Noile-Immune Biotech Inc.
4893・Growth Market・Pharmaceuticals
Noile-Immune Biotech Inc. (Cancer Immunotherapy Drug Discovery Business)
A single-segment R&D company developing genetically modified immune cell therapies for solid tumors, centered on PRIME Technology Platform
| Period | Current | Previous | Change |
|---|---|---|---|
| Business revenue (Q1 cumulative) | ¥0 million | ¥2 million (same period previous year) | ↓ |
| Operating loss (Q1 cumulative) | -¥202 million | -¥241 million (same period previous year) | ↑ |
| Ordinary loss (Q1 cumulative) | -¥153 million | -¥239 million (same period previous year) | ↑ |
| Quarterly net loss (Q1 cumulative) | -¥153 million | -¥240 million (same period previous year) | ↑ |
| Cash and deposits (period-end balance) | ¥3,744 million | ¥3,918 million (end of previous fiscal year) | ↓ |
| Total assets | ¥3,845 million | ¥4,012 million (end of previous fiscal year) | ↓ |
| Net assets | ¥3,779 million | ¥3,932 million (end of previous fiscal year) | ↓ |
| Equity ratio | 98.1% | 97.8% (end of previous fiscal year) | ↑ |
| Net loss per share for the quarter | -¥3.54 | -¥5.55 (same period previous year) | ↑ |
| R&D expenses (Q1 cumulative) | ¥86 million | ¥122 million (same period previous year) | ↓ |
Business Details
Guided by the mission of "contributing to the creation of a society that can overcome cancer," the company develops CAR-T, TCR-T, and other genetically modified immune cell therapies using its proprietary PRIME (Proliferation-inducing and migration-enhancing) technology. It employs a hybrid business model combining "In-house Drug Discovery," led by the company itself, and "Joint Pipeline" programs that license PRIME technology to pharmaceutical companies. The company has entered into joint pipeline agreements with Adaptimmune, Autolus, and Chugai Pharmaceutical.
Recent Overview
Achieved dosing of the first patient in NIB103 Phase I clinical trial; loss amounts improved year-on-year
In Q1 FY2026 (January to March 2026), the company achieved dosing of the first patient in the Phase I clinical trial for its in-house lead product NIB103. Business revenue was not recorded (¥2 million in the same period of the previous year). Meanwhile, R&D expenses decreased to ¥86 million (¥122 million in the same period of the previous year), narrowing the operating loss to ¥202 million (¥241 million in the same period of the previous year). Recording ¥45 million in subsidy income from Yamaguchi Prefecture and Ube City improved the ordinary loss to ¥153 million (¥239 million in the same period of the previous year). There is no note regarding going concern assumptions.
Key Products
Growth Drivers
- Progress toward the clinical stage for the in-house drug discovery pipeline, starting with the achievement of dosing the first patient in the NIB103 Phase I clinical trial
- Potential acquisition of milestone income associated with development progress in the joint pipeline with Adaptimmune, Autolus, and Chugai Pharmaceutical
- Partial offset of R&D expenses through adoption of the Yamaguchi Prefecture "FY2025 Yamaguchi Regenerative Medicine Commercialization and Industrialization Promotion Subsidy Program" and Ube City subsidies (totaling ¥45 million per quarter)
- Expansion of revenue opportunities through early clinical-stage transition of NIB104 and NIB105 and acquisition of co-development partners
- Expansion of next-generation PRIME technology and allogeneic cell therapy development progress through joint research with Yamaguchi University, and expanded opportunities to secure new licensing agreements
Risks
- Business revenue is extremely limited, with no revenue recorded in Q1 FY2026, and the company continues to incur net losses (¥153 million per quarter) that R&D and general administrative expenses cannot be covered by revenue
- Cash on hand of ¥3,744 million has been declining year by year due to continued R&D expenditure, creating a future need for additional fundraising
- Performance carries significant volatility risk depending on clinical trial results for the pipeline and regulatory decisions; full-year earnings guidance for FY2026 (ending December 2026) has not been disclosed
- Structural risk that revenue may fluctuate significantly depending on the progress of partner companies' businesses and the success or failure of new licensing agreements
- Pipeline development discontinuation risks have materialized in the past, including the discontinuation of the NIB101 Phase I clinical trial and the termination of the NIB102 trial by Takeda Pharmaceutical
Last updated: March 23, 2026