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.

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