1. First participants dosed in clinical trial of second-generation gingipain inhibitor differentiated by novel compound properties and anticipated once daily administration

    Clinical advancement of pipeline delivers on commitment to bring innovation to an increasing range of P. gingivalis-related disease indications with high unmet clinical needs

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, today announced that the first cohort of healthy participants have been dosed in the Phase 1 clinical trial of its new drug candidate, COR588. COR588 is a second-generation small-molecule lysine-gingipain…

    First participants dosed in clinical trial of second-generation gingipain inhibitor differentiated by novel compound properties and anticipated once daily administration

    Clinical advancement of pipeline delivers on commitment to bring innovation to an increasing range of P. gingivalis-related disease indications with high unmet clinical needs

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, today announced that the first cohort of healthy participants have been dosed in the Phase 1 clinical trial of its new drug candidate, COR588. COR588 is a second-generation small-molecule lysine-gingipain inhibitor differentiated from the company's lead drug candidate atuzaginstat (COR388) by its improved pharmacokinetic properties and anticipated once daily oral administration. Delivering on its commitment to bring innovation to high unmet clinical needs, Cortexyme expects COR588 to be targeted for use in the treatment of periodontal disease and other P. gingivalis-related indications.

    "Advancing COR588 into the clinic as planned marks an important milestone for Cortexyme as we expand our proprietary drug pipeline and strategically advance our first-in-class gingipain inhibitors for additional indications where the evidence demonstrates P. gingivalis plays a critical role in disease progression," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "Based on this wealth of research, we believe our innovative upstream therapeutic approach has the potential to shift the paradigm for the treatment of diseases with high unmet clinical need in distinct market segments. Building on the momentum of our successfully completed IND-enabling studies of COR588, we look forward to completing the Phase 1 study and advancing the clinical studies of this promising potential therapeutic."

    Sponsored by Cortexyme, the COR588 Phase 1 trial is a randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of oral COR588 capsules in healthy adult patients. The trial will enroll up to 64 participants and is listed under clinicaltrials.gov Identifier: NCT04920903. Future studies will evaluate the ability of COR588, an oral investigational medicine, to slow or halt the progression of periodontal disease, among other potential indications, by inactivating the toxic proteases, or gingipains, released by the keystone bacterium P. gingivalis. Periodontal disease represents a major unmet medical need impacting 65 million Americans. Therapeutic effects of gingipain inhibitors have been demonstrated in both mouse and naturally occurring aged dog models (Arastu-Kapur et al, 2020).

    Cortexyme is evaluating the efficacy of its lead lysine-gingipain inhibitor, atuzaginstat, in the company's pivotal GAIN Trial evaluating the role of P. gingivalis in the progression of Alzheimer's disease in mild to moderate patients, which includes a 233-patient sub-study in periodontal disease called REPAIR (REduction of P. GingivAlIs to ImpRove Pocket Depth). Top-line data from the GAIN Trial and REPAIR sub-study are expected by mid-November 2021.

    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 by mid-November 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," "potential" or other similar words. Examples of forward-looking statements include, among others, statements Cortexyme makes regarding its business plans, strategy, timeline, prospects, and milestone expectations; the characteristics and potential benefits of COR588, including for the treatment of periodontal disease; 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 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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  2. Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, announced that Casey Lynch, chief executive officer, co-founder, and chair, and Chris Lowe, chief operating officer and chief financial officer, will participate in a fireside chat at H.C. Wainwright 23rd Annual Global Investment Conference taking place virtually on Monday, September 13, 2021 at 7:00 a.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, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, announced that Casey Lynch, chief executive officer, co-founder, and chair, and Chris Lowe, chief operating officer and chief financial officer, will participate in a fireside chat at H.C. Wainwright 23rd Annual Global Investment Conference taking place virtually on Monday, September 13, 2021 at 7:00 a.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. The company is advancing its disease-modifying pivotal GAIN Trial in mild to moderate Alzheimer's disease with top-line data expected by mid-November 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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  3. GAIN Trial analysis of anti-P. gingivalis antibodies in cerebrospinal fluid supports upstream role of pathogenic bacterium in key Alzheimer's pathologies

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the presentation of new data demonstrating evidence of P. gingivalis infection of the central nervous system in Alzheimer's disease at the Annual Biomarkers for Alzheimer's Disease Summit taking place virtually on Wednesday, August 25, 2021, at 2:10 p.m. ET followed by a live Q&A at 3:40 p.m. ET.

    In a featured speaker presentation titled "Use of Novel Biomarkers of P. Gingivalis

    GAIN Trial analysis of anti-P. gingivalis antibodies in cerebrospinal fluid supports upstream role of pathogenic bacterium in key Alzheimer's pathologies

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, announced the presentation of new data demonstrating evidence of P. gingivalis infection of the central nervous system in Alzheimer's disease at the Annual Biomarkers for Alzheimer's Disease Summit taking place virtually on Wednesday, August 25, 2021, at 2:10 p.m. ET followed by a live Q&A at 3:40 p.m. ET.

    In a featured speaker presentation titled "Use of Novel Biomarkers of P. Gingivalis Infection & Neuroinflammation in the GAIN Trial: An Ongoing Phase 2/3 Clinical Trial Assessing the Activity of Atuzaginstat in Patients with Mild to Moderate Alzheimer's Disease," Cortexyme's Executive Vice President of Research and Development Leslie Holsinger, Ph.D., will present an analysis of anti-P. gingivalis antibodies in cerebrospinal fluid (CSF) with results demonstrating that:

    • All patients analyzed at baseline in the GAIN Trial (472 out of 472 baseline CSF samples available) were positive for anti-P. gingivalis antibodies (IgG) in their cerebrospinal fluid;
    • Less than 2% of patients analyzed had a leaky blood brain barrier, as defined by an albumin index greater than 9; and
    • Anti-P. gingivalis IgG in the CSF was only very weakly correlated to the albumin index (r=0.22), indicating production in the central nervous system in addition to that shown previously in serum.

    These data add to the growing body of evidence indicating the presence of a P. gingivalis infection within the central nervous system in patients with Alzheimer's disease. Cortexyme will also present other novel biomarkers developed to track markers of P. gingivalis and Alzheimer's disease, in addition to highlighting the upstream role that P. gingivalis plays in key pathologies of Alzheimer's disease progression. The complete presentation will be available here.

    About The GAIN Trial

    Cortexyme is pioneering an innovative, upstream, and disease-modifying therapeutic approach to Alzheimer's disease. The Phase 2/3 GAIN Trial is a 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 an 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 – 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.

    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 by mid-November 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," "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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  4. Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, will participate as a featured speaker covering its pivotal Phase 2/3 GAIN Trial of atuzaginstat and the upstream role that P. gingivalis plays in key pathologies of Alzheimer's disease at the upcoming Annual Biomarkers for Alzheimer's Disease Summit taking place virtually August 24-26, 2021. Cortexyme will present new data demonstrating further evidence of P. gingivalis infection of the central nervous system in Alzheimer's disease as demonstrated by analysis of anti-P. gingivalis antibodies in cerebrospinal fluid from the GAIN trial.

    Annual

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, will participate as a featured speaker covering its pivotal Phase 2/3 GAIN Trial of atuzaginstat and the upstream role that P. gingivalis plays in key pathologies of Alzheimer's disease at the upcoming Annual Biomarkers for Alzheimer's Disease Summit taking place virtually August 24-26, 2021. Cortexyme will present new data demonstrating further evidence of P. gingivalis infection of the central nervous system in Alzheimer's disease as demonstrated by analysis of anti-P. gingivalis antibodies in cerebrospinal fluid from the GAIN trial.

    Annual Biomarkers for Alzheimer's Disease Summit Details

    Topic: Use of Novel Biomarkers of P. Gingivalis Infection & Neuroinflammation in the GAIN Trial: An Ongoing Phase 2/3 Clinical Trial Assessing the Activity of Atuzaginstat in Patients with Mild to Moderate Alzheimer's Disease

    • Speaker: Leslie Holsinger, Ph.D., Cortexyme's Executive Vice President, Research and Development
    • Day/Time: Wednesday, August 25, 2021, at 2:10 p.m. ET followed by a live Q&A at 3:40 p.m. ET

    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 by mid-November 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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  5. GAIN Trial top-line data for disease modification in Alzheimer's expected by mid-November 2021

    Phase 2 REPAIR sub-study results evaluating periodontal disease expected by mid-November 2021

    Current cash position sufficient to fund operations through 2023

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, today provided an update on expected clinical top-line data and reported second quarter 2021 financial results.

    "Evidence demonstrating a causal link between the infectious pathogen P. gingivalis and neurodegeneration continues to grow. We are pleased with the rigorous and efficient execution…

    GAIN Trial top-line data for disease modification in Alzheimer's expected by mid-November 2021

    Phase 2 REPAIR sub-study results evaluating periodontal disease expected by mid-November 2021

    Current cash position sufficient to fund operations through 2023

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, today provided an update on expected clinical top-line data and reported second quarter 2021 financial results.

    "Evidence demonstrating a causal link between the infectious pathogen P. gingivalis and neurodegeneration continues to grow. We are pleased with the rigorous and efficient execution of the GAIN trial and are excited to be rapidly approaching such a significant milestone for our industry. By following the evidence, we have developed a potential therapeutic with a breakthrough mechanism of action upstream of multiple aspects of Alzheimer's disease pathology including inflammation and neurodegeneration. We look forward to sharing a robust top-line data set by mid-November 2021," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair.

    "We believe positive data from the GAIN Trial could fundamentally shift the paradigm of neurodegeneration research and disease-modifying treatment in the Alzheimer's field and we intend to rapidly pursue collaboration with the FDA for the benefit of patients. Cortexyme is confident that we have enrolled the right population and that the study is powered to show a meaningful treatment effect. We remain steadfast in our mission to provide real change for Alzheimer's patients and their caregivers," said Michael Detke, MD, PhD, Cortexyme's chief medical officer.

    Pivotal GAIN Trial Top-line Data Expected by Mid-November 2021

    Cortexyme is pioneering an innovative, upstream, disease-modifying therapeutic approach to Alzheimer's disease with the company's pivotal Phase 2/3 GAIN Trial that enrolled 643 patients with mild to moderate Alzheimer's disease, in addition to its Phase 2 periodontal disease REPAIR sub-study in 233 patients. Less than 100 participants are pending treatment completion in the study. The following are key highlights as the company readies for its GAIN and REPAIR top-line data:

    • The GAIN Trial is powered at approximately 90% to show a 50% slowing of decline as measured by the cognitive and functional co-primary clinical endpoints of ADAS-Cog11 and ADCS-ADL.
    • Top-line data will also include other secondary and exploratory clinical measures and biomarker data to support disease modification in addition to key safety and tolerability outcomes.
    • The Phase 2 periodontal disease REPAIR sub-study of the GAIN Trial evaluates standard clinical endpoints of periodontitis, including gingival pocket depth, clinical attachment level, and bleeding on probing.
    • GAIN Trial baseline demographics confirm a representative patient population of mild to moderate Alzheimer's participants, including the ratio of female patients (57% female to 42% male), a balance of mild and moderate patients (50% mild and 50% moderate based on MMSE measure), a representative proportion of ApoE4 carriers (64%), and approximately three-fourths (74%) of patients using cholinesterase inhibitors/memantine for the treatment of Alzheimer's disease symptoms. Importantly, the GAIN Trial includes higher than average diversity with approximately 20% representation from Black and African American, Hispanic and Latino, and patients of other racial and ethnic backgrounds.

    Scientific and Pipeline Updates

    • Cortexyme continued to expand its evidence base by presenting new data at the International Association for Dental Research (IADR) 2021 demonstrating atuzaginstat disrupts biofilms and is efficacious in preclinical models of periodontal disease. Atuzaginstat penetrates and disrupts bacterial biofilms, a key feature for efficacy in treating P. gingivalis driven disease. Data presented also demonstrated that atuzaginstat reverses alveolar bone loss in mice after oral P. gingivalis infection at doses relevant for therapeutic efficacy in periodontal disease.
    • At the Alzheimer's Association International Conference® 2021 (AAIC®), Cortexyme presented preclinical data linking P. gingivalis to elevated levels of p-tau217, reinforcing evidence of the infectious pathogen as a causative agent of Alzheimer's disease, and these elevations were prevented by treatment with atuzaginstat. In addition, newly presented GAIN Trial baseline data demonstrates that a majority of patients have elevated serum Von Willebrand factor, a marker of endothelial cell injury, and alpha-2-macroglobulin, an endogenous protease inhibitor.
    • Cortexyme successfully completed IND enabling studies of COR588, including nonclinical safety and two-month toxicology studies. First-in-human studies are on schedule to begin in the third quarter 2021.
    • The company announced the selection of a lead 3CLpro inhibitor (COR803) for the treatment of coronavirus infections, including COVID-19 disease, caused by SARS-CoV-2 infection. COR803 is a novel patent-pending small molecule 3CLpro inhibitor. 3CLpro, or Mpro, is a viral cysteine protease and validated drug target shown to be essential in replication of SARS-CoV-2. We believe COR803 has potentially 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.

    Second Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents, and short and long-term marketable securities as of June 30, 2021, were $153.5 million. Cortexyme expects its cash position to be sufficient to fund its operating and capital expenditures through 2023.
    • Research and Development (R&D) Expenses: For the quarter ended June 30, 2021, R&D expenses were $14.7 million primarily due to costs related to the research and development of atuzaginstat, the GAIN Trial, COR588, and personnel-related expenses.
    • General and Administrative (G&A) Expenses: For the quarter ended June 30, 2021, G&A expenses were $7.1 million. The expenses were primarily attributable to personnel-related expenses, insurance, and professional and legal fees.
    • Net Loss: For the quarter ended June 30, 2021, the company's net loss was $21.8 million, or a loss of $0.74 per basic share. Weighted average shares outstanding for the quarter ended June 30, 2021, were 29,587,352.

    About The GAIN Trial

    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 an 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.

    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 by mid-November 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," "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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  6. 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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  7. 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 info@cortexyme.com 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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  8. 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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  9. 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 info@cortexyme.com 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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  10. 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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  11. "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification"

    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 host a corporate sponsored symposium and dinner held in conjunction with the Alzheimer's Association International Conference® 2021 (AAIC®) taking place July 26-30, 2021, in Denver, Colorado, as well as virtually. The symposium titled "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification" will be held on Tuesday, July 27, 2021, from 5:30 p.m. to…

    "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification"

    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 host a corporate sponsored symposium and dinner held in conjunction with the Alzheimer's Association International Conference® 2021 (AAIC®) taking place July 26-30, 2021, in Denver, Colorado, as well as virtually. The symposium titled "Getting to the Root Cause of Alzheimer's Disease: An Innovative, Upstream Approach for Disease Modification" will be held on Tuesday, July 27, 2021, from 5:30 p.m. to 7:30 p.m. Mountain Time at the Hilton Denver City Center. Led by Cortexyme's chief executive officer, co-founder, and chair 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.

    Cortexyme is pioneering an innovative, upstream, and disease-modifying therapeutic approach to Alzheimer's disease as the company advances toward top-line data in the fourth quarter 2021 from its Phase 2/3 GAIN Trial, a potentially pivotal study in 643 mild to moderate Alzheimer's patients. 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 of 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, and 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. Cortexyme's innovative therapeutic approach continues to be supported by research from laboratories around the world published in peer-reviewed scientific journals.

    For AAIC 2021 registered participants wishing to attend Cortexyme's symposium in person, please email info@cortexyme.com to sign up. The symposium may be accessed online by registering to attend AAIC 2021 through its virtual conference experience here. In addition to its symposium discussion at AAIC 2021, Cortexyme will present an update and baseline data from its 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.

    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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  12. Part 1 to be held Friday July 23 at 10:00 a.m. ET: Innovation in Periodontal Disease – A Major Unmet Medical Need

    Part 2 to be held Friday July 30 at 10:00 a.m. ET: Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration

    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, today announced that it will host a key opinion leader (KOL) webinar series on its lead drug candidate atuzaginstat (COR388), a lysine-gingipain inhibitor. The webinar series will be held in two parts: Part 1 will be on Friday, July 23, 2021, at 10:00 a.m. ET, and Part 2 will be on Friday…

    Part 1 to be held Friday July 23 at 10:00 a.m. ET: Innovation in Periodontal Disease – A Major Unmet Medical Need

    Part 2 to be held Friday July 30 at 10:00 a.m. ET: Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration

    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, today announced that it will host a key opinion leader (KOL) webinar series on its lead drug candidate atuzaginstat (COR388), a lysine-gingipain inhibitor. The webinar series will be held in two parts: Part 1 will be on Friday, July 23, 2021, at 10:00 a.m. ET, and Part 2 will be on Friday, July 30, 2021, at 10:00 a.m. ET. The series is being conducted in conjunction with Cortexyme's participation at the International Association for Dental Research (IADR) General Session & Exhibition and Alzheimer's Association International Conference 2021 (AAIC) at which the company will present new baseline data from its pivotal GAIN Trial, in addition to providing further evidence that P. gingivalis acts upstream of Alzheimer's pathologies and atuzaginstat's role in effectively blocking downstream disease.

    Part 1: Innovation in Periodontal Disease – A Major Unmet Medical Need

    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 present data from two abstracts at IADR, entitled "Gingipain Inhibitors Penetrate and Inhibit Gingipains In Porphyromonas gingivalis Biofilms" (abstract #3571509) and "Novel Lysine-Gingipain Inhibitor Atuzaginstat (COR388) Is Efficacious in a Mouse Model of Periodontal Disease" (abstract #1756).

    Cortexyme's management team will also provide an update on REPAIR, its ongoing Phase 2 periodontal sub-study of atuzaginstat, as part of its pivotal Phase 2/3 GAIN Trial. Top-line data from the 233-subject REPAIR study is expected in the fourth quarter 2021. Dr. Ryder and Cortexyme's management will be available to answer questions following the formal presentations.

    To register for this webinar, please click here.

    Part 2: Innovation in Alzheimer's Disease – Getting to the Root Cause of Neurodegeneration

    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. The GAIN Trial is fully enrolled and top-line data is expected in the fourth quarter 2021. Dr. Sabbagh 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.

    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; and the timing of announcements and updates relating to its clinical trials and related data. 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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  13. Baseline demographic and biomarker data reinforce appropriate patient population enrolled ahead of top-line data expected in fourth quarter 2021

    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 the presentation of updated baseline demographic and biomarker data at the American Society of Clinical Psychopharmacology (ASCP) 2021 Annual Meeting.

    Reflecting the complete set of baseline samples available from 643 GAIN study participants, including 233 individuals in the trial's REPAIR periodontal sub-study, key findings reported in today's presentation, titled "An Update and…

    Baseline demographic and biomarker data reinforce appropriate patient population enrolled ahead of top-line data expected in fourth quarter 2021

    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 the presentation of updated baseline demographic and biomarker data at the American Society of Clinical Psychopharmacology (ASCP) 2021 Annual Meeting.

    Reflecting the complete set of baseline samples available from 643 GAIN study participants, including 233 individuals in the trial's REPAIR periodontal sub-study, key findings reported in today's presentation, 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," include:

    • 84% of participants have an Aβ 42/40 cerebral spinal fluid (CSF) ratio associated with Aβ positivity on PET scan.
    • 88% of subjects have total Tau CSF levels consistent with AD.
    • 84% have pTau 181 levels consistent with AD in the Amyloid/Tau/Neurodegeneration (ATN) designation.
    • All subjects had evidence of P. gingivalis-specific IgG at baseline, with 78% exhibiting higher antibody titers associated with periodontal disease. (Offenbacher et al., 2007)
    • Previous research has demonstrated that IgG titers roughly correlate to infection load. (Kojima et al., 1997)
    • More than 90% of participants in the REPAIR periodontal sub-study have moderate to severe periodontal disease at baseline.
    • 64% of the trial participants carry at least one ApoE4 gene and these participants are stratified across the three treatment groups.

    The data (Abstract #3002870) are being presented in an oral session at the ASCP 2021 Annual Meeting today, as well as in a poster session tomorrow, June 2, 2021, as a part of this virtual event. Baseline biomarker data analyses presented at ASCP include 100% of the enrolled subjects with baseline CSF or serum samples available for analysis. The presentation and poster with additional detail will be available at https://ir.cortexyme.com/news-and-events/presentations.

