Generate Biomedicines (GENB) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Company vision and technology

• Founded in 2018 to use machine learning for protein therapeutic design, aiming to make biology programmable by understanding protein code.

• Early adoption of integrated dry and wet labs enables rapid feedback cycles, distinguishing their approach from others in AI drug discovery.

• Utilizes proprietary data, including dynamic cryo-electron microscopy, to train models at atomistic resolution, supporting differentiated results.

• Digital infrastructure has been rebuilt multiple times to stay ahead of technological advances, benefiting from a startup culture that embraces rapid change.

• Emphasizes blending machine learning with clinical and experimental expertise to unlock value and avoid pitfalls seen in early AI-driven biotech startups.

Pipeline highlights and clinical strategy

• Lead program, a long-acting TSLP antibody (GB-0895), is in phase III for severe asthma, with potential in COPD and other indications.

• Phase III SOLARIA trial targets 786 subjects, with primary endpoint of exacerbation reduction; data expected by late 2028 or early 2029.

• Aggressive move from phase I to phase III was based on strong biomarker modulation, target occupancy, and lessons from prior industry approaches.

• First-mover advantage in long-acting TSLP antibodies, with a 9-12 month lead over competitors, and strategic site selection for enrollment.

• COPD program leverages similar mechanisms, with ongoing regulatory discussions and potential for late-stage trials; broader label could enhance market positioning.

Additional pipeline programs

• MMAE neutralizer antibody in phase I aims to reduce toxicities from MMAE-based antibody-drug conjugates without impacting efficacy; proof-of-concept data expected in 2027.

• CAR T program for solid tumors, particularly ovarian cancer, is entering phase I, with potential for dosing without lymphodepletion and transformative impact if successful.

• Oncology trials and other programs are underway, supported by a cash balance of just under $460 million as of June 30.