Advancing a neuromuscular franchise with claseprubart, a highly potent, investigational classical pathway inhibitor, with best-in-disease potential across generalized Myasthenia Gravis (gMG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN)

Phase 3 EMERGE registrational trial of claseprubart in gMG evaluating 300mg/2mL Q2W and 300mg/2mL Q4W on track, with top-line results expected in 2H'28

Phase 3 CAPTIVATE trial of claseprubart in CIDP evaluating 300mg/2mL Q2W now conservatively projected to require less than 200 participants in the open-label Part A in order to randomize 128 responders into the placebo-controlled withdrawal Part B portion of the study, with Part A top-line results expected by YE'27 and Part B top-line results expected by YE'28

Phase 2 MoMeNtum trial of claseprubart in MMN top-line results on track for December '26

DNTH212 continues to advance with Phase 1 single ascending dose (SAD) Part A healthy volunteer preliminary data expected in Q1'27. First SLE patient in Part B of the Phase 1 SAD study was dosed in October, with preliminary results from Part B expected in 2H'27. The Dianthus-led Phase 1 multiple ascending dose (MAD) study is planned to initiate in Q2'27 with preliminary data expected in 2H'27

DNTH312, an internally developed, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL for severe autoimmune diseases, on track to be Phase 1 ready by YE'27

Approximately $1.2 billion of cash as of September 30, 2026 provides expected runway into 2030

NEW YORK and WALTHAM, Mass., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today reported financial results for the third quarter ending September 30, 2026, and provided an update on other recent business achievements.

"The Dianthus team continues to execute on our strategy to build a best-in-disease neuromuscular franchise with claseprubart across gMG, CIDP, and MMN, while advancing an exciting pipeline of potentially best-in-disease bifunctional fusion proteins with DNTH212 and DNTH312," said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. "Following top-line results from our Phase 2 MoMeNtum trial of claseprubart in December, we plan to quickly initiate a Phase 3 trial in MMN in 2027. MMN represents a significant market opportunity, characterized by high unmet needs and limited competition. IVIg is the only approved treatment for patients with MMN, and the lack of patient and physician satisfaction with IVIg presents a meaningful opportunity for claseprubart, given its unique potential for a differentiated, best-in-disease profile due to potent inhibition of the classical pathway and preservation of the lectin and alternative pathways while targeting a patient-friendly, 300mg/2mL, self-administered subcutaneous autoinjector once every two weeks."

Claseprubart: Potential Best-in-Disease aC1s Inhibitor for Neuromuscular Diseases

Claseprubart is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. Claseprubart is designed to enable a more convenient, subcutaneous (S.C.), self-administered injection dosed as infrequently as once every two or four weeks. Claseprubart has the potential to be a best-in-disease pipeline-in-a-product across a range of autoimmune disorders with high unmet need.

Generalized Myasthenia Gravis (gMG)

   -- Phase 3 EMERGE trial on track with top-line results expected in 2H'28: A 
      Phase 3 registrational trial of claseprubart evaluating 300mg/2mL S.C. 
      Q2W and 300mg/2mL S.C. Q4W in gMG patients was initiated in June, with 
      top-line results expected in 2H'28. 
 
   -- MaGic OLE data presented at AANEM: Results from the Phase 2 MaGic 
      open-label extension (OLE) were presented at the American Association of 
      Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting, 
      September 29 to October 2, 2026, and demonstrated sustained efficacy and 
      a continued favorable safety profile for claseprubart in gMG. 

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

   -- 75% response rate observed in Interim Responder Analysis from first 40 
      participants completing Part A of Phase 3 CAPTIVATE trial, exceeding the 
      target response rate of 50% or greater based on precedent set with aC1s 
      inhibition. Results were consistent and clinically meaningful across 
      multiple efficacy measures. Claseprubart was generally well tolerated 
      with no related serious infections, no clinical symptoms of drug-induced 
      lupus (DIL), no related serious adverse events (SAEs) or discontinuations 
      due to safety. 
 
