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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): August
7, 2026
Aim Immunotech Inc.
(Exact name of registrant as specified in its charter)
| Delaware |
|
001-27072 |
|
52-0845822 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
| 2117
SW Highway 484, Ocala, FL |
|
34473 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (352) 448-7797
Not Applicable
(Former name or former address,
if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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, $0.001 par value |
|
AIM |
|
NYSE
American |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item
2.02 |
Results
of Operations and Financial Condition. |
On
August 10, 2026, AIM ImmunoTech Inc. (the “Company”) issued a press release (the “Press Release”) announcing
its financial results for the quarter ended June 30, 2026. A copy of the Press Release is attached to this Current Report on Form 8-K
as Exhibit 99.1 and, other than the quotes by Thomas Equels, is incorporated herein by reference.
The
information in this report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections
11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying Exhibit 99.1 shall
not be deemed incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by AIM ImmunoTech Inc.,
whether made before or after the date hereof regardless of any general incorporation language in such filing.
| Item
9 .01 |
Financial
Statements and Exhibits. |
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release, dated August 10, 2026. |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
| Date:
August 10, 2026 |
AIM
ImmunoTech Inc. |
| |
|
| |
/s/
Thomas K. Equels |
| |
Thomas
K. Equels |
| |
Chief
Executive Officer |
Exhibit
99.1

CONFIDENTIAL
DRAFT NOT FOR IMMEDIATE RELEASE
AIM
ImmunoTech Reports Second Quarter 2026 Financial Results and Highlights Significant Operational Execution Advancing Ampligen® Toward
Planned Phase 3 Development in Pancreatic Cancer
Completed
Enrollment and Ampligen Dosing in Metastatic Pancreatic Cancer Phase 2 Trial, Positioning Company for Key Clinical Milestones Through
Early 2027
Pancreatic
Cancer Remains Strategic Priority as AIM Advances Toward Planned Phase 3 Development While Seeking Select Government-Funded Infectious
Disease Initiatives in Ebola
OCALA,
Fla., August 10, 2026 / AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported
financial results for the second quarter ended June 30, 2026, and provided a business update highlighting continued operational execution
across its lead pancreatic cancer program.
“AIM
continues to execute a clear and disciplined strategy centered on advancing Ampligen in pancreatic cancer,” said AIM Chief Executive
Officer Thomas K. Equels. “Over the past year, we have strengthened our financial position while completing enrollment and Ampligen
dosing in the metastatic pancreatic cancer Phase 2 clinical trial – critical steps as we move toward an anticipated Phase 3 study
in metastatic pancreatic cancer. We anticipate DURIPANC data on clinical benefit in Q1 2027 and on Overall Survival – the gold
standard data point in oncology – in Q3 2027. AIM expects that this data will amplify median Overall Survival findings from Ampligen’s
Dutch-government approved Named Patient Program in late-stage pancreatic cancer, where Ampligen achieved a median Overall Survival of
34.8 months compared to 12.5 months for historical controls – with favorable safety profile and high quality of life – in
a large, easily identifiable and key patient immune biomarker subset. This median improvement of 22.3 months will be a critical component
of the foundation for our pivotal Phase 3 clinical trial design in metastatic pancreatic cancer.”
Second
Quarter and Recent Operational Highlights
| ● | Completed
patient enrollment and Ampligen dosing in the ongoing Phase 2 DURIPANC study evaluating
Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi®
(durvalumab) in metastatic pancreatic cancer. |
| ● | Engaged
Thermo Fisher Scientific’s PPD clinical research business to support study design
of a planned pivotal Phase 3 clinical trial in metastatic pancreatic cancer. |
| ● | Maintained
encouraging observations from Erasmus MC Cancer Institute, including favorable safety
findings, progression-free and overall survival trends, and consistently reported high quality
of life among treated patients. |
| ● | Strengthened
the Company’s balance sheet through multiple financing transactions, providing
additional resources to support continued clinical execution. |
| ● | Successfully
regained full compliance with NYSE American’s continued listing standards. |
| ● | Planning
government-focused initiatives to evaluate Ampligen’s antiviral potential against Ebola
virus disease, consistent with the Company’s strategy of pursuing non-dilutive
funding opportunities for select infectious disease programs while maintaining pancreatic
cancer as its primary strategic focus. |
For
more information, please visit the Company’s website at aimimmuno.com.
