CRTX Cortexyme Inc.

63.22
+6.18  (+11%)
Previous Close 57.04
Open 57.22
52 Week Low 26.6612
52 Week High 66.13
Market Cap $1,870,583,769
Shares 29,588,481
Float 17,000,671
Enterprise Value $1,525,181,061
Volume 169,311
Av. Daily Volume 205,393
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Upcoming Catalysts

Drug Stage Catalyst Date
Atuzaginstat - GAIN
Alzheimer’s disease
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
Atuzaginstat
Parkinson's disease
Phase 2
Phase 2
Phase 2 dosing to commence 3Q 2021.

Latest News

  1. Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with topline data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced that Chris Lowe, the company's chief operating officer and chief financial officer, will participate in a fireside chat at Canaccord Genuity' s 41st Annual Growth Conference taking place virtually on Wednesday, August 11, 2021 at 3:00 p.m. ET / 12:00 p.m. PT.

    A live webcast of the event will be accessible on the Investor Calendar page under the News & Events heading of Cortexyme's investor website at ir.cortexyme.com. The webcast will be archived at that location for 90 days.

    About Cortexyme

    Cortexyme, Inc. (NASDAQ:CRTX

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with topline data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced that Chris Lowe, the company's chief operating officer and chief financial officer, will participate in a fireside chat at Canaccord Genuity' s 41st Annual Growth Conference taking place virtually on Wednesday, August 11, 2021 at 3:00 p.m. ET / 12:00 p.m. PT.

    A live webcast of the event will be accessible on the Investor Calendar page under the News & Events heading of Cortexyme's investor website at ir.cortexyme.com. The webcast will be archived at that location for 90 days.

    About Cortexyme

    Cortexyme, Inc. (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases. The company is advancing its disease-modifying pivotal GAIN Trial in mild to moderate Alzheimer's disease with top-line data expected in the fourth quarter of 2021, in addition to growing a proprietary pipeline of first-in-class small molecule therapeutics for Parkinson's disease, periodontitis, and other diseases with high unmet clinical need. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. The company's causation evidence for Alzheimer's disease and the mechanism of its novel therapeutic has been independently replicated and confirmed by multiple laboratories around the world, as well as published in peer-reviewed scientific journals. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

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  2. New GAIN Trial baseline data demonstrates majority of patients have elevated Von Willebrand factor and alpha-2-macroglobulin

    Cortexyme to host AAIC symposium titled "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification" on Tuesday, July 27

    Join KOL webinar on atuzaginstat titled "Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration" on Friday, July 30 at 10 a.m. ET

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the presentation of new preclinical data linking P. gingivalis to increased…

    New GAIN Trial baseline data demonstrates majority of patients have elevated Von Willebrand factor and alpha-2-macroglobulin

    Cortexyme to host AAIC symposium titled "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification" on Tuesday, July 27

    Join KOL webinar on atuzaginstat titled "Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration" on Friday, July 30 at 10 a.m. ET

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the presentation of new preclinical data linking P. gingivalis to increased levels of phospho-tau217, an emerging biomarker for Alzheimer's disease. This research, along with new baseline data from its pivotal GAIN Trial, is being presented by the company at the Alzheimer's Association International Conference® 2021 (AAIC®) taking place July 26-30, 2021, in Denver, Colorado, as well as virtually. In addition to its presentations, Cortexyme will host a corporate sponsored symposium held in conjunction with the conference titled "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification" on Tuesday, July 27, 2021, from 5:30 p.m. to 7:30 p.m. MT.

    "Cortexyme continues to conduct research that validates and reinforces the gingipain hypothesis and P. gingivalis' role as a causative agent of Alzheimer's disease," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "The GAIN Trial, which is designed to be 90% powered to show a 50% slowing of disease, will read out on the gold standard measures of disease modification as Cortexyme looks to shift the paradigm in effective Alzheimer's treatment."

