Item 1. Financial Statements
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.
2
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.
3
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.
4
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.
5
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.
6
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:
Schedule
of Unvested Stock Option Activity
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
$ —
7
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:
Schedule
of Unvested Stock Option Activity
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
$ —
8
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 )
—
—
—
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 January 1, 2023
166,789
$ 4.05
9.49
$ —
Granted
—
—
—
—
Expired
( 123 )
.38
7.86
—
Vested
( 100,000 )
.46
9.14
—
Unvested June 30, 2023
66,666
$ 9.45
4.59
$ —
Stock-based
compensation expense was approximately $ 132,000 and $ 517,000 for the six months ended June 30, 2023 and 2022, respectively.
On
June 30, 2023, and 2022, respectively, there was approximately $ 85,000 and $ 454,000 of unrecognized equity-based compensation cost related
to options granted under the Equity Incentive Plan.
Note
4: Marketable Securities
Marketable
securities consist of mutual funds. As of June 30, 2023 and December 31, 2022, it was determined that none of the marketable securities
had an other-than-temporary impairment. As of June 30, 2023 and December 31, 2022, all securities were measured as Level 1 instruments
of the fair value measurements standard (See Note 11: Fair Value). As of June 30, 2023, and December 31, 2022 the Company held $ 7,360,000
and $ 7,137,000 in mutual funds, respectively.
Mutual
Funds classified as available for sale consisted of:
June
30, 2023
(in thousands)
Schedule
of Available of Sale
Securities
Fair Value
Short-Term
Investments
Mutual Funds
$ 7,360
$ 7,360
Totals
$ 7,360
$ 7,360
9
Schedule of Equity Securities
June
30, 2023
(in
thousands)
Securities
Net gain recognized during the period on equity securities
$ 109
Less: Net gains and losses recognized during the period on equity securities sold during the period
( 87 )
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date
$ 196
Mutual
Funds classified as available for sale consisted of:
December
31, 2022
(in
thousands)
Securities
Fair Value
Short-Term
Investments
Mutual Funds
$ 7,137
$ 7,137
Totals
$ 7,137
$ 7,137
December
31, 2022
(in
thousands)
Securities
Net losses recognized during the period on equity securities
$ ( 1,679 )
Less: Net gains and losses recognized during the period on equity securities sold during the period
( 751 )
Unrealized gains and losses recognized during the reporting period on equity securities still held at the reporting date
$ ( 928 )
Note
5: Accrued Expenses
Accrued
expenses consist of the following:
Schedule of
Accrued Expenses
June 30, 2023
December 31, 2022
(in thousands)
June 30, 2023
December 31, 2022
Compensation
$ 36
$ 1
Professional fees
313
492
Clinical trial expenses
97
110
Other expenses
82
203
Accrued expenses
$ 528
$ 806
Note
6: Property and Equipment, net
Schedule
of Property and Equipment
June 30, 2023
December 31, 2022
(in thousands)
June 30, 2023
December 31, 2022
Furniture, fixtures, and equipment
2,204
2,233
Less: accumulated depreciation
( 2,059 )
( 2,038 )
Property and equipment, net
$ 145
$ 195
10
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 ten years. Depreciation expense for the six months ending June 30, 2023 and June
30, 2022 was $ 21,000 and $ 20,000 , respectively.
The
Company made a strategic shift on in-house manufacturing and recorded an impairment of the facility in the amount of $ 1,800,000 during
the year ended December 31, 2021. During the period ending June 30, 2022, the Company reported assets held for sale related to the pending
sale of the manufacturing facility located at 783 Jersey Avenue (See Note 11 Fair Value).
Note
7: Patents, and Trademark Rights, Net
Schedule
of Patents, Trademark Rights
December 31, 2021
$ 1,974
Acquisitions
375
Abandonments and expirations
( 190 )
Amortization
( 218 )
December 31, 2022
$ 1,941
Acquisitions
210
Abandonments and expirations
( 7 )
Amortization
( 106 )
June 30, 2023
$ 2,038
Patents
and trademarks are stated at cost. Patents are amortized using the straight-line method over an estimated useful life of 17
years and 10 years, respectively.