Summary
of Financial Highlights for Second Quarter 2026
| ● | As
of June 30, 2026, AIM reported $9.9 million in cash and cash equivalents, as compared to
approximately $3.0 million as of December 31, 2025. |
| ● | Research
and development expenses for the three months ended June 30, 2026 were approximately $589,000,
compared to $1.2 million during the same period in 2025. |
| ● | General
and administrative expenses were approximately $2.9 million for the second quarter of 2026,
compared to $1.5 million during the same period in 2025. |
| ● | Net
loss for the three months ended June 30, 2026 was approximately $(3.8 million), or $(0.43)
per share, compared to $(2.8 million), or $(3.68) per share, for the second quarter of 2025. |
The
Company believes its strengthened financial position supports continued execution of its clinical development strategy and key upcoming
milestones. Please refer to the Company’s Form 10-Q for the quarter ended June 30, 2026, for complete financial results and additional
disclosures.
About
AIM ImmunoTech Inc.
AIM
ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen® (rintatolimod),
for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective
TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.
For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.
Cautionary Statement
This
press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor created by those sections.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied
by such forward-looking statements. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking
statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use
of words such as “believes,” “expects,” “intends,” “may,” “will,” “plans,”
“potential,” “anticipates,” “projects,” or the negative or plural of these words, or other similar
expressions that are predictions or indicate future events or prospects, but the absence of these words does not mean that a statement
is not forward-looking. Any forward-looking statements set forth in this press release speak only as of the date hereof. These forward-looking
statements are based upon the Company’s current expectations, estimates, assumptions, and beliefs concerning future events and
conditions, which are subject to change. Such forward-looking statements may include statements relating to: the anticipated timing of
DURIPANC study data, including clinical benefit data in Q1 2027 and Overall Survival data in Q3 2027; anticipated survival outcomes,
quality-of-life measures, and the safety profile of Ampligen; the Company’s financial position to support clinical development
activities and key milestones; the pursuit of non-dilutive government funding opportunities for select infectious disease programs, including
the evaluation of Ampligen’s antiviral potential against Ebola virus disease; the Company’s Phase 3 clinical trial planning
efforts; the timing of commencement, enrollment, completion, and results of clinical trials; IP expansion and regulatory progress; and
timing for receiving government approvals, if at all. The Company does not undertake to update any of these forward-looking statements
to reflect events or circumstances that occur after the date hereof, except as required by applicable law. The Company is 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 disclosures in the Company’s reports filed with the U.S. Securities and Exchange Commission (the
“SEC”), on its website, and in its press releases set forth its 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 preclinical studies 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, lack of adequate funding, or a change in priorities at the institutions
sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful
or yield any useful data. No assurance can be given that the findings in preliminary studies will prove true or that such studies will
yield favorable results, or that future studies will not result in findings that are different from those reported in the studies referenced
in the Company’s reports filed with the SEC, on the Company’s website, and in its press releases. Operating in foreign countries
carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure
that its potential foreign operations will not be adversely affected by these risks.
For
a detailed discussion of risk factors that could cause actual results to differ materially from those described in the forward-looking
statements, please review the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC. The forward-looking statements in this press release
should be read in conjunction with such filings. These filings are available at www.sec.gov and www.aimimmuno.com. The information found
on the Company’s website is not incorporated by reference into this press release and is included for reference purposes only.
Investor
Contact:
JTC
Team, LLC
Jenene
Thomas
908.824.0775
AIM@jtcir.com