UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
☒
Quarterly Report Pursuant to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
For
the Quarterly Period Ended June 30, 2026
Commission
File Number: 001-27072
AIM
IMMUNOTECH INC.
(Exact
name of registrant as specified in its charter)
Delaware
52-0845822
(State
or other jurisdiction of
(I.R.S.
Employer
incorporation
or organization)
Identification
No.)
2117
SW Highway 484 , Ocala FL 34473
(Address
of principal executive offices) (Zip Code)
(352)
448-7797
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol
Name
of each exchange on which registered
Common
Stock, par value $0.001 per share
AIM
NYSE
American
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
☒
Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was
required to submit and post such files).
☒
Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller
reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
☐
Large accelerated filer
☐
Accelerated filer
☒
Non-accelerated filer
☒
Smaller reporting company
☐
Emerging growth company
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
30,442,139
shares of common stock were outstanding as of August 7, 2026.
PART
I- FINANCIAL INFORMATION
ITEM
1 : Financial Statements
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Condensed
Consolidated Balance Sheets
(in
thousands, except for share and per share amounts)
(Unaudited
June 30, 2026 and Audited December 31, 2025)
June 30, 2026
December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents
$ 9,900
$ 2,985
Marketable investments
64
62
Other receivables
—
7
Prepaid expenses and other current assets
468
241
Total current assets
10,432
3,295
Property and equipment, net
54
71
Right of use asset, net
260
378
Patent and trademark rights, net
1,714
1,661
Other assets
271
377
Total assets
$ 12,731
$ 5,782
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable
$ 480
$ 1,630
Accrued expenses
586
795
Current portion of operating lease liability
259
250
Current portion of note payable, net
3,621
3,549
Total current liabilities
4,946
6,224
Long-term liabilities:
Operating lease liability
41
170
Long-term note payable
—
927
Warrant liability
—
8,244
Total liabilities
4,987
15,565
Commitments and contingencies (Note 10)
-
-
Stockholders’ equity (deficit):
Series A Junior Participating Preferred Stock, $ 0.001 par value, 4,000,000 and 250,000 shares authorized as of June 30, 2026, and December 31, 2025, respectively; issued and outstanding – none
—
—
Series B Convertible Preferred Stock, stated value $ 1,000 per share, 10,000 shares authorized; as of June 30, 2026, and December 31, 2025, respectively; issued and outstanding – none
—
—
Series G Convertible Preferred Stock, par value $ 0.01 per share, with a stated value $ 1,000 per share, 12,000 shares authorized: 529 and 0 issued and outstanding as of June 30, 2026, and December 31, 2025, respectively
—
—
Preferred
Stock value
—
—
Common Stock, $ 0.001 par value, authorized shares - 350,000,000 ; issued and outstanding shares 28,990,073 and 3,069,875 as of June 30, 2026 and December 31, 2025, respectively
29
3
Additional paid-in capital
455,312
431,000
Accumulated deficit
( 447,597 )
( 440,786 )
Total stockholders’ equity (deficit)
7,744
( 9,783 )
Total liabilities and stockholders’ equity
$ 12,731
$ 5,782
See
accompanying notes to condensed consolidated financial statements.
2
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Operations
(in
thousands, except share and per share data)
(Unaudited)
2026
2025
2026
2025
Three months ended June 30,
Six months ended June 30,
2026
2025
2026
2025
Revenues:
Clinical treatment programs - US
$ 26
$ 25
$ 48
$ 41
Total Revenues
26
25
48
41
Costs and Expenses:
Production costs
5
10
9
20
Research and development
589
1,174
1,071
2,254
General and administrative
2,945
1,487
4,707
4,032
Total Costs and Expenses
3,539
2,671
5,787
6,306
Operating loss
( 3,513 )
( 2,646 )
( 5,739 )
( 6,265 )
Gain (Loss) on investments
( 1 )
( 9 )
( 2 )
18
Interest and other income
21
10
29
21
Interest expense and other finance costs
( 295 )
( 149 )
( 631 )
( 273 )
Loss on change in fair value of warrant liability
—
—
( 468 )
—
Net Loss
$ ( 3,788 )
$ ( 2,794 )
$ ( 6,811 )
$ ( 6,499 )
Basic and diluted loss per share
$ ( 0.43 )
$ ( 3.68 )
$ ( 0.96 )
$ ( 8.88 )
Weighted average shares outstanding basic and diluted
17,118,695
759,289
10,819,484
731,650
See
accompanying notes to condensed consolidated financial statements.
3
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
For
the Six Months Ended June 30, 2026 and 2025 (in thousands except share data) (Unaudited)
Series G Preferred Shares
Common Stock Shares
Common Stock
.001 Par Value
Additional
Paid-in
Capital
Accumulated Deficit
Total
Stockholders’ Equity
(Deficit)
Balance December 31, 2025
—
3,069,875
$ 3
$ 431,000
$ ( 440,786 )
$ ( 9,783 )
Shares issued for:
Common stock issuance, net of costs
—
2,032,815
2
1,999
—
2,001
Rights Offering
1,842
—
—
1,662
—
1,662
Conversion of Series G Preferred Stock to Common Stock
( 1,164 )
1,164,000
1
( 1 )
—
—
Warrant Exercise
—
1,593,008
2
2,154
—
2,156
Reclass of Warrants E & F
—
—
—
8,712
—
8,712
Repayment of debt with shares
—
364,084
—
400
—
400
Net comprehensive loss
—
—
—
—
( 3,023 )
( 3,023 )
Balance March 31, 2026
678
8,223,782
$ 8
$ 445,926
$ ( 443,809 )
$ 2,125
Shares issued for:
Common stock issuance, net of costs
—
1,019,570
1
536
—
537
Conversion of Series G Preferred Stock to Common Stock
( 149 )
149,000
—
—
—
—
Warrant Exercise
—
7,451,920
8
3,569
—
3,577
Registered Direct Offering
—
12,145,801
12
5,082
—
5,094
Issuance Costs
—
—
—
199
—
199
Net comprehensive loss
—
—
—
—
( 3,788 )
( 3,788 )
Balance June 30, 2026
529
28,990,073
$ 29
$ 455,312
$ ( 447,597 )
$ 7,744
Series G Preferred Shares
Common Stock Shares
Common Stock
.001 Par Value
Additional
Paid-in
Capital
Accumulated Deficit
Total
Stockholders’
Deficit
Balance December 31, 2024
—
655,263
$ 1
$ 425,505
$ ( 426,828 )
$ ( 1,322 )
Shares issued for:
Common stock issuance, net of costs
—
42,854
—
660
—
660
Equity-based compensation
—
4,242
—
60
—
60
Repayment of Debt with Shares
—
20,541
—
450
—
450
Net comprehensive loss
—
—
—
—
( 3,705 )
( 3,705 )
Balance March 31, 2025
—
722,900
$ 1
$ 426,675
$ ( 430,533 )
$ ( 3,857 )
Balance
—
722,900
$ 1
$ 426,675
$ ( 430,533 )
$ ( 3,857 )
Common stock issuance, net of costs
—
41,339
—
105
—
105
Adjustment for fractional shares
—
( 51 )
—
—
—
—
Net comprehensive loss
—
—
—
—
( 2,794 )
( 2,794 )
Balance June 30, 2025
—
764,188
$ 1
$ 426,780
$ ( 433,327 )
$ ( 6,546 )
Balance
—
764,188
$ 1
$ 426,780
$ ( 433,327 )
$ ( 6,546 )
See
accompanying notes to condensed consolidated financial statements.
4
AIM
IMMUNOTECH INC. AND SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows
For
the Six Months Ended June 30, 2026 and 2025
(in
thousands)
(Unaudited)
2026
2025
Cash flows from operating activities:
Net loss
$ ( 6,811 )
$ ( 6,499 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and Amortization
571
377
Abandonment and expiration of patents and trademark rights
24
615
Equity-based compensation
—
60
Gain on sale of marketable investments
—
( 18 )
Change in fair value of warrants
468
—
Loss on issuance of warrants
32
—
Change in assets and liabilities:
Prepaid expenses and other assets
( 121 )
770
Lease liability
( 120 )
( 78 )
Accounts payable and Accrued Expenses
( 1,359 )
881
Other receivables
7
—
Net cash used in operating activities
( 7,309 )
( 3,892 )
Cash flows from investing activities:
Proceeds from sale of marketable investments
4
2,026
Purchase of marketable investments
( 6 )
( 91 )
Purchase of patent and trademark rights
( 147 )
( 283 )
Net cash (used in) provided by investing activities
( 149 )
1,652
Cash flows from financing activities:
Proceeds from sale of stock, net of issuance costs
2,538
765
Proceeds from note payable, net of issuance costs
—
250
Proceeds from warrant exercise
5,733
—
Repayment of debt obligation
( 821 )
—
Proceeds from Registered Direct Offerings
5,293
—
Proceeds from Rights Offering
1,630
—
Net cash provided by financing activities
14,373
1,015
Net increase (decrease) in cash and cash equivalents
6,915
( 1,225 )
Cash and cash equivalents at beginning of period
2,985
1,701
Cash and cash equivalents at end of period
$ 9,900
$ 476
Supplemental disclosures of non-cash investing and financing cash flow information:
Unrealized gain on marketable investments
$ —
$ 85
Repayment of debt obligation with shares
$ 400
$ 421
See
accompanying notes to condensed 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 are an immuno-pharma company headquartered in Ocala, Florida, with 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. AIM’s products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa). Ampligen
is a double-stranded RNA (“dsRNA”) molecule being developed for the treatment of late-stage pancreatic cancer, in addition
to other 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 it is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue
Syndrome (“CFS”).
The
Company’s research and development of Ampligen includes a variety of diseases and health matters:
●
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.
Ampligen
is a wide-spectrum therapeutic that has shown positive safety and efficacy in clinical trials of several different solid tumor types. Based
specifically on clinical success as to safety and efficacy in our pancreatic cancer Early Access Program and an ongoing Phase 2 trial,
AIM has made the business decision to focus its efforts on the development of Ampligen for the treatment of late-stage pancreatic cancer,
as we believe that this path will potentially lead to the most lucrative outcome. Pancreatic cancer is expected to kill an estimated
100,000 people in the American and European Union markets — and more than 450,000 people worldwide in 2026. When AIM looks at the
global health problem of pancreatic cancer, we see a large market for an unmet medical need and with relatively little clinical competition.
We believe we are well positioned to serve this market with our intellectual property program which includes broad-combination therapy
patents in the United States, Japan and Europe, as well as market exclusivity provided by orphan drug designations in the United States
and the European Union.
Oncology
is an area of biotech which can generate multibillion-dollar mergers and acquisitions – large-market Phase 3 oncology clinical
trials with positive data are a desirable focus for acquisition. AIM strongly believes that such a Phase 3 study will be possible following
the ongoing Phase 2 clinical study evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor
Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the
“DURIPANC” study). The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected
to enroll up to 25 subjects in the Phase 2 portion. The primary objective of the study is to determine the clinical benefit rate of the
combination therapy. The secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring
immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life. According to the Erasmus
MC Cancer Institute, the promising progression-free survival and overall survival seen in Phase 1 of the study – which we believe
supported advancement to the ongoing Phase 2 portion of the study – continue to be seen. As of June 30, 2026, all subjects have
been enrolled in the study and have received the first dose of study medication. Erasmus MC expects that detailed data will be published
later this year. According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo
setting – and Ampligen subjects are consistently reporting “high quality of life” during treatment.
In
March 2026, the Company announced an agreement with the PPD clinical research business of Thermo Fisher Scientific to design AIM’s
anticipated Phase 3 clinical trial in the use of Ampligen in the treatment of late-stage pancreatic cancer. Thermo Fisher Scientific
Inc. is a global leader in scientific progress.
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, 2025, and 2024, contained in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2025, filed on March 27, 2026.
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 our obligations as they become due. The Company has incurred losses from operations and operating cash outflows exceeded cash inflows from operating activities for the six months ended June 30, 2026. 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 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, the Company may be forced 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 included the need for the Company to have stockholders’ equity of $ 6 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 planned to regain compliance by June 11, 2026. The NYSE American accepted the Plan on February 26, 2025, and
the Company has submitted quarterly updates to the NYSE American since that time. If the Company was not able to raise sufficient capital as
set forth in the Plan or by other means, it may have been unable to regain compliance with the NYSE American’s listing standards,
and its securities could have been 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 would 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.
On
April 30, 2025, the Company held a special meeting of stockholders and authorized the Company’s Board of Directors to effect a
reverse split at its discretion on a basis of up to one for 100 outstanding shares of Common Stock. On May 29, 2025, the Board authorized
the reverse split and on June 10, 2025, the Company filed an amendment to its Articles of Incorporation effecting a reverse split of
its outstanding shares of Common Stock on a one for 100 basis (the “Reverse Split”). Stockholders were given cash in lieu
of any fractional shares on a post-split basis.
7
On
June 11, 2025, the Company was notified by the NYSE American that the Company had regained compliance with Section 1003(f)(v) of the
NYSE American’s Company Guide (low selling price) and that trading in the Company’s Common Stock was reinstated on the NYSE
American on June 17, 2025.
During
the third quarter of 2025, an agreement was reached with a vendor surrounding legal fees. The agreement provided that $ 3 million of previously
billed fees would be forgiven in exchange for payments totaling $ 1.9 million. The reduction was included as “other income”
and accounts payable was reduced.
On
January 20, 2026, the Company distributed a stock dividend of one share of our common stock for every 1,000 shares of common stock issued
and outstanding as of January 9, 2026, as well as one share of common stock for every 1,000 outstanding options or 1,000 warrants that
has a right to receive stock dividends. The distribution was effected on January 20, 2026. This resulted in a reset of the terms of our
Class E and Class F Warrants. Per the reset, the exercise price of these warrants dropped to $ 1.439 , additional warrants were issued
and a provision in these warrants that resulted in the classification of these warrants as a liability rather than equity was nullified.
This resulted in a $ 8.7 million increase in stockholders’ equity.
On
May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with certain holders of existing warrants,
pursuant to which the holders agreed to exercise their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately
$ 3.5 million in consideration of the Company’s agreement to issue new warrants upon such exercise.
On
May 21, 2026, the Company issued and sold 7,519,351 shares of common stock, par value $ 0.001 per share, and, in a concurrent private
placement, Class I warrants to purchase up to 15,038,702 shares of common stock to certain investors for aggregate gross proceeds of
approximately $ 2.4 million.
On
June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of
common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476
shares of common stock to certain investors for aggregate gross proceeds of approximately $ 2.6 million. Following the closing of these
transactions, the Company satisfied the NYSE $ 6.0 stockholders equity requirement.
The
NYSE American formally notified the Company on June 12, 2026, confirming that the Company had successfully addressed and resolved all
deficiencies related to Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide. As a result, the “below compliance”
(“.BC”) indicator was removed from the Company’s trading symbol for its common stock, and the Company was removed from
NYSE American’s list of noncompliant issuers on its website. The Company will remain subject to NYSE American’s continued
listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward.
Note
2: 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. ASU 2024-03 “Income
Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement
Expenses” is applicable to AIM beginning for the quarter ending March 31, 2027 and will require additional disclosures for certain
income statement line items. The Company is still evaluating the impact of this update. Accounting pronouncements issued by the FASB
since filing the Annual Report on Form 10-K for the year ended December 31, 2025 did not or are not believed by management to have a
material impact on the Company’s present or future financial statements.
Note
3 : 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. As of June 30, 2026 and at other various times throughout the six months ended
June 30, 2026, some accounts held at financial institutions were in excess of the federally insured limit of $ 250 thousand. The Company
has not experienced any losses on these accounts and believes credit risk to be minimal.
Note
4: Marketable Securities
Marketable
securities consist of mutual funds. At June 30, 2026 and December 31, 2025, it was determined that none of the marketable securities
had an other-than-temporary impairment. At June 30, 2026 and December 31, 2025, all securities were measured as Level 1 instruments of
the fair value measurements standard (See Note 16: Fair Value). At June 30, 2026, and December 31, 2025 the Company held $ 64 thousand
and $ 62 thousand, respectively, in mutual funds.
8
Mutual
Funds classified as available for sale consisted of $ 64 thousand at June 30, 2026. There was no realized gain or loss recognized for
the six-month period ended June 30, 2026 on equity securities. There was no unrealized loss recognized for the six-month period ended
June 30, 2026 on equity securities still held.
Mutual
Funds classified as available for sale consisted of $ 359 thousand at June 30, 2025. The net loss recognized for the six-month period
ended June 30, 2025 on equity securities was ($ 68 ) thousand. The unrealized gains recognized for the six-month period ended June 30,
2025 on equity securities still held was $ 85 thousand. The net gain recognized for the six-month period ended June 30, 2025 on equity
securities was $ 18 thousand.
Note
5: Property and Equipment, Net
Schedule
of Property and Equipment
June 30, 2026
December 31, 2025
(in thousands)
June 30, 2026
December 31, 2025
Furniture, fixtures, and equipment
$ 1,466
$ 1,466
Less: accumulated depreciation
( 1,412 )
( 1,395 )
Property and equipment, net
$ 54
$ 71
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 3 to
ten
years . Depreciation expense for the six months
ended June 30, 2026 and 2025 was $ 17 thousand and $ 19 thousand, respectively.
Note
6: Patents and Trademark Rights, Net
Patent
and trademark rights consist of the following (in thousands):
Schedule
of Patent and Trademark Rights
June 30, 2026
December 31, 2025
Gross Carrying Value
Accumulated Amortization
Net Carrying Value
Gross Carrying Value
Accumulated Amortization
Net Carrying Value
Patents
$ 2,267
$ ( 610 )
$ 1,657
$ 2,150
$ ( 551 )
$ 1,599
Trademarks
182
( 125 )
57
182
( 120 )
62
Net amortizable patents and trademarks rights
$ 2,449
$ ( 735 )
$ 1,714
$ 2,332
$ ( 671 )
$ 1,661
Patent
and trademark rights acquisitions, abandonments and amortization (in thousands):
Schedule
of Changes in Patents, Trademark Rights
December 31, 2025
$ 1,661
Acquisitions
147
Abandonments
( 24 )
Amortization
( 70 )
June 30, 2026
$ 1,714
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 12 years for patents and 3
years for trademarks, respectively. The Company expenses annuity costs related to its trademarks and patents.
