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
March 31, 2024 and Audited December 31, 2023)
March 31, 2024
December 31, 2023
ASSETS
Current assets:
Cash and cash equivalents
$ 3,295
$ 5,439
Marketable investments
7,647
7,631
Funds receivable from New Jersey net operating loss and Other Receivables
—
1,184
Prepaid expenses and other current assets
364
302
Total current assets
11,306
14,556
Property and equipment, net
118
127
Right of use asset, net
763
697
Patent and trademark rights, net
2,314
2,313
Other assets
1,688
1,688
Total assets
$ 16,189
$ 19,381
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$ 6,567
$ 6,443
Accrued expenses
1,446
1,986
Current portion of operating lease liability
240
223
Current portion of note payable, net
1,623
—
Total current liabilities
9,876
8,652
Long-term liabilities:
Operating lease liability
537
495
Note payable, net
950
—
Total liabilities
11,363
9,147
Commitments and contingencies (Notes 9, 10 and 14)
-
Stockholders’ equity:
Series A Junior Participating Preferred Stock, $ 0.001 par value, 4,000,000 and 250,000 shares authorized
as of March 31, 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; 689 and
689 issued and outstanding as of March 31, 2024 and December 31, 2023, respectively
689
689
Preferred Stock,
Value
Common Stock, $ 0.001 par value, authorized shares - 350,000,000 ; issued and outstanding shares 50,251,933 and 49,102,484 as of
March 31, 2024 and December 31, 2023, respectively
50
49
Additional paid-in capital
419,412
419,004
Accumulated deficit
( 415,325 )
( 409,508 )
Total stockholders’ equity
4,826
10,234
Total liabilities and stockholders’ equity
$ 16,189
$ 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
Three months ended March 31,
2024
2023
Revenues:
Clinical treatment programs – US
$ 40
$ 49
Total Revenues
40
49
Costs and Expenses:
Production costs
8
—
Research and development
1,951
2,052
General and administrative
3,815
2,292
Total Costs and Expenses
5,774
4,344
Operating loss
( 5,734 )
( 4,295 )
Gain (Loss) on investments
( 92 )
203
Interest and other income
81
199
Interest Expense and Other Finance Costs
( 72 )
—
(Loss) on sale of assets
—
( 23 )
Gain from sale of income tax operating losses
—
255
Net Loss
$ ( 5,817 )
$ ( 3,661 )
Basic and diluted loss per share
$ ( 0.12 )
$ ( 0.08 )
Weighted average shares outstanding basic and diluted
49,458,023
48,399,950
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, 2023
689
49,102,484
$ 49
$ 419,004
$ —
$ ( 409,508 )
$ 10,234
Shares issued for:
Common Stock issuance, net of costs
—
807,577
1
328
—
—
329
Cashless Exercise of Warrants
—
3,272
—
—
—
—
—
Equity based compensation
—
—
—
80
—
—
80
Series B preferred shares converted to common
—
—
—
—
—
—
—
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
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
Balance ,value
696
48,084,287
$ 48
$ 418,270
$ —
$ ( 380,546 )
$ 38,468
Shares issued for:
Common Stock issuance, net of costs
—
322,583
—
100
—
—
100
Equity based compensation
—
—
—
82
—
—
82
Series B preferred shares converted to common
( 4 )
456
—
4
—
—
—
Net comprehensive loss
—
—
—
—
—
( 3,661 )
( 3,661 )
Balance March 31, 2023
692
48,407,326
$ 48
$ 418,456
$ —
$ ( 384,207 )
$ 34,989
Balance ,value
692
48,407,326
$ 48
$ 418,456
$ —
$ ( 384,207 )
$ 34,989
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, 2024 and 2023
(in
thousands)
(Unaudited)
2024
2023
Cash flows from operating activities:
Net loss
$ ( 5,817 )
$ ( 3,661 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment
9
11
Amortization of patent, trademark rights
49
36
Amortization of Debt Discount and Other Expenses
73
—
Non-cash lease expense
( 67 )
37
Gain from sale of income tax operating losses
—
( 255 )
Equity-based compensation
80
82
Loss (gain) on sale of marketable investments
92
( 203 )
Change in assets and liabilities:
Funds receivable from New Jersey net operating loss
1,184
—
Prepaid expenses and other current assets and other non-current assets
( 62 )
( 180 )
Lease liability
60
( 23 )
Accounts payable
124
586
Accrued expenses
( 540 )
( 110 )
Net cash used in operating activities
( 4,815 )
( 3,680 )
Cash flows from investing activities:
Proceeds from sale of marketable investments
50
598
Purchase of marketable investments
( 158 )
( 712 )
(Purchase) abandonment of patent and trademark rights
( 50 )
7
Proceeds from sales of property and equipment
—
29
Net cash used in investing activities
