AIM ImmunoTech Provides Second Quarter 2021 Business Update

A visual of Ampligen as an intranasal therapy

A visual of Ampligen as an intranasal therapy

OCALA, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) announces financial results for the second quarter ended June 30, 2021 and provides a business update.   

Second Quarter 2021 Financial Highlights:

As of June 30, 2021, AIM had cash, cash equivalents and marketable securities of $57.3 million, compared to $54.4 million as of December 31, 2020.

Research and development expenses for the three months ended June 30, 2021 were $1.3 million, compared to $1.5 million for the three months ended June 30, 2020.

General and administrative expenses for the three months ended June 30, 2021 were $2.1 million, compared to $1.7 million for the three months ended June 30, 2020.

The net loss from operations for the three months ended June 30, 2021 was $5.9 million, or $0.12 per share, compared to $3.4 million, or $0.11 per share, for the three months ended June 30, 2020.

Please refer to the full 10-Q for complete details.

2021 Clinical and Business Highlights

After several years of success in various studies and trials, AIM has decided to strategically narrow its focus to trials and activities that have the shortest path to potential FDA and EMA drug approval, thus putting energy into the tasks where clinical results suggest an opportunity for expedited success. AIM anticipates that these planned trials primarily will be AIM-sponsored and AIM-funded.

Immuno-oncology

Analyses of data collected in the Early Access Program at Erasmus Medical Center (Erasmus MC) in the Netherlands found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Based on these encouraging data, AIM is developing a protocol design and schema — in consultation with Amarex Clinical Research, Buffet Cancer Center at the University of Nebraska and Erasmus MC — to seek regulatory approval to initiate a Phase 2/3 clinical trial of Ampligen in the United States and/or the European Union.

Multiple additional Ampligen clinical trials are underway 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; enrollment has commenced, and 17 subjects have now 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. We await 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. We await 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

COVID-19

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. AIM funded and sponsored the study. This study was designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. All patients had completed treatment by June 2021 and the interim results reported no Severe Adverse Events at any dosage level. The object was to establish safety for intranasal Ampligen as a potential broad spectrum prophylaxis for respiratory viruses, including SARS-CoV-2. 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 trial is expected to commence in Q4 2021. The object is to establish Ampligen’s potential as a broad spectrum prophylaxis for respiratory viruses, including SARS-CoV-2.

In an HCT, subjects are intentionally exposed to particular disease pathogens to test how the diseases will respond to the test treatment. An HCT will allow the Company to expedite the development process for Ampligen by ensuring that all subjects in both the control group and the Ampligen group are exposed to the target pathogen, so as to assess whether there is a prophylactic effect. A successful Phase 2a HCT study could also establish Ampligen’s potential as a prophylaxis against future viral variants and future novel respiratory viruses for which there are no current vaccines or therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.

Immuno-oncology / COVID-19

In June, Ampligen was featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers as a potential treatment option for cancer patients who are infected with SARS-CoV-2. The study’s authors stated that Ampligen has the potential to reduce the severity of the deadly respiratory disease COVID-19, which has so far caused more than 4.3 million deaths globally. The full journal article is titled: “Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients?” Cancers is a peer-reviewed, open access journal of oncology published semimonthly online by MDPI. The study’s authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator for an Early Access Program at Erasmus Medical Center in the Netherlands.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19

On January 6, 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. Additional patients are now in treatment and AIM intends to provide further updates as the trial progresses.

“We continued to make positive clinical and operational progress during the second quarter,” commented, Thomas K. Equels, CEO of AIM ImmunoTech. “With our strong balance sheet, we are well positioned to execute on our corporate strategy and advance our clinical trials to meaningful milestones that we believe will drive significant shareholder value. We anticipate reporting material developments throughout the remainder of this year and through 2022. We remain extremely encouraged by the outlook for Ampligen.”

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, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com        

AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5d6e764a-b8fa-4e05-839c-1c7695edfcc9