On November 16, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported financial results for the third quarter ended September 30, 2021 and provides a business update (Press release, AIM ImmunoTech, NOV 16, 2021, View Source [SID1234595703]).
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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. View Source
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. View Source
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. View Source
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. View Source
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. View Source
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. View Source
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. View Source
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."