Dianthus Therapeutics (DNTH) investor relations material

Pipeline and clinical progress

• Advancing claseprubart, a potent C1s inhibitor, in three neuromuscular indications: MG, CIDP, and MMN, with phase III MG trial starting imminently and phase II MMN data expected in Q4 this year.

• Phase II MG data showed robust, statistically significant efficacy and strong safety, leading to optimized phase III design with QMG screening and larger sample size.

• CIDP interim analysis demonstrated higher responder rates and better efficacy than competitors, attributed to greater potency; phase III open-label data is promising.

• MMN market seen as underdiagnosed but a multi-billion dollar opportunity, with only two competitors; claseprubart is significantly more potent than empasiprubart.

• DNTH212, a bifunctional fusion protein targeting BDCA2 and BAFF/APRIL, is in phase I with healthy volunteers, aiming for SLE, Sjögren's, and dermatomyositis indications.

Commercial and competitive landscape

• MG market is crowded but underpenetrated, with less than 20% of eligible patients on biologics; autoinjector convenience and no box warning seen as key differentiators.

• CIDP treatment paradigm is shifting, with classical pathway inhibition expected to surpass IVIG and FcRn in efficacy and convenience.

• MMN market is smaller but largely untapped due to lack of effective therapies; potency and convenience expected to drive adoption.

• Competitor analysis highlights claseprubart's superior potency and safety profile, especially versus riliprubart and empasiprubart.

• Commercial strategy focuses on rapid execution to capture market share and expand biologic penetration in all three indications.

Financial position and strategic outlook

• $1.2 billion in cash provides runway into 2030, supporting multiple pivotal trials and parallel development.

• Focus on speed and quality in clinical execution to accelerate market entry and maximize commercial opportunity.

• Plans to build a robust rheumatology franchise with DNTH212, complementing the neuromuscular portfolio.

• Team growth and ongoing pipeline expansion are priorities for sustaining long-term independence and value creation.

• Regulatory alignment achieved to streamline MG trial enrollment and reduce screen failures, supporting timely data readout.