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, 2025 and Audited December 31, 2024)
March
31, 2025
December
31, 2024
ASSETS
Current assets:
Cash and cash
equivalents
$ 898
$ 1,701
Marketable investments
1,349
2,276
Other Receivables
19
—
Prepaid
expenses and other current assets
318
199
Total
current assets
2,584
4,176
Property and equipment, net
98
108
Right of use asset, net
554
618
Patent and trademark rights, net
2,267
2,594
Other assets
745
1,112
Total
assets
$ 6,248
$ 8,608
LIABILITIES AND STOCKHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$ 6,944
$ 6,383
Accrued expenses
639
606
Current portion of operating
lease liability
234
239
Current
portion of note payable, net
1,950
2,307
Total
current liabilities
9,767
9,535
Long-term liabilities:
Operating
lease liability
338
395
Total
liabilities
10,105
9,930
Commitments and contingencies (Notes 13 and
14)
-
-
Stockholders’ deficit:
Series A Junior Participating Preferred Stock,
$ 0.001 par value, 4,000,000 and 250,000 shares authorized as of March 31, 2025, and December 31, 2024, respectively; issued and outstanding
– none
—
—
Series B Convertible Preferred Stock, stated
value $ 1,000 per share, 10,000 shares authorized; as of March 31, 2025, and December 31, 2024, respectively; issued and outstanding
– none
—
—
Preferred Stock, value
—
—
Common Stock, $ 0.001 par value, authorized shares - 350,000,000 ; issued
and outstanding shares 72,290,030 and 65,526,320 as of March 31, 2025 and December 31, 2024, respectively
72
66
Additional paid-in capital
426,604
425,440
Accumulated deficit
( 430,533 )
( 426,828 )
Total
stockholders’ deficit
( 3,857 )
( 1,322 )
Total
liabilities and stockholders’ deficit
$ 6,248
$ 8,608
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)
2025
2024
Three
months ended March 31,
2025
2024
Revenues:
Clinical
treatment programs – US
$ 16
$ 40
Total Revenues
16
40
Costs and Expenses:
Production costs
10
8
Research and development
1,080
1,951
General
and administrative
2,545
3,815
Total Costs and Expenses
3,635
5,774
Operating loss
( 3,619 )
( 5,734 )
Gain (Loss) on investments
27
( 92 )
Interest and other income
11
81
Interest Expense and Other
Finance Costs
( 124 )
( 72 )
Net
Loss
$ ( 3,705 )
$ ( 5,817 )
Basic and diluted loss
per share
$ ( 0.05 )
$ ( 0.12 )
Weighted average shares outstanding basic
and diluted
70,329,869
49,458,023
See
accompanying notes to consolidated financial statements.
3
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Consolidated
Statements of Changes in Stockholders’ Equity (Deficit)
(in
thousands except share data)
Series
B
Preferred
Shares
Common
Stock
Shares
Common
Stock .001
Par Value
Additional
Paid-in
Capital
Accumulated
Deficit
Total
Stockholders’
Deficit
Balance December 31, 2024
—
65,526,320
$ 66
$ 425,440
$ ( 426,828 )
$ ( 1,322 )
Shares issued for:
Common Stock issuance, net of costs
—
4,285,401
4
656
—
660
Equity based compensation
—
424,225
—
60
—
60
Repayment of Debt with shares
—
2,054,084
2
448
—
450
Net comprehensive loss
—
—
—
—
( 3,705 )
( 3,705 )
Balance March 31, 2025
—
72,290,030
$ 72
$ 426,604
$ ( 430,533 )
$ ( 3,857 )
Series
B
Preferred
Shares
Common
Stock
Shares
Common
Stock .001
Par Value
Additional
Paid-in
Capital
Accumulated
Deficit
Total
Stockholders’
Equity
Balance December 31, 2023
689
49,102,484
$ 49
$ 419,004
$ ( 409,508 )
$ 10,234
Balance
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
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
Balance
689
50,251,933
$ 50
$ 419,412
$ ( 415,325 )
$ 4,826
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, 2025 and 2024
(in
thousands)
(Unaudited)
2025
2024
Cash flows from operating activities:
Net loss
$ ( 3,705 )
$ ( 5,817 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation of property
and equipment
10
9
Abandonment and expiration
of patents and trademark rights
335
—
Amortization of patent,
trademark rights
48
49
Amortization of Debt Discount
and Other Expenses
64
73
Non-cash lease expense
64
( 67 )
Equity-based compensation
60
80
Loss (gain) on sale of
marketable investments
( 27 )
92
Change in assets and liabilities:
Funds receivable from New
Jersey net operating loss
—
1,184
Other receivables
( 19 )
—
Other assets
367
—
Prepaid expenses and other
current assets and other non-current assets
( 119 )
( 62 )
Lease liability
( 62 )
60
Accounts payable
561
124
Accrued
expenses
62
( 540 )
Net cash used in operating
activities
( 2,361 )
( 4,815 )
Cash flows from investing activities:
