all adjustments necessary for a fair presentation of such 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, ~~2016~~2021 and ~~2015,~~2020, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, ~~2016.~~2021, filed on March 31, 2022.

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 ~~5,970,948~~2,453,782 and ~~2,561,299 for the three months ended September 30, 2017 and 2016~~ 1,672,825, ~~respectively; and 9,392,453 and 4,129,215 shares for the nine months ended September 30, 2017 and 2016, respectively,~~ are excluded from the calculation of diluted net loss per share for the three months ended March 31, 2022, and 2021, respectively, since their effect is ~~anti-dilutive. Due~~antidilutive due to the ~~exchange of warrants described in Note 8(b), the number of equivalent warrants decreased in the three months ended September 30, 2017.~~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~~During the three months ended March 31, 2022 there were ~~1,340,672~~300,000 options granted and ~~247,917~~0 options ~~and equity warrants~~ granted in the ~~nine~~three months ended ~~September 30, 2017 and 2016, respectively.~~March 31, 2021.

~~-6-~~

Stock option for employees’ activity during the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2022, is as follows:

Stock option activity for employees:

Schedule of Stock Option Activity

Number of Options Weighted Average Exercise
Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic
Value
Outstanding January 1, 2017 836,256 $ 16.82 4.47 $ —
Granted 584,795 0.50 — —
Forfeited (208,382 ) 34.09 — —
Outstanding September 30, 2017 1,212,669 $ 5.98 7.14 $ —
Vested and expected to vest September 30, 2017 1,212,669 $ 5.98 7.14 $ —
Exercisable September 30, 2017 747,788 $ 8.25 4.96 $ —

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)			Aggregate Intrinsic Value
Outstanding January 1, 2022		1,498,798		$	4.22		9.11		$	—
Granted		150,000			0.70		9.75			—
Forfeited		—			233.54		—			—
Expired		(739	)		—		—			—
Outstanding March 31, 2022		1,648,059		$	3.80		8.94	��	$	—
Vested and expected to vest March 31, 2022		1,648,059		$	3.80		8.94		$	—
Exercisable March 31, 2022		1,216,894		$	3.15		6.08		$	—

Unvested stock option activity for employees:

Number of Options Weighted Average Exercise
Price Average Remaining Contractual Term (Years) Aggregate Intrinsic
Value
Outstanding January 1, 2017 90,625 $ 1.72 9.33 $ —
Granted 584,795 0.50 — —
Vested (210,539 ) 1.05 — —
Forfeited — — — —
Outstanding September 30, 2017 464,881 $ 0.49 9.86 $ —

Schedule of Unvested Stock Option Activity

	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		9.75		—
Expired		(739	)		233.54		—		—
Vested		(130,596	)		1.52		9.88		—
Unvested March 31, 2022		431,165		$	2.69		7.32	$	—

Stock option activity for non-employees:

Schedule of Stock Option Activity

Number of Options Weighted Average Exercise
Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic
Value
Outstanding January 1, 2017 271,500 $ 10.41 4.66 $ —
Granted 605,877 0.42 — —
Exercised — — — —
Forfeited (40,313 ) 19.67 — —
Outstanding September 30, 2017 837,065 $ 2.73 6.93 $ —
Vested and expected to vest September 30, 2017 837,065 $ 2.73 6.93 $ —
Exercisable September 30, 2017 278,775 $ 7.34 5.00 $ —

	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		9.75		—
Forfeited		—		—		—		—
Expired		—		—		—		—
Outstanding March 31, 2022		429,723	$	4.23		8.40	$	—
Vested and expected to vest March 31, 2022		429,723	$	4.23		8.40	$	—
Exercisable March 31, 2022		222,770	$	6.05		7.96	$	—

~~-7-~~

Unvested stock option activity for non-employees:

Schedule of Unvested Stock Option Activity

Number of Options Weighted Average Exercise
Price Weighted Average Remaining Contractual Term (Years)
Aggregate Intrinsic
Value

Outstanding January 1, 2017 26,389 $ 1.65 8.61 $ —
Granted 605,877 0.42 — —
Vested (71,198 ) 0.82 — —
Forfeited (2,778 ) 1.56 — —
Outstanding September 30, 2017 558,290 $ 0.42 7.82 $ —

	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		9.75		—
Expired		—			—		—		—
Vested		(40,878	)		1.35		—		—
Unvested March 31, 2022		206,953		$	3.66		7.60	$	—

~~The impact on the Company’s results of operations of recording equity-based~~Stock-based compensation expense was approximately $242,000 and $526,000 for the ~~nine~~three months ended ~~September 30, 2017~~March 31, 2022 and ~~2016 was to~~2021, resulting in an increase ~~costs~~in general and administrative expenses, ~~by approximately $286,000~~respectively.

As March 31, 2022, and ~~$344,000, respectively, which decreased earnings per share by $0.01 and $0.02 for September 30, 2017 and 2016, respectively.~~

~~As of September 30, 2017 and 2016,~~2021, respectively, there was ~~$537,000~~approximately $729,000 and ~~$332,000~~$914,000 of unrecognized equity-based compensation cost related to options granted under the Equity Incentive Plan.

In January 2016, the Board, based on the recommendation of its Compensation Committee, established two programs - the 2016 Senior Executive Deferred Cash Performance Award Plan for Dr. William A. Carter and Thomas K. Equels, the Company’s two primary executive officers, and the 2016 Voluntary Incentive Stock Award Plan for Company employees and Board members other than Dr. Carter and Mr. Equels. Both Plans include a Base Pay Supplement provision.

The Company maintains a record of the number of shares of stock represented by each Incentive Right issued out of the 2016 Voluntary Incentive Stock Award Plan. During the nine months ended September 30, 2016, the Company granted rights of 140,936 incentive shares associated with the Plan and recorded $219,000 in equity-based compensation. There were no incentive shares issued during the nine months ended September 30, 2017.

Effective with the semi-monthly period ended April 30, 2017, all of the members of the Company’s Board of Directors agreed to accept 100% of their directors’ fees in the form of options to purchase Company Common Stock. This program was terminated as of August 31, 2017. In this regard, options to purchase 355,772 shares of Company common stock were issued with exercise prices ranging from $0.36 to $0.67, a holding period of 10 years and vesting over three years. In addition, commencing with the semi-monthly period ended June 15, 2017, certain officers of the Company and certain other employees of the Company, agreed to accept 20% of their salary in options to purchase Company Common Stock. This program was also terminated as of August 31, 2017. In this regard, options to purchase 284,795 shares of Company common stock were issued with exercise prices ranging from $0.36 to $0.49, a holding period of 10 years and vesting over three years.

As part of the cash conservation program adopted in August 2017, starting with the month of September 2017, the salaries of all the employees of the Company were paid 50% in the form of unrestricted common stock of the Company. The number of shares issued, in September 2017, to the employees under this program were 408,072 shares at stock prices ranging from $0.34 to $0.38 per share. These shares include a $3,000 bonus paid in shares to each employee to help defray any future losses. This program will continue until discontinued by the Board of Directors

~~Note 4: Inventories~~

~~The Company uses the lower of first-in, first-out (“FIFO”) cost or market method of accounting for inventory.~~

~~-8-~~

Inventories consist of the following: (in thousands)
September 30, 2017 December 31, 2016

Inventory work-in-process, January 1 $ — $ 1,326
Production — —
Transfer to other assets — (1,326 )
Spoilage — —
Inventory work-in-process, end of period $ — $ —

Commercial sales of Alferon® will not resume until new batches of commercial filled and finished product are produced and released by the FDA. The Company will continue the validation of Alferon® production and production of new Alferon® API inventory when funding becomes available. While the facility is approved by the FDA under the Biological License Application (“BLA”) for Alferon®, this status will need to be reaffirmed by an FDA pre-approval inspection. The Company will also need the FDA’s approval to release commercial product once it has submitted satisfactory stability and quality release data.

Due to the Company extending the timeline of Alferon® production to an excess of one year, the Company reclassified Alferon® Work-In-Process inventory to other assets within the Company’s balance sheet. The Alferon® Work-In-Process inventory included an initial payment for fill and finish of $211,000. The Company believes that the benefits from this initial payment will no longer be realized and decided to expense it in the current period.

Note 5: 4: Marketable Securities

Marketable securities consist of mutual funds. ~~For the nine months ended September 30, 2017~~At March 31, 2022 and ~~2016,~~December 31, 2021, it was determined that none of the marketable securities had an other-than-temporary ~~impairments.~~impairment. At ~~September 30, 2017~~March 31, 2022 and December 31, ~~2016,~~2021, all securities ~~were classified as available for sale investments and~~ were measured as Level 1 instruments of the fair value measurements ~~standard.~~standard (See Note 11: Fair Value). As of March 31, 2022, and December 31, 2021 the Company held $15,554,000 and $16,175,000 in mutual funds.

~~Securities~~Mutual Funds classified as available for sale consisted of:

Schedule of Available for Sale

~~September 30, 2017~~March 31, 2022

(in thousands)

Securities	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value		Short-Term Investments		Long Term Investments		Fair Value		Short-Term Investments
Mutual Funds	$	1,771	$	30	$	(1	)	$	1,800	$	1,800	$	—	$	15,554	$	15,554
Totals	$	1,771	$	30	$	(1	)	$	1,800	$	1,800	$	—	$	15,554	$	15,554

Schedule of Equity Securities

March 31, 2022

(in thousands)

Securities
Net losses recognized during the period on equity securities	$	(934	)
Less: Net gains and losses recognized during the period on equity securities sold during the period		(19	)
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date	$	(915	)

Mutual Funds classified as available for sale consisted of:

December 31, ~~2016~~2021

(in thousands)

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

Securities Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-Term Investments Long Term Investments
Mutual Funds $ 3,465 $ — $ (5 ) $ 3,460 $ 3,460 $ —
Totals $ 3,465 $ — $ (5 ) $ 3,460 $ 3,460 $ —

December 31, 2021

~~-9-~~

~~Unrealized losses on investments~~

~~Investments with continuous unrealized losses for less than 12 months and 12 months or greater and their related fair values were as follows:~~

~~September 30, 2017~~

(in thousands)

Total Less Than 12 Months 12 Months or Greater Totals
Securities Number In Loss Position Fair Values Unrealized Losses Fair Values Unrealized Losses Total Fair Value Total Unrealized Losses
Mutual Funds 1 $ 402 $ (1 ) $ - $ - $ 402 $ (1 )
Totals 1 $ 402 $ (1 ) $ - $ - $ 402 $ (1 )

~~December 31, 2016~~

~~(in thousands)~~

Total Less Than 12 Months 12 Months or Greater Totals
Securities Number
In Loss
Position Fair
Values Unrealized
Losses Fair
Values Unrealized
Losses Total
Fair
Value Total
Unrealized
Losses
Mutual Funds 1 $ 1,853 $ (13 ) $ - $ - $ 1,853 $ (13 )
Totals 1 $ 1,853 $ (13 ) $ - $ - $ 1,853 $ (13 )

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 6: 5: Accrued Expenses

Accrued expenses consist of the following:

Schedule of Accrued Expenses

	March 31, 2022		December 31, 2021
	(in thousands)
	March 31, 2022		December 31, 2021
Compensation	$	14	$	1
Professional fees		94		169
Clinical trial expenses		61		61
Other expenses		159		207
Accrued expenses	$	328	$	438

(in thousands)
September 30, 2017 December 31, 2016
Compensation $ 330 $ 297
Professional fees 456 604
Clinical trial expenses 375 158
Other expenses 579 489
$ 1,740 $ 1,548

Note 7: 6: Property and Equipment, net

Schedule of Property and Equipment

(in thousands)
September 30, 2017 December 31, 2016
Land, buildings and improvements $ 10,547 $ 10,530
Furniture, fixtures, and equipment 5,625 5,630
Total property and equipment 16,172 16,160
Less: accumulated depreciation and amortization (7,377 ) (6,646 )
Property and equipment, net $ 8,795 $ 9,514

	March 31, 2022			December 31, 2021
	(in thousands)
	March 31, 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		(2,216	)		(2,206	)
Property and equipment, net	$	137		$	4,047

Property and equipment are recorded at cost. Depreciation and amortization are 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 periods ending March 31, 2022 and March 31, 2021 was $10,000and $162,000, respectively.

The Company ~~also reclassified~~made a strategic shift on in-house manufacturing and recorded an ~~underutilized building as an asset~~impairment of the facility in the amount of $1,800,000 during the year ended December 31, 2021. During the period ending March 31, 2022, the Company reported assets held for ~~resale totaling $764,000 adjacent~~sale related to ~~its New Jersey~~the pending sale of the manufacturing facility ~~site that it~~located at 783 Jersey Avenue, which is inexpected to close within 120 days of the ~~process~~effective date of ~~selling.~~

the Agreement of Sale and Purchase effective March 3, 2022. (See Note 11 Fair Value).

~~-10-~~

Note 7: Patents

Schedule of Patents, Trademark Rights

December 31, 2020	$	1,498
Acquisitions		592
Amortization		(116	)
December 31, 2021	$	1,974
Acquisitions		33
Amortization		(19	)
March 31, 2022	$	1,988

Patents and trademarks are stated at cost 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 and thereafter is as follows:

Schedule of Amortization of Patents and Trademarks

Year Ending December 31,
2022	$	59
2023		153
2024		177
2025		199
2026		235
Thereafter		1,165
Total	$	1,988

Note 8: Stockholders’ Equity

(a) Preferred Stock

The Company is authorized to issue 5,000,000 shares of ~~$0.01~~$0.01 par value preferred stock with such designations, rights and preferences as may be determined by the Board of Directors. ~~There were no~~Of our authorized preferred stock, 250,000 shares have been designated as Series A Junior Participating Preferred ~~Shares issued~~Stock and ~~outstanding~~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, 0 par value, stated value $1,000 per share. As of ~~September 30, 2017~~March 31, 2022, and December 31, ~~2016.~~2021, the Company had 715 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 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 three months ending March 31, 2022, 0 shares of Series B Convertible Preferred Stock were converted into common stock.

(b) Common ~~Stock.~~Stock

The Company’s stockholders approved an amendment to the Company’s corporate Charter at the Annual Shareholder Meeting held in Philadelphia, PA that concluded in December 2011. This amendment increased the Company’sCompany has authorized shares ~~from 200,000,000 to~~ of 350,000,000 with specific limitations and restrictions on the usage of ~~75,000,000~~8,000,000 of the ~~150,000,000 newly~~350,000,000 authorized shares.

~~In September 2015,~~On July 7, 2020, the ~~Company’s stockholders removed~~board of directors approved a plan pursuant to which all directors, officers, and employees could purchase from the ~~limitations and restrictions on 67,000,000 shares. The Company’s stockholders approved~~Company up to an ~~additional 60,000,000~~aggregate of $500,000 worth of shares at the market price. Pursuant to NYSE American rules, this plan was effective for ~~use in capital raising transactions~~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 ~~7,000,000~~employees to buy Company shares ~~for use in the Equity Plan of 2009. In August 2016,~~from the Company ~~effected a 12 to 1 reverse stock split~~at the market price. Subsequent plans were approved by the board of directors upon the ~~outstanding shares, in order to become compliant with~~expiration of prior plans. The latest plan was approved by the ~~NYSE regulations. This did not affect~~board of directors on March 2, 2022.

During the ~~number of authorized shares.~~

~~In September 2016,~~three months ended March 31, 2022, the Company ~~entered into Securities Purchase Agreements with certain investors for~~issued a total of 0 shares of its common stock.

During the ~~sale by~~twelve months ended December 31, 2021, the Company issued a total of ~~3,333,334~~132,238 shares of its common stock at prices ranging from $1.16 to $2.35 for a ~~purchase price~~total of ~~$1.50 per share and sold~~$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 ~~to purchase 2,500,000~~exercisable for 7,148,310 shares of Common Stock ~~for aggregate net proceeds of $4,520,000 after deducting certain fees due to the placement agent~~(the “Pre-funded Warrants”), and the Company’s transaction expenses. Subject to certain ownership limitations, the warrants were initially exercisable six-month after issuance at an exercise price equal to $2.00 per share of Common Stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date.

In June 2017, pursuant to an offer to the holders of the foregoing warrants (the “Exchange Transaction”), the exercise price of the foregoing warrants was changed to $0.50. As a result the warrant holders exercised these warrant and purchased 2,370,000 shares of company common stock. As part of the Exchange Transaction, the Company issued 2,370,000 series A warrants with an exercise price of $0.60 per share, an initial exercise date of December 1, 2017 and expiring March 6, 2022 and 7,584,000 series B warrants with an exercise price of $0.60, an initial exercise date December 1, 2017 per share and expiring March 1, 2018. The Company received net proceeds from the foregoing transaction of approximately $1,055,000, after deducting certain fees due to the placement agent and the Company’s transaction expenses. In July 2017, the warrant holders exercised the remaining 130,000 warrants issued in September 2016 and purchased 130,000 shares of common stock. The Company realized additional net proceeds of $65,000 from this exercise. In conjunction with the foregoing the Company issued an additional 130,000 series A warrants and 416,000 series B warrants (with an exercise price of $0.60 and an initial exercise date January 10, 2018 on the three month anniversary of the of the initial exercise date).The net proceeds received by the Company from these offerings will be used for preparation for technology transfer opportunities, expenses related to Ampligen® manufacturing, working capital and general corporate purposes.

Pursuant to an engagement agreement, the Company paid its placement agent an aggregate fee equal to 7% and 10.5%, respectively, of the gross proceeds received by the Company from the sale of the securities in the offerings and granted to its placement agent or its designees(iii) warrants to purchase up to 5%an aggregate of the aggregate number of shares sold in the transactions amounting to 166,667 and 107,759, respectively, unregistered warrants. The placement agent warrants have substantially the same terms as the investor warrants, except that the 166,667 placement agent warrants will expire September 1, 2021 and have an exercise price equal to $1.875 per share of common stock and the 107,759 placement agent warrants will expire June 1, 2022 and have an exercise price of $0.625.

