Business Of Biotech
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Business Of Biotech
Novel Peptide Delivery With Revolo's Woody Bryan, Ph.D.
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Revolo Biotherapeutics President and CEO Woody Bryan, Ph.D. is pushing the boundaries of peptide therapeutic delivery. On this episode of the Business of Biotech, we dig into Dr. Bryan’s transition to the CEO chair at the company and how that coincided with an aggressive strategic decision to alter the course of administration of its peptide candidates in allergic and autoimmune diseases. That decision didn’t come lightly and its execution wasn’t easy, but it was an important one for the future of the business. Tune in as Dr. Bryan tells us why they did it, how they did it, and the foundation that decision laid for the company’s growth.
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Back in the summer of 2021, I sat down with Revolo's CEO for a conversation about peptide therapeutics. And that was before peptide therapeutics were even cool at least before they were as cool as they are now. But Ravolo isn't a Me Too player in the peptide-crazed metabolic space. Its lead candidate, 11-04, is a phase 2B novel linear peptide in the allergy arena, and that candidate is closely followed by a phase 2 molecule called 18-05 in the autoimmune disease, rheumatoid arthritis. These are big indications and the guy leading their charge today isn't the same guy I sat down with back in 21.
Matt Pillar:Dr Woody Bryan, ceo there since January 24, has been with the company since he joined as chief business officer in 2020. He brought with him a host of startup biotech experience and he's leaned into that experience as he's set a new course at Revolo, beginning with a significant shift in the way the company's drugs are administered. I'm Matt Pillar and on today's episode of the Business of Biotech, we're going to get to know Dr Woody Bryan, we're going to study the business impact of drug delivery decisions and we're going to learn how far Revolo has come over the past three years and where it's going next. Dr Brian, welcome to the show. Thanks Matt, thanks for having me.
Matt Pillar:It's my pleasure to have you. I've been excited about this conversation since we chatted a couple of weeks back and, as I mentioned, you joined Ravolo as chief business officer several years ago. Then you were promoted at some point to president I think it was president and chief business officer and then earlier this year you became CEO. So I want to start with that transition sort of how that unfolded over the past four years. How'd you end up at Ravolo and then kind of walk us through the progression of your leadership there?
Woody Bryan, Ph.D.:Yeah, absolutely. So I actually joined in summer of 2020. Um, and you know, I my my careers is progressed from being actually, uh, starting an industry with a drug delivery background and then progressing through management responsibility across broader operations that span sort of pharmaceutical development and then into the corporate development, licensing sort of strategy side. And so I knew the CEO that had been named in spring of 2020, and he was looking for someone that could come in and wear a number of hats and you know, in a company that's a small early phase to mid-phase company where you wear a lot of hats, right. So I think my background and what the company needed at the time was to build out an organization that could set strategy, move the assets through, build value, obviously for shareholders and advance the programs. It was a nice fit for one another and so I came in and, as chief business officer, obviously helping build the team, helping finance the company, setting strategy and then implementing that strategy, was a natural progression to sort of the title of president and we've come a long way.
Woody Bryan, Ph.D.:You know, our lead asset 1104, at the time I joined was a preclinical asset. We had never generated any efficacy data. It was a very early stage, very exciting asset. And here we stand today, four plus years later. We've completed five studies in humans, one, a phase two EOE study, an allergen sensitivity study, and've also been able to um bring along, if you will, other attributes of the program, like routes of delivery that give us multiple levers for high product differentiation in the allergic disease, th2 disease, disease landscape.
Matt Pillar:Yeah, yeah, and I've got some questions for you about those multiple hats that you've worn from day one of your start in industry, because it's an interesting story to me and I want to kind of drill into that.