( 158 )
( 78 )
Cash flows from financing activities:
Proceeds from sale of stock, net of issuance costs
329
100
Proceeds from note payable, net of issuance costs
2,500
—
Net cash provided by financing activities
2,829
100
Net decrease in cash and cash equivalents
( 2,144 )
( 3,658 )
Cash and cash equivalents at beginning of period
5,439
27,053
Cash and cash equivalents at end of period
$ 3,295
$ 23,395
Supplemental disclosures of non-cash investing and financing cash flow information:
Conversion of Series B preferred
$ —
4
See
accompanying notes to consolidated financial statements.
5
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note
1: Business and Basis of Presentation
AIM
ImmunoTech Inc. and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are
an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple
types of cancers, viral diseases and immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical
and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system
of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.
AIM’s
flagship products are Ampligen (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon
N Injection (Interferon alfa). Ampligen has not been approved by the FDA or marketed in the United States. Ampligen is approved for commercial
sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).
The
Company’s primary business focus involves Ampligen. Ampligen is a double-stranded RNA (“dsRNA”) molecule being developed
for globally important cancers, viral diseases and disorders of the immune system.
The
Company is currently proceeding primarily in four areas:
● Conducting
a randomized, controlled study to evaluate efficacy and safety of Ampligen compared to a
control group to treat locally advanced pancreatic cancer patients.
● Evaluating
Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment
with the goal of increasing anti-tumor responses to checkpoint inhibitors.
● Exploring
Ampligen’s antiviral activities and potential use as a prophylactic or treatment for
existing viruses, new viruses and mutated viruses thereof.
● Evaluating
Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”)
and fatigue and/or Post-COVID conditions of fatigue.
The
Company is prioritizing activities in an order related to the stage of development, with those clinical activities 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 March 29, 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, equity-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 three months ended March 31, 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: Marketable Investments
Marketable
investments consist of mutual funds. At March 31, 2024 and December 31, 2023, it was determined that none of the marketable investments
had an other-than-temporary impairment. At March 31, 2024 and December 31, 2023, all securities were measured as Level 1 instruments
of the fair value measurements standard (See Note 7: Fair Value). At March 31, 2024, and December 31, 2023 the Company held $ 7,647,000
and $ 7,631,000 , respectively, in mutual funds.
Mutual
Funds classified as available for sale consisted of:
Schedule
of Available of Sale
March
31, 2024
(in
thousands)
Securities
Fair
Value
Short-Term
Investments
Mutual Funds
$ 7,647
$ 7,647
Totals
$ 7,647
$ 7,647
Schedule of Equity Securities
Securities
March 31, 2024
(in thousands)
Net gains and losses recognized during the period on equity securities
$ ( 92 )
Less: Net gains and losses recognized during the period on equity securities
sold during the period
( 20 )
Unrealized gains and losses recognized during the reporting period on equity
securities still held at the reporting date
$ ( 72 )
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
7
Securities
March 31, 2023
(in thousands)
Net losses recognized during the period on equity securities
$ 290
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
$ 203
Note
4: Property and Equipment, net
Schedule
of Property and Equipment
March 31, 2024
December 31, 2023
(in thousands)
March 31, 2024
December 31, 2023
Furniture, fixtures, and equipment
$ 1,448
$ 1,448
Less: accumulated depreciation
( 1,330 )
( 1,321 )
Property and equipment, net
$ 118
$ 127
Property
and equipment are recorded at cost. Depreciation is 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 three months ending March 31, 2024 and March 31, 2023 was $ 9,000
and $ 11,000 , respectively.
