Climb Bio (CLYM) Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary

Key milestones and clinical pipeline

• Five clinical data readouts expected in 2024, including subcutaneous (subQ) and intravenous (IV) formulations for two antibodies targeting autoimmune diseases.

• CD19 monoclonal antibody will have healthy volunteer subQ data in H1, and phase 1b/2 data in ITP, SLE, and PMN in H2.

• APRIL-only sweeper antibody for IgA nephropathy will have mid-year data from a healthy volunteer study.

• Parallel studies in China and Australia aim to accelerate pivotal trial readiness for IgAN.

• Cash runway extends into 2028, covering all planned readouts.

CD19 antibody program and clinical strategy

• CD19 antibody offers higher affinity and subQ formulation, aiming for differentiation from UPLIZNA.

• Depleting mechanism seen as critical for efficacy in autoimmune diseases.

• SubQ formulation may allow bridging from IV or serve as a standalone option, with dosing every six months.

• PMN phase 2 study (45 patients, three doses) started in November, with dosing in 6-month cycles.

• Regulatory path for PMN is a single phase 3 study with 150 patients, using complete renal remission as the primary endpoint.

Market opportunity and indication prioritization

• PMN affects about 70,000 US patients, with two-thirds needing intervention.

• ITP pursued for proof of mechanism and potential rapid pivotal advancement if durable response exceeds 20%.

• SLE program is translational, with subtherapeutic dosing and parallel studies in China for lupus nephritis.

• Indication expansion under consideration, leveraging subQ and IV options for broader autoimmune applications.