9
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,
2026
$ 88
2027
156
2028
150
2029
144
2030
135
Thereafter
1,041
Total
$ 1,714
Note
7: Accrued Expenses
Accrued
expenses consist of the following: (in thousands)
Schedule
of Accrued Expenses
June 30, 2026
December 31, 2025
Compensation
$ —
$ 218
Professional fees
478
303
Clinical trial expenses
11
20
Interest
24
64
Other expenses
73
190
Total
$ 586
$ 795
Note
8: Unsecured Promissory Note
During
the years ended 2025 and 2024 the Company entered into three separate agreements with Streeterville Capital LLC (“Streeterville”
or the “Lender”). The terms of the agreements are described below:
Note
1 –
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 $ 2.5 million in exchange for an unsecured
promissory Note with an Original Issue Discount of $ 781 thousand. Under the original terms of the agreement, the Company agreed to pay
$ 3.3 million consisting of the principal amount of the Note, together with the original issue discount and $ 20 thousand of lender transaction
fees, no later than February 16, 2026. The stated interest rate of the note is 10 %.
The
agreement allows the Lender to redeem up to $250 thousand 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.
During
the quarter ended March 31, 2026, the Company entered into an agreement with the Lender to settle a portion of its outstanding loan obligation
in the amount of $ 400 thousand through the issuance of 364,084 shares of common stock rather than cash payment. During the year ended
December 31, 2025, the Company entered into agreements with the Lender to settle a portion of its outstanding loan obligation in the
amount of $ 700 thousand through the issuance of 170,353 shares of common stock, rather than cash payment. These exchanges were completed
pursuant to the terms of the loan agreement, which allows for the settlement of debt through stock issuance under certain conditions.
An
amendment to the Promissory Note was executed with the lender on March 10, 2026. Pursuant to the amendment the maturity date of the Note
was extended until June 30, 2026. Other than the maturity date extension, there were no other changes to the agreement.
On
May 18, 2026, the Company and the Lender entered into Amendment #2, which amended the Note and further extended the maturity date of
the Note until June 30, 2027. Pursuant to the Amendment, the Company agreed to pay the Lender an extension fee in the amount of
$ 10 thousand. The Extension Fee was added to the outstanding balance of the Note. The Amendment also contains customary
representations and warranties of the Company, as well as a representation and warranty of the Company that, as of the date of the
Amendment, the outstanding balance of the Note, following the application of the Extension Fee, was approximately $ 1.7 million.
10
Note
2 –
On
June 30, 2025, 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 $ 250 thousand in exchange for an unsecured
promissory Note with an Original Issue Discount of $ 50 thousand. The Note required the Company to pay $ 310 thousand consisting of the
principal amount of the Note, together with the original issue discount and $ 10 thousand of lender transaction fees, no later than October
28, 2025. On August 12, 2025, the Company repaid the note in full.
Note
3 –
On
November 18, 2025, 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 $ 2.5 million in exchange for an unsecured
promissory Note with an Original Issue Discount of $ 781 thousand. The Company agreed to pay $ 3.3 million consisting of the principal
amount of the Note, together with the original issue discount and $ 20 thousand of lender transaction fees, no later than November 18,
2027. The stated interest rate of the note is 10 %.
The
agreement allows the Lender to redeem up to $250 thousand per calendar month beginning in May 2026, 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.
Maturities
and charges associated with these notes are summarized below:
Debt
schedule at June 30, 2026 (in thousands):
Schedule of Long Term Debt
Note 1
Note 2
Note 3
Total
Long-term debt
$ 1,440
$ —
$ 2,634
$ 4,074
Unamortized Original issue discount
—
—
( 431 )
( 431 )
Unamortized Financing fees
( 8 )
—
( 14 )
( 22 )
Unamortized discount and
debt issuance costs
1,432
—
2,189
3,621
Less current portion of long-term debt, net
( 1,432 )
—
( 2,189 )
( 3,621 )
Long-term debt, net
$ —
$ —
$ —
$ —
Future
maturities for long-term debt as of June 30, 2026, were as follows (in thousands):
Schedule of Maturities of Long-Term Debt
Fiscal years ending December 31:
Note 1
Note 2
Note 3
Total
2026
$ 1,432
$ —
$ 1,500
$ 2,932
2027
—
—
689
689
Total
$ 1,432
$ —
$ 2,189
$ 3,621
Current portion of debt discount
$ —
$ —
$ 431
$ 431
Current portion of origination costs
$ 8
$ —
$ 14
$ 22
Debt
schedule at December 31, 2025 (in thousands):
Note 1
Note 2
Note 3
Total
Long-term debt
$ 1,984
$ —
$ 3,301
$ 5,285
Unamortized Original issue discount
( 49 )
—
( 740 )
( 789 )
Unamortized Financing fees
( 1 )
—
( 19 )
( 20 )
Unamortized discount and
debt issuance costs
1,934
—
2,542
4,476
Less current portion of long-term debt, net
$ ( 1,934 )
$ —
$ ( 1,615 )
$ ( 3,549 )
Long-term debt, net
$ —
$ —
$ 927
$ 927
11
Future
maturities for long-term debt as of December 31, 2025 were as follows (in thousands):
Fiscal years ending December 31:
Note 1
Note 2
Note 3
Total
2025
$ 1,934
$ —
$ 1,615
$ 3,549
2026
—
—
927
927
Total
$ 1,934
$ —
$ 2,542
$ 4,476
Current portion of debt discount
$ 49
$ —
$ 374
$ 423
Current portion of origination costs
$ 1
$ —
$ 10
$ 11
Interest
and other charges related to the Streeterville notes were as follows (in thousands):
Schedule of Interest and
Other Charges
Three months ended June 30, 2026
Note 1
Note 2
Note 3
Total
Interest
$ 40
$ —
$ 76
$ 116
Original issue discount amortization
—
—
179
179
Total interest charges
$ 40
$ —
$ 255
$ 295
Loan fee amortization
$ 2
$ —
$ 3
$ 5
Six months ended June 30, 2026
Note 1
Note 2
Note 3
Total
Interest
$ 84
$ —
$ 160
$ 244
Original issue discount amortization
49
—
306
355
Total interest charges
$ 133
$ —
$ 466
$ 599
Loan fee amortization
$ 3
$ —
$ 5
$ 8
Three months ended June 30, 2025
Note 1
Note 2
Note 3
Total
Interest
$ 87
$ —
$ —
$ 87
Original issue discount amortization
62
—
—
62
Total interest charges
$ 149
$ —
$ —
$ 149
Loan fee amortization
$ 3
$ —
$ —
$ 3
Six months ended June 30, 2025
Note 1
Note 2
Note 3
Total
Interest
$ 139
$ —
$ —
$ 139
Original issue discount amortization
134
—
—
134
Total interest charges
$ 273
$ —
$ —
$ 273
Loan fee amortization
$ 5
$ —
$ —
$ 5
12
Note
9: 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 2026 through 2027, and requiring monthly payments ranging from less than $ 1 thousand
to $ 22 thousand. Certain leases include additional renewal options ranging from 1 to 5 years. AIM has classified all of its leases as
operating leases.
At
June 30, 2026 and December 31, 2025, the balance of the right of use assets was $ 260 thousand and $ 378 thousand, respectively, and the
corresponding operating lease liability balance was $ 300 thousand and $ 420 thousand, respectively. Right of use assets are recorded net
of accumulated amortization of $ 678 thousand and $ 560 thousand as of June 30, 2026 and December 31, 2025, respectively.
AIM
recognized rent expense associated with these leases are follows:
Schedule of AIM
Recognized Rent Expense Associated with Operating Lease
(in thousands)
2026
2025
Six months ended June 30,
(in thousands)
2026
2025
Lease costs:
Operating lease costs
$ 137
$ 151
Short-term and variable lease costs
100
168
Total lease costs
$ 237
$ 319
Classification of lease costs
Research & development
$ 174
$ 215
General and administrative
63
104
Total lease costs
$ 237
$ 319
The
Company’s leases have remaining lease terms between 6 and 17 months. As of June 30, 2026, the weighted-average remaining term was
14 months. At December 31, 2025, the weighted-average remaining term was 20 months. The Company’s weighted average incremental
borrowing rate for its leases was 10 % at June 30, 2026 and December 31, 2025.
Future
minimum payments as of June 30, 2026, are as follows:
Schedule of Operating Lease Future Payments
Year Ending December 31, (in thousands)
2026
$ 136
2027
169
Less imputed interest
( 5 )
Total
$ 300
Note
10: 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.
13
The
Company’s research and development expenses were comprised of the following:
Schedule
of Research and Development Expenses
(in thousands)
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Three months ended
Six months ended
(in thousands)
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Clinical studies
$ 476
$ 734
$ 661
$ 1,328
Manufacturing & Engineering
( 93 )
144
( 23 )
324
Quality control
197
232
395
462
Regulatory
9
64
38
140
Totals
$ 589
$ 1,174
$ 1,071
$ 2,254
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 and six months ended June 30, 2026.
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 six months ended June 30, 2026 and 2025, the Company incurred $ 118 thousand and $ 200 thousand,
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 $ 8.4 million. This estimate includes pass-through costs of approximately $ 1 million 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.
●
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 $ 6.4 million, which
includes passthrough costs of approximately $ 125 thousand, investigator costs estimated at about $ 4.4 million and excludes certain
other third-party costs and escalations. During 2023, the original work order increased to $ 6.6 million 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. The final subject completed the clinical trial in 2023. The end of study close-out tasks finished
in 2025.
Costs
incurred pursuant to the Amarex agreements were as follows (thousands):
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Three months ended
Six months ended
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Pancreatic Cancer
$ 105
$ 94
$ 118
$ 192
Post Covid Conditions
—
—
—
8
Totals
$ 105
$ 94
$ 118
$ 200
14
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.
Subsequently,
on July 31, 2026, the Company entered into a proposal (the “Sterling Proposal Agreement”) with Sterling Pharma Solutions
(“Sterling”) that is related to the Master Service Agreement and a Quality Agreement entered into between the Company and
Sterling in 2022. Pursuant to the Sterling Proposal Agreement, Sterling agreed to manufacture further batches of the polynucleotide drug
substances PolyI and Poly C12U and transfer of associated test methods at Sterling’s Dudley, UK location to produce the polymer
precursors to manufacture the drug Ampligen. The estimated cost to the Company under the Sterling Proposal Agreement is approximately
$ 1.5 million to be paid over a period of 12 months, as set forth in more detail in the Sterling Proposal Agreement. The Company anticipates
using the manufactured product for ongoing and future clinical trials, including potentially a Phase 3 clinical trial for metastatic
pancreatic cancer.
Costs
incurred pursuant to the Sterling Pharma agreements were as follows (thousands):
-
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Three months ended
Six months ended
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Total
$ —
$ —
$ 23
$ —
Azenova
Sales International
In
October 2023, the Company entered into a consulting agreement with Azenova, LLC where 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 received a monthly retainer of $ 30,000 in addition to 3,600 stock options that vest monthly. The monthly retainer
was reduced to $ 10,000 in August 2024 and subsequently amended to payments based on hourly billing only. The agreement will end on April
30, 2028, but may be extended upon written agreement of the parties.
Costs
incurred pursuant to the Azenova agreements were as follows (thousands):
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Three months ended
Six months ended
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Total
$ 2
$ —
$ 2
$ 15
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 $ 30 thousand 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 study is now finalized.
Costs
incurred pursuant to the Alcami agreements were as follows (thousands):
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Three months ended
Six months ended
June 30, 2026
June 30, 2025
June 30, 2026
June 30, 2025
Research
and development expenses
$ 8
$ 3
$ 8
$ 10
Note
11: 401(k) Plan
AIM
has a defined contribution plan-the AIM ImmunoTech Employees 401(k) Plan and Trust Agreement (the “401(k) Plan”).
AIM’s full-time employees are eligible to participate in the 401(k) Plan following 61 days of employment. Subject to certain limitations
imposed by federal tax laws, participants are eligible to contribute up to 15 % of their salary (including bonuses and/or commissions)
per annum. Participants’ contributions to the 401(k) Plan may be matched by us at a rate determined annually by the Board of Directors.
Each
participant immediately vests in his or her deferred salary contributions as well as the Company’s safe harbor contributions.
A 6 %
safe harbor matching contribution by us was reinstated effective January 1, 2021. For the three months ended June 30, 2026 and June
30, 2025 the Company made $ 25 thousand and $ 19 thousand in contributions, respectively. For the six months ended June 30, 2026 and
June 30, 2025, the Company made $ 47
thousand and $ 57 thousand in contributions, respectively.
15
Note
12: 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. After the 100:1 reverse stock split which was effective on June 12, 2025, a maximum of 8,980 shares of common stock 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 July 1, 2025, the number of shares of the Company’s common stock available for grant and issuance
under the 2018 Equity Incentive Plan increased by an additional 15,283 shares. As a result of the 2018 Plan Evergreen Provisions, a maximum
of 24,263 shares of common stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan as of June
30, 2026. Subsequently, on July 1, 2026, the number of shares of the Company’s common stock available for grant and issuance under
the 2018 Plan increased by 580,661 shares. Unless sooner terminated, the 2018 Equity Incentive Plan will continue in effect for a period
of 10 years from its effective date. During the six months ended June 30, 2026, and 2025, there were no options granted.
As
part of the Company’s cash conservation strategy, the Company issued common stock as a substitute for cash salaries to certain
executives and directors. For the year ended December 31, 2025, there were 4,242 shares issued as compensation totaling $ 60 thousand.
During the six months ended June 30, 2026, there were no shares issued related to the cash conservation program. This compensation
is included in the overall equity-based compensation expense.
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.
Stock
options activity during the three months ended June 30, 2026, was as follows:
Stock
option activity for employees:
Schedule of Stock Option Activity
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding March 31, 2026
21,911
$ 244.40
9.56
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
( 10 )
7,128
—
—
Outstanding June 30, 2026
21,901
$ 241.26
9.57
$ —
Vested and expected to vest June 30, 2026
21,901
$ 241.26
9.57
$ —
Exercisable June 30, 2026
21,901
$ 151.48
5.53
$ —
Stock
option activity for non-employees:
Schedule of Stock Option Activity
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding March 31, 2026
6,721
$ 185.06
12.15
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
( 4 )
6,864
—
—
Outstanding June 30, 2026
6,717
$ 181.09
12.16
$ —
Vested and expected to vest June 30, 2026
6,717
$ 181.09
12.16
$ —
Exercisable June 30, 2026
6,717
$ 146.99
12.53
$ —
16
Stock
options activity during the six months ended June 30, 2026, was as follows:
Stock
option activity for employees:
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding January 1, 2026
21,911
$ 244.40
9.56
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
( 10 )
7,128
—
—
Outstanding June 30, 2026
21,901
$ 241.26
9.57
$ —
Vested and expected to vest June 30, 2026
21,901
$ 241.26
9.57
$ —
Exercisable June 30, 2026
21,901
$ 151.48
5.53
$ —
Stock
option activity for non-employees:
Number of
Options
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
(Years)
Aggregate
Intrinsic
Value
Outstanding January 1, 2026
6,721
$ 185.06
12.15
$ —
Granted
—
—
—
—
Forfeited
—
—
—
—
Expired
( 4 )
6,864
—
—
Outstanding June 30, 2026
6,717
$ 181.09
12.16
$ —
Vested and expected to vest June 30, 2026
6,717
$ 181.09
12.16
$ —
Exercisable June 30, 2026
6,717
$ 146.99
12.53
$ —
There
was no unvested stock option activity for employees and non-employees.
Stock-based
compensation expense was $ 0 and $ 60 thousand for the six months ended June 30, 2026 and 2025, respectively, and is recognized in a decrease
in general and administrative expenses.
Note
13: Stock Warrants
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, 56,410 shares of the Company’s common stock (the “Shares”)
and (ii) in a concurrent private placement, the Company issued to the Purchaser Class A common warrants to purchase an aggregate of up
to 56,410 shares of its common stock (the “A Warrants”) at an exercise price of $ 36.30 per share and Class B common warrants
to purchase an aggregate of up to 56,410 shares of its common stock (the “B Warrants” and, along with the A Warrants, the
“Common Warrants”) at an exercise price of $ 36.30 per share.
17
On
September 30, 2024, the Company entered into a Purchase Agreement with the Purchaser in the May 2024 Securities Purchase Agreement as
Purchaser, pursuant to which the Company issued to the Purchaser, (i) in a registered direct offering, 46,530 shares of its common stock
(“Shares”) and (ii) in the concurrent Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up
to 46,530 Shares (the “Common Warrant Shares”) each with an exercise price of $ 28.00 . The Class C and Class D Warrants together,
hereinafter the “Common Warrants”. The purchase price for Shares in the registered direct offering was $ 28.00 per Share.
On
July 30, 2025, the Company announced closing a public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded
warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to
2,000,000 shares of common stock, at a combined public offering price of $ 4.00 per share (or $ 3.999 per pre-funded warrant) and accompanying
warrants. The warrants had an exercise price of $ 4.00 per share and were exercisable immediately upon issuance. The Class E warrants
will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary
of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were $ 8 million. Maxim Group
LLC acted as sole placement agent in connection with this offering.
Based
on a review of the Class E and F Warrants, it was determined that the warrants met the liability criteria which resulted in Class E &
F warrants to be treated as liability under ASC 815 – Derivatives and Hedging. Accordingly, a loss was recognized and the resulting
computed value was classified as a liability on the Company’s balance sheet at December 31, 2025.
On
December 30, 2025, the Company declared a stock dividend of one share of common stock for every 1,000 shares of outstanding common stock
as well as one share of common stock for every outstanding option or warrant that has a right to receive stock dividends (“Alternate
Securities”). On January 13, 2026, the Company distributed a dividend of one share of its common stock for every 1,000 shares of
common stock issued and outstanding as of January 9, 2026, as well as one share of common stock for every outstanding option or warrant
that has a right to receive stock dividends (the “Dividend”). The issuance of the Dividend was a Share Combination Event
under Section 3(g) of the Class E & F Common Stock Purchase Warrants. As a result, the number of outstanding warrants of Class E
& F Common Stock Purchase Warrants both increased to 5,561,125 and the exercise price was reduced to $ 1.439 per share of common stock.
Due to the Share Combination Event trigger of the Class E & F Common Stock Purchase Warrants, the warrants were reevaluated, resulting
in the reclassification of the warrants from liability to equity. The Company recognized a loss on the fair market valuation of the warrants
of $ 468 thousand in the statements of operations for the six months ended June 30, 2026, and reclassified the Class E & F Common
Stock Purchase Warrants from liability to equity in the amount of $ 8.7 million reflected in the Balance Sheet at June 30, 2026.