~~-11-~~

In August 2017, the Holders of the series A warrants and series B warrants exchanged all of their warrants for new warrants (respectively, the “Series A Exchange Warrants” and the “Series B Exchange Warrants” and, collectively, the “Exchange Warrants”) identical to the series A warrants and series B warrants except as follows: the exercise price of both Exchange Warrants is $0.45 per share, subject to adjustment therein, and the number of Series B Exchange Warrants issued was proportionately reduced so that all Exchange Warrants in the Exchange Transaction do not exceed 19.9% of the number of the Company’s issued and outstanding8,888,860 shares of Common Stock as(the “Warrants”). In conjunction with the Offering, a Representative’s Warrant to purchase up to an aggregate of ~~May 31, 2017, the date~~266,665 shares of ~~the Exchange Transaction offer letters.~~common stock (the “Representative’s Warrant”). The ~~issuance~~shares of ~~the Exchange~~Common Stock and Warrants ~~by the Company~~were sold at a combined Offering price of $0.90, less underwriting discounts and commissions. Each Warrant sold with the shares of Common Stock ~~issuable upon exercise of~~represents the ~~Exchange Warrants is exempt from registration pursuant to Sections 3(a)(9) and 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”).~~

In February 2017, the Company entered into Securities Purchase Agreements (each, a “February Purchase Agreement”) with certain investors for the sale by us of 1,818,185 shares of its common stock at a purchase price of $0.55 per share. Concurrently with the sale of the common stock, pursuant to the February Purchase Agreement, the Company also sold unregistered warrantsright to purchase ~~1,363,639 shares~~one share of ~~common stock for aggregate net proceeds of approximately $875,000. The warrants have~~Common Stock at an exercise price of ~~$0.75~~$0.99 per ~~share, are exercisable six months after issuance,~~share. The Pre-Funded Warrants and ~~will expire five years from~~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 ~~initial exercise date. Pursuant to an engagement agreement,~~Offering would otherwise result in the ~~Company paid~~purchaser, together with its ~~placement agent an aggregate fee equal to 7%~~affiliates and certain related parties, beneficially owning more than 4.99% of the ~~gross proceeds received by~~Company’s outstanding Common Stock immediately following the ~~Company from the sale~~consummation of the ~~securities~~Offering, in lieu of shares of Common Stock. Each Pre-Funded Warrant represents the ~~offering and granted to its placement agent or its designees warrants~~right to purchase ~~up to 5%~~one share of the aggregate number of shares sold in the transactions amounting to 90,910 unregistered warrants. The placement agent warrants have substantially the same terms as the investor warrants, except that the placement agent warrants will expire on February 1, 2022 and haveCommon Stock at an exercise price ~~equal to $0.6875~~of $0.001 per ~~share of common stock.~~

share. The ~~common stock issued~~Pre-Funded Warrants are exercisable immediately and may be exercised at any time until the Pre-Funded Warrants are exercised in the above referenced September 6, 2016 and February 1, 2017 offerings were offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3, which was initially filed with the SEC in June 2015 and subsequently declared effective on August 4, 2015 (Registration No. 333-205228) and the base prospectus dated as of August 4, 2015 contained therein. The Company filed a prospectus supplements related to these offerings with the SEC on September 1, 2016 and February 3, 2017, respectively, in connection with the sale of the common stock. The common stock issued pursuant to the above June 1, 2017 exercise of warrants were issued pursuant to an effectivefull. A registration statement on Form S-1, ~~which~~relating to the Offering was ~~initially~~ filed with the SEC ~~in May 2017 as subsequently amended~~ and was declared effective on ~~May 23, 2017 (Registration No. 333-217671) and~~September 25, 2019, the ~~prospectus supplement filed~~net proceeds were approximately $7,200,000. As of March 31, 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 “Offering”). The 2019 EDA replaced a prior EDA with Maxim. For the ~~SEC on May 23, 2017.~~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, ~~of 2009,~~ effective ~~June 24, 2009, as amended and giving effect to the~~September 12, ~~to 1 reverse stock split,~~2018, authorizes the grant of ~~non-qualified~~(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 ~~incentive stock options, stock appreciation rights, restricted stock and other stock awards. A~~(viii) Other Stock Awards. Initially, a maximum of ~~22,000,000~~7,000,000 shares of ~~common stock~~Common Stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive ~~Plan of 2009.~~Plan. Unless sooner terminated, the 2018 Equity Incentive Plan ~~of 2009~~ will continue in effect for a period of 10 years from its effective date. ~~For the nine months ended September 30, 2017,~~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. During December 2020, 675,000 options were issued to employees with an exercise price range of $1.85 to $1.96 for a period of ten years with a vesting period of one year.

As of both periods March 31, 2022, and December 31, 2021, there were ~~1,190,672 options granted by the Company.~~47,994,672 shares outstanding.

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

~~In May 2014,~~During the ~~Financial Accounting Standards Board (“FASB”)~~first quarter of 2022 accounting pronouncements issued ~~Accounting Standards Update No. 2014-09 (ASU 2014-09),~~~~Revenue from Contracts with Customers~~. ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current U.S. GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for reporting periods beginning after December 15, 2017, and early adoption is not permitted. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. Upon the Company realizing operating revenues from the sale of commercialized product, the Company is currently evaluating the impact of adopting this guidance on the Company’s financial statements.

~~-12-~~

~~In January 2016, the (“FASB”) has issued Accounting Standards Update (ASU) No. 2016-01,~~~~Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities~~. The new guidance is intended to improve the recognition and measurement of financial instruments. The new guidance is effective for public companies for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The new guidance permits early adoption of the own credit provision. The Company believes that the adoption of the guidance may have an impact on the Company’s financial statement presentation or disclosures.

~~In February 2016,~~by the FASB ~~issued ASU 2016-02 -~~~~Leases,~~ ~~which amends the existing accounting standards for lease accounting, including requiring lessees~~did not or are not believed by management to recognize most leases on their balance sheets and making targeted changes to lessor accounting. ASU 2016-02 will be effective for annual reporting periods beginning after December 15, 2018, and early adoption of is permitted as of the standard’s issuance date. ASU 2016-02 allows a modified retrospective transition approach for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief. The Company has not adopted ASU 2016-02 and believes such adoption may have an impact on the Company’s financial statement presentation or disclosures.

In August 2016, the FASB issued ASU 2016-15 - Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force). The new guidance is intended to address the diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows under Topic 230, Statement of Cash Flows, and other Topics. The guidance addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. The amendments apply to all entities, including both business entities and not-for-profit entities that are required to present a statement of cash flows under Topic 230. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. An entity that elects early adoption must adopt all of the amendments in the same period. The amendments in this Update should be applied using a retrospective transition method to each period presented. The Company believes that the adoption of the guidance will not have a material impact on the Company’s ~~financial statement presentation~~present or ~~disclosures.~~

~~In 2017, the FASB also issued Accounting Standards Updates (“ASU”) 2017-01 through 2017-13. These updates did not have a significant impact on the~~future financial statements.

Note 11: ~~Funds Received from Sale of Income Tax Net Operating Losses~~

As of December 31, 2016, the Company has approximately $174,000,000 of federal net operating loss carryforwards (expiring in the years 2018 through 2036) available to offset future federal taxable income. The Company also has approximately $36,000,000 of Pennsylvania state net operating loss carryforwards (expiring in the years 2018 through 2033) and approximately $8,000,000 of New Jersey state net operating loss carryforwards (expiring in 2036) available to offset future state taxable income.

~~-13-~~

In January 2016, the Company effectively sold $16,000,000 of its New Jersey state net operating loss carryforward for the year 2014 for approximately $1,320,000, and also sold New Jersey research and development credits for $241,000. In December 2016, the Company effectively sold $14,000,000 of its New Jersey state net operating loss carryforward for the year 2015 for approximately $1,120,000, and also sold New Jersey research and development credits for $189,000. The utilization of certain state net operating loss carryforwards may be subject to annual limitations. With no tax due for the foreseeable future, the Company has determined that the accounting for interest or penalties related to the payment of tax is not necessary at this time.

~~Note 12:~~ Fair Value

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 ~~unlikely~~ occurrence of a Fundamental Transaction. The fair value of the redeemable warrants (“Warrants”) related to the Company’s ~~August 2016,~~ February 2017, June 2017, April 2018, and ~~August 2017~~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~~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 August 2016 Warrants:~~

September 30, 2017 December 31, 2016
Underlying price per share $ 0.32 $0.69-$1.26
Exercise price per share 1.88 1.88 - 2.00
Risk-free interest rate 1.76 % 1.86 %
Expected holding period 3.9 4.70
Expected volatility 75 % 85 %
Expected dividend yield - -

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

Schedule of Assumptions to Estimate Fair Value of Warrants

							March 31,			December 31,
	September 30, 2017			February 1, 2017			2022			2021
Underlying price per share	$	0.32		$	0.64		$	1.06		$	0.92
Exercise price per share		0.69-0.75			0.69-0.75			$30.25-$33.00			$30.25-$33.00
Risk-free interest rate		1.82	%		1.86%-1.93	%		0.71%-0.74%			0.22%-0.23%
Expected holding period		4.3			5.00			0.34-0.35			0.58-0.60
Expected volatility		70%-75	%		80%-85	%		85	%		45	%
Expected dividend yield		-			-			—			—

~~-14-~~

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

							March 31,			December 31,
	September 30, 2017			June 1, 2017			2022			2021
Underlying price per share	$	0.32		$	0.53		$	1.06		$	0.92
Exercise price per share		0.63			0.60-0.63		$	27.50		$	27.50
Risk-free interest rate		1.87	%		1.11%-1.76	%		0.35	%		0.15	%
Expected holding period		4.7			.7-5			0.17			0.42
Expected volatility		70	%		80	%		85	%		50	%
Expected dividend yield		-			-			—			—

The Company utilized the following assumptions to estimate the fair value of the ~~August 2017~~April 2018 Warrants:

							March 31,			December 31,
	September 30, 2017			August 23, 2017			2022			2021
Underlying price per share	$	0.32		$	0.37		$	1.06		$	0.92
Exercise price per share		0.45			0.45		$	17.16		$	17.16
Risk-free interest rate		1.15%-1.83	%		1.11%-1.69	%		2.00	%		0.67	%
Expected holding period		0.4-4.4			0.5-4.5			1.57			1.81
Expected volatility		70	%		70	%		70	%		120	%
Expected dividend yield		-			-			—			—

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

	March 31,			December 31,
	2022			2021
Underlying price per share	$	1.06		$	0.92
Exercise price per share	$	8.80		$	8.80
Risk-free interest rate		2.24	%		0.78	%
Expected holding period		1.94			2.19
Expected volatility		75	%		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-~~0% and this assumption will be continued in future calculations unless the Company changes its dividend policy.

~~(v)~~

(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:

1.	a.	The Company only has one product that is FDA approved but ~~which will~~is currently not be available for commercial ~~sales;~~sales.
2.	b.	The Company ~~may~~will have to perform additional clinical trials for FDA approval of its flagship ~~product;~~product.
3.	c.	Industry and market conditions continue to include ~~a global market recession,~~uncertainty, adding risk to any ~~transaction;~~transaction.
4.	d.	Available capital for a potential buyer in a cash transaction continues to be ~~limited;~~limited.
5.	e.	The nature of a life sciences company is heavily dependent on future funding and high fixed costs, including Research & ~~Development;~~Development.
6.	f.	The Company has minimal revenues streams which are insufficient to meet the funding needs for the cost of operations or construction at their manufacturing facility; and
7.	g.	The Company’s Rights Agreement and Executive Agreements make it less attractive to a potential buyer.

~~-15-~~

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:

Schedule of Range of Probabilities

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 elucidated above, the Company utilized a discrete uniform probability distribution over the Expected Holding Period to model in the potential announcement of a Fundamental Transaction occurring during the Expected Holding Period.
	(vii)	Expected 100 Day Volatility at Announcement of a Fundamental Transaction. An estimate of future volatility is necessary as there is no mechanism for directly measuring future stock price movements. Daily observations of the Company’s historical stock values for the 100 days immediately prior to the Warrants’ grant dates, with a floor of ~~100%~~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., utilizing historical stock prices), the numbers input change from period to period (e.g., the actual historical prices input for the relevant period). The carrying amount and estimated fair value of the above Warrants was approximately ~~$1,018,000~~$4,000 and $35,000 at ~~September 30, 2017~~March 31, 2022 and ~~940,000 at~~ December 31, ~~2016.~~2021, respectively.

The Company applies FASB ASC 820 (formerly Statement No. 157Fair Value Measurements) that defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, 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 (formerly SFAS No. 157) 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:

~~-16-~~

1.	●	Level 1 – Quoted prices are available in active markets for identical assets or liabilities at the reporting date. Generally, this includes debt and equity securities that are traded in an active market.
2.	●	Level 2 – Observable inputs other than Level 1 prices such as quote prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Generally, this includes debt and equity securities that are not traded in an active market.
3.	●	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 2017,~~March 31, 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~~the 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:

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

	(in thousands) As of September 30, 2017								(in thousands) As of March 31, 2022
	Total		Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	1,800	$	1,800	$	-	$	-	$	15,554	$	15,554	$	—	$	—
Liabilities:
Redeemable warrants	$	1,018		-		-	$	1,018	$	4		—	$	—		4

	(in thousands) As of December 31, 2016								(in thousands) As of December 31, 2021
	Total		Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3
Assets:
Marketable Securities	$	3,460	$	3,460	$	-	$	-
Marketable securities									$	16,175	$	16,175	$	—	$	—
Liabilities:
Redeemable warrants	$	940		-		-	$	940
Redeemable warrant									$	35		—		—	$	35

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

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

Balance at December 31, 2016 $ 940
Issuance of warrants 2,074
Modification of warrants 389
Fair value adjustments (2,385 )
Balance at September 30, 2017 $ 1,018

Redeemable warrants:
Balance at December 31, 2021	$	35
Fair value adjustments		(31	)
Balance at March 31, 2022	$	4

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

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

	(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.

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 March 31, 2022 and $14,000 for the period ended March 31, 2021.

Note 13: ~~Note Payable~~Leases

~~In May 2017,~~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 ~~mortgage and note payable agreement with~~Lease Agreement for a ~~bridge funding company~~term of six years commencing on July 1, 2018 pursuant to ~~obtain a two-year funding line of up to $4,000,000 secured by the property and assets located at 783 Jersey Ave., New Brunswick, New Jersey. Subject to the lender’s approval,~~which the Company ~~will be able~~agreed to ~~request up to $1,800,000 of the line in monthly advances during the loan term of 24 months.~~lease approximately 3,000 rentable square feet. The ~~Company will be able to request future advances in excess of $2,000,000 at the lender’s discretion~~base rent increases by 3% each year, and ~~be payable in full upon maturity. The Company will pay interest on this note at a fixed rate of 12%~~ranges from $2,100 per ~~annum~~month for the first 18year 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 yearscommencing 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 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.

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 13 months and ~~change to a~~5 years. As of March 31, 2022, and December 31, 2021, the weighted-average remaining term is 3.7 and 2.72 years, respectively.

The Company has determined that the incremental borrowing rate ~~equal to 800 basis points above~~is 10% as of March 31, 2022, and December 31, 2021, respectively, based upon the ~~prime rate~~recently completed financing transaction in December 2019.

Future minimum payments as of ~~interest during~~March 31, 2022, are as follows:

Schedule of Operating lease Future Payments

Year Ending December 31,
2022	$	49
2023		60
2024		35
2025		14
Less imputed interest		(14	)
Total	$	144

As of March 31, 2022, and December 31, 2021, the ~~remainder~~balance of the ~~term; however,~~right of use assets was $144,000 and $149,000, respectively, and the ~~interest rate will not be less than 12%~~corresponding lease liability balance was $144,000 and $149,000, respectively. The total rent expense for the ~~entire term.~~period ended March 31, 2022, and December 31,2021 amounted to approximately $17,000 and $67,000, respectively. Total rent expense for short term leases for the period ended March 31, 2022 and December 31, 2021 amounted to approximately $3,000 and $12,000, respectively.

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 ~~note will~~Company has paid CHDR approximately $1,010,000. The balance of the agreement is approximately $61,000, to be ~~interest only~~paid in the second quarter of 2022.

In April 2021, the Company approved a proposal from Polysciences Inc. (“Polysciences”) for the manufacture of our Poly I and ~~payable monthly through~~Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the ~~maturity.~~polymer precursors to the drug Ampligen. The Company is ~~permitted~~working with Polysciences to ~~prepay~~negotiate and finalize both a Service Agreement and a Quality Agreement. For the ~~line without penalty commencing after six months. The balance on~~year ended December 31, 2021 the ~~note at September 30, 2017 is $1,466,000 ($1,543,000 less unamortized deferred finance~~Company has incurred an expense and paid Polysciences approximately $250,000. For the period ended March 31, 2022, the Company paid Polysciences $51,390.

In April 2022, AIM executed a work order with Amarex Clinical Research LLC, 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 ~~$77,000).~~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.

Note ~~14:~~ 15: Subsequent Events

~~As part of the Company’s objectives to achieve its commercial goals and increase stockholder value, the Company has initiated the sale of underutilized assets.~~

None.

The Company entered into a sale agreement on September, 11, 2017 for the sale of its property located at 5 Jules Lane, New Brunswick, New Jersey for $1,050,000. This transaction is expected to close within two weeks. The Company has recorded this property as an asset held for sale.

~~The Company has also completed the process for the sale of its 2016 New Jersey Net Operating Loss. The Company expects to collect $820,000 when this sale is completed.~~

~~-17-~~

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

Special Note Regarding Forward-Looking Statements

Certain statements in this Report ~~including statements under “Item 1. Legal Proceedings” and “Item 1A. Risk Factors” in Part II,~~ 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 involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on our management’s current beliefs, expectations and assumptions about future events, conditions and ~~are subject~~results and on information currently available to ~~risks, uncertainties and~~us. Discussions containing these forward-looking statements may be found, among other ~~important factors. We discuss many of these risks, uncertainties and other important factors~~places, in ~~greater detail under “Item 1A. Risk Factors”~~this Report in Part I, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations”; Part II, ~~in this Report. Because~~Item 1. “Legal Proceedings”; and Part II, Item 1A. “Risk Factors”, as well as the ~~risk factors referred to above and in~~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 ~~most recent fiscal year filed with the Securities~~strategy, future operations, financial position, future revenues, projected costs, plans, prospects and Exchange Commission could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us, you should not place undue reliance on any such forward-looking statements.

