Latest / BioBoss / Shaun Bagai: CEO of RenovoRX

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Shaun Bagai: CEO of RenovoRX · BioBoss

• 0:05
  Shaun Bagai: I love learning, changing, pivoting, doing.
• 0:37
  John Simboli: Sean, what led to your role as CEO at RenovoRx?
• 0:44
  Shaun Bagai: I've been in the medical technology space my whole career, and I was med school bound initially. And I turned what was a one-year internship between college and what would have been med school into a career that has gotten me to be able to help build new disruptive therapies over the last few decades, It really was a passion for medicine initially, and then being convinced not to go to med school once I get in to build companies that would someday really help patients at a broader level than one could as a single physician. So with that, through my career, I built up my career to hopefully disrupt medical technology to make those changes, and had the opportunity to take over as CEO of RenovoRx about 11 and a half years ago to really make a big impact in this case on on cancer care.
• 1:27
  John Simboli: When you say to your loved ones, your family, others, and you say, "I'm not going to go down this traditional path," you may feel good about it. How do you deal with how other people feel about stuff like that?
• 1:37
  Shaun Bagai: You know, it's a very interesting question because being the son of Indian parents, you can imagine what happens when you go through the painstaking process of applying to med school, taking the MCATs a couple times, interviews, flying around, and then the very small percentage of people on actually getting into medical school and then declining it.
• 1:55
  Shaun Bagai: You can imagine the backlash from family members, especially with a lot of cardiology in my family, and so my parents were not happy. My cousin, who is an esteemed electrophysiologist and cardiologist, wouldn't talk to me for three years. My aunt, who is probably one of the most world-renowned cardiac pathologists, had berated me. I think for the subsequent six or seven years to go back to med school or reapply and get back in and go, and it wasn't until my late 20s when my career really started to take off that they all kind of stopped, and since then they've been very happy and proud of of what I've been able to accomplish in my career. And I get to do both. I can do medicine and business, which is really satisfying.
• 2:35
  John Simboli: How did you summon the courage between declining medical school and becoming noted in your field so that people would take notice, including your family. How did you how did you work through that interval?
• 2:46
  Shaun Bagai: I think it started with my dad initially. He really said, "Son, listen, you know, follow your heart, follow your passion, and success will come." And he knew that I was passionate about medicine, and before that, I would he knew I was passionate about business, and he said, "Look, if if you're not 100% in this, it's a long road. Don't do it." And so he kind of gave me the initial spark of let me reconsider this, and then the other piece is one of my mentors earlier on, again, the the founder, CEO, physician of my first company, he gave me the confidence that there is a path less taken than what I call the railroad tracks laid out in front of me. Once you got into medical school, there's a very small chance of not becoming a physician if that's your dream.
• 3:27
  Shaun Bagai: That's the hardest part is getting in. Once you're there, it's a matter of execution, and that transition is a tough part.
• 3:32
  Shaun Bagai: And I felt like there was a railroad track of you go to med school, you go to residency, you specialize, you know, private practice or large hospitals, and my success and my involvement in medicine is pretty much laid out. Derailing that to take the unknown path of well, let me become an entrepreneur and hopefully build my career, and failure is not an option was the way I drove it. So I think it sparked from those two influences earlier on, and then just ran with it.
• 4:00
  John Simboli: When you make a choice like that to build a business rather than to treat a patient, there's a shift there, right? Tell me if I'm right.
• 4:07
  John Simboli: That one of them is the hope of making a huge impact on a small number of people, the patients you're treating. The other one is potentially making a big impact on a larger number of patients. Is that an important consideration you had when you were making your choice?
• 4:23
  Shaun Bagai: That was 100% the biggest driver. It was a matter of seeing the opportunity to really disrupt healthcare, and I've been lucky, and hard work has paid off. For every company I worked for has had a major impact on patients that I saw firsthand, on patients that many physicians I worked with, they're trained or collaborated with had on their patients, and and then as my career grew, on on many individuals who go on to do similar things as a leader, and really it's been a great network of my career growth and in terms of medical success in my previous companies and this one as well.
• 4:59
  John Simboli: Can you recall?
• 4:59
  John Simboli: When you were a young person, and and your self image and how you imagined your life might turn out to be? Some of us think about those things at that early age.
