Highlights Significant Progress Made in Recent
Years – and Especially Over Past 18 Months – in Repurposing Lead
Drug Ampligen in Oncology to Benefit Patients and All
Shareholders
Calls on Shareholders to Support Continued
Positive Momentum by Re-Electing the AIM Board and Discarding Any
Materials Received from Jorgl Activist Group
The Board of Directors (“Board”) of AIM ImmunoTech Inc. (NYSE:
American AIM) (“AIM” or the “Company”), today announced that the
Company has filed its Definitive Proxy Statement in connection with
AIM’s upcoming 2022 Annual Meeting of Stockholders (the “Annual
Meeting”), to be held on November 3, 2022, and has mailed this
statement, along with a letter, to shareholders.
The full text of the letter follows.
September 19, 2022
Dear fellow shareholders:
Thank you for your investment and your trust in AIM ImmunoTech
(“AIM” or the “Company”). Now is an exciting time for us as we
continue to strive to bring new life-saving oncology therapies to
market to benefit patients and create value for you, our
shareholders. As we will describe in more detail below, we have
made significant progress in recent years – and especially over the
past 18 months – in repurposing our lead drug, Ampligen, into
oncology. We also have strong momentum building upon the positive
interim results in published data from preeminent cancer centers
that we are now seeing from our clinical trials.
Our 2022 Annual Meeting of Stockholders (the “Annual Meeting”)
will be held on November 3, 2022 and we are writing to ask for your
support of our mission to bring life-saving therapies to
market.
This year your vote is especially important because Jonathan
Jorgl, an AIM shareholder who first purchased 1,000 AIM shares on
June 27, 2022, has nominated two director candidates (together with
Mr. Jorgl, the “Jorgl Activist Group”) for election to the Board at
the upcoming Annual Meeting. If these two individuals were elected,
they would control the Board.
Alarmingly, as they disclosed for the first time only last week,
the Jorgl Activist Group’s proxy campaign is being funded by an
individual whose role and identity the Jorgl Activist Group
previously concealed, most likely because he recently pled guilty
to criminal charges of wire fraud relating to fraudulent securities
trading, material misrepresentations to investors and misuse of
funds. As a result, he was recently sentenced by a federal court to
three years of probation and ordered to pay hundreds of thousands
of dollars in restitution.
Additionally, the Board believes that the Jorgl Activist Group
has an undisclosed arrangement with another individual who pled
guilty to insider trading criminal charges brought by the
Department of Justice, and settled insider trading civil charges
brought by the SEC. More details about the Jorgl Activist Group are
contained in the enclosed proxy materials.
The Board has unanimously determined that Mr. Jorgl’s director
nominations did not comply with AIM’s bylaws and are invalid. Mr.
Jorgl is attempting to fight this determination in a case currently
pending before a court, but the critical point is this: we strongly
urge you to ignore any proxy materials you receive from the Jorgl
Activist Group and vote on the Company’s WHITE proxy card for your
current highly qualified directors to protect your investment.
In contemplating your vote, we ask that you consider the
following:
The Current Management Team and Board is Successfully
Executing on the Company’s Business and Capital Allocation
Strategy
- The Company and its management team installed in 2016 has gone
from having little cash, a sustained period of poor share price
performance resulting in the threat of delisting from the New York
Stock Exchange American, inadequate reserves of Ampligen to support
major oncology clinical trials, and no such trials underway, to now
having financial stability after manufacturing an adequate supply
of Ampligen to support clinical trials. This was a vital first step
that the Company was unable to achieve previously and has allowed
us to move forward with our development process.
- AIM has sufficient liquid assets (~$41.7 million per the
Company’s 10-Q for the period ended June 30, 2022) to advance our
priority development pipeline and fund operations through the end
of 2023.
- Further, we have also initiated and are helping to fund several
ongoing oncology clinical trials and early access programs in large
potential markets with lethal unmet medical needs such as advanced
pancreatic cancer and advanced recurrent ovarian cancer.
- Our clinical trials have been yielding consistently
encouraging, statistically significant interim results with
positive safety profiles, which also have been published in peer
reviewed journals. We have achieved multiple potentially
game-changing clinical and regulatory milestones this year and
expect this positive momentum to continue throughout the rest of
2022 and into next year.
