Item 1. Financial Statements
ITEM
1 : Financial Statements
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
(in
thousands, except for share and per share amounts)
(Unaudited
June 30, 2024 and Audited December 31, 2023)
June 30, 2024
December 31, 2023
ASSETS
Current assets:
Cash and cash
equivalents
$ 3,554
$ 5,439
Marketable securities
6,507
7,631
Funds receivable from New
Jersey net operating loss
—
1,184
Prepaid
expenses and other current assets
300
302
Total
current assets
10,361
14,556
Property and equipment, net
109
127
Right of use asset, net
700
697
Patent and trademark rights, net
2,491
2,313
Other assets
2,054
1,688
Total
assets
$ 15,715
$ 19,381
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$ 5,455
$ 6,443
Accrued expenses
799
1,986
Current portion of operating
lease liability
234
223
Current
portion of note payable, net
2,354
—
Total
current liabilities
8,842
8,652
Long-term liabilities:
Operating lease liability
488
495
Note payable, net
283
—
Total
liabilities
9,613
9,147
Commitments and contingencies (Notes 12 and
13)
-
-
Stockholders’ equity:
Series A Junior Participating Preferred
Stock, $ 0.001
par value, 4,000,000 and 250,000 shares authorized as of June 30, 2024, and December 31, 2023, respectively: issued and outstanding
– none
—
—
Series B Convertible Preferred Stock, stated
value $ 1,000 per share, 10,000 shares authorized; no issued and outstanding as of June 30, 2024 and 689 issued and outstanding as
December 31, 2023
—
689
Common Stock, $ 0.001 par value, authorized
shares - 350,000,000 ; issued and outstanding shares 57,136,680 and 49,102,484 as of June 30, 2024 and December 31, 2023, respectively
57
49
Additional paid-in capital
423,206
419,004
Accumulated deficit
( 417,161 )
( 409,508 )
Total
stockholders’ equity
6,102
10,234
Total
liabilities and stockholders’ equity
$ 15,715
$ 19,381
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)
2024
2023
2024
2023
Three
months ended June 30,
Six
months ended June 30,
2024
2023
2024
2023
Revenues:
Clinical
treatment programs - US
$ 50
$ 42
$ 90
$ 91
Total Revenues
50
42
90
91
Costs and Expenses:
Production costs
8
—
16
—
Research and development
1,145
2,953
3,096
5,005
General
and administrative
2,591
2,550
6,406
4,841
Total Costs and Expenses
3,744
5,503
9,518
9,846
Operating loss
( 3,694 )
( 5,461 )
( 9,428 )
( 9,755 )
Gain (Loss) on investments
( 85 )
( 94 )
( 177 )
109
Interest and other income
2,580
318
2,661
517
Interest expense and other
finance costs
( 179 )
—
( 251 )
—
(Loss) on sale of fixed
assets
—
—
—
( 23 )
(Loss) on warrant issuance
( 458
)
—
( 458
)
—
Gain
from sale of income tax operating losses
—
328
—
582
Net Loss
$ ( 1,836 )
$ ( 4,909 )
$ ( 7,653 )
$ ( 8,570 )
Basic and diluted loss per share
$ ( 0.03 )
$ ( 0.10 )
$ ( 0.15 )
$ ( 0.18 )
Weighted average shares outstanding basic and diluted
52,837,477
48,411,251
51,161,956
48,405,675
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, 2024 and 2023
(in
thousands except share data)
(Unaudited)
Series
B
Preferred Shares
Common
Stock
Shares
Common
Stock .001
Par Value
Additional
Paid-in
Capital
Accumulated
other Comprehensive
Income (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
Balance December 31, 2023
$ 689
49,102,484
$ 49
$ 419,004
$ —
$ ( 409,508 )
$ 10,234
Common stock issuance, net of costs
—
807,577
1
328
—
—
329
Cashless Exercise of Warrants
—
3,272
—
—
—
—
—
Equity-based compensation
—
—
—
80
—
—
80
Committed shares
—
338,600
—
—
—
—
—
Net comprehensive loss
—
—
—
—
—
( 5,817 )
( 5,817 )
Balance March 31, 2024
$ 689
50,251,933
$ 50
$ 419,412
$ —
$ ( 415,325 )
$ 4,826
Common stock issuance, net of costs
—
6,884,747
7
525
—
—
532
Issuance of w arrants
—
—
—
2,500
—
—
2,500
Equity-based compensation
—
—
—
80
—
—
80
Series B preferred shares expired
( 689 )
—
—
689
—
—
—
Net comprehensive loss
—
—
—
—
—
( 1,836 )
( 1,836 )
Balance June 30, 2024
$ —
57,136,680
$ 57
$ 423,206
$ —
$ ( 417,161 )
$ 6,102
Series
B
Preferred Shares
Common
Stock
Shares
Common
Stock .001
Par Value
Additional
Paid-in
Capital
Accumulated
other
Comprehensive
Income (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
Balance December 31, 2022
$ 696
48,084,287
$ 48
$ 418,270
$ —
$ ( 380,546 )
$ 38,468
Common stock issuance, net of costs
—
323,039
—
100
—
—
100
Equity-based compensation
—
—
—
82
—
—
82
Series B preferred shares converted to common
shares
( 4 )
—
—
4
—
—
—
Net comprehensive loss
—
—
—
—
—
( 3,661 )
( 3,661 )
Balance March 31, 2023
$ 692
48,407,326
$ 48
$ 418,456
—
$ ( 384,207 )
$ 34,989
Balance
$ 692
48,407,326
$ 48
$ 418,456
—
$ ( 384,207 )
$ 34,989
Common stock issuance, net of costs
—
12,165
—
5
—
—
5
Equity-based compensation
—
—
—
50
—
—
50
Series B preferred shares converted to common
shares
( 2 )
—
—
2
—
—
—
Net Comprehensive loss
—
—
—
—
—
( 4,909 )
( 4,909 )
Balance June 30, 2023
$ 690
48,419,491
$ 48
$ 418,513
$ —
$ ( 389,116 )
$ 30,135
Balance
$ 690
48,419,491
$ 48
$ 418,513
$ —
$ ( 389,116 )
$ 30,135
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, 2024 and 2023
(in
thousands)
(Unaudited)
2024
2023
Cash flows from operating activities:
Net loss
$ ( 7,653 )
$ ( 8,570 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation of property
and equipment
18
21
Amortization of patent,
trademark rights
101
106
Changes in right of use assets
150
48
Gain from sale of income
tax operating losses
—
( 582 )
Equity-based compensation
160
132
Loss (gain) on sale of
marketable securities
177
( 109 )
Loss on issuance of warrants
458
—
Amortization of financial
obligation
270
—
Change in assets and liabilities:
Funds receivable from New
Jersey net operating loss
1,181
1,676
Prepaid expenses and other
current assets and other non-current assets
5
17
Lease liability
( 149 )
( 34 )
Other assets
( 366 )
( 39 )
Accounts payable
( 988 )
1,774
Accrued
expenses
( 1,187 )
( 278 )
Net cash used in operating
activities
( 7,823 )
( 5,838 )
Cash flows from investing activities:
Proceeds from sale of marketable
securities
1,105
598
Purchase of marketable
securities
( 158 )
( 712 )
Proceeds from sale of property
and equipment
—
35
Purchase
of patent and trademark rights
( 279 )
( 203 )
Net cash provided by (used in) investing activities
668
( 282 )
Cash flows from financing activities:
Proceeds from sale of stock,
net of issuance costs
856
105
Proceeds
from note payable, net of issuance costs
2,367
—
Proceeds from issuance of equity warrants
2,047
—
Net cash provided by
financing activities
5,270
105
Net decrease in cash and cash equivalents
( 1,885 )
( 6,015 )
Cash and cash equivalents
at beginning of period
5,439
27,053
Cash and cash equivalents
at end of period
$ 3,554
$ 21,038
Supplemental disclosures of non-cash investing
and financing cash flow information:
Operating
lease-Right of Use Assets
$ 3
$ ( 48 )
Unrealized
gain on marketable securities
$ 42
$ 196
Conversion
of Series B preferred
$ —
$ 6
See
accompanying notes to consolidated financial statements.