Further, these forward-looking statements represent our estimates and assumptions only as of the date such forward-looking statements are made. You should carefully read this Report completely and with the understanding that our actual future results may be materially different from what we expect. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our business, results of operations and financial condition. Any forward-looking statement speaks only as of the date on which it is made and we undertake no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which will arise. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Any statements in this Report about our expectations, beliefs, plans, objectives ~~assumptions or future events or performance that are not historical facts~~ are forward-looking statements. ~~You can identify these forward-looking statements by the use of words or phrases~~Words such as ~~“believe”, “may”, “could”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “seek”, “plan”, “expect”, “should”, or~~“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.

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 issues related to our New Brunswick, New Jersey facility.

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. 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.

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 now are focusing on the potential of Ampligen to serve as a protective prophylaxis and an early-onset therapeutic for severe respiratory viruses, including SARS-CoV-2. 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, will 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 ~~disclosed~~filed provisional patent applications related to the COVID-19 coronavirus. However, these filings do not assure that inpatents will ultimately be granted.

In February 2013, we received a Complete Response Letter (CRL) from the ~~U.S.~~ Food and Drug Administration, ~~(the “FDA”) declining to approve~~or FDA, for our ~~Ampligen®~~Ampligen New Drug Application, ~~(“NDA”)~~or NDA, for ~~Chronic Fatigue Syndrome Treatment, sometimes referred to as myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), stating~~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®~~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®~~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. ~~With regard~~A proposed confirmatory trial and responses to the CRL are being worked on now by our ~~NDA for Ampligen® to treat ME/CFS, as noted above, there are additional steps which the FDA has advised Hemispherx to take in our seeking approval. The final results of these~~R&D team and other ongoing activities, and of the FDA review, could vary materially from Hemispherx' expectations and could adversely affect the chances for approval of the Ampligen® NDA. Any failure to satisfy the FDA’s requirements could significantly delay, or preclude outright, approval of our drugs for commercial sale in the United States.consultants.

~~-18-~~

~~We also have disclosed that, in~~In August 2016, we received approval of our NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica, ~~(“ANMAT”)~~or ANMAT, for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe ~~ME/~~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 ~~(including possible requirements for~~and ANMAT conducting a final inspection of the product and release tests before granting final approval ~~of final manufacturing)~~to begin commercial sales. This testing and ~~we most likely will need additional funds~~approval process is currently delayed due to manufacture product at a sufficient level for a commercial launch. There are no assurances as to whether or when such multiple subsequent steps will be successfully performed to result in an overall successful commercializationthe COVID-19 pandemic and ~~product launch.~~ANMAT’s internal processes. Approval of rintatolimod for ~~ME/~~severe CFS in the Argentine Republic does not in any way suggest that the ~~Ampligen®~~Ampligen NDA in the United States or any comparable application filed in the European Union or elsewhere will obtain commercial approval.

~~We also have disclosed that,~~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 ~~through our agreement with myTomorrows designed to enable access of Ampligen® to ME/CFS patients has been~~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 iswill be our exclusive service provider for special access activities in ~~Europe and Turkey and will manage all EAP activities relating~~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 (EAP) which is 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 ~~extension of the program.~~or CFS in Canada. No assurance can be given that ~~Ampligen®~~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.

In June 2017, we signed an amendment to the EAP with myTomorrows. This amendment is for MyTomorrows to provide support services to Hemispherx with respect to the execution of the 511-Program (“511-Services”). The ~~511-Services shall be rendered~~agreement was automatically extended for a period of 612 months on May 20, 2021, and will automatically extend 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 ~~renewed with additional 6 month periods with written mutual consent,~~given as to the results of these underway trials. No assurance can be given as to whether some or ~~until termination~~all of the ~~511-Program. The 511-Services shall~~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 ~~rendered free~~successful or yield any useful data. In addition, initiation of ~~charge.~~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®~~Ampligen in the United States and abroad as well as seeking to broaden commercial therapeutic indications for Alferon N ~~Injection®~~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®~~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 ~~outsource~~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 ~~manufacturer~~manufacturers will ~~necessarily~~ pass an FDA pre-approval inspection for ~~Alferon® manufacture.~~Alferon N Injection manufacturing.

The production of new ~~Alferon®~~Alferon N Injection Active Pharmaceutical Ingredient, or API, ~~inventory will not commence until~~is currently on hold. While the ~~validation phase is complete. While the~~New Brunswick facility is approved by the FDA under the Biological License Application, ~~("BLA”)~~or BLA, for ~~Alferon®, this status~~Alferon N Injection, and we intend to maintain a certain amount of space at the to-be-sold facility, the sale of the facility — announced in March 2022 — will ~~need~~move up the timeline for contracting with a CMO, or CMOs, capable of producing Alferon, and receiving FDA approval to ~~be reaffirmed by a successful Pre-Approval Inspection by the FDA~~do so, prior to commercial sale of newly produced inventory product. If and when ~~the Company obtains~~we obtain a reaffirmation of FDA BLA status and ~~has~~have begun production of new ~~Alferon®~~Alferon N Injection API, it will need FDA approval as to the quality and stability of the final product ~~to allow~~before commercial sales tocan resume. We ~~will~~may need additional funds to finance the ~~revalidation process in our facility to initiate commercial manufacturing, thereby readying ourselves for an FDA Pre-Approval Inspection.~~validation process. If we are unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new ~~Alferon®~~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®~~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.

~~Overview~~In December 2020, we added Pharmaceutics International Inc. (“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.

~~General~~There have been delays related to importing Ampligen to China. We are working with Smoore to alleviate these issues and to identify a mutually beneficial course of action that would allow us to move forward with the proposed testing of Ampligen. We will announce when the shipment for testing purposes has been completed. AIM and Smoore signed a two-year extension of their MTA in May 2021. We are exploring avenues to further test Ampligen as an inhalation therapy in the United States and Europe, while Smoore continues to work toward receiving authorization to import Ampligen to China.

~~Hemispherx Biopharma,~~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.

Overview

General

AIM ImmunoTech Inc. and its subsidiaries (collectively, ~~“Hemispherx”~~“AIM”, “Company”, ~~“we"~~“we” or “us”) are ~~a specialty pharmaceutical~~an immuno-pharma company headquartered in ~~Philadelphia, Pennsylvania~~Ocala, Florida, and ~~engaged in~~focused on the ~~clinical~~research and development of ~~new drug therapies based on natural immune system enhancing technologies for the treatment~~therapeutics to treat multiple types of cancers, viral diseases and ~~immune based~~immune-deficiency disorders. We ~~were first formed in 1966 and in the early 1970s were doing contract research for the National Institutes of Health. Since that time, we~~ have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon ~~and nucleic acids~~ 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. We have two domestic subsidiaries BioPro Corp., and BioAegean Corp., both of which are incorporated in Delaware and are dormant. Our foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A. which was established in Belgium in 1998.

~~-19-~~

Our flagship products ~~include~~are Ampligen® (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® ~~and~~(Interferon alfa-n3). Ampligen has not been approved by the ~~experimental therapeutic Ampligen®. Alferon N Injection®~~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 ~~category of STD infection, and Ampligen® represents an experimental RNA~~dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system. ~~Hemispherx' platform technology includes components~~

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 myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or difficulty thinking/concentrating as the predominate Post-COVID conditions (as referenced on CDC website Sept. 16, 2021).

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 New Drug Application (“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”). 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 Clinical Research LLC (“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. The FDA placed the study on Clinical Hold in November 2021 and provided valuable feedback on the study design. We submitted our response to the Clinical Hold 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. 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.

Ampligen has also demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. We have also seen success in increasing survival rates and efficacy in the treatment of ~~various severely debilitating~~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 ~~life threatening diseases.~~

~~The below chart provides a summary~~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, 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 Western Equine Encephalitis Virus, Ebola 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 ~~indications~~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, the Centre for ~~both Ampligen®~~Human Drug Research (“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 ~~Alferon® currently under development.~~

~~We own and operate~~biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a ~~30,000 sq. ft. facility~~placebo in ~~New Brunswick, NJ~~the trial, with the ~~objective~~Ampligen given at four escalating dosages across four cohorts, to a maximum level of ~~producing Alferon®~~1,250 micrograms. All patients had completed treatment by June 2021 and ~~Ampligen® upon FDA approval. As part~~the Final Safety Report reported no Serious or Severe Adverse Events at any dosage level.

Today, some two years after COVID-19 first appeared, the world has a number of ~~our objectives~~vaccines and some promising therapeutics. Our quest to ~~achieve our commercial goals and increase stockholder value,~~prove the antiviral activities of Ampligen continues. If Ampligen has the broad-spectrum antiviral properties that we ~~are~~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 ~~process of selling an underutilized building adjacent to our New Jersey manufacturing facility site.~~future. Unlike most developing therapeutics which attack the virus, Ampligen works differently. We ~~do not~~ believe that it activates antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well.

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 ~~sale~~FDA’s approval for the use of ~~this building will have an impact on the production of our products.~~

Ampligen to treat ME/CFS. In fact, in February 2013, we received a Complete Response ~~Letter~~letter (“CRL”) from the FDA ~~declining to approve~~for our Ampligen NDA for ~~Ampligen®~~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 Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“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 Institutional Review Board (“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 March 31, 2022, there are 11 patients enrolled in this open-label expanded access treatment protocol (including 2 post-COVID-19 patients). Early data from the ongoing AMP-511 Expanded Access Program has indicated that patients with Post-COVID conditions (such as fatigue and cognitive function deficiency) have reported improvements after receiving Ampligen.

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 ~~("CFS"~~(“ME/CFS”)~~. Please see the discussion in "Our Products - Ampligen®" below for more detail.~~” below.

We have taken significant actions to focus on our business and management and reserve capital so the Company can better achieve its commercial goals, including, but not limited to, a strict anti-nepotism policy, listing for sale underutilized assets, aggressively pursuing international sales of clinical grade materials, and implementing a strong financial austerity plan. 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 approved drug Alferon N Injection®.

We have relocated our principal executive office to 860 N. Orange Avenue, Suite B, Orlando, FL 32801, and we are in process of moving our Finance and Administration office within the Philadelphia area. The telephone number for our executive office is (407) 839-0095 and for our Finance & Administration office is 215-988-0080

OUR PRODUCTS

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

Ampligen®

~~Ampligen®~~Ampligen is approved for sale in Argentina (to 2026) for severe Chronic Fatigue Syndrome (“CFS”) and is an experimental drug in the United States currently undergoing clinical development for the treatment of ~~CFS in the United States of America. As noted above~~certain cancers and ~~discussed below, the FDA in its CRL declined to approve our NDA for the treatment of CFS with Ampligen®.~~ME/CFS. Over its developmental history, ~~Ampligen®~~Ampligen has received various designations, including Orphan Drug Product Designation ~~(FDA)~~(FDA and European Medicines Agency [“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). ~~Ampligen® represents the first drug in the class of large (macromolecular) RNA (nucleic acid) molecules to apply for NDA review.~~ Based on the results of published, ~~peer reviewed~~peer-reviewed pre-clinical studies and clinical trials, we believe that ~~Ampligen®~~Ampligen may have broad-spectrum ~~anti-viral~~antiviral and anti-cancer properties.

~~-20-~~

We believe that nucleic acid compounds represent a potential new class of pharmaceutical products ~~as they are~~ 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, DNA~~acids: deoxyribonucleic acid (“DNA”) and ~~RNA.~~ribonucleic acid (“RNA”). DNA is a group of naturally occurring molecules found in chromosomes, the ~~cell's~~cell’s genetic machinery. RNA is a group of naturally occurring informational molecules which orchestrate a ~~cell's~~cell’s behavior which, in turn, regulates the action of groups of cells, including the cells which ~~compromise~~comprise the ~~body's~~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. Our double-stranded~~specifically configured RNA ~~drug product, trademarked Ampligen®,~~and is ~~an experimental, unapproved drug in the United States,~~a selective Toll-like Receptor 3 (“TLR3”) agonist that iscan be administered ~~intravenously. Ampligen®~~intravenously, intranasally and intraperitoneally. Ampligen has been assigned the generic name rintatolimod by the United States Adopted Names Council ~~(USANC)~~(“USANC”) and has the chemical designation poly(I):poly(C₁₂U).

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

We have received approval of ~~these potential uses~~our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS. The product will ~~require additional clinical trials~~be marketed by GP Pharm, our commercial partner in Latin America. Shipment of the drug product to ~~generate~~Argentina was initiated in 2018 to complete the ~~safety and effectiveness data necessary to support regulatory approval.~~

release testing by ANMAT needed for commercial distribution. In ~~February 2013,~~September 2019, we received ~~a CRL~~clearance from the FDA ~~declining~~ to ~~approve our NDA~~ship Ampligen to Argentina for ~~Ampligen® for CFS.~~the commercial launch and subsequent sales. In ~~its CRL,~~June 2020, we received import clearance from ANMAT to import the ~~FDA communicated that Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number~~first shipment of ~~data analyses. The additional clinical study should address,~~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, ~~Ampligen®'s efficacy~~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 ~~treating CFS patients, be~~Argentina is taxing the nation’s health care system and is, understandably, the main priority of ~~sufficient size and duration~~its regulators. Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in Argentina. We continue to assess the safety of Ampligen® and be sufficient to determine appropriate dosing. The FDA set forth the reasons for this action and provided recommendations to address certain outstanding issues. The FDA stated that the submitted data does not provide substantial evidence of efficacy of Ampligen®pursue our Ampligen NDA, for the treatment of CFS and that the data does not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. In addition to the safety and effectiveness issues recommended to be addressed in at least one additional clinical trial, the CRL states that Hemispherx should conduct complete rodent carcinogenicity studies in two species prior to approval and also conduct additional animal toxicology studies providing more comprehensive evaluation of Ampligen® fragments and degradation products. The CRL also requests evaluation of variation between lots of Ampligen® tested in the development process and recommends tighter control of the Ampligen® manufacturing process.

In response to the CRL, we continue to plan to avail ourselves of the opportunity for an “end-of-review” meeting with representatives of the Office of Drug Evaluation II which issued the CRL, in order to clarify and seek to narrow the outstanding issues regarding the further development of Ampligen® for the treatment of CFS.

FDA regulations provide a formal dispute resolution process to obtain review of any FDA decision, including a decision not to approve an NDA, by raising the matter with the supervisor of the FDA office that made the decision. The formal dispute resolution process exists to encourage open, prompt discussion of scientific (including medical) disputes and procedural (including administrative) disputes that arise during the drug development, new drug review, and post-marketing oversight processes of the FDA. Depending on the outcome of a number of initiatives in the CFS community, including the FDA’s Patient Focused Drug Development Initiatives, forthcoming drug guidance and other scientific initiatives by the Institute of Medicine, Center for Disease Control and National Institute of Health, we will continue to examine the opportunity for an “end-of-review” meeting. Depending on the results of these initiatives, we may request an "end-of-review" conference with the FDA as a precursor to a possible submission of a formal appeal to the Office of New Drugs within the FDA's Center for Drug Evaluation and Research regarding the FDA's decision. Please see “~~Risks Associated with Our Business~~~~” in Part I; Item 1A. Risk Factors below.~~

Until we undertake the end-of-review conference(s), or otherwise reach an agreement with the FDA regarding the design of a confirmatory study, we are unable to reasonably estimate the nature, costs, necessary efforts to obtain FDA clearance or anticipated completion dates of any additional clinical study or studies. Utilizing the industry norms for undertaking a Phase III clinical study, we estimate upon acceptance of the study's design that it would take approximately 18 months to three years to complete a new well-controlled Ampligen® clinical study for resubmission to the FDA. Industry norms suggest that it will require three to six months to initiate the study, one to two years to accrue and test patients, three to six months to close-out the study and file the necessary documents with the FDA.

The actual duration to complete the clinical study may be different based on the length of time it takes to design the study and obtain FDA's acceptance of the design, the final design of an acceptable Phase III clinical study, availability of suitable participants and clinical sites along with other factors that could impact the implementation of the study, analysis of results or requirements of the FDA and/or other governmental organizations. We anticipate that the time and cost to undertake clinical trial(s), studies and data analysis are beyond our current financial resources without gaining access to additional funding. Please see "Part II; Item 1A, Risk Factors: "~~We will require additional financing which may not be available~~".

~~-21-~~

~~In May 1997, the FDA~~has authorized an open-label expanded access treatment protocol (“AMP-511”), allowing patient access to ~~Ampligen® for treatment~~Ampligen in ~~an open-label safety~~a study under which severely debilitated CFS patients have the opportunity to be on ~~Ampligen®~~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 ~~a consortium group of~~ clinical sites provide safety information regarding the use of ~~Ampligen®~~Ampligen in patients with CFS. We are establishing an enlarged ~~data base~~database of clinical safety information which we believe will provide further documentation regarding the absence of autoimmune disease associated with ~~Ampligen®~~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®~~Ampligen and/or the design of future clinical ~~studies. In 2015, we engaged an independent certified public accountant to recalculate the cost per dose consistent with the current guidelines, utilizing the costs to produce a vial. In October 2016,~~studies that the FDA ~~granted our request~~requested in a CRL. The FDA approved an increased reimbursement level from $200 to ~~implement the new cost~~$345 per 200 mg vial of Ampligen, due to increased production costs; which was ~~initiated during~~re-authorized in 2021. At this time, we do not plan on passing this adjustment along to the ~~quarter ended~~patients in this program. As of March 31, ~~2017. As of September 30, 2017,~~2022, there are 1811 patients ~~participating~~enrolled in this open-label expanded access treatment ~~protocol.~~

protocol (including 2 Post-COVID-19 patients). In ~~July 2012,~~October 2020, we ~~filed a new drug application for Ampligen® with the ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica), the agency responsible~~received IRB approval for the ~~national regulation~~expansion of ~~drugs, foods~~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; two of the 11 patients enrolled have post-COVID chronic-fatigue-like symptoms. Early data from the ongoing AMP-511 Expanded Access Program has indicated that patients with Post-COVID conditions (such as fatigue and medical technology in Argentina, under the ANMAT’s Orphan Drug regulations. We believe that the approval of Ampligen® as an Orphan Drug may allow reimbursement by the Health Services Authority (SSS), the central health authority in Argentina for patients seeking treatment for CFS. cognitive function deficiency) have reported improvement after receiving Ampligen.