Proceeds from sale of marketable
investments
1,045
50
Purchase of marketable
investments
( 91 )
( 158 )
(Purchase)
abandonment of patent and trademark rights
( 56 )
( 50 )
Net cash provided by (used
in) investing activities
898
( 158 )
Cash flows from financing activities:
Proceeds from sale of stock,
net of issuance costs
660
329
Proceeds
from note payable, net of issuance costs
—
2,500
Net cash provided by financing
activities
660
2,829
Net decrease in cash and cash equivalents
( 803 )
( 2,144 )
Cash and cash equivalents
at beginning of period
1,701
5,439
Cash and cash equivalents
at end of period
$ 898
$ 3,295
Supplemental disclosures of non-cash investing and financing cash flow information:
Unrealized gain (loss) on marketable investments
$ 96
$ ( 73 )
Repayment of debt obligation with shares
$ 421
$ —
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” or the “Company” is 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 and to treat cancers for which there are currently inadequate or unmet therapies. It has established a strong
foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance
the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain
cancers and chronic diseases.
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 five 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.
● Evaluating
Ampligen as a vaccine adjuvant in the combination of Ampligen and AstraZeneca’s FluMist
as an intranasal vaccine for influenza, including avian influenza.
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
New Drug Application (“NDA”). However, AIM’s antiviral experimentation is designed to accumulate additional preliminary
data supporting our 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
has engaged Amarex Clinical Research (“Amarex”), its Clinical Research Organization, with the application and eventual management
of a follow-up Investigational New Drug (“IND”) application for the study of a potential avian influenza combination therapy
of Ampligen and AstraZeneca’s FluMist, a nasal spray vaccine that helps prevent seasonal influenza. It is seeking collaborative
grants from government and industry to defray the cost of the study. In addition, AIM recently announced that the Erasmus Medical Center
Safety Committee granted approval to proceed with a Phase 2 Study of Ampligen and Imfinzi as a potential combination therapy for late-stage
pancreatic cancer.
In
management’s opinion, 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.
The
consolidated financial statements contained herein should be read in conjunction with the Company’s audited consolidated financial
statements for the years ended December 31, 2024, and 2023, contained in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2024, filed on March 27, 2025.
6
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”)
of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the
reporting period. Actual results could differ from those estimates, and those differences may be material. Accounts requiring the use
of significant estimates include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent
and trademark valuations, equity-based compensation calculations, fair value of warrants, and contingency accruals.
Liquidity
and Going Concern
The
accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern.
The going concern basis of presentation assumes that the Company will continue in operation one year after the date these financial statements
are issued and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business.
Pursuant
to the requirements of the Financial Accounting Standards Board’s (the “FASB”) Accounting Standards Codification (“ASC”)
Topic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether
there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue
as a going concern for one year from the date these financial statements are issued. This evaluation does not take into consideration
the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company
as of the date the financial statements are issued. When substantial doubt about the Company’s ability to continue as a going concern
exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt. The mitigating
effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented
within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will
mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern
within one year after the date that the financial statements are issued.