Note
5: Patents and Trademark Rights, Net
Patent
and trademark rights consist of the following (in thousands):
Schedule
of Patent and Trademark Rights
March 31, 2024
December 31, 2023
Gross Carrying Value
Accumulated Amortization
Net Carrying Value
Gross Carrying Value
Accumulated Amortization
Net Carrying Value
Patents
$ 2,995
$ ( 794 )
$ 2,201
$ 2,947
$ ( 750 )
$ 2,197
Trademarks
231
( 118 )
113
229
( 113 )
116
Net amortizable patents and trademarks rights
$ 3,226
$ ( 912 )
$ 2,314
$ 3,176
$ ( 863 )
$ 2,313
Schedule
of Changes in Patents, Trademark Rights
December 31, 2023
$ 2,313
Acquisitions
50
Abandonments
—
Amortization
( 49 )
March 31, 2024
$ 2,314
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.
8
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
$ 186
2025
237
2026
235
2027
212
2028
193
Thereafter
1,251
Total
$ 2,314
Note
6: 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.
At
March 31, 2024 and December 31, 2023, the balance of the right of use assets was $ 763,000 and $ 697,000 , respectively, and the corresponding
operating lease liability balance was $ 777,000 and $ 718,000 , respectively. Right of use assets are recorded net of accumulated amortization
of $ 296,000 and $ 363,000 as of March 31, 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
March 31, 2024
December 31, 2023
(in thousands)
March 31, 2024
March 31, 2023
Lease costs:
Operating lease costs
$ 74
$ 68
Short-term and variable lease costs
49
19
Total lease costs
$ 123
$ 87
Classification of lease costs
Research & development
$ 101
$ 19
General and administrative
22
68
Lease cost
22
68
Total lease costs
$ 123
$ 87
The
Company’s leases have remaining lease terms between 11
and 40
months. As of March 31, 2024, the weighted-average
remaining term was 39
months. At 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 March 31, 2024 and December 31, 2023.
Future
minimum payments as of March 31, 2024, are as follows:
Schedule of Operating Lease Future Payments
Year Ending December 31, (in thousands)
2024
$ 229
2025
273
2026
244
2027
159
Thereafter
—
Less imputed interest
( 128 )
Total
$ 777
9
Note
7: 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
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 March 31, 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.
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 March 31, 2024
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$ 1,478
$ 1,478
$ —
$ —
Marketable investments
$ 7,647
$ 7,647
$ —
$ —
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
$ —
$ —
The
Company’s cash balances are representative of their fair values as these balances are comprised of deposits available on demand.
For certain instruments, including funds receivable from New Jersey net operating loss, accounts payable and accrued expenses, it was
estimated that the carrying values approximated the fair value due to the short-term maturities of these instruments (Level 1).
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. During the first quarter 2024, 205,000
of these Warrants converted on a cashless basis
and the balance expired.
10
Note
8: Accrued Expenses
Accrued
expenses consist of the following:
Schedule
of Accrued Expenses
March 31, 2024
December 31, 2023
(in thousands)
March 31, 2024
December 31, 2023
Compensation
$ 451
$ 414
Professional fees
881
1,352
Clinical trial expenses
103
184
Other expenses
11
36
Total
$ 1,446
$ 1,986
Note
9: 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 %.
The following table summarizes our debt at March
31, 2024 and December 31, 2023:
(in thousands)
Schedule of Long Term Debt
March 31, 2024
December 31, 2023
Long-term debt
$ 3,330
$ -
Unamortized Original issue discount
( 738 )
-
Unamortized Financing fees
( 19 )
-
Unamortized discount
and debt issuance costs
2,573
-
Less current portion of long-term debt, net (1)
( 1,623 )
-
Long-term debt (2)
$ 950
$ -
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
March 31, 2024
December 31, 2023
Interest expense
$ 29
$ -
Interest capitalized
-
-
Total
$ 29
$ -
Amortization
expenses related to long-term debt were as follows:
(in
thousands)
Schedule of Long Term Debt Amortization
Expenses
March 31, 2024
December 31, 2023
Original issue discount
$ 43
$ -
Loan fee amortization
1
-
Total
$ 44
$ -
11
Future
maturities of long-term debt as of March 31, 2024 were as follows:
(in
thousands)
Schedule of Future Maturities of Long
Term Debt
Fiscal years ending December 31:
2024
$ 1,250
2025
2,080
Total
$ 3,330
(1) Current
portion of long-term debt of approximately $ 2,000,000 is net of the current portion of debt discount of approximately $ 367,000 and
the current portion of debt origination costs of approximately $ 10,000 as
of March 31, 2024.
