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Lance Baldo: CEO of Beacon Therapeutics · BioBoss

• 0:06
  Lance Baldo: I had worked in both small and large pharma, and really had thought that my career was going to end in large pharma, hopefully in a senior leadership type role. And then I got drawn away for a couple of biotechs, but in that case, it was as a chief medical officer, a CMO. But I still aspired to that kind of senior leadership position, and really at some point, as you start getting a little bit older and a little bit wiser, I said, I think now is the time to do this. And I guess I was fortunate in that I could be kind of more narrowly focused, and I decided that I wanted it to be an opportunity in ophthalmology because I really loved retina and I really loved ophthalmology, and so I started looking exclusively in ophthalmology..
• 1:23
  John Simboli: You're trained as a physician, and like many CEOs I've worked with, that that is a path. What told you that this branch was the one you want to take, as opposed to that one?
• 1:34
  Lance Baldo: Early in my career, John, people would ask me, like,"Do you feel like you're wasting your medical doctorate? Are you wasting your medical degree?
• 1:39
  Lance Baldo: And that question used to give me some pause for a moment. But now I recognize that while I don't use my medical degree the way many clinicians do, or the way I would have in the past, I still use that education. I still use that lexicon, John.
• 1:53
  Lance Baldo: When you go through medical training, you learn a whole new way of thinking and a whole new way of talking, and I do apply that to the job I have today. It also gives me an extra, I'd like to say more than an extra, but certainly an air of credibility when you're out there talking to physician customers. When you're out there, sometimes even in front of patients, and so I still enjoy that part of my job.
• 2:16
  Lance Baldo: We're fortunate that at Beacon we work in rare diseases, and that the patient community has a really strong voice, and so I'm able to go out there as not only a CEO but also a clinician and hear from these patients and their families about the impact that some of these devastating blindness diseases could have, and that all, you know, hearkens back to my medical training. And and it really is one of the reasons why I have so much passion for what I'm doing and what we're doing here at Beacon..
• 2:42
  John Simboli: So when you decide that you wanted to become a CEO and lead a biopharma company, it's weighty decision. How do you go back to your family and explain that?
• 2:53
  Lance Baldo: The hardest conversation I had to have was almost certainly telling, and particularly, my mother. I come from an Italian American upbringing, and like, you know your mother and your life, and it was easier to tell the chairman of my department that I was leaving surgery than it was to tell my mother. And a little part of it, she said to me, I remember this was like many months later, maybe even many years later. She said, "It used to be really easy for me to tell people what you did. My son is a doctor. My son is a surgeon. I think to this day, John, like to, you know, this is like 25 years later. She's still not quite certain what I do for a living because it's a lot harder to explain. Like, what do you actually do as a CEO or what do you actually do as a leader in biotechnology? No, but I'll never forget that day. It was, you know, pre Zoom and it wasn't face to face and it was over the phone, and I had to call my mother and tell her I was leaving. And the other thing is, John, they were so invested in me. I mean, I couldn't be where I am today if it wasn't for the loving support of my parents and the economic support of my parents. Right? It is not cheap to become a physician, and so I'm still appreciative to this day of all the support that they gave me emotionally and financially for me to get that amazing education, which now I get to apply to medicine a very different way.
• 4:01
  Lance Baldo: The harder transition for me was moving from a big company. I went rom Roche Genentech, to a small company and becoming a CMO for the first time. That was the harder transition for me. I actually feel like there's more parallels to being a small or mid-sized company CMO and actually being a smaller mid-sized company CEO. I was maybe maybe fortunate, although some would say this is unfortunate. When I joined as the CEO of Beacon, we were absent a CMO, so I like to say I was pulling double duty for some period of time. And obviously, well, maybe not obviously, but the comfort level was a lot more being the CMO, the CMO part of the job, and less so on the CEO part of the job. But it did allow me to really dig into the business and really get to know a lot more of the company because I had to kind of pull this double duty for really about nine months until we were able to hire an absolutely excellent chief medical officer that we have right now.
• 4:51
  John Simboli: Each of us, when we try when we have new opportunities, we try to picture what it's going to be like, and some of it is what we picture, and some of it is not. So what?
• 4:59
  John Simboli: Was what you were able to anticipate and what was not for those roles.
• 5:03
  Lance Baldo: When I was at Genentech, I had become quite senior, and I had about about 700 people in my organization.
