AIM ImmunoTech Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

- Year marked by continued execution across clinical development programs and the continued establishment of a growing body of positive data with Ampligen^® in multiple high-value indications

- Company expected to continue advancing oncology-focused pipeline and well positioned to achieve multiple clinical and regulatory value-driving milestones throughout 2022

- Strong balance sheet to execute strategy, with cash expected to fund operations and clinical development programs through 2023

OCALA, Fla., March 31, 2022 (GLOBE NEWSWIRE) -- 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-a 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-a2b 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-a, 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 Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
AIM@jtcir.com  

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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