The Company’s principal source of
liquidity is its cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary
funding to meet its obligations as they become due. The Company has suffered losses from operations and net cash used on operating
activities for the year ended December 31, 2024 and for the period ended March 31, 2025, and has a working capital deficit as of
December 31, 2024 and as of March 31, 2025. Additionally, its stockholders’ equity was below the minimum requirements for
continued listing on the New York Stock Exchange American (“NYSE American”). These conditions raise substantial doubt
regarding the Company’s ability to continue as a going concern for a period of at least one year from the date of issuance of these unaudited
condensed consolidated financial statements. Management evaluated the conditions, and the significance of these conditions related
to the Company’s ability to meet its obligations. If the Company is unable to implement sufficient mitigation efforts, it may need to limit its
business activities or be unable to continue as a going concern, which would have a material adverse effect on its results of
operations and financial condition.
On
December 11, 2024, the Company received an official notice of noncompliance with the NYSE American’s continued listing requirements.
This includes the need for the Company to have stockholders’ equity of $ 6.0 million or more. The NYSE American’s review showed
that the Company was not in compliance with that requirement. As required, the Company submitted a plan (the “Plan”) to the
NYSE American illustrating how it can regain compliance by June 11, 2026. The NYSE American accepted the Plan on February 26, 2025. If
the Company is not able to regain compliance by June 11, 2026, its common stock may be delisted from the NYSE American. As of March 31,
2025, its stockholders’ deficit was ($ 3.9 ) million. It must increase its stockholders’ equity to be at least $ 6 million to
regain compliance with this rule. If it is not able to raise sufficient capital as set forth in the Plan or by other means, it may be
unable to regain compliance with the NYSE American’s listing standards and its securities could be subject to delisting. In addition,
in the event that the price of the common stock drops to $ 0.10 per share, trading in the common stock will automatically be suspended and the common
stock would be subject to delisting. The
price dropped below $ 0.10 and on April 4, 2025, the Company received a delisting letter from the NYSE American and trading in its common
stock on the NYSE American was suspended. AIM sought a review of the delisting and were granted a hearing to be held on June 5, 2025.
Since the suspension of its common stock, AIM trades on the Pink Open Market under the symbol “AIMI”.
On
April 30, 2025, the Company held a special meeting of stockholders to approve a series of alternate amendments to its Certificate of
Incorporation to effect, at the option of its Board of Directors, a reverse stock split of its outstanding common stock at a ratio in
the range of up to 1-for-100 , with such ratio to be determined by the Board of Directors in its sole discretion. At that meeting, stockholders
approved the measure. Before the reverse split can be effected it must be authorized by the Financial Industry Regulatory Authority. That process currently is underway.
7
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, 2025, 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 Securities
Marketable
securities consist of mutual funds. At March 31, 2025 and December 31, 2024, it was determined that none of the marketable securities
had an other-than-temporary impairment. At March 31, 2025 and December 31, 2024, all securities were measured as Level 1 instruments
of the fair value measurements standard (See Note 12: Fair Value). At March 31, 2025, and December 31, 2024 the Company held $ 1,349,000
and $ 2,276,000 respectively, in mutual funds.
Mutual
Funds classified as available for sale consisted of $ 1,349,000
at March 31, 2025. The
net loss recognized for the three-month period ended March 31, 2025 on equity securities was ($ 69,000 ).
The unrealized gains recognized for the three-month period ended March 31, 2025 on equity securities still held was $ 96,000 .
The net gain recognized for the three-month period ended March 31, 2025 on equity securities was $ 27,000 .
Mutual
Funds classified as available for sale consisted of $ 2,276,000 at December 31, 2024. The net loss recognized for the three-month period
ended March 31, 2024 on equity securities was ($ 20,000 ). The unrealized losses recognized during the three-month period ended March 31,
2024 on equity securities still held was ($ 73,000 ). The net loss recognized for the three-month period ended March 31, 2024 on equity
securities was ($ 93,000 ).
