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 June 30, 2023

Commission File Number: 001-27072

AIM IMMUNOTECH INC.

(Exact name of registrant as specified in its charter)

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

2117 SW Highway 484, Ocala FL 34473

(Address of principal executive offices) (Zip Code)

(352) 448-7797

(Registrant’s telephone number, including area code)

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

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

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

☒ Yes ☐ No

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

☒ Yes ☐ No

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

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

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

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

48,670,427 shares of common stock were outstanding, and 690 shares of series B preferred stock were outstanding as of August 11, 2023.

PART I- FINANCIAL INFORMATION

ITEM 1: Financial Statements

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Balance Sheets

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

(Unaudited)

	June 30, 2023			December 31, 2022
ASSETS
Current assets:
Cash and cash equivalents	$	21,038		$	27,053
Marketable securities		7,360			7,137
Funds receivable from New Jersey net operating loss		33			1,676
Prepaid expenses and other current assets		438			455
Total current assets		28,869			36,321
Property and equipment, net		145			195
Right of use asset, net		781			829
Patent and trademark rights, net		2,038			1,941
Other assets		1,784			1,202
Total assets	$	33,617		$	40,488
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,151		$	377
Accrued expenses		528			806
Current portion of operating lease liability		206			178
Total current liabilities		2,885			1,361
Long-term liabilities:
Operating lease liability		597			659
Commitments and contingencies (Notes 12 and 13)		-			-

Stockholders’ equity:
Series B Convertible Preferred Stock, stated value $1,000 per share, 690 and 696 issued and outstanding, respectively		690			696
Common Stock, par value $0.001 per share, authorized 350,000,000 shares; 48,419,491 and 48,084,287, issued and outstanding, respectively		48			48
Additional paid-in capital		418,513			418,270
Accumulated deficit		(389,116	)		(380,546	)
Total stockholders’ equity		30,135			38,468
Total liabilities and stockholders’ equity	$	33,617		$	40,488

See accompanying notes to consolidated financial statements.

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)

	2023			2022			2023			2022
	Three months ended June 30,						Six months ended June 30,
	2023			2022			2023			2022
Revenues:
Clinical treatment programs - US	$	42		$	30		$	91		$	64
Total Revenues		42			30			91			64
Costs and Expenses:
Production costs		—			69			—			147
Research and development		2,953			2,475			5,005			3,511
General and administrative		2,550			2,181			4,841			4,253
Total Costs and Expenses		5,503			4,725			9,846			7,911
Operating loss		(5,461	)		(4,695	)		(9,755	)		(7,847	)
Gain (Loss) on investments		(94	)		(470	)		109			(1,404	)
Interest and other income		318			79			517			124
Interest expense and other finance costs		—			—			—			—
(Loss) on sale of fixed assets		—			—			(23	)		—
Redeemable warrants valuation adjustment		—			3			—			34
Gain from sale of Income tax operating losses		328			232			582			422

Net Loss	$	(4,909	)	$	(4,851	)	$	(8,570	)	$	(8,671	)

Basic and diluted loss per share	$	(0.10	)	$	(0.10	)	$	(0.18	)	$	(0.18	)

Weighted average shares outstanding basic and diluted		48,411,251			48,034,100			48,405,675			48,014,713

See accompanying notes to consolidated financial statements.

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statements of Changes in Stockholders’ Equity

For the Six Months Ended June 30, 2023 and 2022

(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, 2022	$	696		-		48,084,287	$	48	$	418,270	$	—	$	(380,546	)	$	38,468
Common stock issuance, net of costs		—				323,039		—		100		—		—			100
Equity-based compensation		—				—		—		82		—		—			82
Series B preferred shares converted to common shares		(4	)			—		—		4		—		—			—
Net comprehensive loss		—		-		—		—		—		—		(3,661	)		(3,661	)
Balance March 31, 2023	$	692		-		48,407,326	$	48	$	418,456	$	—	$	(384,207	)	$	34,989
Common stock issuance, net of costs		—				12,165		—		5		—		—			5
Equity-based compensation		—				—		—		50		—		—			50
Series B preferred shares converted to common shares		(2	)			—		—		2		—		—			—
Net comprehensive loss		—		-		—		—		—		—		(4,909	)		(4,909	)
Balance June 30, 2023	$	690		-		48,419,491	$	48	$	418,513	$	—	$	(389,116	)	$	30,135

