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)
March
31, 2022
December
31, 2021
ASSETS
Current
assets:
Cash
and cash equivalents
$ 28,989
$ 32,093
Marketable
securities
15,554
16,175
Funds
receivable from New Jersey net operating loss
1,641
1,641
Prepaid
expenses and other current assets
296
304
Assets
held for sale
3,900
—
Total
current assets
50,380
50,213
Property
and equipment, net
137
4,047
Right
of use asset, net
144
149
Patent
and trademark rights, net
1,988
1,974
Other
assets
1,506
1,316
Total
assets
$ 54,155
$ 57,699
LIABILITIES
AND STOCKHOLDERS’ EQUITY
Current
liabilities:
Accounts
payable
$ 378
$ 198
Accrued
expenses
328
438
Current
portion of operating lease liability
60
37
Total
current liabilities
766
673
Long-term
liabilities:
Operating
lease liability
84
112
Redeemable
warrants
4
35
Commitments
and contingencies (Notes 12, 13 and 14)
-
-
Stockholders’
equity:
Series
B Convertible Preferred Stock, stated value $ 1,000 per share, 715 issued and outstanding
715
715
Common Stock, par
value $ 0.001 per share, authorized 350,000,000 shares; 47,994,672 issued and outstanding
48
48
Additional
paid-in capital
417,459
417,217
Accumulated
deficit
( 364,921 )
( 361,101 )
Total
stockholders’ equity
53,301
56,879
Total
liabilities and stockholders’ equity
$ 54,155
$ 57,699
See
accompanying notes to consolidated financial statements.
2
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Comprehensive Loss
(in
thousands, except share and per share data)
(Unaudited)
Three
months ended March 31,
2022
2021
Revenues:
Clinical
treatment programs – US
$ 33
$ 28
Clinical
treatment programs – Europe
—
—
Total
Revenues
33
28
Costs
and Expenses:
Production
costs
77
237
Research
and development
1,036
1,424
General
and administrative
2,072
2,112
Total
Costs and Expenses
3,185
3,773
Operating
loss
( 3,152 )
( 3,745 )
(Loss)
on investments
( 934 )
—
Interest
and other income
45
72
Interest
expense and other finance costs
—
( 50 )
Redeemable
warrants valuation adjustment
31
( 37 )
Gain
from sale of income tax operating losses
190
181
Net
Loss
( 3,820 )
( 3,579 )
Other
comprehensive loss
Reclassification
adjustment for realized investment loss
—
2
Change
in unrealized loss on marketable securities available for sale
—
( 163 )
Net
comprehensive loss
$ ( 3,820 )
$ ( 3,740 )
Basic
and diluted loss per share
$ ( 0.08 )
$ ( 0.08 )
Weighted
average shares outstanding basic and diluted
47,994,672
45,726,855
See
accompanying notes to consolidated financial statements.
3
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Changes in Stockholders’ Equity
(in
thousands except share data)
Series
B
Preferred
Shares
Common
Stock
Shares
Common
Stock .001 Par Value
Additional
Paid-in
Capital
Accumulated
other Comprehensive Income (Loss)
Accumulated
Deficit
Total
Stockholders’ Equity
Balance
December 31, 2021
715 -
47,994,672
$ 48
$ 417,217
$ —
$ ( 361,101 )
$ 56,879
Shares issued for:
Equity
based compensation
— -
—
—
242
—
—
242
Net
comprehensive loss
—
—
—
—
—
( 3,820 )
( 3,820 )
Balance
March 31, 2022
715 -
47,994,672
$ 48
$ 417,459
$ —
$ ( 364,921 )
$ 53,301
Series
B Preferred Shares
Common
Stock
Shares
Common
Stock .001 Par Value
Additional
Paid-in Capital
Accumulated
other Comprehensive Income (Loss)
Accumulated
Deficit
Total
Stockholders’ Equity
Balance
December 31, 2020
732
42,154,371
$ 42
$ 402,541
$ ( 47 )
$ ( 341,974 )
$ 61,294
Shares issued for:
Common
Stock issuance, net of costs
—
5,678,626
6
12,881
—
—
12,887
Equity-based
compensation
—
—
—
526
—
—
526
Series
B preferred shares converted to Common shares
( 7 )
—
—
7
—
—
—
Net
comprehensive loss
—
—
—
—
( 161 )
( 3,579 )
( 3,740 )
Balance
March 31, 2021
725
47,832,997
$ 48
$ 415,995
$ ( 208 )
$ ( 345,553 )
$ 70,967
See
accompanying notes to consolidated financial statements.
