Dianthus Therapeutics (DNTH) investor relations material

Executive summary

• Focused on therapies for severe autoimmune and neuromuscular diseases, with lead candidates claseprubart (monoclonal antibody) and DNTH212 (bifunctional fusion protein) in advanced clinical stages.

• Claseprubart is in Phase 3 trials for gMG and CIDP, with positive interim results and regulatory progress, and is also being studied in MMN.

• DNTH212 is in Phase 1 trials for multiple autoimmune indications, with DNTH312 in preclinical/Phase 1 readiness by YE 2027.

• Claseprubart granted Orphan Drug Designation by FDA for Myasthenia Gravis in May 2026.

• FDA removed ANA as screening criteria in claseprubart trials, reducing screen failures; no SLE or DIL cases observed.

Financial highlights

• Cash, cash equivalents, and investments totaled $1.2 billion as of June 30, 2026, up from $530.9 million at December 31, 2025, providing runway into 2030.

• Net loss was $50.2 million for Q2 2026 and $91.0 million for the six months ended June 30, 2026, compared to $31.6 million and $61.1 million for the same periods in 2025.

• License revenue was $0.8 million for Q2 2026 and $1.2 million for the six months, primarily from the Tenacia Agreements.

• R&D expenses rose to $48.7 million for Q2 2026 and $83.2 million for the six months, reflecting increased clinical activity and headcount.

• G&A expenses increased to $13.6 million for Q2 2026 and $26.0 million for the six months, mainly due to higher headcount.

Outlook and guidance

• Sufficient cash runway projected into 2030 based on current operating plans.

• Top-line results from the Phase 3 EMERGE trial in gMG expected in 2H 2028; CAPTIVATE Part B guidance for CIDP expected by end of 2026.

• MoMeNtum trial for MMN completed enrollment, with results expected December 2026.

• DNTH212 Phase 1 healthy volunteer data anticipated by year-end 2026; DNTH312 aims for Phase 1 readiness by YE 2027.