5
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note
1: Business and Basis of Presentation
AIM
ImmunoTech Inc. and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are
an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple
types of cancers, viral diseases and immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical
and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system
of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.
AIM’s
flagship products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa). Ampligen is a double-stranded RNA (“dsRNA”)
molecule being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has not been approved
by the FDA or marketed in the United States, but is approved for commercial sale in the Argentine Republic for the treatment of severe
Chronic Fatigue Syndrome (“CFS”).
The
Company is currently proceeding primarily in four areas:
● Conducting
clinical trials to evaluate the efficacy and safety of Ampligen for the treatment of pancreatic
cancer.
● Evaluating
Ampligen across multiple cancers as a potential therapy that modifies the tumor microenvironment
with the goal of increasing anti-tumor responses to checkpoint inhibitors.
● Exploring
Ampligen’s antiviral activities and potential use as a prophylactic or treatment for
existing viruses, new viruses and mutated viruses thereof.
● Evaluating
Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”)
and fatigue and/or the Post-COVID condition 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 support a potential future
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.
AIM’s
business plan requires one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen and its Active Pharmaceutical
Ingredients (APIs). This includes utilizing Jubilant HollisterStier and Sterling for the manufacture of Ampligen and our Poly I and Poly
C12U polynucleotides, respectively. Additionally, our relationship with Polysciences Inc. (“Polysciences”) continues and
R&D development of polymer manufacture is ongoing.
In
the opinion of management, all adjustments necessary for a fair presentation of its consolidated financial statements have been included.
Such adjustments consist of normal recurring items. Interim results are not necessarily indicative of results for a full year.
The
interim consolidated financial statements and notes thereto are presented as permitted by the Securities and Exchange Commission (“SEC”),
and do not contain certain information which will be included in the Company’s annual consolidated financial statements and notes
thereto.
These
consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years
ended December 31, 2023, and 2022, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023,
filed on April 1, 2024.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”)
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the
reporting period. Actual results could differ from those estimates, and those differences may be material. Accounts requiring the use
of significant estimates include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent
and trademark valuations, stock-based compensation calculations, fair value of warrants, and contingency accruals.
6
Note
2 : Cash and Cash Equivalents
Cash
includes bank deposits maintained at several financial institutions. The Company considers highly liquid instruments with an original
maturity of three months or less to be cash equivalents. At various times throughout the six months ended June 30, 2024, some accounts
held at financial institutions were in excess of the federally insured limit of $ 250,000 . The Company has not experienced any losses
on these accounts and believes credit risk to be minimal.
Note
3: 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 11,202,957 and 73,524 for the three months
ended June 30, 2024, and 2023, respectively; and 14,589,746 and 2,595,914
shares for the six months ended June 30, 2024 and 2023, respectively, are excluded from the calculation of diluted net loss per
share since their effect is anti-dilutive.
Note
4: Equity-Based Compensation
The
2018 Equity Incentive Plan, effective September 12, 2018, as amended and restated on August 19, 2019 (the “2018 Equity
Incentive Plan”) 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 were reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. When the plan
was amended and restated, an additional 250,000
shares were reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. The number of shares of the
Company’s common stock available for grant and issuance under the 2018 Equity Incentive Plan is subject to an annual increase
on July 1 of each calendar year, by an amount equal to two percent (2%) of the then outstanding shares of the Company’s common
stock (the “2018 Plan Evergreen Provision”). On August 3, 2020 and July 1, 2021, 2022 and 2023, the number of shares of
the Company’s common stock available for grant and issuance under the 2018 Equity Incentive Plan increased by 979,311
shares, 956,660
shares, 960,976
shares and 968,389
shares, respectively. As a result of the 2018 Plan Evergreen Provisions, a maximum of 10,865,336
shares of Common Stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan as of January 1,
2024. Unless sooner terminated, the 2018 Equity Incentive Plan will continue in effect for a period of 10
years from its effective date. During the fiscal year ending December 31, 2018 the Board of Directors (the “Board”)
issued 1,189,284
options to each employee, the officers and directors at the exercise price of $ 9.68
expiring in 10
years. During the fiscal year ending December 31, 2019, 1,727,756
options were issued to each of these officers with an exercise price of $ 9.68
for a period of ten
years with a vesting period of one year. During the fiscal year ending December 31, 2020, 1,025,000
options were issued to each of these officers and directors with an exercise price range of $ 2.77
to $ 3.07
for a period of ten
years with a vesting period of one year During the fiscal year ending December 31, 2021, 613,512
options were issued to officers, directors and consultants 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 the fiscal year ending December 31, 2022, 850,000
options were issued to officers, directors and consultants with an exercise price range of $ 0.31
to $ 0.71
for a period of ten
years with a vesting period of one year. During the fiscal year ending December 31, 2023, 400,000
options were issued to officers with an exercise price range of $ 0.47
for a period of ten
years with a vesting period of one year. During the six months ended June 30, 2024 there were no
options issued.
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, 2024 and 2023, there
were no options granted.
