AIM AIM ImmunoTech Inc.

2.13
-0.08  -4%
Previous Close 2.21
Open 2.28
52 Week Low 0.75
52 Week High 7.11
Market Cap $84,539,726
Shares 39,690,012
Float 2,304,903
Enterprise Value $130,562,439
Volume 5,187,892
Av. Daily Volume 2,162,938
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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 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, cisplatin and pembrolizumab
Ovarian cancer
Phase 2
Phase 2
Phase 2 trial is enrolling - noted 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., Jan. 15, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has rescheduled its investor conference call for 11:00 a.m. Eastern Time on Thursday, January 21, 2021 to discuss the recently announced commencement of the treatment of subjects with COVID-19-induced chronic fatigue-like symptoms in the amended AMP-511 trial, 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 . Management respectfully requests that questions be non-compound, direct and addressing single subjects.

    The conference call will be available on the Company's website at https://aimimmuno.com/events-presentations/

    OCALA, Fla., Jan. 15, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that it has rescheduled its investor conference call for 11:00 a.m. Eastern Time on Thursday, January 21, 2021 to discuss the recently announced commencement of the treatment of subjects with COVID-19-induced chronic fatigue-like symptoms in the amended AMP-511 trial, 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 . Management respectfully requests that questions be non-compound, direct and addressing single subjects.

    The conference call will be available on the Company's website at https://aimimmuno.com/events-presentations/, or via telephone by dialing toll free 877-407-8031 for U.S. callers, or +1 201-689-8031 for international callers.

    For those unable to participate at that time, a replay of the call will be archived on the Company's website or can be accessed by dialing 877-481-4010 for U.S. callers, or +1 919-882-2331 for international callers and entering the pass code 39447. The replay will be available for 90 days.

    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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  2. OCALA, Fla., Jan. 11, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) and its CEO Thomas K. Equels today announced that this week's planned investor conference call will be postponed and rescheduled for a later date following the death of Mr. Equels' mother over this past weekend.

    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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    OCALA, Fla., Jan. 11, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) and its CEO Thomas K. Equels today announced that this week's planned investor conference call will be postponed and rescheduled for a later date following the death of Mr. Equels' mother over this past weekend.

    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: 



    Primary Logo

    View Full Article Hide Full Article
  3. OCALA, Fla., Jan. 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the active AMP-511 Expanded Access Program (EAP) has dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen (rintatolimod), marking a significant milestone in AIM's efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled. The Company also reported it will host an investor conference call on January 12, 2020 at 11AM ET to discuss the AMP-511 trial, believed to be the first clinical trial to treat a patient with COVID-19-induced chronic fatigue-like symptoms, as well as to provide an overall status update…

    OCALA, Fla., Jan. 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) today announced that the active AMP-511 Expanded Access Program (EAP) has dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen (rintatolimod), marking a significant milestone in AIM's efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled. The Company also reported it will host an investor conference call on January 12, 2020 at 11AM ET to discuss the AMP-511 trial, believed to be the first clinical trial to treat a patient with COVID-19-induced chronic fatigue-like symptoms, as well as to provide an overall status update on the Company.

    The Ampligen EAP protocol is authorized at any one time to enroll up to 100 active Chronic Fatigue Syndrome trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nevada.

    "AIM is committed to helping the untold number of people who are already dealing with the long-term effects of COVID-19 infection," said AIM CEO Thomas K. Equels. "The development of an effective therapy for COVID-19-induced chronic fatigue is a critical unmet public health need. SARS-CoV-2 infection-induced chronic fatigue may affect millions in the aftermath of the pandemic. Although AMP-511 is not a controlled trial, patients in this AIM-sponsored study are monitored closely and it may be possible to report important observations as early as May."

    "Hunter-Hopkins Center is excited to have started Ampligen therapy for the first time on a Long Hauler with CFS-like symptoms," said Dr. Lapp. "This is a historic moment. We believe that Long Haulers experience a post-viral fatigue syndrome similar to many persons with Chronic Fatigue Syndrome, and starting treatment early and aggressively should enhance the potential to improve their symptoms and outcomes."

    AIM announced late last year that the Ampligen-involved myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) EAP would be expanded to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – and whose persistence of symptoms has led to the group being dubbed "Long Haulers." Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network). In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. Centers for Disease Control and Prevention's criteria for chronic fatigue syndrome. Early treatment may be a key to successful therapy (See: PLOS ONE).

    View a recent U.S. National Institutes of Health workshop on Post-Acute Sequelae of COVID-19.