4
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Cash Flows
For
the Three Months Ended March 31, 2022 and 2021
(in
thousands)
(Unaudited)
2022
2021
Cash
flows from operating activities:
Net
loss
$ ( 3,820 )
$ ( 3,579 )
Adjustments
to reconcile net loss to net cash used in operating activities:
Depreciation
of property and equipment
10
162
Redeemable
warrants valuation adjustment
( 31 )
37
Amortization
of patent, trademark rights
19
65
Changes
in ROU assets
5
11
Loss
on available for sale marketable securities
19
2
Gain
from sale of income tax operating losses
( 190 )
( 181 )
Equity-based
compensation
242
526
Unrealized
loss on marketable securities
915
—
Amortization
of finance and debt issuance costs
—
36
Change
in assets and liabilities:
Prepaid
expenses and other current assets and other non current assets
8
26
Lease
liability
( 5 )
( 11 )
Accounts
payable
180
( 194 )
Accrued
expenses
( 110 )
55
Net
cash used in operating activities
( 2,758 )
( 3,045 )
Cash
flows from investing activities:
Proceeds
from sale of marketable securities
407
2,039
Purchase
of marketable securities
( 720 )
( 1,151 )
Purchase
of patent and trademark rights
( 33 )
( 365 )
Net
cash (used in) provided by investing activities
( 346 )
523
Cash
flows from financing activities:
Financing
obligation payments
—
( 93 )
Proceeds
from sale of stock, net of issuance costs
—
12,887
Net
cash provided by financing activities
—
12,794
Net
(decrease) increase in cash and cash equivalents
( 3,104 )
10,272
Cash
and cash equivalents at beginning of period
32,093
38,501
Cash
and cash equivalents at end of period
$ 28,989
$ 48,773
Supplemental
disclosures of non-cash investing and financing cash flow information:
Conversion
of Series B preferred
$ —
7
See
accompanying notes to consolidated financial statements.
5
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 dsRNA 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 difficulty thinking/concentrating
as the predominate Post-COVID conditions (as referenced on CDC website Sept. 16, 2021).
The
Company is prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic
cancer, ME/CFS and Post-COVID conditions having priority over antiviral experimentation. The Company intends that priority clinical work
be conducted in FDA or EMA authorized trials which could support a potential future New Drug Application (“NDA”). However,
AIM’s antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis that Ampligen
is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection. Accordingly,
AIM will conduct antiviral programs in those venues most readily available and able to generate valid proof-of-concept data, including
foreign venues.
In
May 2021, AIM exercised the option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale
and lease-back agreement. The Company thereafter sold certain equipment and machinery that they determined to be obsolete and no longer
needed for current or future manufacturing. Then, on March 3, 2022, AIM entered into an Agreement of Sale and Purchase with Acellories,
Inc. as purchaser pursuant to which the Company will sell the property for $ 3.9
million. The buyer has a mortgage contingency,
with the clause expiring on June 1, 2022. Assuming that condition is met, we would anticipate closing on or before July 1, 2022.
