Dianthus Therapeutics Announces Q1 Financial Results and Business Achievements

Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company focused on the development of advanced antibody complement therapeutics to combat severe autoimmune diseases, announced its financial results for the first quarter ending March 31, 2024, alongside updates on recent business progress.

The first quarter of 2024 was marked by significant progress, particularly the initiation of the Phase 2 MaGic trial of DNTH103 for patients with generalized Myasthenia Gravis (gMG). This global, randomized, double-blind, placebo-controlled Phase 2 study aims to involve up to 60 patients who are acetylcholine receptor (AchR) antibody positive. Initial top-line results from this trial are expected in the second half of 2025.

Marino Garcia, CEO of Dianthus Therapeutics, expressed optimism about the company's recent achievements, emphasizing the importance of the ongoing Phase 2 clinical trials for DNTH103 in both Multifocal Motor Neuropathy (MMN) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), slated to start in the second and latter half of 2024, respectively.

DNTH103 is a promising investigational monoclonal antibody designed to selectively inhibit only the active form of the C1s protein within the classical complement pathway, which is a validated therapeutic target. Enhanced with YTE half-life extension technology, DNTH103 allows for subcutaneous, self-administered injections that can be taken as infrequently as once every two weeks. This could potentially make DNTH103 a leading treatment option across various autoimmune disorders with substantial unmet needs.

In addition to the Phase 2 MaGic gMG trial, key highlights included an oral presentation at the American Academy of Neurology (AAN) 2024 Annual Meeting on April 15, which detailed the unique attributes of DNTH103 and its potential benefits in gMG treatment. The company is also actively planning for the Phase 2 trials in MMN and CIDP, with a focus on optimally positioning DNTH103 as a versatile treatment across multiple neuromuscular conditions.

Financially, Dianthus reported a robust cash position, with $377 million in cash, cash equivalents, and short-term investments as of March 31, 2024. This includes proceeds from a successful $230 million PIPE financing completed in January 2024. These funds are expected to support the company's operations into the second half of 2027.

Research and development expenses for the quarter amounted to $13.1 million, up from $5.8 million in the same period the previous year. This increase was primarily driven by higher clinical and manufacturing costs and an expanded team to support the development of DNTH103. General and administrative expenses also rose to $5.6 million from $2.3 million, largely due to increased headcount and professional fees.

Despite these rises in expenditure, the net loss for the quarter was $13.7 million, translating to a $0.54 net loss per share, compared to a net loss of $7.1 million or $8.10 per share in the first quarter of 2023.

Dianthus remains focused on its mission to develop transformative treatments for autoimmune and inflammatory diseases. With the ongoing and upcoming clinical trials for DNTH103, the company aims to make significant strides in addressing the needs of patients with severe neuromuscular disorders.

In conclusion, Dianthus Therapeutics is making substantial progress in its clinical trials and financial stability, positioning itself as a key player in the biotechnology sector aimed at addressing critical unmet needs in autoimmune disease treatments.