AIM ImmunoTech Announces FDA Authorization for First Human Ampligen Trial in COVID-19 Patients with Cancer; Provides Corporate Business Update for the First Quarter of 2020

OCALA, FL / ACCESSWIRE / May 14, 2020 / AIM ImmunoTech (NYSE American:AIM) today announced that the U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of the Company's lead asset, Ampligen (rintatolimod), in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus. The Company also provided a corporate business update and reported financial results for the first quarter ended March 31, 2020.

The new clinical trial, to be conducted at Roswell Park Comprehensive Cancer Center under the leadership of Pawel Kalinski, MD, PhD, a pioneer in developing this combination as an investigational treatment for cancer, and Brahm Segal, MD, will test the safety of this combination regimen in patients with cancer and mild to moderate COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. The phase 1/2b study will enroll approximately 40 patients in two stages. Phase 1 will see 12-24 patients receiving both Ampligen and interferon alfa-2b at escalating doses. Once that initial phase is complete, further study participants will be randomized to two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alfa but will receive best available care. AIM ImmunoTech intends to be a financial sponsor of the study and will provide Ampligen (rintatolimod) at no charge for this study. Additional information on the clinical trial is available at clinicaltrials.gov.

In the years that followed the first SARS-CoV-1 epidemic, studies of SARS-CoV-1 in mouse models showed that Ampligen demonstrated a protective effect. Barnard 2006 showed that Ampligen "reduced virus lung titers to below detectable limits." Day 2009 similarly showed that Ampligen "led to more rapid decline of virus in the lungs compared with untreated animals" with a 100% survival outcome in the mouse study as opposed to a 100% death rate in the control group. These controlled studies evidence Ampligen's activity against SARS-CoV-1.

A comparison of important pathogenic features of SARS-CoV-1 and SARS-CoV-2 (the virus that causes COVID-19) indicated that both viruses utilized the same ACE2 receptor to bind to and infect human cells. In addition, important genetic sequences of both viruses were almost identical. These similarities among the analyzed genetic sequences and the use of the same receptor suggested a potential likely extension of the antiviral effect of Ampligen seen with the above-mentioned SARS-CoV-1 experiments to that of SARS-CoV-2, the virus that caused the COVID-19 pandemic.

Dr. David Strayer, Chief Scientific Officer, stated, "We are extremely pleased that Dr. Kalinski and his team at Roswell Park have obtained FDA authorization to initiate this combinational study using Ampligen in combination with interferon for cancer patients with COVID-19. Historically, Ampligen was shown to have synergistic antitumor and antiviral activity when combined with human interferons in studies published in the 1980s. A clinical study was conducted using Ampligen in combination with interferon in patients with solid tumors. The study showed that the combination was generally well-tolerated. AIM announced February 11, 2020, the filing of three provisional patent applications surrounding Ampligen for use against COVID-19. These applications cover the use of Ampligen, both alone and in combination with interferon as an early onset therapy for COVID-19. Further, we filed for Ampligen as a proposed intranasal coronavirus vaccine enhancer that would combine Ampligen with inactive SARS-CoV-2. At AIM, we believe that Ampligen has the potential to play several important roles in the war against COVID-19."

"Our experience with the combination of interferon alfa with a viral mimic such as Ampligen applied to achieve modulation of the cancer microenvironment convinced us that this could be an effective strategy also against COVID-19," said Dr. Kalinski, who is Vice Chair for Translational Research and Rustum Family Professor for Molecular Therapeutics and Translational Research at Roswell Park, and is scientific lead on the cancer center's studies with this combination. "We hope that these two drugs, given together, will limit viral replication in the infected cells, prevent viral transmission to other cells and spur early innate immune response in cancer patients with COVID-19, before the virus spreads and they become seriously ill. While for decades, immuno-oncology drew heavily from virology, this development suggests that recent progress in the immuno-oncology field may allow us to return the favor and to accelerate the development of new treatments of infectious diseases."

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Thomas K. Equels, CEO of AIM ImmunoTech, commented, "Since this January, when we filed our provisional patent applications, we have been focused on advancing Ampligen as a potential treatment for COVID-19 and believe Ampligen has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus. Dr. Segal, Dr. Kalinski and their teams at Roswell Park, with genius and creativity in this pandemic, are focused on saving the lives of cancer patients. Roswell deserves great credit for exploring the important and potentially life-saving role of Ampligen in cancer patients with COVID-19, a patient population they are dedicated to serving. AIM is very pleased to see that the FDA has authorized this human study at Roswell Park to conduct research on Ampligen in combination with interferon alfa as a possible antiviral treatment for COVID-19 for high risk cancer patients."

Equels further noted, "Following the results of this trial, we hope to expand tests of Ampligen to other high risk and immunocompromised COVID-19 groups as the death rate in these groups is often five to seven times higher than the general population. Ampligen has an extremely well developed safety profile, which is based on more than 100,000 IV doses administered to humans, and has shown minimal side effects in multiple clinical trials which makes it an acceptable drug candidate for study in vulnerable patient populations."

Ellen Lintal, CFO of AIM ImmunoTech, stated, "I am pleased to report we have a solid balance sheet with over $31.1 million in cash, cash equivalents and marketable securities as of March 31, 2020. The strength of our balance sheet allows us to continue to advance both our COVID-19 and oncology programs. As we move forward in the new COVID-19 trials, it is likely we will see a corresponding increase in expenses; however, we continue to carefully manage expenses which has allowed us to generally minimize our burn rate."

Update on Cancer Clinical Trials/Programs

Ampligen clinical trials are currently underway at academic cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors. AIM will promptly update stockholders and the market as more information on these studies becomes available. However, with the nation's health care system increasingly focused on the COVID-19 pandemic - and with cancer patients especially at risk for the disease - AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for some delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency.

First Quarter Financial Highlights:

  • As of March 31, 2020, AIM had cash, cash equivalents and marketable securities of $31.1 million, as compared to $8.8 million as of December 31, 2019.
  • Research and development expenses for the first quarter ended March 31, 2020 were $898,000, compared to $928,000 for the first quarter ended March 31, 2019. General and administrative expenses for the first quarter ended March 31, 2020 were $2.3 million, compared to $2.8 million for the first quarter ended March 31, 2019.
  • Net loss for the first quarter ended March 31, 2020 was $3.8 million, or $0.22 per share, compared to a net loss of $3.5 million, or $2.91 per share, for the first quarter ended March 31, 2019.

The Company's complete financial results are available in the Company's Form 10-Q filed with the Securities and Exchange Commission on May 14, 2020 which is available at www.sec.gov and on the Company's website.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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. These statements involve a number of risks and uncertainties. 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. In this regard, the FDA authorization of the IND is the first step and no assurance can be given as to whether the Roswell trial and/or subsequent trails will prove successful. Some of the world's largest pharmaceutical companies are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that, even if Ampligen proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. 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. With regard to the Company's activities with Ampligen generally, no assurance can be given as to whether current or planned 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. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. 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. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.

Reference:

AIM ImmunoTech Joins with ChinaGoAbroad for an Ampligen China Entry Against COVID-19, the New SARS-like Coronavirus Disease Epidemic

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