CRTX Cortexyme Inc.

12.03
-0.19  -2%
Previous Close 12.22
Open 12.02
52 Week Low 11.7901
52 Week High 121.98
Market Cap $359,427,624
Shares 29,877,608
Float 17,289,798
Enterprise Value $251,302,369
Volume 535,080
Av. Daily Volume 2,262,328
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Drug Pipeline

Drug Stage Notes
Atuzaginstat - GAIN
Alzheimer’s disease
Phase 2/3
Phase 2/3
Phase 2/3 top-line data reported that the trial did not meet its co-primary endpoints, noted October 26, 2021. Phase 2/3 data reported that the 40 mg demonstrated equivalent or better efficacy compared 80 mg, as well as a superior safety profile. Benefits were shown in ADAS-Cog11, CDR-SB, MMSE, and NPI, with increasing separation from placebo throughout the study consistent with disease modification. Benefits were not seen on ADCS-ADL at either dose, noted November 11, 2021.
COR588
P. gingivalis
Phase 1
Phase 1
Phase 1 announced that the first cohort of healthy participants have been dosed September 8, 2021
Atuzaginstat
Parkinson's disease
Phase 2
Phase 2
Phase 2 dosing to commence 3Q 2021.

Latest News

  1. Cortexyme, Inc. (NASDAQ:CRTX) announced that Casey Lynch, chief executive officer, co-founder, and chair, will participate in a fireside chat at the 4th Annual Evercore ISI HealthCONx Conference taking place virtually on Tuesday, November 30, 2021, beginning at 1:25 p.m. Eastern Time.

    A 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. Cortexyme's…

    Cortexyme, Inc. (NASDAQ:CRTX) announced that Casey Lynch, chief executive officer, co-founder, and chair, will participate in a fireside chat at the 4th Annual Evercore ISI HealthCONx Conference taking place virtually on Tuesday, November 30, 2021, beginning at 1:25 p.m. Eastern Time.

    A 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. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain of Alzheimer's patients 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. Evidence supports P. gingivalis as a driver of Alzheimer's in easily identified patient population

    Successful identification of target population and therapeutic dose inform next steps

    Cortexyme, Inc. (NASDAQ:CRTX) will present additional data from its Phase 2/3 GAIN Trial at the 14th Clinical Trials on Alzheimer's Disease Conference (CTAD 2021) as a part of the meeting's Late-Breaking Readout Roundtable program today, Thursday, November 11, 2021, at 11:35 a.m. Eastern Time taking place in Boston, Massachusetts, as well as virtually. The presentation will expand on previously reported top-line results that demonstrated the relationship between the reduction of Porphyromonas gingivalis (P. gingivalis) infection and the slowing of cognitive…

    Evidence supports P. gingivalis as a driver of Alzheimer's in easily identified patient population

    Successful identification of target population and therapeutic dose inform next steps

    Cortexyme, Inc. (NASDAQ:CRTX) will present additional data from its Phase 2/3 GAIN Trial at the 14th Clinical Trials on Alzheimer's Disease Conference (CTAD 2021) as a part of the meeting's Late-Breaking Readout Roundtable program today, Thursday, November 11, 2021, at 11:35 a.m. Eastern Time taking place in Boston, Massachusetts, as well as virtually. The presentation will expand on previously reported top-line results that demonstrated the relationship between the reduction of Porphyromonas gingivalis (P. gingivalis) infection and the slowing of cognitive decline in Alzheimer's disease with atuzaginstat treatment in a prespecified population of patients based on diagnosis of infection.

    The 643-participant 48-week GAIN Trial was the first large study to test the efficacy of an oral small-molecule targeting P. gingivalis for disease modification in mild to moderate Alzheimer's patients. While not meeting statistical significance on its co-primary cognitive and functional endpoints in the overall cohort, the study data showed that treatment with atuzaginstat slowed decline compared to placebo on the majority of clinical endpoints in prespecified populations that were selected based on P. gingivalis infection markers.