• 5:08
  Lance Baldo: And so, my job was truly to kind of communicate and lead, and hopefully guide people to make good decisions. Again, you didn't do too much because you get to that level, and you're hopefully guiding and providing some guardrails for people to get on and do great work, then I jumped to a relatively small biotech company as a CMO, and it was in a new area for me. And like the third week on the job, we had to present something to the FDA. And so I remember, I asked the question. I was like,"Great, who's presenting to the FDA? And they looked at me, and you know where this is going.
• 5:37
  Lance Baldo: And they said, "You." And I was like, "Okay," I said, "Well, where's the content? Where are the slides?" They're like,"Lance, you need to pull together the slides," and I was like, wow, you know, I, and I.
• 5:50
  Lance Baldo: It's not that I couldn't do it, but again, it's using muscles I hadn't used before. And I remember, and I worked with a couple people on the team, and we put together these great slides. And for the first time in probably half a decade of my career, I actually scripted.
• 6:02
  Lance Baldo: This was pre-Zoom, so it was a teleconference. I scripted almost the entire presentation I was going to give because it was just outside of my level of comfort. And I remember after that after that call, John, that evening chatted with my wife, and I said, "You know, I think I'm in over my head. Like I think this is going to be the first time in my career where I'm going to fail." Now fast forward six months later, and you get your legs under you, and everything goes very well. But I remember that that third week on the job, I thought, wow, now you've done it, Lance. You've really put yourself in over your over your head. But it was a great experience. I had a really nurturing group of managers and a CEO over there as well, and it was a really great experience for me. But it could be hard.
• 6:44
  Lance Baldo: That first transition, I tell people from big company to like small company, that could be a hard transition.
• 6:51
  John Simboli: A lot of people would gravitate towards the the surer thing, the comfort zone.
• 6:54
  John Simboli: Some people, for whatever reason, go the other direction.
• 6:58
  John Simboli: So, what was pulling you to try to go someplace new?
• 7:03
  Lance Baldo: I kind of had this epiphany that, like, you need to sometimes get outside your comfort zone, and so I just thought to myself, if I don't get outside my comfort zone, I may. And I tried to live my life with very few, if any, regrets, but I may regret that. And so I decided to kind of get outside my comfort zone, and a lot like leaving clinical medicine, it sure feels scary at the beginning. But often you look back, sometimes months and often years later, and you think,"Hey, that was the right decision. That was the right decision to make." And I often think about. I had a really great mentor, Clive Meanwell, who is quite quite well known now, particularly he was the CEO and founder of The Medicines Company, and then later, Metsera. But he talked about something called lifetime impact, as well. And he kind of, you know, when I had left clinical medicine, and I kind of was regretting like, hey, I'm not going to be helping patients as much anymore. And he said,"Well, think about." He goes,"You may not help patients as much, but think about how many tens of thousands, or even millions of patients, you could actually impact if you have a great career in industry." And that really stuck with me because there was this whole thing which I don't like when people say anymore, John. Like, you know, when you go to industry, you went to the dark side. I just don't think that's a truism. I think when you move from clinical medicine to industry, you can impact science, and you can impact patients, and you can impact society in just a much different way. That's all, and that's what I feel like I'm doing now as a physician working as a CEO.
• 8:29
  Lance Baldo: When I was working abroad, John, so I had worked for Roche Genentech. So when I was working for Roche, I was primarily in Basel, Switzerland, for about five years, and then in New Zealand as a general manager, also for Roche for a couple of years, and the one area where I didn't have too much exposure was actually ophthalmology. And then one of the dream jobs that I wanted in Genentech was a job called franchise head, and I would have been pretty keen on almost any therapy area because that was kind of the dream job that I wanted to have. And one day I got a call from my manager saying, "Hey, there's a franchise head job opening up in the U.S. and it happens to be ophthalmology, and the CEO of Genentech thinks you'd be perfect for it." And I remember I was like, "I've never really focused on ophthalmology before." And what was said to me was, and this this happens to be a specific part of ophthalmology called retina. They said, you know, there's a lot of physician entrepreneurs. They like business minded, scientifically focused leadership, and we think you'd be great for it. And so it was a bit of leap of faith there, as well, when we started talking about leaps of faith in my career. And sure enough, you know, kudos to management there and kudos to leadership. They were right. Like, first couple weeks on the job, unlike when I moved over to Adaptive Biotechnologies, and I really, you know, and I really felt like I was drowning, I felt like I was like in my element right out of the gate at the beginning there, and it was a really formative part of my career. And again, it was one of those times I probably would have stayed, but when you're in a large company, sometimes other opportunities called, and I ended up getting promoted into a more senior role that happened to still have responsibility for ophthalmology, but it was across the whole Roche Genentech portfolio at that time. But it was another one of those times I could have stayed in retina for the rest of my career and been happy.
