CORTEXYME, INC.

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Cortexyme Shares Slide Premarket as FDA Puts Hold on Atuzaginstat

01/26/2022 | 08:52am EDT

By Colin Kellaher


Shares of Cortexyme Inc. tumbled sharply in premarket trading Wednesday after the company said the U.S. Food and Drug Administration has placed a full clinical hold on its investigational new drug application for atuzaginstat, its lead small molecule.

The South San Francisco, Calif., clinical-stage biopharmaceutical company said it has implemented a cost-cutting program aimed at allowing continued support for planned clinical milestones and providing an expected cash runway through 2024.

Cortexyme last year said a Phase 2/3 study of atuzaginstat for the treatment of Alzheimer's disease showed a relationship between reduction of P. gingivalis infection and the slowing of cognitive decline but didn't meet statistical significance on its co-primary cognitive and functional endpoints in the overall cohort.

The company said it plans to prioritize development of COR588, its next-generation gingipain inhibitor, in Alzheimer's disease, and that it will explore alternatives for its coronavirus program and non-Alzheimer's indications for atuzaginstat.

Cortexyme said it plans to provide updates on the atuzaginstat clinical hold pending continued engagement with the FDA.

Cortexyme shares, which closed Tuesday at $9.06, were down 29.6% to $6.47 in premarket trading.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

01-26-22 0852ET

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Financials (USD)
Sales 2022 - - -
Net income 2022 -79,2 M - -
Net cash 2022 65,0 M - -
P/E ratio 2022 -1,33x
Yield 2022 -
Capitalization 98,3 M 98,3 M -
EV / Sales 2022 -
EV / Sales 2023 -
Nbr of Employees 55
Free-Float 74,4%
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Last Close Price 3,26 $
Average target price 7,70 $
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Christopher P. Lowe Chief Executive, Operating & Financial Officer
David A. Lamond Chairman
Leslie J. Holsinger Executive Vice President-Research & Development
Joanna Bolger Vice President-Clinical Operations
Caryn G. McDowell Secretary, Chief Administrative & Legal Officer
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