Enanta Pharmaceuticals (ENTA) investor relations material

Recent achievements and pipeline expansion

• Gained key insights into treating high-risk RSV patients, leading to a registration study for zelicapavir and expansion into immunology and inflammation (I&I) with new clinical candidates.

• Advanced a KIT inhibitor, STAT6 development candidate, and MRGPRX2 program into the clinic, with multiple data readouts expected in the next 12 months.

Zelicapavir RSV program and clinical strategy

• FDA agreed to a single phase III trial for zelicapavir in high-risk adults, using a supportive phase IIb study and focusing on the HR3 population (75+, COPD, or CHF).

• Primary endpoint is time to complete resolution of symptoms, with hospitalization as a key secondary endpoint.

• Phase IIb aims to confirm patient selection and effect size, streamlining the transition to phase III.

Pediatric RSV development and commercial outlook

• LOTUS pediatric study in Thailand targets children 28 days to 3 years, using the RESOLVE-P tool for symptom measurement and aiming for a registration-enabling data set.

• Market research supports a combined adult and pediatric RSV opportunity of several billion dollars, with differentiated dosing but a unified branded approach.