Quarterly Activity Report and Appendix 4C for 30 June 2023

Quarterly Activity Report and Appendix 4C for 30 June 2023

Highlights include:

    • MagSense® HER2 Phase 1 Study achieves enrolment target
    • Expands collaboration with Siemens Healthineers
    • Dr. Isaac Bright appointed as CEO

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 30 June 2023 (Q2 FY2023).

“We are delighted with how our MagSense® HER2 breast cancer imaging technology is progressing and with having achieved our enrollment target for the Phase 1 study,” commented Imagion’s recently appointed CEO, Dr. Isaac Bright. “Our clinical data to-date supports our vision that our targeted nanoparticle technology has the potential to change how MRI can be used to specifically detect cancer.”

Dr. Bright continues, “Our valuable collaboration with Siemens Healthineers has been expanded to include Siemens’ U.S. team in anticipation of Imagion undertaking a multi-site Phase 2 study for the MagSense® HER2 imaging agent. I look forward to the second half of 2023 as we focus on preparing for the multi-site Phase 2 study in the U.S. as we conclude the Phase 1 study.”

Summary of Activities

MagSense® HER2 Phase 1 Study achieves enrolment target

During the quarter, Imagion’s MagSense® HER2 imaging agent Phase 1 study (IBI10103) achieved its enrolment target with 13 patients enrolled, meeting the original goal of 10-15 patients. The Company initiated its plans to close the study as was indicated at the Company’s AGM held on 25 May 2023.

This was a great achievement for Imagion in its first clinical study, whilst recruitment was challenging, the Phase 1 study was a success, as MagSense® HER2 has been well-tolerated and the results are easily interpretable by radiologists. The Company is now well positioned to move ahead with the MagSense® HER2 breast cancer program. The Phase 1 study has been instrumental in revealing the potential clinical utility of the MagSense® HER2 Imaging Agent and confirms that the Company’s targeted nanoparticle technology has the potential to expand MRI utilization with molecular resolution in the detection of cancer.

Results of the study will be published in due course and the Company will use the data in support of an Investigational New Drug (IND) application submission to the US FDA expected late this year or the beginning of 2024.

Expands collaboration with Siemens Healthineers to United States

Imagion extended its collaboration agreement with Siemens Healthineers for an additional two years, during the quarter in anticipation of Imagion undertaking a multi-site Phase 2 study for the MagSense® HER2 imaging agent. The companies have also agreed to collaborate in the United States through Siemens Medical Solutions USA.

The collaboration allows Siemens to provide expertise to Imagion as they work together with Imagion’s clinical advisors and investigators to optimize the Magnetic Resonance Imaging (MRI) protocols in anticipation of Imagion’s MagSense® clinical studies and provide technical support to clinical sites.

The collaboration in place for the MagSense® Phase 1 study in Australia has been very valuable and is expected to continue now in this expanded capacity in the United States.

Dr. Isaac Bright appointed as CEO

Dr. Isaac Bright was appointed as CEO of Imagion in June. Dr. Bright brings over 20 years of experience as a health industry executive and venture capitalist in medical technology, biopharmaceuticals, and oncology-based molecular diagnostics.

This is an exciting new phase for Imagion and Dr. Bright’s track record in strategic partnering, financing and M&A are well suited to support the Company’s vision and drive the next chapter in Imagion’s growth.

Dr. Bright’s appointment followed the retirement of Bob Proulx as CEO, with Mr. Proulx remaining as Chairman of the Board.


Funding initiatives

In June 2023, Imagion received $1.0 million from Mercer Street Global Opportunity Fund LLC, a U.S. based investment fund managed by Mercer Street Capital Partners LLC pursuant to the convertible note agreement between the Company and Mercer announced on the ASX on 7 March 2023.

The Company will use this funding to advance clinical development of the Company’s lead imaging agent as well as for other general working capital expenses.

In April 2023, Imagion received $413k as proceeds from its entitlement offer that was opened in March 2023. The shortfall, of $1.97 million, was placed subsequent to quarter end on 14 July 2023.

Summary of Cash Flow

Imagion’s cash balance at 30 June 2023 was $0.45 million, a decrease of $4.0 million from the prior quarter. The Company reported an operating cash outflow of $3.1 million in the quarter, slightly higher than the prior quarter’s operating cash outflow. This was in line with the Company’s expectations.

Increased research & development outflows ($1.3 million outflow in Q2 compared to $839k in Q1) were partially offset by an increase in receipts from customers ($392k received in Q2 compared to $85k received in Q1). Other costs remain relatively consistent to the prior quarter.

We anticipate administration and corporate costs to remain relatively consistent compared to current run-rate through the remainder of 2023. Research and development costs are expected to increase during the remainder of 2023 as the MagSense® HER2 Breast Cancer program progresses towards an IND filing and undertakes activities outlined above. In addition, the Company will also be planning to advance its development pipeline, and therefore this may add to research and development expenditures.

Receipts from customers are expected to reduce back to Q1 levels as some recent larger customer orders have been filled.

In relation to liquidity the Company anticipates receiving up to $5.47 million from the following financing proceeds in Q3 2023: receipt of $1.97 million under the shortfall associated with the entitlement offer (this has already been received subsequent to quarter end); and receipt of its research and development tax incentive in respect of the 2022 year which is anticipated to be $3.5 million (this
has been lodged with the Australian Taxation Office and although was expected in Q2 2023 it has taken longer than anticipated due to a standard pre-release review being conducted by the Australian Taxation Office).

The Company also paid $153k to related parties and their associates. These payments are related to director fees and executive director salaries.

View the full ASX announcement HERE >> 

About Imagion Biosystems
Imagion Biosystems is developing a new non-radioactive and precision diagnostic molecular imaging technology. Combining biotechnology and nanotechnology, the Company aims to detect cancer and other diseases earlier and with higher specificity than is currently possible. Imagion Biosystems listed on the Australian Securities Exchange (ASX) in June 2017.

Authorisation & Additional information
This announcement was authorised by the Board of Directors of Imagion Biosystems Limited

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