    "Ampligen is approved in Argentina as the world's first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. development pipeline for ME/CFS," said Equels. "We are highly encouraged by the prospects for Ampligen as a potential therapeutic for this devastating illness, and believe that the AMP-511 clinical trial will help validate Ampligen's potential role in combatting COVID-19-induced chronic fatigue."

    For more information, see discussion of AIM in The Wall Street Journal, "Long-Haul COVID Patients Put Hope in Experimental Drugs."

    Conference Call

    AIM CEO Thomas K. Equels will host a conference call at 11:00 AM Eastern Time Tuesday, January 12, 2020. The conference call will be available on the Company's website at https://aimimmuno.com/events-presentations/, or via telephone by dialing toll free 877-407-8031 for U.S. callers, or +1 201-689-8031 for international callers.

    For those unable to participate at that time, a replay of the call will be archived on the Company's website or can be accessed by dialing 877-481-4010 for U.S. callers, or +1 919-882-2331 for international callers and entering the pass code 39447. The replay will be available for 90 days.

    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, no assurance can be given that the Ampligen (rintatolimod) EAP protocol described above will yield positive results and additional testing and trials will be required. 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. There is the potential for delays in clinical trial enrollment and reporting 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. 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/e293adfc-822c-47d9-a917-9b6b233789d4



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  4. OCALA, Fla., Dec. 24, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announced today 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 AIM's flagship pipeline drug Ampligen.

    AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received IRB approval to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – but who now demonstrate post-acute infection chronic fatigue-like symptoms. These patients are commonly…

    OCALA, Fla., Dec. 24, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) announced today 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 AIM's flagship pipeline drug Ampligen.

    AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received IRB approval to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – but who now demonstrate post-acute infection chronic fatigue-like symptoms. These patients are commonly referred to as Long Haulers because of the persistence of their post-COVID-19 symptoms.

    Ampligen is AIM's TLR3 agonist immune-system modulator. It is approved in Argentina as the world's first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. development pipeline for ME/CFS.

    The Ampligen EAP protocol is authorized to enroll up to 100 active trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nev.

    Enrollment is an important milestone in AIM's program to develop Ampligen as a therapy for the millions of people who medical experts predict will suffer from SARS-CoV-2-induced chronic fatigue, including many with brain fog. Nearly 70 million COVID-19 cases have been recorded during the ongoing global pandemic. Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network). In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. Centers for Disease Control and Prevention's criteria for chronic fatigue syndrome.

    Given the massive pandemic caused by SARS-CoV-2, a virus with almost identical genetic sequence and similar in pathogenesis to the first SARS virus with persuasive emerging evidence supporting COVID-19's SARS-CoV-2 induced chronic fatigue is following a similar pattern. The development of an effective therapy is a critical unmet public health need for patients with acute SARS-CoV-2 infection-induced classic chronic fatigue symptoms. For more information, see AIM featured in The Wall Street Journal, "Long-Haul COVID Patients Put Hope in Experimental Drugs."

    Dr. Lapp states, "It is anticipated that COVID-19 will trigger a large number ‘long haulers' suffering COVID induced brain impairment and disabling fatigue. I believe the investigational immune-modulating antiviral drug Ampligen might have a role to play as a future therapy. I believe the data to date suggests that early treatment will lead to better levels of efficacy."

    Dr. Peterson states: "A hypothesis-based re-analysis of CFS patients treated with Ampligen in a randomized-controlled study showed that CFS patients with shorter duration of CFS symptoms were more than twice as likely to respond to Ampligen than the group as a whole. We are cautiously optimistic that early Ampligen treatment of post-COVID-19 patients with Long Hauler chronic fatigue will have the potential to induce a clinically beneficial outcome. This addition to the study will also allow longitudinal follow-up of clinical disease, as well as contribute to the investigation of pathogenesis and prognosis." (See: PLOS ONE).

    AIM CEO Thomas K. Equels states: "While major global pharmaceutical companies have understandably focused their efforts on developing COVID-19 vaccines, AIM believes there is an equally essential need to help post-COVID-19 patients who, while having recovered from the acute infection, may be suffering from long-term and debilitating COVID-induced chronic fatigue symptoms such as brain fog and disabling and profound post-exertional malaise. We hope that the treatment of ‘Long-Hauler' patients in our AMP-511 clinical trial can help us to quickly determine whether Ampligen has potential as an important therapy for this post-COVID-19 syndrome. If successful, this may change millions of lives for the better."

