Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q1 2024 Results Conference Call May 9, 2024 8:00 AM ET Company Participants Lindsey Allen - Head, IR & Communications Justin Klee - Co-CEO Camille Bedrosian - CMO Jim Frates - CFO Josh Cohen - Co-CEO Conference Call Participants Corinne Jenkins - Goldman Sachs Graig Suvannavejh - Mizuho Operator Good morning. My name is Morgan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals First Quarter 20 ...

Amylyx Pharmaceuticals, Inc. (AMLX) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of $0.24. This compares to earnings of $0.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -291.67%. A quarter ago, it was expected that this company would post earnings of $0.20 per share when it actually produced earnings of $0.07, delivering a surprise of -65%.Over the last four quarters, the company h ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------------------------------|------------------------------------------| | | | | For the transition peri ...

Exhibit 99.1 Amylyx Pharmaceuticals Reports First Quarter 2024 Financial Results ˗ Company plans to engage with FDA based on interim data from the Phase 2 HELIOS clinical trial demonstrating improvements in pancreatic function, glycemic control, and vision in participants with Wolfram syndrome treated with AMX0035; topline data from all 12 participants at Week 24 anticipated in fall of 2024 ˗ Interim analysis from the ORION study of AMX0035 in progressive supranuclear palsy continues to be expected in mid-2 ...

Core Viewpoint - Amylyx Pharmaceuticals is withdrawing its ALS drug Relyvrio from the U.S. and Canadian markets following the failure of the late-stage PHOENIX study, which significantly impacted the company's stock performance [1][2][5]. Company Developments - The PHOENIX study, a phase III clinical trial, did not meet its primary endpoint, leading to the decision to remove Relyvrio/Albrioza from the market for new patients, although current patients can transition to a free drug program [2][3]. - The company is restructuring, reducing its workforce by approximately 70% and focusing on key programs for AMX0035 in Wolfram syndrome and progressive supranuclear palsy (PSP) [3][4]. - Amylyx's shares have decreased by 81.2% year-to-date, contrasting with a 5.4% decline in the industry [3]. Clinical Trials and Future Focus - The ongoing PHOENIX Open Label Extension (OLE) and a phase III study, ORION, are evaluating AMX0035 for other neurodegenerative conditions [3][4]. - Interim data from the phase II HELIOS study of AMX0035 in Wolfram syndrome is expected to be presented later this month [3]. Historical Context - Relyvrio was initially approved by the FDA in 2022 based on phase II CENTAUR study data, which showed a significant slow-down in ALS progression [5].

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the addition of Bernhardt G. Zeiher, MD, FCCP, FACP, to its Board of Directors (“Board”). Dr. Zeiher brings more than 20 years of drug development experience where, in his various roles, he oversaw the approval of 15 new treatments that addressed people’s unmet needs in serious diseases with few to no treatment options. Most recently, he served as Chief Medical Officer (“CMO”) of Astell ...

Shares of Amylyx Pharmaceuticals (AMLX) nosedived 82.2% on Mar 8 after management announced topline results from the phase III PHOENIX study evaluating Relyvrio (AMX0035) for the treatment of amyotrophic lateral sclerosis (“ALS”). The study did not meet its primary or secondary endpoints.The PHOENIX study failed to achieve statistical significance in the primary endpoint of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score following 48 weeks of treatment with Relyvrio. ...

Core Insights - Amylyx Pharmaceuticals announced topline results from the PHOENIX trial, which did not meet its primary endpoint of statistical significance in ALSFRS-R total score change at Week 48 (p=0.667) [1][5] - The company plans to engage with regulatory authorities and the ALS community to discuss the trial results and may consider withdrawing RELYVRIO/ALBRIOZA from the market [2][3] - AMX0035 was well-tolerated in the trial, with no new safety signals reported, reinforcing its favorable safety profile [5] PHOENIX Trial Results - The PHOENIX study enrolled 664 adults with ALS, randomized to receive either AMX0035 or placebo, alongside standard-of-care treatments [4][9] - No significant differences were observed in secondary endpoints, and the treatment did not show efficacy in participants who met CENTAUR trial criteria [5] - European participants completing the trial have the option to enroll in an ongoing open-label extension phase [5][9] Future Plans and Community Engagement - The company will share the PHOENIX results with the ALS community and regulatory authorities over the next eight weeks [2][3] - Amylyx remains committed to ALS research and is exploring AMX0035's potential in other neurodegenerative diseases, including Wolfram syndrome and progressive supranuclear palsy [3][6] Ongoing Studies - The ORION trial of AMX0035 in progressive supranuclear palsy is ongoing, with topline results expected in 2025 or 2026 [7] - Preliminary data from the HELIOS trial in Wolfram syndrome is anticipated in the second quarter of 2024 [7] About AMX0035 - AMX0035 is a fixed-dose combination of sodium phenylbutyrate and taurursodiol, approved as RELYVRIO in the U.S. and ALBRIOZA in Canada for ALS treatment [19][20] - The drug targets neurodegenerative pathways by mitigating endoplasmic reticulum stress and mitochondrial dysfunction [6][19]

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has granted stock options and restricted stock units (“RSUs”) to Linda Arsenault, the Company’s newly appointed Chief Human Resources Officer. The Compensation Committee of Amylyx’ Board of Directors approved the grant, effective February 20, 2024, to Ms. Arsenault of non-qualified stock option awards to purchase up to 101,400 shares of the Company’s common stock and 67,600 RSUs ...