	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
Common stock issuance, net of costs		—				—		—		—		—		—			—
Equity-based compensation		—				—		—		242		—		—			242
Series B preferred shares converted to common shares		—				—		—		—		—		—			—
Net comprehensive loss		—		-		—		—		—		—		(3,820	)		(3,820	)
Balance March 31, 2022	$	715		-		47,994,672	$	48	$	417,459	$	—	$	(364,921	)	$	53,301
Balance	$	715		-		47,994,672	$	48	$	417,459	$	—	$	(364,921	)	$	53,301
Common stock issuance, net of costs		—				54,150		—		55		—		—			55
Equity-based compensation		—				—		—		275		—		—			275
Series B preferred shares converted to common shares		—				—		—		2		—		—			—
Net Comprehensive loss		(2	)	-		—		—		—		—		(4,851	)		(4,851	)
Balance June 30, 2022	$	713		-		48,048,822	$	48	$	417,791	$	—	$	(369,772	)	$	48,780
Balance	$	713		-		48,048,822	$	48	$	417,791	$	—	$	(369,772	)	$	48,780

See accompanying notes to consolidated financial statements.

AIM IMMUNOTECH INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

For the Six Months Ended June 30, 2023 and 2022

(in thousands)

(Unaudited)

	2023			2022
Cash flows from operating activities:
Net loss	$	(8,570	)	$	(8,671	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment		21			20
Redeemable warrants valuation adjustment		—			(34	)
Amortization of patent, trademark rights		106			38
Changes in ROU assets		48			(740	)
Gain from sale of income tax operating losses		(582	)		(422	)
Equity-based compensation		132			517
(Loss) on sale of marketable securities		(109	)		1,404
Change in assets and liabilities:
Funds Receivable from New Jersey net operating loss		1,676			1,641
Prepaid expenses and other current assets and other non-current assets		17			(69	)
Lease liability		(34	)		740
Other Assets		(39	)		(73	)
Accounts payable		1,774			514
Accrued expenses		(278	)		64
Net cash used in operating activities		(5,838	)		(5,071	)
Cash flows from investing activities:
Proceeds from sale of marketable securities		598			8,713
Purchase of marketable securities		(712	)		(1,262	)
Proceeds from sale of property and equipment		35			—
Purchase of patent and trademark rights		(203	)		(76	)
Net cash (used in) provided by investing activities		(282	)		7,375
Cash flows from financing activities:
Proceeds from sale of stock, net of issuance costs		105			55
Net cash provided by financing activities		105			55
Net (decrease) increase in cash and cash equivalents		(6,015	)		2,359
Cash and cash equivalents at beginning of period		27,053			32,093
Cash and cash equivalents at end of period	$	21,038		$	34,452
Supplemental disclosures of non-cash investing and financing cash flow information:
Operating lease-Right of Use Assets	$	(48	)	$	761
Unrealized gain (loss) on marketable securities	$	196		$	(225	)
Conversion of Series B preferred	$	6		$	2

See accompanying notes to consolidated financial statements.

AIM IMMUNOTECH INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1: Business and Basis of Presentation

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

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

The Company’s primary present business focus involves Ampligen. Ampligen is a double-stranded RNA (“dsRNA”) molecule being developed for globally important cancers, viral diseases and disorders of the immune system.

