Making Biologics Orally Available With Vivtex's Thomas von Erlach, Ph.D.

On this week's episode of the Business of Biotech, we're speaking with Thomas von Erlach, Ph.D., Cofounder and CEO at Vivtex, a company spun out of the Langer Lab at MIT that's focused on developing orally available biologics. The company announced a deal in late February '26 with Novo Nordisk for up to $2.1 billion to develop next-gen oral drugs for obesity and diabetes, bringing the total number of Vivtex's partnerships to 10. Thomas shares his experiences working in the lab with Dr. Robert Langer, Ph.D., starting up Vivtex around his co-invention (a "GI tract on a chip"), building trust externally and securing the right partnerships, and using a strategic stealth period to refine Vivtex's platform technology before scaling it out. 

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Transcript

Setting The Stage: Vivtex And Langer

Ben Comer 0:03

Welcome back to the Business of Biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today I'm speaking with Thomas von Erlach, Ph.D., co-founder and CEO at Vivtex, a company he co-founded with MIT's Dr. Robert Langer, which is focused on developing orally available biologics as opposed to injected therapies or IV administration through the use of what Dr. Langer has described as a gastrointestinal tract on a chip. Thomas was a postdoc in the Langer lab and helped invent the VivTex platform, and he has experience with biopharma industry co-development partnerships, which we'll talk about. Vivtex very recently announced a partnership with Novo Nordisk worth up to $2.1 billion and has secured several other pharma partnerships. We'll talk about working in the Langer Lab and VivTex's company formation, securing funding, establishing industry partnerships, and negotiating licensing deals, and we'll get an overview of VivTech's technology platform and what it might mean for patients. Thank you so much for being here, Thomas. I'm glad to be here. Thanks, Ben. I wanted to start out with uh with uh Dr. Bob Langer. He's a legend uh in biotechnology. Uh, and I also want to give a shout out to my colleague Ray Dogum at Drug Discovery Online, who spoke with Dr. Langer a couple of months ago and published a video conversation uh of that meeting. Uh, you can find it on the Drug Discovery Online website. And maybe as an added incentive, I'll just say there's a a pretty uh nifty sleight-of-hand card trick involved uh in that video as well. So check that out. Uh, but Thomas, I'm interested in what your experiences were like uh working in the Langer lab um as a postdoc. And maybe first of all, how did you get in? And second, was it about what you expected?

Inside The Langer Lab

Thomas von Erlach, Ph.D. 2:03

Yeah, great, great question. Uh yeah, I um I did my PhD in uh tissue engineering uh at Imperial College in the lab of Molly Stevens. Uh and um uh I don't know if you know this, but Molly Stevens uh is is a pretty well-known uh professor in in tissue engineering um and and and and other other fields. And uh she was a postdoc in in Bob Langer's uh lab uh long time ago. So she knows uh Bob very well. And um after my PhD, when I was sort of thinking what should I do with my life, what should I do next, um she proposed that um I would go over there as a postdoc. And honestly, that sounded pretty nice to me. That sounded pretty kidding. So that's what I did. And um when I came over to Bob's lab, uh I think like many other uh members of his lab, um, you know, I came with a very specific background, um, but not really with a very specific idea what I'm gonna do there. Um and I think that's really really a kind of a unique feature of Bob's lab that um you have uh a lot of uh talented scientists that come from different fields that join his lab. And um he really has a fantastic ability to kind of steer everyone, including myself, towards big problems to solve. And I think that um is really something when I came with my background, I had a certain background in uh advanced um um uh cell model systems, that's really what I've been focusing um my my research on. And naturally I was just kind of trying to do something very similar to what I've been doing during my PhD. And I think through his uh guidance, um um, you know, I think he really steered me towards something much, much bigger. And I think that's really, I think in in general, his um philosophy that you should really focus on uh solving a big problem that might be a little bit riskier. You know, it's not like an incremental improvement, but something that uh really if you're successful, um, you know, would be would have a really big impact. And something also kind of unique um to maybe other academic uh labs out there is that impact should really be something that is not just academic and sort of um you know more research in nature, but really something that ultimately benefits uh society and patients in in some in some direct um in some direct uh way. So um over my time there when I joined his lab, um I got to uh receive that direction, meet a lot of uh talented scientists that I worked together. Um one of the key uh uh individuals that um really helped me throughout my uh career, besides uh Bob Langer, uh is uh Chi Rani Traverse, so he's another um MIT professor now at the um and and but he's also GI doc. And um together we we we decided to tackle the challenge to come up with a new uh um more physiologically relevant um GI model system. And that to me, you know, was not obvious before I joined this lab, but really now in hindsight, I think was a very, very good problem to focus on. Um yeah.

