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,
2022
December
31,
2021
ASSETS
Current assets:
Cash and cash
equivalents
$ 34,452
$ 32,093
Marketable securities
7,320
16,175
Funds receivable from New
Jersey net operating loss
—
1,641
Prepaid expenses and other
current assets
373
304
Assets
held for sale
3,900
—
Total
current assets
46,045
50,213
Property and equipment, net
127
4,047
Right of use asset, net
889
149
Patent and trademark rights, net
2,012
1,974
Other assets
1,811
1,316
Total
assets
$ 50,884
$ 57,699
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$ 712
$ 198
Accrued expenses
502
438
Current
portion of operating lease liability
154
37
Total
current liabilities
1,368
673
Long-term liabilities:
Operating lease liability
735
112
Redeemable warrants
1
35
Commitments and contingencies (Notes 12, 13
and 14)
-
Stockholders’ equity:
Series B Convertible Preferred Stock, stated
value $ 1,000 per share, 713 and 715 issued and outstanding, respectively
713
715
Common Stock, par value $ 0.001 per share, authorized
350,000,000 shares; 48,048,822 and 47,994,672 , issued and outstanding, respectively
48
48
Additional paid-in capital
417,791
417,217
Accumulated deficit
( 369,772 )
( 361,101 )
Total
stockholders’ equity
48,780
56,879
Total
liabilities and stockholders’ equity
$ 50,884
$ 57,699
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)
Three
months ended June 30,
Six
months ended June 30,
2022
2021
2022
2021
Revenues:
Clinical treatment
programs - US
$ 30
$ 23
$ 64
$ 52
Clinical
treatment programs - Europe
—
—
—
—
Total Revenues
30
23
64
52
Costs and Expenses:
Production costs
69
279
147
517
Research and development
2,475
1,317
3,511
2,742
General
and administrative
2,181
2,145
4,253
4,256
Total Costs and Expenses
4,725
3,741
7,911
7,515
Operating loss
( 4,695 )
( 3,718 )
( 7,847 )
( 7,463 )
(Loss) on investments
( 470 )
—
( 1,404 )
—
Interest and other income
79
51
124
120
Interest expense and other
finance costs
—
( 19 )
—
( 67 )
Extinguishment of financing
obligation and note payable
( 2,701 )
—
( 2,701 )
Gain on sale of fixed assets
—
216
—
216
Redeemable warrants valuation
adjustment
3
7
34
( 29 )
Gain
from sale of Income tax operating losses
232
288
422
469
Net Loss
( 4,851 )
( 5,876 )
( 8,671 )
( 9,455 )
Other comprehensive (loss)
Reclassification adjustment
for realized investment loss
—
25
—
25
Change
in unrealized loss on marketable securities available for sale
—
( 62 )
—
( 225 )
Comprehensive loss
$ ( 4,851 )
$ ( 5,913 )
$ ( 8,671 )
$ ( 9,655 )
Basic and diluted loss
per share
$ ( 0.10 )
$ ( 0.12 )
$ ( 0.18 )
$ ( 0.20 )
Weighted average shares outstanding basic
and diluted
48,034,100
47,832,997
48,014,713
46,805,492
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, 2022 and 2021
(in
thousands except share data)
(Unaudited)
Series
B
Preferred
Common
Stock
Shares
Common
Stock .001
Par Value
Additional
Paid-in
Capital
Accumulated
other
Comprehensive
Income (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
Balance December 31, 2021
$ 715
47,994,672
$ 48
$ 417,217
$ —
$ ( 361,101 )
$ 56,879
Equity-based compensation
—
—
—
242
—
—
242
Net comprehensive loss
—
—
—
—
—
( 3,820 )
( 3,820 )
Balance March 31, 2022
$ 715
47,994,672
$ 48
$ 417,459
$ —
$ ( 364,921 )
$ 53,301
Common stock issuance, net of costs
—
54,150
—
55
—
—
55
Equity-based compensation
—
—
—
275
—
—
275
Series B preferred shares converted to common
shares
( 2 )
—
—
2
—
—
—
Net comprehensive loss
—
—
—
—
—
( 4,851 )
( 4,851 )
Balance June 30, 2022
$ 713
48,048,822
$ 48
$ 417,791
$ —
$ ( 369,772 )
$ 48,780
Series
B
Preferred
Common
Stock
Shares
Common
Stock .001
Par Value
Additional
Paid-in
Capital
Accumulated
other
Comprehensive
Income (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
Balance December 31, 2020