• 10:12
  John Simboli: When you were thinking about becoming a CEO and kind of exploring the opportunities, I'm sure there were many that that you you saw and came to you and you thought through. Do you recall what it was about Beacon that really piqued your interest and said,"I'd like to explore that?"
• 10:29
  Lance Baldo: I was exploring a different opportunity, which I was also quite keen on, and I decided to call a friend and a colleague of mine who actually was my hiring manager when I became the franchise head for ophthalmology at Genentech, and I called him up and I said,"Hey, I'm thinking about, you know. my next step in my career, and I'd like to be a CEO. And this is a company I'm looking at. And he's like, "Lance, are you considering CEO jobs in ophthalmology?" And I said,"Yes, I am." And he said, "I've got a better one for you." And it turned out that better one was was Beacon Therapeutics, and truly, I mean, both opportunities are amazing opportunities in different ways.
• 11:03
  Lance Baldo: But what was really appealing to me about Beacon Therapeutics is its clinical stage. We have a drug that's being studied, that's in patients right now, that's fairly close to knowing how well it works and whether or not you can bring it through the regulators and ultimately get it to patients. And that, to me, when I think through my career, that's where I feel like I could have the most impact is when things are in the clinic or getting pretty close to commercialization, and that's what really drew me to Beacon. I mean, there's some sexy technology, and there was some great investors and some really good people that I knew from my past, and all of that kind of just really built out Beacon as being the perfect package for me, and it's been great. I have to say, like this is an amazing experience for me. I tell my team, John, I pinch myself sometimes for the situation that I find myself in because many people in their careers, you know, you can you can usually count on one hand how many times you're involved in a pivotal phase three readout at a very close level. I mean, if you're a CEO of a big company, sure you may have a number, but at a small company, to be this close to where the rubber meets the road, it's really it's all it's all inspiring. Really, it's it's just an amazing place to be.
• 12:11
  John Simboli: I know you can't predict the future, but if things develop at Beacon the way, you hope it will, and you can bring hope and change to patients. How would it affect their lives if you could do what you want to do?
• 12:23
  Lance Baldo: Our lead asset is a is a product called laru-zova, and it's for an indication called XLRP, and it's a genetic blindness, and it affects predominantly males. And these poor young men just slowly and progressively become more and more blind until it starts affecting the way they live, their ability to work, their inability to drive. So it's just devastating. And this word unmet need gets thrown around a lot, John. But here, there's absolutely nothing other than get your life in order that we can do for these patients. And the interesting thing is, not only does the medicine assist with making their vision better, it actually allows them to regain vision, so they actually can gain. And we've all done an eye chart. Imagine gaining one, two, or three lines—not letters—lines on an eye chart-and that's what we've seen in some of our phase two data.
• 13:13
  Lance Baldo: And this is a gene therapy, so it is a needle in your eye. It happens to be done within an operating suite, but it's a needle in your eye, one time, which does help with kind of the treatment burden there as well, John. And that's for our first asset. For our second program, it is for a condition called dry AMD, where right now there is a big treatment burden because you do have to go back and get needles in your eye every month or two, and you actually don't feel any better. It arrests the progression of disease, but it doesn't make you see any better, and that's where we think that a gene therapy, a one-and-done therapy, could be hugely impactful for patients because theoretically it would be one injection, and they're going to get that lifelong benefit afterwards.,
• 13:57
  John Simboli: if I were to say, what is Lance's management approach? How does he get the best out of people? What do you think your team would say?
• 14:04
  Lance Baldo: I'm a very open leader. I tend to kind of wear my heart on my sleeve. I would often say that that I lead with my head and my heart, and I think people do see that. I'd like to think they would say I'm an empowering leader. I'm certainly not command and control. In fact, my belief, one of my strong beliefs in my career, is hire great people and then give them the space to actually operate and get on with what they need to do. I prefer consensus when we can, and so I always try to find what's that path of least resistance, to try to placate everybody to try to have a little bit more like harmony, you know, within the leadership team or within the organization. But that's something as a leader. When I think of what I struggle with, is sometimes you can't always have harmony, and sometimes you have to make the hard decision, and sometimes you have to realize that you're not going to make everyone happy all the time.