Ben Comer 5:54

Yeah, and what what circumstances led to the actual founding of Vivtex? I mean, at what point did you know, you know, that you had created something now, you had gotten something to a point where it could serve as the basis of a new company?

From Idea To Company

CSO To CEO: Shifting Gears

Thomas von Erlach, Ph.D. 6:11

Yeah, it's a great question. I mean, I I think when we started to to build our technology, I I think at some point, I mean, took us took us years, but at some point I got pretty excited about the results. Um and I remember a meeting I had with Bob, um, who basically presented everything, and he told me, you know, the biggest issue that I see with those types of um of technologies is that people don't validate it enough. And I think that really resonated with me because in academia that's not really per se your um primary uh motivator. The motivator is to get a publication out. Um, and of course, one would expect that you know you want to uh have some degree of robust data that you're showing um um uh in your publication, but it's a difference between that and you know really uh extensively validating a new assay um for you know potential industry use. And um he really provided that key feedback. And um that was something that we decided to do initially, you know, just a few experiments, and then that added another few years on top because it took a long time to to go through that um validation stage. But I think it was absolutely key. And after we we got some uh uh uh exciting in vivo data, um not just showing the uh predictability of of the assay, but really kind of going through the whole motion of of actually applying it for the application we are after, which is really all um biologics delivery. If we went through that whole when we went through that whole motion of uh using our assay and then identifying new hits and then validating these in large animal, that was really the the key trigger for us to decide now. I think this technology is ready to be spun out. Okay, okay.

Ben Comer 8:24

And you I think began as chief scientific officer and then became CEO. Is that correct? That's right.

Thomas von Erlach, Ph.D. 8:32

Yeah, yeah. For now, a number of years have been uh uh the CSO. Uh I think you know, if we look at our journey, I could say that um we really have focused um a lot on further building out the scientific platform and the science in general. Um and that really was absolutely key for me uh to focus on. I think we're in a really exciting stage, and I'm very, very excited that I was able to step up as the CEO now.

Ben Comer 9:07

Yeah, well, I wanted you to see what I well, I was curious about what you might say about that uh transition, you know, how your role at the company changed. You're you're clearly deeply involved uh in the science, but I suspect you've had to in some ways relinquish that a little bit to to take on the you know the the day-to-day experience and and operations of being the CEO of a biotech company. Uh, is there anything that you would you would say about that? Anything you learned in that process?

Thomas von Erlach, Ph.D. 9:38

Yeah, yeah, I think that um what really um helps me uh right now is that we made the decision that we also hire an experienced uh finance uh finance and operations uh person. Um so that uh name is Lena Fisher, very, very talented and uh really able to cover a lot of um you know the aspects that uh one really has to deal with um running a company. And you know, I think that to me um feels like a very, very good match that um I can spend my time further trying to move the business along, try to really, thanks to perhaps some of the you know deep technical insights I managed to uh to to to kind of uh gain over the years, I I feel like it really helps me in the day-to-day business to um to move um to direct the company and the science we do in hopefully the right direction. Um work with uh our existing and potential future partners. Uh so that that part I feel like you know really, really is is something that I can um um I can I can focus on and really leverage my existing expertise. But when it comes to non uh uh uh non-R ⁇ D operations or financials, I think what I mean that trying to learn how how how all this works, I can really recommend to just hire someone really experienced and knows how to do this. Um really, really helps to uh yeah, to to hopefully you know grow the company in the right direction.