    The GAIN Trial results showed that the 40 mg BID arm demonstrated equivalent or better efficacy across key endpoints compared to the higher dose, 80 mg BID, as well as a superior safety profile. Trends to benefit at 40 mg BID were seen with multiple prespecified analytic approaches, including on ADAS-Cog11, CDR-SB, MMSE, and NPI, with increasing separation from placebo throughout the study consistent with disease modification. Benefits were not seen on ADCS-ADL at either dose. Changes in P. gingivalis DNA levels in saliva correlated significantly with clinical outcomes during and at the end of treatment, demonstrating that reduced P. gingivalis bacterial load resulted in better clinical outcomes. A trend to slowing of the primary biomarker endpoint of hippocampal atrophy was seen in treatment groups, but did not reach significance.

    "Our ability to identify the right population in historically hard to treat mild to moderate Alzheimer's patients, along with finding an efficacious dose with a differentiated safety profile, is important progress toward a breakthrough treatment for Alzheimer's disease," said Michael Detke, MD, PhD, Cortexyme's chief medical officer. "We saw clinically significant effects ranging from 30% to 50% slowing on ADAS-Cog11 and CDR-SB measures. The benefits on these widely accepted scales provide an informative foundation for a confirmatory study. This landmark study materially advances our understanding of P. gingivalis as an upstream driver of Alzheimer's disease progression, and we look forward to sharing additional study data as it becomes available over the coming months."

    "The GAIN Trial achieved several significant advancements for the Alzheimer's field, first by clinically confirming that P. gingivalis is a key upstream driver of disease progression. Further, the data demonstrated a compelling risk-benefit profile with a clinically significant treatment response in an easily identifiable population of patients," said Marwan Sabbagh, MD, FAAN, lead investigator of the GAIN Trial and Professor of Neurology at the Barrow Neurological Institute. "I am particularly encouraged by GAIN's identification of a target population, which is consistent with the heterogeneous nature of Alzheimer's disease and comparable to treatment advancements based on diagnosis of infectious disease, like HIV dementia and personalized medicine common in other therapeutic areas, like oncology. When coupled with the convenience of oral dosing, atuzaginstat offers the potential to fill a huge gap in the underserved mild to moderate Alzheimer's population in as many as half of those patients. I was gratified to act as the lead investigator for this important study that will hopefully be part of our arsenal of treatments for Alzheimer's in the not-so-distant future."

    Across critical safety measures, the rates in the 40 mg BID treatment arm were either comparable to placebo or substantially better than in the 80 mg BID arm. Most adverse events were mild to moderate in severity. The most common were gastrointestinal, such as diarrhea in up to 16% and nausea in 6% of participants treated with atuzaginstat, versus 3% and 2% of placebo participants, respectively. Atuzaginstat was associated with dose-related liver enzyme elevations >3X the upper limit of normal: 2% on placebo, 7% on 40 mg BID, and 15% on 80 mg BID. These elevations alone were not clinically significant and virtually all participants were asymptomatic. Two participants in the 80 mg BID arm had concomitant bilirubin elevations without alternative explanation. Lab changes resolved while participants remained on drug or after withdrawal without any known long-term adverse effects. Atuzaginstat treated groups showed no increase in ARIA (amyloid-related imaging abnormalities), including microhemorrhage and edema, or superficial siderosis.

    "The data generated from this first-of-its-kind study adds an important new dimension to our understanding of Alzheimer's disease," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "The study was successful in accomplishing many of our objectives, including identification of the appropriate population for treatment and the therapeutic dose. We intend to apply our learnings to progress an anticipated confirmatory study, pending discussions with the FDA and global regulators."

    Accessing Cortexyme's Late-Breaking Readout Roundtable at CTAD 2021

    Cortexyme's late-breaking readout roundtable presentation at CTAD 2021 will be accessible today, Thursday, November 11, 2021, beginning at 11:35 a.m. Eastern Time via the company's Investor Relations website at ir.cortexyme.com, in addition to being accessible to CTAD registered meeting attendees in-person and on its virtual platform.