7
Stock
options activity during the three months ended June 30, 2024, was 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 March 31, 2024
2,408,438
$ 2.50
8.70
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
( 663 )
—
—
—
Outstanding June 30, 2024
2,407,775
$ 2.50
8.70
$ —
Vested and expected
to vest June 30, 2024
2,407,775
$ 2.50
8.70
$ —
Exercisable June 30, 2024
2,241,109
$ 1.83
6.89
$ —
Unvested
stock option activity for employees:
Schedule
of Unvested Stock Option Activity
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Unvested March 31, 2024
266,666
$ 2.75
14.52
$ —
Granted
—
—
—
—
Expired
( 663 )
—
—
—
Vested
( 99,337 )
0.47
7.04
—
Unvested June 30, 2024
166,666
$ 4.11
18.87
$ —
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 March 31, 2024
885,055
$ 2.02
9.23
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
—
—
—
—
Outstanding June 30, 2024
885,055
$ 2.02
9.23
$ —
Vested and expected
to vest June 30, 2024
885,055
$ 2.02
9.23
$ —
Exercisable June 30, 2024
730,055
$ 2.27
10.04
$ —
Unvested
stock option activity for non-employees:
Schedule
of Unvested Stock Option Activity
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Unvested March 31, 2024
245,001
$ 2.33
11.15
$ —
Granted
—
—
—
—
Expired
—
—
—
—
Vested
( 90,000 )
0.46
10.18
—
Unvested June 30, 2024
155,001
$ 3.42
11.30
$ —
Stock-based
compensation expense was approximately $ 80,000 and $ 50,000 for the three months ended June 30, 2024 and 2023, resulting in a decrease
in general and administrative expenses, respectively.
8
Employee
stock option activity during the six months ended June 30, 2024, was as follows:
Stock
option activity for employees:
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding January 1, 2024
2,408,438
$ 2.50
8.70
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
( 663 )
—
—
—
Outstanding June 30, 2024
2,407,775
$ 2.50
8.70
$ —
Vested and expected
to vest June 30, 2024
2,407,775
$ 2.50
8.70
$ —
Exercisable June 30, 2024
2,241,109
$ 1.83
6.89
$ —
Unvested
stock option activity for employees:
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Unvested January 1, 2024
366,666
$ 2.13
12.44
$ —
Granted
—
—
—
—
Expired
( 663 )
—
—
—
Vested
( 199,337 )
0 .47
7.04
—
Unvested June 30, 2024
166,666
$ 4.11
18.87
$ —
Stock
option activity for non-employees:
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term (Years)
Aggregate
Intrinsic
Value
Outstanding January 1, 2024
885,055
$ 2.02
9.23
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
—
—
—
—
Outstanding June 30, 2024
885,055
$ 2.02
9.23
$ —
Vested and expected
to vest June 30, 2024
885,055
$ 2.02
9.23
$ —
Exercisable June 30, 2024
730,055
$ 2.27
10.04
$ —
9
Unvested
stock option activity for non-employees:
Number
of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Unvested January 1, 2024
335,001
$ 1.83
10.70
$ —
Granted
—
—
—
—
Expired
—
—
—
—
Vested
( 180,000 )
0 .46
10.18
—
Unvested June 30, 2024
155,001
$ 3.42
11.30
$ —
Stock-based
compensation expense was approximately $ 160,000 and $ 132,000 for the six months ended June 30, 2024 and 2023, respectively.
On
June 30, 2024, and 2023, respectively, there was approximately $ 134,000 and $ 85,000 of unrecognized equity-based compensation cost related
to options granted under the Equity Incentive Plan.
Note
5: Marketable Securities
Marketable
securities consist of mutual funds. At June 30, 2024 and December 31, 2023, it was determined that none of the marketable securities
had an other-than-temporary impairment. At June 30, 2024 and December 31, 2023, all securities were measured as Level 1 instruments of
the fair value measurements standard (See Note 11: Fair Value). At June 30, 2024, and December 31, 2023 the Company held $ 6,507,000 and
$ 7,631,000 respectively, in mutual funds.
Mutual
Funds classified as available for sale consisted of:
Schedule
of Available of Sale
June
30, 2024
(in
thousands)
Securities
Fair
Value
Short-Term
Investments
Mutual
Funds
$ 6,507
$ 6,507
Totals
$ 6,507
$ 6,507
Schedule of Equity Securities
Securities
For the six
months ended
June
30, 2024
(in
thousands)
Net gain recognized during the
period on equity securities
$ ( 177 )
Less: Net gains and
losses recognized during the period on equity securities sold during the period
( 218 )
Unrealized gains and
losses recognized during the reporting period on equity securities still held at the reporting date
$ 41
Mutual
Funds classified as available for sale consisted of:
December
31, 2023
(in
thousands)
Securities
Fair
Value
Short-Term
Investments
Mutual Funds
$ 7,631
$ 7,631
Totals
$ 7,631
$ 7,631
10
Securities
For the six months ended
June
30, 2023
(in
thousands)
Net losses recognized during the
period on equity securities
$ 109
Less: Net gains and
losses recognized during the period on equity securities sold during the period
( 87 )
Unrealized gains and
losses recognized during the reporting period on equity securities still held at the reporting date
$ 196
Note
6: Accrued Expenses
Accrued
expenses consist of the following:
Schedule
of Accrued Expenses
June
30, 2024
December
31, 2023
(in
thousands)
June
30, 2024
December
31, 2023
Compensation
$ 1
$ 414
Professional fees
518
1,352
Clinical trial expenses
154
184
Interest
118
—
Other expenses
8
36
Total
$ 799
$ 1,986
Note
7: Property and Equipment, net
Schedule
of Property and Equipment
June
30, 2024
December
31, 2023
(in
thousands)
June
30, 2024
December
31, 2023
Furniture, fixtures, and equipment
1,448
1,448
Less: accumulated depreciation
( 1,339 )
( 1,321 )
Property and equipment,
net
$ 109
$ 127
Property
and equipment are recorded at cost. Depreciation and amortization are computed using the straight-line method over the estimated useful
lives of the respective assets, ranging from three to ten years. Depreciation expense for the six months ending June 30, 2024 and June
30, 2023 was $ 18,000 and $ 21,000 , respectively.
