ANVS Annovis Bio Inc.

27.45
+3.23  (+13%)
Previous Close 24.22
Open 25.1
52 Week Low 3.83
52 Week High 47.99
Market Cap $190,702,534
Shares 6,947,269
Float 4,486,380
Enterprise Value $162,660,048
Volume 96,971
Av. Daily Volume 191,108
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Drug Stage Catalyst Date
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)
Phase 2
Phase 2
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ANVS401
Alzheimer’s disease
Phase 2a
Phase 2a
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Latest News

  1. Berwyn, Pennsylvania--(Newsfile Corp. - May 13, 2021) - Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive orphan drug designation for its lead drug candidate, ANVS401, for the treatment of AD in persons with Down syndrome (DS), referred to as DS-AD.

    DS occurs in about 1 in 700 newborns and approximately 200,000 people in the U.S. have the condition. People with DS often experience a gradual decline in cognition as they age, which can lead to AD. Newer screening methods and publications estimate DS-AD begins in people in their…

    Berwyn, Pennsylvania--(Newsfile Corp. - May 13, 2021) - Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive orphan drug designation for its lead drug candidate, ANVS401, for the treatment of AD in persons with Down syndrome (DS), referred to as DS-AD.

    DS occurs in about 1 in 700 newborns and approximately 200,000 people in the U.S. have the condition. People with DS often experience a gradual decline in cognition as they age, which can lead to AD. Newer screening methods and publications estimate DS-AD begins in people in their late thirties, with measurable decline starting before 40 years of age. Remarkably, over 80% of those with DS over age 65 are demented due to AD. There are approximately 17,000 people living with DS-AD in the United States, making the condition an orphan indication.

    With improved healthcare, the DS population is both growing and aging. However, with improved longevity comes a very high risk of AD. The percentage of DS patients with AD is growing faster than the percentage of AD patients in general. The condition results in significant suffering and financial burden for those who care for people with DS.

    ANVS401 is being tested in Phase 2a trials designed to show that it lowers levels of amyloid precursor protein, alpha-synuclein and tau and by doing so can increase axonal transport, lower inflammation, and protect nerve cells from dying. In seven animal models it fully restored the affected function back to normal, including four models of memory and learning: trisomic DS mice, transgenic AD mice, stroke mice and traumatic brain injury rats. Based on these and other data, the Company believes that ANVS401 can change the course of AD in DS patients. Subject to the approval of the orphan drug designation by the FDA, Annovis Bio hopes to initiate a Phase 3 trial in DS-AD patients by the end of 2021.

    Maria Maccecchini, Ph.D., CEO of Annovis Bio, commented, "The FDA orphan drug application for ANVS401 to treat DS-AD is an important milestone for Annovis as we focus on building a robust product pipeline focused on novel uses of AVNS401 to treat significant unmet medical needs. We are currently evaluating ANVS401 in two Phase 2a clinical trials targeting AD and PD. The data from these studies will guide us in the continuing development of ANVS401 for chronic neurodegenerative diseases - specifically in DS-AD and in PD."

    The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). The FDA grants orphan status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. The incidence of DS-AD is well within the limit of 200,000 for orphan indication status. Orphan drug designation would qualify ANVS401 for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.

    About Annovis Bio

    Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD) and Alzheimer's in Down Syndrome (DS-AD). We believe that we are the only company developing a drug for AD, PD and DS-AD that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. We expect our treatment to improve memory loss and dementia associated with AD and DS-AD, as well as body and brain function in PD. We have two ongoing Phase 2a studies: one in AD patients and one in both AD and PD patients. For more information on Annovis, please visit the company's website: www.annovisbio.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words, and include, without limitation, statements regarding the timing, effectiveness and anticipated results of ANVS401 clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including that clinical trials may be delayed. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.

    Investor Relations:
    Dave Gentry, CEO
    RedChip Companies Inc.
    407-491-4498

    SOURCE: Annovis Bio, Inc.

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/83928

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  2. Berwyn, Pennsylvania--(Newsfile Corp. - May 11, 2021) - Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced that management will participate at the Benzinga Global Small Cap Conference taking place online May 13-14, 2021.

    Annovis Bio CEO Maria Maccecchini, Ph.D. will deliver a corporate presentation at 3:10 p.m. ET on May 13, 2021.

    Investors can request a one-on-one meeting with Dr. Maccecchini and Annovis Bio CFO Jeff McGroarty using the networking feature within the virtual conference platform.

    To register for the conference, visit: https://www.benzinga.com/events/small-cap/global/

    About Annovis Bio

    Headquartered…

    Berwyn, Pennsylvania--(Newsfile Corp. - May 11, 2021) - Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced that management will participate at the Benzinga Global Small Cap Conference taking place online May 13-14, 2021.

    Annovis Bio CEO Maria Maccecchini, Ph.D. will deliver a corporate presentation at 3:10 p.m. ET on May 13, 2021.

    Investors can request a one-on-one meeting with Dr. Maccecchini and Annovis Bio CFO Jeff McGroarty using the networking feature within the virtual conference platform.

