Rakuten Medical Raises $100 Million in Oversubscribed Series F to Accelerate Development Toward U.S. Regulatory Approval

• Proceeds to drive global Phase 3 trial for ASP-1929, targeting BLA submission to the U.S. FDA in 2028
• Financing led by international life science fund TaiAx, with participation from the largest number of institutional investors in Rakuten Medical's history, alongside strategic partners and current investors

SAN DIEGO, Jan. 7, 2026 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing its proprietary Alluminox^® platform-based photoimmunotherapy, today announced the closing of a $100 million Series F financing round. This includes $70 million in new capital and the conversion of $30 million in convertible promissory notes with accrued interest.

This upsized financing doubles Rakuten Medical's initial target, underscoring strong investor confidence in its execution capabilities and the potential of the investigational Alluminox platform-based photoimmunotherapy, an innovative cancer treatment modality.

Toward U.S. Approval of ASP-1929
Rakuten Medical will utilize the Series F proceeds to advance its top priority: securing U.S. regulatory approval for ASP-1929, Rakuten Medical's designation for its first investigational photoimmunotherapy drug. The company is currently enrolling patients into its global Phase 3 trial (ASP-1929-381, NCT06699212), evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line therapy for recurrent head and neck cancer. The proceeds will allow Rakuten Medical to strengthen its operational capabilities to accelerate enrollment in the U.S., Taiwan, Japan, Ukraine and Poland. Based on trial results, Rakuten Medical aims to submit a Biologics License Application (BLA) to the U.S. FDA in 2028.

Global Expansion and Broader Clinical Development
Rakuten Medical is leveraging the regulatory dossier submitted in Japan for its approved drug Akalux^® (ASP-1929) and the BioBlade^® Laser System device, along with post-market real-world data, to supplement its efforts in seeking approvals in additional countries. With support from strategic partners who have deep expertise in regional regulatory environments, the company aims to accelerate these efforts.

Disclaimer: Rakuten Medical's Alluminox^® platform-based photoimmunotherapy is investigational outside Japan.

In parallel, Rakuten Medical is expanding development beyond head and neck cancer through internal programs and support for investigator-initiated trials (IITs). These studies will utilize grants and other funding sources to ensure efficient progress. Additionally, the company will continue driving commercial growth of ASP-1929 photoimmunotherapy for head and neck cancer in Japan, both to expand profitability for the Japan entity and to establish a reliable funding engine to fuel global expansion.

Development Program Beyond Head and Neck Cancer

• Solid tumors (including malignant skin tumors): Initiate Phase 1 trial of RM-0256 photoimmunotherapy in Japan in Q2 2026, supported by AMED¹ grant funding.
• Esophageal and gynecologic cancers: Support two ongoing IITs of ASP-1929 photoimmunotherapy in Japan; the gynecologic cancer IIT is supported by AMED funding.
• Pancreatic and non-small cell lung cancers: Support two planned IITs of ASP-1929 photoimmunotherapy in the U.S., potentially supported by external grants

International Composition of Investors
The Series F round was led by TaiAx Life Science Fund L.P. (TaiAx), an international life science venture capital fund. TaiAx was jointly established by Taiwania Capital Management, based in Taipei, Taiwan, and Axil Capital Group, based in Tokyo, Japan.

The round included the largest institutional investor group in company history, including major Japanese financial institutions—Daiwa Securities, Mitsui Sumitomo Insurance, Sumitomo Mitsui Banking—and Taiwanese venture firms ABIES Capital and Nexus CVC. Strategic partner OEP Group also joined, along with existing investors, including SBI Group, Rakuten Group, Inc. and Mickey Mikitani, Rakuten Group Chairman and CEO and Rakuten Medical CEO.

This round creates an exceptionally diverse investor base for Rakuten Medical, anchored in key global markets: the U.S., Japan and Taiwan.

Mickey Mikitani, CEO of Rakuten Medical, commented:
"Securing significant investment from leading life science investors underscores the strength of our technology and the excellence of our team. The Alluminox^® platform underlines a new treatment modality that requires advanced expertise in both drug development and medical device technology. Rakuten Medical is tightly focused and mission driven, having successfully developed, received approval for and commercialized an innovative therapy in 15 years. This financing will enable us to accelerate clinical development, expand our global reach and prepare for the next phase of growth."

Michael Huang, Managing Partner of Taiwania Capital Management, commented:
"This oversubscribed Series F financing reflects our strong conviction in Rakuten Medical's differentiated technology and its ability to address profound unmet medical needs. We are thrilled to lead this round and to form a strong, like-minded global syndicate united by a shared vision to advance the future of cancer care."

Notes
1. Japan Agency for Medical Research and Development (AMED)

About the Alluminox^® Platform
The Alluminox^® platform is Rakuten Medical's investigational technology 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 (690 nm) to transiently activate the drug. Rakuten Medical's preclinical 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.

About ASP-1929
Rakuten Medical's first pipeline drug developed on its Alluminox^® platform is ASP-1929, an antibody-dye conjugate comprised of the anti-epidermal growth factor receptor (EGFR) antibody cetuximab and IRDye^® 700DX, a light activatable dye. ASP-1929 binds to EGFR, a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority.

About TaiAx
TaiAx Life Science Fund L.P. is a venture capital fund dedicated to advancing innovative technologies in the life sciences sector. The fund was established as a joint venture between Taiwania Capital, a Taiwan national investment company, and Axil Capital, a Japanese venture capital firm supported by the Mizuho Group. TaiAx's investment focus broadly covers first-in-class therapeutics, gene and cell therapies and AI-driven medical products, among other novel technologies addressing unmet medical needs. The TaiAx team is actively evaluating investment opportunities globally, with a particular focus on Taiwan, Japan and North America.

About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing its Alluminox^® platform-based photoimmunotherapy, which 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 five countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

Forward Looking Statements
This press release contains forward-looking statements. These statements speak only as of the date of this press release and are subject to a number of 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 plans, status and development of our research, clinical trials and products, including the Alluminox^® platform, combination therapies, product and developmental candidates and related medical devices, as well as our commercial activities, other regulatory and marketing authorization efforts; the potential benefits, efficacy, and safety of our product candidates or other therapies created using the Alluminox platform, and the status, plans and timing of regulatory filings and approvals therefor; plans to advance other pipeline product candidates or discovery efforts; the Company's ability to leverage learnings from experiences in ASP-1929 photoimmunotherapy; and the intended use of proceeds from the financing. The approval and commercial success of any of our products or product candidates may not be achieved. Such statements may include words such as "expect," "believe," "hope," "estimate," "looks as though," "anticipate," "intend," "may," "suggest," "plan," "target," "contemplate," "predict," "potential," "continue," "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 and situations and 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.