Matt Pillar:But before we do, you talked about one of the major changes over the course of time here in recent years, with 1104 at Ravolo being that therapeutic delivery route, so I want to stay there for a minute. As I mentioned, I had the liberty, the advantage of a chat with you a few weeks ago, and I'm using your words, not mine, when I say you referred to yourself as an old drug delivery guy. I don't think you meant that literally. I mean, you're not that old a guy. But as it relates to this lead candidate at Ravolo and the change that you initiated in its route of administration, I want to learn about that change. What prompted it? Maybe the process that Ravolo had to go through to enable it, and then why, from a sort of the business impact standpoint that you just referenced right, like how it differentiates what you guys are doing in the allergy space, so yeah, so let's start with sort of the genesis of that thought process, like, hey, we might want to look at going sub-Q.
Woody Bryan, Ph.D.:Yeah. So if you step back for a moment, there's been an evolution of different types of molecules that have come into the well, a number of spaces. But if you look at the inflammation space that we're playing in immunology in general, where you had these older generation steroids and immunosuppressants that granted, you know, brought some therapeutic benefit but had all sorts of baggage from a safety standpoint, many of them delivered orally back in the day or other routes of administration. And then in the last 10 or 12 years you had the biologics come in, the monoclonal antibodies. You had the JAK inhibitors as well, and the monoclonals, just by what they are chemistry-wise, they're too large to be delivered by anything other than subcutaneous administration and they brought again some nice improvement in efficacy.
Woody Bryan, Ph.D.:But you know, having to self-administer a sub-Q injection is not a walk in the park for everyone, although technology is made a little bit more patient-friendly. And then you have the oral jacks that are delivered orally, but they have black box warnings, all sorts of side effects. So people are constantly battling with do. I lean into the benefit of the efficacy they bring to the table but worry about liver function and immunosuppression and things that go on the downside. So that is sort of a baseline of thought around the fact that if you're developing an entity like 1104, it is a peptide but we had generated some data early on in some animal models that suggested that it's unique in the fact that we saw evidence we could deliver it intravenously, which we started with in the clinic, which is pretty natural for a new entity.
Woody Bryan, Ph.D.:You want to take it in the clinic, see if you have a drug or not and then optimize how you deliver it from a commercial image standpoint.
Woody Bryan, Ph.D.:We also had evidence that we could deliver it subcutaneously and we had a small data set and an animal model we use that suggests we might deliver it sublingually in the oral cavity. But what we had not done and we hesitated to do when I joined we were still using intravenous in the clinic to say, hey, we've got a signal here. Our preclinical suggested that we should take this in the clinic and now we have a drug because it works. So once we generate that data set in our EOE study, in our allergen sensitivity study, we turn our attention to saying, okay, now's the time for us to really, really move forward in developing commercially viable subcutaneous dosage form, subcutaneous dosage form and hey, while we're doing it. This early data we generated really tells us we should do the same from a sublingual standpoint, because if you look at the competitive landscape EOE, you've got dupixent, which is delivered weekly by subcutaneous injection, and you've got oral steroids that nobody wants to take chronically because they have a lot of side effects and chronic concerns.
Woody Bryan, Ph.D.:So the ability for us to bring a sub-Q into that space as a first generation and deliver it our data suggests we could dose it possibly every two weeks, maybe as infrequent as every four weeks, we think can be very competitive and can be a nice. Maybe as infrequent as every four weeks, we think can be very competitive and can be a nice alternative to the patient. If we bring an oral into that category, our sublingual data suggests that we could deliver it, possibly orally, once a week Could be a real game changer. And then, if you look at the other TH2 diseases that we are pursuing, the atopic derm landscape or several monoclonals, including depixin, every two weeks, subcutaneous and the JAKs that are dosed daily but have all this baggage. So again we think we can bring a subcutaneous that can be competitive from an efficacy safety standpoint. Can be competitive from an efficacy safety standpoint. And then if we bring an oral in, we think it could be very disruptive in the category.