   -- CAPTIVATE Part A top-line results expected by YE'27 and Part B top-line 
      results expected by YE'28: The Phase 3 CAPTIVATE trial of claseprubart 
      300mg/2mL S.C. Q2W is now conservatively projected to require less than 
      200 participants in the open-label Part A in order to randomize 128 
      responders into the placebo-controlled withdrawal Part B portion of the 
      study. Top-line results from all participants completing Part A are 
      expected by YE'27, and top-line results from Part B are expected by 
      YE'28. 

Multifocal Motor Neuropathy (MMN)

   -- Phase 2 MoMeNtum trial top-line results on track for December '26: The 
      MoMeNtum trial, a global, randomized, double-blind, placebo-controlled 
      Phase 2 trial in patients with MMN, exceeded its original enrollment 
      target of 36 patients. Top-line results with 46 patients are on track for 
      December '26. Following top-line results, a Phase 3 trial in MMN is 
      planned to initiate in 2027. 

All Programs

   -- Multiple claseprubart data presentations were made at the 18th 
      International Congress on Neuromuscular Diseases (ICNMD), American 
      Academy of Neurology (AAN) Autoimmune Neurology Conference, American 
      Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) 
      Annual Meeting, and American Neurological Association (ANA) Annual 
      Meeting. Among the data presented were results demonstrating a sustained 
      safety and efficacy profile for claseprubart in the Phase 2 MaGic 
      open-label extension, and a 75% response rate observed in the interim 
      responder analysis of the first 40 participants completing unblinded Part 
      A of the Phase 3 CAPTIVATE trial. Presentations are available in the 
      Investors section of the Dianthus website. 

DNTH212: Potential Best-in-Disease, Bifunctional BDCA2 and BAFF/APRIL Inhibitor for Rheumatology Conditions

DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes.

   -- Dosing of SLE patients in Phase 1 Part B initiated in October: DNTH212 is 
      being evaluated in a two-part Phase 1 study in China in healthy 
      volunteers (Part A) and patients with Systemic Lupus Erythematosus (SLE, 
      Part B). Part A is evaluating single ascending doses of DNTH212, with 
      preliminary healthy volunteer data expected in Q1'27. Based upon data 
      seen to date and as previously announced by Leads Biolabs, dosing of SLE 
      patients in Part B of the Phase 1 SAD study was initiated in October, 
      with preliminary Part B SLE data expected in 2H'27. 
 
   -- Dianthus-led MAD study planned to initiate in Q2'27: Dianthus plans to 
      initiate a Phase 1 multiple ascending dose (MAD) study outside of China 
      in healthy volunteers in Q2'27 to support the continued global 
      development of DNTH212, with preliminary data expected in 2H'27. 
 
   -- Update on next steps in prioritized indications by YE'27: Dianthus plans 
      to provide an update on next steps for advancing its first three 
      prioritized indications of Sjögren's Disease (SjD), SLE, and 
      Dermatomyositis (DM) in clinical development by YE'27. 

DNTH312: An Internally Developed, First-in-Class, Next-Generation Bifunctional Fusion Protein Combining Claseprubart and TACI to Target Potent Inhibition of aC1s and BAFF/APRIL for Autoimmune Diseases

DNTH312 is an internally developed, investigational, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL. By targeting two validated pathways with complementary disease-modifying mechanisms, DNTH312 expands Dianthus' leadership position in autoimmune diseases with its potential for best-in-disease efficacy by targeting deeper responses and broader symptom control, while also addressing larger patient populations.

   -- DNTH312 is on track to be Phase 1 ready by YE'27. 

Corporate Updates

   -- Dianthus was selected by Great Place To Work(R) and Fortune magazine for 
      the 2026 Fortune Best Workplaces in BioPharma(TM) List. This was 
      Dianthus' inaugural appearance on the list, ranking among the top 30 
      small- and medium-sized biotechnology and pharmaceutical companies in the 
      United States. The Company was recognized for fostering a high-trust and 
      engaging workplace culture.