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First Close of Series B Funding Round Successfully Completed – Advancing to Phase I Clinical Trial of the BNCT Boron Drug Candidate RN-501 –

9 hours ago
5 min read

RadioNano Therapeutics Inc. (Head Office: Kyoto, Japan; President & CEO: Dr.Masatoshi Chiba; hereinafter, the “Company”), a biotechnology company engaged in the research and development of inorganic nanoparticle formulations for Boron Neutron Capture Therapy (BNCT), today announced the successful completion of the first close of its Series B financing round through a third-party allotment of new shares to Mitsui Kinzoku Co., Ltd. and Kyoto University Innovation Capital Co., Ltd.


The proceeds from this financing round will be used to support the Phase I/IIa clinical trial of the Company’s lead pipeline candidate, RN-501. The Company will also continue its fundraising efforts toward the second close of the Series B round.


■ Background and Purpose of the Financing

Boron Neutron Capture Therapy (BNCT) is a form of radiation therapy that utilizes the nuclear reaction between thermal neutrons and boron (Boron-10). The resulting alpha particles and lithium nuclei selectively destroy cancer cells. Because the range of these particles is extremely localized, BNCT is expected to eradicate cancer cells while minimizing damage to surrounding healthy tissues.

Japan became the first country in the world to approve BNCT for coverage under its national health insurance system in 2020. With the growing adoption of accelerator-based neutron sources, expectations are increasing for both the expansion of treatable cancer indications and the development of next-generation boron agents that will enable such advances.


Guided by its mission to “contribute to the health and future of cancer patients and their families through the research and development of innovative science-based radiation therapies,” RadioNano Therapeutics has been developing RN-501, a novel formulation based on inorganic nanoparticles enriched with boron, leveraging research outcomes from Kyoto University. The Company's technology has also received external recognition, including selection for Forbes JAPAN's “100 Japanese Startups to Watch in 2026” and the Grand Prize at the 22nd Innovation Research and Development Grant Program sponsored by The Senshu Ikeda Bank, Ltd.


To date, the Company has advanced the non-clinical development of RN-501 and made preparations for the initiation of clinical trials, incorporating recommendations obtained through regulatory science consultations with the Pharmaceuticals and Medical Devices Agency (PMDA). The Company has also been developing manufacturing processes and analytical methods for both the investigational drug substance and drug product. In addition, the core patent covering RN-501 has been granted, and the Company is currently pursuing international patent protection in overseas markets through international patent applications.


Having achieved these key development milestones and reached the stage of transition into clinical development, the Company will use the proceeds from this financing round to initiate a Phase I/IIa clinical trial of RN-501, with the objective of evaluating its safety, tolerability, and other clinical characteristics in human subjects.


■ Use of Funds

  • Phase I/IIa Clinical Trial of RN-501

  • Establishment of GMP Manufacturing and Supply Capabilities for the Investigational Product

  • Expansion of Development Capabilities and Organizational Strength


■ Overview of the First Close of the Series B Financing Round

Round: Series B (First Close)

Financing Method: Third-Party Allotment of New Shares

Investors:

  • Mitsui Kinzoku Co., Ltd.

  • Kyoto University Innovation Capital Co., Ltd. (Innovation Kyoto 2021 Investment Limited Partnership)

Amount Raised: Undisclosed

Use of Proceeds:Implementation of the Phase I/IIa Clinical Trial of RN-501 and other related activities.


■ Investor Comments

Mr. Yoshihiro Kagawa, General Manager, 

Market Co-creation Department , Mitsui Kinzoku Co., Ltd.

"We believe that BNCT is a treatment modality in which Japan leads the world, and that boron agents are the key to significantly expanding its potential. We decided to invest in RadioNano Therapeutics because the company combines robust science originating from Kyoto University with a management team that has steadily advanced development toward clinical-stage testing.

To date, Mitsui Kinzoku Co., Ltd., has worked closely with the company on the development of the inorganic nanoparticles that form the core of RN-501. Leveraging our accumulated expertise in inorganic compounds and nanotechnology, we have contributed to the development of manufacturing processes and analytical testing methods for the product.

