Generate Biomedicines (GENB) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Lead TSLP program and clinical strategy

• Lead severe-asthma asset SOLAIRIA is in phase III; early data support potential six-month dosing and showed biomarker reductions at least comparable to tezepelumab.

• Phase II was skipped based on shared epitope, phase I biomarker results, regulatory precedent and modeling that indicated 99.9% target engagement; 300 mg was selected, with no added biomarker reduction above that dose.

• COPD is the planned next indication after asthma; phase Ib showed comparable biomarker reductions to asthma and no difference between 300 mg and 600 mg. Management favors two trials after FDA feedback.

• COPD rationale includes low-single-digit biologic use and high unmet need; cited tezepelumab phase II exacerbation reductions were mid-40% for patients with EOS >300 and 37% for EOS >150.

• EoE ranks third among potential indications; management also cited chronic rhinosinusitis with nasal polyps, food allergy and atopic dermatitis as TSLP opportunities.

MMAE neutralizer

• Designed to bind and clear prematurely cleaved MMAE without disrupting intact ADC, with the goal of reducing PADCEV-associated peripheral neuropathy and widening its therapeutic window.

• By end-2026, management expects to identify a dose targeting a 50% reduction in circulating MMAE; a ~40-patient expansion cohort will assess slowing or preventing progression from grade 1 to grade 2 neuropathy.

• Proof-of-concept data are expected next year; if supportive, a 100–200-patient study could assess neuropathy progression and potentially be registrational. Management said approval could precede the TSLP asset.

• Management sees potential to improve PADCEV access and treatment duration, with longer exposure potentially supporting survival; cited use was 80–90% at academic centers versus 50% in community settings.

Armored CAR-T

• Roswell Park collaboration is testing an IL-18-armored MUC16 CAR-T for ovarian cancer, designed for potent activity; the first patient has been dosed in a phase I trial expected to enroll 10–15 patients.

• Early patient outcomes will inform next steps; management does not plan to become a long-term autologous CAR-T company and may pursue a spinout or partnership if the program succeeds.

• Management framed a potential benchmark as converting partial responses seen with T-cell engagers into complete responses with CAR-T.