    Cortexyme's ongoing pivotal Phase 2/3 GAIN Trial is rooted in a strong body of research outlining the role of P. gingivalis in the neurodegeneration associated with AD. P. gingivalis, which is most commonly associated with periodontal disease, has been discovered in greater than 90% of post-mortem brains of patients with AD and has been shown to produce Alzheimer's pathology in infected animals. The GAIN Trial is evaluating the potential of Cortexyme's lead compound, atuzaginstat, to inhibit the toxic proteases, or gingipains, produced by P. gingivalis in patients with mild to moderate AD and to potentially slow or halt AD progression. The trial has completed enrollment, and 643 subjects have been randomized to one of two doses of atuzaginstat (40mg or 80mg twice daily) or placebo. The co-primary endpoints are mean change in cognition (ADAS-Cog 11) and function (ADCS-ADL) from baseline to 48 weeks compared to placebo. Secondary and exploratory endpoints include change in Winterlight Speech Assessment, cerebral spinal fluid biomarkers, volumetric MRI, and other measures. The GAIN Trial also includes a REPAIR sub-study measuring the efficacy of COR388 on symptoms of periodontal disease, including gingival pocket depth.

    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; its ability to fund planned operating and capital expenditures; the timing of announcements and updates relating to its clinical trials and related data; the timing of and its ability to enroll patients into its clinical trials; the potential therapeutic benefits, safety and efficacy of the company's product candidate or library of compounds; statements about its ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to the company's drug product candidate; and expected cash runway and financial update. 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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  14. 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 at the following virtual investor conferences in June 2021:

    • Jefferies Healthcare Conference on Wednesday, June 2, 2021, at 2:00 p.m. EDT (11:00 a.m. PDT).
    • The JMP Securities Life Sciences Conference on Wednesday, June 16, 2021 at 3:00 p.m. EDT (12:00 p.m. PDT).

    A live webcast of the events will be accessible on the Investor Calendar page under the News & Events heading of Cortexyme's investor website at ir.cortexyme.com

    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 at the following virtual investor conferences in June 2021:

    • Jefferies Healthcare Conference on Wednesday, June 2, 2021, at 2:00 p.m. EDT (11:00 a.m. PDT).
    • The JMP Securities Life Sciences Conference on Wednesday, June 16, 2021 at 3:00 p.m. EDT (12:00 p.m. PDT).

    A live webcast of the events will be accessible on the Investor Calendar page under the News & Events heading of Cortexyme's investor website at ir.cortexyme.com. The webcasts 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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  15. Top-line data from 643-subject Alzheimer's disease pivotal GAIN Trial expected in fourth quarter 2021

    Top-line data from 233-subject periodontal disease Phase 2 REPAIR sub-study of the

    GAIN Trial expected in fourth quarter 2021

    COR588 on track to initiate first-in-human studies in third quarter 2021

    Current cash position sufficient to fund operations through 2023

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today provided an update on expected clinical data readouts and reported first quarter 2021 financial results.

    "We are pleased by our continued…

    Top-line data from 643-subject Alzheimer's disease pivotal GAIN Trial expected in fourth quarter 2021

    Top-line data from 233-subject periodontal disease Phase 2 REPAIR sub-study of the

    GAIN Trial expected in fourth quarter 2021

    COR588 on track to initiate first-in-human studies in third quarter 2021

    Current cash position sufficient to fund operations through 2023

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today provided an update on expected clinical data readouts and reported first quarter 2021 financial results.

    "We are pleased by our continued progress and remain on track for another exciting year with important data readouts from our pivotal GAIN Trial in Alzheimer's and periodontal disease expected in the fourth quarter of 2021," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "The foundational evidence of P. gingivalis as a causal agent of Alzheimer's and other degenerative diseases continues to expand and further validate our disruptive science targeted at high unmet need indications. We have the strategic vision to reach beyond our multiple upcoming milestones and enter this next stage of development with a strong cash position sufficient to fund operations through 2023."

    Pipeline Updates

    • The GAIN Trial continues to progress toward top-line data in the fourth quarter 2021. The study is designed to be powered at approximately 90% and approximately one-third of patients are pending completion in the study.
    • Cortexyme successfully completed a radiolabeled (14C) human mass balance study for atuzaginstat (Study COR388-003), a key clinical pharmacology study necessary for a New Drug Application (NDA).
    • The company successfully completed a six-month transgenic mouse carcinogenicity study for atuzaginstat, another key requirement for an atuzaginstat NDA, with no findings of carcinogenicity.
    • The GAIN Trial includes a periodontal sub-study named REPAIR (REduction of P. GingivAalIs To ImpRove Pocket Depth) that includes 233 subjects with the standard regulatory efficiency endpoints of pocket depth and clinical attachment level at six months and one year. Top-line data for the REPAIR sub-study, which evaluates atuzaginstat in treating periodontitis, is expected in the fourth quarter 2021.
    • COR588 IND-enabling studies are proceeding with a first-in-human study expected to begin in the third quarter 2021. COR588 is a unique small molecule lysine gingipain inhibitor with once-daily oral dosing that Cortexyme intends to advance in periodontal disease and potentially other new indications
    • Two arginine gingipain inhibitors, COR788 and COR822, have been selected as lead compounds to progress toward IND-enabling studies, including manufacturing scale-up and dose range-finding toxicology studies. Arginine gingipain is a distinct target associated with P. gingivalis that contributes to bacterial survival, replication, and toxicity. An arginine gingipain inhibitor may be used as monotherapy in new indications or potentially additively with lysine gingipain inhibitors like atuzaginstat and COR588. Both molecules have novel composition of matter (patents pending), are brain-penetrant, and orally available.

    Scientific Updates

    • Cortexyme announced that Cell Reports Medicine selected its research paper, "Gingipains identified in Alzheimer's disease brains differentially fragment ApoE proteins" (CR-MEDICINE-D-21-00188), for peer review and made the article, as originally submitted, available via Cell Press Sneak Peek. Further documenting the pathogenic role of P. gingivalis in Alzheimer's, the research demonstrates that gingipains in Alzheimer's disease brains preferentially fragment ApoE4 over ApoE3 and ApoE2, linking P. gingivalis to the strongest genetic risk factor for sporadic Alzheimer's. Additionally, analysis of cerebrospinal fluid (CSF) from Alzheimer's subjects administered the gingipain inhibitor atuzaginstat reveals a decrease in ApoE fragments and a slowing in decline of Ab1-42.
    • Abstracts have been accepted for presentations at upcoming scientific meetings, including the 2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on June 1-4, 2021; the International Association for Dental Research (IADR) General Session & Exhibition on July 21-24, 2021; the Alzheimer's Association International Conference (AAIC) on July 26-30, 2021; and the Annual Biomarkers for Alzheimer's Disease Summit on August 24-26, 2021. Cortexyme plans to present additional baseline data from the GAIN Trial, as well as further evidence to support P. gingivalis as an important upstream driver of disease pathology and the efficacy of proprietary gingipain inhibitors at these meetings.
    • Adding to the growing body of evidence linking P. gingivalis and neurodegeneration, Cortexyme presented new research at AD/PD 2021 in March 2021, further reinforcing the company's foundational evidence on P. gingivalis' role in Alzheimer's disease (AD) and new techniques to detect its presence in the human brain. Scientists at the University of Auckland and Cortexyme reported new techniques to determine the ultrastructural localization of the arginine-gingipain (Rgp) virulence factor secreted by P. gingivalis in the human AD brain using electron microscopy. The researchers reported on the intracellular organelles in AD brain cells that Rgp co-localizes with, providing insight for the first time into why some sub-cellular organelles in AD neurons and astrocytes are damaged.

    First Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents, and short and long-term marketable securities as of March 31, 2021 were $170.8 million and include approximately $117.6 million of net proceeds raised in Cortexyme's private placement offering completed in February 2020. Cortexyme expects its cash position to be sufficient to fund its operating and capital expenditures through 2023.
    • Research and Development (R&D) Expenses: For the quarter ended March 31, 2021, R&D expenses were $16.8 million, primarily due to costs related to the research and development of atuzaginstat, the GAIN Trial, and stock-based compensation expense of $3.5 million.
    • General and Administrative (G&A) Expenses: For the quarter ended March 31, 2021, G&A expenses were $6.5 million. The expenses were primarily attributable to personnel-related expenses, insurance, professional and legal fees, and stock-based compensation of $3.5 million.
    • Net Loss: For the quarter ended March 31, 2021, the company's net loss was $23.1 million, or a loss of $0.78 per basic share. Weighted average shares outstanding for the quarter ended March 31, 2021 were 29,554,921.

    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; its ability to fund planned operating and capital expenditures; the timing of announcements and updates relating to its clinical trials and related data; the timing of and its ability to enroll patients into its clinical trials; the potential therapeutic benefits, safety and efficacy of the company's product candidate or library of compounds; statements about its ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to the company's drug product candidate; and expected cash runway and financial update. 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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  16. 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, today announced Chris Lowe, the company's chief operating officer and chief financial officer, will participate in a fireside chat at the BofA Securities 2021 Healthcare Conference, a virtual event, on Tuesday, May 11, 2021, at 3:30 p.m. EDT (12:30 p.m. PDT).

    A live webcast of the fireside chat 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, today announced Chris Lowe, the company's chief operating officer and chief financial officer, will participate in a fireside chat at the BofA Securities 2021 Healthcare Conference, a virtual event, on Tuesday, May 11, 2021, at 3:30 p.m. EDT (12:30 p.m. PDT).

    A live webcast of the fireside chat 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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

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  17. 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, today announced Casey Lynch, the company's chief executive officer, co-founder, and chair, will participate in a fireside chat at the Stifel 3rd Annual CNS Day, a virtual event, on Thursday, April 1, 2021, at 10:00 a.m. EDT / 7:00 a.m. PDT.

    A live webcast of the fireside chat will be accessible on the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 90 days.

    About Cortexyme

    Cortexyme, Inc. (NASDAQ:CRTX) is a clinical stage…

    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, today announced Casey Lynch, the company's chief executive officer, co-founder, and chair, will participate in a fireside chat at the Stifel 3rd Annual CNS Day, a virtual event, on Thursday, April 1, 2021, at 10:00 a.m. EDT / 7:00 a.m. PDT.

    A live webcast of the fireside chat will be accessible on the Investor Calendar page under the News & Events heading of the Cortexyme investor site (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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

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  18. -- Presentation to be webcast on Cortexyme's website --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer's and other degenerative diseases, today announced Chris Lowe, the company's chief operating officer and chief financial officer, will present at the Oppenheimer 31st Annual Healthcare Conference, a virtual event, on Tuesday, March 16, 2021, at 4:00 p.m. EDT / 1:00 p.m. PDT.

    A live webcast of the presentation will be accessible on the Investor Calendar page under the News & Events heading of the Cortexyme investor site (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…

    -- Presentation to be webcast on Cortexyme's website --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer's and other degenerative diseases, today announced Chris Lowe, the company's chief operating officer and chief financial officer, will present at the Oppenheimer 31st Annual Healthcare Conference, a virtual event, on Tuesday, March 16, 2021, at 4:00 p.m. EDT / 1:00 p.m. PDT.

    A live webcast of the presentation will be accessible on the Investor Calendar page under the News & Events heading of the Cortexyme investor site (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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

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  19. -- Partnership with Parkinson Study Group Advisory Panel to collaborate on Parkinson's Disease Program --

    -- Presentation at AD/PD™ 2021 Underscores Relevance of Cortexyme's Approach --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer's and other degenerative diseases, announced that it has partnered with the Parkinson Study Group (PSG) to form an Advisory Board to leverage the group's expertise and further develop the company's Parkinson's disease (PD) program. In addition, Cortexyme will present new data further demonstrating the role of Porphyromonas gingivalis (P. gingivalis) in the development of Alzheimer's disease at AD/PD™ 2021, the 15th International Conference on Alzheimer's & Parkinson's…

    -- Partnership with Parkinson Study Group Advisory Panel to collaborate on Parkinson's Disease Program --

    -- Presentation at AD/PD™ 2021 Underscores Relevance of Cortexyme's Approach --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer's and other degenerative diseases, announced that it has partnered with the Parkinson Study Group (PSG) to form an Advisory Board to leverage the group's expertise and further develop the company's Parkinson's disease (PD) program. In addition, Cortexyme will present new data further demonstrating the role of Porphyromonas gingivalis (P. gingivalis) in the development of Alzheimer's disease at AD/PD™ 2021, the 15th International Conference on Alzheimer's & Parkinson's Diseases, which is being held virtually March 9-14, 2021.

    Hubert Fernandez, M.D., Co-Chair of the Parkinson Study Group Executive Committee and Chair of the PSG Credentialing Committee, and a member of the newly created Advisory Board, stated: "I look forward to working with my colleagues on the Advisory Board. We are collectively eager to further understand the mechanism of gingipain inhibition and its potential to improve the lives of patients suffering from Parkinson's disease. There is a tremendous unmet medical need for PD, and the potential link between P. gingivalis and PD demands further exploration."

    Along with Fernandez, the new Cortexyme/PSG Advisory Board is comprised of expert researchers across the PD field:

    • Patrik Brundin, M.D., Ph.D., Honorary Guest to the PSG
    • Eric Macklin, Ph.D., PSG Executive Committee Member
    • Zoltan Mari, M.D., Co-Chair of the PSG Motor Features of PD Working Group
    • Andrew Siderowf, M.D., PSG Executive Committee Member

    "Our partnership with the PSG demonstrates the importance of Cortexyme's evidence to date and the potential to benefit patients suffering from Parkinson's disease," said Michael Detke, M.D., Ph.D., Cortexyme's Chief Medical Officer. "We are pleased to partner with the PSG and look forward to advancing our work in Parkinson's disease as we make progress towards improving patient outcomes."

    Mounting evidence supports the role of P. gingivalis in Parkinson's disease, including research supporting the epidemiological link between periodontal disease and Parkinson's disease and rodent studies demonstrating that oral P. gingivalis infection causes alpha-synuclein production and degeneration of dopamine-producing neurons in the substantia nigra of the brain. For further details, visit www.cortexyme.com/science.

    AD/PD 2021 Presentation Furthers Link Between P. gingivalis and Neurodegeneration

    Cortexyme will also present research (poster 131/abstract 1544) at AD/PD 2021 further reinforcing Cortexyme's foundational research on P. gingivalis' role in AD and new techniques to detect the presence of P. gingivalis in the human brain.

    In the poster, scientists at the University of Auckland and Cortexyme report new techniques to determine the ultrastructural localization of the arginine-gingipain (Rgp) virulence factor secreted by P. gingivalis in the human AD brain using electron microscopy. The researchers will report on the intracellular organelles in AD brain cells that Rgp co-localizes with, providing insight for the first time on why some sub-cellular organelles in AD neurons and astrocytes are damaged.

    "This research adds to the growing body of evidence that shows the presence of gingipains in the human AD brain and the validation of new electron microscopy techniques that can be leveraged for future research into sub-cellular localization of gingipains within neurons and astrocytes," said Stephen Dominy, M.D., Cortexyme's Co-Founder and Chief Scientific Officer.

    View the abstract "Ultrastructural localization of Porphyromonas gingivalis RgpB virulence factor in the middle temporal gyrus (MTG) of the Alzheimer's disease human brain" here on Cortexyme's website following the conference.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding the partial clinical hold and ongoing correspondence with the FDA, and its related impact on the timing and success of our clinical trials, including with respect to atuzaginstat, the double-blind, placebo-controlled randomized phase of the GAIN Trial and open-label extension phase; the timing of announcements and updates relating to our clinical trials and related data; the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds; statements about our ability to obtain, and the timing relating to, and regulatory submissions and approvals with respect to our 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021, our Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  20. - Double-blind phase of GAIN Trial to continue as planned, with top-line data expected Q4 2021

    - Open-Label Extension of atuzaginstat to stop dosing and enrollment

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer's and other degenerative diseases, received a letter from the U.S. Food and Drug Administration (FDA) stating that a partial clinical hold has been placed on atuzaginstat (COR388) impacting the open-label extension (OLE) phase of the company's ongoing Phase 2/3 study, the GAIN Trial. Under the hold, no new participants will be enrolled in the OLE and currently enrolled OLE participants will be discontinued. Participants in the fully enrolled (N=643) double-blind, placebo-controlled randomized…

    - Double-blind phase of GAIN Trial to continue as planned, with top-line data expected Q4 2021

    - Open-Label Extension of atuzaginstat to stop dosing and enrollment

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical-stage biopharmaceutical company focused on Alzheimer's and other degenerative diseases, received a letter from the U.S. Food and Drug Administration (FDA) stating that a partial clinical hold has been placed on atuzaginstat (COR388) impacting the open-label extension (OLE) phase of the company's ongoing Phase 2/3 study, the GAIN Trial. Under the hold, no new participants will be enrolled in the OLE and currently enrolled OLE participants will be discontinued. Participants in the fully enrolled (N=643) double-blind, placebo-controlled randomized phase of the GAIN Trial will continue to receive study drug at their assigned dose, with top-line results from the double-blind GAIN Trial in Q4 2021.

    The partial clinical hold was initiated following the review of hepatic adverse events in the atuzaginstat trial by the FDA. These events have been reversible and without any known long-term adverse effects for the participants. Cortexyme will continue to collaborate with the FDA on the overall development program for atuzaginstat.

    "Cortexyme's highest priority is the safety of study participants," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "The ongoing double-blind GAIN Trial in mild to moderate Alzheimer's disease will provide a critical assessment of efficacy and safety in the treatment of this devastating disease."

    About the GAIN Trial and its Open Label Extension

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of atuzaginstat (COR388), Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate Alzheimer's disease. The GAIN Trial includes a sub-study measuring the efficacy of atuzaginstat on symptoms of periodontal disease including gingival pocket depth. Top-line results from the GAIN Trial's final analysis are expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.

    The GAIN Trial protocol also includes an open-label extension (OLE) study in the United States. Upon completing the 48-week placebo-controlled period of the GAIN Trial, participants in the GAIN Trial's placebo and active arms in the U.S. are eligible to enroll in the OLE study, where they will receive 40 mg or 80 mg of atuzaginstat twice daily for an additional 48 weeks. The OLE is intended to evaluate long-term safety and efficacy measures of participants in the GAIN Trial. As discussed above, Cortexyme has stopped enrollment and dosing in the OLE following the institution of a partial clinical hold.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding the partial clinical hold and ongoing correspondence with the FDA, and its related impact on the timing and success of our clinical trials, including with respect to atuzaginstat, the double-blind, placebo-controlled randomized phase of the GAIN Trial and open-label extension phase; the timing of announcements and updates relating to our clinical trials and related data; the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds; statements about our ability to obtain, and the timing relating to, and regulatory submissions and approvals with respect to our 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  21. — Chris Lowe Promoted to Chief Operating Officer and Chief Financial Officer
    — Ted Monohon Promoted to Chief Accounting Officer
    —Drew Sukovich, Ph.D., RAC, Joins as Vice President, Regulatory and Quality

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease on schedule to be announced in Q4 2021 and a pipeline of therapeutics for degenerative diseases, today announced a series of leadership appointments to support the continued advancement and commercial planning of atuzaginstat, as well as the company's pipeline expansion and regulatory affairs capabilities.

    "Expanding Cortexyme's leadership team strengthens our overall operations and brings additional depth and expertise to the company as we advance atuzaginstat's…

    — Chris Lowe Promoted to Chief Operating Officer and Chief Financial Officer

    — Ted Monohon Promoted to Chief Accounting Officer

    —Drew Sukovich, Ph.D., RAC, Joins as Vice President, Regulatory and Quality

    Cortexyme, Inc. (NASDAQ:CRTX), a company advancing a pivotal trial in Alzheimer's disease on schedule to be announced in Q4 2021 and a pipeline of therapeutics for degenerative diseases, today announced a series of leadership appointments to support the continued advancement and commercial planning of atuzaginstat, as well as the company's pipeline expansion and regulatory affairs capabilities.

    "Expanding Cortexyme's leadership team strengthens our overall operations and brings additional depth and expertise to the company as we advance atuzaginstat's development and related commercial planning, bolster our regulatory capabilities, and grow our clinical pipeline," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "2020 was a year of significant accomplishment for the company. We anticipate achieving critical milestones in 2021 as we approach important data readouts in Alzheimer's and periodontal disease at the end of the year, further validate the role of gingipains in degenerative disease, and embark on new potential therapeutic indications such as Parkinson's disease."

