DNTH

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 initiated in June ‘26, with top-line results anticipated in 2H’28 75% response rate observed in Interim Responder Analysis from first 40 participants completing Part A of Phase 3 CAPTIVATE trial of claseprubart in CIDP, with Part B top-line guidance expected by YE’26 Phase 2 MoMeNtum trial of claseprubart in MMN exceeded its original enrollment target of 36 patients; top-line results with 46 patients on track for December ’26 Building a rheumatology franchise with DNTH212 across our first three prioritized indications of Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM); Phase 1 healthy volunteer data anticipated by YE’26 Advancing 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; DNTH312 aims to be Phase 1 ready by YE’27 Approximately $1.2 billion of cash as of June 30, 2026 provides expected runway into 2030 NEW YORK and WALTHAM, Mass., Aug. 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 second quarter ending June 30, 2026, and provided an update on other recent business achievements. “Our strong execution in the first half of 2026 reflects the continued focus and discipline of the Dianthus team as we advance both claseprubart and DNTH212 for severe autoimmune diseases,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “With the initiation of our Phase 3 EMERGE registrational trial in gMG, excellent interim results from Part A of our Phase 3 CAPTIVATE trial in CIDP, and completion of enrollment in the Phase 2 MoMeNtum trial in MMN with top-line results expected in December, claseprubart continues to demonstrate its potential as a best-in-disease, pipeline-in-a-product opportunity. In addition, we anticipate Phase 1 healthy volunteer data for DNTH212 by year end. We continue to strengthen our leadership position in autoimmune diseases with today’s announcement of the addition of our innovative, internally developed, first-in-class, next generation, highly potent and half-life extended bifunctional fusion protein, DNTH312.” 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 initiated, with top-line results expected in 2H’28: A Phase 3 registrational trial of claseprubart evaluating 300mg/2mL Q2W S.C. and 300mg/2mL Q4W S.C. in gMG patients was initiated in June, with top-line results expected in 2H’28. 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. Dianthus expects to provide CAPTIVATE Part B top-line guidance by YE’26. Multifocal Motor Neuropathy (MMN) Enrollment completed, exceeding the enrollment target, in the Phase 2 MoMeNtum trial, with 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. All Programs Claseprubart presentations at the American Academy of Neurology (AAN), Peripheral Nerve Society (PNS), and European Academy of Neurology (EAN) meetings described the design of the pivotal Phase 3 CAPTIVATE study in CIDP, Phase 2 MaGic trial results in gMG, Minimal Symptom Expression (MSE) results for claseprubart from MaGic, and potential mechanistic advantages of targeting aC1s in gMG. Presentations are available in the Investors section of the Dianthus website. In March 2026, the Company filed an 8K indicating receipt of written feedback from FDA agreeing to three proposals for all ongoing and planned future claseprubart trials: Of note, there have been no cases of either SLE or DIL to date in any claseprubart program. 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. Phase 1 data anticipated by year end: A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) was initiated in December 2025, with Phase 1 healthy volunteer data anticipated by year end. Upon completion of the Phase 1 study, Dianthus plans to provide an update on next steps for advancing its priority indications in clinical development. Initial indications selected for DNTH212 clinical development: SjD, SLE, and DM were selected as the first three priority indications for DNTH212 clinical development and will serve as the foundation of a synergistic rheumatology franchise for DNTH212. 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 demonstrated comparable in vitro potency and aC1s inhibition to claseprubart across several functional assays of Classical Pathway inhibition and a similar depth of IgM, IgA, and IgG reductions vs. published values for povetacicept following a single dose in non-human primates (NHPs). Additionally, DNTH312 is enhanced with YTE half-life extension technology, and has a similar NHP half-life (22 days) to claseprubart, which has an approximately 60-day half-life in humans. DNTH312 aims to be Phase 1 ready by YE’27. Second-Quarter 2026 Financial Results Cash Position – Approximately $1.2 billion of cash, cash equivalents and investments as of June 30, 2026 is projected to provide runway into 2030. R&D Expenses – Research and development (R&D) expenses for the quarter ended June 30, 2026 were $48.7 million, inclusive of $5.6 million of stock-based compensation, compared to $26.3 million for the quarter ended June 30, 2025, which included $2.5 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs and increased headcount to support claseprubart Phase 2 and Phase 3 development. G&A Expenses – General and administrative (G&A) expenses for the quarter ended June 30, 2026 totaled $13.6 million, inclusive of stock-based compensation of $6.3 million, compared to $8.9 million for the quarter ended June 30, 2025, which included $3.2 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount. Net Loss – Net loss for the quarter ended June 30, 2026 was $50.2 million or $0.90 per share (basic and diluted) compared to $31.6 million or $0.88 per share (basic and diluted) for the quarter ended June 30, 2025. Additional Information – For additional information on the Company’s financial results for the quarter ended June 30, 2026, please refer to the Form 10-Q filed with the SEC. About Claseprubart (DNTH103)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 enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, infrequently dosed, self-administered injection. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, claseprubart has the potential to be a best-in-disease pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Claseprubart was granted Orphan Drug Designation by the FDA for the treatment of Myasthenia Gravis in May 2026. Dianthus is building a neuromuscular franchise with claseprubart and expects to report top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in December ’26, to provide an update on timing of top-line data from Part B of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy by YE’26, and to report top-line results from the Phase 3 EMERGE trial in generalized Myasthenia Gravis in 2H’28. Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About DNTH212DNTH212 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. Dianthus is building a rheumatology franchise with DNTH212 and has selected Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM) as the first three prioritized indications for clinical development. A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is ongoing, with healthy volunteer data expected by YE’26. DNTH212 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About DNTH312DNTH312 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. DNTH312 is enhanced with YTE half-life extension technology, similar to claseprubart. By targeting two validated pathways with complementary disease modifying mechanisms, DNTH312 is designed to expand Dianthus’ leadership position in autoimmune diseases with potential for best-in-disease efficacy by targeting deeper responses and broader symptom control, while also addressing larger patient populations. DNTH312 aims to be Phase 1 ready by YE’27. DNTH312 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus TherapeuticsDianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, 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 Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to claseprubart, DNTH212, and DNTH312, and any developments or results in connection therewith, including the target product profile and administration of claseprubart, DNTH212, and DNTH312; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the clinical trial designs or indications; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding market size, patient population size, and potential market opportunities, in particular with respect to claseprubart, DNTH212 and DNTH312. Claseprubart, DNTH212, and DNTH312 are investigational agents that are not approved as therapies in any indication in any jurisdiction worldwide. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of claseprubart, DNTH212, and DNTH312 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the preliminary interim analysis based on a limited number of patients from the Part A open label portion of the claseprubart CAPTIVATE study in patients with CIDP may not be predictive of the results or success of the remaining patients treated in Part A or patients treated in Part B of the CAPTIVATE study, that the development of claseprubart, DNTH212, or DNTH312 may take longer and/or cost more than planned, that the Company or its partner may be unable to successfully complete the clinical development of the Company’s compounds, that the Company or its partner may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2025, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contact Jennifer Davis RuffDianthus [email protected]

Following the update, investment bank Raymond James reaffirmed its ‘Strong Buy’ rating on Dianthus and kept its price target at $125 per share. The analyst said the 75% response rate exceeded expectations and compared favorably with Sanofi’s competing drug. Sanofi discontinued its late-stage study of riliprubart in patients with CIDP who had failed or responded inadequately to standard treatments earlier this month. Shares of Dianthus Therapeutics, Inc. (DNTH) jumped 8% on Friday after the company reported positive early data from its ongoing late-stage trial of claseprubart, an experimental drug for chronic inflammatory demyelinating polyneuropathy (CIDP). The DNTH stock, on Friday, clocked its best session since early March. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox CIDP is a rare nerve disorder that causes weakness, numbness and loss of function in the arms and legs. It occurs when the immune system mistakenly attacks the nerves. Current treatments often involve frequent infusions or steroids. In the first part of the study, 75% of the initial group of patients showed meaningful improvement after receiving claseprubart, Dianthus said. The company was expecting 50%, and the results clearly exceeded its own targets. The trial has a two-part design. In the initial part, patients received claseprubart. Those who improved were then moved into the next part of the study, where some continued on the drug, and others switched to a placebo. The goal is to see how long it takes for symptoms to return when the drug is stopped. The high response rate in the first part was seen across several measures of how well patients could move and function, the company said. Claseprubart is given as an under-the-skin injection every two weeks using a pre-filled pen, which could make it more convenient than current CIDP treatments like IVIG infusions. Dianthus also said on Friday that it now expects to provide guidance on the timing of the Part B top-line results by the end of 2026. Following the update, investment bank Raymond James reaffirmed its ‘Strong Buy’ rating on Dianthus and kept its price target at $125 per share. The analyst noted that the 75% response rate beat their expectations and stood out favorably compared to Sanofi’s competing drug. They also highlighted that the study’s design — starting with open treatment and then testing what happens when the drug is withdrawn — appears to be a lower-risk approach than the one used in Sanofi’s failed study. Sanofi discontinued its late-stage study of riliprubart in patients with CIDP who had failed or responded inadequately to standard treatments earlier this month. The company announced that an independent data monitoring committee had reviewed interim data and concluded the study was unlikely to meet its efficacy goals. The decision came after riliprubart had shown more modest results in an earlier mid-stage study, where roughly 50% of refractory patients improved at week 24. Sanofi is now evaluating whether to continue its other ongoing late-stage trial in patients already on maintenance IVIg. Dianthus, meanwhile, is also studying claseprubart in generalized myasthenia gravis and multifocal motor neuropathy as well. On Stocktwits, retail sentiment around DNTH stock fell from ‘neutral’ to ‘bearish’ over the past 24 hours, while message volume remained at ‘extremely high’ levels. According to data from Koyfin, all 15 analysts covering DNTH rate it a ‘Buy.’ The stock has a 12-month average price target of $127.67, implying a potential upside of about 56% from Friday’s close. DNTH stock has more than doubled this year. Read More: HOOD Stock: Robinhood Buckles Under SpaceX IPO Demand, Users Report Trading Issues For updates and corrections, email newsroom[at]stocktwits[dot]com. Anan Ashraf has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: SpaceX Closes Up 19% — Secures MSCI, FTSE Fast-Track Index Inclusion Why Did TRAW Stock Slump 28% After Hours? PSKY, WBD Stocks Gain After-Hours As DOJ Greenlights Merger Deal

Early GO decision reached in CAPTIVATE in March 2026 based on GO criteria of 20 confirmed responders achieved with less than 40 planned participants completing open-label Part A Claseprubart granted Orphan Drug Designation by FDA for Myasthenia Gravis Phase 3 registrational trial of claseprubart evaluating 300mg/2mL Q2W and 300mg/2mL Q4W in generalized Myasthenia Gravis (gMG) on track to initiate in mid-2026; top-line results anticipated in 2H’28 Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results on track for Q4’26 Phase 1 healthy volunteer data for DNTH212 anticipated in 2H’26 Building a rheumatology franchise around DNTH212 with first three priority indications of Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM) Further strengthened the balance sheet with approximately $719 million in gross proceeds from an underwritten public offering of common stock and pre-funded warrants Approximately $1.2 billion of cash as of March 31, 2026 provides expected runway into 2030 NEW YORK and WALTHAM, Mass., May 05, 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 first quarter ending March 31, 2026, and provided an update on other recent business achievements. “Q1 of this year was a pivotal period for Dianthus as we were able to make an early GO decision in PART A of the claseprubart CIDP CAPTIVATE study. In CAPTIVATE, we targeted 40 patients completing Part A and a response rate of approximately 50% based on precedent set with aC1s inhibition. We were able to make an early GO decision after 20 confirmed responders were identified with less than the 40 planned participants completing Part A. Claseprubart potency