Regeneron Pharmaceuticals (REGN) investor relations material

Overview and Strategy

• Linvoseltamab (Lynozyfic), a BCMAxCD3 bispecific antibody, aims to transform multiple myeloma treatment across all lines, including precursor conditions and amyloidosis, by simplifying regimens and reducing treatment burden.

• The strategy targets high-risk smoldering myeloma, MGUS, and amyloidosis for disease prevention and potential elimination.

• Focus is on building market share in late-line myeloma, then advancing to earlier lines and prevention, supported by best-in-class late-line and emerging early-line data.

• Eight registrational studies are ongoing or planned, spanning late-line, early-line, and precursor conditions, with pivotal data expected from 2027 to 2029.

• Confirmatory phase III LINKER-MM3 is fully enrolled, with data expected in 2027.

Key Clinical Data and Study Results

• In relapsed/refractory multiple myeloma, linvoseltamab achieved a 71% overall response and 45% complete response at 21.3 months, with rapid, durable responses and median time to response under 1 month.

• Early-line studies (LINKER-MM4) in newly diagnosed patients reported ≥70% VGPR+ and 95% MRD negativity among evaluable patients, with median time to response of 1.2 months.

• Second-line combination with carfilzomib achieved 90% overall response and 76% complete response, with strong MRD negativity and no new safety signals.

• In high-risk smoldering myeloma, monotherapy showed 100% overall response and nearly 40% complete response in under four months.

• Early amyloidosis data demonstrated rapid normalization of free light chains, outperforming standard regimens in speed of response.

Safety and Administration Profile

• Linvoseltamab has a favorable safety profile, with low rates and severity of cytokine release syndrome, manageable adverse events, and no dose-limiting toxicities or grade V events in early-line studies.

• Most CRS events were grade 1, and infection rates decreased over time, especially in early-line patients.

• Step-up dosing and hospitalization after initial doses are used to mitigate CRS and neurologic risks; dosing frequency may be reduced based on response.

• Subcutaneous formulation development is underway, with future data expected.

• Serious risks include CRS, neurologic problems, infections, decreased blood counts, and liver issues; patients must carry a wallet card listing symptoms.