    Chris Lowe has been promoted to Chief Operating Officer and Chief Financial Officer from his prior role as Chief Financial Officer, a position he held since joining the company in January 2019. Mr. Lowe has over two decades of financial leadership, business development, and operational expertise. Mr. Lowe's senior management experience includes experience as Chief Financial Officer, Chief Business Officer, and Chief Executive Officer for private and public life sciences companies including Asthmatx, Peninsula Pharmaceuticals, SentreHEART, and Anthera Pharmaceuticals. Additionally, he currently serves as a member of the Board of Directors of Vincerx Pharma, a biopharmaceutical company.

    Ted Monohon has been promoted to Chief Accounting Officer. Mr. Monohon joined Cortexyme in May 2019 as the company's Vice President, Finance. He has more than 20 years of financial experience spanning roles at private equity, publicly and privately held companies, and major banks. Mr. Monohon's expertise includes key finance functions including financial planning and forecasting, treasury/cash management, and accounting and tax functions. During his career, he completed multiple tracking stock IPOs as well as venture capital and private placement financings. He began his career with Deloitte as a senior staff auditor. Mr. Monohon is a Certified Public Accountant, and he obtained his Bachelor's Degree in Accounting from the Rochester Institute of Technology.

    Drew Sukovich, Ph.D., RAC, joins Cortexyme as Vice President, Regulatory and Quality. Dr. Sukovich has more than 25 years of experience in the discovery, development, and post-approval phases of drug development. Most recently, Dr. Sukovich was a consultant for various biotech companies and previously held regulatory affairs roles of increasing responsibility at Genentech, BioMarin and Zogenix. He has extensive knowledge and hands-on experience on Investigational New Drug (IND) and global clinical trial (CTA) applications, New Drug (NDA) and Marketing Authorisation (MAA) Applications, Expedited Programs for Serious Conditions including Fast Track and Breakthrough Therapy Designations, and REMS. He has successfully led meetings with global health authorities and FDA across multiple therapeutic areas including neurology, oncology, and metabolic disease. Dr. Sukovich received his Ph.D. in Cell and Molecular Biology from the University of Vermont, and his B.A. from Rutgers, The State University of New Jersey.

    Commenting on the new appointments, Ms. Lynch continued: "I'm excited to add Drew Sukovich to the Cortexyme team, and for Chris Lowe and Ted Monohon to take on larger roles with increased responsibilities. We're making these appointments at an important time for Cortexyme as we plan for top-line data from the GAIN Trial in the fourth quarter of 2021, ready new small molecule inhibitors for potential IND filings, and continue to publish evidence connecting gingipain proteases secreted by P. gingivalis to degenerative diseases including Alzheimer's and Parkinson's."

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain and other organs and tied to degeneration and inflammation in humans and animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. 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 our clinical trials and related data; the potential of atuzaginstat to treat Alzheimer's disease, periodontal disease, Parkinson's disease and other potential indications; the timing of announcements and updates relating to our clinical trials and related data; the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds; statements about our ability to obtain, and the timing relating to, and regulatory submissions and approvals with respect to our 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  22. — Based upon successful completion of the GAIN Trial's interim analysis, pipeline expansion announced for 2021

    — Atuzaginstat to be studied in the PEAK trial, a new Phase 2 study for Parkinson's disease

    — COR588, a novel lysine gingipain inhibitor, on track to enter the clinic in Q3 2021

    — Top-line data in 643 subject Alzheimer's disease pivotal GAIN Trial on schedule to be announced in Q4 2021

    — Top-line data in 233 subject periodontal disease clinical study to be announced in Q4 2021

    — Current cash position projected to fund operations into 2023

    — GAIN open-label extension (OLE) rollover to date has been approximately 90% of eligible participants

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential…

    — Based upon successful completion of the GAIN Trial's interim analysis, pipeline expansion announced for 2021

    — Atuzaginstat to be studied in the PEAK trial, a new Phase 2 study for Parkinson's disease

    — COR588, a novel lysine gingipain inhibitor, on track to enter the clinic in Q3 2021

    — Top-line data in 643 subject Alzheimer's disease pivotal GAIN Trial on schedule to be announced in Q4 2021

    — Top-line data in 233 subject periodontal disease clinical study to be announced in Q4 2021

    — Current cash position projected to fund operations into 2023

    — GAIN open-label extension (OLE) rollover to date has been approximately 90% of eligible participants

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced a corporate update and highlighted key milestones anticipated in 2021.

    "2020 was a year of numerous corporate and clinical accomplishments. We exceeded our enrollment target in the pivotal GAIN Trial for Alzheimer's disease on schedule and completed a successful interim analysis in December 2020. The interim analysis was a capstone to our continually growing foundation of evidence, including clinical biomarker data supporting P. gingivalis infection in Alzheimer's subjects and high OLE conversion, which supports the gingipain hypothesis and expansion of our pipeline. Following our successful IPO in 2019 and secondary offering in 2020, we project cash on hand will fund our current clinical development plans through 2023," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair.

    Ms. Lynch continued: "We expect 2021 to be another exciting and productive year. Data from researchers around the world supporting a potential role of gingipains in Parkinson's disease is compelling, and we are excited to expand testing of atuzaginstat into this new and important area of unmet medical need. We look forward to providing additional updates on our development programs during the year."

    Anticipated Key Milestones for 2021

    Atuzaginstat in Mild to Moderate Alzheimer's Disease (AD)

    • The pivotal GAIN Trial's final top-line data read out for atuzaginstat in patients with mild to moderate Alzheimer's disease is planned in Q4 2021.
    • Enrollment into the U.S. GAIN Trial OLE is robust despite the ongoing global pandemic, with approximately 90% of eligible subjects in the United States continuing in the open label portion of the study. Completion of enrollment in the GAIN OLE is expected in Q4 2021.

    Atuzaginstat in Periodontal Disease (PiD)

    • GAIN Trial top-line data for atuzaginstat in periodontal disease is planned in Q4 2021. The GAIN Trial includes a periodontal substudy of 233 subjects with efficacy data on typical regulatory endpoints of pocket depth and clinical attachment level at 6 months and 1 year.

    Atuzaginstat in Parkinson's Disease (PD)

    • The placebo controlled, multicenter Phase 2 study of atuzaginstat in patients with Parkinson's disease, the PEAK Trial (Parkinson's gingipain inhibitor Trial), has begun study start-up activities. The first patient in is expected in Q3 2021.

    Pipeline Progress

    • COR588 IND-enabling studies are proceeding according to expectations and a first-in-human study is expected to begin in Q3 2021. COR588 is a unique small molecule lysine gingipain inhibitor with once daily oral dosing that Cortexyme intends to position in periodontal disease and other new indications.
    • Two arginine gingipain inhibitors, COR788 and COR822, have been selected as lead compounds to progress toward IND-enabling studies, including manufacturing scale-up and dose range-finding toxicology studies based on their properties of potency, selectivity, pharmacologic efficacy, and pharmacokinetics. Arginine gingipain is a distinct target associated with P. gingivalis that contributes to bacterial survival, replication and toxicity. An arginine gingipain inhibitor may be used as monotherapy in new indications or potentially additively with lysine gingipain inhibitors, like atuzaginstat. Both molecules have novel composition of matter (patent pending), are brain penetrant and orally available.
    • Announcements of new original research including potential clinical studies in additional indications are expected during 2021.

    Cash Position and Financial Update

    Cortexyme ended the fourth quarter of 2020 with approximately $184.3 million in cash and investments on a proforma basis. The Company projects that its cash and investments will be sufficient to fund its planned operations into 2023.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. 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 our clinical trials and related data, including with respect to the GAIN and PEAK trials; the potential of atuzaginstat to treat Alzheimer's disease, periodontal disease, Parkinson's disease and other potential indications; our ability to fund planned operating and capital expenditures; the timing of announcements and updates relating to our clinical trials and related data; the timing of and our ability to enroll patients into our clinical trials; the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds; statements about our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidate; and expected cash runway and financial update. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  23. -- GAIN Trial passes futility analysis and will continue to 1-year endpoint following the independent Data Monitoring Committee recommendation; topline results expected on time in December 2021 --

    -- Final study enrollment remains at 643; no sample size adjustment --

    -- Conference call and webcast today, Friday, December 4, 2020, at 8:30 a.m. EST / 5:30 a.m. PST --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced that the independent Data Monitoring Committee (DMC) conducted a pre-planned interim analysis and recommended Cortexyme continue the Phase 2/3 GAIN Trial of atuzaginstat (COR388) as planned to the 1-year endpoint…

    -- GAIN Trial passes futility analysis and will continue to 1-year endpoint following the independent Data Monitoring Committee recommendation; topline results expected on time in December 2021 --

    -- Final study enrollment remains at 643; no sample size adjustment --

    -- Conference call and webcast today, Friday, December 4, 2020, at 8:30 a.m. EST / 5:30 a.m. PST --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced that the independent Data Monitoring Committee (DMC) conducted a pre-planned interim analysis and recommended Cortexyme continue the Phase 2/3 GAIN Trial of atuzaginstat (COR388) as planned to the 1-year endpoint. 

    The interim analysis included approximately 300 patients who have reached 6 months of treatment in the GAIN Trial, a randomized, double-blind, placebo-controlled study of 40 and 80 mg BID of atuzaginstat. As part of the interim analysis, the DMC looked for futility, overwhelming efficacy (p< 0.005 on both co-primary outcomes), a sample size increase if needed to improve powering, as well as safety. Based on the interim analysis, topline data for the fully enrolled population of 643 subjects after the full 1-year treatment period is expected on time in December of 2021. The company remains blinded to all data.

    Dr. Marwan Sabbagh, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health and Principal Investigator of the GAIN trial said: "Given the tremendous unmet need in Alzheimer's disease, it is imperative that we rapidly and efficiently study potential new treatments. We look forward to completing the study and sharing the results with the medical community and patients when the full trial results become available."

    "We are pleased with the DMC recommendation, which we believe supports the study design and statistical powering of the GAIN Trial. The totality of evidence around P. gingivalis and gingipain inhibition shows that blocking this upstream target may impact multiple aspects of disease progression and neurodegeneration," said Michael Detke, M.D., Ph.D., Cortexyme's Chief Medical Officer. "We are grateful to the DMC, the trial investigators, and the patients and caregivers for their participation in the trial as the study continues to its 1-year endpoint."

    Atuzaginstat targets the toxic proteases, or gingipains, produced by P. gingivalis, which have been discovered in greater than 90% of AD patients and shown to produce Alzheimer's pathology and neurodegeneration in infected animals. P. gingivalis is best known as a keystone bacterium in the development of periodontal disease.

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is a Phase 2/3 trial evaluating the efficacy, safety, and tolerability of atuzaginstat (COR388), Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate Alzheimer's disease. The co-primary endpoints for the GAIN trial are mean change in ADAS-Cog 11 and ADCS-ADL from baseline to 48 weeks versus placebo. Secondary and exploratory endpoints include change in CDR-SB, NPI, MMSE, Winterlight Speech Assessment, MRI volumetric measures and biomarkers of infection. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. For more information on the trial, visit www.gaintrial.com.

    Investor Conference Call and Webcast

    Cortexyme management will discuss the interim analysis during a conference call beginning at 8:30 a.m. EST / 5:30 a.m. PST later today, Friday, December 4, 2020. To join the call, participants may dial (866) 221-1774 (domestic) or (270) 215-9925 (international) and provide the conference ID, 7778375. To listen to a live webcast of the conference call, visit the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for one year.

    An audio replay of the conference call will also be available by phone until 11:59 p.m. EST / 8:59 p.m. PST on Sunday, December 6, 2020. Access numbers for the phone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 7778375.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the timing and success of our clinical trials and related data, including the outcome and results of the GAIN trial, the potential of atuzaginstat to treat Alzheimer's disease,  the timing of announcements and updates relating to our clinical trials and related data,  and the potential therapeutic benefits, safety and efficacy of our product candidate and/or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  24. — GAIN Trial enrollment complete with 643 participants

    — GAIN Trial interim analysis on schedule to complete in December 2020

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical-stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced financial results for the third quarter 2020 and provided an update on its business.

    "We are pleased with the strong participation in the GAIN Trial and deeply appreciate the support and dedication of patients and the medical community as we approach the interim analysis before the end of this year," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "With a strong balance sheet and a talented team, we remain confident…

    — GAIN Trial enrollment complete with 643 participants

    — GAIN Trial interim analysis on schedule to complete in December 2020

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical-stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced financial results for the third quarter 2020 and provided an update on its business.

    "We are pleased with the strong participation in the GAIN Trial and deeply appreciate the support and dedication of patients and the medical community as we approach the interim analysis before the end of this year," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "With a strong balance sheet and a talented team, we remain confident that Cortexyme is well positioned to advance new therapeutic options for patients with Alzheimer's and other degenerative diseases."

    GAIN Trial Updates: Evaluating Atuzaginstat, a New Potential Therapy for Alzheimer's Disease

    • The Phase 2/3 GAIN Trial of atuzaginstat (COR388) in mild to moderate Alzheimer's disease (AD) enrolled on time with final enrollment of 643 participants. Target enrollment was exceeded by approximately 12% in light of uncertainties which may be created by the global pandemic. Strong demand allowed the incremental enrollment to occur within projected timelines.
    • Cortexyme remains on track to conduct an interim analysis in the GAIN Trial in December 2020. Management will remain blinded to the interim analysis, which is being conducted by an independent Data Monitoring Committee (DMC). This interim analysis will be conducted after approximately 100 participants in each of the GAIN Trial's three arms reach 24 weeks of treatment. The co-primary endpoints for the GAIN Trial's interim analysis are change from baseline in ADAS-Cog11 and CDR-SB versus placebo. The four possible recommendations from the DMC after the interim analysis, and the only information that will be conveyed to management, are:
      • End the study early for overwhelming efficacy on either dose of atuzaginstat vs. placebo on the co-primary endpoints p< 0.005
      • Continue as planned
      • Increase sample size by up to 100 participants/arm based on favorable trends
      • End the study early for overwhelming futility, placebo vs. atuzaginstat p<0.05
    • A research abstract on the design of the GAIN Trial and its baseline biomarkers was the subject of an oral presentation at the 13th Clinical Trials on Alzheimer's Disease (CTAD) Conference on November 5, 2020. The presentation, "Phase 2/3 GAIN trial of atuzaginstat (COR388), a novel bacterial virulence factor inhibitor for the treatment of Alzheimer's disease: Update and baseline data," highlights key biomarker data for the first 40-50% of participants in the GAIN Trial. All patient samples analyzed to date had evidence of P. gingivalis IgG in serum at baseline indicating immune response to systemic P. gingivalis infection, with 72% showing very high levels associated with higher infection and more severe periodontal disease. Additionally, the vast majority of subjects showed CSF biomarkers consistent with recently defined cutoffs for Alzheimer's disease including amyloid β (Aβ) 42/40 ratio, tau and p-tau. As expected, 65% of the study participants are ApoE4 carriers who have been stratified across the three treatment groups. These data further reinforce the gingipain hypothesis and the design of the GAIN Trial to enroll the appropriate population for testing atuzaginstat.

    Scientific Updates: Generating New Evidence and Expanding Our Pipeline

    As atuzaginstat advances through late-stage clinical development, Cortexyme and external collaborators continue to present and publish new research and study data to advance the gingipain hypothesis for Alzheimer's pathogenesis and identify additional development opportunities. Recent scientific presentations and research accomplishments are the following.

    • Cortexyme scientists presented new data in a poster at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting on November 9, 2020 entitled "PD-L1 is induced by the periodontal pathogen Porphyromonas gingivalis and can be blocked by small molecule gingipain inhibitors, including atuzaginstat." P. gingivalis has been linked to oral, esophageal, gastrointestinal, and pancreatic cancer and there is accumulating evidence that bacterial presence is correlated with worse disease prognosis. This study demonstrated that PD-L1 expression is increased by P. gingivalis infection in an esophageal cell line and this induction is blocked by either the lysine gingipain inhibitor atuzaginstat or an arginine gingipain inhibitor COR613. Infection resulted in nuclear β-catenin and disruption of the Wnt pathway complex regulating β-catenin function, and this is also blocked by gingipain inhibition. Tumor immune evasion markers PD-L1, PD-L2, and CTLA4 ligand CD80 were also induced by Pg infection on primed M2 macrophages, further supporting a role for Pg infection in blocking functional tumor immune surveillance.
    • COR588, a novel lysine gingipain inhibitor from Cortexyme's library, remains on track with IND-enabling studies. Clinical studies are expected to begin in Q3 2021.
    • Cortexyme completed additional screening of its proprietary library of small molecules for a possible treatment for coronaviruses. The Company has identified inhibitors of the 3CL protease of SARS-CoV-2 and other coronaviruses in its library of small molecules which block viral replication in cells. Cortexyme is now proceeding to in vivo efficacy and toxicology testing.

    Financial Results for the Quarter Ended September 30, 2020

    Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and short and long-term marketable securities as of September 30, 2020, were $197.9 million, and includes approximately $117.6 million of net proceeds raised in Cortexyme's private placement offering completed in February 2020. Cortexyme expects current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures through 2022 and the completion of the GAIN Trial.

    Research and Development (R&D) Expenses: For the quarter ended September 30, 2020, R&D expenses were $17.0 million, primarily due to costs related to the research and development of atuzaginstat and the GAIN Trial.

    General and Administrative (G&A) Expenses: For the quarter ended September 30, 2020, G&A expenses were $4.9 million. The expense was primarily attributable to personnel-related expenses, insurance, professional and legal fees, and stock-based compensation.

    Net Loss: For the quarter ended September 30, 2020, net loss was $21.5 million, or a loss of $0.73 per basic share. Weighted average shares outstanding for the quarter ended September 30, 2020 was 29,488,739.

    About Cortexyme, Inc.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the translation to human of pre-clinical data, the pre-clinical results for our product candidates, the timing and success of our clinical trials and related data including the outcome of the interim analysis, the potential of atuzaginstat to treat Alzheimer's disease and the potential therapeutic application in oncology, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on November 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

    Cortexyme, Inc. Condensed Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

    2020

     

    2019

     

    2020

     

    2019

    Operating expenses:

    Research and development

    $

    16,983

     

     

    $

    8,253

     

     

    $

    45,450

     

     

    $

    20,187

     

    General and administrative

     

    4,929

     

     

     

    2,316

     

     

     

    12,591

     

     

     

    6,032

     

    Total operating expenses

     

    21,912

     

     

     

    10,569

     

     

     

    58,041

     

     

     

    26,219

     

    Loss from operations

     

    (21,912

    )

     

     

    (10,569

    )

     

     

    (58,041

    )

     

     

    (26,219

    )

    Interest income

     

    406

     

     

     

    711

     

     

     

    1,747

     

     

     

    1,618

     

    Net loss

     

    (21,506

    )

     

     

    (9,858

    )

     

     

    (56,294

    )

     

     

    (24,601

    )

    Other comprehensive income / (loss):

     

     

     

     

     

     

     

    Unrealized gain / (loss) on available for sales securities

     

    (198

    )

     

     

    16

     

     

     

    453

     

     

     

    145

     

    Total comprehensive loss

    $

    (21,704

    )

     

    $

    (9,842

    )

     

    $

    (55,841

    )

     

    $

    (24,456

    )

    Net loss per share - basic and diluted

    $

    (0.73

    )

     

    $

    (0.37

    )

     

    $

    (1.94

    )

     

    $

    (1.59

    )

    Cortexyme, Inc. Condensed Balance Sheets

    (Unaudited)

    (In thousands)

    September 30, 2020 December 31, 2019

    ASSETS

    Current assets:

    Cash and cash equivalents

    $

    64,246

     

    $

    51,214

    Short term investments

     

    73,548

     

     

    48,650

    Prepaid expenses and other current assets

     

    5,180

     

     

    6,192

    Total current assets

     

    142,974

     

     

    106,056

    Property and equipment, net

     

    500

     

     

    709

    Operating lease right-of-use assets, net

     

    848

     

     

    625

    Long term investments

     

    60,133

     

     

    16,763

    Other assets

     

    209

     

     

    217

    Total assets

    $

    204,664

     

    $

    124,370

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities:

     

     

     

    Accounts payable

    $

    4,309

     

    $

    3,075

    Accrued expenses and other current liabilities

     

    12,100

     

     

    5,817

    Total current liabilities

     

    16,409

     

     

    8,892

    Long-term operating lease liability

     

    244

     

     

    Total liabilities

     

    16,653

     

     

    8,892

    Total stockholders' equity

     

    188,011

     

     

    115,478

    Total liabilities and stockholders' equity

    $

    204,664

     

    $

    124,370

     

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  25. -- Data demonstrate that patients enrolled in the GAIN Trial have baseline biomarkers consistent with Alzheimer's disease and potential responders to atuzaginstat --

    -- Press release issued in advance of CTAD presentation as an SEC exemption to the embargo policy, granted by the conference's organizers --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, announced the presentation of data demonstrating that in a subset of samples analyzed to date, a very high proportion of the adults with mild to moderate Alzheimer's disease (AD) enrolled in the ongoing Phase 2/3 GAIN Trial of atuzaginstat have biomarker profiles consistent with AD…

    -- Data demonstrate that patients enrolled in the GAIN Trial have baseline biomarkers consistent with Alzheimer's disease and potential responders to atuzaginstat --

    -- Press release issued in advance of CTAD presentation as an SEC exemption to the embargo policy, granted by the conference's organizers --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, announced the presentation of data demonstrating that in a subset of samples analyzed to date, a very high proportion of the adults with mild to moderate Alzheimer's disease (AD) enrolled in the ongoing Phase 2/3 GAIN Trial of atuzaginstat have biomarker profiles consistent with AD, and all patients analyzed to date have evidence of immune response to systemic Porphyromonas gingivalis (P. gingivalis) infection, a bacteria believed to play a role in AD pathology. Atuzaginstat is a gingipain inhibitor designed to selectively block P. gingivalis toxicity and reduce bacterial load. The data (Abstract #OC19) are being presented today in an oral session at the 13th Clinical Trials on Alzheimer's Disease Conference (CTAD 2020), which is taking place as a digital event November 4-7.

