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    AMLX
    Earnings call· Jun 2026(Q2 FY26)

    Amylyx Pharmaceuticals Q2 FY26 earnings call AMLX

    Aug 6, 2026 Source

    Executive summary

    Amylyx Pharmaceuticals Q2 FY26 — Avexitide Phase 3 LUCIDITY Data Readout Imminent

    Amylyx Pharmaceuticals is nearing a critical inflection point with the imminent Phase 3 LUCIDITY top-line data readout for avexitide in post-bariatric hypoglycemia (PBH), expected in late August or early September. The company is actively preparing for a potential NDA submission and commercial launch in 2027, while also advancing its broader pipeline and maintaining a cash runway into 2028. The focus remains on execution to bring the first FDA-approved therapy to PBH patients.

    Highlights

    5

    • Phase 3 LUCIDITY trial for avexitide in PBH completed last patient visit in mid-to-late July, on track for top-line data readout in late August or early September.

    • Cash and marketable securities of $250.8 million as of Q2 FY26, providing an anticipated cash runway into 2028.

    • A new ICD-10 code specific to Post-Bariatric Hypoglycemia (PBH) will be effective October 1, 2026, demonstrating growing recognition of the condition.

    • AMX0035 for Wolfram syndrome showed continued stabilization or improvement in measures of glycemic control and vision in week 96 data from the Phase 2 HELIOS trial.

    • AMX0114 for ALS Phase 1 LUMINA trial is progressing with a favorable safety profile, currently enrolling cohort 3.

    Concerns

    2

    • Total operating expenses for Q2 FY26 were $45.7 million, an increase of 7% compared to Q2 FY25.

    • Selling, general and administrative expenses for Q2 FY26 increased to $21.9 million from $15.6 million in Q2 FY25, primarily due to increased legal expenses, including a 1-time legal charge, and investment in commercial strategic initiatives.

    Guidance & targets

    4
    CategoryTargetConfidence
    Avexitide Phase 3 LUCIDITY top-line data readout
    Late August or early September
    high materiality
    High
    Avexitide potential commercial launch
    2027
    high materiality
    High
    AMX0318 IND filing
    2027
    medium materiality
    Medium
    Cash runway
    Into 2028
    high materiality
    High

    Operational metrics

    8
    Cash and marketable securities
    $250.8Mvs $279.8M in Q1 FY26
    Q2 FY26

    Provides anticipated cash runway into 2028.

    Total operating expenses
    $45.7Mup 7% for the same period in 2025
    Q2 FY26

    Reflects disciplined execution and targeted investment.

    Research and development expenses
    $23.8Mcompared to $27.2M in Q2 2025
    Q2 FY26

    Decrease primarily due to AMX0035, offset by increase in avexitide development.

    Selling, general and administrative expenses
    $21.9Mcompared to $15.6M in Q2 2025
    Q2 FY26

    Increase primarily due to increased legal expenses, including a 1-time legal charge, and investment in commercial strategic initiatives.

    Non-cash stock-based compensation expense
    $8.3Mcompared to $7.4M in Q2 2025
    Q2 FY26

    Standard compensation expense.

    PBH prevalent population (US)
    160,000
    Current

    Estimate supported by independent claims analysis, field insights, and published literature.

    PBH prevalent population (US, Roux-en-Y)
    120,000
    Current

    Subset of the total PBH population, relevant for potential narrower label scenario.

    LUCIDITY trial powering
    90%
    Study design

    Powered conservatively based on prior Phase 2 data, which showed a 55% reduction in Level 2/3 composite hypoglycemic events against placebo.

    Industry KPIs

    1
    MetricValueDetails
    Pricing policy impactNew ICD-10 code specific to PBH

    Deals & partnerships

    1
    GubraSecond research collaboration to screen and develop peptide candidates for another rare endocrine disease of high unmet need.

    Follows the collaboration that identified AMX0318. Looking forward to sharing additional updates as the program advances.

    Risks & headwinds

    2
    Potential for FDA to restrict avexitide label to Roux-en-Y gastric bypass PBH patients onlyPost-NDA submission

    Approximately 120,000 of the 160,000 PBH patients in the U.S. had Roux-en-Y gastric bypass.

    Mitigation: Company will strongly make the case for a broad label based on common pathophysiology; if restricted, an efficient study would be conducted to show applicability regardless of surgery type.

