Dianthus Therapeutics (DNTH) investor relations material

Key clinical milestones and data

• Claseprubart showed strong phase II results in myasthenia gravis, with rapid and sustained statistical significance over 13 weeks.

• Interim phase III CIDP data exceeded expectations, with a 75% responder rate, leading to trial modifications and accelerated timelines.

• MMN phase II study over-enrolled, with clean blinded data and grip strength likely as the primary endpoint for phase III.

• Phase III myasthenia gravis trial is underway, with results expected in the second half of 2028.

• CIDP trial design improvements include allowing refractory patients and switching directly from IVIG, enhancing real-world relevance.

Pipeline expansion and strategic direction

• DNTH212 is in phase I in China, with updates expected later this year and plans for a MAD study in 2027.

• DNTH312, a combination of complement inhibition and B-cell modulation, will be phase I ready by end of next year, targeting neuromuscular indications.

• The pipeline is positioned for regular launches, aiming to avoid gaps between blockbuster products.

• Future plans include leveraging clinical and regulatory expertise for rapid development and expansion into additional indications.

• DNTH212 could address larger indications than claseprubart, potentially becoming a major value driver.

Market opportunity and positioning

• CIDP is projected to be at least as large as MG commercially, with an estimated 40,000 U.S. patients and significant unmet need.

• MMN is estimated at 10,000 U.S. patients but is believed to be underdiagnosed and expected to grow.

• Claseprubart is positioned as a first-line or first-switch therapy, offering self-administration, strong efficacy, and favorable tolerability.

• Pricing strategy aims for competitiveness with FcRns in MG, with biweekly dosing for CIDP and MMN.

• The company anticipates regular pipeline updates and milestones over the next 12 months, including MMN phase III initiation and further CIDP/MG progress.