Dianthus Therapeutics Showcases Business Achievements and Q2 Financial Results

16 August 2024

Dianthus Therapeutics, Inc., a biotechnology company focused on developing advanced antibody complement therapeutics for severe autoimmune diseases, has announced its financial results for the second quarter ending June 30, 2024. The company also provided updates on its recent business achievements.

CEO Marino Garcia emphasized the company's progress in clinical programs for DNTH103, targeting generalized Myasthenia Gravis (gMG), Multifocal Motor Neuropathy (MMN), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). DNTH103 is described as a potentially best-in-class inhibitor of the classical complement pathway, featuring a convenient, infrequent subcutaneous self-administration and a favorable safety profile. The company believes in the broad application potential of DNTH103 across various autoimmune diseases, supported by in vitro data and recent competitor clinical data.

DNTH103 is a potent monoclonal antibody aimed at the classical pathway by inhibiting the active form of the C1s protein. It utilizes YTE half-life extension technology, allowing a more convenient bi-weekly self-administered injection. With its selective inhibition method, DNTH103 aims to reduce patient infection risk while preserving immune function of other pathways. The product holds potential for treating multiple autoimmune disorders with significant unmet needs.

Currently, three Phase 2 trials involving DNTH103 are underway or planned:

1. MaGic Trial in gMG: A global, randomized, double-blind, placebo-controlled Phase 2 study targeting patients with generalized Myasthenia Gravis who are acetylcholine receptor (AChR) antibody positive. Top-line results from this trial are expected in the second half of 2025.

2. MoMeNtum Trial in MMN: This Phase 2 trial received FDA clearance in June and will evaluate DNTH103's safety, tolerability, and efficacy in patients with Multifocal Motor Neuropathy. Initial results are anticipated in the second half of 2026.

3. CIDP Trial: Planning is on track for a Phase 2 trial of DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy, expected to begin in the second half of 2024.

Additionally, DNTH103 received attention at recent medical conferences. An oral presentation at the American Academy of Neurology (AAN) Annual Meeting in Denver highlighted its preclinical and in vitro data, safety profile, and neurotransmission activity. Two posters presented at the European Academy of Neurology (EAN) Congress in Helsinki detailed preclinical data and comparisons with other treatments.

On the corporate front, Alison Lawton assumed the role of Chair of the Board of Directors on July 1, 2024, taking over from Lonnie Moulder, who continues as a Board member.

Financially, Dianthus reported having $360.7 million in cash, cash equivalents, and short-term investments as of June 30, 2024, providing a financial runway into the second half of 2027. Research and development expenses for the quarter were $18.1 million, up from $10.3 million in the previous year, primarily due to higher clinical and manufacturing costs, as well as an increase in staff to support DNTH103's development phases. General and administrative expenses also rose to $6.0 million from $2.5 million, driven by increased headcount and consulting fees. The net loss for the quarter was $17.6 million, compared to $11.1 million in the same period last year.

Dianthus Therapeutics continues to push forward in its mission to develop innovative monoclonal antibodies with enhanced selectivity and potency, targeting severe autoimmune and inflammatory diseases. The company operates out of New York City and Waltham, Mass., and is led by a team of experienced biotech and pharmaceutical executives.

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