On March 31, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported financial results for the fiscal year ended December 31, 2020 and provides a business update (Press release, AIM ImmunoTech, MAR 31, 2021, View Source [SID1234577432]).
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2020 Financial Highlights
As of December 31, 2020, AIM had cash, cash equivalents and marketable securities of $54.4 million, compared with $8.8 million as of December 31, 2019.
Research and development expenses for 2020 were $5.7 million, compared with $4.7 million for 2019. General and administrative expenses for 2020 were $8.7 million, compared with $7.0 million for 2019.
The net loss from operations for 2020 was $14.4 million, or $0.45 per share, compared with $9.4 million, or $2.58 per share, for 2019.
Please refer to the full 10-K for complete details.
Update on COVID-19 Pandemic Initiatives
AIM has been actively engaged in determining whether its drug Ampligen could be an effective treatment for COVID-19. Due to Ampligen’s established record of antiviral activity against closely related coronaviruses, AIM believes there is a reasonable probability that its antiviral effects against SARS-CoV-1 will extend to SARS-CoV-2. In animal studies, Ampligen demonstrated complete protection (100% survival) against SARS-CoV-1. This created a compelling case for pre-clinical and clinical testing of Ampligen against SARS-CoV-2 to evaluate Ampligen as a potential prophylactic and early-onset treatment for COVID-19, and, as discussed below, such human clinical trials are now underway.
AIM reached several significant COVID-19 milestones in 2020 and early 2021:
AIM announced that it had identified an effective in vitro model at The Institute for Antiviral Research at Utah State University for testing Ampligen, with the results showing that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
AIM reported that Roswell Park Comprehensive Cancer Center’s Phase 1/2a study evaluating the two-drug combination of AIM’s Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 is fully underway, with the first patient enrolled and treated on the study. Based upon that, in March 2020, the company also announced an Institutional Review Board amendment to add a single-agent Ampligen arm to the study.
AIM announced that the post-COVID-19 "Long Hauler" portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with Ampligen.
Dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen (rintatolimod). Additional patients are in the process of being enrolled.
Entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, for the AMP-COV-100 (CHDR2049) clinical study in the Netherlands on the safety of AIM’s drug Ampligen as an intranasal therapy.
Received approval from the Ethics Committee in the Netherlands to commence its Phase 1 clinical study.
Dosed the first healthy subjects in its Phase 1 clinical study.
Ampligen has shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the only drug approved for severe CFS in the world. As witnessed in the prior SARS epidemic of 2002-03, 27% of hospitalized survivors met the U.S. CDC criteria for chronic fatigue syndrome. More than 30 million people in the United States have been infected with SARS-CoV-2, representing a considerable number of people facing potential COVID-induced ME/CFS-like illness in their future. All these facts support our optimism and hopes for the development of a therapy for COVID-induced chronic fatigue.
Update on Cancer Clinical Trials/Programs
Ampligen demonstrated the potential for standalone efficacy in the clinical setting in a number of solid tumors. Six Ampligen clinical trials are currently underway at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors.
AIM reported receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program treating 27 subjects with advanced pancreatic adenocarcinoma conducted at Erasmus University Medical Center in the Netherlands. Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using AIM’s drug Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Median survival was 7.0 months higher in the Ampligen arm as compared to the historical controls. A manuscript for publication is being prepared by the Erasmus MC team.
Towards this end, AIM intends to seek FDA authorization for a follow-up pancreatic cancer Phase 2/3 clinical trial and cancer centers have already expressed interest in serving as clinical sites.
Additionally, Ampligen was awarded an FDA Orphan Drug Designation for the treatment of pancreatic cancer, and a European Medicines Agency orphan medicinal product designation for pancreatic cancer. AIM intends to seek FDA fast-track status for pancreatic cancer. The company will promptly update stockholders and the market as more information on these studies becomes available.
"We are proud to have achieved a number of important milestones throughout 2020 and believe we have a number of key upcoming catalysts. We are conducting important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs within large addressable markets. We are in a solid financial position that enables us to continue to execute on our corporate strategy without relying on third-party grants or assistance. Our strong balance sheet also allows us to accelerate our clinical trials without the need to wait for grants. We look forward to updating stockholders and the market as developments unfold," commented Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech.