AMLX

EX-99.1

2 amlx-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Amylyx Pharmaceuticals Reports Third Quarter 2026 Financial Results

• Reported positive topline results from Phase 3 LUCIDITY clinical trial of avexitide in post-bariatric hypoglycemia; New Drug Application submission planned by end of 2026 remains on track

• Results from LUCIDITY trial accepted as a late-breaking oral presentation at ObesityWeek® 2026 Annual Meeting on November 15

• Strengthened balance sheet through upsized public offering with net proceeds of approximately $545 million

• Management to host conference call and webcast today at 8:00 a.m. Eastern Time

CAMBRIDGE, Mass., November 5, 2026 – Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial and business results for the third quarter ended September 30, 2026.

“The third quarter was a transformational period for Amylyx, as we reported positive topline results from the Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia, bringing us one step closer to potentially delivering a first ever FDA-approved treatment to people living with PBH,” said Joshua Cohen and Justin Klee, Co-CEOs of Amylyx. “Importantly, the enthusiastic response from the medical community to the strength and consistency of the data demonstrate the significant unmet need in PBH, and we look forward to building on this momentum with the upcoming presentation of LUCIDITY data at ObesityWeek this month. We remain on track to submit our NDA by year-end and are executing on our comprehensive commercial readiness plans ahead of a potential launch of avexitide in 2027, if approved. With a strengthened balance sheet following our recent equity financing, we believe we are well positioned to deliver on our commitment to bring meaningful new treatments to people living with diseases with high unmet needs.”

Third Quarter and Recent Updates:

• Amylyx reported positive topline results from Phase 3 LUCIDITY clinical trial of avexitide in participants with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery. LUCIDITY met the prespecified primary endpoint demonstrating a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003), and met all secondary endpoints demonstrating consistent, highly statistically significant, and clinically meaningful reductions across all endpoints. Avexitide was generally well-tolerated through the double-blind study period with a favorable safety profile. LUCIDITY’s 32-week open label extension (OLE) and the avexitide Expanded Access Program for eligible adults with PBH following RYGB remain ongoing.

• As Amylyx approaches a potential 2027 launch of avexitide, the Company is scaling its commercial organization and launch readiness capabilities. During the third quarter, the Company solidified its full commercial leadership team and continues to invest in the capabilities and talent needed to support a successful launch. This includes key hiring across marketing, market access, patient services, and commercial operations. Furthermore, uncoverPBH.com, the PBH disease state education platform, continues to educate patients and healthcare professionals.

• Amylyx recently completed enrollment of Cohort 3 (n=12) and began enrollment of Cohort 4 of the Phase 1 LUMINA clinical trial of AMX0114, an investigational antisense oligonucleotide targeting calpain-2 with FDA Fast Track Designation for the potential treatment of amyotrophic lateral sclerosis (ALS). The LUMINA trial is a randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial of AMX0114 in people living with ALS. LUMINA is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMX0114 in people living with ALS and assessing both novel and broadly researched ALS biomarkers, including change from baseline in neurofilament light chain levels.

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• Amylyx recently presented data from the Phase 1 LUMINA clinical trial of AMX0114 at the Annual NEALS Meeting from the initial two dose cohorts. The presentation is available on the “Presentations” tab of the Amylyx website.

• Amylyx announced the closing of its underwritten public offering, with net proceeds to Amylyx of approximately $544.6 million. The proceeds strengthen the Company’s financial position, enabling Amylyx to enter 2027 well-funded to commercialize avexitide, if approved.

Upcoming Expected Milestones:

• Amylyx plans to present results from the Phase 3 LUCIDITY clinical trial of avexitide in PBH in a late-breaking oral presentation on November 15, 2026, at the upcoming ObesityWeek® 2026 Annual Meeting, taking place in Washington, D.C. The presentation will be made available on the “Presentations” tab of the Amylyx website.

• Amylyx remains on track to submit a New Drug Application to the FDA by the end of 2026. The FDA previously granted avexitide Breakthrough Therapy Designation for PBH.

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