    "The baseline biomarker and P. gingivalis characteristics reported today give us confidence that we have enrolled an appropriate patient population for testing the efficacy of atuzaginstat in the GAIN Trial," said Michael Detke, M.D. Ph.D., Cortexyme's Chief Medical Officer. "A variety of AD-associated biomarkers have been identified in the vast majority of patients enrolled in the trial to date. Additionally, all patients enrolled in the trial and analyzed to date have evidence of immune response to systemic P. gingivalis infection. More than 90 percent of patients in the trial's dental sub-study had moderate to severe periodontal disease at baseline. Cortexyme remains on track to conduct an interim analysis of the GAIN Trial in December 2020."

    The ongoing Phase 2/3 GAIN Trial is rooted in a strong body of research outlining the role of P. gingivalis in the neurodegeneration associated with AD. P. gingivalis, which is most commonly associated with periodontal disease, has been discovered in greater than 90% of post-mortem brains of patients with AD and has been shown to produce Alzheimer's pathology in infected animals. The GAIN Trial is evaluating the potential of Cortexyme's lead compound, atuzaginstat, to inhibit the toxic proteases, or gingipains, produced by P. gingivalis in patients with mild to moderate AD and to potentially slow or halt AD progression. The trial has completed enrollment, and 643 subjects have been randomized to one of two doses of atuzaginstat (40mg or 80mg twice daily) or placebo. The co-primary endpoints are mean change in cognition (ADAS-Cog 11) and function (CDR-SB or ADCS-ADL) from baseline to 48 weeks compared to placebo. Secondary and exploratory endpoints include change in Winterlight Speech Assessment, cerebral spinal fluid biomarkers, volumetric MRI, and other measures. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease, including gingival pocket depth. An interim analysis of the GAIN Trial is expected in December 2020. Top-line data from the trial's final analysis are expected in the fourth quarter of 2021.

    Key findings reported in today's presentation, titled "Phase 2/3 GAIN trial of atuzaginstat (COR388), a novel bacterial virulence factor inhibitor for the treatment of Alzheimer's disease: Update and baseline data," include:

    • Approximately 75% of analyzed subjects have an amyloid β (Aβ) 42/40 ratio below the assay cut-off (<0.095) associated with AD, and approximately 88% have an Aβ 42/40 ratio associated with Aβ positivity on PET scan (<0.129).
    • 89% of analyzed subjects have total Tau levels above the assay AD cut-off (>290 pg/ml), and 86% have pTau 181 levels consistent with AD in the Amyloid/Tau/Neurodegeneration (ATN) designation (>61 pg/ml).
    • All subjects analyzed to date had evidence of P. gingivalis-specific IgG at baseline, with 72% exhibiting high antibody titers associated with more severe periodontal disease and 97% with titers associated with at least mild periodontal disease according to third party research.1 Previous research has demonstrated that IgG titers roughly correlate to infection load.2
    • More than 90% subjects in the periodontal sub-study included at the time of data cut-off had moderate to severe periodontal disease at baseline.
    • Approximately 65% of the trial participants carry at least one ApoE4 gene and these participants are stratified across the three treatment groups.

    Baseline biomarker analyses presented at CTAD include 40-50% of the enrolled subjects with data available at the time of data cutoff. The presentation with additional detail is now available at https://ir.cortexyme.com/news-and-events/presentations.

    About Cortexyme, Inc.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the timing and success of our clinical trials and related data including the outcome of the interim analysis, the potential of atuzaginstat to treat Alzheimer's disease, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on August 14, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

    1 Offenbacher et al., Journal of Periodontology 2007 Oct;78(10):1911

    2 Kojima et al., Journal of Periodontology 1997. 68 (7): 618

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  26. -- Oral presentation at Clinical Trials on Alzheimer's Disease 2020 will include baseline characteristics of the Phase 2/3 GAIN Trial ahead of planned interim analysis expected to occur before year-end 2020 --

    -- Poster at Society for Immunotherapy of Cancer Annual Meeting evaluates the therapeutic potential of gingipain inhibitors in oncology --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, announced that its work will be the subject of abstracts at two upcoming scientific conferences: the 13th Clinical Trials on Alzheimer's Disease Digital Event (CTAD 2020; November 4-7) and the Society for Immunotherapy of Cancer's 35th Anniversary…

    -- Oral presentation at Clinical Trials on Alzheimer's Disease 2020 will include baseline characteristics of the Phase 2/3 GAIN Trial ahead of planned interim analysis expected to occur before year-end 2020 --

    -- Poster at Society for Immunotherapy of Cancer Annual Meeting evaluates the therapeutic potential of gingipain inhibitors in oncology --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, announced that its work will be the subject of abstracts at two upcoming scientific conferences: the 13th Clinical Trials on Alzheimer's Disease Digital Event (CTAD 2020; November 4-7) and the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting (SITC; November 9-14).

    The oral presentation at CTAD 2020 will provide an update on Cortexyme's ongoing Phase 2/3 GAIN Trial, which is evaluating atuzaginstat in more than 570 patients with mild to moderate Alzheimer's disease (AD). Atuzaginstat targets the toxic proteases, or gingipains, produced by P. gingivalis, which have been discovered in greater than 90% of post-mortem brains of patients with AD and shown to produce Alzheimer's disease pathology in infected animals. By targeting these gingipains, Cortexyme hopes to slow or halt the progression of AD. The CTAD abstract, "Phase 2/3 GAIN trial of atuzaginstat (COR388), a novel bacterial virulence factor inhibitor for the treatment of Alzheimer's disease: Update and baseline data," will be presented on Thursday, November 5th at 11:02 a.m. EST / 8:02 a.m. PST.

    The poster at SITC 2020 demonstrates the potential for atuzaginstat and other gingipain inhibitors to reduce the expression of the immune checkpoint ligand PD-L1 induced by P. gingivalis infection. P. gingivalis has been previously linked to increased risk and worse outcomes in oral, esophageal and other cancers and has been shown to induce PD-L1 on the surface of infected cells, which may allow cancers to evade the immune system. The poster (Abstract #676), "PD-L1 is induced by the periodontal pathogen Porphyromonas gingivalis and can be blocked by small molecule gingipain inhibitors, including atuzaginstat," will be on display in the meeting's virtual poster hall from 8:00 a.m. EST / 5:00 a.m. PST on Monday, November 9th.

    Both presentations will be available at https://ir.cortexyme.com/news-and-events/presentations.

    "As we advance the GAIN Trial of our lead investigational medicine, atuzaginstat, in mild to moderate Alzheimer's disease, our research team also continues to make strides in understanding the critical role that P. gingivalis may play in a variety of therapeutic areas and the corresponding benefits of atuzaginstat," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "We are looking forward to continuing to expand our understanding of the potential benefits of our small molecule library."

    About Cortexyme, Inc.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the translation to human of pre-clinical data, the pre-clinical results for our product candidates, the timing and success of our clinical trials and related data including the outcome of the interim analysis, the potential of atuzaginstat to treat Alzheimer's disease and the potential therapeutic application in oncology, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on August 14, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  27. - Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020

    Cortexyme, Inc. (NASDAQ:CRTX) today announced that its GAIN Trial for Alzheimer's disease (AD) has exceeded its enrollment target of 570 patients. GAIN is a randomized, double-blind, placebo-controlled Phase 2/3 trial of atuzaginstat (COR388), Cortexyme's lead investigational medicine, in patients with mild to moderate AD. The GAIN Trial's protocol includes an interim analysis on the study's co-primary cognitive and global endpoints after approximately 300 patients reach 24 weeks of treatment, and this interim analysis is expected to occur before year-end 2020. Top-line results of the GAIN Trial's final analysis, to be performed once all study subjects complete…

    - Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020

    Cortexyme, Inc. (NASDAQ:CRTX) today announced that its GAIN Trial for Alzheimer's disease (AD) has exceeded its enrollment target of 570 patients. GAIN is a randomized, double-blind, placebo-controlled Phase 2/3 trial of atuzaginstat (COR388), Cortexyme's lead investigational medicine, in patients with mild to moderate AD. The GAIN Trial's protocol includes an interim analysis on the study's co-primary cognitive and global endpoints after approximately 300 patients reach 24 weeks of treatment, and this interim analysis is expected to occur before year-end 2020. Top-line results of the GAIN Trial's final analysis, to be performed once all study subjects complete the one-year study, are expected in Q4 2021.

    The GAIN Trial was designed to enroll patients with mild to moderate Alzheimer's disease, randomized 1:1:1 to receive atuzaginstat 40 mg twice a day, 80 mg twice a day a day, or placebo. GAIN Trial enrollment has already exceeded the enrollment targets in the three double-blind arms. Although new screening of patients for the double-blind arms has ended, eligible patients who have already screened for the study will continue to enroll over the next several weeks.

    "The GAIN Trial is an important study of a potential new approach to addressing Alzheimer's. We are pleased the trial has reached this milestone on schedule, and we look forward to completing the trial's interim analysis before year-end 2020," said Michael Detke, M.D., Ph.D., Cortexyme's Chief Medical Officer. "The significant need for new therapeutic options for Alzheimer's patients grows every day, and we are encouraged by the body of evidence supporting atuzaginstat's mechanism of action, which is ‘upstream' of other approaches."

    Atuzaginstat targets the toxic proteases, or gingipains, produced by P. gingivalis, which have been discovered in greater than 90% of post-mortem brains of patients with AD and shown to produce Alzheimer's pathology in infected animals. P. gingivalis is best known as a keystone bacterium in the development of periodontal disease. The GAIN Trial includes a periodontal sub-study, in which approximately 40% of GAIN Trial participants are also assessed for endpoints of efficacy in periodontal disease. Of the sub-study participants enrolled to date, greater than 90% had moderate to severe periodontal disease at baseline.

    For more information about the GAIN Trial, visit www.GAINtrial.com.

    About the GAIN Trial

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of atuzaginstat (COR388), Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate Alzheimer's disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. The GAIN Trial has been enrolling since the second quarter of 2019, with top-line results from the study's final analysis expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the timing and success of our clinical trials and related data including the outcome of the interim analysis, the potential of atuzaginstat to treat Alzheimer's disease, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on August 14, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  28. -- Presentation to be webcast on Cortexyme's website --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 11:00 a.m. EDT / 8:00 a.m. PDT.

    A live webcast of the presentation will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 30 days.

    About Cortexyme, Inc.

    Cortexyme, Inc. (NASDAQ:CRTX) is a clinical stage…

    -- Presentation to be webcast on Cortexyme's website --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 11:00 a.m. EDT / 8:00 a.m. PDT.

    A live webcast of the presentation will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 30 days.

    About Cortexyme, Inc.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidates or library of compounds in the potential treatment of Alzheimer's Disease and additional indications. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on August 14, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  29.  - New U.S. Patent No. 10,730,826 provides additional composition of matter protection for atuzaginstat (COR388)

    - The '826 patent extends the patent term for atuzaginstat to 2037, with a possible patent term extension of up to an additional five years

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, announced today that the U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 10,730,826 relating to Cortexyme's lead small molecule, atuzaginstat (COR388).

    Cortexyme's ‘826 patent provides additional composition of matter protection for atuzaginstat and gingipain inhibitors, with additional claims pending in related applications…

     - New U.S. Patent No. 10,730,826 provides additional composition of matter protection for atuzaginstat (COR388)

    - The '826 patent extends the patent term for atuzaginstat to 2037, with a possible patent term extension of up to an additional five years

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, announced today that the U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 10,730,826 relating to Cortexyme's lead small molecule, atuzaginstat (COR388).

    Cortexyme's ‘826 patent provides additional composition of matter protection for atuzaginstat and gingipain inhibitors, with additional claims pending in related applications. The patent is expected to provide patent protection for atuzaginstat through September 2037, not including a possible patent term extension of up to five years as provided under the Drug Price Competition and Patent Restoration Act (35 U.S.C. §156).

    Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair commented: "We are particularly excited about the issuance of this composition of matter patent for atuzaginstat in anticipation of upcoming results from our GAIN Phase 2/3 clinical trial in the fourth quarter of 2021. The USPTO's issuance of this patent strengthens our intellectual property protection for gingipain inhibitors and atuzaginstat. This patent further supports our ongoing R&D efforts to develop treatments for Alzheimer's and other degenerative diseases and supports the potential expansion of our pipeline into additional indications."

    About Cortexyme, Inc.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidates or library of compounds in the potential treatment of Alzheimer's Disease and additional indications. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on August 14, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  30. — GAIN Trial enrollment on track to complete in Q4 2020

    — GAIN Trial interim analysis on schedule to complete by year end 2020

    — Clinical pipeline expansion anticipated in 2021

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced financial results for the second quarter 2020 and provided an update on its business.

    "The participation of the medical community and patients in the GAIN study of atuzaginstat in mild to moderate Alzheimer's disease continues to be strong, and we're entering the final months of enrollment with key anticipated milestones on track," said Casey Lynch, Cortexyme's chief executive officer, co-founder…

    — GAIN Trial enrollment on track to complete in Q4 2020

    — GAIN Trial interim analysis on schedule to complete by year end 2020

    — Clinical pipeline expansion anticipated in 2021

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced financial results for the second quarter 2020 and provided an update on its business.

    "The participation of the medical community and patients in the GAIN study of atuzaginstat in mild to moderate Alzheimer's disease continues to be strong, and we're entering the final months of enrollment with key anticipated milestones on track," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "We are looking forward to the GAIN interim analysis before the end of this year, and we anticipate top-line data from the trial in the fourth quarter of 2021. At the same time, our research efforts continue to be productive and we are advancing additional molecules into IND-enabling studies, with the goal of expanding and adding value to our clinical pipeline in 2021. With a strong balance sheet and a talented team, we believe we are well positioned to potentially provide new therapeutic options to patients stricken with Alzheimer's and other neurodegenerative diseases."

    GAIN Trial Updates: Evaluating Atuzaginstat, a New Potential Therapy for Alzheimer's Disease

    • The Phase 2/3 GAIN Trial of atuzaginstat (COR388) versus placebo in patients with mild to moderate Alzheimer's disease (AD) has surpassed 500 patients enrolled and remains on track to report top-line results from its final analysis in the fourth quarter of 2021.
    • Cortexyme remains on track to conduct an interim analysis in the GAIN Trial before year end 2020. This interim analysis for overwhelming efficacy, futility and sample size adjustment will be conducted after approximately 100 patients in each of the GAIN Trial's three arms reach 24 weeks of treatment. The co-primary endpoints for the GAIN Trial's interim analysis are change from baseline in ADAS-Cog11 and CDR-SB versus placebo.
    • The GAIN Trial also includes an ongoing open-label extension (OLE) study in the United States. Upon completing the 48-week placebo-controlled period of the GAIN Trial, participants in the GAIN Trial's placebo and active arms in the U.S. may be eligible to enroll in the OLE study, where they will receive 40 mg or 80 mg of atuzaginstat twice daily for an additional 48 weeks. The OLE is intended to evaluate long-term safety and efficacy measures of participants in the GAIN Trial.
    • A research abstract on the design of the GAIN Trial and its baseline biomarkers has been accepted as an oral presentation at the 13th Clinical Trials on Alzheimer's Disease (CTAD) meeting, which will be held in a hybrid virtual/onsite format in Boston from November 4-7, 2020. The abstract, "GAIN Trial Update and Baseline Biomarkers," will be presented on November 6th.

    Scientific Updates: Generating New Evidence and Expanding Our Opportunities to Help Patients

    As atuzaginstat advances through late-stage clinical development, Cortexyme and external collaborators continue to present and publish new research and study data to advance the gingipain hypothesis for Alzheimer's pathogenesis and identify additional development opportunities. Recent scientific presentations and research accomplishments include:

    • At the virtual Alzheimer's Association International Conference® 2020 (AAIC®) last month, Cortexyme presented three posters, including new preclinical data in collaboration with the Forsyth Institute demonstrating the role of the bacterium P. gingivalis in AD and cardiovascular disease, providing a potential explanation for why the two diseases often occur together. Cortexyme also shared data demonstrating the therapeutic potential of atuzaginstat in treating both diseases.
    • The in-life portion of a human radiolabeled mass balance study for atuzaginstat was completed on schedule and met the goal of achieving mass balance recovery, completing an important step in a study required by regulatory authorities for the registration of a new drug.
    • A novel lysine gingipain inhibitor from Cortexyme's library, COR588, has been selected to begin IND-enabling studies and is expected to enter the clinic in 2021. Cortexyme is advancing a portfolio of gingipain inhibitors toward the clinic with distinct target therapeutic product profiles and intellectual property.
    • Cortexyme completed additional screening of its proprietary library of small molecules for a possible treatment for coronaviruses. The Company has identified inhibitors of the 3CL protease of SARS-CoV-2 that block viral replication in cells. Cortexyme is continuing to screen analogs for potency, selectivity, pharmacokinetics and other important properties to identify potential candidate molecules for further progression.

    Financial Results for the Quarter Ended June 30, 2020

    Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and short and long-term marketable securities as of June 30, 2020, were $210.6 million, and includes approximately $117.6 million of net proceeds raised in Cortexyme's private placement offering completed in February 2020. Cortexyme expects current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures through 2022 and the completion of the GAIN Trial.

    Research and Development (R&D) Expenses: For the quarter ended June 30, 2020, R&D expenses were $14.1 million, primarily due to costs related to the research and development of atuzaginstat and the GAIN Trial.

    General and Administrative (G&A) Expenses: For the quarter ended June 30, 2020, G&A expenses were $4.2 million. The expense was primarily attributable to personnel-related expenses, insurance, professional and legal fees, and stock-based compensation.

    Net Loss: For the quarter ended June 30, 2020, net loss was $17.6 million, or a loss of $0.60 per basic share. Weighted average shares outstanding for the quarter ended June 30, 2020 was 29,442,915.

