Harnessing the Power
of Selectivity in
Complement Therapeutics

Study of lead program will provide proof-of-concept to enable further clinical development in severe autoimmune diseases; full cohort data available in 2H’23

DNTH103 is a next-generation monoclonal antibody that selectively targets only the active form of the C1s protein in the classical complement pathway

DNTH103 designed as an infrequent and convenient subcutaneous injection to improve upon high dose volume and frequency of currently available complement pathway inhibitors

New York City and Waltham, Mass., November 30, 2022 – Dianthus Therapeutics, a biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, today announced that the first healthy volunteers have been dosed in a Phase 1 clinical trial of its lead monoclonal antibody, DNTH103.

“Today marks a pivotal milestone for Dianthus as we transition into a clinical stage company,” said Marino Garcia, President and Chief Executive Officer, Dianthus Therapeutics. “Data from this Phase 1 study will provide important information about the safety, tolerability, pharmacokinetics and pharmacodynamics of DNTH103 in healthy adult volunteers across single and multiple ascending dose cohorts, demonstrating potential proof-of-concept to advance DNTH103 into severe autoimmune diseases where other modalities have not fully addressed the unmet medical need.”

DNTH103 is a selective inhibitor of the active C1s protein in the complement system’s classical pathway. Classical pathway activity is implicated in driving morbidity in a range of autoimmune disorders. Unlike therapies that broadly inhibit the complement system, selective inhibition of the classical pathway preserves immune activity of the lectin and alternative complement pathways against bacterial infections.

“All currently approved complement antibody therapies indiscriminately bind to both active and inactive complement proteins – meaning a large, sometimes frequent dose must be administered while a significant portion of the drug acts unnecessarily on inert proteins,” said Simrat Randhawa, M.D., Chief Medical Officer, Dianthus Therapeutics. “DNTH103 selectively targets the active form of C1s – allowing more of the drug to have a therapeutic effect so we can potentially reduce dose volume and frequency of administration. In addition, by leaving the lectin and alternative pathways intact, the risk of infection from encapsulated bacteria is lower for DNTH103 versus commonly used C5 and C3 inhibitors.”

About Dianthus Therapeutics

Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency over existing complement therapies. Based in New York City and Waltham, Mass. Dianthus is comprised of an expert team of biotech and pharma executives who are leading the next generation of antibody complement therapeutics to deliver transformative medicines for patients with severe autoimmune diseases. Dianthus raised a $100M Series A in April 2022 co-led by 5AM Ventures, Avidity Partners, and Fidelity Management & Research Company, with participation from additional investors including Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures, and Venrock Healthcare Capital Partners. To learn more, please visit www.dianthustx.com and follow us on Twitter and LinkedIn.

Media Contact

Amanda Sellers, Verge Scientific Communications

asellers@vergescientific.com

Lead program DNTH103 to be accelerated to the clinic this year as a highly differentiated and potent monoclonal antibody designed to selectively target the active form of complement C1s

Led by biotech veterans Marino Garcia as Chief Executive Officer and Lonnie Moulder as Chairman of the Board

Financing co-led by 5AM Ventures, Avidity Partners, and Fidelity Management & Research Company with strong investor syndicate

Waltham, Mass. and New York City, May 3, 2022 – Dianthus Therapeutics, a biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, today announced the completion of its $100 million Series A financing led by 5AM Ventures, Avidity Partners, and Fidelity Management & Research Company, with participation from additional investors including Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures, and Venrock Healthcare Capital Partners. The financing will be used to expand leadership and scientific teams, advance the company’s lead program, DNTH103, to the clinic this year, and to accelerate additional discovery pipeline programs for people living with severe and rare autoimmune diseases. DNTH103 is a potent, next-generation monoclonal antibody that selectively targets the active form of complement C1s, potentially enabling a lower dosing volume and a less frequent subcutaneous administration that is further enhanced with half-life extension technology.