Funding And Early Partnerships

Ben Comer 11:30

Yeah, that makes a lot of sense. Um I often hear from CEO, non-scientist CEOs that are working with scientists about how difficult and costly it can be to translate a new technology. Um, it's usually described to me as going from a science experiment to a regulated CMC and GMP environment. And I'm uh so you know, is there anything that I guess you would say, and I uh you referenced the couple of years of you know doing work on top of the experiments, which I suspect is part of, you know, part of that was was working that out. But where where did your initial funding come from to kind of get this to get the company going?

Thomas von Erlach, Ph.D. 12:12

Yeah, so we we we had some initial uh um uh investors that um um I think over over the years were were mostly in the the the private individual front usually um and and some institutionals. Um so that's really where um kind of got us started. I think uh relative to perhaps other biotechs, biotech startups out there, what we managed to do fairly early on, it's kind of maybe a bit unique, is that we managed to get some initial pharma collaborations, and by now we have about 10 uh pharma partners we've been working with over over the years, and that really provided us with a good amount of uh non-dilutive revenue over the years. Um, actually to a point now where you know we are um you know, you could look at us as a profitable company where um revenue positive. So our our sort of need and reliance on investors relative to perhaps other biotech um startups was wasn't as much.

Ben Comer 13:26

Well, that is uh quite an accomplishment. Um, I I can say that straight off. Um, I wonder uh and you mentioned 10 pharma partnerships, uh, which is is significant for for any small uh biotech startup. Um I did I I'm always curious about companies that are operating in stealth mode. And I I've asked other folks about this, and I'd just be curious to get your answer about, you know, maybe what you might say about the reasons for kind of keeping a low profile in this early stage of the company and uh you know what the what the benefits of that are.

Why Operate In Stealth

Thomas von Erlach, Ph.D. 14:03

Yeah. Um you know, I I I don't know how it would have been if we tried not to keep such a low profile. Maybe you know, we would have been awful lot better by now. I don't remember. I uh but no, I think I think the the reasoning around it from from at least our perspective has really been that we had this feeling that we need time to really figure out the technology and the exact application. Um so I think um we obvious we obviously knew what our technology was and that hasn't changed that much uh over the years. I mean, really just try to build it up further and really kind of make that leap from the scientific sort of build out to actually being able to create drug products that our partners can move forward. So so that was really our focus. But I guess when it comes to how exactly we would do that and what exactly we ultimately are able to come up with and provide to our partners, I think we always felt that um as long as we haven't really nailed that, um it's it's just not written in stone. So we wanted to kind of allow ourselves a little bit of a of a of a sort of time window uh during which we really focus on figuring all this out before we try to increase our profile a little better. Because by now I would say um thanks to having now been able to accomplish a bit of of that leap from the scientific build to now creating products, we have a much better sense of what we can actually offer to potential former partners and what actually also we can do as a as a company. So um it's a lot easier for us now to go out and actually tell people what we are doing.

Building To Novo Nordisk

Ben Comer 16:01

Yeah, that makes a lot of sense. You wanted to kind of iron out some of the details of of the technology and the offering before you know making a big splash on the market and then potentially having to backtrack or something if you you know change directions, which is a a common outcome for you know all sorts of uh of discovery and development programs. Um, let's uh let's next talk a little bit about partnerships. You've announced a partnership with Novo Nordisk. I I mentioned it in the introduction, worth up to $2.1 billion to develop uh next generation oral biologic medicines for obesity and diabetes uh and other associated comorbidities. How did that partnership happen?

