Dianthus Therapeutics, Inc. · NASDAQ:DNTH
Dianthus Therapeutics — Investor Presentation (September 2025)
32 slides from Dianthus Therapeutics's investor presentation, Sep 8, 2025
Slide 1: Claseprubart (DNTH103) Top-line Ph. 2 MaGic Results in Generalized Myasthenia Gravis
Claseprubart (DNTH103) Top-line Ph. 2 MaGic Results in Generalized Myasthenia Gravis September 8, 2025
Slide 2: Forward-looking statements
Forward-looking statements Certain statements in this presentation (“Presentation”), other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States P
Slide 3: Agenda
Agenda Introduction Marino Garcia, Chief Executive Officer MaGic Phase 2 Top-line Results Simrat Randhawa, MD, Chief Medical Officer Claseprubart Summary Remarks Marino Garcia, Chief Executive Officer Marino Garcia, Chief Executive Officer Simrat Randhawa, MD, Chief Medical Officer Analyst Q&A John
Slide 4: Introduction
Introduction Marino Garcia, CEO
Slide 5: Claseprubart targets best-in-class properties to effectively treat multiple classical pathway driven diseases
Claseprubart targets best-in-class properties to effectively treat multiple classical pathway driven diseases claseprubart Potent classical Convenient Infrequent Differentiated Pipeline-in-a- Robust IP pathway S.C. self- Q2W dosing safety profile product protection inhibition administration potentia
Slide 6: The multibillion-dollar US gMG market has significant potential to expand
The multibillion-dollar US gMG market has significant potential to expand as <20% of AChR+ patients1 currently treated with biologics Significant opportunity for a highly differentiated, more patient-friendly biologic to expand use of biologics in gMG C5s ~100,000 >4,000 pts FcRns US gMG Market Oppo
Slide 7: Claseprubart TPP aims to address unmet needs in gMG
Claseprubart TPP aims to address unmet needs in gMG by combining key elements of three best-in-class labels C5 EFFICACY C1s SAFETY CONVENIENCE (ULTOMIRIS/SOLIRIS/ZILBRYSQ) (ENJAYMO) (DUPIXENT) Comparable efficacy to C5 Comparable safety to FDA-approved Comparable convenience to complement inhibitors
Slide 8: MaGic top-line results support a potentially best-in-class treatment for gMG
MaGic top-line results support a potentially best-in-class treatment for gMG Efficacy Endpoints Safety Endpoints Optimal Dose Strong results support claseprubart Generally well tolerated, with a Comparable efficacy & safety across potential as a best-in-class potentially differentiated safety both 3
Slide 9: MaGic Phase 2 Top-line Results
MaGic Phase 2 Top-line Results Simrat Randhawa, MD, CMO
Slide 10: MaGic is a global Ph. 2 trial in AChR+ gMG patients
MaGic is a global Ph. 2 trial in AChR+ gMG patients A global, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and PK / PD of claseprubart administered S.C. following initial loading dose Highlights • Design: ~60 male and female subjects 13-week RCT r
Slide 11: Participant baseline characteristics were generally well balanced across arms
Participant baseline characteristics were generally well balanced across arms Claseprubart Claseprubart Placebo 300mg Q2W 600mg Q2W (N=22) AChR+ gMG participants (N=21) (N=22) Age, mean (SD), years 52.2 (16.5) 57.1 (13.7) 55.3 (12.0) Male, n (%) 13 (59%) 14 (67%) 10 (45%) Weight, mean (SD), pounds 1
Slide 12: Statistically significant improvement in MG-ADL score for both claseprubart arms vs. placebo at Week 13
