AIM ImmunoTech Provides Third Quarter 2020 Business Update
November 13 2020 - 7:30AM
AIM ImmunoTech Inc. (NYSE American: AIM), an immuno-pharma company
focused on the research and development of therapeutics to treat
immune disorders, viral diseases and multiple types of cancers,
today provided a business update for the third quarter ended
September 30, 2020.
Third Quarter 2020 Financial Highlights:
- As of September 30, 2020, AIM had
cash, cash equivalents and marketable securities of $54.5 million,
as compared to $8.8 million as of December 31, 2019.
- Research and development expenses
for the three months ended September 30, 2020 were $1.10 million,
compared to $1.19 million for the three months ended September 30,
2019.
- General and administrative expenses
for the three months ended September 30, 2020 were $2.09 million,
compared to $1.85 million for the three months ended September 30,
2019.
The Company’s complete financial results are
available in the Company’s September 30, 2020 Form 10-Q filed with
the Securities and Exchange Commission on November 12, 2020, which
is available at www.sec.gov and on the Company’s website.
Recent Clinical and
Business Highlights
AIM has announced several significant clinical,
research and business milestones since the start of the third
quarter of 2020.
Immuno-oncology
On September 22, AIM announced receipt of
statistically significant positive pancreatic cancer survival
results from a multi-year Early Access Program conducted at Erasmus
University Medical Center in the Netherlands. Prof. Casper van
Eijck, MD Ph.D., and his team at Erasmus MC found a statistically
significantly positive survival benefit when using AIM’s drug
Ampligen in patients with locally advanced/metastatic pancreatic
cancer after systemic chemotherapy. Median survival was
approximately two-fold higher, that is 200%, in the Ampligen arm as
compared to the historical controls. A detailed clinical report and
an article for publication are being prepared by the Erasmus MC
team. AIM intends to facilitate a follow-up pancreatic cancer Phase
2/3 clinical trial based on these data.
Myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS) and COVID-19
On November 2, AIM announced the publication of
statistically significant ME/CFS findings providing further support
for the considerable positive impact Ampligen may have on people
living with ME/CFS when administered in the early stages of the
disease. The data were published in PLOS ONE. AIM researchers
found, in a reanalysis of data from the earlier Phase 3 study, that
the TLR3 agonist Ampligen substantially improved physical
performance in a subset of early-onset ME/CFS patients. The
findings potentially carry special importance for survivors of
COVID-19, many of whom report classic chronic fatigue-like symptoms
after recovering from the acute SARS-CoV-2 infection. These
patients — who are commonly referred to as “Long Haulers” because
of the persistence of these symptoms — are uniquely situated to
potentially benefit from Ampligen as an early onset therapy. As
part of its plan to study this potential benefit, on October 6, AIM
announced the receipt of Institutional Review Board 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.
COVID-19
On August 27, AIM announced the identification
of an effective in vitro model in which Ampligen was shown to be
able to decrease SARS-CoV-2 infectious viral yields by 90% at
clinically achievable intranasal dosage levels. This demonstration
of Ampligen’s bioactivity against SARS-CoV-2 supports the company’s
commitment to the development of Ampligen as both a prophylaxis and
early onset intranasal therapy for COVID-19. To that end, on
September 16, AIM announced that recruitment had begun in Roswell
Park Comprehensive Cancer Center’s Phase 1/2a COVID-19 clinical
study of the effectiveness of Ampligen in combination with
interferon alpha-2b in treating cancer patients with mild or
moderate COVID-19 infection. This followed the Clinical Trial
Agreement between AIM and Roswell Park announced on July 9. Less
than a week earlier, on July 6, AIM also announced its entry into a
trilateral Material Transfer and Research Agreement with Japan’s
National Institute of Infectious Diseases and Shionogi & Co.,
Ltd. to test Ampligen as a potential vaccine adjuvant for COVID-19.
Under the agreement, AIM will provide Ampligen samples for various
research projects.
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 disease caused by the
SARS-CoV-2 virus.
Cautionary StatementThis press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 (the “PSLRA”).
Words such as “may,” “will,” “expect,” “plan,” “anticipate” and
similar expressions (as well as other words or expressions
referencing future events or circumstances) are intended to
identify forward-looking statements. Many of these forward-looking
statements involve a number of risks and uncertainties. Among other
things, for those statements, the Company claims the protection of
safe harbor for forward-looking statements contained in the PSLRA.
For example, significant additional testing and trials will be
required to determine whether Ampligen will be effective in the
treatment of COVID-19 in humans and no assurance can be given that
it will be the case. Results obtained in animal models do not
necessarily predict results in humans. No assurance can be given as
to whether current or planned immuno-oncology 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, the Company cannot assure that the clinical studies will
be successful or yield any useful data or require additional
funding. Some of the world’s largest pharmaceutical companies and
medical institutions are racing to find a treatment for COVID-19.
Even if Ampligen proves effective in combating the virus, no
assurance can be given that the Company’s actions toward proving
this will be given first priority or that another treatment that
eventually proves capable will not make our efforts ultimately
unproductive. The Company recognizes that all cancer centers, like
all medical facilities, must make the pandemic their priority.
Therefore, there is the potential for delays in clinical trial
enrollment and reporting in ongoing studies in cancer patients
because of the COVID-19 medical emergency. No assurance can be
given that future studies will not result in findings that are
different from those reported in the studies referenced. 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. We do not undertake to update
any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof.
Contacts:Crescendo
Communications, LLCPhone:
212-671-1021Email: aim@crescendo-ir.com
AIM ImmunoTech IncPhone:
800-778-4042Email: IR@aimimmuno.com
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