    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. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain of Alzheimer's patients 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," "potential" or other similar words. Examples of forward-looking statements include, among others, the strategic development path for atuzaginstat, its business plans, strategy, planned clinical trials and timeline, prospects, and milestone expectations; the timing and success of the company's clinical trials and related data, including plans and the ability to conduct a confirmatory study with respect to the GAIN Trial; the potential of atuzaginstat to treat Alzheimer's disease; 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, further development of atuzaginstat, regulatory submissions and interactions with regulators, and related response and decisions, including with respect to the company's partial clinical hold, 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 October 29, 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) announced that it will participate at the 14th Clinical Trials on Alzheimer's Disease Conference (CTAD 2021) as a part of the meeting's Late-Breaking Readout Roundtable program on Thursday, November 11, 2021, at 11:35 a.m. Eastern Time in Boston, Massachusetts. During the company's 30-minute presentation, Cortexyme's chief medical officer Michael Detke, MD, PhD, and GAIN Trial lead investigator Marwan Sabbagh, MD, FAAN, will provide additional GAIN Trial top-line results and analysis.

    CTAD 2021 Late-Breaking Readout Roundtable Details

    Title: Top-line Results from the GAIN Trial: A Phase 2/3 Study of Atuzaginstat in Mild to Moderate Alzheimer's Disease.

    • Presenters: Michael Detke, MD, PhD, Cortexyme's chief medical…

    Cortexyme, Inc. (NASDAQ:CRTX) announced that it will participate at the 14th Clinical Trials on Alzheimer's Disease Conference (CTAD 2021) as a part of the meeting's Late-Breaking Readout Roundtable program on Thursday, November 11, 2021, at 11:35 a.m. Eastern Time in Boston, Massachusetts. During the company's 30-minute presentation, Cortexyme's chief medical officer Michael Detke, MD, PhD, and GAIN Trial lead investigator Marwan Sabbagh, MD, FAAN, will provide additional GAIN Trial top-line results and analysis.

    CTAD 2021 Late-Breaking Readout Roundtable Details

    Title: Top-line Results from the GAIN Trial: A Phase 2/3 Study of Atuzaginstat in Mild to Moderate Alzheimer's Disease.

    • Presenters: Michael Detke, MD, PhD, Cortexyme's chief medical officer and GAIN Trial lead investigator Marwan Sabbagh, MD, FAAN, Professor of Neurology at the Alzheimer's and Memory Disorders Division of the Barrow Neurological Institute at Dignity Health/St. Joseph's Hospital and Medical Center.
    • Authors: Michael Detke1, Marwan Sabbagh2, Mark Ryder3, Joanna Bolger1, Dave Hennings1, Vladimir Skljarevski1, Shirin Kapur1, Debasish Raha1, Florian Ermini1, Mai Nguyen1, Ursula Haditsch1, Kim Perry4, Kelly Ritch5, Suzanne Hendrix6, Sam Dickson6, Hatice Hasturk7, Sarah Horine1, Craig Mallinckrodt1, Leslie Holsinger1, Casey Lynch1, and Stephen Dominy1.
    • Access: Cortexyme's CTAD 2021 presentation will be accessible on Thursday, November 11, 2021, beginning at 11:35 a.m. Eastern Time via the company's Investor Relations website at ir.cortexyme.com, in addition to being accessible to CTAD registered meeting attendees in-person and on its virtual platform.

    1Cortexyme - South San Francisco, CA (USA), 2Barrow Neurological Institute, Dignity Health/St. Joseph's Hospital and Medical Center - Phoenix, AZ (USA), 3UCSF - San Francisco, CA (USA), 4Innovative Analytics - Portage, MI (USA), 5Datafy Clinical R&D - Portage, MI (USA), 6Pentara Corporation - Millcreek, UT (USA), 7Forsyth Institute - Cambridge, MA (USA)

    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. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain of Alzheimer's patients 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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  4. In overall population, co-primary endpoints of ADAS-Cog11 and ADCS-ADL were not met

    Pre-specified subgroups representing up to half of the participants based on P. gingivalis infection level showed approximately 50% slowing of cognitive decline

    Clinical data validated upstream mechanism of action and benefits of targeting P. gingivalis

    Additional top-line GAIN Trial results to be presented at CTAD 2021 on November 11th

    Cortexyme to host investor conference call today Tuesday, October 26th at 4:30 p.m. Eastern Time