• 5:08
  Shaun Bagai: It's funny. I was very business minded, as my my father was before he retired, and I liked kind of thinking about building businesses and selling things at a young age when I was a child, and I don't remember I was eight or nine or 10, I used to buy things from India on family trips and then sell them out of my bedroom. And I had a little sign that said Sean's Neat Boutique, and I got made fun of it a lot as a kid.
• 5:35
  Shaun Bagai: But I think there was inherent business mind inside of me that had always been there. And my dad was also an entrepreneur and and different levels, and and I think maybe that kind of came from him to a degree, and also I had a paper route when I was I think 11 years old, and I delivered newspapers, got up every morning at 4o'clock, folded papers, rode my bike around you know the crack of dawn through the rainstorms, and and so always had this kind of business minded you know sense of hard work from a very young age.
• 6:02
  John Simboli: If I were to ask, you know, four, five, ten people in your current team, what's Sean's management style? What do you think management approach?
• 6:09
  John Simboli: What do you think they might say?
• 6:13
  Shaun Bagai: I would say part of it's passion for what I do and and demonstrating everything it takes and anything it takes to get the job done and to make things happen, as disruptive startup companies or smaller companies aren't easy because the road is not laid out for you. It's not just a matter of increasing or growing a certain aspect. It's really learning, discovering, pivoting, taking on the stress. So it's demonstrating the pushing through everything to get things done that you need to, and I think the other piece is remaining calm. It's very important in this environment to, no matter what's going on, to develop and give the team a sense of calmness, of success, of handling situations. There's nothing that's insurmountable, and not being the opposite of that, not looking stressed or distraught or confused, which I've seen a lot of leaders sometimes they can't internalize the stresses that they face and they externalize what they're feeling, and it really disrupts the team in terms of them being able to function and feel confident that the ship's going to keep going and we're going to be successful. And being in this company for 11 and a half years, we've had a lot of situations where, you know, we're running out of money, or there's a slowdown in the clinical trial, or you know, many different things that happen in early stage companies. And having the team not feel the stresses that have to deal with, and confident that whatever it is, I'll find a way around it, and we will together find a way around it.
• 7:42
  Shaun Bagai: is really important.
• 7:44
  John Simboli: When you met the person you described as your mentor at the first company that you worked at, do you think it was the case that he said, "Oh, I see a kindred spirit. There's some qualities in Sean that I recognize in myself. Therefore, I'm going to advise him this way," or was it more like "I tell everybody this because I believe in this for myself?"
• 8:05
  Shaun Bagai: You know, I haven't been asked that before. It's a funny story because I kept asking him. Now, this was when I was I had worked with him before when I was 18-19, in an internship at Stanford, met the company through their animal facility, and then did a one year internship after college.
• 8:20
  Shaun Bagai: So, the age of 22, the first several months, I kept going to his office and hounding him, asking, "You're a doctor. Why don't you practice? What are you doing here in an office?" And he would never give me a straight answer. He would kind of blow it off. And after maybe the 50th time I asked him, he said,"Sean, come here." And this is probably a few months into the job. He closed the door and said, "Here's the deal. I love medicine," and he's very inventive. He's gone on to start and build and sell many companies that have made big impact to medicine since then.
• 8:45
  Shaun Bagai: And he said, "I want to build companies to help patients." and he said, "I see that in you." And he said, "You work very hard, and you find any way and every way to get something done.
• 8:57
  Shaun Bagai: And I think those skill sets put together, and also on the other side of it, once you specialize in one area of medicine, you're kind of stuck with that specialty, and it could get mundane for you. And I can see your passion for what you do, and I can see your passion for medicine, and you put all those things together, and I think you could basically do what I do and and build a career and and disrupt technologies," like he was starting to do back then, now he's done many times since.
• 9:21
  Shaun Bagai: So, 100% I believe he saw similar traits and qualities, and then helped set me on a path, which he was reluctant to talk about, I think, until he got to know me better.
• 9:33
  John Simboli: Why don't you take me a little bit through the path of how it was you picked out RenovoRx out of all the opportunities that you might have chosen? Why that one? What what was it that spoke to you about that one?
• 9:43
  Shaun Bagai: RenovRx, it was the founder of the company. You mentioned earlier relationships, as a cardiologist by day job, biomedical engineer by initial training. I'd known him for now, I'd say, almost pushing 30 years. So he was a research fellow at Cleveland Clinic when I first met him in my first job, Transvascular, and then we stayed in touch over the years.