    To register for the conference, visit: https://www.benzinga.com/events/small-cap/global/

    About Annovis Bio

    Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD) and Alzheimer's in Down Syndrome (AD-DS). We believe that we are the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. We expect our treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. We have two ongoing Phase 2a studies: one in AD patients and one in both AD and PD patients. For more information on Annovis, please visit the company's website: www.annovisbio.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words, and include, without limitation, statements regarding the timing, effectiveness and anticipated results of ANVS401 clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including that clinical trials may be delayed. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.

    Investor Relations:
    Dave Gentry, CEO
    RedChip Companies Inc.
    407-491-4498

    SOURCE: Annovis Bio, Inc.

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/83598

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  3. Berwyn, Pennsylvania--(Newsfile Corp. - May 10, 2021) -  Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, is pleased to announce that its CEO Maria Maccecchini, Ph.D. will ring The Closing Bell at the New York Stock Exchange (NYSE) today, May 10, to celebrate the recent reporting of positive interim data from its ongoing Phase 2a trial in AD and PD.

    "We are honored to ring the Closing Bell, and we want to thank our investors for their continued support," said Dr. Maccecchini. "Considering the positive initial interim data we reported in March, we believe Annovis is entering a very exciting period of corporate development. Our…

    Berwyn, Pennsylvania--(Newsfile Corp. - May 10, 2021) -  Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, is pleased to announce that its CEO Maria Maccecchini, Ph.D. will ring The Closing Bell at the New York Stock Exchange (NYSE) today, May 10, to celebrate the recent reporting of positive interim data from its ongoing Phase 2a trial in AD and PD.

    "We are honored to ring the Closing Bell, and we want to thank our investors for their continued support," said Dr. Maccecchini. "Considering the positive initial interim data we reported in March, we believe Annovis is entering a very exciting period of corporate development. Our two ongoing Phase 2a trials are nearing completion, and we look forward to sharing additional data in the coming months that should set the stage for pivotal trials."

    The New York Stock Exchange will stream the Closing Bell ringing on its website: https://www.nyse.com/bell. The bell ringing is scheduled for 4:00 p.m. ET. A video of the bell ringing will also be archived on the same page after livestream.

    About Annovis Bio

    Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD) and Alzheimer's in Down Syndrome (AD-DS). We believe that we are the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. We expect our treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. We have two ongoing Phase 2a studies: one in AD patients and one in both AD and PD patients. For more information on Annovis, please visit the company's website: www.annovisbio.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words, and include, without limitation, statements regarding the timing, effectiveness and anticipated results of ANVS401 clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including that clinical trials may be delayed. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.

    Investor Relations:

    Dave Gentry, CEO
    RedChip Companies Inc.
    407-491-4498

    SOURCE: Annovis Bio, Inc.

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/83476

    View Full Article Hide Full Article
  4. Berwyn, Pennsylvania--(Newsfile Corp. - May 6, 2021) -  Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced the U.S. Patent and Trademark Office (USPTO) granted the Company's patent (US 16/504,813) for a method of treating tauopathies, such as frontotemporal dementia and chronic traumatic encephalopathy by administering ANVS401.

    This is the Company's third issued patent in its chronic neurodegenerative patent family. Previously, the USPTO requested the Company to split its original neurodegenerative patent application into a number of patents, each covering individual diseases targeted by ANVS401. The two previously…

    Berwyn, Pennsylvania--(Newsfile Corp. - May 6, 2021) -  Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced the U.S. Patent and Trademark Office (USPTO) granted the Company's patent (US 16/504,813) for a method of treating tauopathies, such as frontotemporal dementia and chronic traumatic encephalopathy by administering ANVS401.

    This is the Company's third issued patent in its chronic neurodegenerative patent family. Previously, the USPTO requested the Company to split its original neurodegenerative patent application into a number of patents, each covering individual diseases targeted by ANVS401. The two previously issued patents cover AD and alpha-synucleopathies, such as PD; the new patent covers tauopathies, such as frontotemporal dementia and chronic traumatic encephalopathy. This latest patent was issued because ANVS401 lowers the levels of tau and phospho-tau.

    From the acute patent family, which provides intellectual property protection through 2036, Annovis Bio has been issued two patents: one covering Europe and one covering Japan. As with its chronic neurodegenerative patent family, in the US, the Company is targeting patents in each individual acute disease and has already filed divisional applications for treatment of traumatic brain injury, stroke, and spinal cord injury by administering ANVS405.

    "We are thrilled to further expand our intellectual property protections," said Maria Maccecchini, Ph.D., Founder and Chief Executive Officer. "Our unique approach to treating neurodegeneration targets the same toxic cascade leading to nerve cell death in chronic as well as acute brain injuries. The same mechanism starts out with high levels of neurotoxic proteins that leads to impairment in axonal transport, inflammation and to nerve cells dying. With additional patent applications pending, we look forward to providing further updates as new allowances are granted."

    ANVS401 and ANVS405 can work in chronic and acute indications because nerve cells die by the same mechanism in these diseases. ANVS401 and ANVS405 stop the toxic cascade leading to nerve cell death. Capitalizing on that knowledge, Annovis Bio is conducting two Phase 2 studies to show in both AD and PD patient populations that what was demonstrated in animals can be reproduced in humans and that ANVS401 protects the nerve cells from dying, and by doing so, preserves the associated function.

