Full Press Release Details
Cortexyme Announces Pipeline Update and Anticipated 2021 Milestones
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
SOUTH SAN FRANCISCO, Calif. January 26, 2021 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
Anticipated Key Milestones for 2021
Atuzaginstat in Mild to Moderate Alzheimer s Disease (AD)
Atuzaginstat in Periodontal Disease (PiD)
Atuzaginstat in Parkinson s Disease (PD)
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.
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.