    Increased legal expenses and a 1-time legal chargeQ2 FY26

    Selling, general and administrative expenses increased to $21.9 million in Q2 FY26 from $15.6 million in Q2 FY25.

    What to watch in Q3 FY26

    4

    Avexitide Phase 3 LUCIDITY top-line data readout

    Late August or early September
    CurrentLast patient visit completed mid-to-late July; database not yet locked.
    TargetPositive top-line data.

    Why it matters

    This is the pivotal data for avexitide, determining its regulatory path and commercial potential as the first FDA-approved therapy for PBH.

    We are on track and eagerly anticipating the top-line data readout in late August or early September.

    Q&A highlights

    5

    When was the last patient visit for LUCIDITY, what factors are key for database lock, and how is the EAP progressing, including patient recruitment and demand?

    The last patient visit for LUCIDITY was mid-to-late July. The team is diligently working on data cleaning and ensuring all data matches for database lock. The EAP is in its early days, open to LUCIDITY completers and prior avexitide trial participants, with great enthusiasm for participation.

    “The initial phase, if you will, of the EAP as we abbreviate it, is for those individuals in LUCIDITY who have completed the study, double-blind period, of course, and then the open-label extension. And then they had the opportunity to roll over into the EAP.”

    asked by Seamus Fernandez · answered by Camille Bedrosian

    2 min read6 chapters

    Detailed Narrative

    01

    Avexitide Phase 3 LUCIDITY Trial Progress

    The pivotal Phase 3 LUCIDITY trial for avexitide in post-bariatric hypoglycemia (PBH) has completed its last participant visit in mid-to-late July and is on track for top-line data readout in late August or early September. The trial is a randomized, double-blind, placebo-controlled study evaluating avexitide 90 mg once daily in adults with PBH following Roux-en-Y gastric bypass surgery. The primary endpoint is the FDA-agreed-upon outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through week 16. The company remains blinded to the data, with database lock pending.

    02

    PBH Market Opportunity and Awareness

    Amylyx estimates approximately 160,000 people in the U.S. are living with PBH following the two most common bariatric procedures, with about 120,000 of these having undergone Roux-en-Y gastric bypass. Market research indicates a high intent among endocrinologists to treat PBH with an approved therapy. Growing recognition of PBH is evidenced by a new ICD-10 code specific to the condition, effective October 1, 2026, which will aid in tracking and diagnosis within the medical community.

    03

    Commercial Readiness for Avexitide

    The company is actively preparing for NDA readiness and regulatory submissions, alongside strengthening launch readiness for potential commercialization of avexitide in 2027, if approved. This includes deploying field medical affairs teams for HCP scientific exchange, building out marketing, market access, and commercial operations teams, and launching a disease state education campaign, 'Uncover the Mystery of Post-Bariatric Hypoglycemia,' which includes the UncoverPBH.com platform for both HCPs and patients.

    04

    Broader Pipeline Advancement

    Beyond avexitide, Amylyx is advancing its broader pipeline. For AMX0035 in Wolfram syndrome, week 96 data from the Phase 2 open-label HELIOS trial continued to show stabilization or improvement in measures of glycemic control and vision. The Phase 1 LUMINA multiple ascending dose clinical trial for AMX0114 in ALS is progressing, currently enrolling cohort 3, having exhibited a favorable safety profile. IND-enabling studies are underway for AMX0318, a long-acting GLP-1 receptor antagonist, targeting a 2027 IND filing.

    05

    New Research Collaboration with Gubra

    Amylyx entered into a second research collaboration with Gubra in July, following the collaboration that identified AMX0318. This new collaboration aims to screen and develop peptide candidates for another rare endocrine disease of high unmet need, aligning with Amylyx's focus on serious unmet needs where treatments are inadequate or non-existent.

    06

    Financial Position and Investment Strategy

    The company ended Q2 FY26 with $250.8 million in cash and marketable securities, providing an anticipated cash runway into 2028. This funding supports operations through key milestones including the avexitide top-line readout, potential FDA approval, and commercial launch. Total operating expenses for the quarter were $45.7 million, reflecting disciplined investment in the LUCIDITY trial and commercial strategic initiatives, alongside increased legal expenses.

    AI-generated summary of the company’s earnings call. Not investment advice.