Events or conditions that raise significant doubt regarding the going-concern assumption
シンバイオ製薬株式会社 Group (consolidated)
Research and development business centered on BCV (brincidofovir), and the IVD business
The business model requires substantial research and development expenses and considerable time before a pharmaceutical product can be commercialized and generate revenue, and research and development activities centered on BCV require a certain period to recover the investment
Interim net loss attributable to owners of the parent of ¥3,619,930 thousand. Net assets at the end of the interim consolidated accounting period were negative ¥582,847 thousand. This was not recognized as an extraordinary loss
Second quarter (interim period) of the fiscal year ending December 2026 (1 January 2026 to 30 June 2026)
The consolidated earnings forecast for the fiscal year ending December 2026 remains unchanged from the figures announced on 5 February 2026. The interim net loss of ¥3,619 million represents approximately 83.6% of the full-year forecast net loss of ¥4,331 million.
Change in voting rights ownership ratio
The voting rights ownership percentage is the proportion of the voting rights exercisable at a shareholders' meeting held by the shareholder.
Yoshida Fuminori (吉田 文紀): number of voting rights: Not disclosed; percentage of voting rights held: 2.30% (before the transaction on 29 July 2026)
Yoshida Fuminori (吉田 文紀): number of voting rights: Not disclosed; percentage of voting rights held: 5.75% (as of 29 July 2026)
Company response
International joint Phase Ib clinical trial for patients with malignant lymphoma (temporarily suspended)
The Company will advance the global Phase III clinical trial of BCV and the Phase II clinical trial for PML, the early commercialization of the IVD business, discussions on financing, including equity financing, negotiations on partnerships with other companies, expense reductions, and a review of payment terms. The outcome of the financing and business partnership discussions, and the timing of eliminating excess liabilities, remain uncertain at this time.
If the relevant license agreement is concluded, the Company will promptly disclose it.
| Item | Details |
|---|---|
| Event name | Events or conditions that raise significant doubt regarding the going-concern assumption |
| Date of occurrence | End of the interim consolidated accounting period (30 June 2026) |
| Subject Entity | シンバイオ製薬株式会社 Group (consolidated) |
| Target Locations / Products | Research and development business centered on BCV (brincidofovir), and the IVD business |
| Cause | The business model requires substantial research and development expenses and considerable time before a pharmaceutical product can be commercialized and generate revenue, and research and development activities centered on BCV require a certain period to recover the investment |
| Amount of Impact on Business Performance | Interim net loss attributable to owners of the parent of ¥3,619,930 thousand. Net assets at the end of the interim consolidated accounting period were negative ¥582,847 thousand. This was not recognized as an extraordinary loss |
| Accounting period in which recognized | Second quarter (interim period) of the fiscal year ending December 2026 (1 January 2026 to 30 June 2026) |
| Impact on Earnings Forecast | The consolidated earnings forecast for the fiscal year ending December 2026 remains unchanged from the figures announced on 5 February 2026. The interim net loss of ¥3,619 million represents approximately 83.6% of the full-year forecast net loss of ¥4,331 million. |
| Suspended operations | International joint Phase Ib clinical trial for patients with malignant lymphoma (temporarily suspended) |
| Voting rights ownership percentage before the change | Yoshida Fuminori (吉田 文紀): number of voting rights: Not disclosed; percentage of voting rights held: 2.30% (before the transaction on 29 July 2026) |
| Voting rights ownership percentage after the change | Yoshida Fuminori (吉田 文紀): number of voting rights: Not disclosed; percentage of voting rights held: 5.75% (as of 29 July 2026) |
| Outlook | The Company will advance the global Phase III clinical trial of BCV and the Phase II clinical trial for PML, the early commercialization of the IVD business, discussions on financing, including equity financing, negotiations on partnerships with other companies, expense reductions, and a review of payment terms. The outcome of the financing and business partnership discussions, and the timing of eliminating excess liabilities, remain uncertain at this time. |
| Planned follow-up disclosure | If the relevant license agreement is concluded, the Company will promptly disclose it. |
Items this document does not state (12)
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 cites its research and development-focused business model as a reason, noting that commercialization and monetization of pharmaceutical products require substantial research and development expenses and considerable time, and that it takes a certain period to recover the investment. The Company also explains that research and development expenses increased during the interim period as research and development activities got fully underway, while partnership income expected for the full fiscal year has not yet been recorded.