Molecular Partners (MOLN) investor relations material

Program Overview and Study Rationale

• MP0712 is a DLL3-targeted Radio-DARPin using lead-212 for alpha therapy in small cell lung cancer, designed to address high unmet need in relapsed/refractory cases.

• The platform leverages rapid internalization and replenishment of DLL3, enabling high tumor accumulation even with low DLL3 expression.

• DARPins serve as efficient vectors for radiopharmaceuticals, with 212Pb as a potent therapeutic payload.

• Preclinical data showed strong tumor accumulation, rapid internalization, and favorable safety profile, with potent efficacy at clinically relevant doses.

• The technology supports fast, cost-effective clinical translation and pipeline growth.

Initial Human Imaging and Clinical Translation

• First human SPECT/CT images show specific uptake in primary and metastatic lesions, with limited healthy organ exposure.

• Imaging with 203Pb precedes 212Pb therapy, enabling patient restaging and informing study design.

• Case study patient demonstrated sustained tumor uptake over 4 days and was reclassified to Stage 4 after imaging revealed liver metastases.

• Early imaging data de-risks the trial and supports rapid development.

• Full imaging and dosimetry data from the compassionate care program will be presented at TWC 2026.

Clinical Development and Study Design

• Phase I IND has been filed in the US, with trial initiation expected before end of 2025 and initial data anticipated in 2026.

• The study will use a compressed dose-escalation design, starting at an effective dose, with imaging preceding therapy.

• Every patient will undergo imaging with 203Pb before 212Pb treatment; dose escalation and expansion phases will assess safety, efficacy, and recommended phase 2 dose.

• Initial focus is on small cell lung cancer, with plans to expand to other neuroendocrine cancers.

• Ongoing dialogue with FDA regarding regulatory clearance for the trial.