AIM ImmunoTech Reports Second Quarter 2022 Financial Results and Provides Corporate Update
15 Août 2022 - 2:05PM
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 second quarter 2022 and provided a
business update.
“As the second quarter results demonstrate, we
believe we are closer than ever to unlocking Ampligen’s commercial
potential,” commented Thomas K. Equels, Chief Executive Officer of
AIM. “Notably, we have recently seen the publication of positive
clinical data regarding several unmet medical needs in highly
lethal malignancies. We have a strong clinical development program,
sufficient operating capital and enough Ampligen to support new
clinical trials. Despite ongoing headwinds for the biotech sector,
we believe we are well-positioned to take advantage of the
value-driving catalysts across our pipeline and look forward to
generating near- and long-term shareholder value. Finally, we
remain focused on delivering sufficient data on Ampligen in
oncology, which we believe could contribute to significant value
creation.”
Recent Highlights
- Reported positive follow-on patient
data from a Single-Center Named Patient Program evaluating Ampligen
as maintenance therapy for advanced pancreatic cancer indicating
additional progression-free and overall survival over previously
published data.
- Provided a summary of Ampligen data
supporting synergistic potential with checkpoint blockade
therapies. See: “Combined loco-regional and systemic, triple agent
chemoimmunotherapy increases biomarkers of T cell chemotaxis in
ovarian cancer.”
- Provided an update on advancement
of Ampligen clinical development program for the treatment of
pancreatic cancer and announced the engagement of Amarex Clinical
Research LLC, a world-renowned CRO, to conduct the upcoming Phase 2
study.
- Reported positive data from Phase
2a study evaluating Ampligen as a component of a chemokine
modulatory (CKM) regimen for the treatment of colorectal cancer
metastatic to the liver.
- Reported positive data from a Phase
1 study evaluating Ampligen for the treatment of stage 4 metastatic
triple negative breast cancer.
- Reported positive preliminary pilot
study data from its ongoing Expanded Access Program (AMP-511)
evaluating Ampligen as a therapeutic for “Long COVID.” The
preliminary data from this uncontrolled clinical trial 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, AIM is
working to move forward with a Phase 2 controlled trial.
- Secured new state-of-the-art
facility for product development and testing to advance research
and development of Ampligen to treat multiple types of cancers,
immune disorders, and viral diseases.
- Bolstered intellectual property
portfolio for Ampligen with issuance of new Netherlands utility
patent covering Ampligen and other AIM-developed dsRNA products for
use in COVID-19 treatment or prevention.
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 therapeutic synergy with
checkpoint inhibitors, including increasing survival rates and
efficacy, in the treatment of animal tumors when used in
combination with checkpoint blockade therapies. The first detection
of Ampligen’s synergistic potential with checkpoint blockade
therapeutics was witnessed in pre-clinical mouse models of melanoma
and pancreatic cancers. Additionally, the Company now has data from
two clinical studies — in advanced recurrent ovarian cancer and
triple negative breast cancer — that indicate that the drug may
have similar anti-tumor activity in humans.
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 U.S.. Ampligen is also being
used 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
- Locally Advanced Pancreatic Cancer
(“LAPC”) – The Company recently reported new, positive data
following evaluation of the initial data reported from the
single-center named patient program at Erasmus for both metastatic
and LAPC patient populations, analyzing the subset of patients with
LAPC. While the predominance of the data collected by Erasmus is in
metastatic cancer and those data show high statistical
significance, a small cohort of five (5) LAPC patients also
exhibited marked improvement with the Ampligen maintenance therapy
following FOLFIRINOX. The overall survival from the start of
FOLFIRINOX therapy of two (2) of the patients was 34 and 43 months
and one patient was still surviving at the last reported checkup in
April 2022 at 54 months. The Company’s Phase 2a study
Investigational New Drug (“IND”) application was cleared by the
U.S. Food and Drug Administration (“FDA”) and is on track to
commence in Q3 2022. The study will compare the efficacy of
Ampligen following FOLFIRINOX versus a control group that
previously received FOLFIRINOX but no Ampligen for subjects with
locally advanced pancreatic adenocarcinoma. Approximately 90
subjects expected to be enrolled across up to 30 centers in the
U.S. and Europe.
