Highlights:
- Announced preliminary performance of MagSense® HER2 Imaging Agent in phase 1 study after study closure (post quarter end)
- Entered a strategic partnership with Prestige Biopharma to develop early pancreatic cancer diagnosis platform
- Presented new animal data on MagSense® MRI ovarian cancer detection at AACR conference (post quarter end)
- Received AU$3.5 million in R&D tax incentives
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 September 2023 (Q3 FY2023).
Imagion Biosystems’ Chief Executive Officer, Dr. Isaac Bright said,
I have now been in the CEO seat for more than four months and I must say I am pleased with the progress we are making and I am looking forward to the remainder of 2023 and what 2024 has in store for our company. We have increased focus and efficiency with our revised business model, and the team’s response to our corresponding re-organization has been inspiring. We remain on schedule to submit our IND application to the FDA in the first quarter of 2024. Business partnering opportunities are a key for this business to succeed and I was pleased to execute the MOU with Prestige Biopharma during the quarter. Further opportunities are in the pipeline and we will update shareholders upon successful execution.
Summary of Activities
MagSense® HER2 breast cancer study
Subsequent to quarter end in October, the Company announced preliminary performance of its MagSense® HER2 imaging agent (MSH2IA) in relation to its Phase 1 study (IBI10103). The Company also announced that the study was now closed with the final study site now taking no further enrolments.
Imagion’s MSH2IA is designed to enable molecular MRI that detects lymph node metastatic HER2+ breast cancer in newly diagnosed patients. In the IBI101013 study, 13 patients were administered with the MagSense® HER 2 Imaging Agent. The drug was safe and well-tolerated, as there were no MSH2IA-related adverse events. 8 patients’ MSH2IA molecular MRI results were interpretable by blinded radiologists participating in the study, while 3 subjects’ tumour invasion impaired lymphatic drainage of the drug, and 2 subjects’ MSH2IA molecular MRIs were marred by common MRI artifacts. Of the 8 interpretable patients, the actual pathology results from resected lymph node tissue agreed with the blinded radiologists’ reports for 7 patients. Complete results will be released at December’s San Antonio Breast Cancer Symposium and subsequently published, as previously announced.
The Company will use the data in support of an Investigational New Drug (IND) application submission to the US FDA ,expected in Q1 2024.
A link to the ASX announcement can be found HERE >>
Presented new animal data on MagSense® molecular MRI detection of ovarian cancer at AACR Ovarian Cancer Conference
Subsequent to quarter end in October, Dr. Marie Zhang (our VP of R&D) presented a poster in relation to Imagion’s preclinical ovarian cancer research at the American Association for Cancer Research (AACR) Special Conference on Ovarian Cancer.
The poster presented from Imagion’s preclinical in vivo animal studies showed that our MagSense® folate receptor nanoparticles can provide target-specific delivery to cancerous tissue and create molecular T2 contrast in Magnetic Resonance Imaging (MRI). Notably, multiple types of orthotopic mice models were used with efficient delivery and binding of the MagSense® folate receptor nanoparticles to ovarian tumour cells being detectable using MRI.
A link to the ASX announcement can be found HERE >>
Announced strategic partnership with Prestige Biopharma to develop early pancreatic cancer diagnosis platform
In August, a Memorandum of Understanding (MOU) was executed with Prestige Biopharma, a biopharmaceutical company specializing in innovative antibody therapies. Together, Imagion and Prestige Biopharma will jointly pursue the development of the world’s first non-invasive early detection diagnosis and staging platform for pancreatic cancer. Combining MagSense® molecular MRI and Prestige Biopharma’s PAUF-based antibody drug, PBP1510, the partnership aims to accelerate accurate diagnosis and therapeutic intervention.
The MOU covers preclinical feasibility research that should be completed in the short-term. Should the research produce favorable results, both companies may then agree to expand the collaboration to further advance the technologies.
This initiative expands Imagion’s growing pipeline of MagSense® imaging agents within the Company’s MagSense® platform. The Company is now developing MagSense® targeted nanoparticles to revolutionize cancer diagnosis via MRI molecular imaging for HER2 breast cancer, ovarian cancer, prostate cancer, brain cancer and pancreatic cancer.
A link to the ASX announcement can be found HERE >>
Extraordinary General Meeting
We recently released a video of Dr. Bright explaining the rationale for the resolutions being tabled at the upcoming Extraordinary General Meeting to be held on 13 November 2023. We are holding the meeting as both a physical and virtual meeting and encourage shareholders to attend.
A link to the video can be found HERE >>
Funding initiatives
In July 2023, the Company placed the entitlement offer shortfall, raising $1.97 million (pre-costs).
In August 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.
In September 2023, the $3.53 million 2022 R&D tax incentive claim was received from the Australia Taxation Office.
The Company is using this funding to advance the clinical development of the Company’s lead imaging agent as well as for other general working capital expenses.
Summary of cash flows
Imagion’s cash balance as at 30 September 2023 was $2.43 million, an increase of $1.98 million from the prior quarter. The Company reported an operating cash outflow of $0.46 million in the quarter (or $3.99 million when adjusted for $3.5 million R&D tax incentive received during the quarter). The adjusted operating outflows have increased by $0.89 million from the prior quarter’s operating cash outflow. This was in line with the Company’s expectations.
Research & development outflows increased during the quarter ($1.8 million outflow in Q3 compared to $1.3 million in Q2). They are expected to increase again in Q4 2023 as the MagSense® HER2 Breast Cancer program progresses towards an IND filing (in Q1 2024). In addition, the Company continues to advance its development pipeline, and therefore this may add to research and development expenditures.
Payroll costs are expected to reduce slightly in Q4 2023 and then from Q1 2024 by ~20% as a result of the headcount reduction that took place in early October.
Receipts from customers remained strong with $375 thousand received during Q3 from the sale of nanoparticles. This revenue is expected to reduce in Q4 as some recent larger customer orders have been filled.
In relation to liquidity the Company has capacity within the convertible securities agreement with Mercer and is looking at other funding alternatives in Australia and the US.
The Company also paid $130 thousand to related parties and their associates. These payments are related to director fees and executive director salaries.
View the full Quarterly Activity Report and Appendix 4C HERE >>
-ENDS-
About Imagion Biosystems
Established in 2017 and headquartered in San Diego, California, US, Imagion Biosystems is an ASX-listed company dedicated to developing innovative medical imaging technologies for various cancer types. Imagion Biosystems is advancing clinical development of its MagSense® platform technology to revolutionize cancer diagnosis, introducing molecular imaging to MRI. The Company’s lead program has demonstrated its innovative technology embodied in MagSense® HER2 Imaging Agent (MSH2IA) is safe and well-tolerated in patients diagnosed with HER2+ breast cancer. Imagion Biosystems’ MagSense® pipeline includes prostate cancer, ovarian cancer, pancreatic cancer, and brain cancer programs.
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Authorisation & Additional information
This announcement was authorised by the Disclosure Committee of Imagion Biosystems Limited.
