Rakuten Aspyrian Closes $284 Million Series C Financing for Late-Stage Oncology Pipeline

SAN FRANCISCO, Dec. 20, 2018 /PRNewswire/ -- Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, today announced that it has raised an additional $134 million in a second tranche of its Series C financing, bringing the total amount raised to $284 million. New investors include the SBI Group, Japan and Rakuten Inc. Rakuten Aspyrian has raised approximately $372 million in equity since it was founded in 2015.

Rakuten Aspyrian (PRNewsfoto/Aspyrian Therapeutics, Inc.)

"My unwavering confidence in the vision and potential of Rakuten Aspyrian's Photoimmunotherapy platform has grown tremendously and was the impetus behind my further financial investment in the company," said Mickey Mikitani, CEO of Rakuten Aspyrian. "Our entire organization is committed to developing treatments for cancer patients and we will continue pressing forward with our corporate mission of conquering cancer."

"We are excited to support Rakuten Aspyrian, and strongly believe in the potential of its Photoimmunotherapy platform, which the company is studying in clinical trials for the selective destruction of cancer cells with minimal effects on normal cells developed by Dr. Hisataka Kobayashi of the Center for Cancer Research at the National Institutes of Health," said Mr. Yoshitaka Kitao, representative director, president & CEO of SBI Holdings.

The Series C financing supports the advancement of Rakuten Aspyrian's proprietary investigational compound, ASP-1929 Photoimmunotherapy, currently in Phase 3 development for the treatment of patients with recurrent local regional head and neck squamous cell carcinomas (HNSCC), and new proof-of-concept Phase 1/2 studies in additional solid tumors to be initiated in early 2019. The financing will also support manufacturing processes to support the initial launch and commercialization of ASP-1929 if approved in the United States, Japan and Europe. The company also announced that it has established its corporate headquarters in San Mateo, California, where it will expand clinical, commercial and corporate functions.

"With this financing, we have expanded our team and footprint: We have established our corporate headquarters in San Mateo, California, where we will execute on our goal of building a full-fledged pharmaceutical company, and will continue advancing a number of our photoimmunotherapy programs in various cancer types," said Takashi Toraishi, Ph.D., President and Chief Operating Officer of Rakuten Aspyrian. "In addition, proceeds from this financing will support continued development of our lead program, ASP-1929, which we recently announced has entered into a global, pivotal Phase 3 clinical trial for head and neck cancer. We thank our generous investors for their belief and support of Rakuten Aspyrian as we continue executing on our mission."

About ASP-1929 Photoimmunotherapy
ASP-1929, a conjugate of cetuximab and IRDye 700DX®, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, pancreas and other cancers. This first-in-class therapy targets cancer cells, after which the compound is locally activated with red light using a proprietary investigational laser and fiber optics. The local activation of the tumor-selective conjugate targets the tumor but not surrounding normal tissues and structures. ASP-1929 received Fast Track designation by the U. S. Food and Drug Administration for the treatment of HNSCC.

Interim results of a Phase 1/2 trial in patients with HNSCC showed a clinically meaningful improvement in the objective response rate, and potential improvements in progression free survival and overall survival when compared to historical data for the standard of care treatments currently available to this patient population. Top line results of the ASP-1929 Phase 1/2 trial are expected in the first quarter of 2019.

ASP-1929 is an investigational compound that is not approved for any use in any country.

About Rakuten Aspyrian, Inc.
Rakuten Aspyrian, Inc. is a privately funded clinical stage biotechnology company developing tumor-targeted precision therapies based on its proprietary platform Photoimmunotherapy. Photoimmunotherapy combines key advantages of antibody mediated targeting of the cancer cells to achieve high tumor specificity, together with laser-activation of a biophysical mechanism that induces rapid cancer cell death with precision. Treatments with the Photoimmunotherapy platform lead to targeted and rapid tumor cell death by necrosis, with minimal effects on normal tissue.  Rakuten Aspyrian is studying Photoimmunotherapy for use as a monotherapy and in combination with other drugs. For more information about Rakuten Aspyrian Inc., please visit www.rakutenaspyrian.com.

About SBI Holdings
SBI Holdings is an Internet-based financial conglomerate, headquartered in Tokyo, Japan. It has a customer base of approximately 24 million people, with more than 190 subsidiaries and over 6,000 employees. Its three mainstay businesses are financial services, asset management that primarily involves the operation of investment funds, and biotechnology-related businesses. The SBI Group companies include SBI SECURITIES, SBI Sumishin Net Bank and a variety of other financial companies.

Forward Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Rakuten Aspyrian actual results, plans and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These "forward-looking" statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to Rakuten Aspyrian's products such as ASP-1929. Such approvals or success may not be obtained or achieved on a timely basis or at all. Forward-looking statements include statements relating to the potential benefits, safety and efficacy of ASP-1929, and the status of current regulatory filings. These statements may be identified by words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "intends," "potential," "may," "suggest, "plan," "strategy," "should," "will" and all other similar expressions, and are based on our current beliefs. In addition, this press release includes qualifying terms such as "significant," "remarkable," "extraordinary," etc. that describe opinions on clinical data. 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. 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 or otherwise except to the extent required by applicable laws. If Rakuten Aspyrian updates one or more forward-looking statement(s), no inference should be drawn that we will make additional updates with respect to that, those or other forward-looking statements.

Media Contact
Jessica Tieszen
Canale Communications
619-849-5385
jessica@canalecomm.com

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SOURCE Rakuten Aspyrian, Inc.

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