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,
2023
$ 108
2024
212
2025
205
2026
203
2027
183
Thereafter
1,127
Total
$ 2,038
Note
8: Stockholders’ Equity
(a)
Preferred Stock
The
Company is authorized to issue 5,000,000 shares of $ 0.01 par value preferred stock with such designations, rights and preferences as
may be determined by the Board of Directors. Of our authorized preferred stock, 250,000 shares have been designated as Series A Junior
Participating Preferred Stock and 8,000 shares have been designated as Series B Convertible Preferred Stock. The Series B Convertible
Preferred Stock has a stated value of $ 1,000 per share.
The
Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $ 1,000 per share. As of June 30,
2023, and December 31, 2022, the Company had 690 and 696 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 does not carry voting Rights.
11
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 six months ending June 30, 2023, 2 shares of Series B Convertible Preferred Stock were converted
into common stock.
On
May 10, 2023, the Company filed a Certificate of Increase in Delaware, increasing the number of preferred stock designated as Series
A Junior Participating Preferred Stock to 4,000,000 .
(b)
Common Stock and Equity Finances
The
Company has authorized shares of 350,000,000 with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000
authorized shares.
On
July 7, 2020, the board of directors approved a plan pursuant to which all directors, officers, and employees could purchase from the
Company up to an aggregate of $ 500,000 worth of shares at the market price. Pursuant to NYSE American rules, this plan was effective
for a sixty-day period commencing upon the date that the NYSE American approved the Company’s Supplemental Listing Application.
The Company created successive new plans following the expiration of the plan. During the fiscal years ended December 31, 2021 and 2022,
the Company issued 132,238 and 86,817 shares of its common stock at prices ranging from $ 1.16 to $ 2.35 ; and from $ 0.76 to $ 1.02 /per
share under these plans. The latest plan was approved by the board of directors in June 2023.
During
the six months ended June 30, 2023, the Company issued a total of 322,583 shares of its common stock at a price of $ 0.31 for total proceeds
of $ 100,000 .
During
the six months ended June 30, 2022, the Company issued a total of 53,922 shares
of its common stock at prices ranging from $ 1.02 for
total proceeds of $ 55,000 as part of the employee stock purchase plan, not from the 2018 Equity Incentive Plan .
On
September 27, 2019, the Company closed a public offering underwritten by A.G.P./Alliance Global Partners, LLC (the “Offering”)
of (i) 1,740,550 shares of Common Stock; (ii) pre-funded warrants exercisable for 7,148,310 shares of Common Stock (the “Pre-funded
Warrants”), and (iii) warrants to purchase up to an aggregate of 8,888,860 shares of Common Stock (the “Warrants”).
In conjunction with the Offering, a Representative’s
Warrant to purchase up to an aggregate of 266,665 shares of common stock (the “Representative’s Warrant”) .
The shares of Common Stock and Warrants were sold at a combined Offering price of $ 0.90 , less underwriting discounts and commissions.
Each Warrant sold with the shares of Common Stock represents the right to purchase one share of Common Stock at an exercise price of
$ 0.99 per share. The Pre-Funded Warrants and Warrants were sold at a combined Offering price of $ 0.899 , less underwriting discounts and
commissions. The Pre-Funded Warrants were sold to purchasers whose purchase of shares of Common Stock in the Offering would otherwise
result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99 % of the Company’s
outstanding Common Stock immediately following the consummation of the Offering, in lieu of shares of Common Stock. Each Pre-Funded Warrant
represents the right to purchase one share of Common Stock at an exercise price of $ 0.001 per share. The Pre-Funded Warrants are exercisable
immediately and may be exercised at any time until the Pre-Funded Warrants are exercised in full. A registration statement on Form S-1,
relating to the Offering was filed with the SEC and was declared effective on September 25, 2019, the net proceeds were approximately
$ 7,200,000 . During the year ending December 31 , 2020, 1,870,000 of the Pre-funded Warrants
were exercised and 8,873,960 Warrants were exercised. In addition, on March 25, 2020, the Representative’s Warrant was amended
to permit exercise of such warrant to commence on March 30, 2020. These warrants were exercised on March 31, 2020 and an aggregate of
266,665 shares were issued upon exercise of this warrant for gross proceeds of approximately $ 264,000 and a $ 46,000 expense for the warrant
modification. As of June 30, 2023, there are 15,000 Warrants outstanding.
