Highlights:
- Announced positive results from IBI10103 Phase I Study demonstrating safety and clinical feasibility of molecular MRI with MagSense® HER2 Imaging Agent
- Presented new animal data on MagSense® MRI ovarian cancer detection at AACR conference
- Achieves best year of revenue totaling AU$1.28M from nanoparticle sales
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 2023 (Q4 FY2023).
Imagion Biosystems’ Executive Chairman, Mr. Bob Proulx said, “Completing our first Phase 1 study during last quarter marks a significant milestone for the company. We are the first to undertake molecular imaging by MRI, and we take pride in knowing that our technology could impact the future of cancer detection.
“The sudden departure of our CEO on January 15th was a surprise to us all, and as I resume management responsibility our cash position is not where we would like it to be. It’s no secret that the capital markets, particularly for microcap biotech, remained challenging throughout last year and we find ourselves in a very similar situation to many of our peers in Australia and the US with regard to accessing the capital markets. As a result, we will be making some adjustments to our cost structure to better align with our financial position while we work on some initiatives with our key nanoparticles customers to increase revenue. Additionally, though capital markets are tight, we will look to raise some funds on the equity markets to help us continue to take our technology forward.
“I will remain in the position of Executive Chair whilst we try to shore up our financial position. We will provide an update regarding the role of CEO at a later date.”
Summary of Activities
MagSense® HER2 Breast Cancer Study
The Company closed the Phase I study (IBI10103) for its HER2 breast cancer imaging agent in October 2023. The study was a multi-center open-label study in Australia which enrolled 13 newly diagnosed HER2 breast cancer patients to evaluate the safety and clinical feasibility of the Company’s MagSense® HER2 Imaging Agent (MSH2IA).
In December, the Company presented the study results at the San Antonio Breast Cancer Symposium, reporting that there were no safety issues, toxicity or drug-related adverse events. Additionally, the Company reported that an international panel of blinded radiologists assessed pre-dose versus post-dose MRI scans of treated patients, and for those patients with interpretable scans (8 of 13) the MRI assessment of post-MSH2IA imaging achieved parity or outperformed standard-of-care axillary ultrasound imaging. Furthermore, molecular MRI with MSH2IA achieved nearly perfect patient-level concordance, as 7 of these 8 patients identified with tumor-metastasized lymph nodes post-MSH2IA MRI imaging were confirmed by post-surgical pathology analysis to have metastatic disease.
The Company’s Investigational New Drug (IND) application for submission to the US FDA, which was initially planned for Q1:2024, will be delayed until adequate resources are secured to pursue further clinical development of the MagSense® imaging technology.
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
In October, the Company presented its preclinical ovarian cancer research data at the American Association for Cancer Research (AACR) Special Conference on Ovarian Cancer.
The poster presentation included preclinical in vivo animal studies showing that our MagSense® nanoparticles can provide folate receptor specific delivery to cancer cells expressing the folate receptor and create molecular T2 contrast in Magnetic Resonance Imaging (MRI), similar to the HER2 imaging agent. Notably, multiple types of ovarian cancer animal models were used with efficient delivery and detectability of the MagSense® folate receptor nanoparticles.
A link to the ASX announcement can be found HERE.
US Patent Allowed
In December the Company was notified that the U.S. Patent and Trademark Office has now allowed a patent application related to its magnetic relaxometry technology. The Company will file for issuance of the patent, further strengthening its intellectual property portfolio.
Record Revenues
In December, the Company received a large purchase order for the supply of nanoparticles from a customer the Company has been working with for two years. The order is being fulfilled across December 2023 and January 2024 and ensure receipts of US$462,000 (~AU$700,000). The Company received payment of US$138,600 (~AU$210,000) in December 2023 with the balance of US$323,400 (~AU$490,000) expected in full in early February 2024. In total, in 2023 the Company generated AU$1.283M in revenue from the supply of nanoparticles to 3rd parties, achieving its best year of non-dilutive revenue.
Subsequent to the close of the quarter, the Company has engaged its two largest customers in discussions for 2024 purchase orders which are expected to result in ~ US$592,000 (~AU$910,000) in nanoparticle sales over the next six months.
The Company will also be due its 2023 R&D tax incentive (expected on or around Q2 2024), this is expected to be less than prior years as will only include Australian based costs. It is expected this will be in the order of $AU400,000.
As noted above, the Company will also look to raise funds in the short-term (pending placement capacity availability) though capital markets to advance the clinical development of the Company’s lead imaging agent as well as for other general working capital expenses. There is a risk that such funding will not materialize in the current challenging market conditions. The Company will ensure all current shareholders will be able to participate at some level in any raise and we will be sure to continue to update the markets accordingly.
Summary of Cash Flows
Imagion’s cash balance as at 31 December 2023 was AU$0.23 million, a decrease of AU$2.21 million from the prior quarter. The Company reported an operating cash outflow of AU$1.84 million in the quarter. The adjusted operating outflows have decreased by AU$2.15 million from the prior quarter’s adjusted operating cash outflow (when adjusted for R&D tax incentive received in Q3). Operating cash flows were less than the Company’s expectations as the Company is carrying a level of creditors at the end of Q4 as it seeks further funding.
Payroll costs were reduced in Q4 2023 (by 12%). Beginning from Q1 2024 payroll and other operating costs will reduce even more as a result of additional organizational and restructuring steps taking place as well as the recent loss of the CEO.
Receipts from customers remained strong with $464k received during Q4 2023 from the sale of nanoparticles. This revenue is expected to increase in first half of 2024 based on discussions with existing customers.
The Company also paid $138k to related parties and their associates during the quarter for director fees and executive director salaries. However, it should be noted that all directors suspended their fees effective December 1, and that Mr. Proulx is receiving no compensation at this time as a director or for his executive role.
View the FULL Quarterly Report and Appendix 4C HERE
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.
