ENVALITH
ノイルイミューン・バイオテック株式会社 logo

Noile-Immune Biotech Inc.

4893・Growth Market・Pharmaceuticals

Official website
ノイルイミューン・バイオテック株式会社 logo
Noile-Immune Biotech Inc.4893

Business

Noile-Immune Biotech Inc. was founded in 2015 as a biotech company originating from Yamaguchi University and the National Cancer Center. Based on its proprietary PRIME (Proliferation-inducing and migration-enhancing) technology, the company is an R&D-focused enterprise developing genetically modified immune cell therapies, including CAR-T cell therapy and TCR-T cell therapy, targeting solid tumors. Solid tumors account for approximately 90% of all cancers, and this is an area where the efficacy of existing CAR-T therapies has not been established. PRIME technology is unique in that it induces the accumulation and proliferation of immune cells within solid tumor tissue by causing them to produce IL-7 and CCL19. The company listed on the TSE Growth Market in June 2023. It operates as a single segment: the Cancer Immunotherapy Drug Discovery Business.

Business Model

The revenue model consists of two pillars: "In-house Drug Discovery" and "Joint Pipeline." In in-house drug discovery, the company leads clinical trials and aims for large-scale income by licensing out to pharmaceutical companies at the approval stage or partway through development. In the joint pipeline, the company licenses PRIME Technology to pharmaceutical companies, obtaining technology access fees, upfront contract payments, development milestones, and royalties while keeping development costs down. The company has a track record of contracts with Adaptimmune, Autolus, and Chugai Pharmaceutical. Current business revenue is extremely limited at ¥5 million, and future milestone and royalty income will be key to monetization.

Company Strengths

PRIME technology is a platform technology that induces CAR-T cells to produce IL-7 and CCL19, driving immune cell accumulation, proliferation, and long-term survival within solid tumor tissue. In mouse models, it demonstrated significantly superior therapeutic efficacy compared to conventional CAR-T, and the results were published in Nature Biotechnology. The technology has potential applications across diverse modalities including CAR-T, TCR-T, and oncolytic viruses.

The company has already concluded PRIME technology license agreements with Adaptimmune Therapeutics plc in 2019, Autolus Therapeutics plc in the same year, and Chugai Pharmaceutical in 2022. Each partner holds an exclusive worldwide license, while the company retains the right to receive development milestone payments and royalties. This demonstrates that the technology has been validated through evaluation by global pharmaceutical companies.

In June 2025, the company submitted a clinical trial notification for NIB103 (targeting Mesothelin) to the PMDA, and following completion of the review, the Phase I clinical trial is now underway. As of the end of December 2025, cash and cash equivalents stood at ¥3,918 million, providing ample funds on hand; at the current net loss level of ¥793 million per period, this secures approximately five years' worth of development funding.

ENVALITH's Perspective

The net loss for Q1 FY2026 was ¥153 million, a 37% improvement from the same period last year (¥240 million). However, the main driver of the improvement was the recognition of ¥45 million in subsidy income, while business revenue remained zero. On an operating loss basis, the loss also narrowed to ¥202 million (¥241 million in the same period last year), but this was mainly due to a decrease in R&D expenses (from ¥122 million to ¥86 million), and it is difficult to characterize this as structural progress toward monetization.

Against cash and deposits of ¥3,744 million as of the end of March 2026, the quarterly net loss was approximately ¥153 million. A simple calculation suggests about 24 quarters (6 years) of funding capacity remains; however, expenses may increase as clinical trials progress, so the need for and timing of additional fundraising require ongoing monitoring. There was no note regarding going-concern assumptions for this quarter either.

Achieving dosing of the first patient in the Phase I clinical trial for NIB103 (In-house Drug Discovery) is an important milestone. Future accumulation of safety and efficacy data will help demonstrate the value of the PRIME Technology Platform, directly linking to new licensing agreements and the achievement of milestones with existing partners. In terms of the external environment, expansion of the cancer immunotherapy market is a positive tailwind, but intensifying development competition among rival CAR-T products is also a headwind requiring the maintenance of technological differentiation.

Growth Strategy

Aiming for monetization through in-house drug discovery and joint pipeline expansion, centered on advancing NIB103 clinical development

Advancing the Phase I clinical trial for NIB103 (In-house Drug Discovery), the in-house drug discovery pipeline for solid tumors. Administration to the first patient was achieved in Q1 FY2026 (ending March 2026), and demonstrating the clinical value of PRIME technology through the accumulation of safety and efficacy data is the top priority.

For NIB104 / NIB105 (In-house Drug Discovery), the in-house drug discovery pipeline following NIB103, the company aims to advance them to the early clinical stage through all possible approaches, including co-development. Securing co-development partners is important both for accelerating development and for sharing costs.

While supporting the development progress of the existing Joint Pipeline (ADAP01, AUTL01, CHUG01) with Adaptimmune, Autolus, and Chugai Pharmaceutical, the company aims to secure partnerships with new partners. Obtaining milestone income and royalties is the primary path to monetization.

In the joint research with Yamaguchi University, which has continued since 2017, the company continues research on next-generation PRIME Technology Platform and cancer immune cell therapy using allogeneic cells. The aim is to create new pipelines and expand future licensing opportunities.

Last updated: July 17, 2026