12
The
2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock
Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards,
(vii) Performance Cash Awards, and (viii) Other Stock Awards. Initially, a maximum of 7,000,000 shares of Common Stock is reserved for
potential issuance pursuant to awards under the 2018 Equity Incentive Plan. Unless sooner terminated, the 2018 Equity Incentive Plan
will continue in effect for a period of 10 years from its effective date. On October 17, 2018, the Board of Directors issued 26,324 options
to the officers and directors at the exercise price of $ 9.68 expiring in 10 years, and on November 14, 2018, the Board of Directors issued
23 options to each employee, officer and director at the exercise price of $ 9.68 expiring in ten years . On January 28, 2019, 27,570 options
were issued to each of these officers with an exercise price of $ 9.68 for a period of ten years with a vesting period of one year. In
August 2020, 400,000 options were issued to each of these officers with an exercise price range of $ 2.77 to $ 3.07 for a period of ten
years with a vesting period of one year. During the fiscal year ending December 31, 2022, 850,000 options were issued to employees with
an exercise price range of $ 0.31 to $ 1.71 for a period of ten years with a vesting period of one year. During the 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.
On
April 19, 2023, the Company entered into an Equity Distribution Agreement (the “EDA”) with Maxim Group LLC (“Maxim”),
pursuant to which the Company may sell, from time to time, shares of its common stock having an aggregate offering price of up to $ 8.5
million through Maxim, as agent (the “Offering”). Sales under the EDA were registered under the S-3 Shelf Registration Statement.
Under the terms of the EDA, Maxim will be entitled to a transaction fee at a fixed rate of 3.0 % of the gross sales price of shares sold
under the EDA. For the six months ended June 30, 2023, the Company sold 11,937 shares under the EDA for total gross proceeds of $ 5,593 ,
which includes a 3.0 % fee to Maxim of $ 168 . Subsequent to the period ended June 30, 2023, the Company sold 234,386 shares under the EDA
for total gross proceeds of $ 152,579 , which includes a 3.0 % fee to Maxim of $ 4,577 .
On
May 12, 2023, the Company amended and restated its November 14, 2017 Rights Plan with American Stock Transfer & Trust Company as
Rights Agent (the “Rights Plan”).
As
of June 30, 2023, and December 31, 2022, there were 48,419,491 and 48,084,287 shares outstanding, respectively.
Note
9 : Cash and Cash Equivalents
AIM
considers all highly liquid interest-earning investments with an original maturity of three months or less at the date of purchase to
be cash equivalents.
Note
10: Recent Accounting Pronouncements
The
Company has implemented all new accounting pronouncements that are in effect. These pronouncements did not have any material impact
on the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting
pronouncements that have been issued that might have a material impact on its financial position or results of operations. Accounting pronouncements issued by the FASB since filing the Annual Report on Form 10-K for the year ended December 31, 2022 did not or are not believed by management to have a material
impact on the Company’s present or future financial statements.
Note
11: Fair Value
Fair
Value
The
Company complies with the provisions of FASB ASC 820 “Fair Value Measurements” for its financial and non-financial assets
and liabilities. ASC 820 defines fair value, establishes a framework for measuring fair value and expands disclosure for each major asset
and liability category measured at fair value on either a recurring or nonrecurring basis.
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 and are considered a Level 1 instrument of the fair value measurements standard. The Company
also has certain warrants with a cash settlement feature in the occurrence of a Fundamental Transaction. The fair value of the redeemable
warrants (“Warrants”) related to the Company’s April 2018 and March 2019 common stock and warrant issuance, are calculated
using a Monte Carlo Simulation.