    Cortexyme is pioneering an innovative, upstream, and disease-modifying therapeutic approach to Alzheimer's disease. The Phase 2/3 GAIN Trial is a potentially pivotal study in 643 patients with mild to moderate Alzheimer's Disease. Cortexyme's seminal discovery, along with confirmatory clinical and preclinical studies, demonstrate that the intracellular pathogen, P. gingivalis, is found in the brain of more than 90% of Alzheimer's patients and that a simple oral infection with P. gingivalis in animals results in brain infiltration and downstream hallmark Alzheimer's pathologies, including Aβ42 production, tau hyperphosphorylation, microglial activation, and neurodegeneration. The company's lead drug candidate, atuzaginstat (COR388), is a first-in-class, orally administered, brain penetrant small molecule targeting P. gingivalis, which is upstream of neuronal death and Alzheimer's disease pathology. Atuzaginstat blocks gingipains, protease virulence factors secreted by P. gingivalis, which are required for its survival and responsible for its toxicity. The GAIN Trial also includes a REPAIR sub-study of 233 patients targeting P. gingivalis – most commonly known as a keystone bacterium associated with periodontal disease – and measuring the efficacy of atuzaginstat on clinical endpoints of periodontal disease. Cortexyme's innovative therapeutic approach continues to be supported by research from laboratories around the world published in peer-reviewed scientific journals.

    Cortexyme's work will be featured in two poster presentations at AAIC 2021:

    • Increased Levels of Phospho-tau217 Linked to P. gingivalis Reduced by Atuzaginstat: In its poster "Increased levels of phospho-tau217 in neuron cultures and CVN mice infected with Porphyromonas gingivalis" (Poster #52438), Cortexyme demonstrates P. gingivalis infected neuronal cell cultures and chronically infected CVN mice display elevated tau phosphorylation at T217 (phospho-tau217). Using IPSC-derived neuron cultures, neuron-astrocyte-microglia co-cultures, and CVN mice (APPSwDI/NOS2 bigenic) as model systems for P. gingivalis-induced Alzheimer's disease, the company demonstrated that phospho-tau217 was susceptible to P. gingivalis-induced and gingipain dependent digestion in a dose-dependent manner. At lower infection levels, tau protein persisted and an elevated phospho-tau217/total tau ratio was observed in a manner that might reflect the physiological level of gingipain exposure. In CVN mice chronically infected with P. gingivalis, the phospho-tau217/total tau ratio was elevated in the brain in infected compared to uninfected mice. Furthermore, after five weeks of treatment with atuzaginstat, the level of phospho-tau217 was similar to that seen in uninfected controls, while tau degradation was completely inhibited by treatment with atuzaginstat.
    • New Baseline Data from GAIN Trial: In its poster titled "An update and baseline data from the Phase 2/3 GAIN trial of COR388 (atuzaginstat) a novel bacterial virulence factor inhibitor for the treatment of Alzheimer's Disease" (Poster #50624), Cortexyme shares updated and new baseline biomarker data from the full set of patients in the study that supports that this is an appropriate population for testing atuzaginstat for Alzheimer's disease. In addition to demonstrating that 100% of patients have evidence of systemic P. gingivalis exposure, GAIN baseline biomarker highlights include traditional CSF biomarkers Aβ, total tau, and phospho-tau 181. New data shows that a majority of patients have elevated Von Willebrand factor (vWF), a vascular injury marker, and alpha-2-macroglobulin (A2M), an endogenous protease inhibitor, in serum. GAIN baseline demographics also demonstrate that 90% of its periodontal disease REPAIR sub-study patients have moderate to severe periodontitis without requiring it as a criterion for study participation.

    Cortexyme AAIC Symposium – Getting to the Root Cause of Alzheimer's Disease

    Cortexyme will host a corporate sponsored symposium and dinner held in conjunction with AAIC 2021 titled "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification" on Tuesday, July 27, 2021, from 5:30 p.m. to 7:30 p.m. MT at the Hilton Denver City Center. Led by Cortexyme's chief executive officer and co-founder Casey Lynch and chief medical officer Michael Detke, M.D., Ph.D., the symposium will provide an informative presentation on how Cortexyme is moving beyond the prevailing targets to deliver a game-changing shift in Alzheimer's disease treatment. For AAIC 2021 registered participants wishing to attend Cortexyme's symposium in person, please email to sign up. The symposium also may be accessed online by registering to attend AAIC 2021 through its virtual conference experience here.

