I'm Shaun Bagai, the CEO of RenovoRx, and I'm here to talk about a new development we've had in solid tumor treatment and really how we can treat cancers differently with our late-stage biotechnology. These are forward-looking statements on our website. To give a little background on RenovoRx, we're trying to tackle cancer differently. When you think of cancer patients and how cancer patients are treated, you really think about systemic chemotherapy delivery as the standard of care, which really is about blasting as much chemo through the body as possible, hoping some get to the tumor, and hoping our loved ones actually get to live a few weeks, days, months, maybe longer. I want to go into the background about how we're trying to flip this whole treatment paradigm on its head and what we've developed over the last decade in Los Altos, California.
A little background on the company: the company was founded back in 2009 by a physician with first external funding in 2012. Our last private financing was led by Boston Scientific in 2018. They still remain one of our larger shareholders, and we went public via traditional IPO in Q3 2021, based in Los Altos, California, in Silicon Valley, just south of San Francisco. We're developing a whole new platform to treat these cancers. We call this platform Trans-Arterial Micro-Perfusion, or TAMP, and our goal is to improve the therapeutic index of different agents. And when I say improve the therapeutic index, that means reduce systemic toxicities and side effects and increase the potential efficacy of those agents. Currently, we're in the middle of a Phase III registration trial called TIGeR-PaC. The study had an interim analysis last year which demonstrated a positive overall survival and decreased side effects.
Again, when you think of new cancer therapies, it's really that trade-off: can you actually have patients live longer, but you really trade off the quality of life and increase in side effects and toxicity? We're trying to improve on both of those fronts, and I'll demonstrate, I'll show you the data we've got so far. We have FDA Breakthrough Therapy Designation for RenovoGem, which is our first product candidate, both in pancreatic cancer and bile duct cancer. And if you look just at non-metastatic, locally advanced pancreatic cancer, we anticipate about a $500 million U.S. market alone, and then scale that as you look outside the world, beyond the U.S., and also with other indications. And I'll go into more details about how we come up with those numbers. Well, let's first talk about locally advanced pancreatic cancer.
So when I say locally advanced, these are patients that are not resectable. When you think about pancreatic cancer, the goal is, can we take the tumor out? Unfortunately, in 80%-90% of those patients, the tumor can't be taken out because it's grown to the point where it's involving other structures. And the other part of locally advanced is non-metastatic, so the tumor hasn't spread throughout the entire body yet. Focusing on those patients is really not great treatments. All we do right now, for the most part, is give systemic chemotherapy, hoping to downstage them to surgery, which doesn't often happen, or let them live a little bit longer. We're focusing on that locally advanced population, which is about 20% of the market. So of the 60,000 patients diagnosed with pancreatic cancer per year in the U.S., 20,000 patients is our total available market.
Pancreatic cancer, unfortunately, is not seeing much benefit from recent therapies and is soon to become the second leading cause of cancer-related death in the U.S. As we look at our data, we want to put this in context with what we expect in terms of survival for locally advanced pancreatic cancer patients. Looking across the breadth of clinical trials done in the last decade, with contemporary treatments, we only expect patients to live, unfortunately, about 1-1.5 years. So that's the range I keep in mind: about 12-18 months is the expectation of survival for these patients with locally advanced pancreatic cancer. If you look back from an approval standpoint, only three drugs have been approved by the FDA to treat locally advanced pancreatic cancer in the last 10 years, and these aren't great survival increases.
If you look at the last major advancement of nab-paclitaxel or Abraxane plus gemcitabine delivered systemically, it showed a very narrow benefit to gemcitabine by itself. If you look at the survival curves, there's a small window there. A seven-week survival benefit is what led to not just approval but adoption almost overnight because of the survival benefit, and I put that in quotes, "of seven weeks" or "less than two months." And that came with side effects and toxicities. And that's the trade-off, again, we're seeing: hopefully a few weeks of survival, and then a lot of toxicities and side effects that come with it. Again, we're trying to tackle both of those issues with the current state of cancer treatment. So what moves the needle?
6-8 weeks is really what we're seeing in terms of last approvals and adoption as we're changing the way that cancer is treated. We did pull through a third party talking to medical oncologists what's going to change their practice patterns to send all of their patients to treatment like this, or at least 95% plus the other patients. And they said, "Look, if you can show me 3-4 months of benefit, which is double what we've seen from previous therapies, they would send almost all of their patients for a new treatment paradigm like this." So what did we see? In the first interim analysis of our Phase III trial, which is based on 45 patients randomized, we saw a 6-month survival benefit.