    About Cortexyme, Inc.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the translation to humans of pre-clinical data; the pre-clinical results for our product candidates, the timing and success of our clinical trials and related data, the potential of atuzaginstat to treat Alzheimer's disease and cardiovascular disease, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on August 14, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

    Cortexyme, Inc. Condensed Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)

    Three Months Ended

    June 30,

    Six Months Ended

    June 30,

    2020

    2019

    2020

    2019

    Operating expenses:

    Research and development

    $

    14,086

    $

    7,109

    $

    28,467

    $

    11,934

    General and administrative

     

    4,185

     

    2,466

     

    7,662

     

    3,716

    Total operating expenses

     

    18,271

     

    9,575

     

    36,129

     

    15,650

    Loss from operations

     

    (18,271)

     

    (9,575)

     

    (36,129)

     

    (15,650)

    Interest income

     

    659

     

    513

     

    1,341

     

    907

    Net loss

     

    (17,612)

     

    (9,062)

     

    (34,788)

     

    (14,743)

    Other comprehensive income:

    Unrealized gain on available for sales securities

     

    748

     

    103

     

    651

     

    129

    Total comprehensive loss

     

    (16,864)

     

    (8,959)

     

    (34,137)

     

    (14,614)

    Net loss per share - basic and diluted

     

    (0.60)

     

    (0.57)

     

    (1.21)

     

    (1.52)

    Cortexyme, Inc. Condensed Balance Sheets

    (Unaudited)

    (In thousands, per share amounts)

    June 30, 2020

    December 31, 2019

    ASSETS

    Current assets:

    Cash and cash equivalents

    $

    66,156

    $

    51,214

    Short term investments

     

    78,348

     

    48,650

    Restricted cash

     

     

    Prepaid expenses and other current assets

     

    7,104

     

    6,192

    Total current assets

     

    151,608

     

    106,056

    Property and equipment, net

     

    565

     

    709

    Operating lease right-of-use assets, net

     

    686

     

    625

    Long term investments

     

    66,107

     

    16,763

    Other assets

     

    244

     

    217

    Total assets

    $

    219,210

    $

    124,370

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    Current liabilities:

    Accounts payable

    $

    5,091

    $

    3,075

    Accrued expenses and other current liabilities

     

    8,602

     

    5,817

    Short-term lease liability

     

     

    Total current liabilities

     

    13,693

     

    8,892

    Long-term operating lease liability

     

    50

     

    Total liabilities

     

    13,743

     

    8,892

    Total stockholders' equity

     

    205,467

     

    115,478

    Total liabilities and stockholders' equity

    $

    219,210

    $

    124,370

     

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  31. - Open label extension is currently active for GAIN Trial completers in the United States with robust conversion of eligible patients

    - Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020

    Cortexyme, Inc. (NASDAQ:CRTX) today announced that enrollment in its GAIN Trial for Alzheimer's disease (AD) has reached 500 patients toward the study's previously announced enrollment target of 570 subjects. GAIN is a randomized, double-blind, placebo-controlled Phase 2/3 trial of atuzaginstat (COR388), Cortexyme's lead investigational medicine, in patients with mild to moderate AD. The GAIN Trial's protocol includes an interim analysis on the study's co-primary cognitive and functional endpoints after approximately 300…

    - Open label extension is currently active for GAIN Trial completers in the United States with robust conversion of eligible patients

    - Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020

    Cortexyme, Inc. (NASDAQ:CRTX) today announced that enrollment in its GAIN Trial for Alzheimer's disease (AD) has reached 500 patients toward the study's previously announced enrollment target of 570 subjects. GAIN is a randomized, double-blind, placebo-controlled Phase 2/3 trial of atuzaginstat (COR388), Cortexyme's lead investigational medicine, in patients with mild to moderate AD. The GAIN Trial's protocol includes an interim analysis on the study's co-primary cognitive and functional endpoints after approximately 300 patients reach 24 weeks of treatment; this interim analysis is expected to occur before year-end 2020. Top-line results of the GAIN Trial's final analysis, to be performed once all study subjects complete the one-year study, are expected in Q4 2021.

    Atuzaginstat targets the toxic proteases, or gingipains, produced by P. gingivalis, which have been discovered in greater than 90% of post-mortem brains of patients with AD and shown to produce Alzheimer's pathology in infected animals. P. gingivalis is best known as a keystone bacterium in the development of periodontal disease. The GAIN Trial includes a periodontal sub-study, in which approximately 40% of GAIN Trial participants are also assessed for endpoints of efficacy in periodontal disease. Of the sub-study participants enrolled to date, greater than 90% had moderate to severe periodontal disease at baseline.

    "We are gratified to see the continued high level of engagement of our clinical sites and study participants and their caregivers, especially during the last several months," said Michael Detke, M.D., Ph.D., Cortexyme's chief medical officer. "The fact that GAIN Trial timelines have not been impacted by the COVID-19 pandemic reflects the devastating impact of Alzheimer's disease, the significant need for new therapeutic options for patients, and the growing interest in atuzaginstat's mechanism of action, which is ‘upstream' of other approaches. We expect to complete GAIN enrollment in the next few months and look forward to sharing study results when available."

    For more information about the GAIN Trial, visit www.GAINtrial.com.

    About the GAIN Trial

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of atuzaginstat (COR388), Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate Alzheimer's disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. The GAIN Trial has been enrolling since the second quarter of 2019, with top-line results from the study's final analysis expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the timing and success of our clinical trials and related data, the potential of atuzaginstat to treat Alzheimer's disease , our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  32. Presentations to be webcast on Cortexyme's website

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will present at the following two investor conferences in August 2020:

    • The Canaccord Genuity 40th Annual Growth Conference: Ms. Lynch's presentation will start at 2:00 p.m. EDT / 11:00 a.m. PDT on Wednesday, August 12.
    • The JMP Securities CNS Forum: Ms. Lynch will participate in a fireside chat at 1:00 p.m. EDT / 10:00 a.m. on Wednesday, August 19.

    Both events will take place virtually, with live webcasts accessible at the Investor Calendar

    Presentations to be webcast on Cortexyme's website

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will present at the following two investor conferences in August 2020:

    • The Canaccord Genuity 40th Annual Growth Conference: Ms. Lynch's presentation will start at 2:00 p.m. EDT / 11:00 a.m. PDT on Wednesday, August 12.
    • The JMP Securities CNS Forum: Ms. Lynch will participate in a fireside chat at 1:00 p.m. EDT / 10:00 a.m. on Wednesday, August 19.

    Both events will take place virtually, with live webcasts accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). Each webcast will be archived at that location for 30 days.

    About Cortexyme, Inc.

    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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the translation to humans of pre-clinical data; the pre-clinical results for our product candidates, the timing and success of our clinical trials and related data, the potential of atuzaginstat to treat Alzheimer's disease and cardiovascular disease, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  33. -- Presentation to be webcast on Cortexyme's website

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced Stephen Dominy, M.D., the company's chief scientific officer and co-founder, will participate in a fireside chat hosted by LifeSci Capital on Thursday, July 30 at 3:00 p.m. EDT / 12:00 p.m. PDT. The conversation will focus on the link between P. gingivalis and Alzheimer's disease pathology.

    A live webcast of the fireside chat will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 14 days.

    -- Presentation to be webcast on Cortexyme's website

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced Stephen Dominy, M.D., the company's chief scientific officer and co-founder, will participate in a fireside chat hosted by LifeSci Capital on Thursday, July 30 at 3:00 p.m. EDT / 12:00 p.m. PDT. The conversation will focus on the link between P. gingivalis and Alzheimer's disease pathology.

    A live webcast of the fireside chat will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 14 days.

    About Cortexyme, Inc.

    Cortexyme (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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the timing and success of our clinical trials and related data, the potential of atuzaginstat to treat Alzheimer's disease , our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  34. -- Researchers presented new preclinical data on atuzaginstat and the potential impact on cardiovascular disease and AD-associated neurodegeneration in two poster presentations at AAIC 2020

    -- Cortexyme also presented phase 1b clinical data demonstrating atuzaginstat‘s therapeutic potential in blocking AD-associated ApoE fragmentation

    Cortexyme, a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases, today announced new preclinical data demonstrating the role of the bacterium P. gingivalis in Alzheimer's disease (AD) and cardiovascular disease, providing a potential explanation for why the two diseases often occur together…

    -- Researchers presented new preclinical data on atuzaginstat and the potential impact on cardiovascular disease and AD-associated neurodegeneration in two poster presentations at AAIC 2020

    -- Cortexyme also presented phase 1b clinical data demonstrating atuzaginstat‘s therapeutic potential in blocking AD-associated ApoE fragmentation

    Cortexyme, a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases, today announced new preclinical data demonstrating the role of the bacterium P. gingivalis in Alzheimer's disease (AD) and cardiovascular disease, providing a potential explanation for why the two diseases often occur together. Cortexyme also provided data demonstrating the therapeutic potential of its lead compound, atuzaginstat (COR388), in treating both diseases. This data, along with two other poster presentations on atuzaginstat, are being presented by Cortexyme at the Alzheimer's Association International Conference® 2020 (AAIC®), which is taking place virtually from July 27-31.

    "Atuzaginstat is the subject of the GAIN Trial, a Phase 2/3 clinical trial evaluating its potential to slow or halt Alzheimer's disease progression by blocking the toxic proteases, or gingipains, released by P. gingivalis as it invades the brain," said Casey Lynch, Cortexyme's chief executive officer and co-founder, and a co-author of all three presentations. "As evidence mounts regarding P. gingivalis' role in a variety of serious health conditions, including cardiovascular disease, we are pleased to play a leading role in the research and development of gingipain inhibitors, and believe that this novel class of compounds may have significant therapeutic breadth and applicability."

    The Role of P. gingivalis and Potential for Atuzaginstat in Cardiovascular Disease

    Previous research led by Cortexyme has demonstrated a causative association between the bacterial pathogen P. gingivalis and AD. Cortexyme's lead gingipain inhibitor atuzaginstat has been shown to block the neuropathology triggered by P. gingivalis in animal models. Researchers have also found an association between P. gingivalis and the atherosclerotic plaques associated with cardiovascular disease, with a 2017 study by Mougeot et al. demonstrating P. gingivalis as the pathogen found most abundantly in coronary and femoral artery tissues in atherosclerosis and linked to the development of this disease pathology.

    In a poster presented at AAIC today, "Targeting Porphyromonas gingivalis to treat Alzheimer's disease and comorbid cardiovascular disease" (Abstract 47058P3), researchers demonstrated that oral infection with P. gingivalis accelerated atherosclerosis in a rabbit model of disease and showed that atuzaginstat reduced inflammation and the formation of unstable atherosclerotic plaques. Specifically, the gingipain inhibitor reduced deposits of lipids in the aortas of infected animals and prevented the progression of atherosclerosis linked to P. gingivalis infection.

    "Building on strong prior research linking P. gingivalis to cardiovascular disease, our research shows improvements in lipid deposition, progression of atherosclerosis and levels of systemic inflammation in the P. gingivalis-infected groups treated with atuzaginstat," said Hatice Hasturk, D.D.S., Ph.D., director of the Center for Clinical and Translational Research at the Forsyth Institute and a principal investigator of the research presented today. "These data are highly suggestive that atuzaginstat may have therapeutic potential in mitigating cardiovascular disease in people with P. gingivalis infection, a common oral infection thought to effect more than 50% of the adult population, which is capable of promoting systemic infection and inflammation."

    "We are proud to lead global research demonstrating the role of P. gingivalis in Alzheimer's disease and, in turn, the therapeutic potential for the gingipain inhibitor atuzaginstat in treating and preventing Alzheimer's pathology," said Stephen Dominy, M.D., Cortexyme's chief scientific officer and co-founder, and co-author on the presentation. "We are encouraged by this new data demonstrating the potential impact of atuzaginstat on cardiovascular disease, a condition where P. gingivalis has previously been implicated, and believe this therapeutic approach warrants further study."

    Cortexyme's work was featured in two additional poster presentations at the virtual AAIC 2020 event:

    Atuzaginstat Protects Against AD-Associated Synaptic Loss

    In a poster titled "Comprehensive Alzheimer's pathology is induced by Porphyromonas gingivalis infection: atuzaginstat (COR388) and other proprietary gingipain inhibitors protect against synaptic loss" (Abstract 44023P1), researchers showed additional evidence supporting COR388 as a potential AD therapy. This study, conducted in neuron cultures and neuron-astrocyte-microglia co-cultures, showed that atuzaginstat and proprietary gingipain inhibitors protected neurons infected with P. gingivalis from synapse loss. Additionally, atuzaginstat reduced the bacterial load in neurons, astrocytes and microglia infected with P. gingivalis and protected against deficits in other pathways impacted by the bacterium, including synaptic transmission.

    Atuzaginstat Also Decreases ApoE Fragmentation

    The third Cortexyme presentation, titled "COR388 (atuzaginstat), a novel gingipain inhibitor, decreases ApoE fragmentation in the CNS of Alzheimer's disease patients" (Abstract 40578P3), presents data indicating P. gingivalis gingipains target and cleave ApoE proteins in the nervous system of AD patients. Data from Cortexyme's Phase 1b trial of atuzaginstat show that gingipains preferentially fragment the ApoE4 protein variant, suggesting why the APOE4 gene variant may increase the risk of developing AD, i.e., the protein is more susceptible to gingipain cleavage and, in turn, AD-associated neurodegeneration.

    To view the full poster presentations, please visit the Presentations page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com).

    About Forsyth Institute

    Founded in 1910, The Forsyth Institute is the only independent research organization in the United States dedicated to understanding the important connections between oral health and overall wellness. Forsyth scientists have identified and characterized many of the oral bacteria that play role in oral health and have capacity to increase risk for other diseases in the body. Forsyth Institute is a not-for-profit organization that is also committed to treating underserved populations in local communities and on a national and global scale. To learn more about Forsyth, visit www.forsyth.org

    About Cortexyme, Inc.

    Cortexyme (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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the translation to humans of pre-clinical data; the pre-clinical results for our product candidates, the timing and success of our clinical trials and related data, the potential of atuzaginstat to treat Alzheimer's disease and cardiovascular disease, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  35. Cortexyme, Inc. (NASDAQ:CRTX) today announced that its work to pioneer upstream therapeutic approaches to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases will be the subject of three research abstracts at the Alzheimer's Association International Conference® 2020 (AAIC®). The largest international meeting dedicated to advancing dementia science, AAIC will be held as a virtual event this year from July 27-31, 2020.

    The accepted abstracts further document the role that P. gingivalis, the bacterium most commonly associated with chronic periodontal disease, plays as a driver of Alzheimer's-like neuropathology, and highlight the potential of atuzaginstat (formerly COR388), Cortexyme's investigational medicine…

    Cortexyme, Inc. (NASDAQ:CRTX) today announced that its work to pioneer upstream therapeutic approaches to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases will be the subject of three research abstracts at the Alzheimer's Association International Conference® 2020 (AAIC®). The largest international meeting dedicated to advancing dementia science, AAIC will be held as a virtual event this year from July 27-31, 2020.

    The accepted abstracts further document the role that P. gingivalis, the bacterium most commonly associated with chronic periodontal disease, plays as a driver of Alzheimer's-like neuropathology, and highlight the potential of atuzaginstat (formerly COR388), Cortexyme's investigational medicine to target the virulence factor proteases released by the bacterium. In a Developing Topics poster, Cortexyme researchers, in collaboration with researchers at The Forsyth Institute, will present preclinical data about the role of P. gingivalis in the acceleration of atherosclerosis, the underlying condition of cardiovascular disease that frequently presents alongside Alzheimer's, and for the first time, the potential utility of atuzaginstat in attenuating this effect.

    "Our research team continues to generate compelling data documenting P. gingivalis' role in driving Alzheimer's-like neuropathology, and of the potential for atuzaginstat to slow or stop Alzheimer's disease progression," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "With several significant clinical milestones anticipated in the coming quarters, we are looking forward to sharing our latest findings with the international Alzheimer's research community at AAIC next week."

    The full roster of Cortexyme presentations expected at the meeting is as follows:

    [Abstract 44023P1] "Comprehensive Alzheimer's pathology is induced by Porphyromonas gingivalis infection: COR388 (atuzaginstat) and other gingipain inhibitors protect against synaptic loss"

    Florian Ermini, Ph.D., et al.

    Poster: Basic Science and Pathogenesis – Molecular and Cell Biology

    Presented Monday, July 27, 2020

    [Abstract 47058P3] "Targeting Porphyromonas gingivalis to treat Alzheimer's disease and comorbid cardiovascular disease"

    Florian Ermini, Ph.D., et al.

    Developing Topic Poster: Drug Development

    Presented Wednesday, July 29, 2020

    [Abstract 40578P3] "COR388 (atuzaginstat), a novel gingipain inhibitor, decreases fragmentation of ApoE in the central nervous system of Alzheimer's disease patients"

    Debasish Raha et al.

    Poster: Drug Development – Human Trials

    Presented Wednesday, July 29, 2020

    About Forsyth Institute

    Founded in 1910, The Forsyth Institute is the only independent research organization in the United States dedicated to understanding the important connections between oral health and overall wellness. Forsyth scientists have identified and characterized many of the oral bacteria that play role in oral diseases and have capacity to increase risk for other diseases in the body. Forsyth Institute is a not-for-profit organization that is also committed to treating underserved populations in local communities and on a national and global scale. To learn more about Forsyth, visit www.forsyth.org

    About Cortexyme, Inc.

    Cortexyme (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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, the translation to humans of pre-clinical data; the pre-clinical results for our product candidates, the timing and success of our clinical trials and related data, the potential of atuzaginstat to treat Alzheimer's disease and cardiovascular disease, our ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  36. Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases, today announced that the International Nonproprietary Naming Committee of the World Health Organization (WHO) has selected atuzaginstat (pronounced "a too za' gin stat") as the proposed International Nonproprietary Name, or pINN, for the company's lead product candidate COR388. Atuzaginstat is an oral, twice-daily investigational medicine in late stage clinical development for Alzheimer's disease that is designed to inhibit lysine gingipain, a virulence factor protease released by P. gingivalis.

    "Atuzaginstat is a first-in-class small…

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering upstream therapeutic approaches to improve the lives of patients diagnosed with Alzheimer's and other degenerative diseases, today announced that the International Nonproprietary Naming Committee of the World Health Organization (WHO) has selected atuzaginstat (pronounced "a too za' gin stat") as the proposed International Nonproprietary Name, or pINN, for the company's lead product candidate COR388. Atuzaginstat is an oral, twice-daily investigational medicine in late stage clinical development for Alzheimer's disease that is designed to inhibit lysine gingipain, a virulence factor protease released by P. gingivalis.

    "Atuzaginstat is a first-in-class small molecule with a novel mechanism of action. WHO's INN Expert Group created a new suffix ‘-ginstat' for designation of this and future gingipain inhibitors," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "When a substance exhibits a novel mode of action, a new INN stem may be established. We look forward to potentially making atuzaginstat available as a disease-modifying therapeutic option for patients with Alzheimer's."

    WHO's INN Expert Group assigns simple, informative and unique nonproprietary names for drugs to allow for clear communication among health professionals and to identify chemical/pharmacological relationships.

    About Cortexyme, Inc.

    Cortexyme (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. Based upon the evidence generated to date, Cortexyme is currently advancing its lead therapeutic candidate, atuzaginstat (COR388), in the GAIN Trial, an ongoing Phase 2/3 clinical trial in patients with mild to moderate Alzheimer's disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  37. Interim analysis for the GAIN Trial on track for Q4 2020, with top-line results from study's final analysis expected in Q4 2021

    Cortexyme shared additional scientific evidence supporting the gingipain hypothesis via multiple presentations and publications

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced financial results for the first quarter 2020 and provided an update on its business.

    "The current global environment is challenging on many levels, but Cortexyme continues to execute and progress toward our goal of developing a novel treatment to halt progression of Alzheimer's disease," said Casey Lynch, Cortexyme's…

    Interim analysis for the GAIN Trial on track for Q4 2020, with top-line results from study's final analysis expected in Q4 2021

    Cortexyme shared additional scientific evidence supporting the gingipain hypothesis via multiple presentations and publications

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimer's and other degenerative diseases, today announced financial results for the first quarter 2020 and provided an update on its business.

    "The current global environment is challenging on many levels, but Cortexyme continues to execute and progress toward our goal of developing a novel treatment to halt progression of Alzheimer's disease," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "We remain highly focused on the execution of the GAIN Trial, which is currently on track to complete enrollment of 570 patients this year and for which top-line results are anticipated in the fourth quarter of 2021. At the same time, we continue to research and publish new data that sheds light on the potential clinical utility of gingipain inhibitors for treatment of Alzheimer's and other diseases. With a strong balance sheet and a talented team, we're committed to creating value for all of our stakeholders, especially the neurodegenerative disease patients and caregivers in need of new therapeutic options."

