Video Transcript:

First up, we have Imagion Biosystems Limited. The ASX code is IBX. The market cap is just over 15 million. And today we welcome Isaac Bright, CEO and Managing Director. Imagion Biosystems are developing next-generation molecular imaging technologies that find cancer and other diseases using bio-safe magnetic nanoparticles.

Isaac, welcome, and please take it away.

Thank you, Manny, and good afternoon, everyone. Happy to meet you all. I’m Isaac Bright. CEO here at Imagion Biosystems. I’m happy to share how we’re changing the way that we look at cancer. We are an ASX listed company. I’ll be sharing forward looking statements.

Imagion Biosystems is the first company in the world to enable molecular MRI. We have a platform that we’ve built called MagSense®, which leverages superparamagnetic iron oxide nanoparticles to give us a new way to see cancer non-invasively with standard installed base molecular MRI instruments.

Our lead program, MagSense HER2 imaging agents, has just completed a 13 patient Phase I study in Australia. I’ll be sharing some of the results today and we’ll be announcing the full results globally for the San Antonio Breast Cancer Symposium in December. The MagSense platform has been extended to go well beyond HER2+ breast cancer, and I’m really thrilled to share that vision with you now.

MagSense is a technology platform that’s built on a stack, including superparamagnetic iron oxide nanoparticles, where we are able to synthesize these nanoparticles in-house using a number of different synthesis methods. Tightly control the size and distribution of size, which enables a number of different biomedical applications.

We have proprietary and commercially available coding technologies that we apply to give us different measures of bioavailability and hooks for functionality. And ultimately, we direct our nanoparticles to appropriate biology by conjugating or intercalating targeting moieties that range from small molecules all the way to full proteins, the size of human bodies.

With this, we’re able to molecularly target in vivo are magnetic nanoparticles for imaging by magnetic resonance imaging. MagSense works with a simple, single injection, generally in the case of MagSense HER2, near the tumor itself or into the vascular bed where systemic circulation can then deliver the particles to the targeted cancer.

Once the target is bound by our targeting moiety in the MagSense particles, that binding allows it to enforce its paramagnetism when induced by the magnetic waves of the MRI instrument. The particles are processed and cleared by normal physiology in the liver generally going through the pathway to ferritin and then hemoglobin, part of our normal circulatory process.

MagSense changes the way we look at cancer because it gives a new level of molecular resolution to what has been an ambiguous and gross view provided by MRI, a mainstay in the practice of precision oncology in the last couple of decades. MRI is a massive installed base, but for the first time, MagSense allows us to tag particular tumor tissue and identify it noninvasively as malignant, or to identify suspicious lesions on MRI that now actually demonstrate normal physiology in the presence of MagSense particles.

So, it’s a really unique technology. The MagSense HER2 Imaging Agent is our lead program. We’ve just completed a 13-patient study, and what you’ll see on the right in the film as it advances, looks like we’re not getting it to advance, but what you will notice is a difference.

You’ll notice a difference in the way that malignant nodes appear on MRI imaging relative to what benign nodes look like on MRI as confirmed by radiologists. In this 13-patient study, we had a total of eight patients that gave us interpretable data. Unfortunately, we had a couple of MRI susceptibility failures and three patients with disease that invaded the lymphatics responsible for draining our nanoparticles to the lymph nodes. But what we were able to see is in those eight interpretable patients, seven of the eight had full concordance between the blinded radiologist reads of malignant or benign nodes, relative to the actual surgical specimens removed from those patients.

So for the first time, noninvasively and with a simple MRI in the order of 20 or 30 minutes, we’re able to identify malignant tumor or benign odd shaped inflammatory node that’s normal physiology. This is a revolution in molecular imaging.

Again, we’re able to provide answers that are both positive and negative with regard to the outcome and staging of the patient in the images you see in the top across the screen. In both cases, a radiologist would identify those nodes as oddly shaped and suspicious worth taking out in a surgery.

But notably, when you look at the processing of the MagSense nanoparticles in a normal lymph node, as shown on the lower left, you have a very clear sense that the entire node is holistically darkened. That is a very clear sign of normal lymphatic function whereas with tumor invaded lymph nodes on the bottom right, you see this cortical darkening and a speckling around the hilum and meatus of the lymph node. That is a hallmark of metastatic disease for these HER2 positive breast cancer patients.

And it fits directly into the clinical workflow. MRI is already a part of standard diagnostic process. These patients, once they’re diagnosed, have a matter of days to get to full staging and a plan for medical and surgical treatment.

So, we fit right into that platform and in the order of 3 to 4 days post-diagnosis, you’ll have a clear, noninvasive staging results from MagSense, HER2 Imaging Agent.

Our approach to market is one that leverages the fact that we have strong fundamentals where cancer is increasingly treated with targeted therapies.