If you remember that survival curve we saw previously a couple of slides ago, that benefit was just 7 weeks for addition. Here we're seeing a 6-month difference. So instead of patients living 1-1.5 years, we start to push 2 years. And if you remember, we expect patients with locally advanced pancreatic cancer to live roughly 15 months, 12-18 months. That's exactly what we saw in our control arm. So the study is tracking what we expect in terms of 15.5 months of survival for standard of care IV gemcitabine + Abraxane or nab-paclitaxel versus our therapy of RenovoGem using TAMP to deliver this with almost 22 months of survival from time of diagnosis. So a marked potential benefit for these patients in this early interim analysis. Let's look to the other side. What about toxicity and side effects?
As I mentioned, usually it's a trade-off, but we're not giving up here. We're actually seeing a benefit. Because we're localizing therapy, our patients are not just living longer, but they're not seeing the same side effects you'd expect with cancer treatment. These patients have seen a reduction of 65% of adverse events and toxicity in 11 of 13 categories, almost across the board, showing actually we're not just treating patients to have them live longer, but they're almost going back to normal daily life. Anecdotally, several of our patients don't look or feel like cancer patients because they don't have that same systemic toxicity side effect issue you see with current standard of care systemic delivery. What does this mean in terms of dollars? From a market perspective, this is a drug-device combination being investigated as a new drug product by the FDA.
We anticipate launching the therapy to be in alignment with what you'd expect for a new drug product. The average cost of a new oncology drug product is about $150,000 per treatment year. So if we price our therapy fairly and each patient undergoes 8 treatments over 4 months, we anticipate a revenue, peak revenue in the U.S., of about $450 million-$500 million, and that's just with locally advanced pancreatic cancer. I'll go into the pipeline in a few moments here, but that's just U.S., just pancreatic cancer. So obviously, there's a very large opportunity in this huge unmet need. From a pipeline perspective, given how well this has been working in pancreatic cancer patients, our physicians and investigators have pushed us to look beyond pancreatic cancer. The next opportunity for us is in bile duct cancer or cholangiocarcinoma.
Bile duct tumors behave similar to pancreatic cancer tumors, and it's the same drug used. Gemcitabine is the backbone of a RenovoGem combination or kit. Right now, the standard of care for all of these tumors is gemcitabine delivered systemically. If we can localize the chemotherapy like we're doing for pancreatic cancer, we can tackle other tumors as well. The most advanced in our thinking is bile duct cancer, and we anticipate, hopefully, doing patients this year. Then beyond that, these other tumors are tumors where gemcitabine is used systemically, and we've done some initial exploration to see if we can expand the pipeline beyond pancreatic cancer to these as well. One important one, of course, is non-small cell lung cancer. We have explored in the animal model that we can deliver local high doses of gemcitabine to lung tissue via the pulmonary arteries.
But we don't have to stop with just gemcitabine. We have a platform delivery system that can deliver agents through the vessel wall into the tissue. Beyond gemcitabine or other drugs like that, we're exploring what partnerships can be had to deliver other agents, such as Imugene. Last year, we announced a collaboration with Imugene to deliver their oncolytic virus to potentially use the body's own immune system to tackle tumors that are beyond the pancreas. Looking at immunotherapeutics such as oncolytic viruses and Toll-like receptor blockers, we can actually, hopefully, turn the tumors "hot" to have the body tackle metastases as well and potentially expand our therapy even to metastatic cancer that's beyond just the pancreas. Let's take a step back and talk about how the platform works and why this is working. When you think of current standard of care therapy, as I mentioned, it's systemic chemotherapy.
Most tumors in the body or many tumors in the body have a large blood supply that feeds the tumors, which makes them great targets for systemic and local delivery. In this example, a liver tumor has large blood vessels that feed the tumor directly. When you give it systemic chemotherapy, while you have side effects, it does reach the tumor itself. Our target tumors are considered hypovascular. They don't have that direct connection to the blood supply. Pancreatic tumors, for example, don't have a large blood supply. They grow slowly. They die on the inside, and that systemic chemotherapy doesn't reach the tumor at high doses. Our therapy platform aims to tackle that by pushing drug into the tumor directly. Interventional radiologists use our therapy platform to advance under X-ray guidance.
They place our system adjacent to the tumor, and using guidance, they can adjust the system such that they can isolate a segment of artery that doesn't have any side branches or escape routes. Then they infuse a full dose and volume of systemic drug in a small space over 20 minutes. That creates a pressure head to force the therapy through the vessel wall and not just bathe the chemotherapy through the wall in the tumor, but really saturate that area. Looking at animal studies, we actually see a 100-fold increase in tissue concentration at the tumor site via this method, which makes sense because there aren't direct connections with a normal circulatory system. So systemic chemotherapy doesn't really reach the tumor, but by forcing it via this new proprietary mechanism, we can really tackle the tumors locally and aggressively.
