Generate Biomedicines (GENB) Corporate presentation summary

Platform and development model

• Integrated computational and biohardware platform uses models, agents and scalable experimentation to generate proprietary therapeutic data; cycles can run in ~8 days with up to 1 billion designed variants.

• Eight programs reached candidate nomination and five clinical or clinic-ready candidates were created; both programs that initiated proof-of-concept trials achieved clinical PoC.

• Estimated time and cost to proof of concept: 3–5 years and $25–60 million, versus 6–8 years and $380 million for traditional discovery.

• Modular capabilities include affinity optimization, conditional and de novo binding, viral neutralization, internalization, T-cell activation, protein composition and developability.

GB-0895 respiratory program

• Long-acting anti-TSLP antibody designed for Q6M dosing; reported 106 fM binding affinity, ~20x higher than tezepelumab, and 98-day human half-life.

• In Phase 1 asthma patients, 300 mg showed sustained biomarker reductions over six months; the program advanced directly from Phase 1 to Phase 3 in severe asthma.

• Phase 1 safety profile: most treatment-emergent adverse events were Grade 1–2; three Grade 3 serious adverse events were assessed as unrelated to treatment, and low ADA did not affect PK.

• SOLAIRIA-1 and -2 are parallel Phase 3 studies, each enrolling 786 severe asthma patients; 300 mg SC or placebo is given at Weeks 0 and 26, with AAER over 52 weeks as the primary endpoint.

• COPD Phase 1b was fully enrolled; preliminary data showed sustained six-month reductions in EOS, FeNO, IL-13 and IL-5 at 300 mg and 600 mg.

Oncology pipeline

• GB-4362 is designed to bind free MMAE and reduce toxicity from MMAE-based ADCs; initial development targets combination use with enfortumab vedotin and pembrolizumab in first-line metastatic urothelial cancer.

• GB-4362 Phase 1 is ongoing in patients receiving enfortumab vedotin plus pembrolizumab; Cohort 1 was fully enrolled, with expansion assessing peripheral neuropathy, free MMAE and antitumor activity.

• In monkey studies, adding GB-4362 reduced free MMAE in a dose-dependent manner; Grade 4 neutropenia was 33% with 4 mg/kg GB-4362 plus enfortumab vedotin versus 100% with enfortumab vedotin alone.

• GB-5267 is an IL-18-armored MUC16 CAR T candidate for platinum-resistant ovarian cancer; its Phase 1 dose-escalation and expansion study was planned to begin in 2H26.