Summary of Financial Results for the First Quarter of the Fiscal Year Ending December 2026 [Japanese GAAP] (Consolidated)
AnGes,Inc. and its consolidated subsidiaries, including EmendoBio, Inc. and AnGes Clinical Research Laboratory
Single segment: Pharmaceutical Business; the treatment for progeria Zokinvy, HGF gene therapy products, NF-κB decoy oligodeoxynucleotide, a DNA vaccine for hypertension, Tie2 receptor agonists, and ACRL's expanded newborn screening, among others
The widening of the operating loss was due to higher research and development expenses resulting from increased outsourcing fees related to applications to the U.S. FDA and higher manufacturing and testing costs for HGF gene therapy products. The narrowing of the ordinary loss was due to the recognition of a foreign exchange gain following the revaluation of U.S. dollar-denominated loans to EmendoBio, Inc. as a result of foreign exchange rate fluctuations. Regarding the going concern assumption, the company cited the substantial funding and lengthy period required to commercialize products in its pharmaceutical business, continuing operating losses and negative operating cash flow, insufficient revenue, and uncertainty regarding future financing.
Operating revenue: ¥203 million; operating loss: ¥1,496 million; ordinary loss: ¥1,110 million; quarterly net loss attributable to owners of the parent: ¥1,082 million. A foreign exchange gain of ¥385 million was recorded as non-operating income.
First quarter of the fiscal year ending December 2026 (1 January 2026 to 31 March 2026)
The consolidated earnings forecast for the fiscal year ending December 2026 remains unchanged at this time. The company forecasts operating revenue of ¥1,330 million, an operating loss of ¥10,230 million, an ordinary loss of ¥10,240 million, and net loss attributable to owners of the parent of ¥10,250 million.
Related procedures
U.S. FDA (Food and Drug Administration)
For HGF gene therapy products, the company will continue preparing application documents with a view to submitting a BLA (biologics license application) by the end of 2026. It will clarify priorities among the pharmaceutical products under development and advance their development, expand its development pipeline and business base, and consider partnerships with pharmaceutical companies and others. It will also pursue financing through stock acquisition rights and other instruments.
If the company determines that a change in the forecast amounts for the current fiscal year has occurred and that the earnings forecast needs to be revised, it will make an announcement promptly.
| Item | Details |
|---|---|
| Event name | Summary of Financial Results for the First Quarter of the Fiscal Year Ending December 2026 [Japanese GAAP] (Consolidated) |
| Date of occurrence | 31 March 2026 (end of the first quarter of the current consolidated accounting period); 8 May 2026 (disclosure date of the summary of financial results) |
| Subject Entity | AnGes,Inc. and its consolidated subsidiaries, including EmendoBio, Inc. and AnGes Clinical Research Laboratory |
| Target Locations / Products | Single segment: Pharmaceutical Business; the treatment for progeria Zokinvy, HGF gene therapy products, NF-κB decoy oligodeoxynucleotide, a DNA vaccine for hypertension, Tie2 receptor agonists, and ACRL's expanded newborn screening, among others |
| Cause | The widening of the operating loss was due to higher research and development expenses resulting from increased outsourcing fees related to applications to the U.S. FDA and higher manufacturing and testing costs for HGF gene therapy products. The narrowing of the ordinary loss was due to the recognition of a foreign exchange gain following the revaluation of U.S. dollar-denominated loans to EmendoBio, Inc. as a result of foreign exchange rate fluctuations. Regarding the going concern assumption, the company cited the substantial funding and lengthy period required to commercialize products in its pharmaceutical business, continuing operating losses and negative operating cash flow, insufficient revenue, and uncertainty regarding future financing. |
| Amount of Impact on Business Performance | Operating revenue: ¥203 million; operating loss: ¥1,496 million; ordinary loss: ¥1,110 million; quarterly net loss attributable to owners of the parent: ¥1,082 million. A foreign exchange gain of ¥385 million was recorded as non-operating income. |
| Accounting period in which recognized | First quarter of the fiscal year ending December 2026 (1 January 2026 to 31 March 2026) |
| Impact on Earnings Forecast | The consolidated earnings forecast for the fiscal year ending December 2026 remains unchanged at this time. The company forecasts operating revenue of ¥1,330 million, an operating loss of ¥10,230 million, an ordinary loss of ¥10,240 million, and net loss attributable to owners of the parent of ¥10,250 million. |
| Court or authority | U.S. FDA (Food and Drug Administration) |
| Outlook | For HGF gene therapy products, the company will continue preparing application documents with a view to submitting a BLA (biologics license application) by the end of 2026. It will clarify priorities among the pharmaceutical products under development and advance their development, expand its development pipeline and business base, and consider partnerships with pharmaceutical companies and others. It will also pursue financing through stock acquisition rights and other instruments. |
| Planned follow-up disclosure | If the company determines that a change in the forecast amounts for the current fiscal year has occurred and that the earnings forecast needs to be revised, it will make an announcement promptly. |
Items this document does not state (14)
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 the operating loss widened because research and development expenses increased, mainly due to higher outsourcing fees related to applications to the U.S. FDA and higher manufacturing and testing costs for HGF gene therapy products. The ordinary loss narrowed because fluctuations in foreign exchange rates resulted in the revaluation of U.S. dollar-denominated loans to EmendoBio, Inc., resulting in a foreign exchange gain of ¥385 million. Regarding the going concern assumption, the company cited the substantial funding and lengthy period required to commercialize products in its pharmaceutical business, continuing operating losses and negative operating cash flow, insufficient revenue, and uncertainty regarding the method, amount and timing of future financing.