Rege Nephro Acquires Tamibarotene-Related Assets from Syros Pharmaceuticals for U.S. Clinical Trials

KYOTO,Japan,April 15,2025 -- Rege Nephro Co.,Ltd. (Headquarter: Kyoto,Japan; Chief Executive Officer: Akifumi Morinaka) has announced that it has successfully acquired Tamibarotene-related clinical and non-clinical assets from Syros Pharmaceuticals,Inc. (Headquarters: Boston,MA; NASDAQ:SYRS),through a mutual agreement. The acquisition was completed on February 26,2025.

Tamibarotene (RN-014) is a retinoic acid receptor agonist for which Rege Nephro is currently conducting a Phase 2 clinical trial in Japan in autosomal dominant polycystic kidney disease (ADPKD). Rege Nephro expects to initiate clinical trials in the United States,after confirming the efficacy and safety in Japan. Syros Pharmaceuticals has previously carried out a Phase 3 clinical trial of Tamibarotene for indications including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

This acquisition,encompassing their clinical and non-clinical data including human safety study for New Drug Application (NDA),contracts with a contract manufacturing organization (CMO),and Tamibarotene active pharmaceutical ingredient (API) and drug products,is expected to enhance Rege Nephro's capabilities and streamline operations for its clinical trial operations in the United States.

About Rege Nephro:

Rege Nephro,founded in 2019,is a clinical-stage biotech company leveraging technology based on research of Prof. Kenji Osafune,deputy director of the Center for iPS Cell Research and Application (CiRA),Kyoto University. The company is developing therapeutics and cell therapy for diseases related to the kidneys,liver,and pancreas. For more information,please visit www.regenephro.co.jp/en.

About RN-014:

RN-014 is a therapeutic candidate for autosomal dominant polycystic kidney disease (ADPKD). It is a retinoic acid receptor (RAR) agonist expected to suppress cyst formation and improve renal function. Rege Nephro initiated a Phase 2 clinical trial in December 2023,and enrollment for the second stage has now been completed. To date,no significant safety concerns have arisen and preliminary efficacy has been demonstrated.