    KOL Webinar: Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration

    In conjunction with its participation at AAIC 2021, Cortexyme is hosting a key opinion leader (KOL) webinar titled "Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration" on Friday, July 30, 2021, at 10:00 a.m. ET. The webinar will feature KOL Marwan Noel Sabbagh, M.D., (Cleveland Clinic) who will discuss the current treatment landscape of Alzheimer's disease and dementia, the unmet medical need, as well as recent activity and evidence to support the role of P. gingivalis as an important upstream driver of Alzheimer's disease pathology. Dr. Sabbagh will also address new baseline data from Cortexyme's pivotal Phase 2/3 GAIN Trial of atuzaginstat for the treatment of Alzheimer's disease being presented at AAIC 2021. Cortexyme's management team will provide an update on its ongoing pivotal Phase 2/3 GAIN Trial, which builds on Phase 1 data demonstrating atuzaginstat was well tolerated in both healthy subjects and in patients with Alzheimer's disease. Dr. Sabbagh and Cortexyme's management will be available to answer questions following the formal presentations. To register for this webinar, please click here.

    Marwan Noel Sabbagh, M.D., board certified neurologist and geriatric neurologist, hopes to work himself out of a job. Considered one of the leading experts in Alzheimer's and dementia, he is the Camille and Larry Ruvo Endowed Chair for Brain Health and Director of Translational Research at Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. Dr. Sabbagh has dedicated his career to finding a cure for Alzheimer's and other age-related neurodegenerative diseases. Dr. Sabbagh is a leading investigator for many prominent national Alzheimer's prevention and treatment trials. Dr. Sabbagh is on the editorial board for Journal of Alzheimer's Disease and BMC Neurology. He is now editor in chief of Neurology and Therapy. He has authored and co-authored almost 370 medical and scientific articles on Alzheimer's research. Dr. Sabbagh is the author of The Alzheimer's Answer: Reduce Your Risk and Keep Your Brain Healthy, with foreword by Justice Sandra Day O'Connor, and The Alzheimer's Prevention Cookbook: 100 Recipes to Boost Brain Health. He has edited Palliative Care for Advanced Alzheimer's and Dementia: Guidelines and Standards for Evidence Based Care and Geriatric Neurology published in 2014 and Fighting for my Life: living in the shadow of Alzheimer's disease published in 2019. He has been recognized with numerous awards, including WestMarc Innovator Award, 2015; Fellow of the American Academy of Neurology, 2004. Dr. Sabbagh earned his undergraduate degree from the University of California, Berkeley and his medical degree from the University of Arizona in Tucson. He received his residency training in neurology at Baylor College of Medicine, Houston, Texas, and completed his fellowship in geriatric neurology and dementia at the University of California, San Diego School of Medicine, where he served on the faculty as assistant professor. Before joining the faculty of the Cleveland Clinic, he was at the Barrow Neurological Institute where he served for three years, and prior to that he was the director of the Banner Sun Health Research Institute for 15 years.

    About Cortexyme

    Cortexyme, Inc. (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases. The company is advancing its disease-modifying pivotal GAIN Trial in mild to moderate Alzheimer's disease with top-line data expected in the fourth quarter of 2021, in addition to growing a proprietary pipeline of first-in-class small molecule therapeutics for Parkinson's disease, periodontitis, and other diseases with high unmet clinical need. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. The company's causation evidence for Alzheimer's disease and the mechanism of its novel therapeutic has been independently replicated and confirmed by multiple laboratories around the world, as well as published in peer-reviewed scientific journals. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    Forward-Looking Statements

    Statements in this news release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this news 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. Examples of forward-looking statements include, among others, statements we make regarding our business plans, strategy, timeline, prospects, and milestone expectations; the timing and success of the company's clinical trials and related data, including with respect to the GAIN and REPAIR Trials; the potential of atuzaginstat to treat Alzheimer's disease, periodontal disease, and other potential indications; the timing of announcements and updates relating to its clinical trials and related data; the potential therapeutic benefits, safety and efficacy of the company's product candidate or library of compounds and statements about its ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to the company's drug product candidate. Forward-looking statements are based on Cortexyme's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in Cortexyme's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, its Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

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  3. Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the selection of a lead 3CLpro inhibitor (COR803) for treatment of coronavirus infections, including COVID-19 disease, caused by SARS-CoV-2 infection.