• 10:02
  Shaun Bagai: Once he moved to California, became a full-fledged cardiologist. I worked for Medtronic. He was one of my biggest customers in sales, and he tapped me on the shoulder.
• 10:11
  Shaun Bagai: And what attracted me to RenovoRx is he was finding a way to actually localize therapy for cancer treatment, so they wouldn't have the side effects.
• 10:18
  Shaun Bagai: You'd have much better efficacy in terms of driving chemotherapy into tumors, and this is an area of need, especially in pancreatic cancer, where we've spent the most of our time focusing, where it's the bar is so low to make a big impact,.
• 10:31
  Shaun Bagai: And here was an avenue, an opportunity to really make a huge impact compared to previous jobs where I believe we did make an impact. So, the choice was obvious there. I had several companies and technologies I looked at when I made the transition, and this one definitely spoke to me because I feel like I could make a big difference. It was also an opportunity to take on a larger leadership role as my first CEO job. Fast forward, rewind to the beginning. The first company I was with, I was helping with clinical. I was an intern. I was helping with preclinical research, helping with animal studies, taking pictures of pig hearts, packing catheter bags for animal labs, taking notes. A lot of intern-like grunt work.
• 11:10
  Shaun Bagai: And once my CEO had told me,"Tell your boss you're not going to med school, and see what happens to your career. Make it a tougher choice once you get in. And after doing that, by the time I got into med school several months later, I was managing animal studies. I was managing the whole process of the animal labs. I was writing the protocols. I was really owning and taking over a lot of that area. I started flying to Europe to train physicians. I became one of the lead proctors on how to teach the technology that we're working on, and really saw an avenue and an interest, and my career starts to take off. So, upon declining med school, I went into clinical research. The company saw my talents in the area I was working on. They taught me clinical research through courses, and by the time we got acquired by Medtronic, I was managing their whole clinical research department. And so my early start was heavily rooted in the the science and research and developing data, which eventually turns into adoption of new technologies, improving safety and effectiveness. Then, when we got acquired by Medtronic, the same CEO and other mentors said, "Look, if you're going to build and run companies, you have to carry, quote unquote, you have to carry the bag. You have to go sell to technology, understand what a quota is. Understand what it's like being in the field, working with doctors, because then when you build in technology, you want to make sure you actually have something that is sellable to physicians and will be adoptable. Which was a tough lesson. It's a tough job, and you've got to have a differentiated technology and learn to be an expert on the technology you're selling. So I went into sales, took the opportunity to negotiate, flying around the country for two years to train their sales force and the physicians on the technology they acquired from Transvascular, and then became a senior coronary sales rep in Medtronic for five years.
• 12:57
  Shaun Bagai: Launched disruptive technologies with new drug-coated stents for coronary reuse back then, so I took that opportunity to really understand the sales process cycle, be a sales rep. Then from there, I built my career and went back to startups. I love the startup environment. I love learning, changing, pivoting, doing. The big companies are good at scaling., we, as small companies, are good at getting things done fast and inexpensively, and pivot quickly, and so I went on to two more companies already in Heartflow. The first disruptive and hypertension treatment, we got acquired by Medtronic for a billion dollars, and then Heartflow disruptive and coronary artery disease diagnosis. So, kind of built the career on clinical research initially, sales, market development, physician training, learned the other pieces of running a business along the way, and then was able to take over this job back about nine and a half years ago.
• 13:49
  John Simboli: There seems sometimes to be a sharp divide between people who are interested in medical technology and people interested in therapeutics, and it sounds like you've been interested in both, and your company is following both pathways. So, was there like a roadmap you felt you had to choose, or did you want to pull the two together?
• 14:08
  Shaun Bagai: It's an interesting question because I've always been interested in the device side because you can touch it and feel it. It's there's a tool in your hand, you can see it being used either you know surgically or for our catheter under image guidance.
• 14:21
  Shaun Bagai: Therapeutics always seemed different to me because you can't touch it, feel it, see it, and it was a little more distant. And really, us turning into a biotech therapeutic company was more a matter of both opportunity and need.