Statistically significant improvement in MG-ADL score for both claseprubart arms vs. placebo at Week 13 Mean Change in MG-ADL Score from Baseline at Week 13 Placebo Claseprubart 300mg Q2W Claseprubart 600mg Q2W (n=22) (n=21) (n=22) 0.0 Mean Change from Baseline P-value 300mg 600mg One-sided P=0.0113
Slide 13: Statistically significant improvement in QMG score for both claseprubart arms vs. placebo at Week 13
Statistically significant improvement in QMG score for both claseprubart arms vs. placebo at Week 13 Mean Change in QMG Score from Baseline at Week 13 Placebo Claseprubart 300mg Q2W Claseprubart 600mg Q2W (n=22) (n=21) (n=22) 0.0 Mean Change from Baseline P-value 300mg 600mg -2.0 One-sided P=0.0144*
Slide 14: Rapid, sustained, clinically meaningful improvements in MG-ADL score
Claseprubart arms demonstrated rapid, sustained, and clinically meaningful improvements in MG-ADL score 0.0 Placebo (n=22) Claseprubart 300mg Q2W (n=21) Claseprubart 600mg Q2W (n=22) -1.0 Mean Change from Baseline in MG-ADL Score -2.0 -2.8 -3.0 -1.8 -2.6 P=0.0113* P=0.0006* -4.0 -4.6 -5.0 -5.4 -6.0
Slide 15: Rapid, sustained, clinically meaningful improvements in QMG score
Claseprubart arms demonstrated rapid, sustained, and clinically meaningful improvements in QMG score 0.0 Placebo (n=22) Claseprubart 300mg Q2W (n=21) Claseprubart 600mg Q2W (n=22) Mean Change from Baseline -1.0 -2.0 in QMG Score -2.0 -2.4 -2.5 P=0.0144* P=0.0111* -3.0 -4.0 -4.4 -4.5 -5.0 Statistical
Slide 16: >60% of participants on 300mg achieved ≥5 point improvement in MG-ADL
>60% of participants on claseprubart 300mg achieved ≥5 point improvement in MG-ADL Improvement in MG-ADL Total Score Claseprubart 300mg Q2W Placebo Claseprubart 600mg Q2W Placebo ≥11 ≥11 5% ≥10 ≥10 5% Improvement from Baseline ≥9 11% ≥9 10% in MG-ADL Score ≥8 11% ≥8 14% ≥7 28% ≥7 29% ≥6 50% 14% ≥6 5
Slide 17: >60% of participants on 300mg achieved ≥5 point improvement in QMG
>60% of participants on claseprubart 300mg achieved ≥5 point improvement in QMG Improvement in QMG Total Score Claseprubart 300mg Placebo Claseprubart 600mg Placebo ≥13 6% ≥13 ≥12 6% ≥12 Improvement from Baseline ≥11 6% ≥11 ≥10 17% 5% ≥10 5% in QMG Score ≥9 22% 5% ≥9 10% 5% ≥8 22% 14% ≥8 14% 14% ≥7
Slide 18: 37% of 300mg participants achieved Minimal Symptom Expression on MG-ADL at Week 13
37% of 300mg claseprubart-treated participants achieved Minimal Symptom Expression on MG-ADL at Week 13 Minimal Symptom Expression (MSE) % of Participants Achieving MG-ADL Score of 0 or 1 at Week 13 P=0.1031 P=0.0550* 37% 27% 14% Placebo Claseprubart 300mg Claseprubart 600mg (Week 13) (Week 13) (Wee
Slide 19: Statistically significant improvement in MGC for both claseprubart arms vs. placebo
Statistically significant improvement in MGC for both claseprubart arms vs. placebo at Week 13 Mean Change in MGC Summed Muscle Score from Mean Change in MGC Score from Baseline at Week 13 Baseline at Week 13 (post-hoc analysis) Claseprubart Claseprubart Claseprubart Claseprubart Placebo 300mg Q2W 6
Slide 20: Statistically significant improvement in MG-QoL-15r score for 300mg vs. placebo
Statistically significant improvement in MG-QoL-15r score for 300mg vs. placebo at Week 13 Mean Change in MG-QoL-15r Score from Baseline at Week 13 Placebo Claseprubart 300mg Q2W Claseprubart 600mg Q2W (n=22) (n=21) (n=22) 0.0 -1.0 Mean Change from Baseline in MG-QoL-15r Score -2.0 -3.0 -3.9 -4.0 -5
Slide 21: Across key efficacy measures, claseprubart demonstrated robust and clinically meaningful responses
