Dianthus enters exclusive license agreement with Leads Biolabs for DNTH212

Dianthus (DNTH) Therapeutics entered into an exclusive licensing agreement with Nanjing Leads Biolabs for DNTH212, a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor. DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. A two-part Phase 1 study in China in healthy volunteers and patients with systemic lupus erythematosus is expected to initiate by year end 2025, with top-line results in healthy volunteers expected in the second half of 2026. Under the terms of the agreement, Dianthus will pay Leads Biolabs up to $38M, comprised of $30M in upfront and near-term milestone payments plus an additional $8M milestone upon the initiation of a Dianthus-led Phase 1 study, for exclusive rights to develop and commercialize DNTH212 globally outside of Greater China. Leads Biolabs will also be eligible to receive up to an additional $962M in total development and regulatory approval milestones and sales-based milestones across multiple indications, as well as tiered royalties from mid-single digits up to a low double-digit on ex-Greater China net sales. Dianthus will have an estimated pro forma cash balance of approximately $525 million following the in-licensing of DNTH212. Estimated pro forma cash includes preliminary and unaudited cash, cash equivalents and investments as of September 30, 2025 of approximately $555M less $30M n of upfront and near-term milestone payments made to Leads Biolabs as part of the in-licensing. Dianthus is reaffirming its guidance of cash runway into 2028, including the planned development of DNTH212.