Woody Bryan, Ph.D.:So, being an oral drug delivery guy, I love these sorts of things because it can be very transformative. But in the case of 1104, not only is it really something that brings benefit to the patient. But when you couple this sort of convenience compliance with what we thus far have seen is an incredibly clean safety profile We've not had one patient drop out or report a serious adverse event related to the administration of 1104 across over 150 patients. So when you look at this combination of sort of TPP attributes, if you will, for the product, you get to something that is really revolutionary, if you will, in the space.
Matt Pillar:Yeah, give me a sense for what goes on behind the curtain at Ravolo to enable that change, that route of administration change, how much heavy lifting is involved and who needs to be convinced and influenced to want to pick up that weight and, more than likely, spend some money on that heavy lifting.
Woody Bryan, Ph.D.:Well, yeah, I think, scientifically you have to have a basis to make the argument, because it's not intuitive to think that a peptide could be delivered, certainly subcutaneously, but not orally.
Woody Bryan, Ph.D.:I mean, the highway is littered with companies that have tried to deliver peptides orally and it's no walk in the park. So, the fact that we actually did some early studies they were well-designed in an animal model that we trust and we saw a signal, what really formed the basis to say, hey, this is something that not only has value to the patient and to building a value around the program, but has a probability of success that we really need to invest in. And, of course, you go to your investors and say you know, this is something we need to fund, at least to a next milestone, because this is something that, um, it's not without risk, but if we, if we, you know end up with positive results, this is a really uh, a monumental driver of how we will look at our programs and uh, and what it means to shareholders and, of course, ultimately to the, to the product line itself.
Matt Pillar:Yeah, Is this a case where, um, you know that, that the industry, the space investors hold the truth to be self-evident, so to speak, that you know patients would far prefer, uh, sub, sub Q than than IV, and they'd even more oral than sub-Q. Or is it simply that, like, if we can do it, we all know it's going to be worth doing it? Or was there a little bit more of a I don't know vetting? Not vetting, but a little more scrutiny around? Show us the commercial opportunity numbers and how they shift and change, like, show us the pie and how the pie looks different if we can do this sublingually.
Woody Bryan, Ph.D.:Oh yeah, absolutely.
Woody Bryan, Ph.D.:I mean, part of our decision is to go out and talk with, you know, kols and people who are actually, you know, treating patients in this space and talk about what they're seeing as far as their patient experience across existing therapies and, of course, take the opportunity to speak with them around what we think might be achievable with our own program.
Woody Bryan, Ph.D.:We're always challenging ourselves to do that and, you know, there's other real evidence too. I mean, you see, you know we use a good example. One reason we chose you is because there were other modalities that were being tested, the single cytokine sort of downstream approaches in this disease, and they were failing to translate from histological impact in studies over to patient reported outcome, which is a diary that patients fill out, and we knew, mechanistically, we did something very different. We thought we understand why there wasn't that translation, and so it was independent data sets being generated by some of the big pharma guys with their own programs that sort of made our case for us to pursue and where we thought we might be different and something that physicians and patients would find as being attractive.
Matt Pillar:All right, I don't want to go too deep into the science and manufacturing process, development, formulation, that kind of stuff, but I do want to touch on it because part of that heavy lift, I'm assuming you tell me is going to require some reformulations. You know, perhaps a new device Like there's certainly a scientific element to making the change and shift that you did. So just a little bit of color on how you navigated that you know. Were you leaning heavily into an outsource partner? Did a lot of that work occur internally? Just give us again a peek behind the curtain.
Woody Bryan, Ph.D.:Yeah, Well, if you talk about the IV and subcutaneous formulations, are internally designed and they helped us design our studies and our formulation sort of matrix if you will to develop the original prototypes that ultimately went into our models that we select leads from. So, on the sub-Q side, it's designed to be in a pre-fill syringe. So the idea is that the finished product will be put in the hands of the patients and, as you probably know, you look around in the GOP1s and the Ozempics of the world and the monoclonals and what have you. There are quite a few self-administered sub-Q products in the market today. So it's become something that is much more patient-friendly and we're going to follow that game plan, if you will.
