0000000000-21-014787.txt : 20220204 0000000000-21-014787.hdr.sgml : 20220204 20211209123003 ACCESSION NUMBER: 0000000000-21-014787 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20211209 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Amylyx Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001658551 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 464600503 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 43 THORNDIKE STREET CITY: CAMBRIDGE STATE: MA ZIP: 02141 BUSINESS PHONE: 617-683-0917 MAIL ADDRESS: STREET 1: 43 THORNDIKE STREET CITY: CAMBRIDGE STATE: MA ZIP: 02141 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]#;VQO7!E+UA/8FIE8W0O5VED=&@@,30R."],96YG=&@@,S8U+T)I='-097)# M;VUP;VYE;G0@.#X^7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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Cohen, Justin B. Klee Co-Chief Executive Officers Amylyx Pharmaceuticals, Inc. 43 Thorndike St. Cambridge, Massachusetts 02141 Re: Amylyx Pharmaceuticals, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted November 24, 2021 CIK No, 0001658551 Dear Mr. Cohen: We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Amendment No. 2 to Draft Registration Statement submitted November 24, 2021 Summary Overview, page 2 1. With reference to the disclosure on page 144 concerning the PEGASUS trial, please balance the discussion on page 2 regarding topline results to explain that no differences were seen in the primary or secondary efficacy endpoints. Joshua B. Cohen, Justin B. Klee FirstName LastNameJoshua B. Cohen, Justin B. Klee Amylyx Pharmaceuticals, Inc. Comapany9, December NameAmylyx 2021 Pharmaceuticals, Inc. December Page 2 9, 2021 Page 2 FirstName LastName Clinical Development of AMX0035 for AD, page 144 2. We note your revised disclosures on page 144 presenting the topline results from the PEGASUS trial. Please revise to identify the primary safety and tolerability endpoints and the trial results. Also revise to present the primary efficacy endpoint as well as the additional cognition, function, and imaging endpoints. Present the efficacy trial results so they can be compared to the established endpoints. Also, explain the newly developed composite outcome of cognitive, functional, and imaging measures. You may contact Al Pavot at 202-551-3738 or Christine Torney at 202-551-3652 if you have questions regarding comments on the financial statements and related matters. Please contact Daniel Crawford at 202-551-7767 or Joe McCann at 202-551-6262 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Benjamin K. Marsh, Esq.