Thomas von Erlach, Ph.D. 16:46

Yeah, that wasn't something that happened uh overnight, that that's for sure. As probably would have guessed. So it's um really, I think if we go back in time, I think we could go back many, many years. I would really point to uh Bob Langers and Cheer Travers' uh uh relation, academic relationship they have with Novo. Um so that that that uh thanks to that relationship when we started with we already knew the the the the the key scientific um uh people at Novo that you know really work in in the field of all peptide delivery. And I think throughout the the journey we've been having in RivTex, we um we kept a very, very close uh scientific relationship with with those people. And I think what really uh happened through that is I would say maybe a mutual um um trust, scientific trust that that has built, that um helped when we um essentially reached a point um where we are where we were really excited about essentially more the not just the platform but the the the products we've built, the delivery systems we created. Um I think that was something that then Novo has really uh uh paid attention to very, very quickly, and then after obviously a very extensive due diligence, um ultimately they they have then entered the uh a partnership with us. But yeah, that that uh was really uh years and years uh of of existing relationship, I would say.

Earning Trust Through Data

Ben Comer 18:36

Yeah, and you talk about uh building trust. Is that accomplished through you know just communicating results about things, uh being uh just actively engaged with uh with folks over there, sharing things back and forth? How would you describe you know that process of building trust?

Thomas von Erlach, Ph.D. 18:55

Yeah, I I think that um for the for the most part, at least that's what happened in in our case. You know, we are not we call it a a seven-year overnight success if you if you will uh with with the products with those delivery systems we we now manage to to create. I think in some ways that journey uh that that we had to really uh work towards where we are now, I think we we always kept somewhat of a work of close ties with um with the scientific community. We always presented in conferences and essentially just laid out our our scientific progress, our failures too, you know, the things we've learned over the years. And I think for someone to have um observed us for um you know a period of time and looked at the progression and progress we've made, I think it's it's it's easier to uh gain that kind of trust as someone that you don't know is knocking at your door and basically saying, I have this great delivery system that I just came up with. Um despite that might be you know, might be that might be uh holding up just fine, but um unfortunately in our field at least, there's just a lot of um um there are a lot of activities and um the field has been plagued with a lot of failures, so people are very, very cautious. And I think um I think there there's a general appreciation about us just trying something new that you know by now took about 10 years um of of of work back at MIT and then at VIFTEX. And I guess seeing all that work and data um and and and you know the ups and downs that went into that just gives people some some confidence in in I think the technology. We also try not to overstate uh we we have a very scientific uh approach to our partners. We're not really overly eager to just uh go and partner with just everyone. We don't try to overstate because ultimately it's just as important to deliver on a partnership than to get the partnership in the first place. Arguably it's actually even more important because you don't want to gain a bad reputation of not having you know your technology not not really working out. So I think um it's really important to just be honest and upfront about what we know and what we don't know, what we think we can do and what we think we cannot do. Um, and um uh when we go when we enter into a collaboration.

Ben Comer 21:49

Yeah, yeah, that makes a lot of sense. Um, you mentioned I think 10 total partnerships. Can are there any others that that you could uh talk a little bit about or or just kind of explain?