Woody Bryan, Ph.D.:On the sublingual side, because of the complexity of delivering a peptide orally, what you don't want to be doing is developing a new platform technology alongside a new chemical entity drug, because you've got two parallel tracks of risks there. So I'm not at liberty to say with who, but we went after a tried and true platform in that space and we paid attention to the way that platform is manufactured, because there were some elements of manufacturing on the platform that we chose that allowed us to leverage some things we already knew um from our manufacturer, our IV product, um to to maximize delivery, um to give us a higher chance of having a very stable product, and the data is born, is born out that that was a good choice at this point. So we, we, we choose, we, we chose a tried and true delivery platform to go into.
Matt Pillar:Yeah, tell us a little bit about the reception. So you know, we talked about acceptance, right, like, yeah, we can naturally accept that this is a better route of administration. We'll check the numbers, but we're, you know, everybody's pretty sure of that. But then, where the rubber meets the road, you got to see some return on on the, on the mindshare investment, the commitment investment, the financial investment that you made to make this transition. So what, what's the? What's the output, uh, or reception, been like from the scientific and and um capital communities?
Woody Bryan, Ph.D.:capital communities. Yeah, listen, there's been a realization that in this space there's a long I say a long overdue, there's an overdue need for a next generation of mechanism and delivery of that. There's actually a recent New England Journal of Medicine article that really sort of starts out analyzing sort of Fasemra and its lack of meeting endpoints in this late-stage DOE trial. But within that article they talk about the fact that although the single cytokine pathway approaches have brought a lot of good, there's still a lot of unmet need and there's been a recognition that broader biology and working upstream is needed. And that's exactly what we bring.
Woody Bryan, Ph.D.:So there's, you know there's, the time is right and the recognition that there needs to be approaches that not only hit the effector side, meaning the inflammatory piece of allergy which a lot of these things do steroids, the monoclonals but bringing in the regulatory side, which is a natural regulatory mechanism of the immune system, which we do is long overdue, and so the receptivity to that has been is incredible. Now, you know it's novel. So the other side of that is you have to prove it's safe and you have to show that you can deliver it in a way that is receptive to patients. And that's where the drug delivery piece that we talked about comes in and sort of ties it all together.
Matt Pillar:Yeah, this is a completely speculative question. It's an unfair question for me to ask. I'm going to ask you to speculate a little bit but maybe share how you leaned into that drug delivery experience to muster the courage, energy, conviction to make this change. Would perhaps just, given market conditions and patient receptivity, would perhaps any CEO, who maybe has some experience in this therapeutic arena but maybe not as much drug delivery experience, have made a bold decision to do this, taking on the challenge and the risk? Or do you think you were uniquely qualified to be the guy to carry that mantle?
Woody Bryan, Ph.D.:I do believe my background allows me to look at it a little bit differently and really to understand the risk elements. I think if, thinking about when I joined the company, there was some really early data showing that we could pivot to sub-Q. To me it was almost we have to do us to be able to give a sub-Q and not have to give it with any super frequency, to maybe give it every two weeks or every four weeks. So it was an opportunity, but it was okay. We need to probably go there sooner than later because the expectation is that we need to come to the market with at least a sub queue that has a competitive profile. So the science and the data suggested that there was a very reasonable probability of success. But the motivation to do it sooner than later was pretty high, just because that's kind of the way the market is today, and so we leaned into that.
Woody Bryan, Ph.D.:Now the sublingual, I think, is a different story. Again, we took a little bit of a stepwise progression approach, just because for me to go in front of my border investors and say just trust me, we're going to be successful in delivering a peptide or early is not a brief conversation. So we really just had to look at it incrementally and keep saying, listen, we're going to do a little bit of work better understand this. And then, once we started rolling up the data, we kept looking at the data going. The data now is so exciting that we almost can't afford to not move it forward. So it was a gradual build of the data set to get comfortable to dive into it uh, in a in a bigger way.