In ~~August~~May 2016, we received approval of our NDA from ANMAT for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of ME/CFS. The product will be marketed by GP Pharm, our commercial partner in Latin America. There areentered into a number of actions that must occur before we could be able to commence commercial sales in Argentina. Commercialization in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing) and we most likely will need additional funds to manufacture product at a sufficient level for a commercial launch.

~~In January 2017, we announced that the EAP through our~~five-year agreement with myTomorrows, ~~designed to enable access~~a Netherlands based company, for the commencement and management of ~~Ampligen® to ME/CFS patients has been extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider~~an Early Access Program (“EAP”) in Europe and Turkey ~~and will manage all EAP activities relating~~(the “Territory”) 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 ~~extension of the program.~~

In June 2017, we signed an amendment to the EAP with myTomorrows. This amendment is for myTomorrows to provide support services to Hemispherx with respect to the execution of the 511-Program (“511-Services”).and ME/CFS patients. The ~~511-Services shall be rendered~~agreement was automatically extended for a period of 612 months ~~to be renewed with~~on May 20, 2021 and will automatically extend for an additional ~~6 month periods with written mutual consent, or until termination~~period of ~~the 511-Program. The 511-Services shall be rendered free of charge.~~12 months on May 20, 2022.

In ~~August, 2017~~April 2018, we ~~announced that we have commenced full~~completed data analysis of an intranasal human safety study of ~~Ampligen® plus FluMist®~~Ampligen-plus-FluMist®, known as AMP-600. The study was previously closed ~~but~~after the ~~initiation~~U.S. Centers for Disease Control and Prevention (“CDC”) made a general recommendation against the use of ~~full data analysis awaited the FDA’s evaluation of preliminary reports of blinded study findings. That evaluation was completed per formal notification from the FDA~~FluMist® at that time. Intranasal Ampligen in ~~August, 2017. Intranasal Ampligen~~combination with FluMist® was generally well-tolerated in the ~~study~~study.

In ~~April 2017~~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 blockage 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 ~~entered into~~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 Pharmaceutics International Inc. (“Pii”) as a ~~material transfer agreement with Sanofi Vaccine Technologies, France.~~“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.

Alferon N Injection®

Alferon N ~~Injection®~~Injection is the registered trademark for our injectable formulation of natural alpha ~~interferon, which was approved by the FDA in 1989 for the treatment of certain categories of genital warts. Alferon®~~interferon. Alferon N Injection is the only natural-source, multi-species alpha interferon currently approved for sale in the ~~U.S.~~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”). ~~The U.S. Centers for Disease Control and Prevention (“CDC”) estimates that “~~According to the CDC, HPV is the most common sexually transmitted infection, with approximately ~~twenty~~79 million Americans ~~are currently~~— most in their late teens and early 20s — infected with ~~HPV with another six million becoming newly infected each year. HPV~~HPV. In fact, the CDC states that “HPV is so common that ~~at least 50% of~~nearly all sexually active men and women get itthe 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®~~Injection contains a multi-species form of alpha interferon. The ~~world-wide~~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 ~~U.S.~~United States. Our natural alpha interferon is produced from human white blood cells.

~~-22-~~

The potential advantages of natural alpha interferon over recombinant ~~(synthetic)~~(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 ~~(partially~~(i.e., partially covered with sugar molecules). Such glycosylation is not present on the currently ~~U.S. marketed~~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.

Alferon N ~~Injection®~~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®~~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"~~formation (See “Manufacturing” and ~~"Marketing/Distribution"~~“Marketing/Distribution” sections below for more details on the manufacture and marketing/distribution of Alferon N ~~Injection®~~Injection).

~~Other Diseases~~Immuno-Oncology

~~In December 2013, we announced that we were supporting~~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~~chemokine modulation research initiative, which includes ~~Ampligen®~~the use of Ampligen as ~~an adjuvant.~~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, ~~Hemispherx has~~we have supplied ~~clinical grade Ampligen® (rintatolimod)~~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~~chemokine modulatory regimen developed by Dr. Kalinski’s group and successfully completed the Phase 1 dose escalation in patients with resectable colorectal cancer. In the 1^st1st quarter of ~~this year,~~2017, Dr. Kalinski relocated to Roswell Park ~~Cancer Institute (RPCI)~~ in Buffalo, ~~NY. Dr. Kalinski is currently working to establish~~NY and has established a cancer program ~~at RPCI~~ which will continue to require a supply of ~~Ampligen®~~Ampligen.

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:

●

Advanced Recurrent Ovarian Cancer

	○	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 recently announced interim data from the study, which demonstrated 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). ~~The cancer protocols utilizing Ampligen® at~~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 ~~University of Pittsburgh~~tumor microenvironment have been ~~closed except for~~correlated with favorable tumor responses. All told, the ~~ovarian~~ study ~~for which Dr. Edwards is the investigator. This~~has seen a Clinical Benefit Rate of 61.6%; a study of pembrolizumab alone in the treatment of advanced recurrent ovarian cancer ~~patients which includes Ampligen® as a component~~ found Objective Response Rates of ~~the treatment regimen has enrolled 9 patients to date.~~7.4% and 9.9% across two cohorts. The positive data makes this patent have heightened potential. Similar patents are pending in other counties.

In July 2015, we submitted an application for orphan drug designation to the European Medicines Agency (EMA) for Alferon® N to treat MERS and in January 2016, the EMA forwarded to us both its Public Summary of Opinion and its record designation approving the Orphan Medicinal Products Designation for Alferon N Injection®, also known as interferon alfa-n3, as a potential treatment of MERS. In addition, we concluded our series of collaborations designed to determine the potential effectiveness of Alferon® N and Ampligen® as potential preventative and/or therapeutic treatments for Ebola related disorders. Although we believe that the threat of both MERS and Ebola globally may reemerge

●

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.

●

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. This study is recruiting patients designed for up to 24 patients, 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. https://clinicaltrials.gov/ct2/show/NCT04081389

The below Ampligen clinical trials are in the ~~future, it appears that the spread of these disorders has somewhat diminished. As a result, we have elected to focus our research and development efforts on other areas at this time.~~planning stages:

	●	Phase 2 Pancreatic Cancer Trial - In October 2021, AIM 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. The FDA placed the study on Clinical Hold in November 2021 and provided valuable feedback on the study design. We submitted our response to the Clinical Hold 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 April 2022, we executed a work order with Amarex to manage the clinical trial.

	●	Refractory Melanoma — Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled (See: https://www.clinicaltrials.gov/show/NCT04093323).

Pancreatic Cancer

In January 2017, ~~we announced that~~ the EAP ~~through~~established under our agreement with myTomorrows ~~designed~~ to enable access of ~~Ampligen®~~Ampligen to ME/CFS patients ~~has been~~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.

A total of ~~September 30, 2017, 29~~42 pancreatic cancer patients ~~have~~ received treatment with ~~single-agent Ampligen®~~Ampligen immuno-oncology therapy under the EAP program at Erasmus MC in the Netherlands. Supervised by Prof. Casper 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” and to obtain IND authorizations to conduct follow-up pancreatic cancer Phase 2 clinical trials with potential sites in the Netherlands at Erasmus MC under Prof. 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 for an EAP ~~managed~~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. The AMP-270 clinical trial is planned to be 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. We plan to enroll approximately 90 subjects across up to 30 centers in 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 April 2022, we executed a work order with Amarex to manage the Phase 2 clinical trial. 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 ~~Amsterdam-based myTomorrows,~~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.

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 known as 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.

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.

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.

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 ~~leader~~protections for patents, these three provisional patent applications were converted in ~~providing physician access~~ to ~~experimental medicines.~~two international patent applications based on the date of their filings.

In ~~July 2017,~~April 2020, we entered into a Material Transfer and Research Agreement (“MTA”) with ~~Roswell Park Cancer Institute (RPCI)~~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 ~~Buffalo, NY~~May 2021. There have been obstacles related to ~~continue~~importing Ampligen to China. We have been working with Smoore to alleviate these issues and to identify a mutually beneficial course of action that would allow us to move forward with the ~~cancer studies~~proposed testing of Ampligen outside of China. On parallel paths, over the past year, Smoore focused on the development of a personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA. Contemporaneously, we have studied the safety and efficacy of Ampligen using an ex vivo 3D model in primary human respiratory epithelial cells at Utah State University, which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, and conducted intranasal safety testing. We are exploring avenues to further test Ampligen as an inhalation therapy in the United States and Europe, while Smoore continues to work toward receiving authorization to import Ampligen to China. However, progress in this area is stymied, and due to difficulty importing experimental drugs (such as Ampligen) we are considering our options.

In August 2020, we contracted Amarex Clinical Research LLC (“Amarex”) to act as our Clinical Research Organization and provide regulatory support with ~~Dr. Pawel Kalinski~~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 ~~his associates.~~

~~Laboratory experiments do not necessarily indicate clinical benefit. Some~~non-disclosure agreements with numerous companies for the potential outsourcing of the ~~research both past~~production of polymer, enzyme, placebo as well as Ampligen, and ~~present has been,~~one Contract Research Organization, Amarex, which will provide regulatory and ~~may~~monitoring support related to a clinical trial testing Ampligen’s intranasal safety and potential as a COVID-19 prophylaxis via intranasal delivery.

In addition, in February 2020 we joined with ChinaGoAbroad (“CGA”) to facilitate the ~~future be, sponsored~~entry of Ampligen into the People’s Republic of China (“PRC”) for use as a prophylactic/early-onset therapeutic against COVID-19. CGA is a member-based online information platform and offline advisory firm serving to facilitate two-way international transactions relating to the PRC in ~~part by contracts or grants from us~~collaboration with the China Overseas Development Association (“CODA”). While this relationship is currently inactive, we remain open to ~~various independent research entities.~~utilizing ChinaGoAbroad if and when an opportunity arises.

~~-23-~~

~~Manufacturing~~

~~We had~~In May 2020, the FDA authorized an IND for Roswell Park to conduct a ~~Supply Agreement~~Phase 1/2a study of a regimen of Ampligen and interferon alpha in cancer patients with ~~Jubilant Hollister-Stier LLC~~COVID-19 infections. This clinical trial, sponsored by Roswell Park in collaboration with us, will test the safety of ~~Spokane, Washington (“Jubilant”), pursuant~~this combination regimen in patients with cancer and COVID-19, and the extent to which ~~Jubilant would formulate and package Ampligen®~~this therapy will promote clearance of the SARS-CoV-2 virus from the ~~key raw materials~~upper airway. Several subjects have been treated and recruitment continues. It is planned that ~~Hemispherx would supply~~the phase 1/2a study will enroll up to ~~them. This Supply Agreement expired March 11, 2014.~~ 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 ~~October 2014,~~July 2020, we entered into a ~~purchase commitment~~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.

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 the Centre for Human Drug Research (“CHDR”), a foundation located in the Leiden in the Netherlands, 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 interim results 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.

Following the completion of the Phase 1 dosing, and based on its positive interim results in June 2021 (which have since been publicly supported in a CHDR-created data visualization published in October 2021), we signed a Reservation and Start-Up Agreement with hVIVO, reserving space in hVIVO’s quarantine facility to sponsor a Phase 2a Human Challenge Trial (“HCT”) to test Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (common cold virus) and Influenza. This antiviral study was to be conducted by hVIVO, a subsidiary of Open Orphan plc. We submitted a study protocol to the Oxford Research Ethics Committee (“REC”)/Medicines and Healthcare Regulatory Agency (“MHRA”) in September 2021. The REC approved the protocol, but the MHRA provided a response outlining areas of the submission where it requires additional information. A response was submitted to MHRA in October 2021. The REC provided a “favorable opinion” to proceed, but the MHRA issued a Non-Acceptance response in November 2021. A full revised application was resubmitted in December 2021. The MHRA issued Grounds for Non-Acceptance and requested additional data before moving forward. As the request would require us to first conduct an animal experiment that we believe would take at least six months to complete, we determined that continuing with the HCT application process would not be a prudent use of our resources, so we terminated our agreement with hVIVO and officially notified the MHRA of our decision to withdraw our application. As the MHRA’s Grounds for Non-Acceptance had already been issued, our withdrawal was technically recognized as a rejection of the proposed study.

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 cognitive function. Similarly, in ME/CFS, data supports the claim that Ampligen improves cognitive function. 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). Eighty subjects will be randomized 1:1 to receive twice weekly infusions of Ampligen or placebo for a period of 12 weeks. Amarex Clinical Research, an NSF International company, is managing the FDA submission and will manage the clinical trial. The pre-IND meeting request was transferred to the FDA’s Division of Neurology by the FDA’s Covid Scientific Technical Triage Team. In November 2021, the FDA responded that there was insufficient information to support the proposed indication of Post-COVID Cognitive Dysfunction (PCCD). We are working with Amarex to revise the study and resubmit it to the FDA as Post-COVID conditions.

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.

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.

MANUFACTURING

The Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”) in Argentina approved Ampligen for commercial distribution for the treatment of Chronic Fatigue Syndrome (“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 ~~approximately $700,000~~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 Pharmaceutics International Inc. (“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. Then, on March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc. as purchaser pursuant to which we will sell our property for $3.9 million. The buyer has a mortgage contingency, with the clause expiring on June 1, 2022. Assuming that condition is met, we would anticipate closing on or before July 1, 2022.

Moving forward, we will require one or more Contract Manufacturing Organizations (“CMO”) 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 Inc. (“Polysciences”) for the manufacture of ~~batches of Ampligen®. In January 2017, we entered into a purchase order~~our Poly I and Poly C₁₂U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to ~~replace~~enhance our capacity to produce the ~~previous purchase commitment with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for us. Pursuant~~polymer precursors to the ~~new order, Jubilant will perform tooling and validation activities as well as final fill and finish services. The first lot is expected~~drug Ampligen. We are utilizing Polysciences’s expertise to refine our approach to polymer production. Additionally, we continue to be ~~manufactured~~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.

Our second product, Alferon N Injection, is approved by the FDA for commercial sales in the ~~first quarter~~United States for the treatment of ~~2018, once all validation activities~~genital warts. It is also approved by ANMAT in Argentina for commercial sales for the treatment of genital warts and in patients who are ~~complete.~~

~~In July 2016, we reached an agreement~~refractory to treatment with Avrio Biopharmaceuticals, now Nitto Denko Avecia Inc. (“Avecia”) to serve as an additional contract manufacturer of our experimental drug, Ampligen®. In May 2017, we filed a complaint against Nitto Avecia Pharma Services, Inc. (“NAPS”), the successor to Avrio Biopharmaceuticals, LLC (“Avrio”), primarily for breach of contract. Please see “Item 1: Legal Proceedings” in Part II and “Risks Associated with Our Business” in Part I, Item 1A. Risk Factors within our 2016 Form 10-K filed with the Securities and Exchange Commission on March 31, 2017.

recombinant interferons. Commercial sales of ~~Alferon® and Alferon® API internationally are projected to begin as soon as the necessary regulatory approvals are obtained. However, commercial sales of Alferon®~~Alferon N Injection in the ~~USA~~United States will not resume until new batches of commercial filled and finished product are produced and released by the FDA. While ~~the~~our New Brunswick facility ~~is approved by the~~has FDA approval under the ~~BLA~~Biologics License Application (“BLA”) for ~~Alferon®, this status~~Alferon N Injection, and we intend to maintain a certain amount of space at the to-be-sold facility, we will ~~need to be reaffirmed by an FDA pre-approval inspection. We will also~~ 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.~~data; the FDA has conducted any required inspections; and the FDA has approved our new manufacturing process. Currently, ~~the~~we are not manufacturing ~~process is on hold~~Alferon N Injection and there is no definitive timetable to have the facility back online. We estimate we will need approximately $10,000,000 to commence the manufacturing process. Due to the Company extending the timeline of Alferon® production to an excess of one year, we reclassified Alferon® work-process-inventory to other assets within our balance sheet as of September 30, 2017.~~In addition,~~due to the high cost estimates to bring the facility back online, we will need additional funds to finance the revalidation process in our facility to initiate commercial manufacturing, thereby readying ourselves for an FDA Pre-Approval Inspection. If we are unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon® 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.resume production.

In May 2017, we entered into a mortgage and note payable agreement with a bridge funding company to obtain a two-year funding line of up to $4,000,000 secured by our assets and property located at 783 Jersey Ave., New Brunswick, New Jersey. See Note 13- Note payable above for a more complete description of the terms of the note payable.

To formulate, fill, finish and package (“fill and finish”) Alferon N Injection® drug product, we require a FDA approved third party Contract Manufacturing Organization (“CMO”). In January 2012, we agreed to a Technology, Transfer, Validation and Commercial Supply Agreement with Ajinomoto Althea, Inc., formerly Althea Technologies, Inc. (“Althea”) of San Diego, CA, regarding the fill and finish process for Alferon® N Injection®. In November 2014, we entered into a purchase commitment with Althea for approximately $622,000 for the production of validation batches of Alferon® N Injection for emergency use and/or commercial sale. We have paid approximately $211,000 to Althea with regard to this open purchase commitment as of September 30, 2017 and had recorded this amount within Work-In-Process inventory. We believe that the benefits from this initial $211,000 payment will no longer be realized and have expensed it in the current period.