    Cortexyme, Inc. (NASDAQ:CRTX) today reported top-line results from its Phase 2/3 GAIN Trial, a double-blind, placebo-controlled study evaluating the efficacy of atuzaginstat (COR388), an investigational orally administered small-molecule…

    In overall population, co-primary endpoints of ADAS-Cog11 and ADCS-ADL were not met

    Pre-specified subgroups representing up to half of the participants based on P. gingivalis infection level showed approximately 50% slowing of cognitive decline

    Clinical data validated upstream mechanism of action and benefits of targeting P. gingivalis

    Additional top-line GAIN Trial results to be presented at CTAD 2021 on November 11th

    Cortexyme to host investor conference call today Tuesday, October 26th at 4:30 p.m. Eastern Time

    Cortexyme, Inc. (NASDAQ:CRTX) today reported top-line results from its Phase 2/3 GAIN Trial, a double-blind, placebo-controlled study evaluating the efficacy of atuzaginstat (COR388), an investigational orally administered small-molecule that targets gingipain proteases from the bacterium Porphyromonas gingivalis (P. gingivalis). The 643-participant study in mild to moderate patients with Alzheimer's disease did not meet statistical significance in its co-primary cognitive and functional endpoints as measured by ADAS-Cog11 and ADCS-ADL at end of the treatment period in the overall cohort.

    The pre-specified subgroup of participants with P. gingivalis DNA detectable in saliva at baseline (PG-DS; n=242) showed a dose response, with a 57% slowing of cognitive decline as measured by ADAS-Cog11 in the 80 mg BID arm (p=0.02) and a 42% slowing in the 40 mg BID arm (p=0.07) vs. placebo. Significant benefits in this subgroup were not seen on the other co-primary, ADCS-ADL. The cognitive benefit of atuzaginstat in patients with high P. gingivalis infection was reinforced by similar results in multiple pre-specified infection related subgroups and with multiple methods of analysis. Additionally, reductions in P. gingivalis in saliva at week 24 were significantly correlated with improved outcomes at the end of the treatment period as measured by ADAS-Cog11 (p=0.0007), Clinical Dementia Rating–Sum of Boxes (CDR) (p=0.004), Mini-Mental State Exam (MMSE) (p=0.007), and a beneficial trend on ADCS-ADL (p=0.08).

    The sub-study in periodontal disease demonstrated a trend to benefit on the primary clinical endpoint of pocket depth in the same pre-specified sub-group with P. gingivalis DNA detectable in saliva. Further results will inform the next stage of development in periodontitis and will be presented at a future scientific conference.

    "Today marks a major milestone toward a comprehensive understanding of Alzheimer's and slowing of disease progression. The evidence from the GAIN Trial advances our ability to identify the right patients, impact an upstream target, and improve patient outcomes," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "We are focused on next steps to advance this breakthrough treatment for the benefit of patients and their families."

    Most adverse events were mild to moderate in severity. The most common were gastrointestinal, such as diarrhea in up to 16% and nausea in 6% of participants treated with atuzaginstat vs. 3% and 2% of placebo participants, respectively. Atuzaginstat was associated with dose-related liver enzyme elevations >3X the upper limit of normal: 2% on placebo, 7% on 40 mg BID, and 15% on 80 mg BID. These elevations alone were not clinically significant, and virtually all participants were asymptomatic. Two participants in the 80 mg BID arm had concomitant bilirubin elevations without alternative explanation. Lab changes resolved while participants remained on drug or after withdrawal without any known long-term adverse effects. Atuzaginstat treated groups showed no increase in ARIA (amyloid-related imaging abnormalities), including microhemorrhage and edema, or superficial siderosis.

    "The first large clinical study of a gingipain inhibitor confirmed the benefits of treatment in the appropriate population at doses that reduce P. gingivalis. Disease modification and preservation of cognition as demonstrated in the GAIN Trial provides the foundation for altering the course of Alzheimer's," said Michael Detke, MD, PhD, Cortexyme's chief medical officer. "The P. gingivalis-infected participant population was easily identified with saliva or simple blood tests and was highly responsive to atuzaginstat treatment on multiple clinical measures, and we will be discussing next steps with global regulators promptly. We are grateful to the participants, caregivers, and investigators for their participation and dedication to this important study."