Matt Pillar:Yeah, uh. So, playing off that background, um, your, your, your degree is in, you know, going way back, old, old drug delivery guy. Your degree is in, uh is in pharmaceutics. And your, your first, your first, uh, exposure to the space was with, uh, with sharing, as a formulation scientist and uh, you know, longtime listeners of this show know that I like to dig into this, uh, the, this mind shift that I see when I interview someone who starts out.
Matt Pillar:You know that I see when I interview someone who starts out, you know, working the bench, doing formulation science and big pharma, um, and and transitions to business development, business leadership, the C-suite, um, so tell me why you did that. Why did you? Uh, you know, if I look at I'm I'm not going to go tick by tick through the uh, the companies that you helped found and lead from sharing between sharing and Ravolo, but there are a number of them. Anyone can look up Dr Brian on LinkedIn and see the work history. Soon after you left sharing, I mean you went directly into organizational leadership and business development. What motivated that change?
Woody Bryan, Ph.D.:Yeah, listen, I really enjoyed the formulation side. Sure, it was fantastic for me, but I felt like it was a bit of a big organization for me.
Woody Bryan, Ph.D.:I did have the luxury of sitting on project teams, multi-discipline project teams, and interacting with the clinical folks, even marketing, manufacturing, all the pieces that go into a sort of a fully integrated project team. And it became evident to me even in a big company that you know being in management and even in business development and licensing where I found out later on in smaller companies you really are a big part of the strategy of the company. I enjoyed being active in talking about what are we going to be right? And so when I went to AI after sharing, I was running a drug delivery team and I had an opportunity, just through a conversation, to get over to the BD side and it was really sort of a BD position where we were partnering with bigger companies and convincing them that our technology, married with their drug, would be a great product idea. So there was this technical sort of pitch, viewing the strategy, negotiating the deal that, when I look back, was sort of a microcosm of what you do when you start a company. So that was my first time to sort of try to pull it all together and I was enamored with being able to conceptualize a product, talk the science obviously not just me but the team and then look at the business aspects around.
Woody Bryan, Ph.D.:Well, how do we reduce this to a project? How do we build a rationale for the market opportunity? How do we fund it? And how we? How do we put together a partnership that works for both sides? Is a license agreement of co-development, um, and that was my first foray into being a builder, and then I've done it. You know, I've been a part of a spin out. I've been a part of a sort of a rebranding and a rethinking. I've been in charge of strategy at like three or four of the companies and it's just invigorating. You know, no, two days are the same and many of the conversations you have in the team environment is is impactful in the company and to me and, um, just very dynamic.
Matt Pillar:Yeah.
Matt Pillar:Yeah um, just very dynamic. Yeah, yeah, it starts with a. I mean it. You know, in a situation like yours, it's it's got to start with a seed planted. You know, it sounds like. It sounds like it started via a seed that was planted and nurtured through exposure. Um, I have plenty of conversations with scientists, even physicians turned biotech builders, who say, yeah, you know, the interest was there, uh, it was invigorating, but I was in no way shape or form equipped or prepared. Uh, to you know, I mean things as simple as the language. Right, you're a formulation scientist, you speak, you speak one language. Uh, bd speaks language, bd speaks another. The C-suite adds vocabulary to that language.
Matt Pillar:So I guess this is a two-part question. Where did that initial sort of gumption come from within you? Right, like I know, you're exposed to it. You're like, hey, I kind of dig this. You know this kind of, this kind of feels good. Where, what do you think that comes from from within? Dr Woody Bryan, like you know, do you have entrepreneurial roots, or was your dad an entrepreneur? I don't know? Like, where's, where's that initial spark? And then the second part of the question is I'd like to learn how you tactically and strategically nurtured it.