    GAIN Trial Updates

    • The GAIN Trial, Cortexyme's Phase 2/3 clinical trial of COR388 versus placebo in patients with mild to moderate Alzheimer's disease, remains on track to report top-line results from its final analysis in the fourth quarter of 2021.
    • As announced in February 2020, following discussion with the FDA, Cortexyme intends to conduct an interim analysis for overwhelming efficacy in the GAIN Trial. This interim analysis for overwhelming efficacy is currently planned for the fourth quarter of 2020 and will be conducted after approximately 100 patients in each of the GAIN Trial's three arms reach six months of treatment. As with the study's final analysis, the co-primary endpoints for the GAIN Trial's interim analysis are change from baseline in ADAS-Cog11 and CDR-SB versus placebo.
    • The GAIN Trial includes a periodontal sub-study in which sites with a dental sub-investigator are assessing efficacy endpoints against periodontal disease, including pocket depth, at baseline, six months, and one year. While periodontal disease is not a criterion for enrollment in the GAIN Trial or the sub-study, more than 90% of patients enrolled in the sub-study as of March 2020 had moderate to severe periodontal disease at baseline.
    • The GAIN Trial also includes an open-label extension (OLE) in the United States that is currently dosing patients. Upon completing the 48-week placebo-controlled period of the GAIN Trial, participants in the GAIN Trial's placebo and active arms in the U.S. may be eligible to enroll in the OLE study, where they will receive 80 mg of COR388 twice daily for an additional 48 weeks. The OLE is intended to evaluate long-term safety and efficacy measures of participants in the GAIN Trial.

    Scientific Updates: Advancing a New Understanding of Alzheimer's Causation and Treatment

    As COR388 moves through late-stage clinical development, Cortexyme and external collaborators continue to present and publish new research to advance understanding of the gingipain hypothesis for Alzheimer's pathogenesis and the clinical potential of COR388. Recent scientific presentations and publications are as follows:

    • In January 2020, Cortexyme scientists and collaborators published new data in Pharmacology Research and Perspectives revealing further detail about the pharmacodynamics and utility of COR388. COR388 was efficacious in improving downstream pathology of the infection, namely, gingival pocket depth, a symptom of periodontal disease which affects approximately 65 million Americans. In addition, gingipain antigens and P. gulae DNA were found in the brains of aged dogs, indicating that P. gulae can also migrate from the oral cavity to the brain in a manner similar to that seen for P. gingivalis in Alzheimer's patients.
    • In March 2020, Cortexyme posted on its website two data sets intended for medical meetings that were impacted by the ongoing COVID-19 pandemic. The first data set, slated for the International Association for Dental Research annual meeting, demonstrates the activity of COR388 in multiple animal models of periodontal disease, including mice and naturally aged canines. The second data set, part of the American Chemical Society National Meeting and Expo, highlights COR388's potential to decrease fragmentation of ApoE in the Alzheimer's disease central nervous system.
    • In April 2020, Cortexyme announced a presentation at the virtual AAT-AD/PD Advances in Alzheimer's and Parkinson's Therapies meeting demonstrating that in vivo infection of primary neurons by P. gingivalis results in an Alzheimer's-like phenotype including synaptic loss, ultrastructural changes, and inflammation.
    • In May 2020, Cortexyme announced the planned June 2020 publication in The Journal of Alzheimer's Disease of research further documenting the ability of P. gingivalis to invade neurons and trigger Alzheimer's-like neuropathology. An early online version of the paper is available now so that the important findings can be rapidly shared with the research community.

    Corporate Updates

    • In addition to other ongoing pipeline screening activities, Cortexyme is currently screening its proprietary library of small molecules for a possible treatment for coronaviruses. The virus responsible for COVID-19, SARS-CoV2, expresses a cysteine protease known as Mpro or 3CLpro that is required for replication, and this cysteine protease has been previously validated as a therapeutic target for coronaviruses. An initial screen of representative compounds from Cortexyme's library for 3CLpro protease inhibition identified a family of small-molecule inhibitors. Follow-up studies are being conducted to determine activity and potency of these inhibitors in SARS-CoV2 viral replication screens.
    • In May 2020, Caryn McDowell, J.D. joined Cortexyme's executive leadership team as Chief Legal and Administrative Officer and Corporate Secretary. In this newly created role, she leads Cortexyme's legal, corporate governance, compliance, human resources, and administrative functions. Ms. McDowell has over two decades of leadership in biopharmaceutical organizations, including C-level experience both at development and commercial stage public companies. She joined Cortexyme from Revance, Inc., and previously served in leadership roles at Cytokinetics and Intermune.

    Financial Results for the Quarter Ended March 31, 2020

    Cash, Cash Equivalents and Marketable Securities:
    Cash, cash equivalents, and short and long-term marketable securities as of March 31, 2020, were $223.5 million, and includes approximately $117.7 million of net proceeds raised in Cortexyme's successful private placement offering completed in February 2020. Cortexyme expects current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures through 2022 and the completion of the GAIN Trial.

    Research and Development (R&D) Expenses: For the quarter ended March 31, 2020, R&D expenses were $14.4 million. The expense was primarily due to costs related to the research and development of COR388 and the GAIN Trial.

    General and Administrative (G&A) Expenses: For the quarter ended March 31, 2020, G&A expenses were $3.5 million. The expense was primarily attributable to personnel-related expenses, insurance, professional and legal fees, and stock-based compensation.

    Net Loss: For the quarter ended March 31, 2020, net loss was $17.2 million, or a loss of $0.61 per basic share.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. Cortexyme's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's disease. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, ability to fund planned operating and capital expenditures, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, our Quarterly Report on Form 10-Q filed with the SEC on May 12, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

    Cortexyme, Inc. Condensed Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts) 

     

     

     

    Three Months

     

     

    Three Months

    Ended March

    Ended March

    31, 2020

    31, 2019

    Operating expenses:

     

     

     

     

     

     

    Research and development

     

    $

    14,380

     

    $

    4,825

    General and administrative

     

     

    3,478

     

     

    1,250

    Total operating expenses

     

     

    17,858

     

     

    6,075

    Loss from operations

     

     

    (17,858)

     

     

    (6,075)

    Interest income

     

     

    682

     

     

    394

    Net loss

     

     

    (17,176)

     

     

    (5,681)

    Other comprehensive income/ (loss):

     

     

     

     

     

     

    Unrealized gain / (loss) on available for sales securities

     

     

    (97)

     

     

    26

    Total comprehensive income/(loss)

     

    $

    (17,273)

     

    $

    (5,655)

    Net loss per share - basic and diluted

     

     

    (0.61)

     

     

    (1.61)

    Cortexyme, Inc. Condensed Balance Sheets

    (Unaudited)

    (In thousands, per share amounts)

     

     
         

     

     

    March 31,

     

    December 31,

    2020

    2019

    ASSETS

     

     

     

     

     

    Current assets:

     

     

     

     

     

    Cash and cash equivalents

     

    $

    85,606

    $

    51,214

    Short term investments

     

     

    76,810

     

    48,650

    Prepaid expenses and other current assets

     

     

    6,172

     

    6,192

    Total current assets

     

     

    168,588

     

    106,056

    Property and equipment, net

     

     

    624

     

    709

    Operating lease right-of-use assets

     

     

    637

     

    625

    Long term investments

     

     

    61,139

     

    16,763

    Other assets

     

     

    217

     

    217

    Total assets

     

    $

    231,205

    $

    124,370

     

     

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

    Accounts Payable

     

     

    4,954

     

    3,075

    Accrued expenses and other current liabilities

     

     

    8,153

     

    5,817

    Total current liabilities

     

     

    13,107

     

    8,892

    Long-term operating lease liability

     

     

    57

     

     

    -

    Total liabilities

     

     

    13,164

     

    8,892

    Total stockholders' equity

     

     

    218,041

     

    115,478

    Total liabilities and stockholders' equity

     

    $

    231,205

    $

    124,370

     

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  38. -- Presentation to be webcast on Cortexyme's website

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will participate in a fireside chat at the virtual BofA Securities 2020 Health Care Conference on Wednesday, May 13, 2020 at 1:00 p.m. EDT / 10:00 a.m. PDT.

    A live webcast of the fireside chat will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location…

    -- Presentation to be webcast on Cortexyme's website

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will participate in a fireside chat at the virtual BofA Securities 2020 Health Care Conference on Wednesday, May 13, 2020 at 1:00 p.m. EDT / 10:00 a.m. PDT.

    A live webcast of the fireside chat will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 90 days.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  39.  

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's (AD) and other degenerative diseases, today announced the publication of research further documenting the ability of the pathogen Porphyromonas gingivalis to invade neurons and trigger Alzheimer's-like neuropathology. The findings are to be published in the June 2020 issue of the Journal of Alzheimer's Disease [JAD 75(4)]; an early online version of the paper is available now so that the important findings can be rapidly disseminated to the research community.

    "P. gingivalis is best known for its role as a primary driver of chronic periodontal…

     

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's (AD) and other degenerative diseases, today announced the publication of research further documenting the ability of the pathogen Porphyromonas gingivalis to invade neurons and trigger Alzheimer's-like neuropathology. The findings are to be published in the June 2020 issue of the Journal of Alzheimer's Disease [JAD 75(4)]; an early online version of the paper is available now so that the important findings can be rapidly disseminated to the research community.

    "P. gingivalis is best known for its role as a primary driver of chronic periodontal disease, but researchers at Cortexyme and independent labs around the world have assembled a compelling body of data on its ability to infiltrate the brain and cause pathology characteristic of Alzheimer's disease," said Stephen Dominy, M.D., Cortexyme's chief scientific officer and co-founder, and co-author on the paper. "This latest research strengthens the connection between P. gingivalis and Alzheimer's, and underscores the importance both of studying the pathogen and targeting it with potential therapeutics, such as COR388."

    As a Gram-negative, asaccharolytic bacterium, P. gingivalis breaks down proteins for its primary source of energy by utilizing toxic virulence factor proteases known as gingipains. Previous research led by the team at Cortexyme has demonstrated the presence of gingipains in greater than 90% of post-mortem brains of patients with AD. Cortexyme and others have also shown in animal models that P. gingivalis results in brain infection and classic AD pathology, including neurodegeneration, inflammation, beta-amyloid and tau pathology.

    In the JAD paper available today, researchers demonstrate for the first time in vitro that P. gingivalis can invade and persist in mature human neurons expressing active gingipains, and that these P. gingivalis-infected neurons display signs of Alzheimer's-like neuropathology, including:

    • disruption of the cytoskeleton, which is critical for proper cellular function
    • degradation of tau protein and increased tau phosphorylation, a key regulator of axonal transport mechanisms
    • accumulation of intraneuronal autophagic vacuoles and multivesicular bodies, suggestive of disruption of normal lysosomal function
    • synapse loss, one of the earliest pathological events in the onset of AD

    "This research sheds new light on the ability of P. gingivalis to persistently infect and trigger Alzheimer's-like pathology in human neurons, providing additional evidence for the gingipain hypothesis of Alzheimer's causation that Cortexyme and our fellow researchers are aggressively pursuing," said Casey Lynch, chief executive officer, chair, and co-founder of Cortexyme. "We believe gingipain inhibition has the potential to be an important, differentiated mechanism of action against AD, and are committed to fully evaluating its potential in the GAIN Trial, the ongoing Phase 2/3 clinical study of COR388, our lead investigational medicine, in mild to moderate Alzheimer's disease."

    For more information on the research described above, view the early online version of the paper here. The final publication, "Alzheimer's Disease-Like Neurodegeneration in Porphyromonas gingivalis Infected Neurons with Persistent Expression of Active Gingipains" (DOI: 10.3233/JAD-200393), has been scheduled for Volume 75, issue 4 (June 2020) of the Journal of Alzheimer's Disease.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  40. -- McDowell joins with over two decades of biopharma legal and strategic experience at development and commercial stage companies

    Cortexyme, Inc. (NASDAQ:CRTX), a biopharmaceutical company developing treatments for Alzheimer's disease (AD) and other degenerative diseases, today announced Caryn McDowell, J.D. will join the company's executive leadership team as Chief Legal and Administrative Officer and Corporate Secretary, effective May 11, 2020. In this newly created role, Ms. McDowell will lead Cortexyme's legal, corporate governance, compliance, human resources, and administrative functions.

    "As we continue to advance our pipeline and execute on the GAIN Trial, the ongoing Phase 2/3 clinical study of our lead investigational medicine…

    -- McDowell joins with over two decades of biopharma legal and strategic experience at development and commercial stage companies

    Cortexyme, Inc. (NASDAQ:CRTX), a biopharmaceutical company developing treatments for Alzheimer's disease (AD) and other degenerative diseases, today announced Caryn McDowell, J.D. will join the company's executive leadership team as Chief Legal and Administrative Officer and Corporate Secretary, effective May 11, 2020. In this newly created role, Ms. McDowell will lead Cortexyme's legal, corporate governance, compliance, human resources, and administrative functions.

    "As we continue to advance our pipeline and execute on the GAIN Trial, the ongoing Phase 2/3 clinical study of our lead investigational medicine, COR388, for mild to moderate AD, we are thrilled to add Caryn McDowell's expertise to the Cortexyme leadership team," said Casey Lynch, chief executive officer, chair, and co-founder of Cortexyme. "Caryn brings with her an impressive track record and a wealth of experience in biopharma corporate strategy, legal affairs and corporate governance. She will be a strong addition to the team as we continue to advance our foundational science."

    Ms. McDowell has over two decades of leadership in biopharmaceutical organizations, including C-level experience both at development and commercial stage public companies in multiple therapeutic areas. Her expertise includes corporate governance and legal support for commercial launch, compliance, and business development activities; she has played key roles in leading the structuring, negotiation and execution of global collaboration and licensing deals, as well as providing legal support for two sell side acquisitions worth approximately $18B to shareholders. Ms. McDowell joins Cortexyme from Revance, Inc., where, as Senior Vice President, General Counsel and Corporate Secretary, she drove legal strategy, compliance, privacy, and corporate governance activities. Previously, she served as General Counsel and Chief Compliance Officer at Cytokinetics, Inc. and as Vice President, Deputy General Counsel at InterMune, Inc., where she was instrumental to the approval and launch of Esbriet® (pirfenidone) and the company's acquisition by Roche. Earlier in her life sciences career, Ms. McDowell served in roles of increasing responsibility at Onyx Pharmaceuticals, Affymax, Genentech, and Millennium Pharmaceuticals. Prior to her career in the biopharmaceutical industry, she served in federal and state government roles at the Office of the Inspector General, U.S. Department of Health and Human Services and at the Medicaid Fraud Control Unit of the Commonwealth of Massachusetts, respectively. She obtained her J.D. from the Boston University School of Law and her B.A. from the University of Michigan.

    "With a successful initial public offering, a Phase 2/3 clinical trial well underway, and multiple research publications over the past year, it's an exciting time to join the Cortexyme team," said Ms. McDowell. "I'm thrilled to work with this extraordinary group of experts working to better understand and develop therapies against degenerative diseases that present serious unmet medical needs. I look forward to contributing to the company's progress toward potential new treatments for Alzheimer's and other related conditions."

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  41. -- Presentation to be webcast on Cortexyme's website --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will participate in a fireside chat at the virtual LifeSci Capital Alpha Series Conference on Thursday, April 9, 2020 at 1:00 p.m. EDT / 10:00 a.m. PDT.

    A live webcast of the fireside chat will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location…

    -- Presentation to be webcast on Cortexyme's website --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will participate in a fireside chat at the virtual LifeSci Capital Alpha Series Conference on Thursday, April 9, 2020 at 1:00 p.m. EDT / 10:00 a.m. PDT.

    A live webcast of the fireside chat will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 90 days.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  42. -- New results demonstrate P. gingivalis' ability to infect neurons and cause characteristic Alzheimer's pathology

    -- Cortexyme's lead compound, COR388, targets gingipains produced by P. gingivalis and is currently under investigation in the Phase 2/3 GAIN Trial

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer's and other degenerative diseases, today announced new data supporting the ability of the pathogen Porphyromonas gingivalis to invade brain cells and trigger characteristic Alzheimer's pathology including synaptic loss, ultrastructural changes, and inflammation. The data is being presented this week as part of the Advances in Alzheimer's…

    -- New results demonstrate P. gingivalis' ability to infect neurons and cause characteristic Alzheimer's pathology

    -- Cortexyme's lead compound, COR388, targets gingipains produced by P. gingivalis and is currently under investigation in the Phase 2/3 GAIN Trial

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer's and other degenerative diseases, today announced new data supporting the ability of the pathogen Porphyromonas gingivalis to invade brain cells and trigger characteristic Alzheimer's pathology including synaptic loss, ultrastructural changes, and inflammation. The data is being presented this week as part of the Advances in Alzheimer's and Parkinson's Disease (AAT-AD/PD) Focus Meeting 2020, which was converted to a virtual meeting due to the COVID-19 pandemic and is being held April 2-5.

    "Over the past several years, Cortexyme and scientists around the world have been publishing evidence on the role of P. gingivalis in Alzheimer's disease. Our goal is to continue to understand the unique ability of this pathogen to induce cellular damage related to Alzheimer's disease, and how we can best target it to treat the disease," said Stephen Dominy, M.D., Cortexyme's chief scientific officer, co-founder, and a co-author of today's presentation. "With this latest evidence of P. gingivalis infection of brain cells in vitro, we are seeing verification that the pathogen is able to infiltrate neurons and catalyze the corresponding characteristic pathology, reinforcing the fact that this is an essential upstream target for Alzheimer's treatment."

    P. gingivalis is best known in published literature as the keystone pathogen in the development of periodontal disease. P. gingivalis produces toxic virulence factors known as gingipains, and previous research from Cortexyme has demonstrated the presence of gingipains in greater than 90% of post-mortem brains of Alzheimer's disease (AD) patients. In addition, Cortexyme and others have shown in animal models that oral infection with P. gingivalis results in brain infection and classic AD pathology, which can be blocked with gingipain inhibitors.

    The research presented at AAT-AD/PD investigates changes induced by P. gingivalis at the cellular level. The data shows the expression of P. gingivalis and gingipains inside of co-cultured brain cells after infection, including neurons, astrocytes, and microglial cells and the display of cellular pathology consistent with AD. This outcome reinforces the findings of previous research on the impact of P. gingivalis in the in vivo biological environment of the central nervous system. It also provides support for the premise of Cortexyme's ongoing GAIN Trial studying the efficacy of COR388, a gingipain inhibitor, in improving downstream pathology of the bacterium and alleviating AD symptoms.

    "The Phase 2/3 GAIN Trial of COR388 is supported by years of research that the neurodegeneration associated with Alzheimer's may be caused by a bacterium and the gingipains it releases within the central nervous system," said Casey Lynch, Cortexyme's CEO, co-founder and chair. "The data presented today adds to the preclinical and clinical evidence supporting our approach to this devastating disease. We are committed to optimizing the therapeutic potential of COR388 and the potential benefits this approach could have for the millions of people affected by Alzheimer's disease."

    To view the poster, please visit the Presentations page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com).

    About the Research Presented at AAT-AD/PD

    In the study, infected neurons displayed AD-like neuropathology, including accumulation of autophagic vacuoles and multivesicular bodies, the same structures found in dystrophic, or dysfunctional, neurites in AD brains. The neuron cultures also demonstrated cell loss, tau phosphorylation, neurofilament changes, and a significant loss of synapse density after infection with P. gingivalis, mirroring the changes seen in AD brains.

    The neuron-astrocyte-microglia co-culture model also allowed researchers to observe that, in infected cultures, P. gingivalis was taken up by microglia, where it caused increases in Il-6, Il-8, TNFα and Il-1β cytokines, notable markers of inflammation, signaling an inflammatory immune response similar to that seen in the Alzheimer's-affected brain. At the same time, researchers saw reduced levels of Trem-2, a microglia-secreted protein, and ApoE, a known gingipain substrate, in these infected cultures.

    The results from this in vitro model reinforce the results of previous in vivo studies of P. gingivalis, demonstrating that the pathogen is able to infiltrate the central nervous system and provide support for the role of P. gingivalis in inducing AD pathology.