(2) Long-term
portion of debt of approximately $ 1,330,000 is net of the long-term portion of debt discount
of approximately $ 371,000 and the unamortized debt origination costs of approximately $ 9,000 as
of March 31, 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
10: Equity Purchase Agreement
On
March 28, 2024, the Company entered into a purchase agreement and a registration rights agreement (collectively, the “Atlas Agreements”)
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 agreement.
Under
the terms of the 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 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 agreement. As of March 31, 2024, no sales or purchases had been made pursuant to this 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.
Note
11: 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 March 31, 2024, there were no Series A Junior Participating Preferred Stock outstanding.
12
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”).
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 . During the three months ended March 31, 2024, no shares
of Series B Convertible Preferred Stock were converted into common stock.
At
March 31, 2024 and December 31, 2023, the Company had 689 shares of Series B Convertible Preferred Stock outstanding. Holders shall be
entitled to receive, and the Company shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock
basis) to and in the same form as dividend actually paid on shares of Common Stock when as and if such dividends are paid on shares of
the Common Stock. Each such Preferred Share is convertible into 114 shares of common stock. Upon any liquidation, dissolution or winding-up
of the Company, whether voluntary or involuntary, the Holders shall be entitled to receive out of the assets, whether capital or surplus
of the Company the same amount that a holder of Common Stock would receive if the Preferred Stock was fully converted. The Series B Convertible
Preferred Stock does not carry voting Rights. Subsequent to March 31, 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 March 31, 2024 and December 31, 2023, there were 50,251,933 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 May 10, 2024 and expires in July 2024.
During
the three months ended March 31, 2024, the Company issued a total of 243,009 shares of its Common Stock at a price ranging from $ 0.33
to $ 0.39 for total proceeds of approximately $ 82,500 as part of the employee stock purchase plan.
During
the three months ended March 31, 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.
13
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 March 31, 2024, 205,000
Warrants were exercised, and 5,830,028
Warrants expired unexercised. During the three months ended March 31, 2023, there were no Warrants exercised. As of March 31, 2024 and
December 31, 2023 there were 15,000
and 152,160 post split Warrants outstanding, respectively.
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 March 31, 2024, the Company sold 564,568
shares under the EDA for total gross proceeds
of approximately $ 253,870 ,
which includes a 3.0 %
fee to Maxim of $ 7,616 .
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 .
Subsequent to March 31, 2024, the Company sold 730,110
shares under the EDA for total gross proceeds
of $ 372,223 ,
which includes a 3.0 %
fee to Maxim of $ 11,167 .
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”).
Note
12: 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 3,386,789
and 2,522,390 ,
are excluded from the calculation of diluted net loss per share for the three months ended March 31, 2024, and 2023, respectively,
since their effect is antidilutive due to the net losses recorded for the periods.
Note
13: 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 three months
ended March 31, 2024 there were no options issued.
14
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, 2023 and 2024,
there were no options granted.