On
March 6, 2026, the Company completed a rights offering (the “2026 Rights Offering”) to our stockholders and to holders of
certain of our outstanding options and warrants that had the right to participate in the 2026 Rights Offering as of February 10, 2026,
the record date. In the Rights Offering the Company issued non-transferable subscription rights to purchase 1,842 Units. Each Unit consists
of one share of Series G Convertible Preferred Stock (the “G Preferred”) and 2,000 warrants to purchase common stock (the
“G Warrants”). Each share of G Preferred is convertible, at the option of the holder at any time, into a number of shares
of our common stock equal to the quotient of the stated value of the Preferred Stock ($ 1 thousand) divided by $ 1.00 , the conversion price.
Each G Warrant is exercisable for one share of our common stock at an exercise price of $ 1.00 per share from March 6, 2026, the date
of issuance, through its expiration five years from the date of issuance. The 2026 Rights Offering raised $ 1.8 million in gross proceeds.
On
May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with holders of (i) Class A and Class B common
stock purchase warrants issued on May 31, 2024 (the “Existing May 2024 Warrants”), exercisable for up to an aggregate of
112,820 shares of the Company’s common stock, par value $ 0.001 per share (the “Common Stock”), (ii) Class C and Class
D Common Stock purchase warrants issued on September 30, 2024 (the “Existing September 2024 Warrants”) exercisable for up
to an aggregate of 93,060 shares of Common Stock, and (iii) Class E and Class F Common Stock purchase warrants issued on July 31, 2025
(the “Existing July 2025 Warrants” and together with the Existing May 2024 Warrants and the Existing September 2024 Warrants,
the “Existing Warrants”) exercisable for up to an aggregate of 8,514,048 shares of Common Stock. The Existing May 2024 Warrants
had an exercise price of $ 36.30 per share, the Existing September 2024 Warrants had an exercise price of $ 28.00 , and the Existing July
2025 Warrants had an exercise price of $ 1.439 .
Pursuant
to the Inducement Letter, the Holders agreed to exercise the Existing Warrants for cash at a reduced exercise price of $ 0.48 per share
in consideration of the Company’s agreement to issue the Holders new warrants to purchase up to a number of shares of Common Stock
equal to 200 % of the number of shares of Common Stock issued pursuant to such Holder’s exercise of Existing Warrants, comprised
of new Class H warrants to purchase up to 17,439,856 shares of Common Stock (the “Inducement Warrants” and the shares of
Common Stock underlying the Inducement Warrants, the “Inducement Warrant Shares”) with an exercise term of 5 years from the
initial exercise date. The initial exercise date of the Inducement Warrants is the Stockholder Approval Date, and
the exercise price thereof is $ 0.60 per share.
18
On
May 8, 2026, the Company completed the Inducement Transaction and received aggregate gross proceeds of approximately $ 3.6 million and
issued the Inducement Warrants.
Ladenburg
Thalmann & Co. Inc. acted as placement agent in connection with the Inducement Transaction and received a cash fee of
approximately $ 286
thousand, equal to 8.0 %
of the aggregate gross proceeds, $ 50
thousand for expenses incurred in connection with the offering, and approximately $ 27
thousand, representing a management fee equal to 0.75 %
of the aggregate gross proceeds. The Company also issued to the Placement Agent warrants to purchase up to 6.0 %
of the aggregate number of shares of Common Stock issued upon exercise of the Existing Warrants pursuant to the Inducement Letter.
The Placement Agent Warrants have substantially the same terms as the Inducement Warrants, except that the Placement Agent Warrants
will be exercisable until the five-year anniversary of the date of issuance, will have an exercise price equal to 125 %
of the Reduced Exercise Price, and will include piggyback registration rights that are triggered if there is not an effective
registration statement covering all of the Placement Agent Warrant Shares while the Placement Agent Warrants are
outstanding.
On
May 21, 2026, the Company issued and sold 7,519,351 shares of common stock, par value $ 0.001 per share, and, in a concurrent private
placement, Class I warrants to purchase up to 15,038,702 shares of common stock to certain investors for aggregate gross proceeds of
approximately $ 2.4 million.
On
June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of
common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476
shares of common stock to certain investors for aggregate gross proceeds of approximately $ 2.6 million.
Stock
warrants are issued as needed by the Board of Directors and have no formal plan.
The
fair value of each warrant award is estimated on the date of grant using a Black-Scholes-Merton pricing option 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 warrant. The Company uses historical data to estimate expected dividend
yield, life and forfeiture rates. The expected life of the warrants was estimated based on historical option holder’s behavior
and represents the period of time that options are expected to be outstanding.
For
further information, please refer to Note 14.
Note
14: 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. At June 30, 2026, 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 thousand (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. At June
30, 2026, there were no Series B Convertible Preferred Stock outstanding.
Series
G Convertible Preferred Stock
March
4, 2026, the Company filed a Certificate of Designation of Preference, Rights and Limitations of Series G Convertible Preferred Stock
(the “Certificate of Designation”) with the Delaware Secretary of State creating a new series of its authorized preferred
stock, par value $ 0.01 per share, designated as the “Series G Convertible Preferred Stock” (the “Series G Preferred
Stock”). The number of shares initially constituting the Series G Preferred Stock was set at 12,000 shares.
19
Each
share of Series G Preferred Stock will be convertible, at the option of the holder at any time, into the number of shares of the Company’s
common stock, par value $ 0.001 per share (the “Common Stock”) determined by dividing the $ 1 thousand stated value per share
of the Series G Preferred Stock by a conversion price initially equal to $ 1.00 . In addition, the conversion price per share is subject
to adjustment for stock dividends, distributions, subdivisions, combinations or reclassifications. Subject to limited exceptions, a holder
of the Series G Preferred Stock will not have the right to convert any portion of the Series G Preferred Stock to the extent that, after
giving effect to the conversion, the holder, together with its affiliates, would beneficially own in excess of 4.99 % of the number of
shares of Common Stock outstanding immediately after giving effect to its conversion. A holder of the Series G Preferred Stock, upon
notice to the Company, may increase or decrease the beneficial ownership limitation provisions of such holder’s Series G Preferred
Stock, provided that in no event shall the limitation exceed 9.99 % of the number of shares of Common Stock outstanding immediately after
giving effect to its conversion.
In
the event the Company effects certain mergers, consolidations, sales of substantially all of its assets, tender or exchange offers, reclassifications
or share exchanges in which the Common Stock is effectively converted into or exchanged for other securities, cash or property, the Company
consummates a business combination in which another person acquires 50% of the outstanding shares of Common Stock, then, upon any subsequent
conversion of the Series G Preferred Stock, the holders of the Series G Preferred Stock will have the right to receive any shares of
the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares
of Common Stock then issuable upon conversion in full of the Series G Preferred Stock.
Holders
of Series G Preferred Stock shall be entitled to receive dividends (on an as-if-converted-to-common stock basis) in the same form as
dividends actually paid on shares of the common stock when, as and if such dividends are paid on shares of Common Stock. Except as otherwise
provided in the Certificate of Designation or as otherwise required by law, the Series G Preferred Stock has no voting rights. Upon the
Company’s liquidation, dissolution or winding-up, whether voluntary or involuntary, holders of Series G Preferred Stock will 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 Series G Preferred Stock were fully converted (disregarding for such purpose any conversion limitations under the Certificate
of Designation) to Common Stock, which amounts shall be paid pari passu with all holders of Common Stock. The Company is not obligated
to redeem or repurchase any shares of Series G Preferred Stock. Shares of Series G Preferred Stock are not otherwise entitled to any
redemption rights, or mandatory sinking fund or analogous provisions.
On
March 6, 2026, the Company completed its previously announced rights offering (the “Rights Offering”) pursuant to its effective
registration statement on Form S-1, as amended (Registration No. 333-292085), previously filed with and declared effective by the Securities
and Exchange Commission (the “SEC”), a prospectus and a prospectus supplement filed with the SEC. Pursuant to the Rights
Offering, the Company sold an aggregate of 1,842 units consisting of an aggregate of 1,842 shares of Series G Preferred Stock, with each
share of Series G Preferred Stock initially convertible into shares of Common Stock at a conversion price of $ 1.00 per share, 3,684,000
Class G Warrants, with each warrant exercisable for one share of Common Stock at an exercise price of $ 1.00 per share and expiring five
years from the date of issuance, resulting in gross proceeds to the Company of $ 1.8 million.
At
June 30, 2026 and December 31, 2025, the Company had 529 and 0 shares of Series G Convertible Preferred Stock outstanding, respectively.
Subsequently, on July 1, 2026, 8 shares of the Company’s Series G Preferred stock were converted to 8,000 shares of the Company’s
common stock. As a result of this conversion, the Company’s outstanding shares of common stock increased by 8,000 shares and 521
Series G Preferred stock remains issued and outstanding. The conversions did not result in any cash proceeds to the Company.
(b)
Common Stock and Equity Finances
The
Company has authorized shares of 350,000,000 with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000
authorized shares. As of June 30, 2026, and December 31, 2025, there were 28,990,073 and 3,069,875 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 thousand worth of shares at the market price (including subsequent plans, the “Employee Stock Purchase Plan”).
Pursuant to NYSE American’s 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 (“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. Under the amended rules officers and employees must file a SLAP and the NYSE American must accept the SLAP prior
to the purchase of Company stock.
20
Equity
Distribution Agreement
On
April 19, 2023, the Company entered into an Equity Distribution Agreement (the “EDA”), with Maxim, pursuant to which it may
sell from time to time, shares of its 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 EDA, 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.
On
April 1, 2025, the Company entered into a new EDA, with Maxim (the “Sales Agreement”) pursuant to which it may issue and
sell up to an aggregate of $ 3
million of the Company’s common stock from time to time
through Maxim acting as agent. Under the terms of the Sales Agreement in no event will the Company, inter alia, issue or sell through
the sales agreement 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). For the year ended December
31, 2025, the Company sold 155,874
shares under the new EDA for total gross proceeds of $ 225
thousand, which includes a 3.0 %
fee to Maxim of $ 7
thousand.
On
April 10, 2026, the Company entered into Amendment No. 1 to that certain Equity Distribution Agreement dated April 1, 2025 with Maxim
Group LLC to act as the Company’s exclusive sales agent with respect to the issuance and sale of up to $ 3,000,000
of the Company’s shares of common stock, par value $ 0.001
per share, from time to time, in an at-the-market public offering.
The Amendment removes the limitation of the amount of Shares to be sold under the Sales Agreement. For the three months ended
June 30, 2026, the Company sold 1,019,570 shares under the EDA for total gross proceeds of approximately $558 thousand, which includes
a 3.0% fee to Maxim of approximately $17 thousand related to this agreement. For the six months ended June 30, 2026, the Company sold
3,044,862 shares under the EDA for total gross proceeds of approximately $ 2.6 million, which includes a 3.0 % fee to Maxim of approximately
$ 78 thousand related to this agreement.
Subsequently,
on July 31, 2026, the Company provided notice to the Sales Agent for the mutual termination of the Agreement, effective August 15, 2026.
The Company will not incur any termination penalties as a result of the termination of the Agreement.
Following
such termination, the Company may not offer or sell any additional shares of its common stock under the Agreement or the related prospectus
and prospectus supplement. From April 1, 2025 to July 31, 2026, the Company sold 3,200,736 shares of common stock for aggregate gross
proceeds of approximately $ 2.8 million pursuant to the Agreement. The Company does not intend to issue or sell any additional shares
of common stock under the Agreement prior to its termination.
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 thousand, 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 99,750 shares for resale pursuant to the Atlas Agreements, consisting of 96,364 shares that can be sold by the Company to
Atlas and 3,386 shares that were issued to Atlas as Commitment Shares. The registration statement was declared effective on May 1, 2024.
At December 31, 2024, a total of 7,596 shares were issued pursuant to the purchase agreement for a total of $ 128 thousand after clearing
costs. At December 31, 2025, a total of 30,829 shares were issued pursuant to the purchase agreement for a total of $ 398 thousand after
clearing costs. There were no shares issued subsequent to December 31, 2025. As of February 2026, the purchase agreement is no longer
active.
May
2024 Securities Purchase Agreement
On
May 31, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering
(the “Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which, on June 3, 2024,
the Company issued to the Purchaser, (i) in a registered direct offering, 56,410 shares of the Company’s common stock (the “Shares”)
and (ii) in a concurrent private placement, the Company issued to the Purchaser Class A common warrants to purchase an aggregate of up
to 56,410 shares of its common stock (the “A Warrants”) at an exercise price of $ 36.30 per share and Class B common warrants
to purchase an aggregate of up to 56,410 shares of its common stock (the “B Warrants” and, along with the A Warrants, the
“Common Warrants”) at an exercise price of $ 36.30 per share. The A Warrants and B Warrants are not exercisable for six months
after the issuance date and expire, respectively, five years and six months and twenty-four months after the issuance date. The Common
Warrants and the shares of common stock are issuable upon the exercise of such warrants are offered pursuant to an exemption from the
registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.
The
Shares 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.
21
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 Maxim Group LLC (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 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 $ 2.5
million. For the three and six months ended June 30, 2026, 56,410 Class A Warrants and 56,410 Class B Warrants were exercised at
$ 0.48 per share (See May 2026 Class H Inducement Transaction). There were no Class A or Class B Warrants outstanding at June 30,
2026, related to this agreement.
September
2024 Securities Purchase Agreement
On
September 30, 2024, the Company entered into a Purchase Agreement with the Purchaser in the May 2024 Securities Purchase Agreement as
Purchaser, pursuant to which the Company issued to the Purchaser, (i) in a registered direct offering, 46,530 shares of its common stock
(“Shares”) and (ii) in the concurrent Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up
to 46,530 Shares (the “Common Warrant Shares”) each with an exercise price of $ 28.00 . The Class C and Class D Warrants together,
hereinafter the “Common Warrants”. The purchase price for Shares in the registered direct offering was $ 28.00 per Share.
The
Company received aggregate gross proceeds from the Transactions of $ 1.3 million, before deducting fees to the Placement Agent and other
estimated offering expenses payable by it. 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 were not exercisable until December 3, 2024, and will expire, respectively, twenty-four
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 $ 2.5
million. For the three and six months ended June 30, 2026, 46,530 Class C Warrants and 46,530 Class D Warrants were exercised at
$ 0.48 per share (See May 2026 Class H Inducement Transaction). There were no Class C or Class D Warrants outstanding at June 30,
2026, related to this agreement.
22
July
2025 Public Offering
On
July 30, 2025, the Company announced closing a public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded
warrants in lieu thereof), Class E Warrants to purchase up to 2,000,000 shares of common stock, and Class F Warrants to purchase up to
2,000,000 shares of common stock, at a combined public offering price of $ 4.00 per share (or $ 3.999 per pre-funded warrant) and accompanying
warrants. The warrants had an exercise price of $ 4.00 per share and were exercisable immediately upon issuance. The Class E Warrants
will expire on the fifth anniversary of the original issuance date, and the Class F Warrants will expire on the eighteen-month anniversary
of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were $ 8 million. Maxim Group
LLC acted as sole placement agent in connection with this offering.
Based
on a review of the Class E and F Warrants, it was determined that the warrants met the liability criteria which resulted in Class E &
F warrants to be treated as liability under ASC 815 – Derivatives and Hedging. Accordingly, as the warrants might require the Company
to issue additional stock under certain circumstances, a loss was recognized and the resulting computed value was classified as a liability
on the Company’s balance sheet at December 31, 2025.
On
December 30, 2025, the Company declared a stock dividend of one share of common stock for every 1,000 shares of outstanding common stock
as well as one share of common stock for every outstanding option or warrant that has a right to receive stock dividends (“Alternate
Securities”). On January 13, 2026, the Company distributed a dividend of one share of its common stock for every 1,000 shares of
common stock issued and outstanding as of January 9, 2026 as well as one share of common stock for every outstanding option or warrant
that has a right to receive stock dividends (the “Dividend”). The issuance of the Dividend was a Share Combination Event
under Section 3(g) of the Class E & F Common Stock Purchase Warrants. As a result, the number of outstanding warrants of Class E
& F Common Stock Purchase Warrants both have increased to 5,561,125 and the exercise price reduced to $ 1.439 per share of common
stock. Due to the Share Combination Event trigger of the Class E & F Common Stock Purchase Warrants, reevaluation of the classification
resulted in the reclassification of the warrants from liability to equity. The Company recognized a loss on change of warrant liabilities
of $ 468 thousand in the statements of operations for the six months ended June 30, 2026, and reclassified the Class E & F Common
Stock Purchase Warrants from liability to equity. This reclassification totaling $ 8.7 million is reflected in the Balance Sheet at June
30, 2026.
For the three months ended June 30, 2026, 3,563,055
Class E Warrants and 3,682,985 Class F Warrants were exercised at $ 0.48 per share (See May 2026 Class H Inducement Transaction). For the
six months ended June 30, 2026, 4,045,555 Class E Warrants and 4,483,493 Class F Warrants exercised. At June 30, 2026 there were 1,515,564
Class E Warrants and 1,077,625 Class F Warrants outstanding at an exercise price of $ 1.439 related to this agreement.
March
2026 Rights Offering
On
March 6, 2026, the Company completed a rights offering to its stockholders and to holders of certain of its outstanding options and warrants
that had the right to participate in the 2026 Rights Offering, as of February 10, 2026, the record date. In the Rights Offering the Company
issued non-transferable subscription rights to purchase 1,842 Units. Each Unit consists of one share of Series G Convertible Preferred
Stock (the “G Preferred”) and 2,000 warrants to purchase common stock (the “G Warrants”). Each share of G Preferred
is convertible, at the option of the holder at any time, into a number of shares of common stock equal to the quotient of the stated
value of the Preferred Stock ($ 1 thousand) divided by $ 1.00 , the conversion price. Each G Warrant is exercisable for one share of common
stock at an exercise price of $ 1.00 per share from March 6, 2026, the date of issuance, through its expiration five years from the date
of issuance. Maxim Group LLC acted as the Company’s dealer-manager. The 2026 Rights Offering raised $ 1.8 million in gross proceeds.
