Kringle Pharma, Inc.
4884・Growth Market・Pharmaceuticals
Business
Kringle Pharma is a university-originated drug discovery biotech venture founded in 2001, developing treatments for intractable diseases using HGF (Hepatocyte Growth Factor) protein—discovered by Toshikazu Nakamura, Professor Emeritus of Osaka University—as its sole drug discovery seed. The company has completed or is currently conducting clinical trials in four disease areas: acute spinal cord injury, vocal fold scarring, ALS, and acute kidney injury. Its basic policy is to obtain marketing approval for its pharmaceuticals independently, with sales after approval expected to leverage the supply chain through partnerships with Maruishi Pharmaceutical and Toho Holdings. The company listed on the Tokyo Stock Exchange Mothers market (now Growth Market) in December 2020. It is currently concentrating management resources on two pipelines: acute spinal cord injury and vocal fold scarring.
Business Model
Currently, the only source of revenue is the technical access fee (fixed annual royalty) from Claris Biotherapeutics of the United States (¥72 million in FY2025 (ending September 2025)). After approval, the company anticipates a mix of revenue streams including upfront contract payments, development milestones, sales milestones, royalties, and product sales. Manufacturing is outsourced to external contract organizations, and sales depend on partners (Maruishi Pharmaceutical and Toho HD), adopting an asset-light model. Development expenses are supplemented by public funding (AMED-CiCLE) and capital raised through the exercise of stock acquisition rights.
Company Strengths
In the Phase I/II trial, a significant difference was confirmed at Week 20 for the ASIA motor score, achieving Proof of Concept (PoC). The drug received orphan drug designation in Japan in September 2019, and in June 2025 also obtained Orphan Drug Designation from the FDA in the United States. Institutional benefits such as priority review and development cost subsidies have been secured both domestically and internationally.
Two patents related to HGF formulation composition (HGF formulation and HGF formulation suitable for treatment of neurological disorders) have been secured in five countries/regions: Japan, the United States, Europe, Canada, and South Korea. Even after the expiration of the substance patent, these formulation patents establish an advantageous intellectual property environment for global business development.
For the Acute Spinal Cord Injury product (KP-100IT), an exclusive sales licensing agreement (for 15 years post-approval) has been concluded with Maruishi Pharmaceutical, a specialty pharma company in the emergency medicine field, and an exclusive wholesale distribution rights agreement has been concluded with Toho Holdings. A framework has been put in place to enable immediate commercial sales upon approval.
ENVALITH's Perspective
Performance Trend
For the interim period of FY2026 (ending March 2026) (October 2025 - March 2026), revenue was ¥36 million (up 2.2% year on year), operating loss was ¥515 million, and interim net loss was ¥516 million. Revenue consists entirely of royalty income, with no structural change. The full-year forecast calls for revenue of ¥332 million (up 360% year on year), a sharp increase driven by drug substance supply income from Claris Biotherapeutics (to be recognized in April 2026), which is a one-time item. Operating losses over the past five fiscal years have ranged from ¥358 million to ¥909 million, and SG&A expenses in the interim period of FY2026 (ending March 2026) were ¥552 million, up a slight 0.8% year on year. Total assets stood at ¥1,989 million (down 4.4% from the end of the previous fiscal year), and net assets were ¥948 million (down 27.6% from the end of the previous fiscal year), reflecting a continued contraction of the financial base. The equity ratio declined to 45.9% (from 61.5% at the end of the previous fiscal year).
Growth Strategy
Domestic approval acquisition for KP-100 (Acute Spinal Cord Injury) as the top priority, while maximizing corporate value through vocal fold scarring development, US expansion, and pipeline indication expansion
Following discussions with the PMDA based on preliminary Phase III trial results, the company decided in July 2025 to conduct an additional clinical trial. A trial with a high probability of success is being designed based on findings from the Phase I/II and Phase III trials, with plans to file for approval after obtaining additional efficacy data. Proceeds from the exercise of the 16th series of stock acquisition rights will be allocated to trial costs.
Final case enrollment across 8 sites was completed in January 2026. Data analysis is progressing with the support of public funding under AMED's CiCLE program, with the aim of filing for approval. Stock acquisition rights were issued in August 2025 to raise funds for commercial formulation development costs.
The company obtained FDA Orphan Drug Designation in June 2025 and established its US subsidiary, Kringle Pharma USA, Inc., in November 2025. It is building a collaborative framework with North American KOLs and proceeding with preparations toward an IND filing.
In addition to the fixed annual technology access fee under the License and Supply Agreement, the company is securing revenue through drug substance supply. Since September 2023, a business collaboration aimed at improving manufacturing process efficiency has also begun, with the goal of building a global supply framework.
Exploratory research is being advanced for new indications including idiopathic pulmonary fibrosis (Kanazawa University), Peyronie's disease (Kobe University), peripheral neuropathy (Keio University), and intractable wounds (Kyoto University). The company aims to expand its indication portfolio, primarily centered on fibrotic diseases, to enhance corporate value.
Last updated: July 17, 2026