Dianthus Therapeutics Conference Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Event**: First annual I&I Summit - **Date**: November 12, 2025 Key Points Product Development and Trials - **Claseprubart**: The company is preparing for the Phase 3 trial design for claseprubart, following positive results from the Phase 2 MAGIC study [5][6] - **FDA Interaction**: Dianthus has not yet discussed the Phase 3 trial changes with the FDA but plans to meet to discuss the addition of a Q4 week dosing arm alongside the Q2 week arm [6][8] - **Dosing Strategy**: The company is focusing on a dosing strategy of 300 mg every two weeks and is considering once-a-month dosing based on data consistency from various studies [9][39] Screening Criteria - **QMG Score**: The company is debating the inclusion of a QMG score screening criterion for the Phase 3 trial, noting that previous trials did not use such criteria and that it could complicate patient recruitment [10][11] - **Baseline Characteristics**: The baseline QMG scores in their trial were lower than historical data, which may indicate that the efficacy results are even more impressive given the milder patient population [12][15] Autoantibody Positivity and Safety - **ANA Signal**: The company reported that the ANA signal observed in the MAGIC study does not correlate with clinical symptoms, and they plan to limit ANA testing in future trials to only symptomatic patients [16][19] - **Drug-Induced Lupus**: There is no evidence that the drug causes drug-induced lupus, and the company plans to follow a similar approach to other successful trials by limiting unnecessary testing [17][20] Recruitment and Trial Design - **Captivate Trial**: The Captivate trial is enrolling faster than expected, with interim data anticipated in Q2. The design allows for a more attractive patient experience compared to competitors [22][26] - **Patient Recruitment**: The company believes that the design of their trials, which allows for immediate drug administration and less frequent visits, makes it more appealing for patients and investigators [23][25] Future Plans - **Momentum MMN Study**: The Phase 2 study is expected to report top-line results in the second half of the year, with a focus on safety and efficacy compared to existing treatments [40][41] - **Auto Injector Development**: Dianthus is working on a subcutaneous auto-injector strategy, aiming for a label similar to Dupixent, which would allow for easier patient administration [42][44] Competitive Landscape - **Differentiation**: The company aims to differentiate itself from competitors by offering a more potent classical pathway inhibitor and a more patient-friendly trial design [41][39] Additional Insights - **Market Positioning**: The company is positioning itself strongly in the market by focusing on patient-centric trial designs and effective dosing strategies, which could enhance its competitive edge in the therapeutic landscape [39][26] - **Regulatory Strategy**: The company is confident in its regulatory strategy, leveraging existing successful auto-injector designs to streamline the approval process [44][45]

Core Insights - Dianthus Therapeutics reported significant advancements in the clinical development of claseprubart, particularly in the Phase 2 MaGic trial for generalized Myasthenia Gravis (gMG), showing statistically significant improvements in MG-ADL and QMG scores at Week 13 [1][4][5] - The company has accelerated the timeline for the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to Q2 2026 due to faster enrollment [1][6] - An exclusive licensing agreement for DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor, was announced, with Phase 1 data expected in 2H 2026 [1][8][12] - Dianthus has an estimated cash position of approximately $525 million, providing financial runway into 2028 [1][18] Clinical Development Updates - Claseprubart demonstrated rapid and clinically meaningful improvements in gMG patients, with the 300mg/2mL Q2W dose showing significant efficacy across multiple endpoints [4][5] - The Phase 3 trial for claseprubart in gMG is anticipated to begin in 2026, with a focus on both 300mg/2mL Q2W and Q4W dosing [1][11] - The ongoing Phase 2 MoMeNtum trial for Multifocal Motor Neuropathy (MMN) is expected to yield top-line results in 2H 2026 [1][7] Financial Performance - For Q3 2025, Dianthus reported a net loss of $36.8 million, or $0.97 per share, compared to a net loss of $25.2 million, or $0.74 per share, in Q3 2024 [10][24] - Research and development expenses increased to $32.5 million in Q3 2025, driven by higher clinical costs and increased headcount [10][18] - General and administrative expenses rose to $8.2 million in Q3 2025, reflecting increased staffing [10][18] Corporate Strategy - The company aims to establish itself as a leader in the autoimmune disease treatment space, focusing on delivering best-in-class therapies with infrequent, subcutaneous self-administration [2][3] - The CEO emphasized the importance of executing their plans to advance both claseprubart and DNTH212 as transformative therapies for severe autoimmune diseases [2][3]

