AIM ImmunoTech Reports 2020 Year-End Financial Results
March 31 2021 - 9:15AM
AIM ImmunoTech Inc. (NYSE American: AIM) announces financial
results for the fiscal year ended December 31, 2020 and provides a
business update.
2020 Financial Highlights
As of December 31, 2020, AIM had cash, cash
equivalents and marketable securities of $54.4 million, compared
with $8.8 million as of December 31, 2019.
Research and development expenses for 2020 were
$5.7 million, compared with $4.7 million for 2019. General and
administrative expenses for 2020 were $8.7 million, compared with
$7.0 million for 2019.
The net loss from operations for 2020 was $14.4
million, or $0.45 per share, compared with $9.4 million, or $2.58
per share, for 2019.
Please refer to the full 10-K for complete
details.
Update on COVID-19 Pandemic
Initiatives
AIM has been actively engaged in determining
whether its drug Ampligen could be an effective treatment for
COVID-19. Due to Ampligen’s established record of antiviral
activity against closely related coronaviruses, AIM believes there
is a reasonable probability that its antiviral effects against
SARS-CoV-1 will extend to SARS-CoV-2. In animal studies, Ampligen
demonstrated complete protection (100% survival) against
SARS-CoV-1. This created a compelling case for pre-clinical and
clinical testing of Ampligen against SARS-CoV-2 to evaluate
Ampligen as a potential prophylactic and early-onset treatment for
COVID-19, and, as discussed below, such human clinical trials are
now underway.
AIM reached several significant COVID-19
milestones in 2020 and early 2021:
- AIM announced that it had
identified an effective in vitro model at The Institute for
Antiviral Research at Utah State University for testing Ampligen,
with the results showing that Ampligen was able to decrease
SARS-CoV-2 infectious viral yields by 90% at clinically achievable
intranasal Ampligen dosage levels.
- AIM reported that Roswell Park
Comprehensive Cancer Center’s Phase 1/2a study evaluating the
two-drug combination of AIM’s Ampligen and interferon alpha-2b as a
potential early-onset treatment for patients with cancer and
mild-to-moderate COVID-19 is fully underway, with the first patient
enrolled and treated on the study. Based upon that, in March 2020,
the company also announced an Institutional Review Board amendment
to add a single-agent Ampligen arm to the study.
- AIM announced that the
post-COVID-19 "Long Hauler" portion of the active AMP-511
Expanded Access Program (EAP) protocol received approval from
the Institutional Review Board (IRB) for a public notification of
potential patient enrollment. Eligible patients enrolled in the
trial receive treatment with Ampligen.
- Dosed its first COVID-19 “Long
Hauler” patient with the drug Ampligen (rintatolimod). Additional
patients are in the process of being enrolled.
- Entered into a sponsorship
agreement with the Centre for Human Drug Research (CHDR), an
independent institute located in Leiden in the Netherlands, for the
AMP-COV-100 (CHDR2049) clinical study in the Netherlands on the
safety of AIM’s drug Ampligen as an intranasal therapy.
- Received approval from the Ethics
Committee in the Netherlands to commence its Phase 1 clinical
study.
- Dosed the first healthy subjects in
its Phase 1 clinical study.
Ampligen has shown heightened levels of activity
in Phase 2 and 3 trials with Chronic Fatigue Syndrome patients.
Ampligen, while experimental in the United States for CFS, is
approved in Argentina and is the only late-stage experimental drug
for CFS in the U.S. pipeline. Ampligen is also the only drug
approved for severe CFS in the world. As witnessed in the prior
SARS epidemic of 2002-03, 27% of hospitalized survivors met the
U.S. CDC criteria for chronic fatigue syndrome. More than 30
million people in the United States have been infected with
SARS-CoV-2, representing a considerable number of people facing
potential COVID-induced ME/CFS-like illness in their future. All
these facts support our optimism and hopes for the development of a
therapy for COVID-induced chronic fatigue.
Update on Cancer Clinical
Trials/Programs
Ampligen demonstrated the potential for
standalone efficacy in the clinical setting in a number of solid
tumors. Six Ampligen clinical trials are currently underway at
university cancer centers testing whether tumor microenvironments
can be reprogrammed to increase the effectiveness of cancer
immunotherapy, including checkpoint inhibitors.
AIM reported receipt of statistically
significant positive pancreatic cancer survival results from a
multi-year Early Access Program treating 27 subjects with advanced
pancreatic adenocarcinoma 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 7.0 months higher in the Ampligen
arm as compared to the historical controls. A manuscript for
publication is being prepared by the Erasmus MC team.
Towards this end, AIM intends to seek FDA
authorization for a follow-up pancreatic cancer Phase 2/3 clinical
trial and cancer centers have already expressed interest in serving
as clinical sites.
Additionally, Ampligen was awarded an FDA Orphan
Drug Designation for the treatment of pancreatic cancer, and a
European Medicines Agency orphan medicinal product designation for
pancreatic cancer. AIM intends to seek FDA fast-track status for
pancreatic cancer. The company will promptly update stockholders
and the market as more information on these studies becomes
available.
“We are proud to have achieved a number of
important milestones throughout 2020 and believe we have a number
of key upcoming catalysts. We are conducting important and
potentially groundbreaking pre-clinical and clinical research in
critical unmet medical needs within large addressable
markets. We are in a solid financial position that enables us
to continue to execute on our corporate strategy without relying on
third-party grants or assistance. Our strong balance sheet also
allows us to accelerate our clinical trials without the need to
wait for grants. We look forward to updating stockholders and the
market as developments unfold,” commented Thomas K. Equels, Chief
Executive Officer of AIM ImmunoTech.
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.
The Company cannot assure that the CHDR study will be successful or
yield favorable data and 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.
Significant additional testing and trials will be required to
determine whether Ampligen will be effective in the treatment of
COVID-19 as an intranasal therapy or otherwise, and no assurance
can be given that this will be the case. There is the potential for
delays in clinical trial enrollment and reporting because of the
COVID-19 medical emergency. We do not undertake to update any of
these forward-looking statements to reflect events or circumstances
that occur after the date hereof.
Investor Relations
Contact:Crescendo Communications, LLCPhone:
212-671-1021Email: aim@crescendo-ir.com
AIM ImmunoTech IncPhone: 800-778-4042Email:
IR@aimimmuno.com
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