$ 732
42,154,371
$ 42
$ 402,541
$ ( 47 )
$ ( 341,974 )
$ 61,294
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
—
—
—
—
( 163 )
( 3,579 )
( 3,742 )
Balance March 31, 2021
$ 725
47,832,997
$ 48
$ 415,995
$ ( 210 )
$ ( 345,553 )
$ 70,965
Equity-based compensation
—
—
—
480
—
—
480
Net Comprehensive loss
— -
—
—
—
( 37 )
( 5,876 )
( 5,913 )
Balance June 30, 2021
$ 725
47,832,997
$ 48
$ 416,435
$ ( 247 )
$ ( 351,429 )
$ 65,532
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, 2022 and 2021
(in
thousands)
(Unaudited)
2022
2021
Cash flows from operating activities:
Net loss
$ ( 8,671 )
$ ( 9,455 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation of property
and equipment
20
325
Redeemable warrants valuation
adjustment
( 34 )
29
Extinguishment of financing
obligation and note payable
—
2,701
Amortization of patent,
trademark rights
38
80
Changes in ROU assets
( 740 )
22
Gain on sale of property
and equipment
—
( 216 )
Gain from sale of income
tax operating losses
( 422 )
( 469 )
Equity-based compensation
517
1,006
(Loss) on sale of marketable
securities
1,404
25
Amortization of finance
and debt issuance costs
—
47
Change in assets and liabilities:
Accounts receivable
—
6
Funds Receivable from New
Jersey net operating loss
1,641
1,090
Prepaid expenses and other
current assets and other non-current assets
( 69 )
69
Lease liability
740
( 22 )
Other Assets
( 73 )
—
Accounts payable
514
68
Accrued
expenses
64
( 69 )
Net cash used in operating
activities
( 5,071 )
( 4,763 )
Cash flows from investing activities:
Proceeds from sale of marketable
securities
8,713
1,613
Purchase of marketable
securities
( 1,262 )
( 2,096 )
Purchase of property and
equipment
—
( 26 )
Proceeds from sale of property
and equipment
—
245
Purchase
of patent and trademark rights
( 76 )
( 365 )
Net cash provided by (used in) investing activities
7,375
( 629 )
Cash flows from financing activities:
Payment of financial obligation
—
( 4,732 )
Financing obligation payments
—
( 122 )
Proceeds
from sale of stock, net of issuance costs
55
12,887
Net cash provided by financing
activities
55
8,033
Net (decrease) increase in cash and cash equivalents
2,359
2,641
Cash and cash equivalents
at beginning of period
32,093
38,501
Cash and cash equivalents
at end of period
$ 34,452
$ 41,142
Supplemental disclosures of non-cash investing
and financing cash flow information:
Operating
lease-Right of Use Assets
$ 761
$ —
Unrealized
loss on marketable securities
$ —
$ ( 225 )
Conversion
of Series B preferred
$ 2
$ 7
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”, “the Company”,) are an immuno-pharma company headquartered
in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and
immune-deficiency disorders. The Company has established a strong foundation of laboratory, pre-clinical and clinical data with respect
to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to
aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.
Our
flagship products are Ampligen® (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and
Alferon N Injection® (Interferon alfa-n3). Ampligen has not been approved by the FDA or marketed in the United States. Ampligen is
approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).
Our
primary present business focus involves Ampligen. Ampligen represents a double-stranded RNA being developed for globally important
cancers, viral diseases and disorders of the immune system.
The
Company is currently proceeding primarily in four areas:
● A
randomized controlled study to evaluate efficacy and safety of Ampligen compared to a control
group to treat locally advanced pancreatic cancer patients.
● Evaluate
Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment
with the goal of increasing anti-tumor responses to check point inhibitors.
