Quarterly Activity Report — Quarter Ending 30 September 2021

Q3 highlights:

  • Sites added for MagSense® HER2 Breast Cancer Phase I Study
  • Experienced Chief Development Officer added to Management Team
  • Joint Development Agreement established with Global Cancer Technology to develop nanocrystals for treating breast cancer

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 2021 (Q3 FY2021).

Executive Chairman and CEO Bob Proulx said, “We are pleased to report that we now have four sites across three states actively screening patients for recruitment into the MagSense® Study with multiple cancer patients having been enrolled. As we see how the end of lock downs affects cancer screening, we will have a better indication over Q4 as to the likely cadence of recruitment going forward.”

Summary of activities in Q3

The Company added the Royal Brisbane Women’s Hospital as the third clinical site for its MagSense® Study mid-quarter and a fourth site, the Lake Macquarie Private Hospital (part of Ramsay Health Care) was added subsequent to the close of the quarter.

On 16 March the company announced it had received a CSIRO Federal Government grant that would be used to fund preclinical research for a MagSense® prostate cancer imaging agent in collaboration with researchers from Monash University’s Biomedicine Discovery Institute. During the third quarter the Monash University researchers completed the first round of animal studies with results now being analyzed. The company plans to continue the collaboration as funds from the grant remain available. Prostate cancer is the second most common cancer in men with a clear unmet medical need for improved diagnostic imaging technology to identify high at-risk localized prostate cancer.

Imagion employed Yalia Jayalakshmi, PhD, as Chief Development Officer during Q3. Dr Jayalakshmi comes to Imagion with deep background, knowledge and leadership in cancer imaging and nanotechnology at a depth that is not regularly seen in the industry. Her experience spans drug, device nanoparticle delivery and diagnostic imaging products in oncology, ophthalmology and other therapeutic areas. We look forward to her providing leadership for our current MagSense® HER2 breast cancer Phase I study, and all our future clinical programs.

During the quarter the Company announced it had entered into a Joint Development Agreement with Global Cancer Technology (GCT), to develop GCT’s novel nanoscintillator technology for the treatment of breast cancer, leveraging Imagion’s nanoparticle expertise. Scintillating nanocrystals are nontoxic minerals and rare earth elements that emit photons (light) when activated by a low dose of gamma radiation. Photocleavable linkers release a drug payload when exposed to the small burst of light from the scintillating photons. Employing nanocrystals to deliver a drug payload enables a controlled release of the therapeutic agent. This next generation approach, known as x-ray induced photodynamic therapy, has the potential to deliver a more localized and effective dose of drug product to treat cancers and improve the utility of low dose radiation for the treatment of solid tumours. Under the terms of the Agreement Imagion will be paid for certain R&D services while gaining an ownership interest in the GCT nanoscintillator product being developed. Work on the project commenced during the quarter.

Summary of Q3 Cash Flows

Imagion’s cash balance reduced during the quarter by $1.9 million to $12.0 million. During the quarter $0.1 million was received upon the exercise of options with total year-to-date receipts of $1.7 million.

The Company reported an operating cash outflow of $2.2 million in the quarter, an increase against the prior quarter’s adjusted operating cash outflow of $1.9 million (excluding the $2.6 million R&D tax incentive received in Q2). The increase was mainly attributable to administration and corporate costs with the upfront payment of D&O insurance during the quarter accounting for a large proportion of the increase.

As previously mentioned as the MagSense® Phase I clinical study progresses and the Company advances its development pipeline, research and development expenditures and staff costs are expected to increase in the coming quarters.

During Q4 2021 the Company anticipates further receipts from the exercise of options and in particular the IBXO listed options that are due to expire on 26 November 2021.

During the quarter, $138k was paid to related parties and their associates. These payments related to director fees and executive director salaries.

Please click to review the full announcement at ASX.