Beyond Novo: Pipeline Progress

How The Novo Deal Works

Thomas von Erlach, Ph.D. 22:02

Yeah I'm happy to um for the most part we we we we're unable to disclose uh specific names but we have uh you know one of our uh partnerships uh uh we we're quite um um um um we we are quite far ahead um with the progress we've been able to make um with that one so we actually just dosed um um uh our drug product our formulation we created in phase one just a few weeks ago so very happy about that big milestone for us to have leaped from just the scientific concept to now something that is dosed in humans that was something that made um everyone including myself with text very very happy um and we we do have uh a number of additional preclinical candidates that we we hope will be dosed um at some point later this year in humans as well so uh yeah in terms of that that's essentially giving you maybe an idea on the on the stage of those different programs in terms of the nature of the programs we we do see a lot of interest besides um the metabolic diseases we see a lot of interest in the autoimmune uh disease space um basically I guess um both of these large uh uh uh disease spaces have in common obviously an enormous market but but also chronic dosing so we we do see a lot of interest in in those areas where you know um one has to really um the the patients have to really be um dosed on a on a chronic basis um because obviously our focus and contribution is to be able to provide patients with the opportunity to have an oil alternative as opposed to an injectable so someone that has to take this on an ongoing basis um is is obviously a lot more appreciative about the option of having an oil versus someone that just has to take it for a week or two for certain indications. So so that's basically where we see a lot of the current activities um and and and interest from our existing and and potential partners. There are also some orphan indications or guess the um the dosing frequency and perhaps in some cases even the the the the the age of the um of of the the patients so meaning they have to take it as a very young age um is is is is is an issue and then all would be you know adding a lot of a lot of um um quality of life to to those individuals yeah right okay and i i I saw the novel nordisk partnership press release and let me know if i'm i'm reading this right it sounds like you are licensing the technology uh that novel nordisk will then essentially put into production will will do the development work on their side or or if that's not correct can you give me a sense of um what both companies you know like what vivtex is doing and what novo nordisk is doing through this partnership yeah you you captured it um um exactly the way it uh um it it's laid out so we have essentially it's when we look at at our technology at VivTex um you know we we look we what we have there is essentially this um uh uh tissue level this GI tissue level I throughput screening system and uh that we have over the years paired up with uh computational simulation capabilities so to really do molecular dynamic simulations and really kind of further shed light on on the interactions and and and mechanisms that that that take place um and then obviously also just based on the vast amount of of data we are we are we are generating we are also using predictive models and and ai to further accelerate our our ability to to identify the best possible um formulation the thing over the years what we have managed to to do also is um create the portfolio of existing drug delivery technologies that um you know we can we can use um basically kind of as sort of uh existing off-the-shelf type solutions if you will um and I think that taken I mean that taken together is what we can offer no one know this kind of this um licensing agreement so the ability to access our existing uh formulation technologies that we have created um but also the opportunity to through our um uh screening and and and and computational and AI uh capabilities identify new formulations um for them and and as you were correctly saying uh no one others will then be responsible for the development and commercialization of these okay I see um I know that there are listeners of the business of biotech who would absolutely love to license their technology to a company like Novo or or another big pharmaceutical company and I was wondering Thomas what you might say about that licensing process in terms of how you as Vivtechs evaluate your potential partner and how you ensure that you're getting you know the value of of what you're licensing from your partner.

Ben Comer 27:56

Is there anything you could say about that kind of negotiation process or how you think about it?

Partnering While Building The Plane

Thomas von Erlach, Ph.D. 28:03

