Rakuten Medical, Inc

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox™ platform, which, in pre-clinical studies have shown to lead to rapid and selective cell killing and tumor necrosis. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 6 locations in 5 countries, including Japan, the Netherlands, Germany, Taiwan, and Switzerland. Rakuten Medical Japan K.K. is the Japanese subsidiary of Rakuten Medical, Inc. For further details, visit https://rakuten-med.com/us/ and https://rakuten-med.com/jp/.

Kobe University Graduate School of Medicine

Kobe University Graduate School of Medicine is based at Kobe University Hospital, which began as Kobe Hospital and first opened its doors in 1869, and has been striving to conduct advanced medical research, foster prominent clinicians and residents, and improve medical care in the community. In April 2017, Kobe University Hospital International Clinical Cancer Research Center (ICCRC) was established as part of the Kobe Biomedical Innovation Cluster in order to address the research and development of next-generation pharmaceuticals, new treatments, and medical devices, as well as education, by strengthening coordination with surrounding medical institutions and research institutes.

The Illuminox™ platform

The Illuminox platform is an investigational 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 Illuminox 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 non-thermal 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 Illuminox may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cells and/or the removal of immunosuppressive elements within the microenvironment. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective 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 ASP-1929, Illuminox technology and other regulatory and marketing authorization efforts. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of ASP-1929, 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 ASP-1929, 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 ASP-1929, 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.