• 14:51
  John Simboli: When you're in the the dreaded "elevator situation," someone says, "Hey, Lance, who is Beacon Therapeutics?" What's the short answer you like to give?
• 14:59
  Lance Baldo: We focus on devastating causes of blindness and try to find specific genetic therapies, specifically gene therapies, to be able to make these patients treated or make them see better. And so, the very technical term is ocular gene therapy, but a different way is using genetic medicines, putting them in the eye, and hopefully allowing patients and allowing people to see better.
• 15:21
  Lance Baldo: That's what we do.
• 15:24
  Lance Baldo: When you look at gene therapy, the eye is an ideal organ for making advancements within this space. It's an encapsulated organ, has something called immune privilege. So generally, it's a little bit harder for stuff that gets into the eye to get more broadly into the circulation. And there's a whole bunch of tests we can do, and we've already kind of mentioned some of them with the vision chart. It's a whole bunch of tests that we can do to see if the interventions that we're making are actually improving outcomes in patients. And so it's my personal belief that over time we're going to take some of the great learnings that we're gaining in ocular gene therapy and then apply that to other organ systems across the body, as well as in more systemic gene therapy.
• 16:08
  John Simboli: You must frequently get the question of,"Well, it's awfully hard to do this, Lance, other people have tried. Why are you trying?" Where do you go with that?
• 16:16
  Lance Baldo: I hearken back to some of the innovations of the last 15 or 20 years, particularly biologics. So using monoclonal antibodies to treat disease, and I just remember it was like, wow, this was going to be like science fiction. Using, you know, using antibodies to treat these devastating conditions. Now we use them . .
• 16:35
  Lance Baldo: . ubiquitous is maybe too strong a word, but they're used to treat all kinds of conditions.
• 16:42
  Lance Baldo: And I truly believe that gene therapy is at that same precipice. That we're looking at it now and saying, "Hey, this is hard, and there may only be a few places where this is going to benefit." Then, John, we're going to look back in five or 10 or maybe 20 years and say, "Wow, you know, this really made a lot of sense at that time." If you come out of the gates too fast, and you think you're going to like fix everything, and you think you're going to have all this, you know, perfect success.
• 17:06
  Lance Baldo: You're going to be sorely mistaken, and so I'll tell people it is a marathon and not a sprint, and just be prepared for the long game in this.
• 17:13
  John Simboli: How does the pipeline express your vision for the company going forward?
• 17:17
  Lance Baldo: Our pivotal study, the registrational study, it's called VISTA, fully enrolled last year, and it's going to be reading out towards the end of this year. And this is going to be one of the foundations for the company, to kind of build some of the infrastructure that we need around that, and also to be able to kind of give the confidence in our investors, whether that's going to be private investors or eventual public investors, if we choose that route, to be able to kind of continue to invest in the portfolio as well. The second program that we have is going to be going into the clinic towards the latter half of this year, and so we're opening a so-called IND or investigational new drug application, and then that will allow us to enter the clinic or start testing the medicine in patients and subjects towards the latter half of this year.
• 17:59
  Lance Baldo: And then that allows us to kind of continue to progress that portfolio and mature that portfolio over time. The big challenge that we'll have in front of us will be commercialization of the lead asset, kind of getting ramped up and getting prepared for that as well.
• 18:15
  John Simboli: What can you tell me about the mechanism of action for the lead candidate
• 18:19
  Lance Baldo: in this particular disease, called X-linked retinitis pigmentosa, it is a disease that affects the photoreceptors in the back of the eye. So these are the cells in the back of the eye that pick up light stimuli and then send that message to your brain, so that you can see, so that you can distinguish colors, etc. In this case, there is a mutation in a particular gene called RPGR, and that protein, that RPGR protein, localizes to an area within those photoreceptors, and it allows for protein transport and energy metabolism. And so, when that protein is mutated, basically, those cells stop behaving the way they should behave, and that's why you get initially degradation in vision, and then over time, unfortunately, John, those photoreceptors will eventually just die. And therefore it's very hard, if not impossible, to get them to work anymore.