The armamentarium continues to grow in precision oncology, and we have a very strong reimbursement and government systematic healthcare pull for technologies that look for benign versus malignant disease.

We’re in a space, that is very consolidated with three market leaders owning 75% of the market.
They’re active in dealmaking with an appetite for disruptive technology. And we’re in a space where we have an opportunity to find molecular imaging differently than the current standard. PET imaging has done well, but MRI is more than 4 times the global footprint from an installed base and we have a much easier logistic and clinical implementation pathway.

In this landscape, we again are the 1st mover bringing molecular MRI to reality. There are a number of compelling new products in the MRI contrast space, but we are a real special case with the first chance to demonstrate molecular MRI noninvasively.

And so with this, we expect to transform precision oncology. We’ve already started programs beyond our MagSense HER2 imaging agents into prostate cancer focused on PSMA, folate receptor focused on ovarian cancer – terrible disease – an anti-PAUF program focused on pancreatic cancer that we just launched in August, as well as some really promising data on the vascular imaging.

Going forward, our business model has shifted with the reorganization we just completed. We are focused on transacting our MagSense programs as we advance. There’s a really attractive space for small companies like Imagion to do transactions that get us down the path and enable partners to advance in clinical development and commercialization where our returns are a function of milestone and royalties on the basis of their commercial success.

We’re excited about these opportunities and continue to advance these programs directly.

The pipeline, as you see it here, which I’ve already mentioned very compelling from the MagSense imaging perspective, and we’ve deployed our superparamagnetic iron oxide nanoparticles in other biomedical applications, generating a million dollars, more than a million dollars this year already, so we’ll continue to build that business as we grow.

Just in closing, our investment highlights. We are a first mover, again, the first company in the world to realize molecular MRI with the MagSense nanoparticle platform. Our MagSense HER2 imaging agent is the first of many that give us opportunities in multi-billion-dollar markets and we’re really excited about building with a strong board and leadership.

As you’ll see here, expertise across the space from drug-discovery through imaging, compelling strong team that I continue to build as we build the business.

Thank you for your time. Happy to address any questions.

Q&A Session

Thank you, Isaac. That was that was great. There are a couple of questions.

The first one I believe the company recently got or did a cost out program. Part of that, of course, being unfortunately you did have to reduce head count a little bit. The question is around whether or not the headcount reductions will impact your ability to deliver on these targets, some of these targets that you’ve had, were they key people involved in this, how’s that going to impact you, if at all?

Yeah, this was a very important reorganization to align with our new business model. We have lost a number of folks ranging from quality through research and development and into clinical development. It is across the board that we’ve made these cuts. It is not impairing our ability to move forward. I am a physician by training with extensive experience myself, so the clinical programs will continue on pace. And with our shift to focus on partnerships, we really can focus and stick to our knittings where our core competencies are discovery and development of disruptive imaging agents. Again, as the first mover with molecular MRI, and then we can partner as is so common in the biotechnology space to, to advance the collaboration together across the world.

Right. Thank you. And, and how advanced are some of these discussions with partners and potential collaborators?

We have a number of groups that are doing due diligence now in review of confidential material ranging from the history of the company all the way through particulars of our correspondence with regulatory bodies and obviously deep scientific, technical and medical due diligence that goes along with that. We will continue down that path and we’re excited about the conversations that we’ve started and we have more that are advancing.

One quick question just on the on the competitive landscape. You did touch briefly on this in the presentation, but can you just give us a little bit more color on how Imagion’s particular technology differs to your key competitors. You named two or three, I think. How different is this?

This is unique. We’re the first in the world. The way that it’s differentiated is we’re in a segment known as radiopharmaceuticals, where drugs have activity that depends on radioactivity. Our radioactivity is a paramagnetism that only is enacted when it’s exposed to magnetism from the magnetic resonance imaging system. We end up with a non-ionizing radiation that’s fundamentally found within our particle. It’s unique to the drug. It’s something that no one has delivered before, though the technology has been available, these paramagnetic nanoparticles have quite a compelling history in a number of industries. This is the 1st time that we’re putting them into patients and able to noninvasively differentiate tumor from benign tissue.

One last question before you go. In terms of the supply of the nanoparticles, how are you achieving that and are you in a position to supply the requirements?

Excellent question. We were able to manufacture these nanoparticles ourselves. We work through a supply chain that’s domestic in the states. A lot of the technology and research team is here in the states. And we’re able to scale this sufficiently for the clinical program that lies ahead with MagSense HER2. We’re working on the platform to continue to prepare for scale up and we really see some great signal. We’re expecting to do well.

Great. Okay. That’s fantastic. Thank you, Isaac. And thank you for your time today and have a great weekend.

Thank you all.