Licensing/Collaborations/Joint Ventures

To ~~maximize the~~enable potential availability of ~~Ampligen®~~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®~~Ampligen in their respective global territories of the world. Ideal partners would have the following characteristics: ~~well established~~well-established global and regional experience and ~~coverage,~~coverage; robust commercial ~~infrastructure,~~infrastructure; a strong track record of successful development and registration of in-licensed ~~products, as well as~~products; and a therapeutic area fit (ME/CFS, ~~immuno-oncology. etc.~~immuno-oncology, e.g.).

~~Marketing/Distribution~~MARKETING/DISTRIBUTION

IfIn May 2016, we are unable to achieve licensing, collaboration and/or joint ventures, our marketing strategy for Ampligen® will be to be part of the differing health care systems around the world along with the different marketing and distribution systems that are used to supply pharmaceutical products to those systems. We expect that, subject to receipt of FDA, ANMAT and/or other regulatory approval, Ampligen® may be utilized in four medical arenas: physicians’ offices, clinics, hospitals, and the home treatment setting. In preparation for the FDA’s consideration of our Ampligen® NDA, we undertook early stage development of pre-launch and launch driven marketing plans focusing on audience development, medical support and payer reimbursement initiatives which could facilitate product acceptance and utilization at the time of regulatory approval, if obtained. Similarly, we continued to consider distribution scenarios for the Specialty Pharmacy/Infusion channel which could provide market access, offer 3PL (third party logistics) capabilities and provide the requisite risk management control mechanisms. It is our intent to utilize third party service providers to execute elements of both the marketing/sales and distribution plans. Asentered into a possible option, we considered a plan to utilize a small group of Managed Market account managers to introduce the product to payor, employer and government account audiences. We believe that this approach could establish a market presence and facilitate the generation of revenue without incurring the substantial costs associated with a traditional sales force. Furthermore, Management believes that any approach considered should enable us to retain multiple options for future marketing strategies.

~~-24-~~

In January 2010, we engaged an Argentinean regulatory and business design entity to explore the possibility of initiating clinical trials of Alferon N Injection® and Ampligen® during the influenza season in Argentina. In June 2010, we executed a five yearfive-year exclusive Renewed Sales, Marketing, Distribution and Supply Agreement ~~for Argentina~~(the “Agreement”) with GP ~~Pharm Latinoamerica (“GP Pharm”), an affiliate company of Spanish GP Pharm SA.~~Pharm. Under this Agreement, GP Pharm iswas responsible for gaining regulatory approval in Argentina for ~~Ampligen®~~Ampligen to treat severe CFS in Argentina and for commercializing ~~Ampligen®~~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®~~Injection in Argentina and other Latin America ~~countries. Under these agreements, we will manufacture and supply Ampligen® and Alferon N Injection® to GP Pharm. In November 2010, we amended our June 14, 2010 agreement with~~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 ~~include Mexico in the Territory under the Sales, Marketing, Distribution~~a previous approval to sell and ~~Supply Agreement. Under this Agreement, GP Pharm Mexico will be responsible for seeking regulatory approval in Mexico for Ampligen®, an experimental therapeutic,~~distribute Ampligen to treat severe CFS in ~~Mexico and, if~~Argentina. This extends the approval ~~is obtained, for commercializing Ampligen® for this indication in Mexico.~~ until 2026.

In May 2016, we entered into a five year exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with GP Pharma whereby all material provisions within the Agreement remained consistent with the original agreement.

In January 2012, the ANMAT approved the sale and distribution of Alferon N Injection® (under the brand name “Naturaferon”) in Argentina for five years. This was extended in January 2017 for an additional five years until 2022. The receipt of the ANMAT approval for HPV is the first step of a regulatory process towards the commercial sales of Naturaferon®. In September 2012, we filed with ANMAT an amended NDA for the use of Alferon N Injection® in patients with chronic hepatitis C who have become refractory to recombinant interferon as a result of the appearance of neutralizing antibodies against recombinant interferon. 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 September 2011, we executed an amended agreement with Asembia, formerly Armada Healthcare, LLC, to undertake the marketing, education and sales of Alferon N Injection® throughout the United States. This agreement also provides start-up along with ongoing sales and marketing support to the Company. In July 2015, it was mutually agreed upon to extend this agreement through August 14, 2017 subject to the same terms and conditions. In August 2017 we extended this agreement through August 14, 2019 subject to the same terms and conditions.

In September 2011, we executed a new agreement with specialty distributor, BioRidge Pharma, LLC (“BioRidge”) to warehouse, ship, and distribute Alferon N Injection® on an exclusive basis in support of U.S. sales. In July 2015, it was mutually agreed upon to extend this agreement through August 14, 2017 subject to the same terms and conditions. In August 2017, we extended this agreement through August 14, 2019 subject to the same terms and conditions.

~~In May 2016, we entered into an amended and restated five year~~five-year agreement (the “Impatients Agreement”) with Impatients, N.V. ~~("myTomorrows"~~(“myTomorrows”), a ~~Netherlands based~~Netherlands-based company, for the commencement and management of an ~~Early Access Program (“EAP”)~~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®~~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®~~Ampligen sold in the Territory where Marketing Authorization was ~~obtained, and the maximum royalty would be a percentage of Net Sales.~~obtained. The formula to determine the percentage of Net Sales will be based on the number of patients that are entered into the EAP. ~~The Company believes~~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 8five and 15fifteen 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®~~Ampligen in the Territory. ~~In 2017, the Company commenced sales~~The agreement was automatically extended for a period of ~~recently manufactured Ampligen® in international programs.~~12 months on May 20, 2021.

~~-25-~~

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 under review. In February 2013, we ~~announced~~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®~~Ampligen to ME/CFS patients ~~has been~~was extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider in ~~Europe and Turkey~~the Territory and will manage all EAP activities relating to the pancreatic cancer extension of the program.

In ~~June~~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 and we are currently in discussions with Asembia exploring the continuation and expansion of this relationship.

In February 2018, we signed an amendment to the EAP with myTomorrows. This amendment ~~is for myTomorrows~~extended the territory to ~~provide support services~~cover Canada to ~~Hemispherx with respect~~treat pancreatic cancer patients, pending government approval. In March 2018, we signed an amendment to the ~~execution~~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 ~~511-Program (“511-Services”~~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”). ~~The 511-Services shall~~Our full time employees are eligible to participate in the 401(k) Plan following one year 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 ~~rendered for~~matched by us at a ~~period~~rate determined annually by the Board of ~~6 months to be renewed with additional 6 month periods with written mutual consent, or until termination of the 511-Program. The 511-Services shall be rendered free of charge.~~Directors.

~~401(k) Plan~~

Each participant immediately vests in his or her deferred salary contributions, while ~~Company~~our contributions will vest over one year. ~~The~~A 6% ~~Company~~ matching contribution by us was ~~terminated~~reinstated effective January 1, ~~2016.~~2021. For the ~~nine months ended September 30, 2017,~~period ending March 31, 2022 we made $37,000 in contributions and for the ~~Company did not make any~~period ending December 31, 2021 $139,000 contributions ~~towards the 401(k) Plan.~~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~~“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, ~~2016.~~2021

RESULTS OF OPERATIONS

Three months ended ~~September 30, 2017~~March 31, 2022 versus three months ended ~~September 30, 2016~~March 31, 2021

Net Loss

Our net loss was approximately ~~$1,252,000~~$3,820,000 and ~~$2,862,000~~$3,579,000 for the three months ended ~~September 30, 2017~~March 31, 2022, and ~~2016,~~2021, respectively, representing ~~a decrease~~an increase in loss of approximately ~~$1,610,000~~$241,000 or ~~56% when compared to the same period~~7%. This increase in ~~2016. This decrease in~~ loss ~~for these three months~~ was primarily due to the following:

	1)●	an increase ~~from the redeemable warrant valuation adjustment~~in loss on investments, net of ~~$1,335,000;~~$934,000;
	2)
	●	an increase in ~~Ampligen® sales~~gain from sale of ~~approximately $68,000; and~~Income tax operating of $9,000;
	3)
	●	an increase of the quarterly revaluation of certain redeemable warrants of $68,000; offset by

	●	a decrease in interest and other income of $27,000;

	●	a decrease in interest expense and finance cost of $50,000;

	●	a decrease in research and development ~~expense~~expenses of ~~$555,000 or 41%; offset by~~$388,000;
	4)	~~an increase~~
	●	a decrease in general and administrative expenses of $40,000;

	●	a decrease in production costs of ~~$127,000 or 47% and~~
	5)	~~a decrease in net insurance proceeds of $190,000 received in 2016 but none in 2017,~~$160,000.

Net loss per share was ~~$(0.04)~~$ (0.08) and ~~$(0.13)~~$(0.08) for the ~~three months~~years ended ~~September 30, 2017~~March 31, 2022, and ~~2016,~~2021, respectively. The weighted average number of shares of our common stock outstanding as of ~~September 30, 2017~~March 31, 2022, was ~~30,096,500~~47,994,672 as compared to ~~21,832,940~~45,726,855 as of ~~September 30, 2016.~~March 31, 2021.

~~-26-~~

Revenues

~~Revenues~~

Revenues from our Ampligen® Cost Recovery Program were ~~$90,000~~$33,000 and ~~$22,000~~$28,000 for the ~~three months~~quarters ended ~~September 30, 2017~~March 31, 2022 and ~~2016,~~2021, respectively. The ~~reason for~~change was due primarily to the increase in ~~revenues of $68,000, an increase of 309%, between periods was primarily due to our EAP through our agreement with myTomorrows designed to enable access of Ampligen® to pancreatic cancer patients in~~drug utilization for the ~~Netherlands. For~~AMP-511 study for the ~~three months ended September 30, 2017~~two sites that are open and 2016, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® ~~for treatment in an open-label safety study.~~treating patients.

Production Costs

Production costs were approximately ~~$399,000~~$77,000 and ~~$272,000,~~$237,000, respectively, for the three months ended ~~September 30, 2017~~March 31, 2022, and ~~2016,~~2021, representing ~~an increase~~a decrease of ~~$127,000~~$160,000 in production costs in the current period. ~~These costs~~The decrease was due primarily ~~represent stability testing and pre-production expenses related~~ to ~~Alferon®.~~a reduction in depreciation for the building that is held for sale.

In addition, we recorded a charge in the current period of $211,000 related to amounts paid to Althea for costs to fill and finish Alferon® and had recorded these amounts within Work-In-Process inventory. We no longer believe that the benefits from these payments will be realized and have written off the amount in the current period.

Research and Development Costs

Overall Research and Development (“R&D”) costs for the three months ended ~~September 30, 2017~~March 31, 2022, were approximately ~~$787,000~~$1,036,000 as compared to ~~$1,342,000~~$1,424,000 for the same period a year ago, reflecting a decrease of approximately ~~$555,000 or 41%.~~$388,000. The primary ~~reasons~~reason for the decrease in research and development costs ~~were~~was largely due to a decrease in ~~Ampligen® stability and compliance testing of approximately $162,000 for use~~clinical trials that ended in the ~~EAP to treat pancreatic cancer patients~~prior year and not starting new trials in the ~~Netherlands, a decrease in AMP 511 costs~~current period, of ~~approximately $294,000 associated with Ampligen® clinical study work and a decrease in Alferon® related activity~~$686,000 offset by an increase of ~~approximately $99,000.~~$121,000 for outside contractors due to outsourcing testing

General and Administrative Expenses

General and Administrative (“G&A”) expenses for the three months ended ~~September 30, 2017~~March 31, 2022, and ~~2016,~~2021, were approximately ~~$1,556,000~~$2,072,000 and ~~$1,634,000,~~$2,112,000, respectively, reflecting a decrease of approximately ~~$78,000 or 5%.~~$40,000. The decrease in G&A expenses ~~were essentially flat~~ during the current period was mainly due to a decrease in stock compensation of $284,000, offset by an increase in accounting, professional and legal fees of $213,000, insurance expense of $120,000, salaries and payroll expenses of $24,000, travel of $16,000.

Loss on Investments, net

Loss on investments for the three months ended ~~September 30, 2017 compared~~March 31, 2022, and 2021 represents a loss of approximately $934,000, driven primarily from the unrealized loss on securities of $915,000.

Interest and Other Income

Interest and other income for the three months ended March 31, 2022 and 2021 represents a net decrease of approximately $27,000 due to ~~September 30, 2016, reflecting normal operational fluctuations.~~the financing obligation of the sale leaseback in the period ending March 31, 2021 and not in the period ending March 31, 2022.

Redeemable Warrants

The quarterly ~~fiscal~~ revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted to a gain of $31,000 for the three months ended ~~September 30, 2017 amounting~~March 31, 2022, compared to a ~~higher gain~~loss of approximately ~~$1,335,000~~$37,000 in March 31, 2021 (see ~~Part I; Item 1; Financial Statements; “Note 12:~~“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

~~Insurance Proceeds from Legal Settlement~~

InThe quarterly income tax benefit for the three months ended ~~September 30, 2016 insurance proceeds, net of costs,~~March 31, 2022 amounted to a gain of approximately $190,000 ~~were received from the settlement~~compared to a gain of ~~litigations. There were no insurance proceeds received in~~$181,000 for the three months ended ~~September 30, 2017.~~March 31, 2021 due primarily to a deferred tax asset recorded in 2021 for the New Jersey NOL to be sold in 2022.

~~Gain (Loss)~~Liquidity and Capital Resources

Cash used in operating activities for the period ended March 31, 2022, was approximately $2,758,000 compared to approximately $3,045,000 for the same period in 2021, representing a change of $287,000. The primary reasons for this change in cash used in operations in 2022 was related to non-cash charges which primarily consisted of $242,000 in stock compensation, $915,000 of loss on ~~Sale~~investments, net, and $227,000 of ~~Marketable Securities~~gain from sale of income tax operating losses. The main changes in working capital were an increase in accounts payable and a decrease in accrued expenses.

~~There~~Cash used in/provided by investing activities for the period ended March 31, 2022, was ~~no gain or (loss) on sale~~approximately $346,000 used in compared to $523,000 provided by for the same period in 2021, representing a change of $869,000. The primary reason for the change during the current period is the purchase of marketable securities for the ~~three months~~years ended ~~September 30, 2017 as~~March 31, 2022 and March 31,2021 of $720,000 and $1,151,000, respectively offset by the sale of marketable securities of $407,000 and $2,039,000, respectively.

Cash provided by financing activities for the period ended March 31, 2022, was approximately $0 compared to ~~a gain of~~ approximately ~~$31,000~~$12,794,000 for ~~the three months ended September 30, 2016.~~

~~-27-~~

~~Nine months ended September 30, 2017 versus nine months ended September 30, 2016~~

~~Net Loss~~

Our net loss was approximately $6,266,000 and $6,329,000 for the nine months ended September 30, 2017 and 2016, respectively, representing a decrease in loss of approximately $63,000 or 1.0% when compared to the same period in ~~2016. This increase in loss for these nine months was primarily due to the following:~~

	1)	2021, a decrease ~~in the gain from sale of income tax net operating losses of $1,561,000;~~
	2)	~~a decrease in net insurance proceeds of $1,626,00 received in 2016 but none in 2017;~~
	3)	~~an increase in research and development expense of $40,000 or 1%; offset by,~~
	4)	~~a decrease in general and administrative expense of $882,000 or 15%;~~
	5)	~~an increase in Ampligen® sales of approximately $311,000; and~~
	6)	~~an increase from the redeemable warrant valuation of $2,258,000.~~

~~Net loss per share was $(0.23) and $(0.30) for the nine months ended September 30, 2017 and 2016, respectively. The weighted average number~~ of ~~shares of our common stock outstanding as of September 30, 2017 was 27,598,715 as compared to 21,046,418 as of September 30, 2016.~~

~~Revenues~~

Revenues from our Ampligen® Cost Recovery Program were $387,000 and $76,000 for the nine months ended September 30, 2017 and 2016, respectively. The increase in revenues of $311,000, an increase of 409%, between periods was primarily due to our EAP through our agreement with MyTomorrows designed to enable access of Ampligen® to pancreatic cancer patients in the Netherlands. For the nine months ended September 30, 2017 and 2016, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.

~~Production Costs~~

Production costs were approximately $887,000 and $830,000, respectively, for the nine months ended September 30, 2017 and 2016, representing an increase of $57,000 in production costs in the current period. These costs primarily represent stability testing and pre-production expenses related to Alferon®.

~~Research and Development Costs~~

Overall Research and Development (“R&D”) costs for the nine months ended September 30, 2017 were approximately $3,284,000 as compared to $3,244,000 for the same period a year ago, reflecting an increase of approximately $40,000 or 1%.$12,794,000. The primary reason for this decrease was our receipt of $12,887,000 in net proceeds from the ~~increase in research and development costs was an increase in AMP 511 costs~~sale of ~~approximately $245,000 associated with Ampligen® clinical study work. This was offset by a decrease in Alferon® related activity of approximately $192,000.~~

~~General and Administrative Expenses~~

General and Administrative (“G&A”) expenses for the nine months ended September 30, 2017 and 2016, were approximately $4,839,000 and $5,721,000, respectively, reflecting a decrease of approximately $882,000 or 15%. The decrease in G&A expenses during the current period was mainly due to a one-time charge of $850,000 in 2016 resulting from a severance payment to a former executive upon termination.

~~-28-~~

~~Redeemable Warrants~~

The quarterly fiscal revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability for the nine months ended September 30, 2017 amounting to a higher gain of approximately $2,258,000 (see Part I; Item 1; Financial Statements; “Note 12: Fair Value” for the various factors consideredshares in the ~~valuation~~first three months of ~~redeemable warrants).~~2021.

~~Insurance Proceeds from Legal Settlement~~

In the nine months ended September 30, 2016 insurance proceeds, net of costs, of approximately $1,626,000 were received from the settlement of litigations. There were no insurance proceeds received in the nine months ended September 30, 2017.