For the three months ended June 30, 2026,
149 shares of the Series G Preferred had been converted for 149,000 shares of common stock and no Class G Warrants were exercised. For
the six months ended June 30, 2026, 1,313
shares of the Series G Preferred had been converted for 1,313,000
shares of common stock, and 310,000
Class G Warrants had been exercised. Subsequent to June 30,
2026, 8
shares of the G Preferred had been converted to 8,000
shares of common stock. At June 30, 2026, 3,374,000
Class G Warrants and 529
Series G Preferred were outstanding.
May
2026 Class H Inducement Transaction
On
May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders
agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price
of $ 0.48 per share, generating gross proceeds to the Company of approximately $ 3.6 million. In connection with the inducement, the Company
reduced the exercise price of the outstanding Class A through Class F Warrants to $ 0.48 per share. In consideration for the immediate
exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise
price of $ 0.60 per share and a five-year term commencing on the Stockholder Approval Date. In connection with the inducement
transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc. with an exercise price of
$ 0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9,
2026. The Class H Warrants and Class H Placement Agent Warrants are equity-classified. The Class H Warrants are not exercisable
until the Company obtains stockholder approval ( See Note 17: Subsequent Events) and include
a beneficial ownership limitation of 4.99 %, or 9.99 % upon election, customary anti-dilution adjustments, cashless exercise rights if
there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction
provisions.
The
Company evaluated the temporary reduction in the exercise price of the Class A through Class F Warrants as a modification of freestanding
equity-classified written call options. The incremental fair value effect of the modification was approximately $ 8,235 based on a class-by-class
analysis and was attributable to the Class A and Class C Warrants. The aggregate fair value of the new Class H Warrants issued to the
exercising holders was approximately $ 6.6 million. Accordingly, the aggregate value transferred to the exercising warrant holders was
approximately $ 6.6 million.
The
Company also incurred approximately $ 561 thousand of placement-agent costs in connection with the transaction, consisting of approximately
$ 363 thousand of cash placement-agent fees and approximately $ 198 thousand representing the fair value of the Class H Placement Agent
Warrants. Total holder-side consideration and placement-agent costs associated with the transaction were therefore approximately $ 7.2
million.
The
transaction generated gross exercise proceeds of approximately $ 3.6 million. The Company recognized equity issuance costs equal to the
gross proceeds of the transaction, consisting of approximately $ 561 thouand of placement-agent costs and approximately $ 3.0 million of
holder-side inducement consideration. The remaining approximately $ 3.6 million of value transferred to the exercising warrant holders
exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend. Because the Company had an accumulated
deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
The
deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net loss
available to common stockholders for purposes of calculating basic earnings per share. The noncash entries associated with the Class
H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’
equity. After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately
$ 3.2 million, representing the net cash proceeds received.
23
At
June 30, 2026 447,116 Placement Agent Warrants and 14,903,840 Class H warrants were outstanding.
May
2026 Class I Offering
On
May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of
7,519,351 registered shares of common stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $ 0.325 per share, exercisable for a five-year period commencing on the Stockholder Approval Date.
The
combined offering price was $ 0.325 per share of common stock and accompanying Class I Warrants. Although the Class I Securities Purchase
Agreement permitted each Purchaser to elect Pre-Funded Warrants in lieu of common stock, no Purchaser elected to receive Pre-Funded Warrants
at closing, and consequently no May 2026 Pre-Funded Warrants were issued. Gross proceeds to the Company totaled approximately $ 2.4 million.
Ladenburg
Thalmann & Co., Inc. acted as the placement agent for the May 2026 Class I Offering and received an 8.0 %
cash commission of approximately $ 196 thousand, a 0.75 %
management fee of approximately $ 18
thousand, reimbursement of expenses of $ 100 thousand, and 451,161
Placement Agent Warrants exercisable at approximately $ 0.41
per share ( 125 %
of the offering price) for a five-year period from the effective date of the Registration Statement. The Class I Warrants and Class
I Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method
per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the Class I Warrants, resulting in allocations of
approximately $ 939
thousand to common stock and $ 1.5 million
to Class I Warrants. The Class I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is
required to seek at a stockholder meeting to be held no later than July 21, 2026. (See Note 17: Subsequent Events)
At June 30, 2026 there were 451,161 Placement Agent
Warrants and 15,038,702 Class I Warrants outstanding.
June
2026 Class J Offering
On
June 10, 2026, the Company closed a registered direct offering and concurrent private placement (the “June 2026 Class J Offering”)
of 2,554,119
registered shares of common stock, 771,503
unregistered shares of common stock, Pre-Funded Warrants to
purchase up to 1,782,616
shares of common stock at a nominal exercise price of $ 0.001
per share (fully pre-funded at closing), and Class J Common
Stock Purchase Warrants to purchase up to 10,216,476
shares of common stock at an exercise price of approximately
$ 0.52
per share, exercisable for a five-year period commencing on
the Stockholder Approval Date.
The
combined offering price was approximately $ 0.52 per share and accompanying warrant. Gross proceeds to the Company totaled approximately
$ 2.6 million.
Ladenburg
Thalmann & Co., Inc. acted as the placement agent for the June 2026 Class J Offering and received an 8.0 %
cash commission of approximately $ 212
thousand, a 0.75 %
management fee of approximately $ 20
thousand, reimbursement of expenses of $ 100
thousand, and 306,494
Placement Agent Warrants exercisable at approximately $ 0.65
per share with a five-year term. The Class J Warrants, June 2026 Pre-Funded Warrants, and Class J Placement Agent Warrants are all
classified within stockholders’ equity. The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the
gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants. The Class J Warrants will become exercisable only
upon receipt of stockholder approval, which the Company is required to seek at a stockholder meeting to be held no later than July
21, 2026 (concurrent with the Class I and Class H Warrants). (See Note 17: Subsequent Events)
For the three months ended June 30, 2026, prefunded warrants were exercised for 1,300,828 shares of common stock. At June 30, 2026, 481,788
Pre-Funded Warrants, 306,494 Placement Agent Warrants and 10,216,476 Class J Warrants were outstanding.
Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the
pre-funded warrants and received nominal cash proceeds from the exercise.
24
Note
15: 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 48,470,384 and 4,334,512 of stock options and warrants, are excluded from the calculation of
diluted net loss per share for the periods ended June 30, 2026 and December 31, 2025, respectively, since their effect is antidilutive
due to the net loss of the Company.
The deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net
loss available to common stockholders for purposes of calculating basic earnings per share. The noncash entries associated with the Class
H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’
equity. After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately $ 3.2 million,
representing the net cash proceeds received.
Note
16: 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 Black-Scholes Model. 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 Black-Scholes Model. The fair value
of the Class E and Class F warrants (“July 2025 Warrants”) related to the Company’s July 2025 common stock and warrant
issuance, are calculated using a Black-Scholes Model. The fair value of the Class G warrants (“March 2026 Warrants”) related
to the Company’s March 2026 common stock and warrant issuance, are calculated using a Black-Scholes Model.
The
Company estimated the fair value of the Class A Warrants, Class B Warrants, Class C Warrants, Class D Warrants, Class E Warrants, Class
F Warrants, Class G Warrants, Class H Warrants, Class I Warrants, Class J 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
$ 35.00
Exercise price per share
$ 36.30
Risk-free interest rate
4.42 %
Expected holding period
5.5 years
Expected volatility
110 %
Expected dividend yield
—
Warrants measurement input
—
The
Company utilized the following assumptions to estimate the fair value of the Class B Warrants:
June 30,
2024
Underlying price per share
$ 35.00
Exercise price per share
$ 36.30
Risk-free interest rate
4.82 %
Expected holding period
2 years
Expected volatility
89 %
Expected dividend yield
—
Warrants measurement input
—
25
The
Company utilized the following assumptions to estimate the fair value of the Class C Warrants:
October 1,
2025
Underlying price per share
$ 26.00
Exercise price per share
$ 28.00
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,
2025
Underlying price per share
$ 26.00
Exercise price per share
$ 28.00
Risk-free interest rate
3.5 %
Expected holding period
5.5 years
Expected volatility
91 %
Expected dividend yield
—
Warrant measurement input
—
The
Company utilized the following assumptions to estimate the fair value of the Class E Warrants:
December 31,
January 20,
2025
2026
Underlying price per share
$ 1.13
$ 1.18
Exercise price per share
$ 1.44
$ 1.439
Risk-free interest rate
3.7 %
3.8 %
Expected holding period
4.58 years
4.52 years
Expected volatility
106 %
107 %
Expected dividend yield
—
—
Warrant measurement input
—
—
The
Company utilized the following assumptions to estimate the fair value of the Class F Warrants:
December 31,
January 20,
2025
2026
Underlying price per share
$ 1.13
$ 1.18
Exercise price per share
$ 1.44
$ 1.439
Risk-free interest rate
3.5 %
3.5 %
Expected holding period
1.09 years
1.03 years
Expected volatility
168 %
172 %
Expected dividend yield
—
—
Warrant measurement input
—
—
26
The
Company utilized the following assumptions to estimate the fair value of the Class G Warrants:
March 6,
2026
Underlying price per share
$ 0.694
Exercise price per share
$ 1.00
Risk-free interest rate
3.5 %
Expected holding period
5 years
Expected volatility
104 %
Expected dividend yield
—
Warrant measurement input
—
The
Company utilized the following assumptions to estimate the fair value of the Class H Warrants:
May 7,
2026
Underlying price per share
$ 0.56
Exercise price per share
$ 0.60
Risk-free interest rate
4.04 %
Expected holding period
5 years
Expected volatility
109 %
Expected dividend yield
—
Expected dividend yield
—
The
Company utilized the following assumptions to estimate the fair value of the Class I Warrants:
May 20,
2026
Underlying price per share
$ 0.2531
Exercise price per share
$ 0.4063
Risk-free interest rate
4.22 %
Expected holding period
5 years
Expected volatility
115 %
Expected dividend yield
—
Warrant measurement input
—
The
Company utilized the following assumptions to estimate the fair value of the Class J Warrants:
June 10,
2026
Underlying price per share
$ 0.4376
Exercise price per share
$ 0.6486
Risk-free interest rate
4.27 %
Expected holding period
5 years
Expected volatility
125 %
Expected dividend yield
—
The
significant assumptions using the Black-Scholes Model 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.
27
(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.
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
Black-Scholes Model 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 Black-Scholes Model 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.
28
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, 2025, 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 Black-Scholes Model in valuing
the warrants.
The
Company’s marketable securities consist solely of mutual funds. The Company determine realized gains and losses for marketable
securities using the specific identification method and measure the fair value of our marketable securities using a market approach where
identical or comparable prices are available. If quoted market prices are not available, fair values of investments are determined using
prices from a pricing service, pricing models, quoted prices of investments with similar characteristics or discounted cash flow models.
The
table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy
as (in thousands):
Schedule
of Assets and Liabilities Measured at Fair Value on a Recurring Basis
As of June 30, 2026
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$ 8,989
$ 8,989
$ —
$ —
Marketable securities
$ 64
$ 64
$ —
$ —
As of December 31, 2025
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents
$ 931
$ 931
$ —
$ —
Marketable securities
$ 62
$ 62
$ —
$ —
Liabilities:
Warrant liability
$ 8,244
$ —
$ —
$ 8,244
Note
17: Subsequent Events
Company’s
Amended and Restated 2018 Equity Incentive Plan
On
July 1, 2026, 8
shares of the Company’s Preferred Series G stock were
converted to 8,000
shares of the Company’s common stock. As a result of
this conversion, the Company’s outstanding shares of common stock increased by 8,000
shares and 521
Preferred Series G remains issued and outstanding. The conversions
did not result in any cash proceeds to the Company.
On
July 9, 2026, the Company filed a Registration Statement registering additional shares of common stock under the Company’s Amended
and Restated 2018 Equity Incentive Plan. The number of shares of the Company’s common stock available for grant and issuance under
the Plan is subject to an annual increase on July 1 of each calendar year, by an amount equal to two percent ( 2 %) of the then outstanding
shares of the Company’s common stock. On July 1, 2026, the number of shares of the Company’s common stock available for grant
and issuance under the 2018 Plan increased by 580,661 shares pursuant to the 2018 Plan Evergreen Provision.
Special
Meeting of Stockholders
On
July 15, 2026, the Company held a Special Meeting of Stockholders. As of the record date for the Special Meeting, there were 27,724,245
outstanding shares of the Company’s common stock outstanding and entitled to vote at the Special Meeting. Of the record date outstanding
shares, 10,671,690 shares, or approximately 38.5%, were represented at the Special Meeting either in person or by proxy, meaning the
requisite quorum for the meeting of 33 and 1/3% was present.
Based on the final voting results reported by the Inspector of Election, all Proposals were approved.
Equity
Distribution Agreement
On
July 31, 2026, the Company and Maxim mutually agreed to terminate the Equity Distribution Agreement, effective August 15, 2026.
Sterling
Proposal Agreement
On
July 31, 2026, the Company entered into a proposal (the “Sterling Proposal Agreement”) with Sterling Pharma Solutions (“Sterling”)
that is related to the Master Service Agreement and a Quality Agreement entered into between the Company and Sterling in 2022. Pursuant
to the Sterling Proposal Agreement, Sterling agreed to manufacture further batches of the polynucleotide drug substances PolyI and Poly
C12U and transfer of associated test methods at Sterling’s Dudley, UK location to produce the polymer precursors to manufacture
the drug Ampligen. The estimated cost to the Company under the Sterling Proposal Agreement is approximately $ 1.5 million to be paid over
a period of 12 months, as set forth in more detail in the Sterling Proposal Agreement. The Company anticipates using the manufactured
product for ongoing and future clinical trials, including potentially a Phase 3 clinical trial for metastatic pancreatic cancer.
The
foregoing summary of the Sterling Proposal Agreement does not purport to be complete and is qualified in its entirety by reference to
the full text of the Sterling Proposal Agreement, which was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed
on August 6, 2026 and incorporated herein by reference.
Unsecured
Promissory Note
On
August 6, 2026, the Company redeemed 384,911 shares of its common stock issued pursuant to the terms of the promissory note for an aggregate
redemption price of $ 100,000 and redeemed 577,367 shares of its common stock issued pursuant to the terms of the promissory note for
an aggregate redemption price of $ 150,000 .
June
2026 Class J Offering
On
August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the pre-funded warrants
and received nominal cash proceeds from the exercise.
29
ITEM
2: Management’s Discussion and Analysis of Financial Condition and Results of Operations
Special
Note Regarding Forward-Looking Statements
Certain
statements in this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E
of the Exchange Act. All statements, other than statements of historical fact, included or incorporated herein regarding our strategy,
future operations, financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements.
Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,”
“estimate,” “think,” “may,” “could,” “will,” “would,” “should,”
“continue,” “potential,” “likely,” “opportunity” and similar expressions or variations
of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements
and their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance,
and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties. These
statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results
and on information currently available to us. Discussions containing these forward-looking statements may be found, among other places,
below in this Item 2: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in
Part II: Other Information; Item 1A: “Risk Factors” of this report, and in the following sections of our Annual Report on
Form 10-K for the year ended December 31, 2025: Part I; Item 1. “Business”, Part I; Item 1A. “Risk Factors”,
Part I; Item 3. “Legal Proceedings”, and Part II; Item 7. “Management’s Discussion and Analysis of Financial
Condition and Results of Operations”. Among other things, for those statements, we claim the protection of safe harbor for forward-looking
statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this Report
speak only as of the date hereof. We do not undertake to update any of these forward-looking statements to reflect events or circumstances
that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment
of multiple types of viral diseases, cancers, and immune-deficiency disorders and the Report sets forth our current and anticipated future
activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required
to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily
predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans.
No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials
are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions
sponsoring other trials. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or
yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a
small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies
will yield favorable results. Some of the world’s largest pharmaceutical companies are also working on treatments and cures for
different types of cancers. No assurance can be given that the use of Ampligen with these proposed treatments and cures will prove effective.
No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced
or incorporated by reference herein. Operating in foreign countries carries with it a number of risks, including potential difficulties
in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these
risks.
Our
filings are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this Report and
is included for reference purposes only.
We
operate in an evolving environment. New risk factors and uncertainties emerge from time to time, and it is not possible for our management
to predict all risk factors and uncertainties, nor are we able to assess the impact of all of these risk factors on our business or the
extent to which any risk factor, or combination of risk factors, may cause actual results to differ materially from those contained in
any forward-looking statements.
Given
these uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to
update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein
to reflect future events or developments.
30
Overview
General
AIM
ImmunoTech Inc. and its subsidiaries are an immuno-pharma company headquartered in Ocala, Florida, with 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. AIM’s products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa). Ampligen
is a double-stranded RNA (“dsRNA”) molecule being developed for the treatment of late-stage pancreatic cancer, in addition
to other 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 it is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue
Syndrome (“CFS”).
The
Company’s research and development of Ampligen has included a variety of diseases and health matters:
● 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.
Immuno-Oncology
Ampligen
is a wide-spectrum therapeutic that has shown positive safety and efficacy in clinical trials of many different solid tumor types. However,
based specifically on clinical success as to safety and efficacy in our pancreatic cancer Early Access Program and an ongoing Phase 2
trial, AIM has made the business decision to focus its efforts on the development of Ampligen for the treatment of late-stage pancreatic
cancer, as we believe that this path will potentially lead to the most lucrative outcome. Each year pancreatic cancer kills more than
100,000 people in the American and European Union markets and more than 450,000 people worldwide. When AIM looks at the global health
problem of pancreatic cancer, we see a large market in an unmet medical need and with relatively little clinical competition. This large
unmet market is enhanced by an intellectual property program with broad-combination therapy patents in the United States, Japan and Europe,
as well as market exclusivity provided by orphan drug designations in the United States and the European Union.
Oncology
is one of the areas of biotech known for multibillion-dollar mergers and acquisitions deals – large-market Phase 3 oncology clinical
trials with positive data are a desirable focus for acquisition. AIM strongly believes that such a Phase 3 study will be possible following
the ongoing Phase 2 clinical study evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor
Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the
“DURIPANC” study). The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected
to enroll up to 25 subjects in the Phase 2 portion. The primary objective of the study is the clinical benefit rate of the combination
therapy. The secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring
using available tissue biopsies and peripheral immune profiling; and assessing quality of life. According to the Erasmus MC Cancer Institute,
the promising progression-free survival and overall survival seen in Phase 1 of the study – which we believe supported advancement
to the ongoing Phase 2 portion of the study – continue to be seen. As of June 30, 2026, all subjects have been enrolled in the
study and have received the first dose of study medication. Erasmus MC expects that detailed data will be published later this year.
