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Wednesday, 04/12/2023 10:14:44 PM

Wednesday, April 12, 2023 10:14:44 PM

Post# of 9558
Investors update

Newsletter Highlights:

Clinical data and expert review triggers commercial partner outreach efforts
MRI utility drives new IP and AI/ML efforts
Upcoming events and a recap on key media coverage
A Message From the CEO
As we noted in our 2022 Annual Report, last year was a momentous year having reported results from the first cohort of subjects in the MagSense® HER2 Phase 1 study at a global breast cancer meeting and presenting our prostate cancer imaging agent at an imaging conference.


That momentum has continued in the first quarter of this year with the independent review we reported at the beginning of February and the recent news of our communications with the FDA related to our plans to file an IND and proceed with a multi-site study in the U.S. for the MagSense® HER2 imaging agent.


In this newsletter, we are pleased to share some of the additional activities we are undertaking to keep the momentum going.


We look forward to keeping all our stakeholders apprised of the work we are doing to change the way we look at cancer with our MagSense® molecular imaging technology.

Bob Signature 600px (2)
Strategic Partnering Data Room
Our MagSense® imaging agents could be the first-of-its-kind molecular imaging solution for MRI. By changing current practice in medical imaging to include the sensitive and selective detection of cancer cells without using radiation, Imagion’s technology could significantly improve cancer diagnosis and patient care.


Now that our MagSense® imaging agent for HER2 breast cancer detection is progressing towards Phase 2 and our technology is showing positive preclinical results in other areas of high unmet need, including prostate cancer and ovarian cancer, we have a substantial value proposition for the medical imaging sector and are now well-placed to initiate discussions around strategic options with potential commercial partners. Our current pipeline represents a projected global market opportunity of ~ $5Billion* for Imagion and our partner(s).

To facilitate the process, we have established a secure data room where we can share confidential information related to the MagSense® HER2 program as well as our growing pipeline of imaging agents and will begin outreach programs to potential partners in an effort to gauge market interest in our technology.


Parties interested in partnering with Imagion to commercialize our MagSense® molecular imaging technology can contact us via partnering@imagionbio.com.


* Total available market estimates based on market data of current testing and a projected MagSense® price of $1200.

MRI Utility Drives New Areas for IP and Analytics
Data from the MagSense® HER2 Phase 1 study and internal R&D programs have opened new opportunities for Imagion to file for intellectual property and are driving efforts to investigate how analytical methods in Artificial Intelligence (AI) and Machine Learning (ML) might be applied to improve the clinical utility of the MagSense® imaging tests.

A provisional patent application has been filed related to the image pattern(s) associated with presence of the MagSense® targeted imaging agent. This new IP would extend our proprietary position for our magnetic nanoparticles across both magnetic relaxometry and magnetic resonance imaging, providing broader protection against other imaging agents that might try to replicate targeted detection by MRI. While there is no guarantee that the patent will issue, the new IP would provide significant value to Imagion and its commercial partners, carving out a unique space in the medical imaging landscape.

Additionally, the Company has initiated a project with a 3rd party with expertise in image analysis methods including AI and ML, to determine if algorithmic solutions could be applied to the MRI scans resulting from a MagSense® test to improve interpretability. Data from the Phase 1 study has informed the initial investigations and the Company is now looking into how algorithmic solutions may help drive improvements in image acquisition in the Phase 2 study. If algorithmic solutions can be applied, it would open the opportunity for the MagSense® imaging agents to be sold with an associated Software as a Medical Device (SaaMD) solution to aid radiologists in the interpretation of the MagSense® test results.


Since all MagSense® targeted imaging agents use the same underlying magnetic nanoparticle technology, the Company would look to apply the intellectual property and image analysis solutions broadly across the portfolio of MagSense® nanoparticle imaging agents.