    "There continues to be a large unmet need for coronavirus treatment. The target of COR803 is highly conserved across variants and among coronaviruses in general, therefore it is expected to address both current and future coronavirus strains, including the delta variant of SARS-CoV-2," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "We have…

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the selection of a lead 3CLpro inhibitor (COR803) for treatment of coronavirus infections, including COVID-19 disease, caused by SARS-CoV-2 infection.

    "There continues to be a large unmet need for coronavirus treatment. The target of COR803 is highly conserved across variants and among coronaviruses in general, therefore it is expected to address both current and future coronavirus strains, including the delta variant of SARS-CoV-2," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "We have selected COR803 based on compelling data to support its development as a potential therapy that could be prescribed at the first sign of infection or after known exposures without requiring patients to be hospitalized, as well as for those in critical care. The novel characteristics of COR803 reflect the breadth and capabilities of our proprietary research and development as Cortexyme continues to apply our innovative science to areas of high clinical need."

    COR803 is a novel patent-pending small molecule 3CLpro inhibitor discovered and developed by Cortexyme based on its expertise in cysteine protease inhibition. 3CLpro, or Mpro, is a validated antiviral drug target shown to be essential in viral replication of SARS-CoV-2. COR803 has beneficial properties over other COVID-19 therapeutics and 3CLpro inhibitors in development including:

    • Covalent irreversible binding of the viral 3CLpro enzyme;
    • High potency: Antiviral EC90 of 30 nM in human lung cell viral replication assays;
    • Highly selective for 3CLpro versus other cellular proteases including Cathepsin L; and
    • Excellent systemic exposure utilizing intranasal or subcutaneous administration, allowing for clinical use in multiple settings such as outpatient and inpatient.

    About Cortexyme

    Cortexyme, Inc. (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases. The company is advancing its disease-modifying pivotal GAIN Trial in mild to moderate Alzheimer's disease with top-line data expected in the fourth quarter of 2021, in addition to growing a proprietary pipeline of first-in-class small molecule therapeutics for Parkinson's disease, periodontitis, and other diseases with high unmet clinical need. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. The company's causation evidence for Alzheimer's disease and the mechanism of its novel therapeutic has been independently replicated and confirmed by multiple laboratories around the world, as well as published in peer-reviewed scientific journals. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    Forward-Looking Statements

    Statements in this news release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this news 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. Examples of forward-looking statements include, among others, statements we make regarding our business plans, strategy, timeline, prospects, and milestone expectations; the characteristics and potential benefits of COR803, including for the treatment of coronavirus infections, the timing and success of the company's clinical trials and related data; the potential of atuzaginstat to treat Alzheimer's disease, periodontal disease, and other potential indications; the timing of announcements and updates relating to its clinical trials and related data; the potential therapeutic benefits, safety and efficacy of the company's product candidate or library of compounds; and statements about its ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to the company's drug product candidate. Forward-looking statements are based on Cortexyme's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in Cortexyme's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, its Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

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  4. Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced that it will present two poster presentations covering an update from its pivotal Phase 2/3 GAIN Trial of atuzaginstat, in addition to new data demonstrating the upstream role that P. gingivalis plays in key pathology of Alzheimer's disease, at the Alzheimer's Association International Conference® 2021 (AAIC®) taking place July 26-30, 2021, in Denver, Colorado, as well as virtually.