    In light of the GAIN Trial results and the significant unmet medical need in Alzheimer's, Cortexyme is actively engaging with regulators, the medical community, patient advocacy groups, and other key stakeholders to advance development of atuzaginstat and the second-generation lysine-gingipain inhibitor COR588, which is differentiated by novel compound properties and once daily administration.

    Additional Top-line GAIN Trial Results at CTAD 2021 on November 11th

    Cortexyme will present the additional top-line results from the GAIN Trial at the upcoming 14th Clinical Trials on Alzheimer's Disease (CTAD 2021) conference on Thursday, November 11, 2021, at 11:35 a.m. Eastern Time in Boston, Massachusetts. Access to Cortexyme's CTAD 2021 presentation will be available on the company's Investor Relations website at ir.cortexyme.com.

    Investor Call Today at 4:30 p.m. Eastern Time

    Cortexyme management will discuss the GAIN Trial top-line results during an investor conference call beginning at 4:30 p.m. Eastern Time today, Tuesday, October 26, 2021. To join the call, participants may dial 877-451-6152 (domestic) or 201-389-0879 (international) and provide the conference ID: 13724711. To listen to a live webcast of the conference call, visit the Investor Calendar page under the News & Events heading of the Cortexyme's Investor Relations website at ir.cortexyme.com. A replay of the conference call will be made available and accessible on Cortexyme's Investor Relations website shortly after the live call concludes.

    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. Cortexyme's lead program targets a specific, infectious pathogen called P. gingivalis found in the brain of Alzheimer's patients 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," "potential" or other similar words. Examples of forward-looking statements include, among others, plans to present additional data from the GAIN Trial at CTAD 2021 and other medical meetings, the strategic development path for atuzaginstat, its business plans, strategy, planned clinical trials and timeline, prospects, and milestone expectations; the timing and success of the company's clinical trials and related data, including with respect to the GAIN Trial, as well as enabling and human studies of COR588; 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, further development of atuzaginstat and COR588, regulatory submissions and related response and decisions, including with respect to the company's partial clinical hold, 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 August 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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  5. Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal Phase 2/3 trial in Alzheimer's disease and a growing pipeline of therapeutics for degenerative diseases, today announced that it will participate at the upcoming 14th Clinical Trials on Alzheimer's Disease (CTAD 2021) conference scheduled for November 9-12, 2021, in Boston, Massachusetts, as well as virtually. Cortexyme will present results from its Phase 2/3 GAIN Trial evaluating the efficacy of its lead small molecule atuzaginstat in 643 mild to moderate Alzheimer's patients. Cortexyme expects to announce top-line results in advance of its scientific presentation at CTAD 2021. Results of the GAIN Trial's Phase 2 periodontal disease REPAIR sub-study also are expected to be announced…

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal Phase 2/3 trial in Alzheimer's disease and a growing pipeline of therapeutics for degenerative diseases, today announced that it will participate at the upcoming 14th Clinical Trials on Alzheimer's Disease (CTAD 2021) conference scheduled for November 9-12, 2021, in Boston, Massachusetts, as well as virtually. Cortexyme will present results from its Phase 2/3 GAIN Trial evaluating the efficacy of its lead small molecule atuzaginstat in 643 mild to moderate Alzheimer's patients. Cortexyme expects to announce top-line results in advance of its scientific presentation at CTAD 2021. Results of the GAIN Trial's Phase 2 periodontal disease REPAIR sub-study also are expected to be announced by mid-November.

    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 therapy in mild to moderate Alzheimer's disease, in addition to growing a proprietary pipeline of first-in-class small molecule therapeutics for Parkinson's disease, periodontitis, coronavirus 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," "potential" or other similar words. Examples of forward-looking statements include, among others, statements Cortexyme makes regarding the sufficiency of its cash position to fund its operations; its 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, as well as enabling and human studies of COR588; the potential of atuzaginstat to treat Alzheimer's disease, periodontal disease, and other potential indications; the potential of COR803 to treat coronavirus infections; 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 August 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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