Rege Nephro, a Japanese clinical-stage biotechnology company focused on iPS cell-based kidney regenerative medicine and drug discovery, has closed a financing round totalling approximately US$10.6 million.

Through the issuance of Japan-Keep It Simple Security (J-KISS) share acquisition rights, proceeds are expected to support commercialisation activities for RN-014, the company’s lead candidate for autosomal dominant polycystic kidney disease (ADPKD), advance its iPS cell-derived regenerative medicine program RN-032, and fund continued research and development activities. The financing is intended to support the company’s growth through its anticipated Series C financing and beyond.

Background of the funding

Rege Nephro is dedicated to developing therapies and medical technologies for patients with kidney diseases who currently have limited treatment options.

The company’s lead programme, RN-014, recently reached Last Patient Last Visit (LPLV) in its Phase IIa clinical trial. RN-014 is a small-molecule therapeutic candidate identified through screening using an iPS cell-derived ADPKD disease model, and analysis of Phase IIa clinical trial data is currently underway.

In addition, RN-032, an iPS cell-derived regenerative medicine programme based on renal nephron progenitor cells, has completed process development in preparation for nonclinical studies and is progressing to the next stage.

The financing will support continued advancement of these core programs while strengthening the company’s long-term growth strategy.

Future strategy

The capital raised will be allocated across four key priorities:

1. RN-014 commercialisation and global licensing activities

Building on insights generated from the Phase IIa clinical trial, Rege Nephro plans to pursue global licensing and partnering opportunities for RN-014 while continuing development activities aimed at further evaluating the program’s therapeutic potential.

2. Supporting non-clinical development of RN-032

Following the completion of process development for RN-032, the company will advance RN-032 into non-clinical studies to establish the foundation for future clinical trials.

3. Expanding discovery research and kidney regeneration programmes

The company will continue to invest in discovery and translational research, including next-generation kidney regeneration technologies and future pipeline candidates. Rege Nephro ultimately aims to develop therapies that improve outcomes and quality of life for patients with kidney disease while reducing progression to kidney failure.

4. Strengthening organisational capabilities

To support continued growth, Rege Nephro plans to expand its team by recruiting scientific, clinical development, and business development professionals with specialised expertise.

Through this financing, Rege Nephro seeks to advance its pipeline while strengthening the operational foundation required to support future growth and long-term value creation.

List of the investors:

• Arcus South East Asia
• BA7 Venture Capital
• Chushin Venture Capital
• DCI Partners
• JAFCO Group
• JIC Venture Growth Investments
• Kyoshin Social Capital
• Kyoto University Innovation Capital
• Mitsubishi UFJ Capital
• RAP-HI
• SPARX Asset Management
• TaiAn Technologies
• Toho Holdings

Akifumi Morinaka, Representative Director and CEO of Rege Nephro, said: “With RN-014 having completed its Phase IIa clinical trial and RN-032 advancing toward its next stage of development, we believe the company is well positioned for continued growth. We remain committed to addressing unmet medical needs in kidney disease through innovative medicines and regenerative therapies based on iPS cell technology.”