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Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q4 and FY 2024 Financial Results
GlobeNewswire News Room· 2025-03-11 20:01
Core Insights - Dianthus Therapeutics is advancing its investigational monoclonal antibody DNTH103 for severe autoimmune diseases, with key clinical trials ongoing and results expected in the coming years [1][2][3] Clinical Development - The Phase 2 MaGic trial for DNTH103 in generalized Myasthenia Gravis (gMG) is on track to report top-line results in the second half of 2025 [1][4] - The Phase 3 CAPTIVATE trial for DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is ongoing, with an interim responder analysis anticipated in the second half of 2026 [1][5] - The Phase 2 MoMeNtum trial for DNTH103 in Multifocal Motor Neuropathy (MMN) is also ongoing, with top-line results expected in the second half of 2026 [1][6] Financial Position - As of December 31, 2024, the company reported $357.0 million in cash, cash equivalents, and investments, providing a financial runway into the second half of 2027 [1][14] - Research and development expenses for 2024 were $83.1 million, a significant increase from $32.8 million in 2023, primarily due to higher clinical costs and increased headcount [14] - General and administrative expenses for 2024 totaled $25.0 million, up from $18.2 million in 2023, driven by increased headcount and professional services costs [14] Leadership Updates - John C. King was appointed as Chief Commercial Officer, bringing over 25 years of experience in biotechnology, while Sujay Kango joined the Board of Directors with over 26 years in the pharmaceutical and biotechnology sector [7]
Dianthus Therapeutics Strengthens Strategic Commercial Leadership With Appointment of John C. King as Chief Commercial Officer and Welcomes Sujay Kango, A Seasoned Commercial Leader, to Board of Directors
Globenewswire· 2025-03-05 12:00
Core Insights - Dianthus Therapeutics has appointed John C. King as Chief Commercial Officer, bringing over 25 years of experience in biotechnology and complement inhibitors [1][2] - The company is focused on advancing DNTH103, a potential first-line therapy for neuromuscular diseases, with key data expected in the second half of 2025 [2] - Sujay Kango has joined the Board of Directors, contributing over 26 years of experience in the pharmaceutical and biotechnology sectors [3] Company Developments - John C. King previously held significant roles at Alexion Pharmaceuticals and Ra Pharma, where he contributed to the development of blockbuster therapies and led commercial strategies [1][2] - Dianthus is dedicated to developing next-generation antibody complement therapeutics aimed at severe autoimmune diseases [5] - The company is transitioning its Board of Directors, with Tomas Kiselak stepping down [4] Market Position - DNTH103 is positioned as a differentiated therapy with a unique combination of potency, safety, and convenience, targeting diseases like generalized Myasthenia Gravis (gMG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Multifocal Motor Neuropathy (MMN) [2] - The company aims to build a late-stage biotech profile, leveraging the extensive experience of its leadership team to navigate the competitive landscape [2][3]
Dianthus Therapeutics to Participate in Two Upcoming Investor Conferences
Globenewswire· 2025-02-26 12:00
Company Overview - Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation antibody complement therapeutics for severe autoimmune diseases [1][2] - The company aims to design and deliver novel, best-in-class monoclonal antibodies with enhanced selectivity and potency [1] Recent Developments - Dianthus Therapeutics announced its participation in several upcoming investor conferences, indicating active engagement with the investment community [1][2] - CEO Marino Garcia will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on March 5, 2025, and will also host one-on-one meetings with investors [2] - CFO Ryan Savitz will conduct one-on-one investor meetings at the Jefferies Biotech on the Bay Summit on March 12, 2025 [2]
Dianthus Therapeutics (DNTH) Conference Transcript
2025-02-06 15:02
Dianthus Therapeutics (DNTH) Conference Summary Company Overview - **Company**: Dianthus Therapeutics - **Lead Program**: DNTH103, an antibody targeting the active form of C1S in the classical pathway of the complement system [3][4] Key Value Inflicting Milestones - **Indications**: Focus on neuromuscular conditions including myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and multifocal motor neuropathy (MMN) [3][4] - **Dosing**: DNTH103 aims for a low volume of 300 mg in a 2 ml auto-injector, self-administered every two weeks [4][7] - **Safety Profile**: Potentially reduced risk of infections compared to existing treatments due to preservation of lectin and alternative pathways [4][5] Competitive Landscape - **Competitors**: Sanofi's angimosotimab and Rilipibart are mentioned as competitors in the C1S inhibitor space [12][13] - **Differentiation**: DNTH103 is positioned as a more potent antibody requiring lower doses compared to Rilipibart, which requires 600 mg every week [16][30] Clinical Development - **Phase II Trials**: Initiated for MG and MMN, with CIDP in a pivotal Phase III program [9][10] - **Data Expectations**: Anticipated data from MG Phase II in Q3/Q4 2025, followed by MMN and CIDP data in 2026 [10][46] Efficacy and Safety - **Efficacy Benchmark**: Targeting efficacy similar to Ultomiris and Soliris, with a primary endpoint of safety and secondary efficacy measures [49][50] - **Market Comparison**: Ultomiris reported $6.5 billion in sales, with a 33% growth attributed to MG patients [54] Study Design and Recruitment - **CIDP Study Design**: Open-label followed by randomized placebo-controlled trial, allowing refractory patients [20][21] - **MG Study Design**: Three arms with a focus on safety and efficacy, aiming for 20 patients per cohort [49] Market Dynamics - **Market Evolution**: The CIDP market has evolved rapidly, with increased comfort among physicians in diagnosing CIDP [36] - **Potential Head-to-Head Studies**: Depending on competitor data, Dianthus may consider conducting head-to-head studies against IVIG [41][44] Other Considerations - **Oral Compounds**: Discussion on a competitor's oral C1S inhibitor, with skepticism regarding its efficacy and safety profile [59][62] - **Investor Sentiment**: Positive investor response to the CIDP program, leading to a successful $230 million PIPE financing [18] Conclusion Dianthus Therapeutics is advancing its lead program DNTH103 with a focus on safety, efficacy, and patient convenience in treating neuromuscular conditions. The competitive landscape is evolving, and the company is well-positioned to capitalize on upcoming clinical data and market opportunities.