According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo setting –
and Ampligen subjects are consistently reporting “high” quality of life during treatment.
In
March 2026, the Company announced an agreement with the PPD clinical research business of Thermo Fisher Scientific to design AIM’s
anticipated Phase 3 clinical trial in the use of Ampligen in the treatment of late-stage pancreatic cancer. Thermo Fisher Scientific
Inc. is a global leader in scientific progress.
Please
see “Immuno-Oncology” below.
31
Ampligen
as a Potential Antiviral
We
have research and pre-clinical history that indicates the broad-spectrum antiviral capability of Ampligen in animals. We hope to demonstrate
that it has the same effect in humans. To demonstrate this requires a population infected with a virus – among other factors –
which is why our most recent antiviral focus has been on COVID-19 (the disease caused by SARS-CoV-2) and Long COVID. We have conducted
experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. Previous animal studies yielded positive results
utilizing Ampligen to treat viruses such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture
of smallpox vaccine) and SARS-CoV-1. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective
effects against SARS-CoV-2.
Please
see “Ampligen as a Potential Antiviral” below.
Ampligen
as a Treatment for ME/ CFS and Post-COVID Conditions
The
AMP-511 Expanded Access Program (“AMP-511”) is an ongoing open-label treatment protocol allowing patient access to Ampligen
in a study under which severely debilitated CFS patients have the opportunity to receive Ampligen to treat this serious and chronic condition.
In
July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen® as a potential therapeutic for people
with post-COVID conditions (“AMP-518”). We announced in August 2023 that the study had met the planned enrollment of 80 subjects
ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with
a follow-up phase of two weeks. In January 2025, we announced that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov.
The results support our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of
fatigue, and that this would be the likely subject population for any follow-up clinical trial.
Please
see “Ampligen as a Treatment for ME/CFS and Post-COVID Conditions” below.
OUR
PRODUCTS
Our
primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded
(ds) RNA (ribonucleic acid) molecules. Ampligen is the only known TLR3 agonist to avoid helicase activation of NF-κB. Natural dsRNAs
and poly IC which activate NF-κB in the tumor microenvironment (TME) and have the potential to enhance cancer cell proliferation.
Alferon Injection is an FDA-approved natural alpha-interferon product.
Ampligen®
Ampligen
is approved for sale in Argentina (to 2026) for severe CFS and is an experimental drug in the United States currently being developed
for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Over its developmental history, Ampligen
has received various designations, including Orphan Drug Product Designation (FDA and EMA), Treatment protocol (e.g., “Expanded
Access” or “Compassionate” use authorization) with Cost Recovery Authorization (FDA); and “promising” clinical
outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research
and Quality). Based on the results of published, peer-reviewed pre-clinical studies and clinical trials, we believe that Ampligen may
have broad-spectrum antiviral and anti-cancer properties.
We
believe that nucleic acid compounds represent a potential new class of pharmaceutical products designed to act at the molecular level
for treatment of many human diseases. Ampligen represents the first drug in the class of large (macromolecular) dsRNA molecules to apply
for NDA review. There are two forms of nucleic acids: deoxyribonucleic acid (“DNA”) and ribonucleic acid (“RNA”).
DNA is a group of naturally occurring molecules found in chromosomes, the cell’s genetic machinery. RNA is a group of naturally
occurring informational molecules which orchestrate a cell’s behavior which, in turn, regulates the action of groups of cells,
including the cells which comprise the body’s immune system. RNA directs the production of proteins and regulates certain cell
activities, including the activation of an otherwise dormant cellular defense against viruses and tumors. Our drug technology utilizes
specifically configured RNA and is a selective Toll-like Receptor 3 (“TLR3”) agonist that can be administered intravenously,
intranasally and intraperitoneally. Ampligen has been assigned the generic name rintatolimod by the United States Adopted Names Council
(“USANC”) and has the chemical designation poly(I):poly(C12U).
Expanded
Access Program/Early Access Programs/clinical trials of Ampligen that have been conducted or that are ongoing include studies of the
potential treatment of patients with pancreatic cancer, renal cell carcinoma, malignant melanoma, non-small cell lung cancer, ovarian
cancer, breast cancer, colorectal cancer, prostate cancer, ME/CFS, Hepatitis B, HIV, COVID-19 and Post-COVID conditions.
32
We
have received approval of our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe
CFS. The product would be marketed by GP Pharm – now Filaxis – our commercial partner in Latin America. Shipment of the drug
product to Argentina was initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution. In September
2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales. In June 2020,
we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina. Collaboration
with Filaxis continues for commercial launch of Ampligen in Argentina and they are currently in the process of renewing the existing
license. To successfully bring this to market, several key steps are necessary, including building disease awareness, providing medical
education, securing appropriate reimbursement, developing effective market strategies, and finalizing manufacturing preparations for
launch.
The
economic landscape in Argentina has changed dramatically since then with the country experiencing significant hyper-inflation.
As contracts in Argentina are U.S. dollar contracts, the parties must evaluate the impact of the devaluation on the relationship and
the ability to go forward on a U.S.-dollar basis. The combination of the cost and frequency of treatments has rendered CFS treatments
in Argentina cost prohibitive, at least for the time being. We will therefore focus our efforts with Filaxis on an approval in Argentina
for pancreatic cancer.
In
May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands-based company, for the commencement and management of
an Early Access Program (“EAP”) in Europe and Turkey related to ME/CFS. Pursuant to the agreement, as amended, myTomorrows
also is managing all Early Access Programs and Special Access Programs in Europe, Canada, and Turkey to treat pancreatic cancer and ME/CFS
patients. The agreement was automatically extended for a period of 12 months on May 20, 2021 and will continue to be automatically extended
for periods of 12 months every May 20 until terminated or the terms of the agreement are met.
In
June 2018, Ampligen was cited as outperforming two other TLR3 agonists — poly IC and natural double stranded RNA — in creating
an enhanced tumor microenvironment for checkpoint blockade therapy in the journal of Cancer Research. In a head-to-head study in explant
culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer T cells but, unlike the other two TLR3 agonists,
it did so without causing regulatory T cell (Treg) attraction. These findings were considered important because they indicate that Ampligen
selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation (attracting killer T cells),
without amplifying immune-suppressive elements such as regulatory T cells. The study was conducted at the University of Pittsburgh and
Roswell Park as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of Research Excellence (“SPORE”).
AIM
currently has adequate stock of Ampligen for ongoing clinical purposes. As to the production of additional Ampligen when and if needed,
the validation of the polymer production process with Sterling Pharma Solutions (“Sterling”) is ongoing. This will need to
be completed before we can manufacture more polymer, and thus more Ampligen.
Alferon
N Injection®
Alferon
N Injection is the registered trademark for our injectable formulation of natural alpha interferon. Alferon N Injection is the only natural-source,
multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional (within lesions)
treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Alferon
N Injection is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant
interferons. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”).
According to the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million Americans — most in
their late teens and early 20s — infected with HPV. Although they do not usually result in death, genital warts commonly recur,
causing significant morbidity and entail substantial health care costs.
Interferons
are a group of proteins produced and secreted by cells to combat diseases. Researchers have identified four major classes of human interferon:
alpha, beta, gamma and omega. Alferon N Injection contains a multi-species form of alpha interferon. The worldwide market for injectable
alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products are approved for many major
medical uses worldwide. Alpha interferons are manufactured commercially in three ways: by genetic engineering, by cell culture, and from
human white blood cells. All three of these types of alpha interferon are or were approved for commercial sale in the United States.
Our natural alpha interferon is produced from human white blood cells. The potential advantages of natural alpha interferon over recombinant
(i.e., synthetic) interferon produced and marketed by other pharmaceutical firms may be based upon their respective molecular compositions.
Natural alpha interferon is composed of a family of proteins containing many molecular species of interferon. In contrast, commercial
recombinant alpha interferon products each contain only a single species. Researchers have reported that the various species of interferons
may have differing antiviral activity depending upon the type of virus. Natural alpha interferon presents a broad complement of species,
which we believe may account for its higher activity in laboratory studies. Natural alpha interferon is also glycosylated (i.e., partially
covered with sugar molecules). We believe that the absence of glycosylation may be in part responsible for the production of interferon-neutralizing
antibodies seen in patients treated with recombinant alpha interferon. Although cell culture-derived interferon is also composed of multiple
glycosylated alpha interferon species, the types and relative quantity of these species are different from our natural alpha interferon.
The
production of new Alferon N Injection Active Pharmaceutical Ingredient, or API, is currently on hold. We do not know when – or
if ever – our products will be generally available for commercial sale for any indication. Given our focus on developing Ampligen
as an oncology therapy and antiviral, at this time we are not focusing on developing Alferon N Injection.
33
PATENTS
AND NON-PATENT EXCLUSIVITY RIGHTS
We
consider patent exclusivity as a crucial component of our business. As of June 30, 2026, we had 31 patents worldwide with 21 additional
pending patent applications comprising our intellectual property.
We
continually review our patents to assess their value. Please see “Note 6: Patents, and Trademark Rights, Net” under Notes
to the Consolidated Financial Statements for more information on these patents.
There
are no current patent litigation proceedings involving AIM.
Orphan
Drug Designation
We
have received Orphan Drug Designation (ODD) from the FDA for Ampligen used in the treatment of Chronic Fatigue Syndrome, HIV, Metastatic
Melanoma, Renal Cell Carcinoma, Pancreatic Adenocarcinoma and Ebola Virus Disease. U.S. ODD qualifies sponsors for incentives including
tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity after FDA approval.
In
the European Union, ODD carries ten years of market exclusivity after receiving marketing authorization. We have received ODD from the
EU for Ampligen used in the treatment of Ebola Virus Disease and Pancreatic Adenocarcinoma, and for Alferon used in the treatment of
Middle East Respiratory Syndrome.
RESEARCH
AND DEVELOPMENT (“R&D”)
Our
general focus during the past several fiscal years has been on expanding the market potential of Ampligen through investigation of efficacy
(in vitro and in vivo) in different immune-based disorders including cancer and CFS. We also have focused on research and development
of potential prophylactic and therapeutic applications for the treatment of COVID-19, including the long-term effects of COVID-19.
Immuno-Oncology
We
hold multiple patents related to the use of Ampligen as part of a combination therapy when combined with checkpoint inhibitors for the
treatment of cancer. The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment.
AIM’s “synergistic” patents include a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as
part of a combination oncology therapy when paired with an anti-PD-L1 antibody; a patent in Japan (expires December 20, 2039) for the
use of Ampligen in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer; and a patent
in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors,
such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). Additional “synergistic” patent applications
are pending, and AIM will promptly announce when any such patent is issued. Additionally, in June 2025 we received a patent (expires January
25, 2041) covering methods involving the manufacture of a range of therapeutic double-stranded RNA (dsRNA) products, of which Ampligen
is included. Combined with our multiple compositions and methods patents involving Ampligen, this manufacturing patent, along with our
other issued patents, further secures our control over the synthesis and use of the first-in-class drug.
Multiple
Ampligen clinical trials are underway or recently completed at major university cancer centers testing whether tumor microenvironments
can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors.
Pancreatic
Cancer
AIM
has made the business decision to focus its efforts on the development of Ampligen for the treatment of late-stage pancreatic cancer,
as we believe that this path will potentially lead to the most lucrative outcome. Each year, pancreatic cancer kills more than 100,000
people in the American and European Union markets and more than 450,000 people worldwide. AIM’s intellectual property portfolio
includes orphan drug designations for pancreatic cancer in both the United States and Europe. The company announced in March 2026 that
it would seek similar status in Japan.
34
There
are currently two approved clinical studies utilizing Ampligen in the treatment of pancreatic cancer:
● NCT05927142
- The DURIPANC Study is a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s
anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage
pancreatic cancer. The primary objective of the Phase 1b portion was to determine the safety
of combination treatment. Investigators at Erasmus Medical Center (“Erasmus MC”)
in the Netherlands have completed the safety evaluation of subjects enrolled in the first
dose level of the dose escalation design, finding the combination therapy to be generally
well-tolerated with no severe treatment-related adverse events or dose-limiting toxicities.
In February 2025, we announced that the Erasmus MC Safety Committee had approved the clinical
trial to move forward with Phase 2. As of June 18, 2026, the final study subject had received
their first dose. With this final subject, Primary Endpoint analysis is anticipated to begin
in December 2026 and topline results are anticipated in Q1 2027. DURIPANC’s primary
endpoint is Clinical Benefit Rate (“CBR”), defined as the proportion of patients
achieving stable disease, partial response or complete response at 24 weeks following initiation
of combination therapy. Additionally, in March 2026, the Company announced an agreement with
the PPD clinical research business of Thermo Fisher Scientific to design AIM’s anticipated
Phase 3 clinical trial in the use of Ampligen in the treatment of late-stage pancreatic cancer.
● NCT05494697
- The Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm
study with the primary objective of comparing the efficacy of Ampligen in combination with
standard of care (SOC) versus SOC alone following first-line therapy, such as FOLFIRINOX
for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include
comparing safety and tolerability. AMP-270 is designed to enroll approximately 90 subjects
in up to 30 centers across the U.S. and Europe. In August 2022, we received IRB approval
of the trial protocol and so announced the trial’s commencement. In February 2025,
we made a business decision to place screening/enrollment on hold and suspend the study.
The study may be redesigned or amended, pending additional data from the ongoing DURIPANC
clinical trial.
The
active clinical efforts involving Ampligen are built on a strong foundation of both pre-clinical and clinical work. Chief among them
was an early access program (“EAP”) at Erasmus Medical Center in the Netherlands, with Prof. C.H.J. van Eijck, MD, as lead
investigator. The EAP was for Ampligen as a monotherapy in late-stage pancreatic cancer. A total of 42 pancreatic cancer patients initially
received treatment with Ampligen immuno-oncology therapy under the EAP, with more than 80 patients ultimately receiving treatment. Ampligen
was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the
standard of care. The EAP subjects also reported improved quality of life. We are in the process of seeking FDA “fast-track”
status.
Additional
scientific manuscripts supporting AIM’s efforts to develop Ampligen in the treatment of pancreatic cancer include:
● “ Rintatolimod
in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated
T Cell Responses “ in the journal Clinical Cancer Research .
● “ Rintatolimod
(Ampligen) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival
in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX:
A Single-Center Named Patient Program, ” Cancers
● “ Treating
Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod: Hitting Two Targets with One
Arrow? “ International Hepato-Pancreato Biliary Association
● “ Rintatolimod
Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19
Opportunity in Cancer Patients? “ Cancers
Ampligen
Efforts in Other Cancers of Interest
AIM
believes that Ampligen has potential as both a monotherapy and as part of a combination therapy in the treatment of many solid tumor
types. Our clinical work in this area includes:
● Advanced
Recurrent Ovarian Cancer ( NCT02432378 ) - Results of the Phase 1 portion of a Phase
1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer were
published in the American Association for Cancer Research publication, Clinical Cancer Research
(Clin Cancer Res January 19, 2022 DOI: 10.1158/1078-0432.CCR-21-3659). The study results
represent an important extension of prior studies using human tumor explants that showed
Ampligen’s potential role as a TLR3 agonist acting synergistically with high-dose IFNα
and celecoxib to selectively enhance Teff cell-attractants while suppressing Treg-attractants
in the tumor microenvironment with a concomitant increase in the Teff/Treg ratio. The importance
of boosting the Teff/Treg ratio in the tumor microenvironment is that it is associated with
the conversion of ‘cold’ tumors into ‘hot’ tumors, which have an
increased sensitivity to chemo-immunotherapy and an improved chance of showing tumor regression.
The Phase 1 portion was designed to establish intraperitoneal safety. The Phase 2 portion
of the study has been terminated due to lack of funding.
35
● Advanced
Recurrent Ovarian Cancer ( NCT03734692 ) - A Phase 2 study of advanced recurrent ovarian
cancer using cisplatin, pembrolizumab, plus Ampligen; 27 patients enrolled, with 24 evaluable
for response. In May 2026, we announced results from the UPMC Primary Endpoint Report .
The topline results included: 50% Objective Response Rate (ORR), including 21% complete responses;
79% Clinical Benefit Rate; Median Overall Survival of 32.5 months; durable responses exceeding
70+ months in select patients; and no Grade 4 or 5 toxicities observed. Collection of additional
secondary endpoint data including progression-free survival, time to disease progression
and overall survival is expected to be completed in January 2027. Based on these results
and other research suggesting a similar effect in other solid tumor types, AIM sees an Ampligen
combination therapy as having potential across multiple types of cancers. Additional clinical
studies are being planned in these tumor types to further confirm these effects.
● Stage
4 Metastatic Triple Negative Breast Cancer ( NCT03599453 ) - Phase 1 study of metastatic
triple-negative breast cancer using chemokine modulation therapy, including Ampligen and
pembrolizumab. Eight patients were enrolled and 6 patients were evaluable. The key findings
announced in April 2022 and published in November 2023, included:. The pre-determined primary
endpoint of efficacy was met (increase in CD8 in TME). Uniform increase of immune markers
upon treatment was observed: CD8 mRNA (6.1-fold; p-0.034), GZMB mRNA (3.5-fold; p=0.058),
ratios of CD8 /FOXP3 and GZMB/FOXP3 (5.7-fold; p=0.036, and 7.6-fold; p=0.024 respectively),
thus successfully meeting the pre-determined primary endpoint in the study (increase in CD8
in TME). In addition, an increase in CTL attractants CXCL10 (2.6-fold; p=0.104) and CCL5
(3.3-fold; p=0.019) was observed. In contrast, Treg marker FOXP3 or Treg attractants CCL22
or CXCL12 were not enhanced. Three patients had stable disease lasting 2.4, 2.5 and 3.8 months,
as of data cut off September 1, 2021. An additional patient (non-evaluable) had a partial
response (breast tumor autoamputation) with massive tumor necrosis in the post-CKM biopsy.
● Stage
4 Colorectal Cancer Metastatic to the Liver ( NCT03403634 ) - Phase 2a study of Ampligen
as a component of chemokine modulatory regimen on colorectal cancer metastatic to liver;
recruitment has been completed; 19 patients were enrolled and 12 patients were evaluable
for the primary endpoint. The key findings announced in April 2022 included. The study’s
primary endpoint was met, evidenced by increased CD8a expression post-treatment (p=0.046).