Note
4: Property and Equipment, net
Schedule of Property and Equipment
March
31, 2025
December
31, 2024
(in
thousands)
March
31, 2025
December
31, 2024
Furniture, fixtures, and equipment
$ 1,466
$ 1,466
Less: accumulated depreciation
( 1,368 )
( 1,358 )
Property and equipment,
net
$ 98
$ 108
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 3 three to ten years . Depreciation expense for the three months ending March 31, 2025 and March 31, 2024 was $ 10,000
and $ 9,000 , 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, 2025
December
31, 2024
Gross
Carrying Value
Accumulated
Amortization
Net
Carrying Value
Gross
Carrying Value
Accumulated
Amortization
Net
Carrying Value
Patents
$ 2,981
$ ( 808 )
$ 2,173
$ 3,434
$ ( 939 )
$ 2,495
Trademarks
232
( 138 )
94
232
( 133 )
99
Net amortizable patents
and trademarks rights
$ 3,213
$ ( 946 )
$ 2,267
$ 3,666
$ ( 1,072 )
$ 2,594
Schedule of Changes in Patents, Trademark Rights
December 31, 2024
$ 2,594
Acquisitions
56
Abandonments
( 335 )
Amortization
( 48 )
March 31, 2025
$ 2,267
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,
2025
$ 176
2026
233
2027
218
2028
212
2029
196
Thereafter
1,232
Total
$ 2,267
Note
6: Accrued Expenses
Accrued
expenses consist of the following:
Schedule of Accrued Expenses
March
31, 2025
December
31, 2024
(in thousands)
March
31, 2025
December
31, 2024
Compensation
$ 1
$ 1
Professional fees
436
416
Clinical trial expenses
104
145
Interest
44
11
Other expenses
54
33
Total
$ 639
$ 606
Note
7: Unsecured Promissory Note
On
February 16, 2024, the Company (“Borrower”) entered into a Note and Note Purchase Agreement with Streeterville Capital
LLC (“Streeterville” or the “Lender”). Under the terms of the agreements, Streeterville paid the Company
$ 2,500,000
in exchange for an unsecured promissory Note with an Original Issue Discount of $ 781,000 .
The Company will pay $ 3,300,000
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 %. On May 13, 2025, the Lender and the Borrower entered into a Forbearance
Agreement pursuant to which, for a 1 % fee and expenses, the Lender released the Borrower and its affiliates from all defaults under the
Agreements through the date of the Forbearance Agreement and confirmed that, as a result, no Default Interest is due. The outstanding
balance of the Note, following the application for the Forbearance Fee, is $ 2,484,000 .
Schedule of Long Term Debt
Debt schedule at March 31, 2025 (in thousands)
Long-term debt
$ 2,386
Unamortized Original issue discount
( 427 )
Unamortized Financing
fees
( 9 )
Unamortized discount and
debt issuance costs
1,950
Less current portion
of long-term debt, net
( 1,950 )
Long-term debt, net
$ —
Future
maturities for long-term debt as of March 31, 2025 were as follows:
(in
thousands)
Schedule of Maturities of Long-Term Debt
Fiscal years ending December 31:
2025
$ 2,386
Total
$ 2,386
9
Interest
expense related to long-term debt was $ 124,000 at March 31, 2025. This included $ 68,000 in original issue discount and $ 3,000 for loan
fee amortization. Future maturities of long-term debt at March 31, 2025 were $ 2,386,000 for fiscal years ending December 31, 2025.
Current
portion of long-term debt of approximately $ 2,386,000 is net of the current portion of debt discount of approximately $ 427,000 and the
current portion of debt origination costs of approximately $ 9,000 as of March 31, 2025.