Dianthus Therapeutics to Webcast Presentations at Two Investor Conferences
Globenewswire· 2025-01-30 12:00
Core Insights - Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation antibody complement therapeutics for severe autoimmune diseases [1][2] - The company will participate in healthcare investor conferences in February, with presentations by CEO Marino Garcia [1][3] Company Overview - Dianthus Therapeutics is dedicated to designing and delivering novel, best-in-class monoclonal antibodies with enhanced selectivity and potency [2] - The company is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharmaceutical executives [2] Upcoming Events - The company will host a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 6 at 9:00 a.m. ET in New York City [3] - A virtual fireside chat is scheduled for February 12 at 3:20 p.m. ET during the Oppenheimer 35th Annual Healthcare Life Sciences Conference [3]
Dianthus Therapeutics to Webcast Presentation at the 43rd Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-01-08 12:00
Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing next-generation antibody complement therapeutics for severe autoimmune and inflammatory diseases [3] - The company is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharma executives [3] - Dianthus Therapeutics is dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency [3] Upcoming Event - Dianthus Therapeutics will participate in the 43rd Annual J P Morgan Healthcare Conference [1] - CEO Marino Garcia will present a corporate overview on January 15, 2025, at 9:00 a m PST / 12:00 p m EST in San Francisco [1] - A live webcast of the presentation will be available on the company's website under the "News and Events" section in the Investors section [2] Additional Information - More details about Dianthus Therapeutics can be found on their website at www dianthustx com [4] - The company can also be followed on LinkedIn for updates [4]
Dianthus Therapeutics, Inc. (DNTH) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-11-07 23:36
Financial Performance - Dianthus Therapeutics, Inc. reported a quarterly loss of $0.74 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.59, representing an earnings surprise of -25.42% [1] - The company posted revenues of $2.17 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 102.61%, compared to revenues of $0.92 million in the same quarter last year [2] - Over the last four quarters, the company has surpassed consensus revenue estimates three times [2] Stock Performance - Shares of Dianthus Therapeutics, Inc. have increased approximately 182.8% since the beginning of the year, significantly outperforming the S&P 500's gain of 24.3% [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.65 on revenues of $1.07 million, and for the current fiscal year, it is -$2.28 on revenues of $4.16 million [7] - The estimate revisions trend for the company is mixed, resulting in a Zacks Rank 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Dianthus Therapeutics, Inc. belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]
Dianthus Therapeutics to Participate in Three Upcoming Healthcare Investor Conferences
GlobeNewswire News Room· 2024-11-04 12:00
Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing next-generation antibody complement therapeutics for severe autoimmune diseases [2] - The company is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharmaceutical executives [2] Upcoming Events - The company will participate in several healthcare investor conferences in November and December 2024, including: - Guggenheim Healthcare Innovation Conference on November 11 at 1:30 p.m. ET in Boston, MA [1] - Jefferies Global Healthcare Conference on November 19 at 9:00 a.m. GMT in London [1] - 7th Annual Evercore HealthCONx Conference on December 4 at 10:50 a.m. ET in Coral Gables, FL [1] - Live webcasts of the presentations will be available on the company's website under the "News and Events" section [1]
Strength Seen in Dianthus Therapeutics, Inc. (DNTH): Can Its 5.7% Jump Turn into More Strength?
ZACKS· 2024-10-09 08:50
Dianthus Therapeutics, Inc. (DNTH) shares soared 5.7% in the last trading session to close at $27.99. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 4.9% loss over the past four weeks. The growing optimism over the company's lead pipeline candidate DNTH103, which is being developed for treating several autoimmune diseases, like generalized Myasthenia Gravis (gMG), multifocal motor neuropathy (MMN) and chronic inflammatory demyel ...
Dianthus Therapeutics, Inc. (DNTH) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2024-08-08 22:25
Dianthus Therapeutics, Inc. (DNTH) came out with a quarterly loss of $0.51 per share versus the Zacks Consensus Estimate of a loss of $0.50. This compares to loss of $0.80 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -2%. A quarter ago, it was expected that this company would post a loss of $0.43 per share when it actually produced a loss of $0.54, delivering a surprise of -25.58%. Over the last four quarters, the company ...