The Company is currently proceeding primarily in four areas:

	●	Conducting a randomized, controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced pancreatic cancer patients.
	●	Evaluating Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor responses to checkpoint inhibitors.
	●	Exploring Ampligen’s antiviral activities and potential use as a prophylactic or treatment for existing viruses, new viruses and mutated viruses thereof.
	●	Evaluating Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or Post-COVID conditions of fatigue.

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

AIM’s business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen and its Active Pharmaceutical Ingredients (APIs). This includes utilizing Jubilant HollisterStier and Sterling for the manufacture of Ampligen and our Poly I and Poly C12U polynucleotides, respectively. Additionally, our relationship with Polysciences Inc. (“Polysciences”) continues and R&D development of polymer manufacture is ongoing. While AIM believes it has sufficient Ampligen API to meet current needs, it is also continually exploring new efficiencies in order to maximize its ability to fulfill future obligations.

In the opinion of management, all adjustments necessary for a fair presentation of its consolidated financial statements have been included. Such adjustments consist of normal recurring items. 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, 2022, and 2021, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 31, 2023.

Use of Estimates

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

Note 2: Net Loss Per Share

Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Equivalent common shares, consisting of stock options and warrants which amounted to 2,595,914 and 2,447,924, are excluded from the calculation of diluted net loss per share for the six months ended June 30, 2023, and 2022, respectively, since their effect is antidilutive due to the net losses recorded for the periods.

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. During the six months ended June 30, 2023, there were no options granted and 300,000 options granted during the six months ended June 30, 2022.

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

Stock option activity for employees:

Schedule of Vest Stock Option Activity

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding March 31, 2023		2,020,214		$	3.01		8.55	$	—
Granted		—			—		—		—
Forfeited		—			—		—		—
Expired		(663	)		—		—		—
Outstanding June 30, 2023		2,019,551		$	3.01		8.36	$	—
Vested and expected to vest June 30, 2023		2,019,551		$	3.01		8.36	$	—
Exercisable June 30, 2023		1,852,887		$	2.13		6.50	$	—

Unvested stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested March 31, 2023		267,326		$	5.23		8.55	$	—
Granted		—			—		—		—
Expired		(663	)		.30		—		—
Vested		(99,999	)		.44		9.83		—
Unvested June 30, 2023		166,664		$	9.17		6.41	$	—

Stock option activity for non-employees:

Schedule of Vest Stock Option Activity

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding March 31, 2023		579,155		$	3.09		8.36	$	—
Granted		—			—		—		—
Forfeited		—			—		—		—
Expired		(123	)		—		—		—
Outstanding June 30, 2023		579,032		$	3.09		8.36	$	—
Vested and expected to vest June 30, 2023		579,032		$	3.09		8.36	$	—
Exercisable June 30, 2023		512,366		$	2.99		4.67	$	—

Unvested stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested March 31, 2023		104,289		$	11.39		5.75	$	—
Granted		—			—		—		—
Expired		(123	)		.38		7.86		—
Vested		(37,500	)		.46		9.14		—
Unvested June 30, 2023		66,666		$	9.45		4.59	$	—

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

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

Stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2023		2,020,214		$	3.01		8.86	$	—
Granted		—			—		—		—
Forfeited		—			—		—		—
Expired		(663	)		—		—		—
Outstanding June 30, 2023		2,019,551		$	3.01		8.36	$	—
Vested and expected to vest June 30, 2023		2,019,551		$	3.01		8.36	$	—
Exercisable June 30, 2023		1,852,887		$	2.13		6.50	$	—

Unvested stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2023		392,326		$	4.15		5.85	$	—
Granted		—			—		—		—
Expired		(663	)		.30		—		—
Vested		(224,999	)		.44		9.83		—
Unvested June 30, 2023		166,664		$	9.17		6.41	$	—

Stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2023		579,155		$	3.09		7.93	$	—
Granted		—			—		—		—
Forfeited		—			—		—		—
Expired		(123	)

SEC Form 10-Q filed by AIM ImmunoTech Inc.