AIM AIM ImmunoTech Inc.

2.09
+0.01  (+0%)
Previous Close 2.08
Open 2.09
52 Week Low 1.6
52 Week High 3.11
Market Cap $82,952,125
Shares 39,690,012
Float 2,304,903
Enterprise Value $130,562,439
Volume 427,912
Av. Daily Volume 519,670
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Drug Pipeline

Drug Stage Notes
Ampligen
human Rhinovirus hRV
Phase 2a
Phase 2a
Phase 2a trial to commence 4Q 2021.
Ampligen, Intron A, and celecoxib
Colorectal cancer
Phase 2
Phase 2
Phase 2 trial ongoing.
Ampligen, cisplatin and KEYTRUDA (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
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., July 09, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has signed a contract to sponsor a Phase 2a Human Challenge Trial (HCT) to test the company's drug Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (common cold virus) and Influenza.

    This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The trial is expected to commence in Q4 2021.

    A successful Phase 2a study could also establish Ampligen as a potential prophylaxis against future viral variants and future novel…

    OCALA, Fla., July 09, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has signed a contract to sponsor a Phase 2a Human Challenge Trial (HCT) to test the company's drug Ampligen as a potential intranasal antiviral therapy using a human Rhinovirus hRV (common cold virus) and Influenza.

    This antiviral study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world leader in vaccine and antiviral testing using human challenge clinical trials. The trial is expected to commence in Q4 2021.

    A successful Phase 2a study could also establish Ampligen as a potential prophylaxis against future viral variants and future novel respiratory viruses for which there are no current therapies, as well as known viruses such as SARS-CoV-2, which causes COVID-19.

    In an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. An HCT will allow AIM to expedite the development process for Ampligen by ensuring high infection rates for subjects who receive the drug, therefore also ensuring large data sets with potentially statistically significant results.

    This Phase 2a study will come in the wake of AIM's recent announcement that all subjects have completed treatment in the company's Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level. A final study report is expect in the third quarter of 2021.

    Unlike other drugs tailored to combat specific diseases, Ampligen targets and amplifies the natural immune system pathways that fight viruses, meaning that Ampligen delivered via an intranasal device could be an effective preventive therapy for people who may be exposed to, or have recently been exposed to, a respiratory virus such as influenza, or even common coronaviruses and rhinoviruses (like the common cold). Success against these common viruses could also indicate that an Ampligen prophylaxis could help blunt the spread of infection from lethal coronaviruses, as well as other serious viruses. This Phase 2a study will test this proposition in humans.

    AIM CEO Thomas K. Equels, commented: "It is our belief that Ampligen's mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum capabilities as an antiviral prophylaxis and therapeutic. The ability to do a Human Challenge Trial using hRV and Influenza allows us to test in humans Ampligen's potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses."

    Cathal Friel, Executive Chairman of Open Orphan, stated: "We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product and to demonstrate our expertise in testing vaccines and antivirals using our world-leading portfolio of human challenge models. While the pandemic has undoubtedly inflicted a lot of loss and suffering globally, it has also taught us a valuable lesson in pandemic preparedness. It is my belief therefore that the infectious disease market has been utterly transformed and is going to grow exponentially in the years ahead. Challenge studies are a key weapon in the arsenal against infectious diseases as they can bring effective treatments and vaccines to the market both quicker and faster than they could otherwise."

    An Ampligen prophylaxis could potentially benefit vulnerable populations who are at increased risk of transmission due to their environments, such as hospital workers; people on cruise, cargo or military ships; people on commercial airplanes; and service personnel in close quarters on military installations.

    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.

    About Open Orphan plc

    Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organizations.

    Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialized virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world's first COVID-19 human challenge study model as part of the Human Challenge Program and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

    Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

    Open Orphan's Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company's Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

    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. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies 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 respiratory viruses, including SARS-CoV-2, 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., July 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it will host an investor update webcast at 11:00 a.m. Eastern Time on Wednesday, July 14, 2021, to discuss recent accomplishments and upcoming milestones. Investors and other interested parties are invited to submit questions to management prior to the call's start via email to .

    The webcast may be accessed at https://www.webcaster4.com/Webcast/Page/2605/41875 or on the Company's website at https://aimimmuno.com/events-presentations/. For those unable to participate at that time, a replay of the webcast will be available until Thursday, July 14, 2022 on the Company's website.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc…

    OCALA, Fla., July 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it will host an investor update webcast at 11:00 a.m. Eastern Time on Wednesday, July 14, 2021, to discuss recent accomplishments and upcoming milestones. Investors and other interested parties are invited to submit questions to management prior to the call's start via email to .

    The webcast may be accessed at https://www.webcaster4.com/Webcast/Page/2605/41875 or on the Company's website at https://aimimmuno.com/events-presentations/. For those unable to participate at that time, a replay of the webcast will be available until Thursday, July 14, 2022 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 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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  3. OCALA, Fla., June 21, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that all subjects have completed treatment in the Company's Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A final study report is expect in the third quarter of 2021.

    A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level.

    With these positive preliminary results in hand, the Company is now moving forward with the initial planning and negotiations for a follow-up Phase…

    OCALA, Fla., June 21, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that all subjects have completed treatment in the Company's Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A final study report is expect in the third quarter of 2021.

    A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level.

