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Neurogene
Neurogene (NGNE) investor relations material
Neurogene Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary24 Mar, 2026
Executive summary
Achieved full enrollment and dosed over 50% of participants in the Embolden registrational trial for NGN-401, with dosing completion expected in Q2 2026.
NGN-401 received FDA Breakthrough Therapy designation based on positive interim safety and efficacy data from the Phase 1/2 trial.
Commercial manufacturing scale confirmed to match clinical scale, eliminating need for comparability studies for BLA submission.
Strong cash position of $269.0 million as of December 31, 2025, expected to fund operations through Q1 2028.
Financial highlights
Cash, cash equivalents, and short-term investments totaled $269.0 million at year-end 2025.
R&D expenses rose to $75.0 million in 2025 from $60.9 million in 2024, mainly due to increased Rett syndrome trial costs and headcount.
G&A expenses increased to $28.3 million in 2025 from $22.6 million in 2024, driven by higher stock-based compensation and headcount.
Net loss widened to $90.4 million in 2025 from $75.1 million in 2024.
Revenue under licensing agreements was $0.9 million in 2025.
Outlook and guidance
Dosing in the Embolden trial to be completed in Q2 2026, with updated interim safety and efficacy data expected mid-2026.
Process Performance Qualification (PPQ) campaign to begin mid-2026, supporting BLA readiness.
Cash runway projected through Q1 2028.
FDA feedback on NGN-401 manufacturing scale
R&D expense drivers and CLN5 program status
Commercial site conversion and payor research
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Latest events from Neurogene
- NGN-401 shows durable, multidomain benefits in Rett syndrome, advancing toward commercialization.NGNE
Corporate presentation24 Mar 2026 - Pivotal Rett syndrome gene therapy trial shows strong efficacy, safety, and regulatory momentum.NGNEStifel 2026 Virtual CNS Forum18 Mar 2026
- Durable functional gains in Rett syndrome drive NGN-401's pivotal trial and commercial plans.NGNELeerink Global Healthcare Conference 20269 Mar 2026
- Phase III Rett gene therapy shows sustained gains, robust safety, and midyear data update ahead.NGNETD Cowen 46th Annual Health Care Conference4 Mar 2026
- Pivotal study for NGN-401 in Rett syndrome targets Q2 2026 completion, with strong early efficacy.NGNEGuggenheim Securities Emerging Outlook: Biotech Summit 202612 Feb 2026
- Accelerated gene therapy development for Rett syndrome, with key data expected Q4 2024.NGNEGoldman Sachs 45th Annual Global Healthcare Conference3 Feb 2026
- NGN-401 low-dose led to durable, multi-domain gains and strong safety in pediatric Rett syndrome.NGNEStudy Update15 Jan 2026
- NGN-401 delivers durable, multi-domain gains in Rett syndrome, advancing toward pivotal data and launch.NGNE44th Annual J.P. Morgan Healthcare Conference14 Jan 2026
- NGN-401 shows strong efficacy and safety in Rett syndrome, advancing toward commercialization.NGNECorporate presentation12 Jan 2026
Next Neurogene earnings date
Q1 20268 May, 2026
Neurogene
Next Neurogene earnings date
Q1 20268 May, 2026
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