Yeah yeah I mean I think for um VivTechs and perhaps other listeners um you know if you're um um the um at the small biotech uh at you know uh party and and and you're negotiating with a big pharma it's not per se exactly eye to eye what you're right right so um I would say though you know based on this transaction and also other experiences we've been having um I think there's a certain degree of the pharma partner being reasonable um in in the overall terms and I think for the most part if we look at no one others I mean we are really looking at a company that has been in this space for 30 years and really been for the most part also pioneering the the the oil peptide delivery. Yeah absolutely yeah so so I think you know we're looking at a company that had has extensive amount of experience uh when it comes to deal terms in in that exact space so uh um you know we we didn't really feel like there was a lot of um um the there there was a huge amount of misalignment I think it perhaps also comes down to the question what are you expecting as a company uh so maybe more managing the expectation uh of the the biotech startup what what really are you are you expecting I think we came in with a fairly open mind um when we started with techs I think you know there are analogs there are comparables that one can pull uh which obviously help um uh guide you but ultimately what what you really end up um I think what I would trust the most is just the actual market data that you're receiving when you talk to to uh different pharma companies or buy tech companies and they put a term sheet on the table and you start negotiating and you know you you end up uh making a deal or not making a deal sometimes you have multiple term sheets and you're able to get a good sense what is the market really willing to to to pay here um and it's obviously always the the usual dance around you know um uh um um front loaded versus back loaded and all these things that you know royalties and no royalties and all these uh you know aspects that you know I guess just need to be negotiated but you know I would like to think that it's not per se I mean it there there's a certain I guess bandwidth that I think we've been learning over the years that you know I think is reasonable um and I think it has yet to be determined um when we move forward we are further building our our platform how things could look in the future our hope and expectation is that you have a direct correlation between the value you can provide to a partner versus what you will ultimately receive? Yeah yeah absolutely and you know you've you've now you're involved in 10 different partnerships are there any um and I'm just thinking of other leaders uh CEOs that might be listening any kind of additional tips or or even red flags that you might look for in you know those initial potential partnership discussions yeah um I think generally speaking it is challenging to partner um while you're still building the plane while you're flying I would say um and and I think you know in a perfect world you could say oh I'm just gonna completely build up my platform to the to the last T and then I'm gonna partner but the reality is also you really need to get not just input from a consultant or someone you know that has a specific expertise you really need to live through some of these partnerships to also actively tailor and tweak your your platform the right way um so it's it's a little bit of a of a dance I would say in this initial phase um uh but it is really really um important that you know that maybe I would say um everyone is sort of aware that you know what what the platform can really do because I think oftentimes there's a tendency especially if you feel um uh if if our partners potential partners I think in general would say feel extremely excited about a new technology I think one um has maybe yet to really understand what can this technology really do and typically you know if people are excited you tend to hope and assume it can do X, Y, and C. And at some point reality kicks in and you might realize well it's maybe not quite that but you know you can do something else. And I think it's maybe just important not to go too fast in in the application front. But you need some degree of um of input and having lived through trying to work towards the application to also kind of feed that back into the platform design. So it's a bit of a paradox I feel um and I guess when it comes to looking back and trying to you know think what what might be good advice moving forward I would say maybe it's good not to overdo it with the number of partners in the beginning um you know because you can you kind of need to pick your battles and if you're still having to figure out a lot of aspects of your platform I think it's good to have a real good um partner that that um you know can can really help you to ensure that whatever you're doing is somewhat then ultimately serving um you know the partner's interest um but um yeah would maybe not go into 10 right off the bet.