Note
8: Patents, and Trademark Rights, Net
Patent
and trademark rights consist of the following (in thousands):
Schedule
of Patent and Trademark Rights
June
30, 2024
December
31, 2023
Gross
Carrying Value
Accumulated
Amortization
Net
Carrying Value
Gross
Carrying Value
Accumulated
Amortization
Net
Carrying Value
Patents
$ 3,223
$ ( 841 )
$ 2,382
$ 2,947
$ ( 750 )
$ 2,197
Trademarks
232
( 123 )
109
229
( 113 )
116
Net amortizable patents
and trademarks rights
$ 3,455
$ ( 964 )
$ 2,491
$ 3,176
$ ( 863 )
$ 2,313
11
Patent
and trademark rights acquisitions, abandonments and amortization:
Schedule of Changes in
Patents, Trademark Rights
December 31, 2023
$ 2,313
Acquisitions
282
Abandonments
( 3 )
Amortization
( 101 )
June 30, 2024
$ 2,491
Patents
and trademarks are stated at cost (primarily legal fees) and are amortized using the straight-line method over an estimated useful life
of 17 years for patents and 10 years for trademarks. The weighted remaining average amortization period is approximately 12 years for
patents and 7 years for trademarks, respectively. The company expenses annuity costs related to its trademarks and patents.
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,
2024
$ 136
2025
258
2026
255
2027
230
2028
211
Thereafter
1,401
Total
$ 2,491
Note
9: 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 our authorized preferred stock, 4,000,000 shares have been designated as Series A Junior Participating
Preferred Stock and 10,000 shares have been designated as Series B Convertible Preferred Stock.
Series
A Junior Participating Preferred Stock
On
May 10, 2023, the Company filed a Certificate of Increase in Delaware, increasing the number of preferred stock designated as Series
A Junior Participating Preferred Stock to 4,000,000 from 250,000 shares. As of June 30, 2024, there were no Series A Junior Participating
Preferred Stock outstanding.
Series
B Convertible Preferred Stock
The
Company has designated 10,000 shares of its preferred stock as Series B Convertible Preferred Stock (the “Preferred Stock”).
Each share of Preferred Stock has a par value of $ 0.01 per share and a stated value equal to $ 1,000 (the “Stated Value”).
The shares of Preferred Stock shall initially be issued and maintained in the form of securities held in book-entry form and the Depository
Trust Company or its nominee (“DTC”) shall initially be the sole registered holder of the shares of Preferred Stock.
Each
share of Preferred Stock shall be convertible, at any time and from time to time from and after the Original Issue Date at the option
of the Holder thereof or at any time and from time to time on or after the second anniversary of the Original Issue Date at the option
of the Corporation, into that number of shares of Common Stock (subject in each case to the limitations determined by dividing the Stated
Value of such share of Preferred Stock by the Conversion Price). The conversion price for the Preferred Stock shall be equal to $ 0.20 ,
subject to adjustment herein (the “Conversion Price”).
12
Pursuant
to a registration statement relating to a rights offering (the “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 redeemable 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 redeemable warrants are exercisable for five years after the date of issuance. The net proceeds realized from the rights
offering were approximately $ 4,700,000 .
As of June 30, 2024, 689
shares of Series B Convertible Preferred Stock expired, and none were converted prior to expiration.
(b)
Common Stock and Equity Finances
The
Company has authorized shares of 350,000,000 with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000
authorized shares. As of June 30, 2024, and December 31, 2023, there were 57,136,680 and 49,102,484 shares of Common Stock issued and
outstanding, respectively.
Employee
Stock Purchase Plan (Not equity compensation)
On
July 7, 2020, the Board 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 (including subsequent plans, the “Employee Stock Purchase Plan”).
Pursuant to NYSE American rules, this plan was effective for a sixty-day period commencing upon the date that the NYSE American approved
the Company’s Supplemental Listing Application. The Company created successive new plans following the expiration of the July 7,
2020 plan. The latest plan was approved by the Board on June 26, 2024 and expires in August 2024.
During the three months ended
June 30, 2024, the Company issued a total of 92,594 shares of its Common Stock at a price of $ 0.41 for total proceeds of approximately
$ 37,500 as part of the employee stock purchase plan.
During
the six months ended June 30, 2024, the Company issued a total of 335,603 shares of its Common Stock at a price ranging from $ 0.33 to
$ 0.41 for total proceeds of approximately $ 120,000 as part of the employee stock purchase plan.
During the three months ended
June 30, 2023, the Company did no t issue any shares of its Common Stock as part of the employee stock purchase plan.
During
the six months ended June 30, 2023, the Company issued a total of 322,583 shares of its Common Stock at a price of $ 0.31 for total proceeds
of approximately $ 100,000 as part of the employee stock purchase plan.
Rights
Plan
On
May 12, 2023, the Company amended and restated its November 14, 2017 Rights Plan with American Stock Transfer & Trust Company as
Rights Agent (the “Rights Plan”).
Warrants
(Rights offering)
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, we issued a Representative’s Warrant to purchase up to an aggregate of 266,665 shares of common
stock (the “Representative’s Warrant”). The shares of Common Stock and Warrants were sold at a combined Offering price
of $ 0.90 , less underwriting discounts and commissions. Each Warrant sold with the shares of Common Stock represents the right to purchase
one share of Common Stock at an exercise price of $ 0.99 per share. The Pre-Funded Warrants and Warrants were sold at a combined Offering
price of $ 0.899 , less underwriting discounts and commissions. The Pre-Funded Warrants were sold to purchasers whose purchase of shares
of Common Stock in the Offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially
owning more than 4.99 % of the Company’s outstanding Common Stock immediately following the consummation of the Offering, in lieu
of shares of Common Stock. Each Pre-Funded Warrant represents the right to purchase one share of Common Stock at an exercise price of
$ 0.001 per share. The Pre-Funded Warrants are exercisable immediately and may be exercised at any time until the Pre-Funded Warrants
are exercised in full. A registration statement on Form S-1, relating to the Offering was filed with the SEC and was declared effective
on September 25, 2019, the net proceeds were approximately $ 7,200,000 . During the year ended December 31, 2020, 1,870,000 of the Pre-funded
Warrants were exercised and 8,873,960 Warrants were exercised. In addition, on March 25, 2020, the Representative’s Warrant was
amended to permit exercise of such warrant to commence on March 30, 2020. These warrants were exercised on March 31, 2020, and an aggregate
of 266,665 shares were issued upon exercise of this warrant for gross proceeds of approximately $ 264,000 and a $ 46,000 expense for the
warrant modification.
During
the three months ended June 30, 2024, there were no warrants exercised. During the six months ended June 30, 2024, 205,000
warrants were exercised, and 5,830,028
warrants expired unexercised. As of June 30,
2024 and December 31, 2023 there were 15,000
and 152,160
post-split warrants outstanding, respectively.
