Generate Biomedicines (GENB) H.C. Wainwright 28th Annual Global Investment Conference summary

Company overview and technology platform

• Founded eight years ago to use generative machine learning for novel protein therapeutics, focusing on targets traditional drug discovery struggles with.

• Early focus on low biology risk products led to development of a lead TSLP asset with improved binding affinity and half-life.

• Strategic partnerships with Amgen and Novartis provided challenging targets, informing platform evolution and highlighting traditional technique limitations.

• Platform differentiates by combining advanced AI models with high-throughput experimental validation, enabling rapid hypothesis testing.

• Five molecules have advanced to the clinic, demonstrating low immunogenicity and high efficacy.

Lead programs and clinical progress

• Lead anti-TSLP asset targets asthma and COPD, offering six-month dosing versus monthly competitors, with phase III enrollment underway.

• Achieves 99.9% target saturation at 300 mg, with deep biomarker suppression sustained for a year and similar efficacy across doses.

• Phase III trial for asthma expected to complete enrollment by end of 2027, with data anticipated by late 2028 or early 2029.

• COPD data show similar pharmacokinetics and biomarker suppression, with potential for direct phase III advancement.

Oncology pipeline and innovation

• Oncology pipeline includes an MMAE neutralizing antibody in phase I, designed to reduce toxicities from antibody-drug conjugates without impacting tumor efficacy.

• Preclinical studies show up to 80% clearance of free MMAE reduces toxicities without affecting tumor killing; phase I aims for 50% reduction.

• Fast track designation received; proof of concept data expected by early 2027, with expansion cohort targeting patients with peripheral neuropathy.

• Potential for registrational trial with safety endpoint if phase I results are positive.