AIM ImmunoTech Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
01 April 2022 - 07:05AM
AIM ImmunoTech Reports Fourth Quarter and Full Year 2021 Financial
Results and Provides Corporate Update
AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or
the “Company”), 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, today reported its
financial results for the full year 2021 and provided a business
update.
“We believe 2021 was an important, foundational
year for AIM. Our oncology pipeline continued to develop and
generate important data across our clinical programs. This progress
has substantially and positively impacted our growing body of data
– data which continues to be consistent with key findings across
multiple indications. Importantly, this data provides valuable
guidance as we are identifying the clear pathways for next steps
with Ampligen, as a monotherapy as well as its utility as a
combination therapy, in high-value indications with the potential
to fill significant gaps in various treatment paradigms,” commented
Thomas Equels, Chief Executive Officer of AIM. “So far, in 2022
Ampligen data has been published in peer-reviewed journals and
multiple abstracts and posters have been accepted at prestigious
scientific congresses, representing noteworthy progress across our
pipeline. Over the course of 2022, we expect to achieve a number of
additional potentially value-driving clinical, regulatory and
operational catalysts. Our team is laser focused on executing on
our strategy and propelling AIM toward its next phase of
growth.”
Recent Highlights
- 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.
- Announced the publication of
positive data from a single-center, named-patient program treating
advanced and metastatic pancreatic cancer patients.
- Announced the strategic sale of its
facility located in New Brunswick, New Jersey for a purchase price
of $3.9 million.
- Appointed Robert Dickey IV as Chief
Financial Officer, effective April 4, 2022.
- Announced the publication of
positive results from Phase 1/2 study of intraperitoneal
chemo-immunotherapy in advanced recurrent ovarian cancer.
Clinical Program Update
Ampligen® (rintatolimod): dsRNA being developed for globally
important cancers, viral diseases and disorders of the immune
system
Ampligen has demonstrated in the clinic the
potential for standalone efficacy in a number of solid tumors.
Additionally, Ampligen has shown success in increasing survival
rates and efficacy in the treatment of animal tumors when used in
combination with checkpoint blockade therapies. Ampligen is being
evaluated as a combinational therapy for the treatment of a variety
of solid tumor types in multiple clinical trials – both underway
and planned – at major cancer research centers around the country.
Ampligen is also 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.
Immuno-Therapy Targeting Multiple Cancers with High Unmet
Need
- Advanced
Recurrent Ovarian Cancer – Phase 1 portion was completed. A
follow-up Phase 2 study of advanced recurrent ovarian cancer using
cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be
enrolled; numerous patients have commenced treatment.
ClinicalTrials.gov: NCT03734692
- Stage 4
Colorectal Cancer Metastatic to the Liver – Phase 2a study of
Ampligen as a component of a chemokine modulatory regimen on
colorectal cancer metastatic to liver has been completed; 15
patients were enrolled and treated. Data was accepted for a
late-breaking presentation at the American Association for Cancer
Research (AACR) Annual Meeting 2022 being held April 8-13, 2022 and
are under embargo until then. ClinicalTrials.gov: NCT03403634
- Stage 4
Metastatic Triple Negative Breast Cancer – Phase 1/2 study of
metastatic triple-negative breast cancer using chemokine modulation
therapy, including Ampligen and pembrolizumab. Eight patients were
enrolled and treated. Data was accepted for a late-breaking
presentation at the American Association for Cancer Research (AACR)
Annual Meeting 2022 being held April 8-13, 2022 and are under
embargo until then. ClinicalTrials.gov: NCT03599453
-
Early-Stage Prostate Cancer – 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 has been
initiated in this study designed for up to 45 patients.
ClinicalTrials.gov: NCT03899987
-
Early-Stage Triple Negative Breast Cancer – Phase 1 study of
chemokine modulation plus neoadjuvant chemotherapy in patients with
early-stage triple negative breast cancer has received FDA
authorization. The objective of this study is to evaluate the
safety and tolerability of a combination of Ampligen and celecoxib
with or without Intron A, when given along with chemotherapy. The
goal of this approach is to increase survival. This study is
recruiting patients and is designed for up to 24 patients.
ClinicalTrials.gov: NCT04081389
-
Refractory Melanoma – Phase 2 study that will evaluate polarized
dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib
for the treatment of HLA-A2+ refractory melanoma at Roswell Park.
Up to 24 patients to be enrolled. ClinicalTrials.gov:
NCT04093323
- Advanced Ovarian
Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant
Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen
at the University of Pittsburgh.
