AIM ImmunoTech headed in 2021 with $54.4M in capital as it advances Ampligen to treat COVID-19 and cancer

AIM ImmunoTech Inc (NYSEAMERICAN:AIM) announced Wednesday that it ended 2020 with cash, cash equivalents, and marketable securities of $54.4 million.  That’s a sizable increase compared to the $8.8 million in cash it recorded as of December 31, 2019, according to a statement.  AIM also said 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, versus $7 million in 2019. READ: AIM ImmunoTech doses first healthy subject in intranasal Ampligen coronavirus study In addition, the company reported a net loss from operations for 2020 of $14.4 million, or $0.45 per share, compared with $9.4 million, or $2.58 per share, for 2019. Flushed with its cash runway, AIM in 2021 has been using its lead drug Ampligen in the fight against coronavirus (COVID-19). Last month the company received approval from the required Ethics Committee in the Netherlands to commence its Phase 1 clinical study on the safety of Ampligen as an intranasal therapy. It is a critical step in its ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases. It has dosed the first healthy subjects in the Phase 1 study. The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. AIM also is studying Ampligen to treat Chronic Fatigue Syndrome, which the COVID-19 disease can induce in patients.   Cancer trials In addition, AIM said Ampligen has demonstrated the potential for standalone efficacy in the clinical setting in a number of solid cancer tumors. Six 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. Specifically, 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.  Towards this end, AIM said it intends to seek authorization from the US Food and Drug Administration (FDA) for a follow-up pancreatic cancer Phase 2/3 clinical trial -- as cancer centers have already expressed interest in serving as clinical sites. “We are proud to have achieved a number of important milestones throughout 2020 and believe we have a number of key upcoming catalysts,” said CEO Thomas Equels. “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.” Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham