RenovoRx, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Thank you. Thank you, H.C. Wainwright, for hosting us and everyone for joining today, both here and online. At RenovoRx, we're looking at cancer a little bit differently. When we think of cancer treatment, it's usually that balance of destroying the body and destroying the tumor. Unfortunately, we've been hyper-focused on destroying whatever we can to get to the tumor without a really good focus on the patient. What I'd like to go over with you is the background on our technology that actually can focus on both, and some of the results we've had, and now the more exciting news on the commercial launch we've recently had. If I can get this to click over. These are our forward-looking statements online. At a glance, we have two assets, really. We have a commercial opportunity we've embarked on last year.

We are a commercial stage company with a new delivery system technology that's now commercialized in several centers across the country, and we have a phase III asset in the background that has completed enrollment. On the commercial side, we've now launched the FDA-cleared RenovoCath device. This is now in 21 centers across the country as of the last quarterly readout. More since then, and we're growing rapidly in terms of bringing new centers on board, commercially utilizing our delivery system and mechanism. This initial market that we're looking at for the RenovoCath device is about a $400 million peak sales opportunity based on a much larger TAM, as you look at where this catheter could be used and is interested in being used today.

In addition, we're developing drug device combinations that are really based on our proprietary mechanism called TAMP, or Trans-Arterial Micro-Perfusion, that aims to drive high doses of chemotherapy or therapies in the tissue while reducing systemic toxicities. From a phase III asset perspective, we are just finished enrollment in the TIGeR-PaC phase III trial. We'll go into more interesting data on that as well. We have an experienced leadership in place to really drive both the commercial and the clinical fronts forward. First, let's talk about the platform and how it works and why it's different. If we think of tumors, generally, we think of large balls of tumor cells that have a lot of blood flow and blood vessels to them. Many tumors in the body do behave like this, where they have large tumor feeders or blood vessels that actually end inside the tumor directly.

If you think of liver cancers, that's one example. In these cases, these hypervascular tumors accept systemic chemotherapy as much as you do have side effects and toxicities, but also you're getting a lot of drug in the tumor outside the body as well, but there's also local targets. You can place a simple microcatheter in that tumor feeder and position that inside the tumor to give direct therapy. Many tumors in the body don't behave like this. We consider these hypovascular tumors, or tumors that don't have a large blood supply. Pancreas tumors, for example, glioblastoma, non-small cell lung cancer, pelvic tumors, bowel duct tumors behave like this, where there's not a large blood supply because they don't have these large blood vessel tumor feeders feeding them. This poses a major barrier to success for current therapies, as most of them are systemic.

Very little of the drug or therapy gets inside the tumor itself, and there's no local target for a radiologist to position the device or catheter. We found a way to overcome this with our delivery system, and what we've seen is 100 times the tissue concentration at the target site than you would if you gave it systemically. You're getting much higher concentrations of drug at the tumor site. On the flip side, we're seeing much less drug exposure, which is not surprising. The panel on the left was actually an animal study we did for proof of concept in lung tissue. The panel on the right was recently published in a peer-reviewed journal. This was the PK sub-study in our phase III trial, which showed a 50% reduction in systemic exposure to the drug, which would make sense why it's leading to less systemic toxicities.

How does the technology work? This is done under X-ray fluoroscopic guidance by radiologists. Our proprietary delivery system, called the RenovoCath, is positioned adjacent to one of these tumors that doesn't have a large blood supply feeding it directly. Then the radiologist, under X-ray guidance, is able to position the catheter and actually adjust the distance between two occlusive balloons such that they isolate flow so no flow will escape down other feeders or side branches. What that does is it creates a pressure head within the first couple of minutes of filling up the space between the balloons that then forces the agent through the blood vessel wall into the tissue. This results in very large concentrations of drug at the tumor site.

