Welcome to the Fear and Greed daily interview. I'm Sean Aylmer. I love talking to biotech companies for a few reasons. They're different from so many other companies that we talk about. They can be extremely expensive to establish because of the research and testing necessary. They can go for a very long time without seeing a return on their investment and they're largely at the mercy of different countries and jurisdictions, all which have their own regulatory processes. But at their core, they are companies that aim to fix a problem and to help people. My guest today is Bob Proulx, the CEO of ASX listed, Imagion Biosystems, a company leading the charge for better imaging methods for cancer patients. This is groundbreaking stuff. Bob joins me from San Diego. Good morning, Bob.

Welcome to the Fear and Greed daily interview. I'm Sean Aylmer. I love talking to biotech companies for a few reasons. They're different from so many other companies that we talk about. They can be extremely expensive to establish because of the research and testing necessary. They can go for a very long time without seeing a return on their investment and they're largely at the mercy of different countries and jurisdictions, all which have their own regulatory processes. But at their core, they are companies that aim to fix a problem and to help people. My guest today is Bob Proulx, the CEO of ASX listed, Imagion Biosystems, a company leading the charge for better imaging methods for cancer patients. This is groundbreaking stuff. Bob joins me from San Diego. Good morning, Bob.

Good morning, Sean. Nice to be here. Thanks for the invitation.

Good morning, Sean. Nice to be here. Thanks for the invitation.

So, take us through Imagion Biosystems. What are you doing?

So, take us through Imagion Biosystems. What are you doing?

Yeah. So, as you said in the intro, we're working on improving imaging technology to do a better job of being able to detect cancer. So, we're leveraging the capability of tiny magnetic particles to effectively generate, sort of, a magnetic beacon or a magnetic signature when they become attached to cancer. And that will help us improve the ability to detect it at an earlier stage and more specifically. One of the problems we have today is, we've got five great ways to generate images of the body, X- ray, CT, ultrasound, PET and MRI. And they're all good at being able to identify anatomical anomalies of fractured risks, for example, or what might be a spot that looks interesting or concerning. But they can't go beyond identifying, sort of, a region of interest or a suspicious lesion. And we're trying to change that. We're trying to move imaging from being, identifying an area that's of concern, to really being able to say, " No, in fact, that's cancer because we have a molecular signature generating this magnetic signal."

Yeah. So, as you said in the intro, we're working on improving imaging technology to do a better job of being able to detect cancer. So, we're leveraging the capability of tiny magnetic particles to effectively generate, sort of, a magnetic beacon or a magnetic signature when they become attached to cancer. And that will help us improve the ability to detect it at an earlier stage and more specifically. One of the problems we have today is, we've got five great ways to generate images of the body, X- ray, CT, ultrasound, PET and MRI. And they're all good at being able to identify anatomical anomalies of fractured risks, for example, or what might be a spot that looks interesting or concerning. But they can't go beyond identifying, sort of, a region of interest or a suspicious lesion. And we're trying to change that. We're trying to move imaging from being, identifying an area that's of concern, to really being able to say, " No, in fact, that's cancer because we have a molecular signature generating this magnetic signal."

Okay. So, just take me a step back. Those different types of imaging that we have, that we all know about, they seem to have been around for a while. Is this an area where it got to a certain point and it hasn't taken a great leap forward and that's, kind of, what you are trying to do? Or is it something that incrementally has been getting better?

Okay. So, just take me a step back. Those different types of imaging that we have, that we all know about, they seem to have been around for a while. Is this an area where it got to a certain point and it hasn't taken a great leap forward and that's, kind of, what you are trying to do? Or is it something that incrementally has been getting better?

So, those techniques have gotten better and better at image resolution. So, our pictures are getting better, we're seeing more clarity. We can see smaller and smaller structures. Things like artificial intelligence and machine learning are actually increasingly improving that. But diseases like cancer are a cellular phenomenon and not a structural phenomenon. So, the difference is, where those techniques up until now have lacked, is their ability to actually say, " Oh, that spot I see is cancer." We're all probably familiar with a mammogram showing a spot, but is it a malignant form of cancer or just a benign fibrotic tumor? That's what we're trying to change. We're trying to take advantage of all of the good aspects of imaging resolution, but adding that ability to then say, " Well, the spot that I see actually is there because it's generating a magnetic signature associated with the molecular profile of the cells that the particles are attached to."

