Dianthus Therapeutics — Q3 2026 Earnings Summary

Financial Performance:

• Net loss for the quarter ended September 30, 2026, was $46.6 million ($0.81 per share), compared to $36.8 million ($0.97 per share) in the same period in 2025.
• Research and development (R&D) expenses were $45.6 million for the quarter, up from $32.5 million in Q3 2025; this includes $6.3 million of stock-based compensation compared to $2.5 million in the prior year period.
• General and administrative (G&A) expenses totaled $14.1 million for the quarter, compared to $8.2 million in Q3 2025; this includes $6.4 million of stock-based compensation compared to $3.3 million in the prior year period.
• License revenue for the quarter was $1.21 million, compared to $0.40 million in Q3 2025.
• Cash, cash equivalents, and investments totaled approximately $1.2 billion as of September 30, 2026, providing a projected runway into 2030.
• Total assets were $1.28 billion as of September 30, 2026, compared to $530.9 million as of December 31, 2025.
• Total liabilities were $34.8 million as of September 30, 2026, compared to $37.5 million as of December 31, 2025.
• Accumulated deficit increased to $474.4 million as of September 30, 2026, from $336.7 million as of December 31, 2025.
• For the nine months ended September 30, 2026, net loss was $137.7 million, compared to $97.9 million for the same period in 2025.

Guidance and Future Outlook:

• Top-line results for the Phase 3 EMERGE registrational trial of claseprubart in generalized Myasthenia Gravis (gMG) are expected in the second half of 2028.
• Top-line results for Part A of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) are expected by year-end 2027, with Part B results expected by year-end 2028.
• Top-line results for the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy (MMN) are on track for December 2026.
• Preliminary data from the Phase 1 single ascending dose (SAD) Part A healthy volunteer study for DNTH212 is expected in Q1 2027.
• Preliminary results from Part B of the DNTH212 Phase 1 SAD study in SLE patients are expected in the second half of 2027.
• A Dianthus-led Phase 1 multiple ascending dose (MAD) study for DNTH212 is planned to initiate in Q2 2027, with preliminary data expected in the second half of 2027.
• An update on next steps for the prioritized indications of DNTH212 (Sjögren's Disease, SLE, and Dermatomyositis) is planned by year-end 2027.
• DNTH312 is on track to be Phase 1 ready by year-end 2027.
• Following MMN trial results, a Phase 3 trial in MMN is planned to initiate in 2027.

Business Segments and Product Lines:

• Claseprubart (DNTH103) is an investigational monoclonal antibody targeting the classical complement pathway, designed for subcutaneous self-administration every two or four weeks.
• The Phase 3 EMERGE trial in gMG is evaluating 300mg/2mL subcutaneous dosing every two weeks and every four weeks.
• Interim responder analysis from the first 40 participants in Part A of the Phase 3 CAPTIVATE trial in CIDP showed a 75% response rate, exceeding the target of 50% or greater.
• The CAPTIVATE trial design is conservatively projected to require fewer than 200 participants in Part A to randomize 128 responders into the placebo-controlled Part B.
• The Phase 2 MoMeNtum trial in MMN exceeded its original enrollment target of 36 patients, with 46 patients included in the top-line analysis.
• Claseprubart received Orphan Drug Designation from the FDA for the treatment of Myasthenia Gravis in May 2026.
• DNTH212 is an investigational bifunctional fusion protein targeting BDCA2 and BAFF/APRIL, currently in a Phase 1 study in China for healthy volunteers (Part A) and SLE patients (Part B).
• DNTH312 is an internally developed, first-in-class bifunctional fusion protein combining claseprubart and TACI to target aC1s and BAFF/APRIL.
• Multiple data presentations regarding claseprubart were made at the 18th International Congress on Neuromuscular Diseases, AAN Autoimmune Neurology Conference, AANEM Annual Meeting, and ANA Annual Meeting.

Market and Competitive Landscape:

• MMN is characterized by high unmet needs and limited competition, with IVIg being the only approved treatment.
• Claseprubart aims to address patient and physician dissatisfaction with IVIg through a differentiated, best-in-disease profile featuring potent inhibition of the classical pathway while preserving the lectin and alternative pathways.
• Claseprubart's design allows for a patient-friendly, self-administered subcutaneous autoinjector.
• DNTH212 targets both innate and adaptive immune systems to address multiple autoimmune indications including Sjögren's Disease, SLE, and Dermatomyositis.
• DNTH312 is designed to expand leadership in autoimmune diseases by targeting deeper responses and broader symptom control across larger patient populations.

Risks and Challenges:

• Preclinical testing and clinical trial results for claseprubart, DNTH212, and DNTH312 may not be predictive of future success.
• Preliminary interim analysis from the CAPTIVATE study Part A may not be predictive of results for remaining patients or Part B.
• Development timelines may be longer and costs may be higher than planned.
• The Company may be unable to successfully complete clinical development or obtain regulatory approval for its compounds.
• The Company may face delays in initiating, enrolling, or completing planned clinical trials.
• Compounds may not become commercially successful products.

Management Commentary and Tone:

• CEO Marino Garcia stated the team continues to execute on a strategy to build a best-in-disease neuromuscular franchise with claseprubart and advance a pipeline of bifunctional fusion proteins.
• Management expressed confidence in the potential for claseprubart to offer a differentiated profile due to its unique mechanism of action and convenient dosing schedule.
• The tone reflects a focus on advancing clinical programs with high unmet needs and limited competition.

Other Key Points:

• Dianthus was selected by Great Place To Work® and Fortune magazine for the 2026 Fortune Best Workplaces in BioPharma™ List, ranking among the top 30 small- and medium-sized biotechnology and pharmaceutical companies in the United States.
• The company is a clinical-stage biotechnology firm based in New York City and Waltham, Mass., dedicated to developing therapies for severe autoimmune diseases.
• Claseprubart, DNTH212, and DNTH312 are investigational agents not approved as therapies in any jurisdiction worldwide.
• The press release includes a cautionary statement regarding forward-looking statements and potential risks.