~~Gain (Loss) on Sale of Marketable Securities~~

There was a gain (loss) on sale of market securities disclosed a gain of $6,000 for the nine months ended September 30, 2017 as compared to a loss of approximately ($56,000) for the nine months ended September 30, 2016.

~~Sale of New Jersey Tax Net Operating Loss~~

In January 2016, the Company effectively sold $16,000,000 of its approximately $29,000,000 of New Jersey state net operating loss carryforwards (for the year 2014) for approximately $1,320,000 and sold research credits for $241,000. There was no sale of New Jersey state net operating loss in the nine months ended September 30, 2017.

~~Liquidity and Capital Resources~~

As of ~~September 30, 2017, we~~March 31, 2022, AIM had approximately ~~$2,303,000~~$44,543,000 in cash, cash equivalents and marketable securities, inclusive of approximately ~~$1,800,000~~$15,554,000 in Marketable Securities, representing a decrease of approximately ~~$3,565,000~~$3,725,000 from December 31, 2016. Cash used in operating activities for the nine months ended September 30, 2017 was approximately $7,181,000 compared to approximately $5,278,000 for the same period in 2016, an increase of $1,903,000 or 36%. The primary reasons for this increase in cash used in operations in 2017 was the receipt of $1,561,000 in funds in 2016 from the sale of our New Jersey state net operating loss carryforwards and $1,626,000 of insurance proceeds for litigation settlements. There were no such receipt of funds in 2017. In addition, prepaid expenses and other current assets increased by approximately $317,000 as compared to the prior period as a result of a deposit paid to our contract manufacturer of approximately $320,000 in 2017.2021.

Cash provided by investing activities for the nine months ended September 30, 2017 was approximately $1,643,000 compared to cash used in investing activities of approximately $2,943,000 for the same period in 2016, representing a decrease of $1,300,000. The primary reason for the decrease was the sale of marketable securities of approximately $1,699,000 during the current period compared to $3,371,000 the nine months ended September 30, 2016.

Cash provided by financing activities for the nine months ended September 30, 2017 was approximately $3,633,000 compared to approximately $4,693,000 for the same period in 2016, a decrease of $1,060,000. The primary reason for this decrease was that we received net proceeds of $2,180,000 from the~~sale of shares of our common stock and~~ ~~$1,543,000 from a note payable, net of $77,000 debt issuance costs in the current period compared to $4,694,000 from the sale of shares in the corresponding period in 2016.~~

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. In this regard, due to the high cost estimates to bring the facility back online, we most likely will need additional funds to reach our goals to finance the revalidation process in our facility and to initiate commercial manufacturing, thereby readying ourselves for an FDA Pre-Approval Inspection and to commercialize our products. However, there is no assurance that such financing will be available.

~~-29-~~

In an effort to conserve cash, effective with the semi-monthly period ended April 30, 2017, all of the members of the Company’s Board of Directors agreed to accept 100% of their directors’ fees in the form of options to purchase Company Common Stock. This program was terminated as of August 31, 2017. As of September 1, 2017, the directors agreed to defer 100% of their fees until cash is available.

In addition, commencing with the semi-monthly period ended June 15, 2017, certain officers of the Company, and certain other employees of the Company, agreed to accept 20% of their salary in options to purchase Company Common Stock. This program was also terminated as of August 31, 2017. As of September 1, 2017, certain officers agreed to defer 40% of their salaries until cash is available and all employees agreed to be paid 50% of their salaries in the form of unrestricted common stock of the Company.

We have reexamined our fundamental priorities in terms of direction, corporate culture and our ability to fund operations and have made significant changes at the Company. In February 2016, the former CEO of the Company was terminated and the Board of Directors made several changes to the Company’s executive management team to provide effective and competent leadership that, management believes, will properly position the Company to achieve its commercial goals and increase stockholder value. Recent actions include aggressively pursuing international sales of clinical grade materials and implementing a strong financial austerity plan. 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 ~~its~~our experimental ~~drug~~drugs and ~~its~~our FDA approved drug ~~Alferon®. A co-development partner may help in the acceleration of the commercialization of many~~Alferon N Injection.

The development of our ~~potential experimental drugs as they~~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 ~~access~~adequate funds to ~~additional resources~~meet our anticipated operational cash needs and capital; however, there can be no assurance that such co-development partnerships will be on acceptable terms, or that such partnerships, will be acceptable from a profitability standpoint. Management’s primary objectives are to create stockholder value and deliver much needed therapies to patients.

~~In February 2017, we entered into Securities Purchase Agreements (each, a “Purchase Agreement”) with certain investors for~~fund current clinical trials over approximately the sale by us of 1,818,185 shares of our common stock at a purchase price of $0.55 per share. Concurrently with the sale of the common stock, pursuant to the Purchase Agreement, we also sold warrants to purchase 1,363,639 shares of common stock for aggregate net proceeds of approximately $875,000. We also issued placement agent warrants for the purchase of an aggregate of 90,909 shares of our common stock.

In May 2017, we entered into a mortgage and note payable agreement with a bridge funding company to obtain a two-year funding line of up to $4,000,000 secured by our assets and property located at 783 Jersey Ave., New Brunswick, New Jersey. Subject to the lender’s approval, we will be able to request up to $1,800,000 of the line in monthly advances during the loan term of 24next twenty-four months. We will be able to request future advances in excess of $2,000,000 at the lender’s discretion and be payable in full upon maturity. We will pay interest on this note at a fixed rate of 12% per annum for the first 18 months and change to a rate equal to 800 basis points above the prime rate of interest during the remainder of the term; however, the interest rate will not be less than 12% for the entire term. The note will be interest only and payable monthly through the maturity. We are permitted to prepay the line without penalty commencing after six months. The balance on this note is $1,543,000 as of September 30, 2017.

In June 2017, pursuant to an offer (the “Exchange Transaction”) to the holders of warrants issued to investors in September 2016 (the “2016 Warrants”), the exercise price of the 2016 warrants was changed to $0.50. As a result the warrant holders exercised 2016 Warrants and purchased 2,370,000 shares of Company common stock. The Company realized net proceeds of $1,055,000 from this exercise. As part of the Exchange Transaction, the Company issued 2,370,000 series A warrants with an exercise price of $0.60 per share, an initial exercise date of December 1, 2017 and expiring March 6, 2022, and 7,584,000 series B warrants with an exercise price of $0.60, an initial exercise date December 1, 2017 per share and expiring March 1, 2018.

In addition, in ~~July 2017,~~February 2022, the ~~warrant holders exercised~~SEC declared our new S-3 shelf Registration Statement effective which will allow us to raise additional capital in the ~~remaining 130,000 2016 Warrants~~future. At present we do not generate any material revenues from operations, and ~~purchased 130,000 shares of common stock. The Company realized net proceeds of $65,000 from this exercise. In conjunction with~~we do not anticipate doing so in the ~~foregoing~~near future. We may need to obtain additional funding in the Company issued 130,000 series A warrants with an exercise price of $0.60 per share and an initial exercise date of January 10, 2018 an expiring March 6, 2022, and 416,000 series B warrants with an exercise price of $0.60 and an initial exercise date January 10, 2018 on the three month anniversary of the of the initial exercise date.

~~In August 2017, the Holders of the series A warrants and series B warrants exchanged all of their series A warrants and series B warrants~~future for new warrants (respectively, the “Series A Exchange Warrants” and the “Series B Exchange Warrants” and, collectively, the “Exchange Warrants”) identical to the series A warrants and series B warrants except as follows: the exercise price of both Exchange Warrants is $0.45 per share, subject to adjustment therein, and the number of Series B Exchange Warrants issued was proportionately reduced so that all Exchange Warrants in the Exchange Transactionstudies and/or if current studies do not ~~exceed 19.9%~~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 ~~the number of the Company’s issued~~Alferon N Injection, our operations, financial position and ~~outstanding shares of Common Stock as of May 31, 2017, the date of the Exchange Transaction offer letters. The issuance of the Exchange Warrants by the Company~~liquidity may be adversely impacted, and the shares of Common Stock issuable upon exercise of the Exchange Warrants is exempt from registration pursuant to Sections 3(a)(9) and 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”).

~~-30-~~

additional financing may be required. There can be no assurances that, if needed, we will be able to raise adequate funds ~~from these or other sources~~ or enter into licensing, partnering or other arrangements to advance our business goals. Our inability to raise such funds or enter into such arrangements, if needed, could have a material adverse effect on our ability to develop our products. Also, we have the ability to curtail discretionary spending, including some research and development activities, if required to conserve cash. Because of our long-term capital requirements, weWe 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. We may also need additional funding earlier than anticipated, and our cash requirements, in general, may vary materially from those now planned, for reasons including, but not limited to, changes in our research and development programs, clinical trials, acquisitions of intellectual property or assets, enhancements to the manufacturing process, competitive and technological advances, the regulatory processes including the commercializing of Ampligen® products or new utilization of Alferon® products. See Part ~~II,~~I, Item ~~1A. Risk~~1A - “Risk Factors; “We ~~will~~may require additional financing which may not be available"”.

The proceeds from our financing have been used to fund infrastructure growth including manufacturing, regulatory compliance and market development along with our efforts regarding the Ampligen® NDA and preparedness for the FDA pre-approval inspections of the New Brunswick manufacturing facility. There can be no assurances that, if needed, we will raise adequate funds from these or other sources, which may have a material adverse effect on our ability to develop our products. Also, we have the ability to curtail discretionary spending, including some research and development activities, if required to conserve cash.

ITEM 3: Quantitative and Qualitative Disclosures About Market Risk

WeThe Company had approximately ~~$2,303,000~~$44,543,000 in cash, cash equivalents and marketable securities ~~at September 30, 2017~~as of March 31, 2022, as compared to ~~$5,868,000~~$48,268,000 at December 31, ~~2016.~~2021.

To the extent that our cash and cash equivalents exceed our ~~near term~~near-term funding needs, we intend to invest the excess cash in money market accounts, high-grade corporate bonds or fixed-income type bond funds. We employ established conservative policies and procedures to manage any risks with respect to investment exposure.

ITEM 4: Controls and Procedures

~~Evaluation~~

Our Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”) performed an evaluation of ~~Disclosure Controls and Procedures~~

~~We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under~~ the ~~Securities Exchange Act~~effectiveness of ~~1934, as amended (the “Exchange Act”). In designing and evaluating~~ our disclosure controls and procedures, ~~our~~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 ~~disclosure~~any controls and procedures, no matter how well ~~conceived~~designed and operated, can provide only reasonable ~~not absolute,~~ assurance ~~that~~of achieving the desired control objectives, ~~of disclosure controls~~ and ~~procedures are met. Additionally, in designing disclosure controls and procedures, our~~ management ~~necessarily was~~is required to apply its judgment in evaluating the cost-benefit relationship of possible ~~disclosure~~ controls and procedures. ~~The design of any disclosure~~Based on that evaluation, our CEO and CFO concluded that the controls and procedures ~~also is based in part upon certain assumptions about the likelihood~~were effective as of ~~future events,~~March 31, 2022, to ensure that material information was accumulated and ~~there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.~~

~~As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of~~communicated to our management, including our ~~Chief Executive Officer~~CEO and CFO, is appropriate to allow timely decisions regarding required disclosure.

During the three months ended March 31, 2022, we made no change in our ~~Chief Financial Officer, of the effectiveness of our disclosure~~internal controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act. Based on that evaluation and the material weaknesses described below our Chief Executive Officer and Chief Financial Officer had concluded that our disclosure controls and procedures were not effective for the September 30, 2017 period. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting ~~such~~ that ~~there~~has materially affected, or is ~~a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis.~~

~~-31-~~

The material weakness related to the completeness and accuracy of the recording of the exercise of certain redeemable warrants. Specifically, controls over the recording of the exercise of those warrants were insufficient to ensure that the exercised warrants were properly evaluated. The control deficiency could have result in a misstatement of the Company’s retained earnings, additional paid in capital and net income that would not have been prevented or detected.

~~Changes in Internal Controls~~

~~Management has taken the following actions in the current period that materially affect, or are~~ reasonably likely to materially affect, our internal ~~control~~controls over financial reporting and to remediate the material weaknesses described above. We will not deem the material weakness remediated until we have two quarters without any errors and have concluded the additional control is effective to mitigate the material weakness.reporting.

●

~~The Company engaged a third-party subject matter expert to aid in identifying and applying GAAP rules related to complex accounting transactions.~~

Other than discussed above, there have not been any changes in our internal control over financial reporting during the quarter ended September 30, 2017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Part II – OTHER INFORMATION

ITEM 1: Legal Proceedings

In May 2017 Hemispherx filed a complaint in the Philadelphia County Court of Common Pleas Civil Trial Division against Nitto Avecia Pharma Services, Inc. ("NAPS"), the successor to Avrio Biopharmaceuticals, LLC (“Avrio”), primarily for breach of contract. Pursuant to the agreement, Avrio was to provide fill and finish services of Ampligen®. Hemispherx is seeking damages in excess of $650,000 due to Avrio’s gross negligence and omissionsNothing new during the ~~fill and finish process which led to a significant loss of product. In June 2017, NAPS filed an answer denying liability and counter claiming breach of contract by Hemispherx. The litigation is~~quarter ended March 31, 2022. Please see Part I, Item 3. Legal Proceedings in our Annual Report on Form 10-K for the ~~early stages and there can be no guarantee that Hemispherx will be successful.~~year ended December 31, 2021.

ITEM 1A:Risk Factors

~~The following cautionary statements identify important~~Please carefully consider the factors ~~that could cause our actual results to differ materially from those projected~~discussed in ~~the forward-looking statements made in this Form 10-Q. Among the key factors that have a direct bearing on our results of operations are:~~

~~We will require additional financing which may not be available~~.

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. As of September 30, 2017, we had approximately $2,303,000 in cash, cash equivalents and marketable securities (inclusive of approximately $1,800,000 in Marketable Securities). However, 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.

In its CRL, the FDA communicated that Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. Until we undertake the end-of-review conference(s) with the FDA or otherwise reach an agreement with the FDA regarding the design of a confirmatory study, we are unable to reasonably estimate the nature, costs, necessary efforts to obtain FDA clearance or anticipated completion dates of any additional clinical study or studies. Utilizing the industry norms for undertaking a Phase III clinical study, we estimate upon acceptance of the study's design that it would take approximately 18 months to three years to complete a new well-controlled Ampligen® clinical study for resubmission to the FDA. It can be reasonably anticipated that the time and cost to undertake clinical trial(s), studies and data analysis are beyond our current financial resources without gaining access to additional funding. The actual duration to complete the clinical study may be different based on the length of time it takes to design the study and obtain FDA's acceptance of the design, the final design of an acceptable Phase III clinical study design, availability of suitable participants and clinical sites along with other factors that could impact the implementation of the study, analysis of results or requirements of the FDA and/or other governmental organizations.

~~-32-~~

Given the challenging economic conditions, we continue to review every aspect of our operations for cost and spending reductions to assure our long-term financial stability while maintaining the resources necessary to achieve our primary objectives of obtaining NDA approval of Ampligen® along with the manufacturing, marketing and distribution of our products, including Alferon N Injection®. Due to the repair issues mentioned above within our NJ facility and the high cost estimates to bring the facility back online, we will need additional funds to finance the revalidation processPart I, “Item 1A. Risk Factors” in our ~~facility to initiate commercial manufacturing, thereby readying ourselves~~Annual Report on Form 10-K for an FDA Pre-Approval Inspection. We also will need additional capital to eventually commercialize and sell Ampligen® and/or recommence and increase sales of Alferon N Injection® or our other products. We anticipate considering multiple options in an attempt to secure funding, including but not limited to such methods as the ~~sales of additional equity, licensing agreements, partnering with other organizations, debt financing or other sources of capital.~~

~~We did raise approximately $875,000 in February 2017 from the sale of our securities.~~

In June 2017, the exercise price of the 2016 Warrants was changed to $0.50. As a result the warrant holders exercised these warrants and purchased 2,500,000 shares of company common stock. The Company realized net proceeds of $1,120,000 from these exercises.

However, if we are unable to obtain additional funding, through an Equity Distribution Agreement (“EDA”) or other sales of securities and/or otherwise, our ability to develop our products, commercially produce inventory or continue our operations may be materially adversely affected.

~~Our stock price may be adversely affected if a significant amount of shares is sold in the public market.~~

We may issue shares to be used to meet our capital requirements or use shares to compensate employees, consultants and/or Directors. In this regard, we have registered securities for public sale pursuant to a universal shelf registration statement and we had been selling shares under this shelf registration statement. In September 2016, we sold 3,333,334 shares of our common stock and issued warrants to purchase 2,500,000 shares of common stock. The warrants were exercised in June and July 2017. In February we sold 1,818,185 shares of our common stock and issued warrants. In August 2017, these warrants were exchanged for warrants to purchase an aggregate of 5,300,000 shares of common stock at an exercise price of $0.45 per share, most exercisable commencingyear ended December 1, 2017. We have registered the shares issuable upon exercise of these warrants for public sale and, should the market price of our common stock exceed the exercise price of these warrants, some or all of these warrants may be exercised.

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. Sales of substantial amounts of our common stock in the public market, including additional sale of securities pursuant to our equity distribution agreements with Chardan Capital Markets, LLC and Maxim Group LLC or otherwise under the universal shelf registration statement or upon exercise of outstanding options and warrants, could cause the market price for our common stock to decrease. Furthermore, a decline in the price of our common stock would likely impede our ability to raise capital through the issuance of additional shares of common stock or other equity securities.