• 14:36
  Shaun Bagai: Earlier on, it was we had a device, a delivery system that could get therapy to where it matters in a manner that no one else had discovered before. So we invented and developed this whole new platform and patented this concept of pushing drugs across vessel walls, as so it really fits to my device background. Now, having said that, to make the impact, you need to get drugs places. And that's when we had an opportunity and a block where we wanted to get on label for a certain indication of the device and also get reimbursement that would reward us for spending the money on the research and reward my shareholders for spending the money on research to prove the technology really works, and so the drug device combination pathway made sense to us. We got orphan drug designation. We're using a drug which we know works in certain areas, but can't work in tumors like pancreatic cancers because it doesn't get there. So it became more of a shift or an accommodation out of both necessity on a business standpoint and out of potential impact in having a combination product that would really make a big difference. So I enjoy both sides of kind of the pharma biotech world and the device world. But it's got this device at the core, so it does go back to my roots.
• 15:50
  John Simboli: I've heard people say that to be really interested in the therapy side, the therapeutic side, you have to have, your timeline has to account for the fact that you might be at it for 10 years or so before you even know how it's going to work out. With a device, it's a shorter cycle often, right? It can vary, but also inherent in that is is the question of impact on the patients. To use the word you're using a moment ago, so what I'm trying to get at is when your company is strictly developing therapies, it's very hard, I would think, to have connections to patients to understand how it's working because clinical trials take a long time. Did you have any experience on the device side where you could actually see that the device was working? You could see the patient. You could be present.
• 16:36
  John Simboli: You could witness it. Is that was that part of your development as well?
• 16:41
  Shaun Bagai: Yeah, I think that's what gave me the confidence to keep going and knowing I made the right decision because every technology I've worked on, we almost got the instant gratification of seeing the results of our technology. I take the first company out of college, Transvascular. We developed a new device that went inside leg arteries that could open up completely blocked leg arteries, and my job once we got acquired by Medtronic was to fly around the country and train physicians on the procedure using the device. And there were many circumstances where literally a patient was diabetic, they had a blocked leg artery, they have gangrenous feet because they're not getting blood flow, and they basically said, "Look, Sean, if you can't help me open this leg, the patient's having his leg get painted next Friday," and then there was a you know specific patient I can remember. And I you know went in there difficult procedure and impossible to open, but our technology and device was different because it was able to get around blockages and reopen arteries that were impossible to reopen, and seeing blood flow down to the toes and knowing that I just saved this patient's leg, you know, with the help of my technology and my coaching to this physician, it was extremely rewarding. And this happened. I think I probably coached about 500 procedures during my tenure in that position over a year and a half, and flew around the country every day. So it was gratifying to actually see firsthand the impact on individual patients by me, you know, sometimes scrubbing in, being next to physicians at the table on a technology I'd helped develop, and now getting out there and full well knowing that this doctor is going to do this again and again and again, and then teach his fellows to do this again and again and again, and that was my first company at college. And and then from that, Ardian was very similar. We had patients that we treated with a catheter to reduce blood pressure, and I remember talking to physicians after we treated them. I used to fly to Germany almost every week back then to train the doctors, and eventually I helped them commercialize. And talking to physicians, saying, "Remember that patient we treated last month? He went from 13 meds down to two, and now he's actually sleeping every night, staying awake all day, and got his job back because he can function as a human being. So I did get a lot of instant gratification from seeing the effect of these device treatments on patients pretty quickly. And now with Renovo, same thing. If you go to the investors section of our website and go under clinical stories, there are several mainstream news stories about our patients who can function as chemo patients with pancreatic cancer, and seeing these patients firsthand, as much as I'm the CEO of a Nasdaq company, I do get the opportunity to go to the operating room. I used to be one of the proctors of this technology when we were two people in the company, and I still get to to watch or help coach the procedure sometimes.
• 19:15
  Shaun Bagai: And I see the patients come into the operating room, and I see them for their first treatment, and they're in a wheelchair, debilitated from chemotherapy.
• 19:24
  Shaun Bagai: And now, in the fourth, fifth, sixth treatment, because our therapy doesn't have the side effects, watching them walk in with spunk and get on the table and get treated and get out of there in an hour and a half, I can see the material impact we're making on these patients' lives, which is amazing.
