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Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q1 Financial Results
DNTHDianthus Therapeutics(DNTH) GlobeNewswire News Room·2025-05-12 20:01

Core Insights - Dianthus Therapeutics has completed enrollment in the Phase 2 MaGic trial of DNTH103 for generalized Myasthenia Gravis (gMG), with top-line results expected in September 2025, marking the first of three anticipated catalysts for the DNTH103 neuromuscular franchise by the end of 2026 [1][3][11] - The ongoing Phase 3 CAPTIVATE trial for DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is on track for an interim responder analysis in the second half of 2026 [1][6] - The Phase 2 MoMeNtum trial for DNTH103 in Multifocal Motor Neuropathy (MMN) is also ongoing, with top-line results expected in the second half of 2026 [1][7] - The company has a strong cash position of 331.5million,projectedtoprovidefinancialrunwayintothesecondhalfof2027[1][16]ClinicalDevelopment−DNTH103isamonoclonalantibodydesignedtoselectivelyinhibittheactiveformoftheC1sprotein,targetingtheclassicalcomplementpathway[4][11]−Thedrugisintendedforconvenientsubcutaneousself−administration,potentiallyeverytwoweeks,andaimstoaddresshighunmetneedsinautoimmunedisorders[4][11]MarketOpportunity−DespiteexistingbiologicsinthegMGmarket,therearesignificantopportunitiesforimprovedfirst−linetreatmentoptions,withDNTH103positionedtooffereffectivesymptomcontrol,safety,andconvenientadministration[3][11]−ThecompanyisbuildinganeuromuscularfranchisewithDNTH103,targetingthreeindications:gMG,CIDP,andMMN[11][12]FinancialPerformance−ForQ12025,thecompanyreportedanetlossof331.5 million, projected to provide financial runway into the second half of 2027 [1][16] Clinical Development - DNTH103 is a monoclonal antibody designed to selectively inhibit the active form of the C1s protein, targeting the classical complement pathway [4][11] - The drug is intended for convenient subcutaneous self-administration, potentially every two weeks, and aims to address high unmet needs in autoimmune disorders [4][11] Market Opportunity - Despite existing biologics in the gMG market, there are significant opportunities for improved first-line treatment options, with DNTH103 positioned to offer effective symptom control, safety, and convenient administration [3][11] - The company is building a neuromuscular franchise with DNTH103, targeting three indications: gMG, CIDP, and MMN [11][12] Financial Performance - For Q1 2025, the company reported a net loss of 29.5 million, or 0.82pershare,comparedtoanetlossof0.82 per share, compared to a net loss of 13.7 million, or 0.54pershare,inQ12024[16][22]−ResearchanddevelopmentexpensesforQ12025were0.54 per share, in Q1 2024 [16][22] - Research and development expenses for Q1 2025 were 27.0 million, significantly higher than $13.1 million in Q1 2024, primarily due to increased clinical costs and headcount [16][22]