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. In the three months
ended March 31, 2025, the Company entered into agreements with the Lender to settle a portion of its outstanding loan obligation in the
amount of $ 450,000 through the issuance of 2,054,084 shares of common stock, rather than cash payment. This exchange was completed pursuant
to the terms of the loan agreement, which allows for the settlement of debt through stock issuance under certain conditions.
Note
8: 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”). As a result of
the 2018 Plan Evergreen Provisions, a maximum of 12,008,069
shares of common stock is reserved for potential issuance pursuant
to awards under the 2018 Equity Incentive Plan as of January 1, 2025. Unless sooner terminated, the 2018 Equity Incentive Plan will continue
in effect for a period of 10
years from its effective date. There were no
options issues to officers during the three months ended March
31, 2025 and the fiscal year ending December 31, 2024.
10
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, 2025 and 2024,
there were no options granted.
Stock
options activity during the three months ended March 31, 2025, 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, 2025
2,407,632
$ 2.42
8.70
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
—
—
—
—
Outstanding March 31, 2025
2,407,632
$ 2.42
8.70
$ —
Vested and expected
to vest March 31, 2025
2,407,632
$ 1.61
7.26
$ —
Exercisable March 31, 2025
2,407,632
$ 1.61
7.26
$ —
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, 2025
884,960
$ 1.88
9.23
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
—
—
—
—
Outstanding March 31, 2025
884,960
$ 1.88
9.23
$ —
Vested and expected
to vest March 31, 2025
884,960
$ 1.62
9.51
$ —
Exercisable March 31, 2025
884,960
$ 1.62
9.51
$ —
There
was no unvested stock option activity for employees and non-employees.
Stock-based
compensation expense was approximately $ 60,000 and $ 80,000 for the three months ended March 31, 2025 and 2024, resulting in a decrease
in general and administrative expenses, respectively.
At
March 31, 2025, there was no unrecognized equity-based compensation cost related to options granted under the Equity Incentive Plan.
At March 31, 2024, there was approximately $ 214,000 of unrecognized equity-based compensation cost related to options granted under the
Equity Incentive Plan.
11
Note
9: Stockholders’ Equity (Deficit)
(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, 2025, 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”).
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 . At December 31, 2024, 689 shares of Series B Convertible
Preferred Stock had expired, and none were converted prior to expiration. At March 31, 2025 the Company had no shares of Series B Convertible
Preferred Stock outstanding.
(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, 2025 and December 31, 2024, there were 72,290,030 and 65,526,320
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 (a “SLAP”). The Company created successive new plans following the expiration
of the July 7, 2020 plan. Recently, the procedure for purchases under the plan changed. Now, any time an officer or employee purchases
stock from the Company under the plan, that person must file a SLAP with the NYSE American and the purchase cannot be effected until
the NYSE American accepts the SLAP. Subsequent to the quarter ended March 31, 2025, an additional 4,133,859
shares were issued under the Employee Stock Purchase Plan to certain officers and directors.
During
the three months ended March 31, 2025, the Company issued a total of 83,334 shares of its common stock at a price of $ 0.12 for total
proceeds of approximately $ 10,000 as part of the employee stock purchase plan.
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 $ 82,000 as part of the employee stock purchase plan.
12
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 March 31, 2025, there were no warrants exercised. During the three months ended March 31, 2024, 205,000 warrants
were exercised, and 5,830,028 warrants expired unexercised. As of March 31, 2025 and December 31, 2024, there were no warrants outstanding.
13
Equity
Distribution Agreement
On April 19, 2023,
we entered into an Equity Distribution Agreement (the “EDA”), with Maxim, pursuant to which we may sell from time to time,
shares of our common stock having an aggregate offering price of up to $ 8.5 million through Maxim, as agent. The amount was subsequently
reduced from $ 8.5 million to $ 3.1 million. Sales under the EDA were registered under the S-3 Shelf Registration Statement. Under the terms
of the Distribution Agreement, Maxim is 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 year ended December 31, 2024, we sold 1,395,612 shares under the EDA for total gross proceeds of approximately
$ 649,916 , which includes a 3.0 % fee to Maxim of $ 19,497 . Subsequent to December 31, 2024, the Company has sold 1,119,106 shares under
the EDA for total gross proceeds of approximately $ 259,800 , which includes a 3.0 % fee to Maxim of approximately $ 7,800 .