● 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 Post-COVID conditions of fatigue.
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 trials authorized by the FDA or European Medicines Agency (“EMA”),
which trials 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 it 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; AIM will keep some space specifically for its
Alferon activity. The Closing Date was extended to August 31, 2022, subject to AIM’s
right to further extend the Closing Date as set forth in Section 4(b) of the Purchase Agreement.
AIM’s
business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen API. This includes utilizing
Polysciences Inc. (“Polysciences”) for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods.
While AIM believes it has sufficient Ampligen API to meet current needs, it is also continually exploring new efficiencies so as to maximize
its ability to fulfill future obligations.
In
the opinion of management, all adjustments necessary for a fair presentation of 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.
6
These
consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years
ended December 31, 2021 and 2020, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed
with the SEC on March 31, 2022.
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 2,447,924 and 1,621,928 , are excluded from the calculation
of diluted net loss per share for the six months ended June 30, 2022, and 2021, respectively, since their effect is antidilutive due
to the net loss.
Note
3: Equity-Based Compensation
The
fair value of each option and equity warrant award is estimated on the date of grant using a Black-Scholes-Merton option pricing valuation
model. Expected volatility is based on the historical volatility of the price of the Company’s stock. The risk-free interest rate
is based on U.S. Treasury issues with a term equal to the expected life of the option and equity warrant. The Company uses historical
data to estimate expected dividend yield, expected life and forfeiture rates. During the six months ended June 30, 2022 there were 300,000
options granted and no options granted in the six months ended June 30, 2021.
Stock
option for employees’ activity during the six months ended June 30, 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, 2022
1,498,798
$ 4.22
9.11
$ —
Granted
150,000
0.70
9.67
—
Forfeited
—
—
—
—
Expired
( 1,627 )
106.03
—
—
Outstanding June 30, 2022
1,647,171
$ 3.80
8.71
$ —
Vested and expected
to vest June 30, 2022
1,647,171
$ 3.80
8.71
$ —
Exercisable June 30, 2022
1,368,006
$ 2.89
6.30
$ —
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 January 1, 2022
412,500
$ 4.15
5.85
$ —
Granted
150,000
0.70
9.67
—
Expired
( 1,627 )
106.03
—
—
Vested
( 281,708 )
1.48
9.86
—
Unvested June 30, 2022
279,165
$ 3.37
5.93
$ —
7
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, 2022
279,723
$ 6.12
7.93
$ —
Granted
150,000
0.70
9.67
—
Forfeited
—
—
—
—
Expired
—
—
—
—
Outstanding June 30, 2022
429,723
$ 4.23
8.21
$ —
Vested and expected
to vest June 30, 2022
429,723
$ 4.23
8.21
$ —
Exercisable June 30, 2022
222,770
$ 6.05
8.16
$ —
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 January 1, 2022
97,831
$ 3.89
7.82
$ —
Granted
150,000
0.70
9.67
—
Expired
—
—
—
—
Vested
( 40,878 )
1.35
—
—
Unvested June 30, 2022
206,953
$ 3.66
8.52
$ —
Stock-based
compensation expense was approximately $ 517,000 and $ 1,006,000 for the six months ended June 30, 2022 and 2021.
As
June 30, 2022, and 2021, respectively, there was approximately $ 454,000 and $ 434,000 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, 2022 and December 31, 2021, it was determined that none of the marketable securities
had an other-than-temporary impairment. As of June 30, 2022 and December 31, 2021, all securities were measured as Level 1 instruments
of the fair value measurements standard (See Note 11: Fair Value). As of June 30, 2022, and December 31, 2021 the Company held $ 7,320,000
and $ 16,175,000 in mutual funds.