Core Insights - Dianthus Therapeutics presented positive data from the Phase 2 MaGic trial for claseprubart in generalized Myasthenia Gravis (gMG), indicating potential for 300mg/2mL Q4W dosing [1][3][4] - A Phase 3 gMG trial is planned to start in 2026, including QMG ≥10 screening criteria and two treatment arms: 300mg/2mL Q2W and 300mg/2mL Q4W, compared to placebo [1][4][7] - New preclinical data suggest efficacy benefits of upstream (active C1s) versus downstream (C5) complement inhibition [1][5] Company Overview - Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation therapies for severe autoimmune diseases [3][9] - The company aims to build a neuromuscular franchise with claseprubart and plans to initiate a Phase 3 trial in gMG in 2026 [7][9] Clinical Data Highlights - The Phase 2 MaGic trial showed a robust decline in MG-ADL of -2.5 points at week 4 in the open-label extension, with a QMG score reduction of -3.2 points for placebo patients who received only two doses of claseprubart [5][6] - A subgroup analysis indicated a 3-point difference in MG-ADL treatment effect for patients with a QMG score ≥10 at baseline receiving 300mg/2mL Q2W [5][6] Future Outlook - The company is motivated to proceed to Phase 3 trials based on the impressive Phase 2 data and encouraging post hoc analyses [4][7] - Upcoming trials include the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in the second half of 2026 and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy [7]

Core Viewpoint - Dianthus Therapeutics, Inc. has successfully closed a public offering of 7,627,879 shares of common stock, raising approximately $288 million to support its clinical and preclinical development activities as well as general corporate purposes [1][2]. Group 1: Offering Details - The public offering price was set at $33.00 per share, with underwriters fully exercising their option to purchase an additional 1,140,000 shares [1]. - In addition to common stock, pre-funded warrants were offered to certain investors at a price of $32.999 per warrant, allowing for the purchase of up to 1,112,121 shares at an exercise price of $0.001 per share [1]. - The offering was managed by Jefferies, TD Cowen, Evercore ISI, and Stifel, with LifeSci Capital acting as the lead manager [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance the company's preclinical and clinical development activities, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing next-generation antibody complement therapeutics aimed at treating severe autoimmune diseases [5]. - The company is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharmaceutical executives [5].

Core Insights - Dianthus Therapeutics is advancing its investigational monoclonal antibody, claseprubart (DNTH103), targeting severe autoimmune diseases with significant market potential, particularly in generalized Myasthenia Gravis (gMG) [3][4][11] - The company anticipates key clinical trial results for claseprubart, including Phase 2 results from the MaGic trial in gMG in September 2025, and interim analysis from the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the second half of 2026 [1][5][6] - Financially, Dianthus reported a net loss of $31.6 million for Q2 2025, with R&D expenses increasing to $26.3 million, reflecting higher clinical costs and increased headcount [13][19] Clinical Development - The Phase 2 MaGic trial for claseprubart in gMG has completed enrollment with 65 patients, exceeding the target of 60, and results are expected in September 2025 [5] - The ongoing Phase 3 CAPTIVATE trial for CIDP is a two-part, randomized withdrawal study, with interim responder analysis anticipated in the second half of 2026 [6] - The Phase 2 MoMeNtum trial for claseprubart in Multifocal Motor Neuropathy (MMN) is also ongoing, with top-line results expected in the second half of 2026 [1][7] Financial Overview - As of June 30, 2025, the company reported $309.1 million in cash, providing a financial runway into the second half of 2027 [1][13] - R&D expenses for Q2 2025 were $26.3 million, up from $18.1 million in Q2 2024, driven by increased clinical and manufacturing costs [13][19] - General and administrative expenses rose to $8.9 million in Q2 2025, compared to $6.0 million in the same period of 2024, primarily due to increased headcount [13][19]