Stock
options activity during the three months ended March 31, 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 January 1, 2024
2,408,438
$ 2.50
8.70
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
—
—
—
—
Outstanding March 31, 2024
2,408,438
$ 2.50
8.70
$ —
Vested and expected to vest March 31, 2024
2,141,772
$ 1.83
6.89
$ —
Exercisable March 31, 2024
2,141,772
$ 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 January 1, 2024
366,666
$ 2.13
12.44
$ —
Granted
—
—
—
—
Expired
—
—
—
—
Vested
( 100,000 )
0.47
6.89
—
Unvested March 31, 2024
266,666
$ 2.75
14.52
$ —
15
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, 2024
885,055
$ 2.02
9.23
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
—
—
—
—
Outstanding March 31, 2024
885,055
$ 2.02
9.23
$ —
Vested and expected to vest March 31, 2024
640,055
$ 2.27
10.04
$ —
Exercisable March 31, 2024
640,055
$ 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 January 1, 2024
335,001
$ 1.83
10.70
$ —
Granted
—
—
—
—
Expired
—
—
—
—
Vested
( 90,000 )
0.46
9.47
—
Unvested March 31, 2024
245,001
$ 2.33
11.15
$ —
Stock-based
compensation expense was approximately $ 80,000 and $ 82,000 for the three months ended March 31, 2024 and 2023, resulting in a decrease
in general and administrative expenses, respectively.
As
of March 31, 2024, and 2023, respectively, there was approximately $ 214,000 and $ 134,000 of unrecognized equity-based compensation cost
related to options granted under the Equity Incentive Plan.
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 March 31, 2024, research and development expenses were comprised of: clinical studies ($ 948,000 ), manufacturing
and engineering ($ 246,000 ), quality control ($ 550,000 ) and regulatory ($ 207,000 ).
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 three months ended March 31, 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 March 31, 2024 and 2023, the Company incurred approximately $ 521,000 and $ 455,000 ,
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 March 31, 2024, the Company incurred approximately $ 86,000 related
to this agreement.
16
○ During
the three months ended March 31, 2023, the Company incurred approximately $ 174,000 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 March 31, 2024, the Company incurred approximately $ 435,000 related
to this agreement.
○ During
the three months ended March 31, 2023, the Company incurred approximately $ 281,000 related
to this agreement.
Jubilant
HollisterStier
Jubilant
HollisterStier (“Jubilant”) is AIM’s authorized CMO for Ampligen for the approval in Argentina. In 2017, the Company
entered into an agreement with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company. Since the
2017 engagement of Jubilant, two lots of Ampligen consisting of more than 16,000 units were manufactured and released in the year 2018.
The first lot was designated for human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials.
The second lot has been designated for these programs in addition to commercial distribution in Argentina for the treatment of CFS. Jubilant
manufactured additional two lots of Ampligen in December 2019 and January 2020. In March 2023, the Company ordered an additional 27,900
vials from Jubilant at a cost of approximately $ 1,432,000 .
○ During
the three months ended March 31, 2024, the Company incurred approximately $ 1,000 related
to this agreement.
○ During
the three months ended March 31, 2023, the Company did not incur any expense 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 March 31, 2024, the Company incurred approximately $ 129,000 related
to this agreement.
○ During
the three months ended March 31, 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 March 31, 2024, the Company incurred approximately $ 4,000 related
to this agreement.
○ During
the three months ended March 31, 2023, the Company did not incur any expense 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 March 31, 2024, the Company incurred approximately $ 90,000 related
to this agreement.
○ During
the three months ended March 31, 2023, the Company did not incur any expense related to this
agreement.
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 March 31, 2024, the Company incurred approximately $ 10,000 of lab
services from Alcami.
○ During
the three months ended March 31, 2023, the Company incurred approximately $ 8,000 of lab services
from Alcami.
Note
15: Recent Accounting Pronouncements
During
the first quarter of 2024 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
16: Subsequent Events
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 as of March 28, 2024, the Effective Date, 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. In May 2024, Put Notices were issued to Atlas, under the Equity Purchase
Agreement, requiring Atlas to purchase a total of 206,800
shares pursuant to the agreement.
In
April and May of 2024, the Company sold 730,110
shares under the EDA for total gross proceeds of $ 372,223 ,
which includes a 3.0 %
fee to Maxim of $ 11,167 .
In
April 2024, 689 shares of Series B Convertible Preferred Stock expired and none were converted prior to expiration.
Deferred 2023 bonuses of $ 500,000
were paid in May 2024 to Thomas Equels for $ 350,000 and Peter Rodino for $ 150,000 .
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.