Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Date**: February 12, 2026 - **Key Executives**: Marino Garcia (CEO), Ryan Savitz (CFO) Key Industry and Company Insights 1. Transformational Year - 2025 was a pivotal year for Dianthus, marked by the first patient data in myasthenia gravis (MG), which exceeded expectations [2][60] 2. Product Pipeline - **DNTH212**: In-licensed from Leads Biolabs, a bifunctional fusion protein targeting BDCA2 to reduce type I interferon and BAFF/APRIL, showing potential as a best-in-class product [2][3] - **Clasiprubart**: An active C1s inhibitor with promising phase 2 data for MG, with two major catalysts expected in 2026 [3][4] 3. Upcoming Catalysts - **CIDP Phase 3 Study**: Interim responder analysis for the first 40 patients is anticipated in Q2 2026, accelerated from H2 2026 due to strong recruitment [4][16] - **MMN Phase 2 Results**: Expected in the second half of 2026 [4] 4. Competitive Landscape - **Riliprubart**: A competitor from Sanofi, currently in phase 3 studies for CIDP. Dianthus aims to demonstrate at least equal efficacy with a more convenient dosing regimen [10][12] - **Empaciperbart**: Another competitor in MMN, with Dianthus expecting similar efficacy but with advantages in administration and safety [31][39] 5. Efficacy Expectations - For CIDP, Dianthus aims for a responder rate of 40%-50% in the interim analysis, comparable to riliprubart's phase 2 data [12][17] - The company is focusing on a dosing regimen that is more efficient, potentially reducing the number of injections required [12][15] 6. Market Potential - The U.S. market for MG is estimated at $5 billion, with potential growth to $20-$25 billion as biologics penetrate further [60] - Dianthus anticipates capturing 5%-10% of the MG market, translating to $2-$4 billion in sales [60][62] 7. Financial Health - Dianthus ended the year with $514 million in cash, sufficient to fund operations through 2028 and support upcoming milestones [64] 8. Safety and Regulatory Considerations - Concerns about drug-induced lupus (DIL) were addressed, emphasizing the reliability of data from clinical trials versus anecdotal reports [54][56] - The company is confident in the safety profile of its products, with no reported cases of DIL in clinical programs [56] 9. Commercial Strategy - Dianthus plans to leverage the convenience of its auto-injector and the absence of a box warning to differentiate its products in the market [41][44] 10. Recruitment and Trial Design - The company is focusing on efficient recruitment strategies and trial designs that allow for quicker results and better patient outcomes [16][20] Conclusion Dianthus Therapeutics is positioned for significant growth with a strong pipeline and strategic focus on efficacy, safety, and market penetration. The upcoming data releases and competitive advantages in product administration are critical to its success in the evolving biotech landscape.

Core Insights - The Japanese Ministry of Health, Labour and Welfare has granted orphan drug designation to riliprubart for chronic inflammatory demyelinating polyneuropathy (CIDP), highlighting its potential to address significant unmet medical needs in this rare neurological condition [1][5] - Approximately 30% of CIDP patients do not respond to standard therapies, and many who do experience incomplete responses, indicating a substantial market opportunity for riliprubart [3][5] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, leveraging a deep understanding of the immune system [4] - The company is currently conducting two phase 3 studies for riliprubart, aiming to establish it as a first-in-class treatment for CIDP [5] Product Development - Riliprubart (SAR445088) is a humanized IgG4 monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway, potentially reducing inflammation and preventing nerve damage in CIDP [3] - Long-term efficacy and safety data from a phase 2 study of riliprubart were presented, suggesting sustained benefits for CIDP patients [2] Market Context - There are approximately 4,000 diagnosed CIDP patients in Japan, with a significant portion experiencing debilitating symptoms despite existing therapies [1][3] - The orphan drug designation in Japan adds to similar recognitions in the US and Europe, reinforcing the global regulatory acknowledgment of riliprubart's potential [5]

Core Insights - The FDA has granted orphan drug designation to riliprubart for treating antibody-mediated rejection (AMR) in solid organ transplantation, highlighting a significant unmet need in transplant medicine [1][2] - Riliprubart is a first-in-class IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway [3] - Sanofi is conducting multiple clinical studies for riliprubart, including a phase 2 study for kidney transplant recipients and two phase 3 studies for chronic inflammatory demyelinating polyneuropathy [2][6] Company Overview - Sanofi is an R&D driven biopharma company focused on improving lives through innovative medicines and vaccines, leveraging deep understanding of the immune system [5] - The company is committed to addressing urgent healthcare challenges and has a robust pipeline aimed at high unmet medical needs [5] Industry Context - Antibody-mediated rejection is a serious complication post-organ transplantation, where the recipient's immune system attacks the transplanted organ, leading to potential organ failure if untreated [4] - The orphan drug designation reflects the rarity of the condition, affecting fewer than 200,000 people in the US, and underscores the importance of developing targeted therapies in this area [1][4]