Dianthus also announced the appointment of Marino Garcia as President and Chief Executive Officer, joining in November 2021, and Simrat Randhawa, M.D., M.B.A., as Chief Medical Officer. Mr. Garcia, a veteran dealmaker and strategist, brings more than 25 years of industry experience in business development and operational leadership roles at top biotech and pharma companies, most recently as Senior Vice President, Corporate and Business Development at Zealand Pharma. Dr. Randhawa brings over 20 years of clinical practice and pharmaceutical industry experience to Dianthus, including senior leadership roles focused in the autoimmune and rare disease spaces. He most recently served as Senior Vice President of Clinical and Medical Affairs at Aurinia Pharmaceuticals.

“We are committed to improving the lives of people living with severe and rare autoimmune diseases and are confident that our selective antibodies have the potential to be best-in-class therapeutics,” said Marino Garcia, President and Chief Executive Officer, Dianthus Therapeutics. “We are privileged to have a strong syndicate of leading biotech investors, experienced Board members, and accomplished leaders and scientists as we advance our lead candidate into the clinic later this year, further develop our discovery pipeline, and expand our team in the coming months. Dianthus is positioned to become a leading, next-generation complement company guided by a deep understanding of the needs of patients.”

Dianthus harnesses the power of selectivity in complement pathways to create potent monoclonal antibodies with the potential to overcome the limitations of current complement therapeutics. Unlike current antibody therapies that bind to both inactive and active complement proteins, DNTH103 selectively targets only the active form of the C1s complement protein, enabling a lower dosing volume and less frequent administration. Its half-life extension technology also further reduces dosing frequency. With these differentiated attributes and high potency inhibition of C1s, DNTH103 is designed to relieve the burden of high-volume, frequent administration with IV infusions or inconvenient, frequent subcutaneous dosing. Accelerating the development of a more convenient subcutaneous therapy could be transformative in expanding the potential patient populations that could benefit from complement therapies, while reducing the discomfort and disruptions that pervade the lives of patients today – ultimately allowing more patients to live healthier lives to their fullest potential.

“We are proud to support Dianthus Therapeutics in advancing the discovery and development of next-generation, potent, and highly differentiated antibody complement therapeutics,” said Paula Soteropoulos, Board Director of Dianthus and Strategic Advisor to 5AM Ventures. “With the leadership of the recently appointed President and CEO Marino Garcia, and a talented team of seasoned biotech executives and entrepreneurs who hold an extensive track record of success, we look forward to seeing Dianthus bring their novel therapies to patients living with severe and rare autoimmune diseases.”

Dianthus is currently led by an accomplished team of veteran scientists and biotech entrepreneurs, including:

• Marino Garcia, President and Chief Executive Officer
• Simrat Randhawa, M.D., Chief Medical Officer
• Evan Thompson, Ph.D., Chief Operating Officer
• Edward Carr, Chief Accounting Officer
• Rivka Gluck, Senior Vice President, Head of Clinical Operations
• Robert McGarr, Ph.D., Vice President, Program & Alliance Management
• Kristina Maximenko, Head of Human Resources

Dianthus is also supported by an experienced Board of Directors, including:

• Lonnie Moulder, Chairman of the Board at Dianthus, Founder and Managing Member of Tellus BioVentures
• Paula Soteropoulos, Chairman of the Board at Ensoma and former CEO of Akcea Therapeutics
• Lei Meng, Senior Therapeutics Analyst, Avidity Partners
• Tomas Kiselak, Managing Member of Fairmount
• Jonathan Violin, Ph.D., Co-founder and Chief Executive Officer of Viridian Therapeutics
• Marino Garcia, President and Chief Executive Officer, Dianthus Therapeutics

Jefferies LLC served as financial advisor to Dianthus.

About Dianthus Therapeutics

Dianthus Therapeutics is a biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency over existing complement therapies. Based in Waltham, Mass. and New York City, Dianthus is comprised of an expert team of biotech and pharma executives who are leading the next generation of antibody complement therapeutics to deliver transformative medicines for patients with severe and rare autoimmune diseases. To learn more, please visit www.dianthustx.com.

Media Contact

Amanda Sellers, Verge Scientific Communications
asellers@vergescientific.com