Ben Comer 34:49

That would maybe say yeah well uh we haven't talked about the actual technology yet and without you know going too deep scientifically uh Thomas I wonder if you could just give an overview of of how it works and maybe how it's different from other technologies that have been used to make large molecules or or peptide therapies orally available.

From Screens To Solid Dosage

Why Keep Everything In-House

Biggest Challenges And Next Hurdles

Thomas von Erlach, Ph.D. 35:15

Yeah yeah happy to um and I think the the the the the difference really between what we do versus what let's say other drug delivery technologies are doing is that we really don't consider ourselves to be a drug delivery company um in that sense you know we we um when we when we talk about potential competitors or and when people ask what are your competitors I don't really think that you know we we have any because we really look at our technology as uh a technology that is somewhat drug delivery agnostic so we're just having an another approach that basically has a scientific a sort of sort of technology foundation that is used to create a new drug delivery product for specific API um that hopefully then really works out um much better than anything else out there and I think a lot of uh existing approaches they basically focus directly on the product the drug delivery system so essentially coming up with a specific drug delivery technology and and and using that and we're really more of a technology platform company and um currently you're using our technology to create new drug delivery systems but um I don't uh we we don't really have an interest to just stop there. We also see the possibility that we can use our technology to also engineer and modify drugs to be more meanable to be delivered um orally um so the next sort of uh future future application um so yeah so that's basically it's just all around how we position us as a as a company relative to the drug delivery um technologies out there now going back to question how is our technology actually working um so that really kind of gets us all the way back to our um our uh early days of MIT where we discussed all this and sort of decided to come up with with this uh system in the first place that was essentially all motivated by the this sort of general feeling that I think when we look at the gastrointestinal tract and from my background from like looking at different tissues as a tissue engineer I think you really become to appreciate the complexity that we have uh on a tissue level and the GI tract is an extremely fascinating complex um organ. So we we don't just have a sort of a monolayer of cells sitting there that you know you sometimes try people have used to capture the the intestinal tract in V2 but but instead you really have a very very complex architecture of a very complex mucus layer very complex environments um um present and I think over the over over evolution our gastrointestinal tract has become extreme exquisite to um ensure that only the the the chemicals that the body wants to absorb are being absorbed. So if there's a chemical that the the GI tract doesn't want to have absorbed it really make sure that it that doesn't happen. So those barriers that the GI tract has created over evolution are extremely sophisticated and complex. And we really felt that um to be able to overcome these barriers we need to capture the entire complexity of them and find a way how we can do this in a high throughput fashion so that we can essentially empirically test in a in a very systematic fashion how we can possibly overcome these barriers. So what what um is currently being used for any sort of high throughput screening experiments. So we've purposely designed to to kind of meet those standards and by doing so we're really able then to use this in in a very high throughput um so that's really the the core technology that um we've built an MIT uh that works with any uh GI segment so from esophagus all the way down to rectum so it then really allows us to model exactly what happens in the different GI compartments and and uh over the years now we've been able to add to this um mostly on a computational level and also make the leap from what we actually didn't see in our uh uh screening uh ex vivo uh tissue screening platform what we actually see in you know those wells that we are testing how is that actually then going to translate into getting a uh into a solid dosage formulation is a tablet and capsule how can we make that jump and um that's something that we've also spent a number of years in to really figure out how can we really uh uh create a uh commercially and clinically viable solid dosage formulation based on those screening hits and being able to create that that connection and the answers in a lot of data and the computational tools um really really help us to streamline that process so when you're partnering with uh a company novo or or someone else um are you actually the they're accessing your technology where it exists at at MIT and then you're providing them back with the results or are you actually or are they actually bringing technology over to their company uh it we we are trying to keep everything uh in-house as much as possible okay i think the learning we've been having over the years is that um I think uh the the nature of a small company um where when your existence really depends on making the technology work you you really are able to have um um it a a very efficient and and and hardworking team that really really tries to find the fastest way possible to move the program forward um so we we've seen that we part of our I guess um strength uh uh that um if you will um that we've sort of seen over the years is that you know we encounter issues uh like everyone else but I think we just really try because our um existence depends on it to really try to solve them as fast as possible so um if we have to rely on partners or CROs typically um they're just not able to match our pay Okay. So that's why we have decided to keep everything in-house, so the actual assets of all the analysis, which is taking up a lot of um the overall um resources and effort, um, and then also the actual solid dosage uh prototyping and all the studies, the validation studies.

Ben Comer 44:26

What do you think uh are your biggest challenges? The biggest challenges that you face, uh Thomas. What what keeps you up at night?

Internal Programs And AI Data

Thomas von Erlach, Ph.D. 44:35

Yeah. Um, you know, right now I think um, you know, we we um we're doing fortunately, we're doing pretty good that uh this year. I I would say I'm I'm really happy where we are right now. Um it I think uh I don't want to sugarcoat the fact that it it hasn't always been like that. So I think you really have uh I think it's extremely hard to to um keep everything together because it's not entirely clear um uh when do you see you know the the light at the end of the tunnel. Um so so I think it it it's really really I I would have said it's really hard to get through that phase. Um and I think I've been hearing that from other companies and founders, and I would say we're certainly no exception to to that. I think right now we're in a fortunate position, uh, at least to some degree, right now, you know, being not dependent on future uh investor bucks per se, you know, since we're revenue positive, um, gives us a bit of a breather to really decide where are we gonna take this company next? And I think that's a very, very energizing question to ask. Um and I think something that in some ways is is also a little bit stressful because you cannot make not, I mean, even if you don't make a decision on where to take the company next, you will make a decision by not doing anything, really. So so it's it's important now that we are moving very quickly and we're making our space that uh pace that we are really um able to come up with what are we gonna do next? What can we, if you think about it, with the success that we've been able to accomplish so far with those uh delivery platforms we managed to generate? The question is now perhaps less so are we able to beat the existing um you know off-the-shelf formulations that you know people have uh are using to benchmark our technology? So maybe it's less of a question of that, than more of a question can we beat our own formulations to justify our own internal RD efforts to really try to do just that. You know, I think um how much more room do we have to get better than what than what we already are doing? Um and I think like to think there is a lot more room there. There are a lot of additional opportunities in terms of uh all exposure increase, um trying to come up with formulations that are maybe also easier to be dosed in terms of having less restrictions. So there's certainly a lot more opportunities out there, um, my opinion. But we're gonna have to actually walk the talk and prove that. So I think that um is is something that that that is gonna be is gonna be key. And separately, something that I think myself and others at VivTechs are very excited about is also that we we want to look all even beyond the drug delivery application and and and see how we can leverage our technology to uh to uh potentially even help to um create and engineer new drugs that are uh really designed from from the start to be uh particularly uh amenable to all delivery.

