AIM ImmunoTech Reports First Quarter 2022 Financial Results and Provides Corporate Update

• First quarter marked by peer-reviewed journal and abstract publications showcasing statistically significant efficacy data of Ampligen in late-stage pancreatic cancer; results also showcased continued positive data in ovarian and triple-negative breast cancer clinical studies as well as clinical potential with checkpoint inhibitors
• On track to commence Phase 2 study for lead program of Ampligen for pancreatic cancer Q3 2022
• Focus on further advancement of oncology pipeline and well-positioned to achieve multiple clinical and regulatory value-driving milestones throughout 2022
• Cash position of $44.5 million expected to fund company through the end of 2023

OCALA, Fla., May 16, 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 first quarter 2022 and provided a business update.

“The first quarter was marked by the rollout of important clinical data across our pipeline which gives us added confidence in the potential of Ampligen as an important treatment in high-value indications,” commented Thomas Equels, Chief Executive Officer of AIM. “We published clinical efficacy data in our three lead indications, pancreatic, ovarian and triple negative breast cancers in a prestigious peer-reviewed journal and/or at leading oncology scientific congresses. These data were consistent with prior clinical data seen with Ampligen and we believe validate our conviction of its potential in these difficult to treat cancers, including data indicating potentially important effects in combination with checkpoint inhibitors. We remain committed to continue working with preeminent scientific institutions to advance our rich oncology pipeline towards commercialization that we believe will drive the execution of clinical, regulatory and operational catalysts that have the potential to build shareholder value in the near and long-term.”

Recent Highlights

• Provided a summary of clinical data that support the potential of Ampligen® with checkpoint blockade therapies (see AIM’s 4/21/22 press release).
• Engaged world-renowned CRO, Amarex Clinical Research LLC to conduct upcoming Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270).
• 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
• 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 (see: 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 program)
• Announced a contract for the strategic sale of its facility located in New Brunswick, New Jersey for a purchase price of $3.9 million.
• Appointed biotech and finance industry veteran 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 a 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. (See AIM’s 8-K financial filing on 6/14/21 regarding a patent in the Netherlands)

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. 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

• Locally Advanced Pancreatic Cancer – Phase 2 study IND cleared by the U.S. Food and Drug Administration (“FDA”). Study will compare the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX 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. Study is on track to commence in Q3 2022.
• 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); 19 patients were enrolled and 12 patients were evaluable. Data suggest that chemokine modulatory (CKM) regimen with Ampligen may be useful to enhance effectiveness of immunotherapies. Data from the Phase 2a study were 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 – a Phase 1 study of metastatic triple-negative breast cancer using CKM therapy, including Ampligen and pembrolizumab, successfully met its primary endpoint. Eight patients were enrolled and 6 patients were evaluable. Positive data from this proof-of-concept study indicate 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. 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 also conducted laboratory 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 also 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. Patients receiving Ampligen in the ongoing AMP-511 EAP with Long Hauler/Post-COVID conditions (such as fatigue and cognitive function deficiency) have reported improvements after receiving Ampligen.

Recent Ampligen Data Publications

• 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.

Summary of Financial Highlights for First Quarter 2022

• As of March 31, 2022, AIM reported cash and cash equivalents of $44.5 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through 2023.
• Research and development expenses for the three months ended March 31, 2022 were $1.0 million, compared to $1.4 million for the same period in 2021.
• General and administrative expenses were $2.1 million for the three months ended March 31, 2022 and 2021.
• The net loss from operations for the three months March 31, 2022 was $3.8 million, or $0.08 per share, compared to $3.6 million, or $0.08 per share, for the three months ended March 31, 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) approved 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 Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and is currently being evaluated for SARS-CoV-2 and COVID-19 Long Hauler.

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 Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
AIM@jtcir.com

¹Cancers 2022, 14(6), 1377; https://doi.org/10.3390/cancers14061377 (registering DOI)
²Clin Cancer Res January 19 2022 DOI: 10.1158/1078-0432.CCR-21-3659