second quarter 2026
Filed Aug 6, 2026Amylyx reported second-quarter 2026 net loss of $43.4 million and expects cash runway into 2028 as pivotal Phase 3 LUCIDITY topline data remain anticipated in late August or early September 2026.
Amylyx advanced avexitide toward a near-term pivotal-data catalyst and maintained expected cash runway into 2028, while second-quarter net loss was $43.4 million versus $41.4 million in the prior-year period and SG&A expense increased to $21.9 million from $15.6 million.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Research and development expensesGAAP | $23.8 million | – | – |
| Research and development stock-based compensation expenseGAAP | $2.5 million | – | – |
| Selling, general, and administrative expensesGAAP | $21.9 million | – | – |
| Selling, general, and administrative stock-based compensation expenseGAAP | $5.8 million | – | – |
| Net lossGAAP | $43.4 million | – | – |
| Net loss per shareGAAP | $0.39 per share | – | – |
| Cash, cash equivalents, and short-term investmentsother | $250.8 million | – | – |
into 2028 outlook
- NoteCash runway expected to fund operations into 2028.
- NoteTopline data readout for the Phase 3 LUCIDITY clinical trial of avexitide in PBH is on track and anticipated in late August or early September 2026.
- NoteIf approved, commercial launch of avexitide is anticipated in 2027.
- NoteIND-enabling studies for AMX0318 are underway with an IND filing targeted for 2027.
What drove it
- Research and development expense decreased primarily due to decreased spending related to AMX0035 for progressive supranuclear palsy.
- The research and development expense decrease was offset primarily by increased spending related to clinical development of avexitide in PBH and other costs related to avexitide.
- Selling, general, and administrative expense increased primarily due to higher legal expenses and increased investment in commercial strategic initiatives.
- The last participant completed the final study visit in the 16-week double-blind period of the pivotal Phase 3 LUCIDITY trial of avexitide in PBH.
- LUCIDITY enrolled 78 participants and evaluates avexitide in adults with PBH following Roux-en-Y gastric bypass surgery.
- AMX0114 showed no drug-related serious adverse events and no serious neurological adverse events in Cohort 1. Cohorts 1 (12.5 mg) and 2 (25 mg) are fully enrolled, and Cohort 3 (50 mg) is currently enrolling.
Concerns
- Net loss for the three months ended June 30, 2026 was $43.4 million, compared to net loss of $41.4 million for the same period in 2025.
- Selling, general, and administrative expenses were $21.9 million, compared to $15.6 million for the same period in 2025.
- The LUCIDITY topline outcome remains pending.
- Week 96 HELIOS interpretation was limited by the open-label, single-arm design and small sample size (n=9 participants with data at Week 96).
- Commercial launch of avexitide in 2027 is anticipated only if approved.
What to watch
- Topline Phase 3 LUCIDITY data anticipated in late August or early September 2026, including the FDA-agreed-upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16.
- Potential avexitide NDA submission readiness and pre-commercial work supporting a potential 2027 commercial launch, if approved.
- Progress of AMX0114 dose escalation, with Cohort 3 (50 mg) currently enrolling.
- FDA discussions regarding a Phase 3 trial of AMX0035 in Wolfram syndrome.
- AMX0318 IND-enabling studies and the IND filing targeted for 2027.
Balance sheet and cash flow
- Cash, cash equivalents, and short-term investments were $250.8 million at June 30, 2026, compared to $279.8 million at March 31, 2026.
- Based on its current operating plans, Amylyx expects a cash runway into 2028.
Analysis
Amylyx's second-quarter financial results reflect continued investment ahead of the avexitide catalyst. Research and development expenses were $23.8 million, compared to $27.2 million for the same period in 2025. The company attributed the decrease primarily to lower AMX0035 spending in progressive supranuclear palsy, partly offset by higher avexitide clinical-development and related costs.
SG&A expenses were $21.9 million, compared to $15.6 million for the same period in 2025, driven primarily by higher legal expenses and increased commercial strategic investment. Net loss was $43.4 million, or $0.39 per share, compared with net loss of $41.4 million, or $0.46 per share, in the prior-year period. Stock-based compensation expense was $2.5 million in R&D and $5.8 million in SG&A.
The central operating event is completion of the final study visit in the 16-week double-blind portion of the pivotal Phase 3 LUCIDITY trial. Topline data are anticipated in late August or early September 2026. LUCIDITY enrolled 78 participants and is evaluating the FDA-agreed-upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Amylyx is also conducting NDA readiness and pre-commercial work for a potential avexitide submission and, if approved, a potential commercial launch in 2027.
Pipeline activity included dose escalation in the Phase 1 LUMINA trial of AMX0114, where Cohorts 1 and 2 are fully enrolled and Cohort 3 is enrolling. The company also continues to work with the FDA on a Phase 3 trial in Wolfram syndrome for AMX0035 and is conducting IND-enabling work on AMX0318, with an IND filing targeted for 2027. The Week 96 HELIOS update showed patterns consistent with disease stabilization, but the company stated interpretation was limited by the open-label, single-arm design and small sample size.
Liquidity remains an important support for the development plan. Cash, cash equivalents, and short-term investments were $250.8 million at June 30, 2026, compared with $279.8 million at March 31, 2026, and management expects its cash runway to fund operations into 2028. The next material disclosure is the LUCIDITY topline readout, followed by potential regulatory and commercial planning for avexitide.
Management, verbatim
With the last participant’s final study visit recently completed, we are eagerly anticipating the expected topline data readout of the pivotal Phase 3 LUCIDITY trial in post-bariatric hypoglycemia in late August or early September.
Joshua Cohen and Justin Klee, Co-CEOs
Not in the filing
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AlphaAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.