    About the GAIN Trial

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial is evaluating the efficacy, safety, and tolerability of COR388, Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate Alzheimer's disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. The GAIN Trial has been ongoing since the second quarter of 2019, with top-line results expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  43. Following initial public offering and private placement, Cortexyme is well capitalized and focused on high quality execution of the Phase 2/3 GAIN Trial

    Interim analysis for the GAIN Trial on track to be completed before year-end 2020, with top-line results from study's final analysis expected in Q4 2021

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced financial results for the fourth quarter and full year 2019 and provided an update on its business.

    "Throughout 2019, Cortexyme made strong progress toward our goal of stemming the…

    Following initial public offering and private placement, Cortexyme is well capitalized and focused on high quality execution of the Phase 2/3 GAIN Trial

    Interim analysis for the GAIN Trial on track to be completed before year-end 2020, with top-line results from study's final analysis expected in Q4 2021

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced financial results for the fourth quarter and full year 2019 and provided an update on its business.

    "Throughout 2019, Cortexyme made strong progress toward our goal of stemming the tide of Alzheimer's disease by halting its progression," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "As we move through 2020, we are highly focused on the execution of the GAIN Trial, which has enrolled more than 300 patients and for which top-line results are anticipated in Q4 2021. At the same time, we continue to research and publish new data that sheds light on the gingipain hypothesis for Alzheimer's causation and the potential clinical utility of COR388, our lead investigational gingipain inhibitor. With a strong balance sheet and a talented, growing team, we're committed to delivering for all of our stakeholders, especially the neurodegenerative disease patients and caregivers that have been vocal in their calls for new therapeutic options."

    Recent Business Updates and Upcoming Milestones

    GAIN Trial Updates

    • Earlier this month, the company provided an update on its progress enrolling patients in the GAIN Trial, its Phase 2/3 clinical trial of COR388 versus placebo in patients with mild to moderate Alzheimer's disease. The study has now enrolled more than 300 patients and is expected to complete enrollment in Q4 2020. In addition, the GAIN Trial includes a periodontal sub-study in which sites with a dental sub-investigator are assessing efficacy endpoints against periodontal disease, including pocket depth, at baseline, six months, and one year. Periodontal disease is not a criterion for enrollment in the GAIN Trial or the sub-study, and yet more than 90% of patients enrolled in the sub-study to date had moderate to severe periodontal disease at baseline.
    • In February 2020, the company announced that, following discussion with the FDA, it intends to conduct an interim analysis for overwhelming efficacy in the GAIN Trial. The analysis, currently planned before year-end 2020, will be conducted after approximately 100 patients in each of the GAIN Trial's three arms complete six months of treatment. Cortexyme continues to expect top-line results from the GAIN Trial's final analysis in the fourth quarter of 2021. The co-primary endpoints for both analyses will be change from baseline in ADAS-Cog11 and CDR-SB versus placebo.
    • In January 2020, the company announced initiation of an open-label extension (OLE) for the GAIN Trial in the United States. Upon completing the 48-week placebo-controlled period of the GAIN Trial, participants in the GAIN Trial's placebo and active arms may be eligible to enroll in the OLE study, where they will receive 80 mg of COR388 twice daily for an additional 48 weeks. The first patient in the OLE is expected in Q2 2020.

    Advancing a New Understanding of Alzheimer's Causation and Treatment

    As COR388 moves through late-stage clinical development, Cortexyme and external collaborators continue to present and publish new research to advance our understanding of the gingipain hypothesis for Alzheimer's pathogenesis and the clinical potential of COR388.

    This spring, Cortexyme's publication and presentation plans include three data sets at meetings that have either been canceled or become virtual events as a result of the evolving COVID-19 situation. Cortexyme expects to be able to share these presentations on the News & Events > Presentations page of its investor website, ir.cortexyme.com, as they are available. These presentations are:

    • An abstract and roundtable at the International Association for Dental Research 2020 General Session. This conference, which would've been held March 18-21, 2020 in Washington, D.C., has been canceled, but conference organizers expect to publish accepted abstracts online at a later date.
    • An abstract on COR388's potential to decrease fragmentation of ApoE in the Alzheimer's disease central nervous system at the American Chemical Society (ACS) National Meeting and Expo. This meeting, originally planned for March 22-26 in Philadelphia, PA, has similarly been canceled, but the ACS anticipates making abstracts available as well.
    • An abstract at the AAT-AD/PD Advances in Alzheimer's and Parkinson's Therapies meeting demonstrating that in vivo infection of primary neurons by P. gingivalis results in an Alzheimer's-like phenotype. This meeting was originally scheduled for April 2-5, 2020, but will now be held virtually.

    Recent scientific presentations and publications from the fourth quarter of 2019 and early 2020 are detailed below:

    • In January 2020, Cortexyme scientists and collaborators published new data in Pharmacology Research and Perspectives revealing further detail about the pharmacodynamics and utility of COR388. Researchers reported that COR388 demonstrates dose-dependent gingipain target engagement in a naturally occurring P. gulae infection, including in difficult to reach bacterial biofilm niches. P. gulae is the only other bacterial species known to secrete gingipains. COR388 drug was efficacious in improving downstream pathology of the infection, namely gingival pocket depth, a symptom of periodontal disease which affects approximately 65 million Americans. In addition, gingipain antigens and P. gulae DNA were found in the brains of aged dogs, indicating that P. gulae can also migrate from the oral cavity to the brain in a manner similar to that seen for P. gingivalis in Alzheimer's patients.
    • In December 2019, COR388 was the subject of a presentation at the 12th Clinical Trials in Alzheimer's (CTAD) Conference centered on two findings related to the growing interest in ApoE fragmentation as a potential pathogenic mechanism in sporadic Alzheimer's disease.
      • Cells infected with P. gingivalis exhibited gingipain-dependent ApoE cleavage activity that generated ApoE fragments similar to what was seen in the brains and cerebrospinal fluid (CSF) of patients with Alzheimer's disease. Furthermore, P. gingivalis' gingipains cleaved ApoE4 more readily than ApoE3. Finally, in the infected cells, COR388 alone was sufficient to block ApoE fragmentation.
      • In a Phase 1b trial, COR388 reduced ApoE fragments in human CSF. Cortexyme's Phase 1 clinical development program for COR388 included cohorts of healthy volunteers and subjects with Alzheimer's disease. In addition to assessing safety and initial clinical activity, investigators also assessed the level of ApoE fragmentation in the CSF of nine subjects with Alzheimer's disease. Six subjects received 50mg of COR388 twice daily while three subjects received placebo. After 28 days, a statistically significant decrease in ApoE fragments (both ApoE4 and ApoE3) was observed in subjects treated with COR388 versus those treated with placebo. Cortexyme believes this is a downstream indication of target engagement of gingipains in the brain by COR388.

    Corporate Updates

    • In addition to other ongoing pipeline screening activities, Cortexyme is now screening its proprietary library of small molecules for a possible treatment for coronaviruses. The virus responsible for COVID-19, SARS-CoV2, expresses a cysteine protease known as Mpro or 3CLpro that is required for replication, and this cysteine protease has been previously validated as a therapeutic target for coronaviruses. Molecular modeling indicates that Cortexyme's library may potentially include inhibitors to this protease, and the company is screening these compounds for potential activity in collaboration with academic and government researchers.

    Financial Results for the Quarter Ended December 31, 2019

    Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and short and long-term marketable securities as of December 31, 2019, were $116.6 million. In February 2020, Cortexyme completed a successful private placement offering, raising approximately $117.6 million after expenses. Cortexyme expects current cash, cash equivalents and marketable securities plus the net proceeds of the private placement in February 2020 will be sufficient to fund its operating and capital expenditures through 2021 and the completion of the GAIN Trial.

    Research and Development (R&D) Expenses: For the quarter ended December 31, 2019, R&D expenses were $10.0 million. The expense was primarily due to costs related to the research and development of COR388 and the GAIN Trial.

    General and Administrative (G&A) Expenses: For the quarter ended December 31, 2019, G&A expenses were $2.9 million. The expense was primarily attributable to personnel-related expenses, insurance, professional and legal fees, and stock-based compensation.

    Net Loss: For the quarter ended December 31, 2019, net loss was $12.4 million, or a loss of $0.46 per basic share.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, cash forecasts, the timing and success of our clinical trials and related data, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our product candidate or library of compounds. 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 we expect. 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 our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 16, 2020, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

    Cortexyme, Inc. Condensed Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)

     

     

    Three Months Ended

    December 31, 2019

     

     

    Year Ended

    December 31,

    2019

    Operating expenses:

     

     

     

     

     

    Research and development

    $

    10,027

     

    $

    30,214

    General and administrative

     

    2,922

     

     

    8,954

    Total operating expenses

     

    12,949

     

     

    39,168

    Loss from operations

     

    (12,949)

     

     

    (39,168)

    Interest income

     

    570

     

     

    2,188

    Interest expense

     

     

     

    Change in fair value of derivative liability

     

     

     

    Net loss

     

    (12,379)

     

     

    (36,980)

    Other comprehensive income/ (loss):

     

     

     

     

     

    Unrealized gain / (loss) on available for sales securities

     

    (36)

     

     

    109

    Total comprehensive income/(loss)

    $

    (12,415)

     

    $

    (36,871)

    Net loss per share - basic and diluted

     

    (0.46)

     

     

    (1.94)

    Cortexyme, Inc. Condensed Balance Sheets

    (Unaudited)

    (In thousands, per share amounts)

     

    December 31,

     

    2019

    2018

    ASSETS

     

     

     

     

    Current assets:

     

     

     

     

    Cash and cash equivalents

    $

    51,214

    $

    24,872

    Short term investments

     

    48,650

     

    46,844

    Prepaid expenses and other current assets

     

    6,192

     

    868

    Total current assets

     

    106,056

     

    72,584

    Property and equipment, net

     

    709

     

    283

    Operating lease right-of-use assets

     

    625

     

    Long term investments

     

    16,763

     

    Other assets

     

    217

     

    10

    Total assets

    $

    124,370

    $

    72,877

     

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY / (DEFICIT)

     

     

     

     

    Current liabilities:

     

     

     

     

    Accounts Payable

     

    3,075

     

    495

    Accrued expenses and other current liabilities

     

    5,817

     

    962

    Total current liabilities

     

    8,892

     

    1,457

    Total liabilities

     

    8,892

     

    1,457

    Redeemable convertible preferred stock

     

     

    104,046

    Total stockholders' equity / (deficit)

     

    115,478

     

    (32,626)

    Total liabilities and stockholders' equity / (deficit)

    $

    124,370

    $

    72,877

     

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  44. - Sub-study shows greater than 90% of enrolled patients have moderate to severe periodontal disease, indicating relevance to mechanism of action against P. gingivalis

    - Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020

    Cortexyme, Inc. (NASDAQ:CRTX) today announced that enrollment in its GAIN Trial for Alzheimer's disease has reached 300 patients toward the study's previously announced enrollment target of 570 subjects. GAIN is a randomized, double-blind, placebo-controlled Phase 2/3 trial of COR388, Cortexyme's lead investigational medicine, in patients with mild to moderate Alzheimer's disease. GAIN's protocol includes an interim analysis for overwhelming efficacy on its co-primary cognitive and functional…

    - Sub-study shows greater than 90% of enrolled patients have moderate to severe periodontal disease, indicating relevance to mechanism of action against P. gingivalis

    - Interim analysis of the Phase 2/3 GAIN Trial expected to occur before year-end 2020

    Cortexyme, Inc. (NASDAQ:CRTX) today announced that enrollment in its GAIN Trial for Alzheimer's disease has reached 300 patients toward the study's previously announced enrollment target of 570 subjects. GAIN is a randomized, double-blind, placebo-controlled Phase 2/3 trial of COR388, Cortexyme's lead investigational medicine, in patients with mild to moderate Alzheimer's disease. GAIN's protocol includes an interim analysis for overwhelming efficacy on its co-primary cognitive and functional endpoints after 300 patients reach six months of treatment; this interim analysis is expected to occur before year-end 2020. Top-line results from the GAIN Trial's final analysis, to be performed once all study subjects complete one year of treatment, are expected in Q4 2021.

    The target of COR388, gingipains produced by P. gingivalis, have been discovered in the brain of Alzheimer's patients and shown to produce Alzheimer's pathology in infected animals. P. gingivalis is best known as a keystone bacterium in the development of periodontal disease. The GAIN Trial includes a periodontal sub-study, in which approximately 40% of GAIN Trial participants are also assessed for endpoints of efficacy in periodontal disease. The GAIN Trial and the sub-study did not specify inclusion criteria related to periodontal status, and yet greater than 90% of patients enrolled had moderate to severe periodontal disease at baseline.

    "We are pleased with the high level of engagement of our clinical sites and study participants, as well as with the operational execution of our team," said Michael Detke, M.D., Ph.D., Cortexyme's chief medical officer. "The pace of enrollment in the GAIN Trial reflects the need for new therapeutic options for patients with Alzheimer's disease and the interest in our upstream mechanism of action. We believe we are enrolling the right patients at the right time and we look forward to presenting study results when available."

    For more information about the GAIN Trial, visit www.GAINtrial.com.

    About the GAIN Trial

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of COR388, Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate Alzheimer's disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. The GAIN Trial has been enrolling since the second quarter of 2019, with top-line results from the study's final analysis expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.

    About Cortexyme

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Examples of forward-looking statements include, among others, statements we make regarding the timing and success of our clinical trials and related data, the timing of announcements and updates relating to our clinical trials and related data, the timing of and our ability to enroll patients into our clinical trials, and the potential therapeutic benefits, safety and efficacy of our 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 we expect. 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 the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019, Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2019 and other reports as filed with the SEC. Forward-looking statements contained in this press 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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  45. - Interim analysis in the Phase 2/3 GAIN Trial expected to occur in Q4 2020

    Cortexyme, Inc. (NASDAQ:CRTX) today provided an update on its clinical development plans for COR388, the company's lead investigational medicine in development for mild to moderate Alzheimer's disease (AD). The company conducted a Type C meeting with the FDA gathering agreement and feedback on development plans through NDA, including the Phase 2/3 GAIN Trial statistical analysis plan, metabolite characterization, nonclinical studies, population pharmacokinetics, and drug-drug interaction studies.

    Following discussion with the FDA, the company intends to conduct an interim analysis for overwhelming efficacy in the ongoing GAIN Trial. The analysis, currently planned…

    - Interim analysis in the Phase 2/3 GAIN Trial expected to occur in Q4 2020

    Cortexyme, Inc. (NASDAQ:CRTX) today provided an update on its clinical development plans for COR388, the company's lead investigational medicine in development for mild to moderate Alzheimer's disease (AD). The company conducted a Type C meeting with the FDA gathering agreement and feedback on development plans through NDA, including the Phase 2/3 GAIN Trial statistical analysis plan, metabolite characterization, nonclinical studies, population pharmacokinetics, and drug-drug interaction studies.

    Following discussion with the FDA, the company intends to conduct an interim analysis for overwhelming efficacy in the ongoing GAIN Trial. The analysis, currently planned before year-end 2020, will be conducted after approximately 100 patients in each of the GAIN Trial's three arms complete six months of treatment. The co-primary endpoints for the interim analysis will be change from baseline in ADAS-Cog11 and CDR-SB versus placebo.

    "Cortexyme is pleased with the collaborative and productive dialogue with the FDA's Division of Neurology Products," said Michael Detke, M.D., Ph.D., Cortexyme's Chief Medical Officer. "With COR388, we are pursuing a differentiated mechanism of action that targets the gingipains, or toxic proteases, released by the bacterium P. gingivalis, which we believe infects the brain and causes Alzheimer's pathology. The body of preclinical and clinical evidence generated to date suggests COR388 could have a favorable impact on inflammation, neurodegeneration, bacterial load of P. gingivalis, and cognitive testing."

    Cortexyme continues to expect the GAIN Trial's final analysis in the fourth quarter of 2021. The co-primary endpoints will be change from baseline in ADAS-Cog11 and CDR-SB versus placebo. The GAIN Trial is 90% powered to meet statistical significance on both primary endpoints with the planned 570 randomized patients. Additional exploratory endpoints include other cognitive, functional and clinical outcomes, safety and tolerability measures, and biomarkers relating to P. gingivalis infection, as well as traditional AD biomarkers and brain volume measurements. The study is stratified for both AD severity (mild versus moderate) and ApoE4 carriers versus non-carriers.

    For more information about the GAIN Trial, visit www.GAINtrial.com.

    About the GAIN Trial

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of COR388, Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate Alzheimer's disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease. The GAIN Trial has been enrolling since the second quarter of 2019, with top-line results from the study's final analysis expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.

    About Cortexyme

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Forward-looking statements are based on Cortexyme'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. 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 the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019 and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2019. Forward-looking statements contained in this press 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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  46. Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer's and other degenerative diseases, today announced that it has closed its private placement offering. The Company issued 2,500,000 shares of common stock for a purchase price of $50.00 per share, resulting in gross proceeds to the Company of $125 million, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the private placement primarily to advance clinical development, as well as for general corporate purposes.

    BofA Securities and Jefferies served as placement agents for the private placement and Canaccord Genuity LLC, JMP Group…

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer's and other degenerative diseases, today announced that it has closed its private placement offering. The Company issued 2,500,000 shares of common stock for a purchase price of $50.00 per share, resulting in gross proceeds to the Company of $125 million, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the private placement primarily to advance clinical development, as well as for general corporate purposes.

    BofA Securities and Jefferies served as placement agents for the private placement and Canaccord Genuity LLC, JMP Group LLC and LifeSci Capital LLC served as financial advisors.

    The common stock sold in the private placement has not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the common stock, nor shall there be any sale of the common stock in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the common stock under the resale registration statement will only be by means of a prospectus.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's disease. More information about the trial can be found at www.GAINtrial.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 use of proceeds and Cortexyme's plans and strategies for its business. Forward-looking statements are based on Cortexyme'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. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties relating to clinical trials, changes in regulatory requirements or decisions of regulatory authorities, as well as other risks and uncertainties that are described in the section titled "Risk Factors" in the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019. Forward-looking statements contained in this press release are made as of this date and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Cortexyme undertakes no duty to update such forward-looking statements except as required under applicable law.

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  47. Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer's and other degenerative diseases, today announced that it has entered into stock purchase agreements with a group of institutional investors and an entity affiliated with a member of the Company's Board of Directors in connection with a private placement of its common stock. The transaction is expected to result in gross proceeds to the Company of $125 million, before deducting placement agent fees and other offering expenses. The Company plans to use the net proceeds from the private placement primarily to advance clinical development, as well as for general corporate purposes.

    The Company…

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer's and other degenerative diseases, today announced that it has entered into stock purchase agreements with a group of institutional investors and an entity affiliated with a member of the Company's Board of Directors in connection with a private placement of its common stock. The transaction is expected to result in gross proceeds to the Company of $125 million, before deducting placement agent fees and other offering expenses. The Company plans to use the net proceeds from the private placement primarily to advance clinical development, as well as for general corporate purposes.

    The Company will issue 2,500,000 shares of common stock for a purchase price of $50.00 per share, which was based upon the volume weighted average price of the Company's common stock since January 1, 2020, and represents a 9.6% premium to the closing price of the Company's common stock on February 5, 2020.

    The closing of the private placement is subject to certain conditions and is expected to occur on Monday, February 10, 2020.

    BofA Securities and Jefferies served as placement agents for the private placement.