13
Equity
Distribution Agreement
On
April 19, 2023, the Company entered into an Equity Distribution Agreement (the “EDA”) with Maxim Group LLC
(“Maxim”), pursuant to which the Company may sell, from time to time, shares of its common stock having an aggregate
offering price of up to $ 8,500,000
through Maxim, as agent (the “Offering”). Sales under the EDA were registered under the S-3 Shelf Registration
Statement. Under the terms of the EDA, Maxim will be entitled to a transaction fee at a fixed rate of 3.0 %
of the gross sales price of shares sold under the EDA. For the three months ended June 30, 2024, the Company sold 730,110 shares
under the EDA for total gross proceeds of approximately $ 372,223 , which includes a 3.0 % fee to Maxim of $ 11,167 . For the six months
ended June 30, 2024, the Company sold 1,294,678
shares under the EDA for total gross proceeds of approximately $ 626,094 ,
which includes a 3.0 %
fee to Maxim of $ 18,783 .
During the year ended December 31, 2023, the Company sold 598,114
shares under the EDA for total gross proceeds of approximately $ 344,000 ,
which includes a 3.0 %
fee to Maxim of $ 10,326 .
Equity
Purchase Agreement
On
March 28, 2024, the Company entered into a purchase agreement and a registration rights agreement with Atlas Sciences, LLC (“Atlas”), pursuant to which Atlas committed to purchase up to $ 15,000,000 of common stock of the
Company for a period of 24 months from the date of the purchase agreement.
Under
the terms of the purchase agreement, the Company, at its sole discretion, shall have the right to issue Put shares to the Investor
at 95 %
of the Market Price of the shares on the day of trade. Sales under the purchase agreement are limited to a daily maximum of the
lessor of: $ 500,000 ,
the Median Daily Trading volume, and a beneficial ownership limitation of 4.99 %
and a maximum of 19.99 %
of the outstanding shares at the time of the purchase agreement. In April 2024, the Company filed a registration statement with the
SEC on Form S-1 registering a total of 9,975,000
shares for resale pursuant to the Atlas Agreements, consisting of 9,636,400
shares that can be sold by the Company to Atlas and 338,600
shares that were issued to Atlas as Commitment Shares. As of June 30, 2024, a total of 759,685
shares have been issued pursuant to the purchase agreement for a total of approximately $ 128,000 .
Securities
Purchase Agreement
On
May 31, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering
(the “Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which the Company will
issue to the Purchaser, (i) in a registered direct offering, 5,640,958 shares of the Company’s common stock (the “Shares”),
par value $ 0.001 per share (“Common Stock”) and (ii) in a concurrent private placement, the Company will issue to the Purchaser
Class A common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “A Warrants”) at an exercise
price of $ 0.363 per share and Class B common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “B
“Warrants” and, along with the A Warrants, the “Common Warrants”) at an exercise price of $ 0.363 per share. The
A Warrants and B Warrants will not be exercisable for six months after the issuance date and will expire, respectively, 24 months and
five years and six months after the issuance date. The Common Warrants and the shares of common stock issuable upon the exercise of such
warrants are offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of
the Securities Act and Rule 506(b) promulgated thereunder.
The
Shares are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-262280), which was declared
effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).
Pursuant
to the terms of the Purchase Agreement, subject to certain exceptions, the Company cannot issue any equity securities for 60 days following
the issuance date, provided that the Company will be able to utilize its at-the-market offering program with the Placement Agent
after 30 days. Additionally, the Company cannot enter into a variable rate transaction (other than the ATM program with the Placement
Agent) for 120 days after the issuance date. In addition, the Company’s executive officers and each of the Company’s directors
have entered into lock-up agreements with the Company pursuant to which each of them has agreed not to, for a period of 90 days from
the closing of the Transactions, offer, sell, transfer or otherwise dispose of the Company’s securities, subject to certain exceptions.
The
exercise price of the Common Warrants, and the number of Common Warrant Shares, will be subject to adjustment in the event of any stock
dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants.
If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted
for the Company, and may exercise every right and power that the Company may exercise and will assume all of its obligations under the
Common Warrants with the same effect as if such successor entity had been named in the warrant itself. Common Warrant Holders will have
additional rights defined in the Common Warrants. The Common Warrants will be exercisable on a “cashless” basis only if there
is not a current registration statement permitting public resale. In this regard, the Company has agreed to file a registration statement
to register the resale of the Common Warrant Shares as soon as practicable (and in any event within 45 calendar days) providing for the
resale of the Shares issued and issuable upon exercise of the Common Warrants. The Company has agreed to use commercially reasonable
efforts to cause such registration statement to become effective within 181 days following the issuance date and to keep such registration
statement effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.
14
Maxim
Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis,
in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”),
by and between the Company and the Placement Agent. Pursuant to the Placement Agency Agreement, the Placement Agent will be entitled
to a cash fee of 8 % of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement
of certain out-of-pocket expenses.
The Company evaluated
the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity and determined that they were in
scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification and are
classified as equity within the condensed consolidated financial statements. Proceeds allocated to such warrants totaled approximately $ 2.5 million .
For the six months ended June 30,2024, no Common Warrants were exercised, and all remain outstanding on June 30,
2024.
Note
10: Recent Accounting Pronouncements
The
Company has implemented all new accounting pronouncements that are in effect. These pronouncements did not have any material impact on
the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting pronouncements
that have been issued that might have a material impact on its financial position or results of operations. Accounting pronouncements
issued by the FASB since filing the Annual Report on Form 10-K for the year ended December 31, 2023
did not or are not believed by management to have a material impact on the Company’s present or future financial statements.
Note
11: Fair Value
Fair
Value
The
Company complies with the provisions of FASB ASC 820 “Fair Value Measurements” for its financial and non-financial assets
and liabilities. ASC 820 defines fair value, establishes a framework for measuring fair value and expands disclosure for each major asset
and liability category measured at fair value on either a recurring or nonrecurring basis.
The
fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate their carrying values due to
the short-term maturities of these items and are considered a Level 1 instrument of the fair value measurements standard. The Company
also has certain warrants with a cash settlement feature in the occurrence of a Fundamental Transaction. The fair value of the warrants
(“June 2024 Warrants”) related to the Company’s June 2024 common stock and warrant issuance, are calculated using a
Monte Carlo Simulation.
The
Company also had certain redeemable warrants in the Rights Offering with a cash settlement feature in the occurrence of a Fundamental
Transaction. No Fundamental Transaction occurred. In March 2024, 205,000 of these warrants converted on a cashless basis and 5,830,028
expired.
The
Company estimated the fair value of the June 2024 Warrants using the Black-Scholes Model, which uses multiple inputs including the Company’s
stock price, the exercise price of the warrant, volatility of the Company’s stock price, the risk-free interest rate and the expected
term of the warrants.
