Highlights:
- Imagion presented results from MagSense® HER2 Phase I study at global breast cancer meeting showing safety and detectability
- Tasks expert panel of radiologists with independent blinded review of the images from the Phase I study
- Received $2.5 million R&D tax incentive
MELBOURNE – Imagion Biosystems (ASX:IBX), a company dedicated to improving healthcare through the early detection of cancer, today released its Appendix 4C Quarterly Cashflow report and update on company activities for the quarter ending 31 December 2022 (Q4 FY2022).
“We were very pleased to present the interim clinical data at the San Antonio Breast Cancer Symposium in early December,” commented CEO Bob Proulx. “This is truly ground-breaking work and marks the first time that molecularly targeted magnetic nanoparticle technology has been shown to non-invasively detect cancer cells in human patients. Combining these results with the previously reported Safety Committee Review which found no significant issues of safety or tolerability we are confident that the study objectives are being met and that we can now begin to move ahead with the next phase of clinical investigations.” Adding, “Given that molecular imaging by magnetic resonance imaging is new and the data emerging from our study has not previously been seen by the medical community, we felt it prudent to commission a panel of experts for an independent review and confirmation of these very important real patient data. That review is now near completion, and we look forward to reporting the findings shortly.”
Summary of Activities
MagSense® HER2 breast cancer study
In early December the Company reported that it had participated in a global breast cancer meeting, presenting data for the first cohort of patients in its MagSense® HER2 Breast Cancer Phase I study. The announcement and data presented indicated that the MagSense® HER2 imaging agent is detectable by both imaging methods being evaluated in the study (conventional MRI and the Company’s proprietary magnetic relaxometry, MRX). Moreover, that the molecularly targeted nanoparticles exhibit a unique and observable molecular imaging ‘signature’ when cancer cells are present.
Additionally, during the quarter the Company formed an expert panel of breast cancer radiologists to undertake an independent blinded review of the MR images. This review aims to corroborate our findings and aid the Company in defining interpretability and utility for our molecular imaging technology. The review is in process and expected to be completed in early February 2023. The Company will provide an update upon completion of the independent review and plans to host a webinar for investors to more fully address the implications for the Company. The notice of the webinar will be included with the update.
Based on the positive data to date and the fact that the study objectives of safety and detectability are being met, the Company is now planning for the next phase of development, including studies most likely in the US. The Phase I study will remain open for enrolment to accumulate additional data that will contribute to our evaluation of the diagnostic performance and inform future study design considerations.
Summary of cash flows
Imagion’s cash balance at 31 December 2022 was $4.4 million, a decrease of $0.9 million from the prior quarter. The Company reported an operating cash outflow of $0.4 million in the quarter, significantly below the prior quarter’s operating cash outflow due to the receipt of it’s AU$2.5 million research and development tax incentive from the Australian Taxation Office (ATO) in respect of the 2021 year. This was in line with the Company’s expectations.
Excluding receipt of the research and development tax incentive other outflows increased by 4.1% compared to the prior quarter. Administration and corporate costs, and staff costs reduced slightly on the prior quarter while research and development costs increased slightly. Repayment of borrowings and interest costs reduced slightly during the quarter. These relate to the allocation of rent for our San Diego facility, in line with the lease accounting provisions of the accounting standards.
We anticipate costs to remain relatively consistent for the first-half of 2023 increasing in the second-half of 2023 as MagSense® HER2 Breast Cancer program progresses. In addition the Company will also be planning to advance its development pipeline, and therefore this may add to research and development expenditures and staff costs.
The Company also paid $156k to related parties and their associates. These payments are related to director fees and executive director salaries.
Read the full announcement here: 20230130 IBC App 4C
Questions about this announcement or other investor-related inquiries? Please email our investor relations department at: investor@imagionbio.com.
