AIM ImmunoTech Provides Third Quarter 2021 Business Update
AIM ImmunoTech Inc. (NYSE American: AIM) announces financial
results for the third quarter ended September 30, 2021 and provides
a business update.
Third Quarter 2021 Financial
Highlights:
As of September 30, 2021, AIM had cash, cash
equivalents and marketable securities of $53.7 million, compared to
$54.4 million as of December 31, 2020.
Research and development expenses for the three
months ended September 30, 2021 were $2.0 million, compared to $1.1
million for the three months ended September 30, 2020.
General and administrative expenses for the
three months ended September 30, 2021 were $1.8 million, compared
to $2.1 million for the three months ended September 30, 2020.
The net loss from operations for the three
months ended September 30, 2021 was $3.8 million, or $0.08 per
share, compared to $3.3 million, or $0.08 per share, for the three
months ended September 30, 2020.
Please refer to the full 10-Q for complete
details.
2021 Clinical and Business
Highlights
AIM has established a strong foundation of
laboratory, pre-clinical and clinical data with respect to the
development of nucleic acids and natural interferon to enhance the
natural antiviral defense system of the human body, and to aid the
development of therapeutic products for the treatment of certain
cancers and chronic diseases. AIM’s strategy is to advance trials
and activities that have the shortest path to potential FDA and EMA
drug approval, providing opportunities for expedited success. AIM
anticipates that these planned trials primarily will be
AIM-sponsored and AIM-funded.
Immuno-oncology
Following statistically significant positive
survival data collected from the Early Access Program at Erasmus
Medical Center (Erasmus MC) in the Netherlands, AIM and its
Contract Research Organization, Amarex Clinical Research LLC,
submitted an Investigational New Drug application and an
accompanying application for Fast Track status to the U.S. Food and
Drug Administration for a planned Phase 2 study of Ampligen as a
therapy for locally advanced or metastatic late-stage pancreatic
cancer. The Buffett Cancer Center at the University of
Nebraska Medical Center (UNMC) and Erasmus MC in The
Netherlands are expected to be the primary study sites, although
additional sites are expected to participate. Assuming this trial
and subsequent planned clinical trials confirm the existing data,
AIM expects to then submit a New Drug Application for use of
Ampligen in pancreatic cancer patients.
Furthermore, AIM continues to advance multiple
additional Ampligen clinical trials at university cancer centers
testing whether tumor microenvironments can be reprogrammed to
increase the effectiveness of cancer immunotherapy, including with
checkpoint inhibitors:
- Advanced
Recurrent Ovarian Cancer - 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.
https://clinicaltrials.gov/ct2/show/NCT03734692
- 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. AIM awaits publication of data.
https://www.clinicaltrials.gov/ct2/show/NCT03599453
- 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; 15 patients were enrolled
and treated. AIM awaits publication of data.
https://clinicaltrials.gov/ct2/show/NCT03403634
- 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.
https://clinicaltrials.gov/ct2/show/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.
https://clinicaltrials.gov/ct2/show/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.
https://www.clinicaltrials.gov/show/NCT04093323
- Ovarian Cancer
- AIM plans to develop a Phase 2 Cisplatin Resistant Advanced
Recurrent Ovarian Cancer Clinical Study utilizing Ampligen at the
University of Pittsburgh.
Additionally, AIM is awaiting publication of the
results of a Phase 1/2 study of intraperitoneal chemo-
immunotherapy in advanced recurrent ovarian cancer. The Phase 1
portion was designed to establish intraperitoneal safety.
https://clinicaltrials.gov/ct2/show/NCT02432378.
COVID-19 and Antiviral Therapies
In January, AIM entered into a Sponsor Agreement
with the Centre for Human Drug Research (CHDR), a foundation
located in Leiden in the Netherlands, to manage a Phase 1
randomized, double-blind study to evaluate the safety and activity
of repeated intranasal administration of Ampligen. The objective
was to establish safety for intranasal Ampligen as a potential
broad-spectrum prophylaxis for respiratory viruses, including
SARS-CoV-2. All patients had completed treatment by June 2021 and
the interim results reported no Severe Adverse Events at any dosage
level. During the third quarter, AIM released detailed safety data
from the Phase 1 study which is available on the AIM website.