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.
13
The
Company utilized the following assumptions to estimate the fair value of the April 2018 Warrants:
Schedule
of Assumptions to Estimate Fair Value of Warrants
June 30,
December 31,
2023
2022
Underlying price per share
$ 0.67
$ 0.31
Exercise price per share
$ 17.16
$ 17.16
Risk-free interest rate
5.44 %
4.74 %
Expected holding period
0.32
0.81
Expected volatility
75 %
75 %
Expected dividend yield
—
—
Warrants measurement input
—
—
The
Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:
June 30,
December 31,
2023
2022
Underlying price per share
$ 0.67
$ 0.31
Exercise price per share
$ 8.80
$ 8.80
Risk-free interest rate
5.44 %
4.67 %
Expected holding period
0.69
1.19
Expected volatility
90 %
70 %
Expected dividend yield
—
—
Warrants measurement input
—
—
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 . The expected dividend yield is based on the Company’s anticipated
dividend payments over the remaining expected holding period. As the Company has never issued
dividends, the expected dividend yield is 0% and this assumption will be continued in future
calculations unless the Company changes its dividend policy.
(v) Expected
Probability of a Fundamental Transaction. Put rights 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 unlikely because:
1. The
Company only has one product that is FDA approved but is currently not available for commercial
sales.
2. The
Company will have to perform additional clinical trials for FDA approval of its flagship
product.
3. Industry
and market conditions continue to include uncertainty, adding risk to any transaction.
4. The
nature of a life sciences company is heavily dependent on future funding and high fixed costs,
including Research & Development.
5. 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
6. The
Company’s Rights Agreement and Executive Agreements make it less attractive to a potential
buyer.
14
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 %, were utilized
as a proxy for future volatility estimates.
(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 actual historical prices input
for the relevant period input change. As of June 30, 2023 and December 31, 2022 there was no carrying amount and estimated fair value
of the above Warrants.
The
Company accounts for certain assets and liabilities at fair value. The hierarchy below lists three levels of fair value based on the
extent to which inputs used in measuring fair value are observable in the market. AIM categorizes each of its fair value measurements
in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety. These
levels are:
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 June 30, 2023, 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 the warrants.
15
The
table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy
as (in thousands):
Schedule
of Assets and Liabilities Measured at Fair Value on a Recurring Basis
As of June 30, 2023
Total
Level 1
Level 2
Level 3
Assets:
Marketable securities
$ 7,360
$ 7,360
$ —
$ —
Liabilities:
Redeemable warrants
$ —
—
—
$ —
As of December 31, 2022
Total
Level 1
Level 2
Level 3
Assets:
Marketable securities
$ 7,137
$ 7,137
$ —
$ —
Liabilities:
Redeemable warrant
$ —
—
—
$ —
Note
12: Leases
The
Company leases office and storage space, and other equipment under non-cancellable operating leases with initial terms typically ranging
from 1 to 5 years.
At
contract inception, utilizing the guidance of ASC 842 “ Leases ” the Company reviews the facts and circumstances of
each contract to determine its proper treatment and classification in accordance with U.S. GAAP.
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 is recognized as variable lease expenses as incurred.
At
lease inception, lease-related assets and liabilities are measured at the present value of future lease payments over the lease term.
For leases that do not provide an implicit rate, the Company utilizes an estimated incremental borrowing rate based on market observations
existing at lease inception to calculate the present value of future payments.
Leased
assets are disclosed as Right of Use assets on the Company’s consolidated balance sheet and are amortized over the expected useful
life of the lease. Lease liabilities are separately disclosed as a current and non-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 rent under the agreement is $ 1,415 per month.
On
June 13, 2018, the Company entered into a Lease Agreement for a term of six years commencing on July 1, 2018 pursuant to which the Company
agreed to lease approximately 3,000 rentable square feet. The base rent increases by 3 % each year, and ranges from $ 2,100 per month for
the first year to $ 2,785 per month for the sixth year.
