Dianthus Therapeutics (DNTH) investor relations material

Strategic Pipeline Expansion and Opportunity Overview

• DNTH-212 (also DNTH212) is a bifunctional BDCA2 and BAFF/APRIL inhibitor, targeting both innate and adaptive immune systems for potential best-in-class efficacy in autoimmune diseases.

• Announced exclusive global license (excluding Greater China) from Leads Biolabs, with up to $38M in upfront and near-term milestone payments and up to $962M in future milestones and tiered royalties.

• Preclinical data show superior in vitro pDC inhibition versus litifilimab and greater immunoglobulin reduction in non-human primates compared to povetacicept.

• Designed for patient-friendly subcutaneous self-administration every four weeks or less frequently.

• Estimated pro forma cash of $525M by Q3 2025, supporting a cash runway into 2028 and multiple clinical catalysts.

Mechanism of Action and Preclinical Data

• DNTH-212 inhibits type I interferon via BDCA2 and B cell activation via BAFF/APRIL, with extended half-life due to FCYTE mutation.

• Superior pDC depletion and cytokine suppression observed in vitro compared to litifilimab; deeper reductions in IgM, IgA, and IgG in NHPs versus povetacicept.

• Bifunctional approach addresses diseases where both type I interferon and B cells are implicated.

• Clinical proof of concept for both mechanisms established in SLE, IgA nephropathy, and Sjogren's.

• Dual targeting offers potential for first-line use in multiple autoimmune indications with a manageable safety profile.

Clinical Development Plan

• Phase 1 study to enroll healthy volunteers and SLE patients, starting in late 2024 or by end of 2025, with top-line results expected in 2H 2026.

• IND cleared by FDA in September 2025; China IND expected Q4 2025.

• Key endpoints include suppression of interferon levels, immunoglobulin reduction, and assessment of safety, PK/PD, and preliminary efficacy.

• Indication prioritization will consider biological rationale, clinical and commercial success probability, and regulatory pathway clarity, with prioritized indications to be announced in 2026.

• Multiple clinical and regulatory milestones expected through 2026 and beyond, including pivotal data from other pipeline assets.