On
April 1, 2025, the Company entered into a new EDA with Maxim pursuant to which it may issue and sell up to an aggregate of $ 3,000,000
shares of the Company’s common stock from time to time through Maxim acting as agent. Under the terms of the EDA, in no event will
the Company, inter alia, issue or sell through the EDA such number or dollar amount of shares of common stock that would exceed the number
or dollar amount of shares of common stock permitted to be sold under Form S-3 (including General Instruction I.B.6 thereof, if applicable).
The
Company will pay Maxim in cash, upon each sale of the common stock pursuant to the EDA, a commission in an amount equal to 3.0 % of the
aggregate gross proceeds from each sale of common stock. Because there is no minimum offering amount required as a condition to this
offering, the actual total public offering amount, commissions and proceeds to the Company, if any, are not determinable at this time.
The Company has agreed, under certain circumstances, to reimburse a portion of Maxim’s expenses, including legal fees up to a maximum
of $ 50,000 , and $ 5,000 on a quarterly basis thereafter.
Neither
the Universal Shelf Registration Statement nor the At-The Market Offering with Maxim may occur unless and until certain other events
first occur, including but not limited to, the Registration Statement being declared effective by the SEC and AIM’s common stock
recommences trading on the NYSE American.
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 million of common stock of the Company for a period of 24 months from the date of the purchase agreement.
No assurance can be given as to the actual amount that will be raised pursuant to 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. The registration statement was declared effective on May 1, 2024. In the fiscal year ended December
31, 2024, a total of 759,685 shares have been issued pursuant to the purchase agreement for a total of approximately $ 128,000 after clearing
costs. In the three months ended March 31, 2025, a total of 3,082,961 shares have been issued pursuant to the purchase agreement for a total of approximately
$ 398,000 after clearing costs. There were no shares issued subsequent to March 31, 2025.
Securities
Purchase Agreements
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, on June 3, 2024,
the Company issued 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 issued 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 are not exercisable for six months after the issuance date and 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.
14
The
Shares were 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 could not issue any equity securities for 60 days
following the issuance date, provided that the Company was 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, are 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 are exercisable on a “cashless” basis only if there is not a current
registration statement permitting public resale. In this regard, the Company filed a registration statement to register the resale of
the Common Warrant Shares providing for the resale of the Shares issued and issuable upon exercise of the Common Warrants. That registration
statement was declared effective by the SEC on July 11, 2024. The Company has agreed to use commercially reasonable efforts to cause
such registration statement to keep such registration statement effective at all times until no Purchaser owns any Warrants or Warrant
Shares issuable upon exercise thereof.
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 was paid 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 consolidated financial statements. Proceeds allocated to such warrants totaled approximately
$ 2.5 million. For the three months ended March 31,2025, no Common Warrants were exercised, and all remain outstanding on March 31, 2025
related to this agreement.
On
September 30, 2024, the Company entered into a Purchase Agreement with the Selling Stockholder as Purchaser, pursuant to which we issued
to the Selling Stockholder, (i) in a registered direct offering, 4,653,036 shares of our common stock (“Shares”) and (ii)
in the concurrent Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up to 4,653,036 Shares (the “Common
Warrant Shares”) each with an exercise price of $ 0.28 . The Class C and Class D Warrants together, hereinafter the “Common
Warrants”. The purchase price for Shares in the registered direct offering was $ 0.27 per Share.