This doesn't really cause damage to the blood vessel wall that we've seen cause any issues, because there are little micro tunnels that exist, called the vasa vasorum, that give us access to get outside the blood vessel. At these pressures that are not very high pressures, we're able to force drug and chemotherapy into the tissue. If you think about the pressure we're delivering, this is about 6 milliliters per minute. The pressures we're seeing are probably in the 40 to 60 range in animals and maybe 100 to 200 range in humans. It's not very high pressures to force drug out, but enough to get that penetration into the tumor outside the blood vessel.

From a patient and physician experience, this is a little bit easier than other systems in the sense that patients come in and out the same day, so it is an outpatient procedure, unlike many new technologies that require an overnight stay. Also, the patients are not put under general anesthesia, generally. It is under conscious sedation. They are made comfortable, but again, you do not have the side effects and a lot of the longer-term issues with going under general anesthesia multiple times. The patients end up having eight treatments over the course of four months, is what the clinical trial prescribed. That is a little bit different than a lot of chemotherapy infusions, which require weekly visits, and then, of course, the several days of the side effects you see from that. From a physician standpoint, the training is relatively simple. These physicians are well-versed on liver-directed therapies.

We have proctors there for the first couple of procedures just to teach them how to use the device, how to position it, and then they are free to go on their own and even teach their colleagues. It does not require a big field force to train the physicians and work with the physicians on a continual basis. From a market perspective, I mentioned the TAM a little bit earlier. If you look at where we have got experience today, so namely pancreatic cancer, our addressable market will be about 30% of the broader 60,000-patient market on the pancreatic cancer side. By achieving a penetration of about 7,000 patients in that market, so just roughly 10%, along with other potential areas, we can assume a peak U.S. sales revenue recurring at about $400 million. That is based on where we are seeing this being used today. Next steps. The next steps also, bile duct cancer and cholangiocarcinoma is a big area of interest, so we are looking at IITs to launch it there.

Beyond that, there are other tumors that behave like these hypovascular tumors that could be an area of expansion for us down the road. That would include expanding into the large blue bar into other areas of pancreatic cancer and borderline resectable pancreatic cancer and metastatic pancreatic cancer. Beyond the stage III locally advanced pancreatic cancer, where we have the bulk of our experience to date, there are already IIT studies underway to explore those. Let us talk a little bit about the market of where we can see this $400 million market. With that, I will turn it over to Mark.

Let me take you through the market opportunity for RenovoCath. First, taking a look at the market. We command a $6,000 to $8,500 per unit. Our patients average approximately six treatments in total. It is a very attractive economic model. If we assume a modest market share of their total addressable market, we are looking at a revenue opportunity of about $400 million per year. Just as importantly, it is a high-margin business. We are generating 85% gross margins right now. We have a lean operating model, which we believe that we can generate 30% operating margins as we scale the business. In addition to that, we have a highly defensible patented platform. We have 20 patents in place. We have 13 that are pending. This takes patent protection through 2045. We have a portfolio in place that allows us long-term exclusivity for our drug delivery platform.

Great. Thank you, Mark. How do we get to this capitalization of this business? Looking at the market and the way we're able to stay lean is because it's a very focused, condensed market. If you look at where these types of tumors are being treated, there are only about 200 centers in the U.S. that treat the vast majority of these non-metastatic tumors. It is that classic 80/20 rule, where 100 hospitals treat the vast majority of these, and 50 hospitals treat about 50%-60%. With a small sales team of roughly four to five sales reps, we can cover the entire country.

Unlike many other novel technologies, we don't need a large expensive sales force of 20, 40, 50, 80 reps to be able to tackle this market and drive towards those hundreds of millions of dollars of revenue in this initial application. We do have that team in place. We put the team in place early this year. With the Q2 revenue of $909,000, it looks like that is coming to fruition. Doing about $1.5 million the first half of the year was greater than our $1 million of revenue last year before we put the sales infrastructure in place. The teams in place is lean, and they are performing both on the marketing perspective to create awareness and also driving sales penetration. One of the good KPIs to look at beyond just revenue is where we're growing in terms of bringing new centers on board.