Mutual
Funds classified as available for sale consisted of:
Schedule of Available for Sale
June
30, 2022
(in thousands)
Securities
Fair
Value
Short-Term
Investments
Mutual Funds
$ 7,320
$ 7,320
Totals
$ 7,320
$ 7,320
8
Schedule
of Equity Securities
Securities
June
30, 2022
(in thousands)
Net losses
recognized during the period on equity securities
$ ( 1,404 )
Less: Net gains and losses
recognized during the period on equity securities sold during the period
( 583 )
Unrealized gains and
losses recognized during the reporting period on equity securities still held at the reporting date
$ ( 821 )
Mutual
Funds classified as available for sale consisted of:
December
31, 2021
(in thousands)
Securities
Fair
Value
Short-Term
Investments
Mutual Funds
$ 16,175
$ 16,175
Totals
$ 16,175
$ 16,175
Securities
December
31, 2021
(in thousands)
Net losses recognized during the
period on equity securities
$ ( 88 )
Less: Net gains and losses
recognized during the period on equity securities sold during the period
—
Unrealized gains and
losses recognized during the reporting period on equity securities still held at the reporting date
$ ( 88 )
Note
5: Accrued Expenses
Accrued
expenses consist of the following:
Schedule
of Accrued Expenses
(in thousands)
June
30, 2022
December
31, 2021
Compensation
$ 28
$ 1
Professional fees
344
169
Clinical trial expenses
—
61
Other expenses
130
207
Accrued
expenses
$ 502
$ 438
Note
6: Property and Equipment, net
Schedule
of Property and Equipment
(in thousands)
June
30, 2022
December
31, 2021
Land, buildings and improvements
$ —
$ 3,900
Furniture, fixtures, and
equipment
2,353
2,353
Total property and equipment
2,353
6,253
Less: accumulated depreciation
( 2,226 )
( 2,206 )
Property and equipment,
net
$ 127
$ 4,047
9
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 six months ending June 30, 2022
and June 30, 2021 was $ 20,000 and $ 325,000 , 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
Schedule
of Patents, Trademark Rights
December 31, 2020
$ 1,498
Acquisitions
592
Amortization
( 116 )
December 31, 2021
$ 1,974
Acquisitions
76
Amortization
( 38 )
June 30, 2022
$ 2,012
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
$ 40
2023
156
2024
180
2025
203
2026
240
Thereafter
1,193
Total
$ 2,012
Note
8: Stockholders’ Equity
(a)
Preferred Stock
The
Company is authorized to issue 5,000,000 shares of $ 0.01 par value preferred stock with such designations, rights and preferences as
may be determined by the Board of Directors. Of our authorized preferred stock, 250,000 shares have been designated as Series A Junior
Participating Preferred Stock and 8,000 shares have been designated as Series B Convertible Preferred Stock. The Series B Convertible
Preferred Stock has a stated value $ 1,000 per share.
The
Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $ 1,000 per share. As of June 30,
2022, and December 31, 2021, the Company had 713 and 715 shares of Series B Convertible Preferred Stock outstanding, respectively. Holders
shall be entitled to receive, and the Company shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock
basis) to and in the same form as dividend actually paid on shares of Common Stock when as and if such dividends are paid on shares of
the Common Stock. Each such Preferred Share is convertible into 114 shares of common stock. Upon any liquidation, dissolution or winding-up
of the Company, whether voluntary or involuntary, the Holders shall be entitled to receive out of the assets, whether capital or surplus
of the Company the same amount that a holder of Common Stock would receive if the Preferred Stock was fully converted. The Series B Convertible
Preferred Stock shall have no voting Rights.
10
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, 2022 and June 30, 2021, 2 and 7 shares, respectively, of Series
B Convertible Preferred Stock were converted into common stock.
(b)
Common Stock
The
Company has authorized shares of 350,000,000 with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000
authorized shares.
On
July 7, 2020, the board of directors approved a plan pursuant to which all directors, officers, and employees could purchase from the
Company up to an aggregate of $ 500,000 worth of shares at the market price. Pursuant to NYSE American rules, this plan was effective
for a sixty-day period commencing upon the date that the NYSE American approved the Company’s Supplemental Listing Application.
When this plan expired, the board of directors approves subsequent similar $ 500,000 plans for all directors, officers and employees to
buy Company shares from the Company at the market price. Subsequent plans were approved by the board of directors upon the expiration
of prior plans. The latest plan was approved by the board of directors on March 2, 2022.
