DNTH Dianthus Therapeutics Inc

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 announced an oral presentation for DNTH103 at the American Academy of Neurology (AAN) Annual Meeting, taking place April 13-18, 2024 in Denver, Colorado and virtually.

DNTH103 is an investigational classical pathway inhibitor that is uniquely specific to the active form of C1s, and is being evaluated for its potential as an effective, low-volume, convenient and safe treatment option for patients with generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. The oral presentation at AAN will highlight preclinical and in vitro data describing the differentiated safety profile and neurotransmission activity of DNTH103 and a review of previously released Phase 1 healthy volunteer data.

“Currently, therapies for patients with generalized Myasthenia Gravis (gMG) are limited to C5 inhibitors or FcRn inhibitors that can be burdensome for patients and caregivers, and the C5 complement inhibitors available today have an increased risk for serious bacterial infections,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “We aim to demonstrate that DNTH103 may be a best-in-class treatment option with improved safety and infrequent self-administration that provides effective and consistent control of symptoms for people living with neuromuscular conditions.”

Oral Presentation Details:April 15, 2024, 1:00 PM MT / 3:00 PM ETClassical Pathway Inhibition with Anti-Active C1s Antibody DNTH103 Prevents Neurotransmission Impairment in a Preclinical Model of Myasthenia GravisPresenter: Sankalp Gokhale, M.D., Head of Clinical Development, Neurology, Dianthus TherapeuticsSession S15: Autoimmune Neuromuscular Diseases: New Observations and Therapeutic Approaches Program S15.001

Detailed presentation listings for the 2024 AAN Annual Meeting can be found on the meeting website: https://www.aan.com/events/annual-meeting.

About DNTH103DNTH103 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 has initiated a Phase 2 trial in generalized Myasthenia Gravis and plans to initiate additional Phase 2 trials in other neuromuscular indications, including Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy, in 2024.

About Dianthus TherapeuticsDianthus 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.  

Dianthus has initiated a Phase 2 trial of DNTH103, a potential best-in-class active C1s inhibitor, in generalized Myasthenia Gravis and plans to initiate additional Phase 2 trials in other neuromuscular indications, including Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy, in 2024.

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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 of DNTH103; the anticipated timing of the initiation and results from those studies and trials; 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.

Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of DNTH103 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of DNTH103 or the Company's other compounds may take longer and/or cost more than planned, that the Company may be unable to successfully complete the clinical development of the Company’s compounds, that the Company may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2024, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Contact Jennifer Davis RuffDianthus Therapeuticsjdavisruff@dianthustx.com