Amylyx Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $45.5 million ($0.38 per share) for the three months ended September 30, 2026, compared to a net loss of $34.4 million ($0.37 per share) for the same period in 2025.
• Research and development expenses increased to $28.4 million for the quarter, up from $19.9 million in the prior year period, driven by spending on the Phase 3 LUCIDITY trial and offset by decreased spending on AMX0035.
• Selling, general, and administrative (SG&A) expenses rose to $21.3 million for the quarter, compared to $16.2 million in the prior year period, primarily due to pre-commercialization personnel costs and PSU award vesting.
• Cash, cash equivalents, and marketable securities totaled $768.1 million at September 30, 2026, an increase from $250.8 million at June 30, 2026.
• Total operating expenses for the quarter were $49.7 million, compared to $36.0 million in the prior year period.
• Other income, net was $4.2 million for the quarter, compared to $1.6 million in the prior year period.

Guidance and Future Outlook:

• The Company remains on track to submit a New Drug Application (NDA) for avexitide to the FDA by the end of 2026.
• Management targets a potential commercial launch of avexitide in 2027, contingent on approval.
• IND-enabling studies for AMX0318 are underway, with an IND filing targeted for 2027.
• The Company is scaling its commercial organization and launch readiness capabilities to support a potential 2027 launch.

Business Segments and Product Lines:

• Avexitide (PBH): The Phase 3 LUCIDITY trial met its primary endpoint, demonstrating a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003). All secondary endpoints were also met with consistent, statistically significant reductions. Avexitide showed a favorable safety profile.
• AMX0114 (ALS): Enrollment of Cohort 4 of the Phase 1 LUMINA trial began, following the completion of Cohort 3 (n=12). The trial evaluates safety, tolerability, and biomarkers in patients with ALS. Data from the initial two cohorts was presented at the Annual NEALS Meeting.
• AMX0318 (PBH): Selected as a development candidate for a novel GLP-1 receptor antagonist following robust nonclinical and chemical properties; identified through a collaboration with Gubra A/S.
• Commercial Readiness: The Company solidified its full commercial leadership team during the third quarter, hiring across marketing, market access, patient services, and commercial operations. The disease state education platform, uncoverPBH.com, continues to operate.

Market and Competitive Landscape:

• Post-bariatric hypoglycemia (PBH) affects approximately 8% of people in the U.S. who have undergone sleeve gastrectomy or Roux-en-Y gastric bypass (approximately 160,000 people).
• There are currently no FDA-approved therapies for PBH.
• Avexitide holds Breakthrough Therapy Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation from the FDA for PBH and related indications.
• AMX0114 holds FDA Fast Track Designation for the potential treatment of ALS.

Risks and Challenges:

• The success, cost, and timing of program development activities remain uncertain.
• Regulatory approval for avexitide and successful commercialization are not guaranteed.
• The Company faces risks related to funding operations, global macroeconomic uncertainty, geopolitical instability, and public health events.
• Actual results may differ materially from forward-looking statements regarding therapeutic potential, trial timelines, and commercialization plans.

Management Commentary and Tone:

• Co-CEOs Joshua Cohen and Justin Klee described the third quarter as a "transformational period" driven by positive topline results from the LUCIDITY trial.
• Management expressed confidence in the data's strength and consistency, noting an enthusiastic response from the medical community regarding the unmet need in PBH.
• The Co-CEOs stated the Company is "well positioned" to deliver on its commitment to treat diseases with high unmet needs, citing a strengthened balance sheet from recent financing.

Other Key Points:

• Completed an underwritten public offering with net proceeds of approximately $544.6 million (rounded to $545 million in the summary), strengthening the balance sheet to enter 2027 well-funded.
• The LUCIDITY trial results will be presented as a late-breaking oral presentation at ObesityWeek® 2026 Annual Meeting on November 15, 2026.
• The LUCIDITY trial included a 32-week open-label extension (OLE) and an Expanded Access Program which remain ongoing.
• The Company intends to use its website to disclose material non-public information and comply with Regulation FD.