The
Company received aggregate gross proceeds from the Transactions of approximately $ 1.26 million, before deducting fees to the Placement
Agent and other estimated offering expenses payable by us. The Shares were 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. The Common Warrants and the Common Warrant Shares
issued in the Private Placement were not registered under the Securities Act. Rather the Common Warrants and the Common Warrant Shares
were issued pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated
thereunder. The Class C Warrants and the Class D Warrants are not exercisable until December 3, 2024, and will expire, respectively,
24 months and five years and six months after that date.
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 consolidated financial statements. Proceeds allocated to such warrants totaled approximately
$ 2.5 million. For the three months ended March 31,2025, no Common Warrants were exercised, and all remain outstanding on March 31, 2025
related to this agreement.
15
Note
10: 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 23,880,581 and 20,587,988 of stock options and warrants, are excluded from the calculation of
diluted net loss per share for the periods ended March 31, 2025 and December 31, 2024, respectively, since their effect is antidilutive
due to the net loss of the Company.
Note
11: 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, 2024 did not or are not believed by management
to have a material impact on the Company’s present or future financial statements.
Note
12: 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 Class
A and Class B warrants (“June 2024 Warrants”) related to the Company’s June 2024 common stock and warrant issuance,
are calculated using a Monte Carlo Simulation. The fair value of the Class C and Class D warrants (“October 2024 Warrants”)
related to the Company’s October 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 and October 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 Fair Value of Warrants
June
30,
2024
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
—
Warrants measurement input
—
16
The
Company utilized the following assumptions to estimate the fair value of the Class B Warrants:
June
30,
2024
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
—
Warrants measurement input
—
The
Company utilized the following assumptions to estimate the fair value of the Class C Warrants:
October
1,
2024
Underlying price per share
$ 0.26
Exercise price per share
$ 0.28
Risk-free interest rate
3.6 %
Expected holding period
2
years
Expected volatility
82 %
Expected dividend yield
—
Warrants measurement input
—
The
Company utilized the following assumptions to estimate the fair value of the Class D Warrants:
October
1,
2024
Underlying price per share
$ 0.26
Exercise price per share
$ 0.28
Risk-free interest rate
3.5 %
Expected holding period
5.5
years
Expected volatility
91 %
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:
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.
17
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 Range of Probabilities
Range of
Probability
Probability
Low
0.5 %
Medium
1.0 %
High
5.0 %
The
Monte Carlo Simulation has incorporated a 5.0 % probability of a Fundamental Transaction to date for the life of the securities.
(vi) Expected
Timing of Announcement of a Fundamental Transaction. As the Company has no specific expectation
of a Fundamental Transaction, for reasons elucidated above, the Company utilized a discrete
uniform probability distribution over the Expected Holding Period to model in the potential
announcement of a Fundamental Transaction occurring during the Expected Holding Period.
(vii) Expected
100 Day Volatility at Announcement of a Fundamental Transaction . An estimate of future
volatility is necessary as there is no mechanism for directly measuring future stock price
movements. Daily observations of the Company’s historical stock values for the 100
days immediately prior to the Warrants’ grant dates, with a floor of 100 %, were utilized
as a proxy for future volatility estimates.
(viii) Expected
Risk-Free Interest Rate at Announcement of a Fundamental Transaction . The Company utilized
a risk-free interest rate corresponding to the forward U.S. Treasury rate for the period
equal to the time between the date forecast for the public announcement of a Fundamental
Transaction and the Warrant expiration date for each simulation.
(ix) Expected
Time Between Announcement and Consummation of a Fundamental Transaction. The expected
time between the announcement and the consummation of a Fundamental Transaction is based
on the Company’s experience with the due diligence process performed by acquirers and
is estimated to be six months. The Monte Carlo Simulation approach incorporates this additional
period to reflect the delay Warrant Holders would experience in receiving the proceeds of
the Put.
While
the assumptions remain consistent from period to period (e.g., utilizing historical stock prices), the actual historical prices input
for the relevant period input change.
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 December 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.