The
Company utilized the following assumptions to estimate the fair value of the Class A Warrants:
Schedule of Assumptions to
Estimate the Fair Value
June 30,
December 31,
2024
2023
Underlying price per share
$ 0.350
—
Exercise price per share
$ 0.363
—
Risk-free interest rate
4.42 %
—
Expected holding period
5.5 years
—
Expected volatility
110 %
—
Expected dividend yield
—
—
The
Company utilized the following assumptions to estimate the fair value of the Class B Warrants:
June 30,
December 31,
2024
2023
Underlying price per share
$ 0.350
—
Exercise price per share
$ 0.363
—
Risk-free interest rate
4.82 %
—
Expected holding period
2 years
—
Expected volatility
89 %
—
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 . The expected dividend yield is based on the Company’s anticipated
dividend payments over the remaining expected holding period. As the Company has never issued
dividends, the expected dividend yield is 0% and this assumption will be continued in future
calculations unless the Company changes its dividend policy.
(v) Expected
Probability of a Fundamental Transaction. Put rights arise if a Fundamental Transaction
1) is an all cash transaction; (2) results in the Company going private; or (3) is a transaction
involving a person or entity not traded on a national securities exchange. The Company believes
such an occurrence is unlikely because:
15
1. The
Company only has one product that is FDA approved but is currently not available for commercial
sales.
2. The
Company will have to perform additional clinical trials for FDA approval of its flagship
product.
3. Industry
and market conditions continue to include uncertainty, adding risk to any transaction.
4. The
nature of a life sciences company is heavily dependent on future funding and high fixed costs,
including Research & Development.
5. The
Company has minimal revenues streams which are insufficient to meet the funding needs for
the cost of operations or construction at their manufacturing facility; and
6. The
Company’s Rights Agreement and Executive Agreements make it less attractive to a potential
buyer.
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 Potential
Liability
Range of Probability
Probability
Low
0.5 %
Medium
1.0 %
High
5.0 %
The
Monte Carlo Simulation has incorporated a 5.0 % probability of a Fundamental Transaction to date for the life of the securities.
(vi) Expected
Timing of Announcement of a Fundamental Transaction. As the Company has no specific expectation
of a Fundamental Transaction, for reasons elucidated above, the Company utilized a discrete
uniform probability distribution over the Expected Holding Period to model in the potential
announcement of a Fundamental Transaction occurring during the Expected Holding Period.
(vii) Expected
100 Day Volatility at Announcement of a Fundamental Transaction . An estimate of future
volatility is necessary as there is no mechanism for directly measuring future stock price
movements. Daily observations of the Company’s historical stock values for the 100
days immediately prior to the Warrants’ grant dates, with a floor of 100%, were utilized
as a proxy for future volatility estimates.
(viii) Expected
Risk-Free Interest Rate at Announcement of a Fundamental Transaction . The Company utilized
a risk-free interest rate corresponding to the forward U.S. Treasury rate for the period
equal to the time between the date forecast for the public announcement of a Fundamental
Transaction and the Warrant expiration date for each simulation.
(ix) Expected
Time Between Announcement and Consummation of a Fundamental Transaction. The expected
time between the announcement and the consummation of a Fundamental Transaction is based
on the Company’s experience with the due diligence process performed by acquirers and
is estimated to be six months. The Monte Carlo Simulation approach incorporates this additional
period to reflect the delay Warrant Holders would experience in receiving the proceeds of
the Put.
While
the assumptions remain consistent from period to period (e.g., utilizing historical stock prices), the actual historical prices input
for the relevant period input change.
The
Company accounts for certain assets and liabilities at fair value. The hierarchy below lists three levels of fair value based on the
extent to which inputs used in measuring fair value are observable in the market. AIM categorizes each of its fair value measurements
in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety. These
levels are:
1. Level
1 – Quoted prices are available in active markets for identical assets or liabilities
at the reporting date. Generally, this includes debt and equity securities that are traded
in an active market.
2. Level
2 – Observable inputs other than Level 1 prices such as quote prices for similar assets
or liabilities; quoted prices in markets that are not active; or other inputs that are observable
or can be corroborated by observable market data for substantially the full term of the assets
or liabilities. Generally, this includes debt and equity securities that are not traded in
an active market.
3. Level
3 – Unobservable inputs that are supported by little or no market activity and that
are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities
include financial instruments whose value is determined using pricing models, discounted
cash flow methodologies, or other valuation techniques, as well as instruments for which
the determination of fair value requires significant management judgment or estimation. As
of June 30, 2024, 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.
16
The
table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy
as (in thousands):
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis
As
of June 30, 2024
Total
Level
1
Level
2
Level
3
Assets:
Cash
equivalents
$ 114
$ 114
$ —
$ —
Marketable
investments
$ 6,507
$ 6,507
$ —
$ —
As
of December 31, 2023
Total
Level
1
Level
2
Level
3
Assets:
Cash
equivalents
$ 4,805
$ 4,805
$ —
$ —
Marketable
investments
$ 7,631
$ 7,631
$ —
$ —
Note
12: Unsecured Promissory Note
On
February 16, 2024, the Company (“Borrower”) entered into a Note Purchase Agreement with Streeterville Capital LLC
(“Streeterville” or the “Lender”). Under the terms of the agreement, Streeterville paid the Company $ 2,500,000
in exchange for an unsecured promissory Note with an Original Issue Discount of $ 781,250 .
The Company will pay $ 3,301,250
consisting of the principal amount of the Note, together with the original issue discount and $ 20,000
of lender transaction fees, no later than February 16, 2026. The stated interest rate of the note is 10 %.
Debt schedule at June 30, 2024 and December 31, 2023
(in
thousands)
Schedule of Long Term Debt
June
30, 2024
December
31, 2023
Long-term debt
$ 3,301
$ -
Unamortized Original issue discount
( 648 )
-
Unamortized Financing
fees
( 16 )
-
Unamortized discount and debt issuance costs
2,637
-
Less current portion
of long-term debt, net (1)
( 2,354 )
-
Long-term debt,
net (2)
$ 283
$ -
Interest
costs expensed and capitalized related to long-term debt were as follows:
(in
thousands)
Schedule of Long Term Debt Interest Costs Expense and Capital
June
30, 2024
December
31, 2023
Interest expense
$ 133
$ -
Interest capitalized
-
-
Total
$ 133
$ -
Amortization
expenses related to long-term debt were as follows:
(in
thousands)
Schedule of Long Term Debt Amortization Expenses
June
30, 2024
December
31, 2023
Original issue discount
$ 133
$ -
Loan fee amortization
4
-
Total
$ 137
$ -
17
Future
maturities of long-term debt as of June 30, 2024 were as follows:
(in
thousands)
Schedule of Future Maturities of Long Term Debt
Fiscal
years ending December 31:
2024
$ 1,250
2025
2,051
Total
$ 3,301
(1) Current
portion of long-term debt of approximately $ 2,750,000 is net of the current portion of debt
discount of approximately $ 386,000 and the current portion of debt origination costs of approximately
$ 10,000 as of June 30, 2024.