• 19:13
  Lance Baldo: What we do is we take a gene therapy that's called an AAV, an adeno-associated virus vector.
• 19:18
  Lance Baldo: We put that in the back of the eye, so we try to get it as close to those photoreceptors as we can. The gene therapy gets taken up by the cells, and then we code for that protein within the gene that's within. That gene therapy. And then those photoreceptors start producing that protein. But amazingly, that protein goes to where it's supposed to be and allows those photoreceptors to start working the right way again, and therefore they're starting to send the light signals back to the brain, and people can start to see more letters. People can start to see more lines, and so it's that combination of knowing exactly the genetic disease and exactly the protein that kind of needs to be replaced, and then making sure that we get it to the right place in the back of the eye near those photoreceptors.
• 20:05
  John Simboli: When you describe that mechanism of action to a sophisticated audience, let's say to an investor conference, and you get the folks who say,"Yeah, I'm interested. Let's talk more. Then you get the people who say, "No, this this is not something I'm interested in. There's that interest.
• 20:21
  John Simboli: There's that third category sometimes where people say, "Oh
• 20:23
  yeah, I understand,": and then you realize they didn't understand it.
• 20:27
  Lance Baldo: The disconnect is a lot of people are thinking about, like for instance, systemic gene therapy, that you kind of give the medicine and it's going to be taken up by, you know, other cells of interest and start producing something that's going. In this case, I think we have to make it very clear, and I'll often start with, "Hey, this medicine is being administered in the back of the eye. We're trying to get it as close as possible to those cells of cell cells of interest, the ones that we actually want to make sure we can get to start functioning again". That's probably the most common. I think probably the most common objection that we get are people worried about safety. They kind of read through some of the safety issues we've seen with systemic gene therapy, and they just apply that errantly to the eye. And I think that's where I spend a lot of my time on education as to hey, it's not that these drugs are completely safe, John. There's no such thing as a drug that's completely safe. But I already described a little bit about the eye and some of the ways that we can manage some of the side effects. And so, probably the most common objection I get is,"Hey, we've seen that these drugs could be unsafe in disease X, Y, or Z. Explain to me why it's going to be different in the diseases you're working on as well." So that's probably where I spend the largest part of my time.
• 21:34
  John Simboli: What makes a good partner to Beacon Therapeutics?
• 21:37
  Lance Baldo: I'm hoping this is going to be amazing medicine that can help tens of thousands of people around the world. We simply at Beacon . . .it's unlikely that we ever will build the infrastructure that we need around the world to make sure that all these patients potentially could benefit. So we're looking at potential partners to help us to commercialize, to help us to distribute this medicine from around the world. In that setting, what makes a good partner, and this is where the the clinician and me comes out.
• 22:03
  Lance Baldo: I want a partner that's going to take the gravitas that it means to, like, have the responsibility to try to get this medicine, these people, and that they take it as seriously as I would personally. Because I don't want this to get lost in a company where it's simply not important. I don't want it to be struggling in a company that simply doesn't invest behind it.
• 22:23
  Lance Baldo: I mean, ideally, I'd like to find a partner that considers this to be a pillar of their business, and they're going to want to invest behind it, not just with financial resources, but hopefully also great people around the world as well. We're confident that we could commercialize this alone in the U.S. and some of the larger markets, particularly in Europe.
• 22:43
  Lance Baldo: But beyond that, John, most companies our size just don't build that infrastructure—at least not for the first product.
• 22:48
  Lance Baldo: We don't build that infrastructure, so that's what a good partner looks like as well.
• 22:50
  Lance Baldo: And the other area where I'd say
• 22:55
  we already have great partners: the clinical community in inherited retinal diseases, which is the category of disease that this fits into, absolutely amazing. Everything from the advocacy groups to the motivated clinicians to the sites that support our studies—they've been amazing partners. This study was enrolled in about 14 months, and that might sound like a long time for the uninitiated, but enrolling a rare disease study in about 14 months is nothing short of magnificent, and we couldn't have done that alone.
• 23:24
  we already have great partners: It took the commitment of all of the ecosystem around us to help us get that done, and so we just want to give back now, hopefully with positive data, and then with a medicine that's going to help lots of people.
• 23:37
  John Simboli: Thanks for speaking with me today, Lance.
• 23:39
  Lance Baldo: I really enjoyed it. Thank you so much.
• 25:45
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