Merus (MRUS) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Technology platform and clinical pipeline

• Focuses on bispecific and trispecific antibodies, engineered to behave like monoclonal antibodies for simplified manufacturing and reduced immunogenicity.

• Portfolio includes petosemtamab, zenocutuzumab, and MCLA-129, each showing strong clinical activity in various cancer types.

• Risk mitigation in design and manufacturing aims to improve clinical success rates.

Petosemtamab clinical development

• Two global phase 3 trials initiated: LiGeR-HN1 (first-line, head and neck cancer) and LiGeR-HN2 (second-line, head and neck cancer).

• Rapid trial initiation attributed to experienced leadership, strengthened clinical operations, and strong ASCO 2024 data.

• FDA supports accelerated approval pathway using overall response rate (ORR) as a primary endpoint, aligning with Project FrontRunner guidance.

• Phase 2 data showed high ORR and durable responses, especially in HPV-positive patients.

• Upcoming ESMO Asia update will provide further efficacy and dose comparison data.

Commercial and label expansion strategy

• If approved in both first- and second-line settings, petosemtamab could benefit a broad patient population, with first-line use likely limited to PD-L1 positive tumors.

• Second-line use targets patients not previously treated with petosemtamab, including those who received chemotherapy upfront.

• Phase 2 study in colorectal cancer underway, focusing on earlier-line settings after limited activity in heavily pretreated patients.

• Broader label extension opportunities considered, but focus remains on head and neck and colorectal cancer due to resource constraints.