Moving
forward, AIM will require one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen API. While AIM believes
they have sufficient Ampligen API to meet their current needs, they are also continually exploring new efficiencies so as to maximize
their ability to fulfill future obligations. In this regard, in April 2021, AIM approved a proposal from Polysciences Inc. (“Polysciences”)
for the manufacture of Poly I and Poly C 12 U polynucleotides and associated test methods at Polysciences’ Warrington,
PA location to enhance their capacity to produce the polymer precursors to the drug Ampligen. The Company is utilizing Polysciences’s
expertise to refine their approach to polymer production. Additionally, AIM continues to be open to the possibility of agreements with
other CMOs, so as to create redundancy and to meet the potential need for larger quantities of API.
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.
6
The
interim consolidated financial statements and notes thereto are presented as permitted by the Securities and Exchange Commission (“SEC”),
and do not contain certain information which will be included in the Company’s annual consolidated financial statements and notes
thereto.
These
consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years
ended December 31, 2021 and 2020, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed
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 2,453,782 and 1,672,825 , are excluded from the calculation
of diluted net loss per share for the three months ended March 31, 2022, and 2021, respectively, since their effect is 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 three months ended March 31, 2022 there were
300,000 options granted and no options granted in the three months ended March 31, 2021.
Stock
option for employees’ activity during the three months ended March 31, 2022, is as follows:
Stock
option activity for employees:
Schedule of Stock Option Activity
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding
January 1, 2022
1,498,798
$ 4.22
9.11
$ —
Granted
150,000
0.70
9.75
—
Forfeited
—
233.54
—
—
Expired
( 739 )
—
—
—
Outstanding
March 31, 2022
1,648,059
$ 3.80
8.94
$ —
Vested
and expected to vest March 31, 2022
1,648,059
$ 3.80
8.94
$ —
Exercisable
March 31, 2022
1,216,894
$ 3.15
6.08
$ —
Unvested
stock option activity for employees:
Schedule of Unvested Stock Option Activity
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Unvested
January 1, 2022
412,500
$ 4.15
5.85
$ —
Granted
150,000
0.70
9.75
—
Expired
( 739 )
233.54
—
—
Vested
( 130,596 )
1.52
9.88
—
Unvested
March 31, 2022
431,165
$ 2.69
7.32
$ —
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
9.75
—
Forfeited
—
—
—
—
Expired
—
—
—
—
Outstanding
March 31, 2022
429,723
$ 4.23
8.40
$ —
Vested
and expected to vest March 31, 2022
429,723
$ 4.23
8.40
$ —
Exercisable
March 31, 2022
222,770
$ 6.05
7.96
$ —
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
9.75
—
Expired
—
—
—
—
Vested
( 40,878 )
1.35
—
—
Unvested
March 31, 2022
206,953
$ 3.66
7.60
$ —
Stock-based
compensation expense was approximately $ 242,000 and $ 526,000 for the three months ended March 31, 2022 and 2021, resulting in an increase
in general and administrative expenses, respectively.
As
March 31, 2022, and 2021, respectively, there was approximately $ 729,000 and $ 914,000 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. At March 31, 2022 and December 31, 2021, it was determined that none of the marketable securities
had an other-than-temporary impairment. At March 31, 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 March 31, 2022, and December 31, 2021 the Company held $ 15,554,000
and $ 16,175,000 in mutual funds.