18
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, 2025
Total
Level
1
Level
2
Level
3
Assets:
Cash
equivalents
$ 15
$ 15
$ —
$ —
Marketable securities
$ 1,349
$ 1,349
$ —
$ —
As
of
December
31, 2024
Total
Level
1
Level
2
Level
3
Assets:
Cash
equivalents
$ 51
$ 51
$ —
$ —
Marketable securities
$ 2,276
$ 2,276
$ —
$ —
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.
At
March 31, 2025 and December 31, 2024, the balance of the right of use assets was $ 554,000 and $ 618,000 , respectively, and the corresponding
operating lease liability balance was $ 572,000 and $ 634,000 , respectively. Right of use assets are recorded net of accumulated amortization
of $ 490,000 and $ 428,000 as of March 31, 2025 and December 31, 2024, respectively.
AIM
recognized rent expense associated with these leases are follows:
Schedule of AIM Recognized Rent Expense Associated with Operating Lease
March
31, 2025
March
31, 2024
(in
thousands)
March
31, 2025
March
31, 2024
Lease costs:
Operating lease
costs
$ 78
$ 74
Short-term
and variable lease costs
80
49
Total lease costs
$ 158
$ 123
Classification of lease costs
Research & development
$ 108
$ 101
General and administrative
50
22
Lease cost
50
22
Total lease costs
$ 158
$ 123
The
Company’s leases have remaining lease terms between 6 and 29 months. As of March 31, 2025, the weighted-average remaining term
was 28 months. At December 31, 2024, the weighted-average remaining term was 41 months. The Company’s weighted average incremental
borrowing rate for its leases was 10 % at March 31, 2025 and December 31, 2024.
19
Future
minimum payments as of March 31, 2025, are as follows:
Schedule of Operating Lease Future Payments
Year Ending December 31,
(in thousands)
2025
$ 215
2026
254
2027
159
Less imputed interest
( 56 )
Total
$ 572
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, 2025, research and development expenses were comprised of: clinical studies ($ 594,000 ), manufacturing
and engineering ($ 180,000 ), quality control ($ 230,000 ) and regulatory ($ 76,000 ).
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, 2025.
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, 2025 and 2024, the Company incurred approximately $ 105,000 and $ 521,000 ,
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, 2025, the Company incurred approximately $ 3,000 related
to this agreement.
○ During
the three months ended March 31, 2024, the Company incurred approximately $ 86,000 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, 2025, the Company incurred approximately $ 102,000 related
to this agreement.
○ During
the three months ended March 31, 2024, the Company incurred approximately $ 435,000 related
to this agreement.
20
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, 2025, the Company did no t incur any expense related to this
agreement.
○ During
the three months ended March 31, 2024, the Company incurred approximately $ 1,000 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 March 31, 2025, the Company did no t incur any expense related to this
agreement.
○ During
the three months ended March 31, 2024, the Company incurred approximately $ 129,000 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, 2025, the Company did no t incur any expense related to this
agreement.
○ During
the three months ended March 31, 2024, the Company incurred approximately $ 4,000 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 March 31, 2025, the Company incurred approximately $ 15,000 related
to this agreement.
○ During
the three months ended March 31, 2024, the Company incurred approximately $ 90,000 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, 2025, the Company incurred approximately $ 7,000 of lab services
from Alcami.
○ During
the three months ended March 31, 2024, the Company incurred approximately $ 10,000 of lab
services from Alcami.
Note
15: Subsequent Events
A
Special Meeting of Stockholders was held on April 30, 2025. At the meeting, there were 72,290,030 outstanding shares of the Company’s
common stock entitled to vote, and the requisite quorum for the meeting of 33 1/3% was present. The vote found in favor of a proposal
to approve a series of alternate amendments to the Company’s Certificate of Incorporation to effect, at the option of the Company’s
Board of Directors, a reverse stock split of the Company’s outstanding common stock at a ratio in the range of up to 1-for-100 ,
with such ratio to be determined by the Board of Directors in its sole discretion. Before the reverse split can be effected it must be
authorized by FINRA. That process currently is underway.
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.