Nxera Pharma (4565) R&D Day summary

Pipeline overview and program updates

• R&D portfolio restructured to prioritize obesity, metabolism, and endocrinology, with 80% of programs in these areas and non-priority programs to be partnered or terminated.

• Key clinical assets include NXE'149 (schizophrenia), NXE'732 (IBD/solid tumors), and NXE'744 (IBD), each at significant milestones through 2025–2026.

• Seven new proprietary obesity programs launched, advancing next-generation oral therapies for weight management.

• Partnered pipeline includes collaborations with major pharma (Neurocrine, Pfizer, Centessa, AbbVie, Lilly) and co-owned companies, spanning neurology, immunology, and metabolic indications.

• Neurocrine advancing Direclidine (M4 agonist) in phase III for schizophrenia and phase II for bipolar mania; Centessa's ORX750 (narcolepsy) to enter registrational program in Q1 2026.

Clinical trial data and development milestones

• NXE'732 (EP4 antagonist) showed >30% tumor reduction in refractory renal and colorectal cancer; phase IIa expansion ongoing.

• NXE'149 (GPR52 agonist) completed phase I with robust PK and safety data; phase Ib data expected by year-end, with a EUR60m license decision pending.

• NXE'744 (EP4 agonist) completed FTIH SAD/MAD studies with no concerning adverse events; UC patient cohort underway, readout expected Q1 2026.

• ORX750 (OX2R agonist, Centessa) demonstrated strong dose-dependent efficacy in narcolepsy; phase III to start Q1 2026.

• Neurocrine's muscarinic platform, designed using NxWave™, has five clinical-stage programs for neuropsychiatric disorders, with multiple phase II/III trials ongoing.

R&D strategy and innovation priorities

• Renewed R&D focus under new CSO, emphasizing disciplined portfolio decision-making and accelerated program progression.

• Shift to best-in-class, de-risked biology targets and rapid progression to early efficacy signals in prioritized areas.

• Proprietary NxWave™ AI-driven drug discovery platform leveraged for innovation.

• Continued investment in early-stage discovery, especially in obesity and metabolic disorders.

• R&D cost compression and resource reallocation to maximize returns and accelerate discovery.