CRTX Cortexyme Inc.

49.22
+0.62  (+1%)
Previous Close 48.6
Open 49.68
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Market Cap $1,451,891,511
Shares 29,497,999
Float 15,453,867
Enterprise Value $1,296,052,751
Volume 120,209
Av. Daily Volume 113,003
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Latest News

  1. — 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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  2. -- 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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  3. -- 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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  4. - 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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  5. -- 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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