Dianthus Therapeutics (DNTH) 2025 Conference June 05, 2025 09:55 AM ET Speaker0 Good morning, everybody. I'm Marino Garcia, CEO for Dianthus. I will be providing a brief update. Oh, here we go. Maury. How you doing? And then we'll open it up for some Q and A. Before I begin, just again, thank you to Jeffries for this opportunity today. I will be making some forward looking statements, so I urge everyone please to go to our website and where you can read all our SEC filings. This is a very exciting time for ...

NEW YORK and WALTHAM, Mass., May 29, 2025 (GLOBE NEWSWIRE) -- 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 the Company’s participation in the Jefferies Global Healthcare Conference. Marino Garcia, Chief Executive Officer, will participate in a fireside chat on Thursday, June 5, 2025 at 9:55 a.m. EDT in New York City and will host one-on-one ...

Dr. Read brings >30 years of leadership and scientific expertise in the biopharmaceutical industry Previously served as CEO and Founder of Mariana Oncology until its acquisition by Novartis in 2024 and CSO of Ra Pharma until its acquisition by UCB in 2020 NEW YORK and WALTHAM, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune disea ...

Dianthus Therapeutics (DNTH) Conference Summary Company Overview - **Company**: Dianthus Therapeutics - **Focus**: Development of DNTH103, a potent C1S inhibitor for treating severe autoimmune disorders, particularly in neuromuscular conditions [3][4] Key Points Product Development and Pipeline - **DNTH103**: A highly potent active C1S inhibitor designed for subcutaneous self-administration, similar to DUPIXENT, with a dosing schedule of every two weeks [4][13] - **Upcoming Data**: - Phase two data for Myasthenia Gravis (MG) expected in September 2025 [5] - Phase two study for Multifocal Motor Neuropathy (MMN) results anticipated in February 2026 [5] - Phase three interim responder analysis for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in the second half of 2026 [5] Market Potential - **Target Conditions**: - Myasthenia Gravis (MG) - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - Multifocal Motor Neuropathy (MMN) - **Patient Population**: Approximately 150,000 patients in the US across these three conditions, with significant unmet medical needs [6][7] Competitive Landscape - **Market Opportunity**: - MG is a multibillion-dollar market with potential for DNTH103 to become a first-line treatment [7] - CIDP data from competitors (e.g., Sanofi's rilipabart) indicates active C1S inhibition may outperform current standard treatments like IVIG [17][20] - **Comparative Efficacy**: - DNTH103 demonstrated superior potency in vitro compared to rilipabart, requiring lower doses for efficacy [22][23] - DNTH103's dosing is more patient-friendly, with a regimen of 300 mg every two weeks versus rilipabart's 600 mg weekly [21][23] Financial Position - **Balance Sheet**: Dianthus has a strong financial position with $332 million, providing a runway until the second half of 2027 to support ongoing clinical trials and product development [5] Safety and Efficacy Profile - **Safety Profile**: DNTH103 aims to avoid the safety issues associated with other complement inhibitors by selectively inhibiting the classical pathway without affecting the lectin and alternative pathways, reducing infection risks [16][27] - **Efficacy Goals**: The product aims to combine the efficacy of existing treatments while maintaining a favorable safety profile and convenient administration [10][14] Future Outlook - **Catalysts**: The upcoming data releases in 2025 and 2026 are expected to be significant catalysts for the company's stock and market position [5][30] - **Market Growth**: The MMN market is anticipated to grow, with DNTH103 positioned to capture a significant share due to its unique mechanism of action [24][28] Additional Insights - **Research and Development Strategy**: The company is focused on building a leading neuromuscular franchise by targeting three related diseases, leveraging clinical and commercial synergies [6] - **Regulatory Considerations**: The development strategy includes avoiding box warnings by maintaining a selective inhibition approach, which is crucial for market acceptance [16][26] This summary encapsulates the key points from the Dianthus Therapeutics conference, highlighting the company's strategic direction, product pipeline, market potential, and competitive advantages.

Core Insights - Dianthus Therapeutics, Inc. reported a quarterly loss of $0.82 per share, which was better than the Zacks Consensus Estimate of a loss of $0.86, but worse than the loss of $0.54 per share from the previous year, indicating a 51.85% increase in loss year-over-year [1] - The company achieved revenues of $1.16 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 1.13% and showing a 33.33% increase from $0.87 million in the same quarter last year [2] - The stock has underperformed the market, losing approximately 10.1% since the beginning of the year compared to the S&P 500's decline of 3.8% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.93 on revenues of $1.36 million, while for the current fiscal year, the estimate is -$3.38 on revenues of $5.17 million [7] - The estimate revisions trend for Dianthus Therapeutics is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is 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 belongs, is currently ranked in the top 34% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Core Insights - Dianthus Therapeutics has completed enrollment in the Phase 2 MaGic trial of DNTH103 for generalized Myasthenia Gravis (gMG), with top-line results expected in September 2025, marking the first of three anticipated catalysts for the DNTH103 neuromuscular franchise by the end of 2026 [1][3][11] - The ongoing Phase 3 CAPTIVATE trial for DNTH103 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is on track for an interim responder analysis in the second half of 2026 [1][6] - 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][7] - The company has a strong cash position of $331.5 million, projected to provide financial runway into the second half of 2027 [1][16] Clinical Development - DNTH103 is a monoclonal antibody designed to selectively inhibit the active form of the C1s protein, targeting the classical complement pathway [4][11] - The drug is intended for convenient subcutaneous self-administration, potentially every two weeks, and aims to address high unmet needs in autoimmune disorders [4][11] Market Opportunity - Despite existing biologics in the gMG market, there are significant opportunities for improved first-line treatment options, with DNTH103 positioned to offer effective symptom control, safety, and convenient administration [3][11] - The company is building a neuromuscular franchise with DNTH103, targeting three indications: gMG, CIDP, and MMN [11][12] Financial Performance - For Q1 2025, the company reported a net loss of $29.5 million, or $0.82 per share, compared to a net loss of $13.7 million, or $0.54 per share, in Q1 2024 [16][22] - Research and development expenses for Q1 2025 were $27.0 million, significantly higher than $13.1 million in Q1 2024, primarily due to increased clinical costs and headcount [16][22]