On
May 1, 2019, the Company entered into a Lease Agreement for a term of three years commencing on May 1, 2019 , pursuant to which the Company
agreed to lease approximately 3,000 rentable square feet at a base rent of $ 2,500 per month. The Company renewed the lease for a one-year
term extending the rental period to April 2023. On October 5, 2022, the Company renewed the lease for an additional one-year term at
a monthly cost of $ 2,850 commencing on May 1, 2023 .
On
February 17, 2022, the Company entered into a Lease Agreement for a term of two years commencing on March 1, 2022 , pursuant to which
the Company agreed to lease a Canon copier. The base rent is $ 322 per month for the term of the lease.
16
On
June 16, 2022, the Company entered into a Lease Agreement for a term of five years commencing on July 1, 2022 pursuant to which the Company
agreed to lease approximately 5,210 rentable square feet. The base rent increases by 3 % each year, and ranges from $ 15,630 per month
for the first year to $ 18,118 per month for the fifth year.
On
December 9, 2022, the Company entered into a Lease Agreement for a term of two years commencing on April 1, 2023 , pursuant to which the
Company agreed to lease approximately 470 square feet of wet laboratory space. The base rent increases by 6 % each year and ranges from
$ 1,645 per month for the first year to $ 1,744 per month for the second year.
The
expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it is reasonably certain
that the Company would exercise such options. The Company’s leases have remaining lease terms between 9 and 50 months. As of June
30, 2023, and December 31, 2022, the weighted-average remaining term was 46 and 52 months, respectively.
The
Company’s weighted average incremental borrowing rate for its leases was 10 % as of June 30, 2023, and December 31, 2022, respectively.
Future
minimum lease payments as of June 30, 2023, are as follows:
Schedule
of Operating Lease Future Payments
Year Ending December 31,
2023
$ 146
2024
264
2025
221
2026
200
2027
133
Less imputed interest
( 161 )
Total
$ 803
As
of June 30, 2023, the net balance of the right of use assets was $ 781,000 and the corresponding lease liability balance was $ 803,000 .
At December 31, 2022, the balance of the right of use assets was $ 829,000 and the corresponding lease liability balance was $ 837,000 .
Total rent expense was $ 141,000 for the six months ended June 30, 2023, and $ 27,000 for the six months ended June 30, 2022.
Note
13: Research, Consulting and Supply Agreements
The
following represent companies with which AIM has active contracts that it paid toward during the six months ended June 30, 2023.
Amarex
Clinical Research LLC
AIM
has multiple contracts with Amarex Clinical Research LLC (“Amarex”). During the six months ended June 30, 2023, the Company
paid $ 538,000 related to these ongoing agreements:
● Pancreatic
Cancer - In April 2022, AIM executed a work order with Amarex pursuant to which Amarex is
managing a Phase 2 clinical trial in locally advanced pancreatic cancer patients designated
AMP-270. Per the work order, AIM anticipates that Amarex’s management of the study
will cost approximately $ 8.2 million. This estimate includes pass-through costs of approximately
$ 1.0 million and excludes certain third-party and investigator costs and escalations necessary
for study completion. AIM anticipates that the study will take approximately 4.6 years to
complete.
○ During
the six months ended June 30, 2023, the Company paid approximately $ 233,400 related to this
agreement.
17
● Post-COVID
Conditions - On June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex
is managing a Phase 2 trial in patients with Post-COVID Conditions. It is planned that the
study will be conducted at up to 10 sites in the United States. AIM is sponsoring the study.
AIM anticipates that the study will cost approximately $ 6.4 million, which includes pass
through costs of approximately $ 125,470 , investigator costs estimated at about $ 4.4 million,
and excludes certain other third-party costs and escalations.
