Amylyx Pharmaceuticals, Inc. (AMLX)·Q3 2025 Earnings Summary

Executive Summary

• EPS beat with no revenue recognized: Q3 2025 net loss per share was $0.37 vs Wall Street consensus of $0.44 loss, a ~$0.07 beat, driven by lower operating expenses and interest income; revenue was effectively $0, in line with consensus *. Values retrieved from S&P Global.
• LUCIDITY Phase 3 timeline pushed ~one quarter: enrollment now expected to complete in Q1 2026 (was 2025) with topline data in Q3 2026; launch timing for avexitide remains 2027 if approved .
• Cash runway extended into 2028 following ~$191M net proceeds from a September equity offering, ending Q3 with $344.0M cash, vs $180.8M in Q2 .
• Strategic focus: avexitide in PBH remains the core catalyst; December safety readout for AMX0114 in ALS and progress toward a Phase 3 in Wolfram syndrome provide additional optionality .

What Went Well and What Went Wrong

• What Went Well

  • Cost discipline and improved P&L: Total operating expenses fell to $36.0M from $76.1M YoY; net loss per share improved to $0.37 from $1.07 YoY .
  • Financing removes near-term overhang: ~$191M net proceeds extended cash runway into 2028, supporting launch readiness in 2027 .
  • Clear clinical narrative and engagement: “We continue to see high participant interest and broad engagement across LUCIDITY clinical trial sites” (Co-CEOs) ; CMO emphasized a well-powered design replicating prior successful Phase 2 data .

• What Went Wrong

  • LUCIDITY timing slip: enrollment delay from 2025 to Q1 2026 due to steady, not ramping, site enrollment; topline pushed to Q3 2026 .
  • Prior program setback: Company discontinued ORION (AMX0035 in PSP) after failing to show differences vs placebo at Week 24, removing a potential near-term neuro catalyst .
  • Ongoing uncertainty on label breadth: Management noted Phase 3 focuses on Roux‑en‑Y; broader use across surgeries will depend on future data and FDA discussions .

Financial Results

Notes: Margins are not meaningful due to zero/negative product revenue recognition in Q3 2025 .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We continue to see high participant interest and broad engagement across LUCIDITY clinical trial sites… we now expect completion of recruitment in Q1 2026, with topline data expected in Q3 2026.” — Joshua Cohen & Justin Klee, Co‑CEOs .
• “Lucidity is evaluating Avexitide 90 mg once daily… FDA agreed‑upon primary endpoint is reduction in the composite rate of Level 2 and Level 3 hypoglycemic events through week 16… we believe the trial is well‑powered.” — Dr. Camille Bedrosian, CMO .
• “This financing provided approximately $191 million in net proceeds… provides us with an anticipated cash runway into 2028.” — Jim Frates, CFO .

Q&A Highlights

• Enrollment dynamics: Sites are fully activated; management had expected a typical late‑stage enrollment ramp but has observed steady rates, prompting timeline updates; focus remains on quality and dietary adherence oversight with blinded CGM .
• Addressable market and clinical significance: Management reiterated ~160k PBH not controlled on diet; KOLs consider even a single severe hypoglycemic event clinically meaningful .
• Label scope across surgeries: Phase 3 is in Roux‑en‑Y; pathophysiology and Phase 2b data suggest broader potential, subject to FDA discussions and future studies .
• CMC readiness: Registration batches manufactured and on stability; suppliers have strong inspection histories; internal inspection‑readiness ongoing for 2027 launch .
• ALS biomarkers: December presentation to focus on safety; biomarker data (e.g., NfL) expected 1H 2026; multiple pathway measures planned (e.g., SBDP145) .

Estimates Context

Notes: EPS beat driven by lower operating expenses vs prior year (one‑time IPR&D and inventory charges in 2024) and other income; revenue in line with expectations given wind‑down of legacy product . Values retrieved from S&P Global.

Key Takeaways for Investors

• Cost controls and lack of one‑time charges drove a clean EPS beat vs consensus despite zero revenue recognition; the P&L trend is improving YoY *. Values retrieved from S&P Global.
• Avexitide remains the core thesis; timeline slip (~1 quarter) is operational, with quality enrollment prioritized; launch timing unchanged (2027 if approved) .
• Financing removes near‑term capital risk; runway into 2028 supports NDA prep, CMC readiness, and early commercial buildout .
• December ALS safety readout and 1H 2026 biomarker update could add optionality; Wolfram Phase 3 planning continues for 2H 2026 .
• Expect narrative focus on PBH prevalence and severity (160k target population) and payer education; management does not anticipate step therapy given lack of approved alternatives .
• Watch for Gubra candidate nomination and IND‑enabling start in coming months—expands GLP‑1 antagonist franchise beyond avexitide .
• Near‑term stock drivers: periodic LUCIDITY enrollment updates, December ALS safety, and clarity on Wolfram Phase 3 protocol; the trial delay may temper near‑term sentiment, but extended cash runway and maintained launch timing cushion execution risk .

Appendix: Selected KPIs and Operational Metrics

Cross-references:

• Q3 press release & 8‑K: operating results, cash, timeline .
• Earnings call: enrollment, commercial readiness, CMC, market sizing, label scope .
• Prior quarters: baseline guidance, cash runway, and trend context .
• PSP discontinuation press release: removal of a neuro catalyst .