Going forward, we will further strengthen our collaboration with RadioNano Therapeutics and provide our full support toward the successful commercialization of this innovative cancer therapy for the benefit of patients and society."


Dr. Hiroyuki Ueno, Partner, Investment Division II, Kyoto University Innovation Capital Co., Ltd.

"At Kyoto iCAP, our mission is to translate research achievements generated at universities into medical innovations that reach patients. We strongly resonate with RadioNano Therapeutics' vision of delivering new treatment options to cancer patients for whom effective therapies remain limited. Since the Company's establishment, we have supported its efforts to advance into practical application the technologies developed by Professor Naoki Komatsu of the Graduate School of Human and Environmental Studies, Kyoto University, and Professor Minoru Suzuki of the Institute for Integrated Radiation and Nuclear Science, Kyoto University.


We highly value the steady progress achieved during the non-clinical stage, as well as the Company's strategy that thoughtfully integrates both clinical development and business development objectives. Based on this assessment, we have decided to make an additional investment in the Company.


We remain committed to supporting the long-term growth of RadioNano Therapeutics as it works toward its goal of delivering a BNCT therapeutic agent developed in Japan to patients around the world."



■ Comment from Dr.Masatoshi Chiba, President & CEO, RadioNano Therapeutics Inc.

 

Dr.Masatoshi Chiba, President & CEO, RadioNano Therapeutics Inc.

“We are delighted to welcome Mitsui Kinzoku Co., Ltd., as a new shareholder and to receive continued support from Kyoto University Innovation Capital Co., Ltd., following its investments in our Seed and Series A financing rounds. The recognition of our technology and growth potential by a new investor, together with the renewed confidence shown by an existing investor that has closely followed our journey since the early days of the Company, is both highly encouraging and deeply humbling.

Since our founding, we have devoted ourselves to the development of RN-501, and we are now approaching a major milestone as the program advances into the clinical stage. The Phase I clinical trial represents the first, and most important, step toward delivering our technology to patients who may benefit from it.

We would like to express our sincere gratitude to our existing shareholders, research collaborators, and all those who have supported us along the way. United as one team, we remain committed to advancing the development of RN-501 with urgency and determination, with the goal of bringing a new treatment option to patients as quickly as possible.”

■ RN-501

RN-501 is a novel boron agent for Boron Neutron Capture Therapy (BNCT) being developed by RadioNano Therapeutics. It is a new formulation based on boron-rich inorganic nanoparticles designed to deliver high concentrations of boron to tumor tissues.


By leveraging nanotechnology to enhance the selective accumulation of the drug in cancerous tissues, RN-501 aims not only to reduce treatment-related side effects but also to expand the applicability of BNCT to cancer types that have traditionally been difficult to treat with this modality.


RN-501 is currently an investigational product under development, and its safety and efficacy have not yet been established.


■ Company Overview

Company Name: RadioNano Therapeutics Inc.

Head Office:36-1 Yoshida-Honmachi, Sakyo-ku, Kyoto 606-8317, Japan

Representative:Dr.Masatoshi Chiba, President & CEO

Established:April 1, 2024

Capital:JPY 100 million

Business Description:Research and development of boron agents for Boron Neutron Capture Therapy (BNCT)


■ For Inquiries

RadioNano Therapeutics Inc.

Dr.Hiroshi Kawai Senior Executive Vice President & DirectorHead of Administration Division



Cautionary Statement Regarding Forward-Looking Information

The development plans, projections, and other forward-looking statements contained in this press release are based on the Company's judgments and assumptions derived from information available as of the date of this release. Actual results may differ materially from those expressed or implied in such statements due to various factors, including, but not limited to, the progress of research and development activities and decisions made by regulatory authorities.

In addition, any information contained in this press release regarding pharmaceutical products, including investigational products under development, is provided solely for informational purposes and is not intended as promotion, advertising, or medical advice.

 
 
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