Amylyx Pharmaceuticals : Relyvrio™ FDA Approval Conference Call Presentation
September 30, 2022 at 08:44 am EDT
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FDA Approval
Conference Call
September 30, 2022
photo in memory of Mick, a husband and father, who was a gifted tattoo artist and musician
Amylyx Participants
Justin Klee
Josh Cohen
Margaret Olinger
James Frates
Co-CEO
Co-CEO
Global Head of
Chief Financial Officer
Commercial & CCO
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Disclaimer
Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential approval of AMX0035 for the treatment of ALS in countries other than Canada and the United States; the potential of AMX0035 as a treatment for ALS and the Company's plans to explore the use of AMX0035 for other neurodegenerative diseases; the potential market acceptance and market opportunity for RELYVRIO™; the Company's ability to make RELYVRIO available commercially in the United States, as well as access to and coverage for RELYVRIO; and expectations regarding our longer-term strategy. Any forward-looking statements in this presentation are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities, Amylyx' ability to successfully launch RELYVRIO in the United States, Amylyx' ability to execute on its commercial and regulatory strategy, regulatory developments, expectations regarding the timing of EMA review of AMX0035 for the treatment of ALS, Amylyx' ability to fund operations, and the impact that the ongoing COVID- 19 pandemic will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and subsequent filings with the SEC. All forward-looking statements contained in this presentation speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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Our mission is to one day end the suffering caused by neurodegenerative diseases.
Every day, we strive for better therapies.
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is approved in the
United States
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Amylyx Pharmaceuticals Inc. published this content on 30 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 September 2022 12:43:07 UTC.
Amylyx Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company. The Company is engaged in the discovery and development of treatments for neurodegenerative diseases. The Company is focused on the development and commercialization of its product candidate, AMX0035 (sodium phenylbutyrate and taurursodiol, also known as ursodoxicoltaurine) for the treatment of amyotrophic lateral sclerosis (ALS). RELYVRIO (also known as AMX0035), an oral, fixed-dose combination of sodium phenylbutyrate and taurursodiol is approved to treat ALS in adults in the United States. AMX0035 is a dual unfolded protein response (UPR)-Bax apoptosis inhibitor composed of PB and TURSO (also known as TUDCA). Its development of antisense oligonucleotides (ASOs), including lead ASO AMX0114, which targets calpain-2 (CAPN2), a gene encoding calcium-dependent proteolytic enzyme which has been implicated in the pathogenesis of ALS and other neurodegenerative diseases.