• 19:40
  John Simboli: Did the experience you had being around physicians, you know, almost every day? It sounds like for a number of years. Did that did that experience teach anything about your job as a CEO that did give you insight you might not have had if you hadn't had that carrying the bag experience?
• 19:56
  Shaun Bagai: 100% the The biggest challenge with new medical technologies is changing physician behavior. Physicians go through years of training to do a thing a certain way, and once they're done with all that training, then they then teach everyone that they train to do the same thing the same way. And to go in there and tell a physician what you've been learning and doing for the last 15 years is no longer the best way. Do it this way instead is very challenging and very difficult. And understanding that at the core level in the operating room is a great way to truly understand that. And now running a business and over commercializing, understanding what it takes to change that physician behavior is paramount to success of a new medical technology.
• 20:39
  John Simboli: When people say to you who is RenovoRx, and you want to give a concise answer.
• 20:42
  John Simboli: What path do you go down? What do you have to say?
• 20:46
  Shaun Bagai: So generally, physicians have to choose between really efficacy and side effects, and it's a matter of how much drug can we give without causing such damage to the patient that we can actually treat the tumor. And what we found at RenovoRx is we don't have to make that choice. Is we're trying to develop new therapies based on our platform that can drive chemotherapy directly in the tumor at levels that can actually affect the tumor where patients can live longer. But on the flip side, you're not giving up the quality of life. You're not giving up the fact you have to be chemo laden on a couch, not eating, not working, not sleeping, not being able to do activities, and we found this excellent balance of very low risk, very low side effects, with potential for extending life. So, as patients with cancer are trying to extend life as long as possible, it's actually a life worth living.
• 21:37
  Shaun Bagai: And I think that's the biggest difference that we've seen in our technology is it's not a trade-off, but it's hopefully a benefit on both sides of that coin, both quality of life and
• 21:46
  John Simboli: with me a layman's description of how the platform living longer.
• 21:51
  John Simboli: works?
• 21:51
  Shaun Bagai: So, a little bit about how the platform works relies on on the anatomy of these tumors. When you think of tumors, think of a ball of blood vessels with tumor cells in them. So when you give systemic chemotherapy, as much as you get all the side effects as it circulates the body, blood eventually carries the drugs into the tumor. There are many tumors in the body that don't have this high level of blood supply, don't have large blood vessels that connect to the main circulation, and if you think about it, think of a city next to a freeway with no off ramps, a lot of tumors behave that way, like pancreatic cancer, where we have the bulk of our experience.
• 22:27
  Shaun Bagai: And without that off ramp, there's no way for the therapy to get to the tumor. Our technology works in a manner where it's a small catheter, a plastic tube, that a physician inserts under X-ray guidance through a very small incision in the leg, which is a couple millimeters, and they place our device, the Renovocath, adjacent to the tumor, and it pushes drugs across the wall of the blood vessel to saturate the chemotherapy in the tumor area for 20 minutes at a time. So again, think about the freeway analogy: is we're creating these little channels from the freeway to get into the city, and with this, we can bathe the tumor in chemotherapy. You get almost 100 times concentration of chemotherapy at the tissue site than you would if you gave it systemically, which both reduces the systemic toxicities, of course, because it's not circulating the whole body the entire time, and then you get very high doses in the tumor itself.
• 23:19
  John Simboli: I'm sure you get this question at investor conferences and in other situations, like if this is such a good idea, how come nobody else thought of it?
• 23:26
  Shaun Bagai: It's one of those ideas where I've been to conferences many years ago, early on with this company, and a doctor said, "Yeah, why didn't I think of that? It's this. This is so simple. It's so eloquent." And and the reason is because this pathway of going across the vessel wall had never been discovered, and as much as when you're successful and you look back, you look like geniuses. We get lucky along the way, and I look back to one of our first patients where we made this discovery. We thought we're isolating flow to little tumor feeders, little blood vessels that go to the tumor, and what we quickly realized is it wasn't little tumor feeders. We needed to put the device in a manner where there's no escape routes for chemotherapy, and then use pressure to force the drug across the vessel wall. So we were onto something with localized therapy, and along the way, we discovered this what we call transarterial microperfusion or T`AMP, or
• 24:12
  John Simboli: Is there a pattern where people look at renovo and transarterial being across the artery wall, and that's where we developed a lot of our patent portfolio and developed this whole new mechanism of action and chemotherapy delivery that say, "Oh, I see what you're up to, and then you say, "Let me hadn't been discovered before, and now we're developing that.
