Rege Nephro Co. Ltd.

KYOTO, Japan, Oct. 7, 2024 /PRNewswire/ -- Rege Nephro Co., Ltd. () is excited to announce that the company has successfully developed a funding plan of total 25 billion yen in new Series B funding and raised 22.5 billion yen with the first payment. This significant investment brings the company's total funding to 44 billion yen. The funding round attracted a mix of strategic investors, including DCI Partners Co., Ltd. as a lead investor, JIC Venture Growth Investments Co., Ltd., Nippon Venture Capital CO., Ltd., TOHOKU University Venture Partners Co., Ltd., Golden Asia Fund Ventures Ltd., Mitsui Chemicals, Inc., Global Brain Corporation, Kyoto University Innovation Capital Co., Ltd., JAFCO Group Co., Ltd., Mitsubishi UFJ Capital Co., Ltd., ASAHI KASEI CORPORATION, QB Capital, LLC who recognize the potential of Rege Nephro in delivering new treatments to patients suffering from their diseases. The newly acquired funds will be strategically used to advance the clinical trials of RN-014, our promising treatment in Phase II trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD), and to prepare for clinical trials in the United States. Additionally, the funding will support the completion of preclinical trials for our second innovative product, RN-032, aimed at treating Chronic Kidney Disease (CKD) through cell therapy. Investor Statements DCI Partners Co., Ltd. "We are excited to announce that we are the lead investor in this round of investment from our fund. We are fully committed to supporting the growth of Rege Nephro." JIC Venture Growth Investments Co., Ltd. "We strongly believe that his advanced drug discovery research based on Professor Osafune's discoveries will provide new therapeutic solutions for intractable renal diseases." Kyoto University Innovation Capital Co., Ltd. "We are delighted that Rege Nephro, which we have supported since before the company was founded, has finally entered the clinical stage. We hope that this funding will accelerate the clinical trials and bring a new therapeutic drug to patients as soon as possible." JAFCO Group Co., Ltd. "We hope that this financing will further accelerate Rege Nephro research and development in iPS drug discovery and provide new treatment options for patients suffering from diseases with limited treatment options." Mitsubishi UFJ Capital Co., Ltd. "Our continued investment reflects our confidence in Rege Nephro's rapid progress and the potential of Professor Osafune's iPS cell technology to significantly impact medical practice." Series B investors About Rege Nephro Co., Ltd. Rege Nephro Co., Ltd. is a clinical-stage biotech company utilizing induced pluripotent stem cell (iPSC)-based technology from the Center for iPS Cell Research and Application (CiRA), Kyoto University. It is developing therapeutics and cell therapy for kidney, liver, and pancreas diseases. About RN-014 Tamibarotene, under development for ADPKD, is a retinoic acid receptor (RAR) agonist expected to potently inhibit cyst formation and improve renal function. The Phase II clinical trial began in December 2023. This trial includes a pharmacokinetic (PK) phase and a randomization phase. Various safety measures have been established, including phased patient enrollment, periodic independent safety monitoring, strict criteria for dose reduction and discontinuation of the investigational drug, and criteria for discontinuation of the entire trial. There have been no significant issues at this time. About RN-032 Cell therapy using NPCs for Chronic Kidney Disease (CKD). Nephron progenitor cells (NPCs) are cells that give rise to nephrons. Rege Nephro has been tried implanting iNPCs (NPCs induced from allogeneic human iPSCs) into the damaged kidneys, and the improvements in renal function have been confirmed in the several mouse experiments. SOURCE Rege Nephro CO., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

KYOTO, Japan, May 28, 2024 /PRNewswire/ -- Rege Nephro CO., Ltd. () has announced that patient enrollment began in April for the second stage of its Phase II clinical trial of tamibarotene as a developmental product for the treatment of autosomal dominant polycystic kidney disease (ADPKD) under the code RN-014. After reviewing all available safety data from the first stage, which started in December of last year, the decision was made to advance to the second stage. The company aims to complete patient enrollment by the end of 2024. Public Clinical Trial Information jRCT (Japan Registry of Clinical Trials): A system for the submission and publication of clinical research () ClinicalTrials.gov: A public website provided by the U.S. National Library of Medicine () Tolvaptan is the only approved drug for the treatment of ADPKD. Since the launch of tolvaptan, pharmaceutical companies worldwide have been developing numerous clinical trials of new drugs to treat ADPKD, but most of these drugs have already been discontinued due to inefficacy, highlighting the strong need for new treatment options. RN-014 is currently at the most advanced stage of development among the drugs in development for patients with ADPKD. About ADPKD Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary cystic kidney disease. It is characterized by the gradual development and enlargement of multiple cysts in both kidneys, leading to progressive renal dysfunction. Cysts can also occur in the liver and pancreas, and vascular abnormalities throughout the body are common, including high blood pressure, cerebral aneurysms, and heart valve abnormalities. Currently, tolvaptan, which inhibits cyst growth, is the only approved treatment for ADPKD, but there is no curative treatment available. About RN-014 Tamibarotene, under development for ADPKD, is a retinoic acid receptor (RAR) agonist expected to potently inhibit cyst formation and improve renal function. The clinical trial dose identified in multiple mouse model experiments is 4mg/day, and its safety has been confirmed in past studies. With advice from the Pharmaceuticals and Medical Devices Agency (PMDA), the Phase II clinical trial began in December 2023. This trial includes a pharmacokinetic (PK) phase and a randomization phase. Various safety measures have been established, including phased patient enrollment, periodic independent safety monitoring, strict criteria for dose reduction and discontinuation of the investigational drug, and criteria for discontinuation of the entire trial. About Rege Nephro CO., Ltd. Rege Nephro CO., Ltd. is a clinical-stage biotech company utilizing induced pluripotent stem cell (iPSC)-based technology from the Center for iPS Cell Research and Application (CiRA), Kyoto University. It is developing therapeutics and cell therapy for kidney, liver, and pancreas diseases. Media Inquiries: Katsuhisa Yamaguchi, CFO Rege Nephro CO., Ltd. TEL: 075-744-6858 E-mail: [email protected] SOURCE Rege Nephro CO., Ltd.