AIM AIM ImmunoTech Inc.

2.25
-0.03  -1%
Previous Close 2.28
Open 2.28
52 Week Low 1.6
52 Week High 4.3
Market Cap $89,302,527
Shares 39,690,012
Float 2,304,903
Enterprise Value $130,562,439
Volume 471,097
Av. Daily Volume 3,018,233
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Drug Pipeline

Drug Stage Notes
Ampligen, Intron A, and celecoxib
Colorectal cancer
Phase 2
Phase 2
Phase 2 trial ongoing.
Ampligen, cisplatin and pembrolizumab
Ovarian cancer
Phase 2
Phase 2
Phase 2 trial is enrolling - noted August 2020.
Ampligen and interferon alpha-2b
COVID-19
Phase 1/2
Phase 1/2
Phase 1/2a trial commencement of dosing announced November 25, 2020.
Ampligen, Intron A, celecoxib and pembrolizumab
Triple-Negative Breast Cancer
Phase 1
Phase 1
All patients have been treated or are near completion of treatment - August 2020.
Ampligen, Intron A
Prostate Cancer
Phase 2
Phase 2
Phase 2 trial has been initiated - noted August 2020.
Ampligen
CFS
CRL
CRL
CRL February 4, 2013.

Latest News

  1. OCALA, Fla., April 07, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, reporting no serious adverse events, and paving the way for escalation of the dose in Cohort 2. The trial is a critical step in the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

    The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049), titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety…

    OCALA, Fla., April 07, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has completed dosing of Cohort 1 in a Phase 1 clinical study on the safety of AIM's drug Ampligen as an intranasal therapy, reporting no serious adverse events, and paving the way for escalation of the dose in Cohort 2. The trial is a critical step in the company's ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

    The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049), titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects." AIM is the sponsor and is funding the clinical study.

    The study protocol calls for the enrollment of eight healthy subjects in each of four Cohorts to receive Ampligen. In addition, two healthy subjects in each Cohort will receive placebo, for a total of 40 healthy subjects. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. This study will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The protocol design is for subjects in Cohort 1 to receive 75 μg of Ampligen or a matching placebo, Cohort 2 to receive 200 μg of Ampligen or a matching placebo, Cohort 3 to receive 500 μg of Ampligen or a matching placebo, and Cohort 4 to receive 1250 μg of Ampligen or a matching placebo.

    "AIM is pleased with the positive results in this first cohort. This Phase 1 safety study is designed to test the parameters of Ampligen's intranasal tolerance before commencing a Phase 2 study. While the higher doses that we plan to test in this Phase 1 trial may or may not be well tolerated, we plan on moving quickly into Phase 2 studies with the doses that have successfully passed these Phase 1 tests, such as the dose used in Cohort 1." said AIM CEO Thomas K. Equels.

    AIM will continue to provide interim updates on the clinical trial.

    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. The Company cannot assure that the CHDR study will be successful or yield favorable data and 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. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: 

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: 



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  2. OCALA, Fla., March 31, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces financial results for the fiscal year ended December 31, 2020 and provides a business update.

    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…

    OCALA, Fla., March 31, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announces financial results for the fiscal year ended December 31, 2020 and provides a business update.

    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.

    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. The Company cannot assure that the CHDR study will be successful or yield favorable data and 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. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Investor Relations Contact:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email:

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email:



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  3. OCALA, Fla., March 22, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer Center (Roswell Park) has approved a protocol amendment to Roswell Park's ongoing 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.

    The IRB-approved amendment calls for randomization of an additional twenty patients. Ten of these patients will receive a single dose of Ampligen, but no interferon treatment, and the other ten will receive best available care only. Ampligen alone has a generally well-tolerated safety profile with lower…

    OCALA, Fla., March 22, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer Center (Roswell Park) has approved a protocol amendment to Roswell Park's ongoing 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.

    The IRB-approved amendment calls for randomization of an additional twenty patients. Ten of these patients will receive a single dose of Ampligen, but no interferon treatment, and the other ten will receive best available care only. Ampligen alone has a generally well-tolerated safety profile with lower risk of adverse events than is generally expected with interferon therapy.

    "We are excited to see Ampligen tested not only as part of an antiviral treatment combination for COVID-19 among cancer patients, but also as a possible standalone therapy for this terrible virus," said AIM CEO Thomas K. Equels. "An early-onset treatment is especially critical for cancer patients, who face significantly increased risk of severe symptoms or death."

    AIM previously announced in November 2020 that the first patient had been enrolled and received treatment in Roswell Park's study. Funding for the clinical trial is provided, in part, through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.

    Full details about this trial under way at Roswell Park, led by co-Principal Investigators Drs. Brahm Segal and Pawel Kalinski, are available at ClinicalTrials.gov.

    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. 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 Roswell Park Clinical Trial Agreement is one of the first steps and no assurance can be given as to whether the Roswell Park trial and/or subsequent trials 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 the Company is relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its 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 the Company's website is not incorporated by reference herein and is included for reference purposes only.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: 

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: 



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  4. OCALA, Fla., March 10, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that Thomas K. Equels, AIM's Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC.

    The conference will take place March 17-19, from 9:00 am to 5:00 pm ET, and feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers, both domestically and internationally.

    During this virtual conference, AIM ImmunoTech will present along with many other important voices in the health care industry. To attend and access exclusive content, sign up to become an M-Vest…

    OCALA, Fla., March 10, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that Thomas K. Equels, AIM's Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC.

    The conference will take place March 17-19, from 9:00 am to 5:00 pm ET, and feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers, both domestically and internationally.

    During this virtual conference, AIM ImmunoTech will present along with many other important voices in the health care industry. To attend and access exclusive content, sign up to become an M-Vest member HERE and stay tuned for more updates. The presentation will be available on the investor relations section of AIM's website at https://aimimmuno.com/events-presentations/.

    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.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: 

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: 





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  5. OCALA, Fla., March 08, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has dosed the first healthy subjects in its Phase 1 clinical study on the safety of AIM's drug Ampligen as a potential intranasal therapy. AIM's 's goal is to develop Ampligen as a potential intranasal prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases.

    Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study, titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects."

    The current study plans…

    OCALA, Fla., March 08, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has dosed the first healthy subjects in its Phase 1 clinical study on the safety of AIM's drug Ampligen as a potential intranasal therapy. AIM's 's goal is to develop Ampligen as a potential intranasal prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases.

    Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study, titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects."

    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. The trial is designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM is funding the clinical study.

    The prior in vitro modeling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

    Thomas K. Equels, CEO of AIM stated, "We greatly appreciate the tremendous efforts of the entire team at CHDR to help us initiate our Phase 1 study of Ampligen as a potential intranasal therapy. Our objective is to expedite the development of Ampligen as a potential prophylaxis or treatment for COVID-19. Prior results of in vitro modelling were promising, and we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19. We look forward to providing further updates as this critical trial progresses."

    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. The Company cannot assure that the CHDR study will be successful or yield favorable data and 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. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

    Contacts:

    Crescendo Communications, LLC

    Phone: 212-671-1021

    Email: 

    AIM ImmunoTech Inc

    Phone: 800-778-4042

    Email: 



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