    The common stock being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the common stock, nor shall there be any sale of the common stock in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the common stock under the resale registration statement will only be by means of a prospectus.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's disease. More information about the trial can be found at www.GAINtrial.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 use of proceeds and the completion and timing of the closing of the private placement. Forward-looking statements are based on Cortexyme'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. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties related the satisfaction of customary closing conditions related to, and the completion of, the private placement and other risks and uncertainties that are described in the section titled "Risk Factors" in the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019. Forward-looking statements contained in this press 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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  48. -- Data in aged dogs shows oral dosing of COR388 results in target engagement, reduction of bacterial load and beneficial effects on downstream pathology

    -- Lysine-gingipains from P. gulae were found in the neurons of aged dogs, paralleling the discovery of gingipains from P. gingivalis in Alzheimer's brains

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer's and other degenerative diseases, today announced the publication of new data in Pharmacology Research and Perspectives revealing further detail about the pharmacodynamics and utility of the company's lead investigational medicine, COR388. The data provides additional evidence on the…

    -- Data in aged dogs shows oral dosing of COR388 results in target engagement, reduction of bacterial load and beneficial effects on downstream pathology

    -- Lysine-gingipains from P. gulae were found in the neurons of aged dogs, paralleling the discovery of gingipains from P. gingivalis in Alzheimer's brains

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat Alzheimer's and other degenerative diseases, today announced the publication of new data in Pharmacology Research and Perspectives revealing further detail about the pharmacodynamics and utility of the company's lead investigational medicine, COR388. The data provides additional evidence on the ability of COR388 to engage its target, the toxic proteases, or gingipains, released by the bacterium P. gingivalis and the closely related species P. gulae, resulting in beneficial effects on bacterial load and symptoms.

    Cortexyme's foundational research previously identified gingipains in more than 90% of Alzheimer's disease brains studied. P. gingivalis is best known for its role as a keystone bacterium in the development of periodontal disease, and has recently been shown in animal studies to infiltrate the brain after oral infection and trigger pathology of Alzheimer's including neurodegeneration, inflammation, beta-amyloid and tau pathology.

    In this publication, researchers report that COR388 demonstrates dose-dependent gingipain target engagement in a naturally occurring P. gulae infection, including in difficult to reach bacterial biofilm niches. P. gulae is the only other bacterial species known to secrete gingipains. COR388 was efficacious in improving downstream pathology of the infection, namely gingival pocket depth, a symptom of periodontal disease which affects approximately 65 million Americans. In addition, gingipain antigens and P. gulae DNA were found in the brains of aged dogs, indicating that P. gulae can also migrate from the oral cavity to the brain in a manner similar to that seen for P. gingivalis in Alzheimer's patients.

    "Chronic periodontal disease is common in dogs and, as they age, these animals can experience cognitive decline in much the same way humans do," said Stephen Dominy, M.D., Cortexyme's Chief Scientific Officer, Co-founder and co-author on the paper. "This research shows that natural P. gulae infection in canines provides an important model for the study of P. gingivalis infection in humans and emphasizes the ability of this infection to promote degenerative disease in different organs. It also underscores that the anti-gingipain activity of COR388 is effective at reducing bacterial load and has beneficial effects on downstream disease."

    "To change the trajectory of the Alzheimer's epidemic, we need to move upstream and target the root causes of pathology and cell death," said Casey Lynch, Cortexyme's Chief Executive Officer, Co-founder, and Chair. "This paper adds to the growing body of evidence supporting the gingipain hypothesis, the efficacy of COR388 in multiple indications, and the design of the GAIN Trial."

    View the Pharmacology Research & Perspectives paper, "Treatment of Porphyromonas gulae infection and downstream pathology in the aged dog by lysine-gingipain inhibitor COR388," here: https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/prp2.562

    About the GAIN Trial

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating the efficacy, safety, and tolerability of COR388, Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate Alzheimer's disease. The GAIN Trial also includes a sub-study measuring the efficacy of COR388 on symptoms of periodontal disease including gingival pocket depth. The GAIN Trial has been ongoing since the second quarter of 2019, with top-line results expected in the fourth quarter of 2021. For more information on the trial, visit www.gaintrial.com.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Forward-looking statements are based on Cortexyme'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. 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 the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019 and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2019. Forward-looking statements contained in this press 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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  49.  – Open-label extension study will provide COR388 to patients for an additional 48 weeks

    – GAIN Trial to continue as planned following pre-specified DMC safety data review

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced it is initiating an open-label extension study in the United States for its Phase 2/3 GAIN Trial of COR388 in subjects with mild to moderate Alzheimer's disease (AD). Additionally, the GAIN Trial Data Monitoring Committee recently completed its first planned safety review and recommended continuation of the study as planned…

     – Open-label extension study will provide COR388 to patients for an additional 48 weeks

    – GAIN Trial to continue as planned following pre-specified DMC safety data review

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced it is initiating an open-label extension study in the United States for its Phase 2/3 GAIN Trial of COR388 in subjects with mild to moderate Alzheimer's disease (AD). Additionally, the GAIN Trial Data Monitoring Committee recently completed its first planned safety review and recommended continuation of the study as planned.

    "We are pleased to begin an open-label extension study of COR388 and, in doing so, facilitate the opportunity for subjects in the GAIN Trial to continue to participate in research directed at bringing forward a new potential therapeutic option for Alzheimer's disease," said Michael Detke, M.D., Ph.D., Cortexyme's Chief Medical Officer. "We anticipate that the open-label extension of the GAIN Trial will supply valuable data on the safety and clinical activity of COR388 in a larger population of patients, for a longer period of time, and will allow subjects randomized to placebo in the GAIN Trial the opportunity to experience treatment with COR388."

    The GAIN (GingipAIN Inhibitor for Treatment of Alzheimer's Disease) Trial is based on a growing body of scientific evidence showing that the pathogen Porphyromonas gingivalis, or P. gingivalis, most commonly associated with chronic periodontal disease, and its secreted proteases called gingipains can infiltrate the brain and cause AD. The randomized, double-blind, placebo-controlled trial is evaluating the efficacy, safety, and tolerability of COR388, Cortexyme's investigational gingipain inhibitor, in patients with mild to moderate AD. The GAIN Trial has been ongoing since the second quarter of 2019, with top-line results expected in the fourth quarter of 2021.

    Upon completing the 48-week placebo-controlled period of the GAIN Trial, participants in the United States may be eligible to enroll in the open-label extension study, where they will receive COR388 for an additional 48 weeks. During the open-label extension study, safety will be monitored and additional assessments including cognitive tests will be performed. In Phase 1a/1b testing, Cortexyme previously reported favorable safety, tolerability and pharmacokinetics as well as positive biomarker results demonstrating positive trends in patients with AD.

    For more information on the GAIN Trial, visit www.gaintrial.com.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Forward-looking statements are based on Cortexyme'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. 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 the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019 and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2019. Forward-looking statements contained in this press 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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  50. – Corporate presentation by CEO Casey Lynch will be webcast live

    – Lynch will also participate in a roundtable session earlier in the day

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder will present at the 3rd Annual Neuroscience Innovation Forum on Sunday, January 12, 2020 at 3:45 p.m. PST / 6:45 p.m. EST. The Forum will take place on the eve of the J.P. Morgan Healthcare Conference in downtown San Francisco.

    A live webcast of the corporate presentation will be accessible…

    – Corporate presentation by CEO Casey Lynch will be webcast live

    – Lynch will also participate in a roundtable session earlier in the day

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder will present at the 3rd Annual Neuroscience Innovation Forum on Sunday, January 12, 2020 at 3:45 p.m. PST / 6:45 p.m. EST. The Forum will take place on the eve of the J.P. Morgan Healthcare Conference in downtown San Francisco.

    A live webcast of the corporate presentation will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 90 days.

    In addition to the corporate presentation, Ms. Lynch will participate in a plenary session at the Forum, "Advances in Alzheimer's & Other Cognitive Disorders," earlier in the day. This event will feature brief presentations from a panel of neuroscience drug development experts followed by a roundtable discussion moderated by co-chairs Christian Jung, Partner at the Dementia Discovery Fund, and Sumant Kulkarni, Managing Director of Biotechnology Equity Research at Canaccord Genuity LLC.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Forward-looking statements are based on Cortexyme'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. 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 the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019 and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2019. Forward-looking statements contained in this press 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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  51. – In a Phase 1b trial, COR388 reduced levels of fragmented ApoE protein in cerebrospinal fluid of subjects with Alzheimer's –

    –The drug's target, the gingipains from P. gingivalis bacteria, preferentially attack the protein encoded by an APOE genetic variant associated with increased risk for Alzheimer's –

    Cortexyme, Inc. (NASDAQ:CRTX) today announced the presentation of new data supporting the on-target activity of COR388, its lead investigational medicine, and linking the "gingipain hypothesis" for Alzheimer's disease (AD) to the significance of the APOE gene as a major risk factor for the disease. Michael Detke, M.D., Ph.D., the company's chief medical officer, detailed the results in an oral presentation (abstract #OC28) at the 2019 Clinical…

    – In a Phase 1b trial, COR388 reduced levels of fragmented ApoE protein in cerebrospinal fluid of subjects with Alzheimer's –

    –The drug's target, the gingipains from P. gingivalis bacteria, preferentially attack the protein encoded by an APOE genetic variant associated with increased risk for Alzheimer's –

    Cortexyme, Inc. (NASDAQ:CRTX) today announced the presentation of new data supporting the on-target activity of COR388, its lead investigational medicine, and linking the "gingipain hypothesis" for Alzheimer's disease (AD) to the significance of the APOE gene as a major risk factor for the disease. Michael Detke, M.D., Ph.D., the company's chief medical officer, detailed the results in an oral presentation (abstract #OC28) at the 2019 Clinical Trials in Alzheimer's Disease (CTAD) meeting, which is being held December 4-7, 2019 in San Diego.

    Today's CTAD presentation is centered on two findings related to the growing interest in ApoE fragmentation as a potential pathogenic mechanism for sporadic Alzheimer's disease:

    • Gingipains from P. gingivalis cleave ApoE proteins and have a preference for cleaving ApoE4; and COR388, a gingipain inhibitor, prevents this. In in vitro experiments, cells infected with P. gingivalis exhibited gingipain-dependent ApoE cleavage activity that generated ApoE fragments similar to what was seen in the brains and cerebrospinal fluid (CSF) of patients with Alzheimer's disease. In contrast, uninfected cells had no significant ApoE protein-cleaving activity. Furthermore, P. gingivalis gingipains cleaved ApoE4 more readily than ApoE3. Finally, in the infected cells, COR388 alone was sufficient to block ApoE fragmentation.
    • In a Phase 1b trial, COR388 reduced ApoE fragments in CSF. Cortexyme's Phase 1 clinical development program for COR388 included cohorts of healthy volunteers and subjects with Alzheimer's disease. In addition to assessing safety and initial clinical activity, investigators also assessed the level of ApoE fragmentation in the CSF of nine subjects with Alzheimer's disease. Six subjects received 50mg of COR388 twice daily while three subjects received placebo. After 28 days, a statistically significant decrease in ApoE fragments (both ApoE4 and ApoE3) was observed in subjects treated with COR388 versus those treated with placebo.

    "The APOE gene is known to significantly impact Alzheimer's risk, with the APOE2 variant playing a protective role and APOE4 associated with a much higher risk for developing the disease," said Dr. Detke. "The data presented today further illuminate the potential relationship between APOE-driven genetic risk and the presence of gingipains from P. gingivalis in the brain, which we have found in 90-100% of Alzheimer's patients, depending on the method of measurement."

    "Recent research has shown that the APOE gene may play a larger role than previously believed in Alzheimer's disease development, suggesting that a solid understanding of APOE is important to a comprehensive hypothesis of Alzheimer's causation," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair, and a co-author of today's presentation. "We believe the data presented today provide insight into why APOE4 increases the risk for Alzheimer's disease: the ApoE4 protein, which is important for synaptic maintenance and control of neuroinflammation, has a higher propensity to be fragmented by gingipains, compared to other forms of ApoE. Importantly, our human studies have shown the ability of COR388 to protect ApoE proteins from gingipain fragmentation in the brains of study subjects."

    A growing body of evidence points to P. gingivalis as playing a key role in the development of Alzheimer's disease given its identification in the brains of AD patients and its ability to cause neurodegeneration, inflammation, beta-amyloid and tau buildup, and other pathology associated with the disease in animal models. An asacchrolytic bacterium, P. gingivalis has been shown to infiltrate the brain and release toxic proteases called gingipains that cleave ApoE, tau, and other proteins associated with neuronal function. Cortexyme is developing COR388, an investigational small-molecule gingipain inhibitor that is currently in a large, international Phase 2/3 clinical trial (the GAIN Trial). This trial is evaluating the efficacy, safety, and tolerability of COR388 in patients with mild to moderate AD, with top-line results expected in the fourth quarter of 2021.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Forward-looking statements are based on Cortexyme'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. 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 the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019 and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2019. Forward-looking statements contained in this press 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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  52. -- Presentation to be webcast on Cortexyme's website --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will participate in a fireside chat at the Evercore ISI 2nd Annual HealthCONx Conference on Tuesday, December 3, 2019 at 2:00 p.m. EST / 11:00 a.m. PST in Boston.

    A live webcast of the fireside chat will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that…

    -- Presentation to be webcast on Cortexyme's website --

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced Casey Lynch, the company's chief executive officer, chair, and co-founder, will participate in a fireside chat at the Evercore ISI 2nd Annual HealthCONx Conference on Tuesday, December 3, 2019 at 2:00 p.m. EST / 11:00 a.m. PST in Boston.

    A live webcast of the fireside chat will be accessible at the Investor Calendar page under the News & Events heading of the Cortexyme investor site (ir.cortexyme.com). The webcast will be archived at that location for 90 days.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Forward-looking statements are based on Cortexyme'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. 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 the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019 and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2019. Forward-looking statements contained in this press 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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  53. Lead investigational medicine COR388, a potentially transformative new paradigm for addressing Alzheimer's disease, continues to advance in Phase 2/3 GAIN clinical trial

    Following successful May 2019 initial public offering, Cortexyme is well capitalized and focused on high quality execution of the GAIN Trial

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced financial results for the third quarter 2019 and provided an update on its business.

    "The GAIN Trial has been met with enthusiasm from the Alzheimer's clinical and patient communities…

    Lead investigational medicine COR388, a potentially transformative new paradigm for addressing Alzheimer's disease, continues to advance in Phase 2/3 GAIN clinical trial

    Following successful May 2019 initial public offering, Cortexyme is well capitalized and focused on high quality execution of the GAIN Trial

    Cortexyme, Inc. (NASDAQ:CRTX), a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's and other degenerative diseases, today announced financial results for the third quarter 2019 and provided an update on its business.

    "The GAIN Trial has been met with enthusiasm from the Alzheimer's clinical and patient communities since its launch this past spring in the U.S. and, last quarter, in Europe," said Casey Lynch, Cortexyme's chief executive officer, co-founder, and chair. "We look forward to delivering a steady cadence of milestones in the coming quarters. Supported by a strong balance sheet and our experienced and growing professional team, we are well positioned to advance toward our goal of stemming the tide of Alzheimer's disease by halting its progression."

    Recent Business Updates

    GAIN Trial

    • The GAIN Trial, the company's Phase 2/3 study of COR388 versus placebo in patients with mild to moderate Alzheimer's disease, is anticipated to continue on track in 2020. The trial is targeting an enrollment of 570 patients across 90 sites in the United States and Europe, with top-line results from the trial expected in the fourth quarter of 2021. In addition, the company is evaluating the feasibility of conducting an interim analysis, and plans to discuss this strategy with the U.S. Food and Drug Administration (FDA).
    • In September, Cortexyme announced the start of screening in Europe for the GAIN Trial. Cortexyme expects to enroll subjects in five European countries; sites in the UK, Spain, France, and Poland are already active. An updated listing can be found on www.clinicaltrials.gov.

    Advancing a New Understanding of Alzheimer's Causation and Treatment

    • Earlier this month, Cortexyme announced that research on COR388's impact on ApoE in Alzheimer's disease patients will be the subject of an oral presentation at the 12th Clinical Trials on Alzheimer's (CTAD) conference, which is being held December 4-7, 2019, in San Diego. Michael Detke, M.D., Ph.D., Cortexyme's chief medical officer, will deliver the presentation (abstract OC28) at 10:00 a.m. PST on Saturday, December 7th. Additionally, the company will host a lunch symposium on Thursday, December 5th, from 12:30-1:30 p.m. PST. More details, including registration info, are available here.
    • In July, COR388 was the subject of a research abstract presented at the Alzheimer's Association International Conference (AAIC) 2019 in Los Angeles. In a Developing Topics poster that was included in the AAIC press program, researchers highlighted the Phase 1b clinical development experience of COR388 and provided an overview of the design for the GAIN trial. AAIC is the largest international meeting dedicated to advancing dementia science.
    • In June, Cortexyme expanded its Clinical Advisory Board (CAB) with four new key clinical and regulatory experts. The CAB includes leading experts on Alzheimer's, neurodegenerative disorders, and central nervous system drug development. Cortexyme has benefited from the group's insights as it advanced COR388 through Phase 1 testing and laid the groundwork for the GAIN trial. Recently, Cortexyme's regulatory advisor David Hosford, M.D., Ph.D. rejoined the FDA Division of Neurology Products. Thomas Laughren, M.D., a consultant and previous Division Director at the FDA, will now be advising the company on regulatory matters.

    Corporate Updates

    • In May, Cortexyme completed a successful initial public offering, raising approximately $77.8 million after expenses.

    Financial Results for the Quarter Ended September 30, 2019

    Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and short and long-term marketable securities as of September 30, 2019, were $127.8 million. Cortexyme expects current cash, cash equivalents and marketable securities will be sufficient to fund its operating and capital expenditures through 2021 and the completion of the GAIN Trial.

    Research and Development (R&D) Expenses: For the quarter ended September 30, 2019, R&D expenses were $8.3 million, including $0.6 million of stock-based compensation, compared to R&D expenses of $2.3 million for the quarter ended September 30, 2018. The increase was primarily due to costs related to the research and development of COR388, the GAIN Trial, and stock-based compensation.

    General and Administrative (G&A) Expenses: For the quarter ended September 30, 2019, G&A expenses were $2.3 million, which included $0.3 million of stock-based compensation. This compared to G&A expenses of $0.6 million for the quarter ended September 30, 2018. The increase was primarily attributable to personnel-related expenses, professional and legal fees, and stock-based compensation.

    Net Loss: For the quarter ended September 30, 2019, net loss was $9.9 million, or a loss of $0.37 per basic share.

    About the GAIN Trial

    The GAIN Trial is a Phase 2/3 randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of two dose levels of COR388 oral capsules in subjects with mild to moderate AD. The trial is currently enrolling subjects in the U.S. and Europe, and top-line results from the trial are anticipated in the fourth quarter of 2021. More information about the trial can be found at www.GAINtrial.com.

    About Cortexyme, Inc.

    Cortexyme (NASDAQ:CRTX) is a clinical stage biopharmaceutical company pioneering a novel, disease-modifying therapeutic approach to treat what it believes to be a key underlying cause of Alzheimer's disease and other degenerative diseases. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimer's patients and tied to neurodegeneration and neuroinflammation in animal models. The company's lead investigational medicine, COR388, is the subject of the GAIN Trial, an ongoing Phase 2/3 clinical study in patients with mild to moderate Alzheimer's. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

    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. Forward-looking statements are based on Cortexyme'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. 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 the final prospectus related to Cortexyme's initial public offering filed with the Securities and Exchange Commission on May 9, 2019 and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on June 12, 2019. Forward-looking statements contained in this press release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.

    Cortexyme, Inc. Condensed Statements of Operations
    (Unaudited)
    (In thousands, except share and per share amounts)
     

     

     

    Three Months Ended September 30,

     

    Nine Months Ended September 30,

     

     

    2019

     

    2018

     

    2019

     

    2018

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    8,253

     

     

    $

    2,290

     

     

    $

    20,187

     

     

    $

    6,989

     

    General and administrative

     

     

    2,316

     

     

     

    584

     

     

     

    6,032

     

     

     

    1,288

     

    Total operating expenses

     

     

    10,569

     

     

     

    2,874

     

     

     

    26,219

     

     

     

    8,277

     

    Loss from operations

     

     

    (10,569

    )

     

     

    (2,874

    )

     

     

    (26,219

    )

     

     

    (8,277

    )

    Interest income

     

     

    711

     

     

     

    353

     

     

     

    1,618

     

     

     

    434

     

    Interest expense

     

     

     

     

     

     

     

     

     

     

     

    (957

    )

    Change in fair value of derivative liability

     

     

     

     

     

     

     

     

     

     

    (206

    )

    Net loss

     

     

    (9,858

    )

     

     

    (2,521

    )

     

     

    (24,601

    )

     

     

    (9,006

    )

    Other comprehensive income/ (loss):

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Unrealized gain / (loss) on available for sales securities

     

     

    16

     

     

     

    (16

    )

     

     

    145

     

     

     

    (16

    )