8
Mutual
Funds classified as available for sale consisted of:
Schedule of Available for Sale
March
31, 2022
(in
thousands)
Securities
Fair
Value
Short-Term
Investments
Mutual
Funds
$ 15,554
$ 15,554
Totals
$ 15,554
$ 15,554
Schedule
of Equity Securities
March
31, 2022
(in
thousands)
Securities
Net
losses recognized during the period on equity securities
$ ( 934 )
Less:
Net gains and losses recognized during the period on equity securities sold during the period
( 19 )
Unrealized
gains and losses recognized during the reporting period on equity securities still held at the reporting date
$ ( 915 )
Mutual
Funds classified as available for sale consisted of:
December
31, 2021
(in
thousands)
Securities
Fair
Value
Short-Term
Investments
Mutual
Funds
$ 16,175
$ 16,175
Totals
$ 16,175
$ 16,175
December
31, 2021
(in
thousands)
Securities
Net
losses recognized during the period on equity securities
$ ( 88 )
Less:
Net gains and losses recognized during the period on equity securities sold during the period
—
Unrealized
gains and losses recognized during the reporting period on equity securities still held at the reporting date
$ ( 88 )
Note
5: Accrued Expenses
Accrued
expenses consist of the following:
Schedule
of Accrued Expenses
March
31, 2022
December
31, 2021
(in
thousands)
March
31, 2022
December
31, 2021
Compensation
$ 14
$ 1
Professional
fees
94
169
Clinical
trial expenses
61
61
Other
expenses
159
207
Accrued
expenses
$ 328
$ 438
Note
6: Property and Equipment, net
Schedule
of Property and Equipment
March
31, 2022
December
31, 2021
(in
thousands)
March
31, 2022
December
31, 2021
Land,
buildings and improvements
$ —
$ 3,900
Furniture,
fixtures, and equipment
2,353
2,353
Total
property and equipment
2,353
6,253
Less:
accumulated depreciation
( 2,216 )
( 2,206 )
Property
and equipment, net
$ 137
$ 4,047
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 periods ending March 31,
2022 and March 31, 2021 was $ 10,000 and
$ 162,000 ,
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 March 31, 2022, the Company reported assets held for sale related to the pending
sale of the manufacturing facility located at 783 Jersey Avenue, which is expected to close within 120 days of the effective date of
the Agreement of Sale and Purchase effective March 3, 2022. (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
33
Amortization
( 19 )
March
31, 2022
$ 1,988
Patents
and trademarks are stated at cost and are amortized using the straight-line method of the estimated useful life of 17 years.
Amortization
of patents and trademarks for each of the next five years and thereafter is as follows:
Schedule
of Amortization of Patents and Trademarks
Year
Ending December 31,
2022
$ 59
2023
153
2024
177
2025
199
2026
235
Thereafter
1,165
Total
$ 1,988
Note
8: Stockholders’ Equity
(a)
Preferred Stock
The
Company is authorized to issue 5,000,000 shares of $ 0.01 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 March 31,
2022, and December 31, 2021, the Company had 715 and 715 shares of Series B Convertible Preferred Stock outstanding, respectively. Holders
shall be entitled to receive, and the Company shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock
basis) to and in the same form as dividend actually paid on shares of Common Stock when as and if such dividends are paid on shares of
the Common Stock. Each such Preferred Share is convertible into 114 shares of common stock. Upon any liquidation, dissolution or winding-up
of the Company, whether voluntary or involuntary, the Holders shall be entitled to receive out of the assets, whether capital or surplus
of the Company the same amount that a holder of Common Stock would receive if the Preferred Stock was fully converted. The Series B Convertible
Preferred Stock shall no voting Rights.
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 three months ending March 31, 2022, 0 shares 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 three months ended March 31, 2022, the Company issued a total of 0 shares of its common stock.
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 March 31, 2022, there are 15,000 Warrants outstanding.
On
July 19, 2019, the Company entered into a new Equity Distribution Agreement (the “2019 EDA”) with Maxim Group LLC (“Maxim”),
pursuant to which it could sell, from time to time, shares of its Common Stock through Maxim, as agent (the “Offering”).
The 2019 EDA replaced a prior EDA with Maxim. For the 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. During December 2020, 675,000 options were issued to employees with an exercise price range of $ 1.85 to $ 1.96 for a period
of ten years with a vesting period of one year.
11
As
of both periods March 31, 2022, and December 31, 2021, there were 47,994,672 shares outstanding.
Note
9 : Cash and Cash Equivalents
The
Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.
