ENVALITH
NANO MRNA株式会社 logo

NANO MRNA Co., Ltd.

4571・Growth Market・Pharmaceuticals

Official website
NANO MRNA株式会社 logo
NANO MRNA Co., Ltd.4571

Business

NANO MRNA Co., Ltd. is a holding-type biotech venture that transitioned to a holding company structure in April 2026. Its subsidiary NANO MRNA Co., Ltd. conducts the RNA drug discovery business (NANO MRNA business), which handles clinical development of TUG1 ASO (Recurrent Glioblastoma) and RUNX1 mRNA (Osteoarthritis of the Knee), while the dedicated investment subsidiary Nano Bridge Investment Co., Ltd. (NBI) primarily promotes an investment business (NBI business) targeting unlisted companies in the healthcare sector through the "Bio Bridge I" fund jointly formed with the SBI Group. The majority of net sales comes from Cosmetic Raw Material Supply (for Albion) and profit sharing with Theoria Pharma, and the company has invested ¥487 million in research and development expenses, aiming to establish early proof of concept (POC) for multiple RNA pharmaceutical pipelines and to license them out to pharmaceutical companies.

Business Model

In the NANO MRNA business, the company develops RNA drug candidates in-house through nonclinical and early clinical stages, then licenses them out to major pharmaceutical companies before transition to late-stage clinical development, thereby earning milestone payments and royalties. In the NBI business, the company receives a management fee of approximately 2% per annum as stable income during the fund's operating period, while also earning approximately 20% of capital gains as a success fee upon exits such as IPOs or M&A of portfolio companies. Current revenue of ¥174 million is primarily composed of ¥89 million from raw material sales for Albion and ¥84 million from profit-sharing with Theoria Pharma, with licensing-out revenue and fund success fees positioned as future revenue sources.

Company Strengths

TUG1 ASO (Recurrent Glioblastoma) has completed dosing through Level 4 in its Phase I trial with no serious safety concerns, while RUNX1 mRNA (Osteoarthritis of the Knee) has dosed 3 patients in its Australian Phase I trial, giving the company two clinical assets. In addition, in May 2026 the company acquired Luna RD Co., Ltd., which holds PEG-free LNP technology, thereby internalizing a DDS platform applicable to both mRNA and oligonucleotides.

In January 2026, NBI obtained qualified institutional investor certification and jointly formed Bio Bridge I with SBI Shinsei Growth Capital Co., Ltd. The company has built a tripolar investment platform spanning Japan, the US, and China: a deal sourcing framework with the SBI Group domestically, an overseas VC network via Nano Holdings US in the United States, and a collaboration with Norwich Capital in China.

Cash and cash equivalents at the end of the consolidated fiscal year reached ¥4,910 million (up ¥3,713 million from the previous fiscal year-end). Financing income from bond issuance of ¥2,475 million and exercise of stock acquisition rights of ¥1,221 million supports the company's funding base, enabling continued securing of funds for research and development expenses and investment business operations.

ENVALITH's Perspective

Revenue for FY2026 (ending March 2026) recovered to ¥174 million (up 60.8% year on year), but selling, general and administrative expenses ballooned to ¥1,119 million (from ¥833 million in the prior period), widening the operating loss to ¥966 million (from ¥755 million). Net loss attributable to owners of the parent also worsened to ¥944 million (from ¥835 million). Both the investment business and the drug discovery business are expected to require considerable time to become profitable, and given the cash consumption pace relative to cash of ¥4,910 million (operating cash flow of -¥817 million per year), the need for additional fundraising remains a medium-term challenge.

For TUG1 ASO, dose-limiting toxicity was confirmed in Phase I (Level 4), and the optimal dose was determined to be Level 3 or below; long-term stable disease (SD) accompanied by tumor shrinkage was observed in one patient. A Phase Ib clinical trial notification is planned to be filed by around August 2026, and this progress represents an important milestone that could accelerate out-licensing negotiations with pharmaceutical companies. For RUNX1 mRNA (Osteoarthritis of the Knee), administration to three patients has been completed in Australia, and the company is at the stage of accumulating initial safety data. While the government's policy to strengthen drug discovery capabilities serves as an external tailwind, the risk of clinical trial delays remains ever-present.

The change of corporate name and launch of the investment business in December 2025, followed by the transition to a holding company structure in April 2026, can be evaluated as a strategic shift aimed at diversifying revenue away from the standalone drug discovery model. While infrastructure development is progressing, including the formation of Bio Bridge I and the conclusion of non-disclosure agreements with dozens of companies, the company has not disclosed earnings forecasts, citing that the investment business is "significantly affected by the number of investments made and stock market conditions," among other factors, leaving the timing and scale of revenue contribution unclear at this point. The acquisition of Luna RD (¥200 million) and the resulting acquisition of LNP technology can be evaluated as strengthening the technological foundation, but the path to commercialization is expected to be a long one.

Growth Strategy

Realizing out-licensing through clinical progress in the RNA drug discovery pipeline and monetizing the investment business platform

Phase I trial (up to Level 4) has been completed, and the optimal dose has been determined to be Level 3 or below. Long-term SD findings accompanied by tumor shrinkage were confirmed in one case. A Phase Ib trial protocol is currently being formulated, with clinical trial notification submission planned around August 2026. Clinical data accumulation will accelerate out-licensing negotiations with pharmaceutical companies.

The clinical trial site opened in November 2025, with the first patient dosed in February 2026, and a total of three patients dosed to date. The company is working with local medical institutions to expand screening opportunities and accelerate enrollment. Accumulation of initial safety and efficacy data forms the basis for out-licensing activities.

NANO MRNA Co., Ltd. (Single Segment) underwrote a third-party allotment of new shares by Luna RD Co., Ltd. (founded based on research by Professor Tomohiro Asai of the University of Shizuoka), acquiring 66.67% of voting rights (acquisition value: ¥200 million). This acquisition brings new ionizable lipid patents and PEG-free LNP technology, strengthening the technological foundation of the mRNA and nucleic acid drug platform. The company aims to expand joint research and licensing collaborations with pharmaceutical companies and biotech ventures.

The company established NBI, a dedicated investment subsidiary, and formed Bio Bridge I, a joint fund with SBI Shinsei Growth Capital. Confidentiality agreements have been signed with dozens of companies, primarily private healthcare companies and corporate carve-out deals, with investment and business partnerships under consideration. The company aims to capture capital gains through global exit strategies such as IPOs and M&A.

Effective April 1, 2026, the company transitioned to a holding company structure, transferring the drug discovery business to NANO MRNA Co., Ltd. (Single Segment). The company has built an overseas expansion foundation through collaboration with Nano Holdings US and Norwich Capital in China. This platform is intended to connect Japan's superior technologies and business assets to global capital markets.

Last updated: July 19, 2026