Dianthus Therapeutics (NasdaqCM:DNTH) 2025 Conference Transcript

Dianthus Therapeutics Conference Call Summary Company Overview - Company: Dianthus Therapeutics (NasdaqCM:DNTH) - Focus: Development of therapies for autoimmune diseases, specifically targeting myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) Key Developments Claseprubart (C1s Inhibitor) - Phase 2 Data: Positive results for myasthenia gravis with a 300 mg dose every two weeks showing rapid efficacy across five measures [2][3] - Phase 3 Plans: Transitioning to phase 3 with both every two-week and every four-week dosing paradigms [3][10] - Efficacy Comparison: Anticipated better efficacy than traditional complement inhibitors (C5s) due to its upstream inhibition mechanism [5][6] - Placebo Response: Noted a high placebo response in phase 2, which may be mitigated by adjusting screening criteria for future studies [16][17] Financial Position - Funding: Recently raised $288 million, resulting in a cash balance of approximately $525 million, providing a runway into 2028 [8] DNTH212 (Bifunctional Fusion Protein) - Mechanism: Targets both innate and adaptive immune systems, aiming for infrequent subcutaneous self-administration [9] - Phase 1 Study: IND cleared in the U.S. and soon in China, with a single-dose study in healthy volunteers starting imminently [10] Upcoming Catalysts - Phase 3 for Claseprubart: Expected to start in 2026, with details to be announced post-FDA alignment [10][40] - CIDP Interim Analysis: Results anticipated in the second quarter of 2026, moved up from the second half of the year [10][40] - MMN Phase 2 Results: Expected in the second half of 2026 [10][40] Market Positioning and Pricing Strategy - Pricing Considerations: Pricing for MG will inform CIDP and MMN pricing strategies, with potential flexibility based on market dynamics [31][32] Competitive Landscape - Comparison with Competitors: Dianthus aims to differentiate itself from competitors like Sanofi and Argenx by offering improved dosing and administration [22][30][34] Conclusion - Strategic Focus: Dianthus is positioned to leverage its innovative therapies in the autoimmune space, with a strong financial foundation and a clear roadmap for upcoming clinical trials and market entry strategies [40]