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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cortexyme, Inc. (Nasdaq: CRTX), a clinical stage biopharmaceutical company pioneering potential therapeutics for Alzheimers 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 Alzheimers 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 Alzheimers 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, Cortexymes 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 Parkinsons 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 Alzheimers Disease (AD) Atuzaginstat in Periodontal Disease (PiD) Atuzaginstat in Parkinsons Disease (PD) Pipeline Progress 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 Alzheimers 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 Alzheimers disease. Cortexyme is targeting a specific, infectious pathogen found in the brain of Alzheimers 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 Alzheimers disease, periodontal disease, Parkinsons 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 Cortexymes 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.

Answer: Cortexyme Announces Pipeline Update and Anticipated 2021 Milestones Based upon successful completion of the GAIN Trials interim analysis, pipeline expansion announced for 2021 Atuzaginstat to be studied in the PEAK trial, a new Phase 2 study for Parkinsons disease COR588, a novel lysine gingipain inhibitor, on track to enter the clinic in Q3 2021 Top-line data in 643 subject Alzheimers 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