    With these positive preliminary results in hand, the Company is now moving forward with the initial planning and negotiations for a follow-up Phase 2 study testing Ampligen as a potential broad-spectrum respiratory virus prophylaxis. Unlike other drugs tailored to combat specific diseases, Ampligen targets and amplifies the natural immune system pathways that fight viruses, meaning that Ampligen delivered via an intranasal device could be an effective preventive therapy for people who may be exposed to, or have recently been exposed to, a respiratory virus such as influenza, or even common coronaviruses and rhinoviruses (like the common cold). This Phase 2 study will test this proposition in humans. A successful Phase 2 study could also establish Ampligen as a potential prophlyaxis against future viral variants and future novel respiratory viruses for which there are no current therapies. Moreover, an Ampligen prophylaxis could potentially benefit vulnerable populations who are at increased risk of transmission due to their environments, such as hospital workers; people on cruises, cargo or miltary ships; people on commercial airplanes; and service personnel in close quarters on military installations.

    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 is in the preliminary stages of planning a Phase 2 Study of Ampligen as a broad-spectrum respiratory virus prophylaxis. No assurance can be given as to if or when such study will occur, the cost of such study or whether it will be successful or yield favorable data. Studies 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 respiratory viruses, including SARS-CoV-2, 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: 

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8888d6ec-da99-464b-a903-f5d715e997c1



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  4. OCALA, Fla., June 14, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that its drug Ampligen has been featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers as a potential treatment option for cancer patients who are infected with SARS-CoV-2.

    The study's authors stated that Ampligen has the potential to reduce the severity of the deadly respiratory disease COVID-19, which has so far caused more than 3.7 million deaths globally. According to the data presented in the publication, "Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells", including:

    • Stimulation of interferon…

    OCALA, Fla., June 14, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that its drug Ampligen has been featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers as a potential treatment option for cancer patients who are infected with SARS-CoV-2.

    The study's authors stated that Ampligen has the potential to reduce the severity of the deadly respiratory disease COVID-19, which has so far caused more than 3.7 million deaths globally. According to the data presented in the publication, "Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells", including:

    • Stimulation of interferon regulatory factors and activation of the interferon signaling pathway
    • Production of immunomodulatory activity
    • Induction of the expression of MHC class I and II histocompatibility

    The full journal article is titled: "Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients?" Cancers is a peer-reviewed, open access journal of oncology published semimonthly online by MDPI. The study's authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator for an Early Access Program at Erasmus Medical Center in the Netherlands, where Ampligen is being used to treat patients with late-stage pancreatic cancer.

    "I do think Ampligen fully deserves to be developed for potential approval in the treatment of viral infections, including COVID-19. The stimulation of the innate immunity by Ampligen is potentially important in combating aggressive viral infections and could save many lives," said Prof. C.H.J. van Eijck.

    Additionally, AIM was previously granted a patent by the Netherlands. The granted claims include, but are not limited to, the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors (e.g. pembrolizumab, nivolumab). The patent expires December 19, 2039, or 20 years from the date of filing, December 20, 2019.

    "AIM is extremely pleased with the tremendous progress we are making in the Netherlands to advance Ampligen as a therapuetic," said AIM CEO Thomas K. Equels. "Prof. van Eijck and his team are preeminent in their field. The data they present is compelling. Also, this patent issuance by the Netherlands is another successful step in our drug development program."

    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. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective as an immuno-oncology therapeutic or in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. Additionally, no assurances can be given that granted patent applications will result in approved products or therapies. 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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  5. OCALA, Fla., May 27, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has entered into a two-year extension of its Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (Smoore), a subsidiary of Smoore International Holdings Limited (HKEX: 6969), with the goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases.

    AIM entered into the agreement on April 1, 2020, to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. On parallel paths, over the past year, Smoore has focused on the development of a personal inhalation device…

    OCALA, Fla., May 27, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has entered into a two-year extension of its Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (Smoore), a subsidiary of Smoore International Holdings Limited (HKEX: 6969), with the goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases.

    AIM entered into the agreement on April 1, 2020, to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. On parallel paths, over the past year, Smoore has focused on the development of a personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA. Contemporaneously, AIM has studied the safety and efficacy of Ampligen using an ex vivo 3D model in primary human respiratory epithelial cells at Utah State University, which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, and conducted intranasal safety testing. AIM hopes to commence inhalation safety testing before year-end.

    "With Smoore's concept for an Ampligen inhalation delivery device ready to be developed, and Ampligen's track record of both safety and efficacy, we believe AIM is well positioned to move forward with our goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases," said AIM CEO Thomas K. Equels. "We are in the process of planning a Phase 1/2 inhalation clinical study on a parallel track with Smoore's device development testing."

    ‘Application of vaping technology in healthcare and pharmaceutical fields is one of our R&D focus. We are really happy to partner with AIM to explore applications of advanced atomization technology in medical inhalation therapy," Dr. Zhiqiang Shi, Chief Scientist and Director of Global R&D of Smoore, commented. "We will coordinate our device development work along with our partner's plan and the regulation needs to move into next phase testing on schedule.'   

    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 that 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 Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth herein speak only as of the date hereof. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 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, if so, whether the Smoore's delivery technology will prove effective, and no assurance can be given that it will be the case. The agreement with Smoore is to preliminarily study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. The Company is in the process of planning a Phase 1/2 study of Ampligen as an inhalation therapy. No assurance can be given that the preliminary Smoore study or the Phase 1/2 study will proceed or will prove promising or that the Company and Smoore will enter into further agreements. 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, even if Ampligen proves effective, another treatment that eventually proves effective will not make its 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. 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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