Aura Biosciences (AURA) investor relations material

Strategic pipeline and partnerships

• Accelerating a differentiated oncology pipeline through global partnerships with innovative companies.

• Multiple clinical assets in development, including firmonertinib and next-generation ADCs.

• Firmonertinib holds Breakthrough Therapy and Orphan designation for 1L EGFR exon 20 insertion mutant NSCLC.

• ADC portfolio includes ARR-217 (CDH17 targeting, Phase 1) and ARR-002 (NaPi2b x MUC16, IND cleared, Phase 1 planned for 2H 2026).

Firmonertinib clinical development and efficacy

• Structurally differentiated EGFR inhibitor, active against classical and uncommon mutations, with high brain penetration and oral dosing.

• Approved in China for classical EGFR mutations and 2L exon 20 insertion mutations; global pivotal Phase 3 trials ongoing for 1L NSCLC with exon 20 and PACC mutations.

• FAVOUR study showed robust and durable responses in EGFR exon 20 insertion NSCLC, with ORR up to 78.6% in treatment-naïve patients.

• FURVENT Phase 3 trial in 1L EGFR exon 20 insertion NSCLC exceeded target enrollment (398 patients); primary endpoint is PFS.

• FURTHER Phase 1b study in EGFR PACC mutations showed confirmed ORR up to 68.2% at 240 mg, with median PFS of 16.0 months.

Safety and CNS activity

• Firmonertinib demonstrated manageable safety in PACC patients, with no grade 4-5 TRAEs observed.

• CNS activity observed, including complete CNS responses in PACC cohort, potentially delaying need for brain radiation.