Mereo Biopharma Group (MREO) investor relations material

Company overview and portfolio

• Focuses on rare diseases with three main programs: setrusumab, alvelestat, and vantictumab, all funded through partnerships.

• Holds European rights to all programs and expects up to $1 billion in milestones and significant royalty streams.

• Financial runway extends into late 2027.

Alvelestat program and regulatory strategy

• Demonstrated clinical and biomarker efficacy in neutrophilic-driven diseases, notably alpha-1 antitrypsin deficiency, with 90% inhibition of neutrophil elastase and reduced exacerbations.

• Key endpoints under discussion include FEV1, lung density by CT, and exacerbations, with regulatory agencies differing on preferred measures.

• Pooled phase II data show a 40% reduction in exacerbations, supporting differentiation from augmentation therapy.

• Partnership with Sentynl includes upfront and R&D payments intended to fund phase III, with Sentynl's parent handling commercial manufacturing.

• Ex-U.S. rights retained, with up to GBP 475 million in milestones and double-digit U.S. royalties; EU market targets 110,000 severe patients.

Setrusumab program and regulatory interactions

• Phase III missed primary endpoint due to confounding factors, including imbalance in patient severity and increased activity in treated patients.

• Post hoc analyses show marked reductions in vertebral and other fractures, especially in high-fracturing patients.

• Statistically significant reductions in pain observed, with pain ranked as the top patient concern in surveys.

• Agencies remain focused on fracture endpoints, but FDA is open to considering different fracture types and high-fracturing subgroups.

• Ongoing open label extension study shows high patient retention, with updates on regulatory path expected by year-end.