Notice of Investment in Kringle Pharma, Inc.

Keio Innovation Initiative has invested in Kringle Pharma, a regenerative medicine venture utilizing research results from the Keio University School of Medicine, from a fund managed by the company.

To whom it may concern

Kringle Pharma Inc. raises 610 million yen in a third-party allotment of new shares to accelerate and promote the practical application of HGF drugs

(Head office: Ibaraki City, Osaka; President: Kunio Iwatani; hereinafter “Kringle Pharma”) has raised 610 million yen through a third-party allotment of new shares. The allottees this time are a total of eight venture capital firms and operating companies, including DBJ Capital and Keio Innovation Initiative as lead investors, as follows.

Venture capital (operating companies in parentheses)

  1. DBJ Capital Investment Limited Partnership (DBJ Capital Corporation; Representative Director: Fumiyuki Kashima)
  2. Keio Innovation Initiative No. 1 Investment Limited Partnership (Keio Innovation Initiative Co., Ltd.; President: Kotaro Yamagishi)
  3. Toho Furusato Sohatsu Support Fund Investment Limited Partnership (Toho Lease Co., Ltd., Representative Director: Toshiro Hasegawa))
  4. Gogin Capital No.3 Investment Limited Partnership (Gogin Capital Co., Ltd., President: Yasuhiro Takezako)
  5. KSP No.4 Investment Limited Partnership (KSP Corporation; President: Hirohisa Uchida)

Operating companies

  • CYBERDYNE Corporation (Tsukuba City, Ibaraki Prefecture; President: Yoshiyuki Sankai)
  • Nippon Zenyaku Kogyo Corporation (Koriyama City, Fukushima Prefecture; President: Keiichi Takano)
  • ReproCELL Corporation (Yokohama City, Kanagawa Prefecture; President: Shuji Yokoyama)

We are engaged in the pharmaceutical development of recombinant hepatocyte growth factor (HGF) protein, which is a regenerative repair factor in vivo and has the potential to become an epoch-making therapeutic agent for various intractable diseases. We are currently focusing on clinical trials in Japan for intractable neurological diseases (acute spinal cord injury and amyotrophic lateral sclerosis (ALS)), and the funds raised through this capital increase will be used to accelerate and promote Phase I/II trials mainly for the acute stage of spinal cord injury.

Kunio Iwatani, President and Representative Director of the Company, stated, “The financial environment surrounding bio-ventures is becoming increasingly severe. Kunio Iwatani, President and Representative Director of HGF, commented, “In the midst of a challenging financial environment for bio-ventures, our success in raising 610 million yen is nothing less than a reflection of the high expectations our shareholders have for HGF. With this financing, we are on track to complete the Phase I/II study for the acute stage of spinal cord injury. We will do our utmost to confirm the efficacy of the HGF drug in patients through this trial and to make the HGF drug commercially available as soon as possible. In this procurement, we were able to obtain significant cooperation from business companies with which we can expect future synergies for the commercialization of HGF, and we believe that the combination of the HGF drug and cybernetic therapy using CYBERDYNE’s Medical HAL® (the world’s first robotic therapy device) will create a new combined therapy for patients with spinal cord injury and ALS. The combination of HGF pharmaceuticals and cybernetic therapy using CYBERDYNE’s Medical HAL® (the world’s first robotic therapy device) is expected to create a new combined therapy for patients with spinal cord injury and ALS. In addition, the importance of GMP-compliant HGF used in the manufacture of regenerative medical products is increasing for the practical application of regenerative medicine, and new business development with ReproCELL, a leading iPS cell company, is also possible. Ltd. for the development of HGF animal drugs, and we will further strengthen our relationship for the production of recombinant human HGF protein in the future. We expect to maximize the value of HGF through the establishment of relationships with the above companies.”

About HGF (Hepatocyte Growth Factor, Hepatocyte Growth Factor)

HGF is a bioactive protein discovered as a factor that promotes the proliferation of mature hepatocytes, and subsequent studies have revealed that HGF acts on various epithelial and cardiovascular tissues, etc. In addition to its activity to promote cell proliferation and tissue reconstruction, HGF also exhibits activity to prevent cell death and to promote angiogenesis. HGF supports the regeneration and protection of tissues damaged by trauma or disease. In addition, HGF has been shown to exert neuroprotective and axon extensor effects in the cranial nervous system. The therapeutic effect of HGF on spinal cord injury was demonstrated in animal models of spinal cord crush injury (rats and marmosets) by Professor Eiyuki Okano of the Department of Physiology and Professor Masaya Nakamura of the Department of Orthopaedic Surgery at Keio University School of Medicine and his group. These studies have raised expectations for HGF as a therapeutic agent for spinal cord injury.

About Kringle Pharma, Inc
http://www.kringle-pharma.com/

Kringle Pharma was established in December 2001 as a drug discovery venture from Osaka University, aiming to develop and commercialize novel biopharmaceuticals based on HGF. The company is currently developing recombinant human HGF protein as a treatment for 1) acute spinal cord injury (Phase I/II study ongoing), 2) ALS (Phase II study (investigator-initiated) ongoing), 3) acute kidney injury (Phase Ia and Ib studies completed), and 4) vocal cord scar (Phase I/II study (investigator-initiated) ongoing).

About Keio Innovation Initiative, Inc
http://www.keio-innovation.co.jp/

Keio Innovation Initiative (KII) is a venture capital established by Keio University. Its mission is to contribute to the development of society by promoting the social implementation of university research results and creating new industries through investment and nurturing of venture companies that utilize the results of Keio University’s research.

About DBJ Capital Inc
https://www.dbj-cap.jp/

(DBJ) is a wholly owned subsidiary of the Development Bank of Japan (DBJ) and is responsible for the DBJ Group’s venture capital operations. DBJ Capital invests in venture companies that are growing globally competitive by making full use of new technologies and business models, regardless of business field or size, and provides equity investment as growth capital. We also provide financial support by utilizing various networks including DBJ, and arrange solutions for the entire DBJ Group that meet the needs of the investee companies.

For inquiries, please contact

Kiichi Adachi
Kringle Pharma, Inc.
Director and General Manager of Business Development Dept.
TEL 072-641-8739
e-mail kpinfo@kringle-pharma.com

Tomokatsu Hongo
Keio Innovation Initiative Co.
Executive Officer
TEL 03-6435-0945
e-mail hongo@keio-innovation.co.jp

DBJ Capital Co.
Senior Investment Manager
TEL 03-3231-2324
e-mail mitsuguchi@dbj-cap.jp