- We received notification from the U.S. Food and Drug
Administration (“FDA”) that the FDA’s Clinical Hold on AIM’s
investigational new drug (“IND”) application for a Phase 2 study of
Ampligen as a therapy for locally advanced pancreatic cancer
(AMP-270) has been lifted and the Company may proceed with the
study.
- In April of this year, we announced several positive
developments related to Ampligen, including the following:
- The Independent Investigators from preeminent oncology research
centers presented strongly positive data in three different cancer
indications at the prestigious American Association for Cancer
Research Annual Meeting.
- The Erasmus Medical Center presented published data (Cancers)
demonstrating Ampligen’s potential to offer beneficial anti-tumor
effects in late-stage pancreatic cancer patients, including
Ampligen treatment’s association with higher progression-free and
overall survival in late-stage pancreatic cancer patients when
compared to well-matched historical controls.
- We reported positive data from a Phase 2a study evaluating
Ampligen as a component of a chemokine modulatory (CKM) regimen for
the treatment of colorectal cancer metastatic to the liver.
- We reported positive data from a Phase 1 study evaluating
Ampligen for the treatment of stage 4 metastatic triple negative
breast cancer.
- Further, on July 28, 2022, we reported positive preliminary
pilot study data from our ongoing Expanded Access Program (AMP-511)
evaluating Ampligen in patients with chronic fatigue symptoms
following COVID infections (a form of “Long COVID”).
- The preliminary data from this uncontrolled clinical protocol
found that patients reported significant improvements in fatigue
symptoms after treatment with Ampligen compared to baseline, which
the investigators considered a clinically significant decrease in
fatigue-related measures. Based on these early results, we are
working to move forward with a Phase 2 controlled trial in post
COVID Conditions (also known as “Long COVID”).
An Experienced, Well-Qualified Board
Your Board has the right experience, skill sets and deep
knowledge of the Company and its drug candidates to continue
overseeing the successful execution of our strategy to deliver
therapies for patients and value for our shareholders. More
detailed biographies of our directors are contained in the enclosed
proxy materials.
- Stewart L. Appelrouth possesses key financial and
regulatory expertise as a certified public accountant with over 40
years of accounting and audit experience.
- Thomas K. Equels, M.S. J.D., Executive Vice Chairman,
Chief Executive Officer and President, has over 25 years of
experience as a practicing attorney specializing in complex
business litigation. He also has extensive experience in clinical
trial design and development, creating intellectual property
concepts, and in financing drug development.
- Dr. William M. Mitchell, Chairman, has extensive medical
industry experience, including as a Professor of Pathology at
Vanderbilt University School of Medicine, a board-certified
physician and a former member of the Board of Directors of Chronix
Biomedical, a company involved in next generation DNA sequencing
for medical diagnostics.
We encourage you, as an AIM shareholder, to support the Board –
and ensure the Company has the leadership to protect investors – by
voting online, by phone or by mail, using the WHITE proxy card.
***
WE URGE YOU TO COMPLETE, DATE, AND SIGN THE
ENCLOSED WHITE PROXY CARD AND MAIL IT
PROMPTLY IN THE POSTAGE-PAID ENVELOPE PROVIDED, OR VOTE BY
TELEPHONE OR THE INTERNET AS INSTRUCTED ON THE WHITE PROXY CARD, WHETHER OR NOT YOU PLAN TO
ATTEND THE ANNUAL MEETING.
THE BOARD RECOMMENDS A VOTE “FOR ALL” OF OUR BOARD’S NOMINEES (STEWART
L. APPELROUTH, THOMAS K. EQUELS AND WILLIAM M. MITCHELL)ON
PROPOSAL 1 USING THE ENCLOSED WHITE
PROXY CARD.
Sincerely,
The AIM ImmunoTech Board of Directors
If you have any
questions or need assistance voting, please contact the Company’s
proxy solicitor Morrow Sodali LLC (“Morrow Sodali”) using the below
information.