- Advanced
Recurrent Ovarian Cancer – Phase 1/2 study of intraperitoneal
chemo-immunotherapy in advanced recurrent ovarian cancer. Phase 1
portion was completed. The Phase 2 portion of the study is planned
to be conducted in the future. ClinicalTrials.gov: NCT02432378
- 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. 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 was completed and met primary
endpoint, evidenced by increased CD8a expression post-treatment
(p=0.046).; 15 patients were treated and 12 patients were evaluable
for the primary endpoint. Data suggest that chemokine modulatory
(CKM) regimen with Ampligen may be useful to enhance effectiveness
of immunotherapies. The data from the Phase 2a study was presented
in April 2022 at the American Association for Cancer Research
(AACR) Annual Meeting 2022. ClinicalTrials.gov: NCT03403634
- Stage 4
Metastatic Triple Negative Breast Cancer – Phase 1 study of
metastatic triple-negative breast cancer using CKM therapy,
including Ampligen and pembrolizumab, successfully met primary
endpoint. Positive data from this proof-of-concept study
demonstrate that short-term systemic CKM followed by pembrolizumab
is well-tolerated and selectively enhances local cytotoxic
T-lymphocyte (CTL) infiltration in the tumor microenvironment
(TME). The data from the Phase 1 study was presented at the
American Association for Cancer Research (AACR) Annual Meeting 2022
in April 2022. 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. Investigators are
currently analyzing data. 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 in Western Equine Encephalitis Virus, Ebola,
Vaccinia Virus (which is used in the manufacture of smallpox
vaccine) 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.
The FDA has authorized Ampligen in a clinical
trial of patients with COVID-19 who have a pre-existing cancer.
That Phase 1/2a study utilizing Ampligen is underway in the
investigator-sponsored Phase 2 trial at the Roswell Park
Comprehensive Cancer Center. ClinicalTrials.gov: NCT04379518
Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic
fatigue syndrome (ME/CFS) / COVID-19 Long Hauler
The Company is currently sponsoring an ongoing,
FDA-authorized AMP-511 (See: ClinicalTrials.gov: NCT00215813)
expanded access program (EAP) for ME/CFS patients in the United
States. AIM has enrolled four post-COVID patients with new onset
ME/CFS following acute COVID-19. Following at least 12 weeks of
Ampligen treatment, each of these four patients indicated they had
experienced a reduction in fatigue, as measured via
Patient-Reported Outcomes questionnaires. A statistical analysis of
these data indicated that the decrease in fatigue compared to
baseline was statistically significant (p<0.002), despite the
small number of patients. Based in part on these early positive
data, AIM is working toward filing an IND application with the FDA
for a Phase 2 study of Ampligen for the treatment of post-COVID
conditions.
Recent Ampligen Data Publications
-
Presented data at the prestigious American Association for Cancer
Research (AACR) Annual Meeting 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
- Presented
Rintatolimod: a potential therapeutic molecule for human pancreatic
cancer cells expressing Toll-Like Receptor 3 at the 15th Annual
International Hepato-Pancreato-Biliary Association (IHPBA) World
Congress.
Summary of Financial Highlights for
Second Quarter 2022
- As of June 30, 2022, AIM reported
cash and cash equivalents of $34.5 million, compared to $32.1
million as of December 31, 2021.
- Research and development expenses
for the three months ended June 30, 2022 were $2.5 million,
compared to $XX1.3 million for the same period in 2021.
- General and administrative expenses
were $2.2 million for the three months ended June 30, 2022,
compared to $2.1 million for the same period in 2021.
- The net loss from operations for
the three months June 30, 2022 was $4.9 million, or $0.10 per
share, compared to $5.9 million, or $0.12 per share, for the three
months ended June 30, 2021.
Please refer to the full 10-Q for complete
details.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immune-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) authorized 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 treatments and
COVID-19 Long Hauler treatment.
For more information, please visit aimimmuno.com
and connect with the Company on Twitter, LinkedIn, and
Facebook.
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
A photo accompanying this announcement is available at
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