Summary of Dianthus Therapeutics Conference Call Company Overview - **Company**: Dianthus Therapeutics - **Focus**: Development of DNTH103, a classical pathway inhibitor targeting activated C1S protein for treating classical pathway-driven diseases [4][5] Key Points and Arguments Product Development and Pipeline - **DNTH103**: A highly potent classical pathway inhibitor designed for self-administration via an auto-injector, with dosing every two weeks [4][5] - **Upcoming Catalysts**: - Phase II results for Myasthenia Gravis (MG) expected in September 2023 [5][6] - Phase II trial for Multifocal Motor Neuropathy (MMN) results anticipated in the second half of 2026 [6] - Phase III trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) with interim analysis also in the second half of 2026 [6] Efficacy and Safety - **Efficacy Goals**: Aim for efficacy comparable to C5 inhibitors (e.g., Ultomiris) with a target improvement of 1.6 to 2.1 on the MG Activities of Daily Living (ADL) scale [8][26] - **Safety Profile**: Targeting a clean safety label without box warnings, similar to existing C1S inhibitors [9][63] - **Dosing Confidence**: Confidence in achieving efficacy with a 300 mg dose every two weeks, significantly above the IC90 threshold [12][14] Market Potential - **Market Size**: Potential for a multi-billion dollar blockbuster, not only in MG but also in CIDP and MMN [38] - **Competitive Landscape**: Positioning as a first-line biologic treatment for MG, competing against existing therapies like IVIG and FcRn inhibitors [34][46] Clinical Trial Design - **Phase II Trial for MG**: Largest trial conducted in MG, designed primarily for safety with secondary efficacy endpoints [25][30] - **CIDP and MMN Trials**: Following similar designs to successful trials by competitors, focusing on classical pathway inhibition [51][53] Future Indications and Expansion - **Exploration of New Indications**: Ongoing work to identify additional indications that meet scientific and commercial viability criteria [61] Important but Overlooked Content - **Cash Position**: Dianthus has over $330 million in cash, providing a runway until the second half of 2027, sufficient to support upcoming clinical trials [65] - **In Vitro Studies**: Conducted experiments showing that DNTH103 can effectively kill encapsulated bacteria, supporting its safety profile [63] - **Investor Sentiment**: Emphasis on the importance of upcoming data releases and the potential impact on investor confidence and market perception [60][66] This summary encapsulates the critical aspects of the conference call, highlighting the company's strategic direction, product pipeline, and market positioning.

Core Insights - Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation antibody complement therapeutics for severe autoimmune diseases [1][3] - The company will participate in two upcoming investor events, including a fireside chat and a corporate overview presentation [1][4] Company Overview - Dianthus Therapeutics is dedicated to designing and delivering novel, best-in-class monoclonal antibodies with enhanced selectivity and potency [3] - The company is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharmaceutical executives [3] Upcoming Events - Marino Garcia, the Chief Executive Officer, will participate in a fireside chat webcast on May 6 at 1:30 p.m. EDT [4] - The CEO will also present a corporate overview at the Bank of America 2025 Health Care Conference on May 14 at 5:35 p.m. EDT and will conduct one-on-one meetings with investors [4]

Company Overview - Dianthus Therapeutics, Inc. (DNTH) shares increased by 6.1% to close at $17.86, supported by high trading volume, contrasting with a 15.3% loss over the past four weeks [1] - The company reported strong financial results for Q4 and full-year 2024, along with pipeline updates and business goals for 2025, which likely contributed to the recent share price increase [1] Financial Performance - The upcoming quarterly report is expected to show a loss of $0.86 per share, reflecting a year-over-year decline of 59.3%, while revenues are projected to be $1.15 million, an increase of 32.2% from the previous year [2] - The consensus EPS estimate for Dianthus has been revised 0.5% lower in the last 30 days, indicating a negative trend in earnings estimate revisions, which typically does not lead to price appreciation [3] Industry Context - Dianthus is part of the Zacks Medical - Biomedical and Genetics industry, where another company, Techne (TECH), saw a 1.8% increase in its stock price, closing at $58.38, but has returned -4.6% over the past month [3] - Techne's consensus EPS estimate for its upcoming report remains unchanged at $0.52, representing an 8.3% increase from the previous year [4]

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]