• 24:32
  John Simboli: let me explain a little further because we're actually not doing that. We're doing this.
• 24:35
  Shaun Bagai: When you think of chemotherapy, you think of blood vessels that take the drugs there. If you think about pancreatic cancer tumors. You think of high pressure, what they call desmoplastic barriers around the tumor, just impenetrable to chemotherapy.
• 24:46
  Shaun Bagai: But technically, it's not that they're impenetrable. It's just there are no pathways to get into the tumor, and so everyone's always thinking about blood flow into tumors, and that's how you get there. And what we discovered is we're not using the blood vessels, we're pushing the therapy outside the blood vessels in the tissue, and it takes even physicians, not just investors, sometimes two, three, four, five, 10 times to understand this is a different mechanism of action. It's a different way to think about the anatomy because it hasn't been done before. So it is confusing at first because a lot of physicians, investors, people in general say, "Oh, that makes sense. You're finding the little blood vessels to push chemotherapy through, and you're you're blocking it and isolating." It's like, no, not quite. But we're going outside the blood vessels, and that once people start to click on that piece of the anatomy, it starts to look at how we're doing this.
• 25:36
  Shaun Bagai: It makes sense that this is something we've never seen before.
• 25:41
  John Simboli: Do you get the question of, well, are you a device company? Are you a therapeutics company? Are you both? And then how do you work through that?
• 25:49
  Shaun Bagai: That's actually one of the tougher for investor questions I have because a lot of institutional investors and analysts put you in a bucket.
• 25:55
  Shaun Bagai: It's either you're a device company, medical technology, or you're a pharma company, the biotech side, and so being both is very confusing to a lot of people. On the flip side, and this is where savvy investors who see the disconnect in our valuation where we're going see the commercial opportunity of the device being a multi-100 million dollar business opportunity that we're embarking on now. And oh yeah, by the way, in the background, we've got this phase three therapeutic clinical trial using that same device in combination that could be a multi-billion-dollar opportunity.
• 26:28
  John Simboli: When you think about the pipeline and how it's an expression of your vision for the company, can you take me down the paths of, you know, the device itself, how it's used in combination of the therapy?
• 26:39
  Shaun Bagai: So the initial inception of this device technology came from the founder, Dr. Ramtin Agah, where he saw a need in the pancreas specifically. So this was actually designed initially for pancreatic treatment of some kind. Chemotherapy is where we've taken it for pancreatic cancer treatment. From a pipeline perspective, we've been using in our clinical trials a drug called gemcitabine. It's been around for decades. It's generic. Our drug device combination in a phase three trial is with this combination or device, the Renovocath plus this specific drug. From a pipeline perspective, what's amazing about the technology is this is a platform. It could be used with, I'd say, any drug or agent, and it could be delivered to almost any tumor next to a blood vessel. We've been hyper focused to show success in inone of the most challenging tumors of all times, pancreatic cancer.
• 27:28
  Shaun Bagai: And with that, we can then apply this. Okay, let's look at different drugs, maybe immunotherapeutics, cells, agents, antibodies, oncolytic viruses. So there's a whole platform that we could develop in terms of drug device combinations. And beyond pancreatic cancers, there are other tumors in the body that behave very similarly to pancreatic cancer, and either other tumors that are a little bit different, where they could benefit from localized kind of isolated treatment. So, from a pipeline perspective, I see both sides, and this goes back to your question about pharma versus device. On the device side, this device, this platform, can be used with almost any agent. It's a delivery system for almost any tumor, and then on the pharma biotech side, and we talk to biotech companies on this. Is there are partnerships to be had on let's explore taking out the toxicity profile of your drug by localizing the therapy because we have the best in class platform to deliver local therapy in a mechanism that hasn't been seen before.
• 28:19
  Shaun Bagai: There are several tumor types and classes of drugs that would make sense to go next, and we're exploring several of those now.
• 28:25
  Shaun Bagai: We got FDA clearance for the device component back in 2014, but this goes back to my early roots when I talked about physician adoption and changing physician behavior. We recognized right off the bat we're not going to have this device or product used unless you have data to demonstrate that what you're doing is actually has the potential to work. So instead of commercializing the product, we went directly into clinical trials with the approved device.
