Rakuten Medical Announces New Management Team to Drive the Next Phase of Growth and Innovation

• Mickey Mikitani, as sole CEO, reaffirms his commitment to the company's mission of conquering cancer for patients all over the world
• Minami Maeda has been appointed as the new President to expedite pipeline development, with a strategic focus on securing FDA approval for ASP-1929, expanding into broader Asia, and further driving commercial growth in Japan
• A new global Phase 3 clinical trial for ASP-1929 photoimmunotherapy in combination with anti-PD-1 is expected to be initiated in 2H 2024

SAN DIEGO, Aug. 19, 2024 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing oncology precision, cell-targeting photoimmunotherapy through its proprietary Alluminox™ platform, announces that Hiroshi "Mickey" Mikitani now serves as its sole Chief Executive Officer and Vice Chairman of the Board, and Minami Maeda has been appointed as its new President, effective August 9, 2024. Takashi "Tora" Toraishi has chosen to step down from his role as Co-Chief Executive Officer, President and Board Director.

The new management team is set to further advance Rakuten Medical's Alluminox™ platform and prioritize obtaining FDA approval for ASP-1929 as early as possible. The company's new global Phase 3 study of ASP-1929 photoimmunotherapy in combination with anti-PD-1 for first-line recurrent head and neck squamous cell carcinoma (HNSCC) is expected to commence first in the United States in 2H 2024.

Rakuten Medical also aims to extend its reach into Asian markets, where many countries face high unmet medical needs, by leveraging its growing expertise from commercial treatments in Japan. Asia accounts for half of the world's cancer incidence and has the highest cancer mortality rate^*. Rakuten Medical's strong track record of commercial success in Japan has generated substantial scientific publications, which the company believes would help support new medical communities' better understanding of the Alluminox™ platform. In Japan, the company will continue to drive growth and vigorously support the realization of its strategic agenda in the U.S. and Asia.

Mickey Mikitani, Chief Executive Officer and Vice Chairman of the Board of Rakuten Medical, stated, "The appointment of Minami as President and the formation of our new management team underscores our unwavering commitment to advancing our innovation for patients in need. We continue striving to advance cancer treatment through our technology platform, and I am fully committed to further driving the company's vision and strategic direction."

"I am honored to take on this pivotal role at such a critical time for Rakuten Medical," said Minami Maeda, President of Rakuten Medical. "Our treatment has positively impacted patients' lives in Japan, as demonstrated by our robust commercial growth there. I am excited to collaborate with our talented team to build an even stronger company and extend our contributions to more patients and broader communities as we continue to pursue our global development efforts."

Since joining Rakuten Medical in November 2017, Maeda has demonstrated outstanding leadership and strategic acumen. Most recently serving as Chief Commercial Officer of Rakuten Medical, Inc., and Representative Director & President of Rakuten Medical K.K., he has significantly contributed to commercial growth and established a scalable business model for the company's innovative drug-device combination in Japan. His efforts have greatly enhanced the company's global growth and technological advancements. Prior to his tenure at Rakuten Medical, Maeda gained extensive experience in business and public policy through his work at McKinsey & Company's Tokyo and Johannesburg offices. He also served as Chief of Staff to Japan's Minister of Health, Labor, and Welfare.

Rakuten Medical extends its gratitude to Toraishi for his strong leadership and contributions since 2017. His tenure has been marked by significant achievements, including the successful development and the world-first approval of ASP-1929 in Japan, and the establishment of a strong foundation for future growth.

Disclaimer: Rakuten Medical's therapies based on Alluminox™ platform are investigational outside of Japan.

* Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID: 38572751.

About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing and tumor necrosis. Alluminox therapies have not yet been approved outside of Japan. Rakuten Medical is committed to its mission to conquer cancer by delivering its innovative treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

About Alluminox™ platform
The Alluminox™ platform is an investigational technology platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and team from the National Cancer Institute in the United States. Rakuten Medical is developing the Alluminox platform as a technology consisting of a drug, device, and other related components. The drug component of the platform consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding. The device component consists of a light source that locally illuminates the targeted cells with light to transiently activate the drug. Pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cancer cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Outside of Japan, Alluminox therapies have not yet been approved by any regulatory authority.

Forward Looking Statements
This press release contains forward looking statements that correspond to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include various risks, uncertainties, and assumptions that may cause Rakuten Medical's business plans and results to differ from the anticipated results and expectations expressed in these statements. These "forward looking statements" contain information about the status and development of our products, including the Alluminox™ platform, as well as other regulatory and marketing authorization efforts, the potential benefits, efficacy, and safety of therapies created using the Alluminox platform, and the status of regulatory filings. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of our therapies, and the status of regulatory filings. Such statements may include words such as "expect," "believe," "hope," "estimate," "looks as though," "anticipate," "intend," "may," "suggest," "plan," "strategy," "will," and "do", and are based on our current beliefs. In addition, this press release uses terms such as "important," "notable," and "abnormal" to express opinions about clinical trial data. Ongoing clinical trial studies include various risks and uncertainties, in particular, problems that arise during the manufacturing stage of our therapies, the occurrence of adverse safety events, situations in failure to demonstrate therapeutic benefits, and other various risks and uncertainties, both reasonable and unreasonable. For this reason, actual results, including regulatory approvals and uncertainties in the commercialization process of our therapies, may differ from published information. Except to the extent required by applicable law, we undertake no obligation to publicly update this or any other forward-looking statement, whether because of new information, future developments or events, changes in assumptions, changes in the factors affecting forward-looking statements. If one or more forward-looking statement(s) is updated, no inference should be drawn that additional updates will be made to those or other forward-looking statements.

Contact Us

SOURCE Rakuten Medical, Inc.