Increase in the CD8a/CD4 (p=0.03), CD8a/FOXP3 (p<0.01) and GZMB/FOXP3 (p<0.01) ratios.
The expression of CTL-attracting chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and CXCL10 (p=0.06)
were increased, while expression of the Treg/MDSC attractant CXCL12 (p=0.07) was decreased
post-treatment. OS was 10.5 (90% CI 2.2-15.2) months, and the median PFS was 1.5 (90% CI
1.4, 1.8) months. No tumor responses were seen. The treatment was well tolerated. Of all
enrolled patients (N=19), adverse events were noted in 74% of patients, with the most common
being fatigue (58%). Grade 3 or higher adverse events were rare (5%).
● Early-Stage
Prostate Cancer ( NCT03899987 ) - Phase 2 study investigating the effectiveness and
safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to
no drug treatments in a randomized three-arm study of patients with prostate cancer before
undergoing radical prostatectomy. Patient enrollment was initiated in this study designed
for up to 45 patients. The study was temporarily suspended due to the Merck discontinuation
of Intron-A production. Roswell Park has had a Type-C meeting with the FDA and has performed
the necessary experiments to replace Intron-A with a generic alpha-interferon. As of August
2025, the study is no longer recruiting patients. A total of 12 patients were enrolled.
● Early-Stage
Triple Negative Breast Cancer ( NCT04081389 ) - The objective of this Phase 1 study
is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or
without Intron A, when given along with chemotherapy in patients with early-stage triple
negative breast cancer. The now completed (as of September 2022) topline results from the
study confirm the positive findings that were previously presented at the 2022 Society for
Immunotherapy of Cancer (SITC) 37th Annual Meeting in a poster presentation titled Safety
and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer
(TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib). The primary
endpoint of the study was safety and tolerability. The results demonstrated that treatment
was well-tolerated with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without
dose-limiting toxicities (DLTs) or delayed or immune-related toxicities. DLT was defined
as grade 3 or higher toxicities within the first 3 weeks. Secondary endpoints included pCR
rate where 5/9 (56%) of patients attained pCR and 1 more patient attained ypTmic. Tumor and
blood biomarkers were also analyzed in exploratory studies.
● Refractory
Melanoma ( NCT04093323 ) - Roswell Park Comprehensive Cancer Center (“Roswell
Park”), in a clinical trial fully funded by the National Cancer Institute (NCI), has
commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant
melanoma. The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine
in combination with tumor-selective chemokine modulation (“CKM”) comprised of
Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib. Up to 24 patients are to be enrolled.
The study was temporarily suspended due to the Merck discontinuation of Intron-A production
but has since resumed recruitment. In June 2025, the study was terminated with 1 patient
enrolled, funding completed.
● Metastatic
or Unresectable Triple Negative Breast Cancer ( NCT05756166 ) - This phase 1/2a trial
tests the safety, side effects, and best dose of chemokine modulation therapy (rintatolimod,
celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of
patients with triple negative breast cancer that has spread from where it first started (primary
site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable).
In June 2025, the study was terminated with 5 patients enrolled, funding ended.
36
Ampligen
as a Potential Antiviral
We
have research and pre-clinical history that indicates the broad-spectrum antiviral capability of Ampligen in animals. We hope to demonstrate
that it has the same effect in humans. To demonstrate this requires a population infected with a virus – among other factors –
which is why our most recent antiviral focus has been on COVID-19 (the disease caused by SARS-CoV-2). We have conducted experiments in
SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. Previous animal studies yielded positive results utilizing Ampligen
to treat viruses such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine)
and SARS-CoV-1. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2.
● The
Barnard 2006 study found that Ampligen reduced virus lung levels to below detectable
limits.
● The
Day 2009 study found that, instead of 100% mortality, there was 100% protective survival
using Ampligen.
SARS-CoV-2
shares important genomic and pathogenic similarities with SARS-CoV-1. Since Ampligen has shown antiviral activity against more distantly
related coronaviruses, there is a reasonable probability that the antiviral effects of Ampligen against SARS-CoV-1 will extend to SARS-CoV-2,
and in fact Ampligen has demonstrated ex vivo antiviral activity against SARS-CoV-2. Additionally, research at Utah State University’s
Institute for Viral Research showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable
intranasal Ampligen dosage levels.
Our
intellectual property portfolio includes a Japanese patent for the treatment of severe acute viral infections, including influenza and
SARS.
In
May 2020, the FDA authorized an IND for Roswell Park to conduct a Phase 1/2a study of a regimen of Ampligen and interferon alpha in cancer
patients with COVID-19 infections. This clinical trial ( NCT04379518 ), sponsored in collaboration with Roswell Park, was designed
to test the safety of the combination regimen in patients with cancer and COVID-19, and the extent to which this therapy might promote
clearance of the SARS-CoV-2 virus from the upper airway. The first patient enrolled and treated in November 2020. This study was amended
to add 20 patients but ultimately terminated in January 2026 due to low accrual. Roswell Park reported partial results from the study,
4 patients were enrolled.
In
January 2021, we entered into a Sponsor Agreement with the Center for Human Drug Research (“CHDR”) to manage a Phase 1 randomized,
double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen. AIM funded and sponsored the
study. This study was designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally.
A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages
across four cohorts, to a maximum level of 1,250 micrograms. The study was completed, and the Final Safety Report reported no Serious
or Severe Adverse Events at any dosage level. We believe that the trial is a critical step in our efforts to develop Ampligen as a potential
prophylaxis or treatment for COVID-19 and other respiratory viral diseases.
We
believe that these results create a compelling case for further clinical trials to evaluate Ampligen as a potential tool in the fight
against COVID-19.
Ampligen
as a Treatment for ME/CFS and Post-COVID Conditions
Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), also known as Chronic Fatigue Immune Dysfunction Syndrome (“CFIDS”)
and Chronic Fatigue Syndrome (CFS), is a serious and debilitating chronic illness and a major public health problem. ME/CFS is recognized
by both the government and private sector as a significant unmet medical need, including the U.S. National Institutes of Health (“NIH”),
FDA and the CDC.
Many
severe ME/CFS patients become completely disabled or totally bedridden and are afflicted with severe pain and mental confusion even at
rest. ME/CFS is characterized by incapacitating fatigue with profound exhaustion and extremely poor stamina, sleep difficulties and problems
with concentration and short-term memory. It is also accompanied by flu-like symptoms, pain in the joints and muscles, tender lymph nodes,
sore throat and new headaches. A distinctive characteristic of the illness is a worsening of symptoms following physical or mental exertion,
which do not subside with rest.
The
AMP-511 Expanded Access Program (“AMP-511”) is an open-label treatment protocol allowing Ampligen access to severely debilitated
CFS patients. The AMP-511 protocol started in the 1990s and is ongoing. The data collected from the AMP-511 protocol through clinical
sites provide safety information regarding the use of Ampligen in patients with CFS. We are establishing an enlarged database of clinical
safety information which we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen
treatment. We believe that continued efforts to understand existing data, and to advance the development of new data and information,
will ultimately support our future filings for Ampligen and/or the design of future clinical studies that the FDA requested in a CRL.
The FDA approved an increased reimbursement level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs; which
was re-authorized in 2021, 2022, 2023, 2024, 2025 and 2026. At this time, we do not plan on passing this adjustment along to the patients
in this program.
37
In
October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include
patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms
known as Post-COVID conditions. As of June 30, 2026, there were 4 patients enrolled in this open-label expanded access treatment protocol
(including one patient with Post-COVID Conditions). In July 2022, AIM reported positive preliminary results based on data from the first
four Post-COVID Condition patients enrolled in the study. The data show that, by week 12, compared to baseline, the investigators observed
what they considered a clinically significant decrease in fatigue-related measures. To date, there have been eight such Post-COVID patients
treated in this study.
In
November 2020, we announced the publication of statistically significant data detailing how Ampligen could have a considerable positive
impact on people living with ME/CFS when administered in the early stages of the disease. The data were published in PLOS ONE, a peer-reviewed
open access scientific journal published by the Public Library of Science. AIM researchers found that the TLR3 agonist Ampligen substantially
improved physical performance in a subset of ME/CFS patients.
In
July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen as a potential therapeutic for people with
post-COVID conditions (“AMP-518”). We announced in August 2023 that the study had met the planned enrollment of 80 subjects
ages 18 to 60 years who had been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with
a follow-up phase of two weeks. All patients completed the study, and topline data was reported in February 2024.
In
January 2025, we announced that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov. Study subjects with
Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received
a placebo. The 6MWT measured the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks. A clear
signal of significant potential (p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than
205 meters, who saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group
who received the placebo. These results support our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe
Post-COVID condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial.
We
are holding off on further research and development in ME/CFS/Long-COVID until the ongoing DURIPANC clinical study in pancreatic ductal
adenocarcinoma is complete.
Ampligen
and Other Diseases
Endometriosis
● In
October 2024, we were granted U.S. patent No. 12,102,649, covering both compositions and
methods comprising a range of TRL3 agonist, within the drug Ampligen, in the treatment of
endometriosis, a painful chronic condition in which tissue similar to the lining of the uterus
grows outside the uterus, causing severe pelvic pain and making it difficult or impossible
to become pregnant. The patented method involves the administration of a therapeutically
effective amount of pharmaceutical composition containing our proprietary double-stranded
RNA products. The versatile administration options offer flexibility for patient-specific
needs and care. The patent also covers treatments targeting recurrent endometriosis and includes
options for co-administration with interferons, including well-known types such as alpha
and beta interferons.
Ebola-related
Disorders - We concluded our series of collaborations designed to determine the potential effectiveness of Ampligen and Alferon N
Injection as potential preventive and/or therapeutic treatments for Ebola-related disorders. Although we believe that the threat of both
MERS and Ebola globally may reemerge in the future, it appears that the spread of these disorders has diminished.
● In
April 2021, we entered into an MTA with the University of Cagliari Dipartimento di Scienze
della Vita e dell’Ambiente (“UNICA”), an educational institution, under
the laws of Italy, located in Monserrato (Cagliari), Italy. The MTA relates to the research
and development of the effects of Ampligen and its ability to induce interferon production
in several cell lines, and also on the ability of the Ebola virus protein VP35 to bind to
viral dsRNA and impede interferon’s upregulation and activity, and on Ampligen’s
ability to reverse VP35 inhibition of interferon production in biological systems. The data
analysis was published in the peer-reviewed journal Antiviral Research, in a manuscript titled
“Ebola virus disease: In vivo protection provided by the PAMP restricted TLR3 agonist
rintatolimod and its mechanism of action.” We believe that the analysis supports a
dual mechanism of action when Ampligen is used as a prophylactic therapy against Ebola Virus
Disease.
● In
November 2022, we received notice that the FDA had granted Orphan Drug Designation to Ampligen
for the treatment of Ebola virus disease.
38
Alzheimer’s
Disease
● In
May 2021, we filed a U.S. Provisional Patent Application for Ampligen as a potential therapeutic
to possibly slow, halt, or reverse the progression of Alzheimer’s disease. A similar
patent application was filed in Europe in 2022.
Avian
Influenza
● We
announced in February 2025 our intention to pursue a study of a potential avian influenza
combination therapy of Ampligen and AstraZeneca’s FluMist, a nasal spray vaccine that
helps prevent seasonal influenza. The new proposed clinical trial would expand upon previous
Company-sponsored clinical research at the University of Alabama-Birmingham (“UAB”),
which indicated that intranasal delivery of Ampligen after the intranasal delivery of the
FluMist seasonal influenza vaccine increased the immune response to seasonal variants in
the vaccine by greater than four-fold and induced cross-reactive secretory Immunoglobulin
A against highly pathogenic avian influenza virus strains H5N1, H7N9 and H7N3. We are seeking
collaborative grants from government and industry to defray the cost of the study. We believe
that pre-clinical and clinical work to date – combined with the ever-growing threat
of Avian influenza – strongly supports our decision to move forward with this second
Ampligen and FluMist study in humans.
MANUFACTURING
AIM’s
operations, research and development facility is housed in the New Jersey Bioscience Center and leased with the New Jersey Economic Development
Authority.
Jubilant
HollisterStier (“Jubilant”) has been our authorized CMO for Ampligen since 2017. Multiple lots of Ampligen were produced
from 2018 to 2023. AIM currently has adequate stock of Ampligen for ongoing clinical purposes. In addition, we have supplied GP Pharm,
now Filaxis, with the Ampligen required for testing and ANMAT release under the agreement that GP Pharm, now Filaxis, would be the eventual
distributor in Argentina.
Our
business plan calls for the potential utilization of one or more CMOs. While we believe we have sufficient Ampligen API to meet our current
needs, we are also continually exploring new efficiencies so as to maximize our ability to fulfill future obligations. In December 2022,
we entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”) for the manufacture
of our 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. We are utilizing Sterling’s expertise to refine our approach to polymer
production; the validation of the polymer production process with Sterling is ongoing.
Licensing/Collaborations/Joint
Ventures
We
have embarked on a strategy to license the product and/or to collaborate and/or create a joint venture with companies that have demonstrated
capabilities and commitment to successfully gain approval and commercialize Ampligen in their respective global territories of the world.
Ideal partners would have well-established global and regional experience and coverage; robust commercial infrastructure; a strong track
record of successful development and registration of in-licensed products; and a therapeutic area fit (e.g., ME/CFS, immuno-oncology).
As
Filaxis has now turned its focus to oncology, we are exploring the potential for the use of Ampligen in Argentina for the treatment of
pancreatic cancer as either a monotherapy or in combination with immunotherapies.
MARKETING/DISTRIBUTION
Beginning
in May 2016, we have had an exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with
GP Pharm, now Filaxis. Under this Agreement, GP Pharm is responsible for gaining regulatory approval in Argentina for Ampligen to treat
severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina. We granted GP Pharm the right to expand rights
to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones.
The contract ended date May 24, 2024. While we are in discussions with Filaxis to extend the agreement, we are also open to the possibility
of looking for a new partner. In August 2021, ANMAT granted a five-year extension to a previous approval to sell and distribute Ampligen
to treat severe CFS in Argentina. This extends the approval until 2026.
39
In
May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V. (“myTomorrows”),
a Netherlands-based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related
to ME/CFS. We supplied Ampligen to myTomorrows at a predetermined transfer price. In the event that we receive Marketing Authorization
in any country in the Territory, we will pay myTomorrows a royalty on products sold. Pursuant to the Impatients Agreement, the royalty
would be a percentage of Net Sales of Ampligen sold in the Territory where Marketing Authorization was obtained. The formula to determine
the percentage of Net Sales will be based on the number of patients that are entered into the EAP. We believe that disclosure of the
exact maximum royalty rate and royalty termination date could cause competitive harm. However, to assist the public in gauging these
terms, the actual maximum royalty rate is somewhere between 2% and 10% and the royalty termination date is somewhere between five and
fifteen years from the First Commercial Sale of a product within a specific country. The parties established a Joint Steering Committee
comprised of representatives of both parties to oversee the EAP. No assurance can be given that activities under the EAP will result
in Marketing Authorization or the sale of substantial amounts of Ampligen in the Territory. The agreement was automatically extended
for a period of 12 months on May 20, 2021; has been automatically extended for 12 months on each subsequent May 20; and will continue
to be automatically extended for periods of 12 months every May 20 until terminated or the terms of the agreement are met.
Alferon
N Injection is approved by the FDA for commercial sales in the United States for the treatment of genital warts. Commercial sales of
Alferon N Injection in the United States will not resume until new batches of commercial filled and finished product are produced and
released by the FDA. We will need the FDA’s approval to release commercial product once we have identified our new manufacturing
approach and submitted satisfactory stability and quality release data. We are not currently manufacturing Alferon N Injection and have
no definitive timetable to resume production.
In
February 2013, we received approval from Argentina’s ANMAT for Alferon N Injection (under the brand name “Naturaferon”)
for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon. In JANMAT granted a
five-year extension in 2017; a request to extend the approval beyond 2022 has been filed and is still under review. GP Pharm, now renamed
Filaxis, has decided not to move forward with this project and has sent us a notice of termination for this project. However, as there
are numerous companies in Argentina now providing patients treatment with recombinant interferon, we believe these companies and their
patients would benefit greatly from having the opportunity to treat those refractory patients with Naturaferon. We are continuing to
seek out potential partners.
In
January 2017, the myTomorrows EAP designed to enable access of Ampligen to ME/CFS patients was extended to pancreatic cancer patients
beginning in the Netherlands. In February 2018, we signed an amendment to the EAP with myTomorrows to extend the Territory to cover Canada
to treat pancreatic cancer patients, pending government approval. In March 2018, we signed an amendment to make myTomorrows our exclusive
service provider for special access activities in Canada for the supply of Ampligen for the treatment of ME/CFS.
New
Accounting Pronouncements
See
“ Note 2: Recent Accounting Pronouncements”.
Critical
Accounting Policies and Estimates
There
have been no material changes in our critical accounting policies and estimates from those disclosed in Part II; Item 7: “Management’s
Discussion and Analysis of Financial Condition and Results of Operations; Critical Accounting Policies” contained in our Annual
Report on Form 10-K for the year ended December 31, 2025.
40
RESULTS
OF OPERATIONS
The
Company’s operating results may fluctuate significantly depending on the pace of patient enrollment in our clinical trials, particularly
the ongoing DURIPANC study for pancreatic cancer. Patient enrollment has varied, which directly impacts the timing and amount of clinical
trial expenditures. Additionally, our ability to maintain compliance with NYSE American listing requirements and the trading status of
our common stock may affect our ability to raise capital and, consequently, our ability to fund ongoing operations and clinical development
activities. We cannot predict with certainty the timing of regulatory decisions or clinical trial outcomes, which represent material
uncertainties that could significantly impact our future results of operations.