Please also see Part I, Item IA – “Risk Factors” for more information concerning risks associated with our business and risks associated with an investment in our common stock contained within our 2016 Form 10-K31, 2021 filed with the SEC on March 31, ~~2017.~~

~~Special Note Regarding Forward Looking Statements~~

~~Because the risk factors referred to above~~2022, which could ~~cause actual results or outcomes to differ~~ materially from those expressed in any forward-looking statements made by us, you should not place undue reliance on any such forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made and we undertake no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which will arise. In addition, we cannot assess the impact of each factor onaffect our business, financial condition, or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Our research in clinical efforts may continue for the next several years and we may continue to incur losses due to clinical costs incurredfuture results. The risks described in the ~~development of Ampligen® for commercial application. Possible losses~~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 ~~fluctuate from quarter to quarter as a result of differences in the timing of significant expenses incurred~~materially adversely affect our business, financial condition and ~~receipt of licensing fees and/or cost recovery treatment revenue.~~operating results. Please also see ~~“Cautionary Statement~~“Special Note Regarding Forward-Looking Statements” ~~set forth before Part I of this report.~~above.

~~-33-~~

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

In August 2017, in an exchange transaction, the Holders of Series A Warrants and Series B Warrants issued in June and July 2017 exchanged all of their warrants for new warrants (respectively, the “Series A Exchange Warrants” and the “Series B Exchange Warrants” and, collectively, the “Exchange Warrants”) identical to the warrants except as follows: The exercise price of both Exchange Warrants is $0.45 per share, subject to adjustment therein, and the number of Series B Exchange Warrants issued was proportionately reduced so that all Exchange Warrants in the Exchange Transaction do not exceed 19.9% of the number of the Company’s issued and outstanding shares of Common Stock as of May 31, 2017, the date of the Exchange Transaction offer letters. Series A Exchange Warrants for an aggregate of 2,500,000 shares and Series B Exchange Warrants for an aggregate of 2,800,000 shares were issued in this exchange transaction. The issuance of the Exchange Warrants by the Company and the shares of Common Stock issuable upon exercise of the Exchange Warrants is exempt from registration pursuant to Sections 3(a)(9) and 4(a)(2) of the Securities Act.None.

Effective with the semi-monthly period ended April 30, 2017, all of the members of the Company’s Board of Directors agreed to accept 100% of their directors’ fees in the form of options to purchase Company Common Stock until it was no longer necessary. In this regard, options to purchase 355,772 shares of Company common stock were issued. This program was terminated as of August 31, 2017. In addition, commencing with the semi-monthly period ended June 15, 2017, certain officers of the Company, and certain other employees of the Company, agreed to accept 20% of their salary in options to purchase Company Common Stock until it was no longer necessary. In this regard, options to purchase 284,795 shares of Company common stock were issued. This program was also terminated as of August 31, 2017.

ITEM 3: Defaults upon Senior Securities

None.

ITEM 4: Mine Safety Disclosures

Not Applicable.

ITEM 5: Other Information

~~As part of the Company’s objectives to achieve its commercial goals and increase stockholder value, the Company has initiated the sale of underutilized assets.~~Not Applicable

~~The Company has also completed the process for the sale of its 2016 New Jersey Net Operating Loss. The Company expects to collect $820,000 when this sale is completed.~~

The Board determined that it was in the best interests of the Company to extend the term and amend certain other provisions of its Rights Agreement. As a result, on November 14, 2017, the Company executed a Second Amended and Restated Rights Agreement with American Stock Transfer & Trust Company, LLC, its Rights Agent (the “Rights Agreement”).

~~-34-~~

On November 19, 2002, the Board declared a dividend distribution of one Right for each outstanding share of Common Stock to stockholders of record at the close of business on November 29, 2002 (the “Record Date”). Pursuant to the Rights Agreement, each Right entitles the registered holder to purchase from the Company a unit consisting of one one-hundredth of a share (a “Unit”) of Series A Junior Participating Preferred Stock, par value $0.01 per share (the “Series A Preferred Stock”) at a Purchase Price of $21.00 per Unit, subject to adjustment. The description and terms of the Rights are set forth in the Rights Agreement.

Initially, the Rights attached to all Common Stock certificates representing shares outstanding at the Record Date. The Rights attach to all certificates (or book entry notation) of shares of Common Stock issued after the Record Date. No separate Rights Certificates will be distributed. Subject to certain exceptions specified in the Rights Agreement, the Rights will separate from the Common Stock and a Distribution Date will occur upon the earlier of (i) 10 days following a public announcement that a person or group of affiliated or associated persons (an “Acquiring Person”) has acquired beneficial ownership of 15% or more of the outstanding shares of Common Stock (the “Stock Acquisition Date”), other than as a result of repurchases of stock by the Company or certain inadvertent actions by institutional or certain other stockholders or (ii) 10 business days (or such later date as the Board shall determine) following the commencement of a tender offer or exchange offer that would result in a person or group becoming an Acquiring Person. Until the Distribution Date, (i) the Rights will be evidenced by certificates and Book Entry Notations for the Common Stock (collectively, “Common Stock Certificates”) and will be transferred with and only with such Common Stock Certificates, (ii) new Common Stock Certificates issued after the Record Date will contain a notation incorporating the Rights Agreement by reference and (iii) the surrender for transfer of any Common Stock Certificates outstanding will also constitute the transfer of the Rights associated with the Common Stock represented by such Common Stock Certificate. Pursuant to the Rights Agreement, the Company reserves the right to require prior to the occurrence of a Triggering Event (as defined below) that, upon any exercise of Rights, a number of Rights be exercised so that only whole shares of Preferred Stock will be issued.

The Rights are not exercisable until the Distribution Date and will expire at 5:00 P.M. (New York City time) on November 14, 2022, unless such date is extended or the Rights are earlier redeemed or exchanged by the Company as described below.

As soon as practicable after the Distribution Date, Rights Certificates will be mailed to holders of record of the Common Stock as of the close of business on the Distribution Date and, thereafter, the separate Rights Certificates alone will represent the Rights. Except as otherwise determined by the Board of Directors, only shares of Common Stock issued prior to the Distribution Date will be issued with Rights.

In the event that a Person becomes an Acquiring Person, except pursuant to an offer for all outstanding shares of Common Stock which the Board determines to be fair and not inadequate and to otherwise be in the best interests of the Company and its stockholders, after receiving advice from one or more investment banking firms (a “Qualified Offer”), each holder of a Right will thereafter have the right to receive, upon exercise, Common Stock (or, in certain circumstances, cash, property or other securities of the Company) having a value equal to two times the exercise price of the Right. Notwithstanding any of the foregoing, following the occurrence of the event set forth in this paragraph, all Rights that are, or (under certain circumstances specified in the Rights Agreement) were, beneficially owned by any Acquiring Person will be null and void. However, Rights are not exercisable following the occurrence of the event set forth above until such time as the Rights are no longer redeemable by the Company as set forth below.

In the event that, at any time following the Stock Acquisition Date, (i) the Company engages in a merger or other business combination transaction in which the Company is not the surviving corporation (other than a merger or business combination with an entity which acquired the shares pursuant to a Qualified Offer in which holders of the Company common stock receive the same consideration per share as in the Qualified Offer), (ii) the Company engages in a merger or other business combination transaction in which the Company is the surviving corporation and the Common Stock of the Company is changed or exchanged, or (iii) 50% or more of the Company's assets, cash flow or earning power is sold or transferred, each holder of a Right (except Rights which have previously been voided as set forth above) shall thereafter have the right to receive, upon exercise, common stock of the acquiring company having a value equal to two times the exercise price of the Right. The events set forth in this paragraph and in the second preceding paragraph are referred to as the “Triggering Events”.

At any time after a person becomes an Acquiring Person and prior to the acquisition by such person or group of fifty percent (50%) or more of the outstanding Common Stock, the Board may exchange the Rights (other than Rights owned by such person or group which have become void), in whole or in part, at an exchange ratio of one share of Common Stock, or one one-hundredth of a share of Preferred Stock (or of a share of a class or series of the Company's preferred stock having equivalent rights, preferences and privileges), per Right (subject to adjustment).

The Purchase Price payable, and the number of Units of Preferred Stock or other securities or property issuable, upon exercise of the Rights subsequent to the reverse split of the Company’s outstanding shares of Common Stock effected in August 2016 are subject to adjustment from time to time to prevent dilution (i) in the event of a stock dividend on, or a subdivision, combination or reclassification of, the Preferred Stock, (ii) if holders of the Preferred Stock are granted certain rights or warrants to subscribe for Preferred Stock or convertible securities at less than the current market price of the Preferred Stock, or (iii) upon the distribution to holders of the Preferred Stock of evidences of indebtedness or assets (excluding regular quarterly cash dividends) or of subscription rights or warrants (other than those referred to above).

~~No fractional Units will be issued and, in lieu thereof, an adjustment in cash will be made based on the market price of the Preferred Stock on the last trading date prior to the date of exercise.~~

At any time prior to such time as any Person becomes an Acquiring Person, the Company may redeem the Rights in whole, but not in part, at a price of $0.01 per Right (payable in cash, Common Stock or other consideration deemed appropriate by the Board of Directors). Immediately upon the action of the Board of Directors ordering redemption of the Rights, the Rights will terminate and the only right of the holders of Rights will be to receive the $0.01 redemption price.

Until a Right is exercised, the holder thereof, as such, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends. While the distribution of the Rights will not be taxable to stockholders or to the Company, stockholders may, depending upon the circumstances, recognize taxable income in the event that the Rights become exercisable for Common Stock (or other consideration) of the Company or for common stock of the acquiring company or in the event of the redemption of the Rights as set forth above.

Any of the provisions of the Rights Agreement may be amended by the Board of Directors of the Company prior to the Distribution Date. After the Distribution Date, the provisions of the Rights Agreement may be amended by the Board in order to cure any ambiguity, to make changes which do not adversely affect the interests of holders of Rights, or to shorten or lengthen any time period under the Rights Agreement. The foregoing notwithstanding, no amendment may be made at such time as the Rights are not redeemable.

This summary description of the Rights Agreement and the Rights does not purport to be complete and is qualified in its entirety by reference to the Rights Agreement, which is incorporated herein by reference.

~~-35-~~

ITEM 6: Exhibits

(i)

Exhibits - See exhibit index below.

Exhibit No.		Description
		~~Amendment to the~~
3.1(i)		Amended and Restated Certificate of ~~Designations, Preferences and Rights~~Incorporation of the ~~Series A Junior Participating Preferred Stock. (included in Exhibit 4.3)~~Company, as amended, along with Certificates of Designations (incorporated by reference to exhibits of the Company’s Registration Statement on Form S-1 (No. 33-93314) filed November 2, 1995).
~~4.1~~
3.2(i)		Amendment to Certificate of Incorporation (incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (No. 001-13441) filed September 16, 2011).

3.3(i)		Amendment to Certificate of Incorporation(incorporated by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (No. 000-27072) filed June 27, 2016).

3.4(i)		Amendment to Certificate of Incorporation(incorporated by reference to exhibit 3.11 to the Company’s Current report on Form 8-K (No. 001-27072) filed June 5, 2019).
		~~Form of New Series A Warrant issued in August 2017. (1)~~
~~4.2~~3.5(i)		Amendment to Certificate of Incorporation (incorporated by reference to exhibit 3.11 to the Company’s Current report on Form 8-K (No. 001-27072) filed August 23, 2019).

3.6(i)		Certificate of ~~New~~Designation of Preference, Rights and Limitations of Series B ~~Warrant issued in August 2017. (1)~~Convertible Preferred Stock (incorporated by reference to exhibit 3.5 to the Amendment to the Company’s Registration Statement on Form S-1/A (No. 333-229051) filed February 6, 2019).
~~4.3~~		~~Second~~
3.7(ii)		Amended and Restated By-Laws of Registrant (incorporated by reference to exhibit 3.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed June 10, 2016).

4.1		Specimen certificate representing our Common Stock (incorporated by reference to exhibits of the Company’s Registration Statement on Form S-1 (No. 33-93314) filed November 2, 1995).

4.2		Amended and Restated Rights Agreement, dated as of November ~~xx,~~14, 2017, between the Company and American Stock Transfer & Trust Company LLC. The ~~Second~~ Amended and Restated Right Agreement includes the Form of ~~Amendment to the Amended and Restated~~ Certificate of ~~Designations,~~Designation, Preferences and Rights of the Series A Junior Participating Preferred Stock, the Form of Rights Certificate and the Summary of the Right to Purchase Preferred ~~Stock.(2)~~Stock (incorporated by reference to exhibit 1 to the Company’s Registration Statement on Form 8-A12B (No. 001-27072) filed November 14, 2017).
~~10.1~~
4.3		Form of Indenture filed with Form S-3 Universal Shelf Registration Statement (incorporated by reference to exhibit 4.4 to the Company’s Form S-3 Registration Statement (No. 333- 262280) filed January 21, 2022).

4.4		Form of Warrant pursuant to August 30, 2016 Securities Purchase Agreement (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No. 000-270720 filed September 1, 2016).

4.5		Form of Warrant pursuant to February 1, 2017 Securities Purchase Agreement (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed February 3, 2017).

4.6		Form of Series A Warrant-June 2017 (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed June 1, 2017).

4.7		Form of Series B Warrant-June 2017(incorporated by reference to exhibit 4.2 to the Company’s Current report on Form 8-K (No. 000-27072) filed June 1, 2017).

4.8		Form of New Series A Warrant-August 2017 (incorporated by reference to exhibit 4.1 the Company’s Current report on Form 8-K (No. 000-27072) filed August 23, 2017).

4.9		Form of New Series B Warrant-August 2017 (incorporated by reference to exhibit 4.2 the Company’s Current report on Form 8-K (No. 000-27072) filed August 23, 2017).

4.10		Form of Warrant issued to Purchaser of facility (incorporated by reference to exhibit 4.8 to the Company’s Annual report on Form 10-K (No. 000-27072) for the year ended December 31, 2017).

4.11		Form of Class A Warrant- April 2018 (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed April 20, 2018).

4.12		Form of Class B Warrant- April 2018 (incorporated by reference to exhibit 4.2 to the Company’s Current report on Form 8-K (No. 001-27072) filed April 20, 2018).

4.13		September 28, 2018 Secured Convertible Promissory Note from the Company to Iliad Research and Trading, L.P. (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No. 001-27072) filed October 4, 2018).

4.14		Rights Offering Form of Non-Transferable Subscription Rights Certificate (incorporated by reference to exhibit 4.14 to the Company’s Registration Statement on Form S-1/A (No. 333-229051) filed February 6, 2019).

4.15		Rights Offering Form of Warrant Agreement (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K filed February 27, 2019 and is hereby incorporated by reference).

4.16		Rights Offering Form of Warrant Certificate (incorporated by reference to exhibit 4.15 to the Company’s Registration Statement on Form S-1/A (No. 333-229051) filed February 6, 2019).

4.17		Rights Offering Warrant Agency Agreement with American Stock Transfer & Trust (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No.001-27072) filed March 8, 2019).

4.18		AGP Offering-Form of Pre-Funded Warrant (incorporated by reference to exhibit 4.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed September 27, 2019).

4.19		AGP Offering-Form of Warrant (incorporated by reference to exhibit 4.2 to the Company’s Current report on Form 8-K (No. 001-27072) filed September 27, 2019).

4.20		AGP Offering-Form of Representative’s Warrant (incorporated by reference to exhibit 4.20 to the Company’s Registration Statement on Form S-1/A (No. 333-233657) filed September 24, 2019).

4.21		March 2019 Amendment to September 28, 2018 Secured Convertible Promissory Note from the Company to Iliad Research and Trading, L.P. (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed March 15, 2019).

4.22		December 5, 2019 Secured Promissory Note with Atlas Sciences, LLC (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No.001-27072) filed December 11, 2019).

4.23		Description of Common Stock (incorporated by reference to exhibit 4.23 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2021).

10.1		Form of Confidentiality, Invention and Non-Compete Agreement (incorporated by reference to exhibits of the Company’s Registration Statement on Form S-1 (No. 33-93314) filed November 2, 1995).

10.2		Form of Clinical Research Agreement (incorporated by reference to exhibits of the Company’s Registration Statement on Form S-1 (No. 33-93314) filed November 2, 1995.

10.3		Supply Agreement with HollisterStier Laboratories LLC dated December 5, 2005 (incorporated by reference to exhibit 10.46 to the Company’s Annual report on Form 10-K (No. 001-13441) for the year ended December 31, 2005).

10.4		Amendment to Supply Agreement with HollisterStier Laboratories LLC dated February 25, 2010 (incorporated by reference to exhibit 10.68 to the Company’s Annual report on Form 10-K (No. 001-13441) for the year ended December 31, 2009).

10.5		Vendor Agreement with Armada Healthcare, LLC dated August 15, 2011 (incorporated by reference exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 001-131) for the period ended September 30, 2011).

10.6		Amendment to Supply Agreement with HollisterStier Laboratories LLC executed September 9, 2011 (incorporated by reference to exhibit 10.22 to the Company’s Annual report on Form 10-K (No. 001-13441) for the year ended December 31, 2011).

10.7		Vendor Agreement extension with Armada Healthcare, LLC dated August 14, 2012 (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed August 15, 2012).

10.8		Vendor Agreement extension with Armada Healthcare, LLC dated July 19, 2013 (incorporated by reference to exhibit 10.22 to the Company’s Annual report on Form 10-K (No. 000-27072) for the year ended December 31, 2013).

10.9		Vendor Agreement extension with Bio Ridge Pharma, LLC and Armada Healthcare, LLC dated August 8, 2014. (incorporated by reference to exhibit 10.24 to the Company’s Annual report on Form 10-K (No. 000-27072) for the year ended December 31, 2014).

10.10		Sales, Marketing, Distribution, and Supply Agreement with Emerge Health Pty Ltd. dated March 9, 2015. (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.25 to the Company’s Annual report on Form 10-K (No. 000-27072) for the year ended December 31, 2014).

10.11		Vendor Agreement extension with Armada Healthcare, LLC dated July 29, 2015 (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2015).

10.12		Early Access Agreement with Impatients N.V. dated August 3, 2015.(Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 001-13441) for the period ended September 30, 2015).

10.13		Sales, Marketing, Distribution, and Supply Agreement with Emerge Health Pty Ltd. dated August 6, 2015. (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.4 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2015).

10.14		Addendum to Early Access Agreement with Impatients N.V. dated October 16, 2015. (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 001-13441) for the period ended September 30, 2015).

