Crystalys Therapeutics Launches with $205M Series A Financing to Transform the Treatment of Gout

Novo Holdings, SR One and Catalys Pacific co-led the financing

Company emerges from stealth to advance lead asset, dotinurad, through global Phase 3 clinical trials

Dotinurad is a next-generation, once daily oral, URAT1 inhibitor with  potential for best-in-class safety and efficacy, as supported by extensive clinical data from Japan, China and other Asian markets where the drug is approved

SAN DIEGO, Sept. 30, 2025 /PRNewswire/ -- Crystalys Therapeutics Inc., ('Crystalys' or 'the Company'), a clinical-stage biopharmaceutical company, is announcing its launch with a $205 million Series A financing to support its mission of addressing the significant unmet medical needs of people living with gout. The financing round was co-led by Novo Holdings, SR One and Catalys Pacific with participation from a broad syndicate of investors, including Perceptive Xontogeny Venture Funds, Lightstone Ventures, AN Venture Partners, funds managed by abrdn Inc., KB Investments, Pontifax, Longwood Fund, Alexandria Venture Investments, Wedbush Healthcare Partners and Prebys Ventures Fund. 

The financing round will support the advancement of global Phase 3 clinical studies evaluating the company's lead asset, dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential best-in-class safety and efficacy for the treatment of gout. 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.

"Crystalys was built to bring forward a new therapeutic option for the millions of people struggling with gout," said James Mackay, Ph.D., President and Chief Executive Officer of Crystalys Therapeutics. "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."

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.

"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," said BT Slingsby, M.D., Ph.D., M.P.H., Co-founder and Chairman of the Board of Crystalys Therapeutics. "We are proud to continue to support Crystalys as it advances dotinurad into two global Phase 3 trials."

"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," said Nihar Bhakta, M.D., Chief Medical Officer of Crystalys Therapeutics. "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."

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.

About Crystalys Therapeutics

Crystalys Therapeutics is a clinical-stage biopharmaceutical company transforming the treatment of gout. Headquartered in San Diego, California, and co-founded by Catalys Pacific and Novo Holdings, Crystalys brings together a world-class team with deep expertise in gout drug development, dedicated to delivering more effective options for people living with gout. The company's lead candidate, dotinurad, is a next-generation, once daily oral, URAT1 inhibitor in clinical development as a second-line therapy aimed to reduce uric acid, gout flares and tophi. Dotinurad was invented by Fuji Yakuhin and has obtained regulatory approval in Japan, China, Philippines and Thailand. With best-in-class potential for both safety and efficacy, dotinurad is supported by clinical data from multiple Asian markets where it is approved. Crystalys is advancing dotinurad in global Phase 3 trials toward regulatory approval and commercial launch.

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SOURCE Crystalys Therapeutics