Broad-Spectrum Immune System Response Against SARS-CoV-2
(COVID-19)
Previous animal studies yielded positive results
utilizing Ampligen to treat Western Equine Encephalitis Virus,
Ebola and SARS-CoV-1. The Company has conducted experiments in
SARS-CoV-2 showing Ampligen has a powerful impact on viral
replication. The prior studies of Ampligen in SARS-CoV-1 animal
experimentation may predict similar protective effects against
SARS-CoV-2. AIM is currently evaluating the safety and
effectiveness of intravenous Ampligen to reduce replication of
SARS-CoV-2 virus from upper airway in patients in an ongoing Phase
1/2 study for the treatment of COVID-19 cancer patients. The
Company plans to conduct an intranasal study of Ampligen to
potentially enhance and expand natural immunity.
Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic
fatigue syndrome (ME/CFS) / COVID-19 Long Hauler
The Company is currently sponsoring an expanded
access program (EAP) for ME/CFS patients in the United States, and
in 2021 AIM dosed its first “Long Hauler” patient with Ampligen in
its post-COVID-19 “Long Hauler” portion of the active AMP-511 EAP
in the United States. Early data from the ongoing AMP-511 EAP and
data from an earlier study, AMP-502, has indicated that patients
with cognitive function deficiency have reported improvements in
cognitive function after Ampligen treatment.
Summary of Recent Ampligen Data
Publications
- Abstracts
accepted for presentation at American Association for Cancer
Research (AACR) Annual Meeting 2022, being held April 8-13, 2022:
- Negative
impact of paclitaxel on human breast tumor microenvironment and its
reversal by the combination of interferon-α with TLR3 agonist
rintatolimod
- Initial
results of a phase II study evaluating a chemokine-modulatory (CKM)
regimen in patients with colorectal cancer metastatic to the
liver
- Systemic
Rintatolimod and Interferon-α2b selectively reprogram local tumor
microenvironment in patients with metastatic triple negative breast
cancer for enhanced influx of cytotoxic T-lymphocytes but not
regulatory T-cells
- Combined
loco-regional and systemic, triple agent chemoimmunotherapy
increases biomarkers of T cell chemotaxis in ovarian cancer
- Positive
data from a single-center named patient program was published in
March 2022. The manuscript titled, “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 program1,” was published in the peer-reviewed
journal, Cancers Special Issue: Combination and Innovative
Therapies for Pancreatic Cancer.
- Positive
results of a Phase 1/2 study of intraperitoneal chemo-
immunotherapy in advanced recurrent ovarian cancer were published
in January 2022. The manuscript titled, “Phase I trial combining
chemokine-targeting with loco-regional chemo-immunotherapy for
recurrent, platinum-sensitive ovarian cancer shows induction of
CXCR3 ligands and markers of type 1 immunity2” was published in the
American Association for Cancer Research publication, Clinical
Cancer Research.
- Rintatolimod
Induces Antiviral Activities in Human Pancreatic Cancer Cells:
Opening for an Anti-COVID-19 Opportunity in Cancer Patients?
- Phase II Trial
of Adjuvant Dendritic Cell Vaccine in Combination with Celecoxib,
Interferon-α, and Rintatolimod in Patients Undergoing Cytoreductive
Surgery and Hyperthermic Intraperitoneal Chemotherapy for
Peritoneal Metastases
Summary of Financial Highlights for
Fiscal Year 2021
- As of December 31, 2021, AIM
reported cash and cash equivalents of $48.3 million, compared to
$54.4 million as of December 31, 2020.
- Research and development expenses
for the year ended December 31, 2021 were $7.6 million, compared to
$5.7 million for the year ended December 30, 2020.
- General and administrative expenses
for the year ended December 31, 2021 were $8.7 million, compared to
$8.7 million for the year ended December 31, 2020.
- The net loss from operations for
the year December 31, 2021 was $19.1 million, or $0.40 per share,
compared to $14.4 million, or $0.45 per share, for the year ended
December 31, 2020.
Please refer to the full 10-K for complete
details.
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. For
more information, please visit www.aimimmuno.com.
Cautionary Statement
This 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 does not undertake
to update any of these forward-looking statements to reflect events
or circumstances that occur after the date hereof.
Investor Relations ContactJTC
Team, LLCJenene Thomas 833-475-8247AIM@jtcir.com
________________________________
1 Cancers 2022, 14(6), 1377;
https://doi.org/10.3390/cancers14061377 (registering DOI)2 Clin
Cancer Res January 19 2022 DOI: 10.1158/1078-0432.CCR-21-3659
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