    AAIC 2021 Poster Presentation Details

    Topic: An update and baseline data from the Phase 2/3 GAIN trial of COR388 (atuzaginstat), a novel bacterial…

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced that it will present two poster presentations covering an update from its pivotal Phase 2/3 GAIN Trial of atuzaginstat, in addition to new data demonstrating the upstream role that P. gingivalis plays in key pathology of Alzheimer's disease, at the Alzheimer's Association International Conference® 2021 (AAIC®) taking place July 26-30, 2021, in Denver, Colorado, as well as virtually.

    AAIC 2021 Poster Presentation Details

    Topic: An update and baseline data from the Phase 2/3 GAIN trial of COR388 (atuzaginstat), a novel bacterial virulence factor inhibitor for the treatment of Alzheimer's Disease

    • Presenter: Michael Detke, MD, PhD, Cortexyme's Chief Medical Officer
    • Authors: Michael Detke, MD, PhD1, Shirin Kapur, PhD1, Marwan Sabbagh, MD2, Mark Ryder, DMD3, Ira Goodman, MD4, Debasish Raha, PhD1, Florian Ermini, PhD1, Mai Nguyen, PhD1, Ursula Haditsch, PhD1, Joanna Bolger1, Dave Hennings, PhD1, Kim Perry, PhD5, Kelly Ritch, MS6, Casey Lynch1, Hatice Hasturk, DDS, PhD6, Leslie J. Holsinger, PhD1, Stephen Dominy, MD1

    Topic: Examining phospho-tau217 in neuron cultures and CVN mice infected with Porphyromonas gingivalis and effects of gingipain inhibition

    • Presenter: Florian Ermini, PhD, Cortexyme's Associate Director, In Vivo Pharmacology and Translational Biology
    • Authors1: Florian Ermini, PhD, Ursula Haditsch, PhD, Aurora Martinez-Horta, Leo Rodriguez, Sean Broce, Mai Nguyen, PhD, Debasish Raha, PhD, Shirin Kapur, PhD, Leslie Holsinger, PhD, Casey Lynch, Stephen Dominy, MD

    Cortexyme's posters will be available on Monday, July 26, 2021, beginning at 10:00 a.m. Eastern Time (8:00 a.m. Mountain Time) via AAIC 2021's virtual conference experience here, as well as on the company's website under the Science section accessible here.

    Cortexyme AAIC Symposium – Getting to the Root Cause of Alzheimer's Disease

    In conjunction with AAIC 2021, Cortexyme also will host a corporate sponsored symposium and dinner titled "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification" on Tuesday, July 27, 2021, from 5:30 p.m. to 7:30 p.m. Mountain Time at the Hilton Denver City Center in Denver, Colorado. Led by Cortexyme's Chief Executive Officer, Co-founder, and Chair Casey Lynch and Chief Medical Officer Michael Detke, MD, PhD, the symposium will provide an informative presentation on how Cortexyme is moving beyond the prevailing targets to deliver a game-changing shift in Alzheimer's disease treatment. For AAIC 2021 registered participants wishing to attend Cortexyme's symposium in person, please email to sign up. The symposium may be accessed online by registering to attend AAIC 2021 through its virtual conference experience here.

    About Cortexyme

    Cortexyme, Inc. (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases. The company is advancing its disease-modifying pivotal GAIN Trial in mild to moderate Alzheimer's disease with top-line data expected in the fourth quarter of 2021, in addition to growing a proprietary pipeline of first-in-class small molecule therapeutics for Parkinson's disease, periodontitis, and other diseases with high unmet clinical need. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. The company's causation evidence for Alzheimer's disease and the mechanism of its novel therapeutic has been independently replicated and confirmed by multiple laboratories around the world, as well as published in peer-reviewed scientific journals. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    Forward-Looking Statements

    Statements in this news release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this news 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. Examples of forward-looking statements include, among others, statements we make regarding our business plans, strategy, timeline, prospects, and milestone expectations; the timing and success of the company's clinical trials and related data, including with respect to the GAIN and REPAIR Trials; the potential of atuzaginstat to treat Alzheimer's disease, periodontal disease, and other potential indications; the timing of announcements and updates relating to its clinical trials and related data; the potential therapeutic benefits, safety and efficacy of the company's product candidate or library of compounds; and statements about its ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to the company's drug product candidate. Forward-looking statements are based on Cortexyme's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in Cortexyme's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, its Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