So, those techniques have gotten better and better at image resolution. So, our pictures are getting better, we're seeing more clarity. We can see smaller and smaller structures. Things like artificial intelligence and machine learning are actually increasingly improving that. But diseases like cancer are a cellular phenomenon and not a structural phenomenon. So, the difference is, where those techniques up until now have lacked, is their ability to actually say, " Oh, that spot I see is cancer." We're all probably familiar with a mammogram showing a spot, but is it a malignant form of cancer or just a benign fibrotic tumor? That's what we're trying to change. We're trying to take advantage of all of the good aspects of imaging resolution, but adding that ability to then say, " Well, the spot that I see actually is there because it's generating a magnetic signature associated with the molecular profile of the cells that the particles are attached to."

Okay. So, I'm just thinking this through. So, recently I had a son who was having kidney issues. He had all the scans and eventually they took a biopsy, they put a big needle into his kidneys and took a bit out to work out what was going on. Thankfully, all is fine but, potentially, what you are talking about, you won't need that big needle and you won't have to go through all these different scans because you'll actually know, upfront, what it is.

Okay. So, I'm just thinking this through. So, recently I had a son who was having kidney issues. He had all the scans and eventually they took a biopsy, they put a big needle into his kidneys and took a bit out to work out what was going on. Thankfully, all is fine but, potentially, what you are talking about, you won't need that big needle and you won't have to go through all these different scans because you'll actually know, upfront, what it is.

So, you're spot on with the idea that, today, for almost every form of cancer, we can get an image, but we ultimately confirm the presence of the cancer by doing a biopsy. For some things like melanoma, that's not such a bad deal. But for things like deep body tissues, like pancreatic cancer, or you take a man with elevated PSA and he's going to have a prostate biopsy, these all are relatively risky procedures. There could be significant side effects in everything. So, we're not as concerned about replacing biopsy per se, as eliminating the unnecessary biopsies for when it's negative, right? So, if you're a man who has an elevated PSA but you don't have clinically significant disease, you're still going to get a biopsy and then you have the risk of erectile dysfunction and incontinence, et cetera. If we could take a patient and say, " You've got an elevated PSA, but the MagSense signature doesn't show up at your prostate, therefore we don't think PSA is elevated because you have cancer, it's something else." Now let's look at what else it might be. And we've avoided having to do that biopsy for some of those patients.

So, you're spot on with the idea that, today, for almost every form of cancer, we can get an image, but we ultimately confirm the presence of the cancer by doing a biopsy. For some things like melanoma, that's not such a bad deal. But for things like deep body tissues, like pancreatic cancer, or you take a man with elevated PSA and he's going to have a prostate biopsy, these all are relatively risky procedures. There could be significant side effects in everything. So, we're not as concerned about replacing biopsy per se, as eliminating the unnecessary biopsies for when it's negative, right? So, if you're a man who has an elevated PSA but you don't have clinically significant disease, you're still going to get a biopsy and then you have the risk of erectile dysfunction and incontinence, et cetera. If we could take a patient and say, " You've got an elevated PSA, but the MagSense signature doesn't show up at your prostate, therefore we don't think PSA is elevated because you have cancer, it's something else." Now let's look at what else it might be. And we've avoided having to do that biopsy for some of those patients.

Stay with me, Bob, we'll be back in a minute. I'm speaking to Bob Proulx, CEO of ASX listed, Imagion Biosystems. Okay, so where's Imagion Biosystems up to in the process of developing this better imaging?

Stay with me, Bob, we'll be back in a minute. I'm speaking to Bob Proulx, CEO of ASX listed, Imagion Biosystems. Okay, so where's Imagion Biosystems up to in the process of developing this better imaging?

Right. So, we have our first product that's focused on breast cancer, lymph nodal detection in breast cancer. It's in the clinic in Australia. We began that clinical study about a year, or a year and a half or so ago. We're coming up towards the end, we still have some more patients to recruit, but in March of this year, we reported the interim results for the first five patients indicating that the imaging agent is safe and tolerated. And we're now just trying to get enough patients to, sort of, demonstrate that, in fact, we think the imaging capability is going to be effective before we go to a large scale clinical study. Behind that, we started to develop a pipeline of other imaging agents for prostate cancer. We've got early stage program and brain cancer and ovarian cancer. So, our focus was always on getting the first product into the clinic so that we could actually demonstrate that this idea of using targeted magnetic particles will actually work. And now that we've started to see traction in that early stage clinical work, we've started to put some effort behind filling out a pipeline, so that we can say that we've got imaging agents for a variety of different cancers.