Ben Comer 48:21

What uh what year? I should have asked this at the beginning, but what year did uh Vivtex actually start up? Oh 2018. 2018, okay. So you're about eight years in, I guess, uh at this point. Um do you do you anticipate ever doing any um just internal non-partnered drug development? Is that something that that you're considering?

Thomas von Erlach, Ph.D. 48:46

Yes, yes, we we we are actively doing that also. Um it's you know the way what we are trying to do, we we have actually most of our efforts are internal. Um really, okay. Yeah, because that is really where we are feeling we can advance our technology the most. Um, because we can really do this in a in a in a way that we control. Uh obviously, we are spending a lot of time and effort um in in building, expanding our data sets for for AI modeling. So that's really something that um you know we we we we all do with internal RD um um efforts. And when we think about new applications, what we like to do and actively are doing is we're trying to think of new applications, and then we we we try to do in a sort of stealth-type setting. We we run a program that sometimes takes six to twelve months um um to generate some data. We then test drive this with stakeholders, potential partners, and kind of based on that, then decide to to uh to build this out um more broadly. So we have a number of these stealth programs, if you will, that have been going on now for for some time that are all internal, that um are really intended right now to help us uh grow in the right direction in terms of building the platform capability.

2026 Priorities And Human Translation

Ben Comer 50:21

That's excellent. Well, we're we're coming up on the end of our time, Thomas. It's been a real pleasure speaking with you, but I I wanted to ask as a final question what your top priorities are for 2026? And are you gonna potentially be announcing some of those uh internal candidates this year?

Thomas von Erlach, Ph.D. 50:40

Yeah, um, perhaps, you know, it depends a little bit how far we're gonna take them. I think it uh it depends sometimes whether or not it makes sense to just uh partner these uh as reformulation uh um and um uh type products. Um but yeah, we we we currently actively trying to to uh figure out you know in what way um makes it sense for us um to further push these internal programs into, let's say, humans or to partner them a little earlier. Could also be that we are doing a combination of of those. But in terms of priorities, I think we are very excited and interested to look at the human translation. I think for us, we really would love the idea that we've seen multiple programs going in in humans and you know, hopefully translating the way we we predict. And I think to us that would really mark a very, very big uh milestone for us. Um I mean we've been obviously using our programs, we've been evaluating these and in many different animal models. Um so there's there's always, I mean, there's obviously a um a good amount of de-risking that took place, but I think for ourselves and also for our partners, it's obviously going to be key to see how they translate in in humans. And we really see that as a key aspect because we're also using our platform with actual intact, fully intact um uh uh human tracts. So we're really trying to also ensure that that human translation is happening in the most efficient uh way possible. So that's something that is a key priority for us. And then other than that, I think we really are eager to find the right partners, not just anyone, but really the the the the right partners. And we really feel that right now, based on what we've seen with our data, there are a lot more uh programs out there that I think could really benefit from from our technology. So we really hope to be able to partner with some of those select uh companies this year as well.

Ben Comer 53:09

Well, it's a really interesting company, uh Thomas. Thanks again for coming on the show. I appreciate it.

Thomas von Erlach, Ph.D. 53:15

Oh, likewise. Thank you so much, Ben, for having me.

Closing And Where To Subscribe

Ben Comer 53:18

We've been speaking with Thomas Von Erlach, PhD, co-founder and CEO at Viv at VivTechs. I'm Ben Comer, and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts, and be sure to check out new weekly video casts of these conversations every Monday under the Business of Biotech tab at lifescienceleader.com. We'll see you next week, and thanks as always for listening.