Climb Bio (CLYM) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Pipeline overview and clinical progress

• Budoprutug, a CD19 naked monoclonal antibody, is in phase II for PMN, phase Ib for ITP, and phase Ib for SLE, with all trials expected to report data this year.

• Early data showed compelling B-cell depletion, autoantibody serum negativity, and 60% complete renal response in PMN.

• The second asset, an APRIL-only sweeper monoclonal antibody for IgA nephropathy, was licensed in January last year and is expected to have healthy volunteer data this summer.

• Subcutaneous formulation development is underway for budoprutug, aiming for broader adoption.

• Both assets are positioned for rapid advancement into pivotal studies based on upcoming proof-of-concept data.

Competitive landscape and differentiation

• CD19 targeting offers broader B-cell lineage depletion than CD20, potentially benefiting patients who failed CD20 therapies.

• Budoprutug's safety profile and redosing potential distinguish it from CAR Ts and TCEs, which carry higher risks.

• PMN competitors include CD20 agents like obinutuzumab, but budoprutug aims for deeper B-cell and autoantibody depletion.

• In ITP, the efficacy bar is set by BTK and SYK inhibitors, with durable platelet response as a key endpoint.

• The APRIL-only approach for IgA nephropathy may offer improved safety and efficacy over BAFF-APRIL dual targeting agents.

Strategic direction and market opportunity

• The company is well-capitalized with a recent $110 million raise, providing runway into 2028.

• Plans to independently pursue pivotal studies in PMN, IgAN, and ITP, with potential partnerships for broader indications like SLE.

• IgA nephropathy market is expanding due to updated KDIGO guidelines and increased focus on early, aggressive treatment.

• Pricing paradigms for IgAN therapies are evolving, with recent agents priced up to $390,000 per year.

• Efficient clinical trial design is anticipated due to regulatory recognition of disease-modifying therapies.