Following the completion of the Phase 1 dosing,
and based on its positive interim results, in July 2021 AIM signed
a Reservation and Start-Up Agreement with hVIVO, reserving space in
hVIVO’s quarantine facility to sponsor a Phase 2a Human Challenge
Trial (HCT) to test Ampligen as a potential intranasal antiviral
therapy using a human Rhinovirus hRV (a common cold virus) and
Influenza as challenge viruses. This antiviral study will be
conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly
growing specialist pharmaceutical services clinical research
organization and world leader in vaccine and antiviral testing
using human challenge clinical trials. The objective is to
establish Ampligen’s potential as a broad-spectrum prophylaxis for
respiratory viruses, a category that includes SARS-CoV-2 and future
emerging pathogens with pandemic potential.
AIM submitted its study protocol to the Oxford Research Ethics
Committee (REC)/Medicines and Healthcare Regulatory Agency (MHRA)
on September 10, 2021. The REC approved the protocol, but the MHRA
provided a response outlining areas of the submission where it
requires additional information. The Company intends to re-submit
its proposed protocol as soon as possible.
Myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS) / COVID-19 Long Hauler
Earlier this year, AIM announced that the
post-COVID-19 “Long Hauler” portion of the active AMP-511
Expanded Access Program (EAP) in the U.S. dosed its first
“Long Hauler” patient with the drug Ampligen, marking a significant
milestone in AIM’s efforts to develop an effective therapeutic for
people suffering from post-COVID-19 infection chronic fatigue-like
symptoms. As of September 30, 2021, there are 14 patients enrolled
in this open-label expanded access treatment protocol including
three post-COVID-19 patients with cognitive dysfunction. Early data
from the ongoing AMP-511 Expanded Access Program has indicated that
patients with cognitive function deficiency have reported
improvements in cognitive function after Ampligen treatment. AIM
intends to provide updates as the trial progresses.
Patents / Intellectual Property
During the quarter, AIM filed two COVID-19
related provisional patent applications. In August, AIM filed an
application for Ampligen as both an intranasal and an intravenous
therapy for what the Company describes as Post-COVID-19 Cognitive
Dysfunction (“PCCD”). The U.S. Centers for Disease Control and
Prevention refers to Long COVID or Long Haulers as Post COVID
Conditions. One of these conditions is difficulty thinking or
concentrating, sometimes referred to as brain fog. The people
suffering from PCCD, including some young adults, can be afflicted
with severe difficulties in concentrating; serious memory problems;
and the inability to live an active lifestyle, to work and even to
perform everyday tasks. Early data has demonstrated that patients
with symptoms of PCCD being treated with Ampligen in the ongoing
AMP-511 Expanded Access Program have reported improvements in
cognitive function. Similarly, in ME/CFS, data from the AMP-502
study showed that Ampligen improved cognitive function.
In September, AIM filed a patent application for
Ampligen as a potential early-onset intranasal therapy designed to
enhance and expand infection-induced immunity, epitope spreading,
cross-reactivity and cross-protection in patients exposed to a wide
range of RNA respiratory viruses, such as influenza, Rhinoviruses
and SARS-CoV-2.
AIM believes that these two provisional patent
applications are important steps towards advancing proposed studies
in these areas.
“We are proud of the progress made through the
third quarter,” commented, Thomas K. Equels, CEO of AIM ImmunoTech.
“We continue to advance multiple clinical trials towards major
inflection points that we believe will provide significant benefits
for patients and drive shareholder value. Given the broad
immunological effects of Ampligen, as illustrated by our growing
pre-clinical and clinical data, we believe Ampligen has tremendous
market potential across a wide range of indications. We have
maintained a strong balance sheet, which provides us funding to
execute our corporate strategy, as well as internally fund clinical
trials, which should accelerate our therapeutic development. We
remain very encouraged by the outlook for the business and look
forward to reporting on key upcoming developments.”
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 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. We are 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. Significant additional testing and
trials will be required to determine whether Ampligen will be
effective in the treatment of these conditions. The Company cannot
assure that its many studies 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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