Novo Holdings co-leads $205 million Series A financing of Crystalys Therapeutics to transform treatment of gout

Financing to support global Phase 3 development of dotinurad, Crystalys’ next-generation, oral URAT1 inhibitor with the potential for best-in-class safety and efficacy

San Francisco, US – September 30, 2025 – Novo Holdings, a leading international life science investor, today announced that it has co-led a $205 million Series A financing of Crystalys Therapeutics, a clinical-stage biopharmaceutical company dedicated to transforming the treatment of gout. Proceeds of the financing will enable Crystalys to advance dotinurad, the company’s once-daily oral URAT1 inhibitor, into global Phase 3 trials. Dotinurad has already demonstrated robust efficacy and a well-defined safety profile across multiple clinical studies, supporting its approval in Japan, China, Philippines and Thailand.

Many patients in the U.S. and E.U. who do not respond adequately to available therapies lack suitable second-line options. Dotinurad has the potential to fill this treatment gap and has demonstrated robust efficacy and a well-defined safety profile across multiple clinical studies. Since the first approval in 2020, more than 1.2 million patients have been treated with dotinurad, consistently achieving target serum uric acid levels linked to meaningful clinical benefits.

Led and co-founded by James Mackay, Ph.D., President and Chief Executive Officer, a veteran biotech leader with over 40 years of drug development experience, six drug approvals, and a history of founding and leading innovative companies while contributing to San Diego’s life sciences ecosystem, Crystalys brings together a world-class team with a proven record in gout drug development and deep regulatory success with URAT1 inhibitors. Fellow co-founders of Crystalys include Dr. Nihar Bhakta, Dr. Ashwin Ram and Ms. DeAnne Reid. Dr. Bhakta, Chief Medical Officer at Crystalys, has extensive clinical and regulatory experience in immunology and inflammation, having led the team that secured the most recent small molecule FDA and EU approvals for hyperuricemia associated with gout. Dr. Ram, Chief Operating Officer, has extensive experience as an investor and operator, having managed multiple new company creations as a Partner at Catalys Pacific. Ms. Reid, Executive Director of Operations and Business Development, has significant biotech and gout drug development experience from her roles at Ardea Biosciences and Aristea Therapeutics.

James Mackay, Ph.D., President and Chief Executive Officer of Crystalys Therapeutics, said, “Crystalys was built to bring forward a new therapeutic option for the millions of people struggling with gout. Our lead asset, with its proven efficacy and well-defined safety profile, has already demonstrated its ability to provide meaningful relief for people living with gout. Thanks to the support of our investors, our experienced team is now well-positioned to accelerate dotinurad’s development in the US and Europe as a much needed second-line therapy for patients who do not respond adequately to first-line treatments.”

Ken Harrison, Senior Partner, Novo Holdings, said, “Crystalys has brought together a world-class team with deep expertise in gout drug development and proven regulatory success advancing URAT1 inhibitors. Supporting innovative science that addresses major health challenges is central to Novo Holdings’ mission, and we are pleased to back Crystalys as it seeks to transform care for patients with gout worldwide.”

BT Slingsby, M.D,, Ph.D., M.P.H., Co-founder and Chairman of the Board of Crystalys Therapeutics, said, “Since its inception, Crystalys has been guided by a singular vision: uniting a world-class gout drug development team with Japan’s excellence in pharmaceutical innovation to deliver transformative therapies for patients with gout. We are proud to continue to support Crystalys as it advances dotinurad into two global Phase 3 trials.”

Nihar Bhakta, MD, Chief Medical Officer of Crystalys Therapeutics, said, “The clinical effectiveness of dotinurad for treating hyperuricemia associated with gout has already been well validated across 22 trials involving 1,300 subjects, and since its approval in Japan in 2020, more than 1.2 million patients have been treated with dotinurad, consistently achieving target serum uric acid levels linked to meaningful clinical benefits. Our upcoming Phase 3 trials are designed to highlight the superior efficacy of dotinurad in reducing serum uric acid levels, gout flares and tophus area.”

Crystalys was co-founded by investors Novo Holdings and Catalys Pacific. The Series A financing was co-led with SR One and Catalys Pacific, with additional participation from a broad syndicate of international investors including Perceptive Xontogeny Venture Funds, Lightstone VC, AN Venture Partners, funds managed by abrdn Inc., KB Investments, Pontifax, Longwood Fund, Alexandria Venture Investments, Wedbush Healthcare Partners and Prebys Ventures Fund.

About Gout

Gout is the most common form of inflammatory arthritis. It is a condition which is very debilitating for patients and characterized by sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints. This disease arises from excess uric acid in the body, known as ‘hyperuricemia,’ which causes buildup of uric acid crystals and inflammation, leading to tophaceous gout in people with chronic or undertreated disease. Despite available therapies that aim to reduce uric acid levels below the target 6 mg/dL, a major treatment gap remains between first-line xanthine oxidase inhibitors (XOIs) and last-line uricase therapy. Currently, no suitable second-line options exist in the U.S. or E.U., leaving a critical unmet need for patients who fail to respond to first-line treatments.