Imagion Biosystems Limited provided an update on its capital management and progress towards an Investigational New Drug (IND) application to the US FDA in relation to the MagSense HER2 Program. The Company has been invited to present the results of its MagSense® Phase 1 study for HER2
metastatic breast cancer detection on at the 2023 San Antonio Breast Cancer Symposium Spotlight session entitled "Shining a new light on breast cancer: Novel molecular and functional imaging to detect and characterize breast cancer." The company presented preliminary findings from the study at the 2022 SABCS meeting and will be presenting more complete data at this year's meeting now that the study has concluded. Please watch for additional announcements related to the meeting to be held in early December. Additionally, as we have previously indicated, the Company is aiming to file an Investigational New Drug (IND) application for the MagSense® HER2 imaging agent with the US FDA in the first quarter of 2024. To achieve this, the Company is currently focused on the following areas: ®
Manufacturing a new clinical lot of the MagSense HER2 imaging agent. This is happening at present and is on schedule to be completed prior to the end of 2023 to enable inclusion in the IND application in early 2024. Conducting IND-enabling studies in line with FDA guidance. The Company is currently completing its toxicology study as requested by the FDA. This is also on schedule to be completed prior to the end of 2023.