During
the six months ended June 30, 2022, the Company issued a total of 53,922 with shares of its common stock at price of $ 1.02 for a total
of $ 55,000 as part of the employee stock purchase plan, not from the 2018 Equity Incentive Plan.
During
the twelve months ended December 31, 2021, the Company issued a total of 132,238 shares of its common stock at prices ranging from $ 1.16
to $ 2.35 for a total of $ 205,000 .
On
September 27, 2019, the Company closed a public offering underwritten by A.G.P./Alliance Global Partners, LLC (the “Offering”)
of (i) 1,740,550 shares of Common Stock; (ii) pre-funded warrants exercisable for 7,148,310 shares of Common Stock (the “Pre-funded
Warrants”), and (iii) warrants to purchase up to an aggregate of 8,888,860 shares of Common Stock (the “Warrants”).
In conjunction with the Offering, a Representative’s
Warrant to purchase up to an aggregate of 266,665 shares of common stock (the “Representative’s Warrant”) .
The shares of Common Stock and Warrants were sold at a combined Offering price of $ 0.90 , less underwriting discounts and commissions.
Each Warrant sold with the shares of Common Stock represents the right to purchase one share of Common Stock at an exercise price of
$ 0.99 per share. The Pre-Funded Warrants and Warrants were sold at a combined Offering price of $ 0.899 , less underwriting discounts and
commissions. The Pre-Funded Warrants were sold to purchasers whose purchase of shares of Common Stock in the Offering would otherwise
result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% of the Company’s
outstanding Common Stock immediately following the consummation of the Offering, in lieu of shares of Common Stock. Each Pre-Funded Warrant
represents the right to purchase one share of Common Stock at an exercise price of $0.001 per share. The Pre-Funded Warrants are exercisable
immediately and may be exercised at any time until the Pre-Funded Warrants are exercised in full. A registration statement on Form S-1,
relating to the Offering was filed with the SEC and was declared effective on September 25, 2019, the net proceeds were approximately
$ 7,200,000 . As of June 30, 2022, there are 15,000 Warrants outstanding.
On
July 19, 2019, the Company entered into a new Equity Distribution Agreement (the “2019 EDA”) with Maxim Group LLC (“Maxim”),
pursuant to which it could sell, from time to time, shares of its Common Stock through Maxim, as agent.
The 2019 EDA replaced a prior EDA with Maxim. For the year ended December 31, 2020, the Company sold 20,444,807 shares under the 2019
EDA for total gross proceeds of $ 53,936,615 , which includes a 3.5 % fee to Maxim of $ 1,888,727 . During the period ended December 31, 2021,
the Company sold 5,665,731 shares under the 2019 EDA for total gross proceeds of $ 13,301,526 , which includes a 3.5 % fee to Maxim of $ 465,533 .
The 2019 EDA was terminated in early February 2021.
The
2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock
Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards,
(vii) Performance Cash Awards, and (viii) Other Stock Awards. Initially, a maximum of 7,000,000 shares of Common Stock is reserved for
potential issuance pursuant to awards under the 2018 Equity Incentive Plan. Unless sooner terminated, the 2018 Equity Incentive Plan
will continue in effect for a period of 10 years from its effective date. During first quarter of 2022, 300,000 options were issued to
employees with an exercise price of $ .70 for a period of ten years with a vesting period of one year. During fourth quarter of 2021,
613,512 options were issued to employees with an exercise price range of $ 1.11 to $ 1.71 for a period of ten years with a vesting period
of one year.
11
As
of June 30, 2022, and December 31, 2021, there were 48,048,822 and 47,994,672 shares outstanding, respectively.
Note
9 : Cash and Cash Equivalents
The
Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.
Note
10: Recent Accounting Pronouncements
During
the second quarter of 2022 accounting pronouncements issued by the FASB did not or are not believed by management to have a material
impact on the Company’s present or future financial statements.
Note
11: Fair Value
Fair
Value
The
Company is required under U.S. GAAP to disclose information about the fair value of all the Company’s financial instruments, whether
or not these instruments are measured at fair value on the Company’s consolidated balance sheets.