Note
10: Recent Accounting Pronouncements
During
the first 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, June 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
March
31,
December
31,
2022
2021
Underlying
price per share
$ 1.06
$ 0.92
Exercise price per
share
$ 30.25 -$ 33.00
$ 30.25 -$ 33.00
Risk-free
interest rate
0.71 %- 0.74 %
0.22 %- 0.23 %
Expected holding
period
0.34 - 0.35
0.58 - 0.60
Expected
volatility
85 %
45 %
Expected
dividend yield
—
—
12
The
Company utilized the following assumptions to estimate the fair value of the June 2017 Warrants:
March
31,
December
31,
2022
2021
Underlying
price per share
$ 1.06
$ 0.92
Exercise price per
share
$ 27.50
$ 27.50
Risk-free
interest rate
0.35 %
0.15 %
Expected holding
period
0.17
0.42
Expected
volatility
85 %
50 %
Expected
dividend yield
—
—
The
Company utilized the following assumptions to estimate the fair value of the April 2018 Warrants:
March
31,
December
31,
2022
2021
Underlying
price per share
$ 1.06
$ 0.92
Exercise price per
share
$ 17.16
$ 17.16
Risk-free
interest rate
2.00 %
0.67 %
Expected holding
period
1.57
1.81
Expected
volatility
70 %
120 %
Expected
dividend yield
—
—
The
Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:
March
31,
December
31,
2022
2021
Underlying
price per share
$ 1.06
$ 0.92
Exercise price per
share
$ 8.80
$ 8.80
Risk-free
interest rate
2.24 %
0.78 %
Expected holding
period
1.94
2.19
Expected
volatility
75 %
125 %
Expected
dividend yield
—
—
The
significant assumptions using the Monte Carlo Simulation approach for valuation of the Warrants are:
(i)
Risk-Free
Interest Rate . The risk-free interest rates for the Warrants are based on U.S. Treasury constant maturities for periods commensurate
with the remaining expected holding periods of the warrants.
(ii)
Expected
Holding Period . The expected holding period represents the period of time that the Warrants are expected to be outstanding until
they are exercised. The Company utilizes the remaining contractual term of the Warrants at each valuation date as the expected holding
period.
(iii)
Expected
Volatility . Expected stock volatility is based on daily observations of the Company’s historical stock values for a period
commensurate with the remaining expected holding period on the last day of the period for which the computation is made.
(iv)
Expected
Dividend Yield . Expected dividend yield is based on the Company’s anticipated dividend payments over the remaining expected
holding period. As the Company has never issued dividends, the expected dividend yield is 0 % and this assumption will be continued
in future calculations unless the Company changes its dividend policy.
13
(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.
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 $ 4,000 and $ 35,000 at March 31, 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 March 31, 2022, the Company has classified the warrants with cash settlement
features as Level 3. Management evaluates a variety of inputs and then estimates fair value based on those inputs. As discussed above,
the Company utilized the Monte Carlo Simulation Model in valuing 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 March 31, 2022
Total
Level
1
Level
2
Level
3
Assets:
Marketable
securities
$ 15,554
$ 15,554
$ —
$ —
Liabilities:
Redeemable
warrants
$ 4
—
$ —
4
(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
( 31 )
Balance
at March 31, 2022
$ 4
The
table below presents the balances of assets and liabilities measured at fair value on a nonrecurring basis by level within the hierarchy
as:
Schedule
of Assets and Liabilities Measured at Fair Value on a NonRecurring Basis
(in
thousands)
As of December 31, 2021
Total
Level
1
Level
2
Level
3
Total
Gains (Losses)
Assets:
Long
lived assets held and used (a)
$ 3,900
$ —
$ —
$ 3,900
$ 1,800
(a)
In
accordance with Subtopic 360-10, long-lived assets held and used with a carrying amount of $ 5,700,000 were written down to their fair
value of $ 3,900,000 , resulting in an impairment charge of $ 1,800,000 , which was included in earnings for the period ending December
31, 2021.
