Dianthus Therapeutics FY Conference Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Focus**: Development of autoimmune therapeutics with best-in-class potential, specifically targeting myasthenia gravis and other neuromuscular indications [6][16] Key Products and Pipeline 1. **Clecipabar** - A potent active C1s inhibitor aimed at treating myasthenia gravis - Recent phase two data showed statistically significant efficacy across five measures, including MGADL and QMG [8][14] - Moving forward with a phase three trial using a 300 mg dose every two weeks, with potential for a once-a-month dosing strategy [14][16] 2. **DNTH212** - A bifunctional fusion protein licensed from Leed BioLabs, targeting two mechanisms of action for improved efficacy in autoimmune diseases [7][15] - Expected to allow for dosing every four to eight weeks, enhancing patient convenience [15][17] Clinical Data Highlights - **Phase Two Data for Clecipabar**: - 300 mg dose showed robust efficacy with a 2.8 response on MGADL in placebo patients transitioning to treatment [12][14] - Additional data suggested that dosing every four weeks could be as effective as every two weeks [13][14] - Historical comparisons indicate potential for superior efficacy over existing treatments [14][38] - **CIDP Program**: - Accelerated interim responder analysis expected in Q2 2026, showcasing operational efficiency in patient recruitment [16][18] - Unique trial design allows for immediate switch from IVIG to clecipabar without requiring patient relapse [20][21] Market Positioning and Strategy - **CIDP Treatment Paradigm**: - Potential to shift treatment standards if clecipabar demonstrates superior efficacy compared to IVIG and FcRNs [37][38] - Emphasis on patient-friendly administration and reduced side effects compared to current therapies [38] - **MMN Program**: - Smaller but untapped market with potential for significant revenue, aiming for a self-administered autoinjector [43][44] - Expected phase two data by the end of 2026, with comparisons to existing treatments [44] Financial Position - **Cash Reserves**: Approximately $525 million, sufficient to fund operations and milestones through 2028 [17] Additional Insights - The company has a strong focus on operational execution and has successfully accelerated timelines compared to competitors [19][22] - The strategic decision to include all patient types (refractory, stable, naive) in trials enhances recruitment and reflects a more inclusive approach [30][31] - The potential for upstream inhibition of pro-inflammatory cytokines (C3a, C3b) may lead to better efficacy outcomes compared to downstream inhibitors like C5 [40][42] This summary encapsulates the key points from the Dianthus Therapeutics FY Conference, highlighting the company's innovative approach to autoimmune therapeutics and its strategic positioning in the market.

Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Date**: October 16, 2025 - **Focus**: Development of next-generation therapeutics for autoimmune diseases Key Points Industry and Product Development - Dianthus announced an exclusive license agreement with Nanjing Leads Biolabs for **DNTH212**, a bifunctional BDCA2 and BAFF-APRIL inhibitor, which is phase 1-ready [2][3] - The agreement grants Dianthus global rights outside of Greater China for DNTH212, enhancing its position in autoimmune therapeutics [3][4] - DNTH212 is designed to target both the innate and adaptive immune systems, potentially offering enhanced efficacy for autoimmune diseases [4][6] Clinical Data and Mechanism of Action - Favorable clinical data from previous therapies (Lidofilumab and POVITAF-SET) support the efficacy of DNTH212 [4][8] - DNTH212 has shown superior in vitro inhibition of plasmacytoid dendritic cells (PDCs) and immunoglobulin reductions in non-human primates (NHPs) compared to existing therapies [4][8] - The drug is expected to have a convenient dosing regimen, potentially allowing for subcutaneous self-administration every four weeks or less [4][5] Financial and Strategic Position - Following the transaction, Dianthus estimates a pro forma cash balance of approximately **$525 million**, providing a cash runway into 2028 [5][12] - The transaction includes an upfront payment of **$30 million** and potential milestone payments totaling up to **$962 million** based on development and sales success [11][12] Future Expectations and Trials - A phase 1 trial for DNTH212 is expected to begin in Q4 2025, with results anticipated in the second half of 2026 [5][16] - The company plans to announce prioritized indications for DNTH212 in 2026, focusing on conditions where type I interferon and B cells are implicated [13][16] Collaboration and Market Position - The partnership with Nanjing Leads Biolabs is viewed as a strong collaboration, allowing for data sharing and joint development efforts [43][44] - Dianthus aims to leverage its expertise and the collaboration to maximize the potential of DNTH212 across various autoimmune indications [51][53] Competitive Landscape - There are currently no known competing BDCA2 and BAFF-APRIL inhibitors in development, positioning DNTH212 uniquely in the market [59][60] - The company emphasizes the scientific rationale behind targeting both pathways, which has been well-received by key opinion leaders in rheumatology [60][62] Conclusion - Dianthus Therapeutics is poised to enhance its leadership in autoimmune therapeutics with DNTH212, which is expected to deliver superior efficacy and patient-friendly administration [14][65] - The company is committed to advancing its pipeline and addressing significant unmet needs in the autoimmune disease space [65]