Amylyx Pharmaceuticals, Inc. · NASDAQ:AMLX
Amylyx Pharmaceuticals — Phase 3 LUCIDITY Trial of Avexitide in PBH Topline Data Conference Call (August 2026)
17 slides from Amylyx Pharmaceuticals's conference presentation, Aug 18, 2026
Slide 1: Phase 3 LUCIDITY Trial of Avexitide in PBH Topline Data Conference Call
Phase 3 LUCIDITY Trial of Avexitide in Post-Bariatric Hypoglycemia (PBH) Topline Data Conference Call August 18, 2026 Maggie, a mom and advocate living with post-bariatric hypoglycemia (PBH). Pancreatic islet cells
Slide 2: Opening Remarks
Opening Remarks Lindsey Allen Vice President, Investor Relations & Communications at Amylyx
Slide 3: Disclaimer
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
Slide 4: Phase 3 LUCIDITY Topline Data
Phase 3 LUCIDITY Topline Data Camille Bedrosian, MD Chief Medical Officer of Amylyx
Slide 5: LUCIDITY Met Its Primary and All Secondary Endpoints
LUCIDITY Met Its Primary and All Secondary Endpoints Consistent, statistically significant, and clinically meaningful reductions in Level 2 and Level 3 hypoglycemic events vs. placebo An investigational, first-in-class GLP-1 receptor antagonist designed to reduce the exaggerated GLP-1 Avexitide resp
Slide 6: Phase 3 LUCIDITY Trial Design
Phase 3 LUCIDITY Trial Design PHASE 3 LUCIDITY TRIAL DESIGN - Multicenter, randomized, double-blind, placebo-controlled trial (N=78) 16-week Double-blind Treatment Period 32-week Open-label Extension Period 3:2 Randomization Avexitide 90 mg Once Daily N=78 21-day Eligibility Run-in Period Avexitide
Slide 7: LUCIDITY Met Primary Endpoint
LUCIDITY Met Primary Endpoint Statistically significant 55% reduction in composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo Composite Level 2/3 Hypoglycemic Event Rate Reduction vs. Placebo, Week 16 100 (ITT, N=78) 90 80 LS Mean % Reduction vs Placebo Primary Analysis 70 5
Slide 8: LUCIDITY Met All Secondary Endpoints
LUCIDITY Met All Secondary Endpoints Consistent, highly statistically significant, and clinically meaningful reductions ✓ ✓ ✓ Level 2 Level 2 Level 3 hypoglycemic hypoglycemic hypoglycemic events (SMBG) events (CGM) events 8
Slide 9: Avexitide was Generally Well-Tolerated with a Favorable Safety Profile Through 16 Weeks
Avexitide was Generally Well-Tolerated with a Favorable Safety Profile Through 16 Weeks • Adverse events were generally mild or moderate • No treatment-related serious adverse events • Most common adverse events were diarrhea, injection site erythema, and injection site bruising • No changes in body
Slide 10: The Burden of PBH
The Burden of PBH Marilyn Tan, MD, FACE Principal Investigator of the LUCIDITY clinical trial and Clinical Professor of Medicine at Stanford University School of Medicine Relevant Disclosures: Dr. Tan has received research payments from Amylyx Pharmaceuticals as primary investigator and received con
Slide 11: Post-Bariatric Hypoglycemia (PBH): A Chronic, Debilitating Condition with High Unmet Need
Post-Bariatric Hypoglycemia (PBH): A Chronic, Debilitating Condition with High Unmet Need ~160,000 People Currently Living with PBH in the U.S.1 No approved treatment options PBH Can be Dangerous and Life-Altering Hypoglycemic events can Can feel like a constant cycle Can affect someone’s ability In
Slide 12: Avexitide Targets a Central Pathway of PBH Pathophysiology
Avexitide, an Investigational, First-in-Class GLP-1 Receptor Antagonist, Targets a Central Pathway of PBH Pathophysiology GLP-1 Receptor Antagonism 1 2 3 4 Hypersecretion of Insulin Avexitide Binds to Mitigates Insulin Hypersecretion Altered Stomach Results in Recurrent, Rapid GLP-1 Receptor and Pro
Slide 13: Avexitide has the Potential to be a First-in-Class Treatment for PBH
Avexitide has the Potential to be a First-in-Class Treatment for PBH Phase 3 LUCIDITY Trial Topline Data Summary Patient Impact Avexitide met primary and secondary endpoints Preventing a single Level 2 or Level 3 hypoglycemic demonstrating statistically significant and event could enable someone to
Slide 14: Next Steps
Next Steps Josh Cohen Co-Chief Executive Officer & Co-Founder of Amylyx Justin Klee Co-Chief Executive Officer & Co-Founder of Amylyx
Slide 15: Preparing for NDA Submission and Potential Commercialization with Urgency
Preparing for NDA Submission and Potential Commercialization with Urgency Regulatory Submission Work Disease State Education ✓ Already Underway ✓ Campaign Launched Continuing to Gain Key ✓ Insights into the PBH Market Building Medical Affairs and ✓ Commercial Organization with Key Hires Leadership t
Slide 16: Avexitide Path to Potential Commercial Launch in 2027
Avexitide Path to Potential Commercial Launch in 2027 ✓ 2027 Strong IP position with patent rights through 2037, potential for By End of 2026 Anticipated additional term through August 2026 Expected NDA commercial Patent Term Extensions submission to launch in 2027, Announced positive the FDA if app
Slide 17: Q&A
Q&A YY AMYLYX