Imagion Bio CEO, Robert Proulx, presents company information to investors at the 2022 Switzer Small & Micro Cap Conference in September.
Thank you, Peter. I’m very glad to be part of Switzer September Investor Day presentations. Imagion Biosystems is a clinical-stage biotechnology company, developing the next generation of medical imaging technologies to improve the way cancer and other diseases are detected and treated. We’re an Australian-listed entity with US R&D operations in San Diego.
To understand what we’re doing and why it’s important, I think it’s best to start with a current problem in cancer diagnosis. We’re probably all familiar with the five well-established imaging technologies, X-ray, ultrasound, magnetic resonance imaging (MRI), CT and positron emission technology (PET).
Each of them in various ways are used as an aid in diagnosing diseases or abnormalities. The images they produce help identify structural or anatomical anomalies, and certainly recent advances in artificial intelligence and machine learning are yielding better sensitivity and image resolution.
But many diseases, especially cancer, are a cellular phenomenon. So, while a trained radiologist might be able to identify an abnormal spot and an MR, or a CT, they can’t know if the spot or lesion is cancer or something more benign. Think of a classic mammogram where a spot is identified. But now you need to know if it’s truly cancer or say, for example, a fibrotic mass or a brain scan that shows an abnormal area. Is it cancer or some other type of tumor? So to confirm if the so-called region of interest is in fact cancer, we need to biopsy the lesion and look at the cells. For some forms of cancer, the biopsy might not be too invasive, but for others, it can be difficult and painful.
If you’re a 50-year-old male with an elevated PSA blood count, the prospect of having your prostate punched by 12 needles to obtain a biopsy sample, it’s not too enticing. From Imagion’s perspective, finding a way to eliminate or reduce the dependency on invasive procedures to confirm a cancer diagnosis is where the true unmet medical need is.
At Imagion, we’re developing a new generation of molecular imaging agents that are specifically designed to find and bind to various forms of cancer. Imaging agents, as you may know, are also known as contrast agents and are often used with imaging technologies.
Think of gadolinium for MRIs or iodized agents for CT. These injectable agents improve image contrast and help elucidate structures, but they’re not cancer or tissue specific. Newer PET imaging agents are more specific, but unfortunately, PET imaging does not have very good resolution, and the imaging agents use a radioactive tracer.
Imagion’s MagSense® molecular imaging agents are the first to use bio-safe, magnetic nanoparticles. The particles act as a magnetic beacon when they become attached to the target cancer. By using molecularly targeted particles, we believe we can transform imaging from detecting a region of interest to a noninvasive method for determining if the suspected lesion is actually cancer. In doing that, we can reduce the need for invasive biopsy procedures, and oh by the way, we avoid the use and exposure to radioactivity.
Our first molecular imaging agent is for the detection of HER2 metastatic breast cancer. HER2, as you may know, is one of the more aggressive forms of breast cancer so detecting whether cancer has metastasized and spread to the lymph nodes is important.
Today, imaging methods like ultrasound and MRI can look for abnormalities of the lymph nodes, but they can’t know if a tumor has spread.
With our MagSense HER2 molecular imaging agent, we aim to show that we can noninvasively determine which patients have nodal involvement. Being able to noninvasively determine nodal status, will eliminate unnecessary biopsies on those women with no metastatic disease and will save millions of dollars in healthcare costs that come from doing unnecessary bio procedures and the concomitant morbidity that comes from those nodal biopsies.
Here, think of lymphedema. Because this test would be a safer and better alternative than current standard of care, our MagSense, HER2 molecular imaging agent was designated by the US FDA as a breakthrough device. I think it’s important to note that our MagSense molecular imaging technology can be applied to a wide variety of cancers and other diseases.
For many types of cancers, there are known biomarkers or molecular signatures. Using the same underlying magnetic particle, we can couple it to a molecule that targets another form of cancer. We already have an R&D pipeline that includes the imaging agent I just referred to for HER2 breast cancer as well as prostate cancer and ovarian cancer, and an early-stage program to look at brain cancer.
That first MagSense HER2 breast cancer imaging agent is already in clinical phase of testing in a multi-site study being undertaken in Australia. This is a first-of-its-kind study. As this is the first time a targeted agent has been used for magnetic imaging.
In March of this year, we were very pleased to report the interim results from the first five patients that had enrolled in the study. There we reported against the two primary endpoints of safety and tolerability. We’ve continued to accrue patients into the study with results from those patients in line with what we previously reported, and we expect to reach our goal of test subjects in the near future.
Our business strategy is quite simple. Use this first product, the MagSense, HER2 breast cancer test as the proof of principle that molecular imaging with magnetic particles can transform imaging from being a tool to simply identifies abnormalities to one that actually is detecting disease tissue.
With clinical evidence of our technology in hand and a robust pipeline of high gross margin molecular imaging agents, we believe there is a clear value proposition for Imagion Biosystems.
In August, we reported our half-yearly financial results and are shortly expecting our R&D tax incentive. We have a widely held register with strong liquidity.
We believe we are approaching a value inflection point as we continue to report progress on our clinical study.
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