    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, no assurance can be given that the Ampligen EAP protocol described above will yield positive results and additional testing and trials will be required. 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. There is the potential for delays in clinical trial enrollment and reporting 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. Company personnel were involved in the PLOSONE article referenced above. 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: 

    Photos accompanying this announcement are available at:

    https://www.globenewswire.com/NewsRoom/AttachmentNg/34b80e21-269d-47dd-baf9-885e123d042c

    https://www.globenewswire.com/NewsRoom/AttachmentNg/7d09de7a-05e3-4f9d-a77b-922fcd9496c3



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  5. AIM ImmunoTech Announces Availability of the ME/CFS Clinical Trial of its Drug Ampligen for Enrollment to COVID-19 ‘Long Haulers'

    Institutional Review Board Authorizes Public Notification for Potential Enrollment of Subjects

    OCALA, FL / ACCESSWIRE / December 24, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) announced today 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 AIM's flagship pipeline drug Ampligen.

    AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received…

    AIM ImmunoTech Announces Availability of the ME/CFS Clinical Trial of its Drug Ampligen for Enrollment to COVID-19 ‘Long Haulers'

    Institutional Review Board Authorizes Public Notification for Potential Enrollment of Subjects

    OCALA, FL / ACCESSWIRE / December 24, 2020 / AIM ImmunoTech Inc. (NYSE:AIM) announced today 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 AIM's flagship pipeline drug Ampligen.

    AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received IRB approval to include patients previously diagnosed with SARS-CoV-2 - which causes the disease COVID-19 - but who now demonstrate post-acute infection chronic fatigue-like symptoms. These patients are commonly referred to as Long Haulers because of the persistence of their post-COVID-19 symptoms.

    Ampligen is AIM's TLR3 agonist immune-system modulator. It is approved in Argentina as the world's first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. development pipeline for ME/CFS.

    The Ampligen EAP protocol is authorized to enroll up to 100 active trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nev.

    Enrollment is an important milestone in AIM's program to develop Ampligen as a therapy for the millions of people who medical experts predict will suffer from SARS-CoV-2-induced chronic fatigue, including many with brain fog. Nearly 70 million COVID-19 cases have been recorded during the ongoing global pandemic. Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network). In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. Centers for Disease Control and Prevention's criteria for chronic fatigue syndrome.

    Given the massive pandemic caused by SARS-CoV-2, a virus with almost identical genetic sequence and similar in pathogenesis to the first SARS virus with persuasive emerging evidence supporting COVID-19's SARS-CoV-2 induced chronic fatigue is following a similar pattern. The development of an effective therapy is a critical unmet public health need for patients with acute SARS-CoV-2 infection-induced classic chronic fatigue symptoms. For more information, see AIM featured in The Wall Street Journal, "Long-Haul COVID Patients Put Hope in Experimental Drugs."

    Dr. Lapp states, "It is anticipated that COVID-19 will trigger a large number ‘long haulers' suffering COVID induced brain impairment and disabling fatigue. I believe the investigational immune-modulating antiviral drug Ampligen might have a role to play as a future therapy. I believe the data to date suggests that early treatment will lead to better levels of efficacy."

    Dr. Charles Lapp, Hunter-Hopkins Center, Charlotte, N.C.

    Dr. Daniel Peterson, Sierra Internal Medicine, Incline Village, Nev.

    Dr. Peterson states: "A hypothesis-based re-analysis of CFS patients treated with Ampligen in a randomized-controlled study showed that CFS patients with shorter duration of CFS symptoms were more than twice as likely to respond to Ampligen than the group as a whole. We are cautiously optimistic that early Ampligen treatment of post-COVID-19 patients with Long Hauler chronic fatigue will have the potential to induce a clinically beneficial outcome. This addition to the study will also allow longitudinal follow-up of clinical disease, as well as contribute to the investigation of pathogenesis and prognosis." (See: PLOS ONE).

    AIM CEO Thomas K. Equels states: "While major global pharmaceutical companies have understandably focused their efforts on developing COVID-19 vaccines, AIM believes there is an equally essential need to help post-COVID-19 patients who, while having recovered from the acute infection, may be suffering from long-term and debilitating COVID-induced chronic fatigue symptoms such as brain fog and disabling and profound post-exertional malaise. We hope that the treatment of ‘Long-Hauler' patients in our AMP-511 clinical trial can help us to quickly determine whether Ampligen has potential as an important therapy for this post-COVID-19 syndrome. If successful, this may change millions of lives for the better."

    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, no assurance can be given that the Ampligen EAP protocol described above will yield positive results and additional testing and trials will be required. 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. There is the potential for delays in clinical trial enrollment and reporting 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. Company personnel were involved in the PLOSONE article referenced above. 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:

    SOURCE: AIM ImmunoTech Inc



    View source version on accesswire.com:
    https://www.accesswire.com/622264/AIM-ImmunoTech-Announces-Availability-of-the-MECFS-Clinical-Trial-of-its-Drug-Ampligen-for-Enrollment-to-COVID-19-Long-Haulers

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