Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q1 Financial Results

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 DNTH103

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. 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 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 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.

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