Across key efficacy measures, claseprubart demonstrated robust and clinically meaningful responses Claseprubart 300mg Q2W Claseprubart 600mg Q2W Placebo Placebo- Placebo- Absolute Absolute adjusted adjusted MG-ADL mean change from -1.8 -2.6 -2.8 -4.6 -5.4 baseline at Week 13 (P=0.0113)* (P=0.0006)*
Slide 22: Claseprubart was generally well tolerated with a potentially differentiated safety profile
Claseprubart was generally well tolerated, with a favorable, potentially differentiated safety profile in Phase 2 Placebo Claseprubart 300mg Q2W Claseprubart 600mg Q2W (N=22) (n=21) (n=22) Clinical adverse events (AEs)(1) 11 (50.0%) 13 (61.9%) 15 (68.2%) Related serious AEs 1 (4.5%) 0 (0%) 0 (0%) RC
Slide 23: Potential Ph. 3 trial design pending regulatory feedback
Potential Ph. 3 trial design pending regulatory feedback Considering adding a second claseprubart arm testing 300mg Q4W based on early PK/PD data from Phase 2 OLE, to be discussed with regulatory authorities S.C. Treatment Period TBD Open-Label Extension Claseprubart 300mg S.C. Q2W Screening Period
Slide 24: Claseprubart Summary Remarks
Claseprubart Summary Remarks Marino Garcia, CEO
Slide 25: Statistically significant and clinically meaningful improvements in MG-ADL
Claseprubart demonstrated statistically significant and clinically meaningful improvements in MG-ADL Claseprubart S.C. Ultomiris IV Soliris IV Zilbrysq QD PFS Ph II MAGIC Ph III CHAMPION MG Ph III REGAIN Ph III RAISE Week 13 Week 26 Week 26 Week 12 n = 65 n = 78 n = 62 n = 86 BL = 8.4 BL = 9.1 BL =
Slide 26: Additional secondary efficacy measures support best-in-class potential
Additional secondary efficacy measures support claseprubart potential as best-in-class complement inhibitor QMG Score Minimal Symptom Expression (MSE) Claseprubart S.C. Ultomiris IV Claseprubart S.C. Ultomiris IV Ph II MAGIC Ph III CHAMPION MG Ph II MAGIC Ph III CHAMPION MG Week 13 Week 26 Week 13 W
Slide 27: Opportunity to compete as a first-line biologic in the U.S. neuromuscular market
Claseprubart has opportunity to compete as a first-line biologic in large and growing U.S. neuromuscular market gMG is just the first step in building a leading neuromuscular franchise with claseprubart >150K patients >10K MMN patients POC supporting classical pathway >140K patients inhibition and l
Slide 28: Multiple near-term catalysts driven by clinical data readouts in CIDP and MMN
Multiple internal and external near-term catalysts driven by clinical data readouts in CIDP and MMN gMG CIDP MMN Phase 3 2026: Claseprubart registrational Ph. 3 study 2H’26: Claseprubart interim responder analysis 2H’26: Claseprubart top-line Ph. 2 data from initiation from CAPTIVATE expected MOMENT
Slide 29: Pursuing the power of consistent control…with one-click!
Pursuing the power of consistent control…with one-click! claseprubart CONFIDENCE CLASSICAL CONVENIENCE Aim for Potent, Rapid, Upstream Inhibition of <10-Second Consistent Efficacy Classical Pathway Only Autoinjector Potential for Potential to Preserve One-Click Best-in-Class Profile Immune Function
Slide 30: Q&A
Q&A Top-line Ph. 2 MaGic Results in Generalized Myasthenia Gravis September 8, 2025
Slide 31: Appendix
Appendix
Slide 32: Rationale for adding 300mg Q4W in addition to 300mg Q2W in future Ph. 3 study
Rationale for adding 300mg Q4W in addition to 300mg Q2W in future Ph. 3 study Mean Change in MG-ADL Score from RCT Baseline to OLE Week 4 Placebo OLE Treated 9.0 8.5 OLE Data Support 300mg Q4W 8.0 Dosing in Future Ph. 3 Study Mean Change from Baseline 7.0 -2.8 • Placebo patients switching over to in
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