Patient Access and Reimbursement

Amylyx Pharmaceuticals to Present CENTAUR Long-Term Survival Data of AMX0035 for ALS in Plenary Session at 2021 Virtual American Academy of Neurology (AAN) Annual Meeting April 13, 2021

– Abstract Awarded Merit of Distinction and Selected for Oral Presentation in Contemporary Clinical Issues Plenary Session – Abstract Will Be Featured at AAN’s Top Science Press Conference Ahead of Annual Meeting on April 13 Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and other neurodegenerative diseases, today announced that long-term survival data from the CENTAUR trial of AMX0035 in patients with ALS were selected for an oral presentation in the Contemporary Clinical Issues Plenary Session on April 19 at the 2021 American Academy of Neurology (AAN) Annual Meeting. The meeting is being held virtually on April 17-22. The abstract, “Long-Term Survival of Participants in the CENTAUR Trial of AMX0035 for ALS,” was one of 26 abstracts awarded the merit of distinction by the American Academy of Neurology and the Science Committee. The distinction is awarded to the abstract deemed

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Paul Fonteyne Joins Amylyx Pharmaceuticals Board of Directors March 29, 2021

Former Boehringer Ingelheim U.S. CEO Adds More than Thirty Years of Executive Leadership Experience and Commercial Expertise to the Amylyx Board of Directors Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, today announced the appointment of Paul Fonteyne to its Board of Directors. Mr. Fonteyne’s deep commercialization and leadership experience will support the company’s global plans to bring new treatments to people with neurodegenerative diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210329005384/en/ Paul Fonteyne, Amylyx Board of Directors member (Photo: Business Wire) “Paul is a true leader in the health care industry with a proven record of success in building effective teams, launching global products and running commercial organizations focused on delivering for

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Amylyx Pharmaceuticals to Present New Long-Term Data from the Pivotal CENTAUR Trial in ALS at the Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference March 18, 2021

– Significantly Lower Long-Term Risk of Death or Permanent Assisted Ventilation and Risk of First Hospitalization Among Participants Originally Randomized to AMX0035 Versus Placebo – Data were Consistent with CENTAUR and CENTAUR OLE Primary Outcome Measures of Statistically Significant Slowing of Functional Decline and Long-Term Survival Results Associated with the Administration of AMX0035 CAMBRIDGE, Mass. […]

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Amylyx Pharmaceuticals Plans Regulatory Filing of AMX0035 for the Treatment of ALS in Canada March 9, 2021

– Marketing Application in Canada (New Drug Submission) Planned for First Half of 2021 – Amylyx Also Plans to Pursue Early Access Options in Canada Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and other neurodegenerative diseases, today announced plans to submit a New Drug Submission (NDS) for AMX0035 for the treatment of ALS with Health Canada in the first half of 2021. The decision to submit is based on the positive clinical data from the CENTAUR trial and feedback from Health Canada. In addition, Amylyx will explore options for early access to AMX0035 in Canada, including a potential special access program (SAP) in collaboration with the Canadian ALS Research Network, and aims to finalize plans by the end of the second quarter of 2021. “Results from CENTAUR demonstrated that AMX0035 has both functional and long-term survival benefits which were seen on top of baseline use of

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Amylyx Supports Rare Disease Day® and #ShowYourStripes Campaign to Raise Awareness for Rare Disease Communities February 22, 2021

#ShowYourStripes In Community Solidarity by Using New Facebook Filter or Downloadable Video Conferencing Background Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and other neurodegenerative diseases, has joined forces with the National Organization for Rare Disorders (NORD®) to help raise awareness for this year’s Rare Disease Day® on February 28 th . Rare Disease Day is an annual awareness day dedicated to elevating public understanding of rare diseases and emphasizing the special challenges the community faces. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210222005597/en/ #ShowYourStripes Video Conferencing Background Available for Download (Graphic: Business Wire) Amylyx is honored to be a Rare Disease Day “Campaign Supporter” and participate in NORD’s #ShowYourStripes campaign, which aims to empower advocates,

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James Frates Joins Amylyx Pharmaceuticals as Chief Financial Officer January 14, 2021

– Former Alkermes Chief Financial Officer Expands Amylyx Executive Leadership Team as the Company Grows and Scales Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and other neurodegenerative diseases, today announced the appointment of James Frates as Chief Financial Officer (CFO), effective Jan. 25, 2021. Mr. Frates joins Amylyx following his tenure as CFO at Alkermes, since 1998. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005141/en/ James Frates, Amylyx Chief Financial Officer (Photo: Business Wire) “We are so excited for Jim to join us at this critical juncture for Amylyx,” said Joshua Cohen, Co-CEO, Chairman and Co-Founder of Amylyx. “Jim’s depth and breadth of experience as a biopharmaceutical executive coupled with his financial acumen and personal mission for bringing promising treatments to patients

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Amylyx Pharmaceuticals Announces Publication of CENTAUR Survival Data Demonstrating Statistically Significant Survival Benefit of AMX0035 for People with ALS October 16, 2020

Data From CENTAUR Trial Published in Muscle & Nerve Demonstrates That Administration of AMX0035 Results in Longer Survival for People With ALS Early Administration of AMX0035 Reduced the Risk of Death by 44% Over the Duration of Follow-Up AMX0035 is the First ALS Therapeutic to Demonstrate Both a Statistically Significant Survival and Functional Benefit in ALS in a Randomized Controlled Trial Majority (77%) of Patients Were Receiving One or More Approved ALS Therapies at or Before Study Entry Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, today announced the publication of an overall survival analysis from the CENTAUR trial evaluating AMX0035 in people with ALS in the neuromuscular disease journal Muscle & Nerve . The survival analysis followed each CENTAUR participant for up to three years from the start of the trial regardless of

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Amylyx Pharmaceuticals Highlights New Long-Term Safety Data from CENTAUR Study of AMX0035 in People with ALS at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2020 Virtual Meeting October 9, 2020

Data from New Long-Term Safety Analysis Show No New Safety Concerns with AMX0035 Identified in the Open-Label Extension Study Data Were Consistent with Primary Outcome of Statistically Significant Slowing of the Functional Decline Associated with the Administration of AMX0035 Company Also Presented Secondary Outcome Results Demonstrating the Administration of AMX0035 Resulted in Statistically Significant Slower […]

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