Right. So, we have our first product that's focused on breast cancer, lymph nodal detection in breast cancer. It's in the clinic in Australia. We began that clinical study about a year, or a year and a half or so ago. We're coming up towards the end, we still have some more patients to recruit, but in March of this year, we reported the interim results for the first five patients indicating that the imaging agent is safe and tolerated. And we're now just trying to get enough patients to, sort of, demonstrate that, in fact, we think the imaging capability is going to be effective before we go to a large scale clinical study. Behind that, we started to develop a pipeline of other imaging agents for prostate cancer. We've got early stage program and brain cancer and ovarian cancer. So, our focus was always on getting the first product into the clinic so that we could actually demonstrate that this idea of using targeted magnetic particles will actually work. And now that we've started to see traction in that early stage clinical work, we've started to put some effort behind filling out a pipeline, so that we can say that we've got imaging agents for a variety of different cancers.

Okay. And then in the case of the breast cancer imaging, which is where you are furthest along because you're having trials at the moment, is it that if there's a lump in the breast, you can determine whether it's malignant or benign?

Okay. And then in the case of the breast cancer imaging, which is where you are furthest along because you're having trials at the moment, is it that if there's a lump in the breast, you can determine whether it's malignant or benign?

No. So, we focused on a smaller clinical problem. So, most women today, when you've been diagnosed with a primary tumor, and that follows the normal process of a clinical assessment, probably a mammogram and a biopsy as we were just describing, getting a biopsy from a lump in the breast is not that difficult. So, we thought the bigger problem here was that the second thing you want to know is, once you've identified a primary tumor, you want to know is it spread to the lymph nodes? Has it started to metastasize? And here the problem is, again, same thing, the standard of care in this approach has been to go in and do lymph nodal biopsies, that is, we actually remove the lymph nodes from patients to go look in the petri dish, right? But more than 50% of women have no nodal disease. So, the problem here is, that the doc goes back to the patient and says, " Good news, no metastatic spread. Bad news, I just cut your lymph nodes out to get you that answer." And of course, we're probably familiar with morbidity problems like lymphedema and that, that affect women when your lymph nodes have been removed. So, our clinical application is to take a patient, who already we know has breast cancer, and help to non- invasively determine if they have nodal spread and metastatic disease.

No. So, we focused on a smaller clinical problem. So, most women today, when you've been diagnosed with a primary tumor, and that follows the normal process of a clinical assessment, probably a mammogram and a biopsy as we were just describing, getting a biopsy from a lump in the breast is not that difficult. So, we thought the bigger problem here was that the second thing you want to know is, once you've identified a primary tumor, you want to know is it spread to the lymph nodes? Has it started to metastasize? And here the problem is, again, same thing, the standard of care in this approach has been to go in and do lymph nodal biopsies, that is, we actually remove the lymph nodes from patients to go look in the petri dish, right? But more than 50% of women have no nodal disease. So, the problem here is, that the doc goes back to the patient and says, " Good news, no metastatic spread. Bad news, I just cut your lymph nodes out to get you that answer." And of course, we're probably familiar with morbidity problems like lymphedema and that, that affect women when your lymph nodes have been removed. So, our clinical application is to take a patient, who already we know has breast cancer, and help to non- invasively determine if they have nodal spread and metastatic disease.

Okay. I'm going to change (inaudible) now. Why are you listed on the ASX? Because most of your work... You are based in San Diego, Bob, most of your work... Although you do do some work with Royal Brisbane and Women's Hospital, I think, and Monash Health, is that right?

Okay. I'm going to change (inaudible) now. Why are you listed on the ASX? Because most of your work... You are based in San Diego, Bob, most of your work... Although you do do some work with Royal Brisbane and Women's Hospital, I think, and Monash Health, is that right?

Yes.

Yes.

But I'm just interested that we... Australia seems to be quite a good place to list for a few sectors. Biotech being one, gaming being another one, oddly enough, and (inaudible) being the other one. But why list in Australia?

But I'm just interested that we... Australia seems to be quite a good place to list for a few sectors. Biotech being one, gaming being another one, oddly enough, and (inaudible) being the other one. But why list in Australia?

So, I think a couple of things there. One is that, because of the restructuring that we'd done from our prior company, we knew that we wanted to be a listed entity. We were not going to go private and do that. And so, when you start to look across the globe at where biotech companies can list, of course you've got the NASDAQ and the New York Stock Exchange here in the United States, but the cost of compliance for those in the United States is very high. And if you're an early stage biotech company, you're at risk of becoming delisted, if you will, if you come out of compliance in any way, shape or form. And so, we looked at where we were in the stage of development and wanting to be a listed company, felt that the US markets were probably not the right approach. And then when you look globally, where then might you want to go? What we really liked about the ASX is, it's very good compliance. Investors have good clarity as to what's happening in the company. There's good disclosure requirements, et cetera. So, we thought that it was, sort of, the compromise that would allow us to be a listed company in an exchange that was well respected, as you said, sort of growing the biotech sector in there, but still would offer investors comfort because of the disclosure and compliance regulations.

