Rakuten Medical Secures Additional Investment from Rakuten to Further Develop its Photoimmunotherapy Platform Capabilities

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SAN MATEO, Calif. and TOKYO, August 1, 2019 /PRNewswire/ -- Rakuten Medical, Inc., a clinical-stage, global biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy (PIT) platform, has raised approximately US $100 million on July 31, 2019, in a Series C-1 Preferred Stock financing from Rakuten, Inc., a global leader in internet services headquartered in Japan. This investment is increasing Rakuten's equity share of Rakuten Medical to 22.6 percent.

Rakuten Medical intends to use the additional injection of capital to expand the development of the company's oncology-focused PIT platform, strengthen its business and commercial functions, and provide resources to further identify and evaluate new investigational compounds and indications for the potential treatment of other types of cancers using PIT.

"The additional investment from Rakuten solidifies our commitment to accelerating Rakuten Medical's business and commercial development," said Mickey Mikitani, chairman and CEO of Rakuten Medical. "I believe we can cultivate a sustainable health care ecosystem to provide patients with safe and easy access to, and better care in, the treatment of cancer, regardless of their nationality or income. Culturally, the technology industry has revolutionized society by being bold, action-driven and innovative; and we hope to do the same at Rakuten Medical by exploring opportunities that will combine Rakuten's technology expertise with Rakuten Medical's first-in-class Photoimmunotherapy platform."

Based on the additional investment, Rakuten Medical will become an equity-method affiliate of Rakuten in the third quarter of this fiscal year.

About Photoimmunotherapy
Photoimmunotherapy (PIT) is an investigational, anti-cancer treatment platform that is comprised of a drug and device combination that utilizes monoclonal antibodies conjugated to a dye (IRDye^® 700DX). Transient excitation of IRDye 700Dx with non-thermal red light (690 nm) is believed to result in anti-cancer activity, which is mediated by biophysical processes that may compromise the membrane integrity of cells. The requirement of targeted binding of antibody-IR700 conjugate to a specific antigen on the cell surface and subsequent illumination is believed to result in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. PIT may also lead to the systemic induction of innate and adaptive immunity.

About Rakuten Medical
Rakuten Medical is a privately funded, clinical-stage, global biotechnology company with offices in the U.S., Japan, Taiwan, Germany and Netherlands. Rakuten Medical aims to become a leader in precision-targeted medicines through its proprietary photoimmunotherapy platform, which is being studied in ongoing clinical trials, evaluating its safety and effectiveness as a cancer-treatment option that can be administered independently, or in combination with other drugs. Rakuten Medical's lead product, ASP-1929, has achieved Fast Track designation from both the FDA and the Japanese Ministry of Health, Labour, and Welfare; and is conducting a global Phase 3 clinical trial for recurrent head and neck squamous cell carcinoma. Additional Phase 2 studies for ASP-1929 PIT are also underway to evaluate the safety in patients with other cancer types. For more information, visit www.rakuten-med.com.                                      

About Rakuten
Rakuten, Inc. (TSE: 4755) is a global leader in internet services that empower individuals, communities, businesses and society. Founded in Tokyo in 1997 as an online marketplace, Rakuten has expanded to offer services in e-commerce, fintech, digital content and communications to more than 1.2 billion members around the world. The Rakuten Group has over 17,000 employees, and operations in 30 countries and regions. For more information visit https://global.rakuten.com/corp/.

Forward Looking Statement
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the (United States) Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties, and assumptions that could cause Rakuten Medical's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These forward-looking statements include, among others, information concerning the benefits of the financing, Rakuten Medical's planned uses of the funds raised in the financing and the effects thereof, the integration of technologies between Rakuten, Inc. and Rakuten Medical, the commercialization of services related to Rakuten Medical products such as ASP-1929 and other initiatives toward regulatory approval to be sold and marketed. These products may not successfully be granted regulatory approval to be sold and marketed, or may not be commercially successful. Forward-looking statements may suggest, among other things, potential profitability, efficacy and safety, and the status of the application for approval. Rakuten Medical has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "intends," "potential," "may," "suggest," "plans," "strategizes," "likely," "will," and similar expressions. Forward-looking statements are neither historical facts nor assurances of future performance.  Such forward-looking statements are based upon Rakuten Medical's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Rakuten Medical's control. Rakuten Medical's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Moreover, this press release states an opinion related to clinical research data, hence the use of expressions such as "important," "notable" and "abnormal." Ongoing clinical studies involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in regulatory approval or commercialization of ASP-1929 which may be impacted by, among other things, problems with the manufacturing process for ASP-1929, the occurrence of adverse safety events, failure to demonstrate therapeutic benefit, and the other risks and uncertainties, both reasonable and unreasonable. Rakuten Medical undertakes no obligation to release publicly the results of any revisions to any forward-looking statements that may be made to reflect new information obtained, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. In the event of one or more revisions to Rakuten Medical's forward-looking statement, it should not be inferred that such revisions or other forward-looking statements will be further revised.

SOURCE Rakuten Medical, Inc.