So to recap, hypervascular tumors like liver tumors have direct connections to the blood supply, and they're actually fed by systemic chemotherapy. You can even place small microcatheters or small plastic tubes via X-ray into those tumor feeders. Tumors like pancreatic tumors, glioblastoma, uterine tumors, cholangiocarcinomas, non-small cell lung cancer tumors as well don't have large blood supplies. So we tackle this with our system to increase chemotherapy penetration and reduce systemic exposure. As I mentioned, we have done some experiments in lungs. This is a log-rank scale, and we see a hundredfold increase in tissue concentration at the tumor site by forcing drug across the vessel wall. Now, again, flipping that to systemic exposure, the panel on the right was actually presented at ASCO GI several years ago. Within our Phase III trial, we had a subset of patients that did a PK analysis.
And if you look at the drug exposure systemically versus locally with our TAMP therapy with RenovoGem, we see a greater than 50% reduction of floating gemcitabine in the body. It's no wonder we're not seeing side effects, and it's no wonder patients are feeling better. From a patient perspective, this is an outpatient procedure, so the patients don't have to stay overnight at the hospital, and they're not put under general anesthesia. They're just given drugs to feel comfortable. The patients come in every two weeks. If you look at standard of care systemic chemotherapy of Gem/Abraxane, patients have to come in on a weekly basis, so three out of four weeks. So we reduce hospital visits. The patients go home the same day, and they don't have that same chemotherapy hangover in general. From a clinician standpoint, it's not a complicated technique.
The whole procedure takes about 90 minutes with a 20-minute infusion on average. On subsequent procedures, given they see 8 procedures, we actually see a reduction in time. So from a learning curve perspective, we're actually there to proctor for the physicians for the first handful of procedures, and then they're free to go on their own. So from a commercial aspect, it's not a heavy lift to get the physicians trained and get this adopted. Just to highlight our technology, as I mentioned, we've de-risked this Trans-Arterial Micro-Perfusion approach to really decrease side effects and increase tumor penetration. A lead product candidate of this platform is called RenovoGem. It's a combination of a drug plus our delivery system. We've demonstrated early promise of data with our first interim analysis with a 6-month overall survival benefit and a 65% reduction in side effects.
Looking at just locally advanced pancreatic cancer, we're seeing a $1 billion global addressable market and then with other pipeline indications with this combination down the road. Then beyond that, we're looking at what other agents we can deliver, what other companies can we partner with to do clinical trials to advance their technologies in a manner that's safer for patients potentially and actually can get the drug to the tumor and hopefully have patients live longer. Now, from a patent standpoint, we have nine issued patents, eight in the U.S. We've really discovered, developed, and patented this idea of Trans-Arterial Micro-Perfusion. It's such a different way to treat cancer by crossing the vessel wall and saturating the tumor. We also have patents in Europe and patents pending in Europe, Asia, and additional patents in the U.S.
To touch on our team, we've got the right team in place to take this to the next level. Both our management team and our board of directors have extensive experience across the breadth of medical devices, biotech, combination therapies with medical devices and biotech, and getting not just through the FDA but also successfully in the commercial space. So we have the right team in place with the right timing to advance this from the clinic to commercial to really have this reach a wide variety of patients. We're revamping and building out our scientific advisory board. The most two notable additions are Dr. Margaret Tempero, who's the chair of the NCCN guideline committees, who writes the guidelines on what therapy should be used. She came on board after seeing our data and was impressed by it, and she's obviously a leader in the field of medical oncology.
Globally, we're looking at Dr. Michel Ducreux, who just joined our board as well. He's the head of GI cancer at Gustave Roussy in Paris, also very experienced in developing new therapies, and he's helping build out our pipeline beyond just RenovoGem for pancreatic cancer. What's coming up? So the next major milestone we anticipate is the completion of our second interim analysis. This is an event-based study. So at the 26th event or death, that's when we did the interim analysis, the first interim analysis last year. The second interim analysis is predicated upon the 52nd event or death. That's estimated to take place sometime in late this year. Beyond that, this year really is going to be proving out and building the pipeline. We do have additional data. This is public information. We will be publishing our pre-Phase III final dataset in the near term.
Then beyond that, this year is going to be building out the pipeline for both RenovoGem and potentially identifying other partnerships to be had outside of gemcitabine. Final data readout is expected in 2026. By Q2 next year, we should accelerate and complete enrollment of the trial, and then it's a matter of readout. So to summarize, we've de-risked a drug development pathway with the TAMP platform using a known drug. Just to touch on gemcitabine, we know actually works very well to kill cancer tumors. It's just a matter of getting the therapy there. We've experienced great potential data in our first interim analysis. And not on this slide, as you're probably aware, we just recently completed two sequential financings of $17.1 million. That gives us cash runway well past this next interim analysis, past through 2025 and into 2026. Thank you so much for your time.