Dianthus Therapeutics (DNTH) investor relations material

Strategic focus and pipeline overview

• Advancing two clinical-stage autoimmune therapeutics: claseprubart (aC1s mAb) and DNTH212 (BDCA2 and BAFF/APRIL bifunctional fusion protein), both with best-in-class, pipeline-in-a-product potential and patient-friendly, infrequent subcutaneous self-administration.

• Claseprubart targets the classical complement pathway with a long half-life and is positioned for first-line use in neuromuscular diseases, showing positive Phase 2 results in gMG and early Phase 3 progress in CIDP.

• DNTH212 targets both innate and adaptive immune systems, demonstrating superior in vitro efficacy compared to competitors and offering broad potential across multiple autoimmune diseases.

• Strong financial position with ~$1.2B in cash and runway expected into 2030, supporting multiple near- and long-term milestones.

Clinical data and efficacy highlights

• Claseprubart Phase 2 MaGic trial in gMG showed rapid, sustained, and statistically significant improvements in MG-ADL and QMG scores versus placebo, with robust responder rates and a favorable safety profile.

• Over 60% of patients on claseprubart achieved ≥5-point improvement in MG-ADL and QMG, and 37% reached minimal symptom expression at Week 13.

• Safety profile was comparable to placebo, with no serious infections, autoimmune activation, or drug-induced lupus observed.

• Open-label extension and PK/PD data support convenient Q2W and Q4W dosing, with sustained efficacy and consistent symptom control.

Market opportunity and competitive positioning

• Claseprubart is positioned to compete as a first-line biologic in large, growing US markets for gMG (>100,000 patients), CIDP (>40,000), and MMN (>10,000), with potential to expand biologic use due to differentiated efficacy, safety, and convenience.

• Current biologic penetration in gMG is <20%, with significant opportunity for growth as the market is expected to exceed $8B by 2035.

• Surveyed US neurologists confirm high unmet need for more durable, convenient, and safer therapies in gMG, CIDP, and MMN.

• Claseprubart’s upstream inhibition may offer efficacy advantages over C5 inhibitors, with a lower risk of infection and no boxed warning or REMS.