Woody Bryan, Ph.D.:Sure, yeah, first of all I am a scientist. I come from a medical family, my father's a veterinarian, but was sort of an entrepreneur, did a number of things etc. But I think my scientific curiosity around the overall process and seeing how things work you know business process, scientific process I think transitioning from being a science detail-oriented person to being a business development management person is learning when to be quiet and listen and you know it's the old sort of sales dynamic, right is listening to what whoever on the other side is telling you. It started at AI. I was out pitching these technologies and in the beginning I felt compelled to tell them all the details, but you actually learn. Ads are more important to ask them what are you looking for? You know what. Do you think your molecule needs to be more differentiated? Does it sustain release? Is it? You know, bioavailability enhancement, how are you envisioning it? And lots of times they'll lay the groundwork for orders you have to offer. So I think the number one thing is the listening piece and the probing and asking open-ended questions and then trying to process that and how it fits into what you might be trying to accomplish. That's probably the biggest learning.
Woody Bryan, Ph.D.:I've been very fortunate to work for some fantastic mentors and I think on the finance side, which is a big part of it modeling, looking at markets scenario planning, looking at markets scenario planning I've learned a lot of that on the fly but I give credit to some mentors I've had that have allowed me to have exposure to that and learning how a P&L works and how important scenario planning is.
Woody Bryan, Ph.D.:And certainly when you're raising capital, you better be accurate on saying what is it I'm trying to raise and what I'm going to do with it and what I want to deliver within that budget and and and and. You know you learn the importance of that. You spend a lot of time doing it and sometimes it can be exhausting, but there's nothing more important if you're funding an initiative and saying I'm going to deliver on this. Um is to is to be clear and be accurate and uh and understand how those pieces fit together. I think that's where my background development comes, comes in and plays um a valuable role, because I've been on development teams so I understand how discovery and research fits together with CMC fits together with clinical fits, together with marketing and sales, and so when you're doing scenario planning with your team all the time, having lived, that, is incredibly valuable.
Matt Pillar:What about that chief fundraiser hat that you need to wear? How naturally did that come to you? How much introspection did it take to get comfortable in that role? Are you comfortable in that role?
Woody Bryan, Ph.D.:I enjoy it, you know, I think it's. I love being part of a team that has to put together a story. I mean, we're a data-heavy industry, right? So the ability to really sort of boil down a lot of data into saying what does it really tell you and to be able to communicate that to an audience, we do it all day long. Sometimes you get investors that are generalist, sometimes you get investors that are very savvy, and then sometimes you're talking to potential partners that typically are quite savvy, but the ability to distill down what it is you have how it's different. What are you going to do with it? Why should they be interested in?
Woody Bryan, Ph.D.:It is a constant learning process. I think it's fun, but I think the common, you know, mechanistic part of that is you've got to listen to what they're asking you. You know and you always learn, and you do the same presentation 50 times. You learn something every time you give the presentation, because somebody asks maybe the same question a different way or they may ask a totally novel question. Every time you give the presentation because somebody asks maybe the same question a different way or they may ask a totally novel question, and I think you have to challenge yourself to stand back and say, okay, that's a good question. Could I have done a better job of of of addressing it proactively? And, um, it's a constant sort of look in the mirror. Uh, around, um, you know how you're telling your story, your value proposition, and make it easy for them to understand so they can make a decision on whether they want to invest or partner.
Matt Pillar:Yeah, when you find yourself in the day-to-day of leading Ravolo as CEO there, to what degree how often do you find yourself thankful for or leaning into that? That scientific background? Uh, you know way back at in your, in your um, your your post-grad and work at Shurink Right Every day.
Woody Bryan, Ph.D.:I mean, you know, I think it serves me well in that, first of all, we have a fantastic team, but leaning into the science piece is not just about me sort of telling a story around the nuances of our development program and our decision-making, but it's also, I think, the ability to put the right people in the right jobs and responsibility in the company and to understand where they're coming from. You know, I'm not an expert in every aspect of what we do, but I've been around it enough to hear them out, you know, and a big part of my job is to lead, but another big part of my job is to listen to our team. When I think something's a great idea and go, yeah, we ought to be doing this, it's really an answer to the program. You know, I need to really, you know, sort of talk to the team and see if they agree, because it could be that in my initial assumption set that I've missed something. You know it's not exactly what I thought it was. Did I've missed something? You know it's not exactly what I thought it was, but I think my scientific background allows me to understand when they're making a counterpoint.
