The next Alexion Pharmaceuticals, focused on autoimmune diseases via novel complement inhibition.

The Vertex Pharmaceuticals for severe autoimmune diseases.

• DNTH103: A clinical-stage, next-generation complement C1s inhibitor being developed for various severe autoimmune diseases.

Dianthus Therapeutics (symbol: DNTH) is a clinical-stage biotechnology company focused on the development of novel complement inhibitor treatments for patients with severe autoimmune diseases.

As a clinical-stage company, Dianthus Therapeutics does not yet have commercialized products available for sale on the market. Its primary focus is on research and development, and conducting clinical trials for its drug candidates. Therefore, Dianthus Therapeutics does not currently have "major customers" in the traditional sense of companies or individuals purchasing its products or services.

The company's operations are funded through investments, such as equity offerings, to advance its developmental pipeline through various stages of clinical trials.

null

Marino Garcia, President and Chief Executive Officer

Mr. Garcia has served as President and Chief Executive Officer of Dianthus Therapeutics since November 2021. Prior to joining Dianthus, he held senior leadership roles, including Senior Vice President, Corporate and Business Development at Zealand Pharma A/S, and Executive Vice President, Chief Strategy Officer at Synergy Pharmaceuticals. Mr. Garcia was involved with Aptalis Pharma when it was acquired by Forest Laboratories in 2014, and Aspreva Pharmaceuticals, which was acquired by Vifor Pharma in 2007. He began his career in commercial and strategic roles at multinational biopharmaceutical companies such as Merck & Co., Pfizer Inc., and Eli Lilly and Co. Mr. Garcia also executed a licensing deal in 2019 for a pre-clinical complement inhibitor with Alexion Pharmaceuticals.

Ryan Savitz, Chief Financial Officer

Mr. Savitz has served as Chief Financial Officer of Dianthus Therapeutics since June 2022. Before joining Dianthus, he was a Managing Director in Citigroup's Healthcare Investment Banking division from June 2010 to June 2022, where he advised biopharma companies on private and public capital raising, partnering, and mergers and acquisitions.

Simrat Randhawa, M.D., Executive Vice President, Head of R&D

Dr. Randhawa brings over 20 years of clinical practice and pharmaceutical industry experience to Dianthus. He most recently served as Senior Vice President of Clinical and Medical Affairs at Aurinia Pharmaceuticals, an autoimmune-focused company, where he supported clinical development and investor relations. Dr. Randhawa has held various senior commercial and medical leadership roles in the autoimmune and rare disease spaces at companies like Novartis and Biomarin.

John C. King, Chief Commercial Officer

Mr. King was appointed Chief Commercial Officer in March 2025. Previously, he was the Chief Commercial Officer at Vor Bio, where he led commercial planning and business development for engineered cell therapies. His career in biotech began at Wyeth Pharmaceuticals, working on Enbrel®, and he later served as Vice President, U.S. Neurology Business Unit at Alexion Pharmaceuticals, where he led the commercial team and strategy for the launch of Soliris® (eculizumab).

Edward Carr, Chief Accounting Officer

Mr. Carr has served as Chief Accounting Officer of Dianthus Therapeutics since April 2022. Prior to Dianthus, he was Chief Financial Officer of Abeona Therapeutics, a publicly traded clinical-stage biotechnology company, from August 2021 to March 2022, and its Chief Accounting Officer from November 2018 to August 2021. Mr. Carr also held positions as Assistant Controller at Coty Inc. and Chief Accounting Officer at Foster Wheeler AG. He is a Certified Public Accountant and began his career at Ernst & Young LLP.

The key risks to Dianthus Therapeutics (DNTH) primarily revolve around the inherent uncertainties of clinical-stage biotechnology, its financial sustainability, and the competitive landscape of its target markets.

1. Clinical Trial Outcomes for DNTH103

The most significant risk for Dianthus Therapeutics is the successful development and regulatory approval of its lead drug candidate, DNTH103. DNTH103 is currently undergoing multiple clinical trials, including a Phase 2 trial for generalized Myasthenia Gravis (gMG) with top-line data expected in the latter part of 2025, a Phase 3 trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) with interim data anticipated in the second half of 2026, and a Phase 2 trial for Multifocal Motor Neuropathy (MMN). There is no guarantee that these trials will yield positive results regarding efficacy, safety, or tolerability to warrant further development, late-stage testing, or ultimately, regulatory approval. The failure of DNTH103 in any of these critical stages would severely impact the company's future prospects.

2. Financial Sustainability and Need for Future Funding

As a clinical-stage biotechnology company, Dianthus Therapeutics is not yet profitable and generates no meaningful product revenue. The company experiences negative revenue growth, negative free cash flow, and rising research and development (R&D) as well as general and administrative (G&A) expenses. Dianthus is heavily reliant on its current cash position and the ability to raise additional capital through future financing rounds to fund its ongoing operations and costly drug development programs. Continued losses, increasing expenses, and the need for future funding pose a substantial financial risk.

3. Intense Competition in Complement Inhibition Therapy

Dianthus operates in a highly competitive therapeutic area, specifically complement inhibition for autoimmune disorders. Several C5 inhibitors are already approved and established treatments for gMG and other conditions. Furthermore, other pharmaceutical companies are actively developing competing compounds in mid- to late-stage clinical development. A notable competitor is Sanofi, which is advancing its C1s inhibitor drug, riliprubart, for CIDP and has already posted positive Phase 2 results and is conducting two Phase 3 studies. This competitive landscape could make market penetration difficult and expensive for DNTH103, even if approved.

The clear emerging threat to Dianthus Therapeutics (DNTH) is the development and anticipated market entry of **Novartis's iptacopan (LNP023)**. Iptacopan is an oral Factor B inhibitor that targets the alternative complement pathway, similar to DNTH103 (a Factor D inhibitor). It is significantly ahead in clinical development, having shown positive Phase 3 results in multiple complement-mediated diseases (e.g., PNH, C3G, IgAN) and is under regulatory review in certain regions. Its oral formulation offers a potential convenience advantage over DNTH103, which is an investigational monoclonal antibody likely requiring subcutaneous or intravenous administration. Given Novartis's vast resources and iptacopan's advanced stage and potential for an oral standard of care, it poses a significant competitive threat to DNTH103's future market penetration.

Dianthus Therapeutics (DNTH) Addressable Markets

Dianthus Therapeutics (DNTH) is a clinical-stage biotechnology company focused on developing therapies for severe autoimmune and inflammatory diseases. The company's future revenue growth over the next 2-3 years is primarily expected to be driven by the advancement and potential commercialization of its pipeline candidates, particularly DNTH103 (claseprubart) and DNTH212.

Here are 3-5 expected drivers of future revenue growth:

1. Advancement and potential approval of DNTH103 (claseprubart) in generalized Myasthenia Gravis (gMG): Dianthus Therapeutics reported positive Phase 2 MaGic trial results for claseprubart in gMG in Q3 2025, with top-line data anticipated in September 2025. The company plans to initiate a Phase 3 trial in gMG in 2026. DNTH103 is designed to offer infrequent, self-administered subcutaneous injections, which could provide a significant commercial advantage upon approval.
2. Advancement and potential approval of DNTH103 (claseprubart) in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): The company anticipates initiating a pivotal Phase 3 trial in CIDP by the end of 2024. The interim responder analysis for the Phase 3 CAPTIVATE trial in CIDP has been accelerated to Q2 2026. Successful progression and eventual approval in this indication would open another revenue stream.
3. Advancement and potential approval of DNTH103 (claseprubart) in Multifocal Motor Neuropathy (MMN): Dianthus expects to report top-line data from the Phase 2 MoMeNtum trial for claseprubart in MMN in the second half of 2026. Positive results and subsequent clinical development could lead to a new product offering.
4. Development and potential commercialization of DNTH212: In October 2025, Dianthus entered into an exclusive license agreement for DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor. A Phase 1 study in China for DNTH212 is expected to commence by the end of 2025, with initial results in healthy volunteers anticipated in the second half of 2026. This new clinical candidate is viewed as having "pipeline-in-a-product potential" across various severe autoimmune indications.
5. "Pipeline-in-a-product" strategy for DNTH103: Beyond the initial indications, DNTH103 (claseprubart) is considered to have broader "pipeline-in-a-product potential" across a range of autoimmune disorders due to its mechanism of action as a selective complement inhibitor. Success in current trials could enable expansion into additional autoimmune diseases, thereby driving further revenue growth.

Share Issuance

• In September 2025, Dianthus Therapeutics completed an upsized underwritten public offering of common stock, generating aggregate gross proceeds of approximately $288 million.
• The company reported significant common stock issuances, with $270.29 million in fiscal year 2024 and $40.7 million for the trailing twelve months ended June 2025.
• A reverse merger completed on September 11, 2023, involved the issuance of shares to former stockholders of Dianthus Therapeutics OpCo, Inc.

Inbound Investments

• On April 19, 2022, Dianthus Therapeutics secured $100 million in Series A funding, with key investors including 5AM Ventures, Fidelity Investments, and Avidity Partners.
• Prior to the September 2023 Reverse Merger, Dianthus (OpCo) raised aggregate gross proceeds of $121.5 million from private placements to fund its operations.

Capital Expenditures

• Dianthus Therapeutics reported relatively low capital expenditures, totaling $0.11 million in fiscal year 2024, $0.11 million in fiscal year 2023, and $0.14 million in fiscal year 2022.
• These capital expenditures are primarily focused on supporting the company's preclinical and clinical development activities, including chemistry, manufacturing, and controls (CMC) costs.