○ During
the six months ended June 30, 2023, the Company paid approximately $ 304,600 related to this
agreement.
hVIVO
Services Limited
In
July 2021, the Company executed a Reservation and Start-Up Agreement (the “Agreement”) with hVIVO Services Limited (“hVIVO”),
and subsequently signed a clinical trial agreement (“CTA”) in September. For the year ended December 31, 2021, the Company
incurred an expense and paid hVIVO approximately $ 2,340,000 for services incurred in 2021. In March 2022, the Company announced that
it had officially withdrawn its application from the Medicines and Healthcare Regulatory Agency and terminated its agreement with hVIVO
and incurred a cancelation fee of $ 60,000 which was paid in the first quarter 2022.
Impatients
N.V.
In
2016, the Company entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V. (“myTomorrows”),
a Netherlands-based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related
to ME/CFS. Pursuant to the agreement, myTomorrows, as exclusive service provider and distributor in the Territory, is performing EAP
activities. The agreement was automatically extended for a period of 12 months on May 20, 2021; has been automatically extended for 12
months on each subsequent May 20; and will continue to be automatically extended for periods of 12 months every May 20 until terminated
or the terms of the agreement are met.
○ During
the six months ended June 30, 2023, the Company paid approximately $ 18,000 related to this
agreement.
Jubilant
HollisterStier
Jubilant
HollisterStier (“Jubilant”) is AIM’s authorized CMO for Ampligen for the approval in Argentina. In 2017, the Company
entered into an agreement with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company. Since the
2017 engagement of Jubilant, two lots of Ampligen consisting of more than 16,000 units were manufactured and released in the year 2018.
The first lot was designated for human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials.
The second lot has been designated for these programs in addition to commercial distribution in Argentina for the treatment of CFS. Jubilant
manufactured additional two lots of Ampligen in December 2019 and January 2020. In March 2023, the Company submitted a purchase order
for a total of $ 1,432,257 to manufacture additional lots of Ampligen at Jubilant.
○ There
were no payments related to this agreement during the six months ended June 30, 2023. Subsequent to June 30, 2023, the Company paid $ 1,432,257
related to this agreement.
Pharmaceutics
International Inc.
In
December 2020, AIM added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance
the AIM’s capacity to produce the drug Ampligen. This addition amplifies AIM’s manufacturing capability by providing redundancy
and cost savings. The contracts augment AIM’s existing fill and finish capacity. As agreed to in the Master Services Agreement,
the terms of each of AIM’s projects with Pii will be negotiated separately and defined in individual Service Contracts. For the
year ended December 31, 2022, the Company had incurred an expense and paid Pii approximately $ 278,000 .
○ During
the six months ended June 30, 2023, the Company paid approximately $ 55,400 related to this
agreement.
Polysciences
Inc.
In
April 2021, AIM approved a proposal from Polysciences Inc. (“Polysciences”) for the manufacture of our Poly I and Poly C12U
polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer
precursors to the drug Ampligen. The Company is working with Polysciences to negotiate and finalize both a Service Agreement and a Quality
Agreement. For the year ended December 31, 2021, the Company incurred an expense and paid Polysciences approximately $ 250,000 .
○ During
the six months ended June 30, 2023, there were no payments related to this agreement.
18
Yamasa
Corporation
AIM
also utilizes Yamasa Corporation (“Yamasa”) for the production of raw materials required to create polymer precursors to
manufacture the drug Ampligen. In March 2023, the Company submitted a work order for $ 327,730 related to the purchase of raw materials
from Yamasa. These raw materials will be used in the manufacture of polymer precursors at Sterling.
○ During
the six months ended June 30, 2023, there were no payments related to this agreement.
Sterling
Pharma Solutions
On
December 5, 2022, the Company entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”)
for the manufacture of the Company’s Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’
Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen.
○ During
the six months ended June 30, 2023, the Company paid approximately $ 357,000 related to this
agreement.
Note
14: Subsequent Events
As disclosed in a Schedule 13D/A filed with the SEC on August 7, 2023, a stockholder submitted a notice of intent to nominate individuals
for election as directors at the Company’s 2023 Annual Meeting of Stockholders.
19
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.