    (1) Cortexyme, South San Francisco, CA; (2) Cleveland Clinic, Las Vegas; (3) UCSF, San Francisco, CA; (4) Bioclinica, Orlando, FL; (5) Innovative Analytics, Portage, MI; (6) Datafy Clinical R & D

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  5. Leading drug candidate penetrates and disrupts bacterial biofilms, a key feature for efficacy in treating P. gingivalis driven disease

    Atuzaginstat reverses alveolar bone loss in mice after oral P. gingivalis infection at doses relevant for therapeutic efficacy in periodontal disease

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced new preclinical data demonstrating efficacious dose range finding data for its lead drug candidate atuzaginstat (COR388) in periodontal disease in conjunction with its participation at the International Association for Dental Research (IADR

    Leading drug candidate penetrates and disrupts bacterial biofilms, a key feature for efficacy in treating P. gingivalis driven disease

    Atuzaginstat reverses alveolar bone loss in mice after oral P. gingivalis infection at doses relevant for therapeutic efficacy in periodontal disease

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected in the fourth quarter of 2021 and a growing pipeline of therapeutics for degenerative diseases, announced new preclinical data demonstrating efficacious dose range finding data for its lead drug candidate atuzaginstat (COR388) in periodontal disease in conjunction with its participation at the International Association for Dental Research (IADR) 2021 General Session & Exhibition, a virtual event. Periodontal disease represents a significant unmet market of 65 million people in the U.S. alone.

    New data presented at the IADR 2021 conference by Cortexyme showed its lead clinical small molecule, atuzaginstat, was able to engage and inhibit its target, lysine-gingipain from P. gingivalis, within a biofilm and disrupt the biofilm integrity. The inability of traditional antibiotics to penetrate oral biofilms at therapeutic concentrations is a major reason for their lack of efficacy in treating chronic periodontitis. The company also confirmed that a second-generation lysine-gingipain inhibitor, COR588, demonstrated biofilm penetration and target engagement similar to atuzaginstat and is planned to begin Phase I studies in the third quarter 2021. In a second presentation at IADR 2021, Cortexyme presented data from preclinical studies demonstrating that atuzaginstat was efficacious in reversing alveolar bone loss induced by oral P. gingivalis infection.

    "As top-line data for our GAIN Trial rapidly approaches in the fourth quarter 2021, Cortexyme is in a unique position with a pivotal clinical study of our lead drug candidate atuzaginstat that targets the infectious pathogen P. gingivalis not only as the causative agent of Alzheimer's disease, but also its well-established role as a keystone bacterium for periodontal disease. This presents us with the potential to provide innovative and breakthrough treatments in two high unmet clinical need areas with a first-in-class, orally administered small molecule," said Casey Lynch, Cortexyme's chief executive officer, co-founder and chair. "The 233-patient periodontal disease REPAIR sub-study of the GAIN Trial evaluates standard clinical endpoints of periodontitis, including gingival pocket depth, clinical attachment, and bleeding on probing. We look forward to reporting top-line data from the REPAIR sub-study in the fourth quarter 2021."

    New data will be featured in two poster sessions at IADR 2021:

    • Atuzaginstat Penetrates Biofilms for Periodontal Disease Therapeutic Efficacy: At Cortexyme's IADR 2021 poster session titled "Gingipain Inhibitors Penetrate And Inhibit Gingipains In Porphyromonas gingivalis Biofilms" (Abstract #3571509) taking place Friday, July 23, 2021, starting at 3:45 p.m. ET, new data will be presented demonstrating the efficacy of atuzaginstat and COR588 to penetrate in vitro surface attached biofilms. Biofilms are one of the primary reasons that other molecules like broad spectrum antibiotics are ineffective against P. gingivalis. Biofilm cultures demonstrated decreased potency of the broad-spectrum antibiotic amoxicillin relative to planktonic growth as expected for robust biofilms. Atuzaginstat and the company's second generation COR588 exhibited significant time and concentration-dependent inhibition of lysine-gingipain activity, while maintaining their target selectivity within the biofilms to inhibit lysine-gingipain. Other similarly potent gingipain inhibitors were less capable of activity within the biofilm.
    • Atuzaginstat Efficacious in Mouse Model of Periodontal Disease: At Cortexyme's IADR 2021 poster session titled "Novel lysine-gingipain inhibitor atuzaginstat (COR388) is efficacious in a mouse model of periodontal disease" (Abstract #1756) taking place Friday, July 23, 2021, starting at 11:00 a.m. ET, new data will be presented that demonstrates that atuzaginstat, a first-in-class brain-penetrant lysine-gingipain inhibitor, was effective in reversing alveolar bone loss in mice after repeated oral P. gingivalis infection. Mice were orally infected with P. gingivalis for 42 days and treated from day 35 through day 70 with oral administration of atuzaginstat. Multiple studies were used to determine an effective exposure and dose regimen. A previously peer-reviewed publication established efficacy of atuzaginstat in reducing oral infection and periodontal disease in a naturally occurring aged dog model (Aratsu-Kapur et al. 2021).

    KOL Webinar: Innovation in Periodontal Disease – A Major Unmet Medical Need

    In conjunction with its participation at IADR 2021, Cortexyme is hosting a key opinion leader (KOL) webinar titled "Innovation in Periodontal Disease – A Major Unmet Medical Need" on Friday, July 23, 2021, at 10:00 a.m. ET. The webinar will feature KOL Mark Ryder, D.M.D., (University of California, San Francisco) who will discuss the unmet medical need in treating patients with P. gingivalis-induced periodontal disease and Cortexyme management will present new data from the company's IADR 2021 abstracts. An update on the REPAIR Phase 2 periodontal sub-study of atuzaginstat as part of its pivotal Phase 2/3 GAIN Trial in Alzheimer's disease will also be presented. Dr. Ryder and Cortexyme's management will be available to answer questions following the formal presentations. To register for this webinar, please click here.

    Mark Ryder, D.M.D., is a Professor of Periodontology and former Chair of Periodontology and Director of the Postgraduate program in Periodontology at the University of California, San Francisco where he has been a faculty member for the past 41 years. He received his dental and specialty training from the Harvard School of Dental Medicine. He is the author of over 190 articles, abstracts, and book chapters and has lectured extensively on a variety of research and educational topics. He serves as an Associate Editor of the Journal of Periodontal Research and is on the Editorial Board of several dental research journals. He has also served as a chair and/or reviewer on several NIH study sections and other national and international peer review grant organizations, in addition to serving as a consultant for several national and international accreditation programs for dental education. His current research interests include connections between periodontal diseases and Alzheimer's Disease, the links between oral and systemic health in HIV patients, and basic research and clinical trials on novel periodontal therapies.

    About Cortexyme

    Cortexyme, Inc. (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches designed to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases. The company is advancing its disease-modifying pivotal GAIN Trial in mild to moderate Alzheimer's disease with top-line data expected in the fourth quarter of 2021, in addition to growing a proprietary pipeline of first-in-class small molecule therapeutics for Parkinson's disease, periodontitis, and other diseases with high unmet clinical need. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. The company's causation evidence for Alzheimer's disease and the mechanism of its novel therapeutic has been independently replicated and confirmed by multiple laboratories around the world, as well as published in peer-reviewed scientific journals. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    Forward-Looking Statements

    Statements in this news release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this news 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. Examples of forward-looking statements include, among others, statements we make regarding our business plans, strategy, timeline, prospects, and milestone expectations; the timing and success of the company's clinical trials and related data, including with respect to the GAIN and REPAIR Trials; the potential of atuzaginstat to treat Alzheimer's disease, periodontal disease, and other potential indications; the timing of announcements and updates relating to its clinical trials and related data; the potential therapeutic benefits, safety and efficacy of the company's product candidate or library of compounds; and statements about its ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to the company's drug product candidate. Forward-looking statements are based on Cortexyme's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in Cortexyme's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, its Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

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