Neurogene (NGNE) Q3 2026 earnings summary

Executive summary

• Embolden completed dosing 25 participants at 1E15 vg; topline data expected in H2 2027.

• Phase 1/2 data for 10 participants showed improvement on CGI-I and at least one developmental milestone gained by each; gains continued through 30 months with no plateau observed.

• NGN-401 at 1E15 vg remained generally well tolerated across 35 Phase 1/2 and Embolden participants as of Nov. 8, 2026; no HLH cases reported.

Financial highlights

• Cash, cash equivalents and short-term investments totaled $359.7 million at Sept. 30, 2026, supporting planned operations into Q1 2029.

• Q3 2026 net loss was $29.0 million vs. $21.0 million YoY; net loss per share was $1.05 vs. $0.99.

• 9M 2026 net loss was $94.4 million vs. $65.6 million YoY; operating expenses rose to $102.4 million from $75.8 million.

• Q3 R&D expense was $23.5 million vs. $17.2 million; G&A was $8.9 million vs. $6.6 million YoY, reflecting higher clinical, CMC, staffing, stock compensation and pre-commercial costs.

Outlook and guidance

• Embolden topline data expected in H2 2027; no trial data updates are planned before then.

• BLA-enabling PPQ runs remain on track for completion by year-end 2026; commercial manufacturing scale matches clinical scale, avoiding drug-substance comparability studies.

• Commercial-readiness activities continue alongside BLA preparation; R&D and G&A expenses are expected to rise with clinical development, manufacturing and pre-commercial needs.