Note
12: Financing Obligation Arising from Sale Leaseback Transaction
On
March 16, 2018, the Company sold land and a building for $ 4,080,000 and concurrently entered into an agreement to lease the property
back for ten years at $408,000 per year for two years through March 31, 2020. The lease payments would increase 2.5% per year for the
next three years through March 31, 2023, and the lease payments would increase 3% for the remaining five years through March 31, 2028 .
As part of the sale of this building, warrants were provided to the buyer for the purchase of up to 73,314 shares of Company common stock
for a period of five years at an exercise price of $ 17.05 per share, 125 % of the closing price of the common stock on the NYSE American
on the date of execution of the letter of intent for the purchase. The sale of the property included an option to repurchase the property
based on a contractual formula which does not permanently transfer all the risks and rewards of ownership to the buyer. Because the sale
of the property included the option to repurchase the property and included the above attributes, the transaction was accounted for as
a financing transaction whereby the Company recorded the cash received and a financing obligation. The warrants cannot be exercised to
the extent that any exercise would result in the purchaser owning in excess of 4.99% of our issued and outstanding shares of common stock.
15
On
May 13, 2021, the Company completed its repurchase of the property for cash of $ 4,732,637 . The repurchase resulted in the related liability
recorded upon sale being extinguished on the date of the repurchase. A loss on the extinguishment was recorded based on the difference
between the carrying value of the financing obligation including unamortized debt discount and the amount exchanged to extinguish the
debt.
Interest
expense relating to this financing agreement was $ 0 for the period ended March 31, 2022 and $ 14,000 for the period ended March 31, 2021.
Note
13: 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.
16
On
February 17, 2022, the Company entered into a Lease Agreement for a term of two years commencing on March 1, 2022, pursuant to
which the Company agreed to lease a Canon copier. The base rent is $ 322
per month for the term of the lease.
The
expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it is reasonably certain
that the Company would exercise such options. The Company’s leases have remaining lease terms between 13 months and 5 years. As
of March 31, 2022, and December 31, 2021, the weighted-average remaining term is 3.7 and 2.72 years, respectively.
The
Company has determined that the incremental borrowing rate is 10 % as of March 31, 2022, and December 31, 2021, respectively, based upon
the recently completed financing transaction in December 2019.
Future
minimum payments as of March 31, 2022, are as follows:
Schedule
of Operating lease Future Payments
Year
Ending December 31,
2022
$ 49
2023
60
2024
35
2025
14
Less
imputed interest
( 14 )
Total
$ 144
As
of March 31, 2022, and December 31, 2021, the balance of the right of use assets was $ 144,000 and $ 149,000 , respectively, and the corresponding
lease liability balance was $ 144,000 and $ 149,000 , respectively. The total rent expense for the period ended March 31, 2022, and December
31,2021 amounted to approximately $ 17,000 and $ 67,000 , respectively. Total rent expense for short term leases for the period ended March
31, 2022 and December 31, 2021 amounted to approximately $ 3,000 and $ 12,000 , respectively.
Note
14: Research, Consulting and Supply Agreements
In
January 2021, the Company entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1
clinical study to assess the safety, tolerability, and biological activity of Ampligen as a potential intranasal therapy. The Company
has paid CHDR approximately $ 1,010,000 . The balance of the agreement is approximately $ 61,000 , to be paid in the second quarter of 2022.
In
April 2021, the Company approved a proposal from Polysciences Inc. (“Polysciences”) for the manufacture of our Poly I and
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 March 31, 2022, the Company paid Polysciences $ 51,390 .
In
April 2022, AIM executed a work order with Amarex Clinical Research LLC, our contract research organization, pursuant to which Amarex
will manage a Phase 2 clinical trial in advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM anticipates that
the study will cost approximately $ 8.2 million, which includes pass through costs of approximately $ 1.0 million and excludes certain
third-party costs and escalations. AIM anticipates that the study will take approximately 4.6 years to complete.
Note
15: Subsequent Events
None.
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.