Strategic Direction Fueling Organic Growth
Imaging Biometrics Limited is shifting its strategic focus from a Phase 2 clinical trial for gallium maltolate to prioritize near-term commercial objectives for its imaging solutions, believing this will better serve shareholders. While the Phase 1 trial for oral gallium maltolate in recurrent glioblastoma is nearing completion with results being prepared for publication, the company has decided not to proceed with further clinical development of this therapeutic. Imaging Biometrics retains valuable orphan drug, rare pediatric disease, and FDA Fast Track designations for gallium maltolate, preserving future options. The company will monitor the independent GABRIEL pediatric trial for scientific insights. This strategic pivot aims to capitalize on the promising commercial performance and expanding clinical adoption of its imaging business, strengthening the company's financial foundation and long-term outlook.
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Imaging Biometrics, Ltd, (LSE: IBAI) is pleased to provide an update on its involvement in the development of gallium maltolate as well as its strategic priorities for 2026.
In early 2022, IBAI sponsored a Phase 1 clinical trial evaluating oral gallium maltolate for the treatment of recurrent glioblastoma. While the trial remains open as one patient continues to receive treatment, enrollment was formally closed in November. The study authors are currently preparing the Phase 1 results for submission to a peer‑reviewed journal.
The directors believe it is no longer in shareholders' interests to embark on a Phase 2 clinical trial of gallium maltolate as previously intended. The financial and operational resources would be better employed to concentrate upon nearer-term commercial objectives of our imaging solutions.
The Company continues to hold two orphan drug designations, two rare pediatric disease designations, and an FDA Fast Track designation, all of which remain valuable assets that preserve future optionality.
We also acknowledge the GABRIEL pediatric trial-Gallium Maltolate for Better Outcomes in Relapsed/Refractory Atypical Teratoid Rhabdoid Tumor and High‑Grade Glioma-planned at Children's Hospital of Wisconsin. Imaging Biometrics is not formally involved in this study, but we will closely monitor its progress for any scientific insights that may emerge. Developments from this trial may help inform the broader landscape of research related to gallium maltolate, and we will continue to follow it with interest.
Our decision reflects a disciplined commitment to focus-ensuring that we invest where we can deliver the greatest value for patients, clinicians, and shareholders in the near term. The imaging business is promising stronger commercial performance, expanding clinical adoption, and increasing recognition for its technological differentiation. Concentrating our efforts here allows us to build on this momentum and continue scaling in a way that strengthens the Company's financial foundation and long‑term outlook.
The Directors of the Company accept responsibility for the contents of this announcement.
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