On March 31, 2020 AIM ImmunoTech (NYSE American:AIM) reported financial results for the fiscal year ended December 31, 2019, and provides a business update (Press release, AIM ImmunoTech, MAR 31, 2020, View Source;id=188690&p=2174742&I=1206939-c7Z3G6f3m8 [SID1234556048]).
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2019 Financial Highlights
As of December 31, 2019, AIM had cash, cash equivalents and marketable securities of $8.778 million, compared with $1.825 million as of December 31, 2018.
Research and development expenses for 2019 were $4.651 million, compared with $4.778 million for 2018. General and administrative expenses for 2019 were $7.039 million, compared with $6.201 million for 2018.
The net loss from continuing operations for 2019 was $9.533 million, or $2.62 per share, compared with $9.827 million, or $9.77 per share, for 2018.
Please refer to the full 10-K for complete details.
Update on COVID-19 Pandemic Response
Since the outbreak of SARS-CoV-2 – which causes the disease COVID-19 – AIM has been actively engaged in determining whether its drug Ampligen could be an effective treatment for this virus. The company believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the new virus as both a protective prophylaxis and an early-onset therapy.
AIM has reached several significant COVID-19 milestones over the past two months:
AIM filed provisional patent applications to secure the company’s intellectual property before seeking domestic and international research partners.
Japan’s National Institute of Infectious Diseases (NIID) agreed to experiment with Ampligen as a potential treatment for COVID-19. The testing and research will be conducted by laboratories at the NIID and the University of Tokyo. AIM will report immediately upon receipt of results.
AIM engaged ChinaGoAbroad (CGA) to facilitate pre-clinical and clinical trials of Ampligen in the People’s Republic of China (PRC).
AIM is in discussions with GP-Pharm in Argentina to advance Ampligen for potential use against COVID-19. Ampligen is an approved drug in Argentina for use against myalgic encephalomyelitis/chronic fatigue syndrome.
AIM is in discussions in The Netherlands – where Ampligen was recently used to treat pancreatic cancer patients – to explore expedited pre-clinical and clinical trials of Ampligen.
AIM is currently targeting the United States, Europe, Asia and Argentina for new clinical trials and, as necessary steps before clinical trials could begin, the company is in the process of soliciting one or more sites and qualified principal investigators in one or more countries. Protocols for potential clinical trial are in the final stages of development. AIM intends, as a next step, to as rapidly as possible seek Institutional Review Board approvals and governmental authorizations to commence the clinical trials of Ampligen as both a protective prophylaxis and an early-onset therapy.
Update on Cancer Clinical Trials/Programs
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. The company will promptly update stockholders and the market as more information on these studies becomes available. Cancer patients are especially at risk with COVID-19. AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients as a consequence of the COVID-19 medical emergency