GSK (GSK) investor relations material

Key clinical program updates

• Phase III readouts for camlipixant in chronic cough (CALM-1 and CALM-2) expected this year, with CALM-1 completed and CALM-2 fully enrolled; studies enriched for high cough frequency and increased sample size to meet FDA requirements.

• Camlipixant aims for a clinically meaningful 15% placebo-adjusted reduction in cough frequency, with lower taste disturbance rates than gefapixant due to higher selectivity.

• Bepirovirsen filing with FDA on track for Q1, targeting a 15% functional cure rate in hepatitis B, a significant improvement over current therapies.

• Efimosfermin (FGF21) positioned as best-in-class for MASH, with advantages in immunogenicity, scalability, and weekly dosing; efficacy preserved even with GLP-1 background therapy.

• Broad respiratory pipeline includes ultra-long-acting biologics and novel mechanisms, with segmentation of COPD based on underlying biology and treatable traits.

Market opportunity and strategy

• Chronic cough represents a large unmet need, with 40 million affected globally and significant demand for effective, tolerable therapies.

• Bepirovirsen's commercial opportunity estimated at $2 billion peak sales, with initial uptake expected in the U.S. and expansion in low/middle-income countries as diagnosis rates improve.

• R&D strategy focuses on validated biological mechanisms with potential for differentiation, leveraging translational confidence and market need.

• Recent deals (e.g., RAPT, FGF21) target overlooked or underexploited validated pathways, aiming for improved patient experience and broader applicability.

Innovation and technology

• AI is integrated into drug discovery, enabling rapid candidate selection and multimodal data analysis for target-trait pairing.

• AI-driven approaches have informed combination strategies (e.g., IL-33/TSLP) and accelerated development timelines.

• Human datasets with proteomics, genetics, and imaging are leveraged to map disease biology and optimize clinical development.