Woody Bryan, Ph.D.:And again, in a small company you wear a lot of hats and although we have titles, I tell everyone you know everybody's contributing. You never know when the regulatory person is going to be in a conversation and say, listen, you know, when I worked at AstraZeneca or somewhere else, I saw this scenario before and we did X Y, z and it wasn't a typical path you would take. But you know my experience may be applicable to this situation and it may be a CMC item, it may be something that's kind of out of their job description. So I think the ability for you know this goes into more culture than anything else, but the ability for everybody to challenge conventional wisdom and there are no bad questions is what we really try to instill and I think is paramount to an organization like ours.
Matt Pillar:Yeah, that's funny. I've had conversations with the CEOs who had deep scientific backgrounds, who who, uh, you know have confided in me that at times their team kind of like rolls their eyes. Here he comes, he knows he knows more than he should, because so many other times I'm interviewing CEOs who come at it from a venture capital background or a business background or some you know background out of left field and they need to trust everyone else when it comes to you know, formulation, development, process development, cmc, regulatory affairs.
Woody Bryan, Ph.D.:My team is used to having me say, okay, here comes the crazy question of the day, yeah, and, and I you know it's, it's. I think it allows them to relax and and I mean that in that I wouldn't ask the question if I didn't think it had some merit, obviously, but but the point is that I want to ask the question, I want somebody to tell me that I've looked at it the wrong way, and if they, and if they, if they don't have a difference of opinion, then we progress and talk about it further. But I'm okay. I mean, the point is, I'm okay if I suggest something that's maybe formulation related and they go no, not what you thought it was. And I'm okay with them telling me that, in fact, I want them to challenge anything that I throw out there and I want them to do that amongst themselves as well.
Matt Pillar:Yeah, yeah, very good. Uh, in the time that we have left, let's talk a little bit about what's going on at Ravolo today and tomorrow. Um, so we'll start with today. What, what's, uh, what are you in the throes of Both you as CEO, you personally in that role, and what is that leadership contributing to in terms of the next step Revolo is going to take?
Woody Bryan, Ph.D.:Yeah. So listen, we've generated a lot of really, really value-added data across our 1104 program. As we mentioned, we've got, you know, the EOE data set, we've got the sub-Q work and sublingual work. So our top priority going forward is to advance 1104 and EOE into a larger phase 2B study. We think we have a great opportunity to have a wonderful chronic treatment option here. We intend to bring the subcutaneous into the next study at a minimum.
Woody Bryan, Ph.D.:You can imagine, with the sublingual press release that we had a couple of weeks ago, a lot of investor and partner interest there because they realize subq can be very competitive. They think sublingual can be a potential game changer. It's not quite as far along but but it can be in short order. So a lot of investor discussions around raising funds to advance into the clinic, um, and in parallel talking to quite a few interested pharma partners that have an interest in 1104 in general. And of course then we have ongoing day-to-day things we're doing. You know we continue to move sub-Q along, sub-limbo, along planning for the clinic. There are different elements of that. There's the ADME talks piece, there's the CMC preparation. So that there's the ADME talks piece, there's the CMC preparation. We're always doing things sort of on a research basis to expand our understanding of 1104 and to inform us around other indications that we may pursue down the road.
Matt Pillar:So that's what we're busy. Clinical step is what? And I mean you know, without putting a pin on the calendar, what's the time frame look like?
Woody Bryan, Ph.D.:Yeah, so we'll be at the ready early in 25 to commence a larger phase two EOE study. There are a couple of different designs that we looked at, depending on where we land from a funding standpoint, but it will have elements of looking at longer dosing than what we were able to administer in the first DOE study and introducing subcutaneous. It'll be anywhere from a 10 to a 16-week study and you know we'll be assuming we start it in the first half of 25, we'll read out in calendar 26. The second priority is to conduct a smaller phase two atopic dermatitis trial and that will be a smaller trial, again just a POC study, smaller trial, again just a POC study, and we are in a position, subject to this funding round, to commence that study in first half of 25 as well, and it's about eight months to initiate, enroll and complete. So very late 25, early 26 readout on that data set.