• 28:49
  Shaun Bagai: So our phase one, two trials, now the phase three trial has all been using this approved medical device. It's more recently where physicians are seeing the benefit in patients.
• 28:59
  Shaun Bagai: They're seeing the early data, and they're saying, "Look, this device is cleared. I want it today to treat patients because we need this." That pushed us to commercialize the product last year. And when I say use it now commercially, as I mentioned, we are in several clinical trials earlier. The phase three that we have ongoing is a drug device combination, pretty much like a therapeutic study. It's run by the Drug Division of the FDA.
• 29:23
  Shaun Bagai: It's for the combination therapy of this approved medical device through RenovoCath and the combination products using a drug, gemcitabine, in pancreatic cancer specifically. So the goal of that study is to demonstrate safety and efficacy of that combination specifically for locally advanced pancreatic cancer. So that's where we have this dual-pronged approach to our business, where we have a device business in sales. We have a therapeutic business that's on the horizon, nearing completion of our phase three study. One of the reasons why we've been able to build and run this business much more frugally than most companies is that we have been receiving compensation for the device because it is FDA cleared and reimbursed, and now with with increase in reimbursement and more data out there, we're seeing adoption and driving a commercial operation that helps support the financing of all our clinical trials and studies as well.
• 30:14
  Shaun Bagai: This is very different than most therapeutic companies, where it's a cash burn for decades until there's a potential windfall at the end. We're now able to reduce our burn and hopefully get to a point of break even or profitability, even before the clinical trial has a complete readout and we get approval for the combination. So it's a different animal in that sense, and that's where the de-risking comes from as well. There's a viable, established business in place without a big cash burn, and we found ways along the way to always run the business very lean.
• 30:44
  John Simboli: If the phase three clinical trial develops in the way you hope, and any other data readouts that you need, and things progress, and the FDA approves the combination someday, if all those things, your dream is realized, if it's successful, how will the day-to-day life of a patient treated it in this way, how would it change compared to now?
• 31:03
  Shaun Bagai: What we're seeing in a lot of our patients, and I go back to the the clinical news section in our investor website.
• 31:08
  Shaun Bagai: We had patients say that I'm building my kitchen again. I'm bicycle riding with my grandkids. I'm going out to dinner with my family. These aren't things that chemotherapy patients don't really say that much. So it's great to see that the day-to-day lives of a lot of our patients seem largely unaffected, especially if they've had upfront systemic chemotherapy. So they compare and they share their stories about how life was before and after RenovaRx.
• 31:34
  John Simboli: Sean, thanks for speaking with me today.
• 31:36
  Shaun Bagai: Thank you, John. It was great for the opportunity, and I appreciate your questions.
• 31:38
  Shaun Bagai: They've really helped explain a little bit of my background and our great story.
• 31:44
  John Simboli: Working alongside biopharma founders and CEOs, and getting to know their insights about leadership through our conversations on BioBoss, I understand there can be many pathways to success. My discussion with Shaun Bagai, CEO at Renovo RX reminds me how energizing the journey can be.
• 32:05
  John Simboli: Deciding to build a company focused on serving patients is a worthy goal, but that doesn't mean there is a blueprint for how to get there. Like several founders and CEOs I've spoken with, Sean chose to follow both his scientific and entrepreneurial interests, and take what he calls the path less traveled, the railroad tracks laid out in front of me. In our conversation, Sean described the satisfaction that comes from having a positive effect on the life of an individual patient, but Sean realized that his contribution could take the form of pioneering new therapies that could change the way cancer is treated. Sean shared his understanding that leadership is a test of the capacity for vision, problem solving, and resolve. As he said to me, "I love learning, changing, pivoting, doing. Big companies are good at scaling. We, as small companies, are good at getting things done fast. The ability to balance imagination and clarity, vision and competence, is a leadership skill in its own right. I'm thankful to have met biopharma founders and CEOs who find their way to pursue this symmetry. I'm John Simboli. You're listening to BioBoss.
• 33:30
  Unknown: BioBoss is brought to you by Wyant Simboli, a strategic branding firm focused on helping life sciences companies advance. We partner with companies to define their story, structure their brand, and inspire their audience.
• 33:45
  Unknown: Visit Wyantsimboli.com for more information.