The
following table sets forth, for the periods indicated, certain items in our Condensed Consolidated Statements of Income ($ in thousands):
Three months ended June 30,
Change
2026
2025
$
%
Revenues:
Clinical treatment programs – US
$ 26
$ 25
$ 1
4.0 %
Total Revenues
$ 26
$ 25
$ 1
4.0 %
Costs and Expenses:
Production costs
5
10
(5 )
-50.0 %
Research and development
589
1,174
(585 )
-49.8 %
General and administrative
2,945
1,487
1,458
98.0 %
Total Costs and Expenses
$ 3,539
$ 2,671
$ 868
32.5 %
Operating loss
$ (3,513 )
$ (2,646 )
$ (867 )
32.8 %
Gain (Loss) on investments
(1 )
(9 )
8
-88.9 %
Interest and other income
21
10
11
110.0 %
Interest Expense and Other Finance Costs
(295 )
(149 )
(146 )
98.0 %
Net Loss
$ (3,788 )
$ (2,794 )
$ (994 )
35.6 %
The Company’s net loss for the quarter
ended June 30, 2026 was $3.8 million compared with a net loss of $2.8 million for the quarter ended June 30, 2025, an increase of $1.0
million. The increase in net loss was primarily attributable to offering related costs incurred in connection with multiple equity transactions
completed during the quarter, including placement agent fees, legal fees, accounting fees, and other direct transaction costs, as discussed
below.
Total costs and expenses increased to $3.5 million
for the quarter ended June 30, 2026, compared with $2.7 million for the quarter ended June 30, 2025, an increase of approximately 32.5%.
Equity
transactions
May
2026 Class H Inducement Transaction
On
May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders
agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price
of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million. In connection with the inducement, the Company
reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share. In consideration for the immediate
exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise
price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date. In connection with the inducement
transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc. with an exercise price of
$0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9,
2026. The Class H Warrants and Class H Placement Agent Warrants are equity-classified. The Class H Warrants are not exercisable
until the Company obtains stockholder approval ( See Note 17: Subsequent Events) and include
a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if
there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction
provisions.
The
Company evaluated the temporary reduction in the exercise price of the Class A through Class F Warrants as a modification of freestanding
equity-classified written call options. The incremental fair value effect of the modification was approximately $8,235 based on a class-by-class
analysis and was attributable to the Class A and Class C Warrants. The aggregate fair value of the new Class H Warrants issued to the
exercising holders was approximately $6.6 million. Accordingly, the aggregate value transferred to the exercising warrant holders was
approximately $6.6 million.
The
Company also incurred approximately $561 thousand of placement-agent costs in connection with the transaction, consisting of approximately
$363 thousand of cash placement-agent fees and approximately $198 thousand representing the fair value of the Class H Placement Agent
Warrants. Total holder-side consideration and placement-agent costs associated with the transaction were therefore approximately $7.2
million.
The
transaction generated gross exercise proceeds of approximately $3.6 million. The Company recognized equity issuance costs equal to the
gross proceeds of the transaction, consisting of approximately $561 thouand of placement-agent costs and approximately $3.0 million of
holder-side inducement consideration. The remaining approximately $3.6 million of value transferred to the exercising warrant holders
exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend. Because the Company had an accumulated
deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
The
deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net loss
available to common stockholders for purposes of calculating basic earnings per share. The noncash entries associated with the Class
H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’
equity. After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately
$3.2 million, representing the net cash proceeds received.
41
At
June 30, 2026 447,116 Placement Agent Warrants and 14,903,840 Class H Warrants were outstanding.
May
2026 Class I Offering
On
May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common
stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per
share, exercisable for a five-year period commencing on the Stockholder Approval Date.
The
combined offering price was $0.325 per share of common stock and accompanying Class I Warrants. Although the Class I Securities Purchase
Agreement permitted each Purchaser to elect Pre-Funded Warrants in lieu of common stock, no Purchaser elected to receive Pre-Funded Warrants
at closing, and consequently no May 2026 Pre-Funded Warrants were issued. Gross proceeds to the Company totaled approximately $2.4 million.
Ladenburg
Thalmann & Co., Inc. acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately
$196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement
Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date
of the Registration Statement. The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity.
The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the
Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants. The Class
I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder
meeting to be held no later than July 21, 2026. (See Note
17: Subsequent Events)
At
June 30, 2026 there were 451,161 Placement Agent Warrants and 15,038,702 Class I Warrants outstanding.
June
2026 Class J Offering
On
June 10, 2026, the Company closed a registered direct offering and concurrent private placement (the “June 2026 Class J Offering”)
of 2,554,119 registered shares of common stock, 771,503 unregistered shares of common stock, Pre-Funded Warrants to purchase up to 1,782,616
shares of common stock at a nominal exercise price of $0.001 per share (fully pre-funded at closing), and Class J Common Stock Purchase
Warrants to purchase up to 10,216,476 shares of common stock at an exercise price of approximately $0.52 per share, exercisable for a
five-year period commencing on the Stockholder Approval Date.
The
combined offering price was approximately $0.52 per share and accompanying warrant. Gross proceeds to the Company totaled approximately
$2.6 million.
Ladenburg
Thalmann & Co., Inc. acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately
$212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement
Agent Warrants exercisable at approximately $0.65 per share with a five-year term. The Class J Warrants, June 2026 Pre-Funded Warrants,
and Class J Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method
per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants. The Class
J Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at
a stockholder meeting to be held no later than July 21, 2026 (concurrent with the Class I and Class H Warrants). (See Note
17: Subsequent Events)
For the three months ended June 30, 2026,
prefunded warrants were exercised for 1,300,828 shares of common stock. At June 30, 2026 481,788 Pre-Funded Warrants, 306,494 Placement
Agent Warrants and 10,216,476 Class J Warrants were outstanding.
Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the
pre-funded warrants and received nominal cash proceeds from the exercise.
42
Research
and development
Research
and development costs declined to $589 thousand during the quarter ended June 30, 2026 compared with $1.2 million during the quarter
ended June 30, 2025. Research costs declined as the Company completed a Phase II study in 2026 and shifted its focus toward a European
Pancreatic Cancer study which is funded by a grant and in collaboration with a major pharmaceutical interest. The Company expects to
begin new studies shortly and the timing and amount of clinical expenditures is dependent on recruiting patients and therefore can be
difficult to project and lead to significant expense variations between periods.
General
and administrative
General
and administrative costs for the quarter ended June 30, 2026 were $1.5 million above those during the three months ended June 30, 2025
due to increases in issuance costs together with legal and accounting fees associated with the equity transactions
Interest
expense was $295 thousand and $149 thousand for the three months ended June 30, 2026 and 2025, respectively. The increase in interest
expense is due to additional debt. On November 18, 2025, 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 $2.5 million in exchange for an unsecured promissory Note with an Original Issue Discount of $781 thousand. The Company
will pay $3.3 million consisting of the principal amount of the Note, together with the original issue discount and $20 thousand of lender
transaction fees, no later than November 18, 2027. The stated interest rate of the note is 10%.
Six months ended June 30,
Change
2026
2025
$
%
Revenues:
Clinical treatment programs – US
$ 48
$ 41
$ 7
17.1 %
Total Revenues
$ 48
$ 41
$ 7
17.1 %
Costs and Expenses:
Production costs
9
20
(11 )
-55.0 %
Research and development
1,071
2,254
(1,183 )
-52.5 %
General and administrative
4,707
4,032
675
16.7 %
Total Costs and Expenses
$ 5,787
$ 6,306
$ (519 )
-8.2 %
Operating loss
$ (5,739 )
$ (6,265 )
$ 526
-8.4 %
Gain (Loss) on investments
(2 )
18
(20 )
-111.1 %
Interest and other income
29
21
8
38.1 %
Interest Expense and Other Finance Costs
(631 )
(273 )
(368 )
131.1 %
Loss on change in fair value of warrant liability
(468 )
-
(468 )
-
Net Loss
$ (6,811 )
$ (6,499 )
$ (312 )
4.8 %
The
Company’s net loss for the six months ended June 30, 2026 was $6.8 million compared with a net loss of $6.5 million for the six
months ended June 30, 2025, an increase of $300 thousand. The increase in net loss was primarily attributed to offering related costs
incurred in connection with multiple equity transactions completed during the period, including placement agent fees, legal fees, accounting
fees, and other direct costs, as discussed below. These increased costs were partially offset by lower research and development expenses.
Total
costs and expenses decreased to $5.8 million for the six months ended June 30, 2026, compared with $6.3 million for the six months ended
June 30, 2025, representing a decrease of approximately 8.2%.
43
Equity
transactions
March
2026 Rights Offering
On
March 6, 2026, the Company completed a rights offering to its stockholders and to holders of certain of its outstanding options and warrants
that had the right to participate in the 2026 Rights Offering, as of February 10, 2026, the record date. In the Rights Offering the Company
issued non-transferable subscription rights to purchase 1,842 Units. Each Unit consists of one share of Series G Convertible Preferred
Stock (the “G Preferred”) and 2,000 warrants to purchase common stock (the “G Warrants”). Each share of G Preferred
is convertible, at the option of the holder at any time, into a number of shares of common stock equal to the quotient of the stated
value of the Preferred Stock ($1 thousand) divided by $1.00, the conversion price. Each G Warrant is exercisable for one share of common
stock at an exercise price of $1.00 per share from March 6, 2026, the date of issuance, through its expiration five years from the date
of issuance. Maxim Group LLC acted as the Company’s dealer-manager. The 2026 Rights Offering raised $1.8 million in gross proceeds.
For
the three months ended June 30, 2026, 149 shares of the Series G Preferred had been converted for 149,000 shares of common stock and
no Class G Warrants were exercised. For the six months ended June 30, 2026, 1,313 shares of the Series G Preferred had been converted
for 1,313,000 shares of common stock, and 310,000 Class G Warrants had been exercised. Subsequent to June 30, 2026, 8 shares of the G
Preferred had been converted to 8,000 shares of common stock. At June 30, 2026 3,374,000 Class G Warrants and 529 Series G Preferred
were outstanding.
May
2026 Class H Inducement Transaction
On
May 7-8, 2026, the Company entered into inducement letter agreements with eight existing warrant holders pursuant to which such holders
agreed to immediately exercise an aggregate of 7,451,920 previously outstanding Class A through Class F Warrants at an exercise price
of $0.48 per share, generating gross proceeds to the Company of approximately $3.6 million. In connection with the inducement, the Company
reduced the exercise price of the outstanding Class A through Class F Warrants to $0.48 per share. In consideration for the immediate
exercises, the Company issued to such holders an aggregate of 14,903,840 new Class H Common Stock Purchase Warrants with an exercise
price of $0.60 per share and a five-year term commencing on the Stockholder Approval Date. In connection with the inducement
transaction, the Company also issued 447,116 Placement Agent Warrants to Ladenburg Thalmann & Co., Inc. with an exercise price of
$0.60 per share and a five-year term commencing on the issue date, issued pursuant to the Investment Banking Agreement dated April 9,
2026. The Class H Warrants and Class H Placement Agent Warrants are equity-classified. The Class H Warrants are not exercisable
until the Company obtains stockholder approval ( See Note 17: Subsequent Events) and include
a beneficial ownership limitation of 4.99%, or 9.99% upon election, customary anti-dilution adjustments, cashless exercise rights if
there is no effective registration statement or available prospectus for resale of the underlying shares, and fundamental transaction
provisions.
The
Company evaluated the temporary reduction in the exercise price of the Class A through Class F Warrants as a modification of freestanding
equity-classified written call options. The incremental fair value effect of the modification was approximately $8,235 based on a class-by-class
analysis and was attributable to the Class A and Class C Warrants. The aggregate fair value of the new Class H Warrants issued to the
exercising holders was approximately $6.6 million. Accordingly, the aggregate value transferred to the exercising warrant holders was
approximately $6.6 million.
The
Company also incurred approximately $561 thousand of placement-agent costs in connection with the transaction, consisting of approximately
$363 thousand of cash placement-agent fees and approximately $198 thousand representing the fair value of the Class H Placement Agent
Warrants. Total holder-side consideration and placement-agent costs associated with the transaction were therefore approximately $7.2
million.
The
transaction generated gross exercise proceeds of approximately $3.6 million. The Company recognized equity issuance costs equal to the
gross proceeds of the transaction, consisting of approximately $561 thouand of placement-agent costs and approximately $3.0 million of
holder-side inducement consideration. The remaining approximately $3.6 million of value transferred to the exercising warrant holders
exceeded the proceeds available to absorb the transaction costs and was recognized as a deemed dividend. Because the Company had an accumulated
deficit, the deemed dividend was recorded as a reduction of additional paid-in capital.
The
deemed dividend did not affect the Company’s net loss or total stockholders’ equity but was deducted in determining net loss
available to common stockholders for purposes of calculating basic earnings per share. The noncash entries associated with the Class
H Warrants, the Existing Warrant modification, and the Class H Placement Agent Warrants also had no net effect on total stockholders’
equity. After payment of the cash placement-agent costs, the transaction increased total stockholders’ equity by approximately
$3.2 million, representing the net cash proceeds received
At
June 30, 2026 447,116 Placement Agent Warrants and 14,903,840 Class H Warrants were outstanding.
May
2026 Class I Offering
On
May 21, 2026, the Company closed a registered direct offering (the ‘May 2026 Class I Offering’) of 7,519,351 registered shares of common
stock and Class I Common Stock Purchase Warrants to purchase up to 15,038,702 shares of common stock at an exercise price of $0.325 per
share, exercisable for a five-year period commencing on the Stockholder Approval Date.
The
combined offering price was $0.325 per share of common stock and accompanying Class I Warrants. Although the Class I Securities Purchase
Agreement permitted each Purchaser to elect Pre-Funded Warrants in lieu of common stock, no Purchaser elected to receive Pre-Funded Warrants
at closing, and consequently no May 2026 Pre-Funded Warrants were issued. Gross proceeds to the Company totaled approximately $2.4 million.
44
Ladenburg
Thalmann & Co., Inc. acted as the placement agent for the May 2026 Class I Offering and received an 8.0% cash commission of approximately
$196 thousand, a 0.75% management fee of approximately $18 thousand, reimbursement of expenses of $100 thousand, and 451,161 Placement
Agent Warrants exercisable at approximately $0.41 per share (125% of the offering price) for a five-year period from the effective date
of the Registration Statement. The Class I Warrants and Class I Placement Agent Warrants are all classified within stockholders’ equity.
The Company applied the relative fair value method per ASC 470-20-25-2 to allocate the gross proceeds between the common stock and the
Class I Warrants, resulting in allocations of approximately $939 thousand to common stock and $1.5 million to Class I Warrants. The Class
I Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at a stockholder
meeting to be held no later than July 21, 2026. (See Note
17: Subsequent Events)
At
June 30, 2026 there were 451,161 Placement Agent Warrants and 15,038,702 Class I Warrants outstanding.
June
2026 Class J Offering
On
June 10, 2026, the Company closed a registered direct offering and concurrent private placement (the “June 2026 Class J Offering”)
of 2,554,119 registered shares of common stock, 771,503 unregistered shares of common stock, Pre-Funded Warrants to purchase up to 1,782,616
shares of common stock at a nominal exercise price of $0.001 per share (fully pre-funded at closing), and Class J Common Stock Purchase
Warrants to purchase up to 10,216,476 shares of common stock at an exercise price of approximately $0.52 per share, exercisable for a
five-year period commencing on the Stockholder Approval Date.
The
combined offering price was approximately $0.52 per share and accompanying warrant. Gross proceeds to the Company totaled approximately
$2.6 million.
Ladenburg
Thalmann & Co., Inc. acted as the placement agent for the June 2026 Class J Offering and received an 8.0% cash commission of approximately
$212 thousand, a 0.75% management fee of approximately $20 thousand, reimbursement of expenses of $100 thousand, and 306,494 Placement
Agent Warrants exercisable at approximately $0.65 per share with a five-year term. The Class J Warrants, June 2026 Pre-Funded Warrants,
and Class J Placement Agent Warrants are all classified within stockholders’ equity. The Company applied the relative fair value method
per ASC 470-20-25-2 to allocate the gross proceeds among the common stock, Pre-Funded Warrants, and Class J Warrants. The Class
J Warrants will become exercisable only upon receipt of stockholder approval, which the Company is required to seek at
a stockholder meeting to be held no later than July 21, 2026 (concurrent with the Class I and Class H Warrants). (See Note
17: Subsequent Events)
For
the three months ended June 30, 2026, prefunded warrants were exercised for 1,300,828 shares of common stock. At June 30, 2026 481,788
Pre-Funded Warrants, 306,494 Placement Agent Warrants and 10,216,476 Class J Warrants were outstanding.
Subsequently, on August 4, 2026, a holder exercised pre-funded warrants to purchase 481,788 shares of common stock upon exercise of the
pre-funded warrants and received nominal cash proceeds from the exercise.
45
Research
and development
Research
and development costs declined to $1.1 million during the six months ended June 30, 2026 compared with $2.3 million during the six months
ended June 30, 2025. During the first quarter of 2025, the Company decided to direct its focus and efforts on the development of Ampligen
for the treatment of late-stage pancreatic cancer, with the belief that this path will potentially lead to the most lucrative outcome.
As a result, the Company evaluated its patent portfolio and made a decision to reduce its annual maintenance fees and development of
patents not meeting its current core objective. As a result, $335 thousand was charged to clinical expenses during the first quarter
of 2025 related to prior costs of developing and maintaining patents not specific to the primary focus and was a significant factor in
the variance between the quarters.
Additionally,
the Company’s Phase 2 study for pancreatic cancer was put on hold in 2025, which resulted in reduced clinical costs during the first six months of 2026 than during the same time period in 2025. The Company has shifted its focus toward a European Pancreatic Cancer study which is funded by a grant and in
collaboration with a major pharmaceutical interest. The Company expects to begin a pivotal phase 3 clinical trial after the final DURIPANC study results
become available and a study protocol has been finalized and the timing and amount of
clinical expenditures is dependent on recruiting patients and therefore can be difficult to project and lead to significant expense
variations between periods.
General
and administrative
General
and administrative costs for the six months ended June 30, 2026 were $675 thousand above the six months ended June 30, 2025 as a result
of increases in issuance costs together with legal and accounting fees associated with the equity transactions. During the six months
ended June 30, 2025, the Company was receiving final billings related to a shareholder dispute which was settled during the fourth quarter
of 2024 which reduced the impact of the additional fees incurred during the current year.
Interest
expense was $599 thousand and $273 thousand for the six months ended June 30, 2026 and 2025, respectively. The increase in interest expense
is due to additional debt. On November 18, 2025, 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
$2.5 million in exchange for an unsecured promissory Note with an Original Issue Discount of $781 thousand. The Company will pay $3.3
million consisting of the principal amount of the Note, together with the original issue discount and $20 thousand of lender transaction
fees, no later than November 18, 2027. The stated interest rate of the note is 10%.
