Third-quarter financial results for the fiscal year ending December 2026 and revision of the consolidated earnings forecast for the fiscal year ending December 2026
AnGes,Inc. and 3 consolidated subsidiaries (the consolidated group)
Zokinvy, an early-aging syndrome treatment; HGF gene therapy products; and expanded newborn screening tests conducted by AnGes Clinical Research Laboratory (ACRL)
Higher business expenses, higher manufacturing testing costs for HGF gene therapy products, and higher outsourcing fees related to applications to the US FDA. Regarding the going concern assumption, the company disclosed continuing operating losses, negative operating cash flow, insufficient revenue, a weakened financial base and requests for payment deferrals on certain liabilities.
For the nine months ended September 2026: operating loss of ¥5,025 million, ordinary loss of ¥4,932 million, and net loss attributable to owners of the parent of ¥5,081 million. The company recorded an impairment loss of ¥41 million as an extraordinary loss. The full-year forecast for the fiscal year ending December 2026 is an operating loss of ¥8.9 billion, an ordinary loss of ¥9.0 billion, and a net loss attributable to owners of the parent of ¥9.1 billion.
Nine months ended September 2026 and the full fiscal year ending December 2026
The company revised the figures announced on 10 February 2026 and expects business revenue of ¥1.0 billion, an operating loss of ¥8.9 billion, an ordinary loss of ¥9.0 billion, and a net loss attributable to owners of the parent of ¥9.1 billion.
Related procedures
US FDA (procedures related to the BLA filing and approval of HGF gene therapy products)
The company will pursue funding through new financing, cost reductions, deferral of non-urgent activities, requests for payment deferrals from certain business partners, and partnerships or organizational restructuring with other companies concerning ACRL’s testing business. For HGF gene therapy products, the company is targeting submission of the initial BLA review documents in the fourth quarter of 2026, submission of the final review documents in the first quarter of 2027, and execution of a sales partner agreement in the first half of 2027.
| Item | Details |
|---|---|
| Event name | Third-quarter financial results for the fiscal year ending December 2026 and revision of the consolidated earnings forecast for the fiscal year ending December 2026 |
| Date of occurrence | 30 September 2026 (end of the third quarter of the consolidated fiscal period; publication date of the earnings report: 13 November 2026) |
| Subject Entity | AnGes,Inc. and 3 consolidated subsidiaries (the consolidated group) |
| Target Locations / Products | Zokinvy, an early-aging syndrome treatment; HGF gene therapy products; and expanded newborn screening tests conducted by AnGes Clinical Research Laboratory (ACRL) |
| Cause | Higher business expenses, higher manufacturing testing costs for HGF gene therapy products, and higher outsourcing fees related to applications to the US FDA. Regarding the going concern assumption, the company disclosed continuing operating losses, negative operating cash flow, insufficient revenue, a weakened financial base and requests for payment deferrals on certain liabilities. |
| Amount of Impact on Business Performance | For the nine months ended September 2026: operating loss of ¥5,025 million, ordinary loss of ¥4,932 million, and net loss attributable to owners of the parent of ¥5,081 million. The company recorded an impairment loss of ¥41 million as an extraordinary loss. The full-year forecast for the fiscal year ending December 2026 is an operating loss of ¥8.9 billion, an ordinary loss of ¥9.0 billion, and a net loss attributable to owners of the parent of ¥9.1 billion. |
| Accounting period in which recognized | Nine months ended September 2026 and the full fiscal year ending December 2026 |
| Impact on Earnings Forecast | The company revised the figures announced on 10 February 2026 and expects business revenue of ¥1.0 billion, an operating loss of ¥8.9 billion, an ordinary loss of ¥9.0 billion, and a net loss attributable to owners of the parent of ¥9.1 billion. |
| Court or authority | US FDA (procedures related to the BLA filing and approval of HGF gene therapy products) |
| Outlook | The company will pursue funding through new financing, cost reductions, deferral of non-urgent activities, requests for payment deferrals from certain business partners, and partnerships or organizational restructuring with other companies concerning ACRL’s testing business. For HGF gene therapy products, the company is targeting submission of the initial BLA review documents in the fourth quarter of 2026, submission of the final review documents in the first quarter of 2027, and execution of a sales partner agreement in the first half of 2027. |
Items this document does not state (15)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The company explained that it had revised its earnings forecast in light of recent performance trends. It also stated that research and development expenses increased due to higher manufacturing testing costs for HGF gene therapy products and higher outsourcing fees related to applications to the US FDA.