Matt Pillar:Yeah, sounds like a pretty busy 25 coming for you and Rivolo.
Woody Bryan, Ph.D.:No doubt.
Matt Pillar:What haven't I asked you that I would have if I were a better interviewer?
Woody Bryan, Ph.D.:Oh, I don't know. I mean, I'm always anxious to talk about what a fantastic team we have and the receptivity around what we're doing. We think we're on the cutting edge of the next generation of therapies in this space and I am always proud of all the things we've accomplished as a lean team. We're a small, scrappy, uh very talented group of folks and, um, we've put a lot of time into creating a culture, um, that's fun and rewarding and and everybody's contributing on a daily basis. I don't think there's anything more rewarding than having a voice and and feeling you know like you're contributing.
Matt Pillar:And all of our folks have been incredible in that respect. Are they distributed?
Woody Bryan, Ph.D.:I mean, you're down in the Research Triangle area, correct? Yeah, I'm in the Carolinas, that's correct, and our research group is. We have a small R&D group in the UK, in London. Both of our assets actually came out of academic institutions and in London we continue to foster those relationships and we have a number of vendor relationships in that area. And then the balance of our team is on the East Coast. So we have a clinical operations regulatory CMC this sort of split between Research Triangle in the DC greater DC area and then our finance group is in the New York area. So we're all in the Eastern time zone.
Matt Pillar:Yeah, yeah, but distributed nonetheless. What tips or tricks do you have? I mean, we talk with a lot of companies that are distributed, virtual, whatever word you want to use right From a management perspective. I mean, that's different from, I'm sure, your days at sharing. So what advice do you have for leaders of companies that are managing?
Woody Bryan, Ph.D.:Yeah, yeah, we're quite versatile in what we do. Our group in London. They get together in person multiple times a week, just kind of the nature of what they're doing. And then you know we are mindful of getting together in person. We have workspaces in all of the areas I mentioned RTP, dc and New York so we have the ability to go and sit and get the group together and do a deep dive every three to six months, sort of do an inventory, sort of a broader look at where we are and what we need to be doing beyond just the day-to-day project-driven task.
Woody Bryan, Ph.D.:But yeah, you got to strike a balance and going forward. We certainly have a focus in trying to locate certain functional groups in certain geographies. We've begun to do that and we will continue to do that. You know, clinical development, clinical operations in the triangle area I mentioned CMC regulatory and some of the preclinical stuff in the triangle area. I mentioned CMC regulatory and some of the preclinical stuff in the DC area. And because all of those groups work together on even a more frequent basis than the rest of the team, right, yeah Well, very good, Very good.
Matt Pillar:I wish you luck. Like I said, busy 25 coming on the horizon for Rivolo. I wish you luck. I look forward to catching up. You know, like I said, last time I talked with Rivolo was 21. We need to make it a more frequent visit than that. Perhaps next year when you're in the clinic and starting to generate some data you can talk about we can get back together.
Woody Bryan, Ph.D.:Yeah, listen, absolutely. The future's bright. We're excited about it. We really appreciate the opportunity to join you today and to catch up going forward.
Matt Pillar:Appreciate the chat. Thanks, woody. So that's Ravolo Biotherapeutics CEO, dr Woody Bryan, I'm Matt Pillar and you just listened to the Business of Biotech. We come to you with a fresh episode every Monday morning and if you'll go ahead and subscribe to our show wherever you listen to podcasts, you won't miss any of them. You can always catch our videocast under the Listen and Watch tab at bioprocessonlinecom as well. Those links are in the show notes, so check them out. Have a great week. Thanks for listening.