Liquidity
and Capital Resources
Change
6/30/2026
12/31/2025
$
%
Cash and cash equivalents
$ 9,900
$ 2,985
$ 6,915
231.7 %
Marketable securities
64
62
2
3.2 %
Highly liquid assets
$ 9,964
$ 3,047
$ 6,917
227.0 %
Six months ended June 30,
Change
2026
2025
$
%
Cash used in operating activities
$ (7,309 )
$ (3,892 )
$ (3,417 )
87.8 %
Cash (used in) provided by investing activities
(149 )
1,652
(1,801 )
-109.0 %
Cash provided by financing activities
14,373
1,015
13,358
1316.1 %
Net change in cash
$ 6,915
$ (1,225 )
$ 8,140
664.5 %
46
Cash
balances increased by $6.9 million or 231.7% during the six months ended June 30, 2026, primarily the result of ongoing financing
initiatives. The Company raised $1.8 million from a grant of rights offering, $2.5 million from its ATM offering, and $5.7 million
from warrant exercises, $1.6 million from the rights offering and $5.3 million from registered directs net of issuance costs during
the quarter ended June 30, 2026.
Cash
used by operating activities increased during the six months ended June 30, 2026 when compared to the six months ended June 30, 2025
primarily due to the utilization of cash for accounts payable and accrued expenses as well as administrative costs associated with equity
transactions.
During
the six months ended June 30, 2025, the Company utilized a portion of its investments to provide cash for operations. During the six
months ended June 30, 2026, the Company utilized financing activities to provide the necessary operating funds which caused a $1.8 million
difference in cash from investing activities when comparing the periods.
Our
principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to
provide the necessary funding to meet our obligations as they become due. As of June 30, 2026, we had $10.0 million in cash, cash
equivalents and marketable investments, inclusive of $64 thousand in marketable securities, compared with $3.0 million as of December
31, 2025.
On
September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature
of the remaining execution fee of $725 thousand. The amendment allowed that the remainder would not be exclusive to the agreement dated
on April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied
to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to
exhaust the balance, that the refund would be refunded in cash. Due to the changes brought about by the amendment, the nature of the
payment changed to deposit status. At June 30, 2026, we had a remaining deposit of $128 thousand which may be used to offset future clinical
research expenditures. This deposit is listed as a non-current asset on the balance sheet but could provide working capital if the timing
of expenditures are realized within the next 12 months.
On
April 4, 2025, trading of the Company’s common stock had been suspended by NYSE American. Leading up to this event, the Company
and Streeterville (the “Lender”) were in regular communication, regarding the potential impact on the loan agreements. On
May 13, 2025, we entered into a Forbearance Agreement with the Lender pursuant to which, for a 1% fee and expenses, the Lender released
the Company 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 was due, with no adverse effect on liquidity.
On
March 6, 2026, we completed a rights offering (the “2026 Rights Offering”) to our stockholders and to holders of certain
of our outstanding options and warrants that had the right to participate in the 2026 Rights Offering as of February 10, 2026, the record
date. In the Rights Offering we issued non-transferable subscription rights to purchase 1,842 Units. Each Unit consists of one share
of Series G Convertible Preferred Stock (the “G Preferred”) and 2,000 warrants to purchase common stock (the “G Warrants”).
Each share of G Preferred is convertible, at the option of the holder at any time, into a number of shares of our common stock equal
to the quotient of the stated value of the Preferred Stock ($1 thousand) divided by $1.00, the conversion price. Each G Warrant is exercisable
for one share of our common stock at an exercise price of $1.00 per share from March 6, 2026, the date of issuance, through its expiration
five years from the date of issuance. The 2026 Rights Offering raised $1.8 million in gross proceeds.
We
entered into an amendment to a Promissory Note with our Lender on March 10, 2026. The maturity date for the Note was extended until June
30, 2026, and then further extended to June 30, 2027. Other than the maturity date extension, there were no other changes to the agreement.
On May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with holders of (i) Class A and Class B
common stock purchase warrants issued on May 31, 2024 (the “Existing May 2024 Warrants”), exercisable for up to an aggregate of
112,820 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), (ii) Class C and Class D Common
Stock purchase warrants issued on September 30, 2024 (the “Existing September 2024 Warrants”) exercisable for up to an aggregate
of 93,060 shares of Common Stock, and (iii) Class E and Class F Common Stock purchase warrants issued on July 31, 2025 (the “Existing
July 2025 Warrants” and together with the Existing May 2024 Warrants and the Existing September 2024 Warrants, the “Existing Warrants”)
exercisable for up to an aggregate of 8,514,048 shares of Common Stock. The Existing May 2024 Warrants had an exercise price of $36.30
per share, the Existing September 2024 Warrants had an exercise price of $28.00, and the Existing July 2025 Warrants had an exercise price
of $1.439.
47
Pursuant to the Inducement Letter, the Holders agreed
to exercise the Existing Warrants for cash at a reduced exercise price of $0.48 per share in consideration of the Company’s agreement
to issue the Holders new warrants to purchase up to a number of shares of Common Stock equal to 200% of the number of shares of Common
Stock issued pursuant to such Holder’s exercise of Existing Warrants, comprised of new Class H warrants to purchase up to 17,439,856
shares of Common Stock (the “Inducement Warrants” and the shares of Common Stock underlying the Inducement Warrants, the “Inducement
Warrant Shares”) with an exercise term of 5 years from the initial exercise date. The initial exercise date of the Inducement Warrants
is the Stockholder Approval Date, and the exercise price thereof is $0.60 per share.
On May 8, 2026, the Company completed the Inducement
Transaction and received aggregate gross proceeds of approximately $3.6 million and issued the Inducement Warrants.
Ladenburg Thalmann & Co. Inc. acted as placement
agent in connection with the Inducement Transaction and received a cash fee of approximately $286 thousand, equal to 8.0% of the aggregate
gross proceeds, $50 thousand for expenses incurred in connection with the offering, and approximately $27 thousand, representing a management
fee equal to 0.75% of the aggregate gross proceeds. The Company also issued to the Placement Agent warrants to purchase up to 6.0% of
the aggregate number of shares of Common Stock issued upon exercise of the Existing Warrants pursuant to the Inducement Letter. The Placement
Agent Warrants have substantially the same terms as the Inducement Warrants, except that the Placement Agent Warrants will be exercisable
until the five-year anniversary of the date of issuance, will have an exercise price equal to 125% of the Reduced Exercise Price, and
will include piggyback registration rights that are triggered if there is not an effective registration statement covering all of the
Placement Agent Warrant Shares while the Placement Agent Warrants are outstanding.
On May 21, 2026, the Company issued and sold 7,519,351
shares of common stock, par value $0.001 per share, and, in a concurrent private placement, Class I warrants to purchase up to 15,038,702
shares of common stock to certain investors for aggregate gross proceeds of approximately $2.4 million.
On June 10, 2026, the Company issued and sold 2,554,119
shares of common stock and, in a concurrent private placement, 771,503 shares of common stock, pre-funded warrants to purchase up to 1,782,616
shares of common stock, and Class J warrants to purchase up to 10,216,476 shares of common stock to certain investors for aggregate gross
proceeds of approximately $2.6 million
As
a research and development company, we are conducting research necessary to bring our product, Ampligen, to market. As such, we primarily
rely on financing activities to provide the necessary funding to meet our obligations as they become due. AIM has a long and demonstrated
history of success in these efforts, however, there is no assurance that we will be successful in attaining the necessary funding in
the future.
Compliance
with NYSE American
On
December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listing requirements
specifically relating to a required stockholders’ equity of $6 million or more. The NYSE American’s review showed that
we were not in compliance with that requirement. We submitted a plan (the “Plan”) to the NYSE American detailing actions
we would take to regain compliance by June 11, 2026. The NYSE American accepted our Plan on February 26, 2025. If we had been unable to regain compliance by June 11, 2026, our common stock was subject to delisting from the NYSE American. As of June 30, 2026, our
stockholders’ equity was $7.7 million.
On
April 30, 2025, the Company held a special meeting of stockholders and authorized the Company’s Board of Directors to effect a
reverse split at its discretion on a basis of up to one for 100 outstanding shares of Common Stock. On May 29, 2025, the Board authorized
the Reverse Split and on June 10, 2025, the Company filed an amendment to its Articles of Incorporation effecting a reverse split of
its outstanding shares of Common Stock on a one for 100 basis (the “Reverse Split”). Stockholders were given cash in lieu
of any fractional shares on a post-split basis.
On
June 11, 2025, the Company was notified by the NYSE American that the Company had regained compliance with Section 1003(f)(v) of the
NYSE American’s Company Guide (low selling price) and that trading in the Company’s Common Stock was reinstated on the NYSE
American on June 17, 2025.
During
the third quarter of 2025, an agreement was reached with a vendor surrounding legal fees. The agreement provided that $3 million of previously
billed fees would be forgiven in exchange for payments totaling $1.9 million. The reduction was included as “other income”
and accounts payable was reduced.
48
On
January 20, 2026, the Company distributed a stock dividend of one share of our common stock for every 1,000 shares of common stock issued
and outstanding as of January 9, 2026, as well as one share of common stock for every 1,000 outstanding options or 1,000 warrants that
has a right to receive stock dividends. The distribution was effected on January 20, 2026. This resulted in a reset of the terms of our
Class E and Class F Warrants. Per the reset, the exercise price of these warrants dropped to $1.439, additional warrants were issued
and a provision in these warrants that resulted in the classification of these warrants as a liability rather than equity was nullified.
This resulted in a $8.7 million increase in stockholders’ equity.
On May 7, 2026, the Company entered into a warrant
exercise inducement offer letter agreement with certain holders of existing warrants, pursuant to which the holders agreed to exercise
their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately $3.6 million in consideration of the
Company’s agreement to issue new warrants upon such exercise.
On May 21, 2026, the Company issued and sold 7,519,351
shares of common stock, par value $0.001 per share, and, in a concurrent private placement, Class I warrants to purchase up to 15,038,702
shares of common stock to certain investors for aggregate gross proceeds of approximately $2.4 million.
On
June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of
common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476
shares of common stock to certain investors for aggregate gross proceeds of approximately $2.6 million. Following the closing of these
transactions, the Company believed it currently had stockholders’ equity in excess of the $6.0 million minimum requirement.
The
NYSE American formally notified the Company on June 12, 2026, confirming that the Company had successfully addressed and resolved all
deficiencies related to Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide. As a result, the “below compliance”
(“.BC”) indicator was removed from the Company’s trading symbol for its common stock, and the Company was removed from
NYSE American’s list of noncompliant issuers on its website. The Company will remain subject to NYSE American’s continued
listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward.
We
are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed
to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.
The
development of our products requires the commitment of substantial resources to conduct time-consuming research, preclinical development,
and clinical trials that are necessary to bring pharmaceutical products to market. We believe, based on our current financial condition,
that we do not have adequate funds to meet our anticipated operational cash needs and fund current clinical trials. At present we do
not generate any material revenues from operations, and we do not anticipate doing so in the near future. We will need to obtain additional
funding in the future to continue operations and for new studies and/or if current studies do not yield positive results, require unanticipated
changes and/or additional studies.
AIM is actively working to explore the potential of Ampligen as an antiviral. We believe that Ampligen’s ability to activate antiviral
immune system pathways could make the drug an effective broad-spectrum therapeutic tool against current viruses - such as SARS-CoV-2 -
and future viruses that may emerge either as variants, or as entirely new challenges.
At
present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future. We will need
to obtain additional funding in the future for new studies and/or if current studies do not yield positive results, require unanticipated
changes and/or additional studies. If we are unable to commercialize and sell Ampligen and/or recommence material sales of Alferon N
Injection, our operations, financial position and liquidity may be adversely impacted, and additional financing may be required. There
can be no assurances that, if needed, we will be able to raise adequate funds or enter into licensing, partnering or other arrangements
to advance our business goals. We may seek to access the public equity market whenever conditions are favorable, even if we do not have
an immediate need for additional capital at that time. We are unable to estimate the amount, timing or nature of future sales of outstanding
common stock or instruments convertible into or exercisable for our common stock. Any additional funding may result in significant dilution
and could involve the issuance of securities with rights, which are senior to those of existing stockholders. See Part I, Item 1A - “Risk
Factors; We will require additional financing which may not be available”.
49
Material
Cash Requirements
Over
the next 12 months, we anticipate that our primary cash requirements will include funding ongoing clinical trials for pancreatic cancer,
general and administrative expenses, and debt service obligations. As of June 30, 2026, we had approximately $10.0 million in cash, cash
equivalents, and marketable securities. We estimate that our short-term (annual) working capital requirements currently range between
$7.2 million and $10.8 million depending on the progress of clinical trials and financing sources.
Our
long-term capital needs will depend significantly on the outcome of our ongoing clinical trials, regulatory decisions, and our ability
to secure strategic partnerships or licensing arrangements. If Ampligen receives regulatory approval for any indication, we would require
substantial additional capital to support commercialization activities. We may seek to raise additional capital through public or private
equity offerings, debt financing, or collaborative arrangements with strategic partners.
As of June 30, 2026,
we did not have any off-balance sheet arrangements, as defined in Item 303(b) of Regulation S-K, that have or are reasonably likely to
have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations,
liquidity, capital expenditures or capital resources that is material to investors.
Possible
Sources of Funding
Equity Distribution
Agreement
The
Company plans to enter into a new Equity Distribution Agreement in August 2026.
ITEM
3: Quantitative and Qualitative Disclosures About Market Risk
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required
under this item.
ITEM
4: Controls and Procedures
Our
Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”) performed an evaluation of the effectiveness
of our disclosure controls and procedures, which have been designed to permit us to effectively identify and timely disclose important
information. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management
is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on that evaluation,
our CEO and CFO concluded that the disclosure controls and procedures were effective as of June 30, 2026, to ensure that material information
was accumulated and communicated to our management, including our CEO and CFO, is appropriate to allow timely decisions regarding required
disclosure.
Change
in Internal Control over Financial Reporting
During
the six months ended June 30, 2026, we made no change in our internal controls over financial reporting that has materially affected,
or is reasonably likely to materially affect, our internal controls over financial reporting.
50
Part
II – OTHER INFORMATION
ITEM
1: Legal Proceedings
Please
see Part 1; Item 3 “Legal Proceeding” in our annual report in Form 10K for the fiscal year ended December 31, 2025, filed
with the SEC on March 27, 2026.
ITEM
1A: Risk Factors
Please
carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year
ended December 31, 2025 filed with the SEC on March 27, 2026, which could materially affect our business, financial condition, or future
results. The risks described in the above reports are not the only risks we face. Additional risks and uncertainties not currently known
to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition and operating
results. Please also see “Special Note Regarding Forward-Looking Statements” above. In addition to the risk factors previously disclosed in our Annual Report
on Form 10-K for the year ended December 31, 2025, stockholders should carefully consider the following updates to our risk factors:
We have issued a significant number of shares
and warrants, which may result in substantial dilution to existing stockholders.
During the six months ended June 30, 2026, we completed multiple equity
transactions, including a rights offering, inducement transactions, and registered direct offerings, which raised aggregate gross proceeds
of approximately $10.4 million. These transactions resulted in the issuance of a substantial number of shares of common stock, preferred
stock, and warrants. As of June 30, 2026, we had approximately 48.5 million warrants outstanding with various exercise prices. If all
outstanding warrants are exercised, existing stockholders would experience significant dilution. Additionally, the exercise of these warrants
or the sale of shares issuable upon exercise could depress the market price of our common stock. We may need to raise additional capital
in the future, which could result in further dilution to stockholders.
ITEM
2: Unregistered Sales of Equity Securities and Use of Proceeds
None.
ITEM
3: Defaults upon Senior Securities
None.
ITEM
4: Mine Safety Disclosures
Not
Applicable.
ITEM
5: Other Information
Director
and Executive Officer Trading
During
the quarter ended June 30, 2026, no director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements
(as defined in Item 408 of Regulation S-K).
51
ITEM
6: Exhibits
Exhibit
No.
Description
3.1
Certificate of Incorporation as Amended and Restated through June 10, 2025 (incorporated by reference to Exhibit 3.1(i) to the Company’s Current Report on Form 8-K filed with the SEC on October 29, 2025).
3.2
Amended and Restated By-Laws of Registrant (incorporated by reference to Exhibit 3.7(ii) to the Company’s Current Report on Form 8-K filed with the SEC on February 26, 2025).
3.3
Certificate of Designation of Series G Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on March 6, 2026).
3.4
Amendment to the Company’s Amended and Restated By-Laws dated June 9, 2026 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-27072) filed with the SEC on June 10, 2026).
10.1
Amendment to Equity Distribution Agreement with Maxim Group, LLC dated April 10, 2026 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 10, 2026).
10.2
Amendment #2 to Promissory Note with Streeterville Capital, LLC dated May 18, 2026 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-27072) filed with the SEC on May 19, 2026).
10.3
Placement Agency Agreement with Ladenburg Thalman & Co, Inc dated May 20, 2026 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K (File No. 001-27072) filed with the SEC on May 21, 2026).
10.4
Security Purchase Agreement with Institution Investors dated June 9, 2026 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-27072) filed with the SEC on June 11, 2026).
10.5
Placement Agency Agreement with Ladenburg Thalmann dated June 9, 2026 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K (File No. 001-27072) filed with the SEC on June 11, 2026).
10.6
Amendment to the Company’s Amended and Restated By-Laws dated June 9, 2026 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-27072) filed with the SEC on June 10, 2026).
10.7
Mutual Termination of Controlled Equity Distribution Agreement dated April 1, 2025 effective August 15,2026 signed July 31, 2026 with Maxim Group, LLC*#
10.8
Proposal to GMP Manufacture Poly I and Poly C12U with Sterling Pharma Solutions dated July 31, 2026 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K (File No. 001-27072) filed with the SEC on August 6, 2026).
31.1
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer. *
31.2
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer. *
32.1
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer. **
32.2
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer. **
101.INS
Inline
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document.
*
Filed
herewith.
**
The
certifications attached as Exhibit 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are deemed furnished and not filed
with the Securities and Exchange Commission.
#
Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions
with an asterisk because the identified confidential portions (i) are not material and (ii) are the type that the Company treats as private
or confidential. The Company hereby agrees to furnish a copy of any redacted portion to the SEC upon request.
52
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
AIM
IMMUNOTECH INC.
/s/
Thomas K. Equels
Thomas
K. Equels, Esq.
Chief
Executive Officer & President
/s/
Robert Dickey IV
Robert
Dickey IV
Chief
Financial Officer
Date:
August 7, 2026
53
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.