(2) Long-term
portion of debt of approximately $ 551,000 is net of the long-term portion of debt discount
of approximately $ 262,000 and the unamortized debt origination costs of approximately $ 6,000
as of June 30, 2024.
The
agreement allows the Lender to redeem up to $250,000 per calendar month beginning in August 2024, upon providing written notice to Borrower.
The Note further contains triggering events which can be remedied by the Lender requiring the Borrower to correct the triggering event,
increasing the outstanding balance by applying the triggering effect, or making the Note immediately due and payable.
Note
13: Leases
The
Company leases office and lab facilities and other equipment under non-cancellable operating leases with initial terms typically ranging
from 1 to 5 years, expiring at various dates during 2024 through 2027, and requiring monthly payments ranging from less than $ 1,000 to
$ 17,000 . Certain leases include additional renewal options ranging from 1 to 5 years. AIM has classified all of its leases as operating
leases.
As
of June 30, 2024 and December 31, 2023, the balance of the right of use assets was $ 700,000 and $ 697,000 , respectively, and the corresponding
operating lease liability balance was $ 722,000 and $ 718,000 , respectively. Right of use assets are recorded net of accumulated amortization
of $ 352,000 and $ 363,000 as of June 30, 2024 and December 31, 2023, respectively.
AIM
recognized rent expense associated with these leases are follows:
Schedule of AIM Recognized Rent Expense Associated with Operating Lease
June
30, 2024
June
30, 2023
(in
thousands)
June
30, 2024
June
30, 2023
Lease costs:
Operating lease
costs
$ 150
$ 141
Short-term
and variable lease costs
124
201
Total lease costs
$ 274
$ 342
Classification of lease costs
Research & development
$ 227
$ 295
General and administrative
47
47
Lease
cost
47
47
Total lease costs
$ 274
$ 342
18
The
Company’s leases have remaining lease terms between 9 and 37 months. As of June 30, 2024, the weighted-average remaining term was
35 months. As of December 31, 2023, the weighted-average remaining term was 41 months. The Company’s weighted average incremental
borrowing rate for its leases was 10 % at June 30, 2024 and December 31, 2023.
Future
minimum payments as of June 30, 2024, are as follows:
Schedule of Operating Lease Future Payments
Year
Ending December 31,
(in
thousands)
2024
$ 153
2025
273
2026
244
2027
159
Thereafter
—
Less imputed interest
( 107 )
Total
$ 722
Note
14: Research, Consulting and Supply Agreements
The
Company has entered into research, consulting and supply agreements with third party service providers to perform research and development
activities on therapeutics, including clinical trials. The identification of research and development costs involves reviewing open contracts
and purchase orders, communicating with applicable company and third-party personnel to identify services that have been performed, and
corroborating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced
or otherwise notified of actual expenses. The Company expenses these research and development costs when incurred.
During the three months ended
June 30, 2024, research and development expenses were comprised of: clinical studies ($ 350,000 ),
manufacturing and engineering ($ 330,000 ), quality control ($ 284,000 )
and regulatory ($ 180,000 ).
During the three months ended
June 30, 2023 , research and development expenses were comprised of: clinical studies ($ 777,000 ),
manufacturing and engineering ($ 321,000 ), quality control ($ 253,000 ) and regulatory ($ 1,601,000 ).
During the six months ended June 30, 2024, research and development expenses were comprised of: clinical studies ($ 1,298,000 ), manufacturing
and engineering ($576,000), quality control ($834,000) and regulatory ($389,000).
During the six months ended June
30, 2023, research and development expenses were comprised of: clinical studies ($ 1,929,000 ),
manufacturing and engineering ($ 955,000 ), quality control ($ 501,000 )
and regulatory ($ 1,621,000 ).
The
following summarizes the most substantial of our contracts relating to research, consulting, and supply costs for AIM as they related
to research and development costs for the six months ended June 30, 2024.
Amarex
Clinical Research LLC
Amarex
is the principal administrator of several of AIM’s largest clinical studies. AIM has multiple contracts with Amarex Clinical Research
LLC (“Amarex”). During the three months
ended June 30, 2024 and 2023, the Company incurred approximately $ 125,200 and $ 377,300 , respectively, related to these ongoing agreements.
During the six months ended June 30, 2024 and 2023, the Company incurred approximately $ 607,000
and $ 849,400 ,
respectively, related to these ongoing agreements:
● Pancreatic
Cancer - In April 2022, AIM executed a work order with Amarex pursuant to which Amarex is
managing a Phase 2 clinical trial in locally advanced pancreatic cancer patients designated
AMP-270. Per the work order, AIM anticipates that Amarex’s management of the study
will cost approximately $ 8,400,000 . This estimate includes pass-through costs of approximately
$ 1,000,000 and excludes certain third-party and investigator costs and escalations necessary
for study completion. AIM anticipates that the study will take approximately 4.6 years to
complete.
○ During the three months ended June 30, 2024, the Company
incurred approximately $ 66,500 related to this agreement.
○ During the three months
ended June 30, 2023, the Company incurred approximately $ 198,900 related to
this agreement.
○ During
the six months ended June 30, 2024, the Company incurred approximately $ 153,700 related to
this agreement.
○ During
the six months ended June 30, 2023, the Company incurred approximately $ 233,400 related to
this agreement.
● Post-COVID
Conditions - In September 2022, AIM executed a work order with Amarex, pursuant to which
Amarex is managing a Phase 2 trial in patients with Post-COVID Conditions. AIM is sponsoring
the study. AIM anticipates that the study will cost approximately $ 6,400,000 , which includes
pass through costs of approximately $ 125,000 , investigator costs estimated at about $ 4,400,000 ,
and excludes certain other third-party costs and escalations. During 2023, the original work
order increased to approximately $ 6,600,000 for the addition of patient reported outcome
(PRO) electronic questionnaires (devices/tablets for patients to complete); services associated
with the ePRO system and additional safety monitoring services as well as changes to study
documentation (such as protocol amendments) which resulted in additional IND submissions
to FDA. This study was completed in 2023, although certain activities are still ongoing.
○ During
the three months ended June 30, 2024, the Company incurred approximately $ 59,000 related
to this agreement.
○ During
the three months ended June 30, 2023, the Company incurred approximately $ 61,000 related to this agreement.
○ During
the six months ended June 30, 2024, the Company incurred approximately $ 352,000 related to
this agreement.
○ During
the six months ended June 30, 2023, the Company incurred approximately $ 341,500 related to
this agreement.