The
Company estimates that the fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate
their carrying values due to the short-term maturities of these items. The Company also has certain warrants with a cash settlement feature
in the occurrence of a Fundamental Transaction. The fair value of the redeemable warrants (“Warrants”) related to the Company’s
February 2017, April 2018, and March 2019 common stock and warrant issuance, are calculated using a Monte Carlo Simulation. While the
Monte Carlo Simulation is one of a number of possible pricing models, the Company has determined it to be industry accepted and fairly
presented the fair value of the Warrants. As an additional factor to determine the fair value of the Put’s liability, the occurrence
probability of a Fundamental Transaction event was factored into the valuation.
The
Company recomputes the fair value of the Warrants at the issuance date and the end of each quarterly reporting period. Such value computation
includes subjective input assumptions that are consistently applied each period. If the Company were to alter its assumptions or the
numbers input based on such assumptions, the resulting fair value could be materially different.
The
Company utilized the following assumptions to estimate the fair value of the February 2017 Warrants:
Schedule
of Assumptions to Estimate Fair Value of Warrants
June 30,
December 31,
2022
2021
Underlying price per share
$ 0.78
$ 0.92
Exercise price per share
$ 30.25 -$ 33.00
$ 30.25 -$ 33.00
Risk-free interest rate
1.29 %- 1.32 %
0.22 %- 0.23 %
Expected holding period
0.09 - 0.10
0.58 - 0.60
Expected volatility
45 %
45 %
Expected dividend yield
—
—
12
The
Company utilized the following assumptions to estimate the fair value of the April 2018 Warrants:
June 30,
December 31,
2022
2021
Underlying price per share
$ 0.78
$ 0.92
Exercise price per share
$ 17.16
$ 17.16
Risk-free interest rate
2.84 %
0.67 %
Expected holding period
1.32
1.81
Expected volatility
65 %
120 %
Expected dividend yield
—
—
The
Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:
June 30,
December 31,
2022
2021
Underlying price per share
$ 0.78
$ 0.92
Exercise price per share
$ 8.80
$ 8.80
Risk-free interest rate
2.88 %
0.78 %
Expected holding period
1.69
2.19
Expected volatility
70 %
125 %
Expected dividend yield
—
—
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 . 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. 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. 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. Available
capital for a potential buyer in a cash transaction continues to be limited.
5. The
nature of a life sciences company is heavily dependent on future funding and high fixed costs,
including Research & Development.
6. 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. The
Company’s Rights Agreement and Executive Agreements make it less attractive to a potential
buyer.
13
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 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 $ 1,000 and $ 35,000 as of June 30, 2022 and December 31, 2021, respectively.
The
Company applies FASB ASC 820 (formerly Statement No. 157 Fair 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:
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, 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 the warrants.
14
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 June 30, 2022
Total
Level
1
Level
2
Level
3
Assets:
Marketable
securities
$ 7,320
$ 7,320
$ —
$ —
Liabilities:
Redeemable
warrants
$ 1
—
—
$ 1
(in
thousands)
As of December 31, 2021
Total
Level
1
Level
2
Level
3
Assets:
Marketable
securities
$ 16,175
$ 16,175
$ —
$ —
Liabilities:
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
Redeemable warrants:
Balance at December 31, 2021
$ 35
Fair value adjustments
( 34 )
Balance at June 30, 2022
$ 1
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.
15
Interest
expense relating to this financing agreement was $ 0 for the period ended June 30, 2022 and $ 67,000 for the six months ended June 30,
2021.
Note
13: Leases
The
Company leases office and storage space, and other equipment under non-cancellable operating leases with initial terms typically ranging
from 1 to 5 years. At contract inception, the Company reviews the facts and circumstances of the arrangement to determine if the contract
is or contains a lease. The Company follows the guidance in Topic 842 “ Leases ” to evaluate whether the contract has
an identified asset; if the Company has the right to obtain substantially all economic benefits from the asset; and if the Company has
the right to direct the use of the underlying asset. When determining if a contract has an identified asset, the Company considers both
explicit and implicit assets, and whether the supplier has the right to substitute the asset. When determining if the Company has the
right to direct the use of an underlying asset, the Company considers if it has the right to direct how and for what purpose the asset
is used throughout the period of use and if it controls the decision-making rights over the asset.
