#United States #San Diego #Rakuten Medical #ASP-1929 #Alluminox

Rakuten Medical's Remarkable Fundraising Achievement

In a significant boost to its operational capabilities, Rakuten Medical, Inc., a leading biotechnology firm specializing in innovative cancer treatments, has successfully closed a $100 million Series F financing round. This financing, which is recognized as the largest in the company’s history, reflects the growing investor confidence in its proprietary Alluminox® platform-based photoimmunotherapy technology. The round consisted of $70 million in fresh capital and $30 million converted from previous notes, thereby doubling the initial financial target set by the company.

Aiming for U.S. Regulatory Approval

The proceeds from this funding will primarily be directed towards advancing the clinical development of ASP-1929, Rakuten Medical’s flagship investigational drug. This particular drug is under evaluation in a global Phase 3 clinical trial that explores the combination of ASP-1929 photoimmunotherapy with pembrolizumab as a first-line treatment for recurrent head and neck cancer. The firm plans to enhance patient enrollment across various countries, including the U.S., Japan, Taiwan, Ukraine, and Poland, with an aim to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) by 2028.

Global Expansion Initiatives

In addition to its focus on securing U.S. approval, Rakuten Medical seeks to broaden its regulatory footprint. The company is utilizing the dossier submitted in Japan for its previously approved drug, Akalux® (ASP-1929), to facilitate approvals in other regions. With support from strategic partners experienced in navigating regional regulations, Rakuten Medical is poised to accelerate its expansion efforts.

Diversified Investor Base

The Series F round showcases the diverse composition of Rakuten Medical’s investor base. Led by TaiAx Life Science Fund L.P. — a collaborative venture by Taiwania Capital Management and Axil Capital Group — the financing also welcomed major institutional players, including Daiwa Securities and Mitsui Sumitomo Insurance from Japan, as well as Taiwanese venture firms such as ABIES Capital. This capital infusion marks a significant point for Rakuten Medical, establishing a robust foundation across major markets including the U.S., Japan, and Taiwan.

Future Growth and Development

In tandem with the continued development of ASP-1929, Rakuten Medical is focused on advancing its research into other forms of solid tumors. Planned trials in Japan and the U.S. seeks to further investigate the potential of ASP-1929 in treating esophageal, gynecologic, pancreatic, and non-small cell lung cancers, supported by various funding sources. These initiatives underscore Rakuten Medical's commitment not only to addressing pressing medical needs but also to ensuring sustained commercial growth for ASP-1929.

Statement from Leadership

Mickey Mikitani, CEO of Rakuten Medical, viewed this investment as a testament to both the innovative nature of their technology and the expertise of their team. He emphasized that the Alluminox® platform represents a revolutionary treatment approach, requiring a blend of drug development knowledge and medical device expertise. This funding will empower Rakuten Medical to expedite its clinical development while enhancing its prospective global reach.

Michael Huang, Managing Partner at Taiwania Capital Management, echoed Mikitani's sentiments, expressing enthusiasm for the potential of Rakuten Medical’s unique technology to meet unmet medical needs, thereby strengthening the company’s mission to enhance cancer care worldwide.

Conclusion

Rakuten Medical’s recent success in fundraising not only reflects a strong belief in its innovative therapies but also positions the company towards significant advancements in cancer treatment. As it works towards U.S. regulatory approval for ASP-1929 and expands into other therapeutic areas, the spotlight remains on Rakuten Medical and its promising future in biotechnology and cancer treatment.