Rakuten Medical Expands Academic Access to IR700 Dye Through Fee-Only Provision, Greater Publication Freedom and Expanded IP & Commercialization Opportunities

• Rakuten Medical’s light-activatable IR700 dye is a clinically validated component used in the approved medicine Akalux
• With hydrophilicity and low toxicity¹, IR700 dye is adaptable to diverse therapeutic modalities
• Broader academic access to IR700 dye will accelerate open innovation and drive new medical discoveries

SAN DIEGO, Jan. 20, 2026 /PRNewswire/ — Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox® platform-based photoimmunotherapy, today announced that it will provide IRDye® 700DX N-hydroxy succinimide (NHS) ester (IR700 dye), at an administrative fee-only acquisition cost for academic research with increased flexibility for publication, intellectual property (IP) and commercialization opportunities.

IR700 dye is a pivotal component of Rakuten Medical’s proprietary Alluminox platform, which is protected by IP covering manufacturing technologies, clinical applications and I700 dye-conjugate compositions. Rakuten Medical manufactures and supplies IR700 dye worldwide, ensuring reliable quality and consistent availability.

The quality and safety of Rakuten Medical’s IR700 dye to date have been demonstrated to be acceptable within risk–benefit considerations through its use in multiple pre-clinical and clinical programs involving the company’s investigational and commercial drug assets. Among these is Akalux IV Infusion 250 mg, which is approved in Japan for unresectable locally advanced or recurrent head and neck cancer. Photoimmunotherapy with Akalux has been provided more than 1,200 times under Japan’s national health insurance coverage (as of January 19, 2026).

Disclaimer: Rakuten Medical’s Alluminox platform-based photoimmunotherapy is investigational outside Japan.

Through this initiative, Rakuten Medical will:

• Provide IR700 dye for academic research under an administrative fee-only model (Material Transfer Agreement required)
• Enable academic researchers to freely publish their findings with prior notification
• Offer favorable conditions for IP rights arising from research outcomes
• Expand commercialization opportunities for new innovations

Mickey Mikitani, Chief Executive Officer of Rakuten Medical, commented, “IR700 dye is a high-potential asset with applications beyond photoimmunotherapy, spanning a wide range of therapeutic modalities. By expanding academic access under more flexible terms for research, publication and innovation, we aim to accelerate the development of new treatment technologies and contribute meaningfully to advances in global healthcare.”

For inquiries regarding IR700 provision for academic research purposes, please visit:
https://rakuten-med.com/us/contact/bd/

About IRDye® 700DX N-hydroxy succinimide (NHS) ester (IR700 dye)
IR700 dye, a modified phthalocyanine, is distinguished by its hydrophilic structure, low toxicity, and light activation properties at a wavelength of 690 nm¹. Since light at approximately 690 nm can penetrate tissues to a certain depth, IR700 dye is suitable for various light-based therapies, including photoimmunotherapy. Its applications range from basic research in academia to use in clinical trials. However, the complex and sensitive nature of the dye requires strict control over its synthesis, mass production, conjugation, and rigorous quality assurance processes. Rakuten Medical has developed proprietary manufacturing capabilities to ensure a stable commercial supply.

1.	Mitsunaga, Makoto et al. “Cancer cell-selective in vivo near infrared photoimmunotherapy targeting specific membrane molecules.” Nature medicine vol. 17,12 1685-91. 6 Nov. 2011, doi:10.1038/nm.2554

About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox® platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical’s photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering 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 Rakuten Medical’s investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical’s 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 tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical’s Alluminox platform-based photoimmunotherapy is investigational.

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.

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