    About Annovis Bio

    Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD) and Alzheimer's in Down Syndrome (AD-DS). We believe that we are the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. We expect our treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. We have two ongoing Phase 2a studies: one in AD patients and one in both AD and PD patients. For more information on Annovis, please visit the company's website: www.annovisbio.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words, and include, without limitation, statements regarding the timing, effectiveness and anticipated results of ANVS401 clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including that clinical trials may be delayed. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.

    Investor Relations:

    Dave Gentry, CEO
    RedChip Companies Inc.
    407-491-4498

    SOURCE: Annovis Bio, Inc.

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/83123

    View Full Article Hide Full Article
  5. Collaborative mice study with UC San Diego to study brain development from embryo to old age

    Berwyn, Pennsylvania--(Newsfile Corp. - April 29, 2021) - Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced a new research collaboration with Professor William Mobley and Dr. Xuqiao Chen at the University of California San Diego designed to study the ability of the Company's lead compound, ANVS401, to normalize brain development in Down Syndrome (DS) mice.

    "While we know quite a bit about how the brain degenerates in the later stages of life, extraordinarily little is known about how neurodegeneration may start very early…

    Collaborative mice study with UC San Diego to study brain development from embryo to old age

    Berwyn, Pennsylvania--(Newsfile Corp. - April 29, 2021) - Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced a new research collaboration with Professor William Mobley and Dr. Xuqiao Chen at the University of California San Diego designed to study the ability of the Company's lead compound, ANVS401, to normalize brain development in Down Syndrome (DS) mice.

    "While we know quite a bit about how the brain degenerates in the later stages of life, extraordinarily little is known about how neurodegeneration may start very early in life. We, therefore, plan to look at the brain in embryonic development in DS mice," said Maria Maccecchini, Ph.D., Founder and Chief Executive Officer.

    The study will dose healthy and DS female mice starting before fertilization with either placebo or ANVS401 and follow the mother through pregnancy to lactation and the fertilized egg from embryo through old age. At different points, the study will measure levels of various neurotoxic proteins, axonal transport, and inflammation in the brains of the mothers and the offspring to see the differences between a healthy brain, a DS brain, and an ANVS401-treated DS brain. The study will also measure learning and cognition throughout the life span of the mice and will obtain interim data at every step of development while following the mice into old age.

    "It is commonly understood that those with DS have elevated amyloid which in turn induces the toxic cascade that ultimately drives AD. What is not yet known is the impact on early brain development. Through this study we hope to gain a clearer understanding of brain development and how ANVS401 could play a much earlier role for DS and other patients," continued Dr. Maccecchini.

    The study will be led by Dr. Mobley, associate dean for neuroscience initiatives at UC San Diego School of Medicine, the Florence Riford Chair for Alzheimer's Research, and director of the Down Syndrome Center for Research and Treatment (DSCRT). Dr. Mobley is one of the world's foremost experts on the neurobiology of Down Syndrome, and the DSCRT is one of the first programs in the country to connect academic researchers with treatment of adults and children with Down Syndrome.

    "We are thrilled to have access to an excellent model of brain development, a great laboratory to collaborate with, and to be able to follow brain development through the life of a mouse. Ultimately, we hope to generate positive data that demonstrates the potential of ANVS401 to normalize brain development in DS," said Dr. Maccecchini.

    In September 2020, Annovis announced the publication of peer-reviewed data demonstrating the ability of its lead candidate, ANVS401, also known as Posiphen, to improve axonal transport, the information highway of nerve cells. The publication, "Targeting increased levels of APP in Down syndrome: Posiphen-mediated reductions in APP and its products reverse endosomal phenotypes in the Ts65Dn mouse model," was published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association., and the study was conducted at UCSD in Dr. Mobley's lab.

    AD and DS share several characteristics, including high levels of neurotoxic proteins; specifically, amyloid precursor protein (APP), its C-terminal fragment, phospho-tau and alpha-synuclein. High levels of these proteins impair the transport of vesicles carrying neurotrophic factors. The resulting AD pathology is driven by compromised transport of neurotrophic signals. Treatment of DS mice with ANVS401 normalized levels of neurotoxic proteins and reversed deficits in axonal transport, regulated brain homeostasis, lowered inflammation, and normalized mouse behavior.

    About Annovis Bio

    Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD) and Alzheimer's in Down Syndrome (AD-DS). We believe that we are the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. We expect our treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. We have two ongoing Phase 2a studies: one in AD patients and one in both AD and PD patients. For more information on Annovis, please visit the company's website: www.annovisbio.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words, and include, without limitation, statements regarding the timing, effectiveness and anticipated results of ANVS401 clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including that clinical trials may be delayed. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.

    Investor Relations:
    Dave Gentry, CEO
    RedChip Companies Inc.
    407-491-4498

    SOURCE: Annovis Bio, Inc.

    To view the source version of this press release, please visit https://www.newsfilecorp.com/release/82263

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