Generate Biomedicines (GENB) Morgan Stanley 24th Annual Global Healthcare Conference summary

Industry landscape and innovation

• China’s rapid innovation in biotech is driving the need for advanced, differentiated R&D strategies, especially leveraging AI and machine learning to address complex biological challenges beyond what can be easily replicated or brute-forced.

• AI adoption in drug discovery is accelerating, with generative models now enabling solutions to complex biological functions, though AI is most disruptive in molecular generation rather than the entire drug development chain.

• Regulatory uncertainty, particularly at the FDA, and potential U.S. government price negotiations (MFN) are seen as significant industry risks, potentially impacting profitability and long-term investment.

Platform and pipeline strategy

• The business is positioned as a platform with a pipeline, aiming to demonstrate the value of its AI-driven drug discovery by producing multiple transformative products rather than focusing on a single asset.

• The lead program, GB-0895, exemplifies the platform’s capabilities, with technology enabling profound changes in antibody binding regions and efficient exploration of functional space, resulting in a molecule with improved properties.

• Strategic choices in target selection and innovative clinical development pathways have accelerated GB-0895’s progress from phase I to phase III.

Clinical development and competitive positioning

• GB-0895 offers a six-month dosing interval, providing a significant convenience advantage over monthly alternatives, which is expected to improve patient adherence and potentially real-world efficacy and cost savings.

• The phase III program is designed to be highly powered for efficacy endpoints, with robust biomarker data supporting sustained pharmacodynamic effects for at least a year.

• Recruitment for pivotal asthma trials is on track, with global regulatory approvals and enrollment expected to complete by end of 2027, targeting top-line data in 2028.

• COPD represents a major growth opportunity, with low biologics penetration and the potential for the six-monthly dosing to be especially valuable for this frail patient population.