AIM ImmunoTech Provides Third Quarter 2020 Business Update

OCALA, Fla., Nov. 13, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today provided a business update for the third quarter ended September 30, 2020.

Third Quarter 2020 Financial Highlights:

• As of September 30, 2020, AIM had cash, cash equivalents and marketable securities of $54.5 million, as compared to $8.8 million as of December 31, 2019.
• Research and development expenses for the three months ended September 30, 2020 were $1.10 million, compared to $1.19 million for the three months ended September 30, 2019.
• General and administrative expenses for the three months ended September 30, 2020 were $2.09 million, compared to $1.85 million for the three months ended September 30, 2019.
  

The Company’s complete financial results are available in the Company’s September 30, 2020 Form 10-Q filed with the Securities and Exchange Commission on November 12, 2020, which is available at www.sec.gov and on the Company’s website.

Recent Clinical and Business Highlights

AIM has announced several significant clinical, research and business milestones since the start of the third quarter of 2020.

Immuno-oncology

On September 22, AIM announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program 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 approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls. A detailed clinical report and an article for publication are being prepared by the Erasmus MC team. AIM intends to facilitate a follow-up pancreatic cancer Phase 2/3 clinical trial based on these data.

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

On November 2, AIM announced the publication of statistically significant ME/CFS findings providing further support for the considerable positive impact Ampligen may have on people living with ME/CFS when administered in the early stages of the disease. The data were published in PLOS ONE. AIM researchers found, in a reanalysis of data from the earlier Phase 3 study, that the TLR3 agonist Ampligen substantially improved physical performance in a subset of early-onset ME/CFS patients. The findings potentially carry special importance for survivors of COVID-19, many of whom report classic chronic fatigue-like symptoms after recovering from the acute SARS-CoV-2 infection. These patients — who are commonly referred to as “Long Haulers” because of the persistence of these symptoms — are uniquely situated to potentially benefit from Ampligen as an early onset therapy. As part of its plan to study this potential benefit, on October 6, AIM announced the receipt of Institutional Review Board approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously diagnosed with SARS-CoV-2.

COVID-19

On August 27, AIM announced the identification of an effective in vitro model in which Ampligen was shown to be able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal dosage levels. This demonstration of Ampligen’s bioactivity against SARS-CoV-2 supports the company’s commitment to the development of Ampligen as both a prophylaxis and early onset intranasal therapy for COVID-19. To that end, on September 16, AIM announced that recruitment had begun in Roswell Park Comprehensive Cancer Center’s Phase 1/2a COVID-19 clinical study of the effectiveness of Ampligen in combination with interferon alpha-2b in treating cancer patients with mild or moderate COVID-19 infection. This followed the Clinical Trial Agreement between AIM and Roswell Park announced on July 9. Less than a week earlier, on July 6, AIM also announced its entry into a trilateral Material Transfer and Research Agreement with Japan’s National Institute of Infectious Diseases and Shionogi & Co., Ltd. to test Ampligen as a potential vaccine adjuvant for COVID-19. Under the agreement, AIM will provide Ampligen samples for various research projects.

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. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the 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. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that the Company’s actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. The Company 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 because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

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