Cortexyme to Present New GAIN Trial Data at AD/PD 2022

March 14, 2022 at 08:00 AM EDT

New data expands evidence base of role of P. gingivalis in Alzheimer’s disease

Discussion to include new biomarker results and correlations between biomarkers and clinical outcomes

Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company pioneering upstream therapeutic approaches to improve the lives of patients diagnosed with degenerative diseases, announced that the company will participate at the AD/PD™ 2022 International Conference on Alzheimer’s and Parkinson’s Diseases, which is a hybrid event taking place March 15-20, 2022 in Barcelona, Spain, as well as virtually. Cortexyme’s chief medical officer Michael Detke, MD, PhD, will present new GAIN Trial results and biomarker data examining the role of P. gingivalis in Alzheimer’s disease and the P. gingivalis-positive population, in addition to sharing study data that reinforces the efficacy of the company’s first-in-class gingipain inhibitor in slowing cognitive decline in Alzheimer’s disease with P. gingivalis. These new data analyses will be reviewed at AD/PD 2022 and at additional conferences as more data becomes available throughout 2022.

AD/PD 2022 Abstract Details

Title: Data from the Phase 2/3 GAIN Trial of COR388 (Atuzaginstat) for the Treatment of Mild-Moderate Alzheimer’s Disease

Presenter: Michael Detke, MD, PhD, Cortexyme’s chief medical officer.

Authors: Michael Detke¹, Marwan Sabbagh², Mark Ryder³, Joanna Bolger¹, Dave Hennings¹, Vladimir Skljarevski¹, Shirin Kapur¹, Debasish Raha¹, Florian Ermini¹, Mai Nguyen¹, Ursula Haditsch¹, Kim Perry⁴, Kelly Ritch⁵, Suzanne Hendrix⁶, Sam Dickson⁶, Hatice Hasturk⁷, Sarah Horine¹, Craig Mallinckrodt¹, Leslie Holsinger¹, Casey Lynch¹, and Stephen Dominy¹.

Access: Cortexyme’s AD/PD 2022 presentation will take place on Sunday, March 20, 2022, at 10:50 a.m. CET (5:50 a.m. EDT) and will be accessible to AD/PD 2022 registered meeting attendees in-person and on its virtual platform. The company will issue a news release summarizing highlights of the presentation and post the presentation to the science section of its corporate website shortly after the conclusion of the presentation.

¹Cortexyme - South San Francisco, CA (USA), ²Barrow Neurological Institute, Dignity Health/St. Joseph’s Hospital and Medical Center - Phoenix, AZ (USA), ³UCSF - San Francisco, CA (USA), ⁴Innovative Analytics - Portage, MI (USA), ⁵Datafy Clinical R&D - Portage, MI (USA), ⁶Pentara Corporation - Millcreek, UT (USA), ⁷Forsyth Institute - Cambridge, MA (USA)

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 degenerative diseases, including Alzheimer’s disease, periodontitis, and oral potentially malignant disorders, among others. Cortexyme’s innovative approach targets a specific, infectious pathogen called P. gingivalis found in the brain of Alzheimer’s patients and other organs and tied to degeneration and inflammation in humans and animal models. The company’s causation evidence for Alzheimer’s disease and the mechanism of its novel therapeutic has been independently replicated and confirmed by multiple laboratories around the world, as well as published in peer-reviewed scientific journals. To learn more about Cortexyme, visit www.cortexyme.com or follow @Cortexyme on Twitter.

Forward-Looking Statements

Statements in this news release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this news release may be identified by the use of words such as “outcomes,” “intends,” “will,” “estimate,” “potential,” “correlations,” “reinforces” or other similar words. Examples of forward-looking statements include, among others, the strategic development path for atuzaginstat; its business plans, internal and external development of the pipeline, strategy, planned FDA submissions and clinical trials and timeline, prospects, and milestone expectations; the timing and success of the company’s clinical trials and related data, including plans and the ability to initiate, conduct and/or complete current and additional studies; the timing of announcements and updates relating to its clinical trials and related data; the potential therapeutic benefits, safety and efficacy of the company’s product candidate or library of compounds; and statements about its ability to obtain, and the timing relating to, further development of atuzaginstat and other programs or indications, regulatory submissions and interactions with regulators, and related response and decisions, and approvals with respect to the company’s drug product candidate. Forward-looking statements are based on Cortexyme’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in Cortexyme’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2022, its Quarterly Report on Form 10-Q filed with the SEC on October 29, 2021, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Cortexyme undertakes no duty to update such information except as required under applicable law.