Dianthus Therapeutics Announces Q3 Results and Business Achievements

Dianthus Therapeutics, Inc., a clinical-stage biotechnology firm listed on Nasdaq under the ticker DNTH, has announced its financial outcomes for the third quarter ending September 30, 2024, and shared updates regarding its recent business milestones. Focused on developing advanced antibody complement therapeutics to address severe autoimmune diseases, the company is progressing with multiple clinical trials for its lead candidate, DNTH103.

DNTH103 is a potent monoclonal antibody designed to selectively inhibit the active form of the C1s protein, a validated target in the classical complement pathway. Enhanced with YTE half-life extension technology, DNTH103 is developed for subcutaneous administration, potentially allowing dosing as infrequently as every two weeks. The drug aims to offer a best-in-class solution for various autoimmune disorders with significant unmet needs.

In the area of clinical development, Dianthus is extending the application of DNTH103 across several autoimmune diseases. The ongoing Phase 2 MaGic trial targets generalized Myasthenia Gravis (gMG), a global, randomized, double-blind, placebo-controlled study in patients positive for acetylcholine receptor (AChR) antibodies. This trial is on schedule to deliver top-line results in the second half of 2025. Recent poster presentations at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) and the International Congress on Neuromuscular Diseases (ICNMD) highlighted the promising preclinical and in vitro data for DNTH103 in gMG.

For Multifocal Motor Neuropathy (MMN), the ongoing Phase 2 MoMeNtum trial is also a global, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of DNTH103 in MMN patients. This trial is expected to yield top-line results in the second half of 2026.

Dianthus plans to initiate a pivotal Phase 3 trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) by the end of 2024. This two-part, randomized withdrawal trial will begin with an open-label phase where participants receive a loading dose followed by 300mg DNTH103 administered every two weeks via subcutaneous injection for up to 13 weeks. An interim analysis will determine responders, who will proceed to Part B, a double-blind, placebo-controlled phase lasting up to 52 weeks to evaluate relapse prevention, safety, and tolerability. This trial aims to support a Biologics License Application (BLA) filing in CIDP patients. Further details about the trial design and timelines will be disclosed by the end of 2024. Additionally, poster presentations at AANEM and ICNMD showcased the differentiated profile of DNTH103 in CIDP, along with comparative data against riliprubart.

Corporate developments include the appointment of Dr. Steven Romano to the Dianthus Therapeutics Board of Directors, effective September 16, 2024. Dr. Romano, with over 28 years of experience in drug development, currently holds the position of Executive Vice President and Chief Research and Development Officer at Silence Therapeutics.

Financially, Dianthus reported a cash position of approximately $343 million as of September 30, 2024, projected to sustain operations into the second half of 2027. Research and development expenses for the quarter amounted to $25.5 million, a significant increase from $8.0 million in the same quarter of the previous year, driven by higher clinical costs and increased headcount to support the Phase 2 and Phase 3 development of DNTH103. General and administrative expenses decreased to $6.5 million from $8.7 million in the previous year, primarily due to lower personnel costs. The net loss for the quarter was $25.2 million, compared to $14.8 million in the third quarter of 2023.

Dianthus Therapeutics remains committed to advancing DNTH103 as a transformative treatment across multiple autoimmune diseases, leveraging its strong financial position and experienced leadership team to achieve its clinical and corporate objectives.