The
Company’s lease terms may include options to extend or terminate the lease. The Company exercises judgment to determine the term
of those leases when extension or termination options are present and include such options in the calculation of the lease term when
it is reasonably certain that it will exercise those options.
The
Company has elected to include both lease and non-lease components in the determination of lease payments. Payments made to a lessor
for items such as taxes, insurance, common area maintenance, or other costs commonly referred to as executory costs, are also included
in lease payments if they are fixed. The fixed portion of these payments are included in the calculation of the lease liability, while
any variable portion would be recognized as variable lease expenses, when incurred. Variable payments made to third parties for these,
or similar costs, such as utilities, are not included in the calculation of lease payments.
At
lease commencement, lease-related assets and liabilities are measured at the present value of future lease payments over the lease term.
As most of the Company’s leases do not provide an implicit rate, the Company exercises judgment in determining the incremental
borrowing rate based on the information available when the lease commences to measure the present value of future payments.
Operating
leases are included in other assets, current operating lease obligations, and operating lease obligations (less current portion) on the
Company’s consolidated balance sheet. Short term leases with an initial term of 12 months or less are not presented on the balance
sheet with expense recognized as incurred.
The
Company entered into a Lease Agreement for a term of five years commencing on September 14, 2020 pursuant to which the Company agreed
to lease two Sharp copiers. The base of $ 1,415 per month.
On
June 13, 2018, the Company entered into a Lease Agreement for a term of six years commencing on July 1, 2018 pursuant to which the Company
agreed to lease approximately 3,000 rentable square feet. The base rent increases by 3 % each year, and ranges from $ 2,100 per month for
the first year to $ 2,785 per month for the sixth year.
On
May 1, 2019, the Company entered into a Lease Agreement for a term of three
years commencing on May
1, 2019 , pursuant to which the Company agreed
to lease approximately 3,000
rentable square feet. The base rent is $ 2,500
per month for the term of the lease. On October
4, 2021, the Company executed a request to renew the lease for a one-year term as defined in the Lease Agreement. The request was accepted
and the one-year term commenced on April 30, 2022.
On
February 17, 2022, the Company entered into a Lease Agreement for a term of two years commencing on March 1, 2022 , pursuant to which
the Company agreed to lease a Canon copier. The base rent is $ 322 per month for the term of the lease.
On
June 16, 2022, the Company entered into a Lease Agreement for a term of five years commencing on July 1, 2022 pursuant to which the Company
agreed to lease approximately 5,210 rentable square feet. The base rent increases by 3 % each year, and ranges from $ 15,630 per month
for the first year to $ 18,118 per month for the fifth year.
16
The
expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it is reasonably certain
that the Company would exercise such options. The Company’s leases have remaining lease terms between 11 months and 5 years. As
of June 30, 2022, and December 31, 2021, the weighted-average remaining term is 2.67 and 2.72 years, respectively.
The
Company has determined that the incremental borrowing rate is 10 % as of June 30, 2022, and December 31, 2021, respectively, based upon
the recently completed financing transaction in December 2019.
Future
minimum payments as of June 30, 2022, are as follows:
Schedule
of Operating lease Future Payments
Year Ending December 31,
2022
$ 54
2023
153
2024
174
2025
158
Thereafter
373
Less imputed interest
( 23 )
Total
$ 889
As
of June 30, 2022, and December 31, 2021, the balance of the right of use assets was $ 889,000 and $ 149,000 , respectively, and the corresponding
lease liability balance was $ 889,000 and $ 149,000 , respectively. The total rent expense for the six months ended June 30, 2022, and June
30, 2021 amounted to approximately $ 34,000 and $ 22,000 , respectively. Total rent expense for short term leases for the six months ended
June 30, 2022 and June 30, 2021 amounted to approximately $ 10,000 for both periods.
Note
14: Research, Consulting and Supply Agreements
In
January 2021, the Company entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1
clinical study to assess the safety, tolerability, and biological activity of Ampligen as a potential intranasal therapy. The Company
has paid CHDR approximately $ 1,066,000 .