19
Jubilant
HollisterStier
Jubilant
HollisterStier (“Jubilant”) is AIM’s authorized CMO for Ampligen for the approval in Argentina. In 2017, the Company
entered into an agreement with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company. Since the
2017 engagement of Jubilant, two lots of Ampligen consisting of more than 16,000 units were manufactured and released in the year 2018.
The first lot was designated for human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials.
The second lot has been designated for these programs in addition to commercial distribution in Argentina for the treatment of CFS. Jubilant
manufactured additional two lots of Ampligen in December 2019 and January 2020. In December 2023, Jubilant completed manufacturing of
9,042 vials of Ampligen for clinical use.
○ During the three months ended June 30, 2024,
the Company incurred approximately $ 1,000 related to this agreement.
○ During
the three months ended June 30, 2023, the Company incurred approximately $ 1,432,000 related to this agreement.
○ During
the six months ended June 30, 2024, the Company incurred approximately $ 1,000 related to
this agreement.
○ During
the six months ended June 30, 2023, the Company incurred approximately $ 1,432,000 related to this agreement.
Sterling
Pharma Solutions
In
2022, the Company entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”)
for the manufacture of the Company’s Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’s
Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen.
○ During the three months ended June 30, 2024,
the Company did not incur any expense r elated
to this agreement.
○ During the three months ended June 30, 2023, the Company
incurred approximately $ 357,000 related to this agreement.
○ During
the six months ended June 30, 2024, the Company incurred approximately $ 129,000 related to
this agreement.
○ During
the six months ended June 30, 2023, the Company incurred approximately $ 357,000 related to
this agreement.
Erasmus
In
December 2022, the Company entered into a joint clinical study agreement with Erasmus University Medical Center Rotterdam to conduct
a Phase II study: Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic
pancreatic ductal adenocarcinoma for therapy efficacy. This is a study in collaboration with AstraZeneca. AIM’s limited responsibilities
are limited to providing Ampligen. Additionally, in April 2023 AIM agreed to provide to Erasmus MC an unrestricted grant of $ 200,000
for immune monitoring in pancreatic cancer patients.
○ During the three
months ended June 30, 2024, the Company incurred approximately $ 75,000 related to this agreement.
○ During the three months ended June 30, 2023, the Company incurred approximately $ 100,000 related to this agreement.
○ During
the six months ended June 30, 2024, the Company incurred approximately $ 79,000 related to
this agreement.
○ During
the six months ended June 30, 2023, the Company incurred approximately $ 100,000 related to this
agreement.
Azenova
Sales International
In
October 2023, the Company entered into a consulting agreement with Azenova, LLC whereas Azenova will provide business development services
for AIM’s Ampligen product for solid tumors for a 12-month term that is extendable upon the agreement of the parties. In exchange
for its services, Azenova will receive a fixed monthly retainer of $ 30,000 per month in addition to 360,000 stock options that vest monthly.
○ During the three
months ended June 30, 2024, the Company incurred approximately $ 90,000 related to this agreement.
○ During the three months ended June 30, 2023, the Company did not incur
any expense related to this agreement.
○ During
the six months ended June 30, 2024, the Company incurred approximately $ 180,000 related to
this agreement.
○ During
the six months ended June 30, 2023, the Company did no t incur any expense related to this
agreement.
20
Alcami
In
September 2023, the Company entered into an agreement with Alcami Corporation to perform an extractables study for a primary packaging
component. The agreement called for fixed costs of approximately $ 30,000 upon completion of the study and issue of the final report,
along with solvent costs, and pass through items to be billed on a per activity basis. The final bill for the initial study was received
in December 2023.
○ During the three
months ended June 30, 2024, the Company incurred approximately $ 3,500 of lab services from Alcami.
○ During the three months ended June 30, 2023, the Company incurred
approximately $ 8,300
of lab services from Alcami.
○ During
the six months ended June 30, 2024, the Company incurred approximately $ 14,000 of lab services
from Alcami.
○ During
the six months ended June 30, 2023, the Company incurred approximately $ 16,000 of lab services
from Alcami.
Note
15: Subsequent Events
Company’s
Amended and Restated 2018 Equity Incentive Plan
On
July 1, 2024, the Company filed a Registration Statement registering additional shares of common stock under the Company’s Amended
and Restated 2018 Equity Incentive Plan. The number of shares of the Company’s common stock available for grant and issuance under
the Plan is subject to an annual increase on July 1 of each calendar year, by an amount equal to two percent ( 2 %) of the then outstanding
shares of the Company’s common stock. On July 1, 2024, the number of shares of the Company’s common stock available for grant
and issuance under the 2018 Plan increased by 1,142,733 shares.
Company
adopted Restated and Amended Bylaws
On
July 31, 2024, the Company adopted Restated and Amended Bylaws. The Restated and Amended Bylaws revise the prior Bylaws by (i) removing
or revising provisions in Section 1.4 of the prior Bylaws (the advance notice portion of the Bylaws) deemed unenforceable or invalid
by the Delaware Supreme Court, (ii) revising other portions of Section 1.4 to ensure that the advance notice bylaws are otherwise appropriately
tailored to further the intended procedural and informational functions of the advance notice bylaws, including in view of guidance from
the Delaware Court of Chancery and Delaware Supreme Court in their opinions in the Kellner litigation, and (iii) making other conforming
and clarifying changes to the prior Bylaws.
In
addition, the Restated and Amended Bylaws add that, in the case of the Company’s 2024 annual meeting of stockholders, a Noticing
Stockholder’s notice of nominations or proposed business shall also be considered timely if it is delivered to the Company’s
Secretary at the principal executive offices of the Company not later than the Close of Business on September 13, 2024.
Amendment to Employment Agreements:
Mr. Equels’ employment agreement was amended
by adding the following to the end of Section 3(a):
(a)(i) Notwithstanding the provisions
of Section 3(a), during the one year period ending November 9, 2024, the Employee’s Short term compensation shall be revised and
shall consist of a base salary of $ 750,000 and shares of the Company’s common stock, $ .001 par value, valued at $ 100,000 , such value
equal to 100% of the closing price of the Company’s common stock on the NYSE American on the trading date immediately preceding
the date of this Agreement.
Mr. Rodino’s employment agreement was amended
by adding the following to the end of Section 3(a):
(a)(i) Notwithstanding the provisions
of Section 3(a), during the one year period ending March 23, 2025, the Employee’s Short term compensation shall be revised and shall
consist of a base salary of $ 375,000 and shares of the Company’s common stock, $ .001 par value, valued at $ 50,000 , such value equal
to 100% of the closing price of the Company’s common stock on the NYSE American on the trading date immediately preceding the date
of this Agreement.
21
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.