CRTX Cortexyme Inc.

32.87
0  0%
Previous Close 32.87
Open 33.14
52 Week Low 26.6612
52 Week High 60.2094
Market Cap $969,599,227
Shares 29,497,999
Float 15,453,867
Enterprise Value $816,710,267
Volume 349,990
Av. Daily Volume 341,913
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Atuzaginstat - GAIN
Alzheimer’s disease
Phase 2/3
Phase 2/3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

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

Latest News

  1. - 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.

    View Full Article Hide Full Article
  2. — 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.

    View Full Article Hide Full Article
  3. — 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.

    View Full Article Hide Full Article
  4. -- 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.

    View Full Article Hide Full Article
  5. — 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

     

    View Full Article Hide Full Article
View All Cortexyme Inc. News