MORROW SODALI
509 Madison Avenue Suite 1206 New York, NY
10022
Banks and Brokers Call: (203) 658-9400
Stockholders Call Toll Free: (800) 662-5200 E-mail:
AIM@investor.morrowsodali.com
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the
research and development of therapeutics to treat multiple types of
cancers, immune disorders, and viral diseases, including COVID-19.
The Company’s lead product, Ampligen® (rintatolimod) is an
immuno-modulator with broad spectrum activity being developed for
globally important cancers, viral diseases and disorders of the
immune system.
Ampligen is currently being used as a monotherapy to treat
pancreatic cancer patients in an Early Access Program (EAP)
approved by the Inspectorate of Healthcare in the Netherlands at
Erasmus Medical Center and AIM plans to initiate a Phase 2 clinical
study in 2022. The Company also has multiple ongoing clinical
trials to evaluate Ampligen as a combinational therapy for the
treatment of a variety of solid tumor types both underway and
planned at major cancer research centers. Additionally, Ampligen is
approved in Argentina for the treatment of severe chronic fatigue
syndrome (CFS) and is currently being evaluated in many aspects of
SARS-CoV-2/COVID-19 myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS) and Post COVID Conditions.
For more information, please visit aimimmuno.com and connect
with the Company on Twitter, LinkedIn, and Facebook.
Forward-Looking
Statements
This press release contains certain forward-looking statements
that involve risks, uncertainties and assumptions that are
difficult to predict. Words and expressions reflecting optimism,
satisfaction or disappointment with current prospects, as well as
words such as “believes,” “hopes,” “intends,” “estimates,”
“expects,” “projects,” “plans,” “anticipates” and variations
thereof, or the use of future tense, identify forward-looking
statements, but their absence does not mean that a statement is not
forward-looking. The Company’s 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, uncertainties and other factors. The Company urges investors
to consider specifically the various risk factors identified in its
most recent Form 10-K, and any risk factors or cautionary
statements included in any subsequent Form 10-Q or Form 8-K, filed
with the Securities and Exchange Commission. You are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date of this press release. Except as required
by law, the Company does not undertake any responsibility to update
any forward-looking statements to take into account events or
circumstances that occur after the date of this press release.
Important Information
The Company has filed a definitive proxy statement and
associated WHITE proxy card with the SEC in connection with the
solicitation of proxies for the Company’s Annual Meeting. Details
concerning the nominees of the Company’s Board of Directors for
election at the Annual Meeting are included in the proxy statement.
BEFORE MAKING ANY VOTING DECISION, INVESTORS AND STOCKHOLDERS OF
THE COMPANY ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH OR
FURNISHED TO THE SEC, INCLUDING THE COMPANY’S PROXY STATEMENT AND
ANY AMENDMENTS OR SUPPLEMENTS THERETO, WHEN THEY BECOME AVAILABLE
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.
Investors and stockholders will be able to obtain a copy of the
definitive proxy statement, any amendments or supplements thereto
and other documents filed by the Company free of charge from the
SEC’s website, www.sec.gov. Copies of these materials will also be
available free of charge on AIM’s Investor Relations website at
https://aimimmuno.com/sec-filings/.
Participants in the
Solicitation
The Company, its directors and certain of its executive officers
are participants in the solicitation of proxies from stockholders
in respect of the Annual Meeting. Information regarding the names
of the Company’s directors and executive officers and their
respective interests in the Company by security holdings or
otherwise is set forth in the Company’s Definitive Proxy Statement,
filed with the SEC on September 19, 2022. To the extent holdings of
such participants in the Company’s securities have changed since
the amounts described in the Definitive Proxy Statement, such
changes have been or will be reflected on Initial Statements of
Beneficial Ownership on Form 3 or Statements of Change in Ownership
on Form 4 filed with the SEC. These documents can be obtained free
of charge from the sources indicated above.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220919005291/en/
Investor Contacts:
JTC Team, LLC Jenene Thomas 833-475-8247 AIM@jtcir.com
OR
Morrow Sodali AIM@investor.MorrowSodali.com
Media Contact:
Longacre Square Partners Dan Zacchei / Joe Germani
dzacchei@longacresquare.com / jgermani@longacresquare.com
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