In
April 2021, the Company approved a proposal from Polysciences for the manufacture of our Poly I and
Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce
the polymer precursors to the drug Ampligen. The Company is working with Polysciences to negotiate and finalize both a Service Agreement
and a Quality Agreement. For the year ended December 31, 2021 the Company has incurred an expense and paid Polysciences approximately
$ 250,000 . For the period ended June 30, 2022, the Company paid Polysciences $ 102,780 .
In
April 2022, AIM executed a work order with Amarex Clinical Research LLC (“Amarex”), our contract research organization, pursuant
to which Amarex will manage a Phase 2 clinical trial in advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM
anticipates that the study will cost approximately $ 8.2 million, which includes pass through costs of approximately $ 1.0 million and
excludes certain third-party costs and escalations. AIM anticipates that the study will take approximately 4.6 years to complete.
On
June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex will manage a Phase 2 trial in patients with Post-COVID
Conditions, once FDA authorization to proceed is received. It is planned that the study will be conducted at up to 10 sites in the United
States. AIM is sponsoring the study. AIM anticipates that the study will cost approximately $ 4.4 million, which includes pass through
costs of approximately $ 125,470 , investigator costs estimated at about $ 2.4 million and excludes certain other third-party costs and
escalations.
In
December 2020, AIM added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance
its capacity to produce Ampligen. This addition amplifies AIM’s manufacturing capability by providing redundancy and cost savings.
The contracts augment our active and in-process fill and finish capacity. For the period ended December 31, 2021, the Company has incurred
an expense and paid Pii approximately $ 89,000 .
For the six months ended June 30, 2022, the Company incurred an expense and paid Pii approximately $ 243,000 .
Note 15: Subsequent Events
AIM received a notice of nominations, dated July 8,
2022 (the “Purported Nomination Notice”), from Jonathan Thomas Jorgl, purporting to give notice of his intent, as a holder
of 1,000 shares of AIM common stock, to nominate two director candidates for election to AIM’s board of directors (the “Board”)
at AIM’s 2022 annual meeting of stockholders (the “Annual Meeting”). As the Board currently comprises three members,
Mr. Jorgl is seeking to change control of the Board. On July 14, 2022, the Board unanimously determined that the Purported Nomination
Notice was defective for noncompliance with the advance notice provisions of AIM’s Amended and Restated Bylaws (the “Bylaws”)
and should be rejected and disregarded. The Board also determined that AIM should institute legal action against Mr. Jorgl and those believed
to be acting in concert with him as an activist group to prevent further harm to the Company.
On July 15, 2022, the Company filed a lawsuit
in the United States District Court for the Middle District of Florida, Ocala Division, against Mr. Jorgl and six other defendants (his
nominees Robert Chioini and Michael Rice as well as Franz Tudor, Todd Deutsch, Ted Kellner and Walter Lautz), seeking to enjoin the seven
defendants from committing any further violations of various federal securities laws. AIM’s lawsuit alleges that these seven individuals
have failed to register as a group pursuant to U.S. securities laws and have committed other unlawful actions in the context of their
attempt to effectuate a takeover of the Board. On July 19, 2022, AIM notified Mr. Jorgl that the Board had determined the Purported Nomination
Notice was invalid and failed to satisfy the Bylaws and that any purported nominations thereunder would be disregarded at the Annual Meeting.
On July 29, 2022, Mr. Jorgl sued AIM and each of
its three directors in the Court of Chancery of the State of Delaware, seeking a declaratory judgement that the Purported Nomination
Notice was valid and that AIM must include Mr. Jorgl’s two purported nominees in AIM’s proxy materials to be distributed
in connection with the Annual Meeting. In his lawsuit, Mr. Jorgl also seeks certain injunctive relief against AIM. On August 12, 2022,
a hearing was held in the Court of Chancery concerning a motion for a temporary restraining order (“TRO”) sought by Mr. Jorgl.
Absent a stipulation of the parties resolving certain issues, the Vice Chancellor expects to rule on the motion for a TRO on Monday,
August 15, 2022.
17
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.