So, I think a couple of things there. One is that, because of the restructuring that we'd done from our prior company, we knew that we wanted to be a listed entity. We were not going to go private and do that. And so, when you start to look across the globe at where biotech companies can list, of course you've got the NASDAQ and the New York Stock Exchange here in the United States, but the cost of compliance for those in the United States is very high. And if you're an early stage biotech company, you're at risk of becoming delisted, if you will, if you come out of compliance in any way, shape or form. And so, we looked at where we were in the stage of development and wanting to be a listed company, felt that the US markets were probably not the right approach. And then when you look globally, where then might you want to go? What we really liked about the ASX is, it's very good compliance. Investors have good clarity as to what's happening in the company. There's good disclosure requirements, et cetera. So, we thought that it was, sort of, the compromise that would allow us to be a listed company in an exchange that was well respected, as you said, sort of growing the biotech sector in there, but still would offer investors comfort because of the disclosure and compliance regulations.

Okay. And what sort of... I mean, in early stage biotech, you need a lot of money to do this. So, where have your shareholders come from?

Okay. And what sort of... I mean, in early stage biotech, you need a lot of money to do this. So, where have your shareholders come from?

Yeah. So, we have an extraordinarily large retail shareholder base at this point in time. Because we're relatively early stage, being able to attract large institutional investors, they want to see us a little further along, which is why it's been so important that we get into the clinical phase of testing, because that's sort of the de- risking event that larger institutional investors want. So, we've got a relatively large, and I will say, very supportive retail investor based to our shares. And we continue to try to do everything we can to keep them well informed with our progress, without, sort of, running a foul, if you will, of the ASX disclosure requirements that are there.

Yeah. So, we have an extraordinarily large retail shareholder base at this point in time. Because we're relatively early stage, being able to attract large institutional investors, they want to see us a little further along, which is why it's been so important that we get into the clinical phase of testing, because that's sort of the de- risking event that larger institutional investors want. So, we've got a relatively large, and I will say, very supportive retail investor based to our shares. And we continue to try to do everything we can to keep them well informed with our progress, without, sort of, running a foul, if you will, of the ASX disclosure requirements that are there.

Okay. So, what's the next milestone for Imagion Biosystems?

Okay. So, what's the next milestone for Imagion Biosystems?

So, I think the things that investors should be looking at from us here are two things in particular. One, is moving towards some form of closure, if you will. I won't necessarily say " completion of the phase one study," but some closure with regard to, what are the data telling us about how well that breast cancer imaging agent is working and our ability to move that forward? And then I think also, further development of the pipeline, so that investors know that we're not, what I refer to, as a one trick pony. That we don't just have the breast cancer product, but we're going to have a portfolio of products. So, even by way of example, today we just put an announcement out this morning with regard to the progress with our prostate cancer imaging agent. We're at a meeting, the World Molecular Imaging Conference this week and presenting our prostate cancer results. So, I think the news flow should be focused on the progress of our portfolio and in particular, how that clinical phase study is going and what that means for further developments of the HER2 product.

So, I think the things that investors should be looking at from us here are two things in particular. One, is moving towards some form of closure, if you will. I won't necessarily say " completion of the phase one study," but some closure with regard to, what are the data telling us about how well that breast cancer imaging agent is working and our ability to move that forward? And then I think also, further development of the pipeline, so that investors know that we're not, what I refer to, as a one trick pony. That we don't just have the breast cancer product, but we're going to have a portfolio of products. So, even by way of example, today we just put an announcement out this morning with regard to the progress with our prostate cancer imaging agent. We're at a meeting, the World Molecular Imaging Conference this week and presenting our prostate cancer results. So, I think the news flow should be focused on the progress of our portfolio and in particular, how that clinical phase study is going and what that means for further developments of the HER2 product.

Good luck with it, Bob. And thank you for talking to Fear and Greed.

Good luck with it, Bob. And thank you for talking to Fear and Greed.

My pleasure, Sean. Thanks for the invite.

My pleasure, Sean. Thanks for the invite.

That was Bob Proulx, CEO of ASX listed, Imagion Biosystems. This is the Fear and Greed Daily interview. Remember, this information is general in nature and you should seek professional advice before making any investment decisions. Join us every morning for the full episode of Fear and Greed, Australia's most popular business podcast. I'm Sean Aylmer. Enjoy your day.

That was Bob Proulx, CEO of ASX listed, Imagion Biosystems. This is the Fear and Greed Daily interview. Remember, this information is general in nature and you should seek professional advice before making any investment decisions. Join us every morning for the full episode of Fear and Greed, Australia's most popular business podcast. I'm Sean Aylmer. Enjoy your day.