Rakuten Medical Closes $119 Million Series E Financing to Further Develop its Alluminox™ Platform

• Supporting Rakuten Medical's efforts to accelerate its global Phase 3 study with the goal of achieving approval of ASP-1929 in US as soon as possible
• Also supporting development of additional pipeline using the Alluminox™ platform, including ASP-1929 photoimmunotherapy in combination with anti-PD-1, development of new drugs and devices, and further leveraging learnings from real-world experiences in ASP-1929 photoimmunotherapy
• New investments by Hikma, a global pharmaceutical company, and Mizuho Bank and Dai-ichi Life, leading financial institutions in Japan, as well as additional investments by SBI Group, Rakuten Group and its Chairman and CEO, Mickey Mikitani
• Mazen Darwazah, Hikma's Executive Vice Chairman and President of MENA region joins the board of directors to fuel the next chapter of growth

SAN DIEGO, March 6, 2024 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, today announced the completion of a $119 million Series E preferred stock financing, including $45 million in new capital and the conversion of $74 million of convertible promissory notes with accrued interest.

Rakuten Medical intends to further develop its proprietary Alluminox™ platform and contribute to the future of patients and healthcare around the world by allocating the funds raised for the following business priorities:

• Continuing efforts to accelerate its global Phase 3 clinical trial (ASP-1929-301 study, ClinicalTrials.gov Identifier: NCT03769506) of Alluminox treatment (photoimmunotherapy) using ASP-1929, with the goal of achieving approval of ASP-1929 in the United States and several other countries and regions as soon as possible
• Supporting ongoing clinical trials and initiating new studies for Alluminox treatment using its three key assets (ASP-1929, RM-1995, and RM-0256), including combination therapy with anti-PD-1, which has shown promising early data that Rakuten Medical believes warrant additional clinical studies
• In-house discovery of new drug conjugates under its drug discovery program, Alluminox Palette™
• Development of new medical devices to improve treatment in the clinic and trials
• Leveraging learnings and experience from Alluminox treatment in the commercial setting in Japan in an effort to improve patient outcomes and for further understanding and development of this treatment technology

Mickey Mikitani, Co-CEO of Rakuten Medical, commented, "We are very proud to have raised $119 million in Series E financing despite the challenging market environment for biotechnology companies in 2023, when we started this financing round. I would like to thank our many investors for having valued our achievements and great potential. The Alluminox™ platform will continue to evolve, and together with our trusted business partners and the healthcare professionals who believe in our technology, we will expand this innovative therapy both geographically and clinically, and pave the way for a brighter future."

One of the major investors in this Series E Financing is Hikma Pharmaceuticals PLC ("Hikma"), a global pharmaceutical company headquartered in the UK, with a local presence across the MENA region, North America and Europe. Other major investors include existing investors such as Rakuten Group, Inc., a global internet services company and its Chairman and CEO, Mickey Mikitani, and SBI Group, a leading venture capital firm in Japan, as well as new investors Mizuho Bank, Ltd. and the Dai-ichi Life Insurance Company, Limited, leading Japanese financial institutions.

Rakuten Medical also welcomed Mazen Darwazah, Hikma's Executive Vice Chairman and President of MENA region, to its Board of Directors. Darwazah is an experienced executive with more than 38 years of pharmaceutical industry experience gained through serving in various positions within the Hikma Group. With his strong operational direction and experience in driving strategic business decisions that grow healthcare businesses in the MENA region and globally, Darwazah will add value as a solid guide for Rakuten Medical as it moves to a new stage of uncovering more potential as a global biotechnology company.

In making this investment and appointment to the Board of Directors, Darwazah commented, "I am honoured to join Rakuten Medical's board. Through this appointment, I am looking forward to driving synergies and facilitating a closer working relationship with an important partner that shares Hikma's vision of shaping a healthier world."

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, 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. 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.

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SOURCE Rakuten Medical, Inc.