10.15		2016 Senior Executive Deferred Cash Performance Award Plan (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed February 4, 2016).

10.16		2016 Voluntary Incentive Stock Award Plan (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No. 000-27072) filed February 4, 2016).

10.17		Amended and Restated 2016 Senior Executive Deferred Cash Performance Award Plan (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed March 1, 2016).

10.18		Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with Scientific Products Pharmaceutical Co. LTD dated March 3, 2016 (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended March 31, 2016).

10.19		Agreement between Avrio Biopharmaceuticals (“Avrio”) and the Company dated July 20, 2016 (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No.000-27072) for the period ended June 30, 2016).

10.20		Licensing Agreement dated April 13, 2016 with Lonza Sales AG (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.2 to the Company’s report Form 10-Q/A (No. 000-27072) for the period ended March 31, 2016).

10.21		Form of Securities Purchase Agreement entered into on August 30, 2016 (incorporated by reference to exhibit 10.1 to the Company’s Current report Form 8-K (No. 000-27072) filed September 1, 2016).

10.22		Amended and Restated Early Access Agreement with Impatients N.V. dated May 20, 2016. (Confidential Treatment granted with respect to portions of the Agreement) (incorporated by reference to exhibit 10.1 to the Company’s report Form 8-K/A (No. 000-27072) filed May 8, 2017).

10.23		December 13, 2016 Amendment No. 1 to Amended and Restated Early Access Agreement with Impatients N.V. (incorporated by reference to exhibit 10.45 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2017).

10.24		June 28, 2017 Amendment No. 2 to Amended and Restated Early Access Agreement with Impatients N.V. (incorporated by reference to exhibit 10.46 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2017).

10.25		February 14, 2018 Amendment No. 3 to Amended and Restated Early Access Agreement with Impatients N.V. (incorporated by reference to exhibit 10.47 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2017).

10.26		March 26, 2018 Amendment No. 4 to Amended and Restated Early Access Agreement with Impatients N.V. (incorporated by reference to exhibit 10.48 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2017).

10.27		Form of Securities Purchase Agreement entered into on February 1, 2017 (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed February 3, 2017).

10.28		August 2017 Form of Employee Pay Reduction Plan (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed August 29, 2017).

10.29		August 2017 Form of Executive Compensation Deferral Plan (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No. 000-27072) filed August 29, 2017).

10.30		August 2017 Form of Directors’ Compensation Deferral Plan (incorporated by reference to exhibit 10.3 to the Company’s Current report on Form 8-K (No. 000-27072) filed August 29, 2017).

10.31		Form of August 2017 Agreement between the Company and the ~~Warrantholders. (1)~~Warrant holders . (incorporated by reference to exhibit 10.1 the Company’s Current report on Form 8-K (No. 000-27072) filed August 23, 2017).

10.32		Form of June 2017 Agreement between the Company and the Warrant holders (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 000-27072) filed June 1, 2017).

10.33		Mortgage and Security Agreement with SW Partners LLC dated May 12, 2017 (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended March 31, 2017).

10.34		Promissory Note with SW Partners LLC dated May 12, 2017 (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended March 31, 2017).

10.35		September 11, 2017 Purchase and Sale Agreement- 5 Jules Lane (incorporated by reference to exhibit 10.57 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2017).

10.36		January 8, 2018 Purchase and Sale Agreement- 783 Jersey Lane (incorporated by reference to exhibit 10.58 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2017).

10.37		Lease Agreement for 783 Jersey Lane (incorporated by reference to exhibit 10.59 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2017).

10.38		Form of ~~Employee Pay Reduction Plan. (3)~~Stock Purchase Agreement entered into on March 21, 2018 (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed March 22, 2018).

10.39		Form of Securities Purchase Agreement entered into on May 24, 2018 (incorporated by reference to exhibit 10.55 to the Company’s Registration Statement on Form S-1 (No. 333-226057) filed July 2, 2018).
~~10.3~~
10.40		2018 Equity Incentive Plan (filed with the Securities and Exchange Commission as Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A (No. 001-27072) filed on August 3, 2018).

10.41		September 28, 2018 Securities Purchase Agreement with Iliad Research and Trading, L.P. (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed October 4, 2018).

10.42		September 28, 2018 Security Agreement with Iliad Research and Trading, L.P. (incorporated by reference to exhibit 10.3 to the Company’s Current report on Form 8-K (No. 001-27072) filed October 4, 2018).

10.43		October 9, 2018, Clinical Trial Agreement with Roswell Park Comprehensive Cancer Center (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended September 30, 2018).

10.44		October 8, 2018, Restated First Amendment to Purchase and Sale Agreement (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended September 30, 2018).

10.45		October 9, 2018, Restated Bill of Sale for the Restated First Amendment and Sale Agreement (incorporated by reference to exhibit 10.3 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended September 30, 2018).

10.46		Form of ~~Executive Compensation Deferral Plan. (3)~~Agreement between the Company and the Warrantholders.- May 2, 2019 (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed May 2, 2019).
~~10.4~~
10.47		Note Purchase Agreement dated August 5, 2019 with Chicago Venture Partners, L.P. (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended June 30, 2019).

10.48		Secured Promissory Note dated August 5, 2019 issued to Chicago Venture Partners, L.P. (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended June 30, 2019).

10.49		Security Agreement dated August 5, 2019 with Chicago Venture Partners, L.P. (incorporated by reference to exhibit 10.3 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended June 30, 2019).

10.50		Salary Reduction and Restricted Stock Award Memo (August 2019) (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed August 26, 2019).

10.51		Form of ~~Directors’ Compensation Deferral Plan. (3)~~Restricted Stock Award (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No. 001-27072) filed August 26, 2019).
~~31.1~~
10.52		December 5, 2019 Note Purchase Agreement with Atlas Sciences, LLC (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No.001-27072) filed December 11, 2019).

10.53		December 5, 2019 Security Agreement with Atlas Sciences, LLC (incorporated by reference to exhibit 10.2 to the Company’s Current report on Form 8-K (No.001-27072) filed December 11, 2019).

10.54		March 20, 2020 Amendment to 2017 Material Transfer and Research Agreement with Roswell Park Cancer Institute (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed March 26, 2020).

10.55		April 1, 2020 Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. )001-27072) filed April 6, 2020).

10.56		April 21, 2020 Mutual Confidentiality Agreement with UMN Pharma Inc., National Institute of Infectious Diseases, and Shionogi & Co., Ltd (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed April 27, 2020).

10.57		June 1, 2020, Material Transfer and Research Agreement with the University of Rochester. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2020).

10.58		June 23, 2020, Specialized Services Agreement with Utah State University. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2020).

10.59		July 1, 2020, Material Transfer and Research Agreement with the Japanese National Institute of Infectious Diseases and Shionogi & Co., Ltd. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.3 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2020).

10.60		July 6, 2020, Clinical Trial Agreement with Roswell Park Comprehensive Cancer Center. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.5 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2020).

10.61		August 6, 2020, Project Work Order with Amarex Clinical Research LLC. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.5 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended June 30, 2020).

10.62		November 10, 2020 employment agreement with Thomas K. Equels. (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended September 30, 2020).

10.63		December 22, 2020 Master Service Agreement with Pharmaceutics International Inc. as a Fill & Finish provider for Ampligen (incorporated by reference to exhibit 10.75 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2020).

10.64		January 11, 2021 Sponsor Agreement with Centre for Human Drug Research. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.76 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2020).

10.65		November 29, 2020, Material Transfer and Research Agreement with Leyden Laboratories, B.V. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.77 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2020).

10.66		December 30, 2020 Amendment to Project Work Order with Amarex Clinical Research LLC. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.78 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2020).

10.67		December 23, 2020 Amendment to Master Service Agreement with Pharmaceutics International Inc. as a Fill & Finish provider for Ampligen (incorporated by reference to exhibit 10.79 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2020).

10.68		March 24, 2021 employment agreement with Peter Rodino (incorporated by reference to exhibit 10.80 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2020).

10.69		March 24, 2021 employment agreement with Ellen Lintal (incorporated by reference to exhibit 10.81 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2020).

10.70		April 1, 2021 extension of April 1, 2020 Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited. (incorporated by reference to exhibit 10.3 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended March 31, 2021).

10.71		Material Transfer And Research Agreement with the University of Cagliari Dipartimento di Scienze della Vita e dell’Ambiente executed on April 5, 2021 (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.4 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended March 31, 2021).

10.72		Material Transfer and Research agreement with Roswell Park Comprehensive Cancer Center executed on April 14, 2021 (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended March 31, 2021).

10.73		April 19, 2021 Purchase and Sale Agreement with Phoenix Equipment Corporation, Branford Auctions, LLC and Perry Videx LLC (incorporated by reference to exhibit 10.1 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended March 31, 2021).

10.74		May 12, 2021 Amendment to the Renewed Sales, Marketing, Distribution and Supply Agreement with GP Pharm. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.5 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended March 31, 2021).

10.75		May 21, 2021 extension of April 1, 2020 Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 001-27072) for the period ended June 30, 2021).

10.76		July 8, 2021 Reservation and Start-Up Agreement with hVIVO Services Limited (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q (No. 000-27072) for the period ended June 30, 2021 filed August 16, 2021)

10.77		September 27, 2021 Clinical Trial Agreement with hVIVO Services Limited (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.2 to the Company’s Quarterly report on Form 10-Q (No. 000-27072) for the period ended September 30, 2021)

10.78		March 1, 2022 Consulting Agreement with Foresite Advisors, LLC pursuant to which Robert Dickey IV will serve as the Company’s Chief Financial Officer (Portions of this agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.78 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2021).

10.79		March 24, 2022 Consulting Agreement with Ellen Lintal (Portions of this agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.79 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2021).

10.80		March 1, 2022 Amendment to Clinical Trial Agreement with hVIVO Services Ltd dated September 27, 2021. (incorporated by reference to exhibit 10.80 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2021).

10.81		March 3, 2022 Agreement of Sale and Purchase with Acellories, Inc for sale of 783 Jersey Avenue, New Brunswick, NJ building. (incorporated by reference to exhibit 10.81 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2021).

10.82		March 8, 2022 Change order to Master Service Agreement with Pharmaceutics International Inc. as a Fill & Finish provider for Ampligen. (incorporated by reference to exhibit 10.82 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2021).

10.83		April 17, 2022 Project Work Order with Amarex Clinical Research LLC.to manage Phase 2 clinical trial in advanced pancreatic cancer patients (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)) (incorporated by reference to exhibit 10.1 to the Company’s Current Report on Form 8-K (No. 001-27072) filed April 12, 2022).

16.1		January 16, 2021 Letter from MBAF (incorporated by reference to exhibit 10.1 to the Company’s Current report on Form 8-K (No. 001-27072) filed APRIL 27, 2020).

21.1		List of Subsidiaries (incorporated by reference to exhibit 21 to the Company’s Annual report on Form 10-K (No. 001-27072) for the year ended December 31, 2021).

31.1		Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the ~~Company's~~Company’s Chief Executive Officer. *

31.2		Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the ~~Company's~~Company’s Chief Financial Officer. *

32.1		Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the ~~Company's~~Company’s Chief Executive Officer. *

32.2		Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the ~~Company's~~Company’s Chief Financial Officer. *

101		The following materials from ~~Hemispherx’ Quarterly~~AIM’ Annual Report on Form ~~10-Q~~10-K for the ~~period~~year ended ~~September 30,~~
		~~2017~~December 31, 2019, formatted in Inline eXtensible Business Reporting Language (“XBRL”): (i) ~~Condensed Balance Sheets; (ii)~~
		the Condensed Consolidated Statements of ~~Comprehensive Loss;~~Income; (ii) the Condensed Consolidated Balance Sheets; (iii) ~~Changes in Stockholders' Equity;~~
		~~(iv)~~the Condensed Consolidated Statements of Cash Flows; and ~~(v)~~(iv) Notes to Condensed Consolidated Financial Statements.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

~~(1)~~	*	Filed ~~with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed August 23, 2017 and is hereby incorporated by reference.~~

~~(2)~~	~~Filed with the Securities and Exchange Commission as an exhibit to the Company’s Registration Statement on Form 8-A filed November 14, 2017 and is hereby incorporated by reference.~~

~~(3)~~	~~Filed with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K filed August 29, 2017 and is hereby incorporated by reference.~~herewith.

~~-36-~~ 44

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the ~~registrant~~Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	~~HEMISPHERX BIOPHARMA,~~AIM IMMUNOTECH INC.

	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer & President

	/s/ ~~Adam Pascale~~Robert Dickey IV
	~~Adam Pascale~~Robert Dickey IV
	Chief Financial Officer

Date: ~~November 14, 2017~~May 13, 2022

~~-37-~~ 45

	September 30, 2017			December 31, 2016
	(Unaudited)			(Audited)
ASSETS
Current assets:
Cash and cash equivalents	$	503		$	2,408
Marketable securities		1,800			3,460
Accounts receivable		42			-
Assets held for sale		764			764
Prepaid expenses and other current assets		626			309
Total current assets		3,735			6,941

Property and equipment, net		8,795			9,514
Patent and trademark rights, net		860			872
Other assets		1,335			1,546
Total assets	$	14,725		$	18,873

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	460		$	887
Accrued expenses		1,740			1,548
Total current liabilities		2,200			2,435

Long- term
Note payable		1,466			-

Redeemable warrants		1,018			940

Commitments and contingencies (Note 6 and Note 13)

Stockholders’ equity:
Preferred stock, par value $0.01 per share, authorized 5,000,000; issued and outstanding; none			_			_
Common stock, par value $0.001 per share, authorized 350,000,000 shares; issued and outstanding 31,077,372 and 24,202,921, respectively		31			24
Additional paid-in capital		316,748			315,980
Accumulated other comprehensive income (loss)		29			(5	)
Accumulated deficit		(306,767	)		(300,501	)
Total stockholders’ equity		10,041			15,498
Total liabilities and stockholders’ equity	$	14,725		$	18,873

	Three months ended September 30,						Nine months ended September 30,
	2017			2016			2017			2016
Revenues:
Clinical treatment programs - US	$	4		$	22		$	101		$	76
Clinical treatment programs - Europe		86			—			286			—

Total revenues		90			22			387			76

Costs and expenses:
Production costs		399			272			887			830
Research and development		787			1,342			3,284			3,244
General and administrative		1,556			1,634			4,839			5,721

Total costs and expenses		2,742			3,248			9,010			9,795

Operating loss		(2,652	)		(3,226	)		(8,623	)		(9,719	)

Interest expense and other finance costs		(51	)		—			(70	)		—
Interest and other income/expense		13			40			60			156
Redeemable warrants valuation adjustment		1,438			103			2,361			103
Insurance proceeds from legal settlement, net		—			190			—			1,626
Gain (Loss) on sales of short term marketable securities		—			31			6			(56	)
Gain from sale of income tax net operating losses and research credits		—			—			—			1,561

Net loss		(1,252	)		(2,862	)		(6,266	)		(6,329	)

Other comprehensive income (loss):
Reclassification adjustments for loss on sales of short term marketable securities included in net loss		—			(31	)		(6	)		56
Unrealized gain on marketable securities		11			15			40			112
Net comprehensive loss	$	(1,241	)	$	(2,878	)	$	(6,232	)	$	(6,161	)

Basic and diluted loss per share	$	(0.04	)	$	(0.13	)	$	(0.23	)	$	(0.30	)

Weighted average shares outstanding, basic and diluted		30,096,500			21,832,940			27,598,715			21,046,418

	Common Stock Shares		Common Stock $0.001 Par Value			Additional Paid-In Capital			Accumulated Other Compre- hensive Income (Loss)			Accumulated Deficit			Total Stockholders’ Equity
Balance at December 31, 2016		24,202,921	$	24		$	315,980		$	(5	)	$	(300,501	)	$	15,498
Equity-based compensation		446,753			_		286			—			—			286
Issuance of redeemable warrants		—		—			(2,050	)		—			—			(2,050	)
Deemed dividends		—		—			(388	)		—				_		(388	)
Common stock issuance, net of costs		4,646,205		5			2,175			—			—			2,180
Common stock issued for accounts payable		1,781,493		2			745			—			—			747
Net comprehensive income (loss)		—		—			—			34			(6,266	)		(6,232	)

Balance at September 30, 2017		31,077,372	$	31		$	316, 748		$	29		$	(306,767	)	$	10,041

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2017		836,256		$	16.82		4.47	$	—
Granted		584,795			0.50		—		—
Forfeited		(208,382	)		34.09		—		—
Outstanding September 30, 2017		1,212,669		$	5.98		7.14	$	—
Vested and expected to vest September 30, 2017		1,212,669		$	5.98		7.14	$	—
Exercisable September 30, 2017		747,788		$	8.25		4.96	$	—

	Number of Options			Weighted Average Exercise Price		Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2017		90,625		$	1.72		9.33	$	—
Granted		584,795			0.50		—		—
Vested		(210,539	)		1.05		—		—
Forfeited		—			—		—		—
Outstanding September 30, 2017		464,881		$	0.49		9.86	$	—

Inventories consist of the following:	(in thousands)
	September 30, 2017		December 31, 2016

Inventory work-in-process, January 1	$	—	$	1,326
Production		—		—
Transfer to other assets		—		(1,326	)
Spoilage		—		—
Inventory work-in-process, end of period	$	—	$	—

	Total		Less Than 12 Months					12 Months or Greater				Totals
Securities	Number In Loss Position		Fair Values		Unrealized Losses			Fair Values		Unrealized Losses		Total Fair Value		Total Unrealized Losses
Mutual Funds		1	$	402	$	(1	)	$	-	$	-	$	402	$	(1	)
Totals		1	$	402	$	(1	)	$	-	$	-	$	402	$	(1	)

Balance at December 31, 2016	$	940
Issuance of warrants		2,074
Modification of warrants		389
Fair value adjustments		(2,385	)
Balance at September 30, 2017	$	1,018