and early efficacy and safety results in CAPTIVATE Part A further build our confidence in claseprubart as a potentially best-in-disease therapy for neuromuscular diseases,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We are also excited to announce the first three priority indications selected for DNTH212, our first-in-class bifunctional fusion protein and next potential best-in-disease pipeline therapeutic: Sjögren’s Disease, Systemic Lupus Erythematosus, and Dermatomyositis. These are areas of high unmet need, where compelling biological rationale and clinical data support the complementary potential of targeting both BDCA2 and BAFF/APRIL to drive differentiated efficacy compared to single-mechanism approaches. Together, these indications represent a strong foundation for establishing a synergistic rheumatology franchise around DNTH212, alongside the synergistic neuromuscular franchise we are building with claseprubart in gMG, CIDP and MMN.” Claseprubart (DNTH103) Clinical Development 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 to initiate in mid-2026, with top-line results expected in 2H’28: Following the successful completion of our end-of-Phase 2 meeting with the FDA in the first quarter of 2026, a Phase 3 registrational trial of claseprubart evaluating 300mg/2mL Q2W S.C. and 300mg/2mL Q4W S.C. in gMG patients is on track to initiate in mid-2026, with top-line results expected in 2H’28. Orphan Drug Designation granted: Claseprubart was granted Orphan Drug Designation by the FDA for the treatment of Myasthenia Gravis. The FDA’s Office of Orphan Products Development grants orphan designation to drugs and biologics intended to treat rare diseases affecting fewer than 200,000 people in the United States. Orphan Drug Designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval. Claseprubart data presented at the 2026 American Academy of Neurology (AAN) Annual Meeting: Two presentations describing results from the Phase 2 MaGic trial of claseprubart in gMG and in vitro data supporting the potential mechanistic advantages of aC1s inhibition are available on the Investors section of the Dianthus website under Scientific Publications. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Early GO decision announced in Phase 3 CAPTIVATE trial in March 2026: The target for the Part A interim responder analysis was a response rate of 50% or greater (i.e., ≥20 confirmed responders out of first 40 participants to complete Part A) based on precedent set with aC1s inhibition. This GO decision was reached early, after 20 confirmed responders were achieved with less than 40 planned participants completing open-label Part A of the trial. Dianthus expects to provide CAPTIVATE Part B top-line guidance by YE’26. Multifocal Motor Neuropathy (MMN) Phase 2 MoMeNtum trial on track for top-line results in Q4’26: The MoMeNtum trial is an ongoing global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with MMN, with top-line results on track for Q4’26. All Programs In March 2026, the Company filed an 8K indicating receipt of written feedback from FDA agreeing to three proposals for all ongoing and planned future claseprubart trials: Removal of anti-nuclear antibodies ("ANAs") as a screening criteria, a common reason for screen failure across all three claseprubart programs; Removal of routine ANA testing during claseprubart clinical trials; and Reclassification of the hypothetical risk of SLE to drug-induced lupus (DIL), a side effect in several classes of widely used medications characterized by the reversal of symptoms upon discontinuation of the precipitating medication. Of note, there have been no cases of either SLE or DIL to date in any claseprubart program. DNTH212 Clinical Development 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. Initial indications selected for DNTH212 clinical development: SjD, SLE, and DM have been selected as the first three priority indications for DNTH212 clinical development and will serve as the foundation of a synergistic rheumatology franchise for DNTH212. Phase 1 data anticipated in 2H’26: A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) was initiated in December 2025, with top-line results in healthy volunteers expected in 2H’26. Upon completion of the Phase 1 study, Dianthus plans to provide an update on next steps for advancing its priority indications in clinical development. Corporate Updates: On March 12, Dianthus announced the closing of an upsized underwritten public offering of common stock and pre-funded warrants, with aggregate gross proceeds of approximately $719 million. First-Quarter 2026 Financial Results Cash Position – Approximately $1.2 billion of cash, cash equivalents and investments as of March 31, 2026 is projected to provide runway into 2030. R&D Expenses – Research and development (R&D) expenses for the quarter ended March 31, 2026 were $34.5 million, inclusive of $4.8 million of stock-based compensation, compared to $27.0 million for the quarter ended March 31, 2025, which included $2.5 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs and increased headcount to support claseprubart Phase 2 and Phase 3 development. G&A Expenses – General and administrative (G&A) expenses for the quarter ended March 31, 2026 totaled $12.5 million, inclusive of stock-based compensation of $5.8 million, compared to $7.3 million for the quarter ended March 31, 2025, which included $2.8 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount. Net Loss – Net loss for the quarter ended March 31, 2026 was $40.8 million or $0.85 per share (basic and diluted) compared to $29.5 million or $0.82 per share (basic and diluted) for the quarter ended March 31, 2025. Additional Information – For additional information on the Company’s financial results for the quarter ended March 31, 2026, please refer to the Form 10-Q filed with the SEC. About Claseprubart (DNTH103) 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 enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, infrequently dosed, self-administered injection. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, claseprubart has the potential to be a best-in-disease pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with claseprubart and expects to initiate a Phase 3 trial in generalized Myasthenia Gravis in mid-2026, with top-line results expected in 2H’28, report top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in Q4’26, and provide an update on timing of top-line data from Part B of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy by YE’26. Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About DNTH212 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. Dianthus is building a rheumatology franchise with DNTH212 and has selected Sjögren’s Disease (SjD), Systemic Lupus Erythematosus (SLE), and Dermatomyositis (DM) as the first three prioritized indications for clinical development. A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is ongoing, with top-line results in healthy volunteers expected in 2H’26. DNTH212 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus Therapeutics Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, 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 Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to claseprubart and DNTH212, and any developments or results in connection therewith, including the target product profile and administration of claseprubart and DNTH212; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the clinical trial designs or indications; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding market size, patient population size, and potential opportunities for complement therapies, in particular with respect to claseprubart and DNTH212. Claseprubart and DNTH212 are investigational agents that are not approved as therapies in any indication in any jurisdiction worldwide. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of claseprubart and DNTH212 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the preliminary interim analysis based on a limited number of patients from the Part A open label portion of the claseprubart CAPTIVATE study in patients with CIDP may not be predictive of the results or success of the remaining patients treated in Part A or patients treated in Part B of the CAPTIVATE study, that the development of claseprubart or DNTH212 may take longer and/or cost more than planned, that the Company or its partner may be unable to successfully complete the clinical development of the Company’s compounds, that the Company or its partner may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2025, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contact Jennifer Davis Ruff Dianthus Therapeutics [email protected]

Claseprubart achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL), Quantitative Myasthenia Gravis (QMG), and other efficacy measures at Week 13 in Phase 2 MaGic trial in gMG New claseprubart data from the MaGic open-label extension supporting potential for 300mg/2mL Q4W dosing and new in vitro data highlighting potential efficacy benefits of upstream (aC1s, claseprubart) vs. downstream (C5, ravulizumab) complement inhibition were presented during the AANEM Annual Meeting in October 2025 Phase 3 gMG trial including two claseprubart treatment arms, 300mg/2mL Q2W and 300mg/2mL Q4W, vs. placebo anticipated to initiate in 2026 Accelerated timing for interim responder analysis for Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); now anticipated in Q2’26 (formerly 2H’26) due to faster than expected enrollment Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 Announced exclusive license agreement for DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor; Phase 1 healthy volunteer data anticipated in 2H’26 Estimated ~$525 million of cash after DNTH212 upfront and near-term milestone payments provides runway into 2028 NEW YORK and WALTHAM, Mass., Nov. 05, 2025 (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, 2025, and provided an update on recent business achievements. “I’m extremely proud of our team’s outstanding track record of execution against our vision to become a leading biotech company in the I&I field. Just in the past 2 months, we delivered impressive results from the gMG MaGic trial, accelerated the timing of the interim responder analysis from our CIDP CAPTIVATE trial from 2H’26 to Q2'26, and in-licensed DNTH212, a new and exciting clinical-stage bifunctional fusion protein. Both claseprubart and DNTH212 have validated mechanisms of action with pipeline-in-a-product potential, and aim to deliver best-in-class efficacy, safety, and convenience with infrequent, subcutaneous self-administration,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “The claseprubart efficacy and safety data from the MaGic trial, including the recently presented data for placebo patients transitioning to claseprubart in the OLE and the post-hoc analyses highlighting the impact of QMG screening criteria on MG-ADL results, strongly support our Phase 3 plans to advance both 300mg/2mL Q2W and 300mg/2mL Q4W as a potential best-in-class treatment option in gMG. We remain focused on execution as we aim to deliver first-line biologic therapies that can meaningfully improve the lives of patients with severe autoimmune diseases.” Claseprubart (DNTH103) Clinical Development 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, self-administered injection dosed as infrequently as once every two or four weeks. Claseprubart has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Generalized Myasthenia Gravis (gMG) Positive Phase 2 data reported in September and presented at AANEM: Results from the MaGic trial, a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with gMG who are acetylcholine receptor (AChR) antibody positive, were reported in September and presented at the American Association of Neuromuscular and Electromagnetic Medicine (AANEM) Annual Meeting. Claseprubart 300mg/2mL and 600mg/4mL Q2W demonstrated rapid, statistically significant and clinically meaningful improvements over placebo as measured by both MG-ADL and QMG, including at Week 1 and at Week 13. The claseprubart 300mg/2mL Q2W dose was also statistically significant and clinically meaningful across other key efficacy endpoints, including Minimal Symptom Expression (MSE), Myasthenia Gravis Composite (MGC) Score and the Myasthenia Gravis Quality of Life Scale (MG-QoL-15r). Claseprubart was generally well tolerated with no drug-related Serious Adverse Events (SAEs) or discontinuations due to any related adverse event. New MaGic data presented during AANEM: New claseprubart data were presented during AANEM and in a Virtual Industry Forum titled Upstream Targeting: Rethinking MG Treatment Through Active C1s Inhibition, which included: A robust MG-ADL decline at week 4 in the open-label extension (OLE) of -2.5 points and QMG score reduction of -3.2 points for patients on placebo during the RCT who received only two doses of claseprubart 600mg/4mL Q2W without a loading dose and achieved a PK level far below the steady state of 300mg/2mL Q2W, supporting potential for Q4W dosing of 300mg/2mL A subgroup analysis of patients enrolled in the MaGic trial with a QMG score ≥10 at baseline which demonstrated a 3-point difference from placebo in MG-ADL treatment effect for 300mg/2mL Q2W In vitro data demonstrating the benefits of upstream (active C1s with claseprubart) vs. downstream (C5 with ravulizumab) inhibition in the prevention of pro-inflammatory split products C3a and C3b Phase 3 trial expected to begin in 2026: An end-of-Phase 2 meeting is planned with the FDA to align on the proposed design of a Phase 3 trial for claseprubart in gMG that investigates both 300mg/2mL Q2W and 300mg/2mL Q4W doses vs. placebo and includes QMG ≥10 screening criteria. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3 CAPTIVATE CIDP trial interim responder analysis now expected in Q2’26: The CAPTIVATE trial is a single, global, two-part, randomized withdrawal Phase 3 trial in patients with CIDP, and an interim responder analysis (n=40) from Part A of this trial is now expected in Q2’26, accelerated from previous guidance of 2H’26 due to faster than expected enrollment. The Company believes this single pivotal trial will support a BLA filing in adult patients with CIDP. Multifocal Motor Neuropathy (MMN) Phase 2 MoMeNtum MMN trial remains on track for top-line results in 2H’26: The MoMeNtum trial is an ongoing global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with MMN. DNTH212 Clinical Development 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. Phase 1 data anticipated in 2H’26: A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is expected to initiate by year-end 2025, with top-line results in healthy volunteers expected in the second half of 2026. An update on indication prioritization for DNTH212 is planned for 2026. Corporate Updates On September 11, Dianthus announced the closing of an upsized underwritten public offering of common stock, with aggregate gross proceeds of approximately $288 million. On October 16, Dianthus entered into an exclusive licensing agreement with Nanjing Leads Biolabs Co., Ltd. (“Leads” (9887.HK)) for DNTH212 (being developed in China by Leads Biolabs as LBL-047), a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor. Third-Quarter 2025 Financial Results Cash Position – An estimated $525 million of adjusted cash, cash equivalents and investments as of September 30, 2025 is projected to provide runway into 2028. This $525 million estimate includes cash, cash equivalents and investments as of September 30, 2025 of approximately $555.5 million, less $30 million of upfront and near-term milestone payments payable to Leads Biolabs. R&D Expenses - Research and development (R&D) expenses for the quarter ended September 30, 2025 were $32.5 million, inclusive of $2.5 million of stock-based compensation, compared to $25.5 million for the quarter ended September 30, 2024, which included $1.7 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs, milestone costs, and increased headcount to support claseprubart Phase 2 and Phase 3 development. G&A Expenses - General and administrative (G&A) expenses for the quarter ended September 30, 2025 totaled $8.2 million, inclusive of stock-based compensation of $3.3 million, compared to $6.5 million for the quarter ended September 30, 2024, which included $2.2 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount. Net Loss - Net loss for the quarter ended September 30, 2025 was $36.8 million or $0.97 per share (basic and diluted) compared to $25.2 million or $0.74 per share (basic and diluted) for the quarter ended September 30, 2024. Additional Information - For additional information on the Company’s financial results for the quarter ended September 30, 2025, please refer to the Form 10-Q filed with the SEC. About Claseprubart (DNTH103) 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 enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, infrequently dosed, self-administered injection. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, claseprubart has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with claseprubart and expects to initiate a Phase 3 trial in gMG in 2026, the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in Q2’26, and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26. Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About DNTH212 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. A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is expected to initiate by year-end 2025, with top-line results in healthy volunteers expected in the second half of 2026. DNTH212 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus Therapeutics Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, 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 Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to claseprubart and DNTH212, and any developments or results in connection therewith, including the target product profile and administration of claseprubart and DNTH212; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the clinical trial designs or indications; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding market size, patient population size, and potential opportunities for complement therapies, in particular with respect to claseprubart and DNTH212. Claseprubart and DNTH212 are investigational agents that are not approved as therapies in any indication in any jurisdiction worldwide. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of claseprubart and DNTH212 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of claseprubart or DNTH212 may take longer and/or cost more than planned, that the Company or its partner may be unable to successfully complete the clinical development of the Company’s compounds, that the Company or its partner may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2024, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contact Jennifer Davis Ruff Dianthus Therapeutics [email protected]

The market expects Dianthus Therapeutics, Inc. (DNTH) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.86 per share in its upcoming report, which represents a year-over-year change of -16.2%. Revenues are expected to be $0.66 million, down 69.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 0.62% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Dianthus Therapeutics, Inc., the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +6.98%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Dianthus Therapeutics, Inc. will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Dianthus Therapeutics, Inc. would post a loss of$0.86 per share when it actually produced a loss of -$0.88, delivering a surprise of -2.33%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Dianthus Therapeutics, Inc. appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Cytokinetics (CYTK), is soon expected to post loss of $1.59 per share for the quarter ended September 2025. This estimate indicates a year-over-year change of -16.9%. This quarter's revenue is expected to be $5.56 million, up 1108.7% from the year-ago quarter. The consensus EPS estimate for Cytokinetics has been revised 0.2% higher over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -5.53%. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Cytokinetics will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Dianthus Therapeutics, Inc. (DNTH) : Free Stock Analysis Report Cytokinetics, Incorporated (CYTK) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Phase 2 MaGic trial of claseprubart (DNTH103) in generalized Myasthenia Gravis (gMG) top-line results anticipated in September 2025; the first of three catalysts for the claseprubart neuromuscular franchise by YE’26 Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26 Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 $309.1 million of cash provides runway into 2H’27 NEW YORK and WALTHAM, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the second quarter ending June 30, 2025, and provided an update on recent business achievements. “We look forward to reporting top-line Phase 2 results from our MaGic trial with claseprubart in gMG in September. We believe the multibillion-dollar gMG market has significant potential to expand, as only approximately 10% of AChR+ patients in the U.S. are currently on FcRn or complement therapies today,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Our recently completed quantitative market research with gMG treating neurologists in the U.S. clearly highlights their desire for new, improved therapies, specifically those with greater durability of symptom control, a differentiated safety profile by eliminating the boxed warning and REMS of C5 inhibitors, and a more convenient, patient-friendly delivery like an infrequent, self-administered autoinjector. We believe claseprubart has the potential to effectively address these unmet needs and help expand the use of biologics earlier in the treatment paradigm with patients that would otherwise delay the use of more burdensome biologics.” Claseprubart (DNTH103) Clinical Development 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, self-administered injection dosed as infrequently as once every two weeks. Claseprubart has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Generalized Myasthenia Gravis (gMG) Top-line Phase 2 MaGic gMG trial results anticipated in September: The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with gMG who are acetylcholine receptor (AChR) antibody positive. As previously announced in May, enrollment in this trial was completed with 65 patients, exceeding the target of 60. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3 CAPTIVATE CIDP trial ongoing: The CAPTIVATE trial is a single, global, two-part, randomized withdrawal Phase 3 trial in patients with CIDP, and it remains on track for an interim responder analysis in 2H’26. The Company believes this single pivotal trial will support a BLA filing in adult patients with CIDP. Multifocal Motor Neuropathy (MMN) Phase 2 MoMeNtum MMN trial ongoing: The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with MMN, and it remains on track to report top-line results in 2H’26. Corporate Updates The International Nonproprietary Name (INN) has been finalized and DNTH103, a potentially best-in-class investigational classical pathway inhibitor, is now called claseprubart. On May 22, 2025, Simon Read, Ph.D., joined the Company’s Board of Directors. Dr. Read is a serial entrepreneur with more than 30 years of biopharmaceutical experience. He served as CEO and Founder of Mariana Oncology until its acquisition by Novartis in 2024 and CSO of Ra Pharma until its acquisition by UCB in 2020. Second-Quarter 2025 Financial Results Cash Position - $309.1 million of cash, cash equivalents and investments as of June 30, 2025 is projected to provide runway into the second half of 2027. R&D Expenses - Research and development (R&D) expenses for the quarter ended June 30, 2025 were $26.3 million, inclusive of $2.5 million of stock-based compensation, compared to $18.1 million for the quarter ended June 30, 2024, which included $1.4 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs, chemistry, manufacturing and controls (CMC) costs, and increased headcount to support claseprubart Phase 2 and Phase 3 development. G&A Expenses - General and administrative (G&A) expenses for the quarter ended June 30, 2025 totaled $8.9 million, inclusive of stock-based compensation of $3.2 million, compared to $6.0 million for the quarter ended June 30, 2024, which included $1.8 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount. Net Loss - Net loss for the quarter ended June 30, 2025 was $31.6 million or $0.88 per share (basic and diluted) compared to $17.6 million or $0.51 per share (basic and diluted) for the quarter ended June 30, 2024. Additional Information - For additional information on the Company’s financial results for the quarter ended June 30, 2025, please refer to the Form 10-Q filed with the SEC. About Claseprubart 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 enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, claseprubart has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with claseprubart and anticipates reporting top-line data from the Phase 2 MaGic trial in generalized Myasthenia Gravis in September 2025, the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in 2H’26, and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26. Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus Therapeutics Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, 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 Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to claseprubart, and any developments or results in connection therewith, including the target product profile and administration of claseprubart; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding the market and potential opportunities for complement therapies, in particular with respect to claseprubart. Claseprubart is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of claseprubart and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of claseprubart or the Company's other compounds may take longer and/or cost more than planned, that the Company may be unable to successfully complete the clinical development of the Company’s compounds, that the Company may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2024, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contact Jennifer Davis Ruff Dianthus Therapeutics [email protected]

The market expects Dianthus Therapeutics, Inc. (DNTH) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended June 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.86 per share in its upcoming report, which represents a year-over-year change of -68.6%. Revenues are expected to be $1.24 million, down 33.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 0.32% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Dianthus Therapeutics, Inc., the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +1.02%. On the other hand, the stock currently carries a Zacks Rank of #4. So, this combination makes it difficult to conclusively predict that Dianthus Therapeutics, Inc. will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Dianthus Therapeutics, Inc. would post a loss of$0.86 per share when it actually produced a loss of -$0.82, delivering a surprise of +4.65%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Dianthus Therapeutics, Inc. doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Inovio Pharmaceuticals (INO), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report loss per share of $0.63 for the quarter ended June 2025. This estimate points to a year-over-year change of +47.1%. Revenues for the quarter are expected to be $0.05 million, down 50% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Inovio has been revised 4.5% up to the current level. Nevertheless, the company now has an Earnings ESP of +10.76%, reflecting a higher Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that Inovio will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Dianthus Therapeutics, Inc. (DNTH) : Free Stock Analysis Report Inovio Pharmaceuticals, Inc. (INO) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Completed enrollment in Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG) Top-line MaGic results anticipated in September 2025 to be the first of three catalysts for the DNTH103 neuromuscular franchise by YE’26 Phase 3 CAPTIVATE trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26 Phase 2 MoMeNtum trial of DNTH103 in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 $331.5 million of cash provides runway into 2H’27 NEW YORK and WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the first quarter ending March 31, 2025, and provided an update on recent business achievements. “The first few months of 2025 represent continued excellence in execution by the Dianthus team, including the timely completion of enrollment in our Phase 2 MaGic trial of DNTH103 in gMG, and we look forward to reporting top-line results in September,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Despite currently approved biologics in the gMG market, significant opportunities remain for improved first-line treatment options. We believe that achieving DNTH103’s target profile of effective, consistent symptom control, differentiated safety, and convenient dosing and administration could position it as a preferred first-line biologic therapy across the three neuromuscular indications of gMG, CIDP and MMN.” DNTH103 Clinical Development DNTH103 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. DNTH103 is designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Generalized Myasthenia Gravis (gMG) Enrollment complete in Phase 2 MaGic gMG trial: The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with gMG who are acetylcholine receptor (AChR) antibody positive. Enrollment in this trial is now complete with 65 patients, exceeding the target of 60, and top-line results are anticipated in September 2025. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3 CAPTIVATE CIDP trial ongoing: The CAPTIVATE trial is a single, global, two-part, randomized withdrawal Phase 3 trial in patients with CIDP, and it remains on track for an interim responder analysis in 2H’26. The Company believes this single pivotal trial will support a BLA filing in adult patients with CIDP. Multifocal Motor Neuropathy (MMN) Phase 2 MoMeNtum MMN trial ongoing: The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with MMN, and it remains on track to report top-line results in 2H’26. Corporate Updates On March 5, 2025, John C. King was announced as Chief Commercial Officer and Sujay Kango joined the Company’s Board of Directors. Mr. King brings to Dianthus more than 25 years of global commercial leadership experience in biotechnology, including neuromuscular and hematological rare diseases. Mr. Kango is an experienced executive with more than 26 years of experience in the pharmaceutical and biotechnology sector.  First-Quarter 2025 Financial Results Cash Position - $331.5 million of cash, cash equivalents and investments as of March 31, 2025 is projected to provide runway into the second half of 2027. R&D Expenses - Research and development (R&D) expenses for the quarter ended March 31, 2025 were $27.0 million, inclusive of $2.5 million of stock-based compensation, compared to $13.1 million for the quarter ended March 31, 2024, which included $0.8 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs, chemistry, manufacturing and controls (CMC) costs, and increased headcount to support DNTH103 Phase 2 and Phase 3 development. G&A Expenses - General and administrative (G&A) expenses for the quarter ended March 31, 2025 totaled $7.3 million, inclusive of stock-based compensation of $2.8 million, compared to $5.6 million for the quarter ended March 31, 2024, which included $1.2 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount. Net Loss - Net loss for the quarter ended March 31, 2025 was $29.5 million or $0.82 per share (basic and diluted) compared to $13.7 million or $0.54 per share (basic and diluted) for the quarter ended March 31, 2024. Additional Information - For additional information on the Company’s financial results for the quarter ended March 31, 2025, please refer to the Form 10-Q filed with the SEC. About DNTH103DNTH103 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. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with DNTH103 and anticipates reporting top-line data from the Phase 2 MaGic trial in generalized Myasthenia Gravis in September 2025, the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in 2H’26, and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26. DNTH103 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus TherapeuticsDianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, 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 Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to DNTH103, and any developments or results in connection therewith, including the target product profile and administration of DNTH103; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding the market and potential opportunities for complement therapies, in particular with respect to DNTH103. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of DNTH103 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of DNTH103 or the Company's other compounds may take longer and/or cost more than planned, that the Company may be unable to successfully complete the clinical development of the Company’s compounds, that the Company may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2024, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contact Jennifer Davis RuffDianthus [email protected]

MaGic trial exceeded enrollment target of 60 patients Top-line results anticipated this September will be the first of three DNTH103 catalysts by YE'26 Building a neuromuscular franchise with DNTH103 in gMG, CIDP and MMN with a potential best-in-class, potent classical pathway inhibitor intended as a self-administered autoinjector dosed once every two weeks NEW YORK and WALTHAM, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today announced completion of enrollment in the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis (gMG). DNTH103 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. Initial top-line results from the MaGic trial are anticipated in September 2025. MaGic is a global, randomized, double-blind, placebo-controlled Phase 2 trial that enrolled 65 patients with acetylcholine receptor (AChR) antibody positive gMG, exceeding the enrollment target of 60 patients. The primary endpoint of the trial is safety and tolerability, and key secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) score assessments. “We are pleased to have reached this important milestone in the development of DNTH103 for gMG, which is well understood to be a classical pathway-driven disease,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Latest estimates indicate that the gMG market in the U.S. exceeds 100,000 patients, approximately 85% of whom have AChR autoantibody-driven disease, with growing first-line biologic use. Despite currently approved treatment options, a significant unmet need exists for patients seeking continuous symptom control, lower risk for infections, and more convenient dosing and administration, which we believe DNTH103 has the potential to address as a first-line therapy.” DNTH103 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. DNTH103 is designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need and is also being evaluated in the ongoing Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the ongoing Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy (MMN). The Company is on track for the interim responder analysis of the Phase 3 CAPTIVATE trial in CIDP and top-line data from the Phase 2 MoMeNtum trial in MMN in 2H’26. About the Phase 2 MaGic TrialThe MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 study in patients with generalized Myasthenia Gravis who are acetylcholine receptor (AChR) antibody positive. Following an initial loading dose, DNTH103 will be administered every two weeks (Q2W) via subcutaneous (S.C.) injection. The S.C. treatment duration will initially be 12 weeks with a 52-week open-label extension. The primary endpoint of the study is safety and tolerability. Secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) score assessments. Initial top-line results from this trial are anticipated in September 2025. About Generalized Myasthenia Gravis (gMG)Generalized Myasthenia Gravis (gMG) is a chronic autoimmune disorder driven by the classical pathway that causes progressive muscle weakness. Over 100,000 people in the U.S. are living with gMG and approximately 85% have AChR autoantibody-driven disease. Despite availability of current treatment options, a significant number of patients remain uncontrolled and are seeking better treatment options which may offer sustained efficacy, lower potential risk for infections, and convenient dosing and administration. About DNTH103DNTH103 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. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with DNTH103 and anticipates reporting top-line data from the Phase 2 MaGic trial in generalized Myasthenia Gravis in September 2025, the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in 2H’26, and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26. DNTH103 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus TherapeuticsDianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, 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 Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to DNTH103, and any developments or results in connection therewith, including the target product profile and administration of DNTH103; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding the market and potential opportunities for complement therapies, in particular with respect to DNTH103. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of DNTH103 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of DNTH103 or the Company's other compounds may take longer and/or cost more than planned, that the Company may be unable to successfully complete the clinical development of the Company’s compounds, that the Company may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2024, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contact Jennifer Davis RuffDianthus [email protected]

Phase 2 MaGic trial of DNTH103 in generalized Myasthenia Gravis (gMG) ongoing; top-line results on track for 2H’25 Phase 3 CAPTIVATE trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ongoing; interim responder analysis anticipated in 2H’26 Phase 2 MoMeNtum trial of DNTH103 in Multifocal Motor Neuropathy (MMN) ongoing; top-line results anticipated in 2H’26 $357.0 million of cash provides runway into 2H’27 NEW YORK and WALTHAM, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases, today reported financial results for the fourth quarter and full year ending December 31, 2024 and provided an update on recent business achievements. “We remain on track to report top-line data in 2H’25 from our Phase 2 clinical trial of DNTH103 in gMG, an indication where a best-in-class, potent active C1s and classical pathway inhibitor with the potential for effective and consistent symptom control along with improved safety and convenience could meaningfully advance the standard of care,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We are excited to have initiated our pivotal Phase 3 CAPTIVATE trial in CIDP, which is on track for an interim responder analysis in 2H’26, along with top-line results from our Phase 2 trial in MMN.” DNTH103 Clinical Development DNTH103 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. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Generalized Myasthenia Gravis (gMG) Phase 2 MaGic gMG trial ongoing: The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with gMG who are acetylcholine receptor (AChR) antibody positive, and it remains on track to report top-line results in 2H’25. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3 CAPTIVATE CIDP trial ongoing: The CAPTIVATE trial is a single, global, two-part, randomized withdrawal Phase 3 trial in patients with CIDP, and it remains on track for an interim responder analysis in 2H’26. The Company believes this single pivotal trial will support a BLA filing in adult patients with CIDP. Multifocal Motor Neuropathy (MMN) Phase 2 MoMeNtum MMN trial ongoing: The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial in patients with MMN, and it remains on track to report top-line results in 2H’26. Corporate Updates On March 5, 2025, John C. King was announced as Chief Commercial Officer and Sujay Kango joined the Company’s Board of Directors. Mr. King brings to Dianthus more than 25 years of global commercial leadership experience in biotechnology, including neuromuscular and hematological rare diseases. Mr. Kango is an experienced executive with more than 26 years of experience in the pharmaceutical and biotechnology sector. Full Year 2024 Financial Results Cash Position - $357.0 million of cash, cash equivalents and investments as of December 31, 2024 is projected to provide runway into the second half of 2027. R&D Expenses - Research and development (R&D) expenses for the year ended December 31, 2024 were $83.1 million, inclusive of $5.6 million of stock-based compensation, compared to $32.8 million for the year ended December 31, 2023, which included $0.9 million of stock-based compensation. This increase in R&D expenses was primarily driven by higher clinical costs, chemistry, manufacturing and controls (CMC) costs and increased headcount to support DNTH103 Phase 2 and Phase 3 development. G&A Expenses - General and administrative (G&A) expenses for the year ended December 31, 2024 totaled $25.0 million, inclusive of stock-based compensation of $7.3 million, compared to $18.2 million for the year ended December 31, 2023, which included $2.0 million of stock-based compensation. This increase in G&A expenses was primarily due to increased headcount and higher professional services costs. Net Loss - Net loss for the year ended December 31, 2024 was $85.0 million or $2.55 per share (basic and diluted) compared to $43.6 million or $8.45 per share (basic and diluted) for the year ended December 31, 2023. Additional Information - For additional information on the Company’s financial results for the year ended December 31, 2024, please refer to the Form 10-K filed with the SEC. About DNTH103DNTH103 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. DNTH103 is enhanced with YTE half-life extension technology designed to enable a more convenient subcutaneous, self-administered injection dosed as infrequently as once every two weeks. Additionally, selective inhibition of the classical complement pathway may lower patient risk of infection from encapsulated bacteria by preserving immune activity of the lectin and alternative pathways. As the classical pathway plays a significant role in disease pathology, DNTH103 has the potential to be a best-in-class pipeline-in-a-product across a range of autoimmune disorders with high unmet need. Dianthus is building a neuromuscular franchise with DNTH103 and anticipates reporting top-line data from the Phase 2 MaGic trial in generalized Myasthenia Gravis in 2H’25, the interim responder analysis of the Phase 3 CAPITIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in 2H’26, and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy in 2H’26. DNTH103 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus TherapeuticsDianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn. Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, 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 Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to DNTH103, and any developments or results in connection therewith, including the target product profile of DNTH103; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the time period over which the Company’s capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding the market and potential opportunities for complement therapies, in particular with respect to DNTH103. The words “opportunity,” “potential,” “milestones,” “runway,” “will,” “anticipate,” “achieve,” “near-term,” “catalysts,” “pursue,” “pipeline,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “strive,” “would,” “aim,” “target,” “commit,” and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of DNTH103 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of DNTH103 or the Company's other compounds may take longer and/or cost more than planned, that the Company may be unable